Patent Publication Number: US-11045351-B2

Title: Versatile light-guided ophthalmic treatment system

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Ser. No. 61/922,477, filed on Dec. 31, 2013, which is incorporated by reference herein in its entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to the administration of therapeutic agents into, on, or near the any portion of an eye globe, and specifically, relates to a light-guided, versatile delivery system employing any one of a variety of therapeutic applicators used in conjunction with transcorneal or transpupillary viewing methods. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The features, their interaction, method of operation, and advantages may be understood with reference to the following detailed description in view of the accompanying drawings in which: 
         FIG. 1A  is a schematic, perspective side-view of a light-guided, ophthalmic-treatment-device, according to an embodiment; 
         FIG. 1B  is a schematic, perspective view of a light-guided, ophthalmic-treatment-device disposed in a treatment position behind an eye globe in which illumination ports are visible through transpupillary viewing techniques, according to an embodiment; 
         FIG. 2A  is a schematic, perspective view of a light-guided, ophthalmic-treatment-wand having a therapeutic applicator implemented as perforated dispenser, according to an embodiment; 
         FIG. 2B  is a schematic, perspective view of a light-guided, ophthalmic-treatment-wand having a therapeutic applicator implemented as an injector array, according to an embodiment; 
         FIG. 2C  is a schematic, perspective view of a light-guided, ophthalmic-treatment-wand having a therapeutic applicator implemented as a treatment-light array, according to an embodiment; 
         FIG. 2D  is a schematic, perspective view of a light-guided, ophthalmic-treatment-wand having a therapeutic applicator implemented as a shielded container for radioactive therapeutics, according to an embodiment; 
         FIG. 3A  is a schematic, perspective view of a light-guided, ophthalmic-treatment-wand having a therapeutic applicator implemented as an medicated-adhesive-patch applicator, according to an embodiment; 
         FIG. 3B  is a schematic, perspective view of a light-guided, ophthalmic-treatment-wand having a therapeutic applicator implemented as a suction-based applicator for medicated-adhesive-patch, according to an embodiment; 
         FIG. 3C  is a schematic, perspective view of a light-guided, ophthalmic-treatment-wand having a therapeutic applicator implemented as a medicated-spurred-patch applicator, according to an embodiment; 
         FIG. 4A  is a schematic perspective view of a light-guided, ophthalmic-treatment-wand having a therapeutic applicator implemented as a drug-coated, micro-needle array, according to an embodiment; 
         FIG. 4B  is schematic perspective view of a light-guided, ophthalmic-treatment-wand having a therapeutic applicator implemented as a micro-needle array of hollow micro-needles, according to an embodiment; 
         FIG. 4C  is schematic perspective view of a light-guided, ophthalmic-treatment-wand fitted with a removable therapeutic-applicator-cover, according to an embodiment; 
         FIG. 4D  is schematic perspective view of a light-guided, ophthalmic-treatment-wand fitted with a slideable therapeutic-applicator-cover, according to an embodiment; 
         FIG. 5A  is a schematic, perspective view of a standard light-guided ophthalmic-treatment-wand of a modular embodiment depicting a multi-use slot and lumens, and a standard connection configuration, according to an embodiment; 
         FIG. 5B  is a sectional view of the standard ophthalmic-treatment-wand of  FIG. 5A , according to an embodiment 
         FIG. 5C  is an enlarged, schematic-perspective view of the engagement configuration of the wand of  FIG. 5B  and a therapeutic applicator, according to an embodiment; 
         FIG. 5D  is an enlarged, schematic-perspective view of a catch mechanism of connection configuration of  FIG. 5B , according to an embodiment; and 
         FIG. 6  is a schematic, sectional view of a mold and interchangeable mold insert employed in the manufacture of an ophthalmic-treatment-wand and various molded-on therapeutic applicators, according to an embodiment. 
     
    
    
     It will be appreciated that for clarity of illustration, device elements may be depicted in a manner not to scale, and reference numerals may be repeated among the figures to indicate corresponding elements. 
     DETAILED DESCRIPTION OF THE PRESENT INVENTION 
     In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. Well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention. 
     The present invention relates to the delivery of therapeutic agents onto, into, or through the scleral wall of the eye, and specifically, relates to the use of various therapeutic applicators in conjunction with illumination markers facilitating placement in the desired location. 
