Magnetic system and method for removing excess iron-containing molecules intravenously

Abstract

A device is provided for increasing a concentration of iron-containing molecules in a location of a body part of a subject. The device includes first and second portions and a magnetic material. The first portion is operable to extend along a first area of the body pail. The second portion is operable to extend along a second area of the body part. The magnetic material is coupled to the first and second portions and is configured to form a magnetic field that helps draw the iron-containing molecules in the body part toward the location.

Description

MAGNETIC SYSTEM AND METHOD FOR REMOVING EXCESS IRON-CONTAINING MOLECULES INTRAVENOUSLYCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the priority benefit of U.S. Provisional Application Serial No. 63 / 607,176, filed December 7, 2023, entitled MAGNETIC SYSTEM AND METHOD FOR REMOVING EXCESS IRON-CONTAINING MOLECULES INTRAVENOUSLY, which is incorporated by reference, in its entirety, into the current patent application.BACKGROUND OF THE INVENTION

[0002] Field of the Invention

[0003] The present invention relates generally to a device, method, and system for increasing a concentration of iron-containing molecules at a location in a patient and for improving or enhancing removal of excess iron-containing molecules from a patient’s bloodstream.

[0004] Discussion of the Prior Art

[0005] Conventional treatment of conditions that lead to excess iron storage in the body include therapeutic phlebotomy, chelating agents, and exchange transfusions. Therapeutic phlebotomy is the most common treatment method for excessive iron storage conditions. However, conventional treatment regimens include weekly or monthly blood draws from the patient until normal iron levels are reached. Only once normal levels of iron in the patient’s body are reached, can less frequent blood draws occur to maintain normal iron levels.

[0006] Thus, there is a need for an improved means for reducing iron levels in a patient.SUMMARY OF THE INVENTION

[0007] Embodiments of the current invention address one or more of the above-mentioned problems and provide a distinct advance in the art of increasing a concentration of iron-containing molecules at a location in a patient and for removing excess iron-containing molecules from a patient through intravenous blood draws.

[0008] A device constructed according to an embodiment of the present invention is for increasing a concentration of iron-containing molecules in a location of a body part of a subject. The device includes first and second portions and a magnetic material. The first portion is operableto extend along a first area of the body part. The second portion is operable to extend along a second area of the body part. The magnetic material is coupled to the first and second portions and is configured to form a magnetic field that helps draw the iron-containing molecules in the body part toward the location.

[0009] Another embodiment of the invention is a method of increasing a concentration of iron- containing molecules at a location of a body pail of a subject. The method includes generating a magnetic field in the body part of the subject so that the magnetic field interacts with iron- containing molecules in the bloodstream of the subject; and maintaining the magnetic field in the body part until the concentration of iron-containing molecules in blood of the body pail at the location is greater compared to a control concentration without the magnetic field.

[0010] Another embodiment of the invention is a method of intravenous removal of iron- containing molecules from a body part of a subject. The method includes generating a magnetic field in the body part of the subject so that the magnetic field interacts with iron-containing molecules in the bloodstream of the subject; maintaining the magnetic field in the body part until a concentration of iron-containing molecules in blood of the body part at a location is greater compared to a control concentration without the magnetic field; and drawing blood from the location of the subject, wherein an amount of iron-containing molecules in the drawn blood is increased as compared to a control blood draw obtained without the magnetic field.

[0011] Another embodiment of the invention is a device for aiding in the intravenous removal of iron-containing molecules from a subject. The device includes a wearable sleeve portion and a magnetic material. The wearable sleeve portion is configured to cover a portion of a subject’s forearm and upper arm and defines a window in which at least a portion of the cubital fossa region of the arm is accessible. The magnetic material is coupled to the wearable sleeve portion.

[0012] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. Other aspects and advantages of the current invention will be apparent from the following detailed description of the embodiments and the accompanying drawing figures.BRIEF DESCRIPTION OF DRAWINGS

[0013] Embodiments of the current invention are described in detail below with reference to the attached drawing figures, wherein:

[0014] FIG. 1 is a perspective view of a device constructed according to an embodiment of the present invention;

[0015] FIG. 2 is a schematic diagram depicting selected components of the device of FIG. 1;

[0016] FIG. 3 is a perspective view of the device of FIG. 1 positioned in contact with a body pail of a subject;

[0017] FIG. 4 is a perspective view of a device constructed according to another embodiment of the present invention;

[0018] FIG. 5 is a perspective view of a first portion of the device of FIG. 4 in relation to a body part of a subject;

[0019] FIG. 6 is a perspective view of the first portion of FIG. 5 being wrapped around the body part of the subject;

[0020] FIG. 7 is a perspective view of the first portion of FIG. 5 being secured around the body part of the subject via hook-and-loop fastening strips;

[0021] FIG. 8 is a perspective view of the first portion of FIG. 5 in relation to a location of the body part of the subject for accessing for a blood draw;

[0022] FIG. 9 is a perspective view of a second portion of the device of FIG. 4 being wrapped around the body part of the subject;

[0023] FIG. 10 is a perspective view of the second portion of FIG. 9 being secured around the body part of the subject via hook-and-loop fastening strips;

[0024] FIG. 11 is a perspective view of the device of FIG. 4 attached to the body part of the subject with a needle constructed according to an embodiment of the present invention;

[0025] FIG. 12 is a perspective view of a device constructed according to another embodiment of the present invention that is attached to a body part of a subject;

[0026] FIG. 13 is a perspective view of the device of FIG. 12;

[0027] FIG. 14 is a flowchart depicting exemplary steps of a method according to an embodiment of the present invention; and

[0028] FIG. 15 is a flowchart depicting exemplary steps of a method according to another embodiment of the present invention.

