The present invention relates to the fixation of implantable medical devices within or onto a human.
A continuing trend in the health care industry is the increasing quantity of devices permanently or temporarily implanted in the human body for therapeutic and monitoring purposes. To be able to optimally perform their functions, such implantable medical devices have to be placed in a proper location and remain in that location for the duration of the treatment. Thus there is a growing need for reliable anchoring assemblies that are simple to apply with standard surgical instruments and that provide enough flexibility to cover most of the individual patient anatomies. It may be desirable to remove and/or exchange the implanted medical device with a replacement device in the same location when, for example, the original medical device malfunctions.
According to a first aspect of the invention there is provided an implantable fixation assembly for removably securing a medical device in a human body, the assembly comprising:
Preferably at least one flexible leg is resiliently flexible.
Preferably the clamp portion comprises a part-cylindrical band, the band having an internal diameter that reduces as the clamp is actuated to grip the device.
Preferably the band has a first end attached towards or at the distal ends of a first of the legs and a second end attached towards or at the distal ends of a second of the legs.
Preferably the screw has a head, the head shaped to receive a driver, whereby a surgeon can selectively grip and release the device using the driver.
Preferably the assembly further comprises a safety catch, the catch operable to reversibly lock the clamp with respect to the device.
Preferably the head defines a plurality of longitudinally extending slits for receiving a screw locking portion of the safety catch.
Preferably the catch comprises a screw locking portion selectively engagable with the slits of the screw head.
Preferably the catch further comprises flexible fingers, each finger having a retention portion that snaps into a recess within the legs or the body so as to reversibly secure the safety catch to the legs or body.
Preferably the anchor portion defines a plurality of holes, the holes facilitating attachment of the anchor portion to the bone with screws.
Preferably the anchor portion is bendable to allow a surgeon to conform the anchor portion to a particular anatomy of a patient.
Preferably the assembly further comprises the device, the device having a grippable outer surface, the device and the clamp mutually shaped to allow sliding and rotational movement of the device with respect to the clamp,
According to a second aspect of the invention there is provided an implantable fixation assembly for removably securing a medical device in a human body, the assembly comprising:
Preferably at least one flexible leg is resiliently flexible.
Preferably the clamp portion comprises a part-cylindrical band, the band having an internal diameter that reduces as the clamp is actuated to grip the device.
Preferably the band has a first end attached towards or at the distal ends of a first of the legs and a second end attached towards or at the distal ends of a second of the legs.
Preferably the nut abuts the legs at a plane that is inclined with respect to a plane orthogonal to the axis of rotation,
Preferably the screw has a head, the head shaped to receive a driver, whereby a surgeon can selectively grip and release the device using the driver.
Preferably the assembly further comprises a safety catch, the catch operable to reversibly lock the clamp with respect to the device.
Preferably the head defines a plurality of longitudinally extending slits for receiving a screw locking portion of the safety catch.
Preferably the safety catch comprises a screw locking portion selectively engagable with the slits of the screw head.
Preferably the catch further comprises flexible fingers, each finger having a retention portion that snaps into a recess within the legs or the body so as to reversibly secure the safety catch to the legs or body.
Preferably the anchor portion defines a plurality of holes, the holes facilitating attachment of the anchor portion to the bone with screws.
Preferably the anchor portion is bendable to allow a surgeon to conform the anchor portion to a particular anatomy of a patient.
Preferably movement of the nut is restricted so as to prevent the nut from separating from the screw.
Preferably the nut has a projection, the projection constrained to move within a slot defined by any of the body, the arm or the anchor portion.
Preferably the nut is cup shaped with an inner surface that engages the distal ends of the legs.
Preferably the assembly further comprise the device, the device having a grippable outer surface the device and the clamp mutually shaped to allow sliding and rotational movement of the device with respect to the clamp,
According to a third aspect of the invention there is provided an implantable fixation assembly for removably securing a medical device in a human body, the assembly comprising:
Preferably the at least one flexible leg is resiliently flexible.
Preferably the clamp portion comprises a part-cylindrical band, the band having an internal diameter that reduces as the clamp is actuated to grip the device.
