U.S. patent application number 11/327880 was filed with the patent office on 2007-07-12 for connector and methods of fabrication.
This patent application is currently assigned to Advanced Bionics Corporation. Invention is credited to Randall Lee Brase, Robert R. Tong.
Application Number | 20070161294 11/327880 |
Document ID | / |
Family ID | 38233297 |
Filed Date | 2007-07-12 |
United States Patent
Application |
20070161294 |
Kind Code |
A1 |
Brase; Randall Lee ; et
al. |
July 12, 2007 |
CONNECTOR AND METHODS OF FABRICATION
Abstract
A connector includes a unitary body defining a hollow center
region configured and arranged to receive a proximal contact
portion of a lead. The unitary body may define connector pockets
and seal features within the hollow center region. The connector
pockets can be spaced-apart and may define openings through the
unitary body. The seal features may be disposed between the
connector pockets.
Inventors: |
Brase; Randall Lee;
(Castaic, CA) ; Tong; Robert R.; (Valencia,
CA) |
Correspondence
Address: |
Advanced Bionics;c/o DARBY & DARBY P.C.
P.O. BOX 5257
NEW YORK
NY
10150-5257
US
|
Assignee: |
Advanced Bionics
Corporation
Sylmar
CA
|
Family ID: |
38233297 |
Appl. No.: |
11/327880 |
Filed: |
January 9, 2006 |
Current U.S.
Class: |
439/668 |
Current CPC
Class: |
A61N 1/0551 20130101;
A61N 1/36017 20130101; Y10S 439/909 20130101; A61N 1/3752
20130101 |
Class at
Publication: |
439/668 |
International
Class: |
H01R 24/04 20060101
H01R024/04 |
Claims
1. A connector comprising: a unitary body defining a hollow center
region configured and arranged to receive a proximal contact
portion of a lead, the unitary body further defining within the
hollow center region a plurality of spaced-apart connector pockets,
wherein each connector pocket defines an opening through the
unitary body, and the unitary body further defining within the
hollow center region a plurality of seal features disposed between
the connector pockets.
2. The connector of claim 1, wherein the openings through the
unitary body are disposed on one side of the unitary body.
3. The connector of claim 1, wherein the connector pockets are
spaced-apart at substantially uniform intervals.
4. The connector of claim 1, wherein the unitary body further
defines a stop pocket at an end of the hollow center region.
5. The connector of claim 1, further comprising a connector block
coupled to the unitary body.
6. The connector of claim 1, further comprising a plurality of
conductive contacts disposed in the openings through the unitary
body.
7. The connector of claim 6, further comprising a plurality of
conductors coupled to the conductive contacts.
8. The connector of claim 1, wherein the unitary body comprises
polysilicone.
9. A stimulation device comprising: a lead with a proximal contact
portion comprising a plurality of contacts; an electronic
subassembly; a connector that receives the proximal contact portion
of the lead, wherein the connector comprises a unitary body that
defines a hollow center region configured and arranged to receive
the proximal contact portion of the lead, wherein the unitary body
further defines within the hollow center region a plurality of
spaced-apart connector pockets, wherein each connector pocket
defines an opening through the connector, and the unitary body
further defining within the hollow center region a plurality of
seal features disposed between the connector pockets; and a
plurality of conductive contacts disposed in the openings of the
connector and configured and arranged to couple the contacts of the
lead to the electronic subassembly.
10. The stimulation device of claim 9, wherein the unitary body
further defines a stop pocket at an end of the hollow region.
11. The stimulation device of claim 9, wherein the connector
pockets are spaced-apart at substantially uniform intervals.
12. The stimulation device of claim 9, further comprising a
connector block coupled to the unitary body.
13. The stimulation device of claim 9, further comprising a
plurality of conductors that couple the electronic subassembly to
the conductive contacts.