[0029] The drawing figures do not limit the current invention to the specific embodiments disclosed and described herein. It will also be appreciated that the drawings arc not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the invention.DETAILED DESCRIPTION OF THE INVENTION

[0030] The following detailed description of the technology references the accompanying drawings that illustrate specific embodiments in which the technology can be practiced. The embodiments are intended to describe aspects of the technology in sufficient detail to enable those skilled in the ail to practice the technology. Other embodiments can be utilized and changes can be made without departing from the scope of the current invention. The following detailed description is, therefore, not to be taken in a limiting sense. The scope of the current invention is defined only by the appended claims, along with the full scope of equivalents to which such claims are entitled.

[0031] Turning to FIG. 1, a device 10 configured according to an embodiment of the present invention is depicted. The device 10 is constructed and operable to direct iron-containing molecules (such as ferritin, ferric oxyhydroxide, apoferritin, and / or the like) within a subject to help increase a concentration of the iron-containing molecules at a target location, area, or region 12 of a body part 14 of the subject. The iron-containing molecules may be located in the bloodstream of the subject and have an inherent magnetic field because iron is ferromagnetic. For example, ferritin is a protein found in cells throughout the body, including within serum, the liquid portion of unclotted blood. This makes ferritin ideal for measuring iron levels in the body, as discussed elsewhere herein. The iron found in ferritin generally carries a positive charge, Fe4+, which has been found to help, along with the iron core of ferritin, to generate a sufficient magnetic field that can interact with external magnetic fields of sufficient strength. For example, the movement of the positively charged particles may generate a magnetic field that may be manipulated by an externally-generated magnetic field of sufficient strength.

[0032] The target location 12 for increasing concentration of iron-containing molecules may be at and / or near a surface of the body part 14. In one or more embodiments, the body part 14 is the arm of the subject, and the location 12 is the cubital fossa region of the arm, commonly known as the inner-elbow, for example, where blood may be drawn and collected from the subject. However, the device 10 may be configured to increase the concentration of iron-containingmolecules at any location of any body part where blood may be drawn without departing from the scope of the present invention. Additionally, while the body part 14 is depicted as being a human arm, the device 10 may be configured to accommodate a subject of any species having iron- containing molecules without departing from the scope of the present invention.

[0033] The device 10 may further be operable to be used when extracting blood from the target location 12 so that a concentration of iron-containing molecules in the blood drawn from the target location 12 (with use of the device) is higher as compared to a control blood draw obtained without the device 10. The device 10 may be used prior to and / or during the extraction of blood from the subject.

[0034] The device 10 is configured to emit a magnetic field 16 that extends into the body part 14 of the subject. The device 10 is configured to generate a magnetic field 16 with sufficient strength to interact with the iron-containing molecules in the subject’s circulating blood, in particular, in and near the target location 12. The device 10 may be manipulated to shift the magnetic field 16 and draw the iron-containing molecules to the target location 12 and / or the device 10 may be positioned so that the magnetic field 16 acts as a magnetic collector in which iron-containing molecules flowing through the body part 14 in the bloodstream are collected or built up at the location 12. In one or more embodiments, the device 10 includes a blood extraction means. For example, the device 10 may include a needle, such as a magnetized needle, for extracting blood having the higher concentration of iron-containing molecules from the location 12.

[0035] In one or more embodiments, the device 10 includes one or more magnetic devices 18, 20 with magnetic material that generate the magnetic field 16. In one or more embodiments, the first magnetic device 18 has magnetic material disposed thereon and is operable to extend along a first area of the body part 14. The second magnetic device 20 is operable to extend along a second area of the body part 14 and includes magnetic material disposed thereon. The second magnetic device 20 may be spaced apart from the first magnetic device 18 to define one or more windows in which at least a portion of the location 12 of the body pail 14 is accessible.

[0036] The magnetic devices 18, 20 may each include two magnetic poles 22, 24, 26, 28. As used herein, “magnetic pole” refers to one of the north pole or the south pole, as conventionally used for describing magnetic polarities. In one or more embodiments, the north pole 24 of the first magnetic device 18 may face the south pole 26 of the second magnetic device 20 to form a strongmagnetic field in the location 12. However, the magnetic devices 18, 20 may be arranged any number of ways without departing from the scope of the present invention, including the arrangements discussed elsewhere herein. For example, the north pole of the first magnetic device may extend toward and face the body part, and the south pole of the second magnetic device may extend toward and face the body part.

[0037] The magnetic field of the first magnetic device 18 may interact with iron-containing molecules in the subject’s blood stream in a manner that will repel them away from the first magnetic device 18, thereby encouraging them to move to a location away from the magnetic materials in the first magnetic device 18. Likewise, the magnetic field of the second magnetic device 20 may interact with iron-containing molecules in the subject’s blood stream in a manner that will attract them, thereby moving them towards the target location 12 of the body part 14. In one or more embodiments, the first magnetic device 18 is configured to and serves to “push” the ferritin upstream within the veins, while the second magnetic device 20 is configured to and serves to “pull” the ferritin towards the target location or area 12, e.g., the blood draw site, such as for therapeutic phlebotomy treatment. The second magnetic device 20 is also configured to and serves to prevent the ferritin moving further upstream from the location 12. In doing so, a directional magnetic field 16 is induced in the patient’s body part 14 having a direction that runs towards the location 12 for, e.g., a therapeutic phlebotomy treatment and facilitates an increase in the amount of ferritin removed in the blood draw, as compared to blood drawn without the device. Further, in one or more embodiments, the needle used for the therapeutic phlebotomy treatment can be configured with a magnetized tip having a south pole (or otherwise pole opposite to the magnetic pole of the first magnetic device 18 nearest to the location) extending into the location 12 to further enhance the attraction of the ferritin towards the location 12 and out of the subject’s body during the blood draw.

