Dissolvable medical sharps

EP4801388A2Pending Publication Date: 2026-09-09HEMINGWAY DESIGNS LLC
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Patent Information

Application Number
EP2024785916
Authority / Receiving Office
EP · EP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-04-07
Filing Date
2024-04-07
Publication Date
2026-09-09

AI Technical Summary

Technical Problem

The disposal of single-use disposable medical devices with sharp components poses environmental pollution and safety hazards due to the inability to recycle metal and plastic components, leading to improper disposal and increased risk of infection and injury.

Method used

Development of dissolvable medical sharps made from magnesium or magnesium alloys that degrade in aqueous solutions, allowing safe disposal without special handling, combined with biodegradable or recyclable plastic components for environmentally friendly disposal.

Benefits of technology

Eliminates the risk of injury from sharp components and reduces environmental pollution by enabling safe disposal of medical waste without specialized containers, while allowing for recycling of plastic components.

✦ Generated by Eureka AI based on patent content.

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Abstract

Embodiments of single-use medical devices incorporating a medical sharp, such as an injection needle or a lancet blade, are described herein. The dissolvable sharps are destroyed by treatment with a weak acid, including nontoxic weak acids commonly found in a typical household, facilitating safe disposal in household trash. Other components forming the single-use disposable medical devices include disclosed herein include bioplastics and other compostable or rapidly degradable environmentally friendly materials.
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Description

DISSOLVABLE MEDICAL SHARPSREFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority of U.S. Provisional Application No. 63 / 458,058 entitled “Single-Use Disposable Medical Device with Dissolvable Magnesium / Magnesium Alloy Sharp” fded on April 7, 2023, the disclosures of which are incorporated herein by reference in their entirety.BACKGROUNDTechnical Field

[0002] The disclosures herein relate to alternative construction of single-use disposable medical devices. Specifically, a plurality of disposable medical devices having a sharp component configured for dissolution, thus facilitating disposal in an ecologically friendly manner are provided.State of the Art

[0003] Single-use, disposable medical devices designed for home use by patients and caregivers has become commonplace. Many of these devices incorporate what is commonly referred to as a “sharp,” which is a metal component comprising a point or edge configured to pierce or cut the skin. The sharp component is mounted on a larger device body which is made of other components, typically plastic. The sharp component it formed from steel or other alloys containing nickel and chromium. Examples of such single-use disposable medical devices incorporating a sharp include lancets for home blood glucose testing, pen needles for mounting on multi-dose pen injectors, single-use syringes and pre-filled syringes, disposable scalpels, and removable needles (Luer-lock and Luer-slip) for use with syringes and infusion sets.

[0004] Because of the proliferation in home health care over the last several decades, a tremendous and growing amount of medical waste comprising disposable sharps and plastic device bodies is generated annually. Based on figures released by the International Diabetes Federation in 2021 and other published data showing that diabetics tend to use an average of 1-3 needles per day, an estimated fifteen to twenty billion disposablelancets, 20-30 billion disposable pen needles, and an additional 20-30 billion disposable syringes are used by patients and caregivers outside of healthcare facilities each year. Because the metallic sharp component is generally fused with a plastic supporting component, such as a needle hub or lancet body, neither the plastic nor the metal can be recycled. This vast amount of medical waste ends up in landfills or the broader environment, thus adding to the global plastic waste burden and increasing environmental pollution generally.

[0005] Moreover, contaminated sharps contaminated with blood or other body fluid are potentially infectious. This creates hazards for both infection and injury arising from accidental skin puncture to household members, caregivers, and sanitation workers. Consequently, disposal of medical sharps is heavily regulated. Proper, safe disposal requires collection of sharps in a designated sealable plastic or metal “sharps” container. The sharps containers must comply with specific labeling, handling, and transportation requirements for transfer to a processing site designated for medical sharps disposal. Specific guidelines for safe handling and disposal of used sharps are issued by manufacturers and federal, state, and local government regulatory agencies. Device instructions typically warn of the hazards of disposal in household trash or recycling. Regardless, many consider such requirements unduly burdensome. It is estimated through survey data that around one third of diabetics receiving home insulin throw their used lancets, needle-bearing syringes, pen needles, and other sharps in the household trash or recycling.

