Intramedullary device including a sensing obturator

Abstract

Disclosed herein are medical device systems and methods thereof for automatic detection of entry into a medullary cavity. Embodiments include an intraosseous access system having a sensing obturator configured to detect a change in a modality at its distal tip, such as pressure, oxygen saturation, electrical impedance, etc. The signal can be transmitted to control logic that can responsively modify activation of the driver. The signal can be transmitted by way of wired or wireless communication. In embodiments, the signal can be transmitted through a conductive polymeric material that forms the obturator and allows the obturator to be sufficiently flexible to mitigate accidental needle stick injuries.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 034,338, filed June 3, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to intraosseous devices including sensing occluders. Summary of the Invention

[0004] The embodiments disclosed herein relate to intraosseous (IO) access devices, including a sensing obturator configured to automatically detect entry into the medullary canal and correct drill activation. Intraosseous access devices typically require training to ensure proper placement. The user must apply sufficient distal driving force to penetrate the bone, but not excessive driving force that could lead to "back walling" (where the needle penetrates the distal wall of the bone). Further complications may occur when accessing bones of varying sizes and densities, depending on the patient's age and health condition. Furthermore, IO access devices are typically used in emergency situations where delay can be fatal, and a well-trained user may not always be available.

[0005] This article discloses an occluder configured for use with an intraosseous access system, the intraosseous access system including the occluder and a sensor disposed distally near the occluder, the sensor being configured to detect modal changes to determine access to the medullary cavity.

[0006] In some embodiments, the sensor includes one of a pressure transducer, an oxygen saturation sensor, an impedance sensor, a temperature sensor, or a pH sensor. The sensor is communicatively coupled to control logic disposed in a actuator of the intraosseous access system, the control logic being configured to correct the operation of the actuator when the sensor detects a modal change. The occluder also includes a sensor interface disposed at the proximal end of the occluder bushing and configured to rotatably and communicatively couple the sensor to the control logic. The occluder includes one of an electrically conductive or optically conductive thermoplastic material configured to communicatively couple the sensor to the sensor interface. The occluder includes a wire extending axially therethrough and configured to communicatively couple the sensor to the sensor interface. The occluder is configured to be disposed within a needle, with the sensor disposed proximal to the distal end of the needle.

[0007] In some embodiments, the occluder further includes a second sensor configured to detect a second mode, the second mode being configured to determine entry into the medullary cavity. The second sensor includes one of a pressure transducer, an oxygen saturation sensor, an impedance sensor, a temperature sensor, or a pH sensor. The sensor includes a passive RFID chip, and control logic is configured to provide an interrogation signal configured to sense a response signal from the passive RFID chip to determine entry into the medullary cavity.

[0008] A method for detecting entry into an internal lumen is also disclosed, comprising: providing an elongated medical device including a sensor disposed at its distal end; causing the elongated medical device to pass through a first tissue; detecting a first modal level; entering the internal lumen; detecting a modal level change from the first modal level to determine entry into the internal lumen; and transmitting the modal level change to control logic.

[0009] In some embodiments, the elongated medical device includes an occluder configured to be disposed within an intraosseous entry needle, wherein the first tissue is cortical bone and the lumen is medullary canal. Sensors include one of a pressure transducer, an oxygen saturation sensor, an impedance sensor, a temperature sensor, or a pH sensor. Control logic is disposed within an intraosseous entry actuator releasably coupled to the elongated medical device. The control logic is configured to correct the operation of the intraosseous entry actuator when the sensors detect a change in modal level.

