This disclosure relates generally to implantable medical devices and related components. More particularly, this disclosure relates to an implantable electrical connector assembly for the implantable medical device.
Implantable devices employ an electrical connector to communicate signals between a controller, a patient's organ (e.g., heart) or a nerve, and/or other implanted devices. The implantable devices may include one, two, or more electrical connectors. For example, Ventricular assist devices, known as VADs, use two electrical connectors. VADs are implantable blood pumps used for both short-term (i.e., days, months) and long-term applications (i.e., years or a lifetime) where a patient's heart is incapable of providing adequate circulation, commonly referred to as heart failure or congestive heart failure. VAD employs two electrically isolated electrical connectors-one coupled to the blood pump and another to an energy transfer system.
According to the American Heart Association, more than five million Americans are living with heart failure, with about 670,000 new cases diagnosed every year. People with heart failure often have shortness of breath and fatigue. Years of living with blocked arteries or high blood pressure can leave a heart too weak to pump enough blood to the body. As symptoms worsen, advanced heart failure develops. A patient may use a VAD while awaiting a heart transplant or as a long-term destination therapy. In another example, a patient may use a VAD while their own native heart recovers. Thus, a VAD can supplement a weak heart (i.e., partial support) or can effectively replace the natural heart's function. VAD systems of the present invention can be fully implanted in the patient's body and powered by an implantable electrical power source inside the patient's body.
The present disclosure relates to implantable medical devices including an implantable electrical connector. The implantable electrical connectors include use a female electrical connector with a conductive member coupled to a full circumferential circular springs and disposed within a connector body. Existing female electrical connector are machined, which is expensive and cost or process prohibitive, e.g., especially when machined out of an expensive corrosion resistant metal like platinum. The present disclosure provides an electrical connector having a rigid, robust, reliable, and functional composite female contact assembly which can significantly reduce the cost of the female electrical connector from stock platinum. For example, the female electrical connector includes an annular conductive member having simple geometric construction such that it can be extruded without loss of precious metal and further mounted on non-conductive side members. A circular spring is disposed at the center of the annular conductive member and retained between the non-conductive side members. The non-conductive side members can be made of polyetheretherketone (PEEK) and the conductive member is made of platinum iridium. It can advantageously eliminate loss of precious metal by extruding a part rather than machining and generating wasteful platinum chips. It also allows for modular scalability of an implantable header of the medical device with minimal disruption in cost of goods.
Thus, in one aspect, an implantable electrical connector assembly including a female electrical connector is described. The 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 annular electrical contacts mounted to and spaced apart along the elongated electrical contact support member. The female electrical connector includes a connector body having an elongated receptacle and female contact assemblies disposed in and distributed along the elongated receptacle for interfacing with the annular electrical contacts of the male electrical connector. Each of the female contact assemblies comprises a circular coil spring, an annular conductive member, a first-side non-conductive retention member, and a second-side non-conductive retention member. The circular coil spring is disposed within the annular conductive member. The first-side non-conductive retention member is mounted to the annular conductive member and disposed on a first side of the circular coil spring. The second-side non-conductive retention member is mounted to the annular conductive member and disposed on a second side of the circular coil spring opposite to the first side of the circular coil spring. The circular coil spring is retained between and by the first-side non-conductive retention member and the second-side non-conductive retention member. In many embodiments, the annular conductive member has a cylindrical shape. The annular conductive member is formed from a cylindrical extrusion.
In many embodiments, the annular conductive member includes a cylindrical inner surface, an annular first end surface, and an annular second end surface. A cylindrical outer surface of the first-side non-conductive retention member is interfaced with a first end portion of the cylindrical inner surface. Each of the non-conductive retention members include an annular flange portion. The annular flange portion of the first-side non-conductive retention member is interfaced with the annular first end surface of the annular conductive member. A cylindrical outer surface of the second-side non-conductive retention member is interfaced with a second end portion of the cylindrical inner surface. The annular flange of the second-side non-conductive retention member is interfaced with the annular second end surface the annular conductive member. The circular coil spring is configured to be interfaced with a central portion of the annular conductive member that extends between the first end portion and the second end portion of the cylindrical inner surface to electrically couple the annular conductive member with a respective one of the annular electrical contacts of the male electrical connector. In many embodiments, the female electrical connector further includes wiper seal assemblies. Each of the female contact assemblies is disposed between two of the wiper seal assemblies. Each of the wiper seal assemblies comprises an annular housing and an annular seal supported by the annular housing. The annular seal is configured to sealing engage the male electrical connector, and wiper seal assembly is configured to cooperate with the male electrical connector to block passage of fluid past the annular seal and along the male electrical connector.