[0038] While the magnetic devices 18, 20 are depicted being in a spaced relationship to the body part 14, the magnetic devices 18, 20 may be positioned at any location relative to the location 12 without departing from the scope of the present invention, including at a distance or in contact with the body part 14, as shown in FIG. 3, or the like. In one or more embodiments, the device 10 includes one or more means 19, 21 (such as straps, sleeves, bands, deformable metal material, or the like) for securing the magnetic devices 18, 20 to the body part 14.

[0039] The magnetic material disposed on the magnetic devices 18, 20 may be any numberand / or types of devices known in the art, including permanent magnets such as neodymium magnets. In one or more embodiments, the magnetic devices 18, 20 include fifteen-millimeter (mm)-by-two-mm neodymium magnets. Ferromagnetic magnets are portable and easy to use; however, their magnetic fields are generally not easily adjustable. Therefore, in one or more embodiments, the magnetic devices 18, 20 additionally or alternatively include one or more electromagnets (depicted in FIG. 2) for helping generate the magnetic field 16. In one or more embodiments, the magnetic devices 18, 20 generate a magnetic field with an intensity of at least about 1 gauss at a surface of the magnetic material. In one or more embodiments, the magnetic devices 18, 20 generate a magnetic field with an intensity of at least about 3.5 gauss at a surface of the magnetic material.

[0040] In one or more embodiments, the device 10 includes a power source 30 for powering the one or more electromagnets 32, 34, a user interface 36, and a control circuit 38 for controlling the electromagnets 32, 34 of the magnetic devices, as depicted in FIG. 2. The power source 30 may comprise a connector for connecting to an external power source (such as an A / C cable, USB cable, or the like) and / or an energy storage device (such as a battery, capacitor, or the like). The user interface 36 is configured to receive inputs and generate signals representative of instructions to activate one or more electromagnets 32, 34, deactivate one or more electromagnets 32, 34, adjust power supplied to one or more electromagnets 32, 34, and / or the like. The control circuit 38 is configured to adjust magnetic field strengths of the electromagnets 32, 34. The electromagnets 32, 34 may include any type of electromagnet known in the art without departing from the scope of the present invention, including electromagnets configured for alternating and / or direct current. In one or more embodiments, the electromagnets 32, 34 are generally configured to convert electrical current to magnetic fields and may include solenoid electromagnets, toroidal electromagnets, superconducting electromagnets, Bitter electromagnets, c-core and / or e-core electromagnets, Helmholtz coils, horseshoe electromagnets, and / or the like. The control circuit 38 may comprise one or more communication elements, one or more memory elements, and one or more processing elements.

[0041] In one or more embodiments, the magnetic devices 18, 20 and / or the electromagnets 32, 34 of the device 10 may alternatively or additionally include electrodes for generating an electric field in the body part 14. For example, the first device 18 may additionally or alternatively include one or more positively-charged electrodes, and the second device 20 (and / or the needle) mayadditionally or alternatively include one or more relatively negatively-charged electrodes (or have a lower electric potential relative to the positive electrode) to form an electric field across the location 12. The electric field may likewise interact with the electric charges of the iron-containing molecules to attract them to the location 12.

[0042] Turning back to FIG. 1, the device 10 may be used in any setting, including settings where therapeutic phlebotomy is performed. Subjects (e.g., those on whom the device 10 is placed) may be patients experiencing an iron storage condition, such as Hemochromatosis, in which the patient’s body accumulates excess iron. The users (e.g., those who place the device 10 in relation to the subject) may include but are not limited to medical professionals such as nurses and physicians, EMTs, phlebotomists, and / or subjects themselves. Thus, also described herein are methods of enhancing or increasing the amount of excess iron from a patient during a blood draw or other therapeutic phlebotomy treatment using a device according to any one of the embodiments described herein.

[0043] In use, the device 10 is used to increase the amount of ferritin removed from the body during an otherwise standard blood draw. The first magnetic device 18 is positioned proximal to a first area of the body part 14 of the subject and secured such that the magnetic materials thereon generate at least a portion of the magnetic field 16. In one or more embodiments, the first magnetic device 18 is positioned proximal to a first area of the body part 14 of the subject and secured such that the magnetic materials thereon are oriented so that their north poles 24 extend toward a space above the location 12 of the body part 14. The second magnetic device 20 is positioned at the second area of the body part 14 of the subject adjacent to the location 12 of the blood draw (e.g., adjacent the cubital fossa region). Next, a waiting period passes, which allows for the magnetic materials within the device 10 to interact with the iron-containing molecules within the patient, as described above. This waiting period can be up to 30 minutes, but is preferably less than 20 minutes, and preferably less than 10 minutes. A phlebotomist, or other competent user, may then perform the blood draw. In one or more embodiments, the phlebotomist may use a needle with a magnetized tip having a magnetic polarity that is opposite to the magnetic polarity of the nearest magnetic pole of the first magnetic device 18. The magnetized tip may have a magnetic polarity that is the same as the magnetic polarity of the nearest magnetic pole of the second magnetic device 20. The resulting magnetic field will further attract the ferritin molecules, and / or other iron- containing molecules, to the draw site 12 and increase the amount of ferritin removed from thebody of the subject. However, it will be appreciated that this feature is optional and the magnetic field of the device 10 may be sufficient without a need for a magnetized needle. Once the phlebotomy session has concluded, the device 10 may be removed from the subject and the magnetic field 16 will no longer affect the subject.

[0044] A device 10A constructed in accordance with another embodiment of the invention is shown in FIGS. 4-11. The device 10A may comprise substantially similar components as device 10; thus, the components of device 10A that correspond to similar components in device 10 have an ‘A’ appended to their reference numerals.

