WO2005030026A2

WO2005030026A2 - Prevention of releasing metal ions from implants in the body device and method

Info

Publication number: WO2005030026A2
Application number: PCT/IL2004/000907
Authority: WO
Inventors: Josef Turner
Original assignee: Josef Turner
Priority date: 2003-09-29
Filing date: 2004-09-28
Publication date: 2005-04-07
Also published as: IL158148A0; WO2005030026A3

Abstract

The present invention is a device for preventing harmful ionization in the human body including an implant situated in the body, a bodily fluid in adjacency to the implant; a gold item, on the human body, and an ELN device situated in adjacency to the gold item and electrically connected to the gold item through the bodily fluid, Further included is a device that includes an implant situated in the body, a bodily fluid in adjacency to the implant; a gold item, on the human body, an ELN device electrically connected to the implant item through the bodily fluid, for readily facilitating flow of ions between the ELN device and the implant.

Description

PREVENTION OF RELEASING METAL IONS FROM IMPLANTS IN

THE BODY DEVICE AND METHOD

FIELD AND BACKGROUND OF THE INVENTION The present invention relates to preventing harmful ion release from implants in the human body and, in particular, preventing harmful ion release from surgically insetted metal implants in the human body, such as bone connection implants, screws, stents, blood vessels nets, pacemakers, which usually contain varying degrees of iron, nickel and chromium. Implants have been used in the human body for many centuries and a variety of metals and metal alloys have been used. Presently, stainless steel implants are commonly being used, containing varying degrees of iron, nickel and chromium. It has been known since at least the 1800's that Iontophoresis can be used for delivering ionized drugs transdermally. However, the metal ions used were invariably silver ions as other metal ions can be toxic and harmful. Thus, occasioning on metal ions such as iron, chromium and nickel being released, from implants undesired and sometimes hazardous results may follow. Toxic metallic ions reaching such areas as the nervous system, the blood system and the like can cause accumulated medical damage. Ionization usually occurs when electrical current flows though an electronically conductive (e.g., elal) portions of the circuit, the current is carried by electrons, while current flowing through the liquid-containing portions of the device (i.e., the patient's body) is carried by ions. As electrical current flows through the body, oxidation and reduction of a chemical species can take place. A variety of medical treatments entail inserting and installing different types of metal implants in various places in the body. A laten deficiency of almost all metallic implants is that ionization of the various metals in the implants can occur due to a variety of circumstances. By way of example, a patient carrying an implant or having a piece of shrapnel in the body who wears gold jewelry, for example, such a combination can lead to creating a potential difference between the implanted metal and the gold. Thus, a galvanic cell is created and ions from the implant and/or the piece of shrapnel are released and oxides can be formed. Often, one of the first symptoms of such an event is an internal inflammation, which starts to develop in the area. Clearly, mass removals of all metallic implants is impractical, expensive and can be very dangerous. A more useful solution would enable physicians and medical staff to reverse or neutralize the ionization of metallic implants, such that harmful and/or toxic ions shall cease from being released. Thus, preventing release of metal ions from various metal implants in the human bod} and/or from shrapnel in the human body by "neutralizing" such a galvanic cell wherein the body fluids form the electrolyte, any gold jewelry serves as the cathode and the body implant as the anode. Due to the fact that the anode and cathode are electrically connected through a conductive channel in which movement of electrons is taking place in the body and due to the fact that almost every person wears gold jewelry, a wedding ring, a chain or a necklace on the neck, a bracelet, a gold watch, a piercing, and ear ring and the like, a more useful solution would be to prevent the implant serving as an anode. This would also seem to be the case with dental fillings, which contain mercury, among other metals. Various theoretical attempts exist to try and prevent such harmful ionization including: coating the gold jewelry with an electrically insulating material, coating the implants with an electrically insulating substance, manufacturing the implants from a non-conductive material, coating the implants with gold, preventing the use of gold jewelry and using non-metallic implants. Coating any and all gold jewelry with an electrically insulating material suffers from at least two deficiencies. First, coating all gold and gold plated jewelry involves expensive and repeated coating as the previous coating deteriorates. Second, jewelry with gems, diamonds or fine artwork can significantly loose luster and value due to such coatings. Coaling the implants already implanted in the human body with an electrically