14. A method of making a stimulation device that provides
electrical pulses to a tissue comprising: forming a connector
comprising a unitary body defining a hollow center region
configured and arranged to receive a proximal contact portion of a
lead, wherein the unitary body further defines within the hollow
center region a plurality of spaced-apart connector pockets,
wherein each connector pocket defines an opening through the
unitary body, and the unitary body further defining within the
hollow center region a plurality of seal features disposed between
the connector pockets; disposing a plurality of conductive contacts
in the openings through the unitary body; and coupling contacts on
a lead to an electronic subassembly through the connector and
conductive contacts.
15. (canceled)
16. The method of claim 14, wherein the connector is formed by
molding, and wherein forming a connector comprises: disposing mold
insert pieces in a mold frame; forming a unitary body around the
mold insert pieces; and removing the mold insert pieces from the
unitary body formed around the mold insert pieces.
17. The method of claim 16, wherein disposing told insert pieces in
a mold frame comprises disposing mold insert pieces in a mold frame
using a locating feature.
18. The method of claim 14, wherein disposing a plurality of
conductive contacts in the openings through the unitary body
comprises swelling the material used to form the unitary body.
19. The method of claim 14, further comprising coupling a connector
block to the unitary body.
20. The method of claim 14, wherein coupling a lead to an
electronic subassembly comprises coupling the lead to the
electronic subassembly Via a plurality of conductors.
21. The connector of claim 1, wherein at least four conductive
contacts are disposed in the openings through the unitary body.
Description
FIELD OF THE INVENTION
[0001] The invention is directed to stimulators and stimulator
components and methods of making the devices. The invention is also
directed to stimulators and stimulator components with a connector,
as well as methods of making the devices.
BACKGROUND OF THE INVENTION
[0002] Stimulators have been developed to provide therapy for a
variety of disorders, as well as for other treatments. For example,
stimulators can be used in neurological therapy by stimulating
nerves or muscles, for urinary urge incontinence by stimulating
nerve fibers proximal to the pudendal nerves of the pelvic floor,
for erectile and other sexual dysfunctions by stimulating the
cavernous nerve(s), for reduction of pressure sores or venous
stasis, etc.
[0003] As one example, spinal cord stimulation is a well accepted
clinical method for reducing pain in certain populations of
patients. Stimulators have been developed to provide therapy for a
variety of treatments. For example, stimulators can be used to
stimulate nerves, such as the spinal cord, muscles, or other
tissue. A stimulator can include a control module (with a pulse
generator), one or more leads, and an array of stimulator
electrodes on each lead. The stimulator electrodes are in contact
with or near the nerves, muscles, or other tissue to be stimulated.
The pulse generator in the control module generates electrical
pulses that are delivered by the electrodes to body tissue. As an
example, electrical pulses can be provided to the dorsal column
fibers within the spinal cord to provide spinal cord
stimulation.
BRIEF SUMMARY OF THE INVENTION
[0004] In one embodiment, a connector includes a unitary body
defining a hollow center region configured and arranged to receive
a proximal contact portion of a lead. The unitary body further
defines within the hollow center region a plurality of spaced-apart
connector pockets. Each connector pocket defines an opening through
the unitary body. The unitary body further defines within the
hollow center region a plurality of seal features disposed between
the connector pockets.
[0005] In another embodiment, a stimulation device includes a lead
with a proximal contact portion comprising a plurality of contacts,
an electronic subassembly, a connector, and a plurality of
conductive contacts. The connector receives the proximal contact
portion of the lead. The connector includes a unitary body that
defines a hollow center region configured and arranged to receive
the proximal contact portion of the lead. The unitary body further
defines within the hollow center region a plurality of spaced-apart
connector pockets. Each connector pocket defines an opening through
the connector. The unitary body further defines within the hollow
center region a plurality of seal features disposed between the
connector pockets. The conductive contacts are disposed in the
openings of the connector and are configured and arranged to couple
the contacts of the lead to the electronic subassembly.
