COMPLIANT IMPLANTABLE CONNECTOR AND METHODS OF USE AND MANUFACTURE
20170324185 · 2017-11-09
Inventors
Cpc classification
H01R13/03
ELECTRICITY
H01R43/26
ELECTRICITY
A61M60/216
HUMAN NECESSITIES
A61M60/878
HUMAN NECESSITIES
H01R13/193
ELECTRICITY
A61M60/178
HUMAN NECESSITIES
A61M2207/00
HUMAN NECESSITIES
International classification
H01R13/193
ELECTRICITY
H01R13/52
ELECTRICITY
Abstract
An implantable connector utilizing having improved electrical and mechanical properties is described herein. In one aspect, the implantable connector utilizes electrical contact pins fabricated from a corrosion resistant metal alloy, such as platinum-iridium, that engage longitudinally and include one or more urging members on a proximal portion of the pin so as to provide at least a desired contact force between conductively coupled pins. Such a configuration allows contact between contact pins to be maintained in applications where the connector may be subject to movement and further allows for reduced resistance so as to allow transmission of voltages and current associated with higher powered implanted devices. In some embodiments, the urging member is defined as a helical cut potion in one or both electrical contacts. Methods of use and manufacture of such connectors are also provided herein.
Claims
1. An implantable connector having interfacing male and female components and adapted for use with an implanted medical device, the connector comprising: one or more male contact pins of the male component, each male contact pin having a proximal portion coupled to a conductor and a distal portion having a distal engaging surface defined therein; and one or more female contact pins of the female component, each female contact pin having a proximal portion coupled to a conductor and a distal portion having a distal engaging surface defined therein that is adapted for engaging with the distal engaging surface of the corresponding male contact pin; wherein one or both of the corresponding male and female contact pins include an urging member defined in a portion of the respective pin proximal of the distal portion thereof, the urging member configured to exert a reaction force in a longitudinal direction when displaced along a longitudinal axis of the respective contact pin to increase a contact force between engaging surfaces of the corresponding male and female pins when conductively coupled.
2. The implantable connector of claim 1, wherein the urging member comprises a helical cut portion defined along a hollow portion of the respective contact pin.
3. The implantable connector of claim 2, wherein each of the female contact pins includes the helical cut portion.
4. The implantable connector of claim 2, wherein each of the male contact pins includes the helical cut portion.
5. The implantable connector of claim 2, wherein each of corresponding male and female contact pins includes the helical cut portion.
6. The implantable connector of claim 2, wherein each of the male and female contact pins are formed of a corrosive resistant metal alloy.
7. The implantable connector of claim 6, wherein each of the male and female contact pins are formed of a platinum iridium alloy.
8. The implantable connector of claim 1, wherein the distal engaging surface of each of the one or more male contact pins is a protruding surface.
9. The implantable connector of claim 8, wherein the distal engaging surface of each of the one more female contact pins is a recessed surface.
10. The implantable connector of claim 9, wherein the protruding surface is a convex surface
11. The implantable connector of claim 10, wherein the recessed surface is a concave surface.
12. The implantable connector of claim 11, wherein each of the convex and concave surfaces is a semi-spherical surface.
13. The implantable connector of claim 1, wherein one or both of the male and female contact pins is formed of a solid metal pin.
14. The implantable connector of claim 2, wherein helical portion comprises any of: a single helical element, a double-helical element, and four parallel helical elements.
15. The implantable connector of claim 2, wherein the male and female components are adapted to interface in a mated configuration that axially displaces the helical cut portion a distance sufficient to exert a desired contact force.
16. The implantable connector of claim 1, wherein each of the male and contact pins is less than 10 mm in length.
17. The implantable connector of claim 1, wherein the cable is suitable for providing a peak power of about 5 W or greater over an extended period of time.
18. The implantable connector of claim 17, wherein the implanted medical device is an implantable heart pump and the connector is adapted for coupling the implantable heart pump to a power source and/or controller.
