Patent Publication Number: US-2022233869-A1

Title: Implantable device having one or more screws

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 14/587,260, filed on Dec. 31, 2014, which is a continuation of U.S. patent application Ser. No. 14/066,062, filed on Oct. 29, 2013, now abandoned, which is a continuation of U.S. patent application Ser. No. 13/099,927 filed on May 3, 2011, now U.S. Pat. No. 8,571,676, which is a divisional of U.S. patent application Ser. No. 10/825,359, filed on Apr. 16, 2004, now U.S. Pat. No. 7,937,156, which claims priority from Australian Provisional Application No. 2003901867, filed on Apr. 17, 2003. Each of these documents is hereby incorporated by reference herein. 
    
    
     BACKGROUND 
     Field of the Invention 
     The present invention relates generally to implantable devices and, more particularly, to implantable devices having osseointegrating protuberances. 
     RELATED ART 
     Medical devices often include one or more components that are permanently or temporarily implanted in a patient. Many such implantable devices are designed to be mounted adjacent to, abutting, or in the surface of one or more bones. Various techniques have been implemented in order to fix such devices in place and to ensure that the devices do not undergo movement once implanted. 
     In one conventional approach, an implantable device is the housing for a receiver/stimulator unit has been positioned on a bone within the head of the recipient by drilling a bed or well into and through the posterior section of the mastoid bone lying behind the recipient&#39;s ear. Such a bed is usually made by drilling the bone down to the lining of the brain or dura mater, so that the receiver/stimulator unit is maintained in position and does not protrude excessively past the skull surface. The tight dimensions of the bed or well relative to the size of the housing together with the eventual growth of a fibrous capsule serves to help retain the housing in its desired position. One disadvantage of this technique is the time taken in the implant surgery to create the bed. A further disadvantage is that there is some potential for the housing to shift out of the well due to an impact to the head of the recipient. Still further, this technique is not always possible depending upon the thickness of the surrounding bone and the age and anatomy of the recipient. 
     Another conventional technique has involved the positioning of at least one suture or Dacron tie (bioresorbable or non-bioresorbable) across the housing to hold it in place. (DACRON is a trademark of E.I. du Pont de Nemours and Company) One problem with this approach is that drilling of the holes into the surrounding bone can be a difficult and time consuming procedure, and especially for young children, much care must be taken by the surgeon to ensure that the drilling does not perforate the dura mater, as the skull thickness in such cases can be quite thin. Further to this, the suture or Dacron ties may not be sufficiently strong enough to withstand a substantial impact to a region of the head adjacent the device and as a result, such a force may dislodge the device from its desired position. In addition, it has been found that if a suture or Dacron tie is inadvertently placed across an inappropriate section of the device, such as across a strain relief of the electrode lead, the suture/tie may cause the lead/device to undergo fatigue and cause failure at this location. 
     SUMMARY 
     In one aspect of the present invention, an implantable device for mounting to a patient&#39;s bone is disclosed. The device comprises a housing including a surface having an abutting portion configured to abut the bone when the housing is implanted in the patient, the abutting portion defining a housing axis orthogonal to the surface; and at least one osseointegrating protuberance extending from the surface of the housing; the at least one protuberance being adapted to abut the patient&#39;s bone; and the at least one protuberance having a substantially smooth shaft. 
     In another aspect of the present invention, an implantable component of a tissue stimulating prosthesis is disclosed. The implantable component comprises a housing including a surface having an abutting portion configured to abut the bone when the housing is implanted in the patient, wherein the abutting portion defines a housing axis orthogonal to the surface; and one or more components of the prosthesis mounted in the housing; and at least one osseointegrating protuberance extending from the surface of the housing; the at least one protuberance being adapted to abut the patient&#39;s bone; and the at least one protuberance having a substantially smooth shaft. 
