Device, system and method for killing viruses in blood through electrode wires
20200009375 ยท 2020-01-09
Inventors
Cpc classification
A61P31/00
HUMAN NECESSITIES
A61K45/06
HUMAN NECESSITIES
A61P7/00
HUMAN NECESSITIES
A61N1/0428
HUMAN NECESSITIES
A61M1/14
HUMAN NECESSITIES
A61N1/306
HUMAN NECESSITIES
A61N1/05
HUMAN NECESSITIES
A61N1/325
HUMAN NECESSITIES
International classification
A61N1/30
HUMAN NECESSITIES
A61M1/14
HUMAN NECESSITIES
Abstract
A device for killing blood-borne pathogens, and a method of using this device to effectively remove blood-borne pathogens from the body of a human or animal is claimed. The device comprises a wire that is inserted into the blood stream of a patient, which releases metallic ions which effectively kill the pathogens. There are several embodiments, each of which has a combination of covered and uncovered portions of the wire. The wire is electrically connected to both a source of power and a Power Supply with PCB or controller/software, which controls the intensity and during of the treatment.
Claims
1. A device for treating a blood borne pathogen within a blood stream comprising an iontophoretic wire, where the iontophoretic wire comprises one or more metals; a transformer, where the transformer comprises a plurality of resistors and a transducer, where the transformer is in electrical connection with the power supply, where the one or more metals contains a combination of copper and a second metal, where the iontophoretic wire additionally comprises an electrode, where the electrode comprises a vein portion and an exterior portion, where the vein portion is inserted into a patient's vein, where the exterior portion is located outside of the patient's vein, where the exterior portion is insulated with an exterior insulation such that no ions are released from anywhere other than an intended release point, where the intended release point is located inside the patient's vein, where the vein portion is at least beyond the tip of an introducer needle and an introducer catheter, where the exterior insulation is an FDA-approved material, where the FDA-approved material is selected from the group consisting of synthetics and plastic material, where the exterior insulation of the iontophoretic wire has a durometer, where the durometer is flexible enough to placed safely within the patient's venous system without causing an amount of irritation, where the exterior insulation of the iontophoretic wire has a thickness of between 0.005 and 0.025 inches, where the vein portion has a vein portion length, where the vein portion length is between 0.2 and 1.0 inches, where the vein portion has a vein portion surface area, and where the vein portion surface area is between 0.005 square inches and 0.70 square inches, where an output current from the device has a range of 1.25 to 6 micro amps of current, where the production of a medicant directly within a vein of a patient is greater than 2 billion ions per second.
2. The device of claim 1, where the electrode is a two-part electrode with a first electrode part and a second electrode part, where the first electrode part is a proximal end unit, where the proximal end contains a conductive pin, where the conductive pin comprises copper, where the conductive pin is held within a lure, where the conductive pin allows the transfer of a low intensity direct current to the iontophoretic wire from the power supply, where the pin can be tightened onto the second part through a tightening device, and where the second part is a second part electrode, where the second part electrode has a length of exposed wire at the distal end.
3. The device of claim 2, where the length of exposed wire at the distal end is a bare silver wire.
4. The device of claim 2, where the length of exposed wire at the distal end is a skived window.
5. The device of claim 2, where the tightening device is a set screw.
6. The device of claim 2, where the tightening device is a quantity of conductive glue.
7. The device of claim 1, where the second metal is combination of gold and silver.
8. A device for treating a blood borne pathogen within a blood stream comprising an iontophoretic wire, where the iontophoretic wire comprises one or more metals; a transformer, where the transformer comprises a plurality of resistors and a transducer, where the transformer is in electrical connection with the power supply, where the iontophoretic wire additionally comprises an electrode.
9. The device of claim 8, where the electrode comprises a vein portion and an exterior portion, where the vein portion is inserted into a patient's vein, where the exterior portion is located outside of the patient's vein, where the exterior portion is insulated with an exterior insulation such that no ions are released from anywhere other than an intended release point, where the intended release point is located inside the patient's vein, where the vein portion is at least beyond the tip of an introducer needle and an introducer catheter, where the exterior insulation is an FDA-approved material, where the FDA-approved material is selected from the group consisting of synthetics and plastic material,
10. The device of claim 9, where the exterior insulation of the iontophoretic wire has a durometer, where the durometer is flexible enough to placed safely within the patient's venous system without causing an amount of irritation,
11. The device of claim 10, where the exterior insulation of the iontophoretic wire has a thickness of between 0.005 and 0.025 inches, where the vein portion has a vein portion length, where the vein portion length is between 0.2 and 1.0 inches,
12. The device of claim 11, where the vein portion has a vein portion surface area, and where the vein portion surface area is between 0.005 square inches and 0.70 square inches,
13. The device of claim 12, where an output current from the device has a range of 1.25 to 6 micro amps of current,
14. The device of claim 13, where the production of a medicant directly within a vein of a patient is greater than 2 billion ions per second.
