SYSTEM AND METHOD FOR APPLYING CONTROLLED DOSAGE LIGHT THERAPY FOR TREATMENT OF BODY TISSUE

Abstract

Methods for improving transmucosal delivery of Photobiomodulation to the body of a patient. Near infrared energy can be delivered through natural body openings in order to deliver therapeutic irradiance to deep tissues and organs. The use of a double sheath mechanism of energy introduction may decrease the discomfort associated with the present method of delivery among those patients with allodynia or severe hyperalgesia. Energy device power settings can be further optimized to improve outcomes and decrease the incidence of known adverse events. Furthermore, the availability of intuitive large screen user interfaces provides a unique opportunity to gather real-time, real-world patient experience (RWE) data.

Claims

1. A method for reshaping transmucosal energy delivery to pelvic tissue, said method comprising: a first step of providing an outer sheath with an inner diameter sufficient to allow insertion of a laser fiber probe; followed by a second step of inserting said tubular sheath into a patient body cavity potential space such as a vagina or rectum; followed by a third step of providing a laser fiber probe composed of a laser fiber enclosed in a protective sheath, wherein said laser fiber is capable of emitting laser energy from an area in its distal 4 cm, with said fiber meaningfully connected to a laser energy source; followed by the fourth step of inserting said laser fiber probe into the outer sheath until the laser emitting portion of said laser fiber is within said body cavity; followed by a fifth step of activating said laser energy and transmitting said laser energy through said protective sheath and outer sheath; followed by a sixth step of translating said laser fiber probe distal end back and forth inside the outer sheath to a distal point not exceeding the distal end of the outer sheath and to a proximal point not exiting the body cavity; followed by a seventh step of deactivating said laser energy and removing said outer sheath and laser fiber probe from body cavity.

2. The method of claim 1, wherein said laser energy comprises laser energy in a wavelength in the range from 400 nm to 1064 nm.

3. The method of claim 2, wherein said body cavity is further defined as a vagina.

4. The method of claim 2, wherein said body cavity is further defined as a rectum.

5. The method of claim 1, wherein the user observes markings on outer sheath, protective sheath, fiber cladding, or other fiber covering such marking conveying information on a length of area and or surface area to be treated, user inputs said observations into a user interface of said laser energy source, said input observations resulting in alteration or maintenance of dosing based on dosing information maintained in laser memory.

6. The method of claim 1, wherein said fourth step of translating is further defined as moving said laser fiber probe in a distal and proximal motion relative to the site of said second step of insertion.

7. The method of claim 1, wherein said fourth step of translating comprises a time span of at least one minute.

8. The method of claim 2 wherein the energy output by laser energy source is sufficient to deliver an irradiance between 10 and 400 mW/cm2 at a depth 1 cm from the surface of body cavity tissue when the laser fiber probe is inserted into an outer sheath that is disposed in a pelvic cavity.

9. The method of claim 2 wherein the power output of said source of laser energy is set at a power needed to deliver a surface irradiance ranging from desired tissue irradiance at 0.5 mm to 10 mm depth divided by 0.02 to desired tissue irradiance at 0.5 mm to 10 mm depth divided by 0.10 when the laser fiber probe is inserted into an outer sheath that is disposed in a pelvic cavity.

10. The method of claim 2 wherein the energy output by source of laser energy is sufficient to deliver an irradiance between 0.050 and 0.150 J/cm2 at a depth of 1 cm from the surface of body cavity tissue when the laser fiber probe is inserted into an outer sheath that is disposed in a pelvic cavity.

11. The method of claim 2 wherein the energy output by laser is between 250 mW and 15 W.

12. The method of claim 2 in which the user inputs patient symptom information or diagnostic information into a laser user interface prior to activating laser.

13. The method of claim 2 in which the user inputs patient symptom information or diagnostic information into the laser user interface after activating said laser and before treating next patient.

14. The method of claim 11 in which laser thence generates graphical data to display symptom improvement or worsening on said user interface.

15. The method of claim 12 in which laser thence generates graphical data to display symptom improvement or worsening on said user interface.

16. The method of claim 11 in which laser thence transmits data to a database that is not located within said laser.

17. The method of claim 12 in which laser thence transmits data to a database that is not located within said laser energy source.

