WO2025233263A1

WO2025233263A1 - System and method for implanting a medical implant

Info

Publication number: WO2025233263A1
Application number: PCT/EP2025/062171
Authority: WO
Inventors: R. Hollis Whittington
Original assignee: Biotronik SE and Co KG
Current assignee: Biotronik SE and Co KG
Priority date: 2024-05-08
Filing date: 2025-05-05
Publication date: 2025-11-13
Anticipated expiration: 2026-11-08

Abstract

A system for implanting a medical implant (1) comprises an implantation device (2) having a device member (20), and a medical implant (1) received on the implantation device (2) for implanting the medical implant (1). The implantation device (2) with the medical implant (1) arranged thereon is introducible into a patient (P) for implanting the medical implant (1). The device member (20) of the implantation device (2) is movable with respect to the medical implant (1) to release the medical implant (1) from the implantation device (2) at an implantation site. The device member (20) of the implantation device (2) comprises a passing arrangement (200) which is moved with respect to the medical implant (1) when moving the device member (20). The medical implant (1) comprises a sensing device (10) configured to generate a sense signal dependent on a movement of said passing arrangement (200) relative to the medical implant (1), the medical implant (1) being configured to activate an operational mode based on the sense signal.

Description

SYSTEM AND METHOD FOR IMPLANTING A MEDICAL IMPLANT

The invention relates to a system and method for implanting a medical implant.

More specifically, the present invention relates to a system comprising an implantation device having a device member and a medical implant received in the implantation device for implanting the medical implant. The implantation device with the medical implant arranged thereon or therein is introducible into a patient for implanting the medical implant. The device member of the implantation device is movable with respect to the medical implant to release the medical implant from the implantation device at an implantation site.

By means of the system for example a medical implant such as an implantable monitoring device, e.g. an implantable cardiac monitor designed as a loop recorder, or an implantable pressure sensor may be implanted into a patient. The medical implant may for example be configured for a subcutaneous implantation into a (human or animal) patient. Alternatively, the medical implant may be implanted intravascularly. The medical implant may for example be designed for implantation within or in proximity to the patient’s heart for sensing signals originating from the patient’s heart.

For example, EP 3 381 386 Bl describes an implantation device which is used for subcutaneously implanting a medical implant, for example an implantable cardiac monitor designed as a loop recorder, subcutaneously in a patient. Using an incision tool, a small hole is cut into the patient’s skin, such that a front end of the implantation device with a medical implant contained therein may be introduced into the patient for subcutaneous placement of the medical implant within the patient. By releasing the medical implant from the front end and by withdrawing the front end, the medical implant is placed at the implantation site, for example subcutaneously in the region of the sternum of the patient. Using an implantation device as described in EP 3 381 386 Bl for example a monitoring device such as a loop recorder may be implanted into a patient.

EP 3 785 616 Al describes an implantation catheter for implanting a vascular implant into a vessel of a patient, comprising a catheter shaft and a vascular implant carried by the catheter shaft. Using an implantation catheter as described in EP 3 785 616 Al, for example a medical implant such as a pressure sensor may be implanted intravascularly in a vessel of a patient.

Typically, upon implanting a medical implant, the medical implant is activated using a programmer or activation device external to a patient. By means of the programmer, an operational mode of the medical implant is initiated, such that the medical implant is enabled to operate according to its prescribed functionality, for example to sense sensing parameters, to record sensed parameters and to e.g. establish a communication with an external communication device in order to report sensed data, for example within the context of a home monitoring system.

The use of a programmer for activating an operational mode of a medical implant upon implantation is well-established, but comes with the drawback that the implantation necessarily requires the availability of the programmer. This may pose restrictions in that an implantation of a medical implant may be performed only at a specialized healthcare facility having the required equipment. As medical implants such as implantable cardiac monitors (in short ICMs) may become more widely used such that their implantation may be performed more frequently, it is desirable to be able to implant medical implants outside of an operating room of a specialized healthcare facility, for example in a doctor’s office. For this, however, solutions are required for enabling an easy and reliable activation of a medical implant upon implantation.

It is an object of the present invention to provide a system and method for implanting a medical implant allowing for an easy and reliable activation of the medical implant upon implantation, without the need for using specialized equipment for establishing an operational mode subsequent to implantation. In one aspect, a system for implanting a medical implant comprises: an implantation device comprising a device member; and a medical implant received in the implantation device for implanting the medical implant. The implantation device with the medical implant arranged thereon or therein is introducible into a patient for implanting the medical implant. The device member of the implantation device is movable with respect to the medical implant to release the medical implant from the implantation device at an implantation site. The implantation device comprises a passing arrangement which is moveable with respect to the medical implant. The medical implant comprises an activation sensing device configured to generate a sense signal dependent on a movement of said passing arrangement relative to the medical implant, the medical implant being configured to activate an operational mode based on the sense signal.

