Vascular probe insertion assembly and indwelling vascular probe insertion assembly

Abstract

The utility model discloses a blood vessel probe insertion assembly and an indwelling blood vessel probe insertion assembly, and the blood vessel probe insertion assembly comprises a slotted sleeve which comprises a sharp tip configured to be inserted into a blood vessel anatomical structure of a patient; and a sidewall extending proximally from the sharp tip and defining a slot; a split sheath shaped to surround at least a portion of the sidewall; a digital probe comprising: a sensor tip configured to generate sensor data indicative of operation of the vascular anatomy; and a shaft extending proximal to the sensor tip; and a data hub operatively coupled to the digital probe, where the data hub is configured to receive sensor data and transmit the sensor data to a monitoring system. Vascular probe insertion assemblies described in the present disclosure enable direct intravascular measurement of hemodynamic and blood-based critical patient parameters with minimal footprint on the patient's body.

Description

Technical Field

[0001] The present disclosure generally relates to a vascular probe insertion assembly for inserting a digital probe into a patient's vascular anatomy, and more particularly, to a vascular probe insertion assembly and an indwelling vascular probe insertion assembly. Background Art

[0002] Arterial catheters and systems provide healthcare professionals with a method for monitoring 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 may have a significant risk of blood exposure and other performance issues, such as accurate placement of the arterial catheter. Further, current hemodynamic monitoring and ABG collection systems can be very complex, expensive, and may require significant time and resources to collect the necessary samples. Further, significant time and resources may be required to maintain the arterial line to minimize the risk of complications such as infections and catheter-related bloodstream infections (CRBSIs). Still further, in other procedures associated with currently implemented arterial catheters, significant time and resources may be required to ensure proper line and device flushing and preservation of arterial blood.

[0003] The subject matter claimed in the present disclosure is not limited to embodiments that solve any disadvantages or operate only in environments such as those described in the present disclosure. Rather, this background is provided to describe the environment in which the presently described embodiments may operate. Summary of the Utility Model

[0004] The present disclosure generally relates to a vascular probe insertion assembly for inserting a digital probe into a patient's vascular anatomy. In the embodiments described in the present disclosure, the vascular probe may include a slotted cannula for inserting the vascular probe into the patient's vascular anatomy. This slotted cannula may have a slot formed along the length of the slotted cannula such that the digital probe can be coaxially placed therein. In some embodiments, a split sheath may be coaxially formed outside the slotted cannula to hold the digital probe within the slotted cannula. After inserting the cannula into the patient's vascular anatomy, a data hub operatively coupled to the digital probe may be attached to the patient's body such that the digital probe remains within the patient's vascular anatomy.

[0005] In some embodiments, a vascular probe insertion assembly comprises: a slotted cannula comprising: a sharp tip configured to be inserted into a patient's vascular anatomy; and a sidewall extending proximally from the sharp tip, the sidewall defining a slot; a detachable sheath formed to surround at least a portion of the sidewall; a digital probe comprising: a sensor tip configured to generate sensor data indicative of operation of the vascular anatomy; and a shaft extending proximal to the sensor tip; and a data hub operatively 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.

[0006] In some embodiments, an indwelling vascular probe insertion assembly comprises: a slotted cannula configured to facilitate insertion of the digital probe into a patient's vascular anatomy, the slotted cannula comprising: a sharp tip configured to be inserted into the patient's vascular anatomy; and a sidewall extending proximally from the sharp tip, the sidewall defining a narrow slot; a detachable sheath coaxially formed on the outside of the slotted cannula; a digital probe coaxially formed within the slotted cannula, the digital probe comprising: a sensor tip configured to generate sensor data indicative of operation of the vascular anatomy; and an axis extending proximal to the sensor tip; and a data hub operatively connected to the digital probe; and a needle hub operatively connected to the slotted cannula, the needle hub comprising a fluid container to determine when the slotted cannula is inserted into the patient's vascular anatomy.

[0007] In some embodiments, the needle hub is operably coupled to the slotted cannula.The needle hub may include a fluid reservoir to determine when the cannula has been inserted into the patient's vascular anatomy.

[0008] In some embodiments, the vascular probe includes a needle safety shield including a passageway through which the cannula can pass. The needle safety shield can be operatively coupled to the data hub. In some embodiments, the cannula can slide relative to the needle safety shield as the cannula is proximally withdrawn, and the needle safety shield can cover the bevel when the cannula is removed from the patient's vascular anatomy. In some embodiments, the needle safety shield includes a needle safety shield cutting blade formed within the passageway formed through the needle safety shield to cut the splittable sheath when the vascular probe is retracted from the patient's vascular anatomy.

[0009] In some embodiments, the data concentrator includes a wireless transmitter formed within the data concentrator to wirelessly transmit data received at a digital probe within a patient's vascular anatomy to a vascular monitoring system. In some embodiments, the vascular probe includes contact pins formed at the proximal end of the data concentrator to dock with a wired connection that operatively couples the data concentrator to the vascular monitoring system.

[0010] In some embodiments, the vascular probe may include means for safely inserting the cannula into the patient's anatomy and means for holding the data concentrator to the patient's body (such as the arm). In some embodiments, the vascular probe may include a syringe operatively coupled to the proximal end of the slotted cannula to provide a stable insertion of the slotted cannula into the patient's vascular anatomy. In some embodiments, the vascular probe may include a stabilization platform operatively coupled to the data concentrator to secure the data concentrator to the outer surface of the patient's anatomy while the digital probe is maintained within the patient's vascular anatomy.

[0011] This specification also describes a method of manufacturing a vascular probe. 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 the slotted cannula by passing the slotted cannula through a passage formed in a needle safety shield. In some embodiments, the method may include forming a split sheath around the slotted cannula to secure the digital probe within the slotted cannula during insertion into the patient's vascular anatomy and operatively coupling the data concentrator to the digital probe.

[0012] The vascular probe insertion assembly described in this disclosure enables direct intravascular measurement of hemodynamic and blood-based critical patient parameters with minimal footprint on the patient's body. The vascular probe insertion assembly also allows for continuous or intermittent monitoring without the procedural and workflow difficulties associated with other monitoring systems. Further, the use of a vascular probe insertion assembly as described in this disclosure does not require the use of a separate catheter or vascular access device. Still further, there are risks associated with other systems used to accomplish the measurements that the vascular probe insertion assembly can achieve. The vascular probe insertion assembly described in this disclosure can be used to monitor critical vascular-based parameters short-term or long-term with the digital probe in place.

[0013] It should be understood that the foregoing general description and the following detailed description are both exemplary and explanatory and do not limit the claimed utility model. It should be understood that the various embodiments are not limited to the arrangements and means illustrated in the drawings. It should also be understood that these embodiments can be combined, or other embodiments can be utilized, and structural changes can be made without departing from the scope of the various embodiments of the utility model unless so stated. Therefore, the following detailed description should not be considered restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Example embodiments will be described and explained with additional specificity and detail by using the drawings, in which:

[0015] Figure 1 is a side perspective view of a blood vessel probe insertion assembly according to some embodiments of the present disclosure;

[0016] Figure 2 is a side perspective view of a blood vessel probe insertion assembly according to some embodiments of the present disclosure;

[0017] Figure 3 is a side perspective view of a needle safety shield of a blood vessel probe insertion assembly according to some embodiments of the present disclosure;

[0018] Figure 4 is a perspective view of a digital probe of a blood vessel probe insertion assembly for accessing a blood vessel anatomy according to some embodiments of the present disclosure;

[0019] Figure 5 is a perspective view of a blood vessel probe insertion assembly according to some embodiments of the present disclosure;

[0020] Figure 6 is a side perspective view of a blood vessel probe insertion assembly according to some embodiments of the present disclosure;

[0021] Figure 7 is a side elevation view of a data concentrator and a digital probe of a blood vessel probe insertion assembly according to some embodiments of the present disclosure;

[0022] Figure 8 is a top view of a data concentrator and a digital probe of a blood vessel probe insertion assembly according to some embodiments of the present disclosure;

[0023] Figure 9 is a top view of a data concentrator and a digital probe of a blood vessel probe insertion assembly according to some embodiments of the present disclosure;

[0024] Figure 10 is a top view of a digital probe and a data concentrator according to some embodiments of the present disclosure;

[0025] Figure 11 is a side perspective view of a blood vessel probe insertion assembly according to some embodiments of the present disclosure;

[0026] Figure 12 is a side perspective view of a blood vessel probe insertion assembly according to some embodiments of the present disclosure;

[0027] Figure 13 is a side perspective view of a digital probe inserted into a blood vessel anatomy according to some embodiments of the present disclosure;

[0028] Figure 14 is a top view of a digital probe and a data set hub according to some embodiments of the present disclosure;

[0029] Figure 15 is a top view of a digital probe, a data set hub, and a wired connection portion according to some embodiments of the present disclosure;

[0030] Figure 16 is a top view of a digital probe, a data set hub, and a wired connection portion according to some embodiments of the present disclosure;

[0031] Figure 17 is a perspective view of a blood vessel probe insertion assembly having a wired connection portion according to some embodiments of the present disclosure;

[0032] Figure 18 is a side view of a digital probe having a wired connection portion according to some embodiments of the present disclosure;

[0033] Figure 19 is a top view of a digital probe and a data set hub according to some embodiments of the present disclosure;

[0034] Figure 20 is a top view of a digital probe and a data set hub according to some embodiments of the present disclosure;

[0035] Figure 21 is a side perspective view of a blood vessel probe insertion assembly according to some embodiments of the present disclosure;

[0036] Figure 22 is a side perspective view of a blood vessel probe insertion assembly according to some embodiments of the present disclosure;

[0037] Figure 23 is a side perspective view of a blood vessel probe inserted into a blood vessel anatomy according to some embodiments of the present disclosure;

[0038] Figure 24 is a schematic diagram of a blood vessel probe insertion assembly docked with a data processing and cloud-based system according to some embodiments of the present disclosure;

[0039] Figure 25 is a side cross-sectional perspective view of a blood vessel probe insertion assembly according to some embodiments of the present disclosure;

[0040] Figure 26 is a block diagram of a method of manufacturing a vascular probe insertion assembly according to some embodiments of the present disclosure; and

[0041] Figure 27 is a block diagram of a method of inserting a digital probe of a vascular probe insertion assembly into a patient's anatomy according to some embodiments of the present disclosure. DETAILED DESCRIPTION

[0042] Figure 1 is a side perspective view of a vascular probe insertion assembly 100 according to some embodiments of the present disclosure. A doctor, nurse, or other healthcare professional may use the vascular probe insertion assembly 100 to monitor, detect, and / or measure various blood flow-based parameters within a patient's vascular anatomy. In the present disclosure, the term "vascular anatomy" is understood to mean any blood vessel or artery in which the patient's blood is present. The blood flow-based parameters to be monitored, detected, and / or measured may include, for example, venous or arterial blood pressure, temperature, the pH (acidity or alkalinity) of the patient's blood, the presence of organic compounds such as lactate, the presence and amount of oxygen (O2) in the blood, the percentage of oxygen (SPO2), and other inter-vascular parameters that can be detected.

[0043] The vascular probe insertion assembly 100 may include a variety of 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 length of the slotted cannula 102, in which the digital probe 106 may be placed. The slot formed in the slotted cannula 102 may form sidewalls that extend along the length of the slotted cannula 102. In some embodiments, the sidewalls may maintain the digital probe 106 coaxially or approximately coaxially within the slotted cannula 102, except at the slot. Thus, in some embodiments, as described in the present disclosure, the digital probe 106 may operate coaxially within the slotted cannula 102 until the slotted cannula 102 is removed from the patient's anatomy. In some embodiments, the digital probe 106 may not be coaxial with the slotted cannula 102. In some embodiments, the orientation of the slot formed in the slotted cannula 102 is aligned with a groove or digital probe channel formed through the data concentrator 108, such that when the digital probe 106 is inserted into the patient's vascular anatomy, the digital probe 106 may exit the digital probe channel formed in the data concentrator 108. In some embodiments, the slotted cannula 102 may include a sharp point and / or may be constructed of a rigid material to facilitate entry of the slotted cannula 102 and the split sheath 104 into the patient's vasculature. In some embodiments, the split sheath 104 forms a closed fluid channel around the slotted cannula 102, allowing fluid, such as blood, to flow through the split sheath 104 and providing visual and tactile feedback to the user of the entry of the vascular probe insertion assembly 100 into the patient's vasculature.

[0044] In some embodiments, the digital probe 106 includes a core wire for structure and durability during advancement of the digital probe 106 through a patient's vascular anatomy. The core wire can be a nitinol core wire that runs the length of the digital probe 106 at or off the central axis of the digital probe 106. In some embodiments, the digital probe 106 includes optical fibers and / or wires that are connected to one or more sensors placed along the length of the digital probe 106. In some embodiments, the distal end of the digital probe 106 includes an atraumatic tip that reduces the risk of the digital probe 106 causing injury or complications in a patient's vein or artery.

