Indwelling vascular probe for blood parameter detection

Abstract

A vascular probe insertion assembly may include a slotted cannula having a sharp tip configured for insertion into a patient's vascular anatomical structure, and a side wall extending proximal to the sharp tip, the side wall defining the slot. A vascular probe insertion assembly may also include a digital probe comprising a divisible sheath molded to surround at least a portion of the side wall, a sensor tip configured to generate sensor data indicating the movement of the vascular anatomical structure, and a shaft extending proximal to the sensor tip. A vascular probe insertion assembly may also include a data hub operably coupled to the digital probe. The data hub may be configured to receive sensor data and transmit the sensor data to a monitoring system.

Description

Technical Field

[0001] The present invention relates to a technology of an indwelling vascular probe for detecting blood parameters.

Background Art

[0002] Arterial catheters and systems provide medical personnel with a way to monitor a patient's arterial hemodynamic parameters and provide access for collecting arterial blood for arterial blood gas (ABG) testing and analysis. However, current arterial catheter devices, systems, and methods can have other performance issues such as significant blood exposure risks and accurate placement of arterial catheters. Further, current hemodynamic monitoring and ABG collection systems can be very complex and expensive and may require a significant amount of time and resources to collect the necessary samples. Additionally, a significant amount of time and resources may be required to maintain an arterial line, thereby minimizing the risk of complications such as infections and catheter-related bloodstream infections (BRBSI). Further, among other processes associated with currently implemented arterial catheters, a significant amount of time and resources may be required to ensure proper line and device flushing and to preserve arterial blood.

[0003] [[ID=十六]]The subject matter claimed in this disclosure is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described in this disclosure. Rather, this background art is provided to explain an environment in which the embodiments described herein may operate.

Summary of the Invention

[0004] It should be noted that there is an error in the original text. The Chinese text for is "本開示で請求される主題は、何らかの欠点を解決する実施形態や、本開示に記載されたような環境でのみ動作する実施形態に限定されない。むしろ、この背景技術は、ここで説明される実施形態が動作し得る環境を説明するために提供されるものである。" The translated text for above is corrected according to the correct Chinese text.This disclosure relates, in general terms, to a vascular probe insertion assembly used to insert a digital probe into a patient's vascular anatomy. In embodiments described in this disclosure, the vascular probe may include a slotted cannula for inserting the vascular probe into the patient's vascular anatomy. The slotted cannula may have slots formed along its longitudinal direction so that a digital probe can be coaxially positioned therein. In some embodiments, a detachable sheath may be formed coaxially outside the slotted cannula to hold the digital probe within the slotted cannula. After the cannula has been inserted into the patient's vascular anatomy, a data hub operably coupled to the digital probe may be fixed to the patient's body, thereby maintaining the digital probe within the patient's vascular anatomy.

[0005] In some embodiments, the needle hub may be operably coupled to the slotted cannula. The needle hub may include a fluid reservoir for determining when the cannula is inserted into the patient's vascular anatomical structure.

[0006] In some embodiments, the vascular probe includes a needle safety shield containing vias through which a cannula can pass. The needle safety shield may be operably coupled to a data hub. In some embodiments, when the cannula is withdrawn proximal, the cannula may slide against the needle safety shield, and when the cannula is removed from the patient's vascular anatomical structure, the needle safety shield may cover the bevel. In some embodiments, the needle safety shield includes a needle safety shield cutting blade formed in a via formed through the needle safety shield to cut a divisible sheath when the vascular probe is withdrawn from the patient's vascular anatomical structure.

[0007] In some embodiments, the data hub includes a wireless transmitter formed within the data hub for wirelessly transmitting data received by a digital probe within the patient's vascular anatomical structure to a vascular monitoring system. In some embodiments, the vascular probe includes a contact pin formed at the proximal end of the data hub for interface with a wired connection used to operably connect the data hub to the vascular monitoring system.

[0008] In some embodiments, the vascular probe may include a device used to securely insert the cannula into the patient's anatomical structure and to hold the data hub in place on the patient's body (e.g., the arm). In some embodiments, the vascular probe may include a syringe operably coupled to the proximal end of the slotted cannula to provide stable insertion of the slotted cannula into the patient's vascular anatomical structure. In some embodiments, the vascular probe may include a stabilization platform operably coupled to the data hub to secure the data hub to the outer surface of the patient's anatomical structure while the digital probe remains in place within the patient's vascular anatomical structure.

[0009] This specification also describes methods for manufacturing vascular probes. In some embodiments, the method may include inserting a digital probe into a slotted cannula. In some embodiments, the digital probe may be used to detect parameters of a patient's vascular anatomy. In some embodiments, the method may include forming a needle safety shield around a slotted cannula by passing the slotted cannula through a via formed by penetrating the needle safety shield. In some embodiments, the method may include forming a divisible sheath around a slotted cannula and operably coupling a data hub to the digital probe in order to secure the digital probe within the slotted cannula during insertion into a patient's vascular anatomy.

[0010] It should be understood that both the above summary and the following detailed description are for illustrative and explanatory purposes only and do not limit the invention described to the claims. It should be understood that various embodiments are not limited to the arrangements and means shown in the figures. Furthermore, it should be understood that embodiments may be combined, or other embodiments may be used, and structural modifications may be made without departing from the scope of the various embodiments of the invention, unless otherwise claimed. Therefore, the following detailed description should not be interpreted restrictively. [Brief explanation of the drawing]

[0011] Exemplary embodiments are described and illustrated in more specific and detail with reference to the accompanying drawings.

[0012] [Figure 1] Figure 1 is a side perspective view of a vascular probe insertion assembly according to several embodiments of the present disclosure. [Figure 2] Figure 2 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure. [Figure 3] Figure 3 is a side perspective view of a needle safety shield of a vascular probe insertion assembly according to some embodiments of the present disclosure. [Figure 4] Figure 4 is a perspective view of a digital probe in a vascular probe insertion assembly for accessing vascular anatomical structures, according to some embodiments of the present disclosure. [Figure 5] Figure 5 is a perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure. [Figure 6] Figure 6 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure. [Figure 7] Figure 7 shows side views of a data hub and a digital probe according to several embodiments of the present disclosure. [Figure 8]Figure 8 shows top views of a data hub and a digital probe according to some embodiments of the present disclosure. [Figure 9] Figure 9 shows a top view of a data hub and a digital probe according to some embodiments of the present disclosure. [Figure 10] Figure 10 is a top view of a digital probe and data hub according to some embodiments of the present disclosure. [Figure 11] Figure 11 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure. [Figure 12] Figure 12 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure. [Figure 13] Figure 13 is a side perspective view of a digital probe inserted into a vascular anatomical structure according to some embodiments of the present disclosure. [Figure 14] Figure 14 is a top view of a digital probe and data hub according to some embodiments of the present disclosure. [Figure 15] Figure 15 is a top view of a digital probe, data hub, and wired connection according to some embodiments of the present disclosure. [Figure 16] Figure 16 is a top view of a digital probe, data hub, and wired connection according to some embodiments of the present disclosure. [Figure 17] Figure 17 is a perspective view of a vascular probe insertion assembly with a wired connection according to some embodiments of the present disclosure. [Figure 18] Figure 18 is a side view of a digital probe with a wired connection according to some embodiments of the present disclosure. [Figure 19] Figure 19 is a top view of a digital probe and data hub according to some embodiments of the present disclosure. [Figure 20] Figure 20 is a top view of a digital probe and data hub according to some embodiments of the present disclosure. [Figure 21] Figure 21 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure. [Figure 22] Figure 22 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure. [Figure 23] Figure 23 is a side perspective view of a vascular probe inserted into a vascular anatomical structure according to some embodiments of the present disclosure. [Figure 24] Figure 24 is a graphic of a vascular probe insertion assembly interfacing with a data processing and cloud-based system according to some embodiments of the present disclosure. [Figure 25] Figure 25 is a side cross-sectional perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure. [Figure 26] Figure 26 is a block diagram of a method of manufacturing a vascular probe insertion assembly according to some embodiments of the present disclosure. [Figure 27] Figure 27 is a block diagram of a method of inserting a digital probe of a vascular probe insertion assembly into a patient's anatomical structure according to some embodiments of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

[0013] Figure 1 is a side perspective view of a vascular probe insertion assembly 100 according to some embodiments of the present disclosure. The vascular probe insertion assembly 100 can be used by a physician, nurse, or other healthcare provider to monitor, detect, and / or measure various blood flow-based parameters within a patient's vascular anatomical structure. As used herein and in the appended claims, the term "vascular anatomy" is understood to be any blood vessel or artery in which the patient's blood is present. Blood flow-based parameters that are monitored, detected, and / or measured can include, for example, venous or arterial blood pressure, temperature, the hydrogen ion index (pH) of the patient's blood, the presence of organic compounds such as lactate, the presence and amount of oxygen (O2) in the blood, oxygen saturation (SpO2), and other detectable intravascular parameters.

[0014] The vascular probe insertion assembly 100 may include several devices used by a healthcare professional to introduce a digital probe 106 into a patient's vein or artery. The vascular probe insertion assembly 100 may include a slotted cannula 102. The slotted cannula 102 may include a slot formed along the longitudinal direction of the slotted cannula 102 into which the digital probe 106 can be positioned. The slot formed in the slotted cannula 102 may form a side wall extending along the longitudinal direction of the slotted cannula 102. In some embodiments, the side wall, apart from the slot, may maintain the digital probe 106 coaxially or substantially coaxially within the slotted cannula 102. Thus, in some embodiments, the digital probe 106 may travel coaxially within the slotted cannula 102 until the slotted cannula 102 is removed from the patient's anatomical structure, as described in this disclosure. In some embodiments, the digital probe 106 may not be coaxial with the slotted cannula 102. In some embodiments, the orientation of the slots formed in the slotted cannula 102 is aligned with a trench or digital probe channel formed through the data hub 108, so that the digital probe 106 can leave the digital probe channel formed in the data hub 108 when the digital probe 106 is inserted into the patient's vascular anatomical structure. In some embodiments, the slotted cannula 102 may include a sharp tip and / or may be made of a rigid material to facilitate the entry of the slotted cannula 102 and the divisible sheath 104 into the patient's vascular system. In some embodiments, the divisible sheath 104 creates a closed fluid channel around the slotted cannula 102, allowing fluids such as blood to flow through the divisible sheath 104 and providing the user with visual and tactile feedback that the vascular probe insertion assembly 100 has entered the patient's vascular system.

[0015] In some embodiments, the digital probe 106 includes a core wire for structural integrity and durability as it advances through the patient's vascular anatomical structure. The core wire may be a nitinol core wire running along the longitudinal direction of the digital probe 106, either along the central axis or offset from the central axis. In some embodiments, the digital probe 106 includes optical fibers and / or wires connected to one or more sensors positioned along the longitudinal direction of the digital probe 106. In some embodiments, the distal end of the digital probe 106 includes a non-traumatic tip to reduce the risk of the digital probe 106 causing damage or complications to the patient's veins or arteries.

[0016] The digital probe 106 may be coated with various coatings used to improve the performance of the digital probe 106 and reduce the risk of complications such as thrombosis or probe-related bloodstream infections (e.g., sepsis). These coatings may contain or may not contain antimicrobial additives such as alkanes or saturated hydrocarbons (e.g., CH(x)). The digital probe 106 may also be coated with antithrombotic or antimicrobial coatings and / or polymer additives.

[0017] In some embodiments, the sensors present on the digital probe 106 may include any number or type of sensors that detect or measure parameters of the patient's vascular anatomy. The sensors may be arranged along the digital probe 106 as individual sensors or as a bundle of sensors. Other types of sensors may include sensors that incorporate technology capable of detecting or measuring the presence of the patient's blood pressure (venous or arterial), blood gases, blood pH levels, and electrolytes. In some embodiments, the sensors present on the digital probe 106 may be selected to detect or measure other physiological or procedural parameters of interest.

[0018] The vascular probe insertion assembly 100 may include a divisible sheath 104 formed around a slotted cannula 102. The divisible sheath 104 may extend along the entire length of the slotted cannula 102, except for the oblique portion of the cannula 102. This allows the sharp end of the slotted cannula 102 to puncture the patient's skin when a healthcare professional accesses the patient's vein or artery. The divisible sheath 104 may also prevent the digital probe 106 from coming out of the slot formed along the slotted cannula 102 during insertion of the vascular probe insertion assembly 100 into the patient's vascular anatomical structure.

[0019] The vascular probe insertion assembly 100 may include a needle hub 110 operably coupled to the oblique portion of a slotted cannula 102, which forms a sharp tip configured for insertion into the patient's vascular anatomical structure, and to the proximal end of the slotted cannula 102 opposite to the needle hub 110. The needle hub 110 may include a hollow chamber or fluid reservoir 112 fluidly coupled to the inside of the slotted cannula 102. The fluid reservoir 112 may accept a certain amount of blood when a healthcare professional inserts the slotted cannula 102 into the patient's vascular anatomical structure. In this way, the healthcare professional may determine whether and when the slotted cannula 102 has punctured a vein or artery in the patient by observing whether blood flow has entered the fluid reservoir 112. The volume of the fluid reservoir 112 may be sufficient to allow the healthcare professional to observe this process, while not drawing a large amount of blood from the patient. Since the fluid reservoir 112 is used simply to detect when the slotted cannula 102 has reached a vein or artery, the fluid reservoir 112 described herein, together with the slotted cannula 102 and needle safety shield 114, may be discarded when the digital probe 106 has been introduced into the patient's vascular anatomical structure and the slotted cannula 102 has been withdrawn from the vein or artery.