insulating substance either in-vivo or in-vitro suffers from at least one of two deficiencies. First, removal of certain implants such as stents and the like can entail invasive, high risk surgical procedures. Second, attempting to coat an implant with an electrically insulating substance while the implant is in the human body shall require using potentially harmful materials and total coating is not guaranteed. Occasioning on partial coating being achieved, ionization shall continue, negating any efficacy of such a treatment. Coating of any and all implants prior to being inserted into the human body suffers from at least one of three latent deficiencies. First, any coating shall have to be of sufficient thickness to withstand deterioration of time and of bodily fluids to the degree: that implants which are thickness sensitive, such as stents and dental fillings may fail their intended purpose. Second, various coatings may be harmful or toxic when in the human body and being in contact with a variety of bodily fluids. Third, coating implants with gold prior to inserting an implant into the human body shall increase the manufacturing costs significantly. Furthermore, such coatings can only assist with implants, which have yet to be inserted into the human body. Attempting 1o prevent use of gold jewelry by people with metallic implants suffers from at least one deficiency. A vast array of basic jewelry items are worn by individuals to a degree that permanent removal of all gold and gold plated such as, wedding rings, rings, ear rings, watches and the like may be thwarted. Manufacturing implants from non-metallic and/or non-conductive materials suffers from at least one of two latent deficiencies. First, the physical properties of the material used for non-metallic and/or non-conductive implants can prove to be inefficient compared to current stainless steel implants due to one of a plurality of possible factors including, but not limited to, resiliency, tensile strength, degradability and the like. Second, due to the wide availability of stainless steel implants, manufacturing an entire new line of implants can suffer from low cost-efficiency considerations as well as not resolving the deficiencies of implants already in the human body. Unlortunately, the risks encountered with shrapnel left in the human body cannot be resolved by any of the above theoretical attempts. Clearly, a more useful solution would enable neutralizing the electrochemical circuit created between the implant and/or shrapnel and the gold jewelry, without having to perform high risk surgically invasive procedures, thus, enabling continued use of all existing implants. In addition, such a solution would enable resolving all problems encountered with implants, irrespective whether they have been inserted into the human body. There is thus a widely recognized need for, and it would be highly advantageous to have, an inexpensive and low-risk neutralizing method and device which is capable of efficiently neutralizing the implant from serving as an anode, wherein the body fluids form an electrolyte, any gold jewelry serves as a cathode, without undesired side effects and potential hazard to the patient, and which can then "neutralize" the implant from serving as an anode for extended time periods, which device will provide a solution for a relatively large number of implant types and will make use of a plurality of assemblies which are all identical, for easy assembly and maintenance. SUMMARY OF THE INVENTION According to the present invention there is provided a device for preventing harmful ionization in the human body including: (a) an implant situated in a human body, (b) at least one bodily fluid in adjacency to the implant, (c) a gold item, situated on the human body, and (d) an ELN device situated in adjacency to the gold item and electrically connected to the gold item through the bodily fluid, thereby creating an electro chemical galvanic cell. According to another embodiment according to the present invention the device including: (a) an implant situated in a human body, (b) at least one bodily fluid in adjacancy to the implant, (c) a gold item, situated on the human body, and (d) an ELN attachment element attached to, or integrally formed with an ELN metal, such that the ELM metal comes in contact with the human body, thereby readily facilitating creating a galvanic cell wherein the ELN metal acts as an anode and the gold item acts as a cathode. According to further features in preferred embodiments of the invention described below, Ihe ELN device is attached to, or integrally formed with an ELN metal. According to still further features in preferred embodiments of the invention described below, the ELN metal is a metal selected from the group consisting of: titanium, zinc, aluminum, magnesium and any other metal and/or metallic alloy which metal and/or metallic alloy is more electronegative than the implant material.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic diagram of a galvanic cell created between an implant and a piece of gold jewelry serving as a cathode ; FIG. 2 is a schematic diagram of the galvanic cell of FIG. 1 after "^■neutralization" by an ELN piece of metal; IG. 3 is a side view of an applicator of an ELN similar to an adhesive bandage

