WO2026032702A1 - Procédé et système de support d'une mise en contact de communication avec une pluralité de classes de dispositifs médicaux implantables - Google Patents

Procédé et système de support d'une mise en contact de communication avec une pluralité de classes de dispositifs médicaux implantables

Info

Publication number
WO2026032702A1
WO2026032702A1 PCT/EP2025/071106 EP2025071106W WO2026032702A1 WO 2026032702 A1 WO2026032702 A1 WO 2026032702A1 EP 2025071106 W EP2025071106 W EP 2025071106W WO 2026032702 A1 WO2026032702 A1 WO 2026032702A1
Authority
WO
WIPO (PCT)
Prior art keywords
implantable medical
communication
class
medical device
programming device
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/EP2025/071106
Other languages
English (en)
Inventor
Brian M. TAFF
Dean Bergstrom
Kurt Swenson
Julian Merlin
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.)
Biotronik SE and Co KG
Original Assignee
Biotronik SE and Co KG
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 EP24197913.7A external-priority patent/EP4704108A1/fr
Application filed by Biotronik SE and Co KG filed Critical Biotronik SE and Co KG
Publication of WO2026032702A1 publication Critical patent/WO2026032702A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A61N1/37247—User interfaces, e.g. input or presentation means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37288—Communication to several implantable medical devices within one patient

