Indwelling vascular probe for blood parameter sensing

Abstract

A vascular probe insertion assembly may include a slotted cannula having a sharp tip configured to be inserted into a vascular anatomy of a patient and a sidewall extending proximally from the sharp tip, the sidewall defining a slot. A vascular probe insertion assembly may include a splittable sheath shaped to surround at least a portion of a sidewall, and a digital probe including a sensor tip configured to generate sensor data indicative of operation of a vascular anatomy, and a shaft extending proximal to the sensor tip. The vascular probe insertion assembly may include a data hub operatively coupled to the digital probe. The data hub may be configured to receive the sensor data and transmit the sensor data to a monitoring system.

Description

Background Art

[0001] Arterial catheters and systems provide healthcare professionals with a method for monitoring arterial hemodynamic parameters of a patient 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 significant blood exposure risks and other performance issues, such as accurate placement of arterial catheters. Further, current hemodynamic monitoring and ABG collection systems may be very complex, expensive, and may require a significant amount of time and resources to collect the necessary samples. Further, a significant amount of time and resources may be required to maintain an arterial line to minimize the risk of complications such as infection and catheter-related bloodstream infection (BRBSI). Still further, in other processes associated with currently implemented arterial catheters, a significant amount of time and resources may be required to ensure proper line and device flushing and preservation of arterial blood.

[0002] The subject matter claimed in this disclosure is not limited to those embodiments that solve any disadvantages or that operate only in environments such as those described in this disclosure. Rather, this background is provided to describe the environment in which the presently described embodiments may operate. Summary of the invention

[0003] The present disclosure generally relates to a vascular probe insertion assembly for inserting a digital probe into a patient's vascular anatomy. In 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 so that the digital probe can be coaxially placed therein. In some embodiments, a splittable sheath may be coaxially formed outside the slotted cannula to hold the digital probe within the slotted cannula. After the cannula is inserted into the patient's vascular anatomy, a data concentrator operatively coupled to the digital probe may be attached to the patient's body so that the digital probe is maintained within the patient's vascular anatomy.

[0004] 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.

[0005] In some embodiments, the vascular probe includes a needle safety shield including a passage 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 withdrawn proximally, 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 in a passage formed through the needle safety shield to cut the splittable sheath when the vascular probe is retracted from the patient's vascular anatomy.

[0006] In some embodiments, the data hub includes a wireless transmitter formed within the data hub to wirelessly transmit data received at the digital probe within the patient's vascular anatomy to a vascular monitoring system. In some embodiments, the vascular probe includes contact pins formed at a proximal end of the data hub to interface with a wired connection for operatively coupling the data hub to the vascular monitoring system.

[0007] 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 hub to the patient's body (e.g., arm). In some embodiments, the vascular probe may include a syringe operatively coupled to the proximal end of the slotted cannula to provide stable insertion of the slotted cannula into the patient's vascular anatomy. In some embodiments, the vascular probe may include a stabilizing platform operatively coupled to the data hub to securely attach the data hub to an outer surface of the patient's anatomy while the digital probe is maintained within the patient's vascular anatomy.

[0008] The 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 by the needle safety shield. In some embodiments, the method may include forming a splittable sheath around the slotted cannula to secure the digital probe to the slotted cannula during insertion into the patient's vascular anatomy, and operatively coupling a data hub to the digital probe.

[0009] It should be understood that the foregoing general description and the following detailed description are examples and explanations and do not limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means illustrated in the accompanying drawings. It should also be understood that these embodiments can be combined, or other embodiments can be utilized, and unless so stated, structural changes can be made without departing from the scope of the various embodiments of the present invention. Therefore, the following detailed description should not be considered restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0011] Figure 1 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure;

[0012] Figure 2 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure;

[0013] Figure 3 is a side perspective view of a needle safety shield of a vascular probe insertion assembly according to some embodiments of the present disclosure;

[0014] Figure 4 is a perspective view of a digital probe of a vascular probe insertion assembly accessing a vascular anatomy according to some embodiments of the present disclosure;

[0015] Figure 5 is a perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure;

[0016] Figure 6 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure;

[0017] Figure 7 is a side elevation view of a data concentrator and a digital probe according to some embodiments of the present disclosure;

[0018] Figure 8 is a top view of a data concentrator and a digital probe according to some embodiments of the present disclosure;

[0019] Fig. 9 is a top view of a data concentrator and a digital probe according to some embodiments of the present disclosure;

[0020] Fig.10 is a top view of a digital probe and a data hub according to some embodiments of the present disclosure;

[0021] Fig.11 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure;

[0022] Fig.12 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure;

[0023] Fig.13 is a side perspective view of a digital probe inserted into a vascular anatomical structure according to some embodiments of the present disclosure;

[0024] Fig.14 is a top view of a digital probe and a data hub according to some embodiments of the present disclosure;

[0025] Fig.15 is a top view of a digital probe, a data hub, and a wired connection according to some embodiments of the present disclosure;

[0026] Fig.16 is a top view of a digital probe, a data hub, and a wired connection according to some embodiments of the present disclosure;

[0027] Fig.17 is a perspective view of a vascular probe insertion assembly having a wired connection according to some embodiments of the present disclosure;

[0028] Fig.18 is a side view of a digital probe having a wired connection according to some embodiments of the present disclosure;

[0029] Fig.19 is a top view of a digital probe and a data hub according to some embodiments of the present disclosure;

[0030] Fig. 20 is a top view of a digital probe and a data hub according to some embodiments of the present disclosure;

[0031] Fig.21 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure;

[0032] Fig. 22 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure;

