US20110022102A1 - Connector assembly for use with medical devices - Google Patents
Connector assembly for use with medical devices Download PDFInfo
- Publication number
- US20110022102A1 US20110022102A1 US12/895,324 US89532410A US2011022102A1 US 20110022102 A1 US20110022102 A1 US 20110022102A1 US 89532410 A US89532410 A US 89532410A US 2011022102 A1 US2011022102 A1 US 2011022102A1
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- US
- United States
- Prior art keywords
- contact
- implantable medical
- medical device
- housing
- connector assembly
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Classifications
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R13/00—Details of coupling devices of the kinds covered by groups H01R12/70 or H01R24/00 - H01R33/00
- H01R13/46—Bases; Cases
- H01R13/52—Dustproof, splashproof, drip-proof, waterproof, or flameproof cases
- H01R13/5224—Dustproof, splashproof, drip-proof, waterproof, or flameproof cases for medical use
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/3752—Details of casing-lead connections
-
- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R13/00—Details of coupling devices of the kinds covered by groups H01R12/70 or H01R24/00 - H01R33/00
- H01R13/02—Contact members
- H01R13/15—Pins, blades or sockets having separate spring member for producing or increasing contact pressure
- H01R13/187—Pins, blades or sockets having separate spring member for producing or increasing contact pressure with spring member in the socket
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R2107/00—Four or more poles
-
- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R24/00—Two-part coupling devices, or either of their cooperating parts, characterised by their overall structure
- H01R24/58—Contacts spaced along longitudinal axis of engagement
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
- Y10T29/49117—Conductor or circuit manufacturing
- Y10T29/49204—Contact or terminal manufacturing
Definitions
- a connector assembly having one or more conductive elements in spaced-apart configuration is generally discussed herein with particular discussions extended to connector assemblies for use with implantable medical devices having easy to assemble contact elements.
- Implantable medical devices for providing electrical stimulation to body tissues, for monitoring physiologic conditions, and for providing alternative treatments to drugs are well known in the art.
- exemplary implantable medical devices include implantable cardio defibrillators, pacemakers, and programmable neurostimulator pulse generators, which are collectively herein referred to as “implantable medical devices” or IMDs.
- IMDs typically incorporate a hermetically sealed device enclosing a power source and electronic circuitry.
- the header assembly includes electrical contact elements that are electrically coupled to the electronic circuits or to the power source located inside the can via conductive terminals.
- the header assembly provides a means for electrically communicating, via an external medical lead cable, the electronic circuits or power source located inside the device to the actual stimulation point.
- FIG. 1 is a partial cut-away side view of a connector assembly in an assembled state provided in accordance with aspects of the present invention, the connector assembly comprising a plurality of seal rings, contact rings, and leaf spring contact elements.
- FIG. 2 is a cut-away side view of the connector assembly of FIG. 1 without a medical lead cable.
- FIG. 3 is a partially exploded view of the connector assembly of FIG. 1 .
- FIG. 4 is a perspective view of an alternate embodiment of a connector assembly provided in accordance with aspects of the present invention showing adjacent leads oriented at different angles from one another.
- FIGS. 5-8 are perspective views of various leaf spring contact elements provided in accordance with aspects of the present invention.
- FIGS. 9-10 are isometric cut-away views of alternate embodiments of the present invention incorporating exemplary leaf spring contact elements.
- FIG. 11 is an isometric view of an implantable medical device incorporating a connector assembly in accordance with aspects of the present invention in a header.
- an implantable medical device comprising a header attached to a sealed housing; a connector assembly disposed in the header comprising a contact housing having portions that overlap with a sealing ring, and a spring contact element disposed in a contact groove defined at least in part by an interior surface of the contact housing and a radially facing wall surface of a shoulder on one of the sealing rings.
- a connector assembly for use with an implantable medical device comprising: an end cap; a contact housing comprising a bore and comprising a portion that overlaps with the end cap; a sealing ring comprising a shoulder projecting into the bore of the contact housing; a groove disposed between the shoulder of the sealing ring and an inner circumferential surface of the contact housing having a base ring, having a plurality of spaced apart spring fingers extending therefrom, disposed therein.
- a method of assembling a connector assembly for use with an implantable medical device comprising providing a first contact housing having a slot and an interior surface defining a cavity; inserting a spring contact element comprising a base having a plurality of fingers extending therefrom into the cavity of the first contact housing; inserting a seal ring into the base of the spring contact element; and mounting a second contact housing having a slot and an interior surface defining a cavity around at least a portion of the seal ring.
- the present invention is directed to a connector assembly for use with an implantable medical device that has easy to install contact groove for locating a spring contact element.
