EP4391802A1 - Imitation de conditions physiologiques pendant une perfusion d'organe ou de tissu - Google Patents

Imitation de conditions physiologiques pendant une perfusion d'organe ou de tissu

Info

Publication number
EP4391802A1
EP4391802A1 EP22769635.8A EP22769635A EP4391802A1 EP 4391802 A1 EP4391802 A1 EP 4391802A1 EP 22769635 A EP22769635 A EP 22769635A EP 4391802 A1 EP4391802 A1 EP 4391802A1
Authority
EP
European Patent Office
Prior art keywords
organ
fluid
container
tissue
platform
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
EP22769635.8A
Other languages
German (de)
English (en)
Inventor
Thomas Fernando VALENZUELA
Emma A. SCHINSTOCK
Paul Anthony Iaizzo
Stefan S. Tunev
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.)
Medtronic Ireland Manufacturing ULC
Original Assignee
Medtronic Ireland Manufacturing ULC
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
Priority claimed from US17/820,728 external-priority patent/US20230062798A1/en
Application filed by Medtronic Ireland Manufacturing ULC filed Critical Medtronic Ireland Manufacturing ULC
Publication of EP4391802A1 publication Critical patent/EP4391802A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/10—Preservation of living parts
    • A01N1/14—Mechanical aspects of preservation; Apparatus or containers therefor
    • A01N1/142—Apparatus
    • A01N1/143—Apparatus for organ perfusion
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/30—Anatomical models
    • G09B23/306—Anatomical models comprising real biological tissue

