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WO2025155944A1 - Dispositif d'administration opto-génétique et ses procédés d'utilisation - Google Patents

Dispositif d'administration opto-génétique et ses procédés d'utilisation

Info

Publication number
WO2025155944A1
WO2025155944A1 PCT/US2025/012249 US2025012249W WO2025155944A1 WO 2025155944 A1 WO2025155944 A1 WO 2025155944A1 US 2025012249 W US2025012249 W US 2025012249W WO 2025155944 A1 WO2025155944 A1 WO 2025155944A1
Authority
WO
WIPO (PCT)
Prior art keywords
fiber optic
optic cable
catheter
needle
fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/012249
Other languages
English (en)
Inventor
Robert Benkowski
Darryl Narcisse
Antonio Araujo
Michael Patterson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Opsin Biotherapeutics Inc
Original Assignee
Opsin Biotherapeutics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Opsin Biotherapeutics Inc filed Critical Opsin Biotherapeutics Inc
Publication of WO2025155944A1 publication Critical patent/WO2025155944A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3478Endoscopic needles, e.g. for infusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0601Apparatus for use inside the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/07Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0601Apparatus for use inside the body
    • A61N2005/0612Apparatus for use inside the body using probes penetrating tissue; interstitial probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/063Radiation therapy using light comprising light transmitting means, e.g. optical fibres
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • A61N5/062Photodynamic therapy, i.e. excitation of an agent