In some embodiments, the annular conductive member includes a cylindrical outer surface, an annular first end surface, and an annular second end surface. A cylindrical inner surface of the first-side non-conductive retention member is interfaced with a first end portion of the cylindrical outer surface. An annular flange of the first-side non-conductive retention member is interfaced with the annular first end surface. A cylindrical inner surface of the second-side non-conductive retention member is interfaced with a second end portion of the cylindrical outer surface. An annular flange of the second-side non-conductive retention member is interfaced with the annular second end surface. The circular coil spring is configured to be interfaced with a central portion of the annular conductive member that extends between the first end portion and the second end portion of the cylindrical inner surface to electrically couple the annular conductive member with a respective one of the annular electrical contacts of the male electrical connector. The female electrical connector further comprises wiper seal assemblies. Each of the female contact assemblies is disposed between two of the wiper seal assemblies, and each of the wiper seal assemblies includes an annular housing and an annular seal supported by the annular housing. The annular seal is configured to sealing engage the male electrical connector, and the wiper seal assembly is configured to cooperate with the male electrical connector to block passage of fluid past the annular seal and along the male electrical connector.
In many embodiments, the annular conductive member has an internal diameter greater than 3.2 mm. Each of the first-side non-conductive retention member and the second-side non-conductive retention member is made of polyetheretherketone (PEEK) or thermoplastic polyurethanes (TPU). The annular conductive member is made of a platinum-iridium alloy.
According to another aspect, a method of fabricating a female electrical connector of an implantable electrical connector assembly is described. The method includes receiving a connector body comprising an elongated receptacle, receiving female contact assemblies, and retaining the female contact assemblies within the elongated receptacle of the connector body. Each of the female contact assemblies includes a cylindrical conductive member, a circular coil spring, a first-side non-conductive retention member, and a second-side non-conductive retention member, wherein the circular coil spring is disposed within the cylindrical conductive member. The first-side non-conductive retention member is mounted to the cylindrical conductive member and disposed on a first side of the circular coil spring. The second-side non-conductive retention member is mounted to the cylindrical conductive member and disposed on a second side of the circular coil spring opposite to the first side of the circular coil spring. The circular coil spring is retained between and by the first-side non-conductive retention member and the second-side non-conductive retention member.
In many embodiments, the method further includes retaining wiper seal assemblies within elongated receptacle of the connector body. Each of the female contact assemblies is disposed between two of the wiper seal assemblies. Each of the wiper seal assemblies comprises an annular housing and an annular seal supported by the annular housing and configured to sealingly engage a male electrical connector, and each of the wiper seal assemblies is configured to cooperate with the male electrical connector to block passage of fluid.
The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate one or more embodiments and, together with the description, explain these embodiments. The accompanying drawings have not necessarily been drawn to scale. Any values dimensions illustrated in the accompanying graphs and figures are for illustration purposes only and can or cannot represent actual or preferred values or dimensions.
The description set forth below in connection with the appended drawings is intended as a description of various embodiments of the disclosed subject matter and is not necessarily intended to represent the only embodiment(s). In certain instances, the description includes specific details for the purpose of providing an understanding of the disclosed embodiment(s). However, it will be apparent to those skilled in the art that the disclosed embodiment(s) can be practiced without those specific details. In some instances, well-known structures and components can be shown in block diagram form in order to avoid obscuring the concepts of the disclosed subject matter. In the drawings, like reference numerals represent like parts throughout the several views.
Referring to
The VAD 14, as described in more detail below, can be capable of pumping the entire flow of blood delivered to the left ventricle from the pulmonary circulation (i.e., up to 10 liters per minute). Related blood pumps applicable to the present disclosure are also described in 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, 8,419,609, 8,652,024, 8,668,473, 8,852,072, 8,864,643, 8,882,744, 9,068,572, 9,091,271, 9,265,870, and 9,382,908, all of which are incorporated herein by reference for all purposes in their entirety. The VAD 14 can be attached to the heart 30 via the ventricular cuff 16, which can be sewn to the heart 30 and coupled to the VAD 14. In the illustrated embodiment, the output of the VAD 14 connects to the ascending aorta via the outflow cannula 18 so that the VAD 14 effectively diverts blood from the left ventricle and propels it to the aorta for circulation through the rest of the patient's vascular system.
The controller-to-VAD connection cable 26 connects the VAD 14 to the implantable controller and battery 20, which monitors the system 10 operation. Related controller systems applicable to the present disclosure 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, EP 1812094, 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.
The implantable controller and battery 20 is configured to supply power to and control operation of the VAD 14. The implantable controller and battery 20 is configured to be implanted within the patient 12 in a suitable location spaced apart from the VAD 14 and operatively coupled with the VAD 14 via the controller-to-VAD connection cable 26.