     In a further aspect of the present invention, a method for implanting an implantable device having a housing with an abutting surface configured to prevent osseointegration of the housing with a patient&#39;s bone and at least one osseointegrating protuberance extending from the housing is disclosed. The method comprises forming a pocket in the patient&#39;s bone to receive the housing; positioning the housing in the pocket such that the at least one protuberance is in direct contact with a surface of the patient&#39;s bone forming the pocket; and allowing osseointegration of the at least one protuberance to occur implantable component of a tissue stimulating prosthesis is disclosed. The implantable component comprises a housing including a surface having an abutting portion configured to abut the bone when the housing is implanted in the patient, wherein the abutting portion defines a housing axis orthogonal to the surface; and one or more components of the prosthesis mounted in the housing; and at least one osseointegrating protuberance extending from the surface of the housing; the at least one protuberance being adapted to abut the patient&#39;s bone; and the at least one protuberance having a substantially smooth shaft. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is simplified diagram of a cochlear prosthetic device suitable for implementing the implantable device housing of the present invention. 
         FIG. 2A  is a plan view of one embodiment of an implantable device of the present invention. 
         FIG. 2B  is a side view of the implantable device shown in  FIG. 2A . 
         FIG. 2C  is an end view of the implantable device in  FIG. 2A . 
         FIG. 2D  is a schematic end view of the implantable device shown in  FIG. 2B . 
         FIG. 3A  is a plan view of another embodiment of an implantable device of the present invention. 
         FIG. 3B  is a side view of the implantable device shown in  FIG. 3A . 
         FIG. 3C  is an end view of the implantable device shown in  FIG. 3A . 
         FIG. 3D  is a schematic end view of the implantable device shown in  FIG. 3B . 
         FIG. 4A  is a plan view of a further embodiment of an implantable device of the present invention. 
         FIG. 4B  is a side view of the implantable device shown in  FIG. 4A . 
         FIG. 4C  is an end view of the implantable device shown in  FIG. 4A . 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments of the present invention are directed to one or more osseointegrating protrusions extending from surfaces of an implantable device to secure the device to a bone. Osseointegration is a term commonly used to describe the process in which living bone forms a biological bond to an implanted element, firmly securing the implanted element to the skeletal structure. Osseointegration is thought to occur at a molecular level where the implant becomes part of the bone to which the implant has been mounted. There is a tendency for the formation of this structural connection to continue over time, further adhering the living bone to the surface of an implant. 
     Embodiments of the present invention are described below in connection with one type of implantable device, a cochlear prosthetic device. Cochlear prostheses use direct electrical stimulation of auditory nerve cells to bypass absent or defective hair cells that normally transducer acoustic vibrations into neural activity. Such devices generally use multi-contact electrodes inserted into the scala tympani of the cochlea so that the electrodes may differentially activate auditory neurons that normally encode differential pitches of sound. Such devices are also used to treat a smaller number of patients with bilateral degeneration of the auditory nerve. For such patients, the cochlear prosthetic device provides stimulation of the cochlear nucleus in the brainstem. 
     Exemplary cochlear prostheses in which the present invention may be implemented include, but are not limited to, those systems described in U.S. Pat. Nos. 4,532,930, 6,537,200, 6,565,503, 6,575,894 and 6,697,674. As described therein, cochlear prostheses generally include an external, wearable control unit that determines a pattern of electrical stimulation that is provided to an implanted stimulator unit containing active circuitry in a hermetic enclosure. Electrical stimulation channels are routed through electrodes to provide electrical stimulation of auditory nerve cells. 
       FIG. 1  is a schematic diagram of an exemplary cochlear implant system or prosthetic device  100  in which embodiments of the present invention may be implemented. In the context of such an application, embodiments of the present invention are directed to a carrier member of an electrode array  104  which has a holding member disposed on the surface thereof for the surgeon to grasp during insertion or implantation of the electrode array into the cochlear  122  of a recipient (also referred to herein as a patient). 