[0020] The vascular probe insertion assembly 100 may include a needle safety shield 114. The needle safety shield 114 is formed around a portion of the slotted cannula 102 and can move along the shaft of the slotted cannula 102 during the procedure. In some embodiments, the needle safety shield 114 has vias formed through it so that the slotted cannula 102 can pass through there. Furthermore, in some embodiments, the needle safety shield 114 includes a needle safety shield cutting blade (not shown in Figure 1) used to cut the divisible sheath 104 during withdrawal of the slotted cannula 102 from the patient's vascular anatomical structure.

[0021] The vascular probe insertion assembly 100 may include a data hub 108 operably coupled to a digital probe 106. The data hub 108 may include any type of circuitry used to receive and transmit data detected by the digital probe 106 when the digital probe 106 is successfully inserted into a patient's vein or artery. In some embodiments, this circuitry may include, for example, a wireless radio or other transmitting device that enables wireless transmission of data detected by the digital probe 106 to a vascular monitoring system described in this disclosure. Furthermore, the data hub 108 may include, among other circuits, a power supply, a power management unit (PMU), and a microcontroller or other hardware processing devices. In some embodiments, the data hub 108 may include one or more visual indicators 116 used to inform a healthcare professional that the data hub 108 is detecting parameters of the patient's vascular anatomy because the digital probe 106 is properly inserted into the patient's vascular anatomy. These visual indicators 116 may include various different colored light-emitting diodes (LEDs) that can indicate the proper placement of the digital probe 106 (e.g., a lit green LED), improper placement of the digital probe 106 (e.g., a lit red LED), or suboptimal placement of the digital probe 106 (e.g., a lit yellow LED). In some embodiments, data detected (or not detected) by the digital probe 106 may be used by a microcontroller in a data hub 108 to determine whether the digital probe 106 has been properly, improperly, or suboptimally inserted into the patient's anatomical structure.

[0022] During the operation of the vascular probe insertion assembly 100, the healthcare professional can address the patient's anatomical structure and determine a position where the digital probe 106 can be placed within the patient's vein or artery. Once a suitable injection site is determined, the healthcare professional can insert the vascular probe insertion assembly 100, specifically the slotted cannula 102 with the digital probe 106 and detachable sheath 104, into the vein or artery within the patient's anatomical structure. At this point, the slotted cannula 102 is fluidically coupled to the fluid reservoir 112 of the needle hub 110, so the healthcare professional can visually detect that the slotted cannula 102 has reached the vein or artery by the presence of blood in the fluid reservoir 112. For example, if the needle hub 110 is made of transparent plastic, the healthcare professional can visually detect the filling of the fluid reservoir 112.

[0023] When a healthcare professional detects the presence of blood in the fluid reservoir 112 of the needle hub 110, indicating that the slotted cannula 102 has reached a vein or artery, the healthcare professional may begin to remove the vascular probe insertion assembly 100 from the patient. In some embodiments, the healthcare professional may do this by grasping the needle hub 110 with one hand and the data hub 108 / needle safety shield 114 with the other hand. While holding the data hub 108 / needle safety shield 114 in place, the healthcare professional may begin to pull the needle hub 110 away from the patient and the rest of the vascular probe insertion assembly 100. By doing so, the needle safety shield cutting blade (not shown in Figure 1) of the needle safety shield 114 may begin to cut the divisible sheath 104 as the slotted cannula 102 is pulled through the via formed by penetrating the needle safety shield 114. This continues until the angled portion of the slotted cannula 102 is safely housed within a via formed through the needle safety shield 114. This process may also involve removing the data hub 108 from the needle safety shield 114. In some embodiments, the data hub 108 and the needle safety shield 114 may be coupled together operably via a rail system so that they can be detached from each other by a medical professional pulling the slotted cannula 102 and the detachable sheath 104 through a via formed through the needle safety shield 114.

[0024] When the slanted end of the slotted cannula 102 penetrates the needle safety shield 114 and enters a via, it may be possible to prevent the slotted cannula 102 from being completely removed from the via, in order to prevent the sharp tip of the slotted cannula 102 from touching a healthcare worker and potentially causing harm to the healthcare worker. Furthermore, the divisible sheath 104, which is longitudinally cut along the length of the slotted cannula 102, can be separated from the slotted cannula 102 and discarded together with the needle hub 110, the slotted cannula 102, and the needle safety shield 114.

[0025] Furthermore, once the slotted cannula 102 is withdrawn from the patient's vascular anatomical structure, the digital probe 106 may remain within the patient's vascular anatomical structure. In some embodiments, the auxiliary length 120 of the digital probe may be advanced further into the patient's vascular anatomical structure by a healthcare professional when the slotted cannula 102 is inserted into the vascular anatomical structure. This allows the digital probe 106 to be advanced further into the patient's vascular anatomical structure before the slotted cannula 102 is removed, for example, to keep the digital probe 106 within the vascular anatomical structure and prevent the slotted cannula 102 from withdrawing the digital probe 106 from the vascular anatomical structure. Furthermore, while the slotted cannula 102 is withdrawn from the patient's vascular anatomical structure, the divisible sheath 104 is cut, and the slot formed in the slotted cannula 102 serves as an exit for the digital probe to be removed from the slotted cannula 102, so that the auxiliary length 120 of the digital probe 106 / digital probe can exit from the slotted cannula.

[0026] When the slotted cannula 102, detachable sheath 104, needle safety shield 114, and needle hub 110 are removed from the digital probe 106 and data hub 108, a healthcare professional may determine whether the digital probe 106 has been successfully inserted into the patient's vascular anatomy. This may be done by visually determining whether the digital probe 106 appears to be passing through the patient's anatomy and whether the visual indicator 116 on the data hub 108 indicates proper insertion of the digital probe 106. If the healthcare professional determines that the digital probe 106 has been improperly inserted, the digital probe 106 may be removed by withdrawing it from the patient's vascular anatomy, and a new insertion site may be determined using a new vascular probe insertion assembly 100. Once the healthcare professional determines that the digital probe 106 is properly inserted, they may apply a fixation dressing (not shown in Figure 1) over the auxiliary length 120 of the data hub 108 / digital probe to secure the data hub 108 to an external anatomical structure of the patient (e.g., the arm) and prevent the digital probe 106 from falling out. In some embodiments, the healthcare professional may also apply a skin adhesive to the injection site where the slotted cannula 102 entered the patient's body in order to secure the digital probe 106 to the patient while the digital probe 106 is implanted in the body.

[0027] If the digital probe 106 and data hub 108 are no longer needed by the healthcare professional to detect or measure parameters of the patient's vascular anatomy, the healthcare professional may remove and discard the digital probe 106 and data hub 108. In some embodiments, the healthcare professional may do this by grasping the data hub 108 and pulling the coupled digital probe 106 away from the patient's body. This allows the digital probe 106 to be withdrawn from the vein or artery, pass through the rest of the patient's anatomy, and be removed through the hole formed by the slotted cannula 102 during insertion.

[0028] The vascular probe insertion assembly 100 described herein can provide direct intravascular measurements of hemodynamic and blood-based critical patient parameters with minimal footprint on the patient's body. The vascular probe insertion assembly 100 can also enable continuous or intermittent monitoring without the procedural and workflow difficulties associated with other monitoring systems. Furthermore, the use of the vascular probe insertion assembly 100 described herein may not require the use of a separate catheter or vascular access device. In addition, the vascular probe insertion assembly 100 can reduce the risks associated with other systems used to complete the measurements that the vascular probe insertion assembly 100 can achieve. The vascular probe insertion assembly 100 described herein can be used for short-term or long-term monitoring of critical vascular-based parameters while the digital probe 106 is in a predetermined position within the patient's vein or artery.

[0029] Figure 2 is a side perspective view of a vascular probe insertion assembly 100 according to several embodiments of the present disclosure. The vascular probe insertion assembly 100 shown in Figure 2 may be similar to the vascular probe insertion assembly 100 shown in Figure 1. In the embodiment shown in Figure 2, the digital probe 106 and data hub 108 are removed from the slotted cannula 102, needle safety shield 114, and needle hub 110. The divisible sheath 104 shown in Figure 1 is not shown in Figure 2 because, as described in the present disclosure, the movement of the needle safety shield 114 toward the distal end of the slotted cannula 102, which has a beveled surface, causes the needle safety shield cutting blade of the needle safety shield 114 to cut through the divisible sheath 104 and expose the slotted cannula 102.

[0030] As shown in Figure 2, the needle safety shield 114 may include a plurality of mounting surfaces 201 that engage with complementary mounting surfaces formed on the digital probe 106. The mounting surfaces 201 allow the needle safety shield 114 to be operably coupled to the bottom surface of the data hub 108, at least temporarily, during insertion of the slotted cannula 102 into the patient's vascular anatomical structure. As described in this disclosure, after the slotted cannula 102 has been inserted into the patient's vein or artery, it may then be removed, leaving the digital probe 106 and data hub 108 in place. In embodiments of this disclosure, removal of the slotted cannula 102 leaves the digital probe 106 in the patient's vein or artery and the data hub 108 (operably coupled to the digital probe 106) with the patient. By sliding the needle safety shield 114 laterally away from the data hub 108, the needle safety shield 114, the slotted cannula 102, and the needle hub 110 can be removed from the data hub 108, thereby separating the needle safety shield 114 from the data hub 108. At this point, the needle safety shield 114, the slotted cannula 102, and the needle hub 110 can be discarded or disposed of as biohazardous material using appropriate disposal procedures.

[0031] As described in this disclosure, the needle safety shield 114 may have vias 203 formed through it so that the slotted cannula 102 can pass through it during manipulation by a healthcare professional. Furthermore, in some embodiments, the needle safety shield 114 includes a needle safety shield cutting blade (not shown in Figure 2) used to cut the divisible sheath 104 during withdrawal of the slotted cannula 102 from the patient's vascular anatomical structure.

[0032] The data hub 108 may remain with the patient and may later be fixed to the outer surface of the patient's anatomical structure (e.g., the arm). As described herein, the digital probe 106 may include an auxiliary length 120 of the digital probe, which may, if necessary, allow a healthcare professional to advance the digital probe 106 further into the patient's anatomical structure and into a vein or artery. This advancement of the digital probe 106 using the auxiliary length 120 of the digital probe may be achieved while the slotted cannula 102 is in a vein or artery. Thus, during the removal of the slotted cannula 102, the length of the auxiliary length 120 of the digital probe may vary depending on the healthcare professional's judgment that it is necessary or unnecessary to advance the digital probe 106 further into the patient's vein or artery.

[0033] Figure 2 includes a dashed frame "A" that generally encompasses the needle safety shield 114 shown in Figure 2. Frame "A" is also included in Figure 3 to highlight and display a larger image of the needle safety shield 114 and a portion of the slotted cannula 102. Figure 3 is a side perspective view of the needle safety shield 114 of a vascular probe insertion assembly 100 similar to the vascular probe insertion assembly 100 shown in Figures 1 and 2, according to some embodiments of the present disclosure. Figure 3 shows a magnified view of the needle safety shield 114 including vias 203 and a needle safety shield cutting blade 305 formed on the needle safety shield 114. Figure 3 also shows the slotted cannula 102 in its most retracted position, with the oblique portion of the slotted cannula 102 fully retracted into the via 203.

[0034] As described herein, the needle safety shield 114 may function as both a shield used to protect a healthcare worker from being punctured by the slotted cannula 102 in use and a shield used to cut a divisible sheath (not shown in Figure 3) during operation. In some embodiments, the needle safety shield cutting blade 305 may be positioned at the distal end of the via 203 so that the divisible sheath can be cut by the needle safety shield cutting blade 305. The divisible sheath can be cut by the needle safety shield cutting blade 305 as the slotted cannula 102 and the divisible sheath are pulled through the via 203 of the needle safety shield 114. This opens the divisible sheath along its entire length, allowing the digital probe (not shown in Figure 3) to exit the slotted cannula 102 and be freed from the rest of the vascular probe insertion assembly 100, as described herein.

[0035] In some embodiments, the needle safety shield cutting blade 305 may be positioned at the bottom of the distal portion of the via 203 formed through the needle safety shield 114. In another embodiment, the needle safety shield cutting blade 305 may be positioned at the top or above the via 203 formed through the needle safety shield 114. In some embodiments, the needle safety shield cutting blade 305 may be positioned at the distal entrance of the via 203, so that the digital probe can be released from the slotted cannula 102 simultaneously as the divisible sheath is cut and separated by the needle safety shield cutting blade 305 when the slotted cannula 102 is pulled through the via 203. This allows the digital probe 106 to be released from the slotted cannula 102 via a slot formed along the length of the slotted cannula 102 as the divisible sheath is cut and separated by the needle safety shield cutting blade 305.

[0036] Again, the needle safety shield 114 may include several mounting surfaces 201 that engage with complementary mounting surfaces (not shown in Figure 3) formed on the digital probe. The mounting surfaces 201 allow the needle safety shield 114 to be operably coupled, at least temporarily, to the bottom surface of the data hub 108 during insertion of the slotted cannula 102 into the patient's vascular anatomical structure. As described in this disclosure, after the slotted cannula 102 has been inserted into the patient's vein or artery, it may then be removed, leaving the digital probe 106 and data hub 108 in place. In embodiments of this disclosure, removal of the slotted cannula 102 leaves the digital probe 106 in the patient's vein or artery, and the data hub (operably coupled to the digital probe) remains with the patient. By sliding the needle safety shield 114 laterally from the data hub 108, the needle safety shield 114, the slotted cannula 102, and the needle hub (not shown in Figure 3) are removed from the data hub, thereby separating the needle safety shield 114 from the data hub. At this point, the needle safety shield 114, the slotted cannula 102, and the needle hub 110 can be discarded or disposed of as biohazardous material using appropriate disposal procedures.

