Wireless communication system for transmitting information from a medical device

[0001] The present invention relates generally to systems for conducting wireless communications, and more specifically to such systems for transmitting information from medical devices such as medical instruments, medical implants, surgical tools and the like.

[0002] During the lifetime of a patient, it may be desirable to perform one or more surgical procedures on the patent as a result of, for example, disease or trauma. A number of medical implants and tools may be utilized during the performance of such a procedure.

[0003] The present invention relates to systems for wirelessly transmitting information from medical devices such as medical instruments, medical implants, surgical tools and the like. The present invention may comprise one or more of the features recited in the attached claims, and/or one or more of the following features and combinations thereof. A medical device communication system may comprise a medical device being one of a surgical tool and an implant configured for subcutaneous implantation in a living biological body, and a wireless communication circuit. The wireless communication circuit may be mounted to the medical device and configured to broadcast information relating to the medical device.

[0004] The wireless communication circuit may include a memory unit having stored therein the information relating to the medical device. The memory unit may have stored therein program code for controlling operation of the wireless communication circuit. The wireless communication circuit may include a transceiver electrically connected to the memory unit, the transceiver configured to broadcast the information relating to the medical device. The wireless communication circuit may include an antenna electrically connected to the transceiver, wherein the transceiver broadcasts the information relating to the medical device via the antenna. The system may further include a circuit substrate mounted to the medical device. The circuit substrate may have the transceiver, memory unit and antenna mounted thereto. Alternatively, the circuit substrate may have the transceiver and memory unit mounted thereto, and the antenna may be mounted to the medical device remote from the circuit substrate. The system may further include a secondary coil circuit configured to inductively couple to a primary coil circuit to produce a DC voltage. The DC voltage produced by the secondary coil circuit may provide a supply voltage to the memory unit and to the transceiver. The system may further include a rechargeable voltage source providing a supply voltage to the memory unit and to the transceiver. In this embodiment, the DC voltage produced by the secondary coil circuit may provide a recharging voltage to recharge the rechargeable voltage source.

[0005] Alternatively or additionally, the medical device communication system may further include a sensor producing a sensor signal indicative of a physical property of the medical device, wherein the information relating to the medical device corresponds to the sensor signal. The wireless communication circuit may include a transceiver electrically connected to the sensor, wherein the transceiver is configured to broadcast the information relating to the medical device. The system may further include a circuit substrate mounted to the circuit substrate and having the transceiver and the sensor mounted thereto. Alternatively, the sensor may be mounted to the medical device remote from the circuit substrate. The wireless communication circuit may include an antenna electrically connected to the transceiver and mounted to the circuit substrate. The transceiver may broadcast the information relating to the medical device via the antenna. The wireless communication circuit may include a memory unit electrically connected to the transceiver and mounted to the circuit substrate. The memory unit may have stored therein program code for controlling operation of the wireless communication circuit. The memory unit may include a plurality of memory locations for storing information produced by the sensor. The wireless communication circuit may include an antenna electrically connected to the transceiver and mounted to the medical device remote from the circuit substrate, wherein the transceiver broadcasts the information relating to the medical device via the antenna. The system may further including a secondary coil circuit configured to inductively couple to a primary coil circuit to produce a DC voltage. The DC voltage produced by the secondary coil circuit may provide a supply voltage to the transceiver. The system may further include a rechargeable voltage source providing a supply voltage to the transceiver, and the DC voltage produced by the secondary coil circuit may provide a recharging voltage to recharge the rechargeable voltage source.

[0006] The medical device may be implanted in a living biological body in the form of a medical implant. The system may further include a primary coil circuit positioned outside of the biological body. The primary coil circuit may include a primary coil configured to inductively couple to a secondary coil included within the secondary coil circuit. The primary coil circuit may include an excitation source producing an AC excitation signal at in a frequency range selected to ensure inductive coupling between the primary and secondary coils. The primary coil may be responsive to the excitation signal to inductively couple to the secondary coil. The system may further include a cuff carrying the primary coil. The cuff may be configured to extend at least partially about a limb of the biological body with the primary coil positioned adjacent to the secondary coil.

[0007] These and other features of the present invention will become more apparent from the following description of the illustrative embodiments.