The implantation device may be designed for a subcutaneous implantation of the medical implant, e.g. as it is described in EP 3 381 386 Bl. Alternatively, the implantation device may be an implantation catheter, for example as it is described in EP 3 785 616 Al, for implanting a medical implant in a vessel of a patient, for example within or in proximity to the patient’s heart, for example in the pulmonary artery or the like.

Using the implantation device, the medical implant is introduced into the patient, wherein the medical implant is deployed from the implantation device after reaching an implantation site by releasing the medical implant from a receptacle formed by the implantation device and by withdrawing the implantation device, leaving the medical implant at the implantation site. Herein, in order to achieve an automatic activation of the medical implant at or after implantation, the implantation device comprises a passing arrangement which is moveable relative to the medical implant when withdrawing the implantation device. The medical implant comprises an activation sensing device which is configured to detect or act upon a movement of the passing arrangement relative to the medical implant, such that it may be signaled whether the implantation device is withdrawn from the medical implant. Thereby the relative movement between the passing arrangement and the medical implant is important irrespective whether the medical implant or the passing arrangement is moved. Based on a sense signal of the activation sensing device of the medical implant, then, an operational mode of the medical implant may be activated, and e.g. regular operation of the medical implant may start.

Using the activation sensing device of the medical implant it hence is detected whether the medical implant during implantation is released from the implantation device. This becomes possible by moving the passing arrangement of the implantation device with respect to the sensing device, such that the activation sensing device may produce a sense signal indicative of the movement of the passing arrangement past the activation sensing device. Based on the sense signal the activation of the operational mode of the medical implant may then take place automatically, without the need of an additional activation by means of an external device, such as an external programmer or external activation unit.

As the operational mode of the medical implant is activated automatically during implantation, the activation becomes easy and reliable, hence facilitating the entire implantation procedure. As no specific equipment is required for activating the medical implant upon implantation, implantation may potentially take place outside of an operating room of a specialized healthcare facility, hence easing the implantation and making it suitable for a more widespread use of medical implants, such as implantable cardiac monitors (ICMs).

In one embodiment, the device member of the implantation device comprises the passing arrangement. The device member of the implantation device may comprise a passing arrangement which is moved with respect to the medical implant when the device member is moved. The medical implant comprises an activation sensing device configured to generate a sense signal dependent on a movement of said passing arrangement relative to the medical implant, the medical implant being configured to activate an operational mode based on the sense signal.

In one embodiment, the medical implant may be an implantable loop recorder. In another embodiment, the medical implant may be an implantable pressure sensor. In another embodiment, the medical implant may be an implantable leadless pacemaker. A loop recorder, such as an implantable cardiac monitor, may for example be designed for a subcutaneous implantation. A pressure sensor may for example be designed for an intravascular implantation, for example within the pulmonary artery. A leadless pacemaker may for example be designed for an implantation within a chamber of the hearth (atrium, ventricle).

In one embodiment, the activation sensing device of the medical implant comprises a magnetic sensor designed for detecting the presence of a magnetic field and/or for measuring a magnetic field strength. In one embodiment, the activation sensing device may be a Reed switch which performs as a switch to trigger the activation of the operational mode. In another embodiment, the activation sensing device may be a Giant Magnetoresistance (GMR) sensor producing a signal indicative of a magnetic field strength.

The passing arrangement, in one embodiment, comprises a magnetic element, such as a permanent magnet, producing a magnetic field. When moving the passing arrangement with respect to the activation sensing device, hence, a magnetic field in the vicinity of the activation sensing device changes, which may be detected by the activation sensing device and may cause activation of the operational mode. The operational mode herein may be activated based on a simple switch signal, for example produced by a Reed switch upon the changing of the magnetic field. In another embodiment, the operational mode may be activated based on a processing, using a processor of the medical implant, of the sense signal in order to identify a change of the magnetic field based on the sense signal and to activate the operational mode based on the identification.

In another embodiment, the activation sensing device may comprise an electrical coil element. In this case, the passing arrangement is configured to alter an inductance value of the coil element, in particular to create a current flow via the inductance of the coil element, when moving the device member with respect to the medical implant. The passing arrangement may for example comprise a passing element having the shape of a ferromagnetic armature which, upon moving the implantation device with respect to the medical implant during implantation, is moved past the electrical coil element of the activation sensing device such that an inductance of the coil element changes in the course of the movement. Based on a sense signal as obtained using the coil element the inductance change may be evaluated and may be used to activate an operational mode of the medical implant. A simple way to implement the example above may be a ferromagnetic element passing the coil /moving out of the coil and thereby inductively produce a current in the coil. The inductively produced current could function as the sense signal.