The TETS power receiver 22 is configured to wirelessly receive power transmitted by the external TETS power transmitter 24, which is outside the body for powering operation of the system 10. The TETS power receiver 22 is configured to be implanted within the patient 12 in a suitable location spaced apart from the VAD 14 and the controller and battery 20. The TETS power receiver 22 is operatively coupled with and supplies power to the controller and battery 20 via the implantable TETS power receiver-to-controller connection cable 28. Further, the TETS power transmitter 24 is configured to be coupled to an electric power source 212 such as an electrical wall outlet or other suitable external power sources.
With reference to
Referring to
The puck-shaped housing 110 further includes a peripheral wall 116 that extends between the first face 111 and a removable cap 118. As illustrated, the peripheral wall 116 is formed as a hollow circular cylinder having a width W between opposing portions of the peripheral wall 116. The housing 110 also has a thickness T between the first face 111 and the second face 113 that is less than the width W. The thickness T is from about 0.5 inches to about 1.5 inches, and the width W is from about 1 inch to about 4 inches. For example, the width W can be approximately 2 inches, and the thickness T can be approximately 1 inch.
The peripheral wall 116 encloses an internal compartment 117 that surrounds the dividing wall 115 and the blood flow conduit 103, with the stator 120 and the electronics 130 disposed in the internal compartment 117 about the dividing wall 115. The removable cap 118 includes the second face 113, the chamfered edge 114, and defines the outlet opening 105. The cap 118 can be threadedly engaged with the peripheral wall 116 to seal the cap 118 in engagement with the peripheral wall 116. The cap 118 includes an inner surface 118a of the cap 118 that defines the volute 107 that is in fluid communication with the outlet opening 105.
Within the internal compartment 117, the electronics 130 are positioned adjacent to the first face 111 and the stator 120 is positioned adjacent to the electronics 130 on an opposite side of the electronics 130 from the first face 111. The electronics 130 include circuit boards 131 and various components carried on the circuit boards 131 to control the operation of the VAD 14 (e.g., magnetic levitation and/or drive of the rotor) by controlling the electrical supply to the stator 120. The housing 110 is configured to receive the circuit boards 131 within the internal compartment 117 generally parallel to the first face 111 for efficient use of the space within the internal compartment 117. The circuit boards also extend radially inward towards the dividing wall 115 and radially-outward towards the peripheral wall 116. For example, the internal compartment 117 is generally sized no larger than necessary to accommodate the circuit boards 131, and space for heat dissipation, material expansion, potting materials, and/or other elements used in installing the circuit boards 131. Thus, the external shape of the housing 110 proximate the first face 111 generally fits the shape of the circuits boards 131 closely to provide external dimensions that are not much greater than the dimensions of the circuit boards 131.
With continued reference to
Each of the pole piece 123a-123f is L-shaped and has a drive coil 125 for generating an electromagnetic field to rotate the rotor 140. For example, the pole piece 123a has a first leg 124a that contacts the back iron 121 and extends from the back iron 121 towards the second face 113. The pole piece 123a can also have a second leg 124b that extends from the first leg 124a through an opening of a circuit board 131 towards the dividing wall 115 proximate the location of the permanent magnet 141 of the rotor 140. In an aspect, each of the second legs 124b of the pole pieces 123a-123f is sticking through an opening of the circuit board 131. In an aspect, each of the first legs 124a of the pole pieces 123a-123f is sticking through an opening of the circuit board 131. In an aspect, the openings of the circuit board are enclosing the first legs 124a of the pole pieces 123a-123f.
In a general aspect, the VAD 14 can include one or more Hall sensors that may provide an output voltage, which is directly proportional to a strength of a magnetic field that is located in between at least one of the pole pieces 123a-123f and the permanent magnet 141, and the output voltage may provide feedback to the control electronics 130 of the VAD 14 to determine if the rotor 140 and/or the permanent magnet 141 is not at its intended position for the operation of the VAD 14. For example, a position of the rotor 140 and/or the permanent magnet 141 can be adjusted, e.g., the rotor 140 or the permanent magnet 141 may be pushed or pulled towards a center of the blood flow conduit 103 or towards a center of the stator 120.
