US20090216324A1 - Malleable implantable medical device - Google Patents

Abstract

A malleable implantable medical device for implanting in a recipient comprising a flexible region of the medical device, one or more structures proximate to the flexible region, wherein the one or more structures is configured to provide a bending force to the flexible region, and one or more hermetically sealed medical components coupled to the flexible region, wherein the one or more medical components is configured to provide a therapeutic effect on the recipient.

Description

BACKGROUND
• 1. Field of the Invention
• The present invention relates generally to implantable medical devices, and more particularly, to malleable implantable medical devices.
• 2. Related Art
• Implantable medical devices have been used to provide therapeutic benefits to patients for a host of reasons. For example, implantable medical devices may provide therapeutic benefits for those patients who have experienced hearing loss by enhancing or replacing hearing stimulation which they are no longer able to experience. Hearing loss, which may be due to many different causes, is generally of two types, conductive and sensorineural. In some cases, a person may have hearing loss of both types. Conductive hearing loss occurs when the normal mechanical pathways for sound to reach the hair cells in the cochlea are impeded, for example, by damage to the ossicles. Conductive hearing loss is often addressed with conventional hearing aids which amplify sound.
• Many people who are profoundly deaf, however, have sensorineural hearing loss. This type of hearing loss is due to the absence or destruction of the hair cells in the cochlea which transduce acoustic signals into nerve impulses. Those suffering from sensorineural hearing loss are thus unable to derive suitable benefit from conventional hearing aids due to the damage to or absence of the mechanism for naturally generating nerve impulses in response to sound.
• It is for this purpose that another type of auditory prosthesis, a cochlear implant (also commonly referred to as cochlear prostheses, cochlear devices, cochlear implant devices, and the like; generally and collectively referred to herein as “cochlear implants”) has been developed. Stimulating auditory prostheses such as cochlear implants bypass the hair cells in the cochlea, directly delivering electrical stimulation to the auditory nerve fibers via an implanted electrode assembly. This enables the brain to perceive a hearing sensation resembling the natural hearing sensation normally delivered to the auditory nerve.
• Certain implantable medical devices such as cochlear implants are positioned directly underneath the skin and/or placed into an excavated portion of the recipient's bone or tissue. Other implantable medical devices are placed directly on the bone without excavation. A portion of the implanted devices may extend away from the bone or may extend outward from the bone or excavated portion.
SUMMARY
• Embodiments of the present invention are generally directed to a malleable implantable medical device which is configurable to conform to the shape of a patient's bone, skull or other natural or artificial structure found at the implantation site. In some embodiments, the malleable implantable medical device comprises one or more therapeutic or medical components, a flexible portion of the device coupled to the therapeutic or medical components, and a structure which is configured to provide a bending force to the flexible portion such that the implantable medical device conforms to a desired shape, such as to the curvature of the recipient's bone or skull. In other embodiments, the malleable implantable medical device may be position in or around the patient's bone, skull or other natural or artificial structures found at the implantation site such that one or more of those structures provide a bending force to the flexible portion of the device in order to have the flexible portion conform to the structure at the implantation site. In yet other embodiments, portions of the malleable implantable medical device are optionally removable in order to have the medical device conform to the shape of a patient's bone, skull or other natural or artificial structures found at the implantation site.
• In one embodiment of the present invention, a malleable implantable medical device for implanting in a recipient is provided comprising a flexible region of the medical device, one or more structures proximate to the flexible region, wherein the one or more structures is configured to provide a bending force to the flexible region, and one or more hermetically sealed medical components coupled to the flexible region, wherein the one or more medical components is configured to provide a therapeutic effect on the recipient.
BRIEF DESCRIPTION OF THE DRAWINGS
• Embodiments of the present invention are described below with reference to the attached drawings, in which:
• FIG. 1 is a perspective view of a malleable implantable medical device in accordance with one embodiment of the present invention;
• FIG. 2A is a top view of a malleable implantable medical device in accordance with one embodiment of the present invention;
• FIG. 2B is a cross-sectional view of the malleable implantable medical device ofFIG. 2A in accordance with one embodiment of the present invention;
• FIG. 2C is a perspective view of a malleable implantable medical device in accordance with one embodiment of the present invention as force is being manually applied to the device;
• FIG. 2D is a cross-sectional view of the malleable implantable medical device ofFIG. 2A in accordance with one embodiment of the present invention as an activating light is directed to the device;
• FIG. 3A is a top view of a malleable implantable medical device in accordance with one embodiment of the present invention;
• FIG. 3B is a cross-sectional view of the malleable implantable medical device ofFIG. 3A in accordance with one embodiment of the present invention;
• FIG. 4A is a cross-sectional view of a malleable implantable medical device in accordance with another embodiment of the present invention;
