Hair-like device and method of implanting the same

Abstract

A hair-like device (1) extends between an implant end (2) and a distal end (3). The implant end (2) is configured to be disposed in a follicular hair channel opening and includes a sensing or stimulation device. The distal end (3) is configured to be connected to a remotely disposed controller (5) receiving signals from, or delivering signals to, the implant end (2). A method of implanting the hair-like device (1) and a method of manufacturing the hair-like device are also provided.

Description

HAIR-LIKE DEVICE AND METHOD OF IMPLANTING THE SAME Field

[0001] The invention relates to an apparatus for interfacing with a body for sensing / or actuation and, in particular, to a hair-like device and method of implanting the same.

[0002] The invention has been developed primarily for use in ambulatory and / or everyday monitoring in a person and will be described hereinafter with reference to this application. However, it will be appreciated that the invention is not limited to this particular field of use and is further applicable to delivering stimuli or actuation signals. Background

[0003] The following discussion of the prior art is intended to present the disclosure in an appropriate technical context and allow its advantages to be properly appreciated. Unless clearly indicated to the contrary, however, reference to any prior art in this specification should not be construed as an express or implied admission that such art is widely known or forms part of common general knowledge in the field.

[0004] Monitoring the health and well-being of the person is very well known in both clinical and outpatient settings. It is very well known to apply electrodes to a skin surface to measure changes in electrical activity which can be used for diagnosis, monitoring and / or intervention purposes.

[0005] Electrocardiograms (ECGs) and electroencephalograms (EEGs) are two commonly used non-invasive testing methods, as are electroculograms (EOGs). In the former, electrodes are typically applied around the chest area about the heart region to the skin surface and electrical activity indicative of rhythms of the heart is recorded and this can assist in diagnosing heart conditions such as coronary heart disease or arrhythmia, for example.

[0006] In the case of electroencephalograms, electrodes are placed about the scalp region of a person on the outside of their skull, and these can be particularly useful at diagnosing or monitoring undesirable symptoms such as seizures. It will be appreciated that quite often thelarger the number of electrodes placed on the person will result higher resolution and potentially less noisy signals. This is similarly the case with electroculograms where electrodes are positioned near the eyes.

[0007] In the case of the EEGs, a plurality of spaced apart electrodes are disposed on the scalp surface of a person, and these are typically wet electrodes having a conjunctive gel disposed between the electrode and the skin. Each of the electrodes is typically connected in one or more bundles cables to a recording or monitoring device and those bundles need to be restrained so they are not moved and consequently interfere with the electrodes. The electrodes will often stay attached for only around 10 days.

[0008] Unfortunately, whilst the use of electrodes on a skin surface are particularly useful in a purpose-built clinical environment where a patient is restrained from normal activities, problems are faced when ambulatory and / or every day and relatively long-term monitoring is required. In the case of a person actively having ECG measurements taken, the electrodes can often be secured to the skin via tape and underclothing so that they are not disturbed or moved providing a relatively consistent result. Being clothed also allows recording or controller devices for the electrodes to be placed approximately without a significant visual impact on the user but the electrodes are still vulnerable to inadvertent removal when bathing or performing other activities.

[0009] In addition to requiring similar levels of care against removal as chest electrodes in the case of an ECG, for an EEG the scalp portion carrying the electrodes is typically exposed and so is the neck region of the user. This presents a significant number of potential catch points, and the greater the number of electrodes used, the more of a scalp is covered in wires, and the weight is not insignificant, requiring external support.

[0010] The object of the invention is to overcome or substantially ameliorate one or more of the disadvantages of the prior art, or to provide a useful alternative. Summary of Invention

[0011] According to a first aspect of the invention there is provided a hair-like device extending between an implant end and a distal end, the implant end configured to be disposed ina follicular hair channel opening and including sensing or stimulation device wherein the distal end is configured to be connected to a remotely disposed controller receiving signals from, or delivering signals to, the implant end.

[0012] In one or more embodiments, the implant end includes a sensor configured to detect adjacent electrical activity such that signals from the sensor are communicated to the controller via the distal end.

[0013] In one or more embodiments, the implant end includes an actuator configured to deliver signals adjacent thereto when actuated by the controller.

[0014] In one or more embodiments, the implant end actuator is configured to deliver electrical, electromagnetic or optical signals actuated by the controller transmitted by signals to the device distal end.