     The following terms will used throughout the following document. 
     “Wand”, “treatment wand” or “wand body” all refer to an elongated ergonomic and anatomically matching structure extending from a handle and supporting a therapeutic-agent applicator at its distal end. The wand is contoured to provide optimal access, visibility, and control, and fatigue-preventive ergonomics for the practitioner. In certain embodiments wand is implemented from a light transmissive material like, inter alia, polycarbonate, polysulfone and glass. 
     “Therapeutic-agent” refers to, inter alia, non-radioactive materials, drugs, excipients, cellular or cellular-byproduct materials, and drug-activating or remedial light. In modular applicator embodiments, therapeutic applicator may also be implemented as a radiation dispenser for administering radioactive materials as a therapeutic-agent. 
     “Illumination markers”, “light markers”, “light ports”, “illumination ports” and “markers” all refer to light-based visual references either applied to a surface, embedded, or molded-in to portions of the wand or therapeutic applicator to assist a practitioner using transpupillary viewing methods to place the therapeutic applicator in a proper treatment position. 
     The term “luminescence” refers to emission of light through non-incandescent processes. 
     The term “fluorescence” refers to a type of photoluminescence in which the emission of electromagnetic radiation is released responsively to the absorption of incident radiation, the emission persisting only as long as the incident radiation is applied. 
     The term “phosphorescence” refers to a type of photoluminescence in which the emission of electromagnetic radiation is released responsively to the absorption of incident radiation and persists after removal of the incident radiation. 
     The term “chemiluminescence” refers to the emission of electromagnetic radiation responsively to a chemical reaction. 
     Turning now to the figures,  FIGS. 1 and 2  depict a light-guided ophthalmic-treatment-device  1  configured to administer therapeutic agents onto, into, or through the scleral wall of the eye globe  1   a  by way of any one of a variety of therapeutic applicators  3   a  positioned near a distal end of a wand  3  held by a handle  2 . As shown, the distal end of wand  3  exhibits an indentation  3   d  facilitating abutment with an optic nerve sheath  1   b  or other anatomical feature having a similar surface profile. 
     The ophthalmic-treatment-device  1  includes a plurality of illumination markers  8  defining a line circumscribing therapeutic applicators  3   a  and therapeutic agent  4   f  delivered though it, according to an embodiment. Transpupillary viewing methods enable practitioners to use light emissions  3   b  from light markers  8  to facilitate placement of medicament dispenser  3   a  in a treatment area. Transcorneal or transpupillary viewing methods include, inter alia, observation, ophthalmoscopy, optical coherence tomography and videography. 
     Illumination markers  8  may emit either light propagating through wand  3  from an external light source  3   b , as shown, or alternatively generate their own luminescence from either photoluminescent materials from which markers  8  are constructed or electroluminescent or chemiluminescent material contained within markers  8 , according to embodiments. It should be appreciated that in certain embodiments photoluminescent materials are excited from a light source embedded in wand  3  or applicator  3   a  while in other embodiments the excitation light source is disposed outside wand body  3 . 
     Examples of suitable photoluminescent materials include, inter alia, strontium aluminate based pigments for phosphorescent illumination markers and fluorescein for fluorescent illumination markers. It should be appreciated that other materials exhibiting such functionality are included within the scope of the present invention. 
     Photoluminescent materials of light markers  8  may either be applied to a surface, embedded, or molded-in to portions of the wand or a the therapeutic applicator, according to embodiments. 
     Photoluminescent illumination markers may be excited by either ultra violet (UV) light or any of various frequencies of electromagnetic radiation such as radio waves, microwave, infrared, visible light, x-ray, or gamma rays and also particle radiation like beta particles or other charged particles. Examples of electroluminescent illumination markers include, inter alia, light emitting diodes or organic light emitting diodes disposed in illumination markers  8 . 
     Chemiluminescent markers  8  may be activated through a chemical reaction of chemiluminescent reactants mixing either within a wand or applicator chamber or mixing externally and fed into therapeutic applicator. Examples of suitable reactants include highly oxidized molecules, such as peroxide, and luminol, C 8 H 7 N 3 O 2 , or diphenyl oxalate, C 14 H 10 O 4 . It should be appreciated that other reactants exhibiting such chemiluminescent functionality are also included within the scope of the present invention. 
