Stent insert for the treatment of mastitis

Abstract

A stent insert for retention in a mammary gland of a livestock animal is disclosed, the stent insert having a stent body, the stent body having shape memory, the stent body having an expanded state and a collapsed state, the stent body having a first material that is at least partially elastic. The stent insert further has one or more nodes attached to the stent body, the nodes having a second material, the second material being a bioactive material for release at the mammary gland to prevent mastitis.

Description

Technical Field

[0001] This invention relates to stent inserts that have been used in cattle or other livestock. More specifically, but not exclusively, this invention relates to a stent insert and method for preventing mastitis in cattle or other livestock. Background Technology

[0002] For livestock farmers, animal health is a critical concern. Mastitis (an inflammation of the mammary glands) is one of the most common health problems in cattle. Mastitis is most commonly caused by bacteria that invade the udder, such as *Mycoplasma bovis*, although many other types of bacteria can also be a cause. Mastitis can be classified as clinical mastitis (where there are obvious signs of inflammation) and subclinical mastitis (where there are no obvious symptoms and it is difficult to detect). Both types of mastitis reduce milk yield and quality due to damage to mammary tissue. Although clinical mastitis can be identified and treated at least visually, some estimates suggest that, on average, about 25% of animals in each dairy herd are continuously infected with subclinical mastitis. Therefore, mastitis has a direct impact on the dairy industry's profitability as it reduces milk production. When mastitis repeatedly affects the same animal, that animal may no longer be suitable for milk production.

[0003] Because the cost of diagnosing and treating such problems is quite high, a preventative solution that can be administered holistically may be necessary. Antibiotics are typically used extensively for this purpose. To prevent mastitis, antibiotics can be combined with nipple sealants, which are usually administered via syringe. However, these syringes are typically single-dose, generating significant amounts of plastic waste on a large scale.

[0004] Furthermore, a major problem with the widespread use of antibiotics as disease preventatives in livestock is that it accelerates the development of antibiotic resistance in target bacterial strains. This gradually renders common antibiotics ineffective, ultimately leaving farmers facing deteriorating livestock health with no cost-effective and useful preventative drugs available. This problem is now beginning to significantly impact the industry, leading to a growing desire to find alternative solutions for the prevention and / or treatment of mastitis.

[0005] Cows typically go through different lactation stages, including early lactation, mid-lactation, late lactation, and dry period. Solutions to reduce mastitis (e.g., teat sealants) are usually provided during the dry period because bacteria and other microorganisms are more likely to enter and multiply in the mammary glands during this time. However, the application and removal of these products can be a labor-intensive and costly task to be performed annually. Therefore, alternative solutions for the prevention and / or treatment of mastitis are desirable.

[0006] In this specification, references have been made to external sources of information, including patent specifications and other documents, typically 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 part of common general knowledge in the art, within any jurisdiction.

[0007] For the purposes of this specification, when method steps are described in sequence, the sequence does not necessarily mean that the steps are ordered chronologically, unless there is no other logical way to interpret the sequence.

[0008] The object of the present invention is to provide a stent insert and method for treating mastitis, which overcomes or at least partially improves some of the disadvantages mentioned above or at least provides the public with a useful alternative. Summary of the Invention

[0009] According to a first aspect, the present invention broadly includes a scaffold insert for retention in the mammary glands of livestock animals, the scaffold insert comprising: The support body has shape memory, has an expanded state and a collapsed state, and comprises at least partially elastic first material, wherein the support body is elongated and has a longitudinal axis; One or more nodes are attached to the support body, the nodes comprising a second material, the second material being a bioactive material for release at the mammary gland to prevent mastitis.

[0010] According to another aspect, the stent insert is a dual-material assembly, wherein the first material of the stent body is different from the second material of the one or more nodes.

[0011] According to another aspect, the one or more nodes are flat and aligned with the outer wall of the support body and the longitudinal axis.

[0012] According to another aspect, each of the one or more nodes contains 10 micrograms to 100 micrograms of bioactive material.

[0013] According to another aspect, the one or more nodes are circular.

[0014] According to another aspect, the support insert includes multiple nodes.

[0015] According to another aspect, the support insert comprises four or more nodes.

[0016] According to another aspect, the support insert comprises twelve nodes.

[0017] According to another aspect, the nodes are located at both ends of the support body.

[0018] According to another aspect, the one or more nodes are located at one end of the support body.

[0019] According to another aspect, the stent insert further comprises a bioactive coating.

[0020] According to another aspect, the thickness of the bioactive coating is less than 3 micrometers.

