JPWO2018160864A5 - - Google Patents

Description

The present disclosure generally relates to surgical illuminators and related methods for surgical lighting, including a light source for the illuminating area during the surgical procedure and at least one luminescent element defining an outer layer.

In general, conventional surgical lighting materials provide illumination from external sources such as anatomical microscopes that can be localized within the cavity or attached to surgical instruments. Surgical instruments with illuminating means include retractors, endoscopes, orthoscope tools, suction tubes and the like. However, such conventional means and instruments do not provide adequate lighting during various surgical procedures. Deep surgical approaches, such as during aneurysm surgery, are far more dangerous under low light conditions where the only light source consists of an external light source located outside the body. The visualization in this example is limited and the risk of injury is significantly increased. As another example, various nervous system procedures require deep incisions, but nevertheless the only light source may consist of microscopic light localized outside the patient.

More common surgical procedures may also be susceptible to low light conditions. In addition, laparoscopic surgery is accompanied by a low light intensity condition that only the light source in the abdomen is a single light source from the endoscope. Such restrictions on lighting can limit visibility and, in some cases, can complicate certain procedures.

In particular, with these findings in mind, the various aspects of this disclosure have been conceived and developed.

Corresponding reference numerals indicate corresponding elements in each drawing of the drawing. The items used in the scheme (heading) do not limit the scope of claims.

It is a simplified block diagram of the device for surgical lighting according to the aspect of this disclosure. It is explanatory drawing which shows the plan view of another embodiment of the surgical lighting apparatus according to the aspect of this disclosure. It is a top view of a plurality of examples of the embodiment of the surgical lighting device of FIG. 2A according to the aspect of the present disclosure. It is an illustration which shows the plan view of another embodiment of the surgical lighting apparatus which includes a plurality of light emitting elements according to the aspect of this disclosure. FIG. 5 is a plan view of another embodiment of a surgical lighting device that defines individual light emitting elements having an embedded battery according to aspects of the present disclosure. FIG. 5 is a plan view of another embodiment of a surgical lighting device that defines a light source, including an LED tape, according to aspects of the present disclosure. The first configuration of a light source for use with any of the embodiments of the apparatus described herein according to aspects of the present disclosure is illustrated. A second configuration of a light source for use with any of the embodiments of the apparatus described herein according to aspects of the present disclosure is illustrated. A third configuration of a light source for use with any of the embodiments of the apparatus described herein according to aspects of the present disclosure is illustrated. A fourth configuration of a light source for use with any of the embodiments of the apparatus described herein according to aspects of the present disclosure is illustrated. A fifth configuration of a light source for use with any of the embodiments of the apparatus described herein according to aspects of the present disclosure is illustrated. Illustrative configurations for surgical deployments using multiple luminescent elements according to aspects of the present disclosure are illustrated. A mask layout for use with any of the embodiments of the apparatus described herein according to aspects of the present disclosure. It is sectional drawing of the mask layout of FIG. 12A according to the aspect of this disclosure. It is a schematic circuit diagram for use with any of the embodiments of the apparatus described herein according to aspects of the present disclosure. It is a schematic circuit diagram for use with any of the embodiments of the apparatus described herein according to aspects of the present disclosure. It illustrates one possible machining flow for forming an embodiment of the apparatus described herein according to aspects of the present disclosure. It illustrates one possible machining flow for forming an embodiment of the apparatus described herein according to aspects of the present disclosure. It illustrates one possible machining flow for forming an embodiment of the apparatus described herein according to aspects of the present disclosure. It illustrates one possible machining flow for forming an embodiment of the apparatus described herein according to aspects of the present disclosure.

The present disclosure relates to surgical luminaires, in particular devices and methods for surgical lighting, including luminescent elements. The light emitting element controls a light source localized along the substrate, an outer layer for sealing or enclosing the light source, a power source for supplying power to the light source, and a power source to the light source to illuminate the surgical area. To define the activation mechanism for. In some embodiments, the outer layer is biocompatible and both the substrate and the outer layer are malleable so that the luminescent element is suitable for a variety of surgical applications. With reference to the drawings, embodiments of surgical lighting devices are illustrated and are generally shown as 100, 200, 300, 400, and 500 in FIGS. 1-14.

Referring to FIG. 1, one embodiment of the surgical lighting device represented by 100 includes a light emitting element 102. The light emitting element 102 can define the main body 104, and the main body 104 can be formed in the range of 0.2 cm × 0.2 cm to 4 cm × 4 cm or more. In some embodiments, the body 104 can be formed in micrometer or nanometer scale dimensions, or can be approximately minimal (eg, a given diameter of a few microns), depending on the desire for different applications. In one particular embodiment, the body 104 may be approximately 6 mm in length. In some embodiments, the body 104 can typically define a three-dimensional, substantially polygonal, or rectangular shape as illustrated, but includes certain lighting functions as described herein. Other shapes may be available that are more suitable for various surgical applications.

In some embodiments, the body 104 can be multi-layered as shown. Specifically, the main body 104 of the light emitting element 102 can define a substrate 106 localized at a substantially center position along the main body 104. In some embodiments, the substrate 106 may include a substantially flat member, which is from a polyimide film or other flexible substrate material, with a plurality of copper wires or other conductive pieces along the surface of the polyimide film. It is configured with a line (not shown) formed. The copper wire may be formed in a predetermined pattern so that the substrate 106 is configured as a flexible printed circuit board (PCB), the substrate 106 to adapt to lighting functions as further described herein. Various electrical components (resistors, capacitors, switches, etc., not shown in FIG. 1) can be defined.