Definitions

  • BIOTRONIK SE & Co. KG Applicant: BIOTRONIK SE & Co. KG
  • the invention relates to a method for supporting a communication engagement with a plurality of classes of implantable medical devices. Furthermore, the invention relates to a programming device and system for supporting a communication engagement with a plurality of classes of implantable medical devices.
  • the data throughput associated with their communication engagements with the programmer can be relatively high-speed in nature and avoid a need to mandate that the programmer should serve as the initiator for any command/response interactions using frame-based architectures.
  • the communication infrastructure necessarily embodies slower data throughput modalities as a consequence of the implants’ deeper residence within patient anatomy. This reduced cadence is best served by, in comparison to the norm for traditional pocket-based cardiac rhythm management products, leaning on the programmer to embody the command transmission role in a command/response relationship between the programmer and the leadless pacemaker.
  • Legacy cardiac rhythm management product communication is, most commonly, initiated by physically placing a programmer wand, i.e., a communication unit of a programming device over a single subcutaneously implanted pocket-based implant.
  • Legacy products only expect to represent the singularly relevant/visible implant in communication with the programmer.
  • the surrounding communication infrastructure is thus commonly structured such that after initially awakening the lone in-range implant, typically by using a high-power wake-up signature from the wand, the implant immediately begins
  • the object is solved by a method for supporting a communication engagement with a plurality of classes of implantable medical devices having the features of claim 1. Furthermore, the object is solved by a programming device having the features of claim 12 as well as a system having the features of claim 15.
  • the present invention provides a method for supporting a communication engagement with a plurality of classes of implantable medical devices.
  • the method comprises positioning a communication unit of a programming device within a communication range of an implantable medical device.
  • the method comprises establishing a connection between the programming device and the implantable medical device, and automatically detecting a class of the implantable medical device depending on a communication interface and/or a communication protocol of the implantable medical device. Depending on the detected class of the implantable medical device an auto-interrogation of the implantable medical device is performed or a list comprising at least a list entry representing the implantable medical device positioned within the communication range of the communication unit of a programming device is created.
  • the present invention provides a programming device for supporting a communication engagement with a plurality of classes of implantable medical devices.
  • the programming device comprises a communication unit, a processor, and a memory unit, wherein the memory unit comprises a computer-readable program which causes the processor to perform the following steps when executed on the processor: establishing a connection between the programming device and the implantable medical device when the communication unit (11) of the programming device (12) is positioned within a communication range of the implantable medical device, automatically detecting a class of the implantable medical device depending on a communication interface and/or a communication protocol of the implantable medical device, and depending on the detected class of the implantable medical device performing an auto-interrogation of the implantable medical device or creating a list comprising at least a list entry representing the implantable medical device.
  • the present invention provides a system for supporting a communication engagement with a plurality of classes of implantable medical devices comprising an implantable medical device and a programming device as described above.
  • An idea of the present invention is to provide a solution to the considerations noted above through the introduction of a novel discovery mode capability.
  • This discovery mode combines the needs for selectively engaging with user-specified deeply implanted leadless pacemaker devices while also, in nominal cases, enabling the auto-interrogation needs of subcutaneously implanted pocket-based devices.
  • the invention thus provides a means for avoiding disruptions to the normal expectations relevant to communication support for a bulk of legacy products, i.e., a user simply places a wand (alternative term for communication unit of the programming device) over the implant and the programmer initiates a full interrogation process.
  • a wand alternative term for communication unit of the programming device
  • the invention provides a means for all multi-device engagements to be performed in a manner that can best serve helping a clinician direct system communication
  • the invention offers a means for effectively managing interactions where a mixture of modern and legacy implants may be presented and sidelines responses that would disrupt engagements already initiated with multi-device contextualized implants.
  • the plurality of classes of implantable medical devices includes a first class of implantable medical devices using a broad-band communication scheme or a Pulse-Position-Modulated (PPM) broad-band communication scheme, in particular auto-interrogation capable implantable medical devices, a second class of implantable medical devices using a narrow-band communication scheme or a Phase- Shift-Keying (PSK) narrow-band communication scheme, in particular leadless pacemakers, and/or a third class of implantable medical devices which cannot be automatically detected by the programming device.
  • PPM Pulse-Position-Modulated
  • PSK Phase- Shift-Keying
  • the devices using broadband communication are based on a pulse position scheme (PPM) and the devices using narrow-band communications are based on a phase shift keying (PSK) scheme.
  • PPM pulse position scheme
  • PSK phase shift keying
  • the programmer in this embodiment would selectively filter received signals from the broadband devices to use information in the broader spectrum to analyze the characteristics that would identify this class of devices, while selectively filtering received signals from the narrow-band devices to allow correlating these signals with patterns that would identify this other class of devices.
  • auto interrogation capable implantable medical devices can advantageously be auto interrogated within the common framework for supporting a communication engagement with a plurality of classes of implantable medical devices.
  • the auto-interrogation of the implantable medical device comprises starting an application of the programming device, requesting a full configuration and statistics content from the implant, and starting the relay of medical data, in particular IEGM data.
