WO2019226745A1 - Systèmes et procédés d'administration de thérapie pour dispositifs médicaux pouvant être commandés intra-corporels miniaturisés - Google Patents

Systèmes et procédés d'administration de thérapie pour dispositifs médicaux pouvant être commandés intra-corporels miniaturisés Download PDF

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Publication number
WO2019226745A1
WO2019226745A1 PCT/US2019/033476 US2019033476W WO2019226745A1 WO 2019226745 A1 WO2019226745 A1 WO 2019226745A1 US 2019033476 W US2019033476 W US 2019033476W WO 2019226745 A1 WO2019226745 A1 WO 2019226745A1
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WO
WIPO (PCT)
Prior art keywords
therapy
therapy delivery
medical device
delivery system
devices
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.)
Ceased
Application number
PCT/US2019/033476
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English (en)
Inventor
Christopher J.P. Velis
Matthew P. Palmer
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Individual
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Individual
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Publication of WO2019226745A1 publication Critical patent/WO2019226745A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/07—Endoradiosondes
    • A61B5/073—Intestinal transmitters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments 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
    • A61B1/04—Instruments 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 combined with photographic or television appliances
    • A61B1/041—Capsule endoscopes for imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/0618—Psychological treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1002—Intraluminal radiation therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1014—Intracavitary radiation therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0093—Detecting, measuring or recording by applying one single type of energy and measuring its conversion into another type of energy
    • A61B5/0095—Detecting, measuring or recording by applying one single type of energy and measuring its conversion into another type of energy by applying light and detecting acoustic waves, i.e. photoacoustic measurements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A61N2005/0604—Lungs and/or airways
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A61N2005/0605—Ear
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A61N2005/0606—Mouth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A61N2005/0607—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A61N2005/0608—Rectum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A61N2005/0609—Stomach and/or esophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A61N2005/061—Bladder and/or urethra
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A61N2005/0611—Vagina