[0021] According to another aspect, the thickness of the bioactive coating is approximately 1 micrometer.

[0022] According to another aspect, the bioactive material of the node is the same as the bioactive coating.

[0023] According to another aspect, the bioactive material is an antimicrobial agent.

[0024] According to another aspect, the bioactive material is one or a combination of copper, zinc, silver, and / or cobalt.

[0025] According to another aspect, the first material is one or a combination of nickel-titanium, titanium, and / or chromium.

[0026] According to another aspect, the support body comprises filaments to form an interwoven mesh.

[0027] According to another aspect, the support body comprises a single filament.

[0028] According to another aspect, the shape memory of the stent body allows the stent body to periodically contract and expand to adapt to the pulsation of the mammary gland.

[0029] According to another aspect, the rated load-bearing capacity of the support body is at least 100 million pulsation cycles.

[0030] According to another aspect, the length of the stent insert in the expanded state is 5 mm to 60 mm.

[0031] According to another aspect, the diameter of the stent insert in the expanded state is 2 mm to 30 mm.

[0032] According to another aspect, the stent insert collapses to less than one-fifth of its expansion diameter when it moves to the collapsed state.

[0033] According to another aspect, the stent insert includes a first open end, a second open end, and an unobstructed passage along the longitudinal axis of the stent body from the first open end to the second open end.

[0034] According to another aspect, the stent insert is configured such that milk can flow from the first opening end through the unobstructed channel to the second opening end.

[0035] According to another aspect, the present invention broadly includes a method for preventing mastitis in livestock, the method comprising: A stent insert is provided, the stent insert comprising a stent body having shape memory, the stent body having an expanded state and a collapsed state, and the stent body being at least partially elastic, wherein the stent body is coated with a bioactive material for release at the breast to prevent mastitis and / or the stent body contains nodes of the bioactive material; The scaffold insert is inserted into the mammary gland of the animal; In the expanded state, the scaffold insert is released into the mammary gland of the animal; The stent insert is left in the mammary gland of the animal; The stent insert releases the bioactive material at the breast to prevent mastitis.

[0036] According to another aspect, the method further includes leaving the scaffold insert in the mammary gland during lactation of the animal.

[0037] According to another aspect, the method further includes leaving the scaffold insert in the mammary gland during both the lactation and dry periods of the animal.

[0038] According to another aspect, the method further includes permanently leaving the stent insert in the mammary gland of the animal.

[0039] According to another aspect, the stent insert is inserted in the collapsed state.

[0040] According to another aspect, the method further includes using an introductory tool to guide the scaffold insert into the mammary gland of the animal.

[0041] According to another aspect, the stent insert is provided with a hydrophobic cover, which is removed or retracted by the introduction tool when the stent insert is released.

[0042] According to another method, the stent insert is inserted through or into the nipple duct of the animal.

[0043] According to another method, the support insert is inserted into the animal through an incision.

[0044] According to another method, the stent insert is inserted into the gland cistern of the animal.

[0045] In another aspect, the stent insert is inserted into the teat cistern of the animal. In yet another aspect, the animal is non-human.

[0046] According to another perspective, the animal in question is a cow used for milking.

[0047] According to another aspect, the stent insert includes a first open end, a second open end, and an unobstructed passage along the longitudinal axis of the stent body from the first open end to the second open end.

[0048] According to another aspect, the method further includes milking the cow, wherein milk flows through the unobstructed channel.

[0049] According to another aspect, the present invention broadly includes a method for manufacturing a stent insert, the method comprising: Forming the main body of the support; and The node is attached to the support body.

[0050] According to another approach, the attachment of the node is achieved by marking, pressing, fusion, or hydraulic pressing.

[0051] According to another aspect, the method further includes applying a bioactive coating to the scaffold insert.

[0052] According to another aspect, applying the bioactive coating onto the scaffold insert is a physical vapor deposition (PVD) process.

[0053] According to another aspect, the application of the bioactive coating onto the scaffold is a chemical vapor deposition (CVD) process.

[0054] According to another aspect, the support body is formed by laser cutting from a tube of the first material.

[0055] According to another aspect, the support body is formed by knitting or weaving the first material.

[0056] 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.

[0057] As used in this article, the term “and / or” means “and” or “or” or both.

[0058] As used in this article, the “(s)” following a noun indicates the plural and / or singular form of the noun being referred to.