[0006] These and other unsafe practices result in over 850,000 injuries annually in the United States and Canada from unsafe disposal of home-use sharps. Unsafe disposal is not just a problem in the United States. Studies report rates of unsafe disposal as high as 90% in China and over 85% in India. A recent review reported similar rates in other regions of the world, including Africa, South America, and United Kingdom, the Middle East, and Europe. In many of these regions, a safe disposal infrastructure is not available to most users, leaving disposal of sharps with household trash as the only viable option.

[0007] Consequently, for at least the foregoing reasons, there is a need to remove metal “sharp” components from disposable medical devices to reduce infections risk andphysical injury while simultaneously allowing plastic components to be recycled, thus mitigating environmental plastics pollution and overcoming other deficiencies discussed herein above.BRIEF SUMMARY

[0008] Disclosed herein are embodiments of devices and method incorporating dissolvable medical sharps to facilitate safe diposal of single-use medical devices. . The features and advantages of the invention will be apparent to those of ordinary skill in the art from the following more particular description of several example embodiments of the disclosed system and methods, and the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1A is a perspective view of a medical device comprising a dissolvable medial sharp;

[0010] FIG. IB is a perspective view of a safety cap for coupling together two medical devices;

[0011] FIG. 1C is a perspective view of a plurality of medical devices coupled together for disposal;

[0012] FIG. 2A is a perspective view of an additional embodiment of a medical device comprising a dissolvable medical sharp;

[0013] FIG. 2B is a cutaway view of the additional embodiment of a medical device comprising a dissolvable medical sharp shown in FIG. 2A;

[0014] FIG. 3A is a perspective view of an alternative additional embodiment of a medical device comprising a dissolvable medical sharp;

[0015] FIG. 3B is a partial cutaway view of a different alternative embodiment of a medical device comprising a dissolvable medical sharp incorporating an all-metal design;

[0016] FIG. 3C is a perspective view of a plurality of medical devices coupled together in a stack for disposal;

[0017] FIG. 4A is an yet another additional embodiment of a medical device comprising a dissolvable medical sharp;

[0018] FIG. 4B is a cutaway view of the device shown in FIG. 4A;

[0019] FIG. 5 is a perspective view of an additional embodiment of a medical device comprising a dissolvable medical sharp;

[0020] FIG. 6 is a perspective view of yet another embodiment of a medical device comprising a dissolvable medical sharp;

[0021] FIG. 7 is an illustration of a solvent for treating a medical device comprising a dissolvable medical sharp; and

[0022] FIG. 8 is a diagram of a method for disposing of a medical device comprising a dissolvable medical sharp.DETAILED DESCRIPTION

[0023] Various example embodiments of a single-use dissolvable medical devices incorporating a metal component with a point or an edge; i.e., “sharp,” are disclosed herein.

[0024] Some non-limiting examples of dissolvable medical sharps include needles (solid or hollow) and blades, such as lancets and scalpel blades. The medical sharp-component of the medical device is formed from a metal or metal alloy that fully degrades into a metal salt soluble in an aqueous solution of any one or combination of commonly available, nontoxic, non-hazardous drain-safe household liquids. Following dissolution, the sharp is effectively destroyed and no longer presents an injury hazard or requires special handling pursuant to government regulations or even common-sense safety practices. In some embodiments, remaining non-metallic components of the single-use medical device are formed from biodegradable plastics, such as polyethylene terephthalate (“PET”) and high-density polyethelyene (“HDPE”) that are more easily recycled in a conventional material recovery facility; bioplastics such as polyhydroxyalkanoates (“PHA”), polyhydroxy butyrate (“PHB”), and polylactic acid (“PLA”) which are compostable; pulp and cellulose fiber materials such as bamboo, bagasse, sawdust, and dry-or-wet molded cellulose fiber which are sustainable and compostable, or otherwise rapidly degradable. Alternatively repeatedly recyclable metals such as steel and aluminum are used, in some embodiments.