[0015] In one or more embodiments, the signals delivered by the actuator are configured to actuate an implanted device disposed adjacent the implant end.

[0016] In one or more embodiments, the hair-like device is configured to be disposed toward the lower end of the dermis of skin.

[0017] In one or more embodiments, a plurality of devices are configured to be connected at their respective implant ends to a clip attached to or about the devices. In one or more embodiments, the clip includes the controller associated therewith.

[0018] In one or more embodiments, a sheathed conductive wire and / or optical fibre extends from the distal end to the implant end.

[0019] In one or more embodiments, a hollow core extends through the device from the distal end to the implant end.

[0020] In one or more embodiments, the implant end is substantially rigid and the distal end is flexible.

[0021] In one or more embodiments, the implant end includes a retention portion configured to retain the device in a follicular channel.

[0022] In one or more embodiments, the retention portion includes a bulbous portion, or one or more spaced apart barbs.

[0023] In one or more embodiments, at least a portion of the implant end is biodegradable and configured to all from the follicular channel after a predetermined period of time.

[0024] According to another aspect of the invention there is provided a method of implanting the hair-like device according to the first aspect into a follicular hair channel, the method including the steps of retaining the device adjacent the implant end and inserting the implant end at a predetermined depth into the follicular hair channel and depositing the same therein.

[0025] In one or more embodiments, the method includes the step of retaining the hair-like device within a follicular unit extraction implanter and implanting the hair-like device in the follicular hair channel.

[0026] In one or more embodiments, the method includes the step of implanting a plurality of spaced apart hair-like devices such that the distal end of each hair-like device is individually connected to the controller to receive or deliver substantially the same signal to or from the controller.

[0027] In one or more embodiments, the method includes the step of implanting a plurality of spaced apart hair-like devices such that a predetermined number of device distal ends of the hair-like devices are connected together to receive or deliver substantially the same signal to or

[0028] According to a further aspect of the invention there is provided a method of manufacturing a hair-like device extending between an implant end and a distal end, comprising providing a wire; applying an electrical current to the wire such that the wire breaks into two wire elements; and shaping each wire element into the hair-like device.

[0029] In one or more embodiments, the shaping step comprises allowing a bulbous portion to be formed at one end of each wire element. In one or more embodiments, the shaping stepcomprises allowing a bulbous portion to be formed at one end of each wire element and removing the bulbous portion. In one or more embodiments, the shaping step comprises allowing a bulbous portion to be formed at one end of each wire element and cutting the bulbous portion into a barbed portion.

[0030] It can therefore be seen that there is advantageously provided a device having a natural hair-like appearance that is able to send or receive signals that is not susceptible to unwanted removal. Further, there will be appreciated that the method of placing the device advantageously makes use of existing clinically approved apparatus. Importantly, the device is minimally invasive and most advantageously provides an opportunity to access head / brain signals. Brief Description of Drawings

[0031] Preferred embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0032] Fig.1 is a schematic view of a device according to a one preferred embodiment of the invention;

[0033] Fig.2A is a schematic view of a device according to a second preferred embodiment of the invention;

[0034] Fig.2B is a schematic view of a device according to another preferred embodiment of the invention

[0035] Fig.3 is a schematic view of the device according to a third preferred embodiment of the invention; (rigid and flexible portions)

[0036] Fig.4 is a schematic view of the device according to a fourth embodiment of the invention; (actuator at lower end)

[0037] Fig.5 is a schematic view of the embodiment of the device of fig.1 showing a connecting hairband clip and controller;

[0038] Fig.6 is a schematic view of various configurations of implant end of the device of Fig.1;

[0039] Fig.7 is a schematic view of the device of Fig.4 disposed adjacent an independent implanted device;

[0040] Fig.8 is a schematic view of the device of Fig.1 implanted into the follicular channels of nonliving skin;

[0041] Fig.9 illustrates an arrangement for testing the device of Fig.8;

[0042] Fig.10 shows photos of the testing protocol of the arrangement of Fig.8; and

[0043] Fig.11 shows a bar graph of results sensing variation in electrical signal in the implanted device of Fig.8. Description of Embodiments

[0044] In the description of the preferred embodiments, it will be appreciated that like reference numerals have been used to denote like components unless expressly noted otherwise.