[0010] In some embodiments, the occluder further includes a sensor interface disposed proximally thereto and configured to engage an actuator and a sensor interface communicatively and rotatably coupled to the sensor and control logic. The occluder includes an electrically conductive thermoplastic material configured to communicatively coupled the sensor to the sensor interface. The medical device includes a wire extending axially therethrough and configured to communicatively coupled the sensor to the sensor interface. In some embodiments, the method further includes detecting a second modal level change to determine entry into the lumen and transmitting the second modal level change to the control logic. The sensor includes a passive RFID chip, and the control logic is configured to provide an interrogation signal configured to sense a response signal from the passive RFID chip to determine entry into the medullary canal. Attached Figure Description

[0011] A more specific description of the disclosure will be presented with reference to specific embodiments shown in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and are therefore not intended to limit the scope of the invention. Exemplary embodiments of the invention will be described and explained by way of additional features and details in the drawings, using the accompanying drawings:

[0012] Figure 1AAn exploded view of an embodiment of an intraosseous access medical device system according to the embodiments disclosed herein is shown, wherein the access component sub-components of the system are depicted in a slightly enlarged and front view, and the automatic actuator component is depicted in a perspective view.

[0013] Figure 1B A cross-sectional view of the entry component according to the embodiment disclosed herein is shown.

[0014] Figure 1C The embodiment disclosed herein is shown in a locked position and from Figure 1B A cross-sectional view of the occluder tip and safety shield after the entry component has been removed.

[0015] Figure 1D-1F The embodiments disclosed herein are shown. Figure 1B Enter the close-up detailed view of the component.

[0016] Figure 2A-2C Various embodiments of a sensing blocker according to the embodiments disclosed herein are shown.

[0017] Figures 3A-3B Various embodiments of a sensing blocker according to the embodiments disclosed herein are shown.

[0018] Figure 4 An embodiment of a sensing blocker according to the embodiments disclosed herein is shown. Detailed Implementation

[0019] Before disclosing certain specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that features of the specific embodiments disclosed herein can be readily separated from the specific embodiments and optionally combined with or substituted for features of any of the other embodiments disclosed herein.

[0020] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments and do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a set of features or a set of steps, and do not provide for a sequence or numerical limitation. For example, features or steps “first,” “second,” and “third” do not necessarily need to appear in order, and a particular embodiment including such features or steps is not necessarily limited to these three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used for convenience and do not imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” include plural references.

[0021] For example, when a needle is used on a patient, the terms "proximal," "proximal portion," or "proximal portion" of a needle as disclosed herein include the portion of the needle intended to be close to the clinician. Similarly, for example, when a needle is used on a patient, the "proximal length" of a needle includes the length of the needle intended to be close to the clinician. For example, when a needle is used on a patient, the "proximal end" of a needle includes the end of the needle intended to be close to the clinician. A proximal portion, proximal portion, or proximal length of a needle may include the proximal end of the needle; however, a proximal portion, proximal portion, or proximal length of a needle does not necessarily include the proximal end of the needle. That is, unless the context otherwise requires, a proximal portion, proximal portion, or proximal length of a needle is not the distal portion or distal length of the needle.

[0022] For example, when a needle is used on a patient, the terms "distal," "distal portion," or "distal part" of a needle as disclosed herein include the portion of the needle intended to be near or in the patient. Similarly, for example, when a needle is used on a patient, the "distal length" of a needle includes the length of the needle intended to be near or in the patient. For example, when a needle is used on a patient, the "distal end" of a needle includes the end of the needle intended to be near or in the patient. The distal portion, distal part, or distal length of a needle may include the distal end of the needle; however, the distal portion, distal part, or distal length of a needle does not need to include the distal end of the needle. That is, unless the context otherwise requires, the distal portion, distal part, or distal length of a needle is not the distal portion or distal length of the needle.

[0023] In the following description, certain terms are used to describe various aspects of the invention. For example, in some cases, the term "logic" means hardware, firmware, or software configured to perform one or more functions. As hardware, logic may include circuitry with data processing or storage capabilities. Examples of such circuitry may include, but are not limited to, hardware processors (e.g., microprocessors, digital signal processors, programmable gate arrays, microcontrollers, application-specific integrated circuits "ASICs", etc.) having one or more processor cores, semiconductor memories, or combinations thereof.