[0025] Example embodiments provide single-use disposable standard lancets, safety lancets, injection pen needles, Luer lock and Luer slip needles, syringes with integratedneedles, and scalpels. The various embodiments incorporate a dissolvable metal medical sharp made from magnesium or magnesium-containing alloys.

[0026] In some embodiments, the sharp is incorporated into the medical device using alternative nonmetallic, non-dissolvable supporting components that are rapidly biodegradable, more easily recycled, or metallic supporting components that are more repeatedly recyclable than conventional non-metallic plastic components. Examples of multiply recyclable metals include steel and aluminum. A method of disposal using a dissolvable medical sharp is provided wherein the sharp is first introduced into a solvent to dissolve the metal components, whereupon hazard of injury by the sharp is eliminated. Any remaining, undissolved non-metallic components of the used medical device are retrieved from the solvent and disposed of safely in the household trash, by recycling, or by composting as the type of remaining material warrants. The solvent can be stored for further use or safely disposed of via the household septic or sewer system.Definitions:

[0027] As used herein, “medicament” means an any composition, compound, drug, or other substance used for medical treatment of a disease or condition.

[0028] As used herein, “distal” refers to a direction away from a more central part.

[0029] Details of a dissolvable share disposal system are disclosed with reference to the several drawing figures.

[0030] FIGs 1-6 are examples of dissolvable medical sharps.

[0031] FIG. 1A is a perspective view of a medical device comprising a dissolvable medial sharp; FIG. IB is a perspective view of a safety cap for coupling together two medical devices; and FIG. 1C is a perspective view of a plurality of medical devices coupled together for disposal. FIGs. 1A-C show an example medical device 100 having a dissolvable medical sharp 105 incorporated into a supporting component 110. The example device 100 is a disposable, single-use lancet. The lancet is possibly the most commonly used disposable single-use medical device incorporating a medical sharp in the world, used for daily blood glucose testing. The user grasps supporting component 110 and punctures their skin with sharp 105, usually on the fingertip, whereupon a capillary blood sample is collected to test the user’s blood glucose level. Device 100, a lancet, in this example, requires safe disposal after a single use. Also shown are a slot135, which is a groove extending completely through supporting component 1 10 exposing sharp 105 at one ore more points along its length within component 110 to the action of a dissolving solvent.

[0032] Also shown in FIGs. 1B-C is safety cap 136. In some embodiments, safety cap 136 couples together multiple medical devices 100 for safe storage and convenience. In some embodiments, safety cap 136 is formed from a biodegradable plastic or multiple- recyclable metal.

[0033] FIG. 2A is a perspective view of an additional embodiment of a medical device comprising a dissolvable medical sharp; and FIG. 2B is a cutaway view of the additional embodiment of a medical device comprising a dissolvable medical sharp shown in FIG. 2A. FIGs. 2A-B show medical device 100 comprising a safety lancet. The safety lancet having medical sharp 105 mounted within supporting component 110 and having additional components including an actuator mechanism with a cap 1102 and a spring 139. Device 100 includes dissolvable sharp 105 housed within supporting component 110, shown in cross-section by FIG. 2B. A housing 1101 is also a form of supporting component 110, in some embodiments. The example embodiment, and some other embodiments of device 100, additional comprise other metallic components that are not medical sharps, such as a spring 139. Actuation mechanisms comprising spring 139 are incorporated into a variety of embodiments of single-use medical devices 100, including the safety lancet (as shown in FIGs. 2A-B) and other self-injector devices. FIG. 2A shows device 100 coated with a barrier coating 160. Barrier coating 160 acts to protect supporting components 110 of device 100 from contamination with blood or other biological fluids which may be infectious and is discussed in greater detail below following description of the several drawing figures. Barrier coating 160, in some but not all embodiments, is applied to supporting component 110 an any of the several embodiments of device 100 discussed herein prior to use of device 100.

