# US 2019/0168004 A1 · Centering kit for aligning an external element with respect to an implanted medical device and corresponding method

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- Number: US 2019/0168004 A1
- Document ID: US20190168004A1
- Status: Published application
- Kind: A1
- Application number: 16/095,723
- Filed: 2016-05-24
- Published: 2019-06-06
- Earliest claimed: 2016-05-24
- Assignees: Synergia Medical
- Applicants: Synergia Medical
- Inventors: Pascal DOGUET; Aurelie DE COCK DE RAMEYEN; Gregory THIEBAUT
- Web page: https://patentgrep.com/patent/US20190168004A1

## CPC

- A61N 1/3787: {from an external energy source}
- A61B 5/065: {Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe}
- A61N 1/37223: {Circuits for electromagnetic coupling}
- H02J 7/42: with electronic devices having internal batteries, e.g. mobile phones
- H02J 50/10: using inductive coupling
- H02J 50/30: using light, e.g. lasers
- H02J 50/80: involving the exchange of data, concerning supply or distribution of electric power, between transmitting devices and receiving devices
- H02J 50/90: involving detection or optimisation of position, e.g. alignment
- A61B 2560/0219: of externally powered implanted units
- A61F 2250/0001: Means for transferring electromagnetic energy to implants
- A61N 1/37229: {Shape or location of the implanted or external antenna}
- A61N 1/37235: {Aspects of the external programmer}
- H02J 2105/46: Medical devices, medical implants or life supporting devices
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- H02J: ELECTRIC POWER NETWORKS; CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A kit of parts and a system for centering an external element with respect to an implantable medical device is provided that includes: •An implantable medical device (20) for being implanted under the skin of a patient and having an internal housing with a light source (22) positioned such as to emit a light beam coaxial to a secondary axis (Z2), •An external element (10) having —a number, N> 2, of photodetectors (12a-12d) forming a polygon of N edges, normal to a primary axis (Z1), and —an indicator (4) indicating how the external element is to be displaced over the skin to position the external element with the primary axis (Z1), being coaxial with the secondary axis (Z2), as a function of the energy received by each of the N photodetectors. A corresponding method for aligning the external element and the implantable medical device are provided.

## Claims

### Claim 1

A kit of parts for centering an external element with respect to an implantable medical device, said kit of parts comprising:
An implantable medical device (20) for being implanted under the skin of a patient and comprising;
(a) an internal housing characterized by a secondary axis, (Z2),
(b) a light source (22) positioned such as to emit a light beam coaxial to the secondary axis, (Z2), and of wavelength and intensity sufficient for being transmitted through the tissues and skin separating the implantable medical device from the exterior when implanted under the skin of a patient, and
(B) An external element (10) comprising:
an external housing characterized by a primary axis (Z1), and containing an external electronic unit, the external element comprising:
(a) A number, N>2, of photodetectors (12a-12d) forming a polygon of N edges, normal to the primary axis, (Z1), and which centroid (13) belongs to the primary axis, (Z1), and
(b) An indicator (4) indicating how the external element is to be displaced over the surface of the skin of a patient in order to position the external element with the primary axis, (Z1), being coaxial with the secondary axis, (Z2), of the implantable medical device,
Characterized in that, the external element comprises a processor or an electronic logic control circuit configured to:
(a) Measure the energy received by each of the photodetectors of the external element from the light source,
(b) Calculate the mean energy, Em, defined as the average of the energies, Ei, received by each of the N photodetectors, Em=ΣEi/N, with i=1 to N,
(c) For each photodetector, determine whether the received energy, Ei, falls within an optimal range comprised between (Em−ε) and (Em+ε), wherein ε is a predefined optimal deviation,
(d) If the energy, Ei, received by each of the N photodetectors falls within the optimal range, indicate that the external element is optimally positioned with the primary axis (Z1) being coaxial to the secondary axis (Z2) within the optimal deviation,
(e) If the energy, Ei, of at least one of the N photodetectors falls out of the optimal range, set the indicator to indicate that the external element is not positioned optimally and to indicate the direction the external element must be displaced in order to bring the primary axis (Z1) coaxially to the secondary axis (Z2) of the implantable medical device.

