Apparatus and method for treating and preventing diseases in livestock animals

A biocidal metal device with a porous matrix addresses antibiotic resistance by providing a cost-effective and sustainable solution for preventing and treating livestock diseases, ensuring effective infection prevention and treatment.

JP2025542190APending Publication Date: 2025-12-25CENT FOR DAIRY INTELLIGENCE LTD
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Patent Information

Application Number
JP2025535122
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-12-22
Filing Date
2023-12-22
Publication Date
2025-12-25

AI Technical Summary

Technical Problem

The widespread use of antibiotics in livestock to prevent and treat diseases like mastitis and lameness leads to antibiotic resistance, making them less effective and increasing economic costs, while existing metal-based alternatives are complex, expensive, and have a short lifespan.

Method used

A pharmaceutical device made of biocidal metals like copper, with a porous matrix for sustained release of ions, manufactured through additive manufacturing, is applied to treatment sites to prevent and treat infections without developing resistance.

Benefits of technology

The device effectively prevents and treats infections by releasing biocidal ions, reducing antibiotic resistance and waste, and is cost-effective with a long lifespan, offering a sustainable alternative to antibiotics.

✦ Generated by Eureka AI based on patent content.

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Abstract

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

[Technical Field]

[0001] The present invention relates to devices and / or methods for treating and preventing disease in livestock animals. More particularly, but not exclusively, the present invention relates to pharmaceutical devices and / or methods for treating and preventing disease in cattle. [Background technology]

[0002] Animal health is a major concern for livestock farmers. Lameness, mastitis, and reproductive problems are the most common health problems associated with cattle, and these problems often lead to high economic costs and significantly affect farm profits. Mastitis is most commonly caused by bacteria invading the udder, and lameness can be caused by infections in and around the hooves.

[0003] The costs of identifying and addressing such problems can be significant, so a preventative solution that can be implemented all at once may be the most economical. For this reason, antibiotics are very widely used. To prevent or treat hoof problems such as digital dermatitis or footrot, antibiotics are sometimes used in conjunction with harsh chemical baths on the hooves. To prevent mastitis, antibiotics are used in conjunction with teat sealants, which are typically applied by syringe. These syringes are typically single-dose and generate large amounts of plastic waste on a large scale.

[0004] One major problem with the widespread use of antibiotics as disease preventatives in livestock is that they accelerate the development of antibiotic resistance in targeted bacterial strains. This gradually reduces the effectiveness of common antibiotics and ultimately leaves farmers dealing with problems such as declining livestock health and the availability of cost-effective and effective preventative medications. This problem is now beginning to have a major impact on the industry, making it increasingly desirable to find alternative solutions to prevent and / or treat common health problems such as mastitis and lameness. Alternative solutions need to remain effective against bacteria while also being cost-effective and easy to manufacture and administer.

[0005] One avenue 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, generally understood to be the result of metal ions damaging the cell walls of the microorganisms.

[0006] There has been some existing research into the use of aqueous copper solutions for animal medical purposes, and U.S. Patent No. 4,418,686 discloses an animal implant device that uses a metal strip to create a galvanic cell that releases ions for antibacterial effects. However, these existing attempts to utilize the antibacterial properties of such metals have the drawback of not providing a significant amount of biocidal ions, meaning that they are insufficient as a substitute for antibiotics, which are far more effective, at least until resistance eventually develops. In addition, devices such as those shown in U.S. Patent No. 4,418,686 are highly complex to manufacture, making them far more expensive and uneconomical compared to the mass application of antibiotics. The devices also have a short lifespan, and components remaining when the implant wears out can cause damage to the treatment site.

[0007] References herein to external sources of information, including patents and other literature, are generally for the purpose of providing a context for discussing features of the present invention. Unless otherwise stated, reference to such sources should not be construed as an admission that such sources are prior art or form part of the common general knowledge in the art in any jurisdiction.

[0008] For purposes of this specification, when method steps are listed in a sequence, that sequence does not necessarily imply that the steps are chronologically ordered in that sequence, unless there is some other logical way of interpreting the sequence.

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

[0010] According to a first aspect, the present invention generally relates to a pharmaceutical device for use in animals, the pharmaceutical device comprising: a body made of one or more solid metals, the metals being selected from among metals whose ions have a biocidal effect; the body comprising an inner porous matrix having a porosity of at least 1%, from which biocidal metal ions can be released; The exterior surface of the body is configured to be placed at a treatment site on an animal.

[0011] According to another embodiment, the one or more solid metals are selected from the group consisting of copper, cobalt, zinc, nickel, zirconium, molybdenum, and alloys thereof.

[0012] According to another embodiment, the one or more solid metals are pure metals, such that the one or more solid metals are not alloys.

[0013] According to another aspect, the body is made solely from a single solid piece of metal.

[0014] According to another aspect, the body is made from pure copper.

[0015] According to another embodiment, the inner porous matrix has a porosity of at least 10%.

[0016] According to another embodiment, the inner porous matrix has a porosity of between 20% and 80%.

[0017] According to another embodiment, the inner porous matrix has an average pore size of 50 microns or less.

[0018] According to another embodiment, the body has one or more flow channels therethrough.

[0019] In accordance with another aspect, the invention generally comprises an implant, wherein the body is 20 mm or less in length in any dimension.

[0020] According to another aspect, the body has a plurality of grooves on the exterior surface.

[0021] According to another aspect, the body is a gyroid structure.

[0022] According to another embodiment, the inner porous matrix has a porosity of at least 50%.

[0023] An elongated plug suitable for insertion into the teat canal of a lactating animal, the elongated plug being a medicinal device.

[0024] According to another aspect, the elongate plug includes a port at each of the proximal and distal ends to facilitate fluid drainage in one direction and administration of medication in the other direction.

[0025] According to another embodiment, the inner porous matrix has a porosity of 20% or less.

[0026] A patch suitable for application to an external treatment site on an animal, the patch being a pharmaceutical device, the body of which is formed as a thin layer.

[0027] According to another aspect, the lamina has a plurality of grooves on its outer surface.

[0028] According to another embodiment, the lamina exhibits or is formed as a crossed lattice.

[0029] According to another embodiment, the thin layer exhibits one or more rough sections with high density peaks.

[0030] In accordance with another aspect, the present invention generally comprises a method of manufacturing a pharmaceutical device, the method being an additive manufacturing process and including the step of metal 3D printing.