- the contact groove may be formed without using specialty tools or devices.
- FIG. 1 a partial cut-away view of a connector assembly provided in accordance with aspects of the present invention is shown, which is generally designated 10 .
- the connector assembly 10 is configured to receive a medical lead cable 12 , which has a plurality of electrical terminals 16 interposed in between lead insulators 18 .
- the cable 12 comprises a lead body 17 for carrying a plurality of electrode leads from between the proximal end 19 and a distal end (not shown), which has electrode terminals for providing electrical stimulation to the body tissues.
- the number of electrode leads and corresponding number of electrical terminals can vary depending on the particular implant application, which also determines the number of electrical ring contacts incorporated in the connector assembly 10 , as further discussed below. Accordingly, applications of the connector assemblies discussed herein include unipolar, bipolar, and multi-polar applications by simply changing the number of components used to make the connector assembly.
- the connector assembly 10 comprises a plurality of non-conductive seal rings 24 , contact housings 26 , and leaf spring contact elements 28 .
- the plurality of seal rings 24 , contact housings 26 , and leaf spring contact elements 28 form the basic components of the connector assembly 10 of the present embodiment, which has a common bore for receiving the proximal end 19 of the lead cable 12 .
- the seal rings 24 are each configured to seal, along its internal diameter, against the lead cable 12 and, along the outer periphery of its one or more exterior shoulders, adjacent respective contact housing(s) 26 , from the external environment.
- bodily fluids should be prevented from traveling along the lead cable 12 into the connector assembly or in through the seams between the contact housing 26 and two adjacent seal rings 24 .
- the leaf spring, contact elements 28 are each configured to pass an electric signal from a lead 36 located inside an IMD housing or “can” to a corresponding leaf spring contact element 28 .
- the signal is then passed to a corresponding electrical terminal 16 on the lead cable 12 then onto a corresponding electrode lead located inside the lead body 17 and to a corresponding electrode terminal on the distal end of the cable.
- two sub-classes of seal rings 24 are incorporated, which include an end seal ring 32 and an intermediate seal ring 34 .
- the end seal ring 32 comprises an annular groove 30 adapted to receive an edge of a contact housing 26 and a central opening 37 for receiving an end portion of the lead cable 12 .
- the end seal ring 32 may be sufficiently thick such that the central opening 37 functions as a bore to receive the lead cable 12 but the proximal end is capped to seal the common bore.
- the intermediate seal ring 34 comprises two external shoulders 38 for projecting into two adjacent bores of two adjacent contact housings 26 and/or a leaf spring contact element 28 . The two shoulders project axially from a center section and each includes a radially facing wall surface area.
- an intermediate seal ring 34 can be used in place of the end seal ring 32 without deviating from the spirit and scope of the present invention.
- the contact element 28 includes a series of prongs, spring fingers, or leaf springs 50 spaced from each other and extending from a base 52 , which in one embodiment comprises an open-ended generally circular ring that is flexible.
- the base 52 may also be considered an arcuate element that is capable of flexing when receiving a shoulder on a seal ring.
- the base 52 serves as a common contact point between the plurality of leaf springs 50 and the lead 36 .
- the base 52 is adapted to form an interference fit into the contact groove 42 located between the seal ring 24 and the housing 26 as shown in FIG. 2 .
- the base 52 may include a compression gap 56 which, as described in more detail below, allows the base 52 to expand when the shoulder 38 of the seal ring 24 is inserted therein.
- the prongs 50 each includes a generally concave configuration having an apex extending radially inwardly of an imaginary cylinder defined by the base. Each such apex is configured to contact an electrical terminal 16 on the lead cable 12 when the same is inserted into the common bore of the connector assembly 10 to establish electrical communication between the electronic circuitry of the IMD housing and the lead cable 12 .
- the specific shape of the prongs 50 may be selected to establish one or more than one contact points between each individual prong 50 and the corresponding electrical terminal 16 on the lead cable 12 , which may be selected to vary the surface contact area and/or the frictional forces, as is described in more detail below.
- a lead 36 may extend from the base 52 of each leaf spring contact element 28 for connection to an input or output of an electrical circuit.
- the lead 36 may be welded to the contact element 28 and may be made of different materials than the leaf spring contact element 28 . Alternately, the lead 36 may be integral with the contact element 28 .
- the prongs 50 on each contact element 28 are sized so that each is deflected by the lead cable 12 to about 5% and up to about 60% of its total radial deflection. This deflection range ensures a sufficient spring contact force is generated between the prongs 50 and the electric terminals 16 on the lead cable 12 for transferring electric signals between the two.