[0034] In some embodiments, spring 139 is formed from magnesium or a magnesium alloy. In some embodiments, the magnesium alloy comprised by spring 139 is the same alloy comprised by medical sharp 105. In some embodiments, sharp 105 and spring 139 are formed by magnesium alloys having different concentrations of magnesium between at least 80% and about 100%. Several embodiments of device 100 other than the examplesafety lancet shown in FIGs. 2A-B comprise spring 139 formed from a dissolvable magnesium-containing alloy.

[0035] FIG. 3A is a perspective view of an alternative additional embodiment of a medical device comprising a dissolvable medical sharp; FIG. 3B is a partial cutaway view of a different alternative embodiment of a medical device comprising a dissolvable medical sharp incorporating an all-metal design; and FIG. 3C is a perspective view of a plurality of medical devices coupled together in a stack for disposal. FIGs. 3A and FIG. 3C show medical device 100 in the form of a pen needle comprising dissolvable medical sharp 105 and supporting component 110. FIG. 3B is a cross-sectional view of an alternative embodiment of device 100 incorporating an all-medal design. Supporting components 110 are formed from magnesium or magnesium allow, such that the complete device 100 shown in FIG. 3B can be dissolved by solvent 120 without the need for handling supporting component 110 by disposal, composting, or recycling. FIG. 3C shows three devices 100 coupled together in a stacked configuration with component 110 as an upper device forming a cap for sharp 105 of the lower device in the stack. Pen needle devices are commonly used with multidose injection pens such as those commonly used for home insulin injection in the treatment of diabetes. In some embodiments sharp 105 is formed from a hollow magnesium or magnesium alloy needle and fixedly coupled to a supporting component 110 hub made from a rapidly biodegradable plastic or a multiply recyclable metal. In some embodiments, including the embodiment of device 100 shown in FIG. 3B,

[0036] FIG. 4A is an yet another additional embodiment of a medical device comprising a dissolvable medical sharp; and FIG. 4B is a cutaway view of the device shown in FIG. 4A. FIGs. 4A-B show medical device 100 in the form of a Luer-slip needle comprising dissolvable medical sharp 105. A hollow magnesium or magnesium alloy needle forms sharp 105 which is fixed to a needle hub portion 140 formed from supporting component 110. As the cross-sectional view of FIG. 4B show, supporting component 110 formed as a unitary body with hub portion 140 in this and some other embodiments of device 100. Hub portion 140 is conically shaped and dimensioned according to international standards for the Luer needle hub coupling design for coupling to a standard syringe,fluid tubing, or other related device for handling or delivering fluid medicaments, intravenous fluids, and the like.

[0037] FIG. 5 is a perspective view of an additional embodiment of a medical device comprising a dissolvable medical sharp. FIG. 5 shows device 100 having a dissolvable sharp 105 and multiple supporting components 110. Device 110, in this and some embodiments, is a single-use syringe. In some embodiments, device 100 is a pre-fdled syringe wherein the syringe is delivered from the pharmacy comprising a “pre-fdled” liquid medicament for injection. The needle forming medical sharp 105 is made from magnesium or magnesium alloy, in some embodiments, and is fixed to supporting components 110 forming an integrated device, as shown. Integrated syringe-needle devices are often used for self-injection of insulin by persons with diabetes and are used with other medicaments to treat other medical conditions, in some embodiments.

[0038] FIG. 6 is a perspective view of yet another embodiment of a medical device comprising a dissolvable medical sharp. FIG. 6 shows device 100 having a dissolvable sharp 105 and supporting component 110. Device 110, in this and some embodiments, is a single-use scalpel. The integrated blade forming dissolvable sharp 105 is made from magnesium or magnesium alloy having a total magnesium concentration of between about 80% and about 100%. Single-use scalpels are often used for minor medical procedures both inside and outside of a hospital setting. Supporting component 110 comprises a handle which may be formed from a rapidly biodegradable plastic or multiply recyclable metal, in some embodiments.

