U.S. patent application number 15/157631 was filed with the patent office on 2017-02-23 for implantable magnet arrangements.
The applicant listed for this patent is Marcus Andersson, Fysh Dadd, Jonathon Kirk, Charles Roger Aaron Leigh, Daniel Smyth, Claudiu G. Treaba, Kristien Johanna Maria Verhoeven. Invention is credited to Marcus Andersson, Fysh Dadd, Jonathon Kirk, Charles Roger Aaron Leigh, Daniel Smyth, Claudiu G. Treaba, Kristien Johanna Maria Verhoeven.
Application Number | 20170050027 15/157631 |
Document ID | / |
Family ID | 58052104 |
Filed Date | 2017-02-23 |
United States Patent
Application |
20170050027 |
Kind Code |
A1 |
Andersson; Marcus ; et
al. |
February 23, 2017 |
Implantable Magnet Arrangements
Abstract
Presented herein are separable magnet arrangements for use with
encapsulated implantable components. A separable magnet arrangement
includes an implantable magnet is at least one of fully
encapsulated in, and mechanically severable from, an overmolding of
the encapsulated implantable component or an implantable magnet
that is physically separate from the encapsulated implantable
component.
Inventors: |
Andersson; Marcus;
(Molnlycke, SE) ; Smyth; Daniel; (Dublin, IE)
; Dadd; Fysh; (Lane Cove, AU) ; Verhoeven;
Kristien Johanna Maria; (Mechelen, BE) ; Treaba;
Claudiu G.; (New York, NY) ; Kirk; Jonathon;
(New York, NY) ; Leigh; Charles Roger Aaron;
(Epping, AU) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Andersson; Marcus
Smyth; Daniel
Dadd; Fysh
Verhoeven; Kristien Johanna Maria
Treaba; Claudiu G.
Kirk; Jonathon
Leigh; Charles Roger Aaron |
Molnlycke
Dublin
Lane Cove
Mechelen
New York
New York
Epping |
NY |
SE
IE
AU
BE
US
NY
AU |
|
|
Family ID: |
58052104 |
Appl. No.: |
15/157631 |
Filed: |
May 18, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62206382 |
Aug 18, 2015 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/37518 20170801;
A61N 1/375 20130101; A61N 1/3787 20130101; A61N 1/36038 20170801;
H04R 2225/67 20130101; A61N 1/0541 20130101 |
International
Class: |
A61N 1/375 20060101
A61N001/375; A61N 1/378 20060101 A61N001/378; A61N 1/08 20060101
A61N001/08; A61N 1/36 20060101 A61N001/36 |
Claims
1. An implantable medical device system for implantation into a
recipient, comprising: an encapsulated implantable component
including an implant body and an internal coil that are both
enclosed in a biocompatible overmolding; an aperture in the
overmolding located proximate to the internal coil; and an
independent separable magnet arrangement that is configured to be
secured to the recipient within the aperture independently from the
encapsulated implantable component.
2. The implantable medical device system of claim 1, wherein the
independent separable magnet arrangement includes a bone fixture
that comprises: a threaded body configured to be inserted into a
recipient's bone via the aperture; a coupling section attached to
the threaded body; and an implantable magnet positioned in the
coupling section.
3. The implantable medical device system of claim 2, wherein the
implantable magnet is configured to be magnetically attached to the
coupling section to facilitate removal therefrom.
4. The implantable medical device system of claim 2, wherein the
coupling section includes a threaded connector configured to mate
with a threaded connector attached to the threaded body.
5. The implantable medical device system of claim 2, wherein the
independent separable magnet arrangement is configured to be
positioned in the aperture to provide an interference fit with the
encapsulated implantable component.
6. The implantable medical device system of claim 5, wherein the
independent separable magnet arrangement comprises: an overmolding
fully encapsulating the coupling section, wherein the overmolding
fully encapsulating the coupling section has an outside diameter
that is larger than an a diameter of the aperture such that the
overmolding is laterally compressed when inserted into the aperture
to create the interference fit.
7. The implantable medical device system of claim 5, wherein the
coupling section has a first outside dimension that is larger than
a diameter of the aperture and a circumferential channel with an
interior dimension that is approximately the same as the diameter
of the aperture such that, when the coupling section is located in
the aperture, a portion of the overmolding surrounding the aperture
and the circumferential channel mate with one another to create
interference fit between the circumferential channel and the
portion of the overmolding surrounding the aperture.
8. The implantable medical device system of claim 5, wherein the
coupling section comprises: a first portion having an outside
dimension that is larger than a diameter of the aperture, and an
second portion having an exterior dimension that is smaller than
the outside dimension of the first portion and that is larger than
the diameter of the aperture such that, when the coupling section
is located in the aperture, a portion of the overmolding
surrounding the aperture is seated around the second portion so as
to create the interference fit between the portion of the
overmolding surrounding the aperture and the second portion.
9. An implantable medical device system, comprising: an
encapsulated implantable component comprising an implant body and
an internal coil that are both enclosed in a biocompatible
overmolding; and an integrated separable magnet arrangement located
proximate to the internal coil and comprising: an implantable
magnet, an overmolding portion encapsulating the implantable
magnet, and a removal mechanism at least partially surrounding the
overmolding portion and configured to enable physical separation of
the integrated separable magnet arrangement from a remainder of the
encapsulated implantable component.
10. The implantable medical device system of claim 9, wherein the
removal mechanism comprises: one or more channels located at a
proximal surface of the overmolding at a location between the
implantable magnet and the internal coil.
11. The implantable medical device system of claim 9, wherein the
removal mechanism comprises: a plurality of channels disposed at
one of the proximal and distal surfaces of the overmolding at a
location between the implantable magnet and the internal coil such
that the portion of the overmolding fully encapsulating the
implantable magnet is connected to the remainder of the
encapsulated implantable component via a thinned section of the
overmolding.
12. The implantable medical device system of claim 9, wherein the
removal mechanism comprises: a region of the overmolding that is
formed from at least one of a different material or a different
grade of material having mechanical properties that are different
from a remainder of the overmolding.
13. The implantable medical device system of claim 12, wherein the
region of the overmolding that is formed from at least one of a
different material or a different grade of material having
mechanical properties that are different from the remainder of the
overmolding comprises: a region formed from a bioresorable
material, wherein the remainder of the overmolding is formed from a
non-bioresorable material.