[0031] According to another aspect, the additive manufacturing process is binder jetting of metal powder.

[0032] According to another embodiment, the metal powder has a granule size of 50 microns or less.

[0033] According to another embodiment, the purity of the metal powder is at least 99.95%.

[0034] According to another aspect, the sintering cycle that completes the binder jetting process is of low intensity such that the porosity of the interior porous matrix is ​​substantially preserved.

[0035] According to another aspect, a space holder material is mixed with the metal powder prior to binder jetting, followed by removal of the space holder material by sintering, thereby creating pores in the inner porous matrix.

[0036] According to another aspect, the spacer material is selected from the group consisting of potassium carbonate, sodium chloride, and carbamide.

[0037] According to another aspect, the space holder material is needle-shaped.

[0038] In another aspect, the present invention generally comprises a method for treating or preventing an infectious disease in a livestock animal using a pharmaceutical device, the method comprising applying the pharmaceutical device to a treatment area on the animal.

[0039] According to another aspect, the method includes injecting a medicinal device into the skin near the hoof of an animal to prevent or treat foot rot, digital dermatitis, interdigital dermatitis, white line disease, and / or sole ulcers.

[0040] According to another aspect, the method includes inserting a medicinal device into the teat canal of an animal to prevent or treat mastitis and / or myiasis, to prevent contaminants from entering the teat canal, or as a cannula, teat corrector, internal teat canal skin conditioner, or teat end closure.

[0041] According to another aspect, the method includes externally applying a medicinal device to a wound of an animal to prevent or treat an infection.

[0042] In another embodiment, the animal is a lactating animal selected from the group consisting of cows, goats, pigs, deer, buffalo, sheep, and camels.

[0043] In general, in another aspect, the present invention comprises a pharmaceutical device for use in an animal, the pharmaceutical device comprising: A mounting member; one or more bodies each made from one or more solid metals, the metals being selected from among metals whose ions have a biocidal effect; One or more bodies are attached to the attachment member, and the exterior surface of each of the bodies is configured to be placed against a treatment site on an animal.

[0044] According to another aspect, the drug device is configured as an elongated plug suitable for insertion into the teat canal of a lactating animal.

[0045] According to another embodiment, the mounting member is a shaft and the one or more bodies are mounted along the length of the shaft.

[0046] According to another aspect, the shaft defines an enlarged region toward one end.

[0047] According to another aspect, the expansion region is defined by adjacent branches of a diverging and reconverging shaft.

[0048] According to another aspect, the medication device further comprises an end stop secured to an opposite end of the shaft.

[0049] According to another aspect, the one or more bodies comprise a bead attached to a shaft.

[0050] According to another embodiment, the one or more bodies comprise a wire wrapped around a shaft.

[0051] According to another aspect, the mounting member is flexible and resilient.

[0052] According to another aspect, the mounting member is made from a shape memory alloy.

[0053] According to another aspect, the mounting member is made from nitinol.

[0054] According to another embodiment, the one or more solid metals are selected from the group consisting of copper, cobalt, zinc, nickel, zirconium, molybdenum, and alloys thereof.

[0055] According to another embodiment, the one or more solid metals are pure metals, such that the one or more solid metals are not alloys.

[0056] According to another embodiment, each of the one or more bodies is made solely from a single solid metal.

[0057] According to another aspect, each of the bodies is made from pure copper.

[0058] Other aspects of the present invention will become apparent from the following detailed description, given by way of example only and with reference to the accompanying drawings.

[0059] As used herein, the term "and / or" means "and" or "or," or both.

[0060] As used herein, "(s)" following a noun refers to the plural and / or singular form of the noun.

[0061] The term "comprising" as used in this specification and claims means "comprising at least a portion of." References in this specification and claims containing this term, and in each description, all features preceded by this term must be present, although other features may also be present. Related terms such as "comprise" and "comprised" should be interpreted similarly. The invention will now be described, by way of example only, with reference to the drawings in which: [Brief explanation of the drawings]

[0062] [Figure 1] An enlarged cross-sectional view of the internal porous matrix is ​​shown. [Figure 2A] 1 shows a perspective view of a first embodiment of an implant. [Figure 2B] FIG. 1 shows a perspective cross-sectional view of a first embodiment of an implant with the internal flow channels visible. [Figure 3A] 1 shows a perspective view of a second embodiment of an implant. [Figure 3B] 1 shows a cross-sectional side view of a second embodiment of an implant. [Figure 4] 1 shows a perspective view of a third embodiment of an implant. [Figure 5] 10 shows a perspective view of a longer variant of the third embodiment of the implant. [Figure 6] 1 shows an x-ray image of an implant injected into a treatment site near the hoof of a cow. [Figure 7A] 1 shows a perspective view of a first embodiment of a plug. [Figure 7B] 1 shows a top view of a first embodiment of a plug. [Figure 8A] 1 shows a perspective view of a second embodiment of a plug. [Figure 8B] 1 shows a top view of a second embodiment of a plug. [Figure 8C] 1 shows a cross-sectional side view of a second embodiment of a plug. [Figure 9] 1 shows an x-ray of a plug inserted into a bovine teat canal. [Figure 10A] 1 shows a top perspective view of a first embodiment of a patch. [Figure 10B] 1 shows a bottom perspective view of a first embodiment of a patch. [Figure 11A] FIG. 1 shows a top perspective view of a second embodiment of a patch. [Figure 11B] FIG. 1 shows a bottom perspective view of a second embodiment of a patch. [Figure 12] FIG. 10 shows a top perspective view of a third embodiment of a patch. [Figure 13A] FIG. 10 shows a top view of a third embodiment of a plug. [Figure 13B] FIG. 10 shows a top view of a fourth embodiment of a plug. DETAILED DESCRIPTION OF THE INVENTION

[0063] According to various aspects of the present invention illustrated in Figures 1-9B, there is provided a pharmaceutical device 1, a method of manufacture, and a method of treating and preventing disease in animals, as described herein below.

[0064] It will be appreciated that these diagrams illustrate the general principles of construction and configuration, and that the invention is not limited to the precise arrangements illustrated.

[0065] General Structure and Composition The medical device 1 comprises a body 10 made from one or more solid metals, the metals being selected from among those whose ions have a biocidal effect. As shown in Figure 1, the body 10 includes an internal porous matrix 11 from which biocidal metal ions can be released. Figure 1 is an enlarged cross-section of the body 10 having an internal cavity, with upper and lower sections being walls of the body 10 comprising the internal porous matrix 11 of porous copper. Preferably, the body 10 is monolithic.