- the leaf spring contact elements 28 may be made from a conductive or non-conductive material and may be manufactured by a variety of methods, for example, progressive stamping, hand forming, wire EDM, machining, etching, molding, or a combination thereof. Additionally, the contact elements may incorporate various types of plating to establish, for example, conductivity, non-conductivity, surface hardness and surface finish, among other characteristics.
- the leaf springs are conductive.
- the contact housings 26 are each generally cylindrical in configuration. More preferably, each contact housing 26 has a generally constant inner diameter and outer diameter with two square ends, with normal manufacturing tolerance being acceptable. In other words, the contact housings 26 do not have machined or formed grooves for forming contact grooves therein for accommodating the leaf spring contact elements 28 .
- the housings 26 have a simple profile, which makes manufacturing them and assembling the spring contacts 28 therein easier and therefore more cost effective than grooved housings.
- the contact grooves 42 are each formed instead by a combination of an adjacent seal ring 24 and the inner surface of a contact housing 26 .
- the contact housings 26 each incorporates a notch or slit 48 adapted to accommodate a leaf spring contact element lead 36 when the connector assembly 10 is assembled, as is described in more detail below. While FIG. 1 is a preferred design, alternative contact ring internal geometries are possible in the area of contact with the contact element 28 without compromising ease of assembly for the contact element 28 and contact ring 26 .
- the housings 26 may be made from a conductive and/or a non-conductive material. Further, the housings may be, for example, machined, extruded, formed, molded and/or casted.
- the housings 26 may have a thicker section so that there are at least two internal diameters.
- the leaf spring contact element 28 can then be inserted through the larger internal diameter end of the housing 26 until it abuts the shoulder formed at the intersection between the two different internal diameters.
- different diameters and undulating internal surfaces for the housings 26 are contemplated.
- the plurality of contact housings 26 in a single connector assembly may vary, i.e. are not uniform.
- the seal rings 24 are modified accordingly to engage the different internal diameters of the housing.
- the housings 26 provided herein not only can have a smooth internal diameter, but also machined surfaces and undulating surfaces.
- FIGS. 5 a - 8 b Leaf spring contact elements 28 with various configurations may be used, as shown in FIGS. 5 a - 8 b .
- FIG. 5 a shows the same spring contact element as discussed above with reference to FIG. 5 a .
- a leaf spring contact element 28 b has a plurality of prongs 50 b with a generally concave configuration and two leads 36 b extending from a base 52 b , one lead adjacent each edge of a compression gap 56 b .
- FIGS. 5 a shows the same spring contact element as discussed above with reference to FIG. 5 a .
- a leaf spring contact element 28 b has a plurality of prongs 50 b with a generally concave configuration and two leads 36 b extending from a base 52 b , one lead adjacent each edge of a compression gap 56 b .
- a leaf spring contact element 28 c has a cylindrical wall base 52 c extending along a length of the leaf spring contact element and a plurality of concave prongs 50 c extending from an edge of the base along the inner circumferential surface of the base 52 c .
- a compression gap 56 c may be formed between two adjacent edges of the base 52 c and a lead 36 c may extend from the base similar to previously described embodiments.
- prongs 50 d , 50 e , 50 f and 50 g may be generally S-shaped or sine wave shaped to provide at least two contact points.
- leaf spring contact elements 28 d , 28 e , 28 f and 28 g may have one lead 36 d , 36 g or two leads 36 e , 36 f .
- the S-shaped adjacent prongs may have their peaks and valleys staggered with respect to each other ( FIG. 9 ) or aligned with each other ( FIG. 10 ).
- a method for assembling a plurality of components to form a connector assembly comprising engaging a first seal ring 24 , which may be an end seal ring 32 or an intermediate seal ring 34 to a first contact housing 26 .
- a first leaf spring contact element 28 is then placed into the bore of the first housing such that the lead 36 of the contact element protrudes from the housing at the slit 48 .
- the slit 48 fixes the angular alignment between the contact housing 26 and the contact element 28 and provides an access point for electrical communication between circuits inside an IMD housing and the prongs 50 of the contact element.
- a second seal ring 34 is then connected to the contact housing 26 such that the shoulder 38 of the seal ring is located within an inner circumference of the base 52 of the contact element 28 .
- the compression gap 56 allows the base to expand to ensure sufficient contact with the seal ring.
- the method further comprises the steps of assembling a connector assembly without having to use a specialty tool, or some other means to manipulate, compress, bend, or distort a leaf spring contact element to fit within a contact groove.
- the assembled connector assembly is then placed into a mold cavity and over-molded with an implantable grade polymer or elastomer, such as silicone.