[0033] Fig.23 is a side perspective view of a vascular probe inserted into a vascular anatomy according to some embodiments of the present disclosure;

[0034] Fig.24 is a schematic diagram of a vascular probe insertion assembly interfaced with a data processing and cloud-based system according to some embodiments of the present disclosure;

[0035] Fig.25 is a side cross-sectional perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure;

[0036] Fig.26is a block diagram of a method of manufacturing a vascular probe insertion assembly according to some embodiments of the present disclosure; and

[0037] Fig. 27 is a block diagram of a method of inserting a digital probe of a vascular probe insertion assembly into an anatomical structure of a patient according to some embodiments of the present disclosure. DETAILED DESCRIPTION

[0038] 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 can 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 this specification and the appended claims, the term "vascular anatomy" is understood to mean any blood vessel or artery in which a patient's blood is present. The blood flow-based parameters monitored, detected, and / or measured may include, for example, 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 intervascular parameters that may be detected.

[0039] 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 a sidewall extending along the length of the slotted cannula 102. In some embodiments, the sidewall may maintain the digital probe 106 coaxially or approximately coaxially within the slotted cannula 102, except at the slot. Therefore, in some embodiments, as described in the present disclosure, the digital probe 106 may run coaxially within the slotted cannula 102 until the slotted cannula 102 is removed from the patient's anatomical structure. 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 hub 108, so that when the digital probe 106 is inserted into the patient's vascular anatomy, the digital probe 106 can exit the digital probe channel formed in the data hub 108. In some embodiments, the slotted cannula 102 can include a sharp point and / or can be constructed of a rigid material to facilitate entry of the slotted cannula 102 and the splittable sheath 104 into the patient's vasculature. In some embodiments, the splittable sheath 104 forms a closed fluid channel around the slotted cannula 102, allowing fluid, such as blood, to flow through the splittable sheath 104 and providing visual and tactile feedback to the user that the vascular probe insertion assembly 100 has entered the patient's vasculature.

[0040] In some embodiments, the digital probe 106 includes a core wire for structure and durability during advancement of the digital probe 106 through the patient's vascular anatomy. The core wire can 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 includes optical fibers and / or wires 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 damage or complications in the patient's vein or artery.

[0041] The digital probe 106 can be coated with a variety of coatings to improve the performance of the digital probe 106 and reduce the risk of complications such as thrombosis or probe-related bloodstream infection (e.g., sepsis). These coatings can include silicone lubricants with or without antimicrobial additives such as alkanes or saturated hydrocarbons (e.g., CH(x)). The digital probe 106 can be coated with an anti-thrombotic or antimicrobial coating and / or a polymer additive.

[0042] In some embodiments, the sensors present on the digital probe 106 may include any number or type of sensors that detect or measure parameters of the patient's vascular anatomy. The sensors may be placed along the digital probe 106 as individual sensors or sensor bundles. The sensors may include sensors that incorporate technologies capable of detecting or measuring the patient's blood pressure (venous or arterial), blood gas, blood pH level, and electrolyte presence, 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.

[0043] The vascular probe insertion assembly 100 may include a splittable sheath 104 formed around the slotted cannula 102. The splittable sheath 104 may extend the entire length of the slotted cannula 102 except for the beveled portion along the slotted cannula 102. This allows the sharp terminal end of the slotted cannula 102 to penetrate the patient's skin when the healthcare professional accesses the patient's vein or artery. During the insertion of the vascular probe insertion assembly 100 into the patient's vascular anatomy, the splittable sheath 104 may also prevent the digital probe 106 from exiting the narrow slot formed along the slotted cannula 102.

[0044] 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 102 being opposite to the beveled portion of the slotted cannula 102, the beveled portion of the slotted cannula 102 forming a sharp tip that is configured to be inserted into the vascular anatomy of the patient. The needle hub 110 may include a hollow chamber or fluid container 112 fluidly coupled to the interior of the slotted cannula 102. When the healthcare professional inserts the slotted cannula 102 into the vascular anatomy of the patient, the fluid container 112 may receive a certain amount of blood. In this way, the healthcare professional may determine whether and when the slotted cannula 102 has penetrated the patient's vein or artery by observing whether the blood flow has entered the fluid container 112. The volume of the fluid container 112 may be sufficient to allow the healthcare professional to observe the process without aspirating a large amount of blood from the patient. Because the fluid container 112 is used only to detect when the slotted cannula 102 reaches a vein or artery, the fluid container 112, along with the slotted cannula 102 and needle safety shield 114 described in the present disclosure, can be discarded when the digital probe 106 has been introduced into the patient's vascular anatomy and the slotted cannula 102 has been pulled out of the vein or artery.

[0045] The vascular probe insertion assembly 100 may include a needle safety shield 114. The needle safety shield 114 is formed around a portion of the slotted cannula 102 and 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 includes a needle safety shield cutting blade ( Figure 1 ), 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.

[0046] The vascular probe insertion assembly 100 may include a data hub 108 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 transmission device that allows wireless transmission of data detected at the digital probe 106 to, for example, a vascular monitoring system 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 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, for example, the data hub 108 is detecting parameters of the patient's vascular anatomy because the digital probe 106 is 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 digital probe 106 (e.g., green LED illuminated), incorrect placement of digital probe 106 (e.g., red LED illuminated), or suboptimal placement of digital probe 106 (e.g., yellow LED illuminated). In some embodiments, data detected (or not detected) by digital probe 106 may be used by a microcontroller in data hub 108 to determine whether digital probe 106 has been correctly, incorrectly, or suboptimally inserted into the patient's anatomy.