[0024] Alternatively, logic can be software, such as executable code in the form of an executable application, an application programming interface (API), subroutines, functions, procedures, applets, service applets, routines, source code, object code, shared libraries / dynamically loaded libraries, or one or more instructions. Software can be stored in any suitable type of non-transitory or transient storage medium (e.g., electrical, optical, acoustic, or other forms of propagation 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; semiconductor memories; non-persistent storage devices such as volatile memory (e.g., any type of random access memory "RAM"); or persistent storage devices such as non-volatile memory (e.g., read-only memory "ROM", powered RAM, flash memory, phase-change memory, etc.), solid-state drives, hard disk drives, optical disk drives, or portable storage devices. As firmware, executable code can be stored in persistent storage devices.

[0025] The term "computing device" should be interpreted as an electronic device capable of data processing and / or connecting 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, the following: servers, endpoint devices (e.g., laptops, smartphones, tablets, "wearable" devices such as smartwatches, augmented or virtual reality readers, desktop computers, netbooks, medical devices, or any general or special-purpose user-controlled electronic device), mainframes, internet servers, routers, etc.

[0026] A "message" typically refers to information transmitted as one or more electrical signals that collectively represent electrically stored data in a defined format. Each message can take the form of one or more packets, frames, HTTP-based transmissions, or any other sequence of bits with a defined format.

[0027] The term "computerization" generally refers to any corresponding operation performed by hardware in combination with software and / or firmware.

[0028] As shown in Figure 1, and to aid in describing the embodiments described herein, the longitudinal axis extends substantially parallel to the axial length of the needle 204 extending from the driver 101. The lateral axis extends perpendicular to the longitudinal axis, while the transverse axis extends perpendicular to both the longitudinal and lateral axes.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0030] The disclosure generally relates to an intraosseous (IO) access device system, which includes a sensing occluder configured to detect access to the medullary cavity. Figure 1A An exploded view of an exemplary intraosseous access system (“System”) 100 is shown, with some components shown in a front view and others in a perspective view. In embodiments, the intraosseous access system 100 can be used to penetrate the skin surface tissue layer 70 and the underlying hard bone (i.e., cortical bone 80), for example, for intraosseous access, such as via a path through the interior of the bone (i.e., medullary cavity 90) to access the patient's bone marrow and / or vascular system. As used herein, an “access event” includes access to the medullary cavity 90 using the intraosseous access system 100.

[0031] In one embodiment, system 100 includes an actuator 101 and an entry assembly 109. The actuator 101 can be used to rotate the entry assembly 109 and cause the needle 204 to “drill” into the patient’s bone. In one embodiment, the actuator 101 can be automatic or manual. As shown, the actuator 101 is an automatic actuator 101. For example, the automatic actuator 101 can be a drill that achieves high rotational speeds. In one embodiment, the intraosseous entry system 100 may also include an occluder assembly 102, a safety guard (“guard”) 105, and a needle assembly 202, which may be collectively referred to as the entry assembly 109. The needle assembly 202 may include an entry needle (“needle”) 204 supported by a needle bushing 203. In one embodiment, the occluder assembly 102 includes an elongated occluder body (“occluder”) 104. As used herein, the occluder 104 includes an elongated medical device configured to be disposed within the lumen of the needle and to prevent bone fragments, tissue, etc., from entering the needle lumen. Advantageously, after the needle has been inserted into the medullary cavity 90, the occluder prevents tissue from obstructing fluid flow through the needle lumen. As will be understood, in some embodiments, the occluder 104 may be replaced with different elongated medical devices. As used herein, the term "elongated medical device" is a broad term used in its usual sense, including devices such as needles, cannulas, cannula needles, occluders, core needles, etc. Thus, the occluder assembly 102 may be more generally referred to as an elongated medical device assembly. In a similar manner, the occluder 104 may be more generally referred to as an elongated medical device.