[0012] For the purposes of promoting an understanding of the principles of the invention, reference will now be made to a number of illustrative embodiments illustrated in the drawings and specific language will be used to describe the same.

[0013] Referring now to FIG. 1, a schematic diagram of one illustrative embodiment of a wireless communication circuit 10 for transferring information from a medical device is shown. Central to the communication circuit 10 is a transceiver circuit 12 operable to broadcast information using conventional wireless communications technology. The transceiver circuit 12 may be, for example, an nRF241 E1, 2.4 GHz RF transceiver/transmitter that is commercially available through Nordic Semi-Conductor ASA of Tiller, Norway, although the present disclosure contemplates that the transceiver circuit 12 may alternatively be any known transceiver circuit capable of broadcasting information in the radio frequency range (e.g., 402-405 MHz or so-called MICS band) or other frequency range including, but not limited to, sub radio frequencies. The transceiver circuit 12 operates at a supply voltage, VDD, and at a clock frequency generated by a conventional crystal 20. The crystal 20 in the illustrated embodiment is a 16 MHz crystal, although crystals operating at other clock frequencies may be used.

[0014] The wireless communication circuit 10 further includes a voltage source block supplying the operating voltage VDD. In one embodiment, for example, the voltage source may be provided in the form of a conventional secondary coil circuit 14 configured to inductively couple to a conventional primary coil circuit. In this embodiment, the secondary coil circuit includes a conventional secondary inductive coil that is electrically connected to a conventional AC-to-DC conversion circuit. When an energized primary coil (not shown) inductively couples with the secondary coil, an AC voltage is induced in the secondary coil according to known physical principles. The induced AC voltage is converted to the supply voltage, VDD, by the AC-to-DC conversion circuit. This DC output voltage may be applied directly to the VDD supply line (e.g., VDDO and VSS2), or may alternatively be provided to a rechargeable voltage source 16 interposed between the secondary coil circuit 14 and the operating voltage supply line as shown in phantom in FIG. 1. In the former case, the wireless communication circuit 10 has no internal voltage source, and may be activated for operation only when the secondary coil circuit 14 is inductively coupled to an activated primary coil circuit, one example of which will be described hereinafter with respect to FIG. 3. In the later case, the rechargeable voltage source 16 is operable to produce the operating supply voltage, VDD, for some time period between recharging events. In this embodiment, however, a the secondary coil circuit 14 must be periodically coupled to an activated primary coil circuit so that the secondary coil circuit 14 produces the DC supply voltage, VDD, for a sufficient time to recharge the rechargeable voltage source 16.

[0015] In the embodiment illustrated in FIG. 1 wherein the transceiver circuit 12 is a nRF241 E1, 2.4 GHz RF transceiver/transmitter produced by Nordic Semi-Conductor, such an RF transceiver does not include sufficient memory for storage of program code and/or any generated data. Accordingly, a separate memory unit 18 is provided for the purpose of storing one or more executable algorithms and/or storing data. In the illustrative embodiment, the circuit 18 is a 4.0 Kbyte serial EEPROM that is commercially available through any number of semiconductor manufacturers. In other embodiments, the transceiver circuit 12 may include sufficient on-board memory, in which case the memory circuit 18 may be omitted.

[0016] In the illustrated embodiment, the wireless communication circuit 10 is configured for short-range wireless communication, and in this regard a single-ended antenna 22 is connected via a differential-to-single ended matching network, comprising L1, L2, C3-C4 and C11-C13 to differential antenna inputs, ANT1 and ANT2, of the transceiver circuit 12. In the illustrated embodiment, the antenna 22 is a 50 OHM antenna that may be implemented in any variety of known antenna configurations.