[0047] During the operation of the vascular probe insertion assembly 100, the healthcare professional can address the patient's anatomical structure and determine the position where the digital probe 106 can be placed in the patient's vein or artery. Once the appropriate injection site is determined, the healthcare professional can insert the vascular probe insertion assembly 100, and specifically the slotted sleeve 102 with the digital probe 106 and the split sheath 104 into the vein or artery in the patient's anatomical structure. At this point, because the slotted sleeve 102 is fluidly connected to the fluid container 112 of the needle seat 110, the healthcare professional can visually detect that the slotted sleeve 102 has reached the vein or artery by the presence of blood in the fluid container 112. For example, because the needle seat 110 is made of transparent plastic, the healthcare professional can visually detect the filling of the fluid container 112.

[0048] Once the 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 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 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 ( Figure 1 14. The healthcare professional may then proceed to remove the data hub 108 from the needle safety shield 114. In some embodiments, the data hub 108 and the needle safety shield 114 may be operably coupled together via a track system so that when the healthcare professional pulls the slotted cannula 102 and the split sheath 104 through the passage formed through the needle safety shield 114, they may be slidably removed from each other.

[0049] 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 contacting and possibly injuring the healthcare professional. Additionally, the splittable sheath 104 that has been cut lengthwise along the length of the slotted cannula 102 can be separated from the slotted cannula 102 and thrown away with the needle hub 110, the slotted cannula 102 and the needle safety shield 114.

[0050] Additionally, when the slotted cannula 102 is pulled out of the patient's vascular anatomy, the digital probe 106 may remain in the patient's vascular anatomy. In some embodiments, when the slotted cannula 102 is inserted into the vascular anatomy, the 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 before the slotted cannula 102 is removed, for example, to retain 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 / supplemental length 120 of the digital probe may exit the slotted cannula 102 because the splittable sheath 104 is cut and the slot formed in the slotted cannula 102 serves as an exit from which the digital probe 106 will be removed from the slotted cannula 102.

[0051] When the slotted cannula 102, the splittable sheath 104, the needle safety shield 114, and the needle hub 110 have been removed from the digital probe 106 and the data hub 108, the 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 event that the healthcare professional has determined that the digital probe 106 is not inserted correctly, 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 determine a new insertion site. In the event that the healthcare professional has determined that the digital probe 106 is properly inserted, the healthcare professional can secure the data hub 108 to an external portion of the patient's anatomy (e.g., an arm) and apply a securement dressing ( Figure 1 ) to prevent the digital probe 106 from being displaced. In some embodiments, the healthcare professional can also apply a skin adhesive at the injection site where the slotted cannula 102 enters the patient's body to secure the digital probe 106 to the patient during the indwelling period of the digital probe 106.

[0052] When the healthcare professional no longer needs the digital probe 106 and the data 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 hub 108 and discard them. In some embodiments, the healthcare professional can do this by grasping the data 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.

[0053] The vascular probe insertion assembly 100 described in the present disclosure can provide direct intravascular measurements of hemodynamic and blood-based key patient parameters with 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, the 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. Further, the vascular probe insertion assembly 100 can reduce the risks associated with other systems for completing measurements that can be achieved with 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 key vascular-based parameters.

[0054] 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 FIG. 1 may be similar to Figure 1 The vascular probe insertion assembly 100 shown in FIG. Figure 2 In the embodiment shown in FIG. 1 , the digital probe 106 and the data hub 108 have been removed from the slotted cannula 102 , the needle safety shield 114 , and the needle hub 110 . Figure 1 The splittable sheath 104 shown in FIG. Figure 2 , because as described in the present disclosure, movement of the needle safety shield 114 toward the distal end of the slotted sleeve 102 (where the bevel is formed) causes the needle safety shield cutting blade of the needle safety shield 114 to cut away the splittable sheath 104, exposing the slotted sleeve 102.

[0055] like Figure 2, the needle safety shield 114 may include a plurality of attachment surfaces 201 that interface with complementary attachment surfaces formed on the digital probe 106. 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 during insertion of the slotted cannula 102 into the patient's vascular anatomy. As described in the present disclosure, after the slotted cannula 102 has been inserted into a vein or artery of the patient, it may subsequently be removed while the digital probe 106 and the data hub 108 remain in place. In embodiments of the present disclosure, removal of the slotted cannula 102 allows the digital probe 106 to remain within the patient's vein or artery while the data hub 108 (operatively coupled to the digital probe 106) remains with the patient. The needle safety shield 114, slotted cannula 102, and needle hub 110 may be removed away from the data hub 108 by sliding the needle safety shield 114 laterally 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 treated as a biohazard, taking appropriate disposal steps to dispose of them as such.

[0056] As described in the present disclosure, the needle safety shield 114 can have a passage 203 formed therethrough so that the slotted cannula 102 can be passed therethrough during operation by a healthcare professional. Additionally, in some embodiments, the needle safety shield 114 can include a needle safety shield cutting blade ( Figure 2 ), 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.

[0057] The data hub 108 may remain with the patient and may later allow attachment to the outer surface of the patient's anatomical structure (e.g., arm). As described in the present disclosure, the digital probe 106 may include a supplemental length 120 of the digital probe that allows the healthcare professional to advance the digital probe 106 further into the patient's anatomical structure and, if necessary, into a vein or artery. This advancement of the digital probe 106 using the supplemental length 120 of the digital probe may 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 supplemental length 120 of the digital probe may be changed depending on whether the healthcare professional deems it necessary to further pass the digital probe 106 into the patient's vein or artery.