[0037] In some embodiments, the needle safety shield 114 may include trenches or digital probe channels 118 formed along the needle safety shield 114 that match trenches formed in the data hub. These trenches formed through the needle safety shield 114 and the data hub allow the digital probe to be isolated from the data hub, thereby allowing the auxiliary length of the digital probe to be fixed together with the data hub to the patient's anatomical structure.

[0038] Figure 4 is a perspective view of a digital probe 106 of a vascular probe insertion assembly 100 for accessing a vascular anatomical structure 407, according to some embodiments of the present disclosure. Figure 4 shows the digital probe 106 in its installed position after a healthcare professional has removed, for example, the slotted cannula, detachable sheath, needle safety shield, and needle hub shown in Figures 1 and 2. The digital probe 106 remains in place as the slotted cannula is withdrawn from the patient's vascular anatomical structure 407, as described in the present disclosure. In some embodiments, the auxiliary length 120 of the digital probe may be advanced further into the patient's vascular anatomical structure by a healthcare professional after the slotted cannula has been inserted into the vascular anatomical structure 407, but before the slotted cannula is withdrawn from the patient's anatomical structure. This allows the digital probe 106 to advance further into the patient's vascular anatomical structure before the slotted cannula 102 is removed, for example, to keep the digital probe 106 within the vascular anatomical structure and prevent the slotted cannula from pulling the digital probe 106 back out of the vascular anatomical structure 407. Furthermore, while the slotted cannula is being withdrawn from the patient's vascular anatomical structure 407, the digital probe 106 / auxiliary length 120 of the digital probe may exit the slotted cannula so that the divisible sheath is cut and the slot formed within the slotted cannula serves as an exit for the digital probe 106 as it is removed from the slotted cannula.

[0039] In some embodiments, the data hub 108 can be fixed to an external anatomical structure 409 of the patient. The external anatomical structure 409 to which the data hub is fixed may vary depending on the vascular anatomical structure 407 into which the digital probe 106 is inserted. For example, if the vascular anatomical structure 407 is a vein in the patient's arm, the data hub 108 can be fixed to the patient's arm near where the digital probe 106 has passed through the patient's skin.

[0040] As described in this disclosure, the vascular probe insertion assembly 100 may also include a data hub 108 operably coupled to the digital probe 106. The data hub 108 may include any type of circuitry used to receive and transmit data detected by the digital probe 106 when the digital probe 106 is successfully inserted into a patient's vein or artery. In some embodiments, this circuitry may include, for example, a wireless radio or other transmitting device that enables wireless transmission of data detected by the digital probe 106 to a vascular monitoring system described in this disclosure. Furthermore, the data hub 108 may include, among other circuits, a power supply, a PMU, and a microcontroller or other hardware processing devices.

[0041] In some embodiments, the data hub 108 may include one or more visual indicators 116 used to inform healthcare professionals that the data hub 108 is detecting parameters of the patient's vascular anatomy, for example, because the digital probe 106 is properly inserted into the patient's vascular anatomy. These visual indicators 116 may include light-emitting diodes (LEDs) of various different colors that can indicate the proper placement of the digital probe 106 (e.g., a lit green LED), an improper placement of the digital probe 106 (e.g., a lit red LED), or a suboptimal placement of the digital probe 106 (e.g., a lit yellow LED). In some embodiments, data detected (or not detected) by the digital probe 106 may be used by a microcontroller in the data hub 108 to determine whether the digital probe 106 was properly, improperly, or suboptimally inserted into the patient's anatomical structure. In some embodiments, the data hub 108 may be fixed to the patient's external anatomical structure 409 using, for example, a transparent film dressing (e.g., 3M® TEGADERM® transparent film dressing), so that the healthcare professional can still see the visual indicators 116 present on the data hub 108. The data hub 108 may be fixed to the patient's external anatomical structure 409 using other fixation devices. Furthermore, the fixation devices may be selectively removable so that the healthcare professional can remove the fixation devices to replace a new set of fixation devices or to finally remove the digital 106 and data hub 108 when monitoring of the patient's vascular anatomy 407 is no longer required.

[0042] Figure 5 is a perspective view of a vascular probe insertion assembly 100 according to several embodiments of the present disclosure. The vascular probe insertion assembly 100 shown in Figure 5 may be similar to, for example, the one described in relation to Figure 1. The vascular probe insertion assembly 100 may include a slotted cannula 102. The slotted cannula 102 may include a slot formed along the longitudinal direction of the slotted cannula 102 in which a digital probe 106 can be positioned. The slot formed in the slotted cannula 102 forms a side wall extending along the longitudinal direction of the slotted cannula 102, which, apart from the slot, coaxially holds the digital probe 106 inside. Thus, the digital probe 106 may travel coaxially within the slotted cannula 102 until the slotted cannula 102 is removed from the patient's anatomical structure, as described in the present disclosure.

[0043] In some embodiments, the digital probe 106 may include a core wire for structural integrity and durability as it advances through the patient's vascular anatomy. The core wire may be a nitinol core wire running along the longitudinal direction of the digital probe 106, either along its central axis or offset from it. In some embodiments, the digital probe 106 may include optical fibers and / or wires connected to one or more sensors positioned along the longitudinal direction of the digital probe 106. In some embodiments, the distal end of the digital probe 106 may include a non-traumatic tip to reduce the risk of the digital probe 106 causing damage or complications to the patient's veins or arteries. In some embodiments, the proximal end of the digital probe 106 may be operably coupled within the digital probe 106, and unlike the exemplary embodiment shown in Figure 1, the digital probe 106 does not include an auxiliary length of the digital probe. This allows the healthcare professional to secure the data hub 108 to the patient's external anatomy without also securing any unused portion of the digital probe 106 to the patient's external anatomy. Furthermore, by using a fixed-length digital probe 106, healthcare professionals can understand that when the vascular probe insertion assembly 100 is used appropriately to insert the digital probe 106, the digital probe 106 will be positioned within the patient's vascular anatomy with the length necessary to complete monitoring of important vascular-based parameters.

[0044] In some embodiments, the digital probe 106 may be coated with various coatings used to improve the performance of the digital probe 106 and reduce the risk of complications such as thrombosis or probe-related bloodstream infections (e.g., sepsis). These coatings may include a silicone lubricant, which may or may not contain antimicrobial additives such as alkanes or saturated hydrocarbons (e.g., CH(x)). In some embodiments, the digital probe 106 may be coated with either an antithrombotic or antimicrobial coating and / or a polymer additive.

[0045] The sensors present on the digital probe 106 may include any number or type of sensors that detect or measure parameters of the patient's vascular anatomy. These sensors may be arranged along the digital probe 106 as individual sensors or as a bundle of sensors. These sensors may include other types of sensors, including sensors that incorporate technology capable of detecting or measuring the presence of the patient's blood pressure (venous or arterial), blood gases, blood pH levels, and electrolytes. In some embodiments, sensors present on the digital probe 106 may be selected to detect or measure other physiological or procedural parameters of interest.

[0046] The vascular probe insertion assembly 100 may also include a divisible sheath 104 formed around the slotted cannula 102. In some embodiments, the divisible sheath 104 may extend along the entire length of the slotted cannula 102, except for the oblique portion of the slotted cannula 102. This allows the sharp end of the slotted cannula 102 to puncture the patient's skin when a healthcare professional accesses the patient's vein or artery. The divisible sheath 104 may also prevent the digital probe 106 from coming out of the slot formed along the slotted cannula 102 during insertion of the vascular probe insertion assembly 100 into the patient's vascular anatomical structure.

[0047] The vascular probe insertion assembly 100 may include a needle hub 110 operably coupled to the slanted portion of a slotted cannula 102, which forms a sharp tip configured for insertion into the patient's vascular anatomical structure, and to the proximal end of the slotted cannula 102 opposite to it. In one embodiment, the needle hub 110 may include a hollow chamber or fluid reservoir 112 fluidly coupled inside the slotted cannula 102. The fluid reservoir 112 may accept a certain amount of blood when a healthcare professional inserts the slotted cannula 102 into the patient's vascular anatomical structure. In this way, the healthcare professional can determine whether and when the slotted cannula 102 has punctured a vein or artery in the patient by observing whether blood flow has entered the fluid reservoir 112. The volume of the fluid reservoir 112 may be sufficient to allow the healthcare professional to observe this process, while not drawing a large amount of blood from the patient. Since the fluid reservoir 112 is used simply to detect when the slotted cannula 102 has reached a vein or artery, the fluid reservoir 112 described herein, together with the slotted cannula 102 and needle safety shield 114, may be discarded when the digital probe 106 has been introduced into the patient's vascular anatomical structure and the slotted cannula 102 has been withdrawn from the vein or artery.

[0048] The vascular probe insertion assembly 100 may also include a needle safety shield 114. The needle safety shield 114 is formed around a portion of the slotted cannula 102 and can move along the shaft of the slotted cannula 102 during the procedure. In some embodiments, the needle safety shield 114 has vias formed through it so that the slotted cannula 102 can pass through there. Furthermore, in some embodiments, the needle safety shield 114 may include a needle safety shield cutting blade (not shown in Figure 1) used to cut the divisible sheath 104 during withdrawal of the slotted cannula 102 from the patient's vascular anatomical structure.

[0049] The vascular probe insertion assembly 100 may include a data hub 108 operably coupled to a digital probe 106. The data hub 108 may include any type of circuitry used to receive and transmit data detected by the digital probe 106 when the digital probe 106 is successfully inserted into a patient's vein or artery. In some embodiments, this circuitry may include, for example, a wireless radio or other transmitting device that enables wireless transmission of data detected by the digital probe 106 to a vascular monitoring system described in this disclosure. Furthermore, the data hub 108 may include, among other circuits, a power supply, a power management unit (PMU), and a microcontroller or other hardware processing devices. In some embodiments, the data hub 108 may include one or more visual indicators 116 used to inform a healthcare professional that the data hub 108 is detecting parameters of the patient's vascular anatomy because the digital probe 106 is properly inserted into the patient's vascular anatomy. These visual indicators 116 may include various different colored light-emitting diodes (LEDs) that can indicate the proper placement of the digital probe 106 (e.g., a lit green LED), an improper placement of the digital probe 106 (e.g., a lit red LED), or a suboptimal placement of the digital probe 106 (e.g., a lit yellow LED). In some embodiments, data detected (or not detected) by the digital probe 106 may be used by a microcontroller in a data hub 108 to determine whether the digital probe 106 was properly, improperly, or suboptimally inserted into the patient's anatomical structure.

[0050] During the operation of the vascular probe insertion assembly 100, the healthcare professional can address the patient's anatomical structure and determine a position where the digital probe 106 can be placed within the patient's vein or artery. Once a suitable injection site is determined, the healthcare professional can insert the vascular probe insertion assembly 100, specifically the slotted cannula 102 with the digital probe 106 and detachable sheath 104, into the vein or artery within the patient's anatomical structure. At this point, the slotted cannula 102 is fluidically coupled to the fluid reservoir 112 of the needle hub 110, so the healthcare professional can visually detect that the slotted cannula 102 has reached the vein or artery by the presence of blood in the fluid reservoir 112. For example, if the needle hub 110 is made of transparent plastic, the healthcare professional can visually detect the filling of the fluid reservoir 112.

[0051] When a healthcare professional detects the presence of blood in the fluid reservoir 112 of the needle hub 110, or detects a visualized blood flashback indicating that the slotted cannula 102 has reached a vein or artery, the healthcare professional may advance the digital probe 106 distally into the vascular system to ensure that access to the vascular system is not lost during the removal or proximal withdrawal of the slotted cannula 102. In some embodiments, after the digital probe 106 has advanced distally relative to the slotted cannula 102, the healthcare professional may withdraw the slotted cannula 102. In some embodiments, the healthcare professional may do this by grasping the needle hub 110 with one hand and the data hub 108 / needle safety shield 114 with the other hand. While holding the data hub 108 / needle safety shield 114 in place, the healthcare professional may begin to withdraw the needle hub 110 away from the patient and the rest of the vascular probe insertion assembly 100. By doing so, the needle safety shield cutting blade (not shown in Figure 1) of the needle safety shield 114 may begin cutting the divisible sheath 104 when the slotted cannula 102 is pulled through the via formed through the needle safety shield 114. This continues until the angled portion of the slotted cannula 102 is safely accommodated within the via formed through the needle safety shield 114. This process may also involve removing the data hub 108 from the needle safety shield 114. In some embodiments, the data hub 108 and the needle safety shield 114 may be coupled together operably via a rail system so that they can slide away from each other when a healthcare professional pulls the slotted cannula 102 and the divisible sheath 104 through the via formed through the needle safety shield 114.

[0052] When the slanted end of the slotted cannula 102 penetrates the needle safety shield 114 and enters a via, it may be possible to prevent the slotted cannula 102 from being completely removed from the via, in order to prevent the sharp tip of the slotted cannula 102 from touching a healthcare worker and potentially causing harm to the healthcare worker. Furthermore, the divisible sheath 104, which is longitudinally cut along the length of the slotted cannula 102, can be separated from the slotted cannula 102 and discarded together with the needle hub 110, the slotted cannula 102, and the needle safety shield 114.

[0053] Furthermore, once the slotted cannula 102 is withdrawn from the patient's vascular anatomical structure, the digital probe 106 remains in place. In some embodiments, the auxiliary length 120 of the digital probe can be further advanced into the patient's vascular anatomical structure by a healthcare professional when the slotted cannula 102 is inserted into the vascular anatomical structure. This allows the digital probe 106 to be further advanced into the patient's vascular anatomical structure before the slotted cannula 102 is removed, for example, to keep the digital probe 106 in place and prevent the slotted cannula 102 from withdrawing the digital probe 106 from the vascular anatomical structure. Furthermore, while the slotted cannula 102 is being withdrawn from the patient's vascular anatomical structure, the auxiliary length 120 of the digital probe 106 may exit the slotted cannula 102 so that the divisible sheath 104 is cut and the slot formed within the slotted cannula 102 serves as an exit for the digital probe 106 as it is removed from the slotted cannula 102.

