WO2022246248A1 - Détection de sang avec aiguille à ouverture latérale - Google Patents

Détection de sang avec aiguille à ouverture latérale Download PDF

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Publication number
WO2022246248A1
WO2022246248A1 PCT/US2022/030330 US2022030330W WO2022246248A1 WO 2022246248 A1 WO2022246248 A1 WO 2022246248A1 US 2022030330 W US2022030330 W US 2022030330W WO 2022246248 A1 WO2022246248 A1 WO 2022246248A1
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Prior art keywords
fiber optic
iron
opening
optic waveguide
hollow needle
Prior art date
Application number
PCT/US2022/030330
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English (en)
Inventor
Brian L. Norling
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Acies Medical Llc
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Publication date
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Publication of WO2022246248A1 publication Critical patent/WO2022246248A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/7703—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator using reagent-clad optical fibres or optical waveguides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N2021/7769—Measurement method of reaction-produced change in sensor
    • G01N2021/7786—Fluorescence
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/76—Chemiluminescence; Bioluminescence

Definitions

  • the present disclosure relates to the detection of tissues such as blood using a hypodermic needle and a sensor wherein the needle includes at least one side opening.
  • the intrathecal (or subarachnoid) space of the spinal region houses nerve roots and cerebrospinal fluid (CSF) and lays between two of the three membranes that envelope the central nervous system.
  • the outermost membrane of the central nervous system is the dura mater
  • the second is the arachnoid mater
  • the third, and innermost membrane is the pia mater.
  • the intrathecal space is in between the arachnoid mater and the pia mater.
  • a surgical instrument may need to first get through skin layers, fat layers, the interspinal ligament, the ligamentum flavum, the epidural space, the dura mater, the subdural space, and the intrathecal space. Additionally, in the case of a needle used to administer medication, the entire needle opening must be within the subarachnoid space.
  • spinal cord stimulation a form of minimally invasive spinal procedure wherein small wire leads can be inserted in the spinal epidural space
  • spinal cord stimulation may require that a 14-gauge needle be introduced into the epidural space in order to thread the stimulator lead. Needles of this gauge are technically more difficult to control, posing a higher risk of morbidity.
  • Complications can include dural tear, spinal fluid leak, epidural vein rupture with subsequent hematoma, and direct penetration of the spinal cord or nerves with resultant paralysis.
  • anesthetic agents have been used to allay or eliminate pain associated with invasive operations, i.e., oral and maxillofacial surgery.
  • the infratemporal fossa is a highly vascular area containing the largest artery of the external head, the maxillary artery, and its multiple named branches, as well as an extensive plexus of veins known as the pterygoid plexus.
  • a dentist faces the risk of intravascular injection.
  • An embodiment of the disclosed system for delivery of medical fluids may include a hollow needle that can have a straight shaft and a tapered end, wherein the hollow needle may include an inner diameter and an outer diameter; at least one opening in the straight shaft wherein the at least one opening is not within the tapered end; a fiber optic waveguide that can include a distal end and proximal end, wherein a diameter of the fiber optic waveguide may be less than the inner diameter of the hollow needle, and further wherein the distal end can be disposed within the hollow needle and may be positioned next to the at least one opening.
  • the embodiment may also include an iron- ion detecting substrate, wherein the iron-ion detecting substrate can be in fluidic communication with the at least one opening.
  • an iron-ion detecting substrate which may produce a signal via a luminescent, fluorescent, phosphorescent, or chemiluminescent reactions in the presence of iron ions, and further wherein the signal can be optically transmitted through the fiber optic waveguide to a detector, wherein the detector can be disposed at the proximal end of the fiber optic waveguide.
  • the iron-ion detecting substrate can be disposed on the distal end of the fiber optic waveguide, while at other times, the iron-ion detecting substrate can be disposed within an opening in the shaft.
  • the shaft may include more than one opening; in some cases, it may be two or more. Such embodiments with two openings may include openings that are opposite each other on the hollow needle's shaft.
  • inventions may include a fiber optic waveguide that has a distal end which can comprise a non-perpendicular face with an angle from about 15 degrees to about 60 degrees that may include a mirror coating disposed thereon.
  • the non perpendicular face at the distal end of the fiber optic waveguide can define a long side of the fiber optic waveguide, which then may include the iron-ion detecting substrate to be disposed thereon.