Another way of to implement the embodiment may be a passing arrangement changing the coil configuration, e.g. moving a part of the coil out of line or in line and thereby change the inductivity of the coil arrangement. It may also be suitable to have a passing arrangement comprising a second coil providing a magnetic field and inductively producing a current in in the coil, which could function as the sense signal.

Generally, the activation sensing device is configured to output a sense signal based on a relative movement of the passing arrangement past the sensing device. Different embodiments of the activation sensing device herein are conceivable, a signal output by the activation sensing device generally depending on the passing movement of the passing arrangement, hence allowing for an activation of the operational mode of the medical implant based on a relative movement of the implantation device with respect to the medical implant when releasing the medical implant from the implantation device during implantation.

The implantation device, during implantation, is for example movable with respect to the medical implant along a linear movement direction when releasing the medical implant from the implantation device. During the linear movement the passing arrangement is moved with respect to the activation sensing device, for example past the activation sensing device, such that the activation sensing device generates a sense signal indicative of the movement of the passing arrangement with respect to the activation sensing device.

In one embodiment, the medical implant comprises a processor configured to process the sense signal of the activation sensing device for activating the operational mode based on the processing of the sense signal. Using the processor, for example a signal pattern indicative of the movement of the passing arrangement with respect to the activation sensing device may be identified, and based on the identification of the signal pattern a corresponding operational mode of the medical implant may be activated.

In one embodiment, the passing arrangement comprises a passing element whose position on the device member of the implantation device is user configurable. For example, when the passing element is designed as a magnetic element, an orientation and/or position of the passing element may be user configurable, for example by placing the passing element in different orientations and/or positions on the device member, or by rotating or shifting the passing element using a suitable rotation or shifting mechanism.

For example, the device member may comprise a multiplicity of receptacles for receiving the passing element in different positions on the device member. Based on a specific position of the passing element on the device member, a sense signal as generated by the activation sensing device may exhibit a specific form, wherein based on a specific sense signal as output by the activation sensing device a specific, associated operational mode may be activated. A particular operational mode herein may be associated with a passing member placed at a particular position on the device member, wherein based on a signal pattern characteristic of the passing arrangement a specific, associated operational mode of the medical implant may be activated.

In one embodiment, the passing arrangement comprises a multiplicity of passing elements which are moved with respect to the medical implant when moving the device member with respect to the medical implant during implantation. The processor herein may be configured to identify, based on the sense signal, a signal pattern characteristic of the passing arrangement and to activate an operational mode of the medical implant associated with the signal pattern based on such identification. For example, the device member may comprise multiple receptacles for receiving passing elements of the passing arrangement, for example magnetic elements. Herein, multiple passing elements may be placed in a particular order in some or all of the different receptacles. Dependent on the specific configuration of the passing elements within the receptacles the activation sensing device may sense a particular signal pattern, wherein the processor is configured to assess the sense signal generated by the activation sensing device to identify a specific signal pattern associated with the specific configuration of the passing elements as used on the device member and to activate an operational mode of the medical implant based on the identification.

The passing arrangement herein is user configurable in that a user may place different passing elements in the different receptacles and in this way may define a specific configuration associated with a specific operational mode.

Different operational modes may be predefined within the medical implant. The processor herein may be configured to activate a particular operational mode (out of the multiplicity of predefined operational modes) based on a particular signal pattern as identified based on the sense signal of the activation sensing device. In this way, the medical implant may be configured in different ways during implantation without using a programmer. For example, an operational mode may be started to enable the medical implant to perform a certain program, for example to monitor for cardiac arrhythmias or, alternatively, for atrial fibrillation. Based on the configuration of the passing arrangement, hence, a certain programming of the medical implant during implantation may be achieved without the use of a programmer.

The activation of the operational mode may for example relate to activating the medical implant as a whole. For example, during implantation the medical implant may assume a substantially powerless sleep mode. Upon implantation the medical implant is woken up to perform its regular function, e.g. for sensing parameters for example relating to a cardiac function and for communicating sensed parameters to an external device for example within the scope of a home monitoring system.

In one embodiment, the processor is configured, when activating the operational mode, to enable a communication mode for establishing a communication with a communication device external to the medical implant. For example, communication may be established using a standardized communication scheme, for example based on the MICS protocol, or using the Bluetooth technology, for example Bluetooth Low Energy (BLE). For example, when activating the operational mode, the medical implant may switch into a pairing mode for allowing a pairing with an external communication device using the Bluetooth technology.