19. A method of powering an implantable medical device, the method comprising: interfacing a male contact component with a female contact component, one of the male and female contact component being associated with an implantable medical device while the other of the male and female contact component is associated with a power source or associated cable, the male component including a plurality of male contact pins that correspond with a plurality of female contact pins of the female component; engaging the interfaced male and female contact so as to axially displace an urging member defined in one or both of the male and female contact component such that the urging member exerts a reaction spring force; and mating the male and female component in a mated position such that corresponding male and female contact pins are conductively coupled while the urging member is displaced along a longitudinal axis of the respective contact pin; and maintaining electrical integrity of the conductive coupling between the male and female contact pins by accommodating compliant movement of the male and female contact pins while a reaction force of the displaced urging member provides an increased contact force between corresponding male and female contact pins.
20. The method of claim 19, wherein the urging member comprises a helical cut portion of the respective contact pin, the method further comprising: displacing the helical cut portion of the respective contact pin by a distance sufficient to exert at least a desired contact force between conductively coupled corresponding male and female contact pins.
21. The method of claim 20, further comprising: wherein displacing the helical cut portion comprises matingly engaging the male and female components in a mated configuration.
22. The method of claim 19, wherein the implantable medical device is an implantable heart pump.
23. A method of manufacturing an implantable connector, the method comprising: defining a distal protruding surface in a distal portion of each of one or more male contact pins of a substantially cylindrical shape; defining a distal recessed surface in a distal portion of each of one or more corresponding female pins of a substantially cylindrical shape, wherein the distal recessed surface corresponds to a shape of the distal protruding surface in the respective one or more male contact pins; defining a helical cut portion in a portion of the one or more male contact pins and/or the one or more female contact pins, the portion being proximal of the distal portion of the respective contact pins; electrically coupling an electrical conductor to each of the one or more female contact pins and incorporating the one or more female pins into a female component; electrically coupling an electrical conductor to each of the one or more male contact pins and incorporating the one or more female pins into a male component; and adapting the male and female components to interface with each other such that corresponding male and female components are conductively coupled while the helical portion of each respective male or female contact pin is displaced so as to exert a spring force in response that increases a contact force between conductively coupled contact pins.
24. The method of claim 23, further comprising: defining a geometry of an interfacing portion of each of the male and female components to define a mated configuration in which the helical portion is displaced a sufficient distance to provide at least a desired contact force between conductively coupled contact pins.
25. An implantable connector having interfacing male and female components and adapted for use with an implantable heart pump, the connector comprising: a plurality of contact pins disposed within the male component, each male contact pin having a proximal portion and a distal portion, the proximal portion being conductively coupled to a conductor and the distal portion having a distal engaging surface defined therein; and a plurality of female contact pins of the female component, each female contact pin having a proximal portion and a distal portion, the proximal portion being conductively coupled to a conductor and the distal portion having a distal engaging surface defined therein that is adapted for engaging with the distal engaging surface of a corresponding male contact pin of the plurality; wherein each of the plurality of male and female contact pins are formed of a platinum-iridium alloy and include a helical cut portion defined in a region proximal of the respective distal portion, wherein the helical cut portions are configured to exert a reaction spring force in a longitudinal direction when displaced along a longitudinal axis of the respective contact pin to increase a contact force between distal engaging surfaces of the corresponding male and female contact pins when the male and female components are mated.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0016]
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[0024]
[0025]
DETAILED DESCRIPTION
[0026] The invention relates generally to electrical connectors, and in particular to implantable connectors for use with power cables for powering high-powered implanted medical devices, such as a mechanical circulatory support system or VADs.
[0027] Developing connectors that are implanted in the human body is challenging, particularly for connectors that are designed to be connected and disconnected in a biological environment. The electrical contact set lies at the heart of any connector design. Current research and testing has demonstrated that electrical contacts that are subjected to a biologic environment are susceptible to corrosion—the biggest risk for implantable connector designs. The most robust material to address the corrosion issue in electrical contacts is a blend of a platinum-iridium alloy. Unfortunately, there are considerable challenges associated with use of platinum-iridium alloy for electrical contact designs. This material inherently has certain drawbacks, including exceedingly high cost and limited basic mechanical properties of the material (e.g., Yield Strength, Young's Modulus, brittleness). These materials may also have insufficient plastic deformation properties for certain applications. Current commercially available connectors fail to provide a corrosion resistant design that satisfactorily addresses these issues. The invention allows for an implantable connector having an electrical contact set that largely resolves the above noted issues, while providing a robust and durable electrical connection for use with high-powered implanted medical devices.