[0032] In one embodiment, the occluder assembly 102 includes a coupling bushing 103 attached to the occluder 104 in any suitable manner (e.g., one or more adhesives or overmolding). The coupling bushing 103 may be configured to interface with the actuator 101. The coupling bushing 103 may alternatively be referred to as the occluder bushing 103, or more generally as the elongated instrument bushing 103. In one embodiment, a guard 105 is configured to engage with the occluder 104 to prevent accidental needlestick injury when the occluder is removed after placement of the needle 204.

[0033] In one embodiment, needle assembly 202 includes needle 204. However, in some embodiments, needle 204 may be replaced by a different instrument (e.g., cannula, tube, or sheath) and / or may be referred to by different names, such as one or more of the examples above. Thus, needle assembly 202 may be more generally referred to as cannula assembly or tube assembly. In a similar manner, needle 204 may be more generally referred to as cannula. In one embodiment, needle assembly 202 includes needle bushing 203 attached to needle 204 in any suitable manner. Needle bushing 203 may be configured to engage with occluder bushing 103 and thereby engage with actuator 101. Needle bushing 203 may alternatively be referred to as cannula bushing 203. In one embodiment, cap 107 may be provided to cover at least the distal portion of needle 204 and occluder 104 before use of access assembly 109. For example, in one embodiment, the proximal end of cap 107 may be engaged with occluder bushing 103.

[0034] Figure 1B-1F Further details of entering component 109 are shown. Figure 1B A cross-sectional view of the entry assembly 109 is shown, in which the needle bushing 203 is held by the stopper bushing 103. The stopper 104 is disposed within the needle, and the guard 105 is in the unlocked position within the entry assembly 109. Figure 1C A cross-sectional view of the entry into component 109 is shown, with the stopper 104 removed from the needle and the guard in a second locking operation mode. Figure 1D An exploded view of component 109 is shown. Figure 1E A close-up cross-sectional view of the distal portion of needle 204 is shown. Figure 1F A close-up cross-sectional view of the distal portion of the occluder 104 is shown. In an embodiment, when the occluder 104 is withdrawn from the needle lumen 251, the guard 105 can engage the recess 150 to lock the guard 105 relative to the occluder tip 146 to prevent accidental needlestick injury.

[0035] As discussed herein, the occluder 104 can be formed of any suitable material to inhibit tissue and / or bone from entering the lumen of the needle 204 during an access event. Exemplary materials may include, but are not limited to, metals, alloys, stainless steel, copper, aluminum, titanium, plastics, polymers, thermoplastics, electrically conductive thermoplastics, combinations thereof, etc.

[0036] Continue to refer to Figure 1A The actuator 101 can take any suitable form. The actuator 101 may include a handle 110 that can be held by a user with one hand. In one embodiment, the actuator 101 also includes a coupling interface 112, which is formed as a socket 113 defining a cavity 114. The coupling interface 112 can be configured to engage with the occluder bushing 103. In one embodiment, the socket 113 includes sidewalls that substantially define a hexagonal cavity into which hexagonal protrusions of the occluder bushing 103 can be received. Other suitable coupling interfaces may also be considered.

[0037] The actuator 101 may include any suitable type of energy source 115, which is configured to power and supply rotational motion of the coupling interface 112. For example, in some embodiments, the energy source 115 may include one or more batteries that supply electrical energy to the actuator 101. In some embodiments, the energy source 115 may include one or more springs (e.g., disc springs, leaf springs, etc.) or other biasing members that may store potential mechanical energy that can be released when the actuator 101 is actuated.

[0038] The energy source 115 can be connected to the connection interface 112 in any suitable manner. For example, in some embodiments, the drive 101 includes an electrical, mechanical, or electromechanical connection 116 to the gear assembly 117. In some embodiments, the connection 116 may include an electric motor that generates mechanical motion from electrical energy supplied by the electrical energy source 115. In other embodiments, the connection 116 may include a mechanical link to the gear assembly 117. The drive 101 may include any suitable type of mechanical connection to connect the gear assembly 117 to the connection interface 112. In other embodiments, the gear assembly 117 may be omitted.