15. The device of claim 14, where the electrode is a two-part electrode with a first electrode part and a second electrode part, where the first electrode part is a proximal end unit, where the proximal end contains a conductive pin, where the conductive pin comprises copper, where the conductive pin is held within a lure, where the conductive pin allows the transfer of a low intensity direct current to the iontophoretic wire from the power supply, where the pin can be tightened onto the second part through a tightening device, and where the second part is a second part electrode, where the second part electrode has a length of exposed wire at the distal end.
16. The device of claim 14, where the length of exposed wire at the distal end is a bare silver wire.
17. The device of claim 14, where the length of exposed wire at the distal end is a skived window.
18. The device of claim 14, where the tightening device is a set screw.
19. The device of claim 14, where the tightening device is a quantity of conductive glue.
20. The device of claim 14, where the one or more metals comprises silver.
21. The device of claim 14, where the one or more metals comprises gold.
22. The device of claim 14, where the one or more metals comprises copper.
23. The device of claim 14, where the second metal is combination of gold and silver.
24. The device of claim 14, where the one or more metals contains a combination of copper, and at least a second metal.
25. The device of claim 24, where there are three metals, a first metal, a second metal, and a third metal, and where the first metal is silver, and where the three metals include at least 70% silver and less than 30% of a combination combinations of the second metal and the third metal.
26. The device of claim 25, where the first metal is gold, and where the three metals include at least 70% gold and less than 30% of a combination of the second metal and the third metal.
27. The device of claim 24, where the electrode comprises at least 70% Copper.
28. The device of claim 24, where the electrode has between 1% and 99% each of gold, silver and copper.
29. The device of claim 24, whereas the wire is tempered for proper ionic release and safety of usage of the wire within the venous system.
30. The device of claim 24, whereas the wire is annealed for proper ionic release and safety of usage of the wire within the venous system.
31. The device of claim 24, where an output current from the device is in the range of 1.25-6 micro amps of current, and, where the production of a medicant directly within the venous system in greater than 2 billion ions per second.
32. The device of claim 24, additionally comprising a combination catheter, where the combination catheter allows the simultaneous release of a quantity of metallic ions and a quantity of an IV medicant for the treatment of a quantity of antibiotic resistant bacteria and other blood borne pathogens, where a gauge of the device will range from 12-26 gauge to allow administration from youth to adults; with an IV connection that allows a universal connector to accept multiple available IV piggy back systems; where an external surface of the catheter comprises a spiral wound silver wire, where the exposed spiral wire has a spiral wound silver wire range comprising a length from 0.5 to 2, and additionally comprising a spiral diameter, where the spiral diameter ranges from 0.001 to 0.1.
33. The device of claim 32, where the IV medicant is an IV antibiotic.
34. The device of claim 32, where the means of tightening the copper pin into the second part is a set screw.
35. The device of claim 32, where the means of tightening the copper pin into the second part is a quantity of conductive glue.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0036] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments of the invention and together with the description, serve to explain the principles of this invention.
[0037]
[0038]
[0039]
[0040]
[0041]
[0042]
[0043]
[0044]
[0045]
DETAILED DESCRIPTION OF THE INVENTION
[0046] Many aspects of the invention can be better understood with the references made to the drawings below. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed upon clearly illustrating the components of the present invention. Moreover, like reference numerals designate corresponding parts through the several views in the drawings.
