阅读说明：本技术 骨内装置和数据传输 (Intraosseous device and data transmission ) 是由 E·W·林德库格尔 D·B·布兰查德 于 2021-06-01 设计创作，主要内容包括：本文公开了医疗装置系统及其方法。示例性医疗装置可以包括骨内(IO)进入装置系统或类似的包括动力的医疗装置。实施方案包括可更换的和可再充电的电池,其配置为存储医疗装置的一个或多个性能特性,并且当该电池从医疗装置被移除并且与基站联接以用于再充电时,给基站传输性能特性。然后,基站可以存储来自一个或多个电池和/或医疗装置的性能特性。性能特性可以被从基站传输至一个或多个外部计算装置或网络。(Medical device systems and methods thereof are disclosed herein. An exemplary medical device may include an Intraosseous (IO) access device system or similar medical device including a motive force. Embodiments include a replaceable and rechargeable battery configured to store one or more performance characteristics of a medical device and to transmit the performance characteristics to a base station when the battery is removed from the medical device and coupled with the base station for recharging. The base station may then store performance characteristics from one or more batteries and/or medical devices. The performance characteristics may be transmitted from the base station to one or more external computing devices or networks.)

1. A medical device system, comprising:

a base station; and

a medical device comprising a battery having one of a processor, persistent memory, or communication logic and configured to store one of a performance characteristic or a system update thereon, the battery configured to be removable from the medical device and coupled with the base station to transmit the performance characteristic from the battery to the base station or to transmit the system update from the base station to the battery.

2. The medical device system of claim 1, wherein the medical device system is an intraosseous access system and the medical device is a driver.

3. The medical device system of claim 2, wherein the driver is configured to place an access assembly configured to access a vasculature of a patient.

4. The medical device system of claim 3, wherein the access assembly includes one of a needle, a needle hub, an obturator hub, or a safety shield.

5. The medical device system of claim 4, wherein the obturator is disposed within a lumen of the needle and is configured to prevent tissue from entering the needle lumen.

6. The medical device system of claim 5, wherein the safety shield is configured to couple with a distal tip of the obturator when the obturator is removed from the needle lumen to prevent accidental needle stick injury.

7. The medical device system of claim 1, wherein the base station is configured to recharge a removable battery when coupled thereto.

8. The medical device system of claim 1, wherein the base station is communicatively coupled to one of an external computing device or a network.

9. The medical device system of claim 1, wherein the performance characteristics comprise: one of a brand, model, or serial number of one of the medical device, the battery, or an access component, a number of placement events performed by the medical device, a number of times the access component is attached or unattached, a date or time a placement event occurred, a length of time the medical device is used, a length of time a placement event is completed, a length of time since performance characteristics were last transmitted to the base station, a torque of the motor, a speed of the motor, a number of revolutions of the motor for each placement, a charge of the battery, a number of recharging events, a length of time since the battery was last recharged, a hardware error, a software error, or an operational error of the medical device.

10. The medical device system of claim 1, wherein the medical device further comprises one of a second processor, a second persistent memory, or a second communication logic configured to store performance characteristics of the driver thereon and configured to interface with one of the removable battery or the base station to transmit the performance characteristics from the medical device to the one of the battery or the base station or to transmit the system update from the one of the battery or the base station to the medical device.

11. The medical device system of claim 1, wherein coupling the battery with the base station further comprises one of a wired communication coupling or a wireless communication coupling, and wherein wireless communication coupling comprises one of bluetooth, WiFi, Near Field Communication (NFC), or cellular global system for mobile communications (GSM).

12. The medical device system of claim 1, wherein one of the base station or the medical device is configured to provide an alert to instruct a user to couple one of the battery or the medical device with the base station to transmit the performance characteristic or the system update therebetween.

13. The medical device system of claim 12, wherein the alert is one of a visual, audible, or tactile alert provided by one of the medical device, the battery, or the base station.

14. The medical device system of claim 1, wherein the battery comprises an electrical quantity indicator.

15. A method of using a medical device system, comprising:

providing a base station, a medical device, and a removable battery configured to power the medical device, the removable battery comprising one of a processor, memory, or communication logic and configured to measure and store thereon a performance characteristic of the medical device;

activating the medical device;

measuring a performance characteristic of the medical device;

storing the performance characteristic on the removable battery;

removing the removable battery from the medical device;

coupling the removable battery with the base station; and

transmitting the performance characteristic from the removable battery to the base station.

16. The method of claim 15, wherein the medical device system is an intraosseous access system and the medical device is a driver.

