Abstract:
A surgical tool device, a kit and a method are described which provide a novel dual frequency LED/electrode scheme for use in manipulating nerve and innervated structures. The surgical tool device includes a probe assembly coupled to a handle assembly. The probe assembly has a low frequency light emitting diode (LED), a high frequency LED, and a stimulator electrode. The low frequency LED is used to promote healing and the high frequency LED is to aid in promoting a microbe free surgical area. The handle assembly has a system on a chip (SOC) electrically coupled to the low frequency LED, to the high frequency LED, and to the stimulator electrode. The kit includes the unattached components of the device and may also include an detector electrode probe along with an optional monitoring system. The method includes the steps of adjoining, affixing, attaching, and obtaining.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to a surgical tool device, kit and method thereof. More particularly, the present invention is directed at a surgical tool device having two different frequency light sources and having a stimulating electrode, a kit and a method thereof for use in performing surgical procedures at or near nerve structures. 
       BACKGROUND OF THE INVENTION 
       [0002]    Nearly every surgical operation involves establishing some sort of opening or channel to gain access into and around a given surgical target site. Oftentimes, based on the anatomical location of the surgical target site, surgical tools are required to maintain this working channel within a close proximity to various nerve structures and bundles. Accordingly, the surgeon must be diligent in avoiding, or at least in minimizing, any contact with these exposed nerve structures to avoid injuring the exposed nerve structures. 
         [0003]    Therefore, a need exists for a new and improved dual frequency LED/electrode surgical device having a low frequency LED, a high frequency LED and a stimulator electrode. In this respect, the dual frequency LED/electrode surgical device according to the present invention substantially departs from the conventional concepts and designs of the prior art, and in doing so provides an apparatus primarily developed for the purpose of providing a convenient means for making it possible to promoting healing and sanitizing a surgical wound as well as providing a means for identifying a particular nerve structure. 
       SUMMARY OF THE INVENTION 
       [0004]    The present device, kit and method of using, according to the principles of the present invention, overcomes a number of the shortcomings of the prior art by providing a novel dual frequency LED/electrode surgical device, kit and method for use in promoting healing and sanitizing a surgical wound as well as providing a means for identifying a particular nerve structure. The device includes a probe having a low frequency LED, a high frequency LED and a stimulator electrode. The kit includes the un-interconnected elements of the device. The method includes the steps of adjoining, affixing, attaching, and obtaining. 
         [0005]    The present invention provides an improved dual frequency LED/electrode surgical device, which will be described subsequently in great detail, that provides a new and improved dual frequency LED/electrode surgical device which is not anticipated, rendered obvious, suggested, or even implied by the prior art, either alone or in any combination thereof. 
         [0006]    The present invention essentially comprises a dual frequency LED/electrode surgical device that includes a probe assembly coupled to a handle assembly. The probe assembly has a low frequency light emitting diode (LED), a high frequency LED, and a stimulator electrode. The low frequency LED is used to thought to promote healing and the high frequency LED is thought to promote a microbe free surgical area. The handle assembly has a system on a chip (SOC) electrically coupled to the low frequency LED, to the high frequency LED, and to the stimulator electrode. The kit includes the unattached components of the device and may also include an detector electrode probe along with an optional monitoring system. The method includes the steps of adjoining, affixing, attaching, and obtaining. 
         [0007]    There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood, and in order that the present contribution of the art may be better appreciated. 
         [0008]    The invention of the device may also optionally include a plurality of control switches and a power supply. The invention of the kit may also optionally include a detector electrode probe, a cable, and a monitoring system. The invention of the method may also optionally include the steps of aligning, dispensing, displaying, emitting, irradiating, inserting, making, pressing, pulling, stimulating, and withdrawing. 
         [0009]    The present invention provides a dual frequency LED/electrode surgical device that provides in the apparatuses and methods of the prior art some of the advantages thererof, while simultaneously overcoming some of the disadvantages normally associated therewith. 
         [0010]    Also the present invention provides a kit comprising the non connected components of the dual frequency LED/electrode surgical device. 
         [0011]    Lastly, the present invention provides a new and improved method of using comprising the steps of adjoining, affixing, attaching, and obtaining. 
         [0012]    Numerous other features and advantages of the present invention will be readily apparent to those of ordinary skill in the art upon reading of the following detailed description of presently preferred, but nonetheless illustrative, embodiments of the present invention when taken in conjunction with the accompany drawings. In this respect, before explaining the current embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. 
         [0013]    As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. 