[0066] Biocidal effect is defined to mean that the ions are effective in killing or otherwise inactivating cells of harmful microorganisms such as bacteria, viruses, and parasites. This may be through surface contact of the microorganisms with the metal, or the ions may be carried away from the metal and become suspended in, for example, body fluids, thereby affecting harmful microorganisms not necessarily present on the metal surface.

[0067] The exterior surface of the body 10 is configured to be placed at a treatment site 20 on the animal 2. This treatment site 20 may be an external treatment site, such as a wound site or another topical application site, or an internal treatment site, such as inside the teat canal or under the skin near the hoof. The drug device 1 may be placed at the treatment site 20 manually or with a suitable tool.

[0068] 2-9B illustrate various embodiments of the drug device 1 suitable for various treatment sites 20, including variations of the implant 3, elongate plug 4, and patch 5. Each embodiment is further described herein.

[0069] The terms "medication" and "treatment site" are used broadly herein to encompass uses such as preventing infection, treating active infection, and / or providing other health benefits. The animal 2 receiving the drug device 1 is intended to be a domestic animal, preferably a bovine animal, i.e., a cow, although the present invention may be suitable for use with a wider variety of animals, as described below.

[0070] By providing a source of biocidal metal ions, the medicinal device 1 kills or at least inhibits invasive bacteria from invading the treatment site 20, thus functioning as an infection preventative. The medicinal device 1 can also kill bacteria in already infected treatment site 20, thus treating the infection to some extent. By functioning by a mechanism different from antibiotic drugs, the development of antibiotic resistance in bacterial strains is prevented. Additionally, the inner porous matrix 11 can optionally be loaded with a medicinal agent or other beneficial substance, such as silver, zinc, solids, liquids, gels, antibiotics, micronutrients, or growth hormones, that is slowly released into the treatment site 20 over time prior to application to the treatment site 20. Such a substance can also coat the exterior of the body 10, which can provide another mechanism for killing invasive bacteria or promoting healing.

[0071] For example, the inner porous matrix 11 can be loaded with 1 to 22,000 ppm colloidal silver as a second source of biocidal metal ions in addition to the metal of the inner porous matrix 11 itself.

[0072] A number of metal elements are known to have biocidal properties, in particular ions with biocidal properties. For purposes of the present invention, the solid metals used to form the body with such biocidal properties are preferably selected from the group consisting of copper, zinc, silver, cobalt, nickel, zirconium, molybdenum, and alloys thereof. Some such metals, particularly metals such as lead, which may have toxic effects in small amounts, may be less preferred than others.

[0073] Preferably, the one or more solid metals are pure metals, rather than alloys or other molecular compounds. The term "pure metal" is intended only to mean that the metal is a chemical element, as opposed to an alloy or molecular compound, and does not exclude the possibility that other compounds may be present in trace amounts in the metal without forming an alloy. Compounds that may be present in trace amounts may include residues from liquid binders used in the manufacturing process or small amounts of impurities in the metal powder used in the process. For example, a metal having a purity of 99.95% would be considered "pure" for purposes of this specification.

[0074] Preferably, body 10 is made from only a single solid metal (preferably a pure metal) to simplify the manufacturing process, reduce costs, and provide better control of biocidal ion release. However, if body 10 is made from multiple solid metals (pure metals or alloys), the solid metals may have interfaces between them such that body 10 is divided into multiple sections. This interface may be a mechanical connection, such as a press fit, or the different sections may be fused together by some other manufacturing process.

[0075] The preferred metal for the body 10 is pure copper, since copper ions have a particularly strong biocidal effect, copper is widely known and recognized as a biocidal agent, and copper is a micronutrient for most animals. Copper is also widely available and suitable for a variety of manufacturing processes because it is easy to mold and form, has a long shelf life, and is highly recyclable without damage or impact. Silver ions and zinc ions also have a particularly strong biocidal effect, so the next most preferred metals are pure zinc, pure silver, and any combination of two or three of copper, zinc, and silver.

[0076] The release of the biocidal metal ions is facilitated by the inner porous matrix 11, which, due to its high internal surface area, provides multiple sites for ion release. Naturally, these ions are gradually released to the treatment site, essentially creating a sustained-release mechanism. The inner porous matrix 11 also allows bodily fluids, such as water, blood, or mucus, within the treatment site to enter the pores and stimulate the release of ions due to the presence of the aqueous electrolyte solution. The rate of ion release is affected by the properties of the inner porous matrix 11, i.e., its porosity / density, pore size, and other such factors. Generally, the greater the internal surface area of ​​the inner porous matrix 11, the greater the rate of ion release.

[0077] Increasing the porosity of the inner porous matrix 11 increases the internal surface area, so it is generally desirable to maximize porosity. Porosity can be expressed as a percentage that indicates the proportion of the volume of a material that is made up of voids. It is related to the bulk or effective density of the material, which is a measure of the material's density including the void / pore volume. Higher porosity corresponds to lower bulk density.

[0078] The inner porous matrix 11 has a porosity of at least 1%, and preferably at least 10%. Based on experimentation, applicants have found that matrix porosities of 20% to 30% provide fairly good structural integrity, although for some applications porosities as high as 67% are possible without becoming too weak.

[0079] Maximizing porosity is primarily a manufacturing challenge, and a preferred method for creating highly porous metals is described. Care must be taken to ensure that the structural integrity of the metal is maintained. It will be recognized that optimization of manufacturing techniques and parameters will allow for porosities even higher than 67%; for example, using the spaceholder material described below, porosities as high as 80% may be achievable. The present invention provides general principles of application that are not limited to any particular maximum porosity, except to the extent physically possible.

[0080] The surface roughness of the exterior surface of the body 10 is another characteristic that can affect the exterior surface area and therefore the ion release rate. Generally, higher surface roughness results in higher ion release rates and is therefore desirable. Surface roughness can also be correlated with the porosity of the interior porous matrix 11.

[0081] The inner porous matrix preferably has pore dimensions on the micrometer scale, e.g., an average pore size of about 50 microns. The pore size will depend on the type of metal used and the manufacturing method described below. In general, it is desirable to minimize the pore size, as smaller pore sizes increase the internal surface area.