[0058] Figure 2 Includes the dotted box "A", generally including Figure 2 The needle safety shield 114 is shown in FIG. Figure 3A box “A” is also included in FIG. 1 to highlight and show a larger image of the needle safety shield 114 and a portion of the slotted cannula 102 . Figure 3 According to some embodiments of the present disclosure Figure 1 and Figure 2 8 is a side perspective view of a needle safety shield 114 of a vascular probe insertion assembly 100 similar to the vascular probe insertion assembly 100 shown in FIG. Figure 3 A closer view of the needle safety shield 114 is shown including the passage 203 and a needle safety shield cutting blade 305 formed on the needle safety shield 114 . Figure 3 Also shown is the slotted sleeve 102 in a most retracted position, wherein the beveled portion of the slotted sleeve 102 is fully retracted into the passageway 203 .

[0059] As described in the present disclosure, the needle safety shield 114 can be used both as a shield for protecting a healthcare professional from being stabbed by a used slotted cannula 102 and as a shield for cutting a splittable sheath (in the case of a needle) during operation. Figure 3 203). In some embodiments, a needle safety shield cutting blade 305 may be placed at the distal end of the passage 203 so that the split sheath may 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 may be cut by the needle safety shield cutting blade 305. This allows the split sheath to be opened along its entire length, allowing the digital probe ( Figure 3 The slotted sleeve 102 is removed (not shown) and released from the remainder of the vascular probe insertion assembly 100 as described in the present disclosure.

[0060] In some embodiments, the needle safety shield cutting blade 305 may be placed at the bottom surface of the distal portion of the passage 203 formed through the needle safety shield 114. In another embodiment, the needle safety shield cutting blade 305 may be placed at the top or upper position of the passage 203 formed through the needle safety shield 114. In some embodiments, the needle safety shield cutting blade 305 may be placed at the location of the distal entrance of the passage 203 so that when the slotted cannula 102 is pulled through the passage 203, as the splittable sheath is cut and split by the needle safety shield cutting blade 305, the digital probe may be released from the slotted cannula 102 at the same time. When the splittable sheath is cut and split by the needle safety shield cutting blade 305, this allows the digital probe 106 to be released from the slotted cannula 102 via the slot formed along the length of the slotted cannula 102.

[0061] Likewise, the needle safety shield 114 may include a plurality of attachment surfaces 201 that are complementary to the attachment surfaces ( Figure 3 ) docking. During 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 bottom side of the data hub 108. As described in the present disclosure, after the slotted cannula 102 has been inserted into a vein or artery of the patient, the slotted cannula 102 can subsequently be removed while the digital probe and data hub remain in place. In an embodiment of the present disclosure, removal of the slotted cannula 102 allows the digital probe to remain 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 3 102) is removed away from the data hub, thereby separating the needle safety shield 114 from the data hub. At this point, the needle safety shield 114, slotted sleeve 102 and needle hub can be thrown away or otherwise treated as biohazards, taking appropriate disposal steps to treat them accordingly.

[0062] In some embodiments, the needle safety shield 114 may include grooves or digital probe channels 118 formed along the needle safety shield 114 that match grooves 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 so that a supplemental length of the digital probe can be secured to the patient's anatomy along with the data hub.

[0063] Figure 4 is a perspective view of the digital probe 106 of the vascular probe insertion assembly 100 accessing a vascular anatomy 407 according to some embodiments of the present disclosure. Figure 4 Shown in healthcare professionals have removed e.g. Figure 1 and Figure 2. As described in the present disclosure, the digital probe 106 is retained when the slotted cannula is pulled out of 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, the healthcare professional can 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 the slotted cannula is removed, for example, to retain the digital probe 106 in 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 supplemental length 120 of the digital probe may exit the slotted cannula as the splittable 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.

[0064] In some embodiments, the data hub 108 may be affixed to an external anatomical structure 409 of the patient. The external anatomical structure 409 to which the data hub is affixed may vary depending on the vascular anatomy 407 into which the digital probe 106 is inserted. For example, where the vascular anatomy 407 is a vein within the patient's arm, the data hub 108 may be affixed to the patient's arm proximate to where the digital probe 106 penetrates the patient's skin.

[0065] As described in the present disclosure, the vascular probe insertion assembly 100 may also include a data hub 108 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 transmission device that allows wireless transmission of data detected at the digital probe 106 to, for example, a vascular monitoring system 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.

[0066] 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, as a result of the digital probe 106 being properly 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 by a 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 devices may be selectively removable such that when it is no longer necessary to monitor the patient's vascular anatomy 407, 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.

[0067] 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 FIG. 1 may be combined with, for example, Figure 1 The vascular probe insertion assembly described above is similar. 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 forms a sidewall extending along the length of the slotted cannula 102, except at the slot, the sidewall maintains the digital probe 106 coaxially therein. Therefore, the digital probe 106 can run coaxially within the slotted cannula 102 until the slotted cannula 102 is removed from the patient's anatomical structure, as described in the present disclosure.

[0068] In some embodiments, the digital probe 106 may include a core wire for structure and durability during advancement of the digital probe 106 through the 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 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 damage or complications in the patient's vein or artery. In some embodiments, the proximal end of the digital probe 106 may be operably coupled within the digital probe 106 and coupled to the digital probe 106. Figure 1 Unlike the example embodiment shown in , the digital probe 106 does not include a supplemental length of the digital probe. This enables the healthcare professional to securely attach the data hub 108 to the external anatomy of the patient without having to secure an unused portion of the digital probe 106 to the external anatomy of the patient. Additionally, for a fixed length digital probe 106, the healthcare professional 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 within the patient's vascular anatomy at a length necessary to complete the monitoring of key vascular-based parameters.