         [0014]    Further, the purpose of the foregoing abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientist, engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting as to the scope of the invention in any way. 
         [0015]    These and other features of the invention, along with the various features of novelty that characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be had to the accompanying drawings and description matter in which there are illustrated preferred embodiments of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]    The invention will be better understood will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein: 
           [0017]      FIG. 1  is a perspective view of an embodiment of the surgical tool device constructed in accordance with the principles of the present invention; 
           [0018]      FIGS. 2A ,  2 B, and  2 C depict various probe assembly designs of the surgical tool device of the present invention; 
           [0019]      FIGS. 3A ,  3 B, and  3 C depict a close up partial view of some of the various engagement surfaces of the probe assembly  12  of the surgical tool device  10 ; 
           [0020]      FIG. 4  depicts a perspective view of an assembled kit of the surgical tool device; 
           [0021]      FIG. 5  depicts a logical communication scheme of the surgical tool device; 
           [0022]      FIG. 6  depicts a logical communication scheme of the kit for the surgical tool device; and 
           [0023]      FIGS. 7A ,  7 B,  7 C,  7 D,  7 E,  7 F,  7 G,  7 H, and  7 I depict various electronic schemes for driving the low and high frequency LEDS of the surgical tool device. 
       
    
    
       [0024]    The same reference numerals refer to the same parts throughout the various figures. 
       DETAILED DESCRIPTION 
       [0025]    The following detailed embodiments presented herein are for illustrative purposes. That is, these detailed embodiments are intended to be exemplary of the present invention for the purposes of providing and aiding a person skilled in the pertinent art to readily understand how to make and use of the present invention. 
         [0026]    Accordingly, the detailed discussion herein of one or more embodiments is not intended, nor is to be construed, to limit the metes and bounds of the patent protection afforded the present invention, in which the scope of patent protection is intended to be defined by the claims and their equivalents thereof. Therefore, embodiments not specifically addressed herein, such as adaptations, variations, modifications, and equivalent arrangements, should be and are considered to be implicitly disclosed by the illustrative embodiments and claims described herein and therefore fall within the scope of the present invention. 
         [0027]    Further, it should be understood that, although steps of various the claimed method may be shown and described as being in a sequence or temporal order, the steps of any such method are not limited to being carried out in any particular sequence or order, absent an indication otherwise. That is, the claimed method steps are to be considered to be capable of being carried out in any sequential combination or permutation order while still falling within the scope of the present invention. 
         [0028]    Additionally, it is important to note that each term used herein refers to that which a person skilled in the relevant art would understand such term to mean based on the contextual use of such term herein. To the extent that the meaning of a term used herein, as understood by the person skilled in the relevant art based on the contextual use of such term, differs in any way from any particular dictionary definition of such term, it is intended that the meaning of the term as understood by the person skilled in the relevant art should prevail. 
         [0029]    Furthermore, a person skilled in the art of reading claimed inventions should understand that “a” and “an” each generally denotes “at least one,” but does not exclude a plurality unless the contextual use dictates otherwise. And that the term “or” denotes “at least one of the items,” but does not exclude a plurality of items of the list. 
         [0030]    Unless otherwise defined, all scientific and technical terms used herein are to be construed as having the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present document, including definitions, will control. Unless otherwise indicated, materials, methods, and examples described herein are illustrative only and not intended to be limiting. 
         [0031]    It will be understood that light will be defined herein as an electromagnetic radiation ranging from infrared, visible to ultraviolet wavelengths. Accordingly, the term light will be defined as any electromagnetic radiation ranging between about 250 nm to 1,500 nm. 
         [0032]    It will be understood that a photosensitizer will be defined herein as a chemical compound that produces a biological effect upon photoactivation, or a biological precursor of a compound that produces a biological effect upon photoactivation. The photosensitizer must have a sufficiently low toxicity to permit administration of the photosensitizer to the patient within an acceptable level of safety. Preferably, the photosensitizer is essentially nontoxic, however due to their polycyclic aromatic nature or their multiple conjugated rings that allow for light absorption, fluorescence, phosphorescence and photoactivation, some of these photosensitizers may exhibit some toxicity. 
         [0033]    Referring now to the drawings, and in particular  FIGS. 1 to 7  thereof, one preferred embodiment of the present invention is shown and generally designated by the reference numeral  10 . The same reference numerals refer to the same parts throughout the various figures. 