Definitions

  • One embodiment of the present disclosure includes a modular plug system including a plug housing including a top surface, bottom surface and two opposing side surfaces, a front end and an opening opposite the front end, and a cavity extending from the front end to the opening in the back end, and a load bar sized to engage the cavity in the modular plug, the load bar including two extensions on an upper surface of the load bar, the extensions sized to engage two openings in the top surface of the plug housing when the load bar is inserted into the cavity.
  • the fiber optic cable may include an inner core and a protective film around the inner core.
  • the protective film may be removed from the fiber optic cable before it is inserted into the catheter.
  • the fiber optic cable may be positioned in a first position that allows fluid to flow from the fluid delivery tube into the needle.
  • the fiber optic cable may have a diameter that allows fluid to flow around the fiber optic cable in the needle.
  • an FGNRs/Plasmid fluid may be injected through the fluid delivery tube.
  • the needle may be sized to accept the fiber optic cable without the protective film.
  • the fiber optic cable is sealed within a metallic tube that slides along the seals of the injection device allowing the fiber optic cable to move through the needle so the seals are not on the fiber optic cable, but instead on the metallic tube.
  • Another embodiment of the present disclosure includes a method of performing a gene treatment using a surgical catheter including the steps of inserting a fiber optic cable into a main tube connecting a first opening and a second opening in the catheter via the second opening, injecting a fluid into a patient through the main tube via a fluid delivery tube connected to the main tube and a needle connected to the first opening via a needle base unit, positioning the fiber optic cable in the needle after injection of the fluid, and pressing a button positioned near the fluid delivery tube to transmit light through the fiber optic cable.
  • Another embodiment includes the step of removing the protective film from the fiber optic cable before it is inserted into the catheter.
  • Another embodiment includes the step of positioning the fiber optic cable in a second position where the fiber optic cable extends through the main tube and the needle such that the end of the fiber optic cable extends past the end of the needle.
  • FIG. 5 depicts the inner core of the fiber optic cable in a first position in the catheter
  • FIG. 6 depicts the inner core of the fiber optic cable in a second position in the catheter.
  • FIG. 2 depicts a cut away side view of the catheter 100.
  • the fiber optic cable 110 enters into a channel 202 in the main tube 106 via an opening 204.
  • the fiber optic cable 110 is comprised of an inner core 206 made of a transparent material such as glass that is surrounded by an outer coating made of a solid material such as plastic or rubber.
  • the opening 204 is sized to accommodate the inner core 206 of the fiber optic cable 110 with the outer portion of the opening 204 sloping towards the channel 202 to form a guide 208 to guide the optical cable into the channel 202.
  • the channel 202 includes a material that creates a fluid tight seal with the fiber optic cable 110 inner core 206.
  • the channel 202 extends from the second end 104 to the first end 102 of the catheter 100.
  • the needle base unit 1 14 engages an opening 210 in the first end 102 of the catheter 100.
  • the needle base unit 114 has a threaded end that engages the threaded inner wall of the opening 210.
  • the needle base unit 114 is positioned in the opening 210 such that a needle channel 212 is concentric with the channel 202.
  • the needle channel 212 extends through the needle base unit 114 and through the needle 116 such that inner core 206 of the fiber optic cable 110 extends beyond the end of the needle 116.
  • the fluid delivery tube 108 is positioned at an angle theta (0) from the top surface of the main tube 106. In one embodiment, the angle theta (0) is forty -five degrees. In another embodiment, the angle (0) is less than forty -five degrees. In another embodiment, the angel (0) is greater than forty -five degrees and less than ninety degrees.
  • the fluid delivery tube 108 is secured to the main tube 106 by a support unit 214 that is connected to a lower surface of the fluid delivery tube 108 and a top surface of the main tube 106. In one embodiment, the edge of the support unit 214 furthest from the needle 216 is curved in a concave shape to accept the form of a finger.
  • the button 112 is positioned on the support unit 214 such that a user of the catheter may press the button during use of the catheter 100.
  • a tube channel 216 extends through the center of the needle delivery tube 108 along the entire length of the fluid delivery tube 108. The tube channel 216 extends into the channel 202 such that fluid may be delivered through the tube channel 216 and into the main channel 202 for insertion through the needle 116.
  • An injection unit 218 is positioned on the end of the fluid delivery tube 108 to allow for a syringe to inject fluid into the channel 202 for delivery by the needle 116.
  • FIG. 3 depicts an expanded view of the needle base unit 114 engaging the opening 210 in the first end 102 of the catheter 100.
  • the inner core 206 of the fiber optic cable 110 extends through the channel 202 and into needled channel 212.
  • the needle channel 212 is formed from the inner opening of the needle 116 that is sized to accommodate the inner core 206 of the fiber optic cable 110.
  • the needle 116 prevents light from being disbursed from the inner core 206 reducing the effectiveness of the fiber optic cable 210.
  • the needle base unit 114 includes a rim 302 that extends around the periphery of the portion of the needle base unit 114 that engages the opening 210.
  • the opening 210 includes threads 304 on the inner surface of the opening 210 that engage the rim 302 to secure the needle base unit 114 in the opening 210.
  • FIG. 5 depicts the inner core 206 of the fiber optic cable 110 in the first position in the catheter 100.
  • a fluid can be delivered through the fluid delivery tube 108 and channel 202 to the needle base unit 114 and needle 116.
  • the user of the catheter 100 moves the inner core 206 of the fiber optic cable 110 to the first position in the channel.
  • the user injects a fluid into the fluid delivery tube 108 with a force adequate to push the fluid into the channel 202 and through the needle base unit 114 and needle 116.
  • the fluid exits the needle 116 and enters the location for treatment in a patient’s body.
  • FIG. 6 depicts the inner core 206 of the fiber optic cable 110 in a second position in the catheter 100.
  • the inner core 206 of the fiber optic cable 110 extends through the channel 202 into the needle base unit 114 and through the needle 116.
  • the end 402 of the inner core 206 extends past the end of the needle 216 to allow the application of light onto the area previously injected with fluid.
  • the light passed through the inner core 206 operates at 620-750nm.
  • a mechanical stop is positioned inside the channel 202 to limit the movement of the fiber optic cable 110 between the first position and second position.
  • step 708 fluid is injected into the fluid delivery tube 108 with enough force to push the fluid through the fluid delivery tube 108 into the main channel 202 and through the needle 116.
  • step 710 the fluid is injected into the treatment area by the force created by the injection of the fluid into the fluid delivery tube 108.
  • the fiber optic cable 110 is moved into a second position.
  • the second position is a position where the end of the fiber optic cable 110 extends beyond the end of the needle 116.
  • the second position is a position where the fiber optic cable 110 is inside the needle, but allows for light to transmit out the open end of the needle 116 towards the treatment area.
  • the button 112 on the catheter is pressed and light is emitted out of the fiber optic cable 110 onto the treatment area.
  • the movement of the fiber optic cable 110 to the second position forces fluid remaining in the needle 116 out of the needle 116 and into the injection area.
  • light is transmitted through the fiber optic cable 110 simultaneously with the injection of fluid into the injection area such that the FGNRs assist the fluid in crossing a tissue barrier.
  • the process of moving the fiber optic cable 110 is automated such that the fiber optic cable 110 is moved to the first position and second position in a predetermined manner.
  • the transmission of the light is automated to turn on and off the light a predetermined amount of time after an injection is made into the patient.
  • the predetermined time is based on the type of material in the fluid, the length and type of FGNRs, the amount of light needed to enhance the injection, the amount of time for the fluid to disburse into the patient and the effects of the light on the patient after injection.
  • the automation of the injection prevents extended exposure to the light to avoid negative effects to the injection and burning of the injection location.
  • the catheter, including a surgical catheter comprises a fiber optic that is multi lumen.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Radiology & Medical Imaging (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention porte sur un cathéter chirurgical comprenant une première extrémité, une seconde extrémité, un tube principal reliant la première extrémité à la seconde extrémité, un tube de distribution de fluide relié au tube principal, un câble à fibres optiques s'étendant à partir de la seconde extrémité à travers le tube principal, un bouton positionné à proximité du tube de distribution de fluide et une unité de base d'aiguille dans la première extrémité ayant une aiguille s'étendant à travers l'unité de base d'aiguille dans le tube principal.
PCT/US2025/012249 2024-01-18 2025-01-18 Dispositif d'administration opto-génétique et ses procédés d'utilisation Pending WO2025155944A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463622295P 2024-01-18 2024-01-18
US63/622,295 2024-01-18