• FIG. 4B is a perspective view of a thin membrane used in a malleable implantable medical device in accordance with another embodiment of the present invention;
• FIG. 5A is a side view of a malleable implantable medical device in accordance with one embodiment of the present invention;
• FIG. 5B is a cross-sectional view of the malleable implantable medical device ofFIG. 5A in accordance with one embodiment of the present invention;
• FIG. 6 is a top view of a malleable implantable medical device in accordance with one embodiment of the present invention;
• FIG. 7 is a top view of a malleable implantable medical device in accordance with one embodiment of the present invention;
• FIG. 8A is a perspective view of a malleable implantable medical device in accordance with one embodiment of the present invention;
• FIG. 8B is a cross-sectional view of the malleable implantable medical device ofFIG. 8A in accordance with one embodiment of the present invention;
• FIG. 9A is a bottom view of a malleable implantable medical device in accordance with one embodiment of the present invention;
• FIG. 9B is a cross-sectional view of the malleable implantable medical device ofFIG. 9A depicting a condition of the device before a bending force is applied in accordance with one embodiment of the present invention;
• FIG. 9C is a cross-sectional view of the malleable implantable medical device ofFIG. 9A depicting a condition of the device after a bending force is applied in accordance with one embodiment of the present invention;
• FIG. 10A is a cross-sectional view of a flexible wing proximate to a stimulator unit of a malleable implantable medical device in accordance with an embodiment of the present invention;
• FIG. 10B is a cross-sectional view of a flexible wing proximate to a stimulator unit of a malleable implantable medical device in accordance with an embodiment of the present invention;
• FIG. 10C is a cross-sectional view of a flexible wing proximate to a stimulator unit of a malleable implantable medical device in accordance with an embodiment of the present invention;
• FIG. 10D is a cross-sectional view of a flexible wing proximate to a stimulator unit of a malleable implantable medical device in accordance with an embodiment of the present invention;
• FIG. 10E is a cross-sectional view of a flexible wing proximate to a stimulator unit of a malleable implantable medical device in accordance with an embodiment of the present invention;
• FIG. 11A is a perspective view of a flexible wing proximate to an internal coil of a malleable implantable medical device in accordance with an embodiment of the present invention;
• FIG. 11B is a perspective view of a flexible wing proximate to an internal coil of a malleable implantable medical device in accordance with an embodiment of the present invention;
• FIG. 12 is a perspective view of a flexible wing proximate to an internal coil of a malleable implantable medical device in accordance with an embodiment of the present invention;
• FIG. 13A is a perspective bottom view of a flexible wing proximate to both a stimulator unit and an internal coil of a malleable implantable medical device in accordance with an embodiment of the present invention;
• FIG. 13B is a perspective bottom view of a flexible wing proximate to both a stimulator unit and an internal coil of a malleable implantable medical device in accordance with another embodiment of the present invention;
• FIG. 14A is a perspective view of a removable pedestal proximate to a stimulator unit of a malleable implantable medical device in accordance with an embodiment of the present invention;
• FIG. 14B is a perspective view of a removable pedestal proximate to a stimulator unit of a malleable implantable medical device in accordance with an embodiment of the present invention; and
• FIG. 14C is a perspective view of a removable pedestal proximate to a stimulator unit of a malleable implantable medical device in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION
• Embodiments of the present invention are generally directed to a malleable implantable medical device which can be configured to conform to the shape of a patient's bone, skull or other natural or artificial structures found at the implantation site. In some embodiments, the malleable implantable medical device comprises one or more therapeutic or medical components, a flexible portion of the device which is coupled to the therapeutic or medical components, and a structure which is configured to provide a bending force to the flexible portion such that the implantable medical device conforms to a desired shape, such as to the curvature of the recipient's bone or skull. In other embodiments, the malleable implantable medical device may be position in or around the patient's bone, skull or other natural or artificial structures found at the implantation site such that one or more of those structures provide a bending force to the flexible portion of the device in order to have the flexible portion conform to the structure at the implantation site. In yet other embodiments, portions of the malleable implantable medical device are optionally removable in order to have the medical device conform to the shape of a patient's bone, skull or other natural or artificial structures found at the implantation site.
• The malleable implantable medical device of the present invention will be described in conjunction with an implanted unit of a prosthetic hearing implant, such as a Cochlear™ implant sold by Cochlear Limited. It should be understood to those skilled in the art that the present invention may be used in other implanted medical devices, such as neurostimulators, cardiac pacemakers/defibrillators, etc.