[0059] As used in this specification and claims, the term "comprising" means "consisting at least in part of". When interpreting statements in this specification and claims that include such a term, the feature derived from the term in each statement must be present, but other features may also be present. Related terms such as "comprise" and "comprised" will be interpreted in the same manner. Attached Figure Description

[0060] The invention will now be described by way of example only and with reference to the accompanying drawings, in which: Figure 1 A perspective view of the support insert is shown.

[0061] Figure 2 An end view of the support insert is shown.

[0062] Figure 3 A side view of the bracket insert is shown.

[0063] Figure 4 A close-up view of a support insert with nodes is shown.

[0064] Figure 5 The construction of the node on the support insert is shown.

[0065] Figure 6 Another construction of the node on the support insert is shown.

[0066] Figure 7 This illustrates yet another construction of the node on the support insert.

[0067] Figure 8 The image shows a collapsed stent insert inserted into the glandular pool.

[0068] Figure 9 The image shows a stent insert in an expanded state, released into a glandular cisternives.

[0069] Figure 10 The image shows a collapsed stent insert inserted into the nipple cistern.

[0070] Figure 11 The image shows a stent insert in an expanded state released into the nipple cistern.

[0071] Figure 12 The coating process of coating a scaffold insert with a bioactive material is shown.

[0072] Figure 13 A perspective view of an alternative support insert without nodes is shown.

[0073] Figure 14 A perspective view of an alternative scaffold insert containing a single filament without nodes is shown.

[0074] Figure 15 A side view of an alternative support insert with a tapered end is shown. Detailed Implementation

[0075] According to such Figure 1-12 The various aspects of the invention shown herein provide a stent insert 1 for retention in the mammary gland of a livestock animal and a method for preventing mastitis in livestock animals, which will now be described.

[0076] 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 construction shown.

[0077] Function of the bracket refer to Figure 1 A scaffold insert 1 is provided for retention in the mammary gland of a livestock animal. The scaffold insert 1 is configured to be introduced and retained in the livestock animal to prevent or at least reduce the likelihood and / or severity of mastitis.

[0078] Mastitis (an inflammation of the breast) is caused by the presence of bacteria in the breast. The scaffold insert 1 is configured to release bioactive material to provide an environment where bacteria have difficulty surviving, and thus prevent mastitis.

[0079] Bioactive materials can act on bacteria through physical or chemical means and can exhibit 'contact killing,' for example, by forming bonds with and disrupting bacterial cells. The release of bioactive materials can occur in the form of biocidal ions. The use of scaffold insert 1 and the bioactive materials released therefrom may be superior to typical antibiotics in the prevention of mastitis because antibiotics may have more subtle mechanisms of action that bacteria tend to develop resistance to over time.

[0080] The stent insert 1 is adapted to be usable during lactation in livestock animals and therefore remains in the mammary gland even during milking. The stent insert 1 is adapted to allow milk flow through it via open ends and unobstructed channels between these open ends. Milking involves an inherent risk of foreign bacteria entering the mammary gland and causing mastitis infection; therefore, if the stent insert 1 is placed beforehand, this risk can be mitigated.

[0081] The stent insert 1, described in more detail, features that allow it to withstand typical breast pulsations during lactation, remain in place after insertion without requiring frequent replacement or adjustment, and prevent contamination of the breast tissue it comes into contact with.

[0082] The stent insert 1 can improve average milk yield and quality in livestock during lactation by providing sustained protection against bacterial infections, and thus increase profitability. The benefits may even outweigh those expected from simply preventing a typical number of clinical mastitis cases in a herd, as subclinical mastitis cases or other bacterial infections causing decreased milk yield / quality can be prevented when they go untreated otherwise due to a lack of visible symptoms.

[0083] Key Concept 1: Shape Memory and Elastic Materials of the Scaffold In some constructions, such as Figure 1 As shown, the stent insert 1 includes a stent body 10 with shape memory. The shape memory of the stent is provided by the stent body 10, which is formed of a first material that is at least partially elastic. Additionally, the shape memory is provided by the stent structure, wherein the stent body 10 includes filaments to form an interwoven mesh.

[0084] Interwoven networks can be formed in many different ways, for example, Figure 13 A construction with an alternative mesh structure is shown.

[0085] In alternative constructions, shape memory can be provided by a support body 10 comprising a single filament formed of a first material that is at least partially elastic. For example, Figure 14 The structure with a single filament is shown.

[0086] The support body 10 is sufficiently elastic to have both an expanded and a collapsed state. When pressure is applied to the support body 10, the support body moves to its collapsed state. In the collapsed state, the overall size of the support body insert 1 is smaller, which facilitates safe insertion into the animal (especially through narrow passages, such as through the nipple duct).