Alternatively or in addition, the processor may be configured, when activating the operational mode, to enable a sense mode for sensing at least one operational and/or patient parameter using a sensor device of the medical implant. Within the sense mode, regular sensing operation may be carried out, for example to measure cardiac parameters, for example electrocardiogram signals or pressure signals or the like. In particular, the sense mode may be configured for management of tachyarrhythmias (in particular for monitoring atrial fibrillation), or to a mode of bradyarrhyhmias (in particular for monitoring syncopes).

Alternatively or in addition, the processor may be configured, when activating the operational mode, to change data sampling rate and/or power consumption. Thereby the activated operational mode may have a higher or lower data sampling rate and/or power consumption.

In one embodiment, the processor is configured to identify a time of occurrence of the movement of the passing arrangement relative to the medical implant based on the processing of the sense signal from the activation sensing device. Once the activation sensing device generates a sense signal indicative of a movement of the implantation device with respect to the medical implant during implantation and accordingly it is identified that implantation has taken place, a time of occurrence may be determined and stored within the medical implant. The time of occurrence is indicative of a time of implantation and may be stored within the medical implant for example together with patient data. The time of occurrence indicative of the time of implantation may be reported to an external communication device or to a programmer, for example during a follow up check-up, and may be transmitted to a home monitoring service center to store the time of implantation in the patient record such that it is made available to a physician.

In one embodiment, the processor is configured to activate the operational mode at a predefined delay subsequent to said a time of occurrence. By employing a delay, for example in a range between 1 minute to 1 hour, for example between 5 minutes and 30 minutes, for example 10 minutes, prior to establishing the operational mode it may be achieved that the implantation procedure may be fully completed prior to starting regular operation of the medical implant. For instance, fixation, suturing and bandaging of the surgical area may take time at the end of the implantation procedure. Also, it may take some time for the electrical interface between the tissue and the medical implant to stabilize. The activation of the operational mode may be delayed for example to avoid artifacts such as low signals, loss of signal, or unusual morphologies that may be detected as aberrant events or arrhythmias.

In another aspect, a method for implanting a medical implant comprises: providing an implantation device comprising a device member; placing a medical implant on the implantation device for implanting the medical implant; introducing the implantation device with the medical implant arranged thereon into a patient for implanting the medical implant; moving the device member of the implantation device with respect to the medical implant to release the medical implant from the implantation device at an implantation site; moving a passing arrangement of the device member of the implantation device with respect to the medical implant, in particular when moving the device member; generating, using an activation sensing device of the medical implant, a sense signal dependent on a movement of said passing arrangement relative to the medical implant; and activating an operational mode of the medical implant based on the sense signal.

The advantages and advantageous embodiments described above for the system equally apply also to the method, such that it shall be referred to the above in this respect.

The various features and advantages of the present invention may be more readily understood with reference to the following detailed description and the exemplary embodiments shown in the drawings. Herein,

Fig. 1 shows a schematic drawing of a medical implant subcutaneously implanted within a patient;

Fig. 2 shows a schematic drawing of an intravascular medical implant; Fig. 3 shows a schematic drawing of an implantation device for implanting a medical implant;

Fig. 4 shows a schematic drawing of the implantation device during implantation;

Fig. 5 shows a schematic drawing of the implantation device when releasing a medical implant from the implantation device;

Fig. 6 shows a schematic drawing of the implantation device when withdrawing the implantation device from the medical implant at an implantation site;

Fig. 7 shows a schematic drawing of another embodiment of an implantation device, designed as an implantation catheter, for implanting a medical implant;

Fig. 8 shows a schematic drawing of the implantation device of Fig. 7 when withdrawing an outer catheter for releasing the medical implant from the implantation device;

Fig. 9A shows a schematic drawing of a passing arrangement of an implantation device in relation to a sensing device of a medical implant, in a first configuration;

Fig. 9B shows the passing arrangement of Fig. 9A in another configuration;

Fig. 10 shows another embodiment of a passing arrangement of an implantation device together with a sensing device of a medical implant;

Fig. 11 shows a schematic drawing of a magnetic field as sensed by a sensing device of a medical implant; Fig. 12 shows a schematic drawing of another embodiment of a passing arrangement of an implantation device together with a sensing arrangement of a medical implant;

Fig. 13 shows a schematic drawing of a magnetic field as sensed by a sensing device, e.g. as resulting from the passing arrangement of Fig. 12; and

Fig. 14 shows a schematic drawing of a medical implant including different functional components.

In the following, embodiments of the invention shall be described in detail with reference to the drawings. In the drawings, like reference numerals designate like structural elements.