Definitions

  • This disclosure generally relates to systems for perfusing one or more organs and/or associated tissues while monitoring physiological function, testing medical devices or therapies, or both.
  • Perfusion is the passage of fluid through the circulatory system or lymphatic system to an organ or a tissue.
  • perfusion may indicate a flow of blood that transports oxygen or a metabolic substance to an organ through a capillary network.
  • tissues require an adequate blood supply for health and life, and poor perfusion (e.g., malperfusion) may cause health problems, such as cardiovascular disease, including coronary artery disease, cerebrovascular disease, peripheral artery disease, etc.
  • Container 104 may define an interior cavity 105 configured to receive organs 102. Interior cavity 105, and in turn container 104, may have any dimension suitable for enclosing one or more organs 102. The size and shape of container 104 may depend on the organs 102 which container 104 is configured to house. For example, as shown in FIG. 1, container 104 may be configured to house a left kidney, a right kidney, a portion of an aorta, and at least some surrounding tissue, e.g., including vasculature, nerves, or the like. As other examples, container 104 may be configured to house other organs, such as a liver, a spleen, a heart, one or two lungs, or the like.
  • Path 130 may be formed from a material with a low friction coefficient to reduce resistance to movement of platform 128 in a direction along path 130, which may facilitate the mimicking of fine physiological movements associated with organ 102.
  • system 100 which includes actuator 108, may enable the mimicking, maintenance, and measurement of physiological conditions, such as physiological movements of organs 102 (e.g., caused by breathing or a pain response), during perfusion of organs 102.
  • system 100 may provide a more clinically relevant model that may yield more clinically relevant data and clinician training, potentially reducing the cost and length of pre-clinical and clinical testing and training and accelerating the development and deployment of effective medical devices and therapies.
  • the controller or computing device may receive one or more set points associated with operation of one or more components system 200 and substantially maintain the operation of the one or more components at or near the one or more set points by controlling actuators (e.g., actuator 108), heating elements, and/or other components of system 200.
  • actuators e.g., actuator 108
  • the controller or computing device may control a heating element of system 200 to increase a temperature of fluid 110 (which is in fluid communication with interior cavity 205) or control a heating element that directly heats interior cavity 205 to output more heat until the temperature within interior cavity 205 is within the normothermic range.
  • a normothermic range e.g., less than about 36°C
  • system 200 may be configured to control a fluid level within interior cavity 205 of container 204.
  • a fluid level set point may include single fluid level value or range of fluid level values.
  • the controller or computing device may be configured to control a valve, pump, or the like to control the fluid level within interior cavity 205. if the controller or computing device determines that a fluid level within interior cavity 205 is below a predetermined fluid level range based on measurements from level sensor 244, the controller or computing device may control a valve to close and decrease a flow rate through drain 122 (FIG. 1) until the fluid level is within the pre-determined fluid level range.
  • Medical device 310 may be configured to monitor or treat conditions or functions relating to the at least one organ.
  • medical device 310 may be an electrical stimulation device, a drug delivery device, a sensing device, a catheter, or the like.
  • Medical device 310 may be configured to electrically stimulate one or more nerves to modulate activity of the one or more nerves.
  • the one or more nerves may include a portion of the central nervous system or a portion of the peripheral nervous system.
  • the one or more nerves may include sensory or motor nerves, nerves of the somatic or autonomic systems, or sympathetic or parasympathetic nerves.
  • Medical device 310 may be the portion of the system that is being developed or on which the clinician is being trained.
  • System 300 may include one or more access sites configured to mimic access to the at least one organ via a standard approach, such as radial artery access, femoral artery access, brachial artery access, or the like.
  • electrodes 148 may be implanted at target locations; attached to one or more nerves using alligator clips, needles or another suitable electrical connection; and driven by a stimulator configured to imitate or simulate nervous tissue function.
  • system 300 may approximate or mimic function of nerves associated with the at least one organ, which may allow evaluation of therapies configured to affect nerve tissue or nervous system function (such as neuromodulation, denervation (or nerve ablation), or the like.
  • Example 15 The system of example 13 or 14, wherein the medical device includes a lead carrying at least one electrode.
  • Example 17 The system of any one of examples 1 to 16, further including at least one environmental sensor configured to measure the at least one environmental condition.
  • Example 18 The system of example 17, wherein the at least one environmental sensor includes at least one of a temperature sensor, a humidity sensor, or a weight sensor.
  • Example 19 The system of any one of examples 1 to 18, wherein the fluid is transparent.
  • Example 21 The system of any one of examples 1 to 20, wherein the fluid includes blood.
  • Example 22 The system of example 21, wherein the fluid includes diluted blood.
  • Example 23 The system of any one of examples 1 to 22, wherein the container is configured to receive at least a portion of at least one of a kidney, a liver, a spleen, a heart, a lung, skeletal muscle tissue, an eye, or a gallbladder.
  • Example 26 The system of example 24 or 25, wherein the at least one physiological sensor includes at least one of an electrode, a flow transducer, or a pressure sensor.
  • Example 28 The system of any one of examples 1 to 27, further including at least one image sensor configured to collect image data of the at least one organ or tissue.
  • Example 34 The method of any one of examples 30 to 33, wherein generating, by the pump, the flow of the fluid through the fluid circuit include: controlling, by control circuitry, the pump to generate and regulate the flow of the fluid.
  • Example 35 The method of any one of examples 30 to 34, wherein moving, by the actuator operably coupled to the platform operably coupled to the container, the platform to mimic at least one biological movement includes: controlling, by control circuitry, the at least one actuator to move the platform.
  • Example 37 The method of any one of examples 30 to 36, wherein the at least one actuator includes a servomotor.
  • Example 38 The method of any one of examples 30 to 37, wherein the platform is positioned within the interior cavity of the container, wherein the platform is configured to mechanically support the at least one organ or tissue, and wherein the container is configured to mechanically support the platform.
  • Example 39 The method of example 38, wherein the container defines a path configured to guide movement of the platform, and wherein moving, by the at least one actuator operably coupled to the platform operably coupled to the container, the platform to mimic at least one biological movement includes moving, by the at least one actuator operably coupled to the platform operably coupled to the container, the platform along the path.
  • Example 40 The method of example 39, wherein the path includes at least one of a groove or a railing.
  • Example 52 The method of any one of examples 30 to 51, wherein the at least one organ or tissue includes at least a portion of at least one of a kidney, a liver, a spleen, a heart, a lung, skeletal muscle tissue, an eye, or a gallbladder.
  • Example 55 The method of example 53 or 54, wherein the at least one physiological sensor includes at least one of an electrode, a flow transducer, or a pressure sensor.
  • Example 56 The method of any one of examples 30 to 55, further including delivering electrical signals to at least one nerve associated with the at least one organ or tissue using an electrode positioned within the interior cavity of the container.
  • control circuitry 402 may be implemented, at least in part, in hardware, software, firmware or any combination thereof.
  • various aspects of the described techniques including those described with respect to control circuitry 402, may be implemented within one or more processors or processing circuitry, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components.
  • DSPs digital signal processors
  • ASICs application specific integrated circuits
  • FPGAs field programmable gate arrays
  • a control unit including hardware may also perform one or more of the techniques of this disclosure.

