Implantable medical devices that are electrically powered have become ubiquitous in recent years. There are a wide range of such devices from neurostimulation devices, pacemakers, and cochlear implants to ventricular assist devices, known as VADs.
Typically, an implanted medical device requires transmission of data, power, and/or electrical control signals across leads or cables from a power source and a controller to the implanted medical device. Different types of implantable medical devices can have vastly different power requirements, data transmission requirements, and/or electrical control signal requirements. For example, neurostimulation devices are relatively low power devices. One type of implanted medical device having heightened power requirements is a VAD, which requires relatively high current and continuous voltage requirements as compared to pacemakers, which typically have low and intermittent power requirements. Since loss of power to an implanted VAD or failure to recharge an associated power supply poses life threatening consequences, to ensure continuous operation of the VAD, any connector used with an associated power cable or driveline cable must provide a dependable electrical connection for an extended period of time. Implantable electrical connectors suitable for higher power requirements within the body can be challenging due to the cyclical stresses and strains attributed to flexure and movement of cords and devices within the body. For this reason, many such VAD systems are powered through a driveline that is hardwired directly to the implanted pump with any connectors located outside the body or at least away from the heart in locations that are more stable and readily accessible.
Another challenge with an implanted connector is that the fluid-filled environment within the human body can be corrosive to connector materials conventionally used in high-powered connectors, such as stainless steel and copper. While certain non-corrosive alloys, such as a platinum iridium alloy (Pt—Ir), can be used, a platinum iridium alloy is exceedingly expensive. Given the design challenges associated with implantable medical devices, there is a need for an implantable connector suitable for use with higher power requirements that is affordable, durable, and corrosion resistant.
The following presents a simplified summary of some embodiments of the invention to provide a basic understanding of the invention. This summary is not an extensive overview of the invention. It is not intended to identify key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some embodiments of the invention in a simplified form as a prelude to the more detailed description that is presented later.
Embodiments described herein are directed to circular coil spring contact assemblies for implantable electrical connectors. A circular coil spring assembly disclosed herein employs a non-conductive circular coil spring housing, a conductive circular coil spring disposed and retained within the non-conductive circular coil spring housing, and a conductive lead connected to the conductive circular coil spring. In many embodiments, the non-conductive circular coil spring housing includes an annular outer wall with a conductive lead aperture through which the conductive lead is routed. The use of a conductive lead connected to the conductive circular coil spring enables the use of a monolithic non-conductive housing, thereby saving considerable expense relative to existing circular coil spring assemblies employing a housing made from a platinum iridium alloy (Pt—Ir).
Thus, in one aspect, an implantable electrical connector assembly includes a male electrical connector and a female electrical connector. The male electrical connector includes an elongated electrical contact support member and an electrical contact mounted to the elongated electrical contact support member. The female electrical connector includes a connector body and a female contact assembly disposed in the connector body for interfacing with the electrical contact of the male electrical connector. The female contact assembly includes a conductive circular coil spring, a first conductive lead, and a non-conductive circular coil spring housing. The first conductive lead is electrically connected to the conductive circular coil spring. The conductive circular coil spring is disposed within and retained by the non-conductive circular coil spring housing. The first conductive lead extends from within the non-conductive circular coil spring housing to outside of the non-conductive circular coil spring housing. In many embodiments, the non-conductive circular coil spring housing includes an outer annular wall that includes a first conductive lead aperture through which the first conductive lead is routed.
The first conductive lead can be connected to the conductive circular coil spring in any suitable manner. For example, in many embodiments, the first conductive lead and the conductive circular coil spring are integrally formed. In some other embodiments, the first conductive lead is attached to the conductive circular coil spring. The first conductive lead can be attached to the conductive coil spring in any suitable manner. For example, the first conductive lead can be welded to the conductive circular coil spring.
The configuration of the female contact assembly can be tailored based on the amount of current and/or power to be transferred through the female contact assembly. For example, the diameter of the wire used to form the form the conductive circular coil spring can be based on the amount of current and/or power to be transferred through the conductive circular coil spring. Likewise, the diameter of the first conductive lead can be based on the amount of current and/or power to be transferred through the conductive circular coil spring. The female contact assembly can also include one or more additional conductive leads that are connected to the conductive circular coil spring to increase the total amount of current and/or power that can be conducted through the two or more conductive leads in comparison with one conductive lead. Accordingly, in some embodiments, the female contact assembly further includes a second conductive lead. The second conductive lead is electrically connected to the conductive circular coil spring. The second conductive lead extends from within the non-conductive circular coil spring housing to outside of the non-conductive circular coil spring housing. In some embodiments, the non-conductive circular coil spring housing includes an outer annular wall that includes a first conductive lead aperture through which the first conductive lead and the second conductive lead is routed. In some embodiments, the non-conductive circular coil spring housing includes an outer annular wall that includes a first conductive lead aperture through which the first conductive lead is routed and a second conductive lead aperture through which the second conductive lead is routed. In some embodiments, the conductive circular coil spring, the first conductive lead, and the second conductive lead are integrally formed.