It is to be noted that the embodiments are not limiting for the invention, but merely represent illustrative examples.

Referring now to Fig. 1, a medical implant 1 may for example be designed as a cardiac monitoring device (ICM) which is subcutaneously implanted in the vicinity of the patient’s heart H, for example in the region of the sternum of the patient P, such that the medical implant 1 is enabled to sense cardiac parameters such as electrocardiogram signals. The medical implant 1 may for example function as a so-called a loop recorder which continuously or in an event-driven manner records cardiac parameters for reporting e.g. to an external communication device 3 and, via the communication device 3, to a home monitoring service center 4 in the context of a home monitoring system.

Referring now to Fig. 2, whereas the medical implant 1 of Fig. 1 is designed for a subcutaneous implantation in a patient P, the medical implant 1 of Fig. 2 is designed for an intravascular implantation in a vessel of the patient, for example in the pulmonary artery PA in the region of the patient’s heart H. The intravascular medical implant 1 may for example have the shape of an implantable pressure sensor designed to measure pressure signals e.g. in the pulmonary artery PA and to report measured signals to an external communication device 3 and, via the external communication device 3, to a home monitoring service center 4 in the context of a home monitoring system.

Referring now to Figs. 3 to 6, an implantation device 2 for subcutaneously implanting a medical implant 1, for example as is shown in Fig. 1, may have the shape as it is described in EP 3 381 386 Bl. The implantation device 2 comprises a front end (the distal end with respect to the physician implanting the device) forming a receptacle to receive the medical implant 1 for implantation, the front end being formed by device members 20, 21 which are separable in order to release the medical implant 1 from the implantation device 2 during implantation, as visible e.g. from Figs. 5 and 6.

Using the implantation device 2, implantation may take place by forming a small incision in the patient’s skin. Through the incision, the front end formed by the device members 20, 21 with the medical implant 1 received therein is introduced into the patient. Once the device members 20, 21 are introduced into the patient, the device members 20, 21 are separated, as is shown in Fig. 5, and the implantation device 2 as a whole is withdrawn in a movement direction W while retaining the medical implant 1 in place using a retaining device 22, as visible from Figs. 5 and 6. The medical implant 1 hence is placed at the implantation site, while withdrawing the implantation device 2 in the movement direction W from the implantation site and hence from the patient.

As illustrated in the schematic drawing of Fig. 4, at least one of the device members 20, 21 comprises a passing arrangement 200, whereas the medical implant 1 comprises an activation sensing device 10. During implantation, when withdrawing the implantation device 2 in the movement direction W, the passing arrangement 200 is moved with respect to the activation sensing device 10 of the medical implant 1, such that the activation sensing device 10 may detect a relative movement of the passing arrangement 200 and may output a sense signal indicative of the relative movement. Based on the sense signal, an operational mode of the medical implant 1 may be activated as a result of the implantation, wherein the activation may take place automatically upon detecting the relative movement of the passing arrangement 200 with respect to the activation sensing device 10 by means of the medical implant 1, without requiring the need of an external programmer for activating the medical implant 1.

Referring now to Figs. 7 and 8, in another embodiment an implantation device 2, in particular for implanting a medical implant 1 intravascularly in a vessel of a patient, may have the form of an implantation catheter, having a first device member 20 in the shape of an outer catheter and a second device member 21 in the shape of an inner catheter. The medical implant 1 for implantation may be placed on the inner catheter 21, the outer catheter 20 providing for a sheathing of the medical implant 1 by receiving the medical implant 1 therein as visible from Fig. 7.

The implantation device 2 of Figs. 7 and 8 may have the shape of an implantation catheter as described e.g. in EP 3 785 616 Al.

During implantation, once the implantation site is reached, the outer catheter 20 is withdrawn in a movement direction W, as shown in Fig. 8, and the medical implant 1 is released from the inner catheter 21 at the implantation site, hence placing the medical implant 1 at the implantation site.

As visible from Figs. 7 and 8, the outer catheter 20 comprises a passing arrangement 200, which is moved with respect to an activation sensing device 10 of the medical implant 1 when withdrawing the outer catheter 20 in the movement direction W during implantation. The activation sensing device 10 herein is configured to detect or act upon the relative movement of the passing arrangement 200, such that based on the detection an operational mode of the medical implant 1 may be activated automatically as a result of the implantation.

The passing arrangement 200 of the implantation device 2 and the activation sensing device 10 of the medical implant 1 may take different forms in either the embodiments of Figs. 3 to 6 and Figs. 7 and 8.