[0039] Further details and implementation schemes of the intraosseous access system 100 can be found in WO 2018 / 075694, WO 2018 / 165334, WO 2018 / 165339 and US 2018 / 0116693, each of which is incorporated herein by reference in its entirety.

[0040] In an implementation, as described herein, system 100 may include a sensing blocker 304 supported by a blocker bushing 303 and configured to be coupled to access component 109 and driver 101. Figure 2A-4 An exemplary embodiment of a sensing occluder 304 is illustrated. The sensing occluder 304 may include one or more sensors, such as sensor 310, disposed near the distal tip 146 of the occluder. In an embodiment, sensor 310 may be disposed on the beveled distal surface 147 of the sensing occluder 304 and may contact the patient's tissue during an access event.

[0041] In an implementation, sensor 310 may be configured to detect modal changes to determine whether the distal tip 346 of occluder 304 and the distal tip 246 of needle 204 have entered the medullary cavity 90. As described in more detail herein, exemplary modalities may include, but are not limited to, pressure, oxygen saturation, electrical impedance, temperature, pH, combinations thereof.

[0042] In one embodiment, the sensing blocker 304 may include a sensor interface 320 disposed at its proximal end. In another embodiment, such as... Figure 2A As shown, sensor 310 and sensor interface 320 can be communicatively connected by means of a wire 322 extending axially through sensing occluder 304. In one embodiment, wire 322 can be co-extruded with sensing occluder 304. In another embodiment, wire 322 can extend through the cavity defined by occluder 304.

[0043] In the implementation plan, such as Figure 2B As shown, the occluder 304 can be formed of a conductive material (e.g., an electrically conductive polymer, an optical fiber conductive thermoplastic, or a combination thereof). Thus, the input detected by sensor 310 can be transmitted to sensor interface 320 via the sensing occluder 304 body itself. In an embodiment, the sensing occluder 304 can be formed of an electrically conductive material that also exhibits flexible properties to mitigate needlestick injury. For example, when positioned within needle lumen 251, the occluder 304 can exhibit sufficient compressive strength to prevent tissue from entering needle lumen 251 during an entry event. Furthermore, when removed from needle lumen 251, the occluder 304 can exhibit sufficient flexibility to deform upon application of force and mitigate needlestick injury. Further details and embodiments can be found in U.S. Patent Application No. 17 / 183,820, filed February 24, 2021, which is incorporated herein by reference in its entirety.

[0044] In one embodiment, the sensor interface 320 may be configured to communicatively connect to control logic 380 disposed within the actuator 101. In another embodiment, the sensor interface 320 may be rotatably and communicatively connected to the actuator 101 to allow the entry component 109 and the sensing occluder 304 disposed therein to rotate relative to the actuator 101 while maintaining the communication connection therebetween. As used herein, the control logic 380 may include one or more processors, storage devices, communication logic, etc., configured to receive information from one or more sensors 310, determine whether the distal tip 246 of the needle 204 has entered the medullary cavity 90, and correct the activation of the actuator 101. In another embodiment, reusable components (e.g., control logic 380, associated components, etc.) may be disposed within a reusable drill rig 101. Thus, only the sensor 310 is disposed within the disposable sensing occluder 304 and configured to communicate with the reusable components disposed within the drill rig 101. Advantageously, this reduces the cost and complexity of the disposable components (i.e., the occluder 304).