14. The implantable medical device system of claim 12, wherein the
region of the overmolding that is formed from at least one of a
different material or a different grade of material having
mechanical properties that are different from the remainder of the
overmolding includes: one or more channels located at a surface of
the overmolding.
15. The implantable medical device system of claim 9, wherein the
removal mechanism comprises: one or more markings indicating a
location at which a surgeon should detach the integrated separable
magnet arrangement from the remainder of the encapsulated
implantable component.
16. The implantable medical device system of claim 9, wherein the
removal mechanism comprises: a plurality of discrete spokes that
connect the portion of the overmolding fully encapsulating the
implantable magnet to a remainder of the overmolding.
17. A method, comprising: positioning, in a recipient, an
encapsulated implantable component comprising an overmolding and an
integrated separable magnet arrangement; physically separating the
integrated separable magnet arrangement from a remainder of the
encapsulated implantable component to form an aperture in the
overmolding; and removing the integrated separable magnet
arrangement from the recipient.
18. The method of claim 17, wherein the integrated separable magnet
arrangement includes an overmolding portion fully encapsulating the
implantable magnet and a removal mechanism substantially
surrounding the overmolding portion, wherein the method comprises:
physically separating the integrated separable magnet arrangement
from the remainder of the encapsulated implantable component at the
removal mechanism.
19. The method of claim 18, wherein the removal mechanism comprises
a one or more channels located at a proximal surface of the
overmolding.
20. The method of claim 18, wherein the removal mechanism comprises
opposing plurality of channels each disposed at one of the proximal
and distal surfaces of the overmolding such that the overmolding
portion fully encapsulating the implantable magnet is connected to
the remainder of the encapsulated implantable component via a
thinned section of the overmolding.
21. The method of claim 18, wherein the removal mechanism comprises
a region of the overmolding that is formed from at least one of a
different material or a different grade of material having
mechanical properties that are different from a remainder of the
overmolding.
22. The method of claim 18, wherein the removal mechanism comprises
a plurality of discrete spokes that connect the portion of the
overmolding fully encapsulating the implantable magnet to a
remainder of the overmolding, and wherein the method comprises:
cutting each of the discrete spokes to physically separate the
integrated separable magnet arrangement from a remainder of the
encapsulated implantable component.
23. The method of claim 17, further comprising: positioning, in the
aperture, an independent separable magnet arrangement that is
configured to be secured to the recipient independently from the
encapsulated implantable component.
24. The method of claim 23, wherein the independent separable
magnet arrangement comprises a bone fixture including a threaded
body and a coupling section in which an implantable magnet is
positioned, and wherein the method comprises: inserting the
threaded body into a recipient's bone via the aperture.
25. The method of claim 17, further comprising: implanting in the
recipient an interlocking separable magnet arrangement that
comprises one or more mechanisms to mechanically interlock with the
encapsulated implantable component.
26. The method of claim 25, wherein the interlocking separable
magnet arrangement comprises an implantable magnet configured to be
positioned in the aperture, and wherein the encapsulated
implantable component comprises one or more magnets configured to
be magnetically coupled to the implantable magnet to retain the
implantable magnet within the aperture.
27. The implantable medical device system of claim 10, wherein the
interlocking separable magnet arrangement comprises an implantable
magnet and first and second extension arms extending from the
implantable magnet, and wherein the method comprises: positioning
the first and second extension arms around the encapsulated
implantable component so as to mechanically engage an outer edge of
a portion of the overmolding.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Application No. 62/206,382 entitled "Implantable Magnet
Arrangements," filed Aug. 18, 2015, the content of which is hereby
incorporated by reference herein.
BACKGROUND
[0002] Field of the Invention
[0003] The present invention relates generally to implantable
medical device systems.
[0004] Related Art
[0005] Implantable medical device systems, which include one or
more implantable components, have provided a wide range of
therapeutic benefits to recipients over recent decades. The types
of implantable medical device systems and the ranges of functions
performed thereby have increased over the years. For example, many
implantable medical device systems now often include one or more
instruments, apparatuses, sensors, processors, controllers or other
functional mechanical or electrical components that are permanently
or temporarily implanted in a recipient. These functional
components perform diagnosis, prevention, monitoring, treatment or
management of a disease or injury or symptom thereof, or to
investigate, replace or modify the anatomy or of a physiological
process. Many of these functional components utilize power and/or
data received from external components that are part of, or operate
in conjunction with, the implantable medical device system.
SUMMARY
[0006] In one aspect, an implantable medical device system for
implantation into a recipient is provided. The implantable medical
device system comprises an encapsulated implantable component
comprising an implant body and an internal coil that are both
enclosed in a biocompatible overmolding; an aperture in the
overmolding located proximate to the internal coil; and an
independent separable magnet arrangement that is configured to be
secured to the recipient within the aperture independently from the
encapsulated implantable component.
[0007] In another aspect, an implantable medical device system for
implantation into a recipient is provided. The implantable medical
device system comprises an encapsulated implantable component
comprising an implant body and an internal coil that are both
enclosed in a biocompatible overmolding; and an integrated
separable magnet arrangement located proximate to the internal coil
and comprising: an implantable magnet, an overmolding portion
encapsulating the implantable magnet, and a removal mechanism
circumferentially surrounding the overmolding portion and
configured to enable physical separation of the integrated
separable magnet arrangement from a remainder of the encapsulated
implantable component.
[0008] In another aspect, a method is provided. The method
comprises: positioning, in a recipient, an encapsulated implantable
component comprising an overmolding and an integrated separable
magnet arrangement; physically separating the integrated separable
magnet arrangement from a remainder of the encapsulated implantable
component to form an aperture in the overmolding; and removing the
integrated separable magnet arrangement from the recipient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Embodiments of the present invention are described herein in
conjunction with the accompanying drawings, in which:
[0010] FIG. 1 is a schematic diagram illustrating a cochlear
implant system in accordance with embodiments presented herein;
[0011] FIG. 2A is a top view of an encapsulated implantable
component and a separable magnet arrangement in accordance with
embodiments presented herein;
[0012] FIG. 2B is a cross-sectional view of the encapsulated
implantable component and the separable magnet arrangement of FIG.