The main body 104 further comprises a light source 108 attached to the substrate 106 or otherwise arranged along the substrate 106, with the light source 108 communicating with electrical components of the substrate 106 (not shown in FIG. 1). Can be defined. The light source 108 includes light emitting diodes (LEDs), LED tapes, small halogen bulbs, electrodeless lamps, low / high pressure sodium lamps, fluorescent lamps, metal halide lamps, sulfur lamps, incandescent lamps, discharge lamps, arc lamps, gas discharge lamps, etc. May include one or more of them. In some embodiments, the light source 108 defines an illumination layer located approximately central to the body 104. The light source 108 can take the form of various configurations to provide a lighting device inherent in the surgical area. In one aspect, the light source 108 provides diffuse illumination to improve the surgical field of view for surgical passages that may otherwise be dark or inadequately illuminated.

The body 104 may further define an outer layer 110 localized around the light source 108 and the substrate 106. Thus, the outer layer 110 is such that the light source 108 and the substrate 106 are at least partially or wholly encapsulated in the outer layer 110 to protect the light source 108 from external factors such as body tissue or body fluids. The 108 and the substrate 106 are sealed. The outer layer 110 forms a uniform surface around the substrate 106 and the light source 108 so that the substrate 106 and the light source 108 can be located along approximately the center position of the body 104 when the outer layer 110 is mounted. It may include one or more layers, such as non-absorbent fibers woven near the boundary between the substrate and the light source, or an additional layer. In some embodiments, the outer layer 110 may contain polydimethylsiloxane (PDMS) and / or a plastic, acrylic, parylene coating, sponge material, and / or silicone polymer. In some embodiments, the outer layer 110 is non-absorbable (or absorbable), resistant so that the outer layer 110 may be suitable for a variety of surgical and medical applications and for use in body tissues during surgical procedures. It can be fluid, flexible, insulating, and biocompatible. The outer layer 110 can be woven around the substrate 106 and the light source 108, or can be formed by thin film deposition or other similar methods. In some embodiments, the outer layer 110 of the luminescent element 102 may be formed using one or more surgical putties (not shown) such that the luminescent element 102 may contain a sponge or cotton material. .. For example, the light source 108 may be located within a surgical putty (not shown). In these embodiments, the outer layer 110 is a disposable fiber pad suitable for placement on or around the tissue to provide fluid management or other surgical function, as further described herein. Can be further included. An embodiment of the subject luminescent element 102 is used in nervous system surgery to position normal and healthy neural tissue along the surgical cavity, which can enhance lighting, during a complex surgical incision. It can be protected by making the element non-absorbent.

Also, in some embodiments, the outer layer 110 is involved in deployment, with the outer layer 110 (and generally the body 104) of the light emitting element 102 being deformable or modified to a predetermined shape configuration. A malleable memory-retaining material may also be included so that the composition can be temporarily retained. Such flexibility of the outer layer 110 can be adapted to a light emitting element 102 that is deformed to fit into a difficult, narrow or undulating surgical area, with the deformed light emitting element 102, eg, along the surgical area. Different configurations may be moldable that are suitable for providing a barrier to the fluid. In addition, the luminescent element 102 can be pre-packaged in a compact design, thereby laparoscopy, cystoscopy, or uterus for general surgery, urology, or gynecological surgery applications. It is possible to deploy the light emitting element 102 using the port for microscopy. As a particular embodiment, the luminescent element 102 may be packaged in a folding structure suitable for deployment, for example, through a laparoscopic port (not shown) within the abdomen or pelvic cavity. During deployment, the outer layer 110 further protects the light emitting element 102 from mechanical forces or stresses applied during the movement or operation of the light emitting element 102. For example, the outer layer 110 is a forceps or other surgical instrument that can be used to insulate the light source 108 and to move the light source 108, for example, to grip, deform, and / or move the light emitting element 102 along the surgical area. Suitable for protection from mechanical shear caused by. In one embodiment, the outer layer 110 may include one or more windows that may be arranged above the light source 108 to increase illumination.

In some embodiments, the light emitting element 102 is placed along the body 104 or along the device 100, on the device 100, or anywhere within the device 100, with the radiation opaque marker 112A and It may further include one or more radiodensity markers 112 or indicators, represented by 112B. The radiodensity marker 112 may be located at any location along the body 104, such as the outer layer 110 and / or the surface of the substrate 106, if desired. The radiodensity marker 112 allows the surgeon to track the luminescent element 102 and recover it from the surgical area using an X-ray image (not shown). The radiodensity marker 112 can be defined at individual locations along the body 104 as illustrated, or along a tape-like member or layer applied along the body 104. In one aspect, the radiodensity marker 112 can help reduce the risk of misplaced the luminescent element 102 in the surgical corridor.

As further shown in FIG. 1, the light source 108 of the light emitting element 102 may be electrically coupled (wired or wirelessly) to the power supply 114 and the activation mechanism 116. The power supply 114 may take various forms and may include, for example, a rechargeable or disposable battery. In some embodiments, the power supply 114 may be incorporated within or located along the light emitting element 102. Alternatively, the power supply 114 may be localized outside the light emitting element 102 and, for example, may be located outside the surgical area during deployment of the light emitting element 102. The activation mechanism 116 may include one or more switches for controlling power from the power supply 114 to the light source 108, or a similar electromechanical device. To provide a push-button switch, rocker switch, slide switch, control resistor, transformer, variable resistor, solid-state semiconductor dimmer, or different levels of current to the light source 108, etc., as a switch of the possible activation mechanism 116. Similar devices can be mentioned. The power supply 114 can also be triggered wirelessly by the activation mechanism 116. For example, in one particular embodiment, the activation mechanism 116 may include a reed switch, which is defined along the substrate 106 and when the magnetic source is localized in the vicinity of the activation mechanism 116, the power supply 114. It is configured to activate and / or stop power from. In another embodiment, the activation mechanism 116 provides a receiver or antenna so that when the activation mechanism 116 receives one or more radio frequency signals, the activation mechanism 116 can control the power from the power supply 114 to the light source 108. Can include. Furthermore, the light source 108 (and / or power supply 114) can be driven by amplified radio frequency (RF) energy or "radio power" using a harvester and antenna (not shown), or a base station. Can be driven by inductive coupling from.