[0045] In one implementation, sensor 310 may include a pressure transducer configured to detect changes in compressive force applied to the proximal end of sensing occluder 304 and provide a signal to sensing interface 320. Sensing interface 320 then provides the signal to control logic 380, which detects and interprets the pressure transducer signal. When the pressure transducer signal indicates a relatively high pressure level, control logic 380 may determine that needle tip 246 and occluder tip 346 are positioned within the relatively hard cortical bone 80. When the pressure transducer signal indicates a relatively low pressure level, control logic 380 may determine that needle tip 246 and occluder tip 346 have penetrated the cortical bone 80 and entered the relatively soft tissue positioned within medullary cavity 90. Thus, control logic 380 may automatically stop motor 116 to indicate to the user that they have entered medullary cavity 90 and / or to prevent contact with the posterior wall.

[0046] In one implementation, sensor 310 may include an oxygen saturation sensor configured to detect changes in oxygen saturation of tissue in contact with the distal tip of sensing occluder 304 and provide a signal to sensing interface 320. Sensing interface 320 then provides the signal to control logic 380, which detects and interprets the oxygen saturation signal. If the signal indicates a relatively low oxygen saturation level, control logic 380 may determine that needle tip 246 and occluder tip 346 are positioned within cortical bone 80. If the signal indicates a relative increase in oxygen saturation, control logic 380 may determine that needle tip 246 and occluder tip 346 have penetrated cortical bone 80 and entered relatively oxidized tissue positioned within medullary canal 90. Thus, control logic 380 may automatically stop motor 116 to indicate to the user that they have entered medullary canal 90 and / or to prevent contact with the posterior wall.

[0047] In one embodiment, sensor 310 may include an impedance sensor configured to detect changes in the impedance of tissue in contact with the distal tip of the sensing occluder 304 and to provide a corresponding change in signal to sensing interface 320. Sensing interface 320 then provides the signal to control logic 380 disposed within drill 101, which detects and interprets the impedance signal. If the signal indicates a first impedance, control logic 380 may determine that needle tip 246 and occluder tip 346 are disposed within bone cortex 80. If the signal indicates an impedance change to a second impedance level, control logic 380 may determine that needle tip 246 and occluder tip 346 have penetrated bone cortex 80 and entered tissue disposed within medullary cavity 90. Thus, control logic 380 may automatically stop motor 116 to indicate to the user that they have entered medullary cavity 90 and / or to prevent contact with the posterior wall. These and other modalities are also envisioned, including sensors configured to detect changes in temperature, pH, etc., which could be used to determine when needle tip 251 has entered medullary cavity 90.

[0048] like Figure 2C As shown, the sensing occluder may include two or more sensors 310, such as a first sensor 310A and a second sensor 310B, each configured to detect different modalities, such as pressure, oxygen saturation, electrical saturation, temperature, pH, and combinations thereof. Advantageously, control logic 380 may receive information from two or more sensors 310A, 310B to provide accuracy in determining when the needle tip 251 has penetrated the cortical bone 80 and entered the medullary cavity 90. The first sensor 310A and the second sensor 310B may be communicatively connected to the sensor interface 320 via wires 322A and 322B, respectively.

[0049] like Figure 3AAs shown, in an embodiment, sensor 310 and control logic 380 can be communicatively connected via wireless communication. Exemplary wireless communication modes may include WiFi, Bluetooth, near field communication (NFC), electromagnetic (EM), radio frequency (RF), and combinations thereof. In an embodiment, control logic 380 may include communication logic configured to provide an interrogation signal 382. Sensor 310 may include a passive RFID chip configured to activate in the presence or absence of a given mode or a mode change, as described herein. Examples include a decrease in pressure, an increase in oxygen saturation, a change in relative impedance, and combinations thereof. Thus, when sensor 310 is activated, interrogation signal 382 may prompt sensor 310 to provide a response signal 384, which may be detected and interpreted by control logic 380 to determine that the occluder tip 346 and needle tip 246 have entered the medullary cavity 90, as described herein.