[0047]
[0048] Once the wire 1 is in the patient's blood steam, the wire 1 releases ions which kill pathogens which reside within the patient's blood stream that flow around the wire 1. The insulated covering 2 protects both the wire 1 from being damaged, the patient from being injured by the wire 1 breaking off inside the patient's blood stream and ensures that the proper release of ions for therapy is delivered to destroy the target pathogen(s). At the proximal portion of the invention has a male lure 5 connecting with a female lure 7. The lures protect the more sensitive components and provides threads or other mating items to allow it to be connected to a catheter 11. Within the male lure 5 is a copper pin 6 or other conductive material for the low intensity direct current by which the device is connected to a power supply (not shown in this picture). The purpose of the pin is to supply low intensity direct current to the device which creates the ionic release, or actually accelerates the ionic release. The wire on its own in the blood will release ions, but not at the rate and volume required to effectively destroy pathogens.
[0049]
[0050] The device and method work as follows: The electrode wire is annealed and insulated up to the exposed tip or cut outs so that no ions are released from anywhere other than the intended release point, critical to the therapy, which is well into the vein and flow of blood. This will ensure that there will not be any exposed wire prior to that point there will be ionic release resulting in less than ideal volume of ions released to reach and treat the target pathogen. Due to the rapid release of up to trillions of ions per second, the proximity of the free or bare metal or wire must be a minimum of beyond the tip of the introducer needle or catheter or from the entry point of the vein.
[0051] The inventor has found that the volume of ions released from the wire is dependent on the length and/or surface area of exposed metal, such that having the proper exposed wire, either by length or surface area, is directly related to the potential or efficacy for killing the target pathogens. As such, as variety of lengths of exposed wire and variations on how this proper length is exposed is contemplated, as the length and surface areas of exposed wire is critical to the actual ionic release with LIDC (low intensity direct current). The inventor's research has shown that different pathogens require different loads or releases or volumes of ions (similar to different mg doses of a pharmaceutical drug).
[0052] The invention contemplates three different application electrodes, each more or less efficient depending on the pathogen targeted. These electrodes include: Central Venous Electrode (CVE); Peripheral Venous Electrode (PVE); and PICC Electrode (PICCE) which is an Electrode placed within a peripherally inserted central catheter or PICC. The length of the annealed or insulated wire extending from the proximal or originating point of the lure is critical to proper placement and delivery of the metallic ions for the treatment of blood-borne pathogens. Therefore, the length of the aleated wire in the different electrode designs is different, but a preferred general embodiment calls for a range from 1.5-32 long (1.5 to 6 for PVE, 4-9 for CVE and 15-32 for PICCE).
[0053] The device also relies on waveforms to enhance and increase safety during treatment by this method. The background current waveforms from the device are delivered from the power supply to enhance blood flow to the placement of the electrode and enhance distribution of metallic ions within the venous system to improve the efficacy of the therapy
[0054] The device provides a range that is from 2.0 billion ions per second to 7.0 trillion ions per second. As time passes the current ranges from 2 billion to 7 trillion ions per second, going up to 7 then slowly down to 2 then slowly back up to 7 and so forth. The variable of how long it takes to ramp up and ramp down the volume of ions released is a variable that can be set from the device controller. This can be a continuous-fixed release below 2 m-7B per second, or this can be variable changing rate anywhere between 2 m-7B.
[0055]
[0056] Crucial to the success of the device is its use of phased output current. A timed or phased current release allows higher release of metallic ions over certain periods of the treatment, and lower release of metallic ions over the remaining periods of time. One such example is to lower metallic ion release as viral loads are lowered; another is to lower metallic ion release during hours of sleeping, both making the therapy more efficient and comfortable for the patients.
[0057] The invent also contemplates a combination catheter that allows for the simultaneous release of silver ions and the administration of an IV antibiotic or other medical therapy via a catheter for the treatment of antibiotic resistant bacteria and other blood borne pathogens or infections. The device ranges from 12-26 gauge to properly introduce electrodes. This range of catheters allows for a range of electrode diameters to be inserted into the blood flow of the patient. This range of catheters allows our range of electrode diameters to allow administration from youth to adults; the connection will allow screw-on or a universal connector to accept the multiple available IV piggyback systems; the external or internal surface of the catheter has a spiral-wound silver wire that is designed for the specific ionic release necessary for the applicable therapy, this varies depending upon the patient's size, age and the type of infection (or infections in multiple symptom patients), therefore, the exposed spiral wire has a range covering a length from 0.5 to 2 of the distal end of this special catheter, with a wide or tight spiral. The spiral is contemplated to be either internal or external. Another embodiment of the idea is to braid the wire into the internal or external surface of the catheter. The distance of the braid from the end of the catheter is contemplated to range from 0.5 to 2.0 from the distal end of the catheter.