18. The method of claim 1 in which said laser transmits usage information to a database that is not located within said laser and such information is used to maintain procedure related inventory at location of said laser.

19. A method for using an energy device to treat human tissue, said method comprising; a. a first step of requiring user to respond to a user interface query or queries as part of hazard mitigation prior to allowing activation of said energy device, said hazards having been identified in the device or application failure mode effects analysis; and b. a second step of allowing activation of laser energy only after a user enters a predetermined response or responses to such query or queries into the user interface.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The accompanying drawings, which are incorporated into and form a part of the specification, illustrate one or more embodiments of the present invention and, together with the description, serve to explain the principles of the invention. The drawings are only for the purpose of illustrating the preferred embodiments of the invention and are not to be construed as limiting the invention. In the drawings:

[0036] FIG. 1 depicts a break-away side view of an embodiment of an outer sheath of the invention in which the outer sheath is a tube that is open on a first end and closed on a second end.

[0037] FIG. 2 depicts a break-away side view of an embodiment of an outer sheath of the invention in which the outer sheath is a tube that is open on a first end and open on a second end.

[0038] FIG. 3 depicts a break-away side view of an embodiment of an sheath of the invention in which the protective sheath is a tube that is open on a first end and closed on a second end, and in which the first end has been fluted so as to be of larger diameter than the tube diameter.

[0039] FIG. 4 depicts a break-away side view of an embodiment of an outer sheath of the invention in which the outer sheath is a tube that is open on a first end and open on a second end, and in which the first end has been fluted so as to be of larger diameter than the predominating tube diameter.

[0040] FIG. 5 depicts an embodiment of the system of the invention in which a laser energy source 005 is connected to an optical laser fiber for transmitting light, i.e. optical, energy from the laser energy source 005 to a light emitting area of the optical fiber 007, and wherein the light emitting area of the optical fiber 007 is disposed within any of the disclosed or structural equivalent embodiments of the outer sheath such that light energy is emitted from the optical fiber, through the wall or walls of the protective fiber sheath and the outer sheath.

DETAILED DESCRIPTION OF THE INVENTION

[0041] The following documentation provides a detailed description of the invention.

[0042] Although a detailed description as provided in the attachments contains many specifics for the purposes of illustration, anyone of ordinary skill in the art will appreciate that many variations and alterations to the following details are within the scope of the invention. Accordingly, the following preferred embodiments of the invention are set forth without any loss of generality to, and without imposing limitations upon, the claimed invention. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents, and not merely by the preferred examples or embodiments given.

[0043] As used herein, “photobiomodulation” includes within its meaning a form of light therapy that utilizes non-ionizing light sources, including lasers, light emitting diodes, and/or broadband light, in the visible (400-700 nm) and near-infrared (700-1100 nm) electromagnetic spectrum. Photobiomodulation is a nonthermal process involving endogenous chromophores eliciting photophysical (both linear and nonlinear) and photochemical events at various biological scales. This process results in beneficial therapeutic outcomes including but not limited to the alleviation of pain or inflammation, immunomodulation, and promotion of wound healing and tissue regeneration.1 The term photobiomodulation (PBM) therapy is now being used by researchers and practitioners instead of terms such as low level laser therapy (LLLT), cold laser, or laser therapy and thus includes within its meaning the definitions of these terms. There is consensus that the application of a therapeutic dose of light to impaired or dysfunctional tissue, i.e. photobiomodulation, leads to a cellular response mediated by mitochondrial mechanisms that reduce pain and inflammation and speed healing. In embodiments, the primary target (chromophore) for photobiomodulation is the cytochrome c complex which is found in the inner membrane of the cell mitochondria. Cytochrome c is a vital component of the electron transport chain that drives cellular metabolism. As light is absorbed, cytochrome c is stimulated, leading to increased production of adenosine triphosphate (ATP), the molecule that facilitates energy transfer within the cell. In addition to ATP, laser stimulation also produces free nitric oxide and reactive oxygen species. Nitric oxide is a powerful vasodilator and an important cellular signaling molecule involved in many physiological processes. Reactive oxygen species have been shown to affect many important physiological signaling pathways including the inflammatory response. In concert, the production of these signaling molecules has been shown to induce growth factor production, to increase cell proliferation and motility, and to promote extracellular matrix deposition and pro-survival pathways. Outside the cell, nitric oxide signaling drives vasodilation which improves microcirculation in the damaged tissue, delivering oxygen, vital sugars, proteins, and salts while removing wastes.

