Light assembly and methods for use with a needle or cannula

Abstract

A light assembly system for providing transillumination and delivering materials through tissue is disclosed. The system includes a body with a proximal connector, a channel, and a light source, wherein the light source extends through a tube. The tube, which may be a needle or cannula, is designed for injection purposes and is configured to be connected to the body. Light emitted from the light source provides transillumination through the skin, aiding in the precise placement of the tube. The design enhances visualization and accuracy during medical procedures, reducing reliance on conventional methods and improving efficacy.

Description

LIGHT ASSEMBLY AND METHODS FOR USE WITH A NEEDLE OR CANNULAPriority

[0001] The present application claims priority to U.S. Provisional Application No. 63 / 563,779, the entire disclosure of which is incorporated herein by reference.Field of the Disclosure

[0002] The present disclosure generally relates to a light assembly and methods for use with a needle or cannula for injecting fluid in a superficial subcutaneous location below the skin surface.Background of the Disclosure

[0003] There is a continuing need for an effective approach to improving the appearance of the surface of skin. In one or more approaches, it is desirable to treat cellulite, also known as gynoid lipodystrophy, nodular liposclerosis, edematofibrosclerotic panniculopathy, panniculosis, adiposis edematosa, demopanniculosis deformans or status protrusus cutis.Additionally, there is a need for treatment devices for use in scar release, acne subcision, facial fold and / or facial lift procedures. Moreover, there is a need for proactive treatment modalities that prevent future or reoccurrence of skin discontinuities and which are easy and effective to use.

[0004] Various approaches have been taken to treat or address cellulite. Early treatments involved attempts at increasing circulation and fat oxidation in areas exhibiting cellulite. Here, substances such as hyaluronic acid and aminophylline are injected in the target areas to reduce cellulite. Other approaches involve electroporating the target areas followed by the application of mesotherapy, or applying dermological creams or other supplements to cellulite. These approaches could be supplemented by massage or massage was used alone for the purpose of promoting increased fat reabsorption or drainage of fluids and toxins in the treated areas.Ultrasound has also been proposed to disrupt subcutaneous tissues and fat and has been used in combination with liposuction. Low acoustic pressure in combination with the infiltration of microbubbles has also been employed to reduce the appearance of cellulite, as has the use of other energies such as lasers and radio frequency. More recently, the cutting of septa with blades or needles in the subdermal region has been employed. These procedures target thesuperficial subcutaneous space below the skin surface.

[0005] There are also treatment approaches to treat scars and acne, fine lines and wrinkles, or for use in facial fold and / or facial lift procedures. In conventionally available procedures, treatment devices are required to be inserted within tissue close to the interventional site, and travel within tissue to the site. There is thus a need for a treatment device that can be placed into tissue at more cosmetically desirable locations and advanced under the skin in a safe and efficient manner.

[0006] For many aesthetic and other procedures, infiltration (i.e., injection) of dilute lidocaine is needed to establish local anesthesia for a procedural region. Volumes can vary by procedure target size and area, but volumes delivered can range from 100 to 2000ml, with a typical case delivering approximately 500ml.

[0007] To deliver the dilute lidocaine or other substances, there are a number of traditional ways including syringe and needle, (syringe) handpump and needle, infiltration pump and needle, infiltration pump and cannula. For many procedures, the delivery is in the subcutaneous plane, just below the dermis. To accomplish the safest and most efficient delivery it is helpful to know where the location of the tip of a needle or cannula and / or the depth of delivery. The goal is for the patient to be comfortable during both the anesthesia delivery and the following procedure.

[0008] The current method of understanding the location and depth of the needle or cannula is to use the non-syringe hand to palpate and assess the tip location. This takes practice to understand the tip location during delivery and is typically a higher skill task in the aesthetic clinic or practice. This is especially so in larger areas with curvature. Body curvature and needle deflection which can be a result of attempting to employ long needles and / or cannulas (e.g., about 8 centimeters of longer) having relatively smaller diameters (e.g., about 18 gauge or smaller), increase the challenge and require a higher skill.

[0009] Accordingly, there is a need for safe and efficient approaches to learn how to deliver and to delivering local anesthesia or other substances at a treatment site. These approaches should be associated with predictable results and be relatively easy to employ.

[0010] The present disclosure addresses these and other needs.Summary of the Disclosure

[0011] Briefly and in general terms, the present disclosure is directed towards a light assembly and methods for use with a tube, such as a medical needle or cannula configured to provide or involving providing positional and depth information. In one embodiment, information concerning a location and / or depth of a needle or cannula is provided.

[0012] In one aspect, a light assembly is configured so that light is provided or delivered to a tip or a portion of the tube. The light assembly can be added to a standard needle or cannula, or can be integral with the needle or cannula. The tube may be a needle, and the light assembly may be used to inject material in a superficial, subcutaneous space between about 1 to about 10 mm below the dermis. Light emitted from the light assembly may facilitate transillumination through the dermis which can be used to inform a user as to a location of a tip or other portion of the needle or cannula. The information may be based on the brightness and / or shape of the light. The information regarding the depth of the device may be interpreted by the information, as well as how far the tip of the needle or cannula has traveled from the entry site through the skin.

[0013] In another aspect, the light assembly may be releasably coupled with a tube, such as a needle or cannula, and have a connector configured to connect to a full or wide range of syringe and / or pump or fluid inputs.