2A;
[0013] FIG. 2C is a cross-sectional view of an encapsulated
implantable component and a separable magnet arrangement in
accordance with embodiments presented herein;
[0014] FIG. 2D is a cross-sectional view of an encapsulated
implantable component and a separable magnet arrangement in
accordance with embodiments presented herein;
[0015] FIG. 3 is a top view of an encapsulated implantable
component and a separable magnet arrangement in accordance with
embodiments presented herein;
[0016] FIG. 4A is a top view of an encapsulated implantable
component in accordance with embodiments presented herein;
[0017] FIG. 4B is a top view of the encapsulated implantable
component of FIG. 4A and a separable magnet arrangement in
accordance with embodiments presented herein;
[0018] FIG. 4C is a cross-sectional view of the encapsulated
implantable component and the separable magnet arrangement of FIG.
4B;
[0019] FIG. 5 is a cross-sectional view of an encapsulated
implantable component and a separable magnet arrangement in
accordance with embodiments presented herein;
[0020] FIG. 6 is a cross-sectional view of an encapsulated
implantable component and a separable magnet arrangement in
accordance with embodiments presented herein;
[0021] FIG. 7 is a cross-sectional view of an encapsulated
implantable component and a separable magnet arrangement in
accordance with embodiments presented herein;
[0022] FIG. 8 is a top view of an encapsulated implantable
component and a separable magnet arrangement in accordance with
embodiments presented herein;
[0023] FIG. 9 is a top view of an encapsulated implantable
component and a separable magnet arrangement in accordance with
embodiments presented herein;
[0024] FIG. 10A is a top view of an encapsulated implantable
component and a separable magnet arrangement in accordance with
embodiments presented herein;
[0025] FIG. 10B is a side view of a receptacle formed in an implant
body in accordance with the embodiment of FIG. 10A;
[0026] FIG. 10C is a perspective view of the separable magnet
arrangement of FIG. 10A;
[0027] FIG. 11 is a top view of an encapsulated implantable
component and a separable magnet arrangement in accordance with
embodiments presented herein; and
[0028] FIG. 12 is a flowchart of a method in accordance with
embodiments presented herein.
DETAILED DESCRIPTION
[0029] Embodiments of the present invention are generally directed
to separable magnet arrangements for use with encapsulated
implantable components. A separable magnet arrangement includes an
implantable magnet that is fully encapsulated in, and mechanically
severable from, an overmolding of the encapsulated implantable
component or an implantable magnet that is physically separate from
the encapsulated implantable component.
[0030] As described further below, separable magnet arrangements
comprising an implantable magnet that is fully encapsulated in, but
mechanically severable from, an overmolding are sometimes referred
to herein as "integrated" separable magnet arrangements (i.e., the
implantable magnet is, at least initially, integrated into the
overmolding). Separable magnet arrangements in which the
implantable magnet is physically separate from the encapsulated
implantable component are sometimes referred to herein as
"independent" separable magnet arrangements.
[0031] There are different types of implantable medical device
systems that include components that may be partially or fully
implanted into a recipient, including bone conduction systems
(e.g., percutaneous, transcutaneous, etc.), middle ear auditory
prosthesis systems, direct acoustic stimulator systems, cochlear
implant systems, auditory brainstem stimulator systems, implantable
pacemaker systems, functional electrical stimulation systems, pain
relief systems, visual prosthesis systems, etc. It is to be
appreciated that embodiments presented herein may be used in
connection with any of the above or other implantable medical
device systems. However, merely for ease of description,
embodiments of the present invention are primarily described herein
with reference to a cochlear implant system.
[0032] FIG. 1 is a schematic diagram illustrating a cochlear
implant system 100 in accordance with embodiments presented herein.
The cochlear implant system 100 comprises an external component 102
and an implantable component 104. In this example, the implantable
component 104 is a cochlear implant.
[0033] The external component 102 is directly or indirectly
attached to the body of the recipient and typically comprises a
sound processing unit 106 and an external coil arrangement 108. In
the example of FIG. 1, the sound processing unit 106 is a
behind-the-ear (BTE) unit that comprises one or more sound input
elements 112 (e.g., microphones, telecoils, etc.) for receiving
sound signals, a power source (not shown in FIG. 1) and a sound
processor (also not shown in FIG. 1). The sound processor is
configured to process electrical signals generated by the sound
input element(s) 112.
[0034] The sound processing unit 106 is electrically connected to
the external coil arrangement 108 via a cable or lead 110. Two
portions of the external coil arrangement 108 have been removed to
illustrate that an external radio frequency (RF) coil 112 and,
generally, a magnet 114 fixed relative to the external coil 112,
are positioned in the external coil arrangement 108.
[0035] The cochlear implant 104 comprises an implant body 122, a
lead region 124, and an elongate intra-cochlear stimulating
assembly 118. The implant body 122 comprises, among other
components, an internal receiver/transceiver unit, sometimes
referred to herein as internal transceiver unit, and a stimulator
unit. The internal transceiver unit is electrically connected to an
internal RF coil 116. The internal coil 116 and the implant body
122 are encapsulated in an overmolding 120 that is formed from a
resiliently flexible biocompatible material (e.g., a silicone
elastomer such as a polydimethylsiloxane (PDMS) polymer). The
implant body 122, internal coil 116, and the flexible overmolding
120 enclosing the implant body and the internal coil are
collectively and generally referred to herein as overmolded or
encapsulated implantable component 132.
[0036] The external coil 112 and the internal coil 116 are
typically wire antenna coils each comprising a plurality of wire
loops. In order to transfer power, the external coil 112 and the
internal coil 116 need to be closely-coupled. That is, the coils
112 and 116 need to be substantially aligned with one another such
that a large portion of the magnetic field generated by the
primary/transmitting coil passes through (i.e., is received by) the
secondary/receiving coil. In the case of transmissions from the
external component 102 to the cochlear implant 104, the external
coil 112 is the primary coil and the internal coil 116 is the
secondary coil. The alignment of the external coil 112 with the
internal coil 116 is provided through a magnetic coupling between
the magnet 114 in the external coil arrangement 108 and the
implantable magnet 126 that is fixed relative to the internal coil
116. That is, the magnets 114 and 116 facilitate the operational
alignment of the coils 112 and 116 so as to enable transcutaneous
communication over a closely-coupled RF link 115.