[0017] The wireless communication circuit 10 may include one or more sensors producing sensor signals indicative of one or more corresponding operating conditions of the medical device with which the wireless communication circuit 10 is associated. For example, the wireless communication circuit 10 may be mounted to a medical implant that is then subsequently implanted to biological tissue. In this case, one or more sensors may be suitably positioned relative to the medical implant to provide one or more corresponding sensor signals indicative of one or more corresponding operating characteristics of the implant. Examples of such operating characteristics may include, but are not limited to, temperature, load, strain, torque and the like. As another example, the wireless communication circuit 10 may be mounted to a surgical instrument. In this case, one or more sensors may be suitably positioned relative to the surgical instrument to provide one or more corresponding sensor signals indicative of one or more corresponding operating parameters of the surgical instrument. Examples of such operating parameters may include, but are not limited to, implement (e.g., saw, drill, etc.) speed, implement position, implement operating direction, instrument operating temperature, and the like. In the illustrated embodiment, the wireless communication circuit 10 includes a general operating condition sensor (OCS) 24, which may be or include any sensor of the foregoing type that is electrically connected to one of the analog inputs, e.g., AIN0, of the transceiver circuit 12. Sensory data produced by the sensor 24 may be routed by the transceiver circuit 12 to the memory circuit 18 for storage therein and subsequent wireless transmission via the antenna 22 to a suitable receiving circuit separate from the medical device. Alternatively, the transceiver circuit 12 may be operable to transmit the sensory data in real time via the antenna 22 in a conventional manner.

[0018] The remaining electrical components illustrated in FIG. 1 are provided to support operation of the transceiver circuit 12 and memory circuit 18. Typical values of the illustrated components for one specific implementation of the wireless communication circuit 10 are provided in the following Table 1. In this specific implementation of the wireless communication circuit 10, the rechargeable voltage source 16 is not included, and the operating condition sensor 24 is implemented as a single temperature sensor. It will be understood that such component values are provided only way of example, and that other component values may be used.

[0019]

TABLE 1
Component		Physical
Identification	Description	Size	Value	Tolerance	Units
C1	Ceramic Capacitor, 50 V,	0603/0402	22	±5%	pF
	NPO
C2	Ceramic Capacitor, 50 V,	0603/0402	22	±5%	pF
	NPO
C3	Ceramic Capacitor, 50 V,	0603/0402	22	±5%	pF
	NPO
C4	Ceramic Capacitor, 50 V,	0603/0402	2.2	±10%	nF
	X7R
C5	Ceramic Capacitor, 50 V,	0603/0402	1.0	±10%	nF
	X7R
C6	Ceramic Capacitor, 50 V,	0603/0402	10	±10%	nF
	X7R
C7	Ceramic Capacitor, 50 V,	0603/0402	10	±10%	nF
	X7R
C8	Ceramic Capacitor, 50 V,	0603/0402	1.0	±10%	nF
	X7R
C9	Ceramic Capacitor, 50 V,	0603/0402	1.0	±10%	nF
	X7R
C10	Ceramic Capacitor, 50 V,	0603/0402	33	±10%	nF
	X7R
C11	Ceramic Capacitor, 50 V,	0603/0402	1.0	±0.25	pF	pF
	NPO
C12	Ceramic Capacitor, 50 V,	0603/0402	1.0	±0.25	pF	pF
	NPO
C13	Ceramic Capacitor, 50 V,	0603/0402	1.5	±0.25	pF	pF
	NPO
C14	Ceramic Capacitor, 50 V,	0603/0402	10	±10%	nF
	X7R
L1	Inductor, wire wound	0603/0402	3.6	±5%	nH
L2	Inductor, wire wound	0603/0402	22	±5%	nH
R1	Resistor	0603/0402	1.0	±1%	Mohm
R2	Resistor	0603/0402	22	±1%	Kohm
R3	Resistor	0603/0402	10	±1%	Kohm
R4	Resistor	0603/0402	10	±1%	Kohm
12	nRF241E1 (Nordic	QFN36/
	VLSI)	6 × 6
18	4 Kbyte serial EEPROM	SO8	2XX320
	with SPI interface
20	Crystal, CL = 12 pF,	L × W × H =	16	+/−30	ppm	MHz
	ESR <100 ohm	4.0 × 2.5 × 0.8
24	LM62 2.7 V, 15.6 mV/° C.	SOT-23
	Temperature Sensor
	(National
	Semiconductor)