[0087] When pressure is removed from the stent body 10, the stent body moves (returns) to its expanded state. In the expanded state, the stent body 10 is in its intended default form for retention in the mammary gland (e.g., a nipple cisternion or glandular cisternion within the mammary gland). In the expanded state, the stent insert 1 can be placed in the intended location within the animal, allowing bodily fluids (e.g., milk) to pass through the stent, and / or releasing bioactive materials into the animal as intended.

[0088] The size and dimensions of the stent insert 1 are configured to allow safe introduction into the animal through the nipple duct and also to allow retention within the desired pool (i.e., nipple pool or gland pool) within the mammary gland.

[0089] After the stent insert 1 is introduced into the animal and moved to an expanded state, the shape memory of the stent body 10 allows it to periodically contract and expand to adapt to the pulsation of the mammary glands. This pulsation occurs naturally during milking, and the shape memory thereby prevents internal injury to the animal and ensures retention within the pool. Preferably, the stent insert 1 is rated for at least 100 million pulsation cycles.

[0090] In some configurations, the stent body 10 is elongated and has a longitudinal axis. In some configurations, the stent insert 1 in its expanded state has a length of 5 mm to 60 mm and a diameter of 2 mm to 30 mm.

[0091] Preferably, moving the stent insert 1 to the collapsed state primarily involves a reduction in diameter to facilitate longitudinal insertion. Preferably, the stent insert 1 collapses to less than one-fifth of its expanded diameter, more preferably even larger. For example, the diameter can collapse from an expanded 20 mm to a collapsed 1.5 mm. When moving to the collapsed state, the length of the stent insert 1 can actually be increased slightly, although alternatively, the stent insert 1 can be configured to collapse in both length and diameter.

[0092] It should be understood that the size of the scaffold insert 1 allows for safe and painless insertion into the animal, while also allowing it to remain within the animal's mammary gland and providing sufficient material for the release of significant bioactive material to prevent mastitis. Therefore, the size and degree of collapse should be selected to be suitable for the target animal.

[0093] In some configurations, the stent body 10 comprises a first material, which is one or a combination of nitinol, titanium, and / or chromium, which can produce suitable elastic properties and withstand more than 100 million pulsation cycles as needed. It should be understood that other materials with desired elastic and semi-rigid properties, known to those skilled in the art, can be used to form the stent body 10.

[0094] In some configurations, the stent body 10 is formed from a nickel-titanium alloy (e.g., nickel-titanium NiTi) with shape memory properties. The superplasticity of nickel-titanium provides structural integrity and flexibility for the intended use of the stent insert 1. Additionally, the material of the stent body 10 is rust-resistant, which is suitable for the humid conditions (within the breast) where the stent insert 1 is intended to be used.

[0095] The support body 10 can be manufactured by laser cutting from a tube of the first material (e.g., a nitinol tube) or by a knitting / braiding process.

[0096] In some configurations, the scaffold body 10 is designed to remain within the breast tissue for an extended period. In some configurations, the scaffold body 10 is designed to remain within the breast tissue permanently.

[0097] The elastic properties of the stent body 10 allow it to resist deformation, such as during breast pulsation and / or contraction with pulsation, and once inserted, it can hold the stent insert 1 in place. When the breast pulsates, the stent body 10 moves between its expanded and collapsed states. The stent body 10 returns to its initial expanded state between pulsations. This is possible, although it is anticipated that the stent will undergo millions of pulsation cycles within the breast. Specifically, pulsation is particularly frequent during lactation. The material and geometry of the stent insert 1 allow for this. In contrast, products designed for insertion only during the dry period (such as nipple sealants) are generally not designed for continuous use throughout lactation.

[0098] The material of the scaffold body 10 is semi-rigid and elastic to allow the scaffold body to collapse and expand for insertion into the animal and then remain in the site of action (a pool in the mammary gland). The material should also be non-biodegradable and non-toxic, as the scaffold insert 1 is intended for long-term use in the animal.

[0099] In some configurations, the stent insert 1 may have an opening at each end. In other words, the stent insert may have a first open end and a second open end. The stent insert 1 further includes an unobstructed channel passing through the stent insert 1 between the first open end and the second open end. The unobstructed channel allows milk flow through the stent insert 1.

[0100] refer to Figure 15 In some configurations, the support body 10 may be tapered at one or both of the first and second opening ends. In this configuration, the diameter of the support body 10 at its opening end will be smaller than the diameter of the support body 10 at its center. The tapered end of the support body 10 can increase the ease and safety of inserting the support insert 1 into the animal.