[0054] When the slotted cannula 102, detachable sheath 104, needle safety shield 114, and needle hub 110 are removed from the digital probe 106 and data hub 108, a healthcare professional may determine whether the digital probe 106 has been successfully inserted into the patient's vascular anatomy. This may be done by visually determining whether the digital probe 106 appears to be passing through the patient's anatomy and whether the visual indicator 116 on the data hub 108 indicates proper insertion of the digital probe 106. If the healthcare professional determines that the digital probe 106 has been improperly inserted, the digital probe 106 may be removed by withdrawing it from the patient's vascular anatomy, and a new insertion site may be determined using a new vascular probe insertion assembly 100. Once the healthcare professional determines that the digital probe 106 is properly inserted, they may apply a fixation dressing (not shown in Figure 1) over the auxiliary length 120 of the data hub 108 / digital probe to secure the data hub 108 to an external anatomical structure of the patient (e.g., the arm) and prevent the digital probe 106 from falling out. In some embodiments, the healthcare professional may also apply a skin adhesive to the injection site where the slotted cannula 102 entered the patient's body in order to secure the digital probe 106 to the patient while the digital probe 106 is implanted in the body.

[0055] If the digital probe 106 and data hub 108 are no longer needed by the healthcare professional to detect or measure parameters of the patient's vascular anatomy, the healthcare professional may remove and discard the digital probe 106 and data hub 108. In some embodiments, the healthcare professional may do this by grasping the data hub 108 and pulling the coupled digital probe 106 away from the patient's body. This allows the digital probe 106 to be withdrawn from the vein or artery, pass through the rest of the patient's anatomy, and be removed through the hole formed by the slotted cannula 102 during insertion.

[0056] The vascular probe insertion assembly 100 described herein provides direct intravascular measurement of hemodynamic and blood-based critical patient parameters with minimal footprint on the patient's body. The vascular probe insertion assembly 100 also enables continuous or intermittent monitoring without the procedural and workflow difficulties associated with other monitoring systems. Furthermore, the use of the vascular probe insertion assembly 100 described herein does not require the use of a separate catheter or vascular access device. Furthermore, there are no risks associated with other systems used to complete the measurements that the vascular probe insertion assembly 100 can achieve. The vascular probe insertion assembly 100 described herein may be used for short-term or long-term monitoring of critical vascular-based parameters while the digital probe 106 is in place.

[0057] Figure 6 is a side perspective view of a vascular probe insertion assembly 100 according to several embodiments of the present disclosure. The vascular probe insertion assembly 100 shown in Figure 6 may be similar to the vascular probe insertion assembly 100 shown in Figure 5, having a fixed length for the digital probe 106. In the embodiment shown in Figure 6, the digital probe 106 and data hub 108 are detached from the slotted cannula 102, needle safety shield 114, and needle hub 110. The divisible sheath 104 shown in Figure 5 is not shown in Figure 6 because, as described in the present disclosure, the movement of the needle safety shield 114 toward the distal end of the slotted cannula 102, which has a beveled surface, causes the needle safety shield cutting blade of the needle safety shield 114 to cut through the divisible sheath 104 and expose the slotted cannula 102.

[0058] As shown in Figure 6, the needle safety shield 114 may include a plurality of mounting surfaces 201 that engage with complementary mounting surfaces formed on the digital probe 106. The mounting surfaces 201 allow the needle safety shield 114 to be operably coupled to the bottom surface of the data hub 108, at least temporarily, during insertion of the slotted cannula 102 into the patient's vascular anatomical structure. As described in this disclosure, after the slotted cannula 102 has been inserted into the patient's vein or artery, it may then be removed, leaving the digital probe 106 and data hub 108 in place. In embodiments of this disclosure, removal of the slotted cannula 102 leaves the digital probe 106 in the patient's vein or artery, and the data hub 108 (operably coupled to the digital probe 106) remains with the patient. By sliding the needle safety shield 114 laterally away from the data hub 108, the needle safety shield 114, the slotted cannula 102, and the needle hub 110 can be removed from the data hub 108, thereby separating the needle safety shield 114 from the data hub 108. At this point, the needle safety shield 114, the slotted cannula 102, and the needle hub 110 can be discarded or disposed of as biohazardous material using appropriate disposal procedures.

[0059] The data hub 108 may remain with the patient and may later be fixed to the outer surface of the patient's anatomical structure (e.g., the arm). As described herein, the digital probe 106 may include an auxiliary length 120 of the digital probe, which, if necessary, allows a healthcare professional to advance the digital probe 106 further into the patient's anatomical structure and into a vein or artery. This advancement of the digital probe 106 using the auxiliary length 120 of the digital probe can be achieved while the slotted cannula 102 is in the vein or artery. Thus, during the removal of the slotted cannula 102, the length of the auxiliary length 120 of the digital probe may vary depending on the healthcare professional's judgment that it is necessary or unnecessary to advance the digital probe 106 further into the patient's vein or artery.

[0060] Figure 7 is a side view of a data hub 108 equipped with a digital probe 106 according to several embodiments of the present disclosure. In one embodiment, the data hub 108 and digital probe 106 shown in Figure 7 may be part of the vascular probe insertion assembly 100 shown in Figure 6.

[0061] As described herein, the proximal end of the digital probe 106 may be operably coupled within the digital probe 106, and unlike the exemplary embodiment shown in Figure 1, for example, the digital probe 106 does not include an auxiliary length of the digital probe. This allows the healthcare professional to fix the data hub 108 to the patient's external anatomical structure without fixing any unused portion of the digital probe 106 to the patient's external anatomical structure. Furthermore, by using a fixed-length digital probe 106, the healthcare professional can understand that when the vascular probe insertion assembly 100 is used appropriately to insert the digital probe 106, the digital probe 106 is positioned within the patient's vascular anatomical structure with the length necessary to complete monitoring of important vascular-based parameters.

[0062] Figure 7 also shows a knurled surface 711 that may be formed on the outer surface of the data hub 108. This knurled surface 711 may include any type of surface treatment that can be used by a healthcare professional to better grasp the data hub 108 and the needle safety shield (not shown in Figure 7) operably coupled to the data hub 108 during insertion of the slotted cannula 102 into the patient's vascular anatomical structure 407.

[0063] Figure 8 is a top view of the data hub 108 and digital probe 106 according to several embodiments of the present disclosure. Figure 8 also shows other features of the data hub 108 and digital probe 106 that may be included in the vascular probe insertion assembly 100 described in the present disclosure.

[0064] The data hub 108 may include a strain relief 813 portion that operably connects the digital probe 106 to the data hub 108. The strain relief 813 may serve to prevent damage to the digital probe 106 when the data hub 108 moves relative to the digital probe 106 and when it moves. In some embodiments, the strain relief 813 may be used to prevent the digital probe 106 from detaching from the data hub 108 due to stress caused by bending, twisting, or pulling the data hub 108 relative to the digital probe 106 when a healthcare professional attempts to secure the data hub 108 to a patient's body. In some embodiments, the strain relief 813 may be sized to help distribute the stress between the data hub 108 and the digital probe 106 sufficiently to prevent damage. This prevents, for example, damage to the nitinol core wire 817 and other electrical connections within the digital probe 106.

[0065] The digital probe 106 may also include one or more sensors 815. As described herein, these sensors 815 may be any type of sensor capable of detecting, monitoring, or sensing important vascular-based parameters within the patient's vascular anatomy. These sensors 815 may include those related to detecting, monitoring, or sensing venous or arterial blood pressure, temperature, the hydrogen ion index (pH) of the patient's blood, the presence of organic compounds such as lactate, the presence and amount of oxygen (O2) in the blood, oxygen saturation (SpO2), and other detectable intervascular parameters. In some embodiments, each sensor may be operably coupled to the data hub 108, for example, via an electrical connection that operably couples the sensor 815 to a microcontroller and other circuits within the data hub 108.

[0066] In some embodiments, the data hub 108 may include one or more visual indicators 116 used to inform healthcare professionals that the data hub 108 is detecting parameters of the patient's vascular anatomy, for example, because the digital probe 106 is properly inserted into the patient's vascular anatomy. These visual indicators 116 may include light-emitting diodes (LEDs) of various different colors that can indicate the proper placement of the digital probe 106 (e.g., a lit green LED), an improper placement of the digital probe 106 (e.g., a lit red LED), or a suboptimal placement of the digital probe 106 (e.g., a lit yellow LED). In some embodiments, data detected (or not detected) by the digital probe 106 may be used by a microcontroller in the data hub 108 to determine whether the digital probe 106 was properly, improperly, or suboptimally inserted into the patient's anatomical structure.

[0067] Figure 9 is a top view of a digital probe 106 and a data hub 108 according to some embodiments of the present disclosure. Figure 9 shows a stabilization platform 919 operably coupled to the data hub 108. In some embodiments, the stabilization platform 919 may be semi-rigid, allowing the data hub 108 to be positioned in contact with the patient's external anatomical structure, thereby preventing rotation while the digital probe 106 is positioned within the patient's vascular anatomical structure, as described in the present disclosure. In some embodiments, the stabilization platform 919 may include an adhesive formed on the surface in contact with the patient's external anatomical structure. In some embodiments, the stabilization platform 919 may include a non-slip surface that generates more friction between the stabilization platform 919 and the patient's external anatomical structure. In some embodiments, the stabilization platform 919 may enhance the stability of the data hub 108 when positioned in contact with the patient's external anatomical structure.

[0068] To reiterate, in some embodiments, the data hub 108 may include one or more visual indicators 116 used to inform healthcare professionals that the data hub 108 is detecting parameters of the patient's vascular anatomy, for example, because the digital probe 106 is properly inserted into the patient's vascular anatomy. These visual indicators 116 may include light-emitting diodes (LEDs) of various different colors that can indicate the proper placement of the digital probe 106 (e.g., a lit green LED), an improper placement of the digital probe 106 (e.g., a lit red LED), or a suboptimal placement of the digital probe 106 (e.g., a lit yellow LED). In some embodiments, data detected (or not detected) by the digital probe 106 may be used by a microcontroller in the data hub 108 to determine whether the digital probe 106 was properly, improperly, or suboptimally inserted into the patient's anatomical structure.

[0069] Figure 10 is a top view of a data hub 108 and a digital probe 106 according to several embodiments of the present disclosure. Again, the data hub 108 may include a stabilization platform 919 similar to that described in relation to Figure 9.

[0070] In the embodiment shown in Figure 10, the stabilization platform 919 is also in a predetermined position. As described in this disclosure, the stabilization platform 919 may be semi-rigid in some embodiments, allowing the data hub 108 to be positioned in contact with the patient's external anatomical structure, thereby preventing rotation while the digital probe 106 is positioned within the patient's vascular anatomical structure, as described in this disclosure. In some embodiments, the stabilization platform 919 may include an adhesive formed on the surface in contact with the patient's external anatomical structure. In some embodiments, the stabilization platform 919 may include a non-slip surface that generates more friction between the stabilization platform 919 and the patient's external anatomical structure. In some embodiments, the stabilization platform 919 may enhance the stability of the data hub 108 positioned in contact with the patient's external anatomical structure.

[0071] Furthermore, during the procedure, a healthcare professional may use a fixation dressing 1021 to secure the data hub 108 to the patient's external anatomical structure. In some embodiments, the fixation dressing 1021 may include a rigid boundary 1023 which may contain an adhesive used to firmly secure the fixation dressing 1021 to the patient's external anatomical structure 409. In some embodiments, the fixation dressing 1021 may sandwich the data hub 108 between the bottom surface of the fixation dressing 1021 and the surface of the patient's external anatomical structure. In some embodiments, the fixation dressing 1021 may also include a transparent window 1025 that allows a healthcare professional to view the data hub 108 when the digital probe 106 is within the patient's vascular anatomical structure. In some embodiments, the transparent window 1025 allows a healthcare professional to determine whether the digital probe 106 is maintained within the patient's vascular anatomical structure 407, as well as the state of the data hub 108. As described herein, the data hub 108 may include one or more visual indicators 116 used to inform a healthcare professional that the data hub 108 is detecting parameters of the patient's vascular anatomy, for example, because the digital probe 106 is properly inserted into the patient's vascular anatomy. Thus, the transparent window 1025 allows the healthcare professional to view the status of the visual indicators 116. In some embodiments, the fixation dressing 1021 may be a 3M® TEGADERN® transparent film dressing.

[0072] To reiterate, in some embodiments, the data hub 108 may include one or more visual indicators 116 used to inform healthcare professionals that the data hub 108 is detecting parameters of the patient's vascular anatomy, for example, because the digital probe 106 is properly inserted into the patient's vascular anatomy. These visual indicators 116 may include light-emitting diodes (LEDs) of various different colors that can indicate the proper placement of the digital probe 106 (e.g., a lit green LED), an improper placement of the digital probe 106 (e.g., a lit red LED), or a suboptimal placement of the digital probe 106 (e.g., a lit yellow LED). In some embodiments, data detected (or not detected) by the digital probe 106 may be used by a microcontroller in the data hub 108 to determine whether the digital probe 106 was properly, improperly, or suboptimally inserted into the patient's anatomical structure.