  • the long end may be disposed at an opening of the shaft wherein the opening includes an iron-ion detecting substrate disposed therein.
  • the hollow needle may include a support guide disposed therein, and wherein the support guide may include at least one or more channels.
  • a support guide may include a single channel that can be structured and configured to include a fiber optic waveguide.
  • there may be two channels, both of the channels may end at side-openings within the hollow needle, where one channel can include a fiber optic waveguide and a second channel can act as a fluid channel that may be capable of delivering medical fluids therethrough.
  • the system may include a hollow needle which may have a straight shaft and a tapered end, wherein the hollow needle can include a lumen; at least one opening may be present in the straight shaft; a fiber optic waveguide can have a distal end and proximal end, wherein the fiber optic waveguide can be structured and configured to fit within the lumen, and further wherein the distal end can be disposed within the hollow needle and may be positioned next to the at least one opening.
  • This embodiment may also include an iron-ion detecting substrate, wherein the iron-ion detecting substrate can be in fluidic communication with the at least one opening; and a detector may be disposed on the proximal end of the fiber optic waveguide, wherein the detector may be able to receive an optical signal produced via a luminescent, fluorescent, phosphorescent, or chemiluminescent reaction of the iron-ion detecting substrate.
  • an iron-ion detecting substrate disposed on the distal end of the fiber optic waveguide.
  • the shaft of the hollow needle may include two openings.
  • These embodiments may also include a fiber optic waveguide with a distal end that can comprise a non-perpendicular face with an angle of about 15 degrees to about 60 degrees, where a mirror coating can be disposed.
  • Such a non perpendicular face may also define a long side of the fiber optic waveguide, wherein the iron-ion detecting substrate may be disposed.
  • the iron-ion detecting substrate may be disposed next to the long end by the placement of the iron-ion detecting substrate within an aligned opening in the shaft.
  • a method of use of a system for delivery of medical fluids may include the steps of providing a hollow needle which may have a straight shaft and a tapered end, wherein the hollow needle can include a lumen.
  • the needle may also include at least one opening in the straight shaft, a fiber optic waveguide having a distal end and proximal end, wherein the fiber optic waveguide is structured and configured to fit within the, and further wherein the distal end can be disposed within the hollow needle and may be positioned next to the at least one opening.
  • the needle may also include an iron-ion detecting substrate, wherein the iron-ion detecting substrate can be in fluidic communication with the at least one opening, and a detector can be disposed on the proximal end of the fiber optic waveguide, wherein the detector may be capable of receiving an optical signal produced via a luminescent, fluorescent, phosphorescent, or chemiluminescent reaction of the iron-ion detecting substrate. Then the needle may be inserted into a patient's tissue, which then may be proceeded by the generation of an output from the detector that may correspond to the optical signal. This may all be followed by the step of the end-user removing or repositioning the hollow needle in response to the output.
  • a hollow needle having a support guide disposed within the hollow needle, where the support guide can have at least one channel therein, wherein the at least one channel may end at the at least one opening of the hollow needle.
  • a support guide where a channel may include a fiber optic waveguide positioned therein.
  • FIG. 1 is a cross-section view of an embodiment of a system for iron ion detection that includes a side-opening needle according to the present disclosure.
  • FIG. 2 is a cross-section view of another embodiment of the iron-ion detection system that includes a side-opening needle with two openings according to the present disclosure.
  • FIG. 3 is a cross-section view of another embodiment of the iron-ion detection system that includes a side-opening needle with an ion-detection substrate within a side-opening.
  • FIG. 4 is a cross-section view of another embodiment of the iron-ion detection system that includes a side-opening needle with a support guide according to the present disclosure.
  • FIG. 5A is a cross-section view of another embodiment of the iron-ion detection system that includes a side-opening needle with two openings and a support guide according to the present disclosure.
  • FIG. 5B is another cross-section view of the embodiment of FIG. 5A of the iron-ion detection system that includes a side-opening needle with two openings and a support guide according to the present disclosure.
  • FIG. 6 is a plan view of an embodiment of a system for iron-ion detection that includes a side-opening needle and a detector.
  • biomarker detector systems and methods used to detect biological substances, such as bodily fluids and tissues, including blood.