### Claim 2 (depends on 1)

The kit of parts of claim 1, wherein, (a) the internal housing of the implantable medical device contains an internal electronic unit comprising an internal energy emitter (21) and/or an internal energy receiver (21) defined by a secondary transmission axis, (Y2), and wherein (b) the external electronic unit of the external element comprises an external energy receiver (11) and/or an external energy emitter (11) defined by a primary transmission axis, (Y1), and wherein when the internal energy emitter and/or internal energy receiver faces the external energy emitter and/or external energy receiver with the secondary transmission axis, (Y2), being coaxial to the primary transmission axis, (Y1), the secondary axis, (Z2), of the implantable medical device is positioned coaxially to the primary axis, (Z1), allowing an optimized energy transfer between the internal energy emitter and/or internal energy receiver of the implantable medical device and the external energy emitter and/or external energy receiver of the external element.

### Claim 3 (depends on 2)

The kit of parts of claim 2, having either:
(a) A coaxial configuration wherein;
The secondary transmission axis, (Y2), of the internal energy emitter and/or internal energy receiver of the implantable medical device is coaxial to the secondary axis, (Z2), and
The primary transmission axis, (Y1), of the external energy receiver and/or external energy emitter of the external element is coaxial to the primary axis (Z1), (Y1-Z1), or
(b) An offset configuration wherein;
The secondary transmission axis, (Y2), of the internal energy emitter and/or internal energy receiver of the implantable medical device is parallel to and offset from the secondary axis, (Z2), by a distance, (d), and
The primary transmission axis, (Y1), of the external energy receiver, and the external energy emitter of the external element, or the combination thereof is parallel to and offset from the primary axis, (Z1), by said distance, (d), and wherein
The external element comprises a pointer (14) pointing the angular position with respect to the primary axis, (Z1), required by the external element in order to bring the primary transmission axis, (Y1), coaxially to the secondary transmission axis, (Y2), when the primary axis, (Z1), and secondary axis, (Z2), are coaxial.

### Claim 4 (depends on 3)

The kit of parts according to claim 3, wherein in the coaxial configuration:
(A) The external element is an electric charger connectable to a source of electric current for feeding in electric current a primary coil made of one or more wires coiled about the primary axis (Z1), thus forming an external emitter (11) of magnetic waves, and
(B) The internal electronic unit of the implantable medical device is fed with electric current by a rechargeable battery coupled to a secondary coil made of one or more wires coiled about the secondary axis, (Z2), thus forming an internal receiver (21), Such that when the electric charger is located adjacent to the implantable medical device with the primary axis, (Z1), positioned coaxially to the secondary axis, (Z2), and when the primary coil is fed with electric current, a magnetic link is formed and the induction of an electric current in the secondary coil is optimized, which serves to recharge the battery.

### Claim 5 (depends on 2)

The kit of parts of claim 2, wherein:
(A) The external element is a programming unit and the electromagnetic waves emitted by the external emitter are programming instructions, and
(B) The internal electronic unit of the implantable medical device is programmable, Such that when the external energy emitter of the programming unit is positioned adjacent to the internal energy receiver of the programmable implantable medical device with the primary and secondary transmission axes, (Y1,Y2), positioned coaxially, the programming instructions emitted by the external energy emitter are received optimally by the internal energy receiver and transmitted to the internal electronic unit.

### Claim 6 (depends on 2)

The kit of parts of claim 2, wherein:
(A) The external electronic unit of the external element comprises an external receiver allowing the reception of electromagnetic waves propagating in a direction parallel to the primary transmission axis, (Y1),
(B) The internal electronic unit of the implantable medical device comprises an internal energy emitter configured for emitting electromagnetic waves in a direction parallel to the secondary transmission axis, (Y2), Such that when the external energy receiver of the external element is positioned adjacent to the internal energy emitter of the implantable medical device, with the primary and secondary transmission axes, (Y1, Y2), positioned coaxially, the electromagnetic wave emitted by the internal energy emitter is received optimally by the external energy receiver.

### Claim 7 (depends on 6)

The kit of parts of claim 6, wherein the electromagnetic wave emitted by the internal energy emitter comprises data of the implantable medical device or data collected by the implantable medical device.

### Claim 8 (depends on 1)

The kit of parts according to claim 1, wherein the electromagnetic wave is selected among a magnetic link, an optical wave of wavelength comprised between 400 and 1700 nm, a radiowave of frequency comprised between 1 kHz and 2.5 GHz, or a radiowave of frequency comprised between 300 MHz and 2.4 GHz.