  • the framework for supporting a communication engagement with a plurality of classes of implantable medical devices according to the present invention thus fully supports auto interrogation capable implants.
  • this response dynamic realizes the same interactions as are presently in place for legacy CRM products.
  • the auto interrogation amounts to the initiation of the appropriate device-relevant programmer application and an immediate sending of data from the implant to report its configuration, the contents of its on-board statistics, and an IEGM stream. All of this legacy behavior occurs subject to wand placement over a legacy device in cases where the wand had not already encountered a more modern implant.
  • the detected at least one class of implantable medical devices may be output on an initial page of a graphical user interface of the programming device.
  • the graphical user interface is thus able to present the detected class of implantable medical device within the plurality of potential classes of implantable medical devices.
  • all classes of implantable medical devices may be accessible from the initial page of a graphical user interface of the programming device.
  • the graphical user interface thus offers a means to communicate with a plurality of classes of implantable medical devices from a single starting page.
  • the graphical user interface of the programming device transitions from the initial page to an open application page for the auto-interrogation capable implantable medical device.
  • the configuration of the implantable medical device and its on-board statistics are made available along with a real-time feed of the IEGM data.
  • the application of the program device thus provides a unified means to access a plurality of classes of implantable medical devices.
  • the programming device creates the list comprising at least a list entry representing the implantable medical device detected within the communication range of the communication unit of the programming device.
  • a leadless pacer or, more generally, a device enabled by a newer narrow-band, PSK-encoded communication scheme
  • a list of discovered devices is initiated. Even legacy devices are added to this list if they were seen by the wand after first encountering the more modern types. In effect, legacy (specifically PPM-enabled) devices that are “not seen first” by the wand, skip out on auto-interrogation and instead simply become user-selectable options within the wand-observed set of interrogatable implants.
  • the system By adding these legacy (again, PPM-enabled) devices that are “seen after” the wand has already encountered PSK- enabled devices (rather than simply auto-interrogating any PPM-enabled device that the wand encounters), the system better assists user efforts to engage with PSK-enabled implants without having the system “highjack” attempts to communicate with the newer device class.
  • one or more list entries representing respective further implantable medical devices of the first and/or second class detected within the communication range of the communication unit of the programming device are added to the list. Adding legacy implants to a list-based approach thus occurs in cases where a multi-implant aware device type has been encountered prior as the auto-interrogation dynamic described earlier prevails otherwise.
  • the method further comprises selecting a list entry of the list for accessing a respective implantable medical device of the first and/or second class. This provides a simple to use tool for the user to manage a plurality of classes of implantable medical devices.
  • a subsequent startup of an implant-appropriate programmer application is driven requesting the full configuration and statistics content from the chosen implantable medical device, and starting the relay of IEGM data.
  • Automatic startup of the implant appropriate programmer application conveniently automates the process of communicating with the implantable medical device.
  • the method further comprises, if a desired class cannot be automatically detected, establishing the connection by searching for the desired class in a targeted manner by entering the desired class into the programming device (12).
  • the graphical user interface preferably incorporates an added accessibility where the merged concepts from above can be deliberately sidelined by the clinician and a targeted search for the device class of interest can be enabled by means of a bail-out user selection. This capacity can be preferably enabled through button presses on the initial screen of the graphical user interface.
  • the graphical user interface is configured to display the list and to enable a selection of the list entry for accessing the respective implantable medical device.
  • the graphical user interface comprises a user prompt for searching for a desired class in a targeted manner by entering the desired class, if the desired class cannot be automatically detected.
  • Fig. 1 shows a flowchart of a method for supporting a communication engagement with a plurality of classes of implantable medical devices according to an embodiment of the invention
  • Fig. 2 shows a diagram of a system for supporting a communication engagement with a plurality of classes of implantable medical devices according to an embodiment of the invention.
  • the method for supporting a communication engagement with a plurality of classes Cl, C2of implantable medical devices 10 shown in Fig. 1 comprises positioning SI a communication unit 11 of a programming device 12 within a communication range of an implantable medical device 10.
  • the method furthermore comprises establishing S2 a connection between the programming device 12 and the implantable medical device 10, wherein a class Cl, C2 of the implantable medical device 10 is detected depending on a communication interface and/or a communication protocol of the implantable medical device 10.
  • C2 of the implantable medical device 10 an autointerrogation of the implantable medical device 10 is performed S4a or a list of implantable medical devices 10 positioned within the communication range of the communication unit 11 of a programming device 12 is created S4b.
  • a first class Cl of auto-interrogation capable implantable medical devices is detected, wherein if no other implantable medical device 10 or no other class is detected within the communication range of the communication unit 11 of the programming device 12, auto interrogation of the detected implantable medical device 10 is performed S4a.
  • the autointerrogation of the implantable medical device 10 further comprises starting an application of the programming device 12, requesting a full configuration and statistics content from the implant, and starting the relay of, in particular IEGM, medical data.
  • the detected at least one class of implantable medical device 10 may be output on an initial page of a graphical user interface 14 of the programming device 12. All classes Cl, C2 of implantable medical devices 10 are accessible from the initial page of a graphical user interface 14 of the programming device 12, if at least one C2 device was encountered by the programming device prior to encountering any Cl devices.