Each of the pole pieces 123a-123f also has a levitation coil 127 for generating an electromagnetic field to control the radial position of the rotor 140. Each of the drive coils 125 and the levitation coils 127 includes multiple windings of a conductor around the pole pieces 123a-123f. Particularly, each of the drive coils 125 is wound around two adjacent ones of the pole pieces 123, such as pole pieces 123d and 123e, and each levitation coil 127 is wound around a single pole piece. The drive coils 125 and the levitation coils 127 are wound around the first legs of the pole pieces 123, and magnetic flux generated by passing electrical current though the coils 125 and 127 during use is conducted through the first legs and the second legs of the pole pieces 123 and the back iron 121. The drive coils 125 and the levitation coils 127 of the stator 120 are arranged in opposing pairs and are controlled to drive the rotor and to radially levitate the rotor 140 by generating electromagnetic fields that interact with the permanent magnetic poles S and N of the permanent magnet 141. Because the stator 120 includes both the drive coils 125 and the levitation coils 127, only a single stator is needed to levitate the rotor 140 using only passive and active magnetic forces. The permanent magnet 141 in this configuration has only one magnetic moment and is formed from a monolithic permanent magnetic body 141. For example, the stator 120 can be controlled as discussed in U.S. Pat. No. 6,351,048, the entire contents of which are incorporated herein by reference for all purposes. The control electronics 130 and the stator 120 receive electrical power, data, and control signals from the implanted controller and battery 20 via the controller-to-VAD connection cable 26 (
The rotor 140 is arranged within the housing 110 such that its permanent magnet 141 is located upstream of impeller blades in a location closer to the inlet opening 101. The permanent magnet 141 is received within the blood flow conduit 103 proximate the second legs 124b of the pole pieces 123 to provide the passive axial centering force though interaction of the permanent magnet 141 and ferromagnetic material of the pole pieces 123. The permanent magnet 141 of the rotor 140 and the dividing wall 115 form a gap 108 between the permanent magnet 141 and the dividing wall 115 when the rotor 140 is centered within the dividing wall 115. The gap 108 may be from about 0.2 millimeters to about 2 millimeters. For example, the gap 108 can be approximately 1 millimeter. The north permanent magnetic pole N and the south permanent magnetic pole S of the permanent magnet 141 provide a permanent magnetic attractive force between the rotor 140 and the stator 120 that acts as a passive axial centering force that tends to maintain the rotor 140 generally centered within the stator 120 and tends to resist the rotor 140 from moving towards the first face 111 or towards the second face 113. When the gap 108 is smaller, the magnetic attractive force between the permanent magnet 141 and the stator 120 is greater, and the gap 108 is sized to allow the permanent magnet 141 to provide the passive magnetic axial centering force having a magnitude that is adequate to limit the rotor 140 from contacting the dividing wall 115 or the inner surface 118a of the cap 118. The rotor 140 also includes a shroud 145 that covers the ends of the impeller blades 143 facing the second face 113 that assists in directing blood flow into the volute 107. The shroud 145 and the inner surface 118a of the cap 118 form a gap 109 between the shroud 145 and the inner surface 118a when the rotor 140 is levitated by the stator 120. The gap 109 is from about 0.2 millimeters to about 2 millimeters. For example, the gap 109 is approximately 1 millimeter.
As blood flows through the blood flow conduit 103, blood flows through a central aperture 141a formed through the permanent magnet 141. Blood also flows through the gap 108 between the rotor 140 and the dividing wall 115 and through the gap 109 between the shroud 145 and the inner surface 108a of the cap 118. The gaps 108 and 109 are large enough to allow adequate blood flow to limit clot formation that may occur if the blood is allowed to become stagnant. The gaps 108 and 109 are also large enough to limit pressure forces on the blood cells such that the blood is not damaged when flowing through the VAD 14. As a result of the size of the gaps 108 and 109 limiting pressure forces on the blood cells, the gaps 108 and 109 are too large to provide a meaningful hydrodynamic suspension effect. That is to say, the blood does not act as a bearing within the gaps 108 and 109, and the rotor is only magnetically levitated. In various embodiments, the gaps 108 and 109 are sized and dimensioned so the blood flowing through the gaps forms a film that provides a hydrodynamic suspension effect. In this manner, the rotor can be suspended by magnetic forces, hydrodynamic forces, or both.
Because the rotor 140 is radially suspended by active control of the levitation coils 127 as discussed above, and because the rotor 140 is axially suspended by passive interaction of the permanent magnet 141 and the stator 120, no magnetic field generating rotor levitation components are needed proximate the second face 113. The incorporation of all the components for rotor levitation in the stator 120 (i.e., the levitation coils 127 and the pole pieces 123) allows the cap 118 to be contoured to the shape of the impeller blades 143 and the volute 107. Additionally, incorporation of all the rotor levitation components in the stator 120 eliminates the need for electrical connectors extending from the compartment 117 to the cap 118, which allows the cap to be easily installed and/or removed and eliminates potential sources of pump failure.
In use, the drive coils 125 of the stator 120 generates electromagnetic fields through the pole pieces 123 that selectively attract and repel the magnetic north pole N and the magnetic south pole S of the rotor 140 to cause the rotor 140 to rotate within stator 120. For example, the one or more Hall sensors may sense a current position of the rotor 140 and/or the permanent magnet 141, wherein the output voltage of the one or more Hall sensors may be used to selectively attract and repel the magnetic north pole N and the magnetic south pole S of the rotor 140 to cause the rotor 140 to rotate within stator 120. As the rotor 140 rotates, the impeller blades 143 force blood into the volute 107 such that blood is forced out of the outlet opening 105. Additionally, the rotor draws blood into VAD 14 through the inlet opening 101. As blood is drawn into the blood pump by rotation of the impeller blades 143 of the rotor 140, the blood flows through the inlet opening 101 and flows through the control electronics 130 and the stator 120 toward the rotor 140. Blood flows through the aperture 141a of the permanent magnet 141 and between the impeller blades 143, the shroud 145, and the permanent magnet 141, and into the volute 107. Blood also flows around the rotor 140, through the gap 108 and through the gap 109 between the shroud 145 and the inner surface 118a of the cap 118. The blood exits the volute 107 through the outlet opening 105, which may be coupled to the outflow cannula 18.