[0045] The digital probe 106 can be coated with a variety of coatings for improving the performance of the digital probe 106 and reducing the risk of complications such as thrombus or probe-related bloodstream infections (such as sepsis). These coatings can include silicone lubricants with or without antimicrobial additives such as alkanes or saturated hydrocarbons (such as CH(x)). The digital probe 106 can be coated with an antithrombotic or antimicrobial coating and / or polymer additives.

[0046] In some embodiments, the sensors present on the digital probe 106 can include any number or type of sensors that detect or measure parameters of a patient's vascular anatomy. The sensors can be placed along the digital probe 106 as individual sensors or sensor bundles. The sensors can include sensors incorporating technologies capable of detecting or measuring a patient's blood pressure (venous or arterial), blood gas, blood pH level, and presence of electrolytes, as well as other types of sensors. In some embodiments, the sensors present on the digital probe 106 can be selected to detect or measure other target physiological or procedural parameters.

[0047] The vascular probe insertion assembly 100 can include a split sheath 104 formed around the slotted cannula 102. The split sheath 104 can extend the entire length of the slotted cannula 102 except along the beveled portion of the slotted cannula 102. This allows the sharp terminal end of the slotted cannula 102 to penetrate the patient's skin when a healthcare professional accesses a patient's vein or artery. During insertion of the vascular probe insertion assembly 100 into a patient's vascular anatomy, the split sheath 104 can also prevent the digital probe 106 from exiting the slot formed along the slotted cannula 102.

[0048] The vascular probe insertion assembly 100 may include a needle hub 110 that is operatively coupled to the proximal end of a slotted cannula 102. The proximal end of the slotted cannula 102 is opposite the beveled portion of the slotted cannula 102, and the beveled portion of the slotted cannula 102 forms a sharp tip that is configured to be inserted into a patient's vascular anatomy. The needle hub 110 may include a hollow chamber or fluid reservoir 112 that is fluidly coupled to the interior of the slotted cannula 102. When a healthcare professional inserts the slotted cannula 102 into a patient's vascular anatomy, the fluid reservoir 112 may receive a quantity of blood. In this way, the healthcare professional can determine whether and when the slotted cannula 102 has penetrated the patient's vein or artery 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 the procedure while not aspirating a large quantity of blood from the patient's body. Because the fluid reservoir 112 is only used to detect when the slotted cannula 102 has reached a vein or artery, the fluid reservoir 112, along with the slotted cannula 102 and the needle safety shield 114 described in this disclosure, may be discarded when the digital probe 106 has been introduced into the patient's vascular anatomy and the slotted cannula 102 has been withdrawn from the vein or artery.

[0049] The vascular probe insertion assembly 100 may include a needle safety shield 114. The needle safety shield 114 forms around a portion of the slotted cannula 102 and allows movement along the axis of the slotted cannula 102 during operation. In some embodiments, the needle safety shield 114 has a passage formed therethrough such that the slotted cannula 102 can pass therethrough. Additionally, in some embodiments, the needle safety shield 114 includes a needle safety shield cutting blade ( Figure 1 not shown in the figures) that is used to cut the split sheath 104 during withdrawal of the slotted cannula 102 from the patient's vascular anatomy.

[0050] The vascular probe insertion assembly 100 may include a data set hub 108 operatively coupled to a digital probe 106. The data set hub 108 may include any type of circuitry for receiving and transmitting data detected by the digital probe 106 when the digital probe 106 has been successfully inserted into a patient's vein or artery. In some embodiments, this circuitry may include a radio or other transmitting device that allows for wireless transmission of data detected at the digital probe 106 to be sent to, for example, the vascular monitoring system described in this disclosure. Additionally, the data set hub 108 may include a power source, a power management unit (PMU), and a microcontroller or other hardware processing device, as well as other circuitry. In some embodiments, the data set hub 108 may include one or more visual indicators 116 for signaling to a healthcare professional, for example, that the data set hub 108 is detecting parameters of the patient's vascular anatomy due to the digital probe 106 being correctly inserted into the patient's vascular anatomy. These visual indicators 116 may include light-emitting diodes (LEDs) of a variety of different colors that may indicate correct placement of the digital probe 106 (e.g., green LED illuminated), incorrect placement of the digital probe 106 (e.g., red LED illuminated), or suboptimal placement of the digital probe 106 (e.g., yellow LED illuminated). In some embodiments, the data (detected or not detected) by the digital probe 106 may be used by a microcontroller in the data set hub 108 to determine whether the digital probe 106 has been correctly, incorrectly, or suboptimally inserted into the patient's anatomy.

[0051] During operation of the vascular probe insertion assembly 100, a healthcare professional may address the patient's anatomy and determine a location where the digital probe 106 may be placed within a patient's vein or artery. Once an appropriate injection site has been determined, the healthcare professional may insert the vascular probe insertion assembly 100, and specifically the slotted cannula 102 with the digital probe 106 and the split sheath 104, into a vein or artery within the patient's anatomy. At this point, because the slotted cannula 102 is in fluid communication with the fluid reservoir 112 of the needle hub 110, the healthcare professional may visually detect that the slotted cannula 102 has reached a vein or artery by the presence of blood in the fluid reservoir 112. For example, because the needle hub 110 is made of transparent plastic, the healthcare professional may visually detect the filling of the fluid reservoir 112.

[0052] Once a healthcare professional detects the presence of blood in the fluid container 112 of the needle hub 110, indicating that the slotted cannula 102 has reached a vein or artery, the healthcare professional can begin to remove the vascular probe insertion assembly 100 from the patient. In some embodiments, the healthcare professional can do this by grasping the needle hub 110 in one hand and grasping the data set hub 108 / needle safety shield 114 with the other hand. While holding the data set hub 108 / needle safety shield 114 in place, the healthcare professional can begin to pull the needle hub 110 away from the patient and the remainder of the vascular probe insertion assembly 100. By doing so, as the slotted cannula 102 is pulled through the passage formed through the needle safety shield 114, the needle safety shield cutting blade of the needle safety shield 114 ( Figure 1 (not shown in

[0053] ) can begin to cut the split sheath 104. This will continue until the beveled portion of the slotted cannula 102 is safely received within the passage formed through the needle safety shield 114. This process can also include removing the data set hub 108 from the needle safety shield 114. In some embodiments, the data set hub 108 and the needle safety shield 114 can be operatively coupled together via a track system such that they can slideably be removed from each other as the healthcare professional pulls the slotted cannula 102 and the split sheath 104 through the passage formed through the needle safety shield 114. When the beveled end of the slotted cannula 102 enters the passage formed through the needle safety shield 114, the slotted cannula 102 can be prevented from being completely removed from the passage to prevent the sharp point of the slotted cannula 102 from touching the healthcare professional and potentially injuring the healthcare professional. Additionally, the split sheath 104 that has been longitudinally cut along the length of the slotted cannula 102 can be separated from the slotted cannula 102 and discarded along with the needle hub 110, the slotted cannula 102, and the needle safety shield 114.

[0054] Additionally, when the slotted cannula 102 is withdrawn from the patient's vascular anatomy, the digital probe 106 can remain in the patient's vascular anatomy. In some embodiments, when the slotted cannula 102 is inserted into the vascular anatomy, a healthcare professional can further advance the complementary length 120 of the digital probe into the patient's vascular anatomy. This allows the digital probe 106 to be further advanced into the patient's vascular anatomy before the slotted cannula 102 is removed, such that, for example, the digital probe 106 remains in the vascular anatomy and the slotted cannula 102 does not pull the digital probe 106 back out of the vascular anatomy. Additionally, when the slotted cannula 102 is withdrawn from the patient's vascular anatomy, the digital probe 106 / the complementary length 120 of the digital probe may exit the slotted cannula 102 as the split sheath 104 is cut and the slots formed in the slotted cannula 102 serve as an exit through which the digital probe 106 will be removed from the slotted cannula 102.

[0055] When the slotted cannula 102, split sheath 104, needle safety shield 114, and needle hub 110 have been removed from the digital probe 106 and data set hub 108, a healthcare professional can determine whether the digital probe 106 has been successfully inserted into the patient's vascular anatomy. This can be done by visually determining whether the digital probe 106 appears to be passing into the patient's anatomy and whether a visual indicator 116 on the data set hub 108 indicates proper insertion of the digital probe 106. In the case where a healthcare professional has determined that the digital probe 106 is not properly inserted, the digital probe 106 can be removed by pulling the digital probe 106 from the patient's vascular anatomy, and a new vascular probe insertion assembly 100 can be used to identify a new insertion site. In the case where a healthcare professional has determined that the digital probe 106 has been properly inserted, the healthcare professional can attach the data set hub 108 to an external portion of the patient's anatomy (e.g., the arm) and apply an attachment dressing ( Figure 1 (not shown in) to prevent displacement of the digital probe 106. In some embodiments, a healthcare professional can also apply a skin adhesive at the injection site where the slotted cannula 102 enters the patient's body to attach the digital probe 106 to the patient during the time the digital probe 106 remains in place.

[0056] When a healthcare professional no longer needs the digital probe 106 and the data set hub 108 to detect or measure parameters of a patient's vascular anatomy, the healthcare professional may remove the digital probe 106 and the data set hub 108 and discard them. In some embodiments, the healthcare professional can do this by grasping the data set hub 108 and pulling away from the patient's body on the attached digital probe 106. This allows the digital probe 106 to be pulled out of a vein or artery, through the remainder of the patient's anatomy, and out of the hole formed by the slotted cannula 102 during insertion.

[0057] The vascular probe insertion assembly 100 described in the present disclosure can provide direct intravascular measurement of hemodynamic and blood-based critical patient parameters and has a minimal footprint on the patient's body. The vascular probe insertion assembly 100 can also allow continuous or intermittent monitoring without the procedural and workflow difficulties associated with other monitoring systems. Further, use of the vascular probe insertion assembly 100 described in the present disclosure may not require the use of a separate catheter or vascular access device. Still further, the vascular probe insertion assembly 100 can reduce the risks associated with other systems used to accomplish the measurements achievable by the vascular probe insertion assembly 100. When the digital probe 106 is in place in a patient's vein or artery, the vascular probe insertion assembly 100 described in the present disclosure can be used for short-term or long-term monitoring of critical vascular-based parameters.

[0058] Figure 2 is a side perspective view of a vascular probe insertion assembly 100 according to some embodiments of the present disclosure. Figure 2 The vascular probe insertion assembly 100 shown in Figure 1 can be similar to the vascular probe insertion assembly 100 shown in Figure 2 In the embodiment shown in Figure 1 the digital probe 106 and the data set hub 108 have been removed away from the slotted cannula 102, the needle safety shield 114, and the needle hub 110. Figure 1 The split sheath 104 shown in Figure 2 is not shown in

[0059] As Figure 2As depicted, the needle safety shield 114 may include a plurality of attachment surfaces 201 that mate with complementary attachment surfaces formed on the digital probe 106. During insertion of the slotted cannula 102 into a patient's vascular anatomy, the attachment surfaces 201 permit the needle safety shield 114 to be at least temporarily operatively coupled to the underside of the data hub 108. As described in the present disclosure, after the slotted cannula 102 has been inserted into a patient's vein or artery, it may subsequently be removed while the digital probe 106 and data hub 108 remain in place. In an embodiment of the present disclosure, removal of the slotted cannula 102 leaves the digital probe 106 within the patient's vein or artery while the data hub 108 (operatively 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, slotted cannula 102, and needle hub 110 may be removed away 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, slotted cannula 102, and needle hub 110 may be discarded or otherwise disposed of as a biohazard, taking appropriate disposal steps to do so.

[0060] As described in the present disclosure, the needle safety shield 114 may have a passage 203 formed therethrough such that the slotted cannula 102 may pass therethrough during operation by a healthcare professional. Additionally, in some embodiments, the needle safety shield 114 may include a needle safety shield cutting blade ( Figure 2 not shown in ) for cutting the split sheath 104 during withdrawal of the slotted cannula 102 from the patient's vascular anatomy.

[0061] The data hub 108 may remain with the patient and may later permit attachment to the outer surface of the patient's anatomy (e.g., the arm). As described in the present disclosure, the digital probe 106 may include a supplemental length 120 of the digital probe that permits a healthcare professional to further advance the digital probe 106 into the patient's anatomy and, if necessary, into a vein or artery. This advancement of the digital probe 106 may be accomplished using the supplemental length 120 of the digital probe while the slotted cannula 102 is within the vein or artery. Thus, during withdrawal of the slotted cannula 102, the length of the supplemental length 120 of the digital probe may be varied depending on whether the healthcare professional deems it necessary to further advance the digital probe 106 into the patient's vein or artery.

[0062] Figure 2 including the dashed box "A", generally containing Figure 2 the needle safety shield 114 shown in. Figure 3It also includes a frame "A" to highlight and show a larger image of a part of the needle safety shield 114 and the slotted cannula 102. Figure 3 is a side perspective view of the needle safety shield 114 of the vascular probe insertion assembly 100 similar to the vascular probe insertion assembly 100 according to some embodiments of the present disclosure. Figure 1 and Figure 2 shown in Figure 3 A closer view of the needle safety shield 114 is shown, which includes a passage 203 and a needle safety shield cutting blade 305 formed on the needle safety shield 114. Figure 3 The slotted cannula 102 in its most retracted position is also shown, where the beveled portion of the slotted cannula 102 is fully retracted into the passage 203.

