Driveline systems and methods for use in implantable medical devices

Abstract

Drivelines and driveline systems used in active implantable medical devices can communicate via power conductors in the driveline. The driveline includes four conductors, two for positive power connections and two for negative power connections. Within the driveline, communication is achieved using power line communication (PLC) technology, i.e., the four conductors provide both power and communication functions by superimposing communication signals on the conductors. The four conductors provide redundant power and communication paths, so failure of any conductor in the driveline does not affect driveline functionality. Drivelines and systems employing a four-conductor design provide a more robust driveline cable without increasing the driveline diameter, allowing failure of any conductor to not affect functionality without increasing the driveline's outer diameter, which increases the risk of the driveline penetrating the skin and causing infection.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to a Chinese patent application bearing application number 2024101027927 and entitled "Driveline System and Method Used in Implantable Medical Devices," filed with the State Intellectual Property Office of the People's Republic of China on January 25, 2024, the contents of which are incorporated herein by reference.

[0002] The present invention relates to implantable medical devices, and more particularly to driveline systems and methods for use in implantable medical devices. [Background technology]

[0003] Implantable medical devices are implanted in the human body and help extend a patient's lifespan and improve their quality of life. Some implantable medical devices (e.g., pacemakers) have batteries that can operate for several years before needing replacement and therefore do not require connection to an external power source. However, some implantable medical devices are high-power active implantable medical devices that consume a lot of power and therefore require connection to an external power source. In these cases, a cable, commonly referred to as a driveline, must be connected to the implantable medical device at one end and passed through a portion of the patient's skin at the other end to an external device (which connects to or includes an external power source). Examples of known high-power active implantable medical devices include Left Ventricular Assist Devices (LVADs), Right Ventricular Assist Devices (RVADs), Bi-ventricular Assist Devices (BiVADs), Percutaneous Ventricular Assist Devices (pVADs), Mechanical Circulatory Systems (MCSs), and Total Artificial Hearts (TAHs). Summary of the Invention

[0004] Drivelines and driveline systems used in active implantable medical devices can communicate via power conductors in the driveline. The driveline includes four conductors, two for positive power connections and two for negative power connections. Within the driveline, communication is achieved using power line communication (PLC) technology, i.e., the four conductors provide both power and communication functions by superimposing communication signals on the conductors. The four conductors provide redundant power and communication paths, so failure of any conductor in the driveline does not affect driveline functionality. Drivelines and systems employing a four-conductor design provide a more robust driveline cable without increasing the driveline diameter, allowing failure of any conductor to not affect functionality without increasing the driveline's outer diameter, which increases the risk of the driveline penetrating the skin and causing infection.

[0005] These and other features and advantages of the present invention will become apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings.

[0006] Preferred embodiments of the present invention are described below in conjunction with the accompanying drawings, in which like numerals refer to like elements. [Brief explanation of the drawings]