The memory 54 can store suitable instructions executable by the processor 56 for processing, for example, automatically adjust VAD impeller rotational speed in response to the physiologic demand of the patient, determine any suitable number of physiologic states of the patient, monitor conditions of the VAD 14, and/or other functionalities associated with other components such as the remote accelerometer. The controller battery unit 52 can store energy used to operate the VAD 14, the controller and battery 20, and/or the TETS power receiver 22 during time periods when power is not being received by the TETS power receiver coil. The communication unit 58 can be configured to communicate control commands to the VAD 14 over the implantable controller-to-VAD connection cable 26. The communication unit 58 can also include a suitable wireless communication unit for receiving programming updates and/or for transmitting alarms, VAD operational data, and/or patient physiologic data to an external system monitor.
The controller and battery 20 can be configured so that the haptic unit 60 is operated to generate a haptic alarm to alert the patient that power stored in the controller battery unit 52 and/or the TETS receiver battery unit 40 has dropped below a suitable minimum threshold so that the patient can take action to use the TETS power transmitter 24 to transmit power to the TETS power receiver 22 to recharge the controller battery unit 52 and/or the TETS power receiver battery unit. To guard against a prolonged latent failure of the haptic unit 60, the controller and battery 20 can periodically command operation of the haptic unit 60 to determine whether the haptic unit 60 operated properly or is in a failed state. If the controller and battery 20 determines that the haptic unit 60 is in a failed state, the controller and battery 20 can communicate a suitable alarm indicating the failure of the haptic unit 60 via wireless communication by the communication unit 58.
The circular coil spring 730 is retained between side surfaces of the first-side non-conductive retention member 710 and the second-side non-conductive retention member 720. In some embodiments, the retention members 710 and 720 may include a recessed portion 723 (see
In many embodiments, each of the first-side non-conductive retention member 710 and the second-side non-conductive retention member 720 have hollow cylindrical shape. The non-conductive members 710, 720 are coaxially coupled to the annular conductive member 705 along the central axis A. Each of the non-conductive retention members 710, 720 include a flange portion configured to interface with the annular end surfaces 708, 709, respectively, of the annular conductive member 705. In many embodiments, the non-conductive retention members 710, 720 have a stepped cylindrical shape including a first diameter portion configured to support the annular conductive member 705, and a flange portion extending from the first diameter portion. For example, the annular flange portion is a second diameter portion having a larger diameter than the first diameter portion. The first diameter portions face each other to support the annular conductive member 705. The second diameter portions can provide shoulders against which the end surfaces of the annular conductive member 705 can be retained to prevent axial movement.
For example, as illustrated in
The first diameter portions 711, 721 each has the axial length L1 less than an axial length L2 of the annular conductive member 705. A total axial length of the first diameter portions 711, 721 of the non-conductive retention members 710, 720 is less than that of the annular conductive member 705 so that the circular coil spring 730 can be retained between side surfaces of the first portions 711, 721 of the first-side and the second-side non-conductive retention members 710, 720.
Typically electrical contacts of implantable devices have complex geometries and manufactured using expensive metal alloys that are not only electrically conductive but also biocompatible. These metal alloys are highly expensive and cost prohibitive when manufacturing complex geometries of an electrical contact. For example, typically an entire contact used in an implantable device is manufactured from the Pt/Ir alloy and has complex geometric shape necessitated by compact design specifications while providing high level of functionality for medical purposes. Manufacturing such contacts with complex geometries require several machine operations and material removal, which leads to wastage of expensive alloy material. Advantageously, the non-conductive retention members 710, 720 and a simple annular construction of the conductive member 705 of the present disclosure enables cost-effective manufacturing of implantable electrical connectors. As such, the present disclosure can facilitate cost-effective manufacturing of implantable electrical connectors of small (e.g., an internal diameter greater than 3.2 mm) as well as larger size (e.g., an internal diameter greater than 3.2 mm). For example, each of the first-side non-conductive retention member 710 and the second-side non-conductive retention member 720 can be made of polyetheretherketone (PEEK) or thermoplastic polyurethanes (TPU) or other moldable non-conductive polymer and/or ceramic materials, which can take complex geometric shapes and less expensive to manufacture. The annular conductive member 705 can be made of a conductive and corrosion resistant material such as platinum-iridium (Pt/Ir) alloy or other metals/metal alloys like MP35N, which will be less expensive to manufacture due to its simple and scalable geometry. The annular conductive member 705 can be extruded to form a cylindrical shape using the Pt/Ir material, for example. Extruding eliminates the loss of precious metal compared to than machining and making platinum chips. Furthermore, the female contact assembly 700 also provides modular scalability (e.g., diameter size and number of components that can be assembled) of the female electrical connector without adding exponential cost. Also, advantageously, existing or legacy implantable female electrical connector (e.g., within a header of the implantable device) can be retrofitted cost effectively.