  • biomarker detector systems and methods are described in detail with reference to the drawings, wherein like reference numerals may represent like parts and assemblies throughout the several views.
  • Reference to various embodiments does not limit the scope of the biomarker detector disclosed herein. Additionally, any examples set forth in this specification are not intended to be limiting and merely set forth some of the many possible embodiments for the biomarker detector. It is understood that various omissions and substitutions of equivalents are contemplated as circumstances may suggest or render expedient, but these are intended to cover applications or embodiments without departing from the spirit or scope of the disclosure. Also, it is to be understood that the phraseology and terminology used herein are for the purpose of description and should not be regarded as limiting.
  • the present disclosure provides systems and methods structured, configured, and/or capable of detecting one or more biomarkers via the interaction(s) of the biomarkers with one or more detection materials, and the optical detection of said interaction(s).
  • the interaction of a biomarker with a detection material can result in a luminescent emission of light that can be sensed, with said sensing of luminescent light providing evidence of the interaction, and hence, the presence of the biomarker.
  • the emission of light can be an intrinsic chemiluminescent product of the interaction between the biomarker and the detection material.
  • illumination by an external light source of the detection material when in the presence of the biomarker, can result in a fluorescent or phosphorescent emission of light that can be sensed.
  • the present disclosure provides systems and methods that can provide detection of biomarkers via sensing of chemiluminescence, fluorescence, and/or phosphorescence.
  • iron ions Fe 2+
  • the iron serves as a catalyst for enabling the re-emission of absorbed radiation at a different frequency and is not consumed in a reaction.
  • the fluorescein molecule has a strong affinity and selectivity to iron ions, having two unshared electron pairs available for donation to a metal ion. Once the covalent bond occurs, the molecule gains the ability to fluoresce.
  • biomarker detection systems illustrated and described in the present disclosure include, or can be used in conjunction with, side-opening needles and fluid delivery systems
  • the applications of the disclosed biomarker detection systems and methods are not limited to fluid delivery applications.
  • medicinal fluids can be delivered through the disclosed fluid delivery systems.
  • Surgical needles have been designed to detect specific types of fluids such as, but not limited to, blood or interstitial fluid, and to notify a user upon detection of such fluids (see U.S. Pat. 10,470,712 (issued 2019-11-12), U.S. Pat App. 2022/0015635 (Pub. 2022-01-20), and PCT App. WO2021/133533 (Pub. 2021-07-01).
  • Fiber optic waveguides can be placed in the interior of hollow needles that are used in medical procedures.
  • the proper placement of the needles can be critical in the success of medical procedures such as surgical procedures on the nervous system (i.e., spinal surgery) or dental procedures.
  • the fiber optic waveguide can be used as part of a sensor system that can detect important biological structures. For example, when trying to inject an anesthetic into a patient in a dental setting, it can be desirable to avoid injecting the medication into a blood vessel which can cause negative, undesirable systemic reactions in a patient.
  • a fiber optic sensor in the injection needle can be a part of a detection system that detects iron ions (in blood, for example) and can indicate the improper placement of the needle. In this case, the needle can be relocated so that the anesthetic is properly injected.
  • spinal surgeons may want to locate various biological structures when placing a needle for the administration of a medicament. In these cases, the surgeon may wish to find spinal fluid or avoid other physiological structures.
  • a fiber optic detector can be placed into the needle, which can be part of a detection system that can identify biological tissues in contact with the needle opening.
  • the fiber optic waveguide can be much smaller than the needle bore and its lumen therein, allowing for the injection of fluids, such as medicaments, to flow past the fiber optic waveguide.
  • fluids such as medicaments
  • the entire needle bore can be filled with the fiber optic waveguide. In these cases, it can be necessary to retract or remove the fiber optic waveguide prior to the injection of fluids.
  • Hollow needles useful in anesthesiology are known to commonly have an opening in the point of the needle.
  • hollow needles having side openings are also known.
  • Side-opening needles can be useful for more precise placement of the opening through which medical fluids can be delivered to a patient.
  • a hollow needle having a side opening.
  • the side opening can contain iron-ion detectors, and the needle can be structured and configured to communicate the detection of iron ions to the user in order to enable avoidance of fluid delivery into the bloodstream. Therefore, hollow needles that include iron-ion detectors, such as fiber optic or electrical resistivity sensors, that can also deliver medicaments to a patient, are desirable.