[0063] As described in the present disclosure, the needle safety shield 114 can be used both as a shield to protect healthcare professionals from being stabbed by the used slotted cannula 102 and to cut the split sheath during operation (not shown in Figure 3 ). In some embodiments, the needle safety shield cutting blade 305 can be placed at the distal end of the passage 203 such that the split sheath can be cut by the needle safety shield cutting blade 305. When the slotted cannula 102 and the split sheath are pulled through the passage 203 of the needle safety shield 114, the split sheath can be cut by the needle safety shield cutting blade 305. This causes the split sheath to be opened along its entire length, allowing the digital probe ( Figure 3 not shown in

[0064] to be removed from the slotted cannula 102 and released from the remainder of the vascular probe insertion assembly 100, as described in the present disclosure.

[0065] Similarly, the needle safety shield 114 can include a plurality of attachment surfaces 201, and the attachment surfaces 201 are complementary to the attachment surfaces formed on the digital probe (Figure 3 ...(not shown in the figure) is docked. During the insertion of the slotted cannula 102 into the patient's vascular anatomy, the attachment surface 201 allows the needle safety shield 114 to be at least temporarily operatively coupled to the underside of the data hub 108. As described in the present disclosure, after the slotted cannula 102 has been inserted into the patient's vein or artery, the slotted cannula 102 can subsequently be removed while the digital probe and the data hub remain in place. In an embodiment of the present disclosure, the removal of the slotted cannula 102 leaves the digital probe within the patient's vein or artery while the data hub (operatively coupled to the digital probe) 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 ( Figure 3 ...(not shown in the figure) are removed away from the data hub, thereby separating the needle safety shield 114 from the data hub. At this time, the needle safety shield 114, the slotted cannula 102, and the needle hub can be discarded or otherwise disposed of as biohazardous materials, taking appropriate disposal steps to handle them accordingly.

[0066] In some embodiments, the needle safety shield 114 may include a groove or digital probe channel 118 formed along the needle safety shield 114 that mates with a groove formed in the data hub. These grooves formed through the needle safety shield 114 and the data hub allow the digital probe to be separated from the data hub such that the additional length of the digital probe can be secured to the patient's anatomy together with the data hub.

[0067] Figure 4 ...is a perspective view of the digital probe 106 of the vascular probe insertion assembly 100 for accessing the vascular anatomy 407 according to some embodiments of the present disclosure. Figure 4 ...shows that after a healthcare professional has removed, for example Figure 1 and Figure 2The digital probe 106 after the slotted cannula, split sheath, needle safety shield, and needle hub shown in [Figure 0] are in the installed position. As described in the present disclosure, the digital probe 106 remains when the slotted cannula is withdrawn from the patient's vascular anatomy 407. In some embodiments, after the slotted cannula is inserted into the vascular anatomy 407 but before the slotted cannula is removed from the patient's anatomy, a healthcare professional may further advance the supplemental length 120 of the digital probe into the patient's vascular anatomy. This allows the digital probe 106 to be further advanced into the patient's vascular anatomy 407 before removing the slotted cannula, for example, to keep the digital probe 106 within the vascular anatomy and prevent the slotted cannula from pulling the digital probe 106 back out of the vascular anatomy 407. Additionally, when the slotted cannula is withdrawn from the patient's vascular anatomy 407, the digital probe 106 / supplemental length 120 of the digital probe may exit the slotted cannula since the split sheath is cut and the slots formed in the slotted cannula serve as an exit for the digital probe 106 to be removed from the slotted cannula.

[0068] In some embodiments, the data concentrator 108 may be affixed to the patient's external anatomy 409. The external anatomy 409 to which the data concentrator is affixed may vary depending on the vascular anatomy 407 into which the digital probe 106 is inserted. For example, in the case where the vascular anatomy 407 is a vein within the patient's arm, the data concentrator 108 may be affixed to the patient's arm near the location where the digital probe 106 penetrates the patient's skin.

[0069] As described in the present disclosure, the vascular probe insertion assembly 100 may further include a data concentrator 108 operatively coupled to the digital probe 106. The data concentrator 108 may include any type of circuitry for receiving and transmitting data detected by the digital probe 106 when the digital probe 106 has been successfully inserted into the patient's vein or artery. In some embodiments, this circuitry may include a radio or other transmitting device that allows for wireless transmission of the data detected at the digital probe 106 to be sent to, for example, the vascular monitoring system described in the present disclosure. Additionally, the data concentrator 108 may include a power source, PMU, and microcontroller or other hardware processing device as well as other circuitry.

[0070] In some embodiments, the data hub 108 may include one or more visual indicators 116 for signaling to a healthcare professional that, for example, the data hub 108 is detecting parameters of the patient's vascular anatomy due to the proper insertion of the digital probe 106 into the patient's vascular anatomy. These visual indicators 116 may include light-emitting diodes (LEDs) of various different colors, which may indicate proper placement of the digital probe 106 (e.g., green LED lit), improper placement of the digital probe 106 (e.g., red LED lit), or suboptimal placement of the digital probe 106 (e.g., yellow LED lit). In some embodiments, the 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 has been properly, improperly, or suboptimally inserted into the patient's anatomy. In some embodiments, the data hub 108 may be secured to the patient's external anatomy 409 using, for example, a transparent film dressing (e.g., transparent film dressing) such that the healthcare professional can still observe the visual indicators 116 present on the data hub 108. Other securing devices may be used to secure the data hub 108 to the patient's external anatomy 409. Further, the securing device may be selectively removable such that when monitoring of the patient's vascular anatomy 407 is no longer required, the healthcare professional can remove the securing device to replace it with a new set or ultimately remove the digital probe 106 and the data hub 108.

[0071] Figure 5 is a perspective view of a vascular probe insertion assembly 100 according to some embodiments of the present disclosure. For example, Figure 5 the vascular probe insertion assembly 100 shown in Figure 1 may be similar to the vascular probe insertion assembly described in connection with

[0072] In some embodiments, the digital probe 106 may include a core wire for structure and durability during advancement of the digital probe 106 through a patient's vascular anatomy. The core wire may be a nitinol core wire that runs the length of the digital probe 106 at or offset from the central axis of the digital probe 106. In some embodiments, the digital probe 106 may include optical fibers and / or wires that are connected to one or more sensors placed along the length of the digital probe 106. In some embodiments, the distal end of the digital probe 106 may include an atraumatic tip that reduces the risk of the digital probe 106 causing injury or complications in a patient's vein or artery. In some embodiments, the proximal end of the digital probe 106 is operatively coupled within the digital probe 106 and, unlike Figure 1 the example embodiment shown in, the digital probe 106 does not include a supplemental length of the digital probe. This enables healthcare professionals to affix the data hub 108 to the patient's external anatomy without having to affix the unused portion of the digital probe 106 to the patient's external anatomy. Additionally, for a digital probe 106 of fixed length, healthcare professionals can understand that when the vascular probe insertion assembly 100 is properly used to insert the digital probe 106, the digital probe 106 is positioned within the patient's vascular anatomy at a length necessary to complete the monitoring of critical vascular-based parameters.

[0073] In some embodiments, the digital probe 106 may be coated with a variety of coatings for improving the performance of the digital probe 106 and reducing the risk of complications such as thrombus or probe-related bloodstream infections (e.g., sepsis). These coatings may include silicone lubricants, which may or may not include antimicrobial additives such as alkanes or saturated hydrocarbons (e.g., CH(x)). In some embodiments, the digital probe 106 may be coated with any antithrombotic or antimicrobial coating and / or polymer additive.

[0074] The sensors present on the digital probe 106 may include any number or type of sensors that detect or measure parameters of a patient's vascular anatomy. These sensors may be placed along the digital probe 106 as individual sensors or sensor bundles. These sensors may include sensors incorporating technologies capable of detecting or measuring a patient's blood pressure (venous or arterial), blood gas, blood pH level, and the presence of electrolytes, as well as other types of sensors. In some embodiments, the sensors present on the digital probe 106 may be selected to detect or measure other target physiological or procedural parameters.

[0075] The vascular probe insertion assembly 100 may further include a split sheath 104 formed around the slotted cannula 102. In some embodiments, the split sheath 104 may extend the entire length of the slotted cannula 102 except along the beveled portion of the slotted cannula 102. This allows the sharp distal end of the slotted cannula 102 to penetrate the patient's skin when a healthcare professional accesses the patient's vein or artery. The split sheath 104 also prevents the digital probe 106 from exiting the slot formed along the slotted cannula 102 during insertion of the vascular probe insertion assembly 100 into the patient's vascular anatomy.

[0076] The vascular probe insertion assembly 100 may include a needle hub 110 operatively coupled to the proximal end of the slotted cannula 102, the proximal end of the slotted cannula being opposite the beveled portion of the slotted cannula 102, the beveled portion of the slotted cannula 102 forming a sharp tip configured to be inserted into the patient's vascular anatomy. In one embodiment, the needle hub 110 may include a hollow chamber or fluid reservoir 112 fluidly coupled to the interior of the slotted cannula 102. When a healthcare professional inserts the slotted cannula 102 into the patient's vascular anatomy, the fluid reservoir 112 may receive a quantity of blood. In this manner, the healthcare professional can determine whether and when the slotted cannula 102 has penetrated the patient's vein or artery 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 also not withdrawing a large quantity of blood from the patient. Since the fluid reservoir 112 is only used to detect when the slotted cannula 102 has reached a vein or artery, the fluid reservoir 112, along with the slotted cannula 102 and the needle safety shield 114 described in this disclosure, may be discarded when the digital probe 106 has been introduced into the patient's vascular anatomy and the slotted cannula 102 has been withdrawn from the vein or artery.

[0077] The vascular probe insertion assembly 100 may further include a needle safety shield 114. The needle safety shield 114 forms around a portion of the slotted cannula 102 and allows movement along the axis of the slotted cannula 102 during operation. In some embodiments, the needle safety shield 114 has a passage formed therethrough such that the slotted cannula 102 can pass therethrough. Additionally, in some embodiments, the needle safety shield 114 may include a needle safety shield cutting blade ( Figure 1 not shown) for cutting the split sheath 104 during withdrawal of the slotted cannula 102 from the patient's vascular anatomy.

[0078] The vascular probe insertion assembly 100 may include a data hub 108 that is operatively coupled to the digital probe 106. The data hub 108 may include any type of circuitry for receiving and transmitting data detected by the digital probe 106 when the digital probe 106 has been successfully inserted into a vein or artery of a patient. In some embodiments, this circuitry may include a radio or other transmitting device that allows the data detected at the digital probe 106 to be wirelessly transmitted to, for example, a vascular monitoring system as described herein. Additionally, the data hub 108 may include a power supply, a power management unit (PMU), a microcontroller or other hardware processing device, and other circuitry. In some embodiments, the data hub 108 may include one or more visual indicators 116 for signaling to a healthcare professional that the data hub 108 is detecting parameters of the patient's vascular anatomy, for example, because the digital probe 106 has been correctly inserted into the patient's vascular anatomy. These visual indicators 116 may include a plurality of different colored light emitting diodes (LEDs) that may indicate correct placement of the digital probe 106 (e.g., a green LED illuminated), incorrect placement of the digital probe 106 (e.g., a red LED illuminated), or suboptimal placement of the digital probe 106 (e.g., a yellow LED illuminated). 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 has been correctly, incorrectly, or suboptimally inserted into the patient's anatomy.

[0079] During operation of the vascular probe insertion assembly 100, a healthcare professional can locate the patient's anatomy and determine where the digital probe 106 can be placed within the patient's vein or artery. Once the appropriate injection site has been determined, the healthcare professional can insert the vascular probe insertion assembly 100, and specifically the slotted cannula 102, along with its digital probe 106 and splittable sheath 104, into the patient's anatomy into the vein or artery. At this point, because the slotted cannula 102 is fluidically coupled to the fluid container 112 of the needle hub 110, the healthcare professional can visually detect that the slotted cannula 102 has reached the vein or artery by the presence of blood within the fluid container 112. For example, because the needle hub 110 is made of clear plastic, the healthcare professional can visually detect that the fluid container 112 is filled.