[0006] In another embodiment, a method of making a stimulation
device includes forming a connector, disposing a plurality of
conductive contacts in the openings through the unitary body, and
coupling contacts on a lead to an electronic subassembly through
the connector and conductive contacts. The connector includes a
unitary body defining a hollow center region configured and
arranged to receive a proximal contact portion of a lead. The
unitary body further defines within the hollow center region a
plurality of spaced-apart connector pockets. Each connector pocket
defines an opening through the unitary body. The unitary body
further defines within the hollow center region a plurality of seal
features disposed between the connector pockets.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] Non-limiting and non-exhaustive embodiments of the present
invention are described with reference to the following drawings.
In the drawings, like reference numerals refer to like parts
throughout the various figures unless otherwise specified.
[0008] For a better understanding of the present invention,
reference will be made to the following Detailed Description, which
is to be read in association with the accompanying drawings,
wherein:
[0009] FIG. 1 is a schematic perspective view of one embodiment of
a connector, according to the invention;
[0010] FIG. 2 is a schematic cross-sectional view of the unitary
body of the connector of FIG. 1;
[0011] FIG. 3 is a schematic cross-sectional view of the unitary
body of the connector of FIG. 1 from a different side;
[0012] FIG. 4 is a schematic exterior perspective view of one
embodiment of a stimulator system, according to the invention;
[0013] FIG. 5 is a schematic overview of components of a system for
stimulation, according to the invention;
[0014] FIG. 6 is a schematic perspective view of one embodiment of
a mold frame, an end pin and a locating feature, according to the
invention;
[0015] FIG. 7 is a schematic cross-sectional view of one embodiment
of a mold insert piece, according to the invention;
[0016] FIG. 8 is a schematic cross-sectional view of one embodiment
of a mold insert piece, according to the invention;
[0017] FIG. 9 is a schematic end cross-sectional view of the mold
insert piece of FIG. 7;
[0018] FIG. 10 is a schematic cross-sectional view of one
embodiment of mold insert pieces disposed in a mold frame,
according to the invention;
[0019] FIG. 11 is a schematic cross-sectional view of one
embodiment of mold insert pieces disposed in a mold frame,
according to the invention; and
[0020] FIG. 12 is a schematic cross-sectional view of one
embodiment of a unitary body molded around mold insert pieces
disposed within a mold frame, according to the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0021] The invention is directed to stimulators and stimulator
components and methods of making the devices. The invention is also
directed to stimulators and stimulator components with a connector,
as well as methods of making the devices.
[0022] Examples of stimulators are found in U.S. Pat. Nos. 6,181,
969; 6,516,227; 6,609,029; 6,609,032; and 6,741,892; and U.S.
patent application Ser. No. 11/238,240, all of which are
incorporated by reference.
[0023] In at least some applications, the electronic subassembly of
a stimulator is coupled to the lead, which includes the electrodes
of the stimulator. In at least some designs, the lead has several
contacts that connect to individual connector contacts via a
connector. The connector contacts may be arranged, for example, in
a single row, and are generally electrically isolated from each
other.
[0024] In at least some designs, the spacing and pitch between the
individual contacts may vary due to variation in manufacturing
processes or components. Such variation can result in misalignment
between the contacts of the lead and the individual connector
contacts. To address this, in one embodiment, a connector having a
unitary body with periodically spaced connector contacts
electrically isolates the connections between adjacent pairs of
lead contacts and connector contacts. For example, the connector
can include spaced-apart connector pockets into which conductive
contacts may be inserted.
[0025] As one example, a connector includes a unitary body that
defines a hollow center region configured and arranged to receive a
proximal contact portion of a lead. The unitary body further
defines within the hollow center region spaced-apart connector
pockets, where each connector pocket defines an opening through the
unitary body. Conductive contacts can be disposed in the openings
through the unitary body.
[0026] FIG. 2 illustrates schematically a cross-sectional view of
one embodiment of a unitary body 118 of a connector, according to
the invention. The unitary body 118 defines a hollow center region
124 that is capable of receiving the proximal contact portion of a
lead. Suitable materials for the unitary body 118 include, for
example, silicone and polyurethane. In some instances, the unitary
body 118 may be formed from more than one material.