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Medicinal Chemistry (AREA)
  • Computational Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medical Informatics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Algebra (AREA)
  • Environmental Sciences (AREA)
  • Dentistry (AREA)
  • Mathematical Analysis (AREA)
  • Mathematical Optimization (AREA)
  • Mathematical Physics (AREA)
  • Pure & Applied Mathematics (AREA)
  • Business, Economics & Management (AREA)
  • Educational Administration (AREA)
  • Educational Technology (AREA)
  • Theoretical Computer Science (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

Un système est conçu pour perfuser un ou plusieurs organes et/ou tissus associés tout en surveillant la fonction physiologique et/ou en testant des dispositifs médicaux ou des thérapies. Le système comprend une pompe, un récipient, un circuit de fluide, une plate-forme et au moins un actionneur. La pompe est conçue pour générer l'écoulement d'un fluide. Le récipient délimite une cavité intérieure et est conçu pour recevoir au moins un organe ou un tissu et maintenir au moins une condition environnementale associée audit organe ou tissu à l'intérieur de la cavité intérieure. Le circuit de fluide est conçu pour coupler fluidiquement la pompe audit organe ou tissu. La plate-forme est accouplée de manière fonctionnelle au récipient. Ledit actionneur est conçu pour déplacer la plate-forme pour imiter au moins un mouvement biologique associé audit organe ou tissu.
EP22769635.8A 2021-08-27 2022-08-26 Imitation de conditions physiologiques pendant une perfusion d'organe ou de tissu Pending EP4391802A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163237968P 2021-08-27 2021-08-27
US17/820,728 US20230062798A1 (en) 2021-08-27 2022-08-18 Mimicking physiologic conditions during organ or tissue perfusion
PCT/EP2022/073809 WO2023025948A1 (fr) 2021-08-27 2022-08-26 Imitation de conditions physiologiques pendant une perfusion d'organe ou de tissu

Publications (1)

Publication Number Publication Date
EP4391802A1 true EP4391802A1 (fr) 2024-07-03

Family

ID=83319031

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22769635.8A Pending EP4391802A1 (fr) 2021-08-27 2022-08-26 Imitation de conditions physiologiques pendant une perfusion d'organe ou de tissu

Country Status (2)

Country Link
EP (1) EP4391802A1 (fr)
WO (1) WO2023025948A1 (fr)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9119392B2 (en) * 2010-11-09 2015-09-01 Biomedinnovations, Llc Articulating organ support
US20140370490A1 (en) * 2013-06-12 2014-12-18 Medtronic, Inc. Heart-lung preparation and method of use
JP2017518301A (ja) * 2014-06-02 2017-07-06 トランスメディクス， インク．Ｔｒａｎｓｍｅｄｉｃｓ， Ｉｎｃ． ｅｘ−ｖｉｖｏでの臓器管理システム
US11399536B2 (en) * 2017-09-15 2022-08-02 The Cleveland Clinic Foundation Device for support of an organ ex vivo
GB2587350B (en) * 2019-09-23 2021-12-15 Royal Papworth Hospital Nhs Found Trust Organ perfusion system and method
CN112772636A (zh) * 2021-01-18 2021-05-11 吉林大学第一医院 一种机械灌注肝脏容器

Also Published As

Publication number Publication date
WO2023025948A1 (fr) 2023-03-02

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