[0014] The system may be configured to deliver a material to a treatment site. The material may be an anesthetic. Additionally or alternatively, the material may be one or more of a filler (e g. hyaluronic acid), a deoxycholic acid (e.g. Kybella), a biostimulator (e g. Sculptra), a toxin, a medicament, an extracellular matrix, an allograft, and / or other desired injectable.

[0015] Light can be projected from the tube not just while it is being advanced but also while anesthetic or other fluid is being injected through the tube to help a less experienced healthcare provider to stay consistently near the dermis to localize delivery of the anesthetic to the nerve endings that cause the pain sensation or to deliver the filler for wrinkles in the plane for best effectiveness with the least amount of volume needed.

[0016] A system includes a body having a proximal connector and a channel. The system also includes a light attached to the body and extending through the channel, where the light is configured to provide transillumination through skin. The system also includes a tubedefining a lumen, where the tube is configured to be connected to a distal portion of the body, and the light is configured to extend through the lumen. The proximal connector is configured to connect to a fluid source, and the fluid source is configured to deliver a material through the channel and the lumen when the tube is connected to the distal portion of the body.

[0017] Implementations may include one or more of the following features. The proximal connector can be a female Luer connector. The tube can be permanently attached to the body. The distal portion can be a distal connector configured to releasably connect to the tube. The distal connector can be a male Luer connector. The tube can be a needle or a cannula. The tube can have an opening, and an end of the light can be configured to be disposed at the opening. The end of the light can be within about from 1.27 to 3.81 mm from a tip of the tube. The tube can have a bevel. An end of the light can be laterally exposed through the bevel. The body can have a housing with a chamber, and the light can extend from the chamber into the channel.

[0018] The system may include a battery in the chamber. The light can be a light fiber, and the lens can be configured to focus light emitted by the light source through the light fiber. The system can may include an actuator configured to activate the light. The actuator can be a pull tab configured to interrupt a circuit between a battery and the light, and the battery can be configured to supply power to the light when the pull tab is removed. The material can be at least one of an anesthetic, a filler, deoxycholic acid, a biostimulator, a toxin, or a medicament. The system may include the fluid source. The fluid source can be a syringe.

[0019] One general aspect includes a method of injecting a material. The method also includes providing a body having a proximal connector, a distal connector, and a channel, the body housing a light source coupled to a proximal end of a light fiber, where the light fiber extends out of the body through the distal connector. The method also includes inserting a distal end of the light fiber into a proximal opening of a needle. The method also includes positioning the distal end of the light fiber at a bevel of the needle. The method also includes attaching the needle to the distal connector. The method also includes attaching a source of the material to the proximal connector. The method also includes activating the light source. The method also includes inserting the bevel of the needle through skin. The method also includes visualizing light transilluminating through the skin. The method also includes injecting the material through the needle.

[0020] Implementations may include one or more of the following features. The method where, after the insertion, the bevel of the needle is positioned in a subcutaneous space to inject the material in the subcutaneous space. The subcutaneous space can be between about from 1 to about 10 mm below a dermis. The distal end of the light fiber can be positioned about 1.27 to about 3.81 mm from a tip of the bevel of the needle. The method may include adjusting a position of the bevel of the needle based on the light transilluminating through the skin. The material can be at least one of an anesthetic, a filler, deoxycholic acid, a biostimulator, a toxin, or a medicament.

[0021] One general aspect includes an apparatus for use with a tube defining a lumen. The apparatus also includes a body having a housing, a proximal connector, a distal connector, and a channel, where the proximal connector is configured to attach to a fluid source, the distal connector is configured to attach to the tube, and the fluid source is configured to deliver a material through the channel and the lumen. The apparatus also includes a light fiber attached to the body and extending through the channel, where the light fiber is configured to extend through the lumen of the tube. The apparatus also includes a light source (e.g., a LED) in the housing, where the light source is configured to emit light through the light fiber.

[0022] One general aspect includes a light needle assembly system. The light needle assembly system also includes a handle assembly. The system also includes a needle. The system also includes a light at an end of the needle, the light being configured to provide transillumination through skin. The system also includes a reservoir configured to contain a fluid. The system also includes a fluid input configured to deliver the fluid through the needle.

[0023] Implementations may include one or more of the following features. The system may include a vibrating motor configured to vibrate the needle during insertion of the needle into the skin. The needle can have a plurality of holes spaced axially along the needle. The light can include a light fiber. The light fiber can be within the needle. The light fiber can be outside of the needle. The light fiber can be configured to be adjustable in length. The system may include a hub configured to receive a syringe and / or pump input. The needle can be incorporated into the battery and optics module. The system may include a compact light engine. Based on the brightness and / or shape of the transillumination, a user can be informed of the location and / or depth of a tip of the needle or other portion of the light. The fluid can beat least one of an anesthetic, a filler, deoxycholic acid, a biostimulator, a toxin, or a medicament.

[0024] These and other features of the disclosure will become apparent to those persons skilled in the art upon reading the details of the systems and methods as more fully described below.Brief Description of the Drawings

[0025] Fig. 1 is a perspective view, depicting a first embodiment of a system including a light assembly.

[0026] Figs. 2A-E are side exploded, and cross-sectional views, depicting a second embodiment of a system including a light assembly.

[0027] Fig. 2F is a perspective view, depicting use of a light assembly within tissue.

[0028] Figs. 3A-H are perspective, enlarged and partial cross-sectional views, depicting a third embodiment of a system including a light assembly.

[0029] Figs. 4A-B are side and enlarged perspective views, depicting a further approach to a fourth embodiment of a light assembly.

[0030] Figs. 4C-D are schematic views, depicting directions of delivery of substances.