[0045] The preferred embodiment uses conventional hair transplantation techniques and apparatus such as follicular unit extraction to implant an artificial hair-like device 1 in a follicular channel opening. A plurality of hair-like devices 1 can be provided most preferably to the scalp in the preferred embodiment but any part of the body having hair.

[0046] The artificial hair-like devices one can be used to sense or deliver signals. For example, for measuring the EEG, ECG or EOG signals, or for delivering stimulus to actuate and implanted medical device or pharmaceutical substance. In use, conventional hair transplant plug insertion techniques such as using a Sapphire blade or needle tip apparatus can be used for the implementation.

[0047] The implementation of devices 1 into follicular hair channels provides a subcutaneous implant that is minimally invasive and that does not require newly developed deliverytechnology to implant. It is believed the risk of infection is relatively low and can have a significant useful implantation lifespan.

[0048] Generally, there is provided hair-like device 1 that extends between an implant end 2 and a distal end 3. The implant end 2 is configured to be disposed in a follicular hair channel opening (not clearly illustrated) and can include a sensing and / or stimulation device. The distal end 3 is configured to be connected to a remotely disposed controller 5 and able to receive signals from or deliver signals to the implant end 2.

[0049] Once implanted, the device 1 is intended to have the implant end 2 disposed toward the lower end of the dermis of the skin, at or adjacent the hypodermis interface (not illustrated). In use, the device 1 is implanted using conventional hair transplant techniques such as by means of a follicular unit extraction implanter (also not illustrated) whereby the device 1 is inserted into the channel without damaging the channel for either of the hair erector muscle or the sebaceous gland.

[0050] Whilst each device 1 can be individually connected to controller, 5 it is most preferable, as described below, to provide a plurality of relatively closely spaced apart implanted devices 1 and to connect these collectively or as a group to the controller 5. In this way, signal detection levels can be enhanced if desired. Although not clearly illustrated, when used to measure electrical activity subcutaneously, groups of implanted devices 1 can be used as desired to measure determined signals, for example, EEG, ECG or EOG.

[0051] In one preferred embodiment shown in Fig.5, a hair clip in the form of a hair loop 7 (also seen schematically in Fig.10) is used to connect the distal ends 3 of respective implanted devices 1 to remotely located controller 5. Hair loop 7 includes anchor portions 7’ and intermediate loop portion 7” retaining hair including devices 1. Although only one group of implanted devices 1 is shown in Fig.10 it will be appreciated a plurality of groups can be provided spaced apart over the skin surface as desired such as shown at top left of Fig.5.

[0052] In such case, and particularly when disposed about the scalp surface, having the distal ends 3 connected to a relatively closely adjacent loop portion 7” reduces electrode connector members required to connect to controller 5. This also advantageously provides a more normal appearance as hair loops and clips are relatively common.

[0053] It will be appreciated device 1 can be formed from a sheathed or unsheathed wire extending from the implant end 2 to the distal end 3 whereby electrical signals can be received or delivered by controller 5 via loop portion 7”. It will be appreciated when a plurality of wire- like devices 1 are used, these can be individually or collectively in groups coupled to the hair loop 7 which preferably interfaces with controller 5 being remotely disposed. The hair loop 7 shown upper right of Fig.5 shows a second embodiment having a pair of spaced apart loop portions 7” extending intermediate anchors 7’ such that devices 1 individually or in groups connect to loop portions 7”.

[0054] In the embodiment of Fig.5, signals from devices 1 are communicated to the remotely disposed controller by a wireless communication system disposed in an anchor portion 7’. The anchor portions 7’ may comprise an electronic readout and transmitter, as well as batteries, as shown at bottom left of Fig.5. The loop 7 may also comprise multiple wires for connectivity to specific exposed parts in order to make connection with the artificial hair-like device 1, as shown at bottom right of Fig.5. However, it will be appreciated that the controller 5 may be disposed within hair loop anchors 7’, particularly in cases where electrical signals from the implant end 2 of each device 1 are measured and recorded. The hair loop 7, for example, can include a battery source, receiving electronics and electronic memory for recording signals from individual devices 1 or groups thereof such as when used in EEG or ECG settings, or it may communicate signals for remote processing and receipt of control signals. As shown at the bottom of Fig.5, the hair loop 7 may receive signals from electrodes at the implant end 2 using an analog front-end (AFE) that is connected to a wireless transmission antenna for transmitting data telemetry to a mobile app that interfaces with the cloud.