• FIG. 1 is perspective view of one embodiment of acochlear implant100 implanted in ahuman cochlea140. Referring now toFIG. 1, the relevant components ofouter ear101,middle ear105 andinner ear107 are described next below. In a fully functional earouter ear101 comprises anauricle110 and anear canal102. An acoustic pressure orsound wave103 is collected byauricle110 and channeled into and throughear canal102. Disposed across the distal end ofear canal102 is atympanic membrane104 which vibrates in response tosound wave103. This vibration is coupled to oval window orfenestra ovalis112 through three bones ofmiddle ear105, collectively referred to as theossicles106 and comprising themalleus108, theincus109 and thestapes111.Bones108,109 and111 ofmiddle ear105 serve to filter and amplifysound wave103, causingoval window112 to articulate, or vibrate. Such vibration sets up waves of fluid motion withincochlea140. Such fluid motion, in turn, activates tiny hair cells (not shown) that line the inside ofcochlea140. Activation of the hair cells causes appropriate nerve impulses to be transferred through the spiral ganglion cells andauditory nerve114 to the brain, where they are perceived as sound.
• Cochlear implant100 comprisesexternal component assembly142 which is directly or indirectly attached to the body of the recipient, and aninternal component assembly144 which is temporarily or permanently implanted in the recipient.External assembly142 typically comprisesmicrophone124 for detecting sound, aspeech processing unit126, a power source (not shown), and anexternal transmitter unit128.External transmitter unit128 comprises anexternal coil130 and, preferably, a magnet (not shown) secured directly or indirectly toexternal coil130.Speech processing unit126 processes the output ofmicrophone124 that is positioned, in the depicted embodiment, byauricle110 of the recipient.Speech processing unit126 generates coded signals, referred to herein as a stimulation data signals, which are provided toexternal transmitter unit128 via a cable (not shown).
• Internal assembly144 comprises aninternal receiver unit132, astimulator unit120, and anelongate electrode carrier118.Internal receiver unit132 comprises aninternal coil136, and preferably, a magnet (also not shown) fixed relative tointernal coil136.Internal receiver unit132 andstimulator unit120 are hermetically sealed within a biocompatible housing. The internal and external coils form a transcutaneous link such that the internal coil receives power and stimulation data fromexternal coil130.Elongate electrode carrier118 has a proximal end connected tostimulator unit120 and extends fromstimulator unit120 tocochlea140.Elongate electrode carrier118 is implanted intocochlea140 via acochleostomy122.
• Elongate electrode carrier118 comprises anelectrode array146 disposed at the distal end thereofElectrode array146 comprises a plurality of longitudinally-alignedelectrodes148. Stimulation signals generated bystimulator unit120 are applied byelectrodes148 tocochlea140, thereby stimulatingauditory nerve114.
• External coil130 transmits electrical signals (i.e., power and stimulation data) to theinternal coil136 via a radio frequency (RF) link. Theinternal coil136 is typically comprised of multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire. The electrical insulation of theinternal coil136 is provided by a flexible silicone molding (not shown). In use, implantableinternal receiver unit132 may be positioned in a recess of the temporal bone (not shown)adjacent auricle110 of the recipient.
• FIG. 2A is a top view of acochlear implant100 in accordance with one embodiment of the present invention. As discussed previously,cochlear implant100 comprises aninternal receiver unit132 having aninternal coil136 and is hermetically sealed in biocompatible housing. The portion of the housing forinternal receiver unit132 havinginternal coil136 may be made of a flexible elastomer (e.g. silicone) such that it will bend when a bending force is applied to the housing. In one embodiment of the present invention, this portion, referred to asflexible region202, contains a sealedchamber204 with one or morecurable materials206 contained withinchamber204. The one or morecurable materials206 contained therein may be cured or otherwise activated, as will be discussed further below. By curingcurable materials206 inside of aflexible region202 of the implantable medical device,flexible region202 adopts and retains the shape into whichcurable materials206 are cured. For purposes of this invention, “curable” material should be understood to include materials that can be cured with the application of just energy, such as heat or UV-light, without the addition of other chemicals, compounds or other materials. It should also be understood that “curable” material includes materials which, though not capable of being cured or otherwise activated by itself or even with the addition of various energies such as heat or UV-light, are capable of curing or activating upon the addition of an added chemical, compound or material, either with and without additional energy (e.g., heat, UV-light) being applied to a mixture of the first and second “curable” materials.Curable material206 may be a curable silicone elastomer, but may also be any other material suitable for use according to the present invention.
• In other embodiments of the present invention,chamber204 may be divided into two or more sub-chambers, with different curable materials contained in each sub-chamber. As depicted inFIGS. 2A and 2B, in an exemplary embodiment,first sub-chamber208 may contain a first curable material andsecond sub-chamber210 may contain a second curable material, withsub-chambers208,210 andinternal magnet220 configured and positioned such that the integrity ofsub-chambers208,210 are maintained even with the magnet disposed on or withinflexible region202.Sub-chambers208,210 may be manufactured initially as asingle chamber204 with athin dividing membrane212 attached withinchamber204, thereby dividingchamber204 intosub-chambers208,210, and attached in such a manner that the first and second curable materials placed withinsub-chambers208,210 do not intermix until they are intentionally combined by an external force. Alternatively, sub-chambers208,210 may be manufactured through injection moulding, or some other process now known or later developed, to form the twosub-chambers208,210.