17. The method of claim 15, wherein activating the medical device comprises placing an access assembly to access a vasculature of a patient.

18. The method of claim 17, wherein the access assembly comprises one of a needle, a needle hub, an obturator hub, or a safety shield.

19. The method of claim 18, wherein the obturator is disposed within the lumen of the needle and is configured to prevent tissue from entering the needle lumen.

20. The method of claim 19, further comprising removing the obturator from the needle lumen after the needle has entered the vasculature of the patient, and wherein the safety shield is configured to couple with a distal tip of the obturator when the obturator is removed from the needle lumen to prevent accidental needle stick injury.

21. The method of claim 15, wherein coupling the removable battery with the base station further comprises recharging the removable battery.

22. The method of claim 15, further comprising transmitting the performance characteristic from the base station to one of an external computing device or a network.

23. The method of claim 15, wherein the performance characteristics comprise: one of a brand, model, or serial number of one of the medical device, the battery, or an access assembly, a number of placement events performed by the medical device, a number of attachments or detachments of the access assembly, a date or time that a placement event occurred, a length of time that the medical device was used, a length of time that a placement event was completed, a length of time since performance characteristics were last transmitted to a base station, a torque of a motor, a speed of a motor, a number of revolutions of a motor per placement, a charge of the battery, a number of recharging events, a length of time since the battery was last recharged, a hardware error, a software error, or an operational error of the medical device.

24. The method of claim 15, wherein the medical device further comprises one of a second processor, a second persistent memory, or a second communication logic configured to measure and store thereon performance characteristics of the drive.

25. The method of claim 24, wherein the medical device is communicatively coupled with the removable battery to transfer performance characteristics from the medical device to the battery.

26. The method of claim 15, wherein transmitting the performance characteristic further comprises one of a wired communication link or a wireless communication link, and wherein wireless communication link comprises one of bluetooth, WiFi, Near Field Communication (NFC), or cellular global system for mobile communications (GSM).

27. The method of claim 15, further comprising providing an alarm to instruct a user to transmit the performance characteristic from one of the removable battery or the medical device to the base station.

28. The method of claim 27, wherein the alert is one of a visual, audible, or tactile alert provided by one of the medical device, the removable battery, or the base station.

29. A method of updating a medical device system, comprising:

providing a base station, a medical device, and a removable battery configured to power the medical device, the removable battery comprising one of a processor, memory, or communication logic and configured to store system updates thereon;

transmitting the system update from an external computing device to the base station;

removing the removable battery from the medical device;

coupling the removable battery with the base station;

transmitting the system update from the base station to the removable battery;

removing the removable battery from the base station;

coupling the removable battery with the medical device; and

transmitting the system update from the removable battery to the medical device.

30. The method of claim 29, wherein the medical device system is an intraosseous access system and the medical device is a driver.

31. The method of claim 29, wherein coupling the removable battery with the base station further comprises recharging the removable battery.

32. The method of claim 29, wherein one of i), ii), and iii) comprises one of a wired communication link or a wireless communication link, and wherein the wireless communication link comprises one of bluetooth, WiFi, Near Field Communication (NFC), or cellular global system for mobile communications (GSM):

i) transmitting the system update from an external computing device to the base station,

ii) transmitting the system update from the base station to the removable battery, or

iii) transmitting the system update from the removable battery to the medical device.

33. The method of claim 29, further comprising providing an alert to instruct a user to transmit the system update to the medical device.

34. The method of claim 33, wherein the alert is one of a visual, audible, or tactile alert provided by one of the medical device, the removable battery, or the base station.

Technical Field

The present application relates to the field of medical devices, and more particularly to intraosseous devices and data transmission.

Disclosure of Invention

Embodiments disclosed herein relate to monitoring performance characteristics of medical device systems and methods thereof. An exemplary medical device system includes an Intraosseous (IO) access device including a replaceable and rechargeable battery. The battery may be configured to store one or more performance characteristics of the medical device and to transmit the performance characteristics to the base station when the battery is removed from the medical device and coupled to the base station for recharging. The base station may then store and analyze one or more performance characteristics from one or more batteries and/or medical devices. The performance characteristics may also be transmitted from the base station to one or more external computing devices or networks. Likewise, information may be transmitted to the medical device. Information such as system updates, software upgrades, patches, etc. may be communicated to the base station and transmitted to the medical device via wired or wireless communication. In embodiments, information may be transmitted from the base station to the battery, either wired or wirelessly, and then transmitted from the battery to the medical device when the recharged battery is disposed in the medical device.