[0080] Once a healthcare professional detects the presence of blood in the fluid container 112 of the needle hub 110, or 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 vasculature to ensure that access to the vasculature is not lost during removal or proximal withdrawal of the slotted cannula 102. In some embodiments, after the digital probe 106 has been 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 in one hand and the data set hub 108 / needle safety shield 114 with the other hand. While holding the data set hub 108 / needle safety shield 114 in place, the healthcare professional may begin pulling the needle hub 110 away from the patient and the remainder of the vascular probe assembly 100. By doing so, as the slotted cannula 102 is pulled through the passage formed through the needle safety shield 114, the needle safety shield cutting blade of the needle safety shield 114 ( Figure 1 (not shown) may begin to cut the split sheath 104. This continues until the beveled portion of the slotted cannula 102 is safely received within the passage formed through the needle safety shield 114. The process may also include removing the data set hub 108 from the needle safety shield 114. In some embodiments, the data set hub 108 and the needle safety shield 114 may be operatively coupled together via a track system such that they may slideably be removed from each other as the healthcare professional pulls the slotted cannula 102 and the split sheath 104 through the passage formed through the needle safety shield 114.

[0081] When the beveled end of the slotted cannula 102 enters the passage formed through the needle safety shield 114, the slotted cannula 102 is prevented from being completely removed from the passage to prevent the sharp point of the slotted cannula 102 from contacting the healthcare professional and potentially injuring the healthcare professional. Additionally, the split sheath 104 that has been longitudinally cut along the length of the slotted cannula 102 may be separated from the slotted cannula 102 and discarded along with the needle hub 110, the slotted cannula 102, and the needle safety shield 114.

[0082] Additionally, when the slotted cannula 102 is withdrawn from the patient's vascular anatomy, the digital probe 106 remains. In some embodiments, when the slotted cannula 102 is inserted into the vascular anatomy, the supplemental length 120 of the digital probe can be further advanced into the patient's vascular anatomy by a healthcare professional. This allows the digital probe 106 to be further advanced into the patient's vascular anatomy before the slotted cannula 102 is removed, e.g., to keep the digital probe 106 in the vascular anatomy and prevent the slotted cannula 102 from pulling the digital probe 106 back out of the vascular anatomy. Additionally, when the slotted cannula 102 is withdrawn from the patient's vascular anatomy, the digital probe 106 / supplemental length 120 of the digital probe can exit the slotted cannula 102 since the split sheath 104 is cut and the slots formed in the slotted cannula 102 serve as an exit for the digital probe 106 to be removed from the slotted cannula 102.

[0083] When the slotted cannula 102, split sheath 104, needle safety shield 114, and needle hub 110 have been removed from the digital probe 106 and data set hub 108, a healthcare professional can determine whether the digital probe 106 has been successfully inserted into the patient's vascular anatomy. This can be done by visually determining whether the digital probe 106 appears to be passing into the patient's anatomy and whether the visual indicator 116 on the data set hub 108 indicates proper insertion of the digital probe 106. In the case where a healthcare professional has determined improper insertion of the digital probe 106, the digital probe 106 can be removed by pulling the digital probe 106 out of the patient's vascular anatomy, and a new vascular probe insertion assembly 100 can be used to identify a new insertion site. In the case where a healthcare professional has determined proper insertion of the digital probe 106, the healthcare professional can attach the data set hub 108 to an external portion of the patient's anatomy (e.g., the arm), and apply an attachment dressing ( Figure 1 not shown in) to the data set hub 108 / supplemental length 120 of the digital probe to prevent displacement of the digital probe 106. In some embodiments, a healthcare professional can also apply skin adhesive at the injection site where the slotted cannula 102 enters the patient's body to attach the digital probe 106 to the patient during the time the digital probe 106 is retained.

[0084] When the healthcare professional no longer needs the digital probe 106 and the data set hub 108 to detect or measure parameters of the patient's vascular anatomy, the healthcare professional can remove the digital probe 106 and the data set hub 108 and discard them. In some embodiments, the healthcare professional can do this by grasping the data set hub 108 and pulling away from the patient's body on the attached digital probe 106. This allows the digital probe 106 to be pulled out of the vein or artery, through the remainder of the patient's anatomy, and out of the hole formed by the slotted cannula 102 during insertion.

[0085] The vascular probe insertion assembly 100 described in the present disclosure can provide direct intravascular measurement of hemodynamic and blood-based critical patient parameters and has a minimal footprint on the patient's body. The vascular probe insertion assembly 100 also allows continuous or intermittent monitoring without the procedural and workflow difficulties associated with other monitoring systems. Further, the use of the vascular probe insertion assembly 100 described in the present disclosure does not require the use of a separate catheter or vascular access device. Still further, the risks associated with other systems for accomplishing the measurements that the vascular probe insertion assembly 100 can achieve. When the digital probe 106 is in place, the vascular probe insertion assembly 100 described in the present disclosure can be used for short-term or long-term monitoring of critical vascular-based parameters.

[0086] Figure 6 is a side perspective view of a vascular probe insertion assembly 100 according to some embodiments of the present disclosure. Figure 6 The vascular probe insertion assembly 100 shown in Figure 5 is similar to the vascular probe insertion assembly 100 shown, having a digital probe 106 of fixed length. In the Figure 6 embodiment shown, the digital probe 106 and the data set hub 108 have been removed away from the slotted cannula 102, the needle safety shield 114, and the needle hub 110. Figure 5 The split sheath 104 shown in Figure 6 is not shown in

[0087] As Figure 6As depicted, the needle safety shield 114 can include a plurality of attachment surfaces 201 that mate with complementary attachment surfaces formed on the digital probe 106. During insertion of the slotted cannula 102 into a patient's vascular anatomy, the attachment surfaces 201 allow the needle safety shield 114 to be at least temporarily operatively coupled to the underside of the data hub 108. As described in the present disclosure, after the slotted cannula 102 has been inserted into a patient's vein or artery, it can subsequently be removed while the digital probe 106 and data hub 108 remain in place. In an embodiment of the present disclosure, removal of the slotted cannula 102 leaves the digital probe 106 within the patient's vein or artery while the data hub 108 (operatively 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, slotted cannula 102, and needle hub 110 are removed away 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, slotted cannula 102, and needle hub 110 can be discarded or otherwise disposed of as a biohazard, taking appropriate disposal steps to handle them accordingly.

[0088] The data hub 108 can remain with the patient and can later be secured to the outer surface of the patient's anatomy (e.g., the arm). As described in the present disclosure, the digital probe 106 can include a supplemental length 120 of the digital probe that allows a healthcare professional to further advance the digital probe 106 into the patient's anatomy and, if necessary, into a vein or artery. This advancement of the digital probe 106 can be achieved using the supplemental length 120 of the digital probe while the slotted cannula 102 is within the vein or artery. Thus, during removal of the slotted cannula 102, the length of the supplemental length 120 of the digital probe can be varied depending on whether the healthcare professional deems it necessary to further deliver the digital probe 106 into the patient's vein or artery.

[0089] Figure 7 Is a side elevation view of the data hub 108 and its digital probe 106 according to some embodiments of the present disclosure. In one embodiment, Figure 7 The data hub 108 and digital probe 106 shown in Figure 6 Can be part of the vascular probe insertion assembly 100 shown in

[0090] As described in the present disclosure, the proximal end of the digital probe 106 is operatively coupled within the digital probe 106 and is in communication with Figure 1Different from the example embodiments shown, for example, the digital probe 106 does not include a complementary length of the digital probe. This allows healthcare professionals to attach the data hub 108 to the patient's external anatomy without having to attach the unused portion of the digital probe 106 to the patient's external anatomy as well. Additionally, for a digital probe 106 of fixed length, healthcare professionals can understand that when the vascular probe insertion assembly 100 is properly used to insert the digital probe 106, the digital probe 106 is set at a length necessary to complete the monitoring of critical vascular-based parameters within the patient's vascular anatomy.

[0091] Figure 7 Also shown is a knurled surface 711 that may be formed on the outer surface of the data hub 108. This knurled surface 711 can include any type of surface treatment, and during insertion of the slotted cannula 102 into the patient's vascular anatomy 407, healthcare professionals can use this surface treatment to better grip the data hub 108 and the needle safety shield operatively coupled to the data hub 108 ( Figure 7 not shown in).

[0092] Figure 8 is a top view of the data hub 108 and the digital probe 106 according to some embodiments of the present disclosure. Figure 8 Shows other features of the data hub 108 and the digital probe 106 that can be included in the vascular probe insertion assembly 100 described in the present disclosure.

[0093] The data hub 108 may include a strain relief 813 portion that operatively couples the digital probe 106 to the data hub 108. The strain relief portion 813 can be used to prevent damage to the digital probe 106 if the data hub 108 moves relative to the digital probe 106, and when the data hub 108 moves relative to the digital probe 106. In some embodiments, when a healthcare professional attempts to attach the data hub 108 to the patient's body, the strain relief portion 813 can be used to prevent the digital probe 106 from being displaced from the data hub 108 due to stress caused by the data hub 108 bending, twisting, or pulling against the digital probe 106. In some embodiments, the size of the strain relief portion 813 can be designed to help distribute the stress between the data hub 108 and the digital probe 106 sufficiently to prevent damage. For example, this will prevent damage to the nitinol core wire 817 and other electrical connections within the digital probe 106.

[0094] The digital probe 106 may also include one or more sensors 815. As described in the present disclosure, these sensors 815 can be any type of sensors capable of detecting, monitoring, or sensing critical vessel parameter-based ones within the patient's vascular anatomy. These sensors 815 can include those associated with detecting, monitoring, or sensing venous or arterial blood pressure, temperature, the pH (acidity or alkalinity) of the patient's blood, the presence of organic compounds such as lactate, the presence and amount of oxygen (O2) in the blood, the percentage of oxygen (SPO2), and other inter-vascular parameters that can be detected. In some embodiments, each sensor can be operatively coupled to the data hub 108 via an electrical connection that operatively couples the sensor 815 to, for example, a microcontroller and other circuitry within the data hub 108.

[0095] In some embodiments, the data hub 108 may include one or more visual indicators 116 for signaling to a healthcare professional, for example, that the data hub 108 is detecting parameters of the patient's vascular anatomy due to the proper insertion of the digital probe 106 into the patient's vascular anatomy. These visual indicators 116 can include light-emitting diodes (LEDs) of various different colors that can indicate proper placement of the digital probe 106 (e.g., green LED lit), improper placement of the digital probe 106 (e.g., red LED lit), or sub-optimal placement of the digital probe 106 (e.g., yellow LED lit). In some embodiments, the data (detected or not detected) by the digital probe 106 can be used by the microcontroller in the data hub 108 to determine whether the digital probe 106 has been properly, improperly, or sub-optimally inserted into the patient's anatomy.

[0096] Figure 9 is a top view of the digital probe 106 and the data hub 108 according to some embodiments of the present disclosure. Figure 9 A stabilizing platform 919 operatively coupled to the data hub 108 is shown. In some embodiments, the stabilizing platform 919 can be semi-rigid, which allows the data hub 108 to be placed against the patient's external anatomy such that the data hub 108 does not rotate when the digital probe 106 is placed within the patient's vascular anatomy, as described in the present disclosure. In some embodiments, the stabilizing platform 919 can include an adhesive formed on the surface to abut the patient's external anatomy. In some embodiments, the stabilizing platform 919 can include a non-slip surface that creates greater friction between the stabilizing platform 919 and the patient's external anatomy. In some embodiments, the stabilizing platform 919 can enhance the stability of the data hub 108 placed against the patient's external anatomy.

[0097] Likewise, in some embodiments, the data hub 108 can include one or more visual indicators 116 for signaling to a healthcare professional that the data hub 108 is detecting parameters of the patient's vascular anatomy, for example, due to the digital probe 106 being correctly inserted into the patient's vascular anatomy. These visual indicators 116 can include a plurality of different colored light emitting diodes (LEDs) that can indicate correct placement of the digital probe 106 (e.g., a green LED illuminated), incorrect placement of the digital probe 106 (e.g., a red LED illuminated), or suboptimal placement of the digital probe 106 (e.g., a yellow LED illuminated). In some embodiments, the data detected (or not detected) by the digital probe 106 can be used by a microcontroller in the data hub 108 to determine whether the digital probe 106 has been correctly, incorrectly, or suboptimally inserted into the patient's anatomy.

[0098] Figure 10 is a top view of the data hub 108 and the digital probe 106 according to some embodiments of the present disclosure. Similarly, the data hub 108 may include a Figure 9 The described stabilizing platform is similar to stabilizing platform 919.

[0099] exist Figure 10 In the embodiment shown in , the stabilizing platform 919 is also in place. As described in the present disclosure, in some embodiments, the stabilizing platform 919 can be semi-rigid, which allows the data hub 108 to be placed against the patient's external anatomy so that the data hub 108 does not rotate when the digital probe 106 is placed within the patient's vascular anatomy, as described in the present disclosure. In some embodiments, the stabilizing platform 919 may include an adhesive formed on a surface to be abutted against the patient's external anatomy. In some embodiments, the stabilizing platform 919 may include a non-slip surface that creates greater friction between the stabilizing platform 919 and the patient's external anatomy. In some embodiments, the stabilizing platform 919 can enhance the stability of the data hub 108 when placed against the patient's external anatomy.