In some embodiments, the device 100 may further include a recovery tether 118, which may include a string, a rope, or else define a substantially elongated member connected to the light emitting element 102. obtain. The recovery tether 118 may be composed of a biocompatible material similar to the outer layer 110 and may allow the surgeon to physically recover the luminescent element 102 from the surgical area by pulling the recovery tether 118 as needed. In addition, in other embodiments, the recovery tether 118 may include an insulated electrical conduit for electrically coupling the light source 108 to the power source 114. More specifically, the recovery tether 118 may include one or more conductive layers, wires, or wires surrounded by an insulating layer that electrically connects the power supply 114 and / or the external power source to the light source 108.

Referring to FIG. 2A, another embodiment of the device represented by device 200 and based on the general concept and functionality set forth in FIG. 1 may include a light emitting element 202 that defines the body 204. The main body 204 of the light emitting element 202 may define a substrate 206 localized at a substantially center position along the main body 204. In some embodiments, the substrate 206 may include a substantially flat member, which is from a polyimide film or other flexible substrate material, from a plurality of copper wires or other conductive pieces along the surface of the polyimide film. It is configured with a line (not shown) formed. The copper wire can be formed in a predetermined pattern so that the substrate 206 is configured as a flexible PCB, which is a variety of electrical components (to adapt to lighting functions as further described herein). Resistors, capacitors, switches, etc. (not shown) can be defined.

The body 204 may further define the light source 208, which is attached to, coupled, and supported by the substrate 206, or is localized along the substrate 206. In the device 200, the light source 208 may define a plurality of LEDs 208A-208F that are arranged along the substrate 206 and communicate with electrical components (not shown) of the substrate 206, as shown. In the illustrated embodiment, the plurality of LEDs 208A-208F may be arranged in a straight line as shown, but the present disclosure is not limited in this regard.

The body 204 may further define an outer layer 210 localized around the plurality of LEDs 208A-208F and the substrate 206. In this way, the outer layer 210 encapsulates the light source 208 and the substrate 206 at least partially or wholly to protect the light source 208 from external factors such as body tissue or body fluids. The outer layer 210 forms a uniform surface, and in order to enclose the substrate 206 and the light source 208 in the substantially central position of the main body 204, for example, non-absorbent fibers woven near the boundary between the substrate and the light source are woven. Including, may include one or more layers. In some embodiments, the outer layer 210 may contain polydimethylsiloxane (PDMS) and / or a plastic, acrylic, and / or silicone polymer. The outer layer 210 may be non-absorbent (or absorbent), fluid resistant, flexible, insulating, and biocompatible so that the outer layer 210 is suitable for a variety of surgical and medical applications. Also, in some embodiments, the outer layer 210 is involved in deployment, with the outer layer 210 (and generally the body 204) of the light emitting element 202 being deformable or modified to a predetermined shape configuration. A malleable memory-retaining material may also be included so that the composition can be temporarily retained. In some embodiments, the outer layer 210 of the luminescent element 202 may be formed using one or more surgical putties (not shown) such that the luminescent element 202 may contain a sponge or cotton material. .. For example, the light source 208 may be located within the surgical putty. In these embodiments, the outer layer 210 is a disposable fiber pad suitable for placement on or around the tissue to provide fluid management or other surgical function, as further described herein. Can be further included. The subject luminescent element 202 is used in nervous system surgery and is located along the surgical cavity to enhance lighting and non-absorb normal and healthy neural tissue during complex surgical incisions. It can be protected by making it sex.

As further shown in FIG. 2A, the light source 208 of the light emitting element 202 can be electrically coupled to the power supply 214 and the power supply 214 can be mounted in the form of a battery outside the light emitting element 202, 3-9 volts. However, the present disclosure is not limited in this respect. Thus, the power supply 214 may be located outside the surgical area during deployment of the light emitting element 202. As further illustrated, the power supply 214 may be electrically coupled to the light source 208 through the electrical conduit 215. In some embodiments, the electrical conduit 215 may sketch one or more conductive wires surrounded by an insulating layer.

In some embodiments, the device 200 comprises an activation mechanism 216 that is electrically coupled to the power supply 214 and / or the light source 208 along or in close proximity to the power supply 214. The activation mechanism 216 may include one or more switches for controlling power from the power supply 214 to the light source 208, or a similar electromechanical device. Possible activation mechanism 216 switches include push-button switches, rocker switches, slide switches, adjustable resistors, transformers, variable resistors, solid-state semiconductor dimmers, or to provide different levels of current to light sources 208 and the like. Similar devices can be mentioned. The power supply 214 can also be triggered wirelessly by the activation mechanism 216. For example, in one particular embodiment, the activation mechanism 216 may include a reed switch configured to activate and / or stop power from the power supply 214 when the magnetic source is located near the activation mechanism 216. In another embodiment, the activation mechanism 216 is configured to control the power from the power supply 214 to the light source 208 when the activation mechanism 216 receives one or more radio frequencies. Can include. Furthermore, the light source 208 (and / or power supply 214) can be driven by amplified radio frequency (RF) energy or "radio power", or by inductive coupling from a base station.

The device 200 may include a further aspect illustrated in FIG. In some embodiments, for example, the device 200 may further include one or more radiopaque markers (not shown) arranged along the body 204 or the electrical conduit 215. In addition, a tether similar to the recovery tether 118 illustrated in FIG. 1 (not shown) can be defined along the body 204. As an example, FIG. 2B illustrates a set of devices 200 before deployment.

With reference to FIG. 3, another embodiment of the apparatus represented by 300 and based on the general concept and functionality described in FIG. 1 is a first light emitting element 302A, a second body 304B that defines the first body 304A. The second light emitting element 302B may be included, whereby the first light emitting element 302A and the second light emitting element 302B are localized in a chain configuration. The first main body 304A of the first light emitting element 302A can define the first substrate 306A localized at a substantially center position along the first main body 304A. Similarly, the second main body 304B of the second light emitting element 302B can define the second substrate 306B localized at a substantially center position along the second main body 304B. In some embodiments, the substrates 306A and 306B can each define a substantially flat member, which is from a polyimide film or other flexible substrate material, along the surface of the polyimide film. It is configured with a copper wire or other conductive wire (not shown) formed. The copper wire may be formed in a predetermined pattern so that the substrates 306A and 306B are configured as flexible PCBs. In addition, the substrates 306A and 306B may define various electrical components (resistors, capacitors, switches, etc., not shown) to adapt to lighting functions as further described herein.