         [0034]    One preferred embodiment of a surgical tool device  10  comprises a probe assembly  12  coupled to a handle assembly  14 , in which the probe assembly  12  has a low frequency light emitting diode (LED)  16 , a high frequency LED  18 , and a stimulator electrode  20 ; and the handle assembly  14  has a system on a chip (SOC)  22  electrically coupled to the low frequency LED  16 , to the high frequency LED  18 , and to the stimulator electrode  20 . 
         [0035]    The low frequency LED  16  may be any commercially available low frequency LED  16 . One embodiment is that the low frequency LED  16  is configured to emit light between red and infrared. One embodiment is that the low frequency LED  16  may be configured to emit monochromatic light within a wavelength range between about 600 nm to about 1000 nm. Another embodiment is that the low frequency LED  16  may be configured to emit a spectral band of light of at least 10 nm wide within a wavelength range between about 600 nm to about 1000 nm. Still another embodiment is that the low frequency LED  16  may be configured to emit light at about 1 μW/cm 2  to about 1 W/cm 2 . 
         [0036]    The high frequency LED  16  may be any commercially available high frequency LED  16 . One embodiment of the high frequency LED  18  is that it is configured to emit light between green and ultraviolet. A more preferred embodiment of the high frequency LED  18  is that it is configured to emit monochromatic light within a wavelength range between about 250 nm to about 550 nm. Another embodiment of the high frequency LED  18  is that it is configured to emit a spectral band of light of at least 10 nm wide within a wavelength range between about 250 nm to about 550 nm. Still another embodiment is that the high frequency LED  18  is that it is configured to emit light at about 1 μW/cm 2  to about 1 W/cm 2 . 
         [0037]    The probe assembly  12  of the surgical tool device  10  may be shaped and designed in any configuration suitable for surgical purposes. One preferred embodiment of the shape of the probe assembly is that it has an arcuate engagement surface  28 . 
         [0038]    The stimulator electrode  20  may be powered by AC or DC current or voltage signals driven and coordinated by the SOC. 
         [0039]    Another embodiment of the surgical tool device  10  comprises the probe assembly  12  having the low frequency LED  16 , the high frequency LED  18 , the stimulator electrode  20  and the SOC  22  attached to the probe assembly  12 . The SOC  22  is electrically coupled to the low frequency LED  16 , to the high frequency LED  18 , and to the stimulator electrode  20 . Finally, the handle assembly  14  is attached to the probe assembly  12 . 
         [0040]    An optional plurality of control switches  24  may be added to the surgical tool device  10 . One embodiment of the optional control switches is that it is attached to the handle so that the control switches  24  are electrically coupled to the SOC  22 , to the low frequency LED  16 , to the high frequency LED  18 , and to the stimulator electrode  20 . 
         [0041]    An optional power supply  26  may be added to the surgical tool device  10 . One embodiment is that the optional power supply  26  is attached to the handle so that the power supply  26  is electrically coupled to the SOC  22 , to the low frequency LED  16 , to the high frequency LED  18 , and to the stimulator electrode  20 . The power supply is selected from the group consisting of a battery power supply and a high capacity capacitor power supply. 
         [0042]    One preferred embodiment of the kit for the surgical tool device  10  comprises the unattached probe assembly  12  and the handle assembly  14  of the surgical tool device  10 . The probe assembly  12  of the kit has the low frequency LED  16 , the high frequency LED  18 , and the stimulator electrode  20  attached to the probe assembly  12 . The handle assembly  14  is configured to be attached to the probe assembly  12 , in which the handle assembly  14  has an SOC  22 , a a plurality of control switches  24 , and a power supply  26 . The SOC  22  is configured to be electrically coupled to the low frequency LED  16 , to the high frequency LED  18 , and to the stimulator electrode  20 . The control switches  24  are attached to the handle, in which the control switches  24  are configured to be electrically coupled to the SOC  22 , to the low frequency LED  16 , to the high frequency LED  18 , and to the stimulator electrode  20 . The power supply  26  is attached to the handle, in which the power supply  26  electrically coupled to the SOC  22 , to the low frequency LED  16 , to the high frequency LED  18 , and to the stimulator electrode  20 . 
         [0043]    An optional detector electrode probe  30  may be added to the kit for the surgical tool device  10  in which the detector electrode probe  30  is configured to be electrically coupled to the SOC  22 . 
         [0044]    An optional cable  32  may be added to the kit for the surgical tool device  10  in which the cable  32  is configured to electrically couple together the detector electrode probe  30  to the SOC  22 , and to the stimulator electrode  20 . 
         [0045]    An optional monitoring system  34  may be added to the kit for the surgical tool device  10  in which the monitoring system  34  is configured to be electrically coupled to the detector electrode. 