Typically, the medical device needs to be communicatively coupled with a computer that includes specific software in order to provide system updates and download performance characteristics for further analysis. This can disrupt the use of the medical device and is often ignored due to the need for additional steps, resulting in loss of valuable data due to being overwritten. Advantageously, transferring performance characteristics while recharging the battery integrates system updates and performance characteristic downloads with current use of the medical device. This provides regular time intervals between information transmission events without having to interrupt the use of the medical device itself or lose performance data.

Disclosed herein is a medical device system comprising a base station and a medical device comprising a battery comprising one of a processor, persistent memory, or communication logic configured to store one of a performance characteristic or a system update thereon, and configured to be removable from the medical device and coupled with the base station to transmit the performance characteristic from the battery to the base station or to transmit the system update from the base station to the battery.

In some embodiments, the medical device system is an intraosseous access system and the medical device is a driver. The driver is configured to place an access assembly configured to access a vasculature of a patient. The access assembly includes one of a needle, a needle hub, an obturator hub, or a safety shield. An obturator is disposed within the lumen of the needle and is configured to prevent tissue from entering the needle lumen. The safety shield is configured to couple with the distal tip of the obturator when the obturator is removed from the needle lumen to prevent accidental needle stick injury. The base station is configured to recharge the removable battery when coupled thereto. The base station is communicatively coupled to one of an external computing device or a network.

In some embodiments, the performance characteristic includes a brand (make), model number, or serial number of one of the medical device, battery, or access component, a number of placement events performed by the medical device, a number of attachments or detachments of the access component, a date or time that the placement event occurred, a length of time that the medical device was used, a length of time that the placement event was completed, a length of time since the performance characteristic was last transmitted to the base station, a torque of the motor, a speed of the motor, a number of revolutions of the motor for each placement, a charge level of the battery, a number of recharging events, a length of time since the battery was last recharged, a hardware (e.g., medical device, battery, or base station) error, a software (e.g., one or more logic) error, or an operational error of the medical device. The medical device also includes one of a second processor, a second persistent memory, or a second communication logic configured to store the performance characteristics of the drive thereon and configured to interface with one of the removable battery or the base station to transmit the performance characteristics from the medical device to the one of the battery or the base station or to transmit system updates from the one of the battery or the base station to the medical device.

In some embodiments, coupling the battery to the base station further comprises one of a wired communication coupling or a wireless communication coupling, and wherein the wireless communication coupling comprises one of bluetooth, WiFi, Near Field Communication (NFC), or cellular global system for mobile communications (GSM). In some embodiments, one of the base station or the medical device is configured to provide an alert to instruct a user to couple the one of the battery or the medical device with the base station to transmit the performance characteristic or the system update therebetween. The alert is one of a visual, audible, or tactile alert provided by one of the medical device, the battery, or the base station. The battery includes an electric quantity indicator.

Also disclosed is a method of using a medical device system, comprising: providing a base station, a medical device, and a removable battery configured to power the medical device, the removable battery including one of a processor, memory, or communication logic and configured to measure and store thereon a performance characteristic of the medical device; activating the medical device; measuring a performance characteristic of the medical device; storing performance characteristics on a removable battery; removing the removable battery from the medical device; coupling a removable battery with a base station; and transmitting the performance characteristic from the removable battery to the base station.

In some embodiments, the medical device system is an intraosseous access system and the medical device is a driver. Activating the medical device includes placing an access assembly to access the vasculature of the patient. The access assembly includes one of a needle, a needle hub, an obturator hub, or a safety shield. An obturator is disposed within the lumen of the needle and is configured to prevent tissue from entering the needle lumen. In some embodiments, the method further comprises removing the obturator from the needle lumen after the needle has entered the vasculature of the patient, and wherein the safety shield is configured to couple with the distal tip of the obturator when the obturator is removed from the needle lumen to prevent accidental needle stick injury. In some embodiments, coupling the removable battery with the base station further comprises recharging the removable battery. In some embodiments, the method further comprises transmitting the performance characteristic from the base station to one of an external computing device or a network.

In some embodiments, the performance characteristic includes a brand, model, or serial number of one of the medical device, the battery, or the access component, a number of placement events performed by the medical device, a number of attachments or detachments of the access component, a date or time that the placement event occurred, a length of time that the medical device was used, a length of time that the placement event was completed, a length of time since the performance characteristic was last transmitted to the base station, a torque of the motor, a speed of the motor, a number of revolutions of the motor for each placement, a charge level of the battery, a number of recharging events, a length of time since the battery was last recharged, a hardware error, a software error, or an operational error of the medical device. The medical device also includes one of a second processor, a second persistent memory, or a second communication logic configured to measure and store thereon a performance characteristic of the drive.