[0045] The device 10A includes all the features of device 10 except that the magnetic device 18 A, 20A are in the form of a wearable device, and in a preferred embodiment, the device 10A is in the form of one or more wearable sleeves 18A, 20A. In some embodiments, the device 10A may be sized to cover a portion of the forearm as well as a portion of the upper-arm of the subject adjacent the cubital fossa region 12A of the subject’s arm 14A while leaving the cubital fossa region 12A accessible for phlebotomy treatment. However, the device 10A may be sized to fit a portion of any other body part of the subject without departing from the scope of the present invention. Additionally, the device 10A may be configured to achieve desired aesthetics (e.g., medical, high-tech, stylish) while maintaining appropriate functionality, as described herein.

[0046] The device 10A may be configured for temporary wear (e.g., only in association with an active, acutely administered treatment) or instead configured for prolonged wear (e.g., in association with treatment of an ongoing or chronic treatment or condition). In a preferred embodiment, the sleeve 18A includes a main body or outer protective layer 40. The main body 40 may comprise fabric or cloth, mesh, plastic, rubber, hook-and-loop material, metal composite material, a combination thereof, and / or one or more additional materials. Preferred materials are most preferably easily cleaned and / or sanitized, hypoallergenic, and resistant to breakage.

[0047] The main body 40 may itself include one or more layers or sublayers 42, 44, 46. For instance, an outer sublayer 42 of cloth with hook-and-loop material 44 and an inner layer of flexible mesh or plastic 46. The multiple sublayers 42, 44, 46 may also have varying physical structures. For instance, the outer sublayer 42 might be configured to house magnetic materials 48, while the inner sublayer 46 might include a soft surface for contact with the subject’s skin. The inner sublayer 46 includes material that does not block or interfere with the application of a magnetic field to the subject’s skin from the magnetic materials 48.

[0048] In one or more embodiments, the sleeve 18A is configured to cover a portion of the forearm, preferably extending from the subject’s wrist to the subject’s elbow. The other sleeve portion 20A is configured to cover a portion of the upper-arm of the patient. The sleeve may be a unitary, contiguous structure, as discussed elsewhere herein, or may be configured as multiple separate and distinct bodies without departing from the scope of the present invention.

[0049] In a preferred embodiment, the device 10A defines one or more windows 54 (as best viewed in FIG. 11) for providing access to, for example, the cubital fossa region 12A of the subject’s arm 14A. In one or more embodiments, the window 54 defines an opening in which the region 12A is completely uncovered so as to allow easy access for phlebotomy treatment. Thus, in one embodiment, the fist sleeve 18A is configured to cover a portion of the subject’s forearm, and preferably substantially the entire forearm from wrist to elbow. In one embodiment, the second sleeve 20A is configured to cover a portion of the subject’s upper arm, above the elbow and generally adjacent to (but above) the cubital fossa region 12A of the above. In one embodiment, the second portion 20A is configured as a thin band that covers only a small portion of the subject’s upper arm as compared to a full sleeve.

[0050] As noted previously, the sleeve portions 18 A, 20A are configured to house magnetic materials 48, 50, preferably a plurality of magnets. In a preferred embodiment, the magnetic materials 48 are distributed across the surface area of the sleeve 18A and contained within the inner sublayer. In a preferred embodiment, the magnetic materials 50 are confined to a distinct area adjacent the cubital fossa 12A in the second portion 20A and contained within an inner sublayer 52.

[0051] As discussed elsewhere herein, the magnetic materials 48, 50 may include rare-earth magnets, such as neodymium magnets. In one or more embodiments, the magnetic materials 48, 50 include fifteen-mm-by-two-mm neodymium magnets. Alternatively or additionally, one or more of the magnetic materials 48, 50 include electromagnetic means, such as the electromagnets discussed elsewhere herein.

[0052] In a preferred embodiment, the magnetic materials 48 in the first portion of the sleeve 18A are oriented such that the north poles thereof face the skin of the subject’s forearm. The north pole from the magnetic materials 48 interact with the iron-containing molecules located in the subject’s blood stream that is flowing through the forearm. In one or more embodiments, the magnetic material 50 in the second portion of the sleeve 20A is oriented such that the south polesthereof face the skin of the subject’s upper arm adjacent to (and above) the cubital fossa region 12A.

[0053] In one or more embodiments, the forearm portion of the sleeve 18A serves to “push” the ferritin upstream within the veins, while the upper-arm band portion 20A serves to “pull” the ferritin towards the draw site 12A for the therapeutic phlebotomy treatment. The upper-arm portion of the sleeve 20A also serves to prevent the ferritin moving further upstream from this draw site 12A. In doing so, a magnetic field is induced in the patient’s arm having a direction that runs towards the draw site 12A for the therapeutic phlebotomy treatment and facilitates an increase in the amount of ferritin removed in the blood draw, as compared to blood drawn without the device 10A. Further, the needle used for the therapeutic phlebotomy treatment can include a magnetized tip with a magnetic polarity opposite to the pole of the magnetic materials 48 facing the skin of the subject to further enhance the attraction of the ferritin out of the subject’s body.