[0031] Figs. 5A-B are schematic views, depicting alternative approaches to circuits.Detailed Description

[0032] Before the present systems and methods are described, it is to be understood that this disclosure is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

[0033] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the disclosure, subject to any specifically excluded limit in the statedrange. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

[0034] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure, the preferred methods and materials are now described.

[0035] It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "the system" includes reference to one or more systems and equivalents thereof known to those skilled in the art, and so forth.

[0036] In one or more approaches, there is disclosed herein a light assembly and a light tube assembly configured so that light is provided or delivered to a tip of one or more portions of a tube, such as a needle or cannula. In a superficial subcutaneous space just below the dermis, the light assembly may illuminate light with transillumination that can be used to inform a user as to a location of a tip or other portion of the tube. Furthermore, based on the brightness and / or shape of the light, the light can provide information regarding the depth of the device as well as how far the tip of a needle or cannula has traveled from the entry site through the skin. In this way, the operator experiences a faster learning curve and more feedback than is associated with relying on conventional approaches such as employing palpitation. Moreover, by employing transillumination, a treatment device can be placed with more precision and confidence.

[0037] In various aspects, there is described a light tube assembly that is configured to accommodate a full or wide range of syringe and / or pump inputs.

[0038] Moreover, in various embodiments, the light assembly may include a light fiber that is configured to be adjustable in length. In one aspect, a light emitting portion of the light fiber can be configured to be aligned with a light emitting bevel, or can be manually displaced from the bevel to reduce output.

[0039] Fig. 1 illustrates a first embodiment of a system including a light assembly 150 configured to inject a material to an interventional site. The light assembly 150 may include a light source 152, a body 154, and a tube 155. The light assembly 150 may further include adelivery mechanism including a delivery tube 156 and a delivery device 1 8. The light assembly 150 may be configured to illuminate tissue and inject a material.

[0040] The tube 155 may be a needle or cannula configured to be inserted into a body tissue to inject the material. The tube 155 may be a needle having a sharp beveled tip (e.g., as illustrated in FIG. 3A-B) or a cannula having a blunt tip (e.g., as illustrated in FIGS. 3D-E). The tube 155 may be metal, such as stainless steel. The tube 155 may be opaque such that the light is only transmitted through an opening in the tube 155, such as at a terminal end 160 of the tube 155. The tube 155 may be rigid for penetration of the skin. In one particular embodiment, the light assembly 150 may be used to inject an anesthetic in conjunction with a cellulite treatment procedure. The light assembly 150 may provide enhanced visualization during an interventional procedure, via transillumination, during anesthesia injection or other procedure. The light transmitted from an opening at the terminal end 160 of the tube 155 may provide information concerning depth, orientation of the bevel of the needle and distance from entry of the light assembly within and between tissue layers. By doing so, accuracy and injection precision is enhanced as the user is provided with feedback that is used to adjust angles and approaches of the light assembly 150 as it is advanced through tissue.

[0041] The body 154 may provide a handle and a housing containing components configured to actuate the light source 152. An energy source, such as a battery, and optical module may be housed in the body 154 and configured to provide control to the light source 152, as discussed with reference to FIG. 2A-C. The tube 155 may extend longitudinally from the body 154 to penetrate the tissue and delivery the material.

[0042] The delivery tube 156 may extend from the body 154 and have a lumen in communication with a reservoir (e.g., a IV bag, not shown) containing the material. The delivery device 158 may be a hand pump having a plunger configured to pressurize the material to push the material through the tube 155 and into the body tissue. The body 154 may include a chamber of a syringe. The plunger may be retracted after delivery of the material to reload the chamber after injection. The retraction may be caused by a spring configured to automatically reload the chamber once the piston is released. The retraction may create a negative pressure inside of the body 154 to draw the material from the reservoir through the delivery tube 156. One or more one-way valves may facilitate reloading the hand pump. In some embodiments, the light assembly 150 may have a dual valve assembly allowing for thematerial to be pushed out of the tube 155, making the delivery device 158 available for reloading with the material at the end of the delivery tube 156. With the syringe drawing back, drawing vacuum, one valve may open and allow flow from the reservoir and fill the chamber of the syringe. When the plunger is depressed, a second valve may open allowing the fluid in the syringe to progress to the channel and into the tube 155 to be delivered.

[0043] The material may be one or more of an anesthetic, a filler (e.g. hyaluronic acid), a deoxycholic acid (e.g. Kybella), a biostimulator (e.g. Sculptra), a toxin, a medicament, an extracellular matrix, an allograft, and / or other desired injectable. In some embodiments, the material is an anesthetic. In some embodiments, the material may be processed adipose tissue, such that disclosed in WIPO Publication No. 2024 / 107774, the entire disclosure of which is incorporated herein by reference. The material may be in a fluid state.

[0044] In one aspect, a tissue or body model may be provided so that the light assembly 150 may be used for training purposes. In the case of applying an anesthetic, use of the light assembly 150 may ensure the treatment field is well anesthetized with minimal amount of additional anesthesia and time. In various approaches, the light assembly 150 may include one or more of gauges or flow components such as valves integrated with a pump cooperating with the needle assembly to both control operation and ensure effectiveness of the system. Thus, pain associated with procedures conducted in conjunction with anesthesia can be effectively controlled using the light assembly 150.

