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WO2025078997A1 - Détection de température tissulaire pour scellement bipolaire à l'aide d'un capteur de température infrarouge - Google Patents

Détection de température tissulaire pour scellement bipolaire à l'aide d'un capteur de température infrarouge Download PDF

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Publication number
WO2025078997A1
WO2025078997A1 PCT/IB2024/059920 IB2024059920W WO2025078997A1 WO 2025078997 A1 WO2025078997 A1 WO 2025078997A1 IB 2024059920 W IB2024059920 W IB 2024059920W WO 2025078997 A1 WO2025078997 A1 WO 2025078997A1
Authority
WO
WIPO (PCT)
Prior art keywords
temperature
surgical device
thermal assembly
infrared sensor
tissue area
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/IB2024/059920
Other languages
English (en)
Inventor
Snehashis Haldar
Srimannarayana CHALLARI
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 Advanced Energy LLC
Original Assignee
Medtronic Advanced Energy LLC
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 Medtronic Advanced Energy LLC filed Critical Medtronic Advanced Energy LLC
Publication of WO2025078997A1 publication Critical patent/WO2025078997A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/10—Power sources therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/0063—Sealing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00666—Sensing and controlling the application of energy using a threshold value
    • A61B2018/00678—Sensing and controlling the application of energy using a threshold value upper
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00898—Alarms or notifications created in response to an abnormal condition