The non-conductive circular coil spring housing can have any suitable configuration. For example, in many embodiments, the non-conductive circular coil spring housing includes an outer annular wall, a first side wall, and a second side wall. The outer annular wall circumferentially surrounds the conductive circular coil spring. The first side wall extends radially inward from a first side of the outer annular wall. The first side wall defines a first side wall aperture for the male electrical connector. The second side wall defines a second side wall aperture for the male electrical connector. The first side wall and the second side wall retain the conductive circular coil spring within the non-conductive circular coil spring housing.
The non-conductive circular coil spring housing can be made from any suitable material. For example, the non-conductive circular coil spring housing can be made of polyetheretherketone (PEEK) or thermoplastic polyurethanes (TPU).
In many embodiments, the female electrical connector includes wiper seal assemblies. The female contact assembly can be disposed between two of the wiper seal assemblies. Each of the two wiper seal assemblies can include an annular seal housing and an annular seal supported by the annular seal housing. The annular seal can be configured to sealing engage the male electrical connector. Each of the wiper seal assemblies can be configured to cooperate with the male electrical connector to block passage of fluid past the annular seal.
The implantable electrical connector can be used in any suitable implantable medical device. For example, an implantable medical device can include an electrically powered implantable medical assembly and one or more of the implantable electrical connector assemblies described herein. The implantable medical device can further include an implantable controller configured to control operation of the electrically powered implantable medical assembly The implantable controller can be operatively coupled with the electrically powered implantable medical assembly via the implantable electrical connector assembly. The electrically powered implantable medical assembly can include any suitable electrically powered implantable medical assembly. For example, the electrically powered implantable medical assembly can include a ventricular assist device.
In another aspect, a method of fabricating a female electrical connector of an implantable electrical connector assembly includes receiving a female contact assembly. The female contact assembly includes a conductive circular coil spring, a first conductive lead, and a non-conductive circular coil spring housing. The first conductive lead is electrically connected to the conductive circular coil spring. The conductive circular coil spring is disposed within and retained by the non-conductive circular coil spring housing. The first conductive lead extends from within the non-conductive circular coil spring housing to outside of the non-conductive circular coil spring housing. The method includes incorporating the female contact assembly into a contact body. The female connector can have any suitable configuration, such as any of the configurations described herein.
For a fuller understanding of the nature and advantages of the present invention, reference should be made to the ensuing detailed description and accompanying drawings.
In the following description, various embodiments of the present invention will be described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the embodiments. However, it will also be apparent to one skilled in the art that the present invention may be practiced without the specific details. Furthermore, well-known features may be omitted or simplified in order not to obscure the embodiment being described.
Some existing implantable electrical connectors include a female electrical connector with circular coil spring contact assemblies. Each of the circular coil spring contact assemblies includes a circular coil spring retained within a machined conductive housing. The machined conductive housing may be expensive and/or challenging to produce, especially when made from an expensive implant grade current carrying corrosion resistant metal like platinum.
A machined conductive housing for a circular coil spring contact assembly typically will increase in cost with increased size of the circular coil spring contact assembly. One industry standard for medical device long term implanted connectors is the 3.2 mm diameter male connector lead. Even with a 3.2 mm diameter male connector, a conductive housing for the corresponding circular coil spring assembly machined from a platinum iridium alloy is already somewhat cost prohibitive. If a larger diameter male connector is required (e.g., due to higher power transfer requirements) a corresponding larger platinum iridium housing will be even more expensive.
The circular coil spring contact assembly described herein employs a conductive circular coil spring, a non-conductive housing in which the conductive circular coil spring is disposed and retained, and a conductive lead attached to the conductive circular coil spring. By using a conductive lead attached to the conductive circular coil spring instead of a conductive housing, the cost of the circular coil spring contact assembly may be reduced substantially due to reduced cost of the non-conductive housing relative to an expensive machined platinum iridium housing. The reduction is cost is believed to be even greater for larger diameter male connectors (i.e., greater than 3.2 mm in diameter) do to avoiding the even larger expense of a correspondingly larger machined platinum iridium housing.