• Curable materials206 may be cured or otherwise activated so as to change its state from a liquid or gel or paste into a solid upon activation. In one exemplary embodiment whereinflexible region202 of thecochlear implant100 has asingle chamber204 containing a singlecurable material206, an external energy such as heat or light (e.g. UV-light) may be applied in order to cure or activatecurable material206 contained therein. In another exemplary embodiment depicted inFIGS. 2A-2D,flexible region202 of thecochlear implant100 has twosub-chambers208 and210, each with two differentcurable materials206 which chemically interact with one another, with or without external energy such as heat or UV-light, to change the state ofcurable materials206 into a solid. In other embodiments, the two differentcurable materials206 may not cure or activate even when intermixed without the addition of an external heat or light energy applied to the mixedcurable materials206. By applying manual force toflexible region202 using one or more fingers or hands, as shown inFIG. 2C, or by using other tools, dividingmembrane212 is deformed or broken sufficiently to permit intermixing of the differentcurable materials206 with each other.Curable materials206 may be further mixed by continued massaging or pushing forces applied manually, to ensure a substantially complete intermixing ofcurable materials206. Alternatively, once dividingmembrane212 is sufficiently deformed or broken to allow the intermixing ofcurable materials206,curable materials206 may naturally intermix without external forces being applied to a sufficient level so as to cause the curing or activating ofcurable materials206.
• As shown inFIG. 2D, aftercurable materials206 are intermixed with one another so as to initiate the curing or activating process, theflexible region202 is placed against the patient's bone, skull or other structure so thatcurable materials206 cure or activate, resulting inflexible region202 conforming to the shape of the object being pressed against. In other embodiments, as shown inFIG. 2D,UV curing light214 emitsUV light216 in the direction offlexible region202 to curecurable material206 contained therein, wherecurable material206 is a type which will cure only upon the addition ofUV light216. Whenflexible region202 is placed against the patient's bone or skull, a bandage or other temporary holding means may be used to holdflexible region202 in a fixed location and configuration, allowingcurable materials206 to cure or activate into a desirable shape. Alternatively, measurements of the structure to which the implantable medical device is to conform to may be taken prior to surgery and used to cure or activatecurable materials206 prior to surgery, so that the curedflexible region202 may more accurately reflect the shape to conform to, or so that the amount of time during which the implantation site is open during surgery can be minimized, among other reasons. These measurements may be taken directly by measuring the shape of the bone or skull when accessible, or may be taken indirectly through data gathered during an x-ray, MRI, CT-scan, or other methods now known or later developed. Further, these measurements may be used to create an accurate model of the area the malleable implant is to be placed using a CNC machine to cut the shape from a solid or by using a 3D printer or other method now know or later developed. Upon curing or activating,curable materials206 may remain flexible, and may have a softness on the durometer scale (shore A) of approximately 30-60. It is to be understood that the types of curable materials selected for other embodiments of the present invention may depend on the intended uses for the implantable medical device, the techniques or tools used for implanting the medical device, among other factors.
• In addition tosub-chambers208,210 being positioned in a side-by-side configuration as shown inFIG. 2A, other embodiments of the present invention may be configured to havesub-chambers208,210 in a top-bottom configuration wherein the layers are positioned on top of one another, as shown inFIGS. 3A and 3B. This top-bottom configuration may permit a more complete intermixing, or a faster intermixing, ofcurable materials206A,206B. Additionally, this top-bottom configuration may permit the incorporation of punchingtool302 intosub-chamber208.Punching tool302 has a pushing surface304 against which manual pressure, from a finger or another tool, can push to causesharp tip306 of punchingtool302 to be forced through dividingmembrane212, thus permitting the intermixing ofcurable material206A and206B.Stopper308 may limit the depth to whichpunching tool302 may travel so as not to damage the opposing wall ofchamber204, weresharp tip306 not prevented from traveling too far. The top-bottom configuration depicted inFIGS. 6A and 6B may be preferable when incorporatingpunching tool302 since even a slight pressure applied to the broad surface offlexible region202 will push the tip of punchingtool302 through dividing membrane.
• As shown inFIGS. 4A and 4B, in other embodiments of the present invention, punchingtool302 may not have a sharp tip as in the embodiment described above in conjunction withFIG. 3B. In the embodiment shown inFIGS. 4A and 4B, punchingtool302 has pushing surface304 and a broad or flat pushingtip406. Dividingmembrane212 has perforatedregion402 sized and configured to be pushed apart frommembrane212 by pushingtip406 when a manual force is applied to pushing surface304, which will provide an access forcurable materials206A and206B to travel betweenfirst chamber208 and210 in order thatcurable materials206A and206B can intermix.
• FIGS. 5A and 5B are side and cross-sectional views respectively of acochlear implant100 in accordance with one embodiment of the present invention. In the embodiment shown, first andsecond sub-chambers208 and210 are concentric with respect to one another, within dividingmembrane212 positioned betweensub-chambers208,210. Upon manual pressure being applied to dividingmembrane212,curable materials206A,206B are permitted to intermix, in the manner described above.