[0027] The unitary body 118 further defines connector pockets 120
within the hollow center region 124. The unitary body 118 may
include any number of connector pockets 120. There may be, for
example, two, three, four, five, six, seven, eight, nine, ten,
eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen,
eighteen, or more connector pockets 120. Preferably, the number of
connector pockets 120 is equal to the number of contacts on the
proximal contact portion of the lead.
[0028] In one embodiment illustrated in FIG. 3, the connector
pockets 120 define an opening 134 through the unitary body 118. The
openings 134 through the unitary body 118 may be located on any
side of the unitary body 118. Preferably, the openings 134 are all
located on the same side of the unitary body 118.
[0029] The connector pockets 120 are spaced-apart. The connector
pockets 120 may be spaced-apart in any fashion. For example, the
connector pockets 120 can be regularly (e.g., with a regular
period) spaced-apart. In one embodiment, the connector pockets 120
are spaced-apart at substantially uniform intervals. Preferably,
the connector pockets 120 are spaced-apart such that the openings
134 defined by the connector pockets 120 can be aligned with the
lead contacts of the proximal contact portion of the lead received
by the unitary body 118.
[0030] The opening 134 through the unitary body 118 may have any
dimensions. Preferably, the opening 134 is capable of receiving a
conductive contact 130 (FIG. 1). Conductive contacts 130 may be
made of any material that is conductive including, for example,
metals, alloys, conductive polymers, conductive carbon, etc. There
may be any number of conductive contacts including, for example,
two, three, four, five, six, seven, eight, nine, ten, eleven,
twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen
or more conductive contacts 130. Preferably, the number of
conductive contacts 130 is equal to the number of connector pockets
120.
[0031] The conductive contacts 130 couple the electronic
subassembly 110 (FIG. 4) to the lead 106 (FIG. 4) through the
conductors 156 (FIG. 1). Optionally, the conductors 156 may be
insulated by an insulating material except where the conductor 156
makes contact with the conductive contacts 130, electronic
subassembly 110, or other components of the electrical circuitry.
The insulating material may be any material that is a poor
conductor of an electrical signal including, for example,
Teflon.TM., and non-conductive polymers.
[0032] In one embodiment, the unitary body 118 further defines
within the hollow center region 124 a stop pocket 150 (FIG. 2). The
stop pocket 150 is located at the end of the unitary body 118
opposite the end from which the lead is inserted.
[0033] In one embodiment, the unitary body 118 is coupled to a
connector block 158 as illustrated, for example, in FIG. 1. The
connector block 158 can be made of any conductive or non-conductive
material. Suitable non-conductive materials for the connector block
158 include, for example, non-conductive polymers,
polyetheretherketone (PEEK), ceramics, etc. Suitable conductive
materials include, but are not limited to, metal, alloys,
conductive polymers, conductive carbon, etc.
[0034] In one embodiment, the connector block 158 aids positioning
and/or securing the proximal contact portion of the lead within the
hollow center region 124 of the unitary body 118. In one
embodiment, the connector block 158 has an insertion opening 162
through which the proximal portion of the lead may pass (FIG. 1).
The connector block 158 may also have a securement opening 160 that
may be used to secure the proximal contact portion of the lead
disposed within the hollow center region 124 of the unitary body
118 (FIG. 1). Optionally, the securement opening 160 may be roughly
perpendicular to the insertion opening 162 (FIG. 1). A pin, screw
or other member can be inserted through the securement opening 160
in the connector block 158 to secure the proximal contact portion
of the lead in the hollow center region 124 of the unitary body
118.
[0035] The connector block 158 may be coupled to any end of the
unitary body 118. Preferably, the connector block 158 is coupled to
the end of the unitary body 118 that is opposite the end of the
unitary body 118 where the stop pocket 150 is located.
[0036] In one embodiment, the unitary body 118 further defines seal
features 140 (FIG. 2) within the hollow center region 124. The seal
features 140 are located between the connector pockets 120. A seal
feature(s) 140 may also be disposed between a connector pocket 120
and a stop pocket 150.