Turning now to the drawing figures in which similar reference identifiers refer to similar features,
The female electrical connector 14 includes a connector body 20, the female contact assemblies 18A-18F, wiper seal assemblies 22A-22G (shown in
The male electrical connector 12 includes an elongated contact support member 28, the electrical contacts 16A-16F, and a male connector body 30. The electrical contacts 16A-16F are mounted to and distributed along the contact support member 28. The male connector body 30 includes a slot or a groove 32 configured to be engaged by the connector lock 26. In the illustrated embodiment, the connector lock 26 includes a set screw that can be tightened to securely engage the groove 32 to block disconnection of the male electrical connector 12 from the female electrical connector 14.
The controller 304 is operatively coupled with the blood pump 302 by the first connection cable 308. The controller 304 is operatively coupled with the TETS receiver 306 by the second connection cable 310. The controller includes two instances 14-1, 14-2 of the implantable female connector 14 incorporated into a header portion 318 of a housing 320 of the controller 304. The first female connector 14-1 is configured with a suitable number of suitably configured embodiments of the female contact assemblies 18A-18F for transmitting power and/or operational signals to the blood pump 302 and transmitting and/or receiving data to/from the blood pump 302. The first connection cable 308 includes a first instance 12-1 of the implantable male connector 12. The first implantable male connector 12-1 is configured for connection with the first female connector 14-1. The second female connector 14-2 is configured with a suitable number of suitably configured embodiments of the female contact assemblies 18A-18F for receiving power from the TETS receiver 306 and transmitting and/or receiving data to/from the TETS receiver 306. The second connection cable 310 includes a second instance 12-2 of the implantable male connector 12. The second implantable male connector 12-1 is configured for connection with the second female connector 14-2. The female electrical connectors 14-1, 14-2 are sized to transfer power of a magnitude suitable for the operation of the blood pump 302 and the controller 304 through a circular coil contact spring assembly with a non-conductive circular coil spring housing instead of a conductive machined platinum iridium housing, which may be too expensive to produce to justify usage in the implantable VAD system 300.
In one or more embodiments of the present disclosure, an implantable electrical connector assembly includes a male electrical connector and a female electrical connector. The male electrical connector includes an elongated electrical contact support member and an electrical contact mounted to the elongated electrical contact support member. The female electrical connector includes a connector body and a female contact assembly disposed within the connector body for interfacing with the electrical contact of the male electrical connector. The female contact assembly includes a conductive circular coil spring, a first conductive lead, and a non-conductive circular coil spring housing. The first conductive lead is electrically connected to the conductive circular coil spring. The conductive circular coil spring is disposed within and retained by the non-conductive circular coil spring housing. The first conductive lead extends from within the non-conductive circular coil spring housing to outside of the non-conductive circular coil spring housing. Optionally, the non-conductive circular coil spring housing includes an outer annular wall that includes a first conductive lead aperture. The first conductive lead can extend through the first conductive lead aperture. Optionally, the first conductive lead and the conductive circular coil spring can be integrally formed. Optionally, the first conductive lead can be attached to the conductive circular coil spring. Optionally, the first conductive lead can be welded to the conductive circular coil spring. Optionally, the female contact assembly further can include a second conductive lead that is electrically connected to the conductive circular coil spring and extends from within the non-conductive circular coil spring housing to outside of the non-conductive circular coil spring housing. Optionally, the non-conductive circular coil spring housing includes an outer annular wall comprising a first conductive lead aperture. At least one of the first conductive lead or the second conductive lead can extend through the first conductive lead aperture. Optionally, the conductive circular coil spring, the first conductive lead, and the second conductive lead can be integrally formed. Optionally, the first conductive lead and the second conductive lead can extend through the first conductive lead aperture. Optionally, the outer annular wall further can include a second conductive lead aperture; the first conductive lead can extend through the first conductive lead aperture; and the second conductive lead can extend through the second conductive lead aperture. Optionally, the first conductive lead can be attached to the conductive circular coil spring and the second conductive lead can be attached to the conductive circular coil spring. For example, the first conductive lead can be welded to the conductive circular coil spring and the first conductive lead can be welded to the conductive circular coil spring. Optionally, the non-conductive circular coil spring housing can include an outer annular wall, a first side wall, and a second side wall; the outer annular wall can circumferentially surrounds the conductive circular coil spring; the first side wall can extend radially inward from a first side of the outer annular wall; the first side wall can define a first side wall aperture configured to accommodate the male electrical connector; the second side wall can define a second side wall aperture configured to accommodate the male electrical connector; and the first side wall and the second side wall can retain the conductive circular coil spring within the non-conductive circular coil spring housing. Optionally, the non-conductive circular coil spring housing can be made of polyetheretherketone (PEEK) or thermoplastic polyurethanes (TPU). Optionally, the female electrical connector can further include wiper seal assemblies; the female contact assembly can be disposed between two of the wiper seal assemblies; each of the two wiper seal assemblies can include an annular seal housing and an annular seal supported by the annular seal housing; the annular seal can be configured to sealing engage the male electrical connector; and each of the wiper seal assemblies can be configured to cooperate with the male electrical connector to block passage of fluid past the annular seal.