1TG. 4 is a side view of a dental ELN ring for neutralizing galvanic cells created in the mouth of a patient.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Metal parts and implants, located in the body, are commonly manufactured ol^" medical stainless steel, and are implanted for medical purposes. In addition, metal shrapnel such as steel or lead, which has penetrated the body as a result of an explosion is sometimes left in the body due to attempts to remove the shrapnel having a higher risk factor than leaving the shrapnel in the human body. Such implants and an/or shrapnel could release metal ions in an uncontrolled way subsequent to any gold and/or gold plated items being placed on the body. Such a situation creates a galvanic cell wherein the body fluids serve as an electrolyte, the gold jewelry as a cathode, and the metal implant as an anode. The electrical connection between the anode and cathode exists through the acupuncture system in the body, wherein meridian channels and their extensions amount to hundreds of acupuncture points spread over the skin. By attaching an electric connection to an acupuncture point in the body and a second connection to a random location on the skin, it is possible to measure an electric voltage difference the nature of which stems from the movement of electrons. A further possible electric conductive channel is the nervous system. For the purpose of clarity, the term "implant" as used herein, shall include, but wiJl not be limited to, any metallic implants, metallic stents, pieces of shrapnel, dental fillings, metallic bone-connectors, joint replacements and the like. The term "gold" as used herein, shall include, but will not be limited to, any item made of gold, gold coated, gilded, partially containing gold. For the puipose of preventing ionization of implants, releasing and "migration" of metal ions in the body from metal implants such as cardiological stents or bone- connectors, it is required to eliminate one of the components of the electrochemical circuit. There are many millions of individuals in the world carrying medical steel (i.e. Al SI .i lόlNM) implants or metallic pieces of shrapnel in their body. Occasioning on those individuals wearing gold jewelry, which is not electrically insulated by a suitable coating, a galvanic cell is created in their body, such that potentially hazardous and/or toxic ions from the implants can be released. Namely, the body fluids form an electrolyte, any gold jewelry serves as a cathode and the body implant serves as an anode. The present invention deals with a personal device, which neutralizes an electrochemical connection created between gold jewelry and metallic implants in the bod;y. The present invention is based on inserting a shaped piece of thin metal, which metal is more electronegative (ELN) than the jewelry (e.g. titanium, zinc, aluminum, and the like). Thus, the thin metal piece will function as an anode in the galvanic cell formed between the ELN device and the jewelry, which will become the dominant cell. To this end, the thin metal piece is attached to the body near the area where that person wears a gold jewelry such that the galvanic cell created between the gold jewelry and the ELN device "has preference" regarding the electrochemical connection over the galvanic cell that could exist between the gold jewelry and the implant and/or melallic shrapnel in the body. Such a "preference" is created due to the fact that the distance between the gold jewelry ard the ELN device is shorter than the distance between the gold jewelry and the implant. Furthermore, such a "preference" is also created due to the higher potential difference between the ELN and the gold jewelry compared to the potential difference between the implant and the gold jewelry. Hence, when the ELN serves as an anode, the implant will no more function as an anode in a galvanic cell between the implant and the jewelry and will not degrade and/or release metallic ions in the body. Occasioning on an individual having a sensitivity or an allergic reaction to wearing an ELN proximate to the dermis an alternative ELN metal can be used to alleviate such allergic reactions. Alternatively, ELN's can be transdermally implanted for the purpose of prolonged trouble free use. Optionally, in cases where an individual has amalgam fillings containing mercury and/or gold dental crowns an ELN ring can be implanted on one of the teeth 5 or a piece of E LN metal can be implanted as a mouth implant. Alternatively inserting a short titanium needle under the skin or the soft tissue (preferably at the nearest acupuncture point) can serve to neutralize the galvanic cell and preventing the implant from acting as an anode thereby releasing harmful ions into the body of the patient. 10 The principles and operation of a device and method for preventing implant ionization according to the present invention may be better understood with reference to 1he drawings and the accompanying description. Referring now to the drawings, Figure 1 illustrates a first electro chemical galvanic cell 10 created between a metallic implant 12 and a gold item 14 wherein, a 15 body fluid 16 forms an electrolyte, gold item 14 serves as a cathode and implant 12 serves as an anode As shown in Figure 1, there is a flow of electrons 18 from implant 12 to gold item ϊ 4 and a How of ions 20 from implant 12 to gold item 14. Figure 2 illustrates a preferred embodiment of an ELN device 22 according to