[0037] The unitary body 118 may include any number of seal features
140. There may be, for example, two, three, four, five, six, seven,
eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen,
sixteen, seventeen, eighteen or more seal features 140. For
example, one seal feature 140 is disposed between each pair of
adjacent connector pockets 120. A seal feature 140 may also be
disposed between a connector pocket 120 and a connector block 158.
Preferably, the number of seal features 140 is one greater than the
number of conductive contacts 130.
[0038] The seal features 140 generally electrically isolate
electrical circuitry located in each connector pocket 120 from the
electrical circuitry located in other connector pockets 120. For
example, the seal features 140 may electrically isolate each
connection between a conductive contact 130 and a lead contact of
the lead received by the unitary body 118.
[0039] FIG. 4 illustrates schematically one embodiment of a
stimulation system 100. The stimulation system includes a control
module (e.g., a stimulator or pulse generator) 102, an electrode
array 104, and at least one lead body 106 coupling the control
module to the electrode array. The electrode array 104 and the lead
body 106 form a lead. Examples of leads include, for example,
percutaneous leads and paddle leads. It will be understood that the
system for stimulation can include more, fewer, or different
components and can have a variety of different configurations
including those configurations disclosed in the stimulator
references cited herein. The stimulation system or components of
the stimulation system, including one or more of the lead body 106,
electrode array 104, and the control module 102, may be implanted
into the body.
[0040] The control module 102 typically includes a housing 114 with
an electronic subassembly 110 and, in at least some embodiments, a
power source 112 disposed within a chamber in the housing.
Preferably, the housing is resistant to moisture penetration into
the chamber containing the electronic subassembly and power source.
In some embodiments, water may diffuse through the housing.
Preferably, the diffused water is relatively pure, without
substantial ionic content, as deionized water is relatively
non-conductive.
[0041] The housing 114 may be made of any biocompatible material
including, for example, glass, ceramics, metals, epoxies and
polymers (including plastics). In one embodiment, the housing 114
of the control module is formed of a plastic material that resists
the transport of moisture into the interior of the housing and is
sufficiently sturdy to protect the components on the interior of
the housing from damage under expected usage conditions.
Preferably, the material of the plastic housing is a hydrophobic
polymer material.
[0042] The housing 114 may include additives such as, for example,
fillers, plasticizers, antioxidants, colorants, and the like. The
thickness of the walls of the housing may also impact the moisture
permeability of the housing. A minimum thickness needed to achieve
a particular degree of resistance to moisture transport will often
depend on the material selected for the housing, as well as any
additives.
[0043] Optionally, the housing 114 can be covered, in full or in
part, with a coating. The coating can be provided to improve or
alter one or more properties of the housing 114 including, for
example, biocompatibility, hydrophobicity, moisture permeability,
leaching of material into or out of the housing, and the like. In
one embodiment, a coating can be applied which contains a compound,
such as, for example, a drug, prodrug, hormone, or other bioactive
molecule, that can be released over time when the stimulator is
implanted. (In another embodiment, the housing itself may include
such a compound to be released over time after implantation.)
[0044] The connector 144 is disposed in a portion of the housing
that is, at least initially, not sealed. This allows the proximal
end of the lead 106 to be inserted into the unitary body 118 of the
connector 144. The conductors 156 (FIG. 1), or other electrical
conduits (not shown) attached to the conductors 156, penetrate the
housing 114 into the sealed chamber containing the electronic
subassembly 110, and are attached to the electronic subassembly
110.
[0045] FIG. 5 is a schematic overview of one embodiment of
components of a system for stimulation, including an electronic
subassembly 110 (which may or may not include the power source
112), according to the invention. It will be understood that the
system for stimulation and the electronic subassembly 110 can
include more, fewer, or different components and can have a variety
of different configurations including those configurations
disclosed in the stimulator references cited herein. Some or all of
the components of the system for stimulation can be positioned on
one or more circuit boards or similar carriers within a housing of
a stimulator, if desired.
[0046] Any power source 112 can be used including, for example, a
battery such as a primary battery or a rechargeable battery.