[0101] Key Concept 2: Bioactive Materials Scaffold insert 1 is a bioactive scaffold insert containing bioactive material to be released into the mammary gland to prevent and / or treat conditions and diseases originating from the animal's mammary gland, such as mastitis. It should be understood that scaffold insert 1 can prevent and / or treat other diseases or conditions associated with the mammary gland (including the nipple cistern and glandular cistern) caused by at least bacterial, viral, or fungal problems.

[0102] The scaffold insert 1 releases bioactive material directly at the target site (e.g., a pool in the mammary gland). In some configurations, the bioactive material is one or a combination of copper, zinc, silver, and / or cobalt (e.g., Cu-Zn, Cu-Zn-Ag). It should be understood that other materials with desired bioactive properties known to those skilled in the art can be used to create an unsuitable environment for bacteria. In some configurations, the scaffold insert 1 is at least partially formed of copper or a copper alloy.

[0103] In some configurations, the bioactive material is an antimicrobial agent. The bioactive material particles released at the target site provide an environment in which bacteria cannot survive. This is a different process that triggers an immune response, which occurs under stress conditions. Bioactive materials used to provide an unsuitable environment for bacterial growth are independent of the animal's immune response.

[0104] For example, in some constructions, the bioactive material is copper, which has a biocidal effect against pathogens, including bacteria and viruses. Copper (and other similar materials) can have antimicrobial effects, thus preventing bacterial growth and disposing of and destroying bacteria in situ. Copper is effective against antibiotic-resistant bacteria.

[0105] Another benefit of using copper is that it is non-toxic to animals at moderate concentrations. Copper is a metallic mineral that can be processed and excreted from the body. The copper bioactive sites or regions of the scaffold insert 1 have a positive biocidal effect against unwanted bacteria, and any released copper ions can be safely excreted from the animal's body.

[0106] It should be understood that the bioactive material provided by the scaffold insert 1, along with its specific structural form described in more detail below and its long-term use in animals during lactation, may be advantageous for the purpose of preventing bovine mastitis. The metal ions released in the mammary gland can prevent and treat the growth of bacteria that cause mastitis.

[0107] Key Concept 3: Bioactive Nodes refer to Figure 1 In some configurations, the stent insert 1 includes one or more nodes 11 attached to the stent body 10. The nodes 11 include a second material, which is a bioactive material intended for release at the breast to prevent mastitis. The nodes 11 are attached to the stent body 10 during manufacturing.

[0108] The one or more nodes 11 can be attached to the bracket 10 by a range of different methods, including marking, pressing, fusion, or hydraulic pressing. It should be understood that other pressing or fusion methods can be used to attach the nodes to the bracket body 10.

[0109] In these configurations, the scaffold body 10, formed from a first material that acts as a mesh forming the scaffold, allows for safe insertion and prolonged retention within the mammary gland as intended. Nodes 11, formed from a second material, release bioactive material to prevent mastitis. In these configurations, the structural integrity of the scaffold is not compromised because a durable material can be used for the scaffold body 10, while the nodes 11 have concentrated areas for dispersing the bioactive material. When the scaffold insert 1 is inserted into the nipple cistern or glandular cistern, the mesh-like and hollow nature of the scaffold insert 1 allows milk passage.

[0110] In these configurations, the stent insert 1 is a dual-material assembly, wherein the first material of the stent body and the second material of the one or more nodes are different.

[0111] In the illustrated construction, the scaffold insert 1 has a specific geometry to ensure safe insertion and retention in the animal while supplying sufficient bioactive material over a long period of time.

[0112] In some configurations, each of the one or more nodes contains 10-100 micrograms of bioactive material. The number of nodes and the amount of bioactive material in each node should be selected to avoid any potential toxicity to the target animal.

[0113] In some configurations, each of the one or more nodes has a diameter of approximately 2 mm and a height of approximately 2 mm.

[0114] In some configurations, the one or more nodes 11 are flat and aligned with the outer wall and longitudinal axis of the support body. For example... Figure 4 As best shown, node 11 has a flat structure, so that these nodes do not protrude in a way that could harm the animal. Figure 2 As shown in the end view, node 11 is in a straight line with the outer wall of the support body 10.

[0115] In addition, Figure 4 In some of the best-illustrated configurations, the one or more nodes 11 are again circular to improve product safety and reduce the likelihood of injury to animals, for example, due to internal punctures caused by the stent.