[0100] Additionally, during operation, a healthcare professional may use the attachment dressing 1021 to attach the data hub 108 to the patient's external anatomy. In some embodiments, the attachment dressing 1021 may include a rigid border 1023 that may include an adhesive for tightly attaching the attachment dressing 1021 to the patient's external anatomy 409. In some embodiments, the attachment dressing 1021 may sandwich the data hub 108 between the bottom surface of the attachment dressing 1021 and the surface of the patient's external anatomy. In some embodiments, the attachment dressing 1021 may also include a transparent window 1025 that allows the healthcare professional to observe the data hub 108 when the digital probe 106 is within the patient's vascular anatomy. In some embodiments, the transparent window 1025 allows the healthcare professional to determine whether the digital probe 106 remains within the patient's vascular anatomy 407 and the status of the data hub 108. As described in the present disclosure, the data hub 108 may include one or more visual indicators 116 for signaling to the healthcare professional, for example, that the data hub 108 is detecting parameters of the patient's vascular anatomy because the digital probe 106 has been correctly inserted into the patient's vascular anatomy. Thus, this transparent window 1025 allows the healthcare professional to observe the status of the visual indicator 116. In some embodiments, the attachment dressing 1021 may be a transparent film dressing.

[0101] Similarly, in some embodiments, the data hub 108 may include one or more visual indicators 116 for signaling to the healthcare professional, for example, that the data hub 108 is detecting parameters of the patient's vascular anatomy because the digital probe 106 has been correctly inserted into the patient's vascular anatomy. These visual indicators 116 may include light-emitting diodes (LEDs) of various different colors that may indicate correct placement of the digital probe 106 (e.g., green LED illuminated), incorrect placement of the digital probe 106 (e.g., red LED illuminated), or suboptimal placement of the digital probe 106 (e.g., yellow LED illuminated). In some embodiments, the 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 has been correctly, incorrectly, or suboptimally inserted into the patient's anatomy.

[0102] Figure 11 is a side perspective view of a vascular probe insertion assembly 100 according to some embodiments of the present disclosure. As described in the present disclosure, the vascular probe insertion assembly 100 may include a slotted cannula 102, a split sheath 104, and a digital probe 106, as described in the present disclosure. Figure 11The exemplary embodiment shown in [Fig. 0] shows a digital probe 106 extending through a slotted cannula 102 and a split sheath 104, through a digital probe channel 118 and extending out of the digital probe channel 118. Figure 11 Also shown are various electrical circuits within the digital probe 106 that can be used to operatively couple the digital probe 106 to, for example, a monitoring system as described in the present disclosure.

[0103] In Figure 11 the embodiment shown in [Fig. 0], the sharp end of the slotted cannula 102 can be inserted into the patient's vascular anatomy 407 to introduce the digital probe 106 into a vein or artery as described in the present disclosure. Additionally, when the patient's vascular anatomy 407 has been accessed and the digital probe 106 is in place, a healthcare professional can hold the needle hub 110 in one hand, hold the data set hub 108 in the other hand, and continue to hold the data set hub 108 while the healthcare professional pulls the needle hub 110 away from the data set hub 108. When this occurs, the slotted cannula 102 and the split sheath 104 are pulled through a passage formed in the needle safety shield 114. When the split sheath 104 is pulled through the passage of the needle safety shield 114, a needle safety shield cutting blade ( Figure 11 not shown in [Fig. 0]) cuts the split sheath 104, allowing a section of the digital probe 106 to exit the slotted cannula 102 as described in the present disclosure. In Figure 11 the embodiment shown in [Fig. 0], the digital probe 106 is not operatively coupled to the data set hub 108. Instead, the data set hub 108 can be discarded along with the slotted cannula 102, the split sheath 104, and the needle hub 110. This results in a situation where only the digital probe 106 remains with the patient after the digital probe 106 has been successfully inserted into the patient's vascular anatomy.

[0104] As Figure 11 shown in [Fig. 0], the digital probe 106 can include multiple wires that allow the sensors of the digital probe 106 to be operatively coupled to a monitoring system as described in the present disclosure. The multiple wires can include, for example, a negative voltage rail (V-), a positive voltage rail (V+), and any number of data electrical circuits (e.g., Data 1, Data 2, etc.). The negative voltage rail and the positive voltage rail can be provided to supply current to the sensors of the digital probe 106 such that the sensors can detect, monitor, or otherwise sense critical vascular-based parameters as described in the present disclosure. According to an exemplary embodiment of the present disclosure, each data circuit can be used to transfer data from the sensors to the monitoring system. It should be appreciated that although Figure 11 only two data circuits (e.g., Data 1 and Data 2) are shown, the digital probe 106 can include more or fewer than these two data circuits.

[0105] Figure 12 is a side perspective view of a vascular probe insertion assembly 100 in accordance with some embodiments of the present disclosure. The vascular probe insertion assembly 100 is shown in an orientation where the digital probe 106 has been placed within a patient's vascular anatomy. As described in the present disclosure, retraction of the slotted cannula 102 from within the patient's vascular anatomy causes the split sheath 104 to be cut by the needle safety shield cutting blade of the needle safety shield 114, resulting in the split sheath 104 being detached from the vascular probe insertion assembly 100. The needle safety shield 114 then covers the sharp tip of the slotted cannula 102, such that healthcare professionals are not injured by this sharp tip. Additionally, in Figure 11 , Figure 12 and Figure 13 , the data hub 108 does not remain with the patient and is also discarded along with the slotted cannula 102, the split sheath 104, the needle hub 110 (with its fluid container 112), and the needle safety shield 114. Similarly, this leaves only the digital probe 106 with the patient. The digital probe 106 can then be coupled to a monitoring system, as described in the present disclosure.

[0106] Figure 13 is a side perspective view of the digital probe 106 inserted into the vascular anatomy 407 in accordance with some embodiments of the present disclosure. Figure 13 Shows the digital probe 106 in the installed position after a healthcare professional has removed, for example, the slotted cannula, split sheath, needle safety shield, data hub, and needle hub as shown in Figure 11 . As described in the present disclosure, the digital probe 106 remains when the slotted cannula is pulled out of the patient's vascular anatomy 407. The external anatomy 409 to which a portion of the digital probe 106 is secured can vary depending on the vascular anatomy 407 into which the digital probe 106 is inserted. For example, in the case where the vascular anatomy 407 is a vein within the patient's arm, a portion of the digital probe 106 can be secured to the patient's arm near the location where the digital probe 106 has passed through the patient's skin and vascular anatomy 407.

[0107] Similarly, the digital probe 106 can include multiple wires that allow the sensors of the digital probe 106 to be operatively coupled to a monitoring system, as described in the present disclosure. The multiple wires can include, for example, a negative voltage rail (V-), a positive voltage rail (V+), and any number of data lines (e.g., Data 1, Data 2, etc.). The negative voltage rail and the positive voltage rail can be provided to supply current to the sensors of the digital probe 106 such that the sensors can detect, monitor, or otherwise sense critical vascular-based parameters, as described in the present disclosure. According to example embodiments of the present disclosure, each data line can be used to transfer data from the sensors to the monitoring system. It should be appreciated that althoughFigure 11 Only two data lines (e.g., Data 1 and Data 2) are shown, but the digital probe 106 can include more or fewer than these two data lines.

[0108] Figure 14 is a top view of the digital probe 106 and the data concentrator 108 in accordance with some embodiments of the present disclosure. Similar to Figure 9 , Figure 14 shows a stabilization platform 919 operatively coupled to the data concentrator 108. In some embodiments, the stabilization platform 919 can be semi-rigid, which allows the data concentrator 108 to be placed against the external anatomy of the patient such that when the digital probe 106 is placed within the vascular anatomy of the patient, the data concentrator 108 does not rotate, as described in the present disclosure. In some embodiments, the stabilization platform 919 can include an adhesive formed on the surface to abut the external anatomy of the patient. In some embodiments, the stabilization platform 919 can include an anti-slip surface that creates greater friction between the stabilization platform 919 and the external anatomy of the patient. In some embodiments, the stabilization platform 919 can enhance the stability of the data concentrator 108 placed against the external anatomy of the patient.

[0109] Additionally, in Figure 14 the embodiment shown, the data concentrator 108 can include a strain relief 813 portion that operatively couples the digital probe 106 to the data concentrator 108. The strain relief portion 813 can be used to prevent damage to the digital probe 106 if the data concentrator 108 moves relative to the digital probe 106 and when the data concentrator 108 moves relative to the digital probe 106. In some embodiments, the strain relief portion 813 can be used to prevent the digital probe 106 from shifting from the data concentrator 108 due to stress caused by the data concentrator 108 bending, twisting, or pulling against the digital probe 106 when a healthcare professional attempts to secure the data concentrator 108 to the patient's body. In some embodiments, the size of the strain relief portion 813 can be designed to help distribute stress sufficiently between the data concentrator 108 and the digital probe 106 to prevent damage. This will prevent, for example, the nitinol core wire 817 and other electrical connections within the digital probe 106 from being damaged.

[0110] In some embodiments, the digital probe 106 may further include one or more sensors 815. As described in the present disclosure, these sensors 815 can be any type of sensors capable of detecting, monitoring, or sensing key vascular-based parameters within a patient's vascular anatomy. These sensors 815 can include those associated with detecting, monitoring, or sensing venous or arterial blood pressure, temperature, the pH (acidity) of the patient's blood, the presence of organic compounds such as lactate, the presence and amount of oxygen (O2) in the blood, the percentage of oxygen (SPO2), and other inter-vascular parameters that can be detected. In some embodiments, each sensor can be operatively coupled to the data concentrator 108 via an electrical connection, which operatively couples the sensor 815 to, for example, a microcontroller and other circuitry within the data concentrator 108.

[0111] In some embodiments, the data concentrator 108 may include an electrical interface 1427. The electrical interface 1427 can be used by the data concentrator 108 to couple the data concentrator 108 to the monitoring system via a wired connection. In some embodiments, the electrical interface 1427 can include one or more contact pins that mate with a corresponding wired connection for operatively coupling the data concentrator 108 to the monitoring system. As described in the present disclosure, the data concentrator 108 can be a wireless data concentrator 108 or a wired data concentrator 108, and Figure 14 the example shown is of a wired data concentrator 108, which allows a healthcare professional to connect a wired connection interface to the proximal end of the data concentrator 108.

[0112] Figure 15 is a top view of the digital probe 106, the data concentrator 108, and the wired connection 1529 according to some embodiments of the present disclosure. Figure 15 Also shown is a stabilization platform 919 operatively coupled to the data concentrator 108. In some embodiments, the stabilization platform 919 can be semi-rigid, which allows the data concentrator 108 to be placed against the patient's external anatomy such that the data concentrator 108 does not rotate when the digital probe 106 is placed within the patient's vascular anatomy, as described in the present disclosure. In some embodiments, the stabilization platform 919 can include an adhesive formed on the surface to abut the patient's external anatomy. In some embodiments, the stabilization platform 919 can include a non-slip surface that creates greater friction between the stabilization platform 919 and the patient's external anatomy. In some embodiments, the stabilization platform 919 can enhance the stability of the data concentrator 108 placed against the patient's external anatomy.

[0113] Additionally, in Figure 14In the embodiments shown, the data set hub 108 may include a strain relief 813 portion that operatively couples the digital probe 106 to the data set hub 108. The strain relief portion 813 can be used to prevent damage to the digital probe 106 if and when the data set hub 108 moves relative to the digital probe 106. In some embodiments, when a healthcare professional attempts to attach the data set hub 108 to a patient's body, the strain relief portion 813 can be used to prevent the digital probe 106 from being displaced from the data set hub 108 due to stresses caused by the data set hub 108 bending, twisting, or pulling against the digital probe 106. In some embodiments, the strain relief portion 813 can be sized to help distribute stress sufficiently between the data set hub 108 and the digital probe 106 to prevent damage. This will prevent, for example, the nitinol core wire 817 and other electrical connections within the digital probe 106 from being damaged.

[0114] In some embodiments, the digital probe 106 may also include one or more sensors 815. As described in this disclosure, these sensors 815 can be any type of sensor capable of detecting, monitoring, or sensing key vascular-based parameters within a patient's vascular anatomy. These sensors 815 can include those associated with detecting, monitoring, or sensing venous or arterial blood pressure, temperature, the pH of the patient's blood, the presence of organic compounds such as lactate, the presence and amount of oxygen (O2) in the blood, the percentage of oxygen (SPO2), and other inter-vascular parameters that can be detected. In some embodiments, each sensor can be operatively coupled to the data set hub 108 via an electrical connection that operatively couples the sensor 815 to, for example, a microcontroller and other circuitry within the data set hub 108.

[0115] As described in this disclosure, the data set hub 108 may include an electrical interface 1427. The electrical interface 1427 can be used by the data set hub 108 to couple the data set hub 108 to a monitoring system via a wired connection. In some embodiments, the electrical interface 1427 can include one or more contact pins that mate with a corresponding wired connection that operatively couples the data set hub 108 to the monitoring system. As described in this disclosure, the data set hub 108 can be a wireless data set hub 108 or a wired data set hub 108, Figure 14 The example shown is a wired data set hub 108 that allows a healthcare professional to connect a wired connection interface to the proximal end of the data set hub 108. The use of the electrical interface 1427 allows the monitoring system to disconnect and reconnect as necessary to detect key patient parameters based on blood. For example, the connection at the digital probe 106 allows such disconnection for improved mobility, such as for necessary patient removal.