[0007] [Figure 1] FIG. 1 is a block diagram of a prior art system including an implantable medical device in which a driveline passes through the patient's skin and connects to an external device. [Figure 2] FIG. 2 is a cross-sectional view of a first prior art driveline. [Figure 3] FIG. 3 is a cross-sectional view of a second prior art driveline. [Figure 4]FIG. 4 is a block diagram of a sample system showing an implantable medical device connected to an external controller and further connected to a power source. [Figure 5] FIG. 5 is a cross-sectional view of a prior art driveline containing only two conductors. [Figure 6] FIG. 6 is a cross-sectional view of a driveline according to an embodiment having four conductors. [Figure 7] FIG. 7 is a block diagram of a driveline system according to an embodiment illustrating a situation in which a first power conductor of the four conductors of the driveline shown in FIG. 6 is interconnected with a second power conductor, and a third power conductor is interconnected with a fourth power conductor. [Figure 8] FIG. 8 is a block diagram of a BPSK modulator. [Figure 9] FIG. 9 is a block diagram of a BPSK demodulator. [Figure 10] FIG. 10 is a system block diagram of one possible embodiment of the driveline system 700 in FIG. [Figure 11] FIG. 11 is a block diagram of one possible embodiment of the driveline communication transceiver shown in FIGS. [Figure 12] FIG. 12 is a block diagram of one possible implementation of the driveline system of FIG. 7 using a SIG100 driveline communications transceiver. [Figure 13] FIG. 13 is a flowchart of a method for initializing communications in an implantable medical device using a SIG100 driveline communications transceiver. [Figure 14] FIG. 14 is a flow chart of a method for initializing communications in a controller using a SIG100 driveline communications transceiver. [Figure 15] FIG. 15 is a flow chart of a method for initializing communications in a controller using a SIG100 driveline communications transceiver. [Figure 16]FIG. 16 is a block diagram illustrating how conductors in a driveline are interconnected on a printed circuit board for a driveline communications transceiver. [Figure 17] FIG. 17 is a block diagram illustrating how conductors in a driveline are connected to each other at a first connector. [Figure 18] FIG. 18 is a block diagram showing how the conductors in the driveline are connected to each other at the second connector. [Figure 19] FIG. 19 is a block diagram illustrating how conductors in a driveline are interconnected within the driveline. [Figure 20] FIG. 20 is a flowchart of a method according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0008] Drivelines and driveline systems used in active implantable medical devices can communicate via power conductors in the driveline. The driveline includes four conductors, two for positive power connections and two for negative power connections. Within the driveline, communication is achieved using power line communication (PLC) technology, i.e., the four conductors provide both power and communication functions by superimposing communication signals on the conductors. The four conductors provide redundant power and communication paths, so failure of any conductor in the driveline does not affect driveline functionality. Drivelines and systems employing a four-conductor design provide a more robust driveline cable without increasing the driveline diameter, allowing failure of any conductor to not affect functionality without increasing the driveline's outer diameter, which increases the risk of the driveline penetrating the skin and causing infection.

[0009] Referring to FIG. 1 , a prior art system 100 includes an implantable medical device 110 implanted within a patient's body and a driveline 140 connected to the implantable medical device 110, which passes through the patient's skin 120 and connects to an external device 130. The external device 130 provides power and communications to the implantable medical device 110 via the driveline 140. FIGS. 2 and 3 show two examples of prior art drivelines 140, namely, driveline 140A and driveline 140B, respectively. Referring to FIG. 2 , the prior art driveline 140A includes four conductors 210, 220, 230, and 240. Conductor 210 provides a positive power connection, and conductor 220 provides a negative power connection. Conductor 230 provides a transmit signal TX from the external device 130 to the implantable medical device 110, and conductor 240 provides a receive signal RX from the implantable medical device 110 to the external device 130. Note that TX conductor 230 is the RX input of implantable medical device 110, and RX conductor 240 is the TX output of implantable medical device 110. The drivelines of many known active medical devices include two or more pairs of conductors. For example, the drivelines of the HeartMate II and HeartMate 3 LVADs include six conductors. The HeartMate II and HeartMate 3 LVAD devices are sold by Abbott. HeartMate II and HeartMate 3 are registered trademarks of TC1 LLC, a California company.

[0010] Referring to FIG. 3, another prior art configuration provides a pair of conductors 310 and 320 used for power supply and a conductor 330 for transmitting and receiving information.

[0011] FIG. 4 illustrates an exemplary configuration of an implantable medical device 420 within a patient's body 410. The driveline in FIG. 4 is comprised of cables 430, 440, two cables interconnecting the implantable medical device 420 and a controller 450. The cables 430, 440 are connected together via a mating connector 480, and once connected, comprise the driveline disclosed and claimed by the present invention. Of course, the driveline disclosed and claimed by the present invention does not necessarily include a connector between the two independent components of the driveline. Instead, the driveline may be connected to a connector at the controller 450, and may further include a hard-wire connection at the implantable medical device 420 or a waterproof connector at the implantable medical device 420. The controller 450 is connected to a power source 470 via a cable 460. Power supply 470 may include any suitable source of AC or DC power, including a plug that connects to a wall outlet, a battery, a power source that receives electrical energy from a wall outlet or a battery, or any suitable combination of these power sources, such as a rechargeable battery that is charged via an AC power outlet. Controller 450 may include any suitable power source, such as a rechargeable battery, that can power controller 450 independently of power supply 470 when controller 450 is disconnected from power supply 470. In such a configuration, controller 450 can operate for a period of time using its own internal rechargeable battery (or battery pack) without an external power supply 470, and once controller 450 is again connected to power supply 470, the internal rechargeable battery (or battery pack) can automatically recharge. Although power supply 470 and controller 450 are shown as separate entities in FIG. 4, power supply 470 may also be incorporated within controller 450.