[0039] FIG. 7 is an illustration of a solvent for treating a medical device comprising a dissolvable medical sharp. FIG 7 shows solvent 120, the characteristic of which are discussed in detail herein. Any of the embodiments of medical device 100 shown in FIGs. 1-6 and discussed herein may be disposed following a single use by submerging all portions of medical sharp 105 comprised by device 100 in a liquid solvent 120. Following use, the single-use device 100 is submerged in the nontoxic, nonhazardous, drain-safe liquid forming solvent 120 capable of degrading sharp 105. Once sufficient time has passed for solvent 120 to dissolve sharp 105 to pose no risk as a sharps hazard, the remainder of device 100 comprising supportive component(s) 110 can be disposed of as normal household wase, either in the trash, by recycling, or by composting ifappropriate appropriated compostable materials are used to form components(s) 1 10. Solvent 120 may be safely retained for future use or disposed of according to common recommended household practices. Typically, solvent 120 is drain-safe and is disposed of through the household sewer or septic system.

[0040] A dissolvable sharp processing disposal method utilizes solvent 120 and medical sharp 105 formed from a metal alloy that dissolves in the solvent. Solvent 120 in some embodiments, is a weak acid having a pH between about 2.0 and about 3.0. Some nonexclusive examples of compounds suitable for use as a solvent 120 include household vinegar, which comprises a 4% - 6% aqueous solution of acetic acid and has a pH of about 2.3-2.5. Lemon juice, lime juice, and cranberry juice all have a pH of between about 2.0 and about 2.5 depending on the concentration of citric acid in the juice, which is variable. The use of other non-toxic weak acids having a pH of between about 2.0 and about 3.0 are considered within the scope of the methods disclosed herein.

[0041] In some embodiments, solvent 120 is a weak acid having a pH between about 3.0 and about 4.0. A nonexclusive example is the comestible sold as “soda water,” which is carbonated water having a pH higher than household vinegar and the citrus juices mentioned herein but still of sufficient acidity to dissolve magnesium and magnesium alloys in less than about 24 hours.

[0042] Various alloy compositions incorporating magnesium are suitable for forming medical sharp 105 in the embodiments discussed herein, and in some other embodiments, so long as the alloy contains a magnesium concentration of at least about eighty percent (80%). In some embodiments, the magnesium concentration of the alloy is between about 80% and about 85%. In some embodiments, the magnesium concentration of the alloy is between about 85% and about 90%. In some embodiments, the magnesium concentration of the alloy is between about 90% and about 95 %. In some embodiments, the magnesium concentration of the alloy is greater than about 95%.

[0043] Other metals that are known to rapidly degrade (meaning dissolve in less than about 24 hours) in a weak acid having a pH between about 2.0 and about4.0may be incorporated into the magnesium-containing alloy but in relative amounts less than about twenty (20) percent of the total composition. Incorporating other metals at relative amounts within the total alloy composition greater than about 20% correspondinglyreduces the relative amount of magnesium less than about 80% and has the effect of increasing the sharp dissolution time to greater than twenty-four (24) hours. Zinc is one example of a metal that reacts with a weak acid, but at rates two to three orders of magnitude slower than magnesium, which is unacceptable for devices incorporating a dissolvable sharp component. Dissolution times longer than about 24 hours may considered inconvenient for some users, with the effect of decreasing use in favor of simply disposing of sharps in the household trash. Degradation albeit with incomplete dissolution is acceptable so long as the sharp 105 is substantially destroyed.

[0044] Magnesium metal alloys generally have lower tensile strength and ductility compared to the stainless steel alloys used to manufacture conventional lancets, needles, scalpels, and other single-use medical sharps. Regardless, magnesium and magnesium alloys are suitable for medical use applications because of their low density and elastic modulus, degradability, and proven biological and biomechanical compatibility.Magnesium and its alloys are non-toxic and are incorporated into many implantable medical devices, including cardiovascular stents, orthopedic implants, and others.

[0045] FIG. 8 is a diagram of a method for disposing of a medical device comprising a dissolvable medical sharp. FIG 8 shows method 200 comprising a step 210 using a single-use medical device having a dissolvable sharp; a submerging step 220 placing the dissolvable sharp portion of the used medical device in a solvent comprising a weak acid having a pH between about 2.0 and about 4.0; and a disposing step comprising disposing of undissolved supporting components of the medical device in an environmentally responsible manner such as recycling or composting.