The device 300 is mounted on a plurality of LEDs 308A-308F mounted on the first substrate 306A or otherwise localized along the first substrate 306A, and mounted on the second substrate 306B, otherwise along the second substrate 306B. A light source 308, represented as a plurality of localized LEDs 308G-308L, can be defined. In the illustrated embodiment, the plurality of LEDs 308A-308F and the plurality of LEDs 308G-308L may be arranged in a straight line as shown, but the present disclosure is not limited in this regard.

The first main body 304A may further define the plurality of LEDs 308A to 308F and the outer layer 310A located around the first substrate 306A. In this way, the outer layer 310A encapsulates the plurality of LEDs 308A to 308F and the first substrate 306A at least partially or wholly, and protects the plurality of LEDs 308A to 308F from external factors such as body tissue or body fluid. .. In addition, the outer layer 310A forms a uniform surface, and the first substrate 306A and the plurality of LEDs 308A to 308F are enclosed in a substantially intermediate position along the first main body 304A, for example, of the substrate and the LED. It may include one or more layers, including non-absorbable fibers woven near the boundary. In some embodiments, the outer layer 310A may contain PDMS and / or a plastic, acrylic, and / or silicone polymer. The outer layer 310A may be non-absorbent (or absorbent), fluid resistant, flexible, insulating, and biocompatible so that the outer layer 310A is suitable for a variety of surgical and medical applications. Also, in some embodiments, the outer layer 310A is such that the outer layer 310A (and generally the first body 304A) of the first light emitting element 302A is deformable or modified to a predetermined shape configuration. A malleable memory-retaining material may also be included so that the configuration involved during deployment can be temporarily retained.

In addition, the second body 304B may further define the outer layers 310B located around the plurality of LEDs 308G-308L and the second substrate 306B. In this way, the outer layer 310B encapsulates both the plurality of LEDs 308G to 308L and the second substrate 306B at least partially or wholly, and protects the plurality of LEDs 308G to 308L from external factors such as body tissue or body fluid. do. The outer layer 310B forms a uniform surface, and in order to enclose the second substrate 306B and the plurality of LEDs 308G to 308L in a substantially intermediate position along the second main body 304B, for example, near the boundary between the substrate and the LED. It may include one or more layers, including woven non-absorbable fibers. In some embodiments, the outer layer 310B comprises PDMS and / or may comprise a plastic, acrylic, and / or silicone polymer. The outer layer 310B may be non-absorbable, fluid resistant, flexible, insulating, and biocompatible so that the outer layer 310B is suitable for a variety of surgical and medical applications. Also, in some embodiments, the outer layer 310B is such that the outer layer 310B (and generally the second body 304B) of the second light emitting element 302B is deformable or modified to a predetermined shape configuration. A malleable memory-retaining material may also be included so that the configuration involved during deployment can be temporarily maintained. In some embodiments, the outer layer 310A or outer layer 310B is formed using one or more surgical putties (not shown) such that the luminescent elements 302A and 302B may contain a sponge or cotton material. obtain. For example, the light emitting elements 302A and 302B, respectively, may be located within the surgical putty (not shown). In these embodiments, the outer layer 310A or outer layer 310B is disposable, suitable for placement on or around the tissue to provide fluid management or other surgical function, as further described herein. Fiber pads may be further included.

As further illustrated, the light source 308 of the device 300 can be electrically coupled to the power source 314, which can be mounted in the form of a battery outside the first light emitting element 302A and the second light emitting element 302B. A battery of 3 to 9 volts can be used, but the present disclosure is not limited in this regard. Thus, the power supply 314 may be located outside the surgical area during deployment of the first light emitting element 302A and the second light emitting element 302B. As further illustrated, the power supply 314 can be electrically coupled to the light source 308 through an electrical conduit 315. The electrical conduit 315 may substantially delineate one or more conductive wires surrounded by an insulating layer. More specifically, the electrical conduit 315 creates a chain configuration and extends access to power from the power source 314 and the second light emitting element 302B to the first light emitting element 302A, so that the first light emitting element 302A and It can be electrically coupled along the second light emitting element 302B. In other embodiments, the power supplies 314 may be connected in parallel rather than in series as shown. In some embodiments, each of the first light emitting element 302A and the second light emitting element 302B may be coupled to each individual power source (not shown).

In some embodiments, the device 300 is electrically coupled to the power source 314 and / or the light source 308 along the first substrate 306A and / or the second substrate 306B or in the vicinity of the power source 314. Includes one or more activation mechanisms 316. The activation mechanism 316 may include one or more switches for controlling power from the power source 314 to the light source 308, or a similar electromechanical device. Possible switches for the activation mechanism 316 include push-button switches, rocker switches, slide switches, transformers, variable resistors, dimmers including solid-state semiconductor dimmers, and the like. The power supply 314 can also be triggered wirelessly by the activation mechanism 316. For example, in one particular embodiment, the activation mechanism 316 may include a reed switch configured to activate and / or stop power from the power supply 314 when the magnetic source is localized in the vicinity of the activation mechanism 316. .. In another embodiment, the activation mechanism 316 is configured to control the power from the power supply 314 to the light source 308 when the activation mechanism 316 receives one or more radio frequencies. Can include. Furthermore, the light source 308 (and / or power source 314) can be driven by amplified RF energy or "radio power" or by inductive coupling from the base station.

The device 300 may include a further aspect illustrated in FIG. In some embodiments, for example, the device 300 is arranged along a first light emitting element 302A, a second light emitting element 302B, or an electrical conduit 315 with one or more radiodensity markers (not shown). ) Can be further included. In addition, a tether similar to the recovery tether 118 illustrated in FIG. 1 (not shown) can be defined along the apparatus 300.