     Once implanted, electrodes  102  of the electrode array  104  receive stimulation signals from a stimulator unit  106 . Stimulator unit  106  is typically electrically connected to electrode array  104  by way of electrical lead  108 . Lead  108  is preferably continuous with no electrical connectors external the housing of stimulator unit  106 . 
     Stimulator unit  106  is preferably positioned within a housing that is implantable within the patient. The housing for stimulator unit  106  is typically implantable within a recess in the bone behind the ear posterior to the mastoid. When implanted, the housing preferably contains, in addition to stimulator unit  106 , a receiver unit  110 . Receiver unit  110  is preferably adapted to receive signals  114  from a controller  112 . Controller  112  is, in use, preferably mounted external to the body behind the outer ear  120  of the patient such that signals  114  are transmitted transcutaneously through the skin of the patient. 
     Signals  114  travel from controller  112  to receiver unit  110  and vice versa. Receiver unit  110  includes a receiver antenna, such as an antenna coil, adapted to receive radio frequency (RF) signals from a corresponding transmitter antenna  116 , such as an antenna coil, worn externally of the body. The radio frequency signals may comprise frequency modulated (FM) signals. It should be appreciated that the receiver antenna may also transmit signals, and that the transmitter antenna may receive such signals. The transmitter antenna coil is preferably held in position adjacent the implanted location of the receiver antenna coil by way of respective attractive magnets (not shown) mounted centrally in, or at some other position relative to, the coils. 
     External controller  112  comprises a speech processor (not shown) adapted to receive signals output by a microphone  118 . During use, microphone  118  is preferably worn on the pinna of the recipient, however, other suitable locations may be envisaged, such as a lapel of the recipient&#39;s clothing. The speech processor encodes the sound detected by microphone  118  into a sequence of electrical stimuli in accordance with speech coding strategies now or later developed for cochlear implant systems. The encoded sequence is transferred to the implanted receiver/stimulator unit using the transmitter and receiver antennae. The implanted receiver/stimulator unit demodulates the signals and allocates the electrical pulses to the appropriate electrode  102  by an algorithm which is consistent with the chosen speech coding strategy. 
     External controller  112  may further comprise a power supply (not shown). The power supply may comprise one or more rechargeable batteries. The transmitter and receiver antennae are used to provide power via transcutaneous induction to the implanted receiver/stimulator unit and the electrode array. 
     While cochlear implant system  100  is described as having external components, in another embodiment, the controller, including the microphone, speech processor and power supply may also be implantable. In such embodiments, the controller may be contained within a hermetically sealed housing or the housing used for stimulator unit  106 . 
     It should be appreciated that although embodiments of the present invention are described herein in connection with cochlear prosthetic device  100 , the same or other embodiments of the present invention may be implemented in any implantable device now or later developed, including implantable devices included in other tissue-stimulating prosthetic systems. Examples of such devices include, but are not limited to, other sensory prosthetic devices, neural prosthetic devices, and functional electrical stimulation (FES) systems. In sensory prostheses, information is collected by electronic sensors and delivered directly to the nervous system by electrical stimulation of pathways in or leading to the parts of the brain that normally process a given sensory modality. Neural prostheses are clinical applications of neural control interfaces whereby information is exchanged between neural and electronic circuits. FES devices are used to directly stimulate tissue having contractile cells to produce a controlled contraction of the same. 
     Generally, the osseointegrating protuberance extends from the housing toward the bone when the device is in an implant orientation adjacent the bone. The longitudinal axes of the osseointegrating protuberances may lie in a same imaginary plane or be offset from each other, or may be oriented at an angle relative to an implant axis. The implant axis is substantially orthogonal with an abutting surfaces of the housing and bone, generally reflecting the direction of motion as the housing is brought into contact with the bone. 