[0045] The light assembly 150 may be used with an external light sensor (not shown) configured to detect light emitted by the light source 152. The light sensor may be coupled to the light assembly 150 and be configured to determine the depth of the distal tip of the tube 155. The light assembly 150 may be configured to adjust the light source 152 based on a determined efficiency. In some embodiments, the light assembly 150 may be configured to communicate with the light sensor and automatically adjust the light source based on the detect transillumination. The light assembly 150 may be used with a depth sensor, such as an ultrasound device configured to transmit ultrasound through the skin to detect the depth of the tip.

[0046] Figs. 2A-B illustrates a second embodiment of a system including a light assembly 200. The light assembly 200 may be used with and / or include a fluid delivery assembly 204 and a tube assembly 205. The light assembly 200 may have a body 201 and alight 210. The body 201 may provide a handle for the user. The tube assembly 205 may have a tube 206, and the light 210 may extend distally from the body 201 through a lumen of the tube 206. The entire disclosure of the first embodiment (as discussed with reference to FIG. 1) is incorporated herein by reference for sake of brevity, other than when otherwise indicated.

[0047] The body 201 may have a tubular portion 234 configured to fluidly connect the delivery assembly 204 with the tube assembly 205 to allow delivery of a material (e.g., a fluid) from the delivery assembly 204 into body tissue. The tubular portion 234 may have a proximal connector 238, a distal connector 240, and a channel 242 extending between the proximal connector 238 and the distal connector 240. The delivery assembly 204 may be configured to connect to the proximal connector 238, and the tube assembly 205 may be configured to connect to the distal connector 240, such that the delivery assembly 204 is in fluid communication with the tube assembly 205 via the channel 242. The tubular portion 234 may be releasably attachable to the delivery assembly 204 and / or the tube assembly 205. For example, the proximal connector 238 and / or the distal connector 240 may be Luer connectors. The proximal connector 238 may be a female Luer connector configured to connect to a male Luer connector 239 on the delivery assembly 204. The distal connector 240 may be a male Luer connector configured to connect to a female Luer connector 241 on the tube assembly 205. The proximal connector 238 and / or the distal connector 240 may be other types of connectors and configurations, such as a threaded connector, a friction connector, or a press-fit connector. In some embodiments, at least one of the delivery assembly 204 and / or the tube assembly 205 may be permanently attached to the body 201.

[0048] The delivery assembly 204 may be one or more of a variety of syringes and / or pump inputs. The delivery assembly 204 may embody one or more of an infiltration pump tubing configured to connect to an infiltration pump (not shown), a hand pump 158 (shown in FIG. 1) or a syringe 208. The delivery assembly 204 may include a container or source of the material, such as a barrel of the syringe 208. During assembly, the user may attach the connector 239 of the delivery assembly 204 to the proximal connector 238. The user may feed the light 210 into the lumen of the tube 206, and attach the connector 241 of the tube 206 to the distal connector 240. A width or diameter of the light 210 may be less than an inner width or diameter of the tube 206, such that fluid material may be injected from the delivery assembly 204 through the channel 242 around the light 210 and into the tube 206. Asillustrated in FIG. 3F, the light 210 may be concentric with the tube 206 and be disposed in a longitudinally central portion of the tube 206. The material may flow through the tube 206 around the light 210 and out of an opening at the distal end of the tube 206 into the body tissue. Additionally or alternatively, the material may flow through a lumen of the light 210. At least a portion of the outer periphery of the light 210 may approximate or contact an inner periphery of the tube 206. As illustrated in FIG. 3G, substantially the entire outer periphery or diameter of the light 210 may approximate or contact the inner diameter of the tube 206, enlarging the lumen of the light 210 to improve fluid flow therethrough. As further illustrated in FIG. 3H, the light 210 may be non-concentrically positioned in the tube 206 and / or without a lumen. For example, the light 210 may be D-shaped such that less than an entire outer periphery may approximate or contact the inner periphery of the tube 206, and the material may flow along the remaining outer periphery of the light 210. The configurations of FIGS. 3G and 3H may maximize light output (fiber surface area) and increase the luminal space for material / fluid delivery.

[0049] The body 201 may have a housing 244 with a chamber configured to contain an optics module 202 configured to illuminate the light 210. The optics module may include a light source 226, a lens 228, a ferrule 232, and / or a filter (not shown). The optics module 202 may further include a battery 220 and / or an actuator configured to activate and / or control the light 210. The optics module 202 may further include a PCB board, a controller, and / or an interface (not shown). The controller may include a computer processor to automatically control various aspects of the light assembly 200, and the interface may be a wireless interface (e.g. Wi-Fi or Bluetooth) for the controller to communicate with external components, such as an external light sensor.

[0050] As illustrated in FIGS. 2A-C, E, the actuator may include a pull tab 222 arranged to prevent completion of a circuit between the battery 220 and the light 210. When the pull tab 222 is removed from the housing 244, the circuit may be completed to enable power to flow from the battery 220 to illuminate the light 210 (e.g., via the light source 226). Additionally or alternatively, as illustrated in FIG. 2D, the actuator may include a switch 223 configured to selectively provide power from the battery to illuminate the light 210. The switch 223 may be mechanical, capacitive, and / or magnetic.