[0054] Turning to FIG. 5, in use, the device 10A is placed on a subject and then secured relative to the subject. The device 10A is tightened onto the subject so as to place the plurality of magnets 48 in an opposed face-to-face relationship with the skin of a subject. Turning to FIGS. 6 and 7, the first portion 18A is wrapped around a first portion of the body part while leaving the location for concentrating iron-containing molecules accessible. The first portion 18A is configured to be tightened to the subject with hook-and-loop fastening strips 44. As shown in FIG. 8, the first portion 18A is configured to be secured to the subject’s arm while keeping the cubital fossa region 12A accessible. As shown in FIGS. 9-11, the second portion 20A is secured adjacent to the first portion 18A and spaced apart to define the window 54 for accessing the cubital fossa region 12A. The second portion 20A may be secured so that its magnetic material 50 also is in an opposed face- to-face relationship with the skin of a subject. In one or more embodiments, the magnetic material 50 of the second portion 20A is oriented so that its magnetic pole facing the skin of the subject is opposite to the magnetic polarities of one or more of the magnetic materials 48 facing the skin. The device 10A may be secured to the body part for a period of time, as discussed elsewhere herein, until a desired increase in concentration of iron-containing molecules is achieved as compared to a concentration without the device 10A in place.

[0055] As depicted in FIG. 11, in one or more embodiments, a needle assembly 56 may be used to draw blood from the desired location 12A of the body part 14A. The needle assembly 56 may include a magnetized needle 58 with the tip 60 thereof having a magnetic polarity that is oppositeto the magnetic polarities facing the skin of the body part in the first portion 18 A. This causes the magnetic field to extend from the magnets in the first portion 18 A to the magnetized tip 60 inserted within the body part, thereby drawing iron-containing molecules toward the tip 60. For example, the north poles of the magnets in the first portion 18 A may face the skin of the body part, and the magnetized tip 60 of the magnetized needle 58 may have a magnetic south polarity.

[0056] A device 10B constructed in accordance with another embodiment of the invention is shown in FIGS. 12 and 13. The device 10B may comprise substantially similar components as device 10A; thus, the components of device 10B that correspond to similar components in device 10A have a ‘B’ appended to their reference numerals.

[0057] The device 10B includes all the features of device 10A except that the first and second sleeve portions 18B, 20B arc connected to form a single sleeve 10B. Further, the single sleeve 10B defines one or more windows 50B to provide access to the location 12B for increasing concentration of iron-containing molecules. In one or more embodiments, the windows 50B include one or more holes to define the one or more windows 50B. The hole may be a portion where material of the device 10B is completely removed, cut away, and / or otherwise absent. Further, the second portion 20B includes a plurality of magnetic materials 50B. The device 10B may likewise include hook-and-loop materials 44B that allow the sleeve 10B to be tightened on the body part.

[0058] The flow chart of FIG. 14 depicts the steps of an exemplary method 1400 of increasing a concentration of iron-containing molecules at a location of a body part. In some alternative implementations, the functions noted in the various blocks may occur out of the order depicted in FIG. 14. For example, two blocks shown in succession in FIG. 14 may in fact be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order depending upon the functionality involved. In addition, some steps may be optional. The method 1400 is described below, for ease of reference, as being executed with exemplary devices and components introduced with the embodiments illustrated in FIGS. 1-13.

[0059] Referring to step 1402, a magnetic field is generated in the body pail of the subject so that the magnetic field interacts with iron-containing molecules in the bloodstream of the subject. In one or more embodiments, this step includes placing magnetic material proximal to a first portion of the body part and placing magnetic material proximal to a second portion of the body part. In one or more embodiments, the magnetic material proximal to the first portion of the bodypart is positioned so that its magnetic polarity faces the first portion of the body part. The magnetic material proximal to the second portion of the body part is positioned so that its magnetic polarity faces the second portion. In one or more embodiments, the magnetic pole of the magnetic materials of the first portion facing the body part is opposite to the magnetic pole of the magnetic materials of the second portion facing the body part. In one or more embodiments, the magnetic polarity of the magnetic material of the first portion facing the skin is magnetic north, and the magnetic polarity of the magnetic material of the second portion facing the skin is magnetic south.

[0060] Referring to step 1404, the magnetic field is maintained in the body pail until the concentration of iron-containing molecules in blood of the body part at the location is greater compared to a control concentration without the magnetic field. This may include holding the device with the magnetic field in relation to the body pail for a waiting period. This waiting period can be up to 30 minutes, but is preferably less than 20 minutes, and preferably less than 10 minutes.

[0061] The method 1400 may include additional, less, or alternate steps and / or device(s), including those discussed elsewhere herein.

[0062] The flow chart of FIG. 15 depicts the steps of an exemplary method 1500 of drawing blood from a patient. In some alternative implementations, the functions noted in the various blocks may occur out of the order depicted in FIG. 15. For example, two blocks shown in succession in FIG. 15 may in fact be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order depending upon the functionality involved. In addition, some steps may be optional. The method 1500 is described below, for ease of reference, as being executed by exemplary devices and components introduced with the embodiments illustrated in FIGS. 1-13.

[0063] Referring to step 1502, a magnetic field is generated in the body part of the subject so that the magnetic field interacts with iron-containing molecules in the bloodstream of the subject. This step may include placing magnetic material proximal to a first portion of the body part and placing magnetic material proximal to a second portion of the body part. In one or more embodiments, the magnetic field interacts with iron-containing molecules in the bloodstream of the subject immediately prior to and during the blood draw. The magnetic field may be generated by positioning magnetic material proximal to the first portion of the body part, which has a first magnetic polarity facing the first portion of the body part, and positioning magnetic material proximal to the second portion of the body part that a second magnetic polarity facing the secondportion. In one or more embodiments, the second magnetic polarity is the opposite magnetic polarity of the first magnetic polarity. In one or more embodiments, the first magnetic polarity is the north magnetic pole. This step may additionally or alternatively include inserting a needle with a magnetized tip into the body part at the location. The magnetized tip may have a magnetic polarity that is the opposite magnetic polarity of the first magnetic polarity, or the magnetic materials of the first portion that face the skin.