[0020] Referring now to FIG. 2, an exploded perspective view of one arrangement for mounting one illustrative physical implementation 30 of the wireless communication circuit 10 of FIG. 1 to a medical implant 40 is shown. In the illustrated embodiment, the wireless communication circuit 10 of FIG. 1 is physically implemented in the form 30 of a printed circuit board (PCB) 32 having a number of integrated circuits (ICs) and discrete electrical components mounted thereto. For example, the physical implementation 30 of the wireless communication circuit 10 illustrated in FIG. 2 shows the transceiver circuit 12, secondary coil circuit 14, memory circuit 18, crystal 20, antenna 22 and implant operating condition sensor 24, as well as the number of additional discrete components, mounted to the printed circuit board 32. The implementation illustrated in FIG. 2 does not include a rechargeable voltage source 16 as depicted in phantom in FIG. 1, although it should be understood that other implementations of the wireless communication circuit 10 may include such a rechargeable voltage source 16. It will be understood that the physical implementation 30 of the wireless communication circuit 10 shown in FIG. 2 represents only one example implementation, and that any one or more of the circuit components mounted to the printed circuit board 32 may alternatively be mounted to the medical implant remote from the printed circuit board 32. It should also be understood that the physical implementation 30 of the wireless communication circuit 10 illustrated in FIG. 2 is not intended to depict an actual working layout of the circuit components, but rather to illustrate that the wireless communication circuit 10 is physically realizable in the form of a number of integrated circuits and discrete electrical components mounted to a conventional printed circuit board 32. Alternatively, the wireless communication circuit 10 may be physically implemented in the form of one or more integrated circuits and/or discrete components mounted to one or both sides of a conventional flexible circuit substrate, a multi-layer circuit board or circuit substrate, or surface mounted to a conventional circuit substrate. Alternatively still, two or more components of the wireless communication circuit 10 may be physically implemented in the form of a single application specific integrated circuit (ASIC) that may or may not be mounted to a circuit board or substrate prior to being mounted to the medical implant 40.

[0021] In the illustrated embodiment, the medical implant 40 is shown in the form of a conventional tibial tray having a base 42 and a stem 44 extending away from one face 45 of the base 42. The face 45 of the tibial tray defines a pair of recesses 46A and 46B therein. In accordance with a conventional implant procedure, a proximal portion of a human tibia is removed to provide a planar surface relative to the knee, and the stem 44 of the tibial tray 40 then extends into the tibia with the face 45 of the tray member 42 contacting the now planar surface of the modified tibia. It will be understood that while the medical implant 40 is illustrated in the form of one component of a knee prosthesis, the medical implant 40 may alternatively be any medical implant, or component of a medical implant, configured for subcutaneous implantation in a living biological body.

[0022] The physical implementation 30 of the wireless communication circuit 10 of FIG. 1 may be mounted to any convenient surface of the medical implant 40. In the embodiment illustrated in FIG. 2, for example, the printed circuit board 32 is sized to be mounted within the recess 46B defined in the face 45 of the tray member 42. Alternatively, the print circuit board 32 could be mounted within the recess 46A of the tray member 42. In any case, the printed circuit board 32 is mounted to the tray member 42 via a suitable adhesive 50 dispensed in the recess 46B as illustrated in FIG. 2. In many cases, as is the case with the tibial tray 40, the implant is formed of a metal composite, and is therefore electrically conductive. Likewise, the underside surface of the printed circuit board 32 may define a number of electrically conductive circuit lines and/or electrical components. In such cases, it is accordingly desirable to either provide an electrically insulated member between the circuit board 32 and the implant 40, or to use an adhesive 50 that is electrically non-conductive and ensure that the underside of the printed circuit board 32 does not contact the electrically conductive surface of the implant 40. In other embodiments, the wireless communication circuit 10 may be implemented either as a single application specific integrated circuit or as a number of integrated circuits and discrete electrical components, surface-mounted in a conventional manner to an electrically insulating substrate, e.g., alumina or other ceramic substrate. In such cases, the underside of such a substrate typically will not include any electrically-conductive components, and may therefore be mounted to the medical implant 40 using any desired adhesive and/or conventional attachment structures.