  • the key challenge with side-opening needles, compared to needles that are open at their tips, can be that it is harder to obtain fresh bodily fluids, such as blood, at the same location in the needle as the iron-ion detection sensor.
  • the efficiency of a fluidic communication from the needle's exterior through the side opening and then continued with the iron-ion sensor may depend on the placement of the iron-ion detector in relation to the side opening. This may be critical in embodiments where the iron-ion detector is disposed on the distal end of a fiber optic waveguide.
  • the embodiments described herein offer multiple solutions to improve fluidic communication from the exterior of a side-opening needle to the iron-ion sensor that may provide enhanced signal conduction via the fiber optic waveguide.
  • FIGS. 1-6 illustrate various embodiments of an iron-ion detection system with a side-opening needle.
  • FIG. l is a cross-section view of one embodiment of the iron- ion detection system.
  • FIG. 2 is a cross-section view of another embodiment of the iron-ion detection system.
  • FIG. 3 is a cross-section view of another embodiment of the iron-ion detection system.
  • FIG. 4 is a cross-section view of another embodiment of the iron-ion detection system.
  • FIG. 5A is a cross-section view of another embodiment of the iron-ion detection system.
  • FIG. 5B is another cross-section view of the embodiment of FIG. 5A of the iron-ion detection system.
  • FIG. 6 is a plan view of an embodiment of the iron-ion detection system.
  • FIG. 1 is a cross-section view of one embodiment of the iron-ion detection system and illustrates an iron-ion detection system 100 that includes a side-opening needle.
  • fiber optic waveguide 200 can reside within the inner diameter or lumen of a hollow needle 300.
  • the fiber optic waveguide 200 illustrated in FIG. 1 can include a non-perpendicular face 220 at its distal end 210, wherein the distal end 210 is the end closest to the tip of the hollow needle 300, and the non-perpendicular face 220 may have a mirror coating on its surface and may allow for one edge of the fiber optic waveguide 200 to be longer than an opposite edge.
  • the hollow needle 300 may have a straight shaft 320 and may include an opening 330 within the straight shaft 320.
  • Hollow needle 300 may further include a tapered end 310 at its distal end.
  • the fiber optic waveguide 200 may be positioned within the hollow needle 300 such that the longer edge (as defined by the non-perpendicular face 220) can be disposed next to the opening 330 allowing for fluidic communication to be possible between the fiber optic waveguide 200 and the opening 330.
  • the fiber optic waveguide 200 may also include an iron-ion detecting substrate 230 disposed on the longer edge that may also be in fluidic communication with the opening 330.
  • the iron-ion detection system 100 may be able to detect iron ions when the hollow needle 300 is inserted into a tissue of a patient. If, during the insertion, blood is released from a patient's blood vessel, a visual signal may be generated based on the reaction of the iron-ion detecting substrate 230. Such visual signals may arise from a luminescent, fluorescent, phosphorescent, or chemiluminescent reaction between the blood and the iron-ion detecting substrate 230.
  • the light produced by the reaction between the blood and the iron-ion detecting substrate 230 may be transmitted toward the non-perpendicular face 220 (see vertical arrows pointing from iron-ion detecting substrate 230 toward the non-perpendicular face 220).
  • the non-perpendicular face 220 may have a mirror coating on its surface, which can reflect the light that is produced by the reaction between the blood and the iron-ion detecting substrate 230.
  • the non-perpendicular face 220 may be an angle of at least 15 degrees to an angle of at most 60 degrees. Therefore, such an angle may allow for the efficient transfer of a reflected signal.
  • the signal may then travel from the iron-ion detecting substrate 230, reflect off the non-perpendicular face 220, and travel down the fiber optic waveguide 200, as illustrated by the left-facing arrows 240 in FIG. 1.
  • the iron-ion detecting substrate 230 may be further stimulated via an illumination by an external light source.
  • This light source may be generated from a detector, such as the detector illustrated in FIG. 6, that can be connected to the proximal end of fiber optic waveguide 200, wherein the proximal end of fiber optic waveguide 200 is the end furthest from the tip of the hollow needle 300.