[0064] Referring to step 1504, the magnetic field is maintained in the body part until a concentration of iron-containing molecules in blood of the body part at a location is greater compared to a control concentration without the magnetic field. This may include holding the device with the magnetic field in relation to the body part for a waiting period. This waiting period can be up to 30 minutes, but is preferably less than 20 minutes, and preferably less than 10 minutes.

[0065] Referring to step 1506, blood is drawn from the subject. An amount of iron-containing molecules in the drawn blood is increased as compared to a control blood draw obtained without the magnetic field. This step may include drawing blood from the location of where the concentration of iron-containing molecules has been increased. Thus, a concentration of iron- containing molecules in the drawn blood is increased as compared to a control blood draw obtained without the magnetic field. As discussed elsewhere herein, the blood draw is optionally carried out using a needle with a magnetized tip inserted into the subject’s arm. The tip of the needle may be magnetized and oriented so that a magnetic polarity inserted into the subject is opposite to the magnetic polarity facing the subject of the magnets of the first portion of the device.

[0066] The method 1500 may include additional, less, or alternate steps and / or device(s), including those discussed elsewhere herein.

[0067] It will be appreciated that the methods of use of the devices for enhancing or increasing the amount of excess iron removed from a patient during a blood draw or any other therapeutic phlebotomy treatment may be carried out with any of the device embodiments described or depicted herein. Throughout this specification, references to “one embodiment”, “an embodiment”, or “embodiments” mean that the feature or features being referred to are included in at least one embodiment of the technology. Separate references to “one embodiment”, “an embodiment”, or “embodiments” in this description do not necessarily refer to the same embodiment and are also not mutually exclusive unless so stated and / or except as will be readily apparent to those skilled in the art from the description. For example, a feature, structure, act, etc.described in one embodiment may also be included in other embodiments, but is not necessarily included. Thus, the current invention can include a variety of combinations and / or integrations of the embodiments described herein.

[0068] Although the present application sets forth a detailed description of numerous different embodiments, it should be understood that the legal scope of the description is defined by the words of the claims set forth at the end of this patent and equivalents. The detailed description is to be construed as exemplary only and does not describe every possible embodiment since describing every possible embodiment would be impractical. Numerous alternative embodiments may be implemented, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims.

[0069] Throughout this specification, plural instances may implement components, operations, or structures described as a single instance. Although individual operations of one or more methods are illustrated and described as separate operations, one or more of the individual operations may be performed concurrently, and nothing requires that the operations be performed in the order illustrated. Structures and functionality presented as separate components in example configurations may be implemented as a combined structure or component. Similarly, structures and functionality presented as a single component may be implemented as separate components. These and other variations, modifications, additions, and improvements fall within the scope of the subject matter herein.

[0070] Certain embodiments are described herein as including logic or a number of routines, subroutines, applications, or instructions. These may constitute either software (e.g., code embodied on a machine-readable medium or in a transmission signal) or hardware. In hardware, the routines, etc., are tangible units capable of performing certain operations and may be configured or arranged in a certain manner. In example embodiments, one or more computer systems (e.g., a standalone, client or server computer system) or one or more hardware modules of a computer system (e.g., a processor or a group of processors) may be configured by software (e.g., an application or application portion) as computer hardware that operates to perform certain operations as described herein.

[0071] In various embodiments, computer hardware, such as a processing element, may be implemented as special purpose or as general purpose. For example, the processing element may comprise dedicated circuitry or logic that is permanently configured, such as an application-specific integrated circuit (ASIC), or indefinitely configured, such as an FPGA, to perform certain operations. The processing clement may also comprise programmable logic or circuitry (e.g., as encompassed within a general-purpose processor or other programmable processor) that is temporarily configured by software to perform certain operations. It will be appreciated that the decision to implement the processing element as special purpose, in dedicated and permanently configured circuitry, or as general purpose (e.g., configured by software) may be driven by cost and time considerations.

[0072] Accordingly, the term “processing element” or equivalents should be understood to encompass a tangible entity, be that an entity that is physically constructed, permanently configured (e.g., hardwired), or temporarily configured (e.g., programmed) to operate in a certain manner or to perform certain operations described herein. Considering embodiments in which the processing element is temporarily configured (e.g., programmed), each of the processing elements need not be configured or instantiated at any one instance in time. For example, where the processing element comprises a general-purpose processor configured using software, the general- purpose processor may be configured as respective different processing elements at different times. Software may accordingly configure the processing element to constitute a particular hardware configuration at one instance of time and to constitute a different hardware configuration at a different instance of time.

[0073] The processing element may include processors, microprocessors (single-core and multicore), microcontrollers, DSPs, field-programmable gate arrays (FPGAs), analog and / or digital application-specific integrated circuits (ASICs), or the like, or combinations thereof. The processing element may generally execute, process, or run instructions, code, code segments, software, firmware, programs, applications, apps, processes, services, daemons, or the like. The processing element may also include hardware components such as finite-state machines, sequential and combinational logic, and other electronic circuits that can perform the functions necessary for the operation of the current invention. The processing element may be in communication with the other electronic components through serial or parallel links that include address busses, data busses, control lines, and the like.

[0074] Computer hardware components, such as communication elements, memory elements, processing elements, and the like, may provide information to, and receive information from, other computer hardware components. Accordingly, the described computer hardware components maybe regarded as being communicatively coupled. Where multiple of such computer hardware components exist contemporaneously, communications may be achieved through signal transmission (e.g., over appropriate circuits and buses) that connect the computer hardware components. In embodiments in which multiple computer hardware components are configured or instantiated at different times, communications between such computer hardware components may be achieved, for example, through the storage and retrieval of information in memory structures to which the multiple computer hardware components have access. For example, one computer hardware component may perform an operation and store the output of that operation in a memory device to which it is communicatively coupled. A further computer hardware component may then, at a later time, access the memory device to retrieve and process the stored output. Computer hardware components may also initiate communications with input or output devices, and may operate on a resource (e.g., a collection of information).