Examples of other power sources include super capacitors, nuclear
or atomic batteries, mechanical resonators, infrared collectors,
thermally-powered energy sources, flexural powered energy sources,
bioenergy power sources, fuel cells, bioelectric cells, osmotic
pressure pumps, and the like including the power sources described
in U.S. Patent Application Publication No. 2004/0059392,
incorporated herein by reference.
[0047] As another alternative, power can be supplied by an external
power source through inductive coupling via the optional antenna
124 or a secondary antenna. The external power source can be in a
device that is mounted on the skin of the user or in a unit that is
provided near the stimulator user on a permanent or periodic
basis.
[0048] If the power source 112 is a rechargeable battery, the
battery may be recharged using the optional antenna 124, if
desired. Power can be provided to the battery for recharging by
inductively coupling the battery through the antenna to a
recharging unit 210 (see FIG. 5) external to the user. Examples of
such arrangements can be found in the stimulator references
identified above.
[0049] In one embodiment, electrical current is emitted by the
electrodes 154 to stimulate motor nerve fibers, muscle fibers, or
other body tissues near the stimulator. The electronic subassembly
110 provides the electronics used to operate the stimulator and
generate the electrical pulses at the electrodes 154 to produce
stimulation of the body tissues. FIG. 5 illustrates one embodiment
of components of the electronic subassembly and associated
units.
[0050] In the illustrated embodiment, a processor 204 is generally
included in the electronic subassembly 110 to control the timing
and electrical characteristics of the stimulator. For example, the
processor can, if desired, control one or more of the timing,
frequency, strength, duration, and waveform of the pulses. In
addition, the processor 204 can select which electrodes can be used
to provide stimulation, if desired. In some embodiments, the
processor may select which electrode(s) are cathodes and which
electrode(s) are anodes. In some embodiments with electrodes
disposed on two or more sides of the housing, the processor may be
used to identify which electrodes provide the most useful
stimulation of the desired tissue. This process may be performed
using an external programming unit, as described below, that is in
communication with the processor 204.
[0051] Any processor can be used and can be as simple as an
electronic device that produces pulses at a regular interval or the
processor can be capable of receiving and interpreting instructions
from an external programming unit 208 that allow modification of
pulse characteristics. In the illustrated embodiment, the processor
204 is coupled to a receiver 202 which, in turn, is coupled to the
optional antenna 124. This allows the processor to receive
instructions from an external source to direct the pulse
characteristics and the selection of electrodes, if desired.
[0052] In one embodiment, the antenna 124 is capable of receiving
signals (e.g., RF signals) from an external telemetry unit 206
which is programmed by a programming unit 208. The programming unit
208 can be external to, or part of, the telemetry unit 206. The
telemetry unit 206 can be a device that is worn on the skin of the
user or can be carried by the user and can have a form similar to a
pager or cellular phone, if desired. As another alternative, the
telemetry unit may not be worn or carried by the user but may only
be available at a home station or at a clinician's office. The
programming unit 208 can be any unit that can provide information
to the telemetry unit for transmission to the stimulator. The
programming unit 208 can be part of the telemetry unit 206 or can
provide signals or information to the telemetry unit via a wireless
or wired connection. One example of a suitable programming unit is
a computer operated by the user or clinician to send signals to the
telemetry unit.
[0053] The signals sent to the processor 204 via the antenna 124
and receiver 202 can be used to modify or otherwise direct the
operation of the stimulator. For example, the signals may be used
to modify the pulses of the stimulator such as modifying one or
more of pulse duration, pulse frequency, pulse waveform, and pulse
strength. The signals may also direct the stimulator to cease
operation or to start operation or to start charging the battery.
In other embodiments, the electronic subassembly 110 does not
include an antennae 124 or receiver 202 and the processor 204
operates as programmed.
[0054] Optionally, the stimulator may include a transmitter (not
shown) coupled to the processor and antenna for transmitting
signals back to the telemetry unit 206 or another unit capable of
receiving the signals. For example, the stimulator may transmit
signals indicating whether the stimulator is operating properly or
not or indicating when the battery needs to be charged. The
processor may also be capable of transmitting information about the
pulse characteristics so that a user or clinician can determine or
verify the characteristics.