• Although previously described embodiments have referenced figures in which first andsecond sub-chambers208,210 appear to be equal in size, thus containing approximately equal volumes ofcurable materials206A,206B, it is to be understood thatsub-chambers208,210 may be of different sizes, as shown inFIG. 6. Furthermore, it is to be understood thatsub-chambers208,210 may be completely filled withcurable material206 or may only be partially filled withcurable material206 under the present invention. InFIG. 6,flexible region202 containschamber204 havingfirst sub-chamber208 andsecond sub-chamber210 which is defined by the presence of dividingmembrane212 inchamber204 so as to definesub-chambers208,210. The embodiment ofFIG. 6 may be useful where the volumes ofcurable material206A and206B are necessarily unequal with respect to one another to achieve a desired curing aspect such as speed or type of curing.
• It is further to be understood that, although multi-chamber configurations described previously have referred only to a first and second sub-chamber, more than two sub-chambers may be present inchamber204 according to the present invention. InFIG. 7, in an exemplary embodiment, sub-chambers708,710,712,714 containcurable materials706A,706B,706C,706D respectively, wherein dividingmembrane716 separates sub-chambers708,710 and wherein dividingmembrane718 separates sub-chambers712,714. By having two sets of sub-chambers (708/710 and712/714) in the embodiment ofFIG. 7, a first set may be manipulated and cured prior to manipulating and curing the second set, where doing so may be desirable for accuracy or other reasons. Additionally,curable materials706A,706B intermixed in the first set ofsub-chambers708,710 may be selected to provide a different result, such as a different softness or level of flexibility, thancurable materials706C,706D intermixed in the second set ofsub-chambers712,714.
• FIGS. 8A and 8B are perspective views of acochlear implant100 in accordance with another embodiment of the present invention. In addition to, or instead of, providing acurable material206 inchamber204,curable material206 may be provided to the space defined bychamber204 through the use of asyringe802.Syringe802 may be filled withcurable material206 and inserted into a surface offlexible region202, then plunged so as to fillchamber204 withcurable material206.Curable material206 may be a single material which can be cured or activated without the addition of a catalyst or other material, through one or more energies (e.g., heat) or light (e.g., UV-light) being applied tocurable material206. In alternative embodiments,chamber204 may be filled with a firstcurable material206A of a multi-part curable material arrangement in which a second and necessarycurable material206B, such as a catalyst, may be provided tochamber204 throughsyringe802. In yet another embodiment of the present invention,chamber204 may be substantially empty, wherebycurable materials206A and206B in a self-curing or self-activating are intermixed and immediately provided tochamber204 throughsyringe802 beforecurable materials206A and206B cure or activate in a solid which provides a bending stress toflexible region202, as described previously.
• In yet another embodiment of the present invention in which a bending force is provided to aflexible region202 of an implantable medical device,FIGS. 9A-9C shows an embodiment in which abendable structure902 is provided against a surface offlexible region202 and bent by a desired amount, resulting in the bending offlexible region202. As shown inFIG. 9A, abendable structure902 is adhered to a surface offlexible region202. As shown inFIG. 9B, in other embodiments,bendable structure902 is embedded within siliconeflexible region202. As shown inFIG. 9C, whenbendable structure902 is bent, it retains the angle into which it was bent, and causesflexible region202 to adopt a similar angle.Bendable structure902 may be a metal or alloy such as titanium in some embodiments, and may be configured in the shape of a spine, but may also be a non-metallic structure such as a series of interlocking plastic structures configured to be bent and to retain the bend with sufficient force to counteract any straightening force which may be exerted byflexible region202. In addition tobendable structure902 being positioned on the surface ofinternal receiver unit132 facing the recipient's bone or skull in certain embodiments,bendable structure902 may be positioned along the outer or other surface of internal receiver unit in other embodiments of the present invention, depending on the intended use and other considerations. Multiple bendable structures similar to902 may be used to create different levels of curvature in different locations which may allow still closer fit to the shape of the bone or skull or other feature.
• FIGS. 10A,10B,10C,10D,10E are cross-sectional views of a flexible wing proximate to a stimulator unit of acochlear implant100 in accordance with an embodiment of the present invention.Internal receiver unit132 of acochlear implant100 haswing1004 constructed in various exemplary embodiments of the present invention.Internal receiver unit132 may be implanted into a recipient by attachinginternal receiver unit132 to a bone or tissue or insertinginternal receiver unit132 into an excavated bone.Wing1004 is flexible and may extend around the entire perimeter or circumference ofinternal receiver unit132 or a portion thereof.FIG. 10A showswing1004 attached near anupper surface1006 ofinternal receiver unit132.Wing1004 may extend beyondinternal receiver unit132 so that when inserted,wing1004 may begin to flex outward beforeinternal receiver unit132 rests on the bone or tissue.
• FIG. 10B showswing1004 attached along aside surface1008 ofinternal receiver unit132.Wing1004 has arim1010 that contacts the bone or tissue and also has anindentation1012 along alower surface1014 ofwing1004.
• FIG. 10C showswing1004 having ahinge1016 nearupper surface1006 ofinternal receiver unit132.Hinge1016 allowswing1004 to pivot in addition to flexing.Wing1004 may be adhered to hinge1016, and hinge1016 may be integral or adhered tointernal receiver unit132.Wing1004 is shown with a constant slope, but may have a slope substantially similar toFIG. 10A or10B.