### Claim 9 (depends on 7)

The kit of parts according to claim 7, having a coaxial configuration and wherein the light source (22) of the implantable medical device preferably also acts as internal energy emitter for transferring the data of the implantable medical device or collected by the implantable medical device in the form of an optical wave.

### Claim 10 (depends on 1)

The kit of parts according to claim 1, wherein the external element is mounted on a motorized X-Y table (30) supported in a support structure (31) defining a rim, allowing the external element to be automatically moved with respect to the rim along two directions (X and Y) of the motorized X-Y table, parallel to said rim as a function of the energy received by each of the N photodetectors from the light beam emitted by the light source, until the primary axis (Z1) of the external element is brought coaxially to the secondary axis (Z2) of the implantable medical device, and wherein the X-Y table is preferably actuated by means of wires (38) made of a shape memory alloy connected to a source of electric current, or with electric motors.

### Claim 11

(canceled)

### Claim 12

(canceled)

### Claim 13 (depends on 1)

A method for aligning an external element with an implantable medical device implanted under the skin of a patient, said external element and implantable medical device being as defined in claim 1, said method comprising:
(a) Activate the light source of the implantable medical device in order to emit a light beam along the primary axis, (Z1), through the skin of the patient;
(b) Position the external element on the skin of the patient at an approximate position of the implantable medical device;
(c) Move the external element on the skin following the indications of the indicator, until the primary axis, (Z1), thereof is coaxial to the secondary axis, (Z2), of the implantable medical device, thus defining a coaxial position; and
(d) Keep the external element at the coaxial position.

### Claim 14 (depends on 3, 13)

A method according to claim 13, wherein the external element and implantable medical device have an offset configuration according to claim 3 and wherein as the external element is kept at the coaxial position in step (d) of claim 13, the external element is rotated about the primary axis, (Z1), according to the direction indicated by the pointer (14), until the primary and secondary transmission axes, (Y1, Y2), are coaxial.

### Claim 15 (depends on 10, 13)

The method of claim 13, wherein the external element and implantable medical device are from a kit of parts according to claim 10, said method comprising:
(a) Position the rim of the support structure on the skin of the patient at an approximate position of the implantable medical device such that the implantable medical device be located within a perimeter defined by the rim and maintain the support structure at said position, and
(b) Allow a processor to drive the X-Y table to move the external element as defined in step c) of claim 13 into the coaxial position and keep it at said position, with the primary axis, (Z1), being coaxial to the secondary axis, (Z2), of the implantable medical device.

### Claim 16 (depends on 3)

The kit of parts of claim 3, wherein:
(A) The external element is a programming unit and the electromagnetic waves emitted by the external emitter are programming instructions, and
(B) The internal electronic unit of the implantable medical device is programmable, Such that when the external energy emitter of the programming unit is positioned adjacent to the internal energy receiver of the programmable implantable medical device with the primary and secondary transmission axes, (Y1,Y2), positioned coaxially, the programming instructions emitted by the external energy emitter are received optimally by the internal energy receiver and transmitted to the internal electronic unit.

### Claim 17 (depends on 3)

The kit of parts of claim 3, wherein:
(A) The external electronic unit of the external element comprises an external receiver allowing the reception of electromagnetic waves propagating in a direction parallel to the primary transmission axis, (Y1),
(B) The internal electronic unit of the implantable medical device comprises an internal energy emitter configured for emitting electromagnetic waves in a direction parallel to the secondary transmission axis, (Y2), Such that when the external energy receiver of the external element is positioned adjacent to the internal energy emitter of the implantable medical device, with the primary and secondary transmission axes, (Y1, Y2), positioned coaxially, the electromagnetic wave emitted by the internal energy emitter is received optimally by the external energy receiver.

### Claim 18 (depends on 8)

The kit of parts according to claim 8, having a coaxial configuration and wherein the light source (22) of the implantable medical device also acts as internal energy emitter for transferring the data of the implantable medical device or collected by the implantable medical device in the form of an optical wave.

### Claim 19 (depends on 10, 11, 13)

The method of claim 13, wherein the external element and implantable medical device are from a kit of parts according to claim 10, said method comprising:
(a) Position the rim of the support structure on the skin of the patient at an approximate position of the implantable medical device such that the implantable medical device be located within a perimeter defined by the rim and maintain the support structure at said position, and
(b) Allow a processor to drive the X-Y table to move the external element as defined in step c) of claim 11 into the coaxial position and keep it at said position, with the primary axis (Z1) being coaxial to the secondary axis (Z2) of the implantable medical device.