In some embodiments, the medical device is communicatively coupled with a removable battery to transfer the performance characteristic from the medical device to the battery. The transmission performance characteristic further includes one of a wired communication link or a wireless communication link, and wherein the wireless communication link includes one of bluetooth, WiFi, Near Field Communication (NFC), or cellular global system for mobile communications (GSM). In some embodiments, the method further comprises providing an alert to instruct the user to transmit the performance characteristic from one of the removable battery or the medical device to the base station. The alert is one of a visual, audible, or tactile alert provided by one of the medical device, the removable battery, or the base station.

Also disclosed is a method of updating a medical device system, comprising: providing a base station, a medical device, and a removable battery configured to power the medical device, the removable battery comprising one of a processor, memory, or communication logic and configured to store system updates thereon; transmitting a system update from an external computing device to a base station; removing the removable battery from the medical device; coupling a removable battery with a base station; transmitting a system update from the base station to the removable battery; removing the removable battery from the base station; coupling a removable battery with a medical device; and transmitting the system update from the removable battery to the medical device.

In some embodiments, the medical device system is an intraosseous access system and the medical device is a driver. Coupling the removable battery with the base station further includes recharging the removable battery. i) One of transmitting the system update from the external computing device to the base station, ii) transmitting the system update from the base station to the removable battery, or iii) transmitting the system update from the removable battery to the medical device includes one of a wired communication link or a wireless communication link, and wherein the wireless communication link includes one of bluetooth, WiFi, Near Field Communication (NFC), or cellular global system for mobile communications (GSM). In some embodiments, the method further comprises providing an alert to instruct the user to transmit the performance characteristic to the medical device. The alert is one of a visual, audible, or tactile alert provided by one of the medical device, the removable battery, or the base station.

Drawings

A more particular description of the disclosure will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Exemplary embodiments of the invention will be described and illustrated with additional specificity and detail through the use of the accompanying drawings in which:

fig. 1 illustrates an exploded view of an embodiment of an intraosseous access medical device system in accordance with embodiments disclosed herein, with the access assembly sub-assembly of the system depicted in a somewhat enlarged front view and the automated driver component depicted in a perspective view.

Fig. 2A illustrates a side view of an intraosseous access medical device system according to embodiments disclosed herein.

Fig. 2B illustrates a cross-sectional view of an intraosseous access medical device system according to embodiments disclosed herein.

Fig. 3 illustrates a schematic view of an exemplary use environment for an intraosseous access medical device system, according to embodiments disclosed herein.

Detailed Description

Before disclosing in greater detail some specific embodiments, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It should also be understood that particular embodiments disclosed herein may have features that are readily separable from the particular embodiments, and optionally may be combined with or substituted for the features of any of the several other embodiments disclosed herein.

Term(s) for

With respect to the terminology used herein, it is also to be understood that these terminology is for the purpose of describing some particular embodiments, and that these terminology is not intended to limit the scope of the concepts provided herein. Ordinal words (e.g., first, second, third, etc.) are used generally to distinguish or identify different features or steps in a group of features or steps, and do not provide sequence or numerical limitations. For example, "first," "second," and "third" features or steps need not necessarily occur in a sequential order, and particular embodiments that include such features or steps need not necessarily be limited to these three features or steps. For convenience, the use of labels such as "left", "right", "top", "bottom", "front", "back", etc. is not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such tags may be used to reflect, for example, relative position, orientation, or direction. The singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise.

With respect to "proximal", for example, a "proximal portion" or "proximal portion" of a needle disclosed herein includes a portion of the needle that is intended to be proximate to a clinician when the needle is used on a patient. Likewise, for example, the "proximal length" of the needle includes the length of the needle that is expected to be near the clinician when the needle is used on a patient. For example, the "proximal end" of the needle includes the end of the needle that is intended to be near the clinician when the needle is used on a patient. The proximal portion, or proximal length of the needle may comprise the proximal end of the needle; however, the proximal portion, or proximal length of the needle need not include the proximal end of the needle. That is, unless the context indicates otherwise, the proximal portion, or proximal length of the needle is not the end portion or end length of the needle.

With respect to "distal end," for example, a "distal portion" or "distal portion" of a needle disclosed herein includes a portion of the needle that is intended to be near or in a patient when the needle is used on the patient. Likewise, for example, the "distal length" of a needle includes the length of the needle that is expected to be near or in a patient when the needle is used on the patient. For example, the "distal end" of a needle includes the end of the needle that is intended to be near or in a patient when the needle is used on the patient. The distal portion, or distal length of the needle may comprise the distal end of the needle; however, the distal portion, or distal length of the needle need not include the distal end of the needle. That is, unless the context indicates otherwise, the distal portion, or length of the needle is not the tip portion or length of the needle.