[0037] In general, the implantable magnet 126 is a ferromagnetic or
ferromagnetic element that is encased in a rigid biocompatible
housing formed, for example, from titanium. For ease of
illustration, the ferromagnetic or ferromagnetic element and the
rigid housing are collectively and generally shown at reference 126
and are collectively referred to simply herein as an implantable
magnet.
[0038] In conventional cochlear implant systems, implantable
magnets are typically retained in the overmolding that encapsulates
the internal coil. For example, in certain conventional
arrangements, during the process in which the internal coil is
overmolded in the flexible material, a small cavity (i.e., a
"pocket") is formed in the overmolding and the implantable magnet
is manually positioned therein.
[0039] The use of an overmolded pocket to retain the implantable
magnet may be problematic in certain arrangements. For example, the
small areas between the interior surfaces of the overmolded pocket
and the surfaces of the implantable magnet are exposed to the
implanted environment and, as such, there is a possibility that
bacteria/biofilm may form around the magnet/pocket interface.
[0040] In addition, implanted magnets can negatively affect the
results of Magnetic Resonance Imaging (MRI) tests by casting MRI
shadows. The presence of an implanted magnet also limits the
strength of the magnetic field that may be used during the MRI. As
such, when a recipient needs to undergo an MRI test, an implanted
magnet is typically removed by a surgeon before the recipient
undergoes the MRI test. In the case of an implantable magnet
located in an overmolded pocket, the surgeon opens the surgical
site and manually removes the implantable magnet from the pocket.
The surgeon then closes the surgical site and the recipient
undergoes the MRI test. After the test, the recipient returns to
the surgeon for another surgical procedure in which the implantable
magnet is re-inserted into the overmolded pocket. Often, the
surgeons will tear the overmolding during removal or re-insertion
of the implantable magnet, particularly when using tools and small
surgical incisions. The tears introduced in the overmolding create
areas that are susceptible to biofilm formation and that could
negatively affect the integrity of the overmolding.
[0041] As described further below, the magnet 126 is part of an
independent separable magnet arrangement 150 that, in this example,
is incorporated into the overmolding 120 so as to avoid the need
for an overmolded pocket. That is, FIG. 1 illustrates an example in
which the separable magnet arrangement 150 has a structural
configuration in which the implantable magnet 126 is fully
encapsulated in the overmolding 120 and, as described further
below, mechanically severable therefrom. Because the implantable
magnet 126 is integrated into the overmolding 120, the separable
magnet arrangement 150 substantially reduces or eliminates the
exposed interface between the implantable magnet 126 and the
overmolding 120, while also facilitating explanation/removal of the
implantable magnet from the recipient for tests, surgical upgrades,
etc.
[0042] Elongate stimulating assembly 118 is configured to be at
least partially implanted in the cochlea of a recipient and
includes a plurality of intra-cochlear stimulating contacts 128.
The stimulating contacts 128 collectively form a contact array 130
and may comprise electrical contacts and/or optical contacts.
Stimulating assembly 118 extends through an opening in the cochlea
(e.g., cochleostomy, the round window, etc.) and has a proximal end
connected to the stimulator unit in implant body 122 via lead
region 124 that extends through the recipient's mastoid bone.
[0043] As noted, FIG. 1 illustrates an example in which cochlear
implant system 100 includes an external component 102 with an
external sound processor. It is to be appreciated that the use of
the specific external component is merely illustrative and that the
techniques presented herein may be used in arrangements having an
implanted sound processor, an implanted microphone, and/or an
implanted power source (battery). It is also to be appreciated that
the individual components referenced herein, e.g., sound input
elements, the sound processor, etc., may be distributed across more
than one device, e.g., two cochlear implant systems, and indeed
across more than one type of device, e.g., a cochlear implant, a
middle ear auditory prosthesis, a consumer electronic device, a
remote control device, etc.
[0044] It is to be appreciated that the use of the external
component 102, as shown in FIG. 1, is merely illustrative and that
other embodiments may use alternative external components. For
example, one alternative embodiment may use a so-called "button" or
"coil" sound processing unit having, for example, a generally
cylindrical shape. In such an embodiment, the sound input element,
sound processor, external coil, and external magnet are disposed
within (or adjacent to) the same housing configured to be worn at
the same location as where an external coil is traditionally
located. In another embodiment, one or more of the components
forming part of external component 102 are implanted. However, in
such an embodiment, the cochlear implant 104 operates with an
external device that transcutaneously transmits power and/or data
to the cochlear implant. Therefore, such embodiments still utilize
an external coil that is configured to be inductively coupled to an
internal coil.
[0045] FIGS. 2A and 2B are top and cross-sectional views,
respectively, of the encapsulated implantable component 132 that
includes the integrated separable magnet arrangement 150 in
accordance with embodiments presented herein. As noted above, and
as shown in FIGS. 2A and 2B, the encapsulated implantable component
132 includes an implant body 122 and an internal coil 116, both of
which are encapsulated in an overmolding 120. In the embodiment of
FIGS. 2A and 2B, the separable magnet arrangement 150 comprises the
implantable magnet 126, a surrounding overmolding portion/region
145 that fully encapsulates the implantable magnet 126 (generally
shown between lines 146(A) and 146(B) in FIG. 2B), and a removal
mechanism 155. The separable magnet arrangement 150 is located at
proximate to the wire loops forming the internal coil 116. For
example, the separable magnet arrangement 150 may be located at the
geometric center of the wire loops forming the internal coil 116,
the separable magnet arrangement 150 may be located at the center
of the summed magnetic field, etc.
[0046] The removal mechanism 155 is a mechanically prepared region
that has sufficient strength to ensure attachment of the separable
magnet arrangement 150 to the remainder of the overmolding 120, but
which is also designed to facilitate surgical removal of the
separable magnet arrangement 150. That is, the removal mechanism
155 is configured so as to enable a surgeon to mechanically sever
or separate the separable magnet arrangement 150 from the remainder
of the encapsulated component 132. In the specific arrangement of
FIGS. 2A and 2B, the removal mechanism 155 is a circumferential
channel or groove located at the proximal or skin-facing surface
144 of the overmolding generally between the implantable magnet 126
and the internal coil 116 (i.e., extending circumferentially around
the surrounding overmolding region 145). In certain examples, the
removal mechanism 155 has a configuration (e.g., circumference,
shape, depth, etc.) so as to engage a surgical tool or a
configuration to enable a surgeon to make an accurate cut to detach
the surrounding overmolding region 145 from the rest of the
overmolding 120.