[0069] In some embodiments, the digital probe 106 may be coated with a variety of coatings to improve the performance of the digital probe 106 and reduce the risk of complications such as thrombosis or probe-related bloodstream infection (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.

[0070] The sensors present on the digital probe 106 may include any number or type of sensors that detect or measure parameters of the patient's vascular anatomy. These sensors may be placed along the digital probe 106 as separate sensors or sensor bundles. These sensors may include sensors that incorporate technologies capable of detecting or measuring the patient's blood pressure (venous or arterial), blood gas, blood pH level, and electrolyte presence, 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.

[0071] 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 for the beveled portion along the slotted cannula 102. This allows the sharp terminal end of the slotted cannula 102 to penetrate the patient's skin when the healthcare professional accesses the patient's vein or artery. The split sheath 104 also prevents the digital probe 106 from exiting the narrow slot formed along the slotted cannula 102 during the insertion of the vascular probe insertion assembly 100 into the patient's vascular anatomy.

[0072] 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 to the beveled portion of the slotted cannula 102, the beveled portion of the slotted cannula 102 forming a sharp tip that is configured to be inserted into the vascular anatomy of the patient. In one embodiment, the needle hub 110 may include a hollow chamber or fluid container 112 that is fluidly coupled to the interior of the slotted cannula 102. When the healthcare professional inserts the slotted cannula 102 into the vascular anatomy of the patient, the fluid container 112 may receive a certain amount of blood. In this way, the healthcare professional may determine whether and when the slotted cannula 102 has penetrated the patient's vein or artery by observing whether the blood flow has entered the fluid container 112. The volume of the fluid container 112 may be sufficient to allow the healthcare professional to observe this process without drawing a large amount of blood from the patient. Because the fluid container 112 is used only to detect when the slotted cannula 102 reaches a vein or artery, the fluid container 112, along with the slotted cannula 102 and needle safety shield 114 described in the present disclosure, can be discarded when the digital probe 106 has been introduced into the patient's vascular anatomy and the slotted cannula 102 has been pulled out of the vein or artery.

[0073] 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 1 ), which is used to cut the splittable sheath 104 during extraction of the slotted cannula 102 from the patient's vascular anatomy.

[0074] The vascular probe insertion assembly 100 may include a data hub 108 that is operatively connected 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 described in the present disclosure. 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 that are used to signal 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 is 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 digital probe 106 (e.g., green LED illuminated), incorrect placement of digital probe 106 (e.g., red LED illuminated), or suboptimal placement of digital probe 106 (e.g., yellow LED illuminated). In some embodiments, data detected (or not detected) by digital probe 106 may be used by a microcontroller in data hub 108 to determine whether digital probe 106 has been correctly, incorrectly, or suboptimally inserted into the patient's anatomy.

[0075] During the operation of the vascular probe insertion assembly 100, the healthcare professional can address the patient's anatomical structure and determine the position where the digital probe 106 can be placed in the patient's vein or artery. Once the appropriate injection site is determined, the healthcare professional can insert the vascular probe insertion assembly 100, and specifically the slotted sleeve 102 and its digital probe 106 and the split sheath 104 into the patient's anatomical structure to the vein or artery. At this time, because the slotted sleeve 102 is fluidly connected to the fluid container 112 of the needle seat 110, the healthcare professional can visually detect that the slotted sleeve 102 has reached the vein or artery through the presence of blood in the fluid container 112. For example, because the needle seat 110 is made of transparent plastic, the healthcare professional can visually detect the filling of the fluid container 112.

[0076] Once the healthcare professional detects the presence of blood in the fluid container 112 of the needle hub 110, or a visual flashback of blood, 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 is 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 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 may 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 ( Figure 1 The healthcare professional may then begin cutting the split sheath 104 (not shown). This will continue until the beveled portion of the slotted cannula 102 is safely contained within the passage formed through the needle safety shield 114. The process may also include removing the data hub 108 from the needle safety shield 114. In some embodiments, the data hub 108 and the needle safety shield 114 may be operably coupled together via a track system so that when the healthcare professional pulls the slotted cannula 102 and the split sheath 104 through the passage formed through the needle safety shield 114, they may be slidably removed from each other.

[0077] 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 contacting and possibly injuring the healthcare professional. Additionally, the splittable sheath 104 that has been cut lengthwise along the length of the slotted cannula 102 can be separated from the slotted cannula 102 and thrown away with the needle hub 110, the slotted cannula 102 and the needle safety shield 114.

[0078] Additionally, when the slotted cannula 102 is pulled out of the patient's vascular anatomy, the digital probe 106 is retained. In some embodiments, when the slotted cannula 102 is inserted into the vascular anatomy, the supplementary 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 retain 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 / supplementary length 120 of the digital probe can exit the slotted cannula 102 because the splittable sheath 104 is 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.

[0079] When the slotted cannula 102, the splittable sheath 104, the needle safety shield 114, and the needle hub 110 have been removed from the digital probe 106 and the data hub 108, the 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 event that the 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 determine a new insertion site. In the event that the healthcare professional has determined that the digital probe 106 is properly inserted, the healthcare professional can securely attach the data hub 108 to an external portion of the patient's anatomy (e.g., an arm) and apply a securement dressing ( Figure 1 ), to prevent the digital probe 106 from being displaced. In some embodiments, the healthcare professional may also apply a skin adhesive at the injection site where the slotted cannula 102 enters the patient's body to secure the digital probe 106 to the patient during the indwelling period of the digital probe 106.

[0080] When the healthcare professional no longer needs the digital probe 106 and the data 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 hub 108 and discard them. In some embodiments, the healthcare professional can do this by grasping the data 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.