     A number of features of the osseointegrating protuberances may be selected to achieve a desired implant objective. For example, apertures, ridges and the like can be included in the osseointegrating protuberance to effect a more secure retention of the protuberance. In addition to the physical features of the osseointegrating protuberances, the angle between the longitudinal axes of the osseointegrating protuberances and the implant axis can vary depending on whether a permanent or removable implantation is desired. For example, osseointegrating protuberances that are parallel with the implant axis are generally more easily extricated from the bone than those that are oriented at an angle with the implant axis. In addition, other features, such as threads, can be implemented to provide the ability to manually extricate the housing. 
     The osseointegrating protuberances are either formed of or coated with titanium, a titanium alloy or other material or surface treatment that encourages or facilitates osseointegration. Preferably, the remaining parts of the housing do not osseointegrate with the bone. For example, the housing may be coated with a material that prevents osseointegration, such as a biocompatible silicone, or may be formed from a biocompatible metallic, ceramic and polymeric material. 
       FIGS. 2A-2C  are plan, side and end views of one embodiment of stimulator/receiver unit  106  introduced above in connection with  FIG. 1 . In the embodiment shown in  FIGS. 2A-2C , stimulator unit  106  has a housing  200  in accordance with one embodiment of the present invention. In this exemplary application, housing  200  is configured to have mounted therein electronics and other components (not shown) of receiver/stimulator unit  106 . As such, a receiver antenna coil is operatively connected to housing  200 . In this exemplary embodiment, a casing  202  is attached to housing  200 . Casing  202  is preferably formed by encapsulating the receiver antenna coil in, for example, silicone. 
     Osseointegrating protuberances in the form of loop members  204 A,  204 B (collectively and generally referred to herein a loop(s) or loop member(s)  204 ) extend from housing  200  to engage bone  206 . In this exemplary application of a stimulator/receiver unit, bone  206  is a region of a patient&#39;s skull such as posterior section of the mastoid bone. 
     As shown in  FIGS. 2A-2C , loop members  204  extend outwardly from an abutting surface  208  of housing  202  to engage bone  206 . As a result, the contour of surface  208  that abuts bone  206  generally follows the contour of the bone in the region of contact. However, given the relatively small dimensions of housing  200  and the relatively planar surface of the target region of the skull, abutting surface  208  is substantially planar and, as shown in  FIG. 2D , resides in and defines a plane  210 . 
     In  FIG. 2D , housing  200  is shown spaced apart from the surface of bone  206 , and oriented for implantation. This and similar orientations is/are referred to herein as an implant orientation. In other words, when housing  200  is oriented relative to bone  206  such that housing  200  can be brought into contact with bone  206  while maintaining such orientation to implant the device  106 , housing  200  is said to be in an implant orientation. 
     The direction of movement to bring housing  200  into contact with bone  206  defines an implant axis  216 . Given the relatively planar nature of surface  208  of housing  200 , implant axis  216  is, in this exemplary application, substantially orthogonal to the imaginary plane  210  defined by surface  208 . 
     When housing  200  is in the implant orientation adjacent to bone  206  loop members  204  extend from housing surface  208  toward bone  206 . In the embodiment shown in  FIG. 2D , loop members  204  extend from a surface  208  that abuts bone  206 . It should be appreciated, however, that loop members  204  can extend from or be coupled to other surfaces of housing  200 . As shown in  FIG. 2D , loop members  204  generally have a longitudinal axis  212 . Loop members  204  extend from housing surface  208  at an angle  215  relative to an implant axis  216 . Angles  215  as well as the size and shape of loop members  204  are selected to enable loop members  204  to extend into bone  206  and to facilitate the osseointegration of the loop members in bone  206 . The material that forms or coats protuberances  204  also can be selected to achieve a desired degree of osseointegration. In the embodiment shown in  FIG. 2D , angles  214  are approximately 45 degrees. It should be understood, however, that loop members  204  can be at any angle  215  that provides the desired degree of stability of the implanted device subsequent to sufficient osseointegration. For example, it may be desirable to insure stimulation unit  106  cannot be removed from bone  206 . By orienting loop members  204  at an angle, bone formation over the loop members provides such a permanent retention in addition to the osseointegration of loop members  204 . In such embodiments, then, angles  215  can range, for example, from 5 to 85 degrees. It should be appreciated, however, than angles  215  need not be within this range, as will be shown by the embodiments described below. In some such embodiments, loop members  204  may not be permanently implanted in bone  206 ; that is the implanted device can be extricated from bone  206 . 