[0023] With the physical implementation 30 of the wireless communication circuit 10 mounted to the medical implant 40 as just described, it may be desirable to provide one or more biocompatible passivation layers 52 to the top surface of the physical implementation 30. Such one or more passivation layers 52 should be provided in the form of a composition that is both bio-compatible and fluid/tissue impervious to thereby isolate the circuit components from bodily fluids and tissue.

[0024] It should be noted that in the embodiment illustrated in FIG. 2, the antenna 22 is arranged in a serpentine configuration and is mounted to the printed circuit board 32. Alternatively, the antenna 22 may be provided in the form of any conventional antenna configuration, and/or may be mounted to another surface of the medical implant 40, such as the side surface 48 of the tray member 42, to thereby optimize data broadcast from the wireless communication circuit 10.

[0025] Referring now to FIG. 3, a diagrammatic illustration of a circuit arrangement for supplying an operating voltage to, or for recharging a rechargeable voltage sources associated with, the physical implementation 30 of the wireless communication circuit 10 of FIG. 1 is shown. In the illustrated embodiment, the medical implant 40 is the tibial tray of FIG. 2 mounted to a prepared tibia 60 (and fibula 58) as described hereinabove with the face 45 of the tibial tray 40 in contact with the prepared surface of the tibia 60 and fibula 58. A femoral component 62 is similarly mounted to a prepared end of a femur 64 adjacent to the prepared end of the tibia 60, and a conventional bearing insert 66 is mounted to the proximal surface of the tibial tray 40 and thereby interposed between the tibia tray 40 and the femoral component 62. As illustrated in FIG. 3, the physical implementation 30 of the wireless communication circuit 10 is mounted to the tibial tray 40 as described hereinabove with respective to FIG. 2, and is thus carried by the tibial tray 40 within a patient's leg 56 as shown in FIG. 3. An excitation source 70 is electrically connected via signal paths 72A and 72B to a primary inductive coil 76 inserted into and carried by a cuff 74. The cuff 74 is configured to be slidably received over the patient's leg 56 so that the primary coil 76 is positioned over and adjacent to the physical implementation 30 of the wireless communication circuit 10, as shown in FIG. 3, and thereby over and adjacent to the secondary coil within the secondary coil circuit 14. The excitation source 70 includes conventional signal conditioning circuitry configured to process an AC voltage signal from a suitable source, e.g., conventional building wiring coupled to a service panel, to supply excitation signals to the primary coil in a suitable frequency range. The frequency range will generally be selected, as a function of the distance between the primary coil 76 and the secondary coil within the implanted secondary coil circuit 14, to be in a frequency range that ensures inductive coupling between the primary coil 76 and the secondary coil within the secondary coil circuit 14. As described hereinabove, the secondary coil circuit 14 produces a DC supply voltage, VDD, when inductively coupled to an activated or energized primary coil 76, and the supply voltage, VDD, is used either to supply the operating supply voltage, VDD, directly to the circuit 10 or to recharge a rechargeable VDD voltage source 16.

[0026] Referring now to FIG. 4, a schematic diagram of one illustrative embodiment of a medical instrument 80 that includes therein the physical implementation 30 of the wireless communication 10 of FIG. 1 is shown. In the illustrated embodiment, the physical implementation 30 of the wireless communication circuit 10 does not include either of the secondary coil circuit 14 or the rechargeable voltage source 16, and instead receives its operative supply voltage, VDD, from a conventional voltage source 82 carried by the medical instrument 80. Otherwise, the wireless communication circuit 10 may be as described as hereinabove with respect to FIG. 1, and may include any one or more sensors producing sensory information relating to the identify and/or operation of the medical instrument 80. While the medical instrument 80 is illustrated in FIG. 4 as being a conventional surgical drill, it will be understood that for the purpose of this document the medical instrument 80 may alternatively be any medical instrument, surgical tool or the like that includes one or more electrically acutatable implements such a s a saw, drill or the like, or that does not include any one or more electrically actuatable implements.

[0027] While the invention has been illustrated and described in detail in the foregoing drawings and description, the same is to be considered as illustrative and not restrictive in character, it being understood that only illustrative embodiments thereof have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected. For example, details relating to another medical device system are set forth in U.S. patent application Ser. No. 10/887,766, which is assigned to the assignee of the present invention, and the disclosure of which is incorporated herein by reference.