[0081] The vascular probe insertion assembly 100 described in the present disclosure can provide direct intravascular measurements of hemodynamic and blood-based key patient parameters with 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. Further, the risks associated with other systems for completing measurements that can be achieved with the vascular probe insertion assembly 100 are eliminated. 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 key vascular-based parameters.

[0082] 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 FIG. Figure 5 The vascular probe insertion assembly 100 is similarly shown, with a fixed length digital probe 106. Figure 6 In the embodiment shown in FIG. 1 , the digital probe 106 and the data hub 108 have been removed from the slotted cannula 102 , the needle safety shield 114 , and the needle hub 110 . Figure 5 The splittable sheath 104 shown in FIG. Figure 6 104 , because movement of the needle safety shield 114 toward the beveled distal end of the slotted cannula 102 causes the needle safety shield cutting blade of the needle safety shield 114 to cut away the splittable sheath 104 , exposing the slotted cannula 102 , as described in the present disclosure.

[0083] like Figure 6, the needle safety shield 114 may include a plurality of attachment surfaces 201 that interface with complementary attachment surfaces formed on the digital probe 106. 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 during insertion of the slotted cannula 102 into the patient's vascular anatomy. As described in the present disclosure, after the slotted cannula 102 has been inserted into a vein or artery of the patient, it may subsequently be removed while the digital probe 106 and the data hub 108 remain in place. In an embodiment of the present disclosure, removal of the slotted cannula 102 allows the digital probe 106 to remain within the patient's vein or artery while the data hub 108 (operatively coupled to the digital probe 106) remains with the patient. The needle safety shield 114, slotted cannula 102, and needle hub 110 are removed away from the data hub 108 by sliding the needle safety shield 114 laterally 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 thrown away or otherwise treated as a biohazard, taking appropriate disposal steps to dispose of them as such.

[0084] The data hub 108 can remain with the patient and can be later secured to the outer surface of the patient's anatomical structure (e.g., arm). As described in the present disclosure, the digital probe 106 can include a supplemental length 120 of the digital probe that allows the healthcare professional to advance the digital probe 106 further into the patient's anatomical structure and, if necessary, into a vein or artery. This advancement of the digital probe 106 using the supplemental length 120 of the digital probe can be achieved when the slotted cannula 102 is within a vein or artery. Therefore, during the removal of the slotted cannula 102, the length of the supplemental length 120 of the digital probe can be changed depending on whether the healthcare professional deems it necessary to further pass the digital probe 106 into the patient's vein or artery.

[0085] Figure 7 FIG. 1 is a side elevation view of a 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 FIG. 1 may be Figure 6 A portion of a vascular probe insertion assembly 100 is shown in FIG.

[0086] As described in the present disclosure, the proximal end of the digital probe 106 is operatively coupled within the digital probe 106 and with the Figure 1Unlike the example embodiment shown in , for example, the digital probe 106 does not include a supplemental length of the digital probe. This allows the healthcare professional to securely attach the data hub 108 to the external anatomy of the patient without also securing the unused portion of the digital probe 106 to the external anatomy of the patient. Additionally, for a fixed length digital probe 106, the healthcare professional 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 within the patient's vascular anatomy at a length necessary to complete the monitoring of key vascular-based parameters.

[0087] Figure 7 Also shown is a knurled surface 711 that may be formed on an outer surface of the data hub 108. This knurled surface 711 may include any type of surface treatment and may be used by a healthcare professional to better grip the data hub 108 and a needle safety shield ( ) operatively coupled to the data hub 108 during insertion of the slotted cannula 102 into the patient's vascular anatomy 407. Figure 7 not shown).

[0088] 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 Other features of the data hub 108 and the digital probe 106 that may be included with the vascular probe insertion assembly 100 described in the present disclosure are shown.

[0089] 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 813 may be used to prevent damage to the digital probe 106 if and when the data hub 108 moves relative to the digital probe 106. In some embodiments, the strain relief 813 may be used to prevent the digital probe 106 from being displaced from the data hub 108 due to stress caused by bending, twisting, or pulling of the data hub 108 against the digital probe 106 when a healthcare professional attempts to secure the data hub 108 to the patient's body. In some embodiments, the strain relief 813 may be sized to help adequately distribute stress between the data hub 108 and the digital probe 106 to prevent damage. For example, this will prevent the nitinol core wire 817 and other electrical connections within the digital probe 106 from being damaged.

[0090] 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 sensor capable of detecting, monitoring or sensing key vascular-based parameters within the patient's vascular anatomy. These sensors 815 can include those associated with detecting, monitoring or sensing venous or arterial blood pressure, temperature, 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 intervascular parameters that can be detected. In some embodiments, each sensor can be operatively connected to the data hub 108 via an electrical connection, which operatively connects the sensor 815 to, for example, a microcontroller and other circuits within the data hub 108.

[0091] In some embodiments, data hub 108 may include one or more visual indicators 116 for signaling to a healthcare professional that data hub 108 is detecting parameters of a patient's vascular anatomy, for example, due to proper insertion of digital probe 106 into the patient's vascular anatomy. These visual indicators 116 may include a plurality of different colored light emitting diodes (LEDs) that may indicate proper placement of digital probe 106 (e.g., green LED illuminated), improper placement of digital probe 106 (e.g., red LED illuminated), or suboptimal placement of digital probe 106 (e.g., yellow LED illuminated). In some embodiments, data detected (or not detected) by digital probe 106 may be used by a microcontroller in data hub 108 to determine whether digital probe 106 has been properly, improperly, or suboptimally inserted into the patient's anatomy.