With reference to FIG. 4, another embodiment of the device, represented by 400 and based on the general concept and functionality set forth in FIG. 1, may include a light emitting element 402 that defines the body 404. The main body 404 of the light emitting element 402 can define a substrate 406 localized at a substantially center position along the main body 404. In some embodiments, the substrate 406 may define a substantially flat member, which is from a polyimide film or other flexible substrate material, with a plurality of copper wires or the like along the surface of the polyimide film. (Not shown) is formed in the state of being formed. The copper wire may be formed in a predetermined pattern so that the substrate 406 is configured as a flexible PCB. In addition, substrate 406 may define various electrical components (resistors, capacitors, switches, etc., not shown) to adapt to lighting functions as further described herein.

The body 404 may further define a light source 408 that is attached to or otherwise localized along the substrate 406. In device 400, the light source 408 is one or more LEDs represented by 408A-408F that are arranged along the substrate 406 and telecommunications with electrical components (not shown) of the substrate 406, as shown. May include. In the illustrated embodiment, the plurality of LEDs 408A-408F may be arranged in a straight line as shown, but the present disclosure is not limited in this regard.

The main body 404 can further define a plurality of LEDs 408A to 408F and an outer layer 410 localized around the substrate 406. In this way, the outer layer 410 seals the light source 408 and the substrate 406 at least partially or entirely to protect the light source 408 from external factors such as body tissue or body fluids. The outer layer 410 forms a uniform surface, and in order to enclose the substrate 406 and the light source 408 in a substantially intermediate position of the main body 404, for example, non-absorbent fibers woven near the boundary between the substrate and the light source are woven. Including, may include one or more layers. In some embodiments, the outer layer 410 may contain PDMS and / or a plastic, acrylic, and / or silicone polymer. The outer layer 410 may be non-absorbent (or absorbent), fluid resistant, flexible, insulating, and biocompatible so that the outer layer 410 is suitable for a variety of surgical and medical applications. Also, in some embodiments, the outer layer 410 is involved in deployment, with the outer layer 410 (and generally the body 404) of the light emitting element 402 being deformable or modified to a predetermined shape configuration. A malleable memory-retaining material may also be included so that the composition can be temporarily retained. In some embodiments, the outer layer 410 of the luminescent element 402 may be formed using one or more surgical putties (not shown) such that the luminescent element 402 may contain a sponge or cotton material. .. For example, the light source 408 may be located within the surgical putty. In these embodiments, the outer layer 410 is a disposable fiber pad suitable for placement on or around the tissue to provide fluid management or other surgical function, as further described herein. Can be further included. The subject luminescent element 402 is used in nervous system surgery and is located along the surgical cavity to enhance lighting and non-absorb normal and healthy neural tissue during complex surgical incisions. It can be protected by making it sex.

As further shown, the light source 408 of the light emitting element 402 can be electrically coupled to the power source 414, which can be implemented in the form of a 3-9 volt battery, but the present disclosure is not limited in this regard. .. In this embodiment of the device 400, the power supply 414 may be located along the light emitting element 402 and may be incorporated within the outer layer 410 and mounted, for example, on the substrate 406. As described above, the light emitting elements 402 are substantially individual, and when the light emitting elements are applied, they are wireless.

In some embodiments, the device 400 further comprises an activation mechanism 416 that is electrically coupled to the power supply 414 and / or the light source 408 along or in close proximity to the power supply 414. The activation mechanism 416 may include one or more switches for controlling power from the power source 414 to the light source 408, or a similar electromechanical device, the device being defined along substrate 406. To provide a push-button switch, rocker switch, slide switch, control resistor, transformer, variable resistor, solid-state semiconductor dimmer, or different levels of current to the light source 408, etc., as possible activation mechanism 416 switches. Similar devices can be mentioned. The power supply 414 can also be triggered wirelessly by the activation mechanism 416. For example, in one particular embodiment, the activation mechanism 416 may include a reed switch configured to activate and / or stop power from the power supply 414 when the magnetic source is located near the activation mechanism 416. In another embodiment, the activation mechanism 416 is configured to control the power from the power supply 414 to the light source 408 when the activation mechanism 416 receives one or more radio frequencies. Can include. Furthermore, the light source 408 (and / or power source 414) can be driven by amplified RF energy or "radio power" or by inductive coupling from the base station.

The device 400 may include a further aspect illustrated in FIG. In some embodiments, for example, the device 400 may further include one or more radiodensity markers (not shown) arranged along the body 404. In addition, a tether similar to the recovery tether 118 illustrated in FIG. 1 (not shown) can be defined along the body 404.

With reference to FIG. 5, a fifth embodiment of the device, represented by 500 and based on the general concept and functionality described in FIG. 1, may include a light emitting element 502 that defines the body 504. The body 504 of the light emitting element 502 can define a substrate 506, which is a substantially long and flat member, which is from a polyimide film or other flexible substrate material and is a surface of the polyimide film. It is configured with a plurality of copper wires or other conductive wires (not shown) formed along the above. The copper wire may be formed in a predetermined pattern so that the substrate 506 is configured as a flexible PCB, the substrate 506 may be a variety of electrical components (to adapt to lighting functions as further described herein). Resistors, capacitors, switches, etc. (not shown) can be defined.

The body 504 may further define a light source 508 that is mounted on the substrate 506 or otherwise localized along the substrate 506. In device 500, the light source 508 may define an LED strip light or LED tape that telecommunicationss with electrical components (not shown) on the substrate 506. In some embodiments, the light source 508 comprises a surface mount LED or a surface mount device (SMD) LED that may include different shapes, dimensions, and power levels, depending on the application desired for the device 500. obtain.

