Patent Application
20210220014
This application relates to endoscopes and injection needles, or processes specially adapted or intended to be used for evaluating, examining, or treating human or animal bodies for medical purposes.
In medical treatments by injection of stem cells, platelet enriched plasma treatments, exosomes, and similar biologicals, it is known to position an injection needle based on ultrasound and the physician's knowledge of human anatomy, and inject the biological into the general region of the pathology. The injected biological then marshals the body's own healing systems to repair the pathology.
In general, in a first aspect, the invention features an injection needle. The needle has a point designed to pierce flesh of a living body, and has a fluid passage therethrough designed for delivery of a therapeutic agent at a delivery site within the body, the delivery site to be reached by piercing at which an injection fluid is to be delivered via the fluid passage. The outer diameter of the needle is no more than about 2.1 mm. Solid state illumination circuitry and an imaging sensor are designed to provide illumination and imaging, and are mounted within supporting structure designed to support the illumination circuitry and imaging sensor within the needle arranged for illuminating and viewing the delivery site reached by piercing.
In general, in a second aspect, the invention features a method. A patient is pierced with a needle. The needle has a point designed to pierce flesh of a living body, and having a fluid passage therethrough designed for delivery of a therapeutic agent at a delivery site within the body, the delivery site to be reached by piercing is a site at which an injection fluid is to be delivered via the fluid passage, the outer diameter of the needle being no more than about 2.1 mm. The needle surrounds solid state illumination circuitry and an imaging sensor designed to provide illumination and imaging, mounted within supporting structure designed to support the illumination circuitry and imaging sensor within the needle arranged for illuminating and viewing flesh ahead of the point of the needle during the piercing. When the point of the needle reaches the delivery site, insufflation fluid is passed through a passage of the needle to inflate a cavity at the delivery site. The supporting structure is extended forward through the needle, sufficiently to create a field of view for the imaging sensor wider than the field of view available during the piercing. The imaging sensor and illumination circuitry are rotated around a longitudinal axis of the needle, a rotation or orientation sensor rotationally affixed to the imaging sensor being designed to produce a signal that encodes angular rotation of the image sensor. The video from the image sensor and the encoded angular rotation signal are processed together in image-righting circuitry to compute a corrected video signal that corrects the video signal for rotation to present a video signal consistently oriented relative to a frame of reference of a user of the injection needle.
Embodiments of the invention may include one or more of the following features. These features may be used singly, or in combination with each other. The image sensor may have an axis of view offset from the axis of the needle. The image sensor may be mounted within the supporting structure with its axis of view offset from the axis of the needle. The image sensor may be mounted within the supporting structure with the camera's axis of view parallel to the axis of the needle. A lens may be designed and mounted within the supporting structure to refract an image received by the image sensor off the axis of the needle. The angle of offset may desirably be between about 25° and about 35°, or between about 65° and about 75°. Two or more supporting structures may be designed to support imaging sensors so as to provide different angles of offset for the imaging sensors' fields of view relative to the axis of the needle. A rotation or orientation sensor may be designed to produce a signal that encodes angular rotation of the image sensor. Circuitry may be designed to receive the encoded angular rotation signal and a video signal from the image sensor, and to compute a corrected video signal that corrects the video signal for rotation to present a video signal consistently oriented relative to a frame of reference of a user of the injection needle. Wireless transmission circuitry may be designed to transmit video signal from the imaging sensor to a display monitor without transmission wires connected to the injection needle. One or more reservoirs may be designed of hold insufflation fluid. Controls may be designed to administer the fluid without fluid tubes flowing externally to the injection needle. A piercing point distal from the imaging sensor may be designed to pierce flesh and to simultaneously provide protection to the imaging sensor from the flesh and its fluids, and to allow an image of the flesh to reach the imaging sensor. The outer diameter of the needle may desirably be no more than about 1.66 mm, no more than about 1.28 mm, no more than about 0.91 mm, no more than about 0.82 mm. A proximal portion of a handle may have electronics for drive of the illumination circuitry and to receive imaging signal from the imaging circuitry, the proximal handle portion being designed to permit sterilization between uses. A joint between the proximal handle portion and the needle and supporting structure may be designed to separably connect the needle and supporting structure to the proximal handle portion. The joint may permit removal of the supporting structure for disposal and replacement. The joint, when connected, may be designed to provide mechanical force transfer between a surgeon's hand to the needle, and electrical connectivity between the proximal handle circuitry and the illumination circuitry and imaging sensor. The supporting structure may be slideable within the needle to permit the imaging stricture to be retracted behind the point during the piercing, and to be extended beyond the point to obtain a wider field of view. The patient may be human or animal.