[0116] In some configurations, the scaffold insert 1 includes multiple nodes 11. In some configurations, the scaffold insert 1 has two or more nodes 11. In some configurations, the scaffold insert 1 has four or more nodes 11. In some configurations, the scaffold insert 1 has eight or more nodes 11. In some configurations, the scaffold insert 1 has twelve or more nodes 11. In some configurations, the scaffold insert 1 has twelve nodes 11.

[0117] In some constructions, the nodes are located at one or both ends of the support body 10. For example... Figure 1 As shown, node 11 is located at both ends of the support body. In other configurations, the one or more nodes 11 are located at one end of the support body.

[0118] In these constructions, the scaffold insert 1, comprising one or more nodes 11, can balance the intention of providing a concentrated area for dispersing bioactive materials with allowing structural integrity and shape memory provided by the material of the scaffold body 10. This is because copper (or other similar metallic materials) may be difficult to incorporate into the scaffold body 10 itself, while allowing for the elastic properties of the scaffold body. It should be understood that incorporating copper into the scaffold body 10 may not be desirable, as it may make the scaffold more brittle and therefore not provide or withstand the required manipulation of the scaffold body between expanded and collapsed states.

[0119] Key Concept 4: Bioactive Coating In some configurations, the scaffold insert 1 includes a bioactive coating. (Reference) Figure 12 The bioactive coating is applied to the stent insert 1, preferably across all stent surfaces. The bioactive material 12 is applied to the stent insert 1 to form the bioactive coating, whether by spraying or another application process. Once the stent insert 1 is inserted into an animal, this bioactive material is released into the mammary gland 30.

[0120] When applied to all scaffold surfaces, the bioactive coating can additionally prevent endothelialization, i.e., prevent excessive tissue growth on scaffold insert 1 that could eventually block the release of bioactive material at additional isolation sites (e.g., if node 11 were used without the bioactive coating).

[0121] In one configuration, the bioactive coating is 1 micrometer thick and contains 1 to 3.5 grams of bioactive material on the scaffold surface. The total mass of the bioactive coating will depend on the total surface area of ​​the scaffold, the coating material, and the coating thickness. These factors should be selected to avoid negatively impacting the elasticity of the scaffold body 10 and thus its shape memory. Preferably, the coating thickness is no greater than 3 micrometers.

[0122] In some configurations where one or more nodes 11 are present on the scaffold insert 1, the bioactive material of the nodes may be the same as that of the bioactive coating. In other configurations, the bioactive material of the nodes differs from that of the bioactive coating. In any case, the previously described bioactive material (i.e., copper, zinc, silver, cobalt, or combinations thereof) would be a suitable choice for the bioactive coating.

[0123] In some configurations, the scaffold insert 1 is covered with a nanocoating. The nanocoating of the bioactive material allows it to bind effectively to the scaffold body 10 and resists coating rupture when the scaffold insert 1 is manipulated between an expanded and collapsed state.

[0124] The process for applying the bioactive coating to the scaffold insert 1 can be a physical vapor deposition (PVD) process or, alternatively, a chemical vapor deposition (CVD) process. PVD and CVD processes allow for the application of very fine, thin coatings without cracking, which is a problem for other coating processes such as spraying.

[0125] The bioactive coating is an additional or alternative source of biomaterial for the scaffold insert 1, which is configured to be released in the mammary gland to prevent mastitis.

[0126] In some constructions, for example Figure 13 , 14 As shown in 15, the scaffold insert 1 may not have node 11, but instead rely on the bioactive coating as the sole source of bioactive material.

[0127] Key Concept 5: Prevention Methods, Locations, and Operating Periods Having described the structure of the stent insert 1 and its formation method above, a general description of the method of using the stent insert 1 to prevent mastitis in livestock animals will now be described.

[0128] To prevent mastitis in livestock, the aforementioned stent insert 1 is provided. The stent insert 1 is inserted into the animal's mammary gland in a collapsed state. In an expanded state, the stent insert 1 is released into the animal's mammary gland 30.

[0129] like Figures 8 to 11 As shown, in some configurations, an introduction tool 20 is used to introduce the stent insert 1 into the animal. The introduction tool 20 is inserted into the stent insert 1 through a narrow passage within the animal's body and releases the stent insert to the target location to function. In some configurations, the stent insert 1 is introduced through a passage such as... Figure 8 and 10 The nipple duct 31 of the animal mentioned in the text is inserted. The insertion method can utilize the insertion tool 20 and a camera to locate the precise target position for release.