[0058] The ranges, of spiral or braided wire incorporated into the catheter, specified in this provisional application are the ranges necessary to achieve the proper volume of ionic release in combination with the appropriate volume of antibiotic or other IV medicant for the different infections and patient variables. The basic design of the invention provides that the inserted catheter has a spiral or mesh wound silver wire as part of the catheter make up, allowing it to have the flexibility to be inserted into the venous system; will also have enough metal exposed for the desired volume of metallic ions to be released per second for the therapy; will have a connection point at proximal end of the catheter to connect the low intensity direct current to the catheter so that once the current is turned on it will release the metallic ions for distribution into the venous system; the single or multi lumen catheter will have a connection to an external IV antibiotic or therapy bag so that the desired solution can be administered thru a lumen within the catheter and go directly into the venous system.
[0059] The combination catheter allows the simultaneous release of metallic ions and the administration of an IV antibiotic or other medicant for the treatment of antibiotic resistant bacteria and other blood borne pathogens or infections. The gauge of the catheters, used to introduce the metallic electrode devices being described here, ranges from 12-26 gauge to allow administration from youth to adults; the connection will allow screw-on or a universal connector to accept the multiple available IV piggyback systems; the internal surface or external surface of the catheter will have a spiral wound or braided metallic wire (that dimensional range of wire used being 0.001 to 0.020) that will be designed for the specific ionic release necessary for the applicable therapy, this will vary depending upon the patients size, age and infection, therefore, the exposed spiral wire or braided wire would have a range covering a length from 0.5 to 2 from the distal end of the catheter, with a wide or tight spiral or braid.
[0060] The power supply additionally comprises a clamp for input voltage, a regulator to the actual current flowing to the control board (PCB), disallows too much voltage to the circuit board for protection, and a clamp on the output current generator, current regulator, to protect the electrode from receiving too much current as well to protect the ionic release so not too many ions, and to protect the patient from too much current.
[0061] The goal is to combine technologies to allow the device to be used on a greater range of pathogens, the ranges of items mentioned allows a user of the invention to custom-tailor the iontophoretic release of metallic ions for the target pathogen. This combination also lowers the production cost of the electrode thus making the therapy more affordable; providing a wider therapeutic window for treatment; make the placement of the electrode safer and more comfortable to the patients; makes the application of device less invasive.
[0062]
[0063] As can be seen in this illustration, the introduction of metal ions via insertion of a wire into the venous system of a patient is superior to the prior art of IV drip and iontophoretic release thru skin applied pads, as these methods do not produce enough ions and also does not get the ions into the venous system in high enough volumes to be effective in denaturing or destroying the target blood borne pathogens. Therefore, to effectively treat the target pathogens it is required to have the production of a medicant directly within the venous system in excess of 2 billion ions per second.
[0064] Research by the inventor has shown, especially with certain pathogens, that the time required for treatment may exceed 1-2 days, and that having the ionic release in the chest area can be superior and faster for these extended therapies. To facilitate this method of treatment, the device relies on an electrode that can be used with a peripherally inserted central catheter (PICC). The use of a PICC requires the administrator to measure the proper length required for the patient and to cut it to length before placement, thus the electrode will also need to be modified.
[0065] The inventor has discovered that in that the actual per second volume of ions released is critical to the success of the therapy. Metallic ions, such as but not limited to silver, gold and copper, have a short life within the body and the venous system. After a short period of time they lose their charge and are filtered and excreted from the body. As well, it is imperative that a certain level of concentration of metallic ions be achieved to have the most efficacy for treating the different pathogens targeted; therefore, the iontophoretic constant release of metallic ions, directly in the blood stream from the range of 2 billion to 7 trillion ions per second.
[0066] Research has also determined that with a range of wire diameters, exposed wire of various lengths, annealed wire and volume of ions required that to achieve the appropriate iontophoretic release of metallic cations with the variables stated, an output current from the device in the range of 1.25 to 6.0 micro amps of current for the proper volume release of ions directly within the blood stream for the treatment of blood borne pathogens.
