Implantable diagnostic sensor

Details Implantable diagnostic sensor Implantable diagnostic sensor

1999-07-30

2001-07-31

Winakur, Eric F. (Department: 3736)

Surgery

Diagnostic testing

Measuring or detecting nonradioactive constituent of body...

C128S898000

Reexamination Certificate

active

06267724

ABSTRACT:

TECHNICAL FIELD OF THE INVENTION
This invention relates to implantation of diagnostic tattoos, specifically to a method to continuously and non-invasively monitor a wide array of parameters for both humans and animals. More particularly, the present invention relates to a tattooing method that allows assessment or monitoring of some biologically relevant state or change, including, but not limited to glucose levels, pathogen response chemicals such as interleukin, cytokine and immunoglobulin, temperature, pH, or any condition in which the molecules present in the interstitial fluid of the dermis change and can be monitored. Also covered in this patent are “temporary tattoos” which differ from tattoos in that they are implanted only in the epidermal layer, and thus are subject to wearing off through normal skin processes.
BACKGROUND OF THE INVENTION
Monitoring various biological body parameters is known. For example, diabetics find out their glucose level by pricking themselves several times per day The most common prior art involves taking body fluid samples, most commonly blood, and often sending them to a lab for analysis. Another common method is to expose test patches to a fluid sample, commonly urine. Urine testing has the advantage of not needing an invasive procedure like with blood. It has the limitation, however, of reflecting a cumulative average over hours where blood samples reflect the current state.
The prior art in regards to glucose involves puncturing the skin and collecting a small sample to be analyzed by the patient. This is an especially important case of prior art for two reasons. One reason is the number of tests performed per day is in the millions. Another important aspect of this test is that it typically needs to be and is done entirely by the patient with equipment that can be carried around in a purse or briefcase.
There are many diagnostic tools on the market with yield a visible change to indicate a condition or state of the body. Examples would include home pregnancy tests, pH strips, urine protein sticks, etc. While these are good demonstrations of instant readout of an important physiologic parameter, none of these are done as an implant.
The examples that follow include a glucose tattoo. It is based on the chemistry disclosed in U.S Pat. No. 5,342,789. In this patent there is a reference to tattooing in claim 21. It says “the method of claim 5 wherein said specific binding pair is tattooed into the skin of the individual”. Claims 5 describes the relevant chemistry as being “ . . . comprising of a specific binding pair which comprises a first member which is a glucose-binding ligand labeled with a first light absorbing material and a second member which is a glycoconjugate labeled with a second light absorbing material . . .”. It also claims “ . . . placing a sensor in communication with glucose present in the body fluids of the individual in such a way that once in place said sensor does not exit the skin of the individual . . .” Nowhere in the patent does the means to accomplish this receive attention. How to accomplish this is an aim of this patent, The idea of an implanted sensor does not necessarily mean a dermal implant. Nowhere in the patent is there discussion of making particles suitable for tattooing.
Other patents pertaining to diagnostic tattoos are U.S. Pat. No. 5,494,030, “Apparatus and Methodology for Determining Oxygen in Biological Systems”, and U.S. Pat. No. 5,706,805, “Apparatus and Methodology for Determining Oxygen Tension in Biological Systems”. The '805 Patent is very specific to using EPR (electron paramagnetic resonance) in conjunction with carbon particles for oximetry measurements. The '030 Patent is directed solely at oxygen tension measurements using EPR and India ink. The '805 Patent broadens these claims to include a totally non-invasive approach using India ink or lithium phthalocyanine. It also mentions measuring free radicals, pH and temperature as possibilities using their EPR techniques.
This invention will allow the implantation of a diagnostic tattoo. The said tattoo would allow for continuous, noninvasive monitoring of a wide array of relevant parameters. The benefits of this invention are numerous. They include continuous monitoring capability, virtually any analyte that is present in interstitial fluid may be monitored, once implanted, readings are non-invasive and therefore no risk of infection, are extremely simple to read and understand, immune to contamination problems associate with fluid sample containers and sample acquisition techniques, and works equally well for the unconscious.
SUMMARY OF THE INVENTION
This invention will allow the implantation of a diagnostic tattoo. Said would allow continuous, noninvasive monitoring of a wide array of relevant parameters. For example, diabetics find out their glucose level without the need to prick themselves. The current technology requires them to prick themselves several times a day. If the indicator would reveal certain cytokine levels it could indicate the presence of a pathogen. For a war fighter it could alert him to biological warfare. The current proposed arts involve creating an array of spots that will each respond to a specific pathogen. If the war fighter is exposed to a new or mutated pathogen the array will not detect it. Since this tattoo would respond to the immune system, there would be no specificity to a particular pathogen and no limit to the pathogens which are detectable. If the tattoo were to be read by a photodetector, an alert message could be sent automatically to a base camp monitor that could be monitoring a large number of war fighters.
The diagnostic tattoo, involves creating an array of spots, each responding to a specific pathogen. The method is capable of detecting a biologically relevant state or change in state of a human or animal subject. This method includes selecting a dynamic probe material that produces a measurable change of state over a range of changes in response to a varying biologically relevant state in a human or animal subject. Additionally, the method consists of selecting a reference material that exhibits a measurable state within the range of changes of the dynamic probe material that represents a desired response level of the dynamic probe material with respect to the biologically relevant state. The invention also consists of tattooing the dynamic probe material into the skin of the subject and tattooing the reference material for comparison next to the tattooed dynamic probe material in the skin of the subject and comparing the state of the dynamic probe material to the state of the reference material to ascertain a biologically relevant state of the subject for which the probe was selected.
The diagnostic system will consist of implanted particles that are coated with probes. A person skilled in the art will be able to coal the particles will little or at most routine experimentation. The probes will monitor the surrounding extra cellular fluid by direct contact or in-flow to the interior of the particle. A person skilled in the art of tattooing would be able to implant a suspension of the particles into the correct layer of the skin.
According to an embodiment of the invention, tattoo patterning could be employed in order to facilitate high resolution and accuracy in reading the tattoo, for example, by having a round spot of dynamic particles surrounded by a ring of static particles. The user could then compare the difference in color to determine whether a reaction has occurred.
According to another preferred embodiment of the invention, a second format of patterning for the invention could be a segmented plus non segmented type. The simplest case would be a bar of one type along side a sequence of segments. If the dynamic portion of the tattoo were to change gradually over a range, then the upper bar would be made from dynamic particles and the lower segments would be made from static particles.
According to another preferred embodiment of the invention, a step would be used to s

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