[0130] During insertion, the stent insert 1 can be covered with a hydrophobic covering, which helps to keep the stent insert in a collapsed state. The introduction tool 20 can retract / remove the hydrophobic covering during the release of the hydrophobic covering into the target location.

[0131] In other configurations, the support insert 1 is inserted into the animal through an incision.

[0132] In some configurations, the stent insert 1 is left in the mammary gland 30 of the animal. Once the stent insert 1 is left in the mammary gland, it releases bioactive material at the mammary gland site to prevent mastitis.

[0133] like Figure 8 and 9 As shown, in some configurations, the stent insert 1 is inserted into the gland pool 32 of the animal.

[0134] In other constructions, such as Figure 10 and 11 As shown, the support insert 1 is inserted into the nipple pool 33 of the animal.

[0135] The stent insert 1 is configured for insertion into livestock. The stent insert 1 is intended for non-human use. Specifically, the stent insert 1 is designed for use with milking cows. For example, milking animals / cows may include cows, goats, sheep, deer, etc. These animals supply milk and may experience problems due to the growth of mammary gland bacteria.

[0136] The stent insert 1 can be left in the animal for an extended period of time. During lactation, the stent insert 1 can be left in the mammary gland 30.

[0137] During both the lactation and dry periods of an animal, the scaffold insert 1 can be left in the mammary gland 30.

[0138] In some configurations, the stent insert 1 is permanently left in the animal's mammary gland 30. The stent insert 1 can be retrieved if necessary and can be recovered at any retrieval time (including at the time of animal slaughter).

[0139] In some configurations, the stent insert 1 is configured such that when the stent insert 1 is located in the mammary gland of an animal, milk can flow from an opening at one end through the stent insert 1 to an opening at the other end.

[0140] Although the invention has been described with respect to stent placement in the mammary gland and treatment of mastitis or other such infections, it will be understood that the stent insert 1 can also be adapted for use in other locations within the animal body. For example, the stent insert 1 can be placed in the vascular system and thus release bioactive materials (and / or other drugs) directly into the bloodstream.

[0141] For those skilled in the art, many variations in construction and a wide range of different embodiments and applications of the invention will be apparent without departing from the scope of the invention as defined by the appended claims.

[0142] The invention can also be broadly described as comprising any or all combinations of any two or more of the parts, elements, and features mentioned or indicated individually or collectively in the description of this application, and when a particular integer having a known equivalent in the relevant field of the invention is mentioned herein, such known equivalents are considered to be incorporated herein as if described separately.

Claims

1. A stent insert for retention in the mammary gland of a livestock animal, the stent insert comprising: The support body has shape memory, has an expanded state and a collapsed state, and comprises at least partially elastic first material, wherein the support body is elongated and has a longitudinal axis; One or more nodes are attached to the support body, the nodes comprising a second material, the second material being a bioactive material for release at the mammary gland to prevent mastitis.

2. The stent insert according to the preceding claim, wherein the stent insert is a dual-material assembly, wherein the first material of the stent body is different from the second material of the one or more nodes.

3. The stent insert according to any one of the preceding claims, wherein the one or more nodes are flat and aligned with the outer wall of the stent body and the longitudinal axis.

4. The stent insert according to any one of the preceding claims, wherein each of the one or more nodes comprises 10 micrograms to 100 micrograms of bioactive material.

5. The support insert according to any one of the preceding claims, wherein the one or more nodes are circular.

6. The stent insert according to any one of the preceding claims, wherein the stent insert comprises a plurality of nodes.

7. The stent insert according to any one of claims 1 to 6, wherein the stent insert comprises four or more nodes.

8. The stent insert according to the preceding claim, wherein the stent insert comprises twelve nodes.

9. The stent insert according to any one of the preceding claims, wherein the nodes are located at both ends of the stent body.

10. The stent insert according to any one of claims 1 to 8, wherein one or more nodes are located at one end of the stent body.

11. The stent insert according to any one of the preceding claims, further comprising a bioactive coating.

12. The stent insert according to the preceding claim, wherein the thickness of the bioactive coating is less than 3 micrometers.

13. The stent insert according to the preceding claim, wherein the thickness of the bioactive coating is approximately 1 micrometer.

14. The stent insert according to any one of claims 11 to 13, wherein the bioactive material of the node is the same as the bioactive coating.

15. The stent insert according to any one of the preceding claims, wherein the bioactive material is an antimicrobial agent.

16. The stent insert according to any one of the preceding claims, wherein the bioactive material is one or a combination of copper, zinc, silver and / or cobalt.