The above advantages and features are of representative embodiments only, and are presented only to assist in understanding the invention. It should be understood that they are not to be considered limitations on the invention as defined by the claims. Additional features and advantages of embodiments of the invention will become apparent in the following description, from the drawings, and from the claims.
Referring to
Among the advantages that may be realized are the following. The techniques and apparatus may be useful for cartilage resurfacing, placement of stem cells to regenerate some tissue (such as pancreas or liver cells), foster bone or marrow regeneration, and the like. The technique and apparatus may improve a physician's ability to deliver biologic agents at the site of pathology. This may allow for a greater concentration of proteins (biologic or synthetic) to be delivered at the pathological site. The higher concentration of proteins may modulate and block inflammation, and deliver growth and healing factors to the site. More-precise delivery may reduce pain by blocking inflammation and reducing the distension/disruption of tissue caused by larger injection deliveries, his, in turn, may permit reduction in use of opioids, by an estimated 70%. More-precise delivery may permit delivery of proteins that can promote faster and more organized healing. In addition, greater signaling via exosomes may be sent to cells (induction), to obtain a longer therapeutic effect. The technique and apparatus, especially the small size and minimization of tissue damage, may reduce injury and improve healing, which may allow more procedures to be done as orthobiologic injection in the physician's office, rather than a surgical center, which may reduce costs. The needle tip 112, 122 may be designed to provide standard placement and provide a good field of view, via rotation about its roll axis, which may reduce tissue damage and pain to the patient. Various techniques for enhancing view through rotation are discussed in section IV below.
A typical injection of a biologic begins with a draw from the patient, to prepare an autologous injection. For example, a typical blood draw from a patient of 5-6 cc has about 5 million stem cells, approximately 900,000 stem cells per cc Those stem cells may be concentrated by centrifuging or other separation means.
Referring to
Referring to
Needle/scope 100 may be formed around a hollow metal shaft 110. At or near the tip may be an imaging camera 122. The tip 212 of the needle may be formed from a clear material in a roughly conical shape. Tip 212 may be sharpened to provide a cutting/penetrating tip 214. Rearwards of the cutting tip 214 may be LEDs 250 to provide illumination. Alternatively, an illuminating LED may be somewhat rearward, and light may be conveyed from the LED to the front 250 of the device through light fibers 252. A tube 242 for carrying injectable fluid 140 may end at an exit aperture 244 near the tip. Likewise, a tube for carrying insufflation and cleaning gas (which may be the same as the tube for injectable fluid, or different) may end at an exit aperture near the tip.
The needle may be of diameter of an injection needle, such as less than 2.1 mm (14 gauge), 1.6 mm (16 gauge), 1.47 mm (17 gauge), 1.27 mm (18 gauge), 1.07 mm (19 gauge), or 0.91 mm (20 gauge).
Smaller diameters may reduce pain. Smaller diameters may be especially important in arthroscopic surgery, where the working area between bones is confined, between hard structures such as bone and cartilage. An image sensor 122 that is 1 mm×1 mm has a diagonal dimension of 1.4 mm, leaving sufficient gaps around the four edges for fluid passages 134, 142. With the thickness of the walls of an injection needle, the outer diameter may end up at about 1.65 mm, about the same size as a 16 gauge needle.
Referring to
In some cases, the injection scope may have a passage for inflation by gas or saline 130. Carbon dioxide may be especially desirable as an inflation medium, because of its optical properties, it and it may create a dry environment to confine any tendency of the aqueous biologic agent to flow away. Carbon dioxide, nitric oxide, or another gas may be blown across the front of objective lens 124 of the scope for cleaning, and to blow away smoke and debris created by other instruments. The passage for insufflation gas 134 may be the same as the channel for passage of injection fluid 142, or may be separate.