         [0046]    One preferred embodiment of a method of using a kit for the surgical tool device  10  comprising the steps of adjoining, affixing, attaching, and obtaining. The step comprises obtaining the kit comprising: a probe assembly  12  having: a low frequency light emitting diode (LED)  16  attached to the probe assembly  12 ; a high frequency LED  18  attached to the probe assembly  12 ; and a stimulator electrode  20  attached to the probe assembly  12 ; a handle assembly  14  configured to be attached to the probe assembly  12 , the handle assembly  14  having: a system on a chip attached to the handle, the SOC  22  configured to be electrically coupled to the low frequency LED  16 , to the high frequency LED  18 , and to the stimulator electrode  20 ; a plurality of control switches  24  attached to the handle, the control switches  24  electrically coupled to the SOC  22 ; and a power supply  26  attached to the handle, the power supply  26  electrically coupled to the SOC  22 , and to the control switches  24 ; a detector electrode probe  30  configured to be electrically coupled to the SOC  22 ; a cable  32  configured to electrically couple together the detector electrode probe  30  to the SOC  22 , to the stimulator electrode  20 ; and a monitoring system  34  configured to be electrically coupled to the detector electrode. The attaching step comprises attaching operatively together the probe assembly  12  to the handle assembly  14  so that the SOC  22  is electrically coupled to the low frequency LED  16 , to the high frequency LED  18 , to the stimulator electrode  20 , to the power supply  26 , and to the control switches  24 . The adjoining step comprises adjoining operatively together the cable  32  to the handle and to the detector electrode so that the SOC  22  is electrically coupled to the detector electrode. The affixing step comprises affixing together the detector electrode to the monitoring system  34  so that the detector electrode and the stimulator electrode  20  are operatively coupled to the monitoring system  34 . 
         [0047]    The medical procedure supported by this method may be anyone of the following surgical procedures and non-surgical procedures, such as, endoscopic procedures, fluoroscopic procedures, stent delivery procedures, aortic aneurysm repairs, cranial aneurysm repairs, delivery of drugs, delivery of biological agents, cardiac surgery with cardiopulmonary bypass circuits, cardiac surgery without cardiopulmonary bypass circuits, brain surgery, cardiograms, heart valve repair, heart valve replacement, revascularization procedures, transmyocardial revascularization, percutaneous myocardial revascularization, anstomosis procedures, beating heart surgery, vascular surgery, neurosurgery, electrophysiology procedures, dianostic procedures, therapeutic procedures, ablation procedures, ablation of arrhythmias, endovascular procedures, treatment of the liver, treatment of the spleen, treatment of the heart, treatment of the lungs, treatment of major blood vessels, noninvasive procedures, invasive procedures, imaging procedures, CAT scan procedures, MRI procedures, gene therapy procedures, cellular therapy procedures, cancer therapy procedures, radiation therapy procedures, transplantation procedures, coronary angioplast procedures, atherectomy procedures, atherosclerotic place removal procedures, birthing procedures, spinal cord procedures including intrathecal access, epidural access and transcutaneous access. 
         [0048]    An optional set of steps may be added to the method to further comprise the steps of aligning, dispensing, displaying, emitting, irradiating, inserting, making, pressing, pulling, stimulating, and withdrawing. The making step comprises making a opening into flesh near a nerve. The dispensing step comprises dispensing an aliquot of a photosensitizer into the opening. The inserting step comprises inserting the probe assembly  12  into an opening. The aligning step comprises aligning the probe adjacent to the nerve while the probe is inserted into the opening. The pressing step comprises pressing on one control switch  24  to activate the stimulator electrodes  20  to produce electrical impulses while the probe is aligned adjacent to the nerve. The stimulating step comprises stimulating the nerve with the electrical impulses. The displaying step comprises displaying a response of the detector electrode while stimulating the nerve to identify the nerve and to verify the alignment of the probe. The irradiating step comprises irradiating low frequency light from the low frequency LED  16  onto the nerve while the probe is aligned next to the nerve. The emitting step comprises emitting high frequency light from the high frequency LED  18  onto the nerve while the probe is aligned next to the nerve. The pulling step comprises pulling the nerve aside with the probe assembly  12 . The withdrawing step comprises withdrawing the probe assembly  12  from the opening. 