[0092] Fig. 9 is a top view of the digital probe 106 and the data hub 108 according to some embodiments of the present disclosure. Fig. 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 external anatomy of the patient 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 can include an adhesive formed on a surface to be abutted against the external anatomy of the patient. In some embodiments, the stabilizing platform 919 can include a non-slip surface that creates greater friction between the stabilizing platform 919 and the external anatomy of the patient. In some embodiments, the stabilizing platform 919 can enhance the stability of the data hub 108 placed against the external anatomy of the patient.

[0093] Likewise, in some embodiments, data hub 108 may include one or more visual indicators 116 for signaling to a healthcare professional that data hub 108 is detecting parameters of a patient's vascular anatomy, e.g., due to proper insertion of digital probe 106 into the patient's vascular anatomy. These visual indicators 116 may include a plurality of different colored light emitting diodes (LEDs) that may indicate proper placement of digital probe 106 (e.g., green LED illuminated), improper placement of digital probe 106 (e.g., red LED illuminated), or suboptimal placement of digital probe 106 (e.g., yellow LED illuminated). In some embodiments, data detected (or not detected) by digital probe 106 may be used by a microcontroller in data hub 108 to determine whether digital probe 106 has been properly, improperly, or suboptimally inserted into the patient's anatomy.

[0094] Fig.10 is a top view of a data hub 108 and a digital probe 106 according to some embodiments of the present disclosure. Similarly, the data hub 108 may include a Fig. 9 Described is a stabilizing platform similar to stabilizing platform 919 .

[0095] exist Fig.10 In the embodiment shown in , a 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 external anatomical structure of the patient 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 anatomical structure. 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 anatomical structure. In some embodiments, the stabilizing platform 919 can enhance the stability of the data hub 108 placed against the patient's external anatomical structure.

[0096] Additionally, during operation, the healthcare professional may use the securing dressing 1021 to secure the data hub 108 to the patient's external anatomy. In some embodiments, the securing dressing 1021 may include a rigid border 1023, which may include an adhesive for tightly securing the securing dressing 1021 to the patient's external anatomy 409. In some embodiments, the securing dressing 1021 may sandwich the data hub 108 between the bottom surface of the securing dressing 1021 and the surface of the patient's external anatomy. In some embodiments, the securing 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 a healthcare professional that the data hub 108 is detecting a parameter of the patient's vascular anatomy, for example, because the digital probe 106 is properly 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 Transparent film dressing.

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

[0098] Fig.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 splittable sheath 104, and a digital probe 106, as described in the present disclosure. Fig.11The example embodiment shown in shows the digital probe 106 extending through the slotted sleeve 102 and the splittable sheath 104 , through the digital probe channel 118 , and extending out of the digital probe channel 118 . Fig.11 Also shown are various electrical circuits within the digital probe 106 that may be used to operatively couple the digital probe 106 to, for example, a monitoring system, as described in this disclosure.

[0099] exist Fig.11 In the embodiment shown in , the sharp end of the slotted cannula 102 can be inserted into the patient's vascular anatomy 407, thereby introducing 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 placed in place, the healthcare professional can hold the needle hub 110 with one hand, hold the data hub 108 in the other hand, and continue to hold the data hub 108 while the healthcare professional pulls the needle hub 110 away from the data hub 108. When this occurs, the slotted cannula 102 and the splittable sheath 104 are pulled through the passage formed in the needle safety shield 114. When the splittable sheath 104 is pulled through the passage of the needle safety shield 114, the needle safety shield cutting blade ( Fig.11 104) to allow a segment of the digital probe 106 to exit from the slotted sleeve 102, as described in the present disclosure. Fig.11 In the embodiment shown in , the digital probe 106 is not operatively coupled to the data hub 108, but rather the data hub 108 can be disposed of along with the slotted cannula 102, the splittable sheath 104, and the needle hub 110. This creates 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.

[0100] like Fig.11 As shown in , the digital probe 106 may include multiple wires that allow the sensors of the digital probe 106 to be operatively connected to a monitoring system, as described in the present disclosure. The multiple wires may include, for example, a negative voltage rail (V-), a positive voltage rail (V+), and any number of data electrical lines (e.g., Data 1, Data 2, etc.). Negative and positive voltage rails may be provided to supply current to the sensors of the digital probe 106 so that the sensors can detect, monitor, or otherwise sense key vascular-based parameters described in the present disclosure. According to example embodiments in the present disclosure, each data line may be used to transfer data from a sensor to a monitoring system. It should be appreciated that although Fig.11 Only two data lines are shown (eg, Data 1 and Data 2 ), but digital probe 106 may include more or less than these two data lines.

[0101] Fig.12 is a side perspective view of a vascular probe insertion assembly 100 according to some embodiments of the present disclosure. The vascular probe insertion assembly 100 is shown in an orientation in which the digital probe 106 has been placed within the 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 splittable sheath 104 to be cut by the needle safety shield cutting blade of the needle safety shield 114, causing the splittable sheath 104 to detach from the vascular probe insertion assembly 100. The needle safety shield 114 then covers the sharp point of the slotted cannula 102 so that the healthcare professional is not injured by the sharp point. Additionally, in Fig.11 , Fig.12 and Fig.13 In the embodiment of the present invention, the data hub 108 is not maintained with the patient and is also disposed of along with the slotted cannula 102, the splittable sheath 104, the needle hub 110 (with its fluid container 112), and the needle safety shield 114. Again, 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.