- the connector assembly can also be inserted into a pre-molded header, which resembles a housing having a cavity for receiving the connector assembly and one or more openings for placing the connector assembly into the pre-molded header.
- the one or more openings are then backfilled or sealed, typically after attaching or welding the leads from the sealed housing to the contact housings, to complete the assembly.
- the connector assembly 10 may be assembled starting from the left side of the connector, i.e., starting from the left side of FIG. 1 .
- an alternative method for assembling a connector assembly in which a dowel or assembly pin (not shown) is used, which resembles the proximal end 19 of the lead cable 12 shown in FIG. 1 .
- the assembly pin (not shown) is used to construct the connector assembly 10 by first placing an end seal ring 32 on an end of the assembly pin and then subsequently placing other components on the pin and then sliding them to engage with the earlier placed components as described above.
- the assembled components i.e., the connector assembly, may then be secured by placing the same inside a cavity of a header and over-molding the assembly with an implantable grade polymer or elastomer.
- the seal rings 24 of the present embodiment are each symmetrical about a centerline drawn perpendicular to the axis defined by the cable 12 and through the center of the seal ring.
- a contact groove for accommodating a spring contact is formed at least in part by engaging the housing 26 with an adjacent seal ring 24 .
- the seal rings 24 of the present embodiment are shown each comprising an internal surface for sealing against the lead cable 12 , two or more projections may be incorporated for sealing against a lead cable without deviating from the spirit and scope of the present invention.
- part of the seal ring that projects into the bore of a contact housing can be made separately.
- a seal ring may be made by co-molding or over-molding two separate components.
- the connector assembly is encased inside an implantable elastomer or polymer layer, as previously discussed.
- the connector assembly 10 is preferably molded with an assembly pin located inside the common bore to ensure alignment, both radially and axially, of the various connector components.
- the encased connector may be referred to as a connector header, for placing on a can or sealed housing of an IMD.
- FIG. 4 is a fully assembled view of the connector assembly 10 of FIGS. 1-3 , but with the leads oriented differently for a different IMD application.
- adjacent leads 36 protruding from the housings 26 may be oriented perpendicularly to each other.
- the leads 36 may also protrude at acute and/or obtuse angles from each other and the degree of the angles may vary along the length of the electrical connector 10 .
- the leads may aligned along a generally constant plane.
- an IMD 60 incorporating a connector assembly 10 provided in accordance with aspects of the present invention is shown.
- the connector assembly 10 is shown mounted in a header 62 , which is shown as a transparent material or structure for purposes of discussion only. In practice, the overcoat or over-molding layer is more commonly semi-opaque.
- the header 58 is situated over a can 64 , which is hermetically sealed with a power source and electronic circuits.
- a lead cable 12 is shown inserted into the common bore of the connector assembly 10 .
- Three electrode leads 66 are shown exposed near the opening of the header for illustration purposes. In practice, the lead cable extends to a distal end, which has electrode terminals for providing electrical stimulation to the body tissues or probes for monitoring and/or diagnostics.
- the IMD can be any one of plurality of IMDs for medical treatment, monitoring, or diagnostics.
- leads 36 extending from the lead spring contact elements 26 .
- leads 36 extending from the lead spring contact elements 26 .
- a single connector assembly 10 is shown inside the header 62 , two or more connector assemblies 10 may be used if desired depending on the particular implant application. If two or more connector assemblies are used, they may be stacked side-by-side or on top of one another.
Abstract
Description
- This is a Continuation application of Ser. No. 11/839,103, filed Aug. 15, 2007, the contents of which are expressly incorporated herein by reference.
- A connector assembly having one or more conductive elements in spaced-apart configuration is generally discussed herein with particular discussions extended to connector assemblies for use with implantable medical devices having easy to assemble contact elements.
- Implantable medical devices for providing electrical stimulation to body tissues, for monitoring physiologic conditions, and for providing alternative treatments to drugs are well known in the art. Exemplary implantable medical devices include implantable cardio defibrillators, pacemakers, and programmable neurostimulator pulse generators, which are collectively herein referred to as “implantable medical devices” or IMDs. These IMDs typically incorporate a hermetically sealed device enclosing a power source and electronic circuitry. Connected to the sealed housing, also known as a “can,” is a header assembly. The header assembly includes electrical contact elements that are electrically coupled to the electronic circuits or to the power source located inside the can via conductive terminals. The header assembly provides a means for electrically communicating, via an external medical lead cable, the electronic circuits or power source located inside the device to the actual stimulation point.