[0028] In various embodiments, the invention provides an implantable connector having a male and female component that matingly engage so as to conductively couple corresponding contact pins arranged within. One or both of the contact pins includes an urging member that provides a desired contact force between contact pins to maintain electrical integrity of the connection over an extended period of time. In one aspect, the urging member is adapted to provide the desired contact force while stresses remain low enough to avoid risk of creep or plastic deformation of the contact pins. In some embodiments, the urging member is provided in only the male contact pin or the female contact pin, while in other embodiments, an urging member is included in both the male and female contact pins. The urging member can be a spring or other such resilient member that exerts sufficient force when axially displaced by mating engagement of the male and female components to provide a desired contact force between corresponding male and female contact pins. The desired contact forces depend largely on the voltages and currents being transmitted, as well as the particular geometry of the components. For example, in some embodiments, contact forces can range from about 100 grams to 1,000 grams.
[0029] In general, improved contact forces and/or surface area leads to an improvement in electrical performance. In certain applications, maintaining continuous minimum contact for transmission is even more important than average or peak power transmission. As the contact force increases, the highly localized stress created by contact (e.g., Hertz stresses) experienced by the areas in contact will increase. This means that the highest peaks in contact will yield, expanding the contact area in an effort to counter the additional force. The mating surfaces will then move closer together which allows contact to be made at shorter, wider peaks on both surfaces. This decreases the constriction resistance since there are now more and larger paths for the signal to travel through. Since the contacting surfaces are wider, electrical signals can more easily pass through any film that might exist. Therefore, any film resistance decreases as well. Thus, increased contact force allows the signal to travel across the interface much more easily. At very high contact forces, most of the total resistance of the connector comes from bulk resistance. The resistance is also more stable, since a small change in force will result in a minimal change in contact resistance. Conversely, as contact force decreases, fewer areas will remain in contact, thereby degrading electrical performance and stability of resistance. The advantages of providing improved contact forces can be further understood by referring to The Importance of Contact Force, Technical Tidbits, Issue No. 6—July 2009, the entire contents of which are incorporated herein by reference.
[0030] In some embodiments, each of the corresponding male and female contact pins extend along a longitudinal axis and are conductively coupled by engaging corresponding distal surfaces on a distal portion of each of the corresponding pins. The urging member is disposed at a location proximal of the distal portion of one or both pins and exerts an urging force in a direction along the longitudinal axis to provide a contact force between engaging distal surfaces of corresponding pins.
[0031] In another aspect, a connector includes a male and female electrical contact set that has an integrated compliance feature built into either one or both of the contact pins. The primary advantages of this approach are that this design allows for more compact footprints and can be adapted to achieve proper contact forces between contact pins. It is appreciated that such designs can utilize multiple pin to pin interfaces, including but not limited to the ball and cup configuration described herein. This design is advantageous as it allows the male and female contact to accommodate compliant movement while remaining interface and conductively coupled. This design is also suitable for use with electrical contact pins formed of corrosion resistant materials like platinum-iridium alloys that are not traditional spring materials (i.e., beryllium copper, spring-tempered stainless steels). Secondary advantages of this approach include the ability of the electrical contacts to be able to take up compliance from relative movement between the two halves of the connector body that are subjected to cyclic motion (i.e., a beating heart which produces approximately 32 million cycles per year). Such an approach offers a number of advantages, which include a cost effective contact design by minimizing footprint and hence the cost of materials, improving ease of manufacturing through use of traditional machining operations and improving distribution and management of structural loads within the components. Importantly, this approach also allows for further considerably reduced connector sizes, which is vital for implanted devices, particularly next generation devices having substantially reduced size as compared to current devices. This approach also reduces the risk of interruptions in power transmission from poor contact between the male and female contacts.