In the following description, certain terminology is used to describe various aspects of the invention. For example, in some cases, the term "logic" is representative of hardware, firmware, or software configured to perform one or more functions. As hardware, logic may include circuitry with data processing or storage functionality. Examples of such circuitry may include, but are not limited to, a hardware processor (e.g., a microprocessor with one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application specific integrated circuit "ASIC," etc.), a semiconductor memory, or a combination of elements.

Alternatively, logic may be software, such as executable code in the form of an executable application, an Application Programming Interface (API), a subroutine, a function, a procedure, an applet, a servlet, a routine, source code, object code, a shared library/dynamic load library or one or more instructions. The software may be stored in any type of suitable non-transitory or transitory storage medium (e.g., electrical, optical, acoustical or other form of propagated signals, such as carrier waves, infrared signals, or digital signals). Examples of non-transitory storage media may include, but are not limited to, programmable circuits; a semiconductor memory; volatile memory, such as volatile memory (e.g., any type of random access memory "RAM"); or a persistent store such as a non-volatile memory (e.g., a read-only memory "ROM," power-backed RAM, flash memory, phase-change memory, etc.), a solid-state hard disk, a hard disk drive, an optical drive, or a portable storage device. As firmware, executable code may be stored in persistent memory.

The term "computing device" should be interpreted as an electronic device having data processing capabilities and/or the ability to connect to any type of network, such as a public network (e.g., the internet), a private network (e.g., a wireless data telecommunications network, a local area network "LAN," etc.), or a combination of networks. Examples of computing devices may include, but are not limited to, a server, a terminal device (e.g., a laptop, a smartphone, a tablet, a "wearable" device such as a smart watch, an augmented or virtual reality reader, a desktop computer, a netbook, a medical device, or any general or special purpose, user-controlled electronic device), a host, an internet server, a router, and so forth.

A "message" generally refers to information sent as one or more electrical signals that collectively represent, in a prescribed format, electronically stored data. Each message may be in the form of one or more packets, frames, HTTP-based transmissions, or any other sequence of bits having a prescribed format.

The term "computerized" generally means that any corresponding operation is performed by a combination of hardware and software and/or firmware.

As shown in fig. 1, the longitudinal axis extends substantially parallel to the axial length of the needle 204 extending from the driver 101. The lateral axis extends orthogonal to the longitudinal axis and the transverse axis extends orthogonal to both the longitudinal axis and the lateral axis.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

The disclosure relates generally to monitoring performance characteristics of medical devices and methods thereof. Exemplary medical devices may include Intraosseous (IO) access device systems, ultrasound systems, medical device tracking systems, or similar electronic devices that may include rechargeable and/or replaceable batteries. Fig. 1 illustrates an exploded view of an exemplary intraosseous access system ("system") 100, with some components shown in elevation and others shown in perspective. It will be understood, however, that the medical device is exemplary and is not intended to be limiting in any way. In embodiments, the intraosseous access system 100 may be used to penetrate the skin and underlying hard bone ("cortical bone"), for example, for intraosseous access, such as to access the bone marrow and/or vasculature of a patient via a passageway through the interior of the bone ("medullary cavity").

In an embodiment, the system 100 includes a drive 101 and an access assembly 109. The driver 101 may be used to rotate the access assembly 109 and "drill" the needle 204 into the patient's bone. In embodiments, the driver 101 may be automatic or manual. As shown, the drive 101 is an automated drive 101. For example, the automatic driver 101 may be a drilling machine that achieves high rotational speeds. In embodiments, the intraosseous access system 100 may further include an obturator assembly 102, a safety shield ("shield") 105, and a needle assembly 202, which may be collectively referred to as an access assembly 109. The needle assembly 202 may include an access needle ("needle") 204 supported by a needle hub 203. In an embodiment, the obturator assembly 102 includes an obturator 104 configured to prevent bone debris, tissue, etc. from entering the needle lumen and to block fluid flow therethrough after the needle has been deployed. As will be appreciated, in some embodiments, the obturator 104 may be replaced with a different elongate medical instrument. As used herein, the term "elongate medical instrument" is a broad term used in its ordinary sense, including, for example, devices such as needles, cannulas, trocars, obturators, stylets, and the like. Accordingly, the obturator assembly 102 may be more generally referred to as an elongate medical instrument assembly. In a similar manner, the obturator 104 may be more generally referred to as an elongate medical device.