In manipulating the delivery needle/cannula, it may be desirable to minimize off-axis movement. Forward piercing thrust on a single line is a necessary evil in any injection, but it is desirable to minimize sweep back-and-forth movement, or pitch/yaw bending/rotation. Only roll motion, rotation around the axis, is nondestructive to surrounding tissue. Several techniques may be used to enhance the available view through rotation, to reduce the surgeon's need for other, more-destructive motions.
IV.A. Angular Offset of Image Lens 226
Referring to
Referring to
IV.B. Image Righting
Referring to
In some cases, image processing unit may also correct for the effects of lens distortion.
IV.C. Reducing Tethering by Wireless Connection
The injection scope may be cordless/tetherless to improve a surgeon's ability to maneuver the injection scope. The injection scope may communicate image information to a base station imaging unit via a wireless connection, such as WiFi or Bluetooth. The image may be displayed on a display screen in the surgeon's field of view, driven by an image processing and control computer. Injection scope 100 may have a battery to supply power. The injectable fluid, typically 3 to 6 ccs, may be stored in a small reservoir. If insufflation 130 is by means of carbon dioxide, carbon dioxide may be supplied in a cartridge, for example a medical version of a conventional CO2 cartridge. 30 to 60 ccs of insufflation water or saline may be stored in an on board reservoir.
Reducing tethers may improve the surgeon's ability to rotate needle/scope 100, and may improve sterility by reducing cable flop and contact between nonsterile cables and the patient.
IV.D. Reducing Torque Mass by Reducing Rotational Moment
Referring to
It may be desirable to put as much of the mass of the battery, fluid reservoirs, and any remaining tethers in the stationary part of the scope. Of the mass that must rotate, it may be desirable to concentrate that mass on the axis of needle/scope 100, to reduce the rotational moment and “flopping” of any remaining cords.
V.A. Overview
Referring to
The disposable cap, as this distal-most portion of the handle, may serve as a mounting base for shafts 110, 120, and may disconnect from the remainder 472 of the handle. This disposable cap portion 470 (along with shafts 110, 120 and componentry inside) may be disposable.
Rotation collar 460 may have surface features to allow a surgeon to rotate the rotation collar 460 about the central axis of the handle, that is, about the roll axis of shafts 110, 120. During the injection procedure, insertion shaft 110, 120, disposable cap 470 and rotation collar 460 may be locked to rotate with each other, so that rotating rotation collar 460 effects rotation of the disposable cap 470 and shafts 110, 120.
Proximal stationary handle has a shell surrounding componentry within the handle. The outer diameter and outer surface of the handle may be designed to provide an easy and low-slip grip for a surgeon's hand. Joint 462 between the proximal handle and rotation collar may allow these two components to rotate relative to each other. In some cases, a circuit board and similar componentry inside proximal handle 472 may rotate with disposable cap 110, 120, 470 and rotation collar 460, inside proximal handle.
Disposable cap 110, 120, 470 and rotation collar 460 may be separable from each other at separation joint 474, so that disposable cap and shafts 110, 120, 470 may be disposable, while handle 472 and rotation collar 460 (and componentry inside them) are reusable.
At separation joint 474 between disposable portions 110, 120, 470 and the reusable portions 472 including rotation collar 472, three basic connections may be made:
One or more fluid hoses for injectable liquid or inflation gas (or two hoses, one for the injectable fluid and one for gas) may enter through disposable cap, so that the entire set of fluid tubing for the irrigation/inflation channel may be disposable with the disposable shaft portion. In other cases, a fluid hose may enter the proximal end of the scope, and disconnectable fluid connections within joint for fluid inflow and outflow may be effected by gaskets, O rings, and the like. Alternatively, connectors for the hoses may be outboard of needle/scope 100 itself, either near needle/scope 100 (for applications where it may be desirable to allow “quick change” replacement of the insertion shaft in the course of a single procedure), or far from needle/scope 100, typically at the receptacle for waste fluid, to ease disposal of all hoses that are potentially contaminated by contact with the patient.