[0032] In some embodiments, the urging member is formed in a portion of the respective contact pin by defining a helical cut in a portion of the contact pin such that the portion acts as spring being compressible along a longitudinal axis of the contact pin so as to exert a reaction force towards the interfacing distal surfaces of corresponding contact pins. Typically, the contact pin is hollow along the portion in which the helical cut is formed so as to facilitate a resilient spring action. The contacts pins and helical cut portions are dimensioned so that when the male and female components are matingly engaged the helical cut portion is displaced or compressed a small distance. The helical cut portion can be defined to have a spring constant that provides a desired contact force when compressed. The spring constant required to provide a desired contact force is a function of the material and dimensional properties of the contact pins as well as the distance by which the helical cut portion is compressed when the male and female components are mated. In some embodiments, the urging member (e.g., helical cut) could be put on only one of corresponding male and female contact pins, while in others the urging member could be integrated into both contact pins. Including such an urging member in both male and female contact pins allows for improved balance of stresses and loads and allows for more compliance and/or tune-ability of force, deflection, stress, and strain in the contact set. In addition, several other pin to pin interfaces could be explored as an alternative to a ball and cup design, for example, a flat pin to flat pin or a crowned pin to flat plate.
[0033]
[0034]
[0035] Various aspects of such power cables are described in U.S. Pat. No. 8,562,508 entitled “Mobility-Enhancing Blood Pump System,” filed Dec. 30, 2009; U.S. Application Publication No. 2012/0149229 entitled “Modular Driveline,” published on Jun. 14, 2012; and U.S. Pat. No. 8,682,431 entitled “Driveline Cable Assembly,” filed Jan. 23, 2013; each of which the entire contents are incorporated herein by reference for all purposes.
[0036]
[0037] In this embodiment, the controller assembly 120 is connected to electrical conduit 123 at connector 122 and connected to percutaneous lead at 121. Each of connectors 121 and 122 can be removable to allow for ready detachment and replacement of the internal controller assembly 120 or the percutaneous lead 400 as needed. Since both connectors 121 and 122 are implanted and subject to corrosion as well as period flexure and movement, one or both of these connectors can be configured according to various aspects of the invention described herein. Such improved connectors allow for these improved mechanical and electrical properties and allow for a reduction in size, thereby allowing further miniaturization of the implanted systems described herein.
[0038] Related blood pumps applicable to the present invention are described in greater detail below and in U.S. Pat. Nos. 5,695,471; 6,071,093; 6,116,862; 6,186,665; 6,234,772; 6,264,635; 6,688,861; 7,699,586; 7,976,271; 7,997,854; 8,007,254; 8,152,493; 8,562,508; 8,652,024; and 8,668,473 and U.S. Patent Publication Nos. 2007/0078293; 2008/0021394; 2009/0203957; 2012/0046514; 2012/0095281; 2013/0096364; 2013/0170970; 2013/0121821; 2013/0127253; and 2013/0225909, all of which are incorporated herein by reference for all purposes in their entirety. Related controller systems applicable to the present invention are described in greater detail below and in U.S. Pat. Nos. 5,888,242; 6,991,595; 8,323,174; 8,449,444; 8,506,471; 8,597,350; and 8,657,733 and U.S. Patent Publication Nos. 2005/0071001 and 2013/0314047, all of which are incorporated herein by reference for all purposes in their entirety.
[0039]
[0040] As can be seen in
[0041] To ensure a suitable contact force, Fc, one or both of corresponding contact pins includes an urging member proximal of the distal engaging surface to ensure sufficient contact force is applied and maintained. The urging member is designed specifically to apply the desired contact force, when male and female components 30, 20 are in the fully mated configuration. Typically, the mating configuration is determined by engaging corresponding surfaces of the male and female components, such as a distal outer surface of the male component 30 abutting against a recessed surface or inner lip circumscribing the distal opening of the female component 21. The mated configuration is typically secured by one or more retaining features (e.g., snap-fit, threaded screw, clearance fit, and the like). It is appreciated, however, that male and female components can be configured to interface in a mated configuration or retained in the mated configuration in any number of ways using various mechanisms, as would be known to one of skill in the art from the description herein.