[0082] One potential limiting factor to the desired ion release rate is consideration of metal toxicity with respect to the target animal 2. Regardless of the metal used in the body 10, excessive metal ion release can result in toxic effects on the animal 2, causing health complications, and thus defeating the intended purpose of the drug device 1. For this reason, the inner porous matrix 11 is preferably designed to release metal ions at a rate well below that which would be toxic to the target animal 2. The drug device 1 is also preferably designed so that it will not be toxic even if the entire structure is rapidly released into the animal 2.

[0083] The drug device 1 may be configured for a particular animal or range of animals, for example, the drug device 1 may have an inner porous matrix 11 with a higher porosity if intended for use with cattle, but a lower porosity if intended for use with smaller animals such as sheep.

[0084] method Following the above description of the structure of the present invention, a method for forming a device for treating and preventing disease in cattle will now be outlined.

[0085] The pharmaceutical device 1 is preferably manufactured by a metal additive manufacturing process, i.e., a process that includes the step of metal 3D printing. This allows the body 10 and the internal porous matrix 11 to be precisely manufactured with customized density / porosity and surface roughness characteristics to achieve a desired ion release rate, and also allows the body 10 to be created in any desired form factor with appropriate flow channels 13. The particular additive manufacturing process used is preferably binder jet printing (i.e., binder jet), which will be described shortly.

[0086] However, other manufacturing processes may be suitable for manufacturing the pharmaceutical device 1, provided the process is capable of producing the porous metal structure. For example, CNC tooling can be used to manufacture the pores in a subtractive manner, but sufficient precise control is more difficult and customization of porosity is limited compared to the additive manufacturing processes described herein. Molds can also be used with spacer materials to cast the porous metal structure, but internal features such as small flow channels 13 are difficult to achieve. Mass production may also be more difficult.

[0087] In a preferred manufacturing process for binder jet printing, a roller deposits a layer of metal powder particles onto a print bed. An inkjet print head then deposits a liquid binder on top of the layer to bond the particles. The print bed can then be lowered (or its relative height otherwise adjusted), and the process is repeated multiple times, with the roller depositing another layer and the print head bonding it together. A group of parts can be printed and undergo subsequent steps simultaneously.

[0088] Once printing is complete, a powder removal step is preferably performed to remove unbound metal powder from the part using compressed air and / or under a specific controlled vacuum. The internal geometry of the drug device 1 is configured to ensure that unbound metal powder can be completely removed. Powder removal is preferably automated, but could potentially be performed manually.

[0089] The binder can then be cured by heating to give the part sufficient strength to allow handling.

[0090] Finally, the part undergoes one or more sintering cycles to remove the binder and densify the part into its final configuration, further increasing its strength. Preferably, the part is placed on a ceramic tray during sintering. The sintering cycle can be customized to achieve the desired porosity / density, surface roughness, or other characteristics of the part. The resulting solid metal component is then ready for its final application.

[0091] The choice of metal powder used affects factors such as the pore size and internal surface area of ​​the internal porous matrix 11. Pore size is primarily determined by the powder's particle size; for example, a 50 micron powder will create similar pores. Internal surface area increases as the grain size decreases. Therefore, it is generally desirable to select a powder with a small grain size.

[0092] The selection of the liquid binder is one of several other factors that affect the porosity of the inner porous matrix 11. A variety of binder compositions are possible, and the selection occurs in combination with the selection of an appropriate sintering cycle.

[0093] Prior to sintering, a liquid binder is present in the metal, and during sintering, the liquid binder is removed from the structure, creating voids. Therefore, high porosity can be promoted by selecting an appropriate low-density sintering cycle that does not over-densify the metal. This is typically contrary to the objective of conventional sintering, where strength is the primary consideration and maximum densification (i.e., void removal) is desired. In the present invention, the objective of sintering is to remove the liquid binder but only densify the material to the minimum extent necessary for the part to have sufficient structural rigidity. Thus, the majority of the voids remain, resulting in high porosity.

[0094] Optionally, spacer materials (in addition to the liquid binder) can be interspersed in the part prior to sintering to further promote increased porosity. The spacer can be a material such as potassium carbonate, sodium chloride, or carbamide, preferably in needle-like form. The spacer can be mixed into the metal powder before the binder jet and subsequently removed from the part during sintering by a sintering cycle at an appropriate temperature. The shape, size, and proportion of the spacer used can help customize the shape and dimensions of the pores and allow for higher porosity than with the liquid binder alone.

[0095] Applicants have found that copper is a preferred metal for use with the additive manufacturing processes described in relation to the present invention because it is suitable for binder jet printing and sintering for high porosity, combined with its desirable biocidal properties.

[0096] A preferred metal powder for use in the manufacturing process is copper powder of about 50 microns or less. Preferably, the copper also has a purity of at least 99.95% and more preferably a purity of about 99.99%.

[0097] Additive manufacturing processes are relatively low cost, low energy consumption, and non-polluting, which are advantages over alternative manufacturing methods. The metals used to manufacture each pharmaceutical device can also be recycled into further products at the end of their life, as they can be converted back into their original powder state by appropriate smelting / melting or grinding processes.

[0098] Implants 2A-4, in some embodiments of the present 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 by an implant syringe, an implant gun, or any other suitable mechanically, electrically, or pneumatically ejected device. Preferably, the intended treatment site 20 is near the hoof of the target animal 2 so that the implant can prevent or treat infection around the hoof / foot of the animal 2.

[0099] When configured as an implant 3 for insertion under the skin, body 10 is preferably of a suitably small size to facilitate easy insertion. Preferably, body 10 is 20 mm or less in length in any dimension, i.e., capable of fitting within a bounding sphere of 20 mm diameter. More preferably, body is 10 mm or less in any dimension.

[0100] In a first embodiment of the implant 3 shown in Figures 2A and 2B, the body is formed as a rectangular parallelepiped with rounded edges. Preferably, the body has dimensions of approximately 6 mm in length, 3 mm in width, and 2 mm in height.

[0101] In a second embodiment of the implant 3 shown in Figures 3A and 3B, the body is formed as a cylinder with rounded edges. Preferably, the body has a length of about 6 mm and a diameter of about 2.2 mm.

[0102] These dimensions allow the implant 3 to be injected, for example, through a syringe or gun needle. Larger sizes may also be injectable, but would require larger needles that are less comfortable for the animal, so it is preferable to inject multiple implants 3 to achieve the desired effect rather than using larger implants. Figure 4 shows multiple implants 3 injected under the skin near the hoof.