- Industry wide standards have been adopted for, among other things, the dimensions, size, pin spacing, diameter. etc. for the receptacle and the medical lead cable. Furthermore, sufficient electrical contact must be maintained during the life of the implantable medical device, and the medical lead cable for use with the IMD must not disconnect from the receptacle located in the header, yet be detachable for implanting and programming purposes and for replacing the IMD when necessary.
- Although prior art connector contacts provide viable options for medical device manufacturers, the overall dimensions of existing receptacles pose manufacturing challenges. Among other things, placing stackable rings in between electrically insulating seals and positioning conductive contact elements in between conductive grooves for forming a receptacle prove costly and time consuming. Accordingly, there is a need for a receptacle that not only meets the challenges associated with implantable applications but is also easier to manufacture than a variety of existing receptacles. There is also a need for a receptacle that is easily adaptable with existing implantable medical devices that are easier to manufacture than a variety of existing implantable medical devices.
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FIG. 1 is a partial cut-away side view of a connector assembly in an assembled state provided in accordance with aspects of the present invention, the connector assembly comprising a plurality of seal rings, contact rings, and leaf spring contact elements. -
FIG. 2 is a cut-away side view of the connector assembly ofFIG. 1 without a medical lead cable. -
FIG. 3 is a partially exploded view of the connector assembly ofFIG. 1 . -
FIG. 4 is a perspective view of an alternate embodiment of a connector assembly provided in accordance with aspects of the present invention showing adjacent leads oriented at different angles from one another. -
FIGS. 5-8 are perspective views of various leaf spring contact elements provided in accordance with aspects of the present invention. -
FIGS. 9-10 are isometric cut-away views of alternate embodiments of the present invention incorporating exemplary leaf spring contact elements. -
FIG. 11 is an isometric view of an implantable medical device incorporating a connector assembly in accordance with aspects of the present invention in a header. - Other aspects and features of the receptacles provided herein may be better appreciated as the same become better understood with reference to the specification and claims.
- In accordance with aspects of the present invention, there is provided an implantable medical device comprising a header attached to a sealed housing; a connector assembly disposed in the header comprising a contact housing having portions that overlap with a sealing ring, and a spring contact element disposed in a contact groove defined at least in part by an interior surface of the contact housing and a radially facing wall surface of a shoulder on one of the sealing rings.
- In according to another aspect of the present invention, there is provided a connector assembly for use with an implantable medical device comprising: an end cap; a contact housing comprising a bore and comprising a portion that overlaps with the end cap; a sealing ring comprising a shoulder projecting into the bore of the contact housing; a groove disposed between the shoulder of the sealing ring and an inner circumferential surface of the contact housing having a base ring, having a plurality of spaced apart spring fingers extending therefrom, disposed therein.
- In yet another aspect of the present invention, there is provided a method of assembling a connector assembly for use with an implantable medical device. The method comprising providing a first contact housing having a slot and an interior surface defining a cavity; inserting a spring contact element comprising a base having a plurality of fingers extending therefrom into the cavity of the first contact housing; inserting a seal ring into the base of the spring contact element; and mounting a second contact housing having a slot and an interior surface defining a cavity around at least a portion of the seal ring.
- In one of its broadest scope, the present invention is directed to a connector assembly for use with an implantable medical device that has easy to install contact groove for locating a spring contact element. The contact groove may be formed without using specialty tools or devices.
- The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of connector assemblies for electrically communicating with medical leads. The connector assemblies provided in accordance with aspects of the present invention are not intended to represent the only forms in which the present invention may be constructed or utilized. The description sets forth the features and the steps for constructing and using the connector assemblies of the present invention in connection with the illustrated embodiments. It is to be understood that the same or equivalent functions and structures may be accomplished by different embodiments and are also intended to be encompassed within the spirit and scope of the present invention, especially those incorporating a combination of features shown in the different embodiments included herein. As denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features.