[0055] The optional antenna 124 can have any form. In one
embodiment, the antenna comprises a coiled wire that is wrapped at
least partially around the electronic subassembly within or on the
housing.
[0056] Any method of manufacture of the components of the system
for stimulation can be used. For example, the power source and
antenna can be manufactured as described in U.S. Patent Application
Publication No. 2004/0059392. These components can then be placed
inside the housing (or, alternatively, the housing can be formed,
e.g., molded, around the components).
[0057] In one embodiment, a method of making a stimulation device
includes forming a connector 144 comprising a unitary body 118 and
coupling a lead 106 to an electronic subassembly 110 through the
connector 144. The unitary body 118 of the connector 144 may be
formed by any method that results in the unitary body 118 defining
a hollow center region 124 capable of receiving a proximal contact
portion of a lead. The unitary body 118 is formed such that the
unitary body 118 defines connector pockets 120 within the hollow
center region 124. The unitary body 118 may be formed, for example,
by molding (including injection molding), casting, etc.
[0058] As an example, the unitary body 118 can be formed by
molding. In one embodiment, an end pin 172 is inserted onto one end
of a mold frame 170 as illustrated schematically in FIG. 10.
Suitable materials for the mold frame 170 include, but are not
limited to, metal, wood, wax, polymers, and the like. Preferably,
the mold frame 170 is made of a material such that the mold frame
170 is reusable.
[0059] The interior surface 180 of the mold frame 170 is generally
complementary to the desired external shape of the unitary body
118. Preferably, the unitary body 118 has a cylindrical exterior
shape. The interior surface 180 of the mold frame 170 typically
defines the dimensions of the exterior of the unitary body 118.
Preferably, the mold frame 170 has at least one open surface 182,
which may optionally be sealed with an end pin 172. Optionally, the
final molded unitary body 118 can be removed from the mold frame
170 through the at least one open surface 182 of the mold frame
170.
[0060] Suitable materials for the end pin 172 include, but are not
limited to, metals, wood, wax, polymers, and the like. Preferably,
the end pin 172 is made of a material such that the end pin 172 is
reusable. The end pin 172 may have any shape or dimensions.
Preferably, the end pin 172 has a shape and dimensions such that
the end pin 172 may seal an open surface 182 of the mold frame 170.
The end pin may also have a shape of a stop pocket 150 or a
connector pocket 120.
[0061] In one embodiment, at least one mold insert piece 176 is
disposed within the mold frame 170 (see FIGS. 10 and 11). Suitable
materials for the mold insert piece 176 include, but are not
limited to, metals, wood, wax, polymers, and the like. Preferably,
the mold insert piece 176 is made of a material such that the mold
insert piece 176 is reusable. In one embodiment, a single mold
insert piece 176 is disposed within the mold frame 170. Optionally,
two, three, four, five, six, seven, eight, nine, ten, eleven,
twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen,
or more mold insert pieces 176 can be disposed within the mold
frame 170.
[0062] In one embodiment, the mold insert pieces 176 have a shape
such that the cumulative shape of all the mold insert pieces 176
disposed within the mold frame 170 defines the desired shape of the
hollow center region 124 of the unitary body 118. In one
embodiment, the mold insert pieces 176 have a shape such that, when
the mold insert pieces 176 are located in the mold frame 170, the
exterior surface of the combined mold insert pieces 176 defines the
connector pockets 120, seal features 140, and stop pockets 150, if
any, of the unitary body 118 as illustrated schematically in FIGS.
7 and 8. It will be recognized that, optionally, the end pins 172
can also have the shape of a stop pocket 150 or other mold insert
piece 176.