[0103] With respect to implant 3, the exterior surface of body 10 preferably has grooves 30 to increase the exterior surface area, thereby enhancing the release rate of the biocidal metal ions. Grooves 30 can also aid in retention at the internal treatment site, allowing tissue to grow around grooves 30 to secure body 10 in place.

[0104] The body 10 may also have one or more flow channels 13 therethrough to allow the passage of bodily fluids. This ensures that the flow of excess tissue fluids within the treatment site is not blocked, while also ensuring that the passage of fluids can be used to further activate the internal porous matrix to enhance the rate of biocidal metal ion release. 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.

[0105] In a first embodiment shown in Figures 2A and 2B, two flow channels 13 pass longitudinally through the body 10 and four flow channels 13 pass laterally through the body. In a second embodiment shown in Figures 3A and 3B, one flow channel 13 passes longitudinally through the body 10 and four flow channels 13 pass laterally.

[0106] In a third embodiment of the implant 3, shown in Figure 4, the body 10 has a gyroid structure and the flow channel 13 is part of the gyroid. Figure 5 shows a lengthened version of the third embodiment. The gyroid structure has high strength, a large surface area, and is easily 3D printed as part of the preferred manufacturing process.

[0107] With respect to implant 3, it may be particularly beneficial to provide growth hormones, other metal ions / colloids, and / or micronutrients within the inner porous matrix 11, as the slow release of such substances can promote the growth and hardening of the hoof callus, thereby improving hoof thickness and formation. This may be particularly useful when treating existing hoof conditions, for example, where the existing condition has partially rotted or distorted the hoof, as it can speed healing.

[0108] Copper itself is also an essential micronutrient for livestock animals such as cattle and is typically provided as a nutritional supplement added to the animal's feed. Thus, an implant 3 made of copper can provide some or all of the animal's nutritional copper intake by gradually releasing copper ions directly into the treatment site 20 through the internal porous matrix 11. The implant 3 can be inserted into various delicate locations in the cattle to ensure sufficient copper is absorbed to assist in replacing nutritional supplements added to the feed.

[0109] The implant 3 can inactivate invasive bacteria and other microorganisms through the internal porous matrix 11. For example, when injected near the hoof of an animal 2, the implant 3 can act as a preventative for white line disease, foot rot, sole ulcers, and other conditions typically caused by bacterial infections.

[0110] Over time, the implant 3 completely dissolves at the treatment site 20 due to the small size of the implant 3 and the slow release of material in the form of biocidal metal ions. Factors such as the size and porosity of the implant 3 affect the time it takes for the implant to completely dissolve, which can be monitored via x-ray scanning to determine a suitable reapplication interval for a given embodiment of the implant 3. For example, x-ray monitoring of dissolution may indicate that annual reapplication is appropriate for a particular embodiment of the implant 3.

[0111] Because the implant 3 is small, and because the implant is expected to dissolve over time, high structural integrity after insertion into the treatment site 20 is not important. Therefore, a particularly high porosity of the inner porous matrix 11 is desirable, provided that the implant 3 retains the minimum strength necessary for injection into the treatment site 20. For example, a high porosity of 50% or more may be suitable for the implant 3, where this level of porosity may be inappropriate for other applications.

[0112] The use of the present invention in the form of an implant 3 near the hoof has numerous advantages over existing hoof care solutions. Currently, it is common to periodically apply strong chemical foot baths to prevent or treat hoof problems on livestock. These chemicals can be hazardous and must be transported and handled with care.

[0113] In contrast, the implant 3 according to the present invention is non-toxic and can be handled and transported without any associated risks. The implant 3 according to the present invention also requires less frequent application, for example, a once-yearly application instead of 2-7 foot baths with chemical solutions each year. Considering that standard chemicals are only used once, waste is also significantly reduced.

[0114] Use of implant 3 can also reduce the need for antibiotics as prophylactics for the hoof conditions mentioned above, thus preventing the development of antibiotic resistance and even reducing or eliminating hold times for the sale of animals or their dairy products that arise from having to wait for antibiotics to work their way through the system.

[0115] plug 7A-9, in some embodiments of the present invention, the body 10 is formed as an elongated plug 4 suitable for insertion into the teat canal of a milk-producing animal. The milk-producing animal is preferably a cow, but can also be a goat, pig, deer, buffalo, sheep, camel, or any other animal that produces milk.

[0116] In this arrangement, the body 10 has features that are the same or similar to those described above in the first embodiment (implant), such as flow channels 13. Accordingly, like features are generally designated by the same reference numerals.

[0117] The main difference between these embodiments is that the body 10 is shaped and sized so that it can be effective as a teat plug 4. This means that the shaft 40 is preferably provided with a generally circular cross section. For use with cattle, the shaft 40 preferably has a diameter of about 2 mm.

[0118] In the first embodiment of the plug 4 shown in Figures 7A and 7B, the plug 4 is approximately 20 mm long, a dimension suitable for use with bovine teats.

[0119] In a second embodiment of the plug 4 shown in Figures 8A-8C, the plug 4 is approximately 27mm long, a dimension that is also suitable for use with bovine teats.

[0120] Many variations in length and size are possible, but it will be appreciated that such variations must be tailored to the size of the teat of the target animal 2. For example, a plug 4 for a sheep may be smaller than one intended for a cow, for which the size range is preferably 15-40 mm.

[0121] One flanged end 41 may act as an end stop and the other end may be a tapered end 42 to facilitate easy insertion. The flanged end 41 may be located outside the teat and may allow for easy removal, as well as act as a barrier against dirt and bacteria.

[0122] With respect to plug 4, longitudinal flow channel 13 can facilitate the evacuation of excess milk from the mammary gland through plug 4 and through the teat canal, thereby relieving pressure and reducing the risk of infection. Longitudinal flow channel 13 can also be used in the opposite direction to administer medication deep into the nipple and breast, for example, if the nipple or mammary gland is injured. Plug 4 preferably has a proximal end port 45 and a distal end port 46 to facilitate these functions.

[0123] Additionally, the shaft 40 may be provided with intermediate ports 44 for the longitudinal flow channels 13. For example, in a first embodiment shown in Figure 7B, one intermediate port 44 is provided, while in a second embodiment shown in Figure 8B, two intermediate ports 44 are provided, one approximately in the center of the shaft 40 and one toward the end.