Preferably the band has a first end attached towards or at the distal ends of a first of the legs and a second end attached towards or at the distal ends of a second of the legs.
Preferably the screw has a head, the head shaped to receive a driver, whereby a surgeon can selectively grip and release the device using the driver.
Preferably the assembly further comprises a safety catch, the catch operable to reversibly lock the clamp with respect to the device.
Preferably the head defines a plurality of longitudinally extending slits for receiving a screw locking portion of the safety catch.
Preferably the catch comprises a screw locking portion selectively engagable with the slits of the screw head.
Preferably the catch further comprises flexible fingers, each finger having a retention portion that snaps into a recess within the legs or the body so as to reversibly secure the safety catch to the legs or body.
Preferably the anchor portion defines a plurality of holes, the holes facilitating attachment of the anchor portion to the bone with screws.
Preferably the anchor portion is bendable to allow a surgeon to conform the anchor portion to a particular anatomy of a patient.
Preferably the assembly further comprises the device, the device having a grippable outer surface, the device and the clamp mutually shaped to allow sliding and rotational movement of the device with respect to the clamp,
According to a fourth aspect of the invention there is provided an implantable fixation assembly for removably securing a medical device in a human body, the assembly comprising:
Specific embodiments of the invention will now be described in some further detail with reference to and as illustrated in the accompanying figures. These embodiments are illustrative, and are not meant to be restrictive of the scope of the invention.
Preferred embodiments of the invention are illustrated in the accompanying representations in which:
a and 5b are cross-sectional views of the clamping and locking mechanism shown in the above Figures, taken along a planes through an axis of the screw;
Embodiments of the present invention illustrated in the Figures are generally directed to an implantable fixation assembly for securing an implanted device such as a medical device in a patient. Implantable medical devices may include sensors, actuators and the like. Certain embodiments of the present invention comprise a bone plate having one or more extensions each having one or more holes to screw or otherwise attach the extension to an adjacent bone. The implantable fixation assembly also includes a lockable reversible clamping mechanism operable to detachably secure the medical device to the bone plate, thereby reversibly attaching the medical device to a desired bony structure in the patient's body.
Advantageously, embodiments of the implantable fixation assembly of the present invention provide a surgeon with the capability to place a medical device at any desired location in a patient's body without having to make an incision much larger than the medical device and to easily access the clamping mechanism which may be activated near the body surface.
Advantageously, the clamping mechanism is reversible; that is, it detachably secures the medical device to the patient. As such, a medical device that may need to be replaced, for example, due to an upgrade, recall, damage or other reason, can simply be exchanged by detaching the implanted medical device and securing the replacement medical device, while keeping the fixation assembly in place.
Referring to
A clamp actuating mechanism including a driving member in the form of a nut 4 is shown most clearly in
Bone plate 1 is configured to attach the fixation assembly to one or more selected bones of the patient. Bone plate 1 has one or more extensions 19 configured to attach directly to a bone of the patient. Each extension 19 comprises one or more screw holes 6 which provide a degree of freedom to choose the number and the location of bone screws (not shown) according to the individual needs. As one of ordinary skill in the art would appreciate, the dimensions of screw holes 6 are suitable for the dimensions of the selected screw which, in turn, is dependent upon a variety of factors including, but not limited to, the size of the bone, the functions performed by the medical device, the mass of the medical device, etc.
Preferably, one or more of the extensions 19 can be modified such as by bending, shortening, etc., by a surgeon in order to be adapted to the individual anatomy of the patient. Alternatively, bone plate 1 can be manufactured with a quantity of extensions 19 each having dimensions suitable for a particular application.
Bone plate 1 further comprises an arm portion 18 that joins extensions 19. In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
The clamping and locking features of clamping mechanism 23 will now be described with reference to
Referring to
To anchor a medical device to the bone, the medical device is simply slid into clamp portion 2 until a desired insertion depth is attained. Then, the medical device is secured to clamping mechanism 23 by fastening screw 3. In the illustrative embodiment, screw 3 has a screw head 7 comprising multiple slits 8. Screw head 7 has, in this embodiment, conventional slots 25 to operably receive a screwdriver head of a surgical instrument (not shown).