  • Such a detector may also be able to produce an output signal to an end-user that corresponds to the signal generated from the reaction between the iron-ion detecting substrate 230 and a patient's blood. If no signal is produced, then the fiber optic waveguide 200 may be removed from the lumen of the hollow needle 300 allowing for the passage of medical fluids.
  • FIG. 2 illustrates another embodiment of the iron-ion detection system 400 that includes a side-opening needle according to the present disclosure.
  • the hollow needle 600 can include a first opening 630 and a second opening 640 within the needle's straight shaft 620.
  • the hollow needle 600 may also include a tapered end 610.
  • Fiber optic waveguide 500 may include a perpendicular face 520 at its distal end 510, wherein the distal end 510 is the end of the fiber optic waveguide 500 that is closest to the tip of the hollow needle 600.
  • neither side of the fiber optic waveguide 500 may be longer than the other as the perpendicular face 520 can be at a 90-degree angle, leaving the distal end 510 perpendicular to the length of the fiber optic waveguide 500.
  • the distal end 510 of the fiber optic waveguide 500 may be coated with an iron-ion detecting substrate 530.
  • the iron-ion detecting substrate 530 may be in fluidic communication with the exterior of the hollow needle 600 via either the first opening 630, the second opening 640, or both. This may improve the ability of the iron-ion detecting substrate 530 to readily interact with any blood or iron-ion containing fluids once the hollow needle 600 is inserted into a patient's tissue.
  • the embodiment illustrated in FIG. 2 does not include a mirror coating since the production of the light signal occurs on a flat face of the distal end 510 of the fiber optic waveguide 500.
  • an embodiment of an iron-ion detection system may include two openings in a needle's shaft as well as an angled fiber optic waveguide, in which case a mirror coating may be used to help guide the visual signal down the fiber optic waveguide.
  • a signal may then travel from the iron-ion detecting substrate 530 down the fiber optic waveguide 500.
  • the signal as described in the earlier embodiment, may be generated from the iron-ion substrate reacting with iron ions within a tissue.
  • the signal may be light that travels down the fiber optic waveguide.
  • the iron-ion detecting substrate 530 may be further stimulated via an illumination by an external light source. This light source may be generated from a detector, such as the detector illustrated in FIG. 6, that can be connected to the proximal end of fiber optic waveguide 500, wherein the proximal end of fiber optic waveguide 500 is the end furthest from the tip of the hollow needle 600.
  • Such a detector may also be able to produce an output signal to an end-user that corresponds to the signal generated from the reaction between the iron-ion detecting substrate 530 and a patient's blood. If no signal is produced, then the fiber optic waveguide 500 may be removed from the lumen of the hollow needle 600 allowing for the passage of medical fluids.
  • FIG. 3 illustrates another embodiment of the iron-ion detection system 700.
  • the hollow needle 900 may include at least two openings within the straight shaft 920 of hollow needle 900, where a first opening 930 may include an iron-ion detecting substrate 932 that is held in place with a transparent structure disposed within the first opening 930.
  • the second opening is not illustrated herein, but may be similar in configuration to the embodiment illustrated in FIG. 2.
  • Other second openings have been contemplated where the second opening may be in a nonsymmetrical relationship to the first opening 930.
  • a fiber optic waveguide 800 can reside within the lumen of hollow needle 900 in the same manner as the embodiment of iron-ion detection system 100.
  • the fiber optic waveguide 800 may include a non-perpendicular face 820 at its distal end 810, wherein the distal end 810 is the end of the fiber optic waveguide 800 that is closest to the tip of the hollow needle 900 and may have a mirror coating on its surface.
  • the non-perpendicular face 820 may be an angle of at least 15 degrees to an angle of at most 60 degrees; such an angle may allow for the efficient transfer of a reflected visual signal that is produced by the interaction between the blood and the iron-ion detecting substrate 932.
  • the visual signal may be produced by the iron-ion detecting substrate 932, and portions of this signal may transmit towards the non-perpendicular face 820 of the fiber optic waveguide 800, as illustrated by the left-facing arrows.
  • the visual signal can then be reflected by a mirror coating on the non perpendicular face 820 (similar to the embodiment in FIG. 1 described above) and may then travel down the fiber optic waveguide 800, as illustrated by the downward-facing arrows 840 in
  • the iron-ion detecting substrate 932 may be further stimulated via an illumination by an external light source.
