Abstract:
Deep Tissue Low Intensity Laser Therapy or Treatment (DT-LILT) as described here is a novel methodology through which selective destruction of nociceptive (pain) nerves can be brought upon by a medical laser delivery system using the phenomenon of absorption and cell resonance. Using this method nerve cells that transmit pain can be selectively destroyed leaving the surrounding tissues intact as no heat is generated. The delivery system incorporates a fine needle through which a 703 nm (range 690 to 710) pulsed wave low intensity laser is delivered deep into the body, directly to the area of pain causing selective destruction of pain nerves. Laser devices based on this methodology should be used only by the physician or equivalent professional community since diagnosing and defining the area of pain is critical to providing successful pain relief.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. Pat. No. 12/631,835 filed Jan. 8, 2010, the contents of which are herein incorporated by reference. 
         [0002]    This application is related to U.S. application Ser. No. 13/022,178, filed Feb. 7, 2011; U.S. application Ser. No. 13/329,596, filed Dec. 19, 2011, now U.S. Pat. No. 9,044,594; and U.S. application Ser. No. 14/727,140, filed Jun. 1, 2015, the contents of each are herein incorporated by reference. 
     
    
     TECHNICAL FIELD 
       [0003]    This application relates to laser medical devices and its use in pain medicine. 
       BACKGROUND OF THE INVENTION 
       [0004]    Low level laser therapy (LLLT), also known as photobiomodulation, cold laser therapy, and laser biostimulation, is a medical and veterinary treatment, which uses low-level lasers or light-emitting diodes to stimulate or inhibit cellular function. LLLT uses light sources such as lasers or LEDs to deliver light of certain wavelengths at certain intensities to affect tissue regeneration, inflammation, or pain. Existing deep tissue lasers today use heat generation to cause a non-selective action destroying non-specific tissue on contact. 
       SUMMARY 
       [0005]    In general, one aspect of the subject matter described in this specification may include using a deep tissue low intensity laser (DT-LIL) capable of producing cell resonance within a nerve cell that can selectively cause destruction of the nerve cells without affecting the surrounding tissues. The deep tissue low intensity laser treatment (DT-LILT) selectively destroys nerve cells on contact using absorption and cell resonance. DT-LILT does not generate sufficient heat to destroy tissue, allowing selective destruction when nerve cells selectively absorb the DT-LILT wavelength. Thus, selective deep tissue low intensity laser ablation (DT-LILA) of the nerves, or deep tissue low intensity laser neuroablation (DT-LILNA) takes place. 
         [0006]    The selection of laser wavelength may depend on the absorption characteristics of the nerve cells. Heat may or may not be generated as the selective destruction takes place by cell resonance rather than by heat coagulation. The use of deep tissue low intensity laser neuroablation (DT-LILNA) is described herein and is different from other medical or tissue lasers that use heat generation. Clinical applications include treating chronic pain, soft tissue injury, wound healing and nerve regeneration. 
         [0007]    Definition of Terms: 
         [0008]    1. DT-LILT: Deep Tissue Low Intensity Laser Treatment or Therapy. 
         [0009]    2. DT-LIL: Deep Tissue Low Intensity Laser. 
         [0010]    3. DT-LILA: Deep Tissue Low Intensity Laser Ablation. 
         [0011]    4. DT-LILNA: Deep Tissue Low Intensity Laser Neuroablation. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1  illustrates a schematic diagram of an example laser delivery system for use with DT-LILT. 
           [0013]      FIG. 2  illustrates an AP x-ray view of a lumbar facet joint, a lamina and a spinous process. 
           [0014]      FIGS. 3A-3G  illustrate single lumbar facet joints with various laser point configurations for DT-LILT. 
           [0015]      FIG. 4  illustrates an example laser delivery system for use with DT-LILT. 
       
    
    
       [0016]    In the drawings, like reference numbers represent corresponding parts throughout. 
       DETAILED DESCRIPTION 
       [0017]    Current deep tissue medical lasers are typically high intensity lasers, with output powers usually around 100 mW or above, that generate heat to destroy contact tissue using techniques such as hemo-coagulation. However, these deep tissue medical lasers lack sufficient selectivity or specificity to destroy contact tissue without causing collateral damage to surrounding tissue. Traditional low level laser therapy (LLLT) techniques also lack sufficient specificity. Current LLLT techniques use indirect pain relief techniques such as minimal heat generation, vasodilatation or metabolic changes. These lead to temporary pain relief because they do not destroy problematic pain nerves that cause long-term pain. 