[0012] In clinical applications of high-power active implantable medical devices, infections caused at the site where the driveline 140 passes through the skin 120 are a common problem, often resulting in serious complications and patient readmission. Currently, the industry is striving to reduce driveline infections by optimizing driveline characteristics and implantation techniques. Because a smaller outer diameter of the driveline 140 is believed to be associated with a lower probability of driveline infection, maximizing the outer diameter of the driveline 140 is one of the most direct and most effective means of reducing the probability of driveline infection.

[0013] U.S. Patent No. 9,308,305, issued April 12, 2016 to Chen et al. and assigned to the assignee of the present application, discloses in Figure 7, column 5, lines 54-67, a driveline including only two conductors used for power and communication. Figure 5 shows an exemplary cross-sectional view of a prior art two-conductor driveline. Power and data are both transmitted over two conductors 520, 530, thereby eliminating an extra communication conductor. The driveline 510 in Figure 5 is connected at one end to an implantable medical device and at the other end to a controller.

[0014] The prior art driveline 510 in Figure 5 eliminates the need for the separate pair of conductors 230, 240 shown in Figure 2 for sending / receiving digital messages, and even the separate conductor 330 shown in Figure 3. By eliminating conductors in the driveline dedicated to sending and receiving messages, the diameter of the driveline can be reduced, thereby reducing the likelihood of infection at the site where the driveline passes through the skin.

[0015] Over time, drivelines in implantable medical devices bend and rub, causing one of their conductors to fail. The long-term effects of moisture, for example, inside a patient's body, can corrode contacts and leads, lowering conductor impedance and leading to conductor failure. Failure of any of the four conductors in the prior art driveline 140A shown in FIG. 2 results in a loss of power or communication. Similarly, failure of any of the three conductors in the prior art driveline 140B shown in FIG. 3 results in a loss of power or communication. Failure of any of the two conductors in the prior art driveline 510 shown in FIG. 5 results in a simultaneous loss of power and communication. Failure of any conductor in any of the three prior art drivelines shown in FIGS. 2, 3, and 5 typically requires emergency action, requiring rapid replacement of the implantable medical device and / or driveline to save the patient.

[0016] As shown in Figures 6, 7 and 16-19, according to one embodiment, the driveline and driveline system includes a driveline having four conductors. The four conductors provide a redundant power connection, meaning that both power and communications can be maintained even if one or two conductors fail.

[0017] It is not obvious to those skilled in the art that a driveline can simultaneously provide redundant power and redundant communication over the same conductor. Known drivelines achieve this by increasing the number of conductors. For example, the driveline of the HeartMate 3 LVAD includes six conductors: two positive power conductors, two negative power conductors, and two communication conductors, each capable of bidirectional communication. Therefore, the HeartMate 3 LVAD provides redundant physical power connections and redundant physical data connections, which requires six physical conductors to be attached to the driveline. However, the diameter of a percutaneous power source with six conductors is larger than that of a percutaneous power source with four conductors. Therefore, the physically redundant design of the HeartMate 3 LVAD driveline comes at the expense of increased susceptibility to driveline infection. As shown in Figures 6 and 7, redundant power and communication capabilities can be simultaneously provided by using only four conductors, which is the same number of conductors used in the prior art driveline shown in Figure 2, but without the need to increase the diameter of the driveline, thereby significantly improving reliability.

[0018] Referring to FIG. 6 , driveline 610 includes four conductors 620, 630, 640, and 650. Driveline system 700 in FIG. 7 includes driveline 610 shown in FIG. 6 , with one end connected to driveline communication transceiver 740 in controller 730 and the other end connected to driveline communication transceiver 720 in implantable medical device 710. In a most preferred embodiment, two of the four conductors provide power of a first polarity (positive power) and the remaining two provide power of a second polarity (negative power). As shown in FIG. 7 , conductors 620 and 640 are both connected to a positive power supply in controller 730 (including conductors 620 and 640), the positive power supply being designated P1+ and P2+, respectively. Conductor 630 and conductor 650 are both connected to a negative power supply in controller 730 (including conductors 630 and 650), the negative power supply being designated P1− and P2−, respectively. By providing redundant connections for the two polarities, a failure of either conductor will not affect the operation of the driveline. In fact, one of the two conductors 620, 640 may fail, and one of the two conductors 630, 650 may also fail, again without affecting the operation of the driveline system.