[0042]
[0043] In this embodiment, the distal engaging surfaces 32, 22 of male and female contact pins 31, 21 are configured according to a ball and cup type design. In this design, the distal engaging surface 22 of female contact pin 21 is a recessed portion defined as a semi-spherical concave surface, while the corresponding distal engaging surface 32 of the male contact pin 31 is a protruding portion defined as a semi-spherical convex surface. Corresponding distal engaging surfaces 22, 32 are dimensioned so as to fittingly engage, as shown in the cross-section of
[0044] In this embodiment, female contact pin 21 includes urging member 23 defined as a helical cut potion 23a in a proximal portion thereof. The helical cut can be created by use of standard machining techniques and is defined in a hollowed portion of the contact pin such that the remaining helical element acts as a spring that can be compressed when male and female pins 21, 31 are engaged so as to exert a biasing or urging force longitudinally directed along the pin, which increases contact forces between corresponding distal engaging surfaces. Helical cut portion 23a can be designed to form a spring of a particular spring constant so as to exert a desired contact force pre-determined for a particular application or device. Typically, the particular helical cut design created is a function of the geometry of the contact pin (e.g., a side-wall thickness of the contact pin along the hollow portion, diameter of the contact pin), the material properties of the contact pin, a range of suitable displacements of the spring when the connector is mated, and the contact forces desired. It is appreciated that various helical cut designs can be used to provide a desired contact force. For example, variations in pitch of the helical cut portion can allow for longer or shorter sections that have the same spring constant capable of providing the desired contact forces. In some embodiments, the urging member can include any pattern or design adapted to provide an urging force in a longitudinal direction, for example, by use of a zig-zag, sinusoidal, or coil shaped members or a woven structure or stent-type design.
[0045] As can be seen in
[0046] In some embodiments, each corresponding connector pin is of a relatively small length, such as between 5-25 mm. The helical cut portion can be included along a portion proximal of the distal portion, the portion being extending along a substantial length of the contact pin, for example between about 10% to about 90% of the length of the contact pin. In various embodiments, the helical cut portion extends along at least about 25% of the length of the contact pin, at least about 50% of the length of the contact pin, or at least about 75% of the length of the contact pin. In various embodiments, the helical cut portion extends only along a distal-most end of the contact pin. Typically, in embodiments where corresponding contact pins are about 10 mm or less, the helical cut portion is compressed only about 2-5 mm, which can be a portion of a fully displaced or compressed state or the entire displacement distance. This aspect allows for a connector of a reduced footprint, which allows for implantation of the connector in various locations that were not previously feasible due to the bulk and expense of previously proposed designs. It is appreciated that the concepts described herein are not limited to connectors of any particular size and can be applied to contact pins of various other dimensions, substantially smaller or larger than those described.
[0047]
[0048] In various embodiments, the male and female components, as well as the contact pins, can be configured to control the amount of displacement of the urging member in the mated configuration such that the contact force can be “tuned” as desired. For example, the male and female components can include an adjustable feature that allows the distance by which urging member is displaced to be adjusted, thereby increase or decreasing the resulting reaction force and contact force as desired. In another example, the contact pins could be placed at a greater depth within respective male or female components so as to control the displacement of the urging member and thereby provide the desired contact force.
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[0050] The type of configuration used in the connector can be selected according to a particular need or application, for example, selection can based on the amount and direction of any expected relative movement between devices and/or cables being connected. The configuration in
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[0054] Although the invention is described in terms of an implantable connector for a driveline for a VAD, one will appreciate that the invention may be applied equally to connectors adapted for use with various other devices and applications. It is further appreciated that the invention can be applicable to any connector, including non-implantable connectors used in medical and non-medical applications.
[0055] In the foregoing specification, the invention is described with reference to specific embodiments thereof, but those skilled in the art will recognize that the invention is not limited thereto. Various features and aspects of the above-described invention can be used individually or jointly. Further, the invention can be utilized in any number of environments and applications beyond those described herein without departing from the broader spirit and scope of the specification. The specification and drawings are, accordingly, to be regarded as illustrative rather than restrictive. It will be recognized that the terms “comprising,” “including,” and “having,” as used herein, are specifically intended to be read as open-ended terms of art.