Disposable portion 110, 120, 470 may be designed to facilitate disposability of components that come into contact with bodily fluids. Because sterilization is often imperfect, patient safety may be improved by disposing of components that have come into contact with patient bodily fluids. To improve sterilizability, it may desirable to reduce componentry in the disposable component 110, 120 so that cost of the disposable component may be reduced, and to reduce surface features and crevices that may be difficult to sterilize. Thus, the lens, image sensor 122, illumination LED 250, panning mechanism, and shaft may be disposable. In addition, because shafts 110, 120 are used for fluid inflow and outflow, and are disposable, sealing against bodily fluids may be unnecessary.
Various replaceable components 110, 120, 470 may have different instruments at their tip. For example, various replaceable shafts may have cameras oriented at 0° (directly on-axis), 30°, 45°, 70°, and 90°.
Further features of a partially disposable, partially reusable device are described in U.S. Pub. No. 2019/0374095 A1, incorporated by reference
Shaft 110 may also carry power wires to the illumination LED and the camera, and carry signal wires that carry an optical signal back from the camera to electronics in the reusable portion 472 of the handle. Electrical power to the camera may be supplied over conductors in a flexible cable or on a printed circuit board (flexible or rigid), and insulated with a conformal and insulating coating such as parylene. This same flexible circuit board may have signal conductors for the video signal from the camera. The video signal may be transmitted from the camera to the handle using any video signal protocol, for example, MIN (Mobile Industry Processor Interface) or HDMI. Parylene may also improve biocompatibility.
Shaft 120 may also carry cables or other mechanical elements to control panning of the camera.
Referring to
If camera 122 is pannable or has other controllable features, there may be a control (for example, a lever, or a touch-slide panel, etc.) on the handle to control that adjustment of the camera.
Electrical connectors such as USB-C or mini-HDMI connectors may be used to connect the camera to a circuit board interior to the handle.
Rotation-locking coupling may lock disposable cap in rotational relationship to rotation collar. Various rigid and resilient features may lock them together for other forces and torques, and release buttons may permit them to disengage to allow replacement of disposable cap.
The reusable portion 472 may contain a number of components, typically components that have only incidental patient contact (and therefore present less risk of cross-infection), are higher in cost (and therefore desirably reusable), and either sterilizeable or may be covered by a sterility sleeve. For example, reusable portion 472 may hold power transformers, signal amplifiers, controls for the illumination LED and camera, a mechanical control for panning the camera, rotation sensors for righting of an image from the camera, and the like. The handle may also include connections to external sources and destinations of power, signal, fluid, and the like.
For clarity of explanation, the above description has focused on a representative sample of all possible embodiments, a sample that teaches the principles of the invention and conveys the best mode contemplated for carrying it out. The invention is not limited to the described embodiments. Well known features may not have been described in detail to avoid unnecessarily obscuring the principles relevant to the claimed invention. Throughout this application and its associated file history, when the term “invention” is used, it refers to the entire collection of ideas and principles described; in contrast, the formal definition of the exclusive protected property right is set forth in the claims, which exclusively control. The description has not attempted to exhaustively enumerate all possible variations. Other undescribed variations or modifications may be possible. Where multiple alternative embodiments are described, in many cases it will be possible to combine elements of different embodiments, or to combine elements of the embodiments described here with other modifications or variations that are not expressly described. A list of items does not imply that any or all of the items are mutually exclusive, nor that any or all of the items are comprehensive of any category, unless expressly specified otherwise. In many cases, one feature or group of features may be used separately from the entire apparatus or methods described. Many of those undescribed alternatives, variations, modifications, and equivalents are within the literal scope of the following claims, and others are equivalent. The claims may be practiced without some or all of the specific details described in the specification. In many cases, method steps described in this specification can be performed in different orders than that presented in this specification, or in parallel rather than sequentially, or in different computers of a computer network, rather than all on a single computer.
This application is a nonprovisional of U.S. Provisional application 62/962,987 filed Jan. 18, 2020, incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62962987 | Jan 2020 | US |