[0019] 7 preferably each include one BPSK modulator (e.g., 810 shown in FIG. 8) and one BPSK demodulator (e.g., 910 shown in FIG. 9), allowing driveline communications transceivers 720, 740 to simultaneously communicate digitally over two power conductors for providing power from controller 730 to implantable medical device 710.

[0020] The driveline of one embodiment eliminates the separate pair of conductors 230, 240 shown in Figure 2 for sending / receiving digital messages, eliminates the separate conductor 330 shown in Figure 3, and provides fault redundancy not present in the prior art driveline 510 in Figure 5. One embodiment implements transmission of digital messages over the same conductors that provide power using power line communication (PLC) technology.

[0021] Power Line Communication (PLC) is a communication technology that uses power lines as the communication medium. PLC technology requires one transmitter, one receiver, and one communication medium. The communication medium for PLC is the power line. The transmitter modulates a signal, then couples the signal onto the power line and transmits it to the receiver at the other end of the communication link, which demodulates the signal. The power line itself may be AC ​​or DC. Communication between the transmitter and receiver may be bidirectional. When bidirectional, the device is called a transceiver because it transmits and receives signals simultaneously.

[0022] PLC employs a modulation scheme to transmit data as a frequency coupled onto AC or DC power lines. Several modulation schemes exist for PLC, including amplitude shift keying (ASK), frequency shift keying (FSK) (binary frequency shift keying (BFSK)), and phase shift keying (PSK) (including binary phase shift keying (BPSK)). In one embodiment, BPSK is used to communicate over the driveline's power conductors, thereby eliminating the need for dedicated conductors for transmission / reception in the driveline, which reduces the diameter of the driveline and reduces the likelihood of infection where the driveline passes through the patient's skin. Of the modulation schemes listed above, BPSK is preferred because it resists failures caused by corrosion of contacts or conductors inside the patient's body, which reduces the impedance of the conductor over time. It should be noted that ASK, FSK, BFSK, and PSK can also be used in the driveline disclosed in this invention.

[0023] 8, a suitable BPSK modulator 810 is shown, which includes a bipolar non-return-to-zero level encoder 820 that receives a signal input, a carrier signal generator 840, and a mixer circuit 830. The bipolar non-return-to-zero level encoder 820 converts the signal input to be modulated into an equivalent bipolar non-return-to-zero level sequence that is fed into the mixer circuit 830 along with a carrier signal output by the carrier signal generator 840 to form the final BPSK modulated signal at the signal output.

[0024] The transmitting end uses a BPSK modulator 810 to encode a digital message to be output as a signal. A BPSK demodulator is present at the receiving end, an example of which is shown as 910 in FIG. 9. The BPSK demodulator 910 receives a signal input, i.e., the signal output of the BPSK modulator 810 in FIG. 8. Coherent detection is used to demodulate the BPSK signal input. When using the coherent detection technique, the receiver needs to know the carrier frequency and phase. This can be achieved by using a phase-locked loop (PLL) 930. Therefore, as shown in FIG. 9, the BPSK demodulator 910 includes a PLL 930, a multiplier circuit 920, an integrator 940, a bit synchronizer 950, a switch circuit 960, and a comparator 970. The signal received at the signal input end is multiplied by a reference frequency signal from the PLL 930 via the multiplier circuit 920. The multiplied output signal is integrated within one bit period by an integrator 940, a bit synchronizer 950, and a switch circuit 960. A comparator 970 makes a decision for each integrated bit based on a threshold value. Because a non-return-to-zero signal format is used in the BPSK modulator 810, the threshold value of the comparator 970 is set to zero. The equivalent binary data generated after comparison is the demodulated signal output. Compared to BFSK technology, BPSK technology has stronger noise immunity and occupies less bandwidth.