In many embodiments, the female electrical connector further includes one or more wiper seals and the female contact assembly 700 can be disposed between two wiper seals. For example, the female contact assembly 700 is configured to couple to a wiper seal 800, as shown in
In an illustrated embodiment, as shown in
In many embodiments, each of the female contact assemblies 700A-700F is disposed between two of the wiper seal assemblies (e.g., 800A and 800B). As shown, each wiper seal 800B-800G is disposed between adjacent female contact assemblies to isolate the female contact assemblies from each other. The wiper seals 800A and 800G are disposed at ends of the female contact stack 1100 and connected to corresponding female contact assembly 700A and 700F at these ends, respectively. The end wiper seals 800A and 800G further provides isolation and sealing from ingress of stray electrical currents or fluid from an external environment.
Furthermore, the first-side non-conductive retention members, the second-side non-conductive retention members and the annular conductive members of the female contact assemblies 700A-700F, and the wiper seals 800A-800G are coaxially stacked with respect to each other. The coaxial arrangement facilitates receiving of an elongated male electrical connector to establish electrical contact with each of the annular conductive members of the female contact assemblies 700A-700F.
The elongated electrical contact support member 1210 is an elongated shaft including a plurality of electrical contacts 1201-1206 axially spaced from each other. The relative location of the electrical contacts 1201-1206 correspond to locations of respective conductive members 705 of the plurality of female contact assemblies 700A-700F of the female contact stack 1100. Upon assembly, the electrical contacts 1201-1206 are electrically coupled to corresponding female contact assemblies 700A-700F. Each of the electrical contact of 1201-1206 can be connected to an electrical wire inside the elongated electrical contact support member 1210 and extend from within the elongated electrical contact support member 1210 to an electrical interface 1224 in the proximal lead housing 1220. The electrical interface 1224 include wires 1225 from the elongated electrical contact support member 1210 coupled to or grouped into or integrated within the implantable controller-to-VAD connection cable 26 (see
Upon inserting the elongated electrical contact support member 1210 into the female contact stack 1100, as shown in
In many embodiments, the wiper seals 800A-800G provide electrical isolation between the contacts 700A-700F and 1201-1206 and sealing against fluid ingress therebetween. The non-conductive members 710, 720 also provide additional electrical isolation and sealing against fluid ingress. A wiper seal includes an annular housing and an annular seal supported by the annular housing and configured to block passage of fluid pas the annular seal. In many embodiments, the annular seal is configured to sealing engage the male electrical connector. For example, each of the wiper seals 800A-800G includes a tongue or a flap (e.g., wiper blade style) configured to isolate an electrical contact (e.g., 700A) from other electrical contacts (e.g., 700B). The wiper tongue or flap is a compliant member that allows for adequate contact isolation while facilitating low lead insertion force. Many high-powered medical implant applications, in addition to wiper seals include distal or proximal seals to isolate electrical contacts, particularly the electrical contacts at a proximal end and a distal end of the female contact stack 1100. For example, the wiper tongue on a proximal end and/or a distal end of the female contact stack 1100 may be insufficient for inhibiting stray electrical currents from entering the electrical contacts and/or inhibiting fluid ingress from the outside environment. To boost sealing performance and electrical isolation of the header, additional sealing elements 1405 are provided at the proximal end of the elongated receptacle 1403 (see
In many embodiments, the plurality of female contact assemblies (e.g., 700A-700F in
In many embodiments, the connector body (e.g., 1401) is retained to a housing of the implantable medical device. The connector body can be a header of an implantable medical device. For example, in
In many embodiments, the method 1700 further includes step 1703 that involves retaining a male electrical conductor (e.g., 1200 in
Thus, advantageously, different components such as the non-conductive memebers 710, 720, the conductive member 705, the circular spring 730, and/or the wiper seal 800 can be manufactured sperately using cost-effective manufacturing processes and material and assembled together to provide a desired fuctionality of an implantable device. As such, both manufacturing and assembly resources can be effectively used making the implantable device affordable and timely available for large group of patients.