       FIG. 2A  depicts a treatment wand  3  of a light-guided, ophthalmic-treatment-device having a therapeutic applicator implemented as a perforated head  20  through which therapeutic agents fed through feed line  21  are expelled when disposed in a treatment position. It should be appreciated that various perforation patterns and shapes are included within the scope of the present invention. 
       FIG. 2B  depicts a treatment wand  3  of a light-guided, ophthalmic-treatment-device having a therapeutic applicator implemented as an injection array  23  configured to inject various therapeutic agents fed through feed lines  25  when disposed in a treatment position, according to an embodiment. 
     Injection array  23  is pivotally mounted and biased to assume a non-protruding orientation when in a non-injection position and may be pivoted into an injection position by pulling on control cords or rods  24  when disposed in a treatment position, according to an embodiment. 
     In a certain embodiment, the injector array is implemented as a non-pivotal, retractable array configured to advance and to retract responsively to expansion and deflation of pneumatic or hydraulic devices as is known to those skilled in the art. 
     Furthermore, injector array advancement and retraction may be achieved through various ramping arrangements also as is known to those skilled in the art. 
     It should be noted that arrays implemented with a single injection needle are also included within the scope of the present invention. 
       FIG. 2C  depicts a treatment wand  3  of a light-guided ophthalmic-treatment-device having a therapeutic applicator implemented as a drug actuating or therapeutic light array  26 . In a certain embodiment, light array  26  is implemented as a laser array; however, it should be appreciated that other light emitting sources providing the same functionally are also included within the scope of the present invention. Power may be supplied through a wand slot  51  shown in  FIG. 5A , according to an embodiment. 
     It should be further appreciated that in certain embodiments, the therapeutic applicator is implemented as a reflector arrangement configured to direct a drug-activation or therapeutic light generated externally and propagated through fiber optic  27  is also included within the scope of the present invention. 
       FIG. 2D  depicts a treatment wand  3  of a light-guided, ophthalmic-treatment-device having a therapeutic applicator implemented as a shielded container  28  for holding radioactive therapeutics  29 , according to an embodiment. Container materials may include selective radiation shielding materials known to those skilled in the art. 
       FIG. 3A  depicts a treatment wand  3  of a light-guided ophthalmic-treatment-device having a therapeutic applicator implemented as a medicated-adhesive-patch applicator  30 , according to an embodiment. Shown in a disengaged state, patch  31  has an engagement sleeve or passageway  31 A disposed on the non-adhesive side. Therapeutic applicator  30  includes a patch receptacle  33 A having openings  32  in facing walls so as to enable selective disengagement by wire  34  traversing both receptacle  33 A and engagement sleeve  31 A when patch  31  is seated in receptacle  33 A. Release wire  34  is slideably mounted in sleeve MA disposed in wand  3 , according to an embodiment. 
       FIG. 3B  depicts a treatment wand  3  of a light-guided ophthalmic-treatment-device having a therapeutic applicator implemented as a suction-based applicator  30 B for medicated-adhesive-patch  31 B, according to an embodiment. 
     Shown in a disengaged state, patch  31 B is releasably held to applicator  30 B on a generally flat or concave support surface  37  having an orifice in communication with a tubule  36  traversing the length of the wand. During operation, suction is applied to tubule  36  so as to hold medicated-adhesive-patch  31 B on support surface  37  until the suction is removed when medicated-adhesive-patch  31 B is disposed and secured on the target tissue with adhesive, according to an embodiment. 
       FIG. 3C  depicts a treatment wand  3  of a light-guided ophthalmic-treatment-device having a therapeutic applicator implemented as a medicated-spur-patch applicator  30 C for mechanical attachment of medicated patches, according to an embodiment. 
     Medicated patch  31 C is fitted with a series of circumferentially-spaced, radially-disposed spurs  35 , each one connected to a radial strip emanating from a single engagement patch  35  disposed on the non-medicated side of patch  31 C. Patch dispenser  30 C includes a patch receptacle  33 A analogous to the one described above. When medicated patch  31 C is seated in receptacle  33 A and wire  34  traverses receptacle  33 A between medicated patch  31 C and its engagement patch  35 , wire  34  pulls engagement strap  35  away from medicated patch  31 C thereby rotating spurs  35  outward into a protruding orientation so as to enable penetration into tissue when pressure is applied. 