[0025] FIG. 10 shows a block diagram of system 1000, which is a suitable embodiment including features of system 700 in FIG. 7. System 1000 preferably includes an implantable medical device 1010, which includes a microcontroller unit 1030, a driveline communications transceiver 1040, and a power supply 1050. Microcontroller unit 1030 preferably includes a microprocessor that executes code to control appropriate mechanical devices to perform the desired function of implantable medical device 1010 (e.g., blood pumping). Driveline communications transceiver 1040 preferably includes a BPSK modulator and demodulator, such as transceivers 720, 740 described above in FIG. 7. Power supply 1050 is preferably switchable between an internal battery and a DC power source provided from controller 1020 via driveline 610. The internal battery providing power source 1050 is used to ensure that implantable medical device 1010 continues to operate even if it is briefly disconnected from controller 1020, thereby allowing a different controller to be used to replace controller 1020. Some implantable medical devices do not have an internal power source. For implantable medical devices that do not have an internal power source, power source 1050 in FIG. 10 may be omitted. The present disclosure and claims expressly extend to use in the driveline systems of all active implantable medical devices (whether or not they have an internal power source).

[0026] Controller 1020 preferably includes a microcontroller unit 1070, a driveline communications transceiver 1080, and a power supply 1090. Microcontroller unit 1070 preferably includes a microprocessor that executes code to send digital messages to implantable medical device 1010, thereby controlling the functions of implantable medical device 1010. Driveline communications transceiver 1080 receives digital messages from microcontroller unit 1070, encodes the information via a BPSK modulator, and transmits the message over driveline 610 to driveline communications transceiver 1040 in implantable medical device 1010. Driveline communications transceiver 1040 decodes the digital message and transmits the digital message to microcontroller unit 1030. Microcontroller unit 1030 then performs the desired function corresponding to the received message.

[0027] The power supply 1090 provides power to the controller 1020 and the implantable medical device 1010 via the driveline 610. The power supply 1090 preferably includes a rechargeable battery capable of powering the controller and implantable medical device for several hours. The power supply 1090 can be connected to an external power source 1095, such as an AC power outlet, to power the controller 1020 and the implantable medical device 1010 and charge a rechargeable battery internal to the power supply 1090. In a suitable embodiment, the power supply 1090 in the controller is a rechargeable battery that can be connected to an external power source 1095, which has its own rechargeable battery and an external AC power source. The controller 1020 may select a power source from its own battery, a battery in the external power source, or an AC power source depending on whether the controller is connected to the external power source, the amount of power in the rechargeable batteries in the controller and the external power source, or other factors.

[0028] Driveline 610 interconnects controller 1020 and implantable medical device 1010. A single line 1052 shown in FIG. 10 includes four conductors 620, 630, 640, and 650, as shown in FIGS. 6 and 7. As indicated by arrow 1054 in FIG. 10, driveline 610 provides redundant positive power connections via conductors 620 and 640 and redundant negative power connections via conductors 630 and 650. As indicated by arrow 1056 in FIG. 10, these four conductors in driveline 610 also provide bidirectional digital communication between two driveline communication transceivers 1040 and 1080 via BPSK. The driveline system disclosed in the present invention provides a driveline having four conductors and simultaneously provides redundant power and redundant communication capabilities on these four conductors.

[0029] Referring to Figure 11, a driveline communications transceiver 1110 is a suitable embodiment of driveline communications transceivers 720 and 740 in Figure 7 and 1040 and 1080 in Figure 10. Driveline communications transceiver 1110 includes a BPSK modulator 1120, a BPSK demodulator 1130, and a coupling transformer 1140. Driveline communications transceiver 1110 provides a transmit path, transmitting a TX output signal to the driveline via BPSK modulator 1120 and coupling transformer 1140. Driveline communications transceiver 1110 also provides a receive path, transmitting information received from the driveline to an RX input via coupling transformer 1140 and BPSK demodulator 1130.

[0030] In a suitable embodiment, the driveline communications transceiver is a SIG100 UART / LIN manufactured by Yamar and used in powerline transceivers, and reference is made to system 1200 shown in Figure 12. System 1200 in Figure 12 differs from system 1000 in Figure 10 primarily in that the two driveline communications transceivers 1040, 1080 in Figure 10 have been replaced with SIG100 driveline communications transceivers 1240, 1280 in implantable medical device 1210 and controller 1220, respectively, in Figure 12.