  • the graphical user interface 14 of the programming device 12 transitions from the initial page
  • the programming device 12 detects a second class C2 of implantable medical devices, in particular a leadless pacemaker, first, the programming device 12 creates S4b the list of implantable medical devices 10 detected within the communication range of the communication unit 11 of the programming device 12. Once the list is initiated, implantable medical devices 10 of the first and/or second class detected within the communication range of the communication unit 11 of the programming device 12 are added to the list.
  • any single entry of the list representing an implantable medical device 10 of the first and/or second class is selectable.
  • a selection of any single entry of the list representing an implantable medical device 10 drives a subsequent startup of an implant-appropriate programmer application requesting the full configuration and statistics content from the chosen implantable medical device 10, and starting the relay of IEGM data.
  • connection to an implantable medical device of the desired class may be established by searching for the desired class in a targeted manner.
  • the graphical user interface 14 of the programming device 12 provides a user prompt for establishing a connection with the implantable medical device 10 of the desired class.
  • Fig. 2 shows a schematic diagram of a system for supporting a communication engagement with a plurality of classes Cl, C2 of implantable medical devices 10 according to an embodiment of the invention.
  • the system 1 comprises an implantable medical device 10, and a programming device 12 comprising a communication unit 11 configured to establish a connection between the implantable medical device 10, and a programming device 12 comprising a communication unit 11 configured to establish a connection between the implantable medical device 10, and a programming device 12 comprising a communication unit 11 configured to establish a connection between the implantable medical device 10.
  • the programming device 12 is configured to perform an auto-interrogation of the implantable medical device 10 or to create a list of implantable medical devices 10 positioned within the communication range of the communication unit 11 of a programming device 12.
  • the detected and listed devices may comprise devices in a body area network (e.g. IMD connected to several implanted sensors), as well as leadless DDD devices (atrial leadless pacemaker and ventricular leadless pacemaker) too.
  • a body area network e.g. IMD connected to several implanted sensors
  • leadless DDD devices atrial leadless pacemaker and ventricular leadless pacemaker
  • both systems could be displayed as a group of devices (e.g. BAN system or leadless pacemaker DDD) without the possibility of selecting specific devices in each system, but after selecting the GUI by clicking on the list entry each system device may be selectable and programmable individually.
  • the system could be programmed as a whole, too.
  • BAN body-area network
  • multi-device therapy support e.g., DDD implemented using two leadless pacemakers - one in the atrium and one in the ventricle
  • Distinct devices of different or same class are indicated in the list e.g. on a discovery page of the graphical user interface.
  • the devices may be “linkable” into a shared/coordinated therapy support system - i.e., DDD - after interrogating any single device.
  • DDD shared/coordinated therapy support system
  • release code could be leveraged that permits the user to interact with a specific single underlying implant that helps build this coordinated DDD too.
  • a yet further embodiment might embrace blinding the user to being able to see the two separate DDD-comprising implants even on the discovery page by simply showing something like “leadless pacemaker DDD” and then keeping the fact that the therapy is delivered by two separate devices further obscured from the end-user.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Business, Economics & Management (AREA)
  • General Business, Economics & Management (AREA)
  • Human Computer Interaction (AREA)
  • Epidemiology (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un procédé et un système destinés à supporter une mise en contact de communication avec une pluralité de classes (C1, C2) de dispositifs médicaux implantables (10), le procédé comprenant les étapes consistant à positionner une unité de communication (11) d'un dispositif de programmation (12) dans une plage de communication d'un dispositif médical implantable (10), et établir une connexion entre le dispositif de programmation (12) et le dispositif médical implantable (10), une classe du dispositif médical implantable (10) étant détectée en fonction d'une interface de communication et/ou d'un protocole de communication du dispositif médical implantable (10), et en fonction de la classe détectée du dispositif médical implantable (10), une auto-interrogation du dispositif médical implantable (10) étant effectuée ou une liste de dispositifs médicaux implantables (10) positionnés dans la plage de communication de l'unité de communication (11) d'un dispositif de programmation (12) étant créée.
PCT/EP2025/071106 2024-08-06 2025-07-23 Procédé et système de support d'une mise en contact de communication avec une pluralité de classes de dispositifs médicaux implantables Pending WO2026032702A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202463679747P 2024-08-06 2024-08-06
US63/679,747 2024-08-06
EP24197913.7 2024-09-02
EP24197913.7A EP4704108A1 (fr) 2024-09-02 2024-09-02 Procédé et système pour prendre en charge une mise en contact de communication avec une pluralité de classes de dispositifs médicaux implantables

Publications (1)

Publication Number Publication Date
WO2026032702A1 true WO2026032702A1 (fr) 2026-02-12

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2025/071106 Pending WO2026032702A1 (fr) 2024-08-06 2025-07-23 Procédé et système de support d'une mise en contact de communication avec une pluralité de classes de dispositifs médicaux implantables

Country Status (1)

Country Link
WO (1) WO2026032702A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080027501A1 (en) * 2006-07-28 2008-01-31 Haubrich Gregory J Variable Implantable Medical Device Power Characteristics Based Upon Data or Device Type
US20130154851A1 (en) * 2007-08-31 2013-06-20 Cardiac Pacemakers, Inc. Wireless patient communicator employing security information management

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080027501A1 (en) * 2006-07-28 2008-01-31 Haubrich Gregory J Variable Implantable Medical Device Power Characteristics Based Upon Data or Device Type
US20130154851A1 (en) * 2007-08-31 2013-06-20 Cardiac Pacemakers, Inc. Wireless patient communicator employing security information management

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