     Upon extraction of wire  34 , the spur-rotating-force is removed enabling patch  31 C, biased to resume its original flat disposition, to apply a counter torque to the now embedded spurs to resume their original radial disposition thereby causing them to engage the tissue and hold medicated patch  31 B in place, according to an embodiment. 
     It should be appreciated that these configurations are only examples, and other configurations providing spur engagement functionality are included within the scope of the present invention. 
       FIG. 4A  depicts a treatment wand  3  of a light-guided ophthalmic-treatment-device having a therapeutic applicator implemented as a micro-needle array  40  of drug-coated micro needles  41 , according to an embodiment. 
       FIG. 4B  depicts a treatment wand  3  of a ophthalmic-treatment-device having a therapeutic applicator implemented as a micro-needle array  40 A of hollow micro-needles  42  fed from feed line  43  disposed in wand  3 , according to an embodiment. 
       FIGS. 4C and 4D  depicts a treatment wand  3  of a light-guided, ophthalmic-treatment-device fitted with an therapeutic-applicator cover configured to prevent inadvertent damage to a patient or the therapeutic applicator  3   a  and to also prevent premature or misdirected therapeutic administration during insertion or removal of the device. 
     Specifically,  FIG. 4C  depicts a peelable, therapeutic-applicator cover  44  removably attached to therapeutic applicator  3   a  and wand  3  according to an embodiment. Peelable, therapeutic-applicator cover  44  is constructed from a polymeric sheet and coated with an adhesive material as is known to those skilled in the art. In practice, a practitioner unpeels cover  44  by pulling on its proximal end after therapeutic applicator  3   a  is disposed in a treatment position. 
       FIG. 4D  depicts a slideable, therapeutic-applicator cover  45  slideably attached to wand  3  according to an embodiment. As shown, therapeutic-applicator cover  45  shields therapeutic applicator  3   a  and traverses wand  3  so as to enable a practitioner to reveal therapeutic applicator  3   a  by pulling on a proximal portion of cover when disposed in a treatment position, according to an embodiment. 
       FIG. 5A  and sectional view  FIG. 5B  along B-B depict a standard wand  3  configured to receive any one of the above described therapeutic applicators  3   a  implemented modularly. In a certain embodiment, wand  3  has a wand slot  51  for receiving various service lines for the therapeutic applicator  3   a  like, inter alia, feed lines of therapeutic agents, power lines for driving light arrays, and fiber optics directing externally generated light. Furthermore, modular wand  3  has service lumens  50  for receiving control cords or rods used to actuate or change a disposition of therapeutic applicator  3   a  or a component of it. As noted above, wand  3  also includes illumination markers  8  providing visual markers that may be implemented as either a luminescent illumination marker  8  upon excitation or an emission port for externally generated light  6  propagating through a light transmissive wand, according to embodiments. Furthermore, in a modular embodiment, wand  3  has connection configuration common to a variety of therapeutic applicators  3   a  thereby advantageously enabling any one of them having a corresponding connection configuration to be connected to wand  3 . 
       FIGS. 5C and 5D  depicts a sample connection configuration for modular therapeutic applicators  3   a  and standard wand  3 , according to an embodiment. As shown, therapeutic applicator  3   a  has a ridge  53  corresponding to a mating groove  52  disposed along the distal end of wand  3 . Ramps  54  disposed at both ends of groove  52  gradually negate the groove depth and at the point in which the groove depth is entirely negated the ramps abruptly terminate and have a non-ramped face  55  which acts as a catch against each end of ridge  53  when slid into groove  52 , according to an embodiment. It should be appreciated that thread arrangements and other connection configurations providing selectable engagement are included within the scope of the present invention. 
       FIG. 6  depicts an exchangeable insert mold  60  and  60 A for construction of various therapeutic applicators and a wand mold  62  and  62 A, according to an embodiment. Specifically, each exchangeable mold insert  60  and  60 A is dedicated to a therapeutic applicator and upon molding of a particular therapeutic applicator, the corresponding insert mold  60  and  60 A is inserted into wand mold  62  and  62 A so as to integrally connect the selected therapeutic applicator with the distal portion of the wand during molding, according to an embodiment. 
     It should be appreciated that any combination of features set forth in particular embodiments and multimodal therapeutic applicators are included within the scope of the present invention. “Multimodal therapeutic applicators” employ different applicator types either simultaneously or non-simultaneously. 
     While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.