[0047] FIGS. 2A and 2B illustrate one exemplary configuration for a
separable magnet arrangement and associated removal mechanism
forming a mechanically prepared region that facilitates surgical
removal of the separable magnet arrangement 150. It is to be
appreciated that removal mechanisms in accordance with embodiments
presented herein may have alternative configurations.
[0048] For example, FIG. 2C is a cross-sectional view of an
encapsulated implantable component 232(C) that comprises a
different integrated separable magnet arrangement 250(C) in
accordance with embodiments presented herein. In FIG. 2C, the
implant body 122 and the internal coil 116 are each fully
encapsulated in an overmolding 220(C). The separable magnet
arrangement 250(C) comprises the implantable magnet 126, a
surrounding overmolding portion/region 245(C) that fully
encapsulates the implantable magnet 126, and a removal mechanism
255(C).
[0049] The removal mechanism 255(C) comprises two opposing
circumferential channels or grooves disposed at the surfaces 244
and 247 of the overmolding 220(C) at a location that is between the
implantable magnet 126 and the internal coil 116 (i.e., extending
circumferentially around the surrounding overmolding region
245(C)). In particular, a first groove is located at the proximal
or skin-facing surface 244 of the overmolding 220(C), while a
second groove is located at the distal or skull-facing surface 247
of the overmolding. The opposing grooves forming removal mechanism
255(C) result in the surrounding overmolding region 245(C) being
connected to the remainder of the overmolding 220(C) via a thinned
section 249 of the overmolding. Similar to the example of FIGS. 2A
and 2B, the removal mechanism 255(C) has a configuration so as to
engage a surgical tool or a configuration to enable a surgeon to
make an accurate cut through the thinned section 249, thereby
separating the separable magnet arrangement 250(C) from the
remainder of the encapsulated implantable component 232(C).
[0050] FIG. 2D is a cross-sectional view of another encapsulated
implantable component 232(D) that comprises an integrated separable
magnet arrangement 250(D) in accordance with embodiments presented
herein. In FIG. 2D, the implant body 122 and the internal coil 116
are each fully encapsulated in an overmolding 220(D). The separable
magnet arrangement 250(D) comprises the implantable magnet 126, a
surrounding overmolding portion/region 245(D) that fully
encapsulates the implantable magnet 126, and a removal mechanism
255(D).
[0051] In the embodiment of FIG. 2D, the removal mechanism 255(D)
comprises a circumferential region of the overmolding that is
formed from a different material, or different grade of material,
having mechanical properties that are different from the rest of
the overmolding 220(D). More specifically, in one example, the
removal mechanism 255(D) is formed from a grade or type of silicone
elastomer that is substantially easier to cut (i.e., softer and/or
lower tear strength) than the grade or type of silicone elastomer
used for the remainder of the overmolding 220(D). In another
example, the removal mechanism 255(D) is formed from a resorbable
material, while the remainder of the overmolding 220(D) is formed
from a non-resorbable material.
[0052] FIGS. 2B, 2C, and 2D illustrate different removal mechanisms
in accordance with embodiments presented herein. It is to be
appreciated that the embodiments of FIGS. 2B, 2C, and 2D are not
mutually exclusive and, instead, may be combined in different
forms. For example, it may be possible to use a different material,
or different grade of material, (e.g., FIG. 2D) with the one or
more channels or grooves (e.g., FIG. 2B or 2C).
[0053] It is also to be appreciated that the removal mechanisms
shown in FIGS. 2B, 2C, and 2D are merely illustrative and other
arrangements are possible. For example, rather than circumferential
channels or grooves, embodiments may alternatively use channels,
grooves, or other features that only extend around discrete
portions of the separable magnet arrangement. Again, these discrete
features could be combined with the use of a different material, or
different grade of material, (e.g., FIG. 2D) so as to facilitate
separation of a separable magnet arrangement from the remainder of
the encapsulated implantable component.
[0054] In certain embodiments, the removal mechanisms described
herein may including one or more markings (e.g., a different color,
embossing, etc.) indicating the location at which a surgeon should
detach the separable magnet arrangement from the remainder of the
encapsulated implantable component. For example, in one specific
example, a thin layer of different colored silicone (e.g., white
silicone) is included in the removal mechanism to indicate where
the surgeon should perform the cut.
[0055] FIG. 3 is a top view of another encapsulated implantable
component 332 that comprises an integrated separable magnet
arrangement 350 in accordance with embodiments of the present
invention. Similar to the embodiments of FIGS. 2A-2D, the
encapsulated implantable component 332 includes an implant body 122
and an internal coil 116 encapsulated in an overmolding 320. As
shown, the internal coil 116 is encapsulated in an annular
overmolding portion 352.
[0056] The separable magnet arrangement 350 comprises the
implantable magnet 126, a surrounding overmolding portion/region
345 that fully encapsulates the implantable magnet 126, and a
removal mechanism 355 formed by a plurality of discrete sections or
"spokes" 354 that connect the surrounding overmolding region 345 to
the annular portion 352. In operation, a surgeon can cut each of
the spokes 354 so as to mechanically separate the separable magnet
arrangement 350 from the remainder of the encapsulation component
332, thereby enabling the implantable magnet 126 to be removed from
the recipient. As shown in FIG. 3, the spokes 354 each include an
optional marking 356 indicating where the surgeon should cut the
respective spoke. In certain embodiments, the markings 356 could be
replaced by, or used in combination with, a mechanically prepared
region as described above with references to FIGS. 2A-2D so as to
further facilitate mechanical separation of separable magnet
arrangement 350 from the remainder of the encapsulated implantable
component 332.
[0057] As noted, the embodiments of FIGS. 2A-2D and FIG. 3
illustrate integrated separable magnet arrangements that enable a
surgeon to physically separate the implantable magnet, and a
portion of surrounding overmolding, from the remainder of the
encapsulated implantable component. Upon removal of the respective
separable magnet arrangements, the encapsulated implantable
components of FIGS. 2A-2D and FIG. 3 have an arrangement that is
substantially similar to that which is shown in FIG. 4A. That is,
FIG. 4A is top view of an encapsulated implantable component 432
that initially had a configuration similar to, for example, that
shown in one of FIGS. 2A-2D or FIG. 3, but from which the
integrated separable magnet arrangement (not shown in FIG. 4A) has
been removed by a surgeon.