     It should also be appreciated that loop members  204  may or may not reside in the same plane. In the embodiment shown in  FIGS. 2A-2D , loop members  204  reside in the same plane and, as noted, are oriented at opposing angles  215  relative to implant axis  216 . In addition to insuring a more permanent implantation, such an arrangement also insures that housing  200  will experience minimal relative lateral shifting relative to bone  206 . 
     In  FIGS. 2A-2C , and the surface of the patient&#39;s skull  206  on placement of housing  200  in a periosteal pocket  214  formed in bone  206 . Subsequent to implantation, loops  204  gradually sink into and osseointegrate with bone  206 . In some circumstances, the time duration for substantial osseointegration is approximately 40 days. In other circumstances, the time for osseointegration to occur is more or less than 40 days. During osseointegration, housing  200  is drawn toward bone  206 . Once abutting surface  208  of housing  200  comes into contact with the surface of skull  206 , the implantable component  200  ceases to sink into skull  206  and is so held in place by loops  204  that have osseointegrated with the bony surface of the skull. 
     In accordance with the teachings of the present invention, loop members  204  are either made of, or coated with, a material that stimulates the osseointegration process. In one embodiment, loop members  204  are made of or coated with titanium or a titanium alloy. It should be appreciated, however, that loop members  204  can be made of or coated with other materials now or later developed that stimulate osseointegration. 
       FIGS. 3A-3C  are plan, side and end views of another embodiment of an implantable osseointegrating housing  300 .  FIG. 3D  is a schematic end view of housing  300 . In this embodiment, housing  300  has a casing  302  containing a receiver antenna similar to the embodiment of stimulator/receiver  106  described above in connection with  FIGS. 2A-2D . Housing  300  and casing  302  are implanted in a periosteal pocket  314  in bone  206 . 
     In this embodiment, housing  300  has three (3) studs  304 A- 304 C (collectively and generally referred to herein as stud or studs  304 ) extending from an abutting surface  308  of the housing. Studs  304  are either made of, or coated with, a material that stimulates the osseointegration process. In one embodiment, studs  304  are made of or coated with titanium or a titanium alloy. It should be appreciated, however, that studs  304  can be made of or coated with other materials now or later developed that stimulate osseointegration. 
     Referring to  FIG. 3D , abutting surface  308  of housing  300  generally defines a plane  310 . Each stud  304  has a longitudinal axis  312  which is substantially parallel with implant axis  316 . Studs  304  osseointegrate with the bony surface of skull  206  over time. However, due to the orthogonal orientation of studs  304  and bone  206 , the orientation of studs  304  does not prevent housing  300  from being lifted away from the bony surface of skull  206  in a direction parallel with implant axis  312 . To extricate studs  304 , the bonds formed during osseointegration must be severed. Thus, it is preferential that studs  304  do not include additional integrating features such as apertures. It should be appreciated, however, that studs  304  serve to prevent at least substantial lateral movement of housing  300  relative to bone  306 . This and similar embodiments of osseointegrating protuberances  304  may be utilized in those applications in which it may be necessary to replace the device, access housing  300  or otherwise manipulate, maintain, repair or replace an implantable component. 