[0063] In one embodiment, the mold insert pieces 176 may be located
and/or secured into position within the mold frame 170 by one or
more locating features 174. The locating features 174 may be
anything that aids positioning of the mold insert pieces 176 within
the mold frame 170 or that aids in securing the position of the
mold insert pieces 176 once they are disposed in the mold frame
170. For example, a cylindrical rod disposed within the mold frame
170 may act as a locating feature 174 as illustrated schematically
in FIGS. 8, 12, and 13. Optionally, a positioning aperture 178
disposed within a mold insert piece 176 may act as a locating
feature 174. In one embodiment, a positioning aperture 178 locating
feature 174 is illustrated schematically in FIG. 9. Other locating
features can include pins in one end of the mold insert piece 176
(or end pin 172) that correspond with holes in the end of another
mold insert piece 176 (or end pin 172).
[0064] In one embodiment, cooperating locating features 174 may aid
in disposing or securing mold insert pieces 176 in the mold frame
170. For example, a cylindrical rod locating feature 174 may act
cooperatively with a positioning aperture 178 locating feature 174
disposed within a mold insert piece 176. In one embodiment, the
positioning aperture 178 disposed within mold insert pieces 176 may
be used to thread the mold insert pieces 176 onto the cylindrical
rod locating feature 174. Pins/holes in the end of the mold insert
pieces may also aid in aligning the opening 134-creating
features.
[0065] After disposing the mold insert piece(s) 176 in the mold
frame 170, at least one end pin 172 can be used to seal an open
surface 182 of the mold frame 170 as illustrated schematically in
FIG. 12.
[0066] A material suitable for forming the unitary body 118 is then
added into the mold frame 170 containing the mold insert pieces
176. For example, the material suitable for forming the unitary
body 118 may be injected into the mold frame 170. This material may
then be allowed to cure, harden, or otherwise solidify. In one
embodiment, a polymerizing agent may be added to the material to
facilitate curing.
[0067] Once the unitary body 118 material has cured, hardened, or
otherwise solidified, at least one end pin 172 (and in some
instances, two end pins) is removed. In some instances, the unitary
body 118 is temporarily deformed (e.g., stretched) to remove one or
more of the end pins 172. In some embodiments, locating features
174 may also be removed at this time. For example, a cylindrical
rod locating feature 174 that passes through positioning apertures
178 of the mold insert pieces 176 may be removed at this time.
[0068] In some embodiments, the unitary body 118 is removed from
the mold frame 170. In one embodiment, the mold insert pieces 176
are then removed from the unitary body 118. The mold insert pieces
176 may be removed from the unitary body 118 in any manner.
Optionally, removal of the mold insert pieces 176 may be aided by
altering the properties of the material used to form the unitary
body 118. For example, the unitary body 118 may be formed from
polysilicone and the polysilicone unitary body 118 may be swollen
by treating the polysilicone with hexane or another material that
swells the polysilicone. The swelling of the polysilicone unitary
body 118 may facilitate removal of the mold insert pieces 176
through the openings 134 in the unitary body 118. The openings may
be temporarily deformed (e.g., stretched) during this process. In
such instances, it is preferable that the unitary body 118 be made
of a suitable material which allows such deformation and then
returns to its original shape.
[0069] Once the mold insert pieces 176 are removed, the conductive
contacts 130 are disposed within the connector pockets 120. The
conductive contacts 130 may be disposed within the connector
pockets 120 in any manner. Optionally, disposing the conductive
contacts 130 in the connector pockets 120 may also be aided by
altering the properties of-the material used to form the unitary
body 118. For example, the unitary body 118 may be formed from
polysilicone. The polysilicone unitary body 118 may be swollen by
treatment with hexane or another material that swells the
polysilicone. The conductive contacts 130 may then be disposed
within the connector pockets 120 of the unitary body 118. As the
polysilicone is allowed to dry, the swelling of the polysilicone
unitary body 118 decreases, and the conductive contacts 130 are
disposed within the polysilicone as the polysilicone shrinks around
the conductive contacts 130. Optionally, adhesive may be used to
further attach the conductive contacts 130 to the unitary body
118.
[0070] Conductors 156 may then be coupled to the conductive
contacts 130 by any suitable method including, for example,
welding, soldering, and the like. Optionally, the conductors 156
may be attached to electrical conduits (not shown) that pass
through the housing 114 to the sealed chamber.
* * * * *