Example 1 is an implantable electrical connector assembly that includes a male electrical connector and a female electrical connector. The male electrical connector includes an elongated electrical contact support member and annular electrical contacts mounted to and spaced apart along the elongated electrical contact support member. The female electrical connector includes a connector body having an elongated receptacle and female contact assemblies disposed in and distributed along the elongated receptacle for interfacing with the annular electrical contacts of the male electrical connector. Each of the female contact assemblies includes a circular coil spring, an annular conductive member, a first-side non-conductive retention member, and a second-side non-conductive retention member. The circular coil spring is disposed within the annular conductive member. The first-side non-conductive retention member is mounted to the annular conductive member and disposed on a first side of the circular coil spring. The second-side non-conductive retention member is mounted to the annular conductive member and disposed on a second side of the circular coil spring opposite to the first side of the circular coil spring. The circular coil spring is retained between and by the first-side non-conductive retention member and the second-side non-conductive retention member.
Example 2 is the implantable electrical connector of example 1, wherein the annular conductive member has a cylindrical shape.
Example 3 is the implantable electrical connector of example 2, wherein the annular conductive member is formed from a cylindrical extrusion.
Example 4 is the implantable electrical connector of example 2, wherein the annular conductive member includes a cylindrical inner surface, an annular first end surface, and an annular second end surface, a cylindrical outer surface of the first-side non-conductive retention member is interfaced with a first end portion of the cylindrical inner surface of the annular conductive member, an annular flange portion of the first-side non-conductive retention member is interfaced with the annular first end surface of the annular conductive member; a cylindrical outer surface of the second-side non-conductive retention member is interfaced with a second end portion of the cylindrical inner surface of the annular conductive member, an annular flange of the second-side non-conductive retention member is interfaced with the annular second end surface of the annular conductive member, and the circular coil spring is configured to be interfaced with a central portion of the annular conductive member that extends between the first end portion and the second end portion of the cylindrical inner surface to electrically couple the annular conductive member with a respective one of the annular electrical contacts of the male electrical connector.
Example 5 is the implantable electrical connector of example 4, wherein the female electrical connector further includes wiper seal assemblies, each of the female contact assemblies is disposed between two of the wiper seal assemblies, and each of the wiper seal assemblies includes an annular housing and an annular seal supported by the annular housing. The annular seal is configured to sealing engage the male electrical connector. The wiper seal assembly is configured to cooperate with the male electrical connector to block passage of fluid along the male electrical connector.
Example 6 is the implantable electrical connector of example 2, wherein the annular conductive member includes a cylindrical outer surface, an annular first end surface, and an annular second end surface, a cylindrical inner surface of the first-side non-conductive retention member is interfaced with a first end portion of the cylindrical outer surface of the annular conductive member, an annular flange of the first-side non-conductive retention member is interfaced with the annular first end surface of the annular conductive member, a cylindrical inner surface of the second-side non-conductive retention member is interfaced with a second end portion of the cylindrical outer surface of the annular conductive member, an annular flange of the second-side non-conductive retention member is interfaced with the annular second end surface of the annular conductive member, and the circular coil spring is configured to be interfaced with a central portion of the annular conductive member that extends between the first end portion and the second end portion of the cylindrical inner surface to electrically couple the annular conductive member with a respective one of the annular electrical contacts of the male electrical connector.
Example 7 is the implantable electrical connector of example 6, wherein the female electrical connector further includes wiper seal assemblies, each of the female contact assemblies is disposed between two of the wiper seal assemblies, and each of the wiper seal assemblies includes an annular housing and an annular seal supported by the annular housing. The annular seal is configured to sealing engage the male electrical connector. The wiper seal assembly is configured to cooperate with the male electrical connector to block passage of fluid along the male electrical connector.
Example 8 is the implantable electrical connector of any one of examples 2 through 7, wherein the annular conductive member has an internal diameter greater than 3.2 mm.
Example 9 is the implantable electrical connector of any one of examples 1 through 7, wherein each of the first-side non-conductive retention member and the second-side non-conductive retention member is made of polyetheretherketone (PEEK) or thermoplastic polyurethanes (TPU).
Example 10 is the implantable electrical connector of any one of examples 1 through 7, wherein the annular conductive member is made of a platinum-iridium alloy.
Example 11 is a method of fabricating a female electrical connector of an implantable electrical connector assembly. The method includes receiving a connector body that includes an elongated receptacle, receiving female contact assemblies, and retaining the female contact assemblies within the elongated receptacle of the connector body. Each of the female contact assemblies includes a cylindrical conductive member, a circular coil spring, a first-side non-conductive retention member, and a second-side non-conductive retention member. The circular coil spring is disposed within the cylindrical conductive member. The first-side non-conductive retention member is mounted to the cylindrical conductive member and disposed on a first side of the circular coil spring. The second-side non-conductive retention member is mounted to the cylindrical conductive member and disposed on a second side of the circular coil spring opposite to the first side of the circular coil spring. The circular coil spring is retained between and by the first-side non-conductive retention member and the second-side non-conductive retention member.
Example 12 is the method of example 11, further including retaining wiper seal assemblies within elongated receptacle of the connector body.