[0058] As shown in FIG. 4A, the removal of the separable magnet
arrangement results in a substantially circular aperture 458
extending through the overmolding 420 in between the wire loops
forming the internal coil 116. The internal coil 116 remains
encapsulated in an annular overmolding portion 452.
[0059] As noted above, it is desirable to remove implantable
magnets from a recipient for a variety of reasons, including for
MRI tests. However, also as noted above, presence of the
implantable magnet is required to align the internal coil 116 with
an external coil for transcutaneous transfer of power and/or data
there between. As such, in accordance with the embodiments
presented herein, an integrated separable magnet arrangement that
has been removed from a recipient may be replaced by an independent
separable magnet arrangement in which the implantable magnet is
physically separate from the overmolding of the encapsulated
implantable component.
[0060] More specifically, FIGS. 4B and 4C illustrate the
encapsulated implantable component 432 of FIG. 4A in combination
with an independent separable magnet arrangement 450 in accordance
with embodiments presented herein. In the embodiment of FIGS. 4B
and 4C, the separable magnet arrangement 450 comprises an
implantable magnet 426 attached to a bone fixture 460. The bone
fixture 460 comprises a threaded body (shank) 462 that is
configured to be inserted (e.g., screwed) into the recipient's bone
generally proximate to the wire loops forming the internal coil
116. The bone fixture 460 also comprises a coupling section 464 in
which the implantable magnet 426 is positioned. In this example,
the implantable magnet 426 is magnetically coupled to the coupling
section 464 to enable subsequent removal of the implantable magnet
without removing the bone fixture 460. After insertion, a space or
gap 464 remains between the separable magnet arrangement 450 and
the annular overmolding portion 452.
[0061] In certain examples, the use of an alignment tool or a
template could be used to facilitate the placement separable magnet
arrangement 450. Proper placement of the separable magnet
arrangement 450 is important to ensure alignment of the external
and internal coils. In other embodiments, an adhesive, bone cement,
sutures, etc. around or adjacent to the annular region 452 could
also or alternatively be used to maintain the position of the coil
116 relative to the separable magnet arrangement 450.
[0062] FIGS. 4B and 4C have been described above with reference to
retro-fitting an encapsulated implantable component from which
another separable magnet arrangement was previously removed.
However, the embodiment of FIGS. 4B and 4C should also be viewed as
an example of an initial implantable arrangement for an
encapsulated implantable component. That is, the encapsulated
implantable component 432 may be formed during manufacturing (or in
a pre-surgical procedure) to include the circular aperture 458
extending through the overmolding 420. Once the encapsulated
implantable component 432 is positioned in the recipient, the
surgeon could then implant the separable magnet arrangement 450
(i.e., insert the threaded body 462 into the skull) at the correct
location.
[0063] The embodiments of FIGS. 4B and 4C illustrate one example in
which a bone fixture is used to independently secure the separable
magnet arrangement to the recipient. In alternative embodiments, a
bonding agent (e.g., an ionomeric bone cement or a poly methyl
methacrylate (PMMA) bone cement, a biocompatible adhesive, etc.)
could be used to secure the separable magnet arrangement to the
recipient. That is, the threaded body 462 could be omitted to
provide a flat or textured surface that may be secured to the
recipient's bone with a bonding agent.
[0064] In further embodiments, independent separable magnet
arrangements may utilize different bone fixtures and/or different
coupling mechanisms. For example, FIG. 5 illustrates an independent
separable magnet arrangement 550 for use with the encapsulated
implantable component 432 described above with reference to FIGS.
4A-4C. In this example, the independent separable magnet
arrangement 550 is additionally configured for an interference fit
with the encapsulated implantable component 432.
[0065] The separable magnet arrangement 550 comprises a bone
fixture 560 comprising a threaded body 562 and a coupling section
564 in which an implantable magnet 526 is positioned. In this
example, the coupling section 564 includes a female threaded
connector 545. The female threaded connector 545 is configured to
mate with a male threaded connector 547 attached to the threaded
body 562.
[0066] The threaded body 562 is configured to be inserted into the
recipient's bone generally proximate to the wire loops forming the
internal coil 116. In this example, the implantable magnet 526 is
encapsulated/overmolded in a resiliently flexible material,
referred to herein as overmolding 555. The overmolding 555 is sized
so as to fit tightly into the aperture 558. That is, the
overmolding 555 is configured to substantially fill aperture 555
such that, after connection to the bone fixture 560, little or no
space remains between the separable magnet arrangement 550 and the
annular portion 452. In certain examples, the overmolding 555 has
an outside dimension (e.g., width, diameter, etc.) that is larger
than the outside diameter 570 of aperture 458 so as to be
compressed when inserted into the aperture (i.e., an interference
fit). The compression of the overmolding 555 may substantially
prevent the ingress of fluid between the overmolding 555 and the
annular portion 452, thereby substantially preventing the formation
of biofilm there between.
[0067] As shown in FIG. 5, the separable magnet arrangement 550 may
optionally include securement tabs 557. The securement tabs 557 may
be formed from a substantially rigid material and are configured to
exert a force in the direction of the recipient's bone.
[0068] FIG. 6 is a cross-sectional view of an embodiment of an
independent separable magnet arrangement 650 that is also
configured for an interference fit with an encapsulated implantable
component 632. More specifically, the encapsulated implantable
component 632 includes the implant body 122 and the internal coil
116, both of which are encapsulated in an overmolding 620. As
shown, the encapsulated implantable component 632 includes a
relatively small aperture 658 generally located proximate to the
wire loops forming the internal coil 116.
[0069] The separable magnet arrangement 650 comprises an
implantable magnet 626 enclosed in a bone fixture 660. The bone
fixture 660 comprises a threaded body 662 that is configured to be
inserted into the recipient's bone generally proximate to the wire
loops forming the internal coil 116. The bone fixture 660 also
comprises a coupling section 664 in which the implantable magnet
626 is positioned.
[0070] In general, the coupling section 664 has an outside
dimension 668 (e.g., width, diameter, etc.) that is larger than the
outside diameter 670 of aperture 658. However, the coupling section
664 also includes a circumferential channel/groove 666 with an
interior dimension 672 that is approximately the same as the
diameter of 670 of aperture 658.