With the embodiment described above, the screw is a screw drivable by a conventional screwdriver. Other embodiments of the invention may include a screw or bolt having an alien key head or any other drivable head. It should be understood that, in the context of this application and its claims, the term “screw” encompasses bolts and other cylindrical members with a helical ridge type thread.
As best shown in
To prevent screw 3 from rotating, slits 8 of screw head 7 are to be aligned with opposing grooves 9 in clamp mechanism 23, and safety catch 5 is inserted into clamping mechanism 23, as shown in
When safety catch 5 is inserted into groove 9 of clamping mechanism 2, arms 10 are positioned in slits 8 of screw head 7 and grooves 9 of clamping mechanism 2. Also, a screw locking portion 24 of tab 21 is positioned within slits 8 of screw head 7. Thus, the insertion of safety catch 5 locks screw 3 and secures the anchored medical device in clamp 2. As shown in
By pulling on tab 21, safety catch 5 can be removed due to the slightly inclined upper edge of retention portions 11. As one of ordinary skill in the art would appreciate, the reversible nature of clamping mechanism 2 may be prevented with the application of an adhesive or cement to groove 9.
In alternative embodiments of the invention illustrated in
Referring to
Turning to
Advantageously, embodiments of the implantable fixation assembly detachably anchor an implanted medical device to one or more bones of a patient. In addition, in those embodiments in which the extensions 19 and anchoring arm 18 can be bent, and extensions 19 can be severed, bone plate 1 can be modified as desired to achieve the most therapeutic position and orientation of a desired implantable medical device. Furthermore, the fixation assembly is preferably sufficiently small to permit the implantation of a medical device via a narrow incision, reducing the invasiveness of the implantation procedure. It is anticipated that only minimal manipulation of the fixation assembly will be required, further reducing the likelihood that a larger incision would be necessary.
As one of ordinary skill in the art would appreciate, the implantable fixation assembly of the present invention may be implemented with any completely- or partially-implantable medical device now or later developed. For example, embodiments of the implantable fixation assembly may be used to temporarily secure stimulators, transducers, sensors, drug-delivery devices, etc. in any location in the body, including the cranium, thorax, spinal column, etc., for any therapeutic application such as neurological, cardiac, gastrointestinal, sensory, etc. One exemplary application is to secure an embodiment of an actuator described in commonly-owned U.S. Provisional Application entitled “Implantable Actuator For Hearing Applications,” U.S. application No. 60/613,512, which is hereby incorporated by reference herein in its entirety, and International Patent Application (PCT application) filed concurrently herewith entitled “IMPLANTABLE ACTUATOR FOR HEARING AID APPLICATIONS” which claims priority from said U.S. Application No. 60/613,512.
It will be understood that the term “comprise” and any of its derivatives (eg. comprises, comprising) as used in this specification and its claims is to be taken to be inclusive of features to which it refers, and is not meant to exclude the presence of any additional features unless otherwise stated or implied.
While the present invention has been described in terms of preferred embodiments in order to facilitate a better understanding of the invention, it should be appreciated that various modifications can be made without departing from the principles of the invention. Therefore, the invention should be understood to include all such modifications within the scope.
This application is a national stage application under 35 USC §371(c) of PCT Application No. PCT/AU2005/001800, entitled “Implantable Fixation Assembly For Removably Securing A Medical Device,” filed on Nov. 30, 2005, which claims the priority of U.S. Provisional Patent No. 60/631,508 entitled, “Implantable Fixation System For Anchorage Of A Medical Device,” filed on Nov. 30, 2004, and claims the priority of U.S. Provisional Patent No. 60/631,512 entitled, “Implantable Actuator For Hearing Aid Applications,” filed on Nov. 30, 2004. The entire disclosure and contents of the above applications are hereby incorporated by reference herein.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/AU2005/001800 | 11/30/2005 | WO | 00 | 3/20/2008 |
Publishing Document | Publishing Date | Country | Kind |
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WO2006/058367 | 6/8/2006 | WO | A |
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