[0051] The actuator may be configured to selectively adjust the light 210, for exampleby adjusting the intensity and / or power of the light source 226. Additionally or alternatively, the actuator may adjust the light 210 by adjusting the position and / or configuration of a lens 228, a ferrule 232, and / or a filter. In some embodiments, the light source 226 may be toggled between two discrete states: a high intensity state and a low intensity state. In some embodiments, the light source 226 may allow the user to select from a plurality of predefined light levels (e.g., low, medium, high). The adjustment in light emission may enhance visualization in varying tissue depths, account for differences in skin pigmentation, and / or optimize illumination for different clinical environments. For example, a lower intensity may be beneficial for superficial injections or lighter skin tones, whereas a higher intensity may improve visibility in deeper tissues or darker skin tones. Furthermore, the light fiber length and / or positioning may be adjusted in combination with the intensity control to further refine transillumination effectiveness. These features may improve ease of use and reduce reliance on manual palpitation techniques, particularly for less experienced practitioners. The switch 223 may include a simple mechanical switch, capacitive touch control, and / or software-driven activation configured to allow the user to adjust the intensity based on the procedure. Additionally or alternatively, the switch 223 may include a stepped dial or button control on the body 201. Additionally or alternatively, the actuator may include a touch screen. Additionally or alternatively, the actuator may be automatically controlled by the controller.

[0052] The light 210 may be or include a light fiber extending through the channel 242 and / or through the tube 206. The light source 226 and the lens 228 may be disposed in the housing 236. The light source 226 may be a light-emitting diode (LED). The battery 220 may supply power to the light source 226. The light source 226 may emit light that is focused by the lens 228 through the light fiber 210 to illuminate the light fiber 210 along at least a portion of its length. For example, the lens 228 may be a spherical lens. The fiber 210 may be made of a glass or a polymer, such as a perfluorinated graded-index polymer optical fiber. The ferrule 232 may be configured to control the light emitted into the light fiber 210. The ferrule 232 may be engaged to the light fiber 210, between the lens 228 and a proximal end of the light fiber 210. The ferrule 232 may be manipulated (e.g., by the user) to control the light energy supplied to the fiber 210. Additionally or alternatively, the light assembly 200 may have the filter (not shown) positioned between the light source 226 and the light fiber 210, such as between the lens 228 and the light fiber 210. The filter may allow the user to modify abrightness of the light transmitted from the light source 226, for example, by removing and / or replacing the light fiber 210. The filter may be configured to slide through an opening through the housing 244 for the user to insert and / or remove the filter from the light assembly 200. Further discussion of the light and the optics module is provided in U.S. Pat. Pub. 2022 / 0183714, the entire disclosure of which is incorporated herein by reference.

[0053] The position of the distal end of the light fiber 210 may be adjusted by displacing and / or reducing slack in the light fiber 210 with an adjustment mechanism. For example, the adjustment mechanism may include a linear traveler and / or a pulley positioned in the housing 244 and be configured to deflect a length of the light fiber 210 in the housing 244 to retract and / or extend the distal end of the light fiber 210. For example, a linear traveler may be pushed distally to reduce slack and pull the distal end of the light fiber 210 proximally, and pulled proximally to increase slack and push the distal end of the light fiber 210 distally. Similarly, the pulley may be configured to rotate to wind or unwind the light fiber 210 on a reel. The distal end of the light fiber 210 may be adjusted based on a length of the tube 206. For example, the light assembly 200 may be used with tubes 206 of various lengths, and the light fiber 210 may be adjustable to the lengths to position the distal end of the light fiber 210 at an optimal position. Additionally or alternatively, the light fiber 210 may be adjusted to vary the emission of light. For example, the adjustment mechanism may be configured to pull the light fiber 210 into the tube 206 to reduce light emission or to extend the light fiber 210 to further expose the light fiber 210 through an opening in the tube 206 to increase light emission. The adjustment in light emission may enhance visualization in varying tissue depths, account for differences in skin pigmentation, and / or optimize illumination for different clinical environments. In some embodiments, the controller may be in communication with the external light sensor and be configured to automatically calibrate the light 210, for example with the external light sensor based skin pigmentation.

[0054] In some embodiments, when attaching the tube 206 to the body 201, a light fiber 210 extending from the body 201 may be fed down the lumen of the tube 206. This configuration may be used with any off-the-shelf needle of a specific size (for example, 18 Gauge, 3.5” length). As illustrated in FIGS. 3B, the light fiber 210 may be sized and shaped to extend through the tube 206 such that an end of the light fiber 210 coincides with an opening through the tube 206. The opening of the tube 206 may be a lateral opening such that the lightemission is directed through the skin. The opening may be formed by a bevel 212 at a distal terminal end of the tube 206. In various approaches, the fiber 210 may have a diameter between about 0.01 to about 0.04 inches (0.254 mm to 1.016 mm), and in a preferred embodiment about 0.02 inches (0.508 mm). As so configured, the light fiber 210 may emit sufficient light out the end of the tube 206 and shine light into the surrounding tissue and provide enough illumination to be visible through the skin. In one specific approach, for maximum light output but avoiding damage to the fiber during use, an end of the light fiber ends about 0.05 to 0.15 inches (1.27 to 3.81 mm) from the tip of the needle bevel 212 of a standard needle. In other embodiments, with shallower or steeper bevels the distance is less than or greater than that range. Furthermore (as discussed herein), the length of the light fiber 210 may be adjusted by the user for light output based on needle variability, such as across cannula and needle brands and types. Additionally or alternatively (as discussed herein), the light fiber 210 may be configured to be displaced from the opening to selectively adjust light output. The bevel 212 may provide the tube 206 with a sharp tip. Alternatively, as illustrated in FIGS. 3D-E, the tube may have a blunt tip 309 and an opening 311 along its length. As illustrated in FIG. 3D, an end of the light fiber may be disposed in a lateral plane of the opening 311. Alternatively, as illustrated in FIG. 3E, the light fiber may extend past the opening 311 and be fixed to the blunt tip 309. The distal end of the light fiber may have a flush termination with the distal end of the tube. In some embodiments, the tube 206 may have a plurality of the openings 311, as illustrated and discussed with reference to FIGS. 4B- D. The blunt tip 309 may be formed by a rounded and / or flat distal end of the tube 206. The tube 206 may be positioned to deliver a desired substance at an interventional site.