[0044] The scope and breadth of the present inventive disclosure is applicable across a wide variety of procedures, tissues and anatomical structures. Although the following detailed description contains many specifics for the purposes of illustration, anyone of ordinary skill in the art will appreciate that many variations and alterations to the following details are within the scope of the invention. Accordingly, the following preferred embodiments of the invention are set forth without any loss of generality to, and without imposing limitations upon, the claimed invention.

[0045] The present method of intracavity transmucosal delivery of photobiomodulation utilizes back and forth movement of bulbous translucent probe. Many patients with pain syndromes cannot tolerate this movement, for any number of reasons, including irritation of the body tissue that is in contact with, or even being displaced by, the bulbous probe as it is translated across pelvic tissue. The improved method of the invention utilizes a two-sheath configuration.

[0046] Referring now to FIGS. 1, 2, 3 and 4, an outer sheath 001, 002, 003 or 004, respectively, may comprise material favorable to the transmission of near infrared light. The outer sheath may be inserted into a body cavity such as, by way of example and not limitation, a vagina or rectum of a patient. The outer sheath may be advanced into the body cavity to a maximum depth of proximal treatment (“proximal” being defined as the direction moving away from the medical treatment provider such that the “maximum depth of proximal treatment” is the point of advancement of the proximal end of the outer sheath furthest from the medical provider). In FIGS. 1, 2, 3 and 4, the proximal end is shown as elements 101 (closed end with an arcuate surface) and 102 (open end), but the physical configuration of the proximal end of the outer sheath (e.g. closed, open, partially open or otherwise) may take any physical configuration desired by a user.

[0047] Still referring to FIGS. 1, 2, 3 and 4, the protective sheath 001, 002, 003 or 004, respectively, may be of tubular cross section of outer diameter D, may be of length L, and may have an inner diameter of dimension given by D−2 (T), where T is the tube wall thickness. In embodiments, the tube wall thickness T may be uniform around the outer perimeter of, and along the length L of, the protective sheath 001, 002, 003 or 004. Embodiments may comprise a closed or open first end, 101 and 102, respectively, and may also comprise an optional flared or increased diameter second end 008 as depicted in FIGS. 3 and 4. The optional flared second end 008 may facilitate the insertion of the optical fiber or hand piece 006 structure (not shown in FIGS. 1, 2, 3 and 4 but shown in FIG. 5). The outer sheath 001, 002, 003 or 004 need not be limited to a tubular cross section, nor is it limited to consistent wall thickness along its length or around its periphery. In other words, in embodiments, the outer sheath of the invention may comprise non-uniform wall thickness and may be of non-tubular cross section. The outer sheath may comprise an inner opening 100 into which an optical fiber may be inserted. In a tubular embodiment of the protective sheath, inner opening 100 may be circular in cross section, but such an embodiment is merely exemplary in nature and is therefore non-limiting; i.e., such cross section may be of any shape.

[0048] In a preferred embodiment, any embodiment of an outer sheath of the invention, including but not limited to the embodiments depicted as 001, 002, 003 or 004 of the invention may, but do not necessarily, comprise optional markings 010 on an outer surface of the sheath, such as, for example, hash marks placed along the length of the outer sheath, that are used to allow a medical provider to determine the distance between the most proximal treatment point and most distal treatment point. Such optional markings 010 may take any form and may be, but are not necessarily, be of equal spacing between them.