[0071] In operation, the separable magnet arrangement 650 may be
implanted into a recipient. The overmolding 620 is formed from a
resiliently flexible material such that the aperture 658 may pulled
over the coupling section 664 so as to be seated into the
circumferential channel 666. That is, as shown in FIG. 6, the
coupling section 664 is located in the aperture 658 so as to create
an interference fit between the portion of the overmolding 620
surrounding the aperture and the circumferential channel 666. In
this example, the overmolding 620 surrounding the aperture 658 is
held between a top edge 674(A) and a bottom edge 674(B) of the
circumferential channel 666.
[0072] FIG. 7 is a cross-sectional view of another independent
separable magnet arrangement 750 that is configured for an
interference fit with the encapsulated implantable component 632.
In the embodiment of FIG. 7, the separable magnet arrangement 750
comprises an implantable magnet 726 enclosed in a bone fixture 760.
The bone fixture 760 comprises a threaded body 762 that is
configured to be inserted into the recipient's bone generally
proximate to the wire loops forming the internal coil 116. The bone
fixture 760 also comprises a coupling section 764 in which the
implantable magnet 726 is positioned.
[0073] In general, the coupling section 764 has an outside
dimension 768 (e.g., width, diameter, etc.) that is larger than the
outside diameter 670 of aperture 658. However, the coupling section
764 also includes an upper portion 780 having an exterior dimension
782 that is smaller than the outside dimension 768. In general, the
exterior dimension 782 is slightly larger than the diameter of 670
of aperture 658.
[0074] In operation, the separable magnet arrangement 750 may be
implanted into a recipient. The overmolding 620 is formed from a
resiliently flexible material such that the aperture 658 may pulled
over the coupling section 764 so as to be seated around upper
portion 782. That is, as shown in FIG. 7, the upper portion 780 of
coupling section 764 is located in the aperture 658 so as to create
an interference fit between the portion of the overmolding 620
surrounding the aperture and the upper portion. In this example,
the overmolding 620 surrounding the aperture 658 is positioned on a
ledge 774 of the coupling section 764. Additionally, since exterior
dimension 782 of upper portion 780 is slightly larger than the
diameter of 670 of aperture 658, the overmolding 620 is compressed
and, as such, is secured around the upper portion 780.
[0075] It is to be appreciated that FIGS. 6 and 7 are merely
illustrative of separable magnet arrangements configured for an
interference fit/coupling with the encapsulated implantable
component. It is to be appreciated separable magnet arrangements
configured for an interference fit with an encapsulated implantable
component in accordance with embodiments of the present invention
may have other configurations.
[0076] FIG. 8 is a schematic diagram illustrating an "interlocking"
separable magnet arrangement 850. As used herein, an interlocking
separable magnet arrangement is a separable magnet arrangement
having a structural configuration to enable mechanical interlocking
with an encapsulated implantable component 832. In this example,
the encapsulated implantable component 832 includes the implant
body 122 and the internal coil 116 encapsulated in an overmolding
820. However, unlike encapsulated implantable component 432 (FIG.
4A), the encapsulated implantable component 832 does not include an
aperture extending through the overmolding 820.
[0077] The separable magnet arrangement 850 comprises an
implantable magnet 826 and two extension arms 886(A) and 886(B)
extending from the implantable magnet. As shown in FIG. 8, the
extension arms 886(A) and 886(B) are configured to fit around and
mechanically engage the outer edge of the portion of the
overmolding 820 in which internal coil 116 is positioned. The
mechanical engagement between the extension arms 886(A) and 886(B)
and the outer surface of the overmolding 820 functions to retain
the separable magnet arrangement 850 in a desired location.
[0078] In certain examples, the extension arms 886(A) and 886(B)
are formed from a rigid material (e.g., titanium, platinum, etc.)
having a thickness that makes the extension arms 886(A) and 886(B)
pliable. In other embodiments, the extension arms 886(A) and 886(B)
are formed from an elastomer material having sufficient rigidity to
engage the overmolding 820.
[0079] It is to be appreciated that the separable magnet
arrangement 850 may be partially or fully enclosed in its own
encapsulation/molding, depending on what material is used form the
extension arms. However, merely for ease of illustration, the
separable magnet arrangement 850 has been shown in FIG. 8 without
an encapsulation enclosing the implantable magnet 826 and/or the
extension arms 886(A) and 886(B).
[0080] FIG. 9 is a schematic diagram illustrating another
interlocking separable magnet arrangement 950 that is configured
for mechanical interlocking with the encapsulated implantable
component 432 shown in FIG. 4A. In this example, the separable
magnet arrangement 950 comprises an implantable magnet 926
configured to be located proximate to the wire loops forming the
internal coil 116. The separable magnet arrangement 950 comprises a
plurality of discrete sections or "spokes" 954 that extend from the
implantable magnet 926. The spokes 954 each terminate in a
connector 988 that is configured to mechanically engage the annular
portion 452 that encapsulates the internal coil 116. In one
example, the spokes 954 and connectors 988 are formed from, for
example, a silicone elastomer and the connectors are fit in place
by pressing and elastically deforming the connectors and/or annular
portion 452. In other embodiments, the spokes 954 and connectors
988 are formed from a rigid material (e.g., titanium, platinum,
etc.).
[0081] It is to be appreciated that the separable magnet
arrangement 950 may be partially enclosed in its own
encapsulation/molding. However, merely for ease of illustration,
the separable magnet arrangement 950 has been shown in FIG. 9
without an encapsulation/molding enclosing the implantable magnet
926, spokes 954 and/or connectors 988.
[0082] FIGS. 10A-10C are schematic diagrams illustrating another
interlocking separable magnet arrangement 1050 that is configured
for mechanical interlocking with an encapsulated implantable
component 1032. In this example, the encapsulated implantable
component 1032 includes an implant body 1022 and an internal coil
1016, both of which are encapsulated in an overmolding 1020. The
overmolding 1020 includes a substantially circular aperture 1058
extending through the overmolding. The internal coil 1016 remains
encapsulated in an annular overmolding portion 1052.
[0083] The separable magnet arrangement 1050 comprises an
implantable magnet 1026 configured to be located proximate to the
wire loops forming the internal coil 1016. The separable magnet
arrangement 1050 also comprises a substantially rigid connector arm
1092 extending from the implantable magnet 1026. As shown in FIGS.