[0073] Figure 11 is a side perspective view of a vascular probe insertion assembly 100 according to several embodiments of the present disclosure. As described in the present disclosure, the vascular probe insertion assembly 100 may include a slotted cannula 102, a divisible sheath 104, and a digital probe 106, as described in the present disclosure. An exemplary embodiment shown in Figure 11 shows a digital probe 106 extending through the slotted cannula 102 and the divisible sheath 104, through a digital probe channel 118, and extending from the digital probe channel 118. Figure 11 also shows various electrical wires within the digital probe 106 that may be used to operably couple to a monitoring system, for example, as described in the present disclosure.

[0074] In the embodiment shown in Figure 11, the sharp end of the slotted cannula 102 can be inserted into the patient's vascular anatomical structure 407 to introduce the digital probe 106 into a vein or artery, as described in this disclosure. Furthermore, once the patient's vascular anatomical structure 407 is accessed and the digital probe 106 is positioned, a healthcare professional may hold the needle hub 110 with one hand and the data hub 108 with the other, continuing to hold the data hub 108 while the healthcare professional pulls the needle hub 110 away from the data hub 108. As this occurs, the slotted cannula 102 and the detachable sheath 104 are pulled through vias formed in the needle safety shield 114. As the detachable sheath 104 is pulled through the vias of the needle safety shield 114, a needle safety shield cutting blade (not shown in Figure 11) cuts the detachable sheath 104, allowing the length of the digital probe 106 to extend from the slotted cannula 102, as described in this disclosure. In the embodiment shown in Figure 11, the digital probe 106 is not operably coupled to the data hub 108; instead, the data hub 108 can be discarded along with the slotted cannula 102, the detachable sheath 104, and the needle hub 110. This creates a situation where only the digital probe 106 remains with the patient after it has been successfully inserted into the patient's vascular anatomical structure.

[0075] As shown in Figure 11, the digital probe 106 may include a number of wires that enable the sensor of the digital probe 106 to be operably coupled to a monitoring system, as described in this disclosure. The number of wires may include, for example, a negative voltage rail (V-), a positive voltage rail (V+), and any number of data wires (e.g., data 1, data 2, etc.). The negative and positive voltage rails may be provided to supply current to the sensor of the digital probe 106, as a result the sensor may detect, monitor, or otherwise sense important vascular-based parameters as described in this disclosure. Each data wire may be used to pass data from the sensor to the monitoring system according to exemplary embodiments of this disclosure. Although Figure 11 shows only two data wires (e.g., data 1 and data 2), it will be understood that the digital probe 106 may include more or fewer than these two data wires.

[0076] Figure 12 is a side perspective view of a vascular probe insertion assembly 100 according to several embodiments of the present disclosure. The vascular probe insertion assembly 100 is shown in a orientation in which the digital probe 106 is positioned within the patient's vascular anatomical structure. As described in the present disclosure, the withdrawal of the slotted cannula 102 from within the patient's vascular anatomical structure causes the detachable sheath 104 to be cut by the needle safety shield cutting blade, and the detachable sheath 104 detaches from the vascular probe insertion assembly 100. The needle safety shield 114 then covers the sharp tip of the slotted cannula 102 to prevent the healthcare worker from being injured by this sharp tip. Furthermore, in Figures 11, 12, and 13, the data hub 108 is not retained with the patient and is discarded along with the slotted cannula 102, the detachable sheath 104, the needle hub 110 (including its fluid reservoir 112), and the needle safety shield 114. To reiterate, this leaves only the digital probe 106 in the patient. The digital probe 106 can then be coupled to a monitoring system as described in this disclosure.

[0077] Figure 13 is a side perspective view of a digital probe 106 inserted into a vascular anatomical structure 407 according to several embodiments of the present disclosure. Figure 13 shows the digital probe 106 in its installed position after a healthcare professional has removed, for example, the slotted cannula, detachable sheath, needle safety shield, and needle hub shown in Figure 11. The digital probe 106 remains in place as the slotted cannula is withdrawn from the patient's vascular anatomical structure 407, as described in the present disclosure. The external anatomical structure 409 to which part of the digital probe 106 is fixed may vary depending on the vascular anatomical structure 407 into which the digital probe 106 is inserted. For example, if the vascular anatomical structure 407 is a vein in the patient's arm, part of the digital probe 106 may be fixed to the patient's arm near where the digital probe 106 has passed through the patient's skin and the vascular anatomical structure 407.

[0078] To reiterate, the digital probe 106 may include a number of wires that enable the sensor of the digital probe 106 to be operably coupled to a monitoring system, as described in this disclosure. The number of wires may include, for example, a negative voltage rail (V-), a positive voltage rail (V+), and any number of data wires (e.g., data 1, data 2, etc.). The negative and positive voltage rails may be provided to supply current to the sensor of the digital probe 106, as a result the sensor may detect, monitor, or otherwise sense important vascular-based parameters as described in this disclosure. Each data wire may be used to pass data from the sensor to the monitoring system according to exemplary embodiments of this disclosure. Figure 11 shows only two data wires (e.g., data 1 and data 2), but it will be understood that the digital probe 106 may include more or fewer than these two data wires.

[0079] Figure 14 is a top view of the digital probe 106 and data hub 108 according to some embodiments of the present disclosure. Similar to Figure 9, Figure 14 shows a stabilization platform 919 operably coupled to the data hub 108. In some embodiments, the stabilization platform 919 may be semi-rigid, allowing the data hub 108 to be positioned in contact with the patient's external anatomical structure, thereby preventing rotation while the digital probe 106 is positioned within the patient's vascular anatomical structure, as described in the present disclosure. In some embodiments, the stabilization platform 919 may include an adhesive formed on the surface in contact with the patient's external anatomical structure. In some embodiments, the stabilization platform 919 may include a non-slip surface that generates more friction between the stabilization platform 919 and the patient's external anatomical structure. In some embodiments, the stabilization platform 919 may enhance the stability of the data hub 108 when positioned in contact with the patient's external anatomical structure.

[0080] Furthermore, in the embodiment shown in Figure 14, the data hub 108 may include a strain relief 813 portion that operably connects the digital probe 106 to the data hub 108. The strain relief 813 may serve to prevent damage to the digital probe 106 when the data hub 108 moves relative to and as it moves. In some embodiments, the strain relief 813 may be used to prevent the digital probe 106 from detaching from the data hub 108 due to stress caused by bending, twisting, or pulling the data hub 108 relative to the digital probe 106 when a healthcare professional attempts to secure the data hub 108 to a patient's body. In some embodiments, the strain relief 813 may be sized to help distribute the stress between the data hub 108 and the digital probe 106 sufficiently to prevent damage. This prevents, for example, damage to the nitinol core wire 817 and other electrical connections within the digital probe 106.

[0081] In some embodiments, the digital probe 106 may also include one or more sensors 815. As described herein, these sensors 815 may be any type of sensor capable of detecting, monitoring, or sensing important vascular-based parameters within the patient's vascular anatomy. These sensors 815 may include those related to detecting, monitoring, or sensing venous or arterial blood pressure, temperature, the hydrogen ion index (pH) of the patient's blood, the presence of organic compounds such as lactate, the presence and amount of oxygen (O2) in the blood, oxygen saturation (SpO2), and other detectable intervascular parameters. In some embodiments, each sensor may be operably coupled to the data hub 108, for example, via an electrical connection that operably couples the sensor 815 to a microcontroller and other circuits within the data hub 108.

[0082] In some embodiments, the data hub 108 may include an electrical interface 1427. The electrical interface 1427 may be used by the data hub 108 to connect the data hub 108 to a monitoring system via a wired connection. In some embodiments, the electrical interface 1427 may include one or more contact pins that interconnect with the corresponding wired connection that operably connects the data hub 108 to the monitoring system. As described in this disclosure, the data hub 108 may be a wireless data hub 108 or a wired data hub 108, the example shown in Figure 14 being a wired data hub 108 that allows a healthcare professional to connect a wired connection interface to the proximal end of the data hub 108.

[0083] Figure 15 is a top view of a digital probe 106, a data hub 108, and a wired connection 1529 according to some embodiments of the present disclosure. Figure 15 again shows a stabilization platform 919 operably coupled to the data hub 108. In some embodiments, the stabilization platform 919 may be semi-rigid, allowing the data hub 108 to be positioned in contact with the patient's external anatomical structure, thereby preventing rotation while the digital probe 106 is positioned within the patient's vascular anatomical structure, as described in the present disclosure. In some embodiments, the stabilization platform 919 may include an adhesive formed on the surface in contact with the patient's external anatomical structure. In some embodiments, the stabilization platform 919 may include a non-slip surface that generates more friction between the stabilization platform 919 and the patient's external anatomical structure. In some embodiments, the stabilization platform 919 may enhance the stability of the data hub 108 when positioned in contact with the patient's external anatomical structure.

[0084] Furthermore, in the embodiment shown in Figure 14, the data hub 108 may include a strain relief 813 portion that operably connects the digital probe 106 to the data hub 108. The strain relief 813 may serve to prevent damage to the digital probe 106 when the data hub 108 moves relative to and as it moves. In some embodiments, the strain relief 813 may be used to prevent the digital probe 106 from detaching from the data hub 108 due to stress caused by bending, twisting, or pulling the data hub 108 relative to the digital probe 106 when a healthcare professional attempts to secure the data hub 108 to a patient's body. In some embodiments, the strain relief 813 may be sized to help distribute the stress between the data hub 108 and the digital probe 106 sufficiently to prevent damage. This prevents, for example, damage to the nitinol core wire 817 and other electrical connections within the digital probe 106.

[0085] In some embodiments, the digital probe 106 may also include one or more sensors 815. As described herein, these sensors 815 may be any type of sensor capable of detecting, monitoring, or sensing important vascular-based parameters within the patient's vascular anatomy. These sensors 815 may include those related to detecting, monitoring, or sensing venous or arterial blood pressure, temperature, the hydrogen ion index (pH) of the patient's blood, the presence of organic compounds such as lactate, the presence and amount of oxygen (O2) in the blood, oxygen saturation (SpO2), and other detectable intervascular parameters. In some embodiments, each sensor may be operably coupled to the data hub 108, for example, via an electrical connection that operably couples the sensor 815 to a microcontroller and other circuits within the data hub 108.

[0086] As described in this disclosure, the data hub 108 may include an electrical interface 1427. The electrical interface 1427 may be used by the data hub 108 to connect the data hub 108 to a monitoring system via a wired connection. In some embodiments, the electrical interface 1427 may include one or more contact pins that interconnect with the corresponding wired connection that operably connects the data hub 108 to the monitoring system. As described in this disclosure, the data hub 108 may be a wireless data hub 108 or a wired data hub 108, the example shown in Figure 14 being a wired data hub 108 that allows a healthcare professional to connect a wired connection interface to the proximal end of the data hub 108. The use of the electrical interface 1427 allows the monitoring system to be disconnected and reconnected when necessary to detect important blood-based patient parameters. The connection at the digital probe 106 allows this disconnection, for example, to improve the mobility of the patient transport as needed.

[0087] Figure 15 also shows a wired connection 1529 used to operably couple the data hub 108 of the vascular probe insertion assembly 100 to the monitoring system described herein. The wired connection 1529 may include a wired connection interface 1531 used to interconnect with the electrical interface 1427 of the data hub 108. Thus, in one embodiment, the wired connection interface 1531 may include one or more interface contact pins that interconnect with the contact pins of the electrical interface 1427 on the data hub 108. The wired connection 1529 may also include a plug 1533 used to complete the connection between the data hub 108 and the wired connection 1529 to the monitoring system. In some embodiments, the monitoring system may include a bedside monitoring system, a computer or computing device, a data cloud, or a combination thereof. In some embodiments, the monitoring system may be used, in exemplary embodiments, to compute, classify, process, transmit, receive, acquire, transmit, switch, store, display, manifest, detect, record, reproduce, process, or use any form of information, intelligence, or data for medical diagnosis or other purposes.

[0088] Figure 16 is a top view of a digital probe 106, a data hub 108, and a wired connection 1529 according to some embodiments of the present disclosure. As described in the present disclosure, a vascular probe insertion assembly 100 may include a digital probe 106 operably coupled to a data hub 108 via a strain relief 813. The digital probe 106 may include one or more sensors 815 operably coupled to a nitinol core wire 817 for insertion into the patient's vascular anatomical structure. The data hub 108 may also include a stabilization platform 919 used to provide structural support to the data hub 108 and, in one embodiment, to fix the data hub 108 to the patient's external anatomical structure, for example, via an adhesive.

[0089] As described in this disclosure, the data hub 108 may include an electrical interface 1427. The electrical interface 1427 may be used by the data hub 108 to connect the data hub 108 to a monitoring system via a wired connection. In some embodiments, the electrical interface 1427 may include one or more contact pins that interconnect with the corresponding wired connection that operably connects the data hub 108 to the monitoring system. As described in this disclosure, the data hub 108 may be a wireless data hub 108 or a wired data hub 108, the example shown in Figure 14 being a wired data hub 108 that allows a healthcare professional to connect a wired connection interface to the proximal end of the data hub 108.

[0090] Figure 16 shows a wired connection 1529 described in Figure 16, which is coupled to an electrical interface 1427 and used to operably couple the data hub 108 of the vascular probe insertion assembly 100 to a monitoring system described in this disclosure. The wired connection 1529 may include a wired connection interface 1531 used to interconnect with the electrical interface 1427 of the data hub 108. Thus, in one embodiment, the wired connection interface 1531 may include one or more interface contact pins that interconnect with the contact pins of the electrical interface 1427 on the data hub 108. The wired connection 1529 may also include a plug 1533 used to complete the connection between the data hub 108 and the wired connection 1529 to the monitoring system. In some embodiments, the monitoring system may include a bedside monitoring system, a computer or computing device, a data cloud, or a combination thereof. In some embodiments, the monitoring system may be used, in exemplary embodiments, to compute, classify, process, transmit, receive, acquire, transmit, switch, store, display, manifest, detect, record, reproduce, process, or use any form of information, intelligence, or data for medical diagnosis or other purposes.