?0 the present invention. ELN device 22 preferably includes a metal selected from the group consisting of: titanium, zinc, aluminum, magnesium and any other metal and/or metallic alloy which metal and/or metallic alloy is more electronegative than the implant material. For the purpose of preventing ionization of implants, releasing and "migration" '5 of metal ions in the body from metal implants such as a cardiological stent 24 or bone-connectors, it is required to eliminate one of the components of the first electrochemical circuit 10 shown in Figure 1.

ELN device 22 is geared towards neutralizing an electrochemical connection created between gold item 14 such as jewelry and metallic implants 12 in the body. Preferably, ELN device 22 is more electronegative (ELN) than gold item 14

thereby functioning as an anode in a second electro chemical galvanic cell 26 formed

between ELN device 22 and gold item 14, which second electro chemical galvanic cell 26 will become the dominant cell, such that harmful ions shall no longer flow from implant 12 to gold item 14. Namely, ELN device 22 is attached to the body near the area where the

individual wears a gold item 14, such that second galvanic cell 26 created between the gold item. 14 and ELN device 22 "has preference" regarding the electrochemical

connection over first electro chemical galvanic cell 10 of Figure 1, which could exist

between the gold item 14 and implant 12. Such a "preference" is created due to the fact that the distance between gold item 14 and ELN device 22 is shorter than the distance between the gold item 14 and

implant 12. Furthermore, such a "preference" is also created due to the higher

potential difference between ELN device 22 and gold item 14 compared to the

potential difference between implant 12 and gold item 14. Hence, when ELN device 22 serves as an anode and implant 12 no longer

functions as an anode in first electro chemical galvanic cell 10 created between

implant 12 and gold item 14 and implant 12 will not degrade and/or release metallic

ions in the body. Alternatively, ELN device 22 can be transdermally implanted for the purpose of

prolonged trouble free use. Alternatively, ELN device 22 can be attached to the patients body in a method selected from the group consisting of: affixing an ELN device to a clothing item with a pin. catch clasp, closure and the like; and wearing a ring attached to, or integrally formed with an ELN metal. Figure 3 illustrates exemplary embodiments of ELN devices 22. As shown, a thin piece of ELN metal 28, ELN metal 28 is more electronegative (ELN) than the gold item 14 of Figure 2. As can be seen in Figure 3, preferably, an attachment element 30, such as adhesive bandage 32 is attached to, or integrally formed with ELN metal 28, such that ELN metal 28 comes in contact with a patient's skin 34 when adhesive bandage 32 is affixed to patient's skin 34, thereby readily facilitates creating a galvanic cell similar to second galvanic cell 26 of Figure 2. As shown in Figure 3, a plurality of ELN metal patterns 36 can be used conjunctively with attachment element 30. Figure 4 illustrates a preferred embodiment an ELN dental ring 38 for neutralizing galvanic cells created in the mouth of a patient. Preferably, ELN dental ring 38 includes an ELN metal 28 and ELN dental ring 38 is affixed to a patient's tooth 40, such that where an individual has an amalgam filling 42, which amalgam filling 42 contains mercury and/or a dental crown 44 including a non-noble metal, an ELN dental ring can be affixed to tooth 40. Alternatively, ELN device 22 including a piece of ELN metal 28 can be implanted as ε mouth, implant, added as part of crown 44 or any other crown and the like. Figure 5 shows an ELN stent device 46 attached to, or integrally formed with, an ELN metal 28, which ELN stent device is for being readily inserted in adjacency to an existing stent 48, thereby creating an electro chemical galvanic cell 50 similar in function to second electro chemical galvanic cell 26 of figure 2.

Preferably, a conductive wire 52 connects between ELN stent device 46 and existing stent 48, such that existing stent 48 no longer functions as an anode and any

ioni nation of metal in existing stent 48 is substantially terminated.