[0055] In embodiments where a light fiber 210 occupies a portion of the lumen of the tube 206, an important design consideration is the proportion of the lumen of the tube that remains available for fluid flow. The fiber diameter may be selected such that at least about 0.25 mm2of the cross-sectional area of the lumen of the tube 206 remains open. The cross- sectional area may be adjusted based on design considerations such as the viscosity of the intended fluid and the desired rate of flow.

[0056] In some embodiments, as illustrated in FIG. 2A-C, the tubular portion 234 including the channel 242, the proximal connector 238, and / or the distal connector 240 may be permanently attached and / or integrally formed to the housing 244. For example, the body 201may be formed of a plastic through injection molding to form the housing 244, the channel 242, the proximal connector 238, and / or the distal connector 240 in a single integral body. As further illustrated in FIG. 2C, the light fiber 210 may extend from the housing 244 through an opening 235 and into the channel 242. The opening 235 may be sealed around the light fiber 210 to prevent fluid communication between the channel 242 and the chamber of the housing 244. The light fiber 210 may extend through a center of the distal connector 240 and through the tube 206. In some embodiments, as illustrated in FIG. 2D, the channel 242 may be formed by a body 252 that is separable from the housing 244. For example, the housing 244 and the optical module 202 may form a reusable and / or changeable light component 250 connectable to a disposable component 252 including the light fiber 210, the tube 206, the channel 242, and / or the proximal connector 238. The reusable component 250 and the disposable component 252 may be configured to be releasably secured with a mechanical and / or magnetic attachment. For example, the disposable component 252 may be configured to be snapped into or onto the reusable component 250. The reusable component 250 and / or the disposable component 252 may have an opening and / or window 254 configured to be aligned when assembled to enable light transmission from the lens 228 to the light fiber 210.

[0057] In some embodiments, the light assembly 200 may embody other approaches to provide or generate light. In some embodiments, the light assembly 200 may include one or more of a wired power supply and / or a light guide. In some embodiments, the light 210 may include an elongated shaft having a light source at its distal end. For example, the shaft may be wired and the distal end may include an LED that is positioned at the distal end of the tube 206, as discussed herein. Moreover, in some embodiments, the light 210 may be configured to emit light at one or more points of the tube 206, and / or the light assembly 200 may include one or more fibers for generating light energy. Such additional structures can be used to identify locations of proximal and distal cannula ports, for example. Further, in an alternative or additional embodiment, an energy source can be self-contained (i.e., a battery) and / or be a generative structure or assembly such as a fluid turbine that runs off of flowing anesthetic with capacitive retention. Additionally or alternatively, the light assembly may have a power cord configured to connect to an external power source. In embodiments, a light assembly 200 may embody a compact light engine with minimized molded parts, as well as embodiments with mounted or affixed needles and cannulas. In one particular approach, the assembly mayinclude a light needle cannula with a light fiber bonded to a terminal tip.

[0058] As illustrated in Fig. 2E, the tube 206 may be integrated into the body 201. The integration of the tube 206 may remove a need for the light 210 to be placed by a user within the tube 206 prior to use. Furthermore, the integration of the hypotube 206 may lead to other options for light fiber attachment. In one such alternative approach, the light fiber may run along an outer surface of the tube 206 and be covered in a sleeve, such as a thin wall heat shrink material. Running the light 210 outside the tube 206 allows for the use of fibers near or greater than an internal diameter of the tube 206 and reduces an internal diameter lost to the light 210 for fluid to pass through the tube 206. For example, a fiber may fill the full inner diameter of the needle smaller needles impeding fluid flow. Running a fiber along the outer surface may allow for use of fiber diameters greater than inner diameters of tubes. The integration of the tube 206 may also provide an ability to customize the tube 206 to a desired application as standard off-the-shelf needles may not have ideal lengths or diameters for a particular procedure.

[0059] With reference to Fig. 2F, there is shown a method of using a light assembly. Here, as with each of the disclosed embodiments, a tube 206 of the light assembly 200 is shown advanced within tissue. Transillumination may be generated to provide one or more of positional and depth information. The transillumination may have a shape and / or size when the distal end of the tube 206 is positioned in a desired depth. As the distal end of the tube 206 is deeper in the skin, the transillumination may become smaller and more diffuse. The user may adjust the position of the tube 206 based on the transillumination until the transillumination has the intended shape and / or size. The intended injection may be with the distal end of the tube 206 positioned in a subcutaneous space to inject the material in the subcutaneous space. The subcutaneous space may be between about I mm to about 10 mm below a dermis. The method may include injecting an anesthetic into the dermis. The method may be used a method of separating septa to eliminate or reduce an appearance of cellulite, as disclosed in U.S. Pat. 11,974,767, the entire disclosure of which is incorporated herein by reference.

[0060] FIGS. 3A-B illustrate a third embodiment of a light assembly 300. The light assembly 300 may include a compact light engine 302 and a housing 304 formed from three molded parts to reduce part count and ease in assembly. The entire disclosure of the first andsecond embodiments (as discussed with reference to FIGS. 1 -2F) is incorporated herein by reference for sake of brevity, other than when otherwise indicated.