- Referring now to
FIG. 1 , a partial cut-away view of a connector assembly provided in accordance with aspects of the present invention is shown, which is generally designated 10. Theconnector assembly 10 is configured to receive amedical lead cable 12, which has a plurality ofelectrical terminals 16 interposed in betweenlead insulators 18. Thecable 12 comprises alead body 17 for carrying a plurality of electrode leads from between theproximal end 19 and a distal end (not shown), which has electrode terminals for providing electrical stimulation to the body tissues. The number of electrode leads and corresponding number of electrical terminals can vary depending on the particular implant application, which also determines the number of electrical ring contacts incorporated in theconnector assembly 10, as further discussed below. Accordingly, applications of the connector assemblies discussed herein include unipolar, bipolar, and multi-polar applications by simply changing the number of components used to make the connector assembly. - In one exemplary embodiment, the
connector assembly 10 comprises a plurality ofnon-conductive seal rings 24,contact housings 26, and leafspring contact elements 28. The plurality ofseal rings 24,contact housings 26, and leafspring contact elements 28 form the basic components of theconnector assembly 10 of the present embodiment, which has a common bore for receiving theproximal end 19 of thelead cable 12. - Broadly speaking, the
seal rings 24 are each configured to seal, along its internal diameter, against thelead cable 12 and, along the outer periphery of its one or more exterior shoulders, adjacent respective contact housing(s) 26, from the external environment. As is readily apparent to a person of ordinary skill in the art in an implant application, bodily fluids should be prevented from traveling along thelead cable 12 into the connector assembly or in through the seams between thecontact housing 26 and twoadjacent seal rings 24. - The leaf spring,
contact elements 28 are each configured to pass an electric signal from alead 36 located inside an IMD housing or “can” to a corresponding leafspring contact element 28. The signal is then passed to a correspondingelectrical terminal 16 on thelead cable 12 then onto a corresponding electrode lead located inside thelead body 17 and to a corresponding electrode terminal on the distal end of the cable. - In accordance with aspects of the present invention, two sub-classes of
seal rings 24 are incorporated, which include anend seal ring 32 and anintermediate seal ring 34. Theend seal ring 32 comprises anannular groove 30 adapted to receive an edge of acontact housing 26 and acentral opening 37 for receiving an end portion of thelead cable 12. Alternatively, theend seal ring 32 may be sufficiently thick such that thecentral opening 37 functions as a bore to receive thelead cable 12 but the proximal end is capped to seal the common bore. Theintermediate seal ring 34 comprises twoexternal shoulders 38 for projecting into two adjacent bores of twoadjacent contact housings 26 and/or a leafspring contact element 28. The two shoulders project axially from a center section and each includes a radially facing wall surface area. In one embodiment, anintermediate seal ring 34 can be used in place of theend seal ring 32 without deviating from the spirit and scope of the present invention. - With specific reference to
FIG. 3 , in one exemplary embodiment thecontact element 28 includes a series of prongs, spring fingers, orleaf springs 50 spaced from each other and extending from abase 52, which in one embodiment comprises an open-ended generally circular ring that is flexible. Thebase 52 may also be considered an arcuate element that is capable of flexing when receiving a shoulder on a seal ring. When thecontact element 28 is located between aseal ring 24 and acontact housing 26, thebase 52 serves as a common contact point between the plurality ofleaf springs 50 and thelead 36. Thebase 52 is adapted to form an interference fit into thecontact groove 42 located between theseal ring 24 and thehousing 26 as shown inFIG. 2 . Thebase 52 may include acompression gap 56 which, as described in more detail below, allows thebase 52 to expand when theshoulder 38 of theseal ring 24 is inserted therein. - In one exemplary embodiment, the
prongs 50 each includes a generally concave configuration having an apex extending radially inwardly of an imaginary cylinder defined by the base. Each such apex is configured to contact anelectrical terminal 16 on thelead cable 12 when the same is inserted into the common bore of theconnector assembly 10 to establish electrical communication between the electronic circuitry of the IMD housing and thelead cable 12. As further discussed below, the specific shape of theprongs 50 may be selected to establish one or more than one contact points between eachindividual prong 50 and the correspondingelectrical terminal 16 on thelead cable 12, which may be selected to vary the surface contact area and/or the frictional forces, as is described in more detail below. - A lead 36 may extend from the
base 52 of each leafspring contact element 28 for connection to an input or output of an electrical circuit. Thelead 36 may be welded to thecontact element 28 and may be made of different materials than the leafspring contact element 28. Alternately, thelead 36 may be integral with thecontact element 28. - The
prongs 50 on eachcontact element 28 are sized so that each is deflected by thelead cable 12 to about 5% and up to about 60% of its total radial deflection. This deflection range ensures a sufficient spring contact force is generated between theprongs 50 and theelectric terminals 16 on thelead cable 12 for transferring electric signals between the two. The leafspring contact elements 28 may be made from a conductive or non-conductive material and may be manufactured by a variety of methods, for example, progressive stamping, hand forming, wire EDM, machining, etching, molding, or a combination thereof. Additionally, the contact elements may incorporate various types of plating to establish, for example, conductivity, non-conductivity, surface hardness and surface finish, among other characteristics. Preferably, the leaf springs are conductive. - Referring again to