[0116] Figure 15 A wired connection portion 1529 is also shown, which is used to operatively couple the data concentrator 108 of the vascular probe insertion assembly 100 to the monitoring system described in the present disclosure. The wired connection portion 1529 may include a wired connection interface 1531, which is used to dock with the electrical interface 1427 of the data concentrator 108. Thus, in one embodiment, the wired connection interface 1531 may include one or more docking contact pins, which dock with the contact pins of the electrical interface 1427 on the data concentrator 108. The wired connection portion 1529 may also include a plug 1533, which is used to complete the connection between the data concentrator 108 and the wired connection portion 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 can be used to calculate, classify, process, send, receive, retrieve, generate, switch, store, display, indicate, detect, record, copy, manipulate, or use any form of information, intelligence, or data for medical diagnosis or other purposes in the exemplary embodiments.

[0117] Figure 16 is a top view of the digital probe 106, the data concentrator 108, and the wired connection portion 1529 according to some embodiments of the present disclosure. As described in the present disclosure, the vascular probe insertion assembly 100 may include a digital probe 106, which is operatively coupled to the data concentrator 108 via a strain relief portion 813. The digital probe 106 may include one or more sensors 815, which are operatively coupled to a nitinol core wire 817 to be inserted into a patient's vascular anatomy. The data concentrator 108 may also include a stable platform 919, which is used to give the data concentrator 108 structural support and, in one embodiment, fixedly attach the data concentrator 108 to the patient's external anatomy, such as via an adhesive.

[0118] As described in the present disclosure, the data concentrator 108 may include an electrical interface 1427. The electrical interface 1427 may be used by the data concentrator 108 to couple the data concentrator 108 to the monitoring system via a wired connection portion. In some embodiments, the electrical interface 1427 may include one or more contact pins, which dock with the corresponding wired connection portion that operatively couples the data concentrator 108 to the monitoring system. As described in the present disclosure, the data concentrator 108 may be a wireless data concentrator 108 or a wired data concentrator 108, Figure 14 The example shown in is a wired data concentrator 108, which allows healthcare professionals to connect a wired connection interface to the proximal end of the data concentrator 108.

[0119] Figure 16 shows Figure 16The wired connection portion 1529 described therein is coupled to the electrical interface 1427 and is used to operatively couple the data hub 108 of the vascular probe insertion assembly 100 to the monitoring system described in the present disclosure. The wired connection portion 1529 may include a wired connection interface 1531 for docking with the electrical interface 1427 of the data hub 108. Thus, in one embodiment, the wired connection interface 1531 may include one or more docking contact pins that dock with the contact pins of the electrical interface 1427 on the data hub 108. The wired connection portion 1529 may further include a plug 1533 for completing the connection between the data hub 108 and the wired connection portion 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 to calculate, classify, process, transmit, receive, retrieve, generate, switch, store, display, indicate, detect, record, reproduce, manipulate, or use any form of information, intelligence, or data for medical diagnosis or other purposes in the exemplary embodiments.

[0120] Figure 17 FIG. 4 is a perspective view of a vascular probe insertion assembly 100 with a wired connection portion 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 for placing one or more sensors into the vascular anatomy of a patient. The data hub 108 may further include a stabilization platform 919 for providing structural support to the data hub 108 and, in one embodiment, securing the data hub 108 to the external anatomy of the patient via, for example, an adhesive.

[0121] In Figure 17 FIG. 9, the data hub 108 is further coupled to a wired connection portion 1529 for operatively coupling the data hub 108 to the monitoring system via the wired connection portion. In some embodiments, the wired connection portion 1529 is permanently coupled to the data hub 108 at the proximal end of the data hub 108. The wired connection portion 1529 may further include a plug 1533 for coupling 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 dock with a USB port at the monitoring system. The length of the wired connection portion 1529 may vary and, in one embodiment, may be long enough to reach the monitoring system from the patient.

[0122] Figure 18 FIG. 13 shows the permanent connection of the wired connection portion 1529 to the data hub 108. Figure 18A side view of a digital probe 106 with a wired connection portion 1529 in accordance with some embodiments of the present disclosure. In some embodiments, when the digital probe 106 is placed within a patient's vascular anatomy, the wired connection portion 1529 allows a healthcare professional to operatively couple a plug (not shown) to a monitoring system. In some embodiments, if necessary, the wired connection portion 1529 can be disconnected from the digital probe 106 and the stabilization platform 919 to allow for better patient mobility. When those blood-based critical patient parameters are to be detected or monitored, the wired connection portion 1529 can be subsequently reconnected as described in the present disclosure.

[0123] Figure 19 A top view of the digital probe 106 and the data set hub 108 in accordance with some embodiments of the present disclosure. Figure 19 The data set hub 108 is shown, which includes a tether connector 1935 that operatively couples the data set hub 108 to the digital probe 106. In some embodiments, the length of the tether connector 1935 can vary according to the level of mobility desired by the patient. In some embodiments, the tether connector 1935 and the data set hub 108 can also be secured to the patient's external anatomy to prevent displacement of the digital probe 106.

[0124] Figure 20 A top view of the digital probe 106 and the data set hub 108 in accordance with some embodiments of the present disclosure. In Figure 20 the illustrated embodiment, the data set hub 108 can include a tether connector 1935 that operatively couples the data set hub 108 to the digital probe 106. In some embodiments, the length of the tether connector 1935 can vary according to the level of mobility desired by the patient. In some embodiments, the tether connector 1935 and the data set hub 108 can also be secured to the patient's external anatomy to prevent displacement of the digital probe 106.

[0125] In some embodiments, the stabilization platform 919 is operatively coupled to the intermediate hub 2037 proximate the digital probe 106. In some embodiments, the stabilization platform 919 can be semi-rigid, which allows the data set hub 108 to be placed against the patient's external anatomy such that when the digital probe 106 is placed within the patient's vascular anatomy, the data set hub 108 does not rotate, as described in the present disclosure. In some embodiments, the stabilization platform 919 can include an adhesive formed on a surface to abut the patient's external anatomy. In some embodiments, the stabilization platform 919 can include an anti-slip surface that creates greater friction between the stabilization platform 919 and the patient's external anatomy. In some embodiments, the stabilization platform 919 can enhance the stability of the intermediate hub 2037 placed against the patient's external anatomy. In some embodiments, the intermediate hub 2037 can include some of those elements that can be included within the data set hub 108. In some embodiments, the intermediate hub 2037 can include one or more of a power source, a PMU, and a microcontroller or other hardware processing device, as well as other circuitry. In cases where these devices are included within the intermediate hub 2037, the data set hub 108 does not need to include these devices because the tether connector 1935 operatively couples the intermediate hub 2037 to the data set hub 108.

[0126] Figure 21 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure. Figure 21 The vascular probe insertion assembly 100 shown in Figure 1 can be similar to the vascular probe insertion assembly 100 shown in

[0127] The vascular probe insertion assembly 100 can include a variety of devices used by a healthcare professional to introduce the digital probe 106 into a patient's vein or artery. The vascular probe insertion assembly 100 can include a slotted cannula 102. The slotted cannula 102 can include a slot formed along the length of the slotted cannula 102, in which the digital probe 106 can be placed. The slot formed in the slotted cannula 102 forms side walls that extend along the length of the slotted cannula 102, which coaxially maintain the digital probe 106 therein except at the slot. Thus, the digital probe 106 can run coaxially within the slotted cannula 102 until the slotted cannula 102 is removed from the patient's anatomy, as described in the present disclosure. In some embodiments, the orientation of the slot formed in the slotted cannula 102 can be aligned with a groove or digital probe channel 118 formed through the data set hub 108 such that when the digital probe 106 is inserted into the patient's vascular anatomy, the digital probe 106 can exit the digital probe channel 118 formed in the data set hub 108.

[0128] In some embodiments, the digital probe 106 may include a core wire for structure and durability during advancement of the digital probe 106 through a patient's vascular anatomy. The core wire may be a nitinol core wire that extends the length of the digital probe 106 at or offset from the central axis of the digital probe 106. In some embodiments, the digital probe 106 may include optical fibers and / or wires that are connected to one or more sensors placed along the length of the digital probe 106. In some embodiments, the distal end of the digital probe 106 may include an atraumatic tip that reduces the risk of the digital probe 106 causing injury or complications in a patient's vein or artery.

[0129] In some embodiments, the digital probe 106 may be coated with a variety of coatings for improving the performance of the digital probe 106 and reducing the risk of complications such as thrombus or probe-related bloodstream infections (e.g., sepsis). These coatings may include silicone lubricants with or without 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.

[0130] The sensors present on the digital probe 106 may include any number or type of sensors that detect or measure parameters of a patient's vascular anatomy. These sensors may be placed along the digital probe 106 as individual sensors or sensor bundles. These sensors may include sensors incorporating technologies capable of detecting or measuring a patient's blood pressure (venous or arterial), blood gas, blood pH level, and electrolyte presence, among other types of sensors. In some embodiments, the sensors present on the digital probe 106 may be selected to detect or measure other target physiological or procedural parameters.

[0131] The vascular probe insertion assembly 100 may also include a split sheath 104 formed around the slotted cannula 102. In some embodiments, the split sheath 104 may extend the entire length of the slotted cannula 102 except along the beveled portion of the slotted cannula 102. This allows the sharp terminal end of the slotted cannula 102 to penetrate the patient's skin when a healthcare professional accesses the patient's vein or artery. The split sheath 104 also prevents the digital probe 106 from exiting the slot formed along the slotted cannula 102 during insertion of the vascular probe insertion assembly 100 into the patient's vascular anatomy.

[0132] 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 allows movement along the axis of the slotted cannula 102 during operation. In some embodiments, the needle safety shield 114 has a passage formed therethrough so that the slotted cannula 102 can pass therethrough. Additionally, in some embodiments, the needle safety shield 114 may include a needle safety shield cutting blade ( Figure 21 ), the needle safety shield cutting blade is used to cut the splittable sheath 104 during extraction of the slotted cannula 102 from the patient's vascular anatomy.

[0133] The vascular probe insertion assembly 100 may also include a data hub 108 that is operatively coupled to the digital probe 106. The data hub 108 may include any type of circuitry for receiving and transmitting data detected by the digital probe 106 when the digital probe 106 has been successfully inserted into a vein or artery of the patient. In some embodiments, this circuitry may include a radio or other transmitting device that allows wireless transmission of data detected at the digital probe 106 to, for example, a vascular monitoring system, as described in the present disclosure. Additionally, the data hub 108 may include a power supply, a power management unit (PMU), and a microcontroller or other hardware processing device, as well as other circuitry. In some embodiments, the data hub 108 may include one or more visual indicators 116 for signaling to a healthcare professional that, for example, the data hub 108 is detecting parameters of the patient's vascular anatomy because the digital probe 106 has been correctly inserted into the patient's vascular anatomy. These visual indicators 116 may include a plurality of different colored light emitting diodes (LEDs) that may indicate correct placement of the digital probe 106 (e.g., a green LED illuminated), incorrect placement of the digital probe 106 (e.g., a red LED illuminated), or suboptimal placement of the digital probe 106 (e.g., a yellow LED illuminated). 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 has been correctly, incorrectly, or suboptimally inserted into the patient's anatomy.

[0134] exist Figure 21 In the embodiment shown in , the vascular probe insertion assembly 100 may further include a syringe 2139 operatively coupled to the vascular probe insertion assembly 100 and in fluid communication with the slotted cannula 102 . Figure 1The needle hub described in , syringe 2139 can be used by a healthcare professional to detect whether the slotted cannula 102 has reached the 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 can aspirate a quantity of blood to determine whether the slotted cannula 102 has reached the patient's vein or artery. Additionally, during the insertion of the slotted cannula 102, syringe 2139 can be used by the healthcare professional to better hold the vascular probe insertion assembly 100. By holding the syringe 2139, the healthcare professional can more easily insert the slotted cannula 102 into the patient's anatomy at those relatively more sensitive or critical insertion sites.

[0135] During the operation of the vascular probe insertion assembly 100, the healthcare professional can address the patient's anatomy and determine the location where the digital probe 106 can be placed within the patient's vein or artery. Once the appropriate injection site has been determined, the healthcare professional can insert the vascular probe insertion assembly 100, and specifically the slotted cannula 102 and its digital probe 106 and the split sheath 104, into the patient's anatomy into the vein or artery. 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. Since the barrel 2143 is made of, for example, transparent plastic, the healthcare professional can visually detect the filling of the barrel 2143.