In embodiments, the obturator assembly 102 includes a coupling sleeve 103 attached to the obturator 104 in any suitable manner (e.g., one or more adhesives or overmolding, etc.). Coupling bushing 103 may be configured to interface with drive 101. Alternatively, the coupling sleeve 103 may be referred to as an obturator sleeve 103 or more generally as an elongated instrument sleeve 103. In an embodiment, the shield 105 is configured to couple with the obturator 104 to prevent accidental needle stick injury when the obturator is removed after deployment of the needle 204.

In an embodiment, the needle assembly 202 includes a needle 204. However, in some embodiments, the needle 204 may be replaced with a different instrument, such as a cannula, catheter, or sheath, and/or may be referred to using a different name, such as one or more of the foregoing examples. Thus, the needle assembly 202 may be more generally referred to as a cannula assembly or a catheter assembly. In a similar manner, the needle 204 may be more generally referred to as a cannula.

In an embodiment, the needle assembly 202 includes a needle hub 203 attached to a needle 204 in any suitable manner. The needle hub 203 may be configured to couple with the obturator hub 103, and may thereby couple with the driver 101, as discussed further below. Alternatively, the needle hub 203 may be referred to as a cannula hub 203. In embodiments, a cap 107 may be provided to cover the needle 204 and at least a distal portion of the obturator 104 prior to use of the access assembly 109. For example, in an embodiment, the proximal end of the cap 107 may be coupled to the obturator sleeve 103.

With continued reference to fig. 1, the drive 101 may take any suitable form. The driver 101 may include a handle 110 that may be held in one hand by a user. In an embodiment, the driver 101 further comprises a coupling interface 112 formed as a socket 113 defining a cavity 114. The coupling interface 112 may be configured to couple with the obturator sleeve 103. In an embodiment, the socket 113 includes sidewalls that substantially define a hexagonal cavity that can receive the hexagonal protrusion of the obturator bushing 103. Other suitable connection interfaces are also contemplated.

The driver 101 may include any suitable kind of energy source 115 configured to power and power the rotational movement of the coupling interface 112. For example, in some embodiments, the energy source 115 may include one or more batteries that provide power to the driver 101. In some embodiments, the energy source 115 may include one or more springs (e.g., coil springs, leaf springs, etc.) or other biasing members that may store potential mechanical energy that may be released upon actuation of the driver 101.

The energy source 115 may be coupled with the coupling interface 112 in any suitable manner. For example, in an embodiment, the drive 101 includes an electrical, mechanical, or electromechanical coupling 116 to a gear assembly 117. In some embodiments, coupling 116 may comprise an electric motor that generates mechanical motion from electrical energy provided by power source 115. In still other embodiments, the coupling 116 may include a mechanical link to a gear assembly 117. The drive 101 may include any suitable kind of mechanical linkage to couple the gear assembly 117 with the coupling interface 112. In other embodiments, the gear assembly 117 may be omitted.

Further details and embodiments of the intraosseous access system 100 can be found in WO2018/075694, WO2018/165334, WO2018/165339, US2021/0093358 and US10,893,887, each of which is incorporated by reference in its entirety into the present application.

Fig. 2A shows an embodiment of an intraosseous access device 100 including a driver 101, the driver 101 including a rechargeable replaceable battery power source ("battery") 115. In an embodiment, the battery pack 115 is removable and may be replaced with a similar battery pack. Advantageously, this allows a user of the system 100 to ensure that sufficient power is present when the system 100 is deployed in a placement event. Further, during the placement event, if the power of the first battery pack is depleted, the user may replace the first battery pack with a fully charged second battery pack and proceed to the process without having to wait for the first battery pack to recharge. As used herein, a placement event is considered an event in which the medical device system 100 performs its intended purpose (e.g., the intraosseous access system 100 places the needle 204 to access the intramedullary canal).

FIG. 2B illustrates a cross-sectional view of intraosseous device 100 of FIG. 2A with rechargeable battery pack 115 disposed therein. Fig. 3 shows a schematic view of the entry system 100 in an exemplary use environment. In an embodiment, the battery pack 115 may include a logic board 115A, and the logic board 115A may include one of the processor(s) 302, the memory 304 (i.e., non-transitory storage medium or transitory storage medium), or the communication logic 306 configured to record and store performance characteristics or related parameters of the system 100.