For example, the activation sensing device 10 may be a magnetic sensor which is configured to act upon the presence of a magnetic field or may be designed for measuring a magnetic field strength. The activation sensing device 10 for example may be designed as a Reed switch or as a Giant Magnetoresistance (GMR) sensor. The passing arrangement 200 may for example comprise one or multiple magnet elements, in particular permanent magnet elements, designed for producing a magnetic field. Based on a relative movement of the passing arrangement 200 with respect to the activation sensing device 10 a change of the magnetic field in the vicinity of the activation sensing device 10 occurs, which may be detected by the activation sensing device 10 and may be used to activate an operational mode of the medical implant 1 as a result of implantation.

Referring now to Figs. 9A and 9B, if the passing arrangement 200 comprises a permanent magnet element and the activation sensing device 10 is configured for sensing or acting upon a magnetic field, the passing arrangement 200 may be user configurable in that an orientation of the magnet element of the passing arrangement 200 may be adaptively configured by the user. For example, a user may bring the magnet element of the passing arrangement 200 with its magnetic poles N, S into a position as shown in Fig. 9A, or into a reversed position as shown in Fig. 9B. For example, the magnet element of the passing arrangement 200 may be rotatable on the device member 20 by using a rotation mechanism. Alternatively, the magnet element of the passing arrangement 200 may be insertable into a corresponding receptacle on the device member 20 in different orientations, such that, prior to implantation, a user may configure the implantation device 2 by placing the magnet element of the passing arrangement 200 in a suitable orientation on the device member 20.

Based on the configuration of the magnet element of the passing arrangement 200, different sense signals may be sensed by the activation sensing device 10 during implantation, wherein based on the sense signal a particular operational mode of the medical implant 1 may be activated, as shall be explained in further detail below.

Referring now to Fig. 10, in one embodiment the sensing device 10 may comprise an electrical coil element 100 connected to an electric circuitry 101. The passing arrangement 200 in this case for example may comprise a ferromagnetic armature which, during movement of the device member 20 of the implantation device 2 relative to the medical implant 1 during implantation, is moved with respect to the activation sensing device 10 and causes a change of inductance in the electrical coil element 100. The change of inductance may be detected and is indicative of the relative movement of the device member 20 with respect to the medical implant 1, such that based on the change of inductance the movement may be detected and may be used to activate an operational mode of the medical implant 1.

Fig. 11 shows an example of a sense signal S as generated by an activation sensing device 10 in the embodiment of Fig. 9A, 9B or Fig. 10, a peak Pl in the signal S indicating a movement of the passing arrangement 200 with respect to the activation sensing device 10. The peak Pl may be detected, for example by comparing the signal S to a threshold and identifying the peak Pl based on a threshold crossing, and may be used to automatically - without the need of an external programmer - activate an operational mode of the medical implant 1 upon implantation.

When releasing the medical implant 1 from the implantation device 2, the device member 20 with the passing arrangement 200 arranged thereon is moved with respect to the activation sensing device 10. The passing arrangement 200 herein may be moved past the activation sensing device 10 in that it is caused first to approach the activation sensing device 10, to pass the activation sensing device 10 and to subsequently be moved away from the activation sensing device 10 along the movement direction W, as it e.g. is visible from the transition of Fig. 7 to Fig. 8, yielding a sense signal S it e.g. is shown in Fig. 11.

In another embodiment, the passing arrangement 200 may be placed in the immediate vicinity of the activation sensing device 10 at an initial position during implantation. Upon withdrawing the device member 20 the passing arrangement 200 may be removed from the activation sensing device 10, hence yielding a change in a sense signal.

Based on the detection of movement of the passing arrangement 200 with respect to the activation sensing device 10, an operational mode of the medical implant 1 may be automatically activated as a result of implantation. Whereas nowadays typically an activation of the medical implant 1 upon implantation takes place using a programmer in a specific healthcare facility, with the solution described herein an activation of an operational mode of the medical implant 1 may take place automatically without the need of a specified, additional equipment such as a programmer. By detecting a movement of the passing arrangement 200 of the device member 20 with respect to the activation sensing device 10 during implantation, an operational mode of the medical implant 1 may be automatically started, such that operation of the medical implant 1 may be initiated as a result of the implantation.

During implantation, the medical implant 1 may for example assume a sleep mode which substantially is powerless. The operational mode which is activated as a result of implantation herein may relate to the start of regular operation of the medical implant 1, such that the medical implant 1 is woken up from its sleep mode and may carry out its prescribed functionality.

In one embodiment, the activation of the operational mode may relate to the activation of a communication mode for communicating with an external device 3 (see Figs. 1 and 2) using communication circuitry 14 (see the schematic drawing of Fig. 14). For example, within the communication mode the medical implant 1 may communicate with the external device 3 using a standardized communication technology, such MICS or Bluetooth. For example, when activating the communication mode the medical implant 1 may enter into a pairing mode in order to establish a Bluetooth connection with an external device 3.