[0136] Once the healthcare professional detects the presence of blood within the barrel 2143 of the syringe 2139, indicating that the slotted cannula 102 has reached the vein or artery, the healthcare professional can begin to remove the vascular probe insertion assembly 100 from the patient. In some embodiments, the healthcare professional can do this by grasping the syringe 2139 in one hand and grasping 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 can begin to pull the syringe 2139 away from the patient and the remainder of the vascular probe insertion assembly 100. By doing so, when the slotted cannula 102 is pulled through the passage formed through the needle safety shield 114, the needle safety shield cutting blade of the needle safety shield 114 ( Figure 21(not shown in the figure) can start cutting the split sheath 104. This continues until the beveled portion of the slotted cannula 102 is safely received within the passage formed through the needle safety shield 114. This process may also include removing the data set hub 108 from the needle safety shield 114. In some embodiments, the data set hub 108 and the needle safety shield 114 may be operatively coupled together via a track system such that they can be slidably removed from each other when a healthcare professional pulls the slotted cannula 102 and the split sheath 104 through the passage formed through the needle safety shield 114.

[0137] When the beveled end of the slotted cannula 102 enters the passage formed through the needle safety shield 114, the slotted cannula 102 is prevented from being completely removed from the passage to prevent the sharp point of the slotted cannula 102 from touching the healthcare professional and potentially injuring the healthcare professional. Additionally, the split sheath 104 that has been 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.

[0138] Additionally, when the slotted cannula 102 is pulled out of the patient's vascular anatomy, the digital probe 106 remains. In some embodiments, when the slotted cannula 102 is inserted into the vascular anatomy, the additional length 120 of the digital probe can be further advanced into the patient's vascular anatomy by a healthcare professional. This allows the digital probe 106 to be further advanced into the patient's vascular anatomy before the slotted cannula 102 is removed, for example, to keep the digital probe 106 in the vascular anatomy and prevent the slotted cannula 102 from pulling the digital probe 106 back out of the vascular anatomy. Additionally, when the slotted cannula 102 is pulled out of the patient's vascular anatomy, the digital probe 106 / digital probe additional length 120 can exit the slotted cannula 102 because the split sheath 104 has been cut and the slot formed in the slotted cannula 102 serves as an exit for the digital probe 106 to be removed from the slotted cannula 102.

[0139] When the slotted cannula 102, the split sheath 104, the needle safety shield 114, and the syringe 2139 have been removed from the digital probe 106 and the data hub 108, a healthcare professional can determine whether the digital probe 106 has been successfully inserted into the patient's vascular anatomy. This can be done by visually determining whether the digital probe 106 appears to be passing into the patient's anatomy and whether the visual indicator 116 on the data hub 108 indicates proper insertion of the digital probe 106. In the case where the healthcare professional has determined that the digital probe 106 is not properly inserted, the digital probe 106 can be removed by pulling the digital probe 106 from the patient's vascular anatomy, and a new vascular probe insertion assembly 100 can be used to identify a new insertion site. In the case where the healthcare professional has determined that the digital probe 106 is properly inserted, the healthcare professional can attach the data hub 108 to an external portion of the patient's anatomy (e.g., the arm) and apply an attachment dressing ( Figure 21 not shown in

[0140] ) over the complementary length 120 of the data hub 108 / digital probe to prevent displacement of the digital probe 106. In some embodiments, the healthcare professional can also apply skin adhesive at the injection site where the slotted cannula 102 enters the patient's body to attach the digital probe 106 to the patient during the time the digital probe 106 remains in place.

[0141] The vascular probe insertion assembly 100 described in the present disclosure enables direct intravascular measurement of hemodynamic and blood-based critical patient parameters and has minimal footprint on the patient's body. The vascular probe insertion assembly 100 also allows continuous or intermittent monitoring without the procedural and workflow difficulties associated with other monitoring systems. Further, use of the vascular probe insertion assembly 100 described in the present disclosure does not require the use of a separate catheter or vascular access device. Still further, the risks associated with other systems for accomplishing the measurements that the vascular probe insertion assembly 100 can achieve. When the digital probe 106 is in place, the vascular probe insertion assembly 100 described in the present disclosure can be used for short-term or long-term monitoring of critical vascular-based parameters.

[0142] Figure 22 is a side perspective view of a blood vessel probe insertion assembly 100 in accordance with some embodiments of the present disclosure. Figure 22 The blood vessel probe insertion assembly 100 shown in Figure 21 may be similar to the blood vessel probe insertion assembly 100 shown in Figure 22 In the embodiment shown, the digital probe 106 and the data set hub 108 have been removed away from the slotted cannula 102, the needle safety shield 114, and the syringe 2139. Figure 21 The split sheath 104 shown in Figure 22 is not shown in

[0143] As Figure 22 depicted, the needle safety shield 114 may include a plurality of attachment surfaces 201 that mate with complementary connection surfaces formed on the digital probe 106. During insertion of the slotted cannula 102 into a patient's vascular anatomy, the attachment surfaces 201 allow the needle safety shield 114 to be at least temporarily operatively coupled to the underside of the data set hub 108. As described in the present disclosure, after the slotted cannula 102 has been inserted into a patient's vein or artery, it may subsequently be removed while the digital probe 106 and the data set hub 108 remain in place. In an embodiment of the present disclosure, removal of the slotted cannula 102 leaves the digital probe 106 within the patient's vein or artery while the data set hub 108 (operatively coupled to the digital probe 106) remains with the patient. By sliding the needle safety shield 114 laterally away from the data set hub 108, the needle safety shield 114, the slotted cannula 102, and the syringe 2139 are removed away from the data set hub 108, thereby separating the needle safety shield 114 from the data set hub 108. At this point, the needle safety shield 114, the slotted cannula 102, and the syringe 2139 may be discarded or otherwise disposed of as a biohazard, taking appropriate disposal steps to do so.

[0144] The data set hub 108 can remain with the patient and can later be attached to the outer surface of the patient's anatomy (such as an arm). As described in the present disclosure, the digital probe 106 can include a complementary length 120 of the digital probe, which allows a healthcare professional to further advance the digital probe 106 into the patient's anatomy and, if necessary, into a vein or artery. This advancement of the digital probe 106 using the complementary length 120 of the digital probe can be achieved when the slotted cannula 102 is within a vein or artery. Thus, during removal of the slotted cannula 102, the length of the complementary length 120 of the digital probe can be varied depending on whether the healthcare professional deems it necessary to further deliver the digital probe 106 into the patient's vein or artery.

[0145] Figure 23 is a side perspective view of the digital probe 106 inserted into the vascular anatomy 407 according to some embodiments of the present disclosure. Figure 23 Illustrates the digital probe 106 in the installed position after a healthcare professional has removed, for example, Figure 21 and Figure 22 the slotted cannula, the split sheath, the needle safety shield, and the syringe 2139 as shown. As described in the present disclosure, the digital probe 106 remains when the slotted cannula is pulled out of the patient's vascular anatomy 407. In some embodiments, after the slotted cannula has been inserted into the vascular anatomy 407 but before the slotted cannula is removed from the patient's anatomy, the complementary length 120 of the digital probe can be further advanced into the patient's vascular anatomy by the healthcare professional. This allows the digital probe 106 to be further advanced into the patient's vascular anatomy 407 before removal of the slotted cannula, for example, to keep the digital probe 106 within the vascular anatomy and prevent the slotted cannula from pulling the digital probe 106 back out of the vascular anatomy 407. Additionally, when the slotted cannula is pulled out of the patient's vascular anatomy 407, the digital probe 106 / the complementary length 120 of the digital probe can exit the slotted cannula since the split sheath is cut and the slot formed in the slotted cannula serves as an exit for the digital probe 106 to be removed from the slotted cannula.

[0146] In some embodiments, the data set hub 108 can be attached to the patient's external anatomy 409. The external anatomy 409 to which the data set hub is attached can vary depending on the vascular anatomy 407 into which the digital probe 106 is inserted. For example, in the case where the vascular anatomy 407 is a vein within the patient's arm, the data set hub 108 can be attached to the patient's arm near the location where the digital probe 106 penetrates the patient's skin.

[0147] As described in the present disclosure, the vascular probe insertion assembly 100 may also include a data hub 108 that is operatively coupled to the digital probe 106. The data hub 108 may include any type of circuitry for receiving and transmitting data detected by the digital probe 106 when the digital probe 106 has been successfully inserted into a vein or artery of a patient. In some embodiments, this circuitry may include a radio or other transmitting device that allows wireless transmission of data detected at the digital probe 106 to, for example, a vascular monitoring system, as described in the present disclosure. Additionally, the data hub 108 may include a power supply, a PMU, and a microcontroller or other hardware processing device, as well as other circuitry. In some embodiments, the data hub 108 may include one or more visual indicators 116 for signaling to a healthcare professional that, for example, the data hub 108 is detecting parameters of the patient's vascular anatomy because the digital probe 106 has been correctly inserted into the patient's vascular anatomy. These visual indicators 116 may include a plurality of different colored light emitting diodes (LEDs) that may indicate correct placement of the digital probe 106 (e.g., a green LED illuminated), incorrect placement of the digital probe 106 (e.g., a red LED illuminated), or suboptimal placement of the digital probe 106 (e.g., a yellow LED illuminated). 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 has been correctly, incorrectly, or suboptimally inserted into the patient's anatomy. In some embodiments, the data hub 108 may use, for example, a transparent film dressing (e.g., The digital probe 106 and the data hub 108 may be secured to the patient's external anatomy 409 using a transparent film dressing such as a PET film or a PET film such that the healthcare professional can still observe the visual indicators 116 present on the data hub 108. Other securing devices may be used to secure the data hub 108 to the patient's external anatomy 409. Further, the securing devices may be selectively removable such that when monitoring of the patient's vascular anatomy 407 is no longer necessary, the healthcare professional may remove the securing devices to replace them with a new set of securing devices or ultimately remove the digital probe 106 and the data hub 108.

[0148] Figure 24FIG. 0 is a schematic diagram of a vascular probe insertion assembly 100 interfacing with a data processing and cloud-based system 2445 in accordance with some embodiments of the present disclosure. As described in the present disclosure, the vascular probe insertion assembly 100 may be operatively 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 is operatively 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. When the vascular probe insertion assembly 100 is installed within the patient's vascular anatomy, the 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.

[0149] In some embodiments, the vascular probe insertion assembly 100 may additionally or alternatively be operatively coupled to a mobile phone 2449 or other handheld device within the data processing and cloud-based system 2445. Similar to the patient monitor 2447, when the vascular probe insertion assembly 100 is installed within the patient's vascular anatomy, 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. In some embodiments, the mobile phone 2449 may execute computer-readable program code of a monitoring application associated with the vascular probe insertion assembly 100.

[0150] In some embodiments, the vascular probe insertion assembly 100 is operatively coupled to a vital signs monitor 2451 within the data processing and cloud-based system 2445. In some embodiments, the vital signs monitor 2451 may be located, for example, at a nursing station or other remote desktop where healthcare professionals may monitor blood-based critical patient parameters of the patient detected by the digital probe 106 of the vascular probe insertion assembly 100. It should be appreciated that when the digital probe is placed within the patient's vascular anatomy, any one or all of the patient monitor 2447, the mobile phone 2449, and / or the vital signs monitor 2451 may be used by healthcare professionals to view and monitor the patient's blood-based critical patient parameters. Each of the patient monitor 2447, the mobile phone 2449, and the vital signs monitor 2451 may be coupled to each other for communication between these devices. Further, each of the patient monitor 2447, the mobile phone 2449, and the vital signs monitor 2451 is operatively coupled to, for example, a cloud network 2453 used by a hospital to maintain records related to the patient's blood-based critical patient parameters when the digital probe of the vascular probe insertion assembly 100 is placed within the patient's vascular anatomy. In some embodiments, the cloud network 2453 may include a backend server 2455 for maintaining the data.

[0151] In some embodiments, the data processing and cloud-based system 2445 may include artificial intelligence (AI) data algorithms and computer-readable program code for detecting and predicting the onset of patient complications, treatment response, health improvement, and / or changes in disease state based on data received by the digital probes of the vascular probe insertion assembly 100. Execution of the computer-readable program code of the AI data algorithms may be accomplished using the hardware processing means of any one of the patient monitor 2447, the mobile phone 2449, the vital signs monitor 2451, and / or the backend server 2455, as described in the present disclosure. Accordingly, based on the data received at the digital probes of the vascular probe insertion assembly 100, any one 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. Further, when any complication onset, treatment response, health improvement, and / or disease state change of the patient is detected by executing the AI data algorithms, a warning (e.g., visual warning, audible warning, etc.) may be triggered to healthcare professionals indicating a change in critical patient parameters based on blood, as described in the present disclosure.

[0152] Figure 25 is a side cross-sectional perspective view of the vascular probe insertion assembly 100 according to some embodiments of the present disclosure. Figure 25 shows the vascular probe insertion assembly 100 cross-sectioned along, for example, a digital probe channel (e.g., Figure 1 , 118), showing the digital probe 106 as it passes through the data concentrator 108 prior to insertion of the slotted cannula 102.