[0124] As shown in Figures 7A-8C, the tapered end 42 preferably has a bulb 43 that can be positioned just inside the teat cistern to help retain the plug 4 within the teat canal. The bulb 43 can be pear-shaped, spherical, or another similar shape. The bulb 43 can include an additional horizontal flow channel 13 therethrough to allow the bulb 43 to act as a collection point for milk and other fluids to aid in drainage. The bulb 43 can also act as a bacteria trap from which more biocidal ions are released. As shown in Figure 8C, the flow channel 13 in the bulb 42 is preferably cross-shaped. A distal end port 46 is preferably provided along the tapered end 42 farther than the bulb 43.

[0125] The plug 4 may be manually placeable into the teat canal or a suitable tool may be provided to force the plug 4 into the teat canal. The plug 4 may be coated with a suitable lubricant to facilitate easy placement.

[0126] When placed within the teat canal, the plug 4 prevents invasive bacteria from entering the teat canal via the inner porous matrix 11, thus preventing the development of mastitis in the animal (i.e., bovine mastitis for cattle). It can also act to prevent parasitic diseases that affect teats, for example, preventing myiasis by keeping out blowflies and maggots.

[0127] Thus, plug 4 can be placed during the early weeks of the dry period when animal 2 is not producing milk, which is when mastitis infections typically tend to develop. However, plug 4 can also be placed during lactation between milking sessions to prevent infections or myiasis, which can be particularly beneficial for cows that are leaking milk. Plug 4 can be removed prior to calving, approximately 60 days after application, before being reapplied at the start of the next cycle.

[0128] Because the plug 4 is intended to remain blocking the nipple canal for an extended period of time, it is important that the plug have sufficient structural integrity so that it does not dissolve or become prematurely or easily damaged / deformed. Therefore, a low level of porosity is preferred for the inner porous matrix 11 compared to applications such as the implant 3. For example, a porosity of close to 20% may be suitable for the plug 4 to balance high release rate with structural strength.

[0129] The plug 4 may also have other benefits resulting from the ion release toning the skin of the teat canal, preventing dryness, cracking, and deformation of the teat. Because the plug 4 is essentially self-decontaminating, it may be used as a tool during surgery or treatment of a damaged teat, teat cistern, or teat canal.

[0130] The plug 4 acts as an alternative to teat sealants, which are typically applied and administered by syringe during the dry period to prevent mastitis. However, the plug 4 is easier to remove and therefore more suitable for use between milkings during lactation. Because the plug does not require a pre-filled, single-use syringe, installation is easier and less wasteful; rather, any installation tools are reusable. Additionally, the plug 4 itself can also be recycled or washed and reused.

[0131] patch 10A and 10B, in some embodiments of the present invention, the body 10 is formed as a thin layer 50 that can be applied to an external treatment site as a patch 5. This embodiment may be particularly suitable for treating wounds or existing infections by application directly to the affected treatment site.

[0132] The patch 5 can be round, square, rectangular, or any desired shape to suit a particular application, and has a standard diameter of about 5 mm. However, it will be recognized that many variations in size and shape are possible, for example, the patch 5 can be some other polygonal shape. The patch can be made in a variety of sizes, for example, up to 100 mm in diameter to cover larger wounds.

[0133] 10A and 10B, the thin layer 50 has a plurality of grooves 51 formed in the patch. The grooves 51 contribute to an increased external surface area and may also aid in retention at the treatment site 20 by allowing tissue to grow into the grooves 51. Preferably, the grooves 51 are in a crisscross pattern.

[0134] 11A and 11B, the lamina 50 exhibits intersecting lattices 52 that contribute to high mechanical stability under pressure. The lamina 50 may have an annular rim 52 to provide support for the lattice 52. The lattice 52 may itself form the lamina 50, such that the lattice 52 is supported solely by the rim 52.

[0135] In a third embodiment of patch 5 shown in Figure 12, one side of thin layer 50 exhibits multiple rough sections 54 with a high peak density. Rough sections 54 are separated by radial grooves 51 with smoother surfaces. However, rough sections 54 can also be separated in some other manner, or there can be one rough section 54 spanning part or all of thin layer 50. Rough sections 54 have a particularly large surface area, which is beneficial for biocidal ion release, and also allows tissue growth to occur at the peaks, better holding patch 5 in place.

[0136] Preferably, the patch 5 is flexible (i.e., can be easily deformed elastically and / or plastically) so that it can conform to the contours of the external treatment site. The patch may be secured with some type of adhesive, e.g., glue or tape, or plastic deformation of the patch may be sufficient to hold it in place - for example, the patch may be wrapped around a leg or hoof and held in place by the rigidity of metal.

[0137] The thickness of the patch 5 is preferably either millimeter-scale or micron-scale, but may depend on the structure of the thin layer 50. For example, if a grating 52 forms the thin layer 50, the thin layer 50 may preferably have a thicker thickness of a few millimeters. If the thin layer 50 is formed of a more solid structure rather than as a grating 52, a thinner thickness in the micron range may be preferred.

[0138] In patch 5, the inner porous matrix 11 may be filled with micronutrients or growth hormones to stimulate tissue growth to close the underlying wound. Patch 5 can function independently, but can also be used in conjunction with other therapeutic aids to speed the healing process.

[0139] The patch 5 inactivates bacteria and other microorganisms within the treatment site 20 via the inner porous matrix 11, and can therefore act as an alternative to harsh chemicals that are sometimes used to treat external infections. Another benefit of the patch 5 is that it does not leave any residue. The patch 5, due to its small and thin nature and intended use as a treatment aid, is well suited for applications that support single-use disposability and recyclability.

[0140] When produced by an additive manufacturing process such as binder jetting, the thin layer 50 can be constructed with a relatively small number of roller passes, making the patch 5 particularly suitable for high speed mass production.

[0141] composite equipment 13A and 13B, in another embodiment, the medical device is not comprised of a single, unitary body 10. Rather, the medical device is a "composite" medical device 100 that comprises multiple parts assembled together.

[0142] The composite medical device 100 comprises a mounting member 60 and one or more bodies 62 mounted on the mounting member 60. As previously described, the bodies 62 are made from one or more solid metals selected from among metals whose ions have a biocidal effect. The exterior surface of each of the bodies 62 is configured to be placed at a treatment site on the animal 2.

[0143] Preferably, the composite medical device 100 is formed as an elongated plug 4 suitable for insertion into the teat canal of a lactating animal. Accordingly, Figures 13A and 13B provide third and fourth embodiments, respectively, of the previously described elongated plug 4. The dimensions for the third and fourth embodiments are preferably similar to the previous embodiments of the elongated plug 4, e.g., 15 to 40 mm in length.