       FIGS. 4A-4C  are plan, side and end views of another embodiment of an implantable osseointegrating housing  400 . In this embodiment, housing  400  has a casing  402  containing a receiver antenna similar to the embodiments of stimulator/receiver  106  described above in connection with  FIGS. 2A-3D . Housing  400  and casing  402  are implanted in a periosteal pocket  414  in bone  206 , although, as in all embodiments, housing  400  can be implanted in other beds or wells, or simply on the surface of bone  206 . 
     In this embodiment, housing  400  has two (2) osseointegrating protrusions in the form of threaded shafts  404 A- 404 B (collectively and generally referred to herein as screw or screws  404 ) extending from a surface  409  adjacent to abutting surface  408  of the housing  400 . In this exemplary embodiment, shafts  404  are threadedly mounted to respective flanges  405 A,  405 B. Flanges  405  extend outwardly from sidewall surfaces  409  of housing  400 . It should also be appreciated that other arrangements are possible where flanges  405  extend from a different location on housing  400 . 
     In the embodiment shown in  FIGS. 4A-4C , each threaded shaft  404  is a screw having a slot in the head thereof to receive a tool, such as a screwdriver. On implantation, such screws  404  are preferably not inserted or screwed into the bony surface of bone  206 . Rather, the distal end of each screw is positioned so as to abut the bony surface under pressure applied by the placement of housing  400  in periosteal pocket  414  adjacent the bony surface. Over time, screws  404  will osseointegrate with the bony surface. Should it becomes necessary to remove housing  400 , screws  404  can be unscrewed from bone  206  using a screwdriver and the housing can then be lifted away from the bony surface. The screws  404  may be surgical screws and preferably have a low profile so they do not cause tissue erosion. 
     Threaded shafts  404  are either made of, or coated with, a material that stimulates the osseointegration process. In one embodiment, threaded shafts  304  are made of or coated with titanium or a titanium alloy. It should be appreciated, however, that threaded shafts  404  can be made of or coated with other materials now or later developed that stimulate osseointegration. Also, flanges  405  may be formed from titanium or a titanium alloy, and may be attached to a titanium housing  400  by, for example, welding. Alternatively, flanges  405  may be integrally formed with housing  400 . It should also be appreciated that the flanges  405  may be made from a plastic or elastomeric materials bonded to the implant housing  400 . For example, it may be possible to extend a silicone rubber coating of the implant housing  400  to create a silicone rubber flange which secured to bone  206  via screws  404 . Further, it may be possible to embed a plastic material such as PTFE or polyurethane within the silicone rubber coating of implant housing  400  to form a flange, or even attach such a device to the housing via a mechanical interlock. It may also be possible to make flange  405  of a composite or combination of materials. For example, a Dacron mesh may be used as a reinforcing structure to strengthen the silicone rubber coating. PTFE, polyurethane or carbon fibre materials may also be used as a reinforcing member to form flanges  405 . 
     By providing a flange  405  made from a plastic or elastomeric material it may be possible to allow the surgeon to remove or cut-off the flange during the surgical procedure should they not wish to use such a fixation method, resulting in the fixation mechanism of the present invention being an optional feature. Such a flange would also be easier to form and alter the shape thereof to more appropriately conform to the shape of certain bones, such as a recipient&#39;s skull. Further, a flange made from a plastic or elastomeric material is softer than a metallic flange and will therefore be less prone to causing tissue erosion. Still further, the depicted flanges could be removably mounted to the housing so allowing them to be removed if not required. 
     Alternatively, another aspect of the present invention includes that of a housing for an implantable device to be secured for mounting to a patient&#39;s bone is disclosed. The housing can include a surface having an abutting portion configured to abut the bone when the housing is implanted in the patient, the abutting portion defining a housing axis orthogonal to the surface; and at least one osseointegrating protuberance extending from the surface of the housing; the at least one protuberance being adapted to abut the patient&#39;s bone; and the at least one protuberance having a substantially smooth shaft. Material for the surface of the housing can include, e.g., at least one of a biocompatible metallic, ceramic and polymeric material. 
     It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive. 
     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.