In one or more embodiments of the present disclosure, an implantable medical device an electrically powered implantable medical assembly and the implantable electrical connector assembly operatively coupled with the electrically powered implantable medical assembly. The implantable electrical connector assembly can be configured in accordance with any of the variations described herein of the implantable electrical connector assembly as described herein. Optionally, the implantable medical device can further include an implantable controller configured to control operation of the electrically powered implantable medical assembly. The implantable controller can be operatively coupled with the electrically powered implantable medical assembly via the implantable electrical connector assembly. Optionally, the electrically powered implantable medical assembly can include a ventricular assist device.
In one or more embodiments of the present disclosure, a method of fabricating a female electrical connector of an implantable electrical connector assembly includes receiving a female contact assembly and incorporating the female contact assembly into a connector body. The female contact assembly includes a conductive circular coil spring, a first conductive lead, and a non-conductive circular coil spring housing. The first conductive lead is electrically connected to the conductive circular coil spring. The conductive circular coil spring is disposed within and retained by the non-conductive circular coil spring housing. The first conductive lead extends from within the non-conductive circular coil spring housing to outside of the non-conductive circular coil spring housing. Optionally, the method can further include retaining wiper seal assemblies within the connector body. Optionally, the female contact assembly can be disposed between two of the wiper seal assemblies. Optionally, each of the wiper seal assemblies can include an annular housing and an annular seal supported by the annular housing and configured to sealing engage a male electrical connector. Optionally, each of the wiper seal assemblies can be configured to cooperate with the male electrical connector to block passage of fluid. Optionally, the non-conductive circular coil spring housing can include an outer annular wall that includes a first conductive lead aperture. Optionally, the first conductive lead can extend through the first conductive lead aperture. Optionally, the first conductive lead and the conductive circular coil spring can be integrally formed. Optionally, the first conductive lead can be attached to the conductive circular coil spring. For example, the first conductive lead can be welded to the conductive circular coil spring. Optionally, the female contact assembly can further include a second conductive lead that is electrically connected to the conductive circular coil spring. Optionally, the second conductive lead can extend from within the non-conductive circular coil spring housing to outside of the non-conductive circular coil spring housing. Optionally, the non-conductive circular coil spring housing can include an outer annular wall that includes a first conductive lead aperture. Optionally, at least one of the first conductive lead or the second conductive lead can extend through the first conductive lead aperture. Optionally, the conductive circular coil spring, the first conductive lead, and the second conductive lead can be integrally formed. Optionally, the first conductive lead and the second conductive lead can extend through the first conductive lead aperture. Optionally, the outer annular wall can further include a second conductive lead aperture; the first conductive lead can extend through the first conductive lead aperture; and the second conductive lead can extend through the second conductive lead aperture. Optionally, the first conductive lead can be attached to the conductive circular coil spring; and the second conductive lead can be attached to the conductive circular coil spring. For example, the first conductive lead can be welded to the conductive circular coil spring; and the first conductive lead can be welded to the conductive circular coil spring. Optionally, the non-conductive circular coil spring housing can include an outer annular wall, a first side wall, and a second side wall; the outer annular wall can circumferentially surround the conductive circular coil spring; the first side wall can extend radially inward from a first side of the outer annular wall; the first side wall can define a first side wall aperture for the male electrical connector; the second side wall can define a second side wall aperture for the male electrical connector; and the first side wall and the second side wall can retain the conductive circular coil spring within the non-conductive circular coil spring housing. Optionally, the non-conductive circular coil spring housing can be made of polyetheretherketone (PEEK) or thermoplastic polyurethanes (TPU).
Other variations are within the spirit of the present invention. Thus, while the invention is susceptible to various modifications and alternative constructions, certain illustrated embodiments thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention, as defined in the appended claims.
The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. The term “connected” is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate embodiments of the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
Preferred embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
The present application is a Continuation of PCT/US2023/073037 filed Aug. 29, 2023; which claims the benefit of U.S. Provisional Appln. No. 63/402,581 filed Aug. 31, 2022, the disclosures which are incorporated herein by reference in their entirety for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 63402581 | Aug 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2023/073037 | Aug 2023 | WO |
| Child | 19060182 | US |