[0075] The memory device or element may include data storage components, such as read-only memory (ROM), programmable ROM, erasable programmable ROM, random-access memory (RAM) such as static RAM (SRAM) or dynamic RAM (DRAM), cache memory, hard disks, floppy disks, optical disks, flash memory, thumb drives, universal serial bus (USB) drives, or the like, or combinations thereof. In some embodiments, the memory element may be embedded in, or packaged in the same package as, the processing element. The memory element may include, or may constitute, a “computer-readable medium”. The memory element may store the instructions, code, code segments, software, firmware, programs, applications, apps, services, daemons, or the like that are executed by the processing element.

[0076] The communication element may generally allow communication with systems and / or external devices. The communication element may include signal or data transmitting and receiving circuits, such as antennas, amplifiers, filters, mixers, oscillators, digital signal processors (DSPs), and the like. The communication element may establish communication wirelessly by utilizing RF signals and / or data that comply with communication standards such as cellular 2G, 3G, 4G, 5G, or LTE, WiFi, WiMAX, Bluetooth®, BLE, or combinations thereof. The communication element may be in communication with the processing element and the memory element.

[0077] The user interface generally allows the user to utilize inputs and outputs to interact with the device and is in communication with the one or more processing elements. Inputs may includebuttons, pushbuttons, knobs, jog dials, shuttle dials, directional pads, multidirectional buttons, switches, keypads, keyboards, mice, joysticks, microphones, or the like, or combinations thereof. The outputs of the present invention may include a display and / or any number of additional outputs, such as audio speakers, lights, dials, meters, printers, or the like, or combinations thereof, without departing from the scope of the present invention.

[0078] The various operations of example methods described herein may be performed, at least partially, by one or more processing elements that are temporarily configured (e.g., by software) or permanently configured to perform the relevant operations. Whether temporarily or permanently configured, such processing elements may constitute processing element- implemented modules that operate to perform one or more operations or functions. The modules referred to herein may, in some example embodiments, comprise processing element-implemented modules.

[0079] Similarly, the methods or routines described herein may be at least partially processing element-implemented. For example, at least some of the operations of a method may be performed by one or more processing elements or processing element-implemented hardware modules. The performance of certain of the operations may be distributed among the one or more processing elements, not only residing within a single machine, but deployed across a number of machines. In some example embodiments, the processing elements may be located in a single location (e.g., within a home environment, an office environment or as a server farm), while in other embodiments the processing elements may be distributed across a number of locations.

[0080] Unless specifically stated otherwise, discussions herein using words such as “processing,” “computing,” “calculating,” “determining,” “presenting,” “displaying,” or the like may refer to actions or processes of a machine (e.g., a computer with a processing element and other computer hardware components) that manipulates or transforms data represented as physical (e.g., electronic, magnetic, or optical) quantities within one or more memories (e.g., volatile memory, non-volatile memory, or a combination thereof), registers, or other machine components that receive, store, transmit, or display information.

[0081] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having” or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent tosuch process, method, article, or apparatus.

[0082] The patent claims at the end of this patent application arc not intended to be construed under 35 U.S.C. § 112(f) unless traditional means-plus-function language is expressly recited, such as “means for” or “step for” language being explicitly recited in the claim(s).

[0083] Although the technology has been described with reference to the embodiments illustrated in the attached drawing figures, it is noted that equivalents may be employed and substitutions made herein without departing from the scope of the technology as recited in the claims.

[0084] Having thus described various embodiments of the technology, what is claimed as new and desired to be protected by Letters Patent includes the following:

Claims

CLAIMS1. A device for increasing a concentration of iron-containing molecules in a location of a body part of a subject, the device comprising: a first portion operable to extend along a first area of the body part; a second portion operable to extend along a second area of the body part; and a magnetic material coupled to the first and second portions and configured to form a magnetic field that helps draw the iron-containing molecules in the body part toward the location.

2. The device of claim 1, wherein: the first portion is a first sleeve portion configured to be worn on the forearm of the subject and at least partially defining one or more windows around the cubital fossa region of the arm; and the second portion is a second sleeve portion configured to be worn on the upper aim of the subject and at least partially defining the one or more windows.

3. The device of claim 2, wherein the device is configured to be tightened to the subject with hook-and-loop fastening strips.

4. The device of claim 2, wherein the first and second sleeve portions are connected to form a single sleeve.

5. The device of claim 4, wherein the single sleeve includes one or more holes to define the one or more windows.

6. The device of any of the preceding claims, wherein the first portion comprises a plurality of the magnetic materials oriented to face a first magnetic pole towards the skin of the subject.

7. The device of claim 6, wherein the second portion comprises a magnetic material oriented to face a second magnetic pole towards the skin of the subject, the second magnetic polebeing the opposite magnetic pole of the first magnetic pole.

8. The device of claim 7, wherein the first magnetic pole is the north magnetic pole.

9. The device of any of the preceding claims, wherein the magnetic materials comprise neodymium magnets.

10. The device of any of the preceding claims, wherein magnetic materials comprise electromagnetic means for generating a magnetic field.

11. The device of claim 10, wherein the electromagnetic means comprises a plurality of electromagnets.

12. The device of claim 11, wherein the electromagnetic means includes control circuitry configured to adjust magnetic field strengths of the electromagnets.

13. The device of any of the preceding claims, wherein the magnetic material is configured to generate a magnetic field with an intensity of at least about 1 gauss at a surface of the magnetic material.