[0061] The housing 304 may have a proximal connector 310 and a distal connector 306. The proximal connector 310 may be configured to connect to a number of components including dual check valves, infiltration pump tubing, syringes or the like. The distal connector 306 may be configured to connect to a tube 308. The light engine 302 may include a resistor R, an optic component O and a fiber ferrule F through which a light fiber 312 is configured. The light engine 302 may be configured to reduce or eliminate light bleed or light shining through the light engine parts and becoming visible to a user. The use of opaque material can further limit or prevent the same. Additionally, light blocking tape can be employed where necessary, to create an additional light blocking layer between the housing 304 and lit components. In an alternative or additional embodiment, the light assembly 300 may include a constant current power source for an LED.

[0062] In some embodiments, as illustrated in FIG. 3A, the tube 308 may be integrated to the light assembly 300. As discussed above, the integration of the tube 308 may allow for flexibility in design of the length and size of the tube 308 and configuration of the light fiber 312. The user also does not need to either source or thread / attach a separate needle which thus adds to procedure efficiency and convenience. The tube 308 itself could be bonded or insert molded into the distal connector 306 in the form of a needle hub. As shown in Fig. 3B, a terminal end of a light fiber 312 can be positioned in a terminal end bevel 314 of the tube 308.

[0063] The light fiber 312 may be exposed through the opening in the tube 308 but does not extend past a distal tip of the tube 308 avoiding damage to the fiber 312 during use. In one specific approach, for maximum light output but avoiding damage to the fiber during use, a distal end of the light fiber 312 ends about 0.05 to 0.15 inches (1.27 to 3.81 mm) from the tip of the needle bevel on a standard needle. In other embodiments, with shallower or steeper bevels the distance is less than or greater than that range. Also, in one or more embodiments, the position of the distal and / or length of the fiber 312 can be adjusted by the user for light output based on needle variability, such as across cannula and needle brands and types.

[0064] The light assembly may include an opening at a tip of a tube through which fluid can pass, such as the distal opening in the needle bevel. Alternatively or additionally, thetube may embody side openings configured to allow for more diffuse infiltration of delivered fluids. Various hole patterns as described in FIGS. 4B-4D can also be formed in the needle to ensure efficient delivery of substances to target tissues.

[0065] FIGS. 4A-B illustrate a fourth embodiment of a light assembly 400. The entire disclosure of the first, second, and third embodiment (as discussed with reference to FIGS. 1- 3H) is incorporated herein by reference for sake of brevity, other than when otherwise indicated. The light assembly 400 may include an integrated tube 402. The tube 402 may be attached to a hub 404 of a light assembly housing 406. The tube 402 may have one or more openings 408 along its length. For example, the tube 402 may have a plurality of openings 408 along its length. A light fiber 410 may emit light through the tube 402 at different locations along its length through the openings 408. The tube 402 may additionally or alternatively be configured to release the medicament through the openings 408. The openings 408 may be provided along the entire length of the tube 402 or just a portion thereof.Moreover, the openings 408 may be arranged such that the openings 408 may extend around the entire circumference of the tube 402. Alternatively, the openings 408 may be provided along only a circumferential segment of the tube 402 (less than the entire circumference). For example, the openings 408 may be provided only along a 180 degree circumferential segment of the hypotube 402 directing the material (an anesthetic) to a dermis D, due to the fact that the dermis D contains most of the nerves on to which the anesthetic is going to act. The light fiber 410 may be bonded and configured to terminate at the tip of the tube 402. In one approach, the light fiber 410 can be polished after bonding if required.

[0066] Generally, controlling the locations and spacing of the openings 408 may allow the tube 402 to be optimized for a specific act of limited an anesthetic or other substance delivery. Given the typical delivery of anesthesia in the range of 50-250 ml / min, the openings 408 in the tube 402 may be sized such that pressure drop or loss from the start of the holes to a terminal end of the tube 402 is related, for example, so that each opening 408 is delivering about the same amount of anesthesia or other substance for a set flow rate. This can further allow for an efficient and even distribution. It can also be the case that all the openings 408 are of different sizes to facilitate a desire pressure drop.

[0067] In another aspect, any one of the light assemblies 100-400 of the present disclosure may be equipped with vibration energy capabilities. The introduction of a separatestimulus can limit, block, or mask the recognition of pain under a Gate Control Theory. Thus, the introduction of vibration can be used to block pain from a needle injection. To that end, a small vibrating motor 450 can be wired into a circuit 452 running or controlling a light engine of a light needle assembly. FIG. 5A represents a simplified circuit without a vibrating motor, and FIG. 5B illustrates a simplified circuit with the vibrating motor 450. In this regard, a tab or other actuator can be incorporated into the light needle assembly so that upon manipulation of the actuator, the vibration circuit is activated and the vibration motor is energized to create vibrations along the needle as desired. This vibration then reduces the perceived pain from the needle during an intervention.

[0068] Any one of the light assemblies 100-400 of the present disclosure may be used in a method of injecting a material. The method may include providing a body having a proximal connector, a distal connector, and a channel. The body may house a light source coupled to a proximal end of a light fiber wherein the light fiber extends out of the body through the distal connector. The method may include inserting a distal end of the light fiber into a proximal opening of a needle, positioning a distal end of the fiber at a bevel of the needle, and attaching the needle to the distal connector. The method may include attaching a source of the material to the proximal connector. The method may further include activating the light source, inserting the bevel of the needle through skin. The method may even further include visualizing light transilluminating through the skin; and injecting the material through the needle. The bevel of the needle may be positioned in a subcutaneous space to inject the material in the subcutaneous space. The subcutaneous space may be between about 1mm to about 10mm below a dermis. The distal end of the light fiber is positioned about 0.05 to 0.15 inches from a tip of the bevel of the needle.