[0091] Figure 17 is a perspective view of a vascular probe insertion assembly 100 with a wired connection 1529 according to some embodiments of the present disclosure. As described in the present disclosure, the data hub 108 may include a digital probe 106 used to position one or more sensors within the patient's vascular anatomical structure. The data hub 108 may also include a stabilization platform 919 used to provide structural support to the data hub 108, and in one embodiment, used to fix the data hub 108 to the patient's external anatomical structure, for example, via an adhesive.

[0092] In Figure 17, the data hub 108 is further coupled to a wired connection 1529 used to operably connect the data hub 108 to a monitoring system via a wired connection. In some embodiments, the wired connection 1529 is permanently coupled to the data hub 108 at its proximal end. The wired connection 1529 may further include a plug 1533 used to connect the data hub 108 to the monitoring system. In some embodiments, this plug 1533 may be a Universal Serial Bus (USB) type plug that can interconnect with a USB port in the monitoring system. The length of the wired connection 1529 may vary, and in one embodiment, it may be long enough to reach from the patient to the monitoring system.

[0093] Figure 18 shows a permanent connection of the wired connection 1529 to the data hub 108. Figure 18 is a side view of the digital probe 106 with the wired connection 1529 according to some embodiments of the present disclosure. In some embodiments, when the digital probe 106 is positioned within the vascular anatomical structure of a patient, the wired connection 1529 can be operably coupled to a plug (not shown) and connected into a monitoring system by a healthcare professional. In some embodiments, the wired connection 1529 can be disconnected from the digital probe 106 and the stabilization platform 919 when it is necessary to allow for better patient mobility. The wired connection 1529 can then be reconnected when those blood-based critical patient parameters should be detected or monitored, as described in the present disclosure.

[0094] Figure 19 is a top view of a digital probe 106 and a data hub 108 according to some embodiments of the present disclosure. Figure 19 shows the data hub 108 including a tethered connector 1935 that operably connects the data hub 108 to the digital probe 106. In some embodiments, the length of the tethered connector 1935 may vary depending on the required level of patient mobility. In some embodiments, the tethered connector 1935 and the data hub 108 may also be fixed to the patient's external anatomical structure to prevent the digital probe 106 from falling out.

[0095] Figure 20 is a top view of a digital probe 106 and a data hub 108 according to some embodiments of the present disclosure. In the embodiments shown in Figure 20, the data hub 108 may include a tethered connector 1935 that operably connects the data hub 108 to the digital probe 106. In some embodiments, the length of the tethered connector 1935 may vary depending on the level of patient mobility required. In some embodiments, the tethered connector 1935 and the data hub 108 may also be fixed to the patient's external anatomical structure to prevent the digital probe 106 from falling out.

[0096] In some embodiments, the stabilization platform 919 may be operably coupled to an intermediate hub 2037 near the digital probe 106. In some embodiments, the stabilization platform 919 may be semi-rigid, allowing the data hub 108 to be positioned in contact with the patient's external anatomical structure, thereby preventing rotation while the digital probe 106 is positioned within the patient's vascular anatomical structure, as described in this disclosure. In some embodiments, the stabilization platform 919 may include an adhesive formed on the surface in contact with the patient's external anatomical structure. In some embodiments, the stabilization platform 919 may include a non-slip surface that generates more friction between the stabilization platform 919 and the patient's external anatomical structure. In some embodiments, the stabilization platform 919 may enhance the stability of the intermediate hub 2037, which is positioned in contact with the patient's external anatomical structure. In some embodiments, the intermediate hub 2037 may include some of those elements that may be contained within the data hub 108. In some embodiments, the intermediate hub 2037 may include, among other circuits, one or more of a power supply, a PMU, and a microcontroller or other hardware processing devices. If these devices are included within the intermediate hub 2037, the data hub 108 does not need to include them, as the tethered connector 1935 operably connects the intermediate hub 2037 to the data hub 108.

[0097] Figure 21 is a side perspective view of a vascular probe insertion assembly according to several embodiments of the present disclosure. The vascular probe insertion assembly 100 shown in Figure 21 may be similar to the vascular probe insertion assembly 100 shown in Figure 1, which comprises a syringe 2139 operably coupled to a slotted cannula 102.

[0098] The vascular probe insertion assembly 100 may include several devices used by a healthcare professional to introduce a digital probe 106 into a patient's vein or artery. The vascular probe insertion assembly 100 may include a slotted cannula 102. The slotted cannula 102 may include a slot formed along its longitudinal direction into which the digital probe 106 can be positioned. The slot formed in the slotted cannula 102 forms a side wall extending along its longitudinal direction, which, apart from the slot, holds the digital probe 106 coaxially inside. Thus, the digital probe 106 may travel coaxially within the slotted cannula 102 until the slotted cannula 102 is removed from the patient's anatomical structure, as described herein. In some embodiments, the orientation of the slots formed in the slotted cannula 102 may be aligned with a trench or digital probe channel formed through the data hub 108, so that the digital probe 106 leaves the digital probe channel formed in the data hub 108 when the digital probe 106 is inserted into the patient's vascular anatomical structure.

[0099] In some embodiments, the digital probe 106 may include a core wire for structural integrity and durability as it advances through the patient's vascular anatomical structure. The core wire may be a nitinol core wire running along the longitudinal direction of the digital probe 106, either along its central axis or offset from the central axis. In some embodiments, the digital probe 106 may include optical fibers and / or wires connected to one or more sensors positioned along the longitudinal direction of the digital probe 106. In some embodiments, the distal end of the digital probe 106 may include a non-traumatic tip to reduce the risk of the digital probe 106 causing damage or complications to the patient's veins or arteries.

[0100] In some embodiments, the digital probe 106 may be coated with various coatings used to improve the performance of the digital probe 106 and reduce the risk of complications such as thrombosis or probe-related bloodstream infections (e.g., sepsis). These coatings may include a silicone lubricant, which may or may not contain antimicrobial additives such as alkanes or saturated hydrocarbons (e.g., CH(x)). In some embodiments, the digital probe 106 may be coated with either an antithrombotic or antimicrobial coating and / or a polymer additive.

[0101] The sensors present on the digital probe 106 may include any number or type of sensors that detect or measure parameters of the patient's vascular anatomy. These sensors may be arranged along the digital probe 106 as individual sensors or as a bundle of sensors. These sensors may include other types of sensors, including sensors that incorporate technology capable of detecting or measuring the presence of the patient's blood pressure (venous or arterial), blood gases, blood pH levels, and electrolytes. In some embodiments, sensors present on the digital probe 106 may be selected to detect or measure other physiological or procedural parameters of interest.

[0102] The vascular probe insertion assembly 100 may also include a divisible sheath 104 formed around the slotted cannula 102. In some embodiments, the divisible sheath 104 may extend along the entire length of the slotted cannula 102, except for the oblique portion of the slotted cannula 102. This allows the sharp end of the slotted cannula 102 to puncture the patient's skin when a healthcare professional accesses the patient's vein or artery. The divisible sheath 104 may also prevent the digital probe 106 from coming out of the slot formed along the slotted cannula 102 during insertion of the vascular probe insertion assembly 100 into the patient's vascular anatomical structure.

[0103] The vascular probe insertion assembly 100 may also include a needle safety shield 114. The needle safety shield 114 is formed around a portion of the slotted cannula 102 and can move along the shaft of the slotted cannula 102 during the procedure. In some embodiments, the needle safety shield 114 has vias formed through it so that the slotted cannula 102 can pass through there. Furthermore, in some embodiments, the needle safety shield 114 may include a needle safety shield cutting blade (not shown in Figure 21) used to cut the divisible sheath 104 during withdrawal of the slotted cannula 102 from the patient's vascular anatomical structure.

[0104] The vascular probe insertion assembly 100 may also include a data hub 108 operably coupled to the digital probe 106. The data hub 108 may include any type of circuitry used to receive and transmit data detected by the digital probe 106 when the digital probe 106 is successfully inserted into a patient's vein or artery. In some embodiments, this circuitry may include, for example, a wireless radio or other transmitting device that enables wireless transmission of data detected by the digital probe 106 to a vascular monitoring system described in this disclosure. Furthermore, the data hub 108 may include, among other circuits, a power supply, a power management unit (PMU), and a microcontroller or other hardware processing devices. In some embodiments, the data hub 108 may include one or more visual indicators 116 used to inform a healthcare professional that the data hub 108 is detecting parameters of the patient's vascular anatomy because the digital probe 106 is properly inserted into the patient's vascular anatomy. These visual indicators 116 may include various different colored light-emitting diodes (LEDs) that can indicate the proper placement of the digital probe 106 (e.g., a lit green LED), an improper placement of the digital probe 106 (e.g., a lit red LED), or a suboptimal placement of the digital probe 106 (e.g., a lit yellow LED). In some embodiments, data detected (or not detected) by the digital probe 106 may be used by a microcontroller in a data hub 108 to determine whether the digital probe 106 was properly, improperly, or suboptimally inserted into the patient's anatomical structure.

[0105] In the embodiment shown in Figure 21, the vascular probe insertion assembly 100 may also include a syringe 2139 operably coupled to the vascular probe insertion assembly 100 and in fluid communication with the slotted cannula 102. Similar to the needle hub described in Figure 1, the syringe 2139 may be used by a healthcare professional to detect whether the slotted cannula 102 has reached a patient's vein or artery. The healthcare professional can do this by pulling the plunger 2141 out of the barrel 2143 of the syringe 2139. By pulling the plunger 2141 out of the barrel 2143, the healthcare professional may collect a certain amount of blood to determine whether the slotted cannula 102 has reached a patient's vein or artery. Furthermore, the syringe 2139 may be used by a healthcare professional to better hold the vascular probe insertion assembly 100 during insertion of the slotted cannula 102. By holding syringe 2139, healthcare professionals can more easily insert slotted cannula 102 into the patient's anatomical structures at their relatively more sensitive or critical insertion sites.

[0106] During the operation of the vascular probe insertion assembly 100, the healthcare professional can address the patient's anatomical structure and determine a suitable position for the digital probe 106 to be placed within the patient's vein or artery. Once a suitable injection site is determined, the healthcare professional can insert the vascular probe insertion assembly 100, specifically the slotted cannula 102 with the digital probe 106 and detachable sheath 104, into the vein or artery within the patient's anatomical structure. At this point, since the slotted cannula 102 is fluidly coupled to the syringe 2139, the healthcare professional can visually detect that the slotted cannula 102 has reached the vein or artery by gently pulling the plunger 2141 out of the barrel 2143 of the syringe 2139. For example, since the barrel 2143 is made of clear plastic, the healthcare professional can visually detect when the barrel 2143 is filled.

[0107] When a healthcare professional detects the presence of blood in the barrel 2143 of the syringe 2139, indicating that the slotted cannula 102 has reached a vein or artery, the healthcare professional may begin to remove the vascular probe insertion assembly 100 from the patient. In some embodiments, the healthcare professional may do this by grasping the syringe 2139 with one hand and the data hub 108 / needle safety shield 114 with the other hand. While holding the data hub 108 / needle safety shield 114 in place, the healthcare professional may begin to pull the syringe 2139 away from the patient and the rest of the vascular probe insertion assembly 100. By doing so, the needle safety shield cutting blade (not shown in Figure 21) of the needle safety shield 114 may begin to cut the divisible sheath 104 as the slotted cannula 102 is pulled through the via formed by penetrating the needle safety shield 114. This continues until the angled portion of the slotted cannula 102 is safely housed within a via formed through the needle safety shield 114. This process may also involve removing the data hub 108 from the needle safety shield 114. In some embodiments, the data hub 108 and the needle safety shield 114 may be coupled together operably via a rail system so that they can be detached from each other by a medical professional pulling the slotted cannula 102 and the detachable sheath 104 through a via formed through the needle safety shield 114.

[0108] When the slanted end of the slotted cannula 102 penetrates the needle safety shield 114 and enters a via, it is possible to prevent the slotted cannula 102 from being completely removed from the via, in order to prevent the sharp tip of the slotted cannula 102 from touching a healthcare worker and potentially causing harm to the healthcare worker. Furthermore, the divisible sheath 104, which is longitudinally cut along the length of the slotted cannula 102, can be separated from the slotted cannula 102 and discarded together with the syringe 2139, the slotted cannula 102, and the needle safety shield 114.

[0109] Furthermore, once the slotted cannula 102 is withdrawn from the patient's vascular anatomical structure, the digital probe 106 remains in place. In some embodiments, the auxiliary length 120 of the digital probe can be further advanced into the patient's vascular anatomical structure by a healthcare professional when the slotted cannula 102 is inserted into the vascular anatomical structure. This allows the digital probe 106 to be further advanced into the patient's vascular anatomical structure before the slotted cannula 102 is removed, for example, to keep the digital probe 106 in place and prevent the slotted cannula 102 from withdrawing the digital probe 106 from the vascular anatomical structure. Furthermore, while the slotted cannula 102 is being withdrawn from the patient's vascular anatomical structure, the auxiliary length 120 of the digital probe 106 may exit the slotted cannula 102 so that the divisible sheath 104 is cut and the slot formed within the slotted cannula 102 serves as an exit for the digital probe 106 as it is removed from the slotted cannula 102.