The main body 504 may further define an outer layer 510 localized around the light source 508 and the substrate 506. In this way, the outer layer 510 encapsulates the light source 508 and the substrate 506 at least partially or wholly to protect the light source 508 from external factors such as body tissue or body fluids. The outer layer 510 forms a uniform surface and is non-absorbent, for example, woven near the boundary between the substrate and the light source in order to enclose the substrate 506 and the light source 508 in a substantially intermediate position along the main body 504. It may include one or more layers, including fibers. In some embodiments, the outer layer 510 may contain PDMS and / or a plastic, acrylic, and / or silicone polymer. The outer layer 510 may be non-absorbent (or absorbent), fluid resistant, flexible, insulating, and biocompatible so that the outer layer 510 is suitable for a variety of surgical and medical applications. Also, in some embodiments, the outer layer 510 is involved in deployment, with the outer layer 510 (and generally the body 504) of the light emitting element 502 being deformable or modified to a predetermined shape configuration. A malleable memory-retaining material may also be included so that the composition can be temporarily retained. In some embodiments, the outer layer 510 of the luminescent element 502 may be formed using one or more surgical putties (not shown) such that the luminescent element 502 may contain a sponge or cotton material. .. For example, the light source 508 may be located within a surgical putty (not shown). In these embodiments, the outer layer 510 is a disposable fiber pad suitable for placement on or around the tissue to provide fluid management or other surgical function, as further described herein. Can be further included.

As further shown, the light source 508 of the light emitting element 502 can be electrically coupled to a power source 514 that may include a driver. In the illustrated embodiment, the power supply 514 is built into the outer layer 510 so that the light emitting element 502 is wireless, but the power supply 514 may also include a USB device, a plug, or somehow wired. Can be.

In some embodiments, the device 500 further comprises an activation mechanism 516 located along the substrate 506 or in close proximity to the power source 514 and electrically coupled to the power source 514 and / or the light source 508. The activation mechanism 516 may include one or more switches for controlling power from the power source 514 to the light source 508, or a similar electromechanical device. Possible switches for the activation mechanism 516 include push-button switches, rocker switches, slide switches, transformers, variable resistors, solid-state semiconductor dimmers, and the like. The power supply 514 can also be triggered wirelessly by the activation mechanism 516. For example, in one particular embodiment, the activation mechanism 516 may include a reed switch configured to activate and / or stop power from the power source 514 when the magnetic source is located near the activation mechanism 516. In another embodiment, the activation mechanism 516 is configured to control the power from the power source 514 to the light source 508 when the activation mechanism 516 receives one or more radio frequencies. Can include. Furthermore, the light source 508 (and / or power source 514) can be driven by amplified RF energy or "radio power" or by inductive coupling from the base station.

The device 500 may include a further aspect illustrated in FIG. In some embodiments, for example, the device 500 may further include one or more radiodensity markers (not shown) arranged along the body 504. In addition, a tether similar to the recovery tether 118 illustrated in FIG. 1 (not shown) can be defined along the body 504.

Various embodiments and other aspects and advantages of the light emitting elements 102, 202, 302, 402, 502 described in FIGS. 1-5 are discussed. For example, any one of the light emitting elements 102, 202, 302, 402, 502 can provide miniaturized surgical lighting, and modern μLEDs can be as small as 25x25 micrometers, thus millimeters or centimeters. On a metric scale, it can provide outstanding lighting for low light surgical environments. Further, the luminescent elements 102, 202, 302, 402, 502 are different from the fixed luminaire, so that the luminescent elements 102, 202, 302, 402, 502 can be movable along the surgical area. It can be a sponge material to reduce engagement with the tissue. In some embodiments, voltage waveforms applied to control dimmers, transformers, variable resistors, solid state dimmers in the form of semiconductor devices, light sources 108, 208, 308, 408, and 508. The illumination provided by the light sources 108, 208, 308, 408, and 508 is dimmed and adjusted as needed during deployment by implementing a dimming device that includes other devices for controlling the light source 108, 208, 308, 408, and 508. Can also be possible. In addition, the luminescent element can be manufactured efficiently and can be completely disposable.

With reference to FIG. 6, one possible light source configuration 608A is shown, which configuration can be implemented with any one of the devices 100, 200, 300, 400, 500 described herein. .. In this embodiment, the light source configuration 608A defines a plurality of LEDs arranged in a columnar configuration or row that may be ideal for providing columnar illumination. In other embodiments, the light source configuration 608A may include multiple LEDs arranged in a staggered configuration to provide more diffused illumination or in a close circular array to provide more focused illumination. .. The LEDs of the light source configuration 608A may be further arranged in an offset, alternating, square, or diamond configuration.

With reference to FIG. 7, another light source configuration 608B that can be implemented with any one of the devices 100, 200, 300, 400, 500 described herein is shown, with the light source configuration 608B alone. LED or other light source arranged in a light emitting element similar to the device embodiment of FIGS. 1-5. The use of a single LED or light source is suitable when the individual light emitting elements 102, 202, 302, 402, 502 are desirable to be disposable, or when the size of such light emitting elements is only micrometers. Can be. Each LED of FIGS. 6 and 7 can have a diameter of about tens of thousands of microns, depending on the required illuminance and the size of the light emitting element it contains.

With reference to FIG. 8, another light source configuration 608C that can be implemented with any one of the devices 100, 200, 300, 400, 500 described herein is shown. In this embodiment, the light source configuration 608C includes one or more LEDs or other light sources 108, 208, 308, 408, 508 that emit uniform wavelengths. In contrast, with reference to FIG. 9, another embodiment of the light source configuration 608D that can be implemented with any one of the devices 100, 200, 300, 400, 500 described herein has different wavelengths. Includes one or more LEDs or other light sources 108, 208, 308, 408, 508 to emit. 8 and 9 can be implemented such that different types of LEDs illuminate the surgical area at a particular wavelength to provide different predetermined surgical functions, eg, to achieve different benefits. .. In some embodiments, the wavelength of the light emitted from the light sources 108, 208, 308, 408, 508 can be adjusted and the p- of each LED defined by the light sources 108, 208, 308, 408, 508. It can be determined according to the bandgap energy of a given semiconductor material forming an n-junction. That is, different semiconductor materials can be used to form LEDs that are light sources 108, 208, 308, 408, 508 that can correspond to different desired wavelengths of light. Wavelengths include, for example, specific wavelengths for tumor visualization and blood flow diagnosis, wavelengths that provide disinfectant effects, wavelengths that provide better visual distinction, wavelengths that reduce reflections and glare, or otherwise visual discrimination. At improved wavelengths, certain treatments using excited dyes can be accommodated. For dye-based applications, dyes are often injected or ingested into the body, including vasculature, nervous tissue, and vessels, for better visualization of cancerous tissue and arteries. These dyes contain molecules that emit light that, when activated by light of a particular wavelength, can be detected visually or by various detection devices. This allows the surgeon to detect fluid movement, molecular uptake, occlusion, cutting and the like.