[0046] By using vinegar or other household weak acids to dissolve the metal sharp in single-use disposable medical devices used outside healthcare facilities, the need for a sharps container for disposal is no longer needed. The remaining non-dissolved components of the medical device can be disposed of using means more readily available to households, such as household trash. Further, as vinegar also acts as a cleaning agent and a mild disinfectant, the remaining undissolved components may be disposed of in a more environmentally friendly fashion such as recycling or composting. The components may also be suitable for reuse in the medical device manufacturing process.

[0047] If it is determined that the undissolved components cannot be recycled because a risk of contamination remains even following immersion in vinegar, the method of disposal can include a secondary cleaning and disinfection step using a 3% solution of hydrogen peroxide, another commonly available nonhazardous, nontoxic, drain-safe cleaner and disinfectant found in the home.

[0048] As an alternative to a secondary cleaning and disinfection step, the remaining non-dissolvable supporting components can be coated with a barrier coating during the manufacturing process that is soluble in a weak acid. Examples of barrier coatings include waxes such as carnauba and beeswax, and chitosan. The barrier coating isolates the medical device supporting components 110 components from potentially infectious biological fluids encountered during use of medical device 100. Using solvent 120 to dissolve the barrier coating at the same time as medical sharp 105 allows supporting component(s) 110 to be disposed of in a more environmentally friendly manner or potentially reused in the medical device manufacturing process.

[0049] As the undissolved components can now be safely returned to production processes, a more judicious choice of materials for the non-dissolvable components can be made. Recyclability of the plastics typically used in medical sharps has historically not been a design consideration. In some of the embodiments presented herein, plastics with a higher degree of recyclability can now be considered in the design. PET, particularly transparent PET, and HDPE are examples of more highly recyclable plastics which have been shown to be able to undergo a higher number of recycling loops before significant degradation of mechanical properties. Transparent PET is a preferred material of comestible drink bottlers and is readily retrieved in most municipal material recovery facilities. Many bottlers have committed to a greater use of recycled PET in their products. Many supporting components 110, including a lancet body, a lancet cap, a safety lancet housing, a needle body and plunger, a pen needle hub portion 140, Luer slip needle hub portion 140, syringe with integrated needle hub portion 140, syringe barrel and plunger, and a scalpel handle are all examples of supporting components 110 that can be manufactured from PET or HDPE. A further advantage of transparent PET is to allow the user of device 100 to receive visual confirmation that medical sharp 105 hassufficiently dissolved by solvent 120 to allow for disposal with non-medical routine non- hazardous household waste.

[0050] Regardless of choice of material forming supporting component 110, some embodiments display a resin symbol to guide sorting at material recovery facilities. A resin symbol is typically embossed on a plastic component 110, such as shown on the lancet safety cap 1102 by FIG. 2A, for example.

[0051] The supporting components 110 of the embodiments described herein are generally of small size and run the risk of falling through the standard screen size for sorting screens used at material recovery facilities. Accordingly, some embodiments may incorporate features to link non-dissolvable supporting components 110 together to reach overall dimensions of a sufficient size to survive the sorting process. A safety cap 136 as shown in FIG. IB features two caps which can receive the end of two lancet bodies, as shown in FIG. 1C. This allows the used lancets to be linked together as shown in FIG. 1C, forming an aggregate volume sufficient to meet the size criteria for screening at material recovery facilities. Similarly, FIGs. 3A-Cshow device 100 comprising a pen needle with an annular snap-fit feature, wherein a male rim disposed on the upper outer aspect of a first lower pen cap in a stack fitting into a female groove disposed on the lower inner aspect of a second upper pen cap in a stack of coupled, used pen caps. FIG.3C shows three used pen needle hubs stacked together to achieve dimensions sufficient to meet the size criteria for screening at material recovery facilities.

[0052] The non-dissolvable components 110 of many embodiments disclosed herein may be constructed from renewable bioplastics which are compostable, such as PLA, PHA, or PHB, for example. The non-dissolvable components may also be constructed from renewable, recyclable, or compostable pulp or other cellulosic fiber, such as bagasse, bamboo, or sawdust. Common forming techniques for cellulosic fiber which may be employed in the manufacturing of the non-dissolvable components include compression molding, wet molding, and dry molding.

