This invention generally relates to a phototherapy method, and more specifically to a phototherapy method for assisting transvenous lead placement.
Cardiac resynchronization therapy (CRT) is a new therapeutic procedure that can relieve congestive heart failure (HF) symptoms by improving the coordination of the heart's contractions. The CRT pacing device has three leads (wires) that are implanted through a vein in the right atrium and right ventricle and into the coronary sinus veinous anatomy to pace the left ventricle. The optimal lead position is in a mid-lateral venous anatomy, which is imperative to provide the best resynchronization. One technical challenge facing the transvenous lead placement is that many heart failure patients suffer from distorted coronary sinus anatomy and narrow, irregular veins as resulted from reduced blood flow, which may cause inability or sub-optimal lead placement.
The present invention discloses a phototherapy method for increasing blood flow, dilating blood vessels, and enhancing angiogenesis of the heart in order to assist transvenous lead placement. This method will help increase the percent of leads with optimal lead position which will in turn increase the number of responders to treatment, thereby reducing hospitalizations and the need for transthorasic surgery for epicardial lead placement.
In addition, the described method may also aid in gaining venous access for angioplasty procedures, where balloons, stents, or other medical devices are employed to widen the diameter of blocked blood vessels in the heart, kidney, leg, and neck of the patient.
A phototherapy method for assisting the transvenous lead placement for cardiac resynchronization therapy (CRT) and dilation of occluded veins for any implantable lead placement. The phototherapy treatment helps increase blood flow, reduce inflammation, and enhance angiogenesis to facilitate optimal positioning of the leads.
The accompanying figures, where like reference numerals refer to identical or functionally similar elements throughout the separate views and which together with the detailed description below are incorporated in and form part of the specification, serve to further illustrate various embodiments and to explain various principles and advantages all in accordance with the present invention.
Skilled artisans will appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of embodiments of the present invention.
Before describing in detail embodiments that are in accordance with the present invention, it should be observed that the embodiments reside primarily in combinations of method steps and apparatus components related to a phototherapy method for assisting transvenous lead placement. Accordingly, the apparatus components and method steps have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present invention so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.
In this document, relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by “comprises . . . a” does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.
Referring to
The preferred laser output wavelength for this exemplary embodiment is from 600 nm to 1500 nm, more preferably from 800 nm to 1000 nm, falling in the red to near infrared (NIR) range of the optical spectrum. The laser light in this wavelength range has been demonstrated to be beneficial for increasing cytochrome oxidase activity and ATP content, promoting wound healing, increasing blood flow, and reducing inflammation. In addition, it can penetrate deep (with a penetration depth greater than several centimeters) into the skin for treating internal organs and blood vessels. The output power of the laser is preferably above 0.5 watts to further increase the penetration depth of the laser light into the tissue. A cooling device can be used in combination with the high power laser to keep the surface temperature of the treatment area below a safety level. The cooling device can be a heat conductive material (such as sapphire) or a heat absorbent material (such as phase change material) that is transparent to the laser light or a cooling unit that delivers cold material (cold air, water, etc.) to extract heat from the treatment area. The laser light source may comprise multiple lasers with different output wavelengths, each wavelength matching with the absorption band of a specific chromophore (water, hemoglobin, lipid, protein, etc.) of the subject tissue and blood vessel. For example, the laser light source may comprise two high power diode lasers, one with an output wavelength of 810 nm, the other with an output wavelength of 980 nm. The 810 nm wavelength is well absorbed by the hemoglobin and melanin content of the biological tissue, while the 980 nm wavelength is efficiently absorbed by the water content. The outputs of the multiple laser sources can be combined at adjustable proportions and simultaneously applied to the subject tissue to achieve an enhanced treatment result. The laser sources may operate in a pulsed mode such that a high peak power is produced to increase the penetration depth of the laser light and/or to trigger nonlinear photochemical reactions yet the average power of the laser light is maintained at low levels to avoid any tissue damage.
To further increase the penetration depth of the laser light, the output wand 106 may comprise a protuberance (not shown) at the distal end, which is made of a material substantially transparent at the output wavelength of the laser light source. The protuberance is placed in close contact with the skin tissue of the treatment area. When a force is applied onto the output wand 106, the protuberance executes rubbing and kneading massage to the skin tissue. In the mean time, the laser light transmits through the protuberance to provide phototherapy to the treatment area. The massage action causes a reduction in skin thickness and an increase in skin density. This change in optical property of the skin helps to reduce the overall absorption and scattering loss of the skin and allows the laser light to penetrate deeper to treat internal organs and blood vessels. In addition, the mechanical massage causes an increase in blood circulation and fluid mobilization of the subcutaneous tissue, which enhances the therapeutic effects of the laser light. In the present embodiment, the protuberance is preferably made of sapphire, which offers excellent light transmission and good heat conductivity to reduce surface temperature of the subject treatment area.
In a slight variation of the present embodiment, the laser light source may be replaced with other types of light sources such as lamps, light emitting diodes (LEDs), superluminescent diodes (SLDs), etc. The therapeutic light beam can be directly delivered from the light source onto the subject treatment area without using any optical waveguides, thus avoiding the excessive light intensity loss caused by the inclusion of the optical waveguides. Besides the above disclosed applications, the laser therapy method may also aid in gaining venous access for angioplasty procedures, where balloons, stents, or other medical devices are employed to widen the diameter of blocked blood vessels in the heart, kidney, leg, and neck of the patient.
In the foregoing specification, specific embodiments of the present invention have been described. However, one of ordinary skill in the art appreciates that various modifications and changes can be made without departing from the scope of the present invention as set forth in the claims below. Accordingly, the specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of present invention. The benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential features or elements of any or all the claims. The invention is defined solely by the appended claims including any amendments made during the pendency of this application and all equivalents of those claims as issued.
This application claims an invention which was disclosed in Provisional Patent Application No. 61/161,862, filed Mar. 20, 2009, entitled “LASER THERAPY METHOD FOR ASSISTING TRANSVENOUS LEAD PLACEMENT”. The benefit under 35 USC §119(e) of the above mentioned United States Provisional Applications is hereby claimed, and the aforementioned application is hereby incorporated herein by reference.
Number | Date | Country | |
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61161862 | Mar 2009 | US |