Figure 6 shows a preferred embodiment of a modified stent 56, comprising an existing slent 48 attached to, or integrally formed or retrofitted with, ELN metal 28 lor readily preventing harmful ionization in a human body.

Preferably, modified stent 56, when inserted in a human body, substantially prevents releasing of harmful ions; namely, modified stent 56 no longer acts as an

anode, due to the integration of ELN metal 28. Thus, ELN metal 28 substantially terminates flow of harmful ions from modified stent 56 to gold item 14 (not shown in

Figure 6) due to ELN metal's 28 high level of electronegativity.

Preferably, construction of modified stent 56 includes ELN metal 28

preferably tapered to existing stent 48 or retrofitted thereto. Thus, modified stent 56 will not be appreciably different from existing stent 48 in size, weight, shape,

elϊ'cacy. and the like.

Additii mally, modified stent 56 is preferably constructed such that ELN metal 28 does not appreciably interfere with normative functions of existing stent 48. Al termitively. an amount of ELN metal 28 which amount is less than 1

millimeter is coated over existing stent 48.

More preferably, an amount of ELN metal 28 which amount is between 10 and

1 20 microns is coated over existing stent 48. Thus, modified stent 56 will not be appreciably di fferent from existing stent 48 in size, weight, shape, efficacy, and the

like. Preferably, activity of ELN metal 28 as compared to existing stent 48 is such that ELN metal 28 always emanates greater electronegativity than existing stent 48, thereby ensuring that no harmful ionic emanations originate from modified stent 56. Figure 7 shows a modified orthopedic implant 58, comprised of an existing orthopedic implant 60 attached to, or integrally formed or retrofitted with, ELN metal 28 for readily preventing harmful ionization in a human body. Preferably, modified orthopedic implant 58, when inserted in a human body, substantially prevents releasing of harmful ions; namely, modified orthopedic implant 60 no longer acts as an anode, due to the integration of ELN metal 28. Thus, ELN metal 28 substantially terminates flow of harmful ions from modified orthopedic implant 58 to gold item 14 (not shown in Figure 6) due to ELN metal's 28 high level of electronegativity. Preferably, construction of modified orthopedic implant 58 includes ELN metal 28 preferably tapered to existing orthopedic implant 60 or retrofitted thereto. Thus, modified orthopedic implant 58 will not be appreciably different from existing orthopedic implant 60 in size, weight, shape, efficacy, and the like. Additionally, modified orthopedic implant 58 is preferably constructed such that ELN metal 28 does not appreciably interfere with normative functions of existing orthopedic implant 60. Alternatively, an amount of ELN metal 28 which amount is less than 1 millimeter is coaled over existing orthopedic implant 60. More preferably, an amount of ELN metal 28 which amount is between 10 and 120 microns is coated over existing orthopedic implant 60. Thus, modified orthopedic implant 58 will not be appreciably different from existing orthopedic implant 60 in size, weight, shape, efficacy, and the like. Preferably, activity of ELN metal 28 as compared to existing orthopedic implant 60 is such that ELN metal 28 always emanates greater electronegativity than existing orthopedic implant 60, thereby ensuring that no harmful ionic emanations originate from modified orthopedic implant 58. While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention may be made. Furthermore, it will be appreciated that the above descriptions are intended only to serve as examples, and that many other embodiments are possible within the spirit and the scope of the present invention.

Claims

WHAT IS CLAIMED IS:

1.. Λ device for preventing harmful ionization in the human body comprisi ng: (a) an implant situated in a human body; (b) at least one bodily fluid in adjacency to said implant; (c) a gold item, situated on said human body; and (d) an ELN device situated in adjacency to said gold item and electronically connected to said gold item through said bodily fluid, thereby creating an electro-chemical galvanic cell.

2. The device of claim 1, wherein said ELN device is attached to, or integrally formed with an ELN metal.

3. The device of claim 2, wherein said ELN metal is a metal selected from the group consisting of: titanium, zinc, aluminum, magnesium and any other metal and/or metallic alloy which metal and/or metallic alloy is more electronegative than the implant material.