         [0018]    The deep tissue low intensity laser treatment (DT-LILT) disclosed in this application selectively destroys nerve cells on contact using the phenomenon of absorption and cell resonance. DT-LILT does not generate heat, or the heat generated is not sufficient to destroy tissues, therefore selective destruction is brought upon by cell resonance when the nerve cells selectively absorb the DT-LILT laser wavelength. By causing destruction of nerve cells in this manner, DT-LILT can provide long-term pain relief extending for many months. 
         [0019]      FIG. 1  illustrates a schematic diagram of an example laser delivery system  100  for use with DT-LILT. For example, the system  100  may include a laser generator  102 , a laser fiber  104 , a laser fiber fixator  106 , and a needle  108 . The system  100  may be used in DT-LILT by performing absorption and cell resonance to selectively destroy nerve cells without affecting the surrounding tissues. 
         [0020]    In some implementations, the system  100  is used to specifically destroy nerve cells to provide long-term pain relief This is performed by causing absorption of specific wavelengths by nociceptive nerves when DT-LILT is directly applied to a pain generating area, bringing about the physiologic action of neuroablation (DT-LILNA) of the pain nerves. In such implementations, the DT-LILT may be minimally invasive and designed to be used within the pain generating area. For example, DT-LILT may be applied to specific areas of the spine as shown in  FIGS. 3A-3G . The system  100  may be used to cause destruction of tissue without heat generation. For example, laser generator  102  may be a DT-LIL with power output less than 5 mW to allow deep tissue application. In some implementations, the DT-LIL may fall under laser classification 3R or below. 
         [0021]    In one implementation, the system  100  includes the laser generator  102  capable of generating light of wavelength in the 690 nm to 710 nm range, the laser fiber  104  with diameters between 0.7 and 0.5 mm, and the laser fiber fixator  106  coupled with the needle  108  using a luer lock mechanism. The needle  108  may be a common Quincke spinal needle. The fixation between the laser fiber  104  and the spinal needle  108  can also be achieved by making the laser fiber and the spinal needle as one non detachable unit. 
         [0022]    In some implementations, the laser generator  102  produces a laser with wavelength between 700 nm to 705 nm, laser output average power between 4 mW and 6 mW (with range between 1 mW and 6 mW) , a laser pulsation at nanosecond or picosecond intervals, and timer controlled between 5 seconds and 10 seconds. 
         [0023]    In some implementations, the nerve tissue consists of lipids that absorb the above laser wavelengths without impacting surrounding non-nervous tissue. For example, the laser generator  102  may have a wavelength between 690 nm and 710 nm with an optimal absorption at 703 nm, and with low output and high pulsation, which is absorbed by the nociceptive nerves. In such an example, using a 703 nm laser with the low output and high pulsation causes the nociceptive nerves to be selectively destroyed leaving surrounding tissue intact without heat generation. 
         [0024]    In some implementations, the needle  108  is a fine needle that is 22G or smaller to deliver the laser treatment deep into the tissue. In some implementations, the needle  108  is 25G with a 0.5 mm inner diameter to fit a 300 μm laser fiber  104  and insert the laser fiber  104  below the body surface of a human patient. The fine needle  108  facilitates reaching tissue areas of treatment that may lie deep from the body surface and the inserted laser fiber facilitates the laser delivery to the area of treatment. In some implementations, the needle  108  may be a Quincke spinal needle. The fine needle  108  may provide cost savings as compared to heavier and bigger conduits for laser delivery. 
         [0025]    In some instances, the design of the needle  108  includes laser fiber  104  embedded within the cannula of the needle to form a non-detachable unit. In some instances, the system  100  includes a laser fiber fixator  106  with a luer lock mechanism to facilitate the attachment of different-sized syringes to various sized needles. For example, the laser fiber fixator  106  with a luer lock mechanism may be used to attach the needle  108 , which may be a Quincke spinal needle, to the laser fiber  104 , which fixes the laser fiber within the needle and prevents movement of the fiber during laser delivery. In some implementations, the laser fiber fixator  106  includes a tuohy borst adapter with a blue cap and a male luer lock connector with a spin lock. In such implementations, the dimensions of the laser fiber fixator  106  may be between 2-6 FR (0.026 in-0.083 in) (0.66 mm-2.11 mm) (22-12 Gauge). In such implementations, the material of the laser fiber fixator  106  may be acrylic, polycarbonate, or silicone. 
         [0026]    In some implementations, the system  100  may be used to perform a method that includes an intra-operative treatment using facet joint neuroablation, also known as medial branch neuroablation, as represented in  FIG. 2 . For example, the method may use a simple AP x-ray view and pass a deep tissue low intensity laser to cause a DT-LILNA. In another example, the DT-LIL may cause a DT-LILA. This is in contrast to conventional neuroablation that is based on finding the medial branch nerve in an oblique/lateral X ray view and using heat or chemical substance to destroy the medial branch. 