• FIG. 10D showswing1004 having asolid skirt1018 that extends alongside surface1008 ofinternal receiver unit132.Solid skirt1018 may have arim1010 as shown inFIG. 10B.Solid skirt1018 maybe made of a flexible material that bends and compresses.
• FIG. 10E showswing1004 that extends alongside surface1008 ofinternal receiver unit132 and has a series of removable segments1020. Each removable segment1020 may be detached to accommodate the depth of the bone excavation or the position/arrangement of the bone or tissue. The portion ofwing1004 that remains intact may be flexible or may have asolid skirt1018 as shown inFIG. 10D.
• The wing cross-sections shown inFIGS. 10A,10B,10C,10D, and10E may also be integral with the hermetically sealed biocompatible housing surroundinginternal receiver unit132 of the medical device. In addition, the wing may be part of a slipcover that extends over the housing of the medical device and is held on by an adhesive and/or the friction of the slipcover.
• When a medical device is inserted into a bone excavation the wing will flex outwards to form a smooth transition from the medical device to the bone. In addition, when a medical device rests on a bone or other tissue, the wing may also flex outwards to form a smooth transition. The flexing of the wing may be uniform around the perimeter or circumference of the housing or the wing may flex more along some portions and less along other portions depending on the nature of the medical device and/or the nature of the bone or tissue surrounding the medical device. Embodiments of the present invention may allow the wing to move away from the medical device when the medical device is positioned into the bone excavation. The free end of the wing, i.e., the end not adhered to the medical device, remains in contact with the bone or tissue and may adapt to the curvature of each recipient's bone/tissue structure. In some embodiments the free end of the wing does not contact the bone or tissue, but extends substantially towards the bone or tissue and may have a tapering portion or contour that adapts to the curvature of each recipient's bone/tissue structure.
• An advantage of such a wing of the present invention may be to provide comfort to recipients regardless of where the medical device is implanted or how the medical device is implanted. The recipient using embodiments of the present invention may not notice or feel the protrusion caused by the medical device since the smooth transition makes the medical device less obvious to the touch. In addition, another advantage of the present invention is that the medical device may be placed in an excavation at any depth since the wing will flex outward. Another advantage of the present invention is that the smooth transition may reduce the chances of skin erosion around the medical implant device. Another advantage is that the smooth transition may reduce areas where body fluids may stagnate which could increase the likelihood of infection and/or biofilms forming on the device.
• FIGS. 11A and 11B are perspective top and end views respectively of a flexible wing proximate to an internal coil of acochlear implant100 in accordance with an embodiment of the present invention. Prosthetic hearing implantinternal receiver unit132 is depicted withinternal coil136 andstimulator unit120.Stimulator unit120 is connected to an electrode array146 (not shown) throughtab1108.Wing1110 may be provided on a portion of the perimeter or circumference ofcoil136.Wing1110 has arim1112, but may be constructed to have any other cross-sectional shape as described above.Wing1110 may haveseveral cuts1114 where none of the sloping portion ofwing1110 is present.Rim1112 extends along the length ofcuts1114 to form a continuous piece.
• In an embodiment of the present invention, the wing may be provided without a rim, but still has several cuts in the wing. The cuts create several flaps of the wing that may flex independent of the other flaps. Alternatively, a rim may be positioned between two or more flaps to provide a uniform flexing amongst the flaps that are connected.
• In an embodiment of the present invention, the wing may be provided without any cuts and may have a solid skirt shape as shown in and described in conjunction withFIG. 10D.
• FIG. 12 shows a top perspective view of a prosthetic hearing implantinternal receiver unit132 havinginternal coil136 andstimulator unit120.Stimulator unit120 is connected to an electrode array146 (not shown) throughtab1108.Wing1210 may be adhered to or placed on a portion of the perimeter or circumference ofstimulator unit120.Wing1210 has a rim1212, but maybe constructed to have any other cross-sectional shape as described above.Wing1210 may haveseveral cuts1214 where none of the sloping portion ofwing1210 is present. Rim1212 andwing1210 may extend aroundtab1108.
• FIGS. 13A and 13B show bottom perspective views of a prosthetic hearing implantinternal receiver unit132 havinginternal coil136 andstimulator unit120.Stimulator unit120 is connected to anelectrode array146 throughtab1108.Wing1310 may be adhered to or placed on the perimeter or circumference of implantinternal receiver unit132.Wing1310 has arim1312, but may be constructed to have any other cross-sectional shape as described above.Wing1310 may haveseveral cuts1314 where none of the sloping portion ofwing1310 is present.Rim1312 andwing1310 may extend aroundtab1108.
• Cuts1114,1214,1314 in awing1110,1210,1310 of the present invention may provide fixation ofinternal receiver unit132 by allowing tissue or bone to grow in the vacant area, such as what occurs in osseointegration. In addition,cuts1114,1214,1314 may allow fluid circulation aroundinternal receiver unit132 to prevent bacterial growth.
• Different wing shapes, such as shown inFIGS. 10A,10B,10C,10D, and10E, may be used on or in conjunction withinternal receiver unit132. In addition, one wing shape may be used on a portion of the housing forinternal coil136, while a second wing shape is used on the other portion of the housing. Alternatively, two or more wings may be used that have different wing shapes.