[0050] In the implementation plan, such as Figure 3B As shown, sensor 310 can be communicatively connected to sensor interface 320 via wired connection 322 or via conductive blocker body 304, as described herein. Interface 320 may include a passive RFID chip, and when sensor 310 detects a modal change indicating entry into medullary cavity 90, a signal transmitted to sensor interface 320 can activate the RFID chip, causing the RFID chip to respond to interrogation signal 382. Interrogation 382 can then prompt the RFID to provide a response signal 384, which can be detected and interpreted by control logic 380, as described herein.

[0051] In the implementation plan, such as Figure 4As shown, the distal portion of the blocker 304 may include a marker 390 configured to be detected by a tracking system. In an embodiment, the marker 390 may be a passive magnet configured to be detected by a multi-mode tracking system that may use magnetic, electromagnetic, ultrasonic, or combinations thereof. Details of exemplary tracking systems configured to detect the marker 390 can be found in U.S. Patent Nos. 8,388,541, 8,781,555, 8,849,382, 9,445,743, 9,456,766, 9,492,097, 9,521,961, 9,554,716, and 9,636,031. The following patents can be found: U.S. Patent Nos. 9,649,048, 10,159,531, 10,172,538, 10,413,211, 10,449,330, U.S. Publication Nos. 2014 / 0031674, 2014 / 0188133, 2015 / 0080762, and 2018 / 0116551, each of which is incorporated herein by reference in its entirety. Advantageously, a tracking system can be used to detect and track the occluder 304 with marker 390 and the needle tip 246 to facilitate determination of entry into the medullary canal 90.

[0052] As will be understood, although this document describes an implementation based on a sensing occluder of the intraosseous access system 100, implementations of sensing occluders, elongated medical devices, etc., can also be used with various medical device systems (e.g., ultrasound systems, medical device tracking systems, catheter systems, or similar electronic devices) configured to access the patient's interior. Therefore, sensing occluders, etc., can be used to detect modal changes and correct the operation of the medical device system or to provide an alarm indicating that access to the target area has been achieved.

[0053] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in detail, they are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications will be apparent to those skilled in the art, and are included in a broader sense. Therefore, deviations from the specific embodiments provided herein are permissible without departing from the scope of the concepts disclosed herein.

Claims

1. An obturator assembly configured for use with an intraosseous access system, comprising: The obturator assembly comprises: an elongate obturator body; and an electrical impedance sensor disposed proximate a distal end of the obturator body and configured to detect a modal change to determine entry into a medullary cavity, the electrical impedance sensor communicatively coupled with control logic disposed in a driver of the intraosseous access system, the control logic configured to modify operation of the driver when the electrical impedance sensor detects the modal change, the electrical impedance sensor further comprising an RFID chip, and wherein the modal change detected by the electrical impedance sensor causes the RFID chip to transition from an inactive state to an active state, and wherein the control logic is configured to provide an interrogation signal configured to induce a response signal from the active RFID chip to determine entry into a medullary cavity.

2. The obturator assembly of claim 1, wherein, The obturator body further comprises a sensor interface disposed at a proximal end of a bushing of the obturator body, the sensor interface configured to rotatably and communicatively couple the electrical impedance sensor with the control logic.

3. The obturator assembly of claim 2, wherein, The obturator body comprises one of an electrically conductive thermoplastic material or an optically conductive thermoplastic material configured to communicatively couple the electrical impedance sensor with the sensor interface.

4. The obturator assembly of claim 2, wherein, The obturator body comprises a wire extending axially therethrough to communicatively couple the electrical impedance sensor with the sensor interface.

5. The obturator assembly of claim 1, wherein, The obturator body is configured to be disposed within a needle, and wherein the electrical impedance sensor is disposed proximate a distal end of the needle.

6. The obturator assembly of claim 1, wherein, The obturator body further comprises a second sensor configured to detect a second modal, the second modal configured to determine entry into the medullary cavity.

7. The obturator assembly of claim 6, wherein, The second sensor is selected from the group consisting of a pressure transducer, an oxygen saturation sensor, a temperature sensor, and a pH sensor.

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