Publications (1)

Publication Number Publication Date
WO2025155944A1 true WO2025155944A1 (fr) 2025-07-24

Family

ID=96472024

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/012249 Pending WO2025155944A1 (fr) 2024-01-18 2025-01-18 Dispositif d'administration opto-génétique et ses procédés d'utilisation

Country Status (1)

Country Link
WO (1) WO2025155944A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010023346A1 (en) * 1999-05-04 2001-09-20 Cardiodyne, Inc. Method and devices for creating a trap for confining therapeutic drugs and/or genes in the myocardium
US20060211918A1 (en) * 2005-03-21 2006-09-21 Lieponis Jonas V Surgical instrument with integral optical system
US20150231287A1 (en) * 2013-10-29 2015-08-20 Ultraviolet Interventions, Inc. Systems and methods for sterilization using uv light
US20190275346A1 (en) * 2016-11-17 2019-09-12 Biodynamic Research Foundation Light radiating probe for photodynamic therapy employing endoscope

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010023346A1 (en) * 1999-05-04 2001-09-20 Cardiodyne, Inc. Method and devices for creating a trap for confining therapeutic drugs and/or genes in the myocardium
US20060211918A1 (en) * 2005-03-21 2006-09-21 Lieponis Jonas V Surgical instrument with integral optical system
US20150231287A1 (en) * 2013-10-29 2015-08-20 Ultraviolet Interventions, Inc. Systems and methods for sterilization using uv light
US20190275346A1 (en) * 2016-11-17 2019-09-12 Biodynamic Research Foundation Light radiating probe for photodynamic therapy employing endoscope

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