[0049] Next, referring now to FIG. 5, the second end of a laser optical fiber probe that is connected to a laser energy source, or device, 005 on its first end is inserted into the outer sheath 001, 002, 003, 004. The laser fiber 007 may transmit laser energy from its distal end in a radial direction, i.e. perpendicular to a longitudinal axis of the optical fiber, for a distance A from its proximal end. In an embodiment, A may be, for example and not by way of limitation, 4 cm. The optical laser fiber 007 may be covered by a protective sheath 200 comprising a material favorable to the transmission of near infrared light. The protective sheath 200 is of an outer diameter smaller than the inner diameter of the outer sheath 001, 002, 003, 004. In an embodiment, the protective sheath 200 of the laser fiber 007 bears markings that are used to determine the distance between the most proximal treatment point and most distal treatment point. In an embodiment, such markings may appear on any non-transmissive protective cladding or other covering that covers the laser fiber 007.

[0050] Following insertion of fiber 007 into outer sheath 001, 002, 003, or 004, the fiber, which is in optical communication with and is otherwise meaningfully connected to, or in other words is in optical communication with, a controllable laser power source 005, is activated, meaning that laser energy is delivered from laser source 005 into laser fiber 007. The laser fiber 007 is next motivated back and forth within the outer sheath 001, 002, 003, or 004 such that its most distal end moves in an area between the most distal outer sheath point and a proximal point in the outer sheath 001, 002, 003, or 004 that is within the body cavity. During the movement of laser optical fiber 007 within outer sheath 001, 002, 003, or 004, the outer sheath 001, 002, 003, or 004 may remain stationary with respect to the body cavity body tissue. Following the delivery of a prescribed dose of near infrared energy the laser energy source 005 is deactivated, meaning that optical energy output of the laser is ceased, and the outer sheath 001, 002, 003, or 004 and optical fiber probe 007 and 200 are removed from the body cavity.

[0051] In a preferred embodiment, the laser technician visualizes markings on either of the sheaths that provide information on the depth of sheath insertion, which information includes, for example, body cavity length or surface area, which may be used by the invention as described below. Such information may be entered into the laser user interface by a user as input data, which is used as described below. The laser device may comprise or be in communication with a processor that is in communication with computer-readable and writeable physical storage media. The processor may be adapted to read and to store non-transitory computer-readable and computer-executable instructions on said physical storage media, or memory, and to read and to store information on said computer-readable and writeable physical storage media, or memory. The processor may be in communication with various transceivers, wired or wireless, that are in communication with data networks to provide the communications functions described herein, such as, for example, communication with remote servers or databases. The non-transitory computer-readable and computer-executable instructions on said physical storage may be executed by the processor to carry out any or all of the steps and functions of the invention as described herein. The processor may thus write to and maintain on the physical storage media a database of prescribed energy doses based on body cavity length or body cavity surface area, or both, for a specific user. These prescribed energy doses may be determined by the processor, operating on user input data. The entered user input information may be used as input by the processor, and operated upon by the non-transitory computer readable and executable instructions as they are read from the physical storage media and executed by the processor, to determine the dosage appropriate to length of the cavity or surface area of the cavity to be treated, and to control the laser parameters to achieve a desired dosage of laser energy to the body cavity tissue. Prior to applicant's clinical trials, laboratory evaluations, and gathering of real-world experience data, such dosing was not known in the art. Certain body tissues and certain organs may require higher or lower irradiance to achieve photobiomodulation. It is commonly held in the art that higher irradiances negate the beneficial effects of photobiomodulation, however Applicant's results show just the opposite, and were thus unexpected. Further, the prior art was devoid of information regarding the degradation of near infrared energy as it traverses the various chromophores of the pelvic tissues. Whereas proponents of milliwatt laser systems continue to suggest that such low power systems are capable of treating deep tissues, the inventor was surprised to learn that 500 mW was not capable of penetrating transvaginally to the bladder or pelvic muscles at therapeutic irradiance. Such a result was completely unexpected in the art. The inventor was also surprised to find that power loss with depth did not follow a predictable curve. At 4 mm below the surface of the vaginal mucosa 59% of irradiance was lost. At 7 mm depth, 88% of irradiance was lost. At 10 mm depth 97% was lost. These findings have allowed the inventor to define a range of surface powers and deep tissue irradiances that are effective in reducing symptoms of those with myofascial pelvic pain.