Definitions

  • the present invention relates generally to miniaturized intra-body controllable medical devices. More specifically, the invention relates to intra-body medical devices having a therapy system.
  • the intra-body controllable medical devices may have a propulsion system, a deployment system, a control system, a power supply system, an intra- device storage system, an imaging system, a sample and data gathering system, and/or a material dispensing system.
  • These devices may be externally controllable or may be fully autonomous. They may communicate via a tether or may communicate wirelessly. The devices may work independently or work together in a group. Further, the invention includes materials and methods for using an intrabody controllable medical device for therapy delivery.
  • Natural orifices include the nostrils, mouth, ear canals, nasolacrimal ducts, anus, urinary meatus, vagina, and nipples.
  • the lumens include the interior of the gastrointestinal tract, the pathways of the bronchi in the lungs, the interior of the renal tubules and urinary collecting ducts, the pathways of the vagina, uterus, and fallopian tubes. From within these orifices and lumens, physicians can create an incision to gain access to almost any region of the body.
  • Laparoscopic procedures allow the physician to use a small“key-hole” surgical opening and specially designed instruments to gain access to regions within the body. Initially, laparoscopic instruments were linear in nature, and required a straight obstruction free“line-of-sighf’ to access regions of the body. Endoscopic procedures allow the physician to access regions of the digestive system by passing flexible instruments through either the mouth or rectum. [0005] Recently, physicians have begun to control these instruments using robots. These robots are typically connected in master/slave configuration, where the robot translates the physician’s movements into instrument movements. Robotic controls have also allowed for the advent of flexible laparoscopic instruments. Medical robots still require a physician to be actively controlling the movements and actions of the devices being controlled and require large expensive capital equipment and dedicated operating room spaces.
  • pill capsules have been invented that allow for a patient to ingest the capsule and as it passes through the digestive system takes pictures. There are no means for: controlling the motion of these devices, tracking or controlling the orientation, speed or location of these devices, accurately knowing where pictures were taken, and performing any type of surgical procedure or delivering therapy.
  • the medical device for intra-body conveyance.
  • the medical device includes a host structure and one or more therapy delivery systems.
  • the therapy delivery system includes optical-coherence tomography (OCT) guided laser instruments, radiation discharging sources, chemotherapy deploying devices, pharmaceutical and drug deploying devices, and/or photodynamic therapy devices.
  • OCT optical-coherence tomography
  • the host structure includes a clinically inert material, a sterilizable material, an elastomeric material, a chemically reactive material, a chemically inert material, a disintegrable material, a dissolvable material, a collapsible material and a material having physical and/or chemical properties to withstand exposure to bodily fluids for a predetermined period of time.
  • the therapy delivery systems are configured to travel through a body lumen to provide therapy.
  • the therapy delivery systems are configured to be discharged from the host structure while in the lumen and deposited in a predetermined location in the lumen for ongoing therapy delivery.
  • the therapy delivery systems include a storage medium configured to record a time, a duration and/or a location of a therapy delivery.
  • a method for using the medical device and providing the therapy is disclosed herein.
  • the method is directed to use in a gastro/intestinal tract, use in urology applications, use in a lung, use in a bladder, use in a nasal system, use in a reproductive system, use in performing Transurethral Resection of Bladder Tumors (TURBT), use in Transurethral Resection of the Prostate (TURP), use in trans rectal prostate ultrasound, biopsy, and/or radiation treatment.
  • TURBT Transurethral Resection of Bladder Tumors
  • TURP Transurethral Resection of the Prostate
  • a method of providing therapy utilizing a medical device for intra- body conveyance includes a host structure and one or more therapy delivery systems.
  • the host structure includes a clinically inert material, a sterilizable material, an elastomeric material, a chemically reactive material, a chemically inert material, a disintegrable material, a dissolvable material, a collapsible material and/or a material having physical and chemical properties to withstand exposure to bodily fluids for a predetermined period of time.
  • the therapy delivery system includes optical-coherence tomography (OCT) guided laser instruments, radiation discharging sources, chemotherapy deploying devices, pharmaceutical and/or drug deploying devices, and photodynamic therapy devices.
  • OCT optical-coherence tomography
  • the therapy delivery systems are configured to travel through a body lumen to provide therapy.
  • the therapy delivery systems are configured to be discharged from the host structure while in the lumen and deposited in a predetermined location in the lumen for ongoing therapy delivery.
  • the therapy delivery systems include a storage medium configured to record a time, a duration and/or a location of a therapy delivery.
  • a method of providing therapeutic treatment to a patient includes inserting a medical device into a patient’s body lumen; navigating the medical device to a specific site in need of a site-specific therapy and delivering the site-specific therapy in proximity to the site in need of the therapy.
  • the site-specific therapy includes optical-coherence tomography (OCT) guided laser instruments, radiation discharging sources, chemotherapy deploying devices, pharmaceutical and drug deploying devices, and/or photodynamic therapy devices.
  • OCT optical-coherence tomography
  • the specific site in need of therapy is proximate to the ampulla of Vater, also known as the hepatopancreatic ampulla or the hepatopancreatic duct.
  • FIG. 1 illustrates a representative intra-body controllable therapy delivery device formed in accordance with the present invention
  • FIG. 2 illustrates an alternative representation of an intra-body controllable therapy delivery device formed in accordance with the present invention
  • FIG. 3 A illustrates a medical device with a therapy delivery device therein
  • FIG. 3B illustrates a medical device in communication with therapy delivery device outside of the medical device.
  • FIG. 3C illustrates the therapy delivery device delivering therapy in a body lumen.
  • FIG. 1 illustrates an exemplary intra-body controllable medical device (hereinafter “the medical devices”).
  • the intra-body controllable medical device 5 is capsule shaped.
  • Intra-body controllable medical device 5 has a distal end 10, a proximal end 15, and body 20 connecting the distal end 10 and proximal end 15.
  • a control unit, a power supply system, an intra-device storage system, an imaging system, a therapy system, a sample and data gathering system, and a material dispensing system is located within body 20 of the medical device 5, as described herein.
  • the intra-body controllable medical device may be sized according to the anatomy that it will need to navigate, and the method used to deliver it.
  • overall dimensions for an intra-body controllable device operating within the gastrointestinal track may have a diameter D of about 25mm and a length L of about 75mm. More preferably, the device may have a diameter D of about 15 mm and a length L of about 50mm. Most preferably, the diameter D is less than about l5mm and a length L of less than about 50mm.
  • Overall dimensions for an intra-body controllable device that is delivered using a scope may have a diameter D of about 20mm in diameter D and a length L of about 75mm.
  • the diameter D is about l5mm and the length L is about 50mm. Most preferably, the diameter D is less than l5mm and the length L less than 50mm. Control system, power supply system, intra-device storage system, imaging system, therapy system, sample and data gathering system, and material dispensing systems are sized to fit within these dimensional guidelines.
  • the intra-body controllable medical device 5 is octopus shaped.
  • the intra-body controllable medical device has a main body 30, and appendages 35. Appendages 35 are used for propulsion, covering or wrapping the host structure 20, forming a portion of the host structure 20 or to perform a therapeutic or diagnostic task.
  • a control unit, power supply systems, an intra-device storage system, an imaging system, a therapy system, a sample and data gathering system, and a material dispensing system may be located within main body 30 and/or appendages 35 of the device or in the interior areas 22 of the host structure 20.
  • the present invention is generally directed to an intra-body controllable medical device having one or more therapy delivery systems 215 within (FIG. 3 A) or remote (FIG. 3B) to the intra-body controllable medical device.
  • the therapy delivery systems 215 include optical-coherence tomography (OCT) guided laser instruments, radiation discharging sources, chemotherapy deploying devices, pharmaceutical and drug deploying devices, ablation devices and photodynamic therapy devices.
  • OCT optical-coherence tomography
  • the therapy delivery systems 215 are configured to travel through the lumen in the intra-body controllable medical device and provide therapy.
  • the therapy delivery systems 215 may further be configured to be discharged from the device while in the lumen 100 and deposited in a predetermined location in the lumen 100 for ongoing therapy delivery (FIG. 3C).
  • the therapy delivery systems 215 are configured with a storage medium 216 to record time, duration and application location of the therapy.
  • the therapy device systems 215 are further configured with a transmitting device 217 to transmit real time data to one or more receivers located in other positions in the lumen and those located in other locations and organs in the body (e.g., a human body) and outside of the body.
  • the medical device 5 may then continue to travel through the small intestine without the imaging system.
  • the present invention includes materials for manufacture of an intrabody controllable medical devices, and in particular to materials for such devices that are clinically inert, sterilizable, elastomeric (e.g., contractible and expandable), chemically reactive, chemically inert, dissolvable, collapsible and have physical and chemical properties to withstand exposure to bodily fluids for precise predetermined periods of time.
  • materials include polymers, metallic alloys, shape memory polymers, shape memory metal alloys, shape memory ceramics, composites, silicones, thermoplastic polyurethane-based materials, excipients, zeolite adsorbents and styrene-butadiene rubbers (SBR).
  • Materials may further include biodegradable materials such as paper, starches, biodegradable material such as gelatin or collagen.
  • the intra-body controllable medical devices may be disposable, disintegrable and selectively collapsible intra-body controllable medical devices and materials and structures thereof.
  • the intra-body controllable medical devices are manufactured of a material such as an elastomer (e.g., nitrile) that can expand and contract, for example, by inflating and deflating them.
  • the intra-body controllable medical devices are manufactured from a biodegradable, disintegrable or dissolvable material, including paper, starches, biodegradable material such as gelatin or collagen and/or synthetic natural polymers.
  • the collapsible intra-body controllable medical devices are configured to be flattened, extruded, stretched or disassembled in the lumen.
  • the intra-body controllable medical devices are disposed of in the lumen or via discharge therefrom without the need to recover the intra-body controllable medical devices for analysis, inspection or future use.
  • the present invention is directed to methods for using intra-body controllable medical devices in the medical field and in particular for use in administering medications and therapy, deploying medical devices, imaging, and surgery.
  • the methods for using intra-body controllable medical devices includes applications in the gastro/intestinal tract (e.g. colonoscopy), urology applications, in the lungs, bladder, nasal and reproductive systems, in performing Transurethral Resection of Bladder Tumors (TURBT), Transurethral Resection of the Prostate (TURP) and transrectal prostate ultrasound, biopsy, and radiation treatment.
  • the methods for using intrabody controllable medical devices include use in procedural environments, operatory/surgical procedures, ambulatory/out-patient procedures and unobtrusive normal routine living.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pathology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Social Psychology (AREA)
  • Developmental Disabilities (AREA)
  • Optics & Photonics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychology (AREA)
  • Psychiatry (AREA)
  • Laser Surgery Devices (AREA)
  • Endoscopes (AREA)