In one embodiment, the activation of the operational mode may relate to the activation of a sense mode for sensing patient parameters, such as cardiac parameters, for example electrocardiogram signals or pressure signals, using a sensor device 12 of the medical implant 1 (see the schematic drawing of Fig. 14). Sense patient parameters may be stored in a storage 13 of the medical implant 1 (see Fig. 14) for reporting to the external device 3.

The activation of the operational mode, in a particularly simple embodiment, may take place by activating a switch based on the sense signal S generated by the activation sensing device 10, such that the operational mode is switched on. In one embodiment, the medical implant 1 comprises a processor 11 which is configured to evaluate sense signals S generated by the activation sensing device 10, wherein based on the processing the operational mode is activated.

In one embodiment, multiple different operational modes are predefined within the medical implant 1. Based on the sensing of the activation sensing device 10 and the processing of the processor I l a particular operational mode may be activated.

For example, as visible from Figs. 9A and 9B, a passing element of the passing arrangement 200 may assume different configurations, wherein a particular configuration may yield a particular sense signal, which may be identified by the processor 11 and may be associated with a particular operational mode (out of a multiplicity of different operational modes), such that based on the processing of the processor I l a particular operational mode associated with the particular sense signal is activated.

For example, one operational mode may relate to the monitoring of arrhythmias. Another operational mode may relate to the monitoring of atrial fibrillation. Based on the operational mode the medical implant 1 may function in a particular manner, for example to provide for a specified monitoring functionality.

As visible from Figs. 9A and 9B, the configuration of the passing arrangement 200 may be user configurable. Based on a particular configuration of the passing arrangement 200 as set by a user prior to implementation, a particular operational mode may be activated automatically during implantation. For example, a passing element of the passing arrangement 200 may be placed in different orientations and/or positions on the device member 20, such that based on the orientation and/or position of the passing element a particular sense signal is obtained and may be processed by the processor 11, such that based on the processing a particular operational mode associated with the particular configuration of the passing arrangement 200 may be activated.

Referring now to Fig. 12, in one embodiment the passing arrangement 200 may comprise multiple passing elements 200A-200D which may be placed in receptacles 201 formed on the device member 20. A user herein may choose from a multiplicity of passing elements 200A-200D and may place the passing elements 200A-200D in some or all of the receptacles 200, such that a particular configuration of the passing arrangement 200 is defined. During implantation the device member 20 with the passing elements 200A-200D arranged thereon is moved with respect to the activation sensing device 10 of the medical implant 1 along the movement direction W, resulting in a sense signal S e.g. as shown in an example in Fig. 13.

The sense signal S as shown in Fig. 13 may relate to a magnetic field strength as measured by the activation sensing device 10 (in this case designed as a magnetic sensor). In another embodiment, the sense signal S may relate to a change of inductance.

Due to the multiple passing elements 200A-200D in the embodiment of Fig. 12, multiple peaks P1-P4 may be visible in the sense signal S, as visible from Fig. 13. Based on a processing of the sense signal S the processor 11 may identify a particular signal pattern within the sense signal S and may associate the signal pattern with a particular operational mode, such that based on the processing of the sense signal S a particular operational mode corresponding to the configuration of the passing arrangement 200 may be started.

The processor 11 may cause activation of the operational mode immediately or at a predefined delay subsequent to the detection of movement during implantation. For example, in order to allow the implantation procedure to be completed, for instance for a fixation, suturing and bandaging of the surgical area and for allowing the electrical interface between the tissue and the medical implant 1 to stabilize, the processor 11 may determine a time of occurrence of the movement of the passing arrangement 200 with respect to the activation sensing device 10 and may store the time of occurrence as an indication of the time of implantation. Subsequent to the time of occurrence, that is at a predefined delay subsequent to the time of occurrence, the operational mode is activated, for example at a delay between 1 minute to 1 hour, for example between 5 minutes and 30 minutes, for example at 10 minutes. The operational mode hence is not started immediately, but at a delay subsequent to the time of occurrence of the relative movement of the passing arrangement 200 with respect to the sensing device 10. Because the operational mode of the medical implant 1 is activated automatically during implantation, no external programmer is required for completing the implantation procedure, hence easing implantation and making it possible to carry out the implantation at sites outside a specified healthcare facility. As no additional accessories are required to activate the implant, costs may be minimized while keeping a healthcare environment efficient without additional accessories such as activators, external magnets or other devices.