[0053] The non-dissolvable components of the embodiments may alternatively be constructed from multiply recyclable metals. Metals, such as steel alloys and aluminum has the advantage of being able to undergo a high number of recycling loops.

[0054] The non-dissolvable components of the embodiments may alternatively be formed from advanced ceramics, such as silicon nitride, zirconia, or alumina. The use of advanced ceramics may allow the non-dissolvable supporting components 110 to be reused in the manufacturing process of devices 100. Ceramics are highly durable and can withstand high temperatures. The non-dissolvable supporting components 110 can be returned to the manufacturer, cleaned, inspected and reintegrated into the manufacturing process.

[0055] Some embodiments of device 100 are formed completely from a dissolvable metal. An all-metal lancet may include a dissolvable metal body. An all-metal pen needle may include a dissolvable metal inner hub portion 120 and body. Device 100 constructed completely from dissolvable metal has the advantage of eliminating any post-use disposal steps following dissolution in solvent 120.

[0056] For embodiments of device 100 that include multiple non-dissolvable components that are made from 2 or more materials, device 100 may include a dissolvable metal mechanism that allows the device to be disaggregated only after the dissolvable metal has been degraded. FIGs. 2A-B show device 100 comprising a safety lancet with a housing and a cap. An annular groove in the outer surface of the housing and the inner surface of the cap contains a retaining ring made of the same dissolvable metal as sharp 105. Slots in the cap facilitate exposure of the retaining ring to solvent 120. After sharp 105 metal components have been dissolved by solvent 120, the cap can be removed from the housing and the non-dissolvable internal components such as the needle body, plunger, and springs 139 comprised by an actuation and needle retraction mechanism can be removed and recycled separately.

[0057] Several embodiments of a dissolvable medical sharps device and methods for disposal have been presented. The embodiments and examples set forth herein were presented in order to best explain the present invention and its practical application, and to thereby enable those of ordinary skill in the art to make and use the invention. However, those of ordinary skill in the art will recognize that the foregoing description and examples have been presented for the purpose of illustration and example. The description as set forth is not intended to be exhaustive or to limit the invention to theprecise form disclosed. Many modifications and variations are possible, in light of the teachings herein above.

Claims

CLAIMSWhat is claimed is:

1. A single-use disposable medical device comprising: a dissolvable medical sharp comprising magnesium; a nondissolvable supporting component; wherein submerging the dissolvable medical sharp in a weak acid degrades the dissolvable medical sharp, wherein the medical sharp is dissolved or substantially destroyed and can be separated from the nondissolvable supporting component for safe disposal in household waste.

2. The medical device of claim 1, wherein the magnesium comprises greater than about eighty percent (80%) of the total composition of the medical sharp.

3. The medical device of claim 1, wherein the nondissolvable supporting component comprises a bioplastic.

4. The medical device of claim 1, wherein the medical device is a lancet.

5. The medical device of claim 1, wherein the medical device is pen needle.

6. The medical device of claim 1, wherein the medical device is a prefilled syringe.

7. The medical device of claim 1, wherein the medical device is a scalpel.

8. The medical device of claim 1, wherein the medical device is a Luer slip needle.

9. The medical device of claim 1, further comprising a dissolvable blocking coating disposed on the nondissoluble supporting component.

10. A method for disposing of a single-use medical device having a dissolvable sharp comprising steps using a single-use medical device having a dissolvable sharp; placing the dissolvable sharp of the used medical device in a solvent comprising a weak acid; and disposing of undissolved supporting components of the medical device.

11. The method of claim 10, wherein the weak acid has a pH of between about 2.0 and about 3.0.

12. The method of claim 10, wherein the weak acid has a pH of between about 3.0 and about13. The method of claim 11, wherein the weak acid from the group consisting of lemon juice, lime juice, and cranberry juice.

14. The method of claim 11, wherein the weak acid is household vinegar.

15. The method of claim 12, wherein the weak acid is soda water.