[0144] The mounting member 60 is preferably a shaft that provides the basic shape of the elongated plug 4, although the shaft may have a more complex shape than a simple axial extent. One or more bodies 62 are mounted along the length of the shaft, but not necessarily along the entire length.

[0145] 13A, at least some of the one or more bodies 62 are formed as beads, which may be slidably movable along the shaft to some extent. Some of the bodies 62 may be similar in shape but may be fixed in place, for example, at either end of the shaft to act as end stops that prevent the slidably movable bodies 62 from coming off the shaft. The end stops may alternatively be formed in the shaft itself or may be made of some other material different from the bodies 62.

[0146] In a fourth embodiment shown in Figure 14B, one or more bodies 62 are formed as a wire wrapped around a shaft as shown in Figure 13B. The wire can be pre-wound and slid over the shaft during manufacture, for example as a coil spring, or it can be wrapped around the shaft during manufacture.

[0147] The one or more bodies 62 may be manufactured in a manner equivalent to the body 10 of the previously described embodiment, for example, by additive manufacturing to create the interior porous matrix 11. However, the one or more bodies 62 may also be made by other methods (e.g., conventional machining) and may not necessarily comprise the interior porous matrix 11. Because the mounting member 60 is present to provide structural strength, the shape of the one or more bodies 62 may provide increased surface area (that may otherwise be achieved by porosity) without compromising the structure of the drug device 100.

[0148] In a third embodiment, the body 62 formed as a bead has through holes which increase the available surface area for biocidal ion release, especially when the bead is loosely fitted so that it is slidably movable along the shaft. In a fourth embodiment, formation as a thin wire inherently increases the exposed surface area for a given amount of material compared to a solid body such as a cylinder.

[0149] Preferably, the shaft defines an enlarged region 64 towards one end. The enlarged region 64 performs a function equivalent to the bulb 43 of the previous embodiment, in that it may help retain the elongated plug 4 within the teat canal while still allowing for ejection. The enlarged region 64 is preferably defined by adjacent branches of the diverging and reconverging shaft, which is efficient, particularly in terms of material usage. Preferably, one or more bodies 62 are not present within the enlarged region 64 or are attached to only one or both sides of the enlarged region 64.

[0150] Preferably, the mounting member 60 is flexible and resilient. This allows the enlarged region 64 to contract and expand at least to some extent. The use of beads or wires in one or more of the bodies 62 also facilitates flexing of the elongated plug 4. If the animal 2 lies nipple-down, flexing 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 tools, reducing fragility.

[0151] Preferably, the material of the mounting member 60 is inert, non-corrosive, and resistant to bacterial growth, but is a different material than the one or more bodies 62 .

[0152] The mounting member 60 can be made from a shape memory alloy, preferably Nitinol (i.e., nickel titanium), to provide a sufficient degree of resilience as well as strength. Taking advantage of the material properties of shape memory alloys, the mounting member 60 can be taught to "remember" a desired shape during manufacturing by appropriate heat treatment. This allows the expansion region 64 to be formed by flexing adjacent branches of the shaft and then fixing the resulting geometry so that the mounting member 60 is in a static state. The shape memory is preferably configured to retain the desired shape over a long insertion period (e.g., two months, the typical dry period for a cow), preferably over a high number of flexion cycles, e.g., one million or more cycles.

[0153] Preferably, the composite drug device 100 further comprises an end stopper 66 fixed to the opposite end of the shaft relative to the enlarged region 64. The end stopper 66 may be, for example, spherical or pear-shaped, and may itself be one of the bodies 62 made from a biocidal ion-emitting metal. The end stopper may be enlarged compared to a bead. However, various other shapes of the end stopper 66 are possible. The end stopper 66 may be located just outside the nipple and may act as a barrier against bacteria equivalent to the flanged end 41 of the previous embodiment.

[0154] As with the previous embodiment, one or more bodies 62 may optionally be loaded / coated with a drug or other beneficial substance prior to application to the treatment site 20. Such a substance may also coat the attachment member 60, which may provide another mechanism for killing invasive bacteria or promoting healing.

[0155] summary The drug device 1 achieves a high rate of biocidal metal ion release to the treatment site 20 of the target animal 2 by providing an internal porous matrix 11 of the body 10 made of a suitable metal. Higher porosity and smaller pore size will increase the release rate, as these factors increase the internal surface area from which the ions can be released.

[0156] Additive manufacturing, and in particular binder jet printing, can be used to create a body 10 having an internal porous matrix 11 by bonding metal powder particles together. Various steps can be taken to promote a high level or porosity and small pore size, such as using small granules, using a liquid binder that creates a large number of voids, and using a low intensity sintering cycle to avoid too much void closure.

[0157] The pharmaceutical device 1 can be formed in various embodiments, such as the implant 3, plug 4, and patch 5 that have been described. Other pharmaceutical devices 1, such as ear tags, can be made in the same manner to benefit from the release of biocidal ions as well. Also, other devices, such as surgical instruments, breast cup liners, or water supply filters, could potentially be made in whole or in part in the same manner.

[0158] The applicant conducted experiments to test the rate of biocidal metal ion release for a medical device 1 according to the present invention.

[0159] In the first experiment, a pharmaceutical device 1 in the form of a plug 4 was immersed in a sample of water for multiple days, after which the volume of residual copper in the water sample was weighed. The results are summarized as follows:

[0160] In the control sample of distilled water, the residual copper level after 11 days was 0.6 micrograms per liter.

[0161] For a sample containing 11 low porosity plugs 4 that were soaked for 9 days, the residual copper level was 3130 micrograms per liter.

[0162] For the sample containing four low porosity plugs 4 that were soaked for nine days, the residual copper level was 958 micrograms per liter.

[0163] For the sample containing one low porosity plug 4 that was soaked for six days, the residual copper level was 2380 micrograms per liter.

[0164] As is evident from the results, increasing the porosity of the plug 4 greatly increases the rate and therefore effectiveness of ion release when applied to the treatment site 20 of the animal 2 .

[0165] In a second experiment, the same experiment was performed on a pharmaceutical device 1 in the form of an implant 3. The results are summarized as follows:

[0166] In the control sample of distilled water, the residual copper level after seven days was 10.7 micrograms per liter.

[0167] For the sample containing one low porosity implant 3 that was soaked for seven days, the residual copper level was 86.9 micrograms per liter.