LIST OF REFERENCE NUMERALS

1 Implant

10 Activation sensing device

100 Coil element

101 Electrical circuitry

11 Processor

12 Sensor device

13 Storage device

14 Communication

2 Implantation device

20 Device member

200 Passing arrangement

200A-D Passing element

201 Receptacles

21 Device member

22 Retaining device

3 Communication device

4 Home monitoring service center

H Heart

P Patient

Pl-4 Peak

PA Pulmonary artery

S Signal w Movement direction

Claims

1. System for implanting a medical implant (1), comprising: an implantation device (2) comprising a device member (20); and a medical implant (1) received in the implantation device (2) for implanting the medical implant (1); wherein the implantation device (2) with the medical implant (1) arranged therein is introducible into a patient (P) for implanting the medical implant (1); wherein the device member (20) of the implantation device (2) is movable with respect to the medical implant (1) to release the medical implant (1) from the implantation device (2) at an implantation site; wherein the implantation device (2) comprises a passing arrangement (200) which is moveable with respect to the medical implant (1); and wherein the medical implant (1) comprises an activation sensing device (10) configured to generate a sense signal dependent on a movement of said passing arrangement (200) relative to the medical implant (1), the medical implant (1) being configured to activate an operational mode based on the sense signal.

2. The system according to claim 1, wherein the device member (20) of the implantation device comprises the passing arrangement (200).

3. The system according to claim 1 or 2, wherein the medical implant (1) is an implantable loop recorder or an implantable pressure sensor.

4. The system according to one of claims 1 to 3, wherein the activation sensing device (10) comprises a magnetic sensor, wherein the passing arrangement (200) comprises a magnetic element producing a magnetic field.

5. The system according to one of claims 1 to 4, wherein the activation sensing device (10) comprises an electrical coil element (100), wherein the passing arrangement (200) is configured to alter an inductance value of the coil element (100) when moving the device member (20) with respect to the medical implant (1).

6. The system according to one of the preceding claims, wherein the medical implant (1) comprises a processor (11) configured to process said sense signal of the activation sensing device (10) for activating said operational mode based on the processing of said sense signal.

7. The system according to claim 6, wherein the passing arrangement (200) comprises a passing element (200A-D) whose position on the device member (20) of the implantation device (2) is user configurable, wherein the processor (11) is configured to identify, based on the sense signal, a signal pattern characteristic of the passing arrangement (200) and to activate an operational mode of the medical implant (1) associated with the signal pattern based on said identification.

8. The system according to claim 6 or 7, wherein the passing arrangement (200) comprises a multiplicity of passing elements (200A-D) which are moved with respect to the medical implant (1) when moving the device member (20), wherein the processor (11) is configured to identify, based on the sense signal, a signal pattern characteristic of the passing arrangement (200) and to activate an operational mode of the medical implant (1) associated with the signal pattern based on said identification.

9. The system according to claim 7 or 8, wherein the processor (11) is configured to activate different operational modes for different signal patterns identified based on the sense signal.

10. The system according to one of claims 6 to 9, wherein said processor (11) is configured, when activating said operational mode, to enable a communication mode for establishing a communication with a communication device (2) external to the medical implant (1).

11. The system according to one of claims 6 to 10, wherein said processor (11) is configured, when activating said operational mode, to enable a sense mode for sensing at least one operational parameter using a sensor device (12) of the medical implant (1).

12. The system according to one of claims 6 to 11, wherein said processor (11) is configured to identify a time of occurrence of said movement of the passing arrangement (200) relative to the medical implant (1) based on the processing of said sense signal.

13. The system according to claim 12, wherein said processor (11) is configured to store said time of occurrence for reporting to a communication device (2) external to the medical implant (1).

14. The system according to claim 12 or 13, wherein said processor (11) is configured to activate said operational mode at a predefined delay subsequent to said time of occurrence.

15. The system according to claim 14, wherein said predefined delay is in a range between 1 minute and 1 hour, preferably between 5 minutes and 30 minutes.

16. Method for implanting a medical implant (1), comprising: providing an implantation device (2) comprising a device member (20); placing a medical implant (1) on the implantation device (2) for implanting the medical implant (1); introducing the implantation device (2) with the medical implant (1) arranged thereon into a patient (P) for implanting the medical implant (1); moving the device member (20) of the implantation device (2) with respect to the medical implant (1) to release the medical implant (1) from the implantation device (2) at an implantation site; moving a passing arrangement (200) of the device member (20) of the implantation device (2) with respect to the medical implant (1); generating, using an activation sensing device (10) of the medical implant (1), a sense signal dependent on a movement of said passing arrangement (200) relative to the medical implant (1); and activating an operational mode of the medical implant (1) based on the sense signal.