Definitions

  • This disclosure relates generally to the field of medical devices, systems, and methods for use in surgical procedures. More specifically, this disclosure relates to surgical devices, units, systems, and methods that can provide for hemostasis or sealing of bodily tissues, including bone, while continuously, simultaneously, or periodically monitoring the temperature of the tissue or bone.
  • the management and control of intraoperative bleeding can include the techniques of coagulation, hemostasis, or sealing of tissues and are often performed with the aid of electrodes energized from a suitable power source.
  • Typical electrosurgical devices apply an electrical potential difference or signal between an active electrode and a return electrode on the grounded body of the patient or between an active electrode and a return electrode on the device to deliver electrical energy to the area where tissue is to be affected.
  • Electrosurgical devices pass electrical energy through tissue between the electrodes to provide coagulation to control bleeding and hemostasis to seal tissue.
  • the electrosurgical devices are usually held by the surgeon and connected to the power source, such as an electrosurgical unit having a power generator, via cabling.
  • a temperature monitoring mechanism can in coupled to the handle, wherein the temperature monitoring mechanism includes temperature monitoring technology such that a temperature of at least one of the thermal assembly or a targeted tissue area of a patient is monitored during a procedure with the surgical device, wherein the temperature monitoring technology includes at least one infrared sensor.
  • FIG. 3 illustrates an example block diagram method for temperature detection and monitoring during homeostatic or sealing procedures, according to examples.
  • the dispersed fluid can be implemented to constantly be dispersed while the device is activated.
  • the fluid can disburse constant fluid at a flow rate selectively determined by the clinician or operator.
  • the fluid can be water, saline, or other fluidlike substance that can cool or otherwise reduce the temperature of the area that is undergoing hemostasis or sealing procedures.
  • System 10 can include a source of thermal energy 12 coupled to a heating element 14.
  • the source of thermal energy 12 can include a source of electrical energy electrically coupled to the heating element 14.
  • heating element 14 can be configured as part of heating assembly on a distal tip of a surgical device, e.g., handheld surgical device 100 of FIG. 2.
  • Heating element 14 can include a resistive material that is configured to rise in temperature when an electrical current is passed through heating element 14.
  • the source of thermal energy 12 can be selectively activated via a switch, button, lever, directional pad, or any other input mechanisms to apply the electrical current to the heating element 14.
  • Activation of the thermal assembly can quickly heat heating element 14 into the temperature range of about 80 degrees Celsius to about 110 degrees Celsius, such as to a preselected temperature within that range.
  • the heating element 14 can include a low thermal mass or heat capacity so that heating element 14 can heat to the preselected temperature or temperature range within a predetermine or set period of time (e.g., between one or two seconds of activation) and can cool to a safe temperature (e.g., below a threshold temperature) within a predetermined or set period of time (e.g., between one or two seconds) of deactivation.
  • system 10 can include an alerting mechanism coupled to the system 100 (e.g., LED light, internal speaker, display, etc.) that can produce an alert, such as a visual or audio alert (e.g., activating a light, a continuous flashing light, produce a sound, such as an alarm or alert indication, etc.) when the controller detects the temperature of the heating element 14 or tissue of the patient exceeding a threshold temperature.
  • a visual or audio alert e.g., activating a light, a continuous flashing light, produce a sound, such as an alarm or alert indication, etc.
  • the threshold temperature can be shown via display electrically or wirelessly coupled to the alerting mechanism. If the threshold temperature is reached or exceeded, the alert can be seen or heard by the clinician during hemostasis or sealing procedures and be prompted to stop, at least temporarily, the procedure.
  • the clinician can stop the procedure, based on the alert, or apply additional fluid to the treatment area to allow the temperature of the heating element 14 or the tissue of the patient to cool down to an acceptable temperature level, prior to continuing hemostasis or sealing procedures.
  • an action can be taken automatically or manually by the clinician during hemostasis or sealing procedures.
  • power supplied to heating element 14 can be reduced or turned off automatically.
  • fluid can be automatically supplied to heating element 14 or targeted tissue area automatically.
  • the clinician can stop the procedure, at least temporarily, based on the alert or action taken.
  • the threshold temperature can be modified, either dynamically or automatically, depending on the type of tissue and the location of the procedure being performed within the patient.
  • Surgical device 100 can include a handpiece 106.
  • Handpiece 106 includes a handle 106 that can include a finger or hand grip portion (e.g., with ridges) on the lower surface or bottom portion of the surgical device 100 and intended to be held in the hand of the surgeon or clinician.
  • the device 100 can be wired (e.g., power cables 104) or can be wireless and include the features of a thermal control system within handpiece 104.
  • Handpiece 104 can include a proximal end 108 for balance and to receive electrical communication from power source 12, via power cables 104 or wirelessly (e.g., batteries).
  • input operating mechanisms can provide binary activation (on/off) control for each function and can be configured as a pushbutton, switch lever, etc.
  • user input mechanisms can be pushed or switched to activate thermal assembly 102 and released or repushed to deactivate thermal assembly 102.
  • an additional switch or input (not shown) can be used selectively activate fluid dispersal.
  • surgical system 100 can include temperature monitoring technology 112 (e.g., reflecting the same or similar capabilities to temperature monitoring mechanism 16), such that the temperature of thermal assembly 102 or the temperature of the tissue under hemostasis or sealing can be determined and monitored during surgical procedures (e.g., hemostasis or sealing of tissue, including bone).
  • temperature monitoring technology 112 can include at least one infrared (IR) temperature sensor.
  • IR temperature sensors can include at least one active or passive infrared sensor.
  • additional or alternative user input mechanism can be used to selectively control temperature monitoring technology 112.
  • temperature monitoring technology 112 can be activated (e.g., simultaneously when the surgical device 100 is activated).
  • Temperature monitoring technology 112 can continuously or periodically monitor and detect the temperature of thermal assembly 102 or tissue under sealing 114 while surgical device 100 is activated. In examples, monitoring and detecting of thermal assembly 102 or tissue under sealing 114 can be deactivated upon deactivation of surgical device 100. In examples, temperature monitoring technology 112 can be independently activated and periodically monitor and detect the temperature of thermal assembly 102 or tissue under sealing 114 while the surgical device 100 is in use. In examples, periodic monitoring can include, manually activating and deactivating the monitoring, activating monitoring ‘X’ number of times within a certain time period, or activate monitoring every ‘Y’ seconds/minutes, etc. [0024] In examples, temperature monitoring technology 112 can be coupled with surgical device 100 (e.g., coupled with handle 106 or a probe assembly 122).
  • the temperature monitoring technology 112 (e.g., including at least one IR temperature sensor) can be positioned, angled, or otherwise coupled with surgical device 100 such that an accurate, precise, or at least near-precise field of view 116 to the thermal assembly 102 or the tissue under sealing 114 can be achieved and temperature determined.
  • temperature monitoring technology 112 includes a field of view 116 that is sufficient to for the clinician to monitor the temperature of thermal assembly 102 or tissue under sealing 114 accurately with near precision. It should be understood that other functions and control of surgical device 100 and temperature monitoring technology 112 are contemplated.
  • Electrical pathways of the handpiece 104 and probe assembly 120 can be formed as conductive arms, wires, traces, other conductive elements, and other electrical pathways formed from electrically conductive material (e.g., metal, stainless steel, titanium, gold, silver, platinum or any other suitable material).
  • surgical device 100 can selectively disperse fluid via at least one fluid lumen coupled within shaft 122 and can extend into the handpiece 104 to delivery tubing in a cable extending from proximal end 108.
  • the fluid lumen can include an outlet port disposed on or proximate thermal assembly 102 for selectively dispersing fluid at or near the targeted tissue area 114.
  • a precise control system can be designed to control the temperature to control the rate of flow of saline distributed to targeted tissue area 114 or thermal assembly 102.
  • an alert can include generating a sound, activating a visual indicator (e.g., blinking light optionally coupled with or to surgical device 100) and other alerting mechanisms such that the clinician is notified to perform an action (e.g., introduce additional saline to the monitored area) or to cease an action (e.g., halt, at least temporarily, surgical procedures).
  • a visual indicator e.g., blinking light optionally coupled with or to surgical device 100
  • other alerting mechanisms such that the clinician is notified to perform an action (e.g., introduce additional saline to the monitored area) or to cease an action (e.g., halt, at least temporarily, surgical procedures).
  • an action e.g., reducing power supplied to thermal assembly 102 or expelling fluid
  • an action can be automatically triggered and implemented if the measured temperature reaches or exceeds a threshold temperature.
  • measured or calculated temperature data can be sent or displayed to the clinician (e.g., via a user interface), such as the previous temperature of the monitored area, the new or current temperature of the monitored area, the change in temperature of the monitored area, and other temperature data. It should be understood that additional alerting mechanisms and data associated with surgical procedures are contemplated.
  • FIG. 3 illustrates an example block diagram method for temperature detection and monitoring during homeostatic or sealing procedures, according to examples.
  • the surgical device 100 can be available and used during a homeostasis or sealing procedures.
  • the clinician can initiate homeostasis or sealing of tissue procedures and activate the surgical device 100 at 204.
  • homeostasis or sealing of tissue, including bone is commenced at or near a target tissue area.
  • Example 3 includes the surgical device of example 2, wherein the temperature monitoring mechanism continuously monitors and determines the temperature of the at least one of the thermal assembly or the targeted tissue area of the patient via the at least one infrared sensor.
  • Example 16 includes the method of example 11, further comprising periodically monitoring and determining the temperature of at least one of the targeted tissue area or the thermal assembly by the temperature monitoring mechanism, wherein the temperature monitoring mechanism includes at least one infrared sensor configured to receive infrared radiation within a field of view.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif chirurgical, comprenant une poignée comportant au moins un mécanisme d'entrée d'utilisateur et un arbre s'étendant de manière distale à partir de la poignée, l'arbre comprenant une extrémité distale. Dans des exemples, un ensemble thermique peut être couplé de manière fonctionnelle à l'extrémité distale de l'arbre, comprenant un élément chauffant, l'ensemble thermique comprenant au moins un élément chauffant et étant électriquement couplé à l'au moins un mécanisme d'entrée d'utilisateur. Dans des exemples, un mécanisme de surveillance de température peut être couplé à la poignée, le mécanisme de surveillance de température comprenant une technologie de surveillance de température de telle sorte qu'une température d'au moins l'un de l'ensemble thermique et d'une zone de tissu ciblée d'un patient est surveillée pendant une procédure avec le dispositif chirurgical, la technologie de surveillance de température comprenant au moins un capteur infrarouge.
PCT/IB2024/059920 2023-10-11 2024-10-10 Détection de température tissulaire pour scellement bipolaire à l'aide d'un capteur de température infrarouge Pending WO2025078997A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363589529P 2023-10-11 2023-10-11
US63/589,529 2023-10-11