In one specific possible implementation, blue spectrum illumination in the 375-440 nm range is common when patients are administered 5-aminolevulinic acid (5-ALA) to separate cancerous tissue from healthy tissue. It can be used to visualize gliomas or tumors. Light with a wavelength near 494 nm can be used to excite a fluorescein fluorophore to intraoperatively separate cancerous tissue from healthy tissue. Both 5-ALA and fluorescein have been extensively tested in the United States and Europe to remove high-grade gliomas from healthy tissue. With such an approach, alternative or ancillary excitable light sources may assist the surgeon in visually identifying cancerous tissue. When the luminescent elements 102, 202, 302, 402, 502 are deployed during surgery, the identification of cancerous tissue can be greatly improved. For example, when operating on the deep head and neck for cancer of the ear, nose, or throat, fluorescein excitation with surgical luminescent elements, as described herein, is to reach the lesion of interest. In addition, it can be useful in narrow passages.

Another embodiment for a particular implementation of the light emitting elements 102, 202, 302, 402, 502 is an indocyanine green (ICG) that can be used to visualize arterial blood flow when administered to a patient. Is accompanied by LED emission in the 600-900 nm range to excite. Similar to the applications using 5-ALA and fluorescein described herein, the ICG can be excited by an additional auxiliary light source in the form of the luminescent element, beyond conventional illuminated surgical tools. Allows photoexcitation from.

Yet another embodiment of a particular implementation involves luminescence in the UV C region, which was traditionally considered carcinogenic and cataract-inducing. However, UV C light does not penetrate human cell membranes; therefore, UV C light has recently been shown to be highly bactericidal and viral killing without having a significant effect on human cells. Ultraviolet C light can be deployed from any one of the light emitting elements 102, 202, 302, 402, 502 to purify the surgical area from bacteria. Bacteria that do not respond to antibiotics will also be susceptible to light emitted in the UV C region.

With reference to FIG. 10, another light source configuration 700 for the light emitting element 702 is shown with one or more light sources 708. This embodiment illustrates that the light emitting element 702 can be configured in a different shape and that the light emitting element 702 can be malleable or curvable, if desired. This embodiment further illustrates that the light source 708 may include a plurality of LEDs that are not necessarily arranged in a straight line.

With reference to FIG. 11, a configuration 800 for surgical deployment is illustrated, the configuration 800 comprising a plurality of luminescent elements 802A-802E, wherein the luminescent element is another luminescent element described herein. It can be similar to 102, 202, 302, 402, 502. In the illustrated configuration, the light emitting elements 802A-802E include light sources 808A-808E, respectively. In configuration 800, a plurality of light emitting elements 802A-802E may be arranged along the surgical area in this exemplary orientation illustrated to provide focused illumination 818 to a particular portion of the surgical area. As described herein, the illuminated surgical light emitting elements 802A-802E may be arranged to provide light directed to the focal point in a cylindrical shape. Light can be emitted from only one side or both sides of the light emitting elements of the light emitting elements 802A to 802E. A flexible and convenient predetermined arrangement or method in which the luminescent elements 802A-802E can be localized (and transitioned or moved) can be adapted to focus in a particular direction and, if desired, wider illumination. Can be adapted to. In addition, the plurality of luminescent elements 802A-802E can be arranged as shown (or in other configurations) to provide a liquidtight barrier around the surgical area.

With reference to FIGS. 12A-12B and 13A-13B, various possible electrical properties that may be implemented for any one embodiment of the light emitting elements 102, 202, 302, 402, 502, 702, 802. However, it is illustrated. In particular, FIG. 12A illustrates an exemplary mask layout 900 for the light emitting element 902. The light emitting element 902 defines a substrate 906 containing electrical components 911 such as a plurality of resistors, capacitors, reed switches, etc., and one or more LEDs formed and / or mounted along the substrate 906. In one implementation, the electrical components 911 are 470k resistors (0201) -3 each; 1M resistors (0201) -1 each; 10k resistors (0201) -1 each; 1uF capacitors (0201). ) -1 each; lead switch-1 each; white LED (0201) -2 or 4 each; ProLiant-1 each; and NMOS-2 each. In some embodiments, the various electrical components 911 can be defined by conductive or copper (Cu) wire 916 formed along the substrate 906. As shown, the substrate 906 can be further coupled to the battery 914. With reference to FIG. 12B, the copper wire 916 formed along the substrate 906 can generally define a diameter of about 18 micrometers. As further shown, in some embodiments, the polyimide thin film defining the substrate 906 can be 25 micrometers in diameter and the light emitting element 902 can be about 100 micrometers in diameter. It should be understood that the mask layout 900 can be used with any of the light emitting elements 102, 202, 302, 402, 502, 702, 802, 902 described herein.

With reference to FIGS. 13A and 13B, schematics 950A and 950B show that the LED or other light source of the light emitting element (according to any of the embodiments herein) is turned on or off according to the embodiments of the present disclosure. Illustrated to show the possible interlocking of various electrical components in the process. In particular, Table 1 describes the various electrical components of schematic 950A when the LED is turned on.