[0067]
[0068]
[0069]
[0070]
[0071]
[0072]
[0073] A particularly preferred embodiment of the invention provides:
[0074] A device for treating a blood borne pathogen within a blood stream comprising
[0075] an iontophoretic wire, where the iontophoretic wire comprises one or more metals; a transformer, where the transformer comprises a plurality of resistors and a transducer, where the transformer is in electrical connection with the power supply, where the one or more metals contains a combination of copper and a second metal, [0076] where the iontophoretic wire additionally comprises an electrode, where the electrode comprises a vein portion and an exterior portion, where the vein portion is inserted into a patient's vein, where the exterior portion is located outside of the patient's vein, where the exterior portion is insulated with an exterior insulation such that no ions are released from anywhere other than an intended release point, where the intended release point is located inside the patient's vein, where the vein portion is at least beyond the tip of an introducer needle and an introducer catheter, where the exterior insulation is an FDA-approved material, where the FDA-approved material is selected from the group consisting of synthetics and plastic material, [0077] where the exterior insulation of the iontophoretic wire has a durometer, where the durometer is flexible enough to placed safely within the patient's venous system without causing an amount of irritation, [0078] where the exterior insulation of the iontophoretic wire has a thickness of between 0.005 and 0.025 inches, where the vein portion has a vein portion length, where the vein portion length is between 0.2 and 1.0 inches, [0079] where the vein portion has a vein portion surface area, and where the vein portion surface area is between 0.005 square inches and 0.70 square inches, where an output current from the device has a range of 1.25 to 6 micro amps of current, [0080] where the production of a medicant directly within a vein of a patient is greater than 2 billion ions per second.
[0081] In another embodiment, the electrode is a two-part electrode with a first electrode part and a second electrode part, where the first electrode part is a proximal end unit, where the proximal end contains a conductive pin, where the conductive pin comprises copper, where the conductive pin is held within a lure, where the conductive pin allows the transfer of a low intensity direct current to the iontophoretic wire from the power supply, where the pin can be tightened onto the second part through a tightening device, and where the second part is a second part electrode, where the second part electrode has a length of exposed wire at the distal end.
[0082] In alternative embodiments, the length of exposed wire at the distal end is a bare silver wire or a skived window.
[0083] In various embodiments, the tightening device can be a set screw or a quantity of conductive glue.
[0084] It is also contemplated that the metals used can included a wide range of metals, including but not limited to copper, gold and silver, in various combination. This would include embodiments where there are three metals, a first metal, a second metal, and a third metal, and where the first metal is silver, and where the three metals include at least 70% silver and less than 30% of a combination of the second metal and the third metal. Alternatively, the first metal could be gold, and where the three metals include at least 70% gold and less than 30% of a combination of the second metal and the third metal. In yet another embodiment, the electrode comprises at least 70% Copper, or, has between 1% and 99% each of gold, silver and copper.
[0085] In various embodiments, the wire can be tempered and/or annealed for proper ionic release and safety of usage of the wire within the venous system.
[0086] The device has an output current from the device is in the range of 1.25-6 micro amps of current, and, where the production of a medicant directly within the venous system in greater than 2 billion ions per second.
[0087] The device can additionally comprise a combination catheter, where the combination catheter allows the simultaneous release of a quantity of metallic ions and a quantity of an IV medicant, such as an IV antibiotic, for the treatment of a quantity of antibiotic resistant bacteria and other blood borne pathogens, where a gauge of the device will range from 12-26 gauge to allow administration from youth to adults; with an IV connection that allows a universal connector to accept multiple available IV piggy back systems; where an external surface of the catheter comprises a spiral wound silver wire, where the exposed spiral wire has a spiral wound silver wire range comprising a length from 0.5 to 2, and additionally comprising a spiral diameter, where the spiral diameter ranges from 0.001 to 0.1.
Dual Therapy Catheter
[0088] A catheter as shown in attached drawing which has a threaded or snap type side port to allow either connection, piggy back, to an IV bag connection or similar readily available medical means of adding an IV antibiotic or other medicant.
[0089] Also critical to the design is the fact that the ID of the catheter will be greater than the OD of the utilized RAIN Electrode Having a greater ID will allow any added IV antibiotic of added medicant to flow easily down and around the RAIN electrode and flow into the venous or blood flow of the patient, creating a great combo therapy device.
[0090] It should be understood that while the preferred embodiments of the invention are described in some detail herein, the present disclosure is made by way of example only and that variations and changes thereto are possible without departing from the subject matter coming within the scope of the invention.