[0110] When the slotted cannula 102, detachable sheath 104, needle safety shield 114, and syringe 2139 are removed from the digital probe 106 and data hub 108, a healthcare professional may determine whether the digital probe 106 has been successfully inserted into the patient's vascular anatomy. This may be done by visually determining whether the digital probe 106 appears to be passing through the patient's anatomy and whether the visual indicator 116 on the data hub 108 indicates proper insertion of the digital probe 106. If the healthcare professional determines that the digital probe 106 has been improperly inserted, the digital probe 106 may be removed by withdrawing it from the patient's vascular anatomy, and a new insertion site may be determined using a new vascular probe insertion assembly 100. Once the healthcare professional determines that the digital probe 106 is properly inserted, the healthcare professional may apply a fixation dressing (not shown in Figure 21) over the auxiliary length 120 of the data hub 108 / digital probe to secure the data hub 108 to an external anatomical structure of the patient (e.g., the arm) and to prevent the digital probe 106 from falling out. In some embodiments, the healthcare professional may also apply a skin adhesive to the injection site where the slotted cannula 102 entered the patient's body in order to secure the digital probe 106 to the patient while the digital probe 106 is implanted in the body.

[0111] If the digital probe 106 and data hub 108 are no longer needed by the healthcare professional to detect or measure parameters of the patient's vascular anatomy, the healthcare professional may remove and discard the digital probe 106 and data hub 108. In some embodiments, the healthcare professional may do this by grasping the data hub 108 and pulling the coupled digital probe 106 away from the patient's body. This allows the digital probe 106 to be withdrawn from the vein or artery, pass through the rest of the patient's anatomy, and be removed through the hole formed by the slotted cannula 102 during insertion.

[0112] The vascular probe insertion assembly 100 described herein provides direct intravascular measurement of hemodynamic and blood-based critical patient parameters with minimal footprint on the patient's body. The vascular probe insertion assembly 100 also enables continuous or intermittent monitoring without the procedural and workflow difficulties associated with other monitoring systems. Furthermore, the use of the vascular probe insertion assembly 100 described herein does not require the use of a separate catheter or vascular access device. Furthermore, there are no risks associated with other systems used to complete the measurements that the vascular probe insertion assembly 100 can achieve. The vascular probe insertion assembly 100 described herein may be used for short-term or long-term monitoring of critical vascular-based parameters while the digital probe 106 is in place.

[0113] Figure 22 is a side perspective view of a vascular probe insertion assembly 100 according to several embodiments of the present disclosure. The vascular probe insertion assembly 100 shown in Figure 22 may be similar to the vascular probe insertion assembly 100 shown in Figure 21. In the embodiments shown in Figure 22, the digital probe 106 and data hub 108 are removed from the slotted cannula 102, needle safety shield 114, and syringe 2139. The divisible sheath 104 shown in Figure 21 is not shown in Figure 22 because, as described in the present disclosure, the movement of the needle safety shield 114 toward the distal end of the slotted cannula 102, which has a beveled surface, causes the needle safety shield cutting blade of the needle safety shield 114 to cut through the divisible sheath 104 and expose the slotted cannula 102.

[0114] As shown in Figure 22, the needle safety shield 114 may include a plurality of mounting surfaces 201 that engage with complementary mounting surfaces formed on the digital probe 106. The mounting surfaces 201 allow the needle safety shield 114 to be operably coupled to the bottom surface of the data hub 108, at least temporarily, during insertion of the slotted cannula 102 into the patient's vascular anatomical structure. As described in this disclosure, after the slotted cannula 102 has been inserted into the patient's vein or artery, it may then be removed, leaving the digital probe 106 and data hub 108 in place. In embodiments of this disclosure, removal of the slotted cannula 102 leaves the digital probe 106 in the patient's vein or artery and the data hub 108 (operably coupled to the digital probe 106) with the patient. By sliding the needle safety shield 114 laterally from the data hub 108, the needle safety shield 114, the slotted cannula 102, and the syringe 2139 can be removed from the data hub 108, thereby separating the needle safety shield 114 from the data hub 108. At this point, the needle safety shield 114, the slotted cannula 102, and the syringe 2139 can be discarded or disposed of as biohazards using appropriate disposal procedures.

[0115] The data hub 108 may remain with the patient and may later be fixed to the outer surface of the patient's anatomical structure (e.g., the arm). As described herein, the digital probe 106 may include an auxiliary length 120 of the digital probe, which, if necessary, allows a healthcare professional to advance the digital probe 106 further into the patient's anatomical structure and into a vein or artery. This advancement of the digital probe 106 using the auxiliary length 120 of the digital probe can be achieved while the slotted cannula 102 is in the vein or artery. Thus, during the removal of the slotted cannula 102, the length of the auxiliary length 120 of the digital probe may vary depending on the healthcare professional's judgment that it is necessary or unnecessary to advance the digital probe 106 further into the patient's vein or artery.

[0116] Figure 23 is a side perspective view of a digital probe 106 inserted into a vascular anatomical structure 407 according to some embodiments of the present disclosure. Figure 23 shows the digital probe 106 in its installed position after a healthcare professional has removed, for example, the slotted cannula, detachable sheath, needle safety shield, and syringe 2139 shown in Figures 21 and 22. As described in the present disclosure, the digital probe 106 remains in place as the slotted cannula is withdrawn from the patient's vascular anatomical structure 407. In some embodiments, the auxiliary length 120 of the digital probe may be advanced further into the patient's vascular anatomical structure by a healthcare professional after the slotted cannula has been inserted into the vascular anatomical structure 407, but before the slotted cannula is withdrawn from the patient's anatomical structure. This allows the digital probe 106 to advance further into the patient's vascular anatomical structure 407 before the slotted cannula is removed, for example, to keep the digital probe 106 within the vascular anatomical structure and prevent the slotted cannula from pulling the digital probe 106 back out of the vascular anatomical structure 407. Furthermore, while the slotted cannula is being withdrawn from the patient's vascular anatomical structure 407, the digital probe 106 / auxiliary length 120 of the digital probe may exit the slotted cannula so that the divisible sheath is cut and the slot formed within the slotted cannula serves as an exit for the digital probe 106 as it is removed from the slotted cannula.

[0117] In some embodiments, the data hub 108 can be fixed to an external anatomical structure 409 of the patient. The external anatomical structure 409 to which the data hub is fixed may vary depending on the vascular anatomical structure 407 into which the digital probe 106 is inserted. For example, if the vascular anatomical structure 407 is a vein in the patient's arm, the data hub 108 can be fixed to the patient's arm near where the digital probe 106 has passed through the patient's skin.

[0118] As described in this disclosure, the vascular probe insertion assembly 100 may also include a data hub 108 operably coupled to the digital probe 106. The data hub 108 may include any type of circuitry used to receive and transmit data detected by the digital probe 106 when the digital probe 106 is successfully inserted into a patient's vein or artery. In some embodiments, this circuitry may include, for example, a wireless radio or other transmitting device that enables wireless transmission of data detected by the digital probe 106 to a vascular monitoring system as described in this disclosure. Furthermore, the data hub 108 may include, among other circuits, a power supply, a PMU, and a microcontroller or other hardware processing devices. In some embodiments, the data hub 108 may include one or more visual indicators 116 used to inform a healthcare professional that the data hub 108 is detecting parameters of the patient's vascular anatomy because the digital probe 106 is properly inserted into the patient's vascular anatomy. These visual indicators 116 may include various different colored light-emitting diodes (LEDs) that can indicate proper placement of the digital probe 106 (e.g., a lit green LED), improper placement of the digital probe 106 (e.g., a lit red LED), or suboptimal placement of the digital probe 106 (e.g., a lit yellow LED). In some embodiments, data detected (or not detected) by the digital probe 106 may be used by a microcontroller in the data hub 108 to determine whether the digital probe 106 was properly, improperly, or suboptimally inserted into the patient's anatomical structure. In some embodiments, the data hub 108 may be fixed to the patient's external anatomical structure 409 using, for example, a transparent film dressing (e.g., 3M® TEGADERM® transparent film dressing), so that healthcare professionals can still see the visual indicators 116 present on the data hub 108. The data hub 108 may be fixed to the patient's external anatomical structure 409 using other fixation devices.Furthermore, the fixation device may be selectively removable so that healthcare professionals can remove the fixation device to replace a new set of fixation devices or to eventually remove the digital 106 and data hub 108 when monitoring of the patient's vascular anatomy 407 is no longer required.

[0119] Figure 24 is a graphic diagram of a vascular probe insertion assembly 100 interfaced with a data processing and cloud-based system 2445, according to some embodiments of the present disclosure. As described in the present disclosure, the vascular probe insertion assembly 100 may be operably coupled to the data processing and cloud-based system 2445 via a wired or wireless connection. In some embodiments, the vascular probe insertion assembly 100 may be operably coupled to a patient monitor 2447. In some embodiments, the patient monitor 2447 may be a bedside monitoring system located near the patient in a hospital room. This patient monitor 2447 may allow healthcare professionals to view real-time blood-based critical patient parameters detected by the digital probe of the vascular probe insertion assembly 100 when the digital probe of the vascular probe insertion assembly 100 is placed within the patient's vascular anatomical structure.

[0120] In some embodiments, the vascular probe insertion assembly 100 may be additionally or alternatively operably coupled to a mobile phone 2449 or other handheld device within a data processing and cloud-based system 2445. Similar to the patient monitor 2447, the mobile phone 2449 may provide healthcare professionals with real-time blood-based critical patient parameters detected by the digital probe of the vascular probe insertion assembly 100 when the digital probe of the vascular probe insertion assembly 100 is embedded within the patient's vascular anatomical structure. In some embodiments, the mobile phone 2449 may execute computer-readable program code for a monitoring application associated with the vascular probe insertion assembly 100.

[0121] In some embodiments, the vascular probe insertion assembly 100 may be operably coupled to a vital signs monitor 2451 in a data processing and cloud-based system 2445. In some embodiments, the vital signs monitor 2451 may reside, for example, in a nursing station or other remote desktop, allowing healthcare professionals to monitor the patient's blood-based critical patient parameters detected by the digital probe 106 of the vascular probe insertion assembly 100. It is understood that any or all of the patient monitor 2447, mobile phone 2449, and / or vital signs monitor 2451 may be used by healthcare professionals to confirm and monitor the patient's blood-based critical patient parameters as the digital probe is positioned within the patient's vascular anatomical structure. Each of the patient monitor 2247, mobile phone 2449, and vital signs monitor 2451 may be coupled to one another for communication between these devices. Furthermore, each of the patient monitor 2447, mobile phone 2449, and vital signs monitor 2451 may be operably coupled to a cloud network 2453 used by the hospital to maintain records related to the patient's blood-based critical patient parameters, for example, when the digital probe of the vascular probe insertion assembly 100 is positioned within the patient's vascular anatomical structure. In some embodiments, the cloud network 2453 may include a backend server 2455 used to maintain this data.

[0122] In some embodiments, the data processing and cloud-based system 2445 may include artificial intelligence (AI) data algorithms and computer-readable program code used to detect and predict the onset of complications, treatment response, health improvement, and / or changes in the patient's disease state based on data received by the digital probe of the vascular probe insertion assembly 100. Execution of the computer-readable program code of the AI ​​data algorithms may be completed using any of the hardware processing devices described herein, such as the patient monitor 2447, mobile phone 2449, vital signs monitor 2451, and / or backend server 2455. Thus, any of these devices may be used to detect and predict the onset of complications, treatment response, health improvement, and / or changes in the patient's disease state based on data received by the digital probe of the vascular probe insertion assembly 100. Furthermore, when the execution of the AI ​​data algorithms detects any of the onset of complications, treatment response, health improvement, and / or changes in the patient's disease state, an alert (e.g., a visual alert, an audible alert, etc.) indicating a change in a key blood-based patient parameter may be issued to a healthcare professional, as described herein.

[0123] Figure 25 is a side cross-sectional view of a vascular probe insertion assembly 100 according to some embodiments of the present disclosure. Figure 25 shows a vascular probe insertion assembly 100 cut in cross-section along a digital probe channel (e.g., Figure 1, 118) showing the digital probe 100 as it passes through the data hub 108 before insertion of a slotted cannula 102.

[0124] Figure 25 further shows that the needle hub 110 is in fluid communication with the slotted cannula 102 and the detachable sheath 104. As described herein, this allows a healthcare professional to detect when the slotted cannula 102 has been inserted into the patient's vascular anatomy. The healthcare professional detects this by visually monitoring the presence of blood in the fluid reservoir 112 of the needle hub 110. Once blood is detected in the fluid reservoir 112, the healthcare professional may continue to remove the needle hub 110 from the data hub 108 and the needle safety shield 114, as described herein, thereby removing these elements from the data hub 108 in addition to the patient's vascular anatomy. Furthermore, before removing the slotted cannula 102 from the patient's vascular anatomy, the healthcare professional may use the auxiliary length 120 of the digital probe to advance the digital probe 106 further into the patient's vascular anatomy. In this embodiment, a healthcare professional may grasp the auxiliary length 120 of the digital probe and advance the digital probe 106 further into the digital probe channel 118 and into the slotted cannula 102 / divisible sheath 104 to advance it further into the patient's vascular anatomical structure. As described in this disclosure, a healthcare professional may refer to a visual indicator on the data hub 108 (not shown in Figure 25) to determine whether advancing the auxiliary length 120 of the digital probe into the patient's vascular anatomical structure results in proper placement of the digital probe 106.

[0125] Figure 26 is a block diagram of a method 2600 for manufacturing a vascular probe insertion assembly according to some embodiments of the present disclosure. Method 2600 may include, in block 2605, inserting a digital probe into a slotted cannula. As described in the present disclosure, the slots formed in the slotted cannula form side walls extending along the longitudinal direction of the slotted cannula, which, apart from the slots, coaxially hold the digital probe inside. Thus, the digital probe may travel coaxially within the slotted cannula until the slotted cannula is removed from the patient's anatomical structure, as described in the present disclosure.