[0031] Referring to Figure 13, method 1300 is used to configure the SIG100 driveline communications transceiver 1240 in the implantable medical device 1210 shown in Figure 12. Power on the implantable medical device (step 1310). Reset the SIG100 transceiver (step 1315). Enter command mode of the SIG100 transceiver (step 1320). Set carrier frequency (step 1325). Set communications bit rate (step 1330). Disable local loopback function (step 1335). Disable remote loopback function (step 1340). Disable auto-sleep function (step 1345). Exit command mode of the SIG100 transceiver (step 1350). Start communications protocol stack (step 1355). Wait for a handshake request from the controller (step 1360). If the handshake is not successful (“No” at step 1365), method 1300 returns to step 1360 to wait for the next handshake request from the controller (step 1360). If the handshake is successful (“Yes” at step 1365), method 1300 ends and driveline communications transceiver 1240 in implantable medical device 1210 is ready to communicate with the controller.

[0032] 14 and 15, a method 1400 is used to configure the SIG100 driveline communications transceiver 1280 in the controller 1220 shown in FIG. 12. Power on the controller (step 1410). Reset the SIG100 transceiver (step 1415). Enter command mode of the SIG100 transceiver (step 1420). Set the carrier frequency (step 1425). The carrier frequency in step 1425 corresponds to the carrier frequency in step 1325 shown in FIG. 13. Set the communications bit rate (step 1430). The communications bit rate in step 1430 corresponds to the communications bit rate in step 1330 shown in FIG. 13. Disable the local loopback function (step 1435). Disable the remote loopback function (step 1440). Disable the auto-sleep function (step 1445). Exit command mode of the SIG100 transceiver (step 1450). The communication protocol stack is started (step 1455). Whether an implantable medical device is connected is detected by detecting the current flowing through the driveline (step 1460). As long as an implantable medical device is not connected ("No" at step 1465), method 1400 returns to step 1460 and waits. Once an implantable medical device is connected ("Yes" at step 1465), the controller initiates a handshake with the implantable medical device (step 1470). If the handshake is not successful ("No" at step 1475), method 1400 returns to step 1470 and initiates the handshake again. Once the handshake is successful ("Yes" at step 1475), method 1400 ends, which means the driveline system is ready to communicate over the powerline connection between the controller and the implantable medical device.

[0033] The interconnections between conductors 620, 640 and conductors 630, 650 in FIGS. 6 and 7 can be implemented in any suitable location and in any suitable form. FIGS. 16-19 illustrate interconnections between driveline conductors at different locations. Referring to FIG. 16, a driveline communications transceiver 1630 is connected to a printed circuit board 1620, which is interconnected with two pairs of conductors, which are then connected to the driveline 1610 via connectors 1640, 1650, as shown in FIG. 16. Note that the printed circuit board 1620 and the driveline communications transceiver 1630 may be mounted to a controller or an implantable medical device. Referring to FIG. 17, a driveline communications transceiver 1730 is connected to a printed circuit board 1720, and the conductors may be interconnected within a connector 1740, which is connected to a corresponding mating connector 1750 in the driveline 1610. Referring to FIG. 18, the conductors may be interconnected within a connector 1850 in the driveline 1610, which is mated to a corresponding mating connector 1840 and connected to the driveline communications transceiver 1730. Referring to FIG. 19, the conductors may be interconnected within the driveline 1910 itself, which includes a connector 1950 having two conductors, which is mated to a corresponding mating connector 1940 and connected to the driveline communications transceiver 1730. The printed circuit board and driveline communications transceiver in FIGS. 16-19 may be mounted to a controller or mounted to an implantable medical device. The driveline 1610 in FIGS. 16-18 and the driveline 1910 in FIG. 19 are both specific examples of the driveline 610 shown in FIGS. 6 and 7.

[0034] 16-19, although the conductor pairs in the driveline are interconnected at the same locations (printed circuit board 1620 in FIG. 16, connector C1 1740 in FIG. 17, connector C2 1850 in FIG. 18, and driveline 1910 in FIG. 19), the interconnection points may occur at different locations. Thus, the conductors corresponding to P1+ and P2+ may be interconnected at printed circuit board 1620 in FIG. 16, and the conductors corresponding to P1- and P2- may be interconnected at connector C2 1850 shown in FIG. 18. The present disclosure and claims expressly extend the interconnection points of paired conductors in the driveline to any suitable location or combination of locations.