[0069] While the present disclosure has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the disclosure. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present disclosure. All such modifications are intended to be within the scope of the present disclosure.

Claims

Claims:

1. A system comprising: a body having a proximal connector and a channel; a light attached to the body and extending through the channel, wherein the light is configured to provide transillumination through skin; and a tube defining a lumen, wherein the tube is configured to be connected to a distal portion of the body, and the light is configured to extend through the lumen, wherein the proximal connector is configured to connect to a fluid source, and the fluid source is configured to deliver a material through the channel and the lumen when the tube is connected to the distal portion of the body.

2. The system of claim 1, wherein the proximal connector is a female Luer connector.

3. The system of claim 1 or claim 2, wherein the tube is permanently attached to the body.

4. The system of claim 1 or claim 2, wherein the distal portion has a distal connector configured to releasably connect to the tube.

5. The system of claim 4, wherein the distal connector is a male Luer connector.

6. The system of at least one of the preceding claims, wherein the tube is a needle or a cannula.

7. The system of at least one of the preceding claims, wherein the tube has an opening, and an end of the light is configured to be disposed at the opening.

8. The system of claim 7, wherein the end of the light is within about from 1.27 to 3.81 mm from a tip of the tube.

9. The system of at least one of the preceding claims, wherein the tube has a bevel.

10. The system of claim 9, wherein an end of the light is laterally exposed through the bevel.11 . The system of at least one of the preceding claims, wherein the body has a housing with a chamber, and the light extends from the chamber into the channel.

12. The system of claim 11, further comprising a battery in the chamber.

13. The system of claim 11 or claim 12, further comprising a light source and a lens in the chamber, wherein the light is a light fiber, and the lens is configured to focus light emitted by the light source through the light fiber.

14. The system of at least one of the preceding claims, further comprising an actuator configured to activate the light.

15. The system of claim 14, wherein the actuator is a pull tab configured to interrupt a circuit between a battery and the light, and the battery is configured to supply power to the light when the pull tab is removed.

16. The system of at least one of the preceding claims, wherein the material is at least one of an anesthetic, a filler, deoxycholic acid, a biostimulator, a toxin, or a medicament.

17. The system of at least one of the preceding claims, further comprising the fluid source.

18. The system of claim 17, wherein the fluid source is a syringe.

19. A method of injecting a material, the method comprising: providing a body having a proximal connector, a distal connector, and a channel, the body housing a light source coupled to a proximal end of a light fiber, wherein the light fiber extends out of the body through the distal connector; inserting a distal end of the light fiber into a proximal opening of a needle; positioning the distal end of the light fiber at a bevel of the needle; attaching the needle to the distal connector; attaching a source of the material to the proximal connector; activating the light source; inserting the bevel of the needle through skin; visualizing light transilluminating through the skin; andinjecting the material through the needle.

20. The method of claim 19, wherein, after the insertion, the bevel of the needle is positioned in a subcutaneous space to inject the material in the subcutaneous space.

21. The method of claim 20, wherein the subcutaneous space is between about from 1 to about 10 mm below a dermis.

22. The method of at least one of claims 19-21, wherein the distal end of the light fiber is positioned about 1.27 to 3.81 mm from a tip of the bevel of the needle.

23. The method of at least one of claims 19-22, further comprising adjusting a position of the bevel of the needle based on the light transilluminating through the skin.

24. The method of at least one of claims 19-23, wherein the material is at least one of an anesthetic, a filler, deoxycholic acid, a biostimulator, a toxin, or a medicament.

25. An apparatus for use with a needle defining a lumen, the apparatus comprising: a body having a housing, a proximal connector, a distal connector, and a channel, wherein the proximal connector is configured to attach to a fluid source, the distal connector is configured to attach to the needle, and the fluid source is configured to deliver a material through the channel and the lumen; a light fiber attached to the body and extending through the channel, wherein the light fiber is configured to extend through the lumen of the needle; and a light source in the housing, wherein the light source is configured to emit light through the light fiber.

26. A light needle assembly system, comprising: a handle assembly; a needle; a light at an end of the needle, the light being configured to provide transillumination through skin; a reservoir configured to contain a fluid; and a fluid input configured to deliver the fluid through the needle.

27. The system of claim 26, further comprising a vibrating motor configured to vibrate the needle during insertion of the needle into the skin.

28. The system of claim 26 or claim 27, wherein the needle has a plurality of holes spaced axially along the needle.

29. The system of at least one of claims 26-28, wherein the light includes a light fiber.

30. The system of claim 29, wherein the light fiber is within the needle.

31. The system of claim 29, wherein the light fiber is outside of the needle.

32. The system of at least one of claims 29-31, wherein the light fiber is configured to be adjustable in length.

33. The system of at least one of claims 26-32, further comprising a hub configured to receive a syringe and / or pump input.

34. The system of at least one of claims 26-33, further comprising a battery and optics module, wherein the needle is incorporated into the battery and optics module.

35. The system of at least one of claims 26-34, further comprising a compact light engine.

36. The system of at least one of claims 26-35, wherein, based on a brightness and / or shape of the transillumination, a user can be informed of a location and / or depth of a tip of the needle or other portion of the light.

37. The system of at least one of claims 26-36, wherein the fluid is at least one of a filler, a deoxy cholic acid, a biostimulator, a toxin, a medicament, an extracellular matrix, and / or an allograft.

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