FIG. 1 in combination withFIG. 3 , in one exemplary embodiment, thecontact housings 26 are each generally cylindrical in configuration. More preferably, eachcontact housing 26 has a generally constant inner diameter and outer diameter with two square ends, with normal manufacturing tolerance being acceptable. In other words, thecontact housings 26 do not have machined or formed grooves for forming contact grooves therein for accommodating the leafspring contact elements 28. Thehousings 26 have a simple profile, which makes manufacturing them and assembling thespring contacts 28 therein easier and therefore more cost effective than grooved housings. Thecontact grooves 42 are each formed instead by a combination of anadjacent seal ring 24 and the inner surface of acontact housing 26. In one exemplary embodiment, thecontact housings 26 each incorporates a notch or slit 48 adapted to accommodate a leaf springcontact element lead 36 when theconnector assembly 10 is assembled, as is described in more detail below. WhileFIG. 1 is a preferred design, alternative contact ring internal geometries are possible in the area of contact with thecontact element 28 without compromising ease of assembly for thecontact element 28 andcontact ring 26. For example, thehousings 26 may be made from a conductive and/or a non-conductive material. Further, the housings may be, for example, machined, extruded, formed, molded and/or casted. - Other housing geometries are also contemplated. For example, the
housings 26 may have a thicker section so that there are at least two internal diameters. The leafspring contact element 28 can then be inserted through the larger internal diameter end of thehousing 26 until it abuts the shoulder formed at the intersection between the two different internal diameters. Thus, different diameters and undulating internal surfaces for thehousings 26 are contemplated. Still alternatively, the plurality ofcontact housings 26 in a single connector assembly may vary, i.e. are not uniform. For example, it is possible to use a contact housing with different internal diameters at the distal most end of the connector assembly and housings with a smoother contour as shown inFIG. 1 for the remaining housings. If a housing having two different internal diameters at its two ends is used, the seal rings 24 are modified accordingly to engage the different internal diameters of the housing. Thus, thehousings 26 provided herein not only can have a smooth internal diameter, but also machined surfaces and undulating surfaces. - Leaf
spring contact elements 28 with various configurations may be used, as shown inFIGS. 5 a-8 b.FIG. 5 a shows the same spring contact element as discussed above with reference toFIG. 5 a. As shown inFIG. 5 b, a leafspring contact element 28 b has a plurality of prongs 50 b with a generally concave configuration and two leads 36 b extending from a base 52 b, one lead adjacent each edge of a compression gap 56 b. As shown inFIGS. 6 a and 6 b, a leaf spring contact element 28 c has a cylindrical wall base 52 c extending along a length of the leaf spring contact element and a plurality of concave prongs 50 c extending from an edge of the base along the inner circumferential surface of the base 52 c. A compression gap 56 c may be formed between two adjacent edges of the base 52 c and a lead 36 c may extend from the base similar to previously described embodiments. With reference toFIGS. 7 a, 7 b, 8 a and 8 b, prongs 50 d, 50 e, 50 f and 50 g may be generally S-shaped or sine wave shaped to provide at least two contact points. Additionally, the leafspring contact elements lead 36 d, 36 g or twoleads 36 e, 36 f. As further shown inFIGS. 9 and 10 , the S-shaped adjacent prongs may have their peaks and valleys staggered with respect to each other (FIG. 9 ) or aligned with each other (FIG. 10 ). - In accordance with one aspect of the present invention and looking at the connector from the right side of
FIG. 1 , a method is provided for assembling a plurality of components to form a connector assembly comprising engaging afirst seal ring 24, which may be anend seal ring 32 or anintermediate seal ring 34 to afirst contact housing 26. A first leafspring contact element 28 is then placed into the bore of the first housing such that thelead 36 of the contact element protrudes from the housing at theslit 48. Theslit 48 fixes the angular alignment between thecontact housing 26 and thecontact element 28 and provides an access point for electrical communication between circuits inside an IMD housing and theprongs 50 of the contact element. Asecond seal ring 34 is then connected to thecontact housing 26 such that theshoulder 38 of the seal ring is located within an inner circumference of thebase 52 of thecontact element 28. As noted above, thecompression gap 56 allows the base to expand to ensure sufficient contact with the seal ring. With reference toFIGS. 2 and 3 in addition toFIG. 