         [0049]    Any number of photosensitizers can be used in conjunction in practicing with the claimed method of the present invention. They differ in the properties of light absorption and fluorescence, biodistribution, temporal uptake, clearance, and mechanisms of photoactivatable cytotoxicity. Classes of photosensitizers include acridine dyes, bacteriochlorins, bacteriochlorophylls, chlorins, hematoporphyrins, phthalocyanines, porphyrins, purpurins, naphthalocyanines, non-tetrapyrrole photosensitizers, texaphyrins, uroporphyrins. 
         [0050]    Referring now to  FIG. 1  that depicts a perspective view of an embodiment of the surgical tool device showing the surgical tool device  10  having a probe assembly  12  coupled to a handle assembly  14 . The probe assembly  12  is shown having a low frequency LED  16 , a high frequency LED  18 , and a stimulator electrode  20 . The handle assembly  14  is shown having a system on a chip (SOC)  22  and having plurality of control switches  24 . The SOC  22  of the handle assembly is electrically coupled to the low frequency LED  16 , to the high frequency LED  18 , to the stimulator electrode  20  and to the control switches  24 . 
         [0051]    Referring now to  FIG. 2A ,  2 B, and  2 C that depict various probe assembly  12  designs of the surgical tool device  10 . The probe assembly  12  is shown having any number of designs, including a curved nerve hook design as in  FIGS. 2B and 2C  as well as a straight needle design as shown in  FIG. 2A . Also shown in  FIGS. 2A-2C  are the low frequency LED  16 , the high frequency LED  18 , and a stimulator electrode  20  attached to the probe assembly  12 . 
         [0052]    Referring now to  FIG. 3A ,  3 B, and  3 C that depict a close up partial view of some of the various engagement surfaces  28  of the probe assembly  12  of the surgical tool device  10 . Also shown in  FIG. 3A-3C  are the low frequency LEDs  16 , the high frequency LEDs  18 , and a stimulator electrodes  20  attached to the probe assembly  12 . 
         [0053]    Referring now to  FIG. 4  that depicts a perspective view of an assembled kit of the surgical tool device  10 . The kit is shown to include the surgical tool device  10  having the probe assembly  12  coupled to a handle assembly  14 . The probe assembly  12  is shown having a low frequency LED  16 , a high frequency LED  18 , and a stimulator electrode  20 . The handle assembly  14  is shown attached to the probe assembly  12  and having a plurality of control switches  24 . A cable  32  is shown attached to the handle assembly  14 , to the monitoring system  34  and to the detector electrode probe  30 . 
         [0054]    Referring now to  FIG. 5  that depicts a logical communication scheme of the surgical tool device  10 . The SOC  22  is shown to be in operative communication (i.e., electrically coupled to the power supply  26 , to the low frequency LED  16 , to the high frequency LED  18 , to the stimulator electrode  20  and to the control switches  24 . 
         [0055]    Referring now to  FIG. 6  that depicts a logical communication scheme of the kit for the surgical tool device. The SOC  22  is shown to be in operative communication (i.e., electrically coupled) to the power supply  26 , to the low frequency LED  16 , to the high frequency LED  18 , to the stimulator electrode  20 , to the control switches  24 . The SOC  22  is also shown to be in operative communications, via the cable  32 , with the detector electrode probe  30  and with the monitoring system  34 . 
         [0056]    Referring now to  FIGS. 7A ,  7 B,  7 C,  7 D,  7 E,  7 F,  7 G,  7 H, and  7 I that depict various electronic schemes for driving the low and high frequency LEDS of the surgical tool device. The power supply  26  is shown to be in operative communication (i.e., electrically coupled) with the low frequency LEDs  16  and the high frequency LEDs  18 . 
         [0057]    As to the manner of usage and operation of the present invention, the same should be apparent from the above description. Accordingly, no further discussion relating to the manner of usage and operation will be provided. 
         [0058]    While a preferred embodiment of the dual frequency LED/electrode surgical device has been described in detail, it should be apparent that modifications and variations thereto are possible, all of which fall within the true spirit and scope of the invention. With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention. 
         [0059]    Throughout this specification, unless the context requires otherwise, the word “comprise” or variations such as “comprises” or comprising or the term “includes” or variations, thereof, or the term “having” or variations, thereof will be understood to imply the inclusion of a stated element or integer or group of elements or integers but not the exclusion of any other element or integer or group of elements or integers. In this regard, in construing the claim scope, an embodiment where one or more features is added to any of the claims is to be regarded as within the scope of the invention given that the essential features of the invention as claimed are included in such an embodiment. 
         [0060]    Those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. It is to be understood that the invention includes all such variations and modification which fall within its spirit and scope. The invention also includes all of the steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations of any two or more of said steps or features. 
         [0061]    Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.