Publications (1)

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WO2025078997A1 true WO2025078997A1 (fr) 2025-04-17

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1808145A2 (fr) * 2002-02-06 2007-07-18 Thermage, Inc. Pièce à main pour traitement RF de tissus
EP2444018A2 (fr) * 2005-07-21 2012-04-25 Tyco Healthcare Group LP Systèmes et méthodes pour traiter une structure anatomique creuse
EP2474279A2 (fr) * 2009-04-17 2012-07-11 Domain Surgical, Inc. Instrument chirurgical chauffé par induction
US20140188110A1 (en) * 2012-12-31 2014-07-03 Paul Joseph Weber Apparatus, systems and methods for tissue dissection and modification
EP2853216A1 (fr) * 2013-09-27 2015-04-01 Covidien LP Dispositif médical d'électrochirurgie à modulation de puissance
WO2016032724A1 (fr) * 2014-08-26 2016-03-03 Ethicon Endo-Surgery, Inc. Dispositif chirurgical pour traitement de tissu
US20180310980A1 (en) * 2008-05-27 2018-11-01 Maquet Cardiovascular Llc Surgical instrument and method
WO2023057817A1 (fr) * 2021-10-05 2023-04-13 Stryker European Operations Limited Dispositifs électrochirurgicaux ayant des capteurs intégrés, procédés d'utilisation, et procédés de fabrication

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1808145A2 (fr) * 2002-02-06 2007-07-18 Thermage, Inc. Pièce à main pour traitement RF de tissus
EP2444018A2 (fr) * 2005-07-21 2012-04-25 Tyco Healthcare Group LP Systèmes et méthodes pour traiter une structure anatomique creuse
US20180310980A1 (en) * 2008-05-27 2018-11-01 Maquet Cardiovascular Llc Surgical instrument and method
EP2474279A2 (fr) * 2009-04-17 2012-07-11 Domain Surgical, Inc. Instrument chirurgical chauffé par induction
US20140188110A1 (en) * 2012-12-31 2014-07-03 Paul Joseph Weber Apparatus, systems and methods for tissue dissection and modification
EP2853216A1 (fr) * 2013-09-27 2015-04-01 Covidien LP Dispositif médical d'électrochirurgie à modulation de puissance
WO2016032724A1 (fr) * 2014-08-26 2016-03-03 Ethicon Endo-Surgery, Inc. Dispositif chirurgical pour traitement de tissu
WO2023057817A1 (fr) * 2021-10-05 2023-04-13 Stryker European Operations Limited Dispositifs électrochirurgicaux ayant des capteurs intégrés, procédés d'utilisation, et procédés de fabrication

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