  • This light source may be generated from a detector, such as the detector illustrated in FIG. 6, that can be connected to the proximal end of fiber optic waveguide 800, wherein the proximal end of fiber optic waveguide 800 is the end furthest from the tip of the hollow needle 900.
  • a detector may also be able to produce an output signal to an end-user that corresponds to the signal generated from the reaction between the iron-ion detecting substrate 932 and a patient's blood. If no signal is produced, then the fiber optic waveguide 800 may be removed from the lumen of the hollow needle 900 allowing for the passage of medical fluids.
  • the iron-ion detection system 1000 may include a support-guide 1240 that is disposed within the lumen of the hollow needle 1200.
  • the support-guide 1240 may be structured and configured to align the distal end of a fiber optic waveguide 1100 with an opening 1230 in the straight shaft 1220 of hollow needle 1200, wherein the distal end is the end of the fiber optic waveguide 1100 that is closest to the tip of the hollow needle 1200.
  • the fiber optic waveguide 1100 may include a non-perpendicular face 1120.
  • the support-guide 1240 may be produced with an injection-molding process with materials currently known in the art.
  • the hollow needle 1200 may include a tapered end 1210.
  • the distal end of the fiber optic waveguide 1100 may have an iron-ion detecting substrate 1110 disposed thereon.
  • the fiber optic waveguide 1100 may be utilized without a mirrored surface to guide a visual signal generated from the iron-ion detecting substrate 1110 down the fiber optic waveguide 1100.
  • the generated visual signal may be a result of the luminescent, fluorescent, phosphorescent, or chemiluminescent light produced by the interaction between blood and the iron-ion detecting substrate as described above.
  • the iron- ion detecting substrate 1110 may be further stimulated via an illumination by an external light source. This light source may be generated from a detector, such as the detector illustrated in FIG.
  • Such a detector may also be able to produce an output signal to an end-user that corresponds to the signal generated from the reaction between the iron-ion detecting substrate 1110 and a patient's blood. If no signal is produced, then the fiber optic waveguide 1100 may be removed from the support-guide 1240 and the lumen of the hollow needle 1200, allowing for the passage of medical fluids.
  • the iron-ion detection system 1300 may include a support-guide 1600 that is disposed within the lumen of the hollow needle 1500.
  • FIG. 5 A is a top view that shows the openings 1530 and 1540 within the shaft 1520 along the side of the hollow needle 1500 with support guide 1600 therein.
  • FIG. 5B shows the same hollow needle 1500 but from the right side and illustrates the fluid channel 1550, which can run along the right side on the hollow needle 1500 and within the support guide 1600.
  • the support- guide 1600 may be comprised of an injection-molded material.
  • the support-guide 1600 may include two channels, a first channel wherein the fiber optic waveguide 1400 may be disposed, and a second channel that can act as a fluid channel 1550.
  • Each channel may include an end that can be aligned with separate openings in the straight shaft 1520 of hollow needle 1500.
  • the first channel with the fiber optic waveguide 1400 disposed therein may run along a first side of the hollow needle 1500 and may be aligned with a first opening 1530 that is on a second, opposite side of the hollow needle 1500.
  • the fiber optic waveguide 1400 may be primarily located along one side of the needle until it is within the proximity of the first opening 1530, at which time it crosses over to the opposite side of the hollow needle 1500.
  • Such an alignment may allow the iron-ion detecting substrate 1430, which can be located upon the end of fiber optic waveguide 1400, to be in fluidic communication with the opening 1530.
  • the fiber optic waveguide 1400 may include a non-perpendicular face 1420.
  • the iron- ion detection system 1300 may include an iron-ion detecting substrate 1430 that can be disposed within the opening 1530, similar to the embodiment described above and shown in FIG. 3. This configuration may allow signal generation to propagate down the fiber optic waveguide 1400 as the distal end of fiber optic waveguide 1400 can be aligned with the opening 1530, wherein the distal end is the end of the fiber optic waveguide 1400 that is closest to the tip of the hollow needle 1500.
  • the iron-ion detecting substrate 1430 can generate a visual signal when it reacts with iron ions from a patient's blood.