[0035] Referring to FIG. 20 , method 2000 is performed according to one embodiment. First and second power conductors in the driveline are provided to provide a positive power connection (step 2010). Third and fourth power conductors in the driveline are provided to provide a negative power connection (step 2020). Power is provided from an external controller to the implantable medical device over the first, second, third, and fourth power conductors (step 2030). Digital communication between the external controller and the implantable medical device is performed over the first, second, third, and fourth power conductors by a PLC (step 2040). Method 2000 then ends.

[0036] The terms "positive power connection" and "negative power connection" are used in FIG. 20. These terms are used as specific examples of first and second polarity power and are intended to encompass, in their broadest possible scope, any suitable connection capable of providing power from a controller to an implantable medical device, including, but not limited to, AC and DC connections. In the most preferred embodiment, the driveline system relates to an implantable medical device implanted within a patient's body, so a DC connection is preferred. For example, the first polarity power may be a suitable DC voltage, e.g., +3 volts DC, and the second polarity power may be a ground connection or a suitable DC voltage connection, which may be higher than the first polarity power but is preferably lower than the first polarity power.

[0037] Drivelines and driveline systems used in active implantable medical devices can communicate via power conductors in the driveline. The driveline includes four conductors, two for positive power connections and two for negative power connections. Within the driveline, communication is achieved using power line communication (PLC) technology, i.e., the four conductors provide both power and communication functions by superimposing communication signals on the conductors. The four conductors provide redundant power and communication paths, so failure of any conductor in the driveline does not affect driveline functionality. Drivelines and systems employing a four-conductor design provide a more robust driveline cable without increasing the driveline diameter, allowing failure of any conductor to not affect functionality without increasing the driveline's outer diameter, which increases the risk of the driveline penetrating the skin and causing infection.

[0038] The disclosed subject matter and claims of the present invention support a driveline for use in an implantable medical device, the driveline connecting the implantable medical device to an external controller, wherein the driveline includes first and second power conductors for providing power of a first polarity from the external controller to the implantable medical device, and third and fourth power conductors for providing power of a second polarity from the external controller to the implantable medical device, wherein the first and second power conductors are interconnected, and the third and fourth power conductors are interconnected.

[0039] The disclosed subject matter and claims of the present invention further support a driveline system for use with an implantable medical device, the system connecting the implantable medical device to an external controller, wherein the driveline system includes: (A) a driveline including first and second power conductors and third and fourth power conductors, the first and second power conductors providing power of a first polarity from the external controller to the implantable medical device, the first and second power conductors being interconnected, and the third and fourth power conductors providing power of a second polarity from the external controller to the implantable medical device, the third and fourth power conductors being interconnected; and (B) a power supply located within the implantable medical device and coupled to the first, second, third and fourth power conductors in the driveline. (C) a second driveline communications transceiver located within the external controller and coupled to the first, second, third, and fourth power conductors in the driveline, the transceiver digitally communicating with an implantable medical device via the first, second, third, and fourth power conductors in the driveline.

[0040] The present disclosure and claims further support a method for communicating between an external controller and an implantable medical device, the external controller and the implantable medical device being connected using a driveline, the method including providing first and second power conductors in the driveline to provide a positive power connection from the external controller to the implantable medical device, providing third and fourth power conductors in the driveline to provide a negative power connection from the external controller to the implantable medical device, providing power from the external controller to the implantable medical device over the first, second, third, and fourth power conductors, and performing digital communication between the external controller and the implantable medical device over the first, second, third, and fourth power conductors.

[0041] While the present invention has been particularly shown and described with reference to one embodiment, it will be understood by those skilled in the art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention.

Claims

1. 1. A driveline for use with an implantable medical device for connecting the implantable medical device to an external controller, comprising: The driveline is a first power conductor and a second power conductor connected to each other and providing power of a first polarity from the external controller to the implantable medical device; a third power conductor and a fourth power conductor connected to each other, the third power conductor and the fourth power conductor providing power of a second polarity from the external controller to the implantable medical device.

2. The driveline of claim 1 , wherein the first power conductor and the third power conductor are connected within the implantable medical device.

3. The driveline of claim 1 , wherein the first power conductor and the third power conductor are connected within a connector to the driveline.

4. The driveline of claim 1 , wherein the first power conductor and the third power conductor are connected within the driveline.

5. The driveline of claim 1 , wherein the first power conductor and the third power conductor are connected within the external controller.