Exemplary performance characteristics may include, but are not limited to, information about the medical device system 100, such as the brand, model number, serial number of the medical device, e.g., driver 101, battery 115, access assembly 109, or components thereof; information relating to the use of the medical device, such as the number of placement events, the number of times an access assembly is attached or unattached, the date/time that placement occurred, the length of time that the medical device was used, the length of time that a placement event was completed, the length of time since performance characteristics were last transmitted to the base station, the length of time since system updates were last transmitted to the medical device; information about the operation of the medical device, such as torque (lbs/ft), rotational speed (rpm) and number of revolutions per placement event, operating time, battery charge (volts), number of recharging events, health or longevity of the battery or components of the medical device, length of time since the battery was last recharged, any errors or anomalies noted in hardware, software or device operation, combinations thereof, and the like. In embodiments, the performance characteristics may include any information related to the operation of the device, information related to the interaction with the device, or any other relevant information. For example, where the medical device is a tracking device, the information may relate to tracking events rather than placement events.

In an embodiment, the medical device itself, e.g., the driver 101, may include one of the processor 302, the memory 304, or the communication logic 306, which is configured to record and store information regarding the performance of the system 100, as described herein. In an embodiment, one or more of the processor 302, the memory 304, or the communication logic 306 may be disposed on the access device 101 or the battery 115, and may be communicatively coupled between the device 101 and the battery 115. In an embodiment, the battery 115 may include one of the first processor 302, the first memory 304, or the first communication logic 306, which may be communicatively coupled with one of the second processor 312, the second memory 314, or the second communication logic 316 disposed on the drive 101.

In an embodiment, one of the driver 101, the battery 115, or a combination thereof may include a battery charge indicator 170. Battery charge indicator 170 may include one or more LED lights, LCD displays, icons, dial indicators, gauges, audible, visual, or tactile indicators, etc., that may be turned on or off, change color, or a combination thereof to indicate the charge of battery pack 115. In an embodiment, system 100 includes a charge indicator button that a user may actuate to activate battery charge indicator 170 and determine the charge level of battery pack 115.

In an embodiment, the intraosseous access system 100 may further include a base station 500. The base station 500 may include one of a third processor 322, a third memory 324, or third communication logic 326. The base station 500 may also include a user interface 328 or recharging logic 330. The recharge logic 330 may be configured to recharge the battery 115 from an external primary power source 332. The user interface 180 may include one or more physical buttons, switches, dials, sliders, display screens, touch screens, lights, LED lights, speakers, combinations, and the like, configured to display information and receive input from a user.

In an embodiment, the battery 115 and associated first processor 302, first memory 304, or first communication logic 306, etc. may be removed from the medical device (e.g., driver 101) and may be coupled with the base station 500 to recharge the battery 115. In an embodiment, the driver 101, in which the battery 115 is disposed, may be coupled with the base station 500 and may recharge the battery 115.

In an embodiment, the battery 115 may be coupled in wired or wireless communication with the base station 500 and may communicate one or more performance characteristics to the base station 500. In an embodiment, the base station 500 may transmit one or more system updates to the battery 115, which may then be transmitted to the medical device, such as the driver 101, when the rechargeable battery 115 in the medical device is replaced. Exemplary wireless communications may include bluetooth, WiFi, Near Field Communication (NFC), cellular global system for mobile communications (GSM), combinations thereof, and the like.

In an embodiment, the base station 500 may be coupled with one or more external computing devices 340 or networks 350, either wired or wirelessly. Exemplary external devices the external computing device 340 or network 350 may include external monitors, laptops, computers, mobile devices, smartphones, tablets, "wearable" electronic devices, servers, centralized or decentralized networks, hospital intranet servers, electronic health record ("EHR") systems, "cloud" based networks, the internet, combinations thereof, and the like.

In an embodiment, one or more performance characteristics of the system 100 may be stored on the drive 101, the battery 115, or a combination thereof, and may be transmitted to the base station 500. The base station 500 may then store and analyze the one or more performance characteristics and/or transmit the one or more performance characteristics to one or more external computing devices 340 or the network 350. Likewise, system updates, etc., can be transmitted from one or more external computing devices 340 to the base station 500. The base station 500 may then transmit the system update directly to the medical device (e.g., driver 101) or battery 115. Then, when the battery 115 is coupled to the medical device, the battery 115 may transmit system updates or similar information to the medical device.