         [0027]      FIG. 2  illustrates an AP X-Ray view of lumbar facet joints  202 , a lamina  204  and a spinous process  206 . DT-LILT may be applied to specific areas of the spine as shown in  FIG. 2 , using laser points as shown in  FIGS. 3A-3G . 
         [0028]    Although  FIG. 2  shows the lumbar facet joint as laser points for the application of DT-LILT using the laser delivery system  100 , the laser points used in DT-LILT are also applicable to all facet joints, including thoracic and cervical facet joints. When the size of the facet joint is smaller, the laser points and the laser area for DT-LILT may reduce but the pattern of laser delivery remains the same. 
         [0029]      FIGS. 3A-3G  illustrate single lumbar facet joints with various laser point configurations for DT-LILT. Referring to  FIG. 3A , laser points  312  may be made in eight points in a circular fashion around the facet joint  310 . Referring to  FIG. 3B , laser points  322  may be made in a continuous circular fashion around the facet joint  320 . Referring to  FIG. 3C , the laser points  332  may be made in continuous intermittent fashion around the facet joint  330 . Referring to  FIG. 3D , the laser points  342  may be made in continuous cross fashion across the facet joint  340 . Referring to  FIG. 3E , the laser points  352  may be made in continuous multiple cross fashion across the facet joint  350 . Referring to  FIG. 3F , the laser points  362  may be made in continuous intermittent fashion  4  across the facet joint  360 . Referring to  FIG. 3G , the laser points  372  may be made in a continuous intermittent fashion multiple across the facet joint  370 . 
         [0030]      FIG. 4  illustrates an example laser delivery system  400  for use with DT-LILT. The laser delivery system  400  may be used for a medical procedure for treating reoccurring pain. In some implementations, the laser delivery system  400  is similar to the system  100 . 
         [0031]    In some implementations, the system  100  or the system  400  includes specified operating parameters for DT-LILT. For example, the laser generator  102  generates a 703 nm wavelength laser with 2 nm specified range, has an average 4 mW output power with a 0.8 mW specified range and a peak output power at 40 nW with 8 nW specified range. The laser is pulsed at 25 ns and is timer controlled at 5 s or 10 s. The system  100  or the system  400  includes two types of laser fiber diameters at 200 micron and 300 micron, with a laser area of the tissue under treatment that is confined to the laser fiber diameter with less than 1 mm scatter. 
         [0032]    The laser also operates on rechargeable batteries, does not require a dedicated power supply during operation, and is compatible with the North American 110-120 V/AC standard. The system  100  or the system  400  is also enclosed in a non-conducting insulated casing and does not require separate grounding during charging, operation, or both. In such implementations, because the laser has low output power, its use for pain treatment is safer than current deep tissue medical lasers with high intensity lasers. 
         [0033]    The following sections describe an example DT-LILT procedure using the system  100  or the system  400  in some implementations. The DT-LILT procedure in these implementations does not involve use of sedation, general anesthetics, local anesthetics, or the use of oral or injectable drugs. The DT-LILT is performed bilaterally on the L5-S1 and L4-L5 face joints. During the procedure, a 25 G spinal needle is initially directed bilaterally at each of the L4-L5 and L5-S1 facet joints. Each facet joint is individually treated. Once the needle is embedded at the center of the facet joint, the laser fiber is inserted after removing the stylet. The DT-LILT generator is then switched on to deliver five seconds of laser energy. 
         [0034]    In this manner, four facet joints are treated with one laser delivery point per facet joint with a five second laser delivery time and a 20 second total laser delivery time during the procedure. During the procedure, the patient is aware of the entire procedure to provide feedback. The patient may not feel discomfort other than from insertion of the needle. 
         [0035]    During post procedure testing, which is performed to determine the effectiveness of the procedure in reducing or removing pain symptoms, pain resolution report from the patient is collected and the patient&#39;s ability to stand straight, flex the spine posteriorly are all evaluated. A Kemp test is also performed to assess the lumbar spine facet joints. A patient satisfaction score from a scale 0 to 100 (higher the score better the satisfaction) may be collected to determine pain reduction resulting from the procedure. 
         [0036]    Results of test applications of DT-LILT indicated complete 100% resolution of pain symptoms after the procedure, with the patient able to stand straight and flex the spine posteriorly. The patient had negative Kemp test soon after the procedure. The patient also reported a satisfaction score of 100.