[0168] For the sample containing two low porosity implants 3 that were soaked for seven days, the residual copper level was 151 micrograms per liter.

[0169] For the sample containing three low porosity implants 3 that were soaked for seven days, the residual copper level was 205 micrograms per liter.

[0170] For the sample containing four low porosity implants 3 that were soaked for seven days, the residual copper level was 261 micrograms per liter.

[0171] For a sample containing five low-porosity implants 3 that were soaked for seven days, the residual copper level was 327 micrograms per liter.

[0172] As is evident from these results, the use of multiple implants 3 can increase the rate of biocidal ion release within the treatment site 20, but not necessarily in a linear manner.

[0173] The composite drug device 100 is similarly capable of achieving high rates of biocidal ion release from one or more bodies 62 into the treatment site 20 and is particularly suitable for use as an elongated plug 4. It also provides flexibility that can prevent injury to the animal 2.

[0174] Numerous modifications in the construction and widely different embodiments and applications of the invention will suggest themselves to those skilled in the art to which this invention pertains without departing from the scope of the invention as defined in the appended claims.

[0175] The present invention may also be broadly described as consisting of the parts, elements, and features referred to or shown in the specification of this application, individually or collectively, and any or all combinations of any two or more of such parts, elements, or features, and where specific integers that have known equivalents in the art to which the present invention pertains are referred to herein, such known equivalents are deemed to be incorporated herein as if individually set forth.

Claims

1. 1. A pharmaceutical device for use on animals, comprising: a body made of one or more solid metals, said metals being selected from among metals whose ions have a biocidal effect; the body comprises an inner porous matrix having a porosity of at least 1%, from which biocidal metal ions can be released; The exterior surface of the body is configured to be placed at a treatment site on an animal.

2. 10. The medication device of claim 1, wherein said one or more solid metals are selected from the group consisting of copper, cobalt, zinc, nickel, zirconium, molybdenum, and alloys thereof.

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

4. A pharmaceutical device according to any one of claims 1 to 3, wherein said body is made from a single solid piece of metal.

5. 5. The pharmaceutical device of claim 4, wherein said body is made from pure copper.

6. A pharmaceutical device according to any preceding claim, wherein the inner porous matrix has a porosity of at least 10%.

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

8. A pharmaceutical device according to any preceding claim, wherein said inner porous matrix has an average pore size of 50 microns or less.

9. A medication device according to any preceding claim, wherein the body has one or more flow channels therethrough.

10. 10. A pharmaceutical device according to any preceding claim, wherein the pharmaceutical device is configured as an implant suitable for use at an internal treatment site in an animal, the body being no longer than 20mm in any dimension.

11. 11. The medication device of claim 10, wherein said body has a plurality of grooves on said exterior surface.

12. 11. The pharmaceutical device of claim 10, wherein the body is a gyroid structure.

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

14. A drug device according to any one of claims 1 to 9, wherein the drug device is formed as an elongate plug suitable for insertion into the teat canal of a lactating animal.

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

16. 16. A pharmaceutical device according to claim 14 or 15, wherein said inner porous matrix has a porosity of 20% or less.

17. A 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 on an animal, and the body is formed as a thin layer.

18. 18. The pharmaceutical device of claim 17, wherein said thin layer has a plurality of grooves on said exterior surface.

19. 18. A pharmaceutical device according to claim 17, wherein said lamina exhibits or is formed as a crossing lattice.

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

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

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

23. 23. The method of claim 22, wherein the metal powder has a granule size of 50 microns or less.

24. 24. The method of claim 22 or 23, wherein the metal powder has a purity of at least 99.95%.

25. The method of any one of claims 22 to 24, wherein the sintering cycle completing the binder jetting process is of low intensity such that the porosity of the inner porous matrix is ​​substantially preserved.

26. 26. The method of any one of claims 22 to 25, wherein a space holder material is mixed with the metal powder prior to binder jetting, and the space holder material is subsequently removed by sintering, thereby creating pores in the inner porous matrix.

27. 27. The method of claim 26, wherein the spacer material is selected from the group consisting of potassium carbonate, sodium chloride, and carbamide.

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

29. 21. A method of treating or preventing an infectious disease in a livestock animal using a pharmaceutical device according to any one of claims 1 to 20, said method comprising applying said pharmaceutical device to a treatment area of ​​said animal.

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

31. 30. The method of claim 29, wherein the method comprises inserting the pharmaceutical device into the teat canal of the animal to prevent or treat mastitis and / or myiasis, to prevent contaminants from entering the teat canal, or as a cannula, teat corrector, internal teat canal skin conditioner, or teat end closure.

32. 30. The method of claim 28, wherein the method comprises externally applying the medical device to a wound of the animal to prevent or treat an infection.

33. 33. The method of any one of claims 29 to 32, wherein the animal is a lactating animal selected from the group consisting of cows, goats, pigs, deer, buffalo, sheep, and camels.

34. 1. A pharmaceutical device for use on an animal, said pharmaceutical device comprising: Mounting member, one or more bodies each made from one or more solid metals, said metals being selected from among metals whose ions have a biocidal effect; The one or more bodies are attached to the attachment member, and an exterior surface of each of the bodies is configured to be placed against a treatment site on an animal.

35. 35. The drug device of claim 34, wherein the drug device is formed as an elongated plug suitable for insertion into the teat canal of a lactating animal.

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

37. 37. The medication device of claim 36, wherein the shaft defines an enlarged region toward one end.

38. 38. The pharmaceutical device of claim 37, wherein said expansion region is defined by adjacent branches of said shaft that diverge and reconverge.

39. 39. A medicament device according to claim 37 or 38, wherein the medicament device further comprises an end stop secured to an opposite end of the shaft.

40. 40. A pharmaceutical device according to any one of claims 36 to 39, wherein said one or more bodies comprise a bead attached to said shaft.

41. 40. A pharmaceutical device according to any one of claims 36 to 39, wherein the one or more bodies comprise a wire wrapped around the shaft.

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

43. 43. The medication device of claim 42, wherein said mounting member is made from a shape memory alloy.

44. 44. The medication device of claim 43, wherein the mounting member is made from nitinol.

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

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

47. A medication device according to any one of claims 34 to 46, wherein each of said one or more bodies is made solely from a single solid piece of metal.

48. 48. The medication device of claim 47, wherein each of said bodies is fabricated from pure copper.