6. The driveline of claim 1 , wherein the second power conductor and the fourth power conductor are connected within the implantable medical device.

7. The driveline of claim 1 , wherein the second power conductor and the fourth power conductor are connected within a connector to the driveline.

8. The driveline of claim 1 , wherein the second power conductor and the fourth power conductor are connected within the driveline.

9. The driveline of claim 1 , wherein the second power conductor and the fourth power conductor are connected within the external controller.

10. 1. A driveline system for use with an implantable medical device for connecting the implantable medical device to an external controller, comprising: The driveline system comprises: (A) a drive line including first and second interconnected power conductors for providing power of a first polarity from the external controller to the implantable medical device, and third and fourth interconnected power conductors for providing power of a second polarity from the external controller to the implantable medical device; (B) a first driveline communications transceiver located within the implantable medical device, coupled to the first power conductor, the second power conductor, the third power conductor, and the fourth power conductor in the driveline, for digital communication with the external controller over the first power conductor, the second power conductor, the third power conductor, and the fourth power conductor; (C) a second driveline communications transceiver located within the external controller and coupled to the first power conductor, the second power conductor, the third power conductor, and the fourth power conductor in the driveline, for digital communication with the implantable medical device via the first power conductor, the second power conductor, the third power conductor, and the fourth power conductor.

11. The driveline system of claim 10 , wherein the first power conductor and the third power conductor are connected within the implantable medical device.

12. The driveline system of claim 10 , wherein the first power conductor and the third power conductor are connected within a connector to the driveline.

13. The driveline system of claim 10 , wherein the first power conductor and the third power conductor are connected within the driveline.

14. The driveline system of claim 10 , wherein the first power conductor and the third power conductor are connected within the external controller.

15. The driveline system of claim 10 , wherein the second power conductor and the fourth power conductor are connected within the implantable medical device.

16. The driveline system of claim 10 , wherein the second power conductor and the fourth power conductor are connected within a connector to the driveline.

17. The driveline system of claim 10 , wherein the second power conductor and the fourth power conductor are connected within the driveline.

18. The driveline system of claim 10 , wherein the second power conductor and the fourth power conductor are connected within the external controller.

19. The driveline system of claim 10 , wherein the first driveline communication transceiver and the second driveline communication transceiver communicate with each other using binary phase shift keying (BPSK) modulation and demodulation.

20. The first driveline communication transceiver and the second driveline communication transceiver each include: a coupling transformer coupled to at least one conductor in the driveline; a binary phase shift keying (BPSK) modulator coupled to the coupling transformer for driving a message transmitted to the driveline through the coupling transformer; a BPSK demodulator coupled to the coupling transformer to receive the driveline messages received through the coupling transformer.

21. 11. The driveline system of claim 10, wherein the driveline system maintains power from the external controller to the implantable medical device and further maintains communication between the external controller and the implantable medical device if either the first power conductor or the second power conductor fails.

22. 11. The driveline system of claim 10, wherein the driveline system maintains power from the external controller to the implantable medical device and further maintains communication between the external controller and the implantable medical device if either the third power conductor or the fourth power conductor fails.

23. 11. The driveline system of claim 10, wherein the driveline system maintains power from the external controller to the implantable medical device and further maintains communication between the external controller and the implantable medical device when either the first power conductor or the second power conductor fails and simultaneously either the third power conductor or the fourth power conductor fails.

24. 1. A method for communicating between an external controller and an implantable medical device over a driveline connecting the external controller to the implantable medical device, comprising: providing a first power conductor and a second power conductor in the driveline for providing a positive power connection from the external controller to the implantable medical device; providing a third power conductor and a fourth power conductor in the driveline for providing a negative power connection from the external controller to the implantable medical device; providing power from the external controller to the implantable medical device over the first power conductor, the second power conductor, the third power conductor, and the fourth power conductor; and performing digital communications between the external controller and the implantable medical device over the first power conductor, the second power conductor, the third power conductor, and the fourth power conductor.

25. the implantable medical device includes a first driveline communication transceiver and the external controller includes a second driveline communication transceiver; The method further comprises:

25. The method of claim 24, wherein the first driveline communication transceiver and the second driveline communication transceiver communicate with each other over the driveline using binary phase shift keying (BPSK) modulation and demodulation.

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