4. A device for preventing harmful ionization in the human body comprising: (a) an implant situated in a human body; (b) at least one bodily fluid in adjacency to said implant; (c) a gold item, situated on said human body; and (d) an ELN attachment element attached to, or integrally formed with an ELN metal, such that said ELN metal comes in contact with said human body, thereby readily facilitating creating a galvanic cell wherein said ELN metal acts as an anode and said gold item acts as a cathode.

> 1 he device of claim 4, wherein said ELN device is attached to, or integrally formed with an ELN metal.

o. The device of claim 5, wherein said ELN metal is a metal selected from the group consisting of: titanium, zinc, aluminum, magnesium and any other metal and/or metallic alloy which metal and/or metallic alloy is more electronegative than the implant.

7. A method for preventing harmful ionization in the human body comprisi ng the steps of: (a) providing a system for preventing harmful ionization in the human body including: (i) an implant situated in a human body; (ii) at least one bodily fluid in adjacency to said implant; (iii) a gold item, situated on said human body; and (iv) an ELN attachment element attached to, or integrally formed with, an ELN metal, such that said ELN metal comes in contact with said human body; and (b) inserting said ELN attachment element proximally to said implant, such that said ELN metal acts as an anode and said gold item acts as a cathode.

!:!. The method of claim 7, wherein said ELN metal is a metal selected from the group consisting of: titanium, zinc, aluminum, magnesium and any other metal and/or metallic alloy wherein said metal and/or metallic alloy is more electronegative than said implant.

9. A device for preventing harmful ionization in the human body comprising: (a) an implant situated in a human body; (b) at least one bodily fluid in adjacency to said implant; and (c) an ELN device electrically connected to said implant item through said bodily fluid, for readily facilitating flow of ions between said ELN device and said implant; and, (d) at least one conductive channel for readily facilitating flow of electrons between said implant and said ELN device, thereby creating an electro-chemical galvanic cell.

10. The device of claim 9, wherein said ELN device is attached to, or integrally formed with an ELN metal.

1 1. The device of claim 10, wherein said ELN metal is a metal selected from the group consisting of: titanium, zinc, aluminum, magnesium and any other metal and/or metallic alloy which metal and/or metallic alloy is more electronegative than the implant material.

I 2. A device for preventing harmful ionization in the human body comprisi ng: (a) an implant situated in a human body; (b) al least one bodily fluid in adjacency to said implant; and (c) an ELN attachment element attached to, or integrally formed with an ELN metal, such that said ELN metal comes in contact with said human body for readily facilitating flow of ions from said FLM attachment element and said implant; and (d) al least one conductive channel for readily facilitating flow of electrons between said implant and said ELN attachment element, thereby readily facilitating creating a galvanic cell wherein said FLN metal acts as an anode and said implant acts as a cathode.

I 3. 1 he device of claim 12, wherein said ELN device is attached to, or integrally formed with an ELN metal.

I 4. The device of claim 13, wherein said ELN metal is a metal selected from the group consisting of: titanium, zinc, aluminum, magnesium and any other metal and/or metallic alloy which metal and/or metallic alloy is more electronegative than the implant.

I 5. A method for preventing harmful ionization in the human body comprising the steps of: (a) providing a system for preventing harmful ionization in the human body including: ( i) an implant situated in a human body; (ii) at least one bodily fluid in adjacency to said implant; and ( iii) an ELN attachment element for readily facilitating flow of ions between said ELN device and said implant, said ELN attachment element attached to, or integrally formed with, an ELN metal, such that said ELN metal comes in contact with said human body; and (iv) a conductive channel for readily facilitating flow of electrons between said implant and said ELN attachment element, thereby readily facilitating creating a galvanic cell wherein said ELN metal acts as an anode and said implant acts as a cathode (b) inserting said ELN attachment element proximally to said implant, such that said ELN metal acts as an anode and said implant acts as a cathode.

16. The method of claim 15, wherein said ELN metal is a metal selected from the group consisting of: titanium, zinc, aluminum, magnesium and any other metal and/or metallic alloy wherein said metal and/or metallic alloy is more electronegative than said implant.