Abstract

L'invention concerne un dispositif médical pour un transport intra-corporel comprenant une structure hôte et un ou plusieurs systèmes d'administration de thérapie. Les systèmes d'administration de thérapie comprennent des instruments laser guidés par tomographie par cohérence optique (OCT), des sources de décharge de rayonnement, des dispositifs de déploiement de chimiothérapie, des dispositifs de déploiement de produit pharmaceutique et/ou de médicament, et des dispositifs de thérapie photodynamique.
PCT/US2019/033476 2018-05-22 2019-05-22 Systèmes et procédés d'administration de thérapie pour dispositifs médicaux pouvant être commandés intra-corporels miniaturisés Ceased WO2019226745A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862674838P 2018-05-22 2018-05-22
US62/674,838 2018-05-22

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WO2019226745A1 true WO2019226745A1 (fr) 2019-11-28

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050148847A1 (en) * 2003-09-29 2005-07-07 Olympus Corporation Capsule medication administration system, medication administration method using capsule medication administration system, control method for capsule medication administration system
US20130345670A1 (en) * 2011-01-19 2013-12-26 Fractyl Laboratories Inc. Devices and methods for the treatment of tissue
US20140081360A1 (en) * 2012-09-20 2014-03-20 Photopill Medical Ltd. Capsule phototherapy
US20160166650A1 (en) * 2011-06-29 2016-06-16 Rani Therapeutics, Llc Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US20170007154A1 (en) * 2001-06-26 2017-01-12 Entrack, Inc. Capsule and method for treating or diagnosing conditions or diseases of the intestinal tract

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170007154A1 (en) * 2001-06-26 2017-01-12 Entrack, Inc. Capsule and method for treating or diagnosing conditions or diseases of the intestinal tract
US20050148847A1 (en) * 2003-09-29 2005-07-07 Olympus Corporation Capsule medication administration system, medication administration method using capsule medication administration system, control method for capsule medication administration system
US20130345670A1 (en) * 2011-01-19 2013-12-26 Fractyl Laboratories Inc. Devices and methods for the treatment of tissue
US20160166650A1 (en) * 2011-06-29 2016-06-16 Rani Therapeutics, Llc Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US20140081360A1 (en) * 2012-09-20 2014-03-20 Photopill Medical Ltd. Capsule phototherapy

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