[0126] In block 2610, method 2600 may further include forming a needle safety shield around a slotted cannula by passing a slotted cannula (and digital probe) through a via formed by penetrating the needle safety shield. The needle safety shield is formed around a portion of the slotted cannula and can move along the shaft of the slotted cannula during manipulation by a healthcare professional. Furthermore, in some embodiments, the needle safety shield may include a needle safety shield cutting blade used to cut a divisible sheath during withdrawal of the slotted cannula from the patient's vascular anatomical structure.

[0127] Method 2600 may further include, in block 2615, forming a divisible sheath around a slotted cannula to secure the digital probe to the slotted cannula during insertion into the patient's vascular anatomical structure. As described herein, the divisible sheath may be made of a material that can be cut or otherwise divided using the needle safety shield cutting blade of the needle safety shield.

[0128] Method 2600 may further include, in block 2620, operably coupling a data hub to a digital probe. The data hub may include any type of circuitry used to receive and transmit data detected by the digital probe when the digital probe is successfully inserted into a patient's vein or artery. In some embodiments, this circuitry may include, for example, a wireless radio or other transmitting device that enables wireless transmission of data detected by the digital probe to a vascular monitoring system described in this disclosure. Furthermore, the data hub may include, among other circuits, a power supply, a PMU, and a microcontroller or other hardware processing devices. In some embodiments, the data hub may include one or more visual indicators used to inform a healthcare professional, for example, that the data hub is detecting parameters of the patient's vascular anatomy because the digital probe is properly inserted into the patient's vascular anatomy. These visual indicators may include LEDs of various different colors that can indicate proper placement of the digital probe (e.g., a lit green LED), improper placement of the digital probe (e.g., a lit red LED), or suboptimal placement of the digital probe (e.g., a lit yellow LED). In some embodiments, data detected (or not detected) by the digital probe may be used by a microcontroller in a data hub to determine whether the digital probe was inserted appropriately, inappropriately, or suboptimally within the patient's anatomical structure.

[0129] Figure 27 is a block diagram of a method 2700 for inserting a digital probe of a vascular probe insertion assembly into a patient's anatomical structure, according to some embodiments of the present disclosure. Method 2700 may begin in block 2705 with a healthcare professional inserting the slotted cannula, digital probe, and divisible sheath of the vascular probe insertion assembly into the patient's vascular anatomical structure. This may be done after the healthcare professional has addressed the patient's anatomical structure to determine the position in which the digital probe may be positioned within the patient's vein or artery. As described in the present disclosure, a vascular probe insertion assembly may include a slotted cannula, digital probe, and divisible sheath having a specific length. The length of the slotted cannula, digital probe, and divisible sheath inserted into the patient's anatomical structure and the vascular anatomical structure may depend on the insertion site in the patient's body.

[0130] As described herein, a slotted cannula can be fluidly coupled to a fluid reservoir of a needle hub. Thus, method 2700 may include, in block 2710, determining whether a healthcare professional detects the presence of blood in the fluid reservoir of the needle hub and whether a visual indicator on the data hub indicates proper insertion. Again, the presence of blood in the fluid reservoir allows the healthcare professional to visually detect that the slotted cannula has reached a vein or artery. For example, since the needle hub is made of transparent plastic, the healthcare professional can visually detect the filling of the fluid reservoir. Furthermore, the data hub may include one or more visual indicators used to inform the healthcare professional, for example, that the data hub is detecting parameters of the patient's vascular anatomy because the digital probe has been properly inserted into the patient's vascular anatomy. These visual indicators may include LEDs of various different colors that can indicate proper placement of the digital probe (e.g., a lit green LED), improper placement of the digital probe (e.g., a lit red LED), or suboptimal placement of the digital probe (e.g., a lit yellow LED). In some embodiments, data detected (or not detected) by the digital probe may be used by a microcontroller in a data hub to determine whether the digital probe was properly, improperly, or suboptimally inserted into the patient's anatomical structure.

[0131] If the healthcare professional has not detected the presence of blood in the fluid reservoir, or if a visual indicator on the data hub has detected an improper or suboptimal placement of the digital probe ("No" in block 2710), method 2700 may continue to advance the slotted cannula (equipped with the digital probe and a detachable sheath) and, if available, the auxiliary length of the digital probe, into the patient's vascular anatomical structure, in block 2715. Advancement of the cannula into the patient's anatomical structure to reach the patient's vascular anatomical structure may be continued until the healthcare professional detects blood in the fluid reservoir of the needle hub. Instead of a needle hub, it is understood that the vascular probe insertion assembly may include a syringe for use by the healthcare professional to determine whether the slotted cannula has reached the patient's vascular anatomical structure, as described in this disclosure. Furthermore, if the healthcare professional detects blood in the fluid reservoir (or the barrel of the syringe), the healthcare professional may further advance the auxiliary length of the digital probe into the patient's vascular anatomical structure, as described in this disclosure. According to Method 2700, healthcare workers may continue monitoring for the presence of blood in the needle hub and confirming the proper placement of the digital probe via a visual indicator until both are visually detected.

[0132] If the presence of blood is detected and a visual indicator on the data hub indicates the proper placement of the digital probe, method 2700 may include, in block 2720, a healthcare worker retracting a slotted cannula through a via formed through the needle safety shield. When this occurs, as described in the disclosure, the needle safety shield cutting blades split the divisible sheath to expose the slot formed in the slotted cannula. Also, by pulling the divisible sheath and the slotted cannula through the via formed in the needle safety shield, the angled and sharp tip of the slotted cannula is retained within the needle safety shield, and as a result, this sharp tip does not inadvertently injure the healthcare worker. Furthermore, in block 2725, when the healthcare worker pulls the needle safety shield away from the data hub, the needle safety shield is also pulled away from the data hub.

[0133] Method 2700 may also include, in block 2730, the disposal of the needle safety shield, slotted cannula, detachable sheath, and needle hub by a healthcare worker. Since they have been used, the needle safety shield, slotted cannula, and needle hub may be discarded or treated as biohazards using appropriate disposal procedures.

[0134] Method 2700 may further include, in block 2735, securing the external portion of the digital probe and the data hub to the external anatomical structure of the patient. It is understood that any fixation dressing having a transparent window (e.g., 3M® TEGADERM® transparent film dressing), as well as any fixation dressing including any adhesive stabilization platform for the data hub, may be used.

[0135] The vascular probe insertion assemblies described herein can provide direct intravascular measurements of key hemodynamic and blood-based patient parameters with minimal footprint on the patient's body. The vascular probe insertion assemblies also enable continuous or intermittent monitoring without the procedural and workflow difficulties associated with other monitoring systems. Furthermore, the use of the vascular probe insertion assemblies described herein does not require the use of separate catheters or vascular access devices. Moreover, there are no risks associated with other systems used to complete the measurements that the vascular probe insertion assemblies can achieve. The vascular probe insertion assemblies described herein can be used for short-term or long-term monitoring of key vascular-based parameters while the digital probe is in place.

[0136] All embodiments and conditional statements incorporated herein are intended for educational purposes to help the reader understand the concepts to which the inventors have contributed to further the invention and the art, and should be construed as not being limited to such specifically incorporated embodiments and conditions. Although embodiments of this disclosure are described in detail, it should be understood that various modifications, substitutions, and alternatives can be made to this specification without departing from the spirit and scope of the disclosed embodiments.

Claims

1. A vascular probe insertion assembly, It is a cannula with a slot, A sharp tip designed to be inserted into the patient's vascular anatomical structure, and A slotted cannula comprising a side wall extending proximal to the sharp tip, wherein the side wall defines a slot, A divisible sheath formed to surround at least a portion of the side wall, It is a digital probe, A sensor tip configured to generate sensor data indicating the movement of the vascular anatomical structure, and The digital probe comprises a shaft extending proximal to the tip of the sensor, A data hub operably coupled to the digital probe, wherein the data hub is configured to receive the sensor data and transmit the sensor data to a monitoring system, A vascular probe insertion assembly equipped with the following features.

2. The vascular probe insertion assembly according to claim 1, further comprising a needle hub operably coupled to the proximal end of the slotted cannula, wherein the needle hub includes a fluid reservoir for a healthcare professional to determine when the slotted cannula has been inserted into the patient's vascular anatomical structure.

3. The vascular probe insertion assembly according to claim 1, further comprising a needle safety shield having a via through which the slotted cannula can pass, wherein the needle safety shield is operably coupled with the data hub such that when the slotted cannula is removed from the patient's vascular anatomical structure, the sharp tip slides into the needle safety shield and is received within the needle safety shield slide.

4. The vascular probe insertion assembly according to claim 3, further comprising a needle safety shield cutting blade formed within the via and positioned to cut the divisible sheath when the vascular probe is withdrawn from within the patient's vascular anatomical structure.

5. The vascular probe insertion assembly according to claim 1, further comprising a wireless transmitter formed in the data hub for wirelessly transmitting the sensor data to the monitoring system.

6. The vascular probe insertion assembly according to claim 1, further comprising an electrical interface configured to accept a wired connection on which the sensor data can be transmitted to the monitoring system.

7. The vascular probe insertion assembly according to claim 1, further comprising a syringe coupling function configured to fix the proximal end of the slotted cannula to a syringe, thereby facilitating the insertion of the slotted cannula into the vascular anatomical structure of the patient.

8. The vascular probe insertion assembly according to claim 1, further comprising a stabilization platform operably coupled to the data hub for fixing the data hub to the outer surface of the patient's vascular anatomical structure when the digital probe is maintained within the patient's vascular anatomical structure.

9. A method for inserting a digital probe of a vascular probe insertion assembly into the anatomical structure of a patient, The insertion of a slotted cannula into the vascular anatomical structure of the patient, wherein the slotted cannula is A sharp tip designed to be inserted into the vascular anatomical structure of the patient, A side wall extending proximal to the sharp tip, wherein the side wall defines a slot, A divisible sheath formed to surround at least a portion of the side wall, A needle safety shield is formed coaxially around the slotted cannula, A digital probe operably coupled to a data hub, wherein the digital probe is coaxially arranged within the slotted cannula and a divisible sheath, It is equipped with the ability to insert, The digital probe and data hub are positioned in a predetermined location, and the slotted cannula is drawn in through a via formed by penetrating the needle safety shield. The needle safety shield cutting blade separates the divisible sheath in order to expose the slot formed in the slotted cannula, Removing the needle safety shield from the data hub, A method that includes this.

10. The method according to claim 9, further comprising: the vascular probe insertion assembly further comprising a needle hub operably coupled to the proximal end of the slotted cannula, wherein the needle hub includes a fluid reservoir for a healthcare professional to determine when the slotted cannula has been inserted into the patient's vascular anatomical structure.

11. The method according to claim 9, further comprising the needle safety shield comprising a needle safety shield cutting blade disposed within the via formed through the needle safety shield, wherein the needle safety shield cutting blade comprises cutting the divisible sheath when the slotted cannula is withdrawn from within the patient's vascular anatomical structure.

12. The method according to claim 9, further comprising the data hub comprising a wireless transmitter for wirelessly transmitting data received by the digital probe to a vascular monitoring system when the digital probe is maintained within the vascular anatomical structure of the patient.

13. The method according to claim 9, further comprising the data hub having an electrical interface configured to accept a wired connection on which sensor data from the digital probe can be transmitted to a monitoring system.

14. The method according to claim 9, further comprising the vascular probe insertion assembly having a syringe coupling function configured to fix the proximal end of the slotted cannula to a syringe, thereby facilitating the insertion of the slotted cannula into the patient's vascular anatomical structure.

15. The method according to claim 9, further comprising operably coupling a stabilization platform to the data hub in order to fix the data hub to the outer surface of the patient's anatomical structure when the digital probe is maintained within the patient's vascular anatomical structure.

16. An indwelling vascular probe insertion assembly, A slotted cannula configured to facilitate insertion of the digital probe into the patient's vascular anatomical structure, wherein the slotted cannula is A sharp tip designed to be inserted into the patient's vascular anatomical structure, and A slotted cannula comprising a side wall extending proximal to the sharp tip, wherein the side wall defines a slot, A detachable sheath is formed coaxially on the outside of the aforementioned slotted cannula, A digital probe formed coaxially within the slotted cannula, wherein the digital probe is A sensor tip configured to generate sensor data indicating the movement of the vascular anatomical structure, and The digital probe comprises a shaft extending proximal to the tip of the sensor, A data hub operably coupled to the digital probe, A needle hub operably coupled to the slotted cannula, the needle hub includes a fluid reservoir for determining when the slotted cannula has been inserted into the patient's vascular anatomical structure, An indwelling vascular probe insertion assembly equipped with the following features.

17. The indwelling vascular probe insertion assembly according to claim 16, further comprising a needle safety shield having a via through which the slotted cannula can pass, wherein the needle safety shield is operably coupled with the data hub such that when the slotted cannula is removed from the patient's vascular anatomical structure, the sharp tip slides into the needle safety shield and is received within the needle safety shield slide.

18. The indwelling vascular probe insertion assembly according to claim 17, further comprising a needle safety shield cutting blade formed in the via formed through the needle safety shield to cut the divisible sheath when the digital probe is withdrawn from within the patient's vascular anatomical structure.

19. The indwelling vascular probe insertion assembly according to claim 16, further comprising a wireless transmitter formed in the data hub for wirelessly transmitting the sensor data to a monitoring system.

20. The indwelling vascular probe insertion assembly according to claim 16, further comprising an electrical interface configured to accept a wired connection on which the sensor data can be transmitted to the monitoring system.

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