Advantageously, the performance characteristics may be communicated and stored to the base station 500 at regular time intervals or in response to a trigger. For example, the trigger may be a time-based trigger or an action-based trigger. The performance characteristics may be communicated and stored to the base station 500 after a predetermined period of time has elapsed or in response to a predetermined action. Exemplary action triggers may include when the battery 115 needs recharging, one of the base station 500, the driver 101, or the battery 115 being disconnected or connected after an entry event, in response to an input provided by a user to one of the base station 500, the driver 101, or the battery 115, in response to an input from one of the base station 500, the driver 101, or the battery 115 (e.g., a fault has been detected), or in response to an input from the external computing device 340, etc. The performance information may then be communicated with the external computing device(s) 340 for analysis and monitoring of the performance of the battery 115, the drive 101, or the system 100. For example, a hospital or similar facility may monitor the time of the last use of the access system 100, the time the system 100 needs to be replaced, which devices may be malfunctioning or needing attention, and the like. Likewise, a manufacturer may provide system updates or monitor the use or performance of one or more intraosseous access systems 100 or similar medical device systems in order to improve next generation devices or provide updates to existing systems.

In an embodiment, one of the driver 101, the battery 115, the base station 500, or a combination thereof may provide an alert to a user to indicate that the battery 115 needs to be removed from the driver 101 and coupled with the base station 500. The alert may include a visual, audible, or tactile indication to alert the user that the battery 115 needs to be recharged or that information regarding performance characteristics needs to be transmitted to the base station 500, for example because a predetermined period of time has elapsed, because the storage 304 is approaching capacity, etc.

In embodiments, the energy source 115 of the medical device (e.g., for placement into the assembly 109) may include a spring or similar biasing member. The spring-driven actuator 101 may include a processor 312, memory 314, communication logic 316, an additional power source (e.g., a battery), a combination thereof, and the like, and may be configured to measure and store performance information of the spring-driven actuator 101. The driver 101 may then communicate information with the base station 500 and transmit the information to one or more external computing devices, as described herein.

In an exemplary method of use, a medical device system (e.g., intraosseous access system 100) may be provided that includes a medical device (e.g., driver 101), a battery 115, and a base station 500. One of the medical device (e.g., driver 101) or battery 115 may include one of the processor 302, memory 304, or communication logic 306, or a combination thereof, configured to measure and store a performance characteristic of the medical device. In an embodiment, the performance characteristics may be stored on the battery 115. In an embodiment, the performance characteristics may be stored on the drive 101 and transmitted to the battery 115, which may then be transmitted to the base station 500. In an embodiment, the performance characteristics may be stored on the drive 101 and transmitted directly to the base station 500.

In an embodiment, the performance characteristics may be communicated to the battery 115. The battery 115 may then be removed from the driver 101 and coupled with the base station 500. Optionally, a second battery may be disposed within the drive 101 and may continue to power the drive 101 and record performance characteristics. In an embodiment, the battery 115 may be coupled with the recharge logic 330 and the battery 115 may be recharged. In an embodiment, the battery 115 may be coupled with the base station communication logic 326, either wired or wireless, to communicate performance characteristics from the battery 115 to the base station 500.

In an embodiment, the driver 101 in which the battery 115 is disposed may be coupled with the recharge logic 330 and may recharge the battery 115. In an embodiment, the driver 101 may be coupled with the base station communication logic 326, either wired or wireless, to transmit the performance characteristics from one of the driver 101 or the battery 115 to the base station 500. In an embodiment, the base station 500 may store information from one or more batteries 115 and may transmit the performance characteristics, wired or wireless, to one or more networks 350 or external computing devices 340.

In an embodiment, the system update may be transmitted from one or more external computing devices 340 to the base station 500 directly or through the network 350. The base station 500 may be configured to transmit system updates to one of the battery 115 or the driver 101 when it is coupled thereto. In an embodiment, when the battery 115 has been recharged, the battery 115 may then be removed from the base station 500 and coupled with the driver 101 to transmit system updates to the medical device and continue to measure performance characteristics. In an embodiment, a medical device (e.g., driver 101) having a battery 115 disposed therein may be coupled with the base station 500. The base station 500 may be configured to transmit system updates directly to the drive 101.

As will be appreciated, although embodiments are described herein in terms of performance characteristics of the intraosseous access system 100, embodiments may also be used with various electronic medical devices, such as ultrasound systems, medical device tracking systems, or similar electronic devices. Thus, the performance characteristics of the medical device may be stored to the removable rechargeable battery 115 and transmitted to the base station 500 while the battery 115 is being charged. The performance information of the one or more medical devices 101 may then be transmitted to the one or more external computing devices 340, as described herein. Likewise, in a similar manner, system updates may be transmitted from the external computing device to the medical device.

Although specific embodiments have been disclosed herein, and although details of these specific embodiments have been disclosed, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and/or modifications may occur to those skilled in the art and are intended to be covered in a broader sense. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.