[0055] As shown in Figs.6A to 6C, device 1 can be adapted at the implant end 2 to minimise removal thereof from a follicular channel. For example, device 1 can include a retention portion in the form of a bulbous portion 8 at or about the implant end 2, as shown in Fig.6A. In another example, the retention portion could be collared or include one or more barbed portions 9a and 9b, such as those shown in Figs.6B and 6C. This is to allow the implant end 2 to better engage within the follicular channel.

[0056] It will be appreciated that implant end 2 is most preferably formed from a biocompatible material so that the follicular hair channel grows around and retains the device 1. Further, it will be appreciated that at least a portion of the implant end 2 can be formed from abiodegradable material so that it falls out or can be removed with minimal force after an approximate predetermined period of time.

[0057] The device 1 can also be formed from different materials at the implant end 2 and distal end 3. For example, to provide a more natural hair-like appearance, the implant end 2 of the device 1 can be formed from a relatively rigid material such as gold or a metal alloy, and the distal end 3 from adjacent the skin surface when implanted can be formed from a flexible material. Suitable biocompatible metal alloys include platinum iridium alloys.

[0058] The device 1 may be manufactured using a "fuse wire melting" technique to easily and repeatedly produce multiple devices 1 that are entirely whole or unitary. Biocompatible wires can be purchased in 25 μm to 100 μm diameters for manufacturing the device 1. These biocompatible wires are flexible in nature and not at all rigid. In the manufacturing process, the wire is placed between two electrodes. A relatively large electrical current is passed through the wire, sufficient to nearly melt it, causing the wire to break. This is similar to how a fuse breaks. This is driven by the minimisation of the surface energy of the wire once a sufficiently high temperature is reached to allows for sufficient mobility of the wire atoms. The current is usually smaller than the usual household plug current of 10 A (maximum). As a consequence, the breakage of the wire naturally results in two wire elements or pieces that are used as the artificial hair-like devices 1 that can be implanted using a typical hair transplant machine and its needle, such as a follicular unit extraction implanter. As a result of this process, a bulbous portion 8 naturally forms at one end of each wire element or piece that is used as the implant end 2 of the device 1 that may be implanted in the subscalp area. The wire elements may be further optionally shaped, by removing the bulbous portion or forming the retention portion of the types described above.. For example, the bulbous portion 8 may be suitably shaved or cut to into one of the barbed portions 9a or 9b .

[0059] Turning now to Figs 8-11, there is shown images and schematic representation of a testing apparatus for a device 1 from stainless steel wire. Animal skin was used as a test bed and a plurality of 60 micrometre diameter stainless steel devices 1 were implanted using conventional follicular hair extraction implantation techniques. A density of 200 pairs per square centimetre were disposed over a test area of one square centimetre. The implant ends 2 were implanted to a depth of 3 mm. This is best seen in Fig.8.

[0060] Fig.9 illustrates devices 1 connected at their distal ends as a group to an electrode 11 which is electrically connected to a controller 5 (not illustrated) to receive the signals by means of connectors 13. Fig.10 indicates the testing of a single implanted device 1, three devices 1, six devices 1 and 30 devices 1. The applied frequencies and amplitude are noted in the table and the results are shown in Fig.11 indicating an acceptable signal-to-noise ratio for use with the implant devices 1.

[0061] It will be appreciated that the implant end 2 can include any preferred sensing element to sense electrical, magnetic and / or optical signals. The optical fibre can be in addition to or used independently of a conductive wire or inductive sensor and would connect optically to the controller 5 to receive or deliver optical signals. For example, a fibre only device 1 is shown in Fig.2A where an optical fibre element includes a waveguide extending from the implant end 2 and terminates at the distal end 3 at a fibre coupler. Light into and out of the fibre at the distal end is controlled by controller 5 and includes a light source and / or receiver (not illustrated) coupled to the fibre by the coupler.

[0062] In the case of Fig.2B, there is shown a hollow device 1 having a conduit extending between the implant end 2 and the distal end 3. The conduit is connected at the distal end 3 to a pump 4 drawing a fluid from a reservoir that may be integral. Fluid flow is controlled by controller 5 and it will be appreciated that any desired fluid can be used with such an embodiment of implant 1. In alternative embodiments, not illustrated, fluid samples may be taken periodically from the hollow device 1.