17. The stent insert according to any one of the preceding claims, wherein the first material is one or a combination of nitinol, titanium and / or chromium.

18. The stent insert according to any one of the preceding claims, wherein the stent body comprises filaments to form an interwoven mesh.

19. The stent insert according to any one of the preceding claims, wherein the shape memory of the stent body allows the stent body to periodically contract and expand to adapt to the pulsation of the mammary gland.

20. The stent insert according to the preceding claim, wherein the rated load-bearing capacity of the stent body is at least 100 million pulsation cycles.

21. The stent insert according to any one of the preceding claims, wherein the length of the stent insert in the expanded state is 5 mm to 60 mm.

22. The stent insert according to any one of the preceding claims, wherein the diameter of the stent insert in the expanded state is 2 mm to 30 mm.

23. The stent insert according to any one of the preceding claims, wherein the stent insert collapses to less than one-fifth of its expansion diameter when moved to the collapsed state.

24. The stent insert according to any one of the preceding claims, wherein the stent insert includes a first open end, a second open end, and an unobstructed passage along the longitudinal axis of the stent body from the first open end to the second open end.

25. The stent insert of claim 24, wherein the stent insert is configured such that milk can flow from the first opening end through the unobstructed channel to the second opening end.

26. The stent insert according to any one of the preceding claims, wherein the stent body is tapered at the first opening end or the second opening end or both.

27. A method for preventing mastitis in livestock, the method comprising: A stent insert is provided, the stent insert comprising a stent body having shape memory, the stent body having an expanded state and a collapsed state, and the stent body being at least partially elastic, wherein the stent body is coated with a bioactive material for release at the breast to prevent mastitis and / or the stent body contains nodes of the bioactive material; The scaffold insert is inserted into the mammary gland of the animal; In the expanded state, the scaffold insert is released into the mammary gland of the animal; The stent insert is left in the mammary gland of the animal; The stent insert releases the bioactive material at the breast to prevent mastitis.

28. The method according to the preceding claim, further comprising leaving the stent insert in the mammary gland during lactation of the animal.

29. The method according to the preceding claim, further comprising leaving the scaffold insert in the mammary gland during both the lactation and dry periods of the animal.

30. The method according to the preceding claim, further comprising permanently leaving the stent insert in the mammary gland of the animal.

31. The method according to any one of claims 27 to 30, wherein the stent insert is inserted in the collapsed state.

32. The method according to any one of claims 27 to 31, further comprising guiding the scaffold insert into the mammary gland of the animal using an introductory tool.

33. The method according to the preceding claim, wherein the stent insert is provided with a hydrophobic cover, and when the stent insert is released, the hydrophobic cover is removed or retracted by the introduction tool.

34. The method of claim 32 or 33, wherein the stent insert is inserted through or into the nipple duct of the animal.

35. The method according to any one of claims 27 to 31, wherein the stent insert is inserted into the animal through an incision.

36. The method according to any one of claims 27 to 35, wherein the stent insert is inserted into the mammary cistern of the animal.

37. The method according to any one of claims 27 to 35, wherein the stent insert is inserted into the teat cistern of the animal.

38. The method according to any one of claims 27 to 37, wherein the animal is non-human.

39. The method according to the preceding claim, wherein the animal is a cow used for milking.

40. The method of any one of claims 27 to 39, wherein the stent insert comprises a first open end, a second open end, and an unobstructed passage along the longitudinal axis of the stent body from the first open end to the second open end.

41. The method according to any one of the preceding claims, further comprising milking the cow, wherein milk flows through the unobstructed channel.

42. The method according to any one of claims 27 to 41, wherein the support body is tapered at the first opening end or the second opening end or both.

43. A method of manufacturing a stent insert according to any one of claims 1 to 26, the method comprising: Forming the main body of the support; and The node is attached to the support body.

44. The method according to the preceding claim, wherein attaching the node is achieved by marking, pressing, fusion or hydraulic pressing.

45. The method of claim 43 or 44, further comprising applying a bioactive coating to the stent insert.

46. ​​The method according to the preceding claim, wherein applying the bioactive coating onto the scaffold insert is a physical vapor deposition (PVD) process.

47. The method of claim 45, wherein applying the bioactive coating onto the scaffold is a chemical vapor deposition (CVD) process.

48. The method according to any one of claims 43 to 47, wherein the support body is formed by laser cutting from a tube of the first material.

49. The method according to any one of claims 43 to 47, wherein the support body is formed by knitting or weaving the first material.

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