10B and 10C, the connector arm 1092 terminates in a plug 1092 that
is configured to mechanically mate with a receptacle/socket 1094
disposed in implant body 1022. The plug 1092 and socket 1094 may
each be asymmetrical to ensure that the plug can only inserted into
the socket with a specified orientation. Additionally, the plug
1092 and socket 1094 may provide a snap-in interface (e.g., the
plug and/or socket may be elastically deformable to facilitate a
tight fit therebetween).
[0084] The embodiment shown in FIGS. 10A-10C may be interesting
from a pre-MRI surgery point of view since a small incision would
be enough (i.e., about as wide as the implantable magnet) to remove
the magnet and later replace it. At extraction and/or re-insertion,
the void in the tissue could receive an injection of antibiotics to
avoid bacterial colonization. Furthermore, since the implantable
magnet 1026 is rigidly connected to the implant body 1022, the
magnet would be stabilized during MRI (i.e., it can't turn that
much since the implant body helps to keep it in place).
[0085] FIG. 11 illustrates another separable magnet arrangement
1150 that is configured to be magnetically coupled to an
encapsulated implantable component 1132. In this example, the
encapsulated implantable component 1132 includes an implant body
1122 and an internal coil 1116, both of which are encapsulated in
an overmolding 1120. The overmolding 1120 includes a substantially
circular aperture 1158 extending through the overmolding. The
internal coil 1116 remains encapsulated in an annular overmolding
portion 1152.
[0086] In the embodiment of FIG. 11, the separable magnet
arrangement 1150 comprises an implantable magnet 1126, a
surrounding overmolding portion/region 1145 that fully encapsulates
the implantable magnet 1126. The surrounding overmolding region
1145 has a configuration so as to be positioned in, and to
substantially fill, the aperture 1158.
[0087] The encapsulated implantable component 1132 further
comprises magnets 1195(A) and 1195(B) generally on the implant body
1122 adjacent to the internal coil 1116. The magnets 1195(A) and
1195(B) are configured to magnetically couple to the implantable
magnet 1126 when the separable magnet arrangement 1150 is
positioned in the aperture 1158. That is, FIG. 11 illustrates a
magnetic coupling arrangement for securement of the separable
magnet arrangement 1150 adjacent to the encapsulated implantable
component 1132.
[0088] In certain embodiments, an implant body (as described above)
may include a feature that facilitates proper collocating of the
implant and a separable magnet arrangement. For example, the
implant body may include a horizontal pedestal that is placed in a
channel that has been predrilled into the bone The pedestal
provides a feature from which a surgeon can reliably assess using,
for example a surgical template, where the drilling for a bone
screw (included in a separable magnet arrangement) needs to
occur.
[0089] As noted above, embodiments of the present invention
generally enable surgical removal of a separable magnet
arrangement, which includes an implantable magnet, without removal
of an encapsulated implantable component that relies upon the
implantable magnet for operation. FIG. 12 is a flowchart of one
example surgical method 1201 utilizing separable magnet
arrangements in accordance with embodiments presented herein.
[0090] Method 1201 begins at 1203 wherein an encapsulated
implantable component comprising an overmolding and an integrated
separable magnet arrangement is positioned in a recipient. At 1205,
the integrated separable magnet arrangement is physically separated
from a remainder of the encapsulated implantable component to form
an aperture in the overmolding. At 1207, the integrated separable
magnet arrangement from the recipient.
[0091] As noted above, it is desirable to remove implantable
magnets from a recipient for a variety of reasons, including for
MRI tests. However, also as noted above, presence of the
implantable magnet is required for alignment of external and
internal coils for transcutaneous transfer of power and/or data
there between. As such, in accordance with the embodiments
presented herein, at 1209, method 1201 includes replacement of the
integrated separable magnet arrangement that has been removed from
a recipient with an independent or interlocking separable magnet
arrangement.
[0092] Hearing loss, which may be due to many different causes, is
generally of two types, conductive and/or sensorineural. Conductive
hearing loss occurs when the normal mechanical pathways of the
outer and/or middle ear are impeded, for example, by damage to the
ossicular chain or ear canal. Sensorineural hearing loss occurs
when there is damage to the inner ear, or to the nerve pathways
from the inner ear to the brain.
[0093] Individuals who suffer from conductive hearing loss
typically have some form of residual hearing because the hair cells
in the cochlea are undamaged. As such, individuals suffering from
conductive hearing loss typically receive an auditory prosthesis
that generates motion of the cochlea fluid. Such auditory
prostheses include, for example, acoustic hearing aids, bone
conduction devices, and direct acoustic stimulators.
[0094] In many people who are profoundly deaf, however, the reason
for their deafness is sensorineural hearing loss. Those suffering
from some forms of sensorineural hearing loss are unable to derive
suitable benefit from auditory prostheses that generate mechanical
motion of the cochlea fluid. Such individuals can benefit from
implantable auditory prostheses that stimulate nerve cells of the
recipient's auditory system in other ways (e.g., electrical,
optical and the like). Cochlear implants are often proposed when
the sensorineural hearing loss is due to the absence or destruction
of the cochlea hair cells, which transduce acoustic signals into
nerve impulses. An auditory brainstem stimulator is another type of
electrically-stimulating auditory prosthesis that might also be
proposed when a recipient experiences sensorineural hearing loss
due to damage to the auditory nerve.
[0095] Bone conduction recipients may initially be fitted with a
transcutaneous bone conduction device (i.e., a device that uses an
implanted magnetic bone fixture for transcutaneous transmission of
vibrations from an external transducer/vibrator). However, in
certain cases, the hearing capability of bone conduction recipients
may deteriorate such that they no longer receive suitable benefit
from the bone conduction device (i.e., increased sensorineural
hearing loss). As a result, these recipients are candidates for
upgrades to, for example, a cochlear implant. The embodiments
presented herein facilitate such upgrades from bone conduction
devices to cochlear implants.
[0096] The invention described and claimed herein is not to be
limited in scope by the specific preferred embodiments herein
disclosed, since these embodiments are intended as illustrations,
and not limitations, of several aspects of the invention. Any
equivalent embodiments are intended to be within the scope of this
invention. Indeed, various modifications of the invention in
addition to those shown and described herein will become apparent
to those skilled in the art from the foregoing description. Such
modifications are also intended to fall within the scope of the
appended claims.
* * * * *