Example 13 is the method of example 12, wherein each of the female contact assemblies is disposed between two of the wiper seal assemblies.
Example 14 is the method of example 13, wherein each of the wiper seal assemblies includes an annular housing and an annular seal supported by the annular housing and is configured to sealing engage a male electrical connector and each of the wiper seal assemblies configured to cooperate with the male electrical connector to block passage of fluid.
Example 15 is the method of example 11, wherein the cylindrical conductive member includes a cylindrical inner surface, an annular first end surface, and an annular second end surface, a cylindrical outer surface of the first-side non-conductive retention member is interfaced with a first end portion of the cylindrical inner surface of the cylindrical conductive member, an annular flange portion of the first-side non-conductive retention member is interfaced with the annular first end surface of the cylindrical conductive member, a cylindrical outer surface of the second-side non-conductive retention member is interfaced with a second end portion of the cylindrical inner surface of the cylindrical conductive member, an annular flange of the second-side non-conductive retention member is interfaced with the annular second end surface of the cylindrical conductive member, and the circular coil spring is configured to be interfaced with a central portion of the cylindrical conductive member that extends between the first end portion and the second end portion of the cylindrical inner surface to electrically couple the cylindrical conductive member with a respective one of annular electrical contacts of a male electrical connector.
Example 16 is the method of example 11, wherein the cylindrical conductive member includes a cylindrical outer surface, an annular first end surface, and an annular second end surface, a cylindrical inner surface of the first-side non-conductive retention member is interfaced with a first end portion of the cylindrical outer surface of the cylindrical conductive member, an annular flange of the first-side non-conductive retention member is interfaced with the annular first end surface of the cylindrical conductive member, a cylindrical inner surface of the second-side non-conductive retention member is interfaced with a second end portion of the cylindrical outer surface of the cylindrical conductive member, an annular flange of the second-side non-conductive retention member is interfaced with the annular second end surface of the cylindrical conductive member, and the circular coil spring is configured to be interfaced with a central portion of the cylindrical conductive member that extends between the first end portion and the second end portion of the cylindrical inner surface to electrically couple the cylindrical conductive member with a respective one of annular electrical contacts of a male electrical connector.
Example 17 is the method of any one of examples 11 through 16, further including supporting the connector body via a housing of an implantable medical device.
Example 18 is the method of any one of examples 11 through 16, wherein each of the first-side non-conductive retention member and the second-side non-conductive retention member and second-side non-conductive members is made of polyetheretherketone (PEEK) or thermoplastic polyurethanes (TPU).
Example 19 is the method of any one of examples 11 through 16, wherein the cylindrical conductive member is made of a platinum-iridium alloy.
Example 20 is the method of any one of examples 11 through 16, wherein the cylindrical conductive member has an internal diameter greater than 3.2 mm.
It is to be understood that terms such as “distal,” “proximal,” “side,” “inner,” and the like that can be used herein merely describe points of reference and do not necessarily limit embodiments of the present disclosure to any particular orientation and/or configuration. As used herein, “proximal” refers to a direction toward the end of the female contact stack near the clinician and “distal” refers to a direction away from the clinician and (generally) inside the body of a patient. Furthermore, terms such as “first,” “second,” “third,” etc., merely identify one of a number of portions, components, steps, operations, functions, and/or points of reference as disclosed herein, and likewise do not necessarily limit embodiments of the present disclosure to any particular configuration or orientation.
The terms “longitudinal,” “axial” or “axially” are generally longitudinal as used herein to describe the relative position related to a female contact stack or other components of the system herein. For example, “longitudinal” or “axial” indicates an axis passing along a center of a female contact stack from a proximal end to a distal end. The term “radial” generally refers to a direction perpendicular to the “axial” direction.
Disjunctive language such as the phrase “at least one of X, Y, or Z,” unless specifically stated otherwise, is intended to be understood within the context as used in general to present that an item, term, etc., may be either X, Y, or Z, or any combination thereof (e.g., X, Y, and/or Z). Thus, such disjunctive language is not generally intended to, and should not, imply that certain embodiments require at least one of X, at least one of Y, or at least one of Z to each be present.
While certain embodiments have been described, these embodiments have been presented by way of example only and are not intended to limit the scope of the present disclosures. Indeed, the novel methods, apparatuses and systems described herein can be embodied in a variety of other forms; furthermore, various omissions, substitutions, and changes in the form of the methods, apparatuses and systems described herein can be made without departing from the spirit of the present disclosures. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the present disclosures.
The present application is a Continuation of PCT/US2023/073022 filed Aug. 28, 2023; which claims the benefit of U.S. Provisional Appln. No. 63/401,831 filed Aug. 29, 2022, the disclosures which are incorporated herein by reference in their entirety for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 63401831 | Aug 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2023/073022 | Aug 2023 | WO |
| Child | 19059628 | US |