• FIG. 14A is a perspective view of aremovable pedestal1402 proximate to astimulator unit120 of acochlear implant100 in accordance with an embodiment of the present invention. Other components ofcochlear implant100 such asinternal coil136 are not depicted inFIGS. 14A,14B and14C for purposes of simplicity and clarity. As depicted inFIG. 14A,removable pedestal1402 is attached to a bottom surface ofstimulator unit120. A bottom surface is to be understood as the surface that ofstimulator unit120 which is facing approximately in the direction of the patient's bone or skull.Removable pedestal1402 may be constructed of any suitable material, including the same flexible silicone material which may be used in one embodiment to form the biocompatible housing aroundstimulator unit120 andinternal coil136.
• Removable pedestal1402 andreceiver unit132 may be manufactured and provided to the surgeon already joined to one another. Awire cutter1404 is sandwiched betweenremovable pedestal1402 and a surface ofinternal receiver unit132.Wire cutter1404 is of sufficient length and positioned such that two ends ofwire cutter1404 extend beyondremovable pedestal1402 enough so that a tool or fingers may be used to grip and utilize the ends ofwire cutter1404 to either remove it frominternal receiver unit132 or as a cutting tool for cuttingremovable pedestal1402, as will be described further below in conjunction withFIGS. 14B and 14C. Alternatively,removable pedestal1402 may be manufactured separately frominternal receiver unit132 and provided for surgery as separate parts. When manufactured and provided as separate parts, these separate parts may be assembled and joined together a relatively short time before surgery by methods already known or later developed, such as by glue, screw, corresponding tabs or clips.
• FIG. 14B is a perspective view ofremovable pedestal1402 proximate tointernal receiver unit132 of acochlear implant100 in accordance with an embodiment of the present invention in whichremovable pedestal1402 will remain affixed tointernal receiver unit132 after implantation. Whenremovable pedestal1402 andinternal receiver unit132 are provided to the surgeon as assembled or joined parts from the manufacturer, the surgeon has the option of alteringinternal receiver unit132. The surgeon may do this to make it conform to the shape of the recipient's bone or skull depending on the condition and preparation of the implant site or through a preference for a surgical technique which avoids bone drilling. Where a suitably dimensioned bone bed has been formed in the bone through excavation,internal receiver unit132 may be positioned in the implantation site withremovable pedestal1402 intact. Implantinginternal receiver unit132 withremovable pedestal1402 intact may be useful for maintaining the location ofinternal receiver unit132, as any translational force oninternal receiver unit132 will be counteracted by thepedestal1402 pushing against the adjacent surface of the bone bed. Furthermore,removable pedestal1402 may be useful in maintaining the position ofreceiver unit132 within a bone bed such that a desired distance between the bottom surface ofreceiver unit132 and the surface of the excavated bone bed may be maintained. In this scenario, it may be desirable to removewire cutter1404 to minimize unnecessary objects being placed in the implantation site and to make removable pedestal1402 a permanent part of the implantedreceiver unit132. To removewire cutter1404, a single end ofwire cutter1404 may be pulled which will removewire cutter1404 from theinternal receiver unit132 without cutting or otherwise detachingremoval pedestal1402 frominternal receiver unit132.
• FIG. 14C is a perspective view ofremovable pedestal1402 proximate tointernal receiver unit132 of acochlear implant100 in accordance with an embodiment of the present invention in whichremovable pedestal1402 will be removed frominternal receiver unit132 prior to implantation. As discussed previously, whenremovable pedestal1402 andinternal receiver unit132 are provided to the surgeon as assembled or joined parts from the manufacturer, the surgeon may opt to removeremovable pedestal1402 frominternal receiver unit132 in order to haveinternal receiver unit132 conform to the shape of the recipient's bone or skull. For example, where the surgeon is not excavating a bone bed into which implantable components will be positioned, it may be desirable to modifyinternal receiver unit132 to removeremovable pedestal1402 in order to minimize the thickness ofinternal receiver unit132 or otherwise to haveinternal receiver unit132 better conform to the shape of the recipient's bone or skull at the implantation site. To removeremovable pedestal1402 frominternal receiver unit132, both ends ofwire cutter1404 may be pulled simultaneously in order to cut or otherwise detachremovable pedestal1402. Other mechanisms for makingremovable pedestal1402 easily removable frominternal receiver unit132 are also considered a part of this invention and may be provided or used together with, or instead of,wire cutter1404. For example, a scalpel may be used to cutremovable pedestal1402 partially or completely frominternal receiver unit132. In another exemplary embodiment,removable pedestal1402 may have a abruptly reduced cross-section at a point onremovable pedestal1402 nearinternal receiver unit132. The reduced cross-section may provide a weak point which can be torn by sufficient manual pulling force applied to theremovable pedestal1402 or tointernal receiver unit132. In a yet further exemplary embodiment,removable pedestal1402 may have perforations along its border nearinternal receiver unit132 which are configured to tear when sufficient manual pulling force is applied toremovable pedestal1402 or tointernal receiver unit132.
• Although the present invention has been fully described in conjunction with several embodiments thereof with reference to the accompanying drawings, it is to be understood that various changes and modifications may be apparent to those skilled in the art. Such changes and modifications are to be understood as included within the scope of the present invention as defined by the appended claims, unless they depart therefrom.