14. The device of any of the preceding claims, wherein the magnetic material is configured to generate a magnetic field with an intensity of at least about 3.5 gauss at a surface of the magnetic material.

15. The device of any of the preceding claims, wherein the second portion comprises a needle assembly, and the magnetic material coupled with the second portion comprises a magnetized needle.

16. A method of increasing a concentration of iron-containing molecules at a location of a body part of a subject, the method comprising: positioning a device according to any one of claims 1-15 proximal to the subject;wherein the device creates the magnetic field that interacts with iron-containing molecules in the bloodstream of the subject, wherein a concentration of iron-containing molecules in the location is increased as compared to a control concentration without the device.

17. A method of intravenous removal of iron-containing molecules from a subject comprising: positioning a device according to any one of claims 1-15 proximal to a subject; wherein the device creates a magnetic field that interacts with iron-containing molecules in the bloodstream of the subject; drawing blood from the subject, wherein an amount of iron-containing molecules in the drawn blood is increased as compared to a control blood draw obtained without the device.

18. The method of claim 17, wherein the device is worn by the subject immediately prior to and during the blood draw.

19. The method of claim 17, wherein the blood draw is performed using a needle with a magnetized tip having the south magnetic pole thereof inserted into the subject’s arm.

20. A method of increasing a concentration of iron-containing molecules at a location of a body part of a subject, the method comprising: generating a magnetic field in the body part of the subject so that the magnetic field interacts with iron-containing molecules in the bloodstream of the subject; and maintaining the magnetic field in the body part until the concentration of iron-containing molecules in blood of the body part at the location is greater compared to a control concentration without the magnetic field.

21. The method of claim 20, wherein producing the magnetic field includes placing magnetic material proximal to a first portion of the body part.

22. The method of claim 21 , wherein producing the magnetic field includes placing magnetic material proximal to a second portion of the body part.

23. The method of claim 22, wherein the magnetic material proximal to the first portion of the body part has a first magnetic polarity facing the first portion, and the magnetic material proximal to the second portion of the body part has a second magnetic polarity facing the second portion, the second magnetic polarity being the opposite magnetic polarity of the first magnetic polarity.

24. The method of claim 23, wherein the first magnetic polarity is the north magnetic pole.

25. A method of intravenous removal of iron-containing molecules from a subject comprising: generating a magnetic field in a body part of the subject so that the magnetic field interacts with iron-containing molecules in the bloodstream of the subject; maintaining the magnetic field in the body pail until a concentration of iron-containing molecules in blood of the body part at a location is greater compared to a control concentration without the magnetic field; and drawing blood from the location of the subject, wherein an amount of iron-containing molecules in the drawn blood is increased as compared to a control blood draw obtained without the magnetic field.

26. The method of claim 25, wherein: generating the magnetic field includes inserting a needle with a magnetized tip into the body part at the location, generating the magnetic field includes placing magnetic material proximal to a first portion of the body part that has a first magnetic polarity facing the body part, and the magnetized tip has a second magnetic polarity that is the opposite magnetic polarity of the first magnetic polarity.

27. A device for aiding in the intravenous removal of iron-containing molecules from a subject, the device comprising: one or more wearable sleeve portions configured to cover a portion of a subject’s forearm and upper arm, the one or more wearable sleeve portions defining one or more windows in which at least a portion of the cubital fossa region of the arm is accessible; and a magnetic material coupled to the one or more wearable sleeve portions.

28. The device of claim 27, wherein the one or more wearable sleeve portions comprises: a first sleeve portion configured to be worn on the forearm of the subject and at least partially defining the one or more windows; and a second sleeve portion configured to be worn on the upper arm of the subject and at least partially defining the one or more windows.

29. The device of claim 28, wherein the device is configured to be tightened to the subject with hook-and-loop fastening strips.

30. The device of claim 28, wherein the first sleeve portion comprises a plurality of the magnetic materials oriented to face a first magnetic pole towards the skin of the subject.

31. The device of claim 30, wherein the second sleeve portion comprises a magnetic material oriented to face a second magnetic pole towards the skin of the subject, the second magnetic pole being the opposite magnetic pole of the first magnetic pole.

32. The device of claim 31, wherein the first magnetic pole is the north magnetic pole.

33. The device of any one of claims 27-32, wherein the magnetic materials comprise neodymium magnets.

34. The device of any one of claims 27-33, wherein magnetic materials compriseelectromagnetic means for generating a magnetic field.

35. The device of claim 34, wherein the electromagnetic means comprises a plurality of electromagnets.

36. The device of claim 35, wherein the electromagnetic means includes control circuitry configured to adjust magnetic field strengths of the electromagnets.

37. The device of claim 27, wherein the one or more wearable sleeve portions comprises a single sleeve.

38. The device of claim 27, wherein the single sleeve includes one or more holes to define the one or more windows.

39. The device of any one of claims 27-38, wherein the magnetic material is configured to generate a magnetic field with an intensity of at least about 1 gauss at a surface of the magnetic material.

40. The device of any one of claims 27-39, wherein the magnetic material is configured to generate a magnetic field with an intensity of at least about 3.5 gauss at a surface of the magnetic material.

41. A method of intravenous removal of iron-containing molecules from a subject comprising: securing a device according to any one of claims 27-40 to a subject; wherein the device creates a magnetic field that interacts with iron-containing molecules in the bloodstream of the subject; drawing blood from the subject, wherein an amount of iron-containing molecules in the drawn blood is increased as compared to a control blood draw obtained without the device.

42. The method of claim 41 , wherein the device is worn by the subject immediately prior to and during the blood draw.

43. The method of claim 41, wherein the blood draw is performed using a needle with a magnetized tip having the south magnetic pole thereof inserted into the subject’s arm.

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