[0153] Figure 25Also shown is the needle hub 110 in fluid communication with the slotted cannula 102 and the split sheath 104. As described in the present disclosure, this allows a healthcare professional to detect when the slotted cannula 102 has been inserted into a patient's vascular anatomy. The healthcare professional detects this by visually monitoring for the presence of blood within the fluid container 112 of the needle hub 110. When blood is detected within the fluid container 112, the healthcare professional can proceed to retract the needle hub 110 away from the data set hub 108 and the needle safety shield 114 to remove these components from the patient's vascular anatomy and from the data set hub 108, as described in the present disclosure. Additionally, prior to removing the slotted cannula 102 from the patient's vascular anatomy, the healthcare professional can use the supplemental length 120 of the digital probe to further advance the digital probe 106 into the patient's vascular anatomy. In this embodiment, the healthcare professional can grasp the supplemental length 120 of the digital probe and advance it further into the digital probe channel 118 and into the slotted cannula 102 / split sheath 104 to further advance the digital probe 106 into the patient's vascular anatomy. As described in the present disclosure, the healthcare professional can refer to a visual indicator ( Figure 25 not shown) on the data set hub 108 to determine if the advancement of the supplemental length 120 of the digital probe into the patient's vascular anatomy has resulted in the proper placement of the digital probe 106.

[0154] Figure 26 is a block diagram of a method 2600 of manufacturing a vascular probe insertion assembly according to some embodiments of the present disclosure. Method 2600 may include inserting a digital probe into a slotted cannula at block 2605. As described in the present disclosure, the slots formed in the slotted cannula form sidewalls that extend along the length of the slotted cannula and coaxially maintain the digital probe therein except at the slots. Thus, the digital probe can run coaxially within the slotted cannula until the slotted cannula is removed from the patient's anatomy, as described in the present disclosure.

[0155] At block 2610, method 2600 may further include forming a needle safety shield around the slotted cannula by passing the slotted cannula (and digital probe) through a passage formed through the needle safety shield. The needle safety shield forms around a portion of the slotted cannula and allows the needle safety shield to move along the axis of the slotted cannula during operation by the healthcare professional. Additionally, in some embodiments, the needle safety shield may include a needle safety shield cutting blade for cutting the split sheath during withdrawal of the slotted cannula from the patient's vascular anatomy.

[0156] Method 2600 may further include, at block 2615, forming a split sheath around the slotted cannula to secure the digital probe within the slotted cannula during insertion into the patient's vascular anatomy. As described in the present disclosure, the split sheath may be made of a material that can be cut or otherwise split using a needle safety shield cutting blade of a needle safety shield.

[0157] Method 2600 may further include operatively coupling a data hub to the digital probe at block 2620. The data hub may include any type of circuitry for receiving and transmitting 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 a radio or other transmitting device that allows for wireless transmission of data detected at the digital probe for transmission to, for example, a vascular monitoring system as described in the present disclosure. Additionally, the data hub may include a power source, a PMU, and a microcontroller or other hardware processing device, as well as other circuitry. In some embodiments, the data hub may include one or more visual indicators for signaling to a healthcare professional, for example, that the data hub is detecting parameters of the patient's vascular anatomy due to the digital probe being correctly inserted into the patient's vascular anatomy. These visual indicators may include multiple different colored LEDs that may indicate correct placement of the digital probe (e.g., green LED lit), incorrect placement of the digital probe (e.g., red LED lit), or suboptimal placement of the digital probe (e.g., yellow LED lit). In some embodiments, the data (detected or not detected) by the digital probe may be used by a microcontroller in the data hub to determine whether the digital probe has been correctly, incorrectly, or suboptimally inserted into the patient's anatomy.

[0158] Figure 27 is a block diagram of a method 2700 of inserting a digital probe of a vascular probe insertion assembly into a patient's anatomy in accordance with some embodiments of the present disclosure. Method 2700 may begin at block 2705 where a healthcare professional inserts the slotted cannula, digital probe, and split sheath of the vascular probe insertion assembly into the patient's vascular anatomy. This may occur after the healthcare professional has located the patient's anatomy to determine a location where the digital probe may be placed within the patient's vein or artery. As described in the present disclosure, the vascular probe insertion assembly may include a slotted cannula, a digital probe, and a split sheath of a certain length. The lengths of the slotted cannula, digital probe, and split sheath inserted into the patient's anatomy and vascular anatomy may depend on the insertion location on the patient's body.

[0159] As described herein, the slotted cannula can be in fluid communication with the fluid container of the needle hub. Thus, method 2700 can include, at block 2710, determining whether the healthcare professional detects the presence of blood in the fluid container of the needle hub and whether a visual indicator on the data hub indicates proper insertion. Similarly, the healthcare professional can visually detect whether the slotted cannula has reached the vein or artery by the presence of blood within the fluid container. For example, because the needle hub is made of transparent plastic, the healthcare professional can visually detect the fill level of the fluid container. Furthermore, the data hub can include one or more visual indicators for signaling to the healthcare professional that the data hub is detecting parameters of the patient's vascular anatomy, for example, because the digital probe is correctly inserted into the patient's vascular anatomy. These visual indicators can include a plurality of different colored LEDs that can indicate correct placement of the digital probe (e.g., a green LED illuminated), incorrect placement of the digital probe (e.g., a red LED illuminated), or suboptimal placement of the digital probe (e.g., a yellow LED illuminated). In some embodiments, data detected (or not detected) by the digital probe may be used by a microcontroller in the data hub to determine whether the digital probe has been correctly, incorrectly, or suboptimally inserted into the patient's anatomy.

[0160] If the healthcare professional does not detect the presence of blood in the fluid container, or if the visual indicator on the data hub has detected incorrect or suboptimal placement of the digital probe ("No" at block 2710), method 2700 may continue at block 2715 by advancing the slotted cannula (and the digital probe and splittable sheath), and if applicable, the additional length of the digital probe, further into the patient's vascular anatomy. Advancement of the cannula into the patient's anatomy may proceed until the healthcare professional detects blood in the fluid container of the needle hub. It should be appreciated that, in lieu of a needle hub, the vascular probe insertion assembly may include a syringe as described herein for the healthcare professional to use to determine whether the slotted cannula has reached the patient's vascular anatomy. Additionally, if the healthcare professional has detected blood in the fluid container (or the barrel of the syringe), the healthcare professional may further advance the additional length of the digital probe into the patient's vascular anatomy, as described herein. According to method 2700, the healthcare professional may continue to monitor the needle hub for the presence of blood and confirm correct digital probe placement via the visual indicator until both are visually detected.

[0161] In the case where the presence of blood is detected and the visual indicator on the data hub indicates that the digital probe is correctly positioned, method 2700 may include, at block 2720, a healthcare professional retracting the slotted cannula through the passage formed through the needle safety shield. This occurs when the cutting blade of the needle safety shield splits the separable sheath to expose the slot formed in the slotted cannula, as described in the present disclosure. Additionally, by pulling the separable sheath and the slotted cannula through the passage formed in the needle safety shield, the bevel and sharp tip of the slotted cannula are held within the needle safety shield such that the sharp tip does not accidentally injure the healthcare professional. Further still, at block 2725, when the healthcare professional pulls the needle safety shield away from the data hub, the needle safety shield is also withdrawn from the data hub.

[0162] Method 2700 may further include, at block 2730, a healthcare professional discarding the needle safety shield, the slotted cannula, the separable sheath, and the needle hub. Since they have been used, the needle safety shield, the slotted cannula, and the needle hub can be discarded or otherwise disposed of as biohazards, taking appropriate disposal steps to handle them as such.

[0163] Method 2700 may further include, at block 2735, attaching the digital probe and the external portion of the data hub to the external anatomy of the patient. It should be appreciated that any attachment dressing may be used, including those having a transparent window (e.g., transparent film dressing) and any adhesive stabilization platform of the data hub.

[0164] The intravascular probe insertion assembly described in the present disclosure may perform direct intravascular measurements of hemodynamic and blood-based critical patient parameters and has a minimal footprint on the patient's body. The intravascular probe insertion assembly also allows for continuous or intermittent monitoring without the procedural and workflow difficulties associated with other monitoring systems. Further still, the use of the intravascular probe insertion assembly as described in the present disclosure does not require the use of a separate catheter or vascular access device. Even further, the risks associated with other systems used to accomplish the measurements that the intravascular probe insertion assembly can achieve. The intravascular probe insertion assembly described in the present disclosure may be used to monitor critical vascular-based parameters short-term or long-term with the digital probe in place.

[0165] All of the examples and conditional language recited in the present disclosure are for pedagogical purposes to help the reader understand the utility models and concepts contributed by the inventors to advance the art and should be construed as not being limited to such specifically recited examples and conditions. Although the embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations can be made without departing from the spirit and scope of the disclosed embodiments.

Claims

1. A vascular probe insertion assembly, characterized in that, The vascular probe insertion assembly includes: A slotted cannula, comprising: A sharp tip configured to be inserted into a patient's vascular anatomy; and A sidewall extending proximally from the sharp tip, the sidewall defining a slot; A split sheath shaped to surround at least a portion of the sidewall; A digital probe, the digital probe comprising: A sensor tip configured to generate sensor data indicative of an operation of the vascular anatomy; and A shaft extending proximally of the sensor tip; and A data concentrator operatively coupled to the digital probe, wherein the data concentrator is configured to receive the sensor data and transmit the sensor data to a monitoring system.

2. The blood vessel probe insertion assembly according to claim 1, wherein, The vascular probe insertion assembly further includes: The vascular probe insertion assembly further includes a needle hub operatively coupled to the proximal end of the slotted cannula, the needle hub including a fluid reservoir for a healthcare professional to determine when the slotted cannula is inserted into the patient's vascular anatomy.

3. The blood vessel probe insertion assembly according to claim 1, characterized in that, The vascular probe insertion assembly further includes: A needle safety shield including a passage through which the slotted cannula can pass, wherein the needle safety shield is operatively coupled to the data concentrator such that when the slotted cannula is removed from the patient's vascular anatomy, the sharp tip slides into and is received within a slider of the needle safety shield.

4. The blood vessel probe insertion assembly according to claim 3, characterized in that, The vascular probe insertion assembly further includes: A needle safety shield cutting blade formed within the passage and positioned to cut the split sheath when the vascular probe is retracted from within the patient's vascular anatomy.

5. The blood vessel probe insertion assembly according to claim 1, wherein, The vascular probe insertion assembly further includes: A wireless transmitter formed within the data concentrator to wirelessly transmit the sensor data to the monitoring system.

6. The vascular probe insertion assembly according to claim 1, characterized in that, The vascular probe insertion assembly further includes: An electrical interface configured to receive a wired connection through which the sensor data can be sent to the monitoring system.

7. The vascular probe insertion assembly according to claim 1, wherein The vascular probe insertion assembly further includes: A syringe coupling feature configured to secure the proximal end of the slotted cannula to a syringe to facilitate insertion of the slotted cannula into the patient's vascular anatomy.

8. The vascular probe insertion assembly according to claim 1, characterized in that, The vascular probe insertion assembly further includes: A stabilization platform operatively coupled to the data concentrator to secure the data concentrator to an outer surface of the patient's vascular anatomy while the digital probe is maintained within the patient's vascular anatomy.

9. An indwelling vascular probe insertion assembly, characterized in that, The indwelling vascular probe insertion assembly includes: A slotted cannula configured to facilitate insertion of a digital probe into a patient's vascular anatomy, the slotted cannula comprising: A sharp tip configured to be inserted into a patient's vascular anatomy; and A sidewall extending proximally from the sharp tip, the sidewall defining a slot; A split sheath coaxially formed on the outside of the slotted cannula; A digital probe coaxially formed within the slotted cannula, the digital probe comprising: A sensor tip configured to generate sensor data indicative of an operation of the vascular anatomy; and A shaft extending proximally from the sensor tip; and A data set hub operatively coupled to the digital probe; and A needle hub operatively coupled to the slotted cannula, the needle hub including a fluid container to determine when the slotted cannula is inserted into the patient's vascular anatomy.

10. The indwelling blood vessel probe insertion assembly according to claim 9, wherein The indwelling vascular probe insertion assembly further includes: A needle safety shield including a passage through which the slotted cannula can pass, wherein the needle safety shield is operatively coupled to the data set hub such that when the slotted cannula is removed from the patient's vascular anatomy, the sharp tip slides into and is received within a slider of the needle safety shield.

11. The indwelling blood vessel probe insertion assembly according to claim 10, wherein The indwelling vascular probe insertion assembly further includes: A needle safety shield cutting blade formed within the passage formed through the needle safety shield to cut the split sheath when the digital probe is retracted from within the patient's vascular anatomy.

12. The indwelling blood vessel probe insertion assembly according to claim 9, wherein, The indwelling vascular probe insertion assembly further includes: A wireless transmitter formed within the data set hub to wirelessly transmit the sensor data to a monitoring system.

13. The indwelling blood vessel probe insertion assembly according to claim 9, wherein, The indwelling vascular probe insertion assembly further includes: An electrical interface configured to receive a wired connection through which the sensor data can be sent to a monitoring system.

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