Claims (20)

1. A malleable implantable medical device for implanting in a recipient comprising:

a flexible region of the medical device;

one or more structures proximate to said flexible region, wherein said one or more structures is configured to provide a bending force to said flexible region; and

one or more hermetically sealed medical components coupled to said flexible region, wherein said one or more medical components is configured to provide a therapeutic effect on the recipient.

2. The malleable implantable medical device ofclaim 1, wherein said one or more structures comprises:

one or more chambers disposed within said flexible region; and

one or more curable materials disposed within each of said one or more chambers, wherein said one or more curable materials is configured to be cured while said flexible region is bent such that said cured materials adopts said bent angle thereby providing a bending force to said flexible region after being cured.

3. The malleable implantable medical device ofclaim 2, further comprising at least one dividing membrane configured to be deformed by manual pressure thereby permitting intermixing of said two or more curable materials prior to becoming cured.

4. The malleable implantable medical device ofclaim 2, wherein said two or more curable materials are configured to become cured by a chemical reaction between said two or more curable materials.

5. The malleable implantable medical device ofclaim 2, wherein said two or more curable materials are configured to become cured upon subjection to external energy.

6. The malleable implantable medical device ofclaim 5, wherein said external energy comprises heat.

7. The malleable implantable medical device ofclaim 5, wherein said external energy comprises UV light.

8. The malleable implantable medical device ofclaim 2, wherein said one or more chambers further comprise:

a first and a second chamber disposed substantially in concentric fashion with respect to one another.

9. The malleable implantable medical device ofclaim 2, wherein said one or more chambers further comprise:

a first and a second chamber configured to contain unequal volumes of said curable materials.

10. The malleable implantable medical device ofclaim 3, further comprising:

a punch tool contained within one of said one or more chambers, said punch tool comprising a pushing surface and a tip, wherein said tip is positioned adjacent to said dividing membrane and configured to provide a punch into a second of said one or more chambers through said dividing membrane upon receiving an external pressure.

11. The malleable implantable medical device ofclaim 10, wherein said tip is configured with a sharp point configured to provide said punch into said second chamber.

12. The malleable implantable medical device ofclaim 2, wherein said one or more curable materials disposed within each of said one or more chambers is configured to be provided by an injection device prior to curing and implanting said medical device in said recipient.

13. The malleable implantable medical device ofclaim 1, wherein said one or more structures comprises:

one or more bendable spine, wherein said bendable spine is configured to retain a bend upon being bent to a desired shape.

14. The malleable implantable medical device ofclaim 3, wherein said curable materials is selected and arranged to have a softness on a durometer scale (Shore A) of approximately 30-60 upon being cured.

15. A method for using a malleable implantable medical device for implanting in a recipient comprising:

providing one or more structures proximately to a flexible region of the medical device, wherein the one or more structures is configured to provide a bending force to the flexible region; and

fixing said one or more structures proximate to the flexible region.

16. The method for using a malleable implantable medical device ofclaim 15, wherein said providing one or more structures comprises providing one or more curable materials and further wherein said fixing said one or more structures further comprises subjecting said provided one or more curable materials to external energy.

17. The method for using a malleable implantable medical device ofclaim 16, wherein said providing one or more structures further comprises:

intermixing said provided one or more curable materials prior to said subjecting said provided one or more materials to external energy.

18. The method for using a malleable implantable medical device ofclaim 16, wherein said external energy comprises heat.

19. The method for using a malleable implantable medical device ofclaim 16, wherein said external energy comprises UV light.

20. A malleable implantable medical device for implanting in a recipient comprising:

means for providing one or more structures proximately to a flexible region of the medical device, wherein the one or more structures is configured to provide a bending force to the flexible region; and

means for fixing said one or more structures proximate to the flexible region.

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