[0052] Applicant's clinical trials and real-world experience data brought another unexpected result. Patients improved the most with high irradiances at depth, irradiance at the surface of the levator ani muscle neared 100 mW/cm.sup.2. Applicants were also surprised to learn, and it was not predicted by the prior body of knowledge in the art, that myofascial pelvic pain responded to lower fluences than reported. Excellent results were found at 50-150 mJ/cm.sup.2. This constellation of discoveries resulted in the inventor discovering the ideal power settings for a photobiomodulation laser treating pelvic tissues transvaginally or transrectally. The power output by laser is set at a power needed to deliver a surface irradiance ranging from desired tissue irradiance at 0.5 mm to 10 mm depth divided by 0.02 to desired tissue irradiance at 0.5 mm to 10 mm depth divided by 0.10. The surface irradiance of any laser may be measured by any laser sensor known in the art. Surface irradiance for a laser is routinely measured during required laser calibration. The preferred embodiment of this method utilizes power settings between 2 and 10 W and wavelengths between 400 and 1064 nm. However other embodiments aimed at treating more superficial structures may need power settings as low as 250 mW and embodiments aimed at treating deeper tissues may need power settings as high as 15 W.

[0053] The need for real world experience data in order to improve outcomes and create a more practical regulatory environment has become evident. The preferred embodiment requires the recipient of the photobiomodulation therapy or a technician acting on behalf of the recipient to enter demographic data, and or diagnosis data, and or symptom data, and or other protected health information into the user interface immediately prior to or immediately after each treatment. Such information may be used to generate graphical representations of symptom improvement or exacerbation for viewing on the laser user interface. Such information may also be downloaded by wire, removable drive or wirelessly to a database. Such database may be part of a real-world experience registry (FIG. 3).

[0054] In another embodiment of this invention, the laser energy source or device 005 may transmit usage information, such as, for example and not by way of limitation, optical power levels, distance of travel of the laser fiber probe during treatment, duration of treatment and other treatment parameters to a remotely located server or database 010 via an internet connection or other communication means or communication network, which may be any combination of wired or wireless communication means or systems 011, including but not limited to Internet communication through the World Wide Web, where the remote database 010 is not located within said laser energy source or device 005. Such information may be used to maintain procedure-related inventory at a physical location of laser energy source or device 005.

[0055] As the most recent update to ISO 14971 no longer allows the Instructions for Use label to reduce risk, device level mitigations are needed. In a preferred embodiment, the laser technician is required to respond to prompts or queries from the laser user interface that are specific to hazards and hazard mitigation identified and or contemplated by the device and or application failure modes effect analysis. In embodiments, only by entering predetermined responses to such queries into the laser interface 006 does the system allow the technician to activate the laser.

[0056] While the above description contains much specificity, these should not be construed as limitations on the scope of any embodiment, but as exemplifications of the presently preferred embodiments thereof. Many other ramifications and variations are possible within the teachings of the various embodiments.

[0057] In any embodiment, the source of laser energy 005 may be controllable for control of laser energy power output levels, activating (energizing) or de-activating (de-energizing) laser energy, setting predetermined time periods of laser operation, i.e. laser “ON” time during treatment, controlling wavelength of the laser energy, or controlling other laser or laser energy delivery parameters. In any embodiment, the system of the invention may comprise one or more user interfaces 006 that are in communication with the laser energy source 005 via a wireless communication link 009 or a wired connection 008. The user interface 006 may be, for example, any user interface known in the electronic arts that is operable for accepting input commands or data from a user such as, for example and not by way of limitation, one or more keyboards, keypads, mice, touchscreens, wireless input via wireless signal from an electronic device such as a tablet or smart phone upon entry of a command or data into such electronic device by a user, audio input of user voice commands via a microphone, to control any of the above or other laser source parameters, and for accepting input of information from the user as may be required for operation of the functions of the system. The user interface 006 may be in communication with the laser source 005 by wired 008 or wireless 009 communication. Wireless communication link may be, for example any link such as Bluetooth®, WiFi®, or any other radio frequency or optical wireless communication link. User interface 006 may also comprise the ability to display or otherwise convey information to a user, such as, for example and not by way of limitation, one or more video displays or communication links to remote video displays, speakers for communicating audible speech or audio signals of any types such as beeps, tones, or other audio signals.

[0058] The scope of the invention should be determined by the appended claims and their legal equivalents, and not by the specific examples given shown in the written description and in the drawings.