Table 2 below may describe the interlocking of various electrical components in schematic 950B when the LEDs are turned off.

It should be understood that schematics 950A and 950B can be used with any of the light emitting elements 102, 202, 302, 402, 502, 702, 802, 902 described herein.

14A-14D illustrate one possible machining flow that forms a light emitting element similar to the light emitting elements 102, 202, 302, 402, 502, 702, 802, 902 described herein. .. FIG. 14A shows a first configuration 1002A, illustrating a substrate 1006 that is made of a polyimide thin film and can be flexible or deformable, as described herein. As shown, the plurality of electrical components 1007 can be soldered or otherwise formed along the substrate 1006. Electrical component 1007 may include the components described in FIGS. 12A or 13A and 13B, but the present disclosure is not limited in this regard.

With reference to the second configuration 1002B shown in FIG. 14B, one or more SMD LEDs 1008 or other light sources may be mounted on the substrate 1006. The wire 1009 may be electrically coupled to the LED 1008 of the SMD to form additional electrical connections as described further herein. In some embodiments, the SMD LED 1008 may be mounted on substrate 1006 and the SMD LED 1008 may take any form of a light source embodiment as described herein. As further shown, the reed switch 1011 defined by the electrical component 1007 can be formed or mounted on the substrate 1006 and electrically coupled to the LED 1008 of the SMD.

With reference to the third configuration 1002C shown in FIG. 14C, the surgical putty 1012 can be provided and at least partially cut to define the first portion 1012A and the second portion 1012B of the putty 1012. Using forceps 1014 or other suitable tool, the substrate 106 can be disposed along the surface of the first portion 1012A of the putty 1012 as shown. In some embodiments, an adhesive (not shown) may be applied to maintain the substrate 1006 in a stationary position with respect to the first portion 1012A of the putty 1012. As further shown, the wire 1009 extends from the substrate 1006 and remains available for electrical connection.

With reference to the fourth configuration 1002D shown in FIG. 14D, the first portion 1012A and the second portion 1012B of the putty 1012 are joined together to seal the substrate 1006 (including the LED 1008 of the SMD) in the putty 1012. Thus, a light emitting element 1019 similar to the other light emitting elements described herein can be formed. Thus, in putty 1012, the substrate 1006 is similar to the outer layer embodiment described herein so that the substrate 1006 is completely isolated from, for example, body fluids or other potential contaminants. )I will provide a. The present disclosure is not limited to implementing surgical putty as described in this embodiment, and it is understood that outer layers 110, 210, 310, 410, and 510 can be formed without surgical putty. Should be. For example, the outer layers 110, 210, 310, 410, and 510 can be formed using vapor deposition, sputtering, etching, chemical vapor deposition, or can be woven around each substrate and light source. Alternatively, in other embodiments, the surgical putty may be implemented as part of the outer layers 110, 210, 310, 410, and 510.

As further shown, wire 1009 may be connected to power source 1016, which may include batteries, USB connectors, plugs, or other suitable power sources. During deployment, the SMD LED1008 of the light emitting element 1019 can be engaged and illuminated by passing a magnet 1020 over the light emitting element 1019, thereby activating a reed switch 1011 defined between electrical components 1007. Then, power is drawn from the power supply 1016. Other mechanisms for operating the SMD LED1008 have been considered and described above. In some embodiments, the light emitting element 1019 weighs about 0.8 grams when assembled.

Although illustrated and described for particular embodiments, various modifications can be made to those embodiments without departing from the spirit and scope of the invention, as will be apparent to those skilled in the art. Should be understood from the above. Such changes and modifications are within the scope and teachings of the invention as set forth in the claims herein.

Claims (16)

A device for surgical lighting in the surgical area, the device is:
A substantially flat outer layer that is biocompatible and malleable ;
A substantially flat substrate enclosed in the outer layer and having malleability ;
A light source mounted along the substrate;
Includes a power source coupled to the light source; and an activation mechanism configured to activate the power source to emit light from the light source.
The device is a device configured to be movable in the surgical area . The apparatus according to claim 1, wherein the outer layer contains polydimethylsiloxane. An additional layer localized around the outer layer, further comprising a sponge material to reduce engagement with body tissue so that the device can be moved from the surgical area. , The apparatus according to claim 1. The apparatus according to claim 1, wherein the substrate includes a flexible printed circuit board. The device according to claim 1, wherein the power source includes a disposable battery enclosed in the outer layer. The device of claim 1, further comprising an electrical conduit surrounded by an insulating layer that couples the light source to the power source. The device of claim 1, wherein the light source, power source, activation mechanism, and outer layer together form individual light emitting elements that are localized along the surgical area. The device according to claim 1, wherein the light source includes a plurality of light emitting diodes sealed in the outer layer. The device according to claim 8 , wherein the first light emitting diode of the plurality of light emitting diodes emits light at a first wavelength, and the second light emitting diode of the plurality of light emitting diodes emits light at a second wavelength. The device of claim 8 , wherein the plurality of light emitting diodes are localized in a predetermined arrangement within the outer layer to provide focused illumination along the surgical area. The apparatus according to claim 1, further comprising a plurality of radiodensity markers formed along the outer layer or the light source. The device of claim 1, further comprising a recovery tether coupled to the outer layer, which is configured to remove the device from the surgical area. An antenna coupled to the power source, further comprising an antenna configured such that the activation mechanism activates the power source and transmits a radio frequency signal to the antenna in order to emit light from the light source. The device according to claim 1. The device of claim 1, further comprising a reed switch for engaging the power source, further comprising a reed switch configured to actuate the power source in response to a magnet to emit light from the light source. .. The method for forming a surgical lighting device in a surgical area according to any one of claims 1 to 14, wherein the method is:
Steps to provide a light source configured to illuminate the surgical area;
A method comprising the step of sealing the light source in a biocompatible, malleable, substantially flat outer layer; and the step of coupling the light source to a power source. 15. The method of claim 15 , wherein the power source is sealed within the outer layer and located adjacent to the light source.