1 , when aseal ring 24 engages thecontact element 28, thebase 52 of the contact element is located in acontact groove 42 formed between theseal ring 24 and thecontact housing 26. The method further comprises the steps of adding other seal rings, contact housings, and leaf spring contact elements to form a connector assembly having a desired number of contact grooves for accommodating a desired number of contact elements. More preferably, the method further comprises the steps of assembling a connector assembly without having to use a specialty tool, or some other means to manipulate, compress, bend, or distort a leaf spring contact element to fit within a contact groove. The assembled connector assembly is then placed into a mold cavity and over-molded with an implantable grade polymer or elastomer, such as silicone. The connector assembly can also be inserted into a pre-molded header, which resembles a housing having a cavity for receiving the connector assembly and one or more openings for placing the connector assembly into the pre-molded header. The one or more openings are then backfilled or sealed, typically after attaching or welding the leads from the sealed housing to the contact housings, to complete the assembly. Alternatively, theconnector assembly 10 may be assembled starting from the left side of the connector, i.e., starting from the left side ofFIG. 1 . - In accordance with other aspects of the present invention, an alternative method is provided for assembling a connector assembly in which a dowel or assembly pin (not shown) is used, which resembles the
proximal end 19 of thelead cable 12 shown inFIG. 1 . The assembly pin (not shown) is used to construct theconnector assembly 10 by first placing anend seal ring 32 on an end of the assembly pin and then subsequently placing other components on the pin and then sliding them to engage with the earlier placed components as described above. The assembled components. i.e., the connector assembly, may then be secured by placing the same inside a cavity of a header and over-molding the assembly with an implantable grade polymer or elastomer. - Referring again to
FIG. 2 , the seal rings 24 of the present embodiment, except for theend seal ring 32, are each symmetrical about a centerline drawn perpendicular to the axis defined by thecable 12 and through the center of the seal ring. However, non-symmetry or other configurations are possible so long as a contact groove for accommodating a spring contact is formed at least in part by engaging thehousing 26 with anadjacent seal ring 24. Furthermore, while the seal rings 24 of the present embodiment are shown each comprising an internal surface for sealing against thelead cable 12, two or more projections may be incorporated for sealing against a lead cable without deviating from the spirit and scope of the present invention. Still furthermore, part of the seal ring that projects into the bore of a contact housing can be made separately. In other words, a seal ring may be made by co-molding or over-molding two separate components. - Following assembly of the various components to form the
connector assembly 10 shown inFIG. 2 , the connector assembly is encased inside an implantable elastomer or polymer layer, as previously discussed. Theconnector assembly 10 is preferably molded with an assembly pin located inside the common bore to ensure alignment, both radially and axially, of the various connector components. The encased connector may be referred to as a connector header, for placing on a can or sealed housing of an IMD. -
FIG. 4 is a fully assembled view of theconnector assembly 10 ofFIGS. 1-3 , but with the leads oriented differently for a different IMD application. As shown inFIG. 4 , adjacent leads 36 protruding from thehousings 26 may be oriented perpendicularly to each other. However, theleads 36 may also protrude at acute and/or obtuse angles from each other and the degree of the angles may vary along the length of theelectrical connector 10. Still alternatively, the leads may aligned along a generally constant plane. - Referring now to
FIG. 11 , anIMD 60 incorporating aconnector assembly 10 provided in accordance with aspects of the present invention is shown. Theconnector assembly 10 is shown mounted in aheader 62, which is shown as a transparent material or structure for purposes of discussion only. In practice, the overcoat or over-molding layer is more commonly semi-opaque. The header 58 is situated over acan 64, which is hermetically sealed with a power source and electronic circuits. Alead cable 12 is shown inserted into the common bore of theconnector assembly 10. Three electrode leads 66 are shown exposed near the opening of the header for illustration purposes. In practice, the lead cable extends to a distal end, which has electrode terminals for providing electrical stimulation to the body tissues or probes for monitoring and/or diagnostics. As previously discussed, the IMD can be any one of plurality of IMDs for medical treatment, monitoring, or diagnostics. - Also shown in
FIG. 11 are leads 36 extending from the leadspring contact elements 26. Although asingle connector assembly 10 is shown inside theheader 62, two ormore connector assemblies 10 may be used if desired depending on the particular implant application. If two or more connector assemblies are used, they may be stacked side-by-side or on top of one another. - Although limited preferred embodiments and methods for making and using connector assemblies provided in accordance with aspects of the present invention have been specifically described and illustrated, many modifications and variations will be apparent to those skilled in the art. For example, various material changes may be used, incorporating different mechanical engagement means to attach the various components to one another, making use of two or more different materials or composites, making a sealing ring from multiple pieces rather than a singularly molded piece, etc. Accordingly, it is to be understood that the connector assemblies constructed according to principles of this invention may be embodied in other than as specifically described herein. The invention is also defined in the following claims.
Claims (20)
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US7822477B2 (en) | 2010-10-26 |
US20090048638A1 (en) | 2009-02-19 |
US7890175B1 (en) | 2011-02-15 |
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