[0063] It will also be appreciated that implant end 2 can include an actuator or actuation element 6 that is configured to deliver electrical, magnetic and / or optical stimulation within the follicular hair channel, as best shown in Figs.4 and 7. Furthermore, medical devices may be implanted under the hypodermis to be actuated by signals delivered by implant end 2 of the device 1, as best shown in Fig.7. For example, predetermined pulse signals may be used to actuate a pharmaceutical delivery device implanted adjacent thereto.

[0064] Notwithstanding use of the invention provides a reliable means for brain and head measurements, it will also be appreciated the use of existing follicular unit transplantation techniques is minimally invasive and is shown to be relatively safe particularly from infection. See for example Kerure & Patwardhan, “Complications in Hair Transplantation”, J CutanAesthet Surg.2018 Oct-Dec; 11(4): 182–189. doi: 10.4103 / JCAS.JCAS_125_18 or Norwood & Rhoades, “Infection with hair transplant surgery”, Cutis .1979 May;23(5):642-5.

Claims

CLAIMS 1. A hair-like device extending between an implant end and a distal end, the implant end configured to be disposed in a follicular hair channel opening and including a sensing or stimulation device wherein the distal end is configured to be connected to a remotely disposed controller receiving signals from, or delivering signals to, the implant end.

2. The device according to claim 1 wherein the implant end includes a sensor configured to detect adjacent electrical activity such that signals from the sensor are communicated to the controller via the distal end.

3. The device according to claim 1 wherein the implant end includes an actuator configured to deliver signals adjacent thereto when actuated by the controller.

4. The device according to claim 3 wherein the implant end actuator is configured to deliver electrical, electromagnetic or optical signals actuated by the controller transmitted by signals to the device distal end.

5. The device according to claim 3 or 4 wherein the signals delivered by the actuator are configured to actuate an implanted device disposed adjacent the implant end.

6. The device according to any one of claims 1 to 5, configured to be disposed toward the lower end of the dermis of skin.

7. The device according to any one of claims 1 to 6 wherein a plurality of devices are configured to be connected at their respective implant ends to a clip attached to or about the devices.

8. The device according to claim 7 wherein the clip includes the controller associated therewith.

9. The device according to any one of claims 1 to 8 including a sheathed conductive wire and / or optical fibre extending from the distal end to the implant end.

10. The device according to any one of claims 1 to 9 including a hollow core extending through the device from the distal end to the implant end.

11. The device according to any one of claims 1 to 10 wherein the implant end is substantially rigid and the distal end is flexible.

12. The device according to any one of claim 1 to 11 wherein the implant end includes a retention portion configured to retain the device in a follicular channel.

13. The device according to claim 12 wherein the retention portion includes a bulbous portion, or one or more spaced apart barbs.

14. The device according to any one of claims 1 to 13 wherein at least a portion of the implant end is biodegradable and configured to all from the follicular channel after a predetermined period of time.

15. A method of implanting the hair-like device of any one of claims 1 to 14 into a follicular hair channel, the method including the steps of retaining the hair-like device adjacent the implant end and inserting the implant end at a predetermined depth into the follicular hair channel and depositing the hair-like device therein.

16. The method according to claim 15 including the step of retaining the hair-like device within a follicular unit extraction implanter and implanting the hair-like device in the follicular hair channel.

17. The method according to claim 15 or 16 including the step of implanting a plurality of spaced apart hair-like devices such that the distal end of each hair-like device is individually connected to the controller to receive or deliver substantially the same signal to or from the controller.

18. The method according to claim 15 or 16 including the step of implanting a plurality of spaced apart hair-like devices such that a predetermined number of device distal ends of the hair- like devices are connected together to receive or deliver substantially the same signal to or from the controller.

19. A method of manufacturing a hair-like device extending between an implant end and adistal end, comprising providing a wire; applying an electrical current to the wire such that the wire breaks into two wire elements; and shaping each wire element into the hair-like device.

20. The method of claim 19, wherein the shaping step comprises at least one of:allowing a bulbous portion to be formed at one end of each wire element; allowing a bulbous portion to be formed at one end of each wire element and removing the bulbous portion; and allowing a bulbous portion to be formed at one end of each wire element and cutting the bulbous portion into a barbed portion.

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