  • the visual signal may arise from a luminescent, fluorescent, phosphorescent, or chemiluminescent reaction between the blood and the iron-ion detecting substrate 1430, and the light produced by the reaction between the blood and the iron- ion detecting substrate 1430 may be transmitted down the fiber optic waveguide 1400.
  • a second opening 1540 may be on the first side of the hollow needle 1500 and may be in alignment with the end of the fluid channel 1550, which can run along the second, opposite side of the hollow needle 1500.
  • the fluid channel 1550 may be primarily located along one side of the needle until it is within the proximity of the second opening 1540, at which time it crosses over to the opposite side of the hollow needle 1500. In such a configuration, where there are two channels, there may be no need to remove the fiber optic waveguide 1400 from the system for iron-ion detection 1300 as the fluid channel 1550 can allow passage of medical fluids from the lumen of hollow needle 1500 through the opening 1540 even while the fiber optic waveguide 1400 is within the hollow needle 1500.
  • FIG. 6 illustrates an overview example of an iron-ion detection system 1700 where at least a fiber optic waveguide 1800 can have a distal end within a hollow needle, and the proximal end can be attached to a detector 2000, wherein the proximal end of fiber optic waveguide 1800 is the end furthest from the tip of the hollow needle.
  • a detector 2000 may be capable of receiving a signal from the system for iron-ion detection 1700 and producing an output signal for an end- user.
  • This output signal may be visual or auditory such as, but not limited to, a number on an output display, a light, a sound, a notification, a hepatic, and combinations thereof.
  • embodiments may comprise fewer features than illustrated in any individual embodiment described by example or otherwise contemplated herein.
  • Embodiments described herein are not meant to be an exhaustive presentation of ways in which various features may be combined and/or arranged. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the relevant arts. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.

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  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne des systèmes et des procédés pour distribuer des fluides médicaux qui peuvent avoir une aiguille creuse, l'aiguille creuse pouvant comprendre des ouvertures latérales à l'intérieur de son arbre. Dans la lumière de l'aiguille, un guide d'ondes à fibre optique peut être disposé. De tels guides d'ondes à fibres optiques peuvent comprendre une variété d'angles découpés au niveau de l'extrémité distale. L'extrémité distale peut, à son tour, être située à côté d'une ouverture latérale à l'intérieur de l'arbre de l'aiguille. L'extrémité distale, ou l'ouverture, peut comprendre un substrat de détection d'ions ferreux, qui peut être capable de produire un signal par l'intermédiaire d'une réaction luminescente, fluorescente, phosphorescente ou chimioluminescente en présence d'ions ferreux. Le signal provenant du substrat de détection d'ions ferreux peut circuler à travers le guide d'ondes à fibres optiques jusqu'à une extrémité proximale qui peut être intégrée à un détecteur pour fournir une rétroaction à un utilisateur.
PCT/US2022/030330 2021-05-21 2022-05-20 Détection de sang avec aiguille à ouverture latérale WO2022246248A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5460182A (en) * 1992-09-14 1995-10-24 Sextant Medical Corporation Tissue penetrating apparatus and methods
US20080091104A1 (en) * 2006-10-12 2008-04-17 Innoscion, Llc Image guided catheters and methods of use
US20150057530A1 (en) * 2012-03-30 2015-02-26 Koninklijke Philips N.V. Medical needle
US20170173275A1 (en) * 2014-06-25 2017-06-22 Massachusetts Institute Of Technology Optical sensor for needle-tip tissue identification and diagnosis
WO2020106555A1 (fr) * 2018-11-21 2020-05-28 Sipple Medical, Llc Systèmes et procédés de détection destinés à des dispositifs médicaux

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5460182A (en) * 1992-09-14 1995-10-24 Sextant Medical Corporation Tissue penetrating apparatus and methods
US20080091104A1 (en) * 2006-10-12 2008-04-17 Innoscion, Llc Image guided catheters and methods of use
US20150057530A1 (en) * 2012-03-30 2015-02-26 Koninklijke Philips N.V. Medical needle
US20170173275A1 (en) * 2014-06-25 2017-06-22 Massachusetts Institute Of Technology Optical sensor for needle-tip tissue identification and diagnosis
WO2020106555A1 (fr) * 2018-11-21 2020-05-28 Sipple Medical, Llc Systèmes et procédés de détection destinés à des dispositifs médicaux

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