[0102] Fig.13 is a side perspective view of the digital probe 106 inserted into a vascular anatomy 407 according to some embodiments of the present disclosure. Fig.13 Shown in healthcare professionals have removed e.g. Fig.11 , the digital probe 106 is in an installed position after the slotted cannula, splittable sheath, needle safety shield, data hub, and needle hub are attached as shown in . As described in the present disclosure, the digital probe 106 is retained when the slotted cannula is pulled out of the patient's vascular anatomy 407. The external anatomical structure 409 to which a portion of the digital probe 106 is affixed can vary depending on the vascular anatomy 407 into which the digital probe 106 is inserted. For example, where the vascular anatomy 407 is a vein within the patient's arm, a portion of the digital probe 106 can be affixed to the patient's arm near where the digital probe 106 has passed through the patient's skin and the vascular anatomy 407.

[0103] Likewise, the digital probe 106 may include a plurality of 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 plurality of wires may include, for example, a negative voltage rail (V-), a positive voltage rail (V+), and any number of data electrical lines (e.g., Data 1, Data 2, etc.). Negative and positive voltage rails may be provided to supply current to the sensors of the digital probe 106 so that the sensors may detect, monitor, or otherwise sense key vascular-based parameters, as described in the present disclosure. According to example embodiments in the present disclosure, each data line may be used to transfer data from a sensor to a monitoring system. It should be appreciated that, although Fig.11 Only two data lines are shown (eg, Data 1 and Data 2 ), but digital probe 106 may include more or less than these two data lines.

[0104] Fig.14 is a top view of a digital probe 106 and a data hub 108 according to some embodiments of the present disclosure. Fig. 9 , Fig.14 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 external anatomy of the patient 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 can include an adhesive formed on a surface to be abutted against the external anatomy of the patient. In some embodiments, the stabilizing platform 919 can include a non-slip surface that creates greater friction between the stabilizing platform 919 and the external anatomy of the patient. In some embodiments, the stabilizing platform 919 can enhance the stability of the data hub 108 placed against the external anatomy of the patient.

[0105] Additionally, in Fig.14 In the embodiment shown in , 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 813 may be used to prevent damage to the digital probe 106 if and when the data hub 108 moves relative to the digital probe 106. In some embodiments, the strain relief 813 may be used to prevent the digital probe 106 from being displaced from the data hub 108 due to stress caused by bending, twisting, or pulling of the data hub 108 against the digital probe 106 when the healthcare professional attempts to secure the data hub 108 to the patient's body. In some embodiments, the strain relief 813 may be sized to help adequately distribute stress between the data 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.

[0106] In some embodiments, 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 sensor capable of detecting, monitoring or sensing key vascular-based parameters within the patient's vascular anatomy. These sensors 815 may include those associated with detecting, monitoring or sensing venous or arterial blood pressure, temperature, 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 intervascular parameters that can be detected. In some embodiments, each sensor can be operatively connected to the data hub 108 via an electrical connection, which operatively connects the sensor 815 to, for example, a microcontroller and other circuits within the data hub 108.

[0107] In some embodiments, the data hub 108 may include an electrical interface 1427. The electrical interface 1427 may be used by the data hub 108 to couple the data hub 108 to a monitoring system via a wired connection. In some embodiments, the electrical interface 1427 may include one or more contact pins that interface with corresponding wired connections that operatively couple the data hub 108 to the monitoring system. As described in the present disclosure, the data hub 108 may be a wireless data hub 108 or a wired data hub 108, and Fig.14 The example shown in FIG. 1 is a wired data hub 108 that allows a healthcare professional to connect a wired connection interface to a proximal end of the data hub 108 .

[0108] Fig.15 is a top view of the digital probe 106 , the data hub 108 , and the wired connection 1529 according to some embodiments of the present disclosure. Fig.15 Also shown is a stabilizing platform 919 operatively coupled to the data hub 108. In some embodiments, the stabilizing platform 919 can be semi-rigid, which allows the data hub 108 to be placed against the external anatomical structure of the patient 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 can include an adhesive formed on a surface to be abutted against the external anatomical structure of the patient. In some embodiments, the stabilizing platform 919 can include a non-slip surface that creates greater friction between the stabilizing platform 919 and the external anatomical structure of the patient. In some embodiments, the stabilizing platform 919 can enhance the stability of the data hub 108 placed against the external anatomical structure of the patient.

[0109] Additionally, in Fig.14In the embodiment shown in , 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 813 may be used to prevent damage to the digital probe 106 if and when the data hub 108 moves relative to the digital probe 106. In some embodiments, when a healthcare professional attempts to secure the data hub 108 to the patient's body, the strain relief 813 may be used to prevent the digital probe 106 from being displaced from the data hub 108 due to stress caused by bending, twisting, or pulling the data hub 108 against the digital probe 106. In some embodiments, the strain relief 813 may be sized to help adequately distribute stress between the data 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.

[0110] In some embodiments, 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 sensor capable of detecting, monitoring or sensing key vascular-based parameters within the patient's vascular anatomy. These sensors 815 may include those associated with detecting, monitoring or sensing venous or arterial blood pressure, temperature, 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 intervascular parameters that can be detected. In some embodiments, each sensor can be operatively connected to the data hub 108 via an electrical connection, which operatively connects the sensor 815 to, for example, a microcontroller and other circuits within the data hub 108.

[0111] As described in the present disclosure, the data hub 108 may include an electrical interface 1427. The electrical interface 1427 may be used by the data hub 108 to couple the data hub 108 to a monitoring system via a wired connection. In some embodiments, the electrical interface 1427 may include one or more contact pins that interface with corresponding wired connections that operatively couple the data hub 108 to the monitoring system. As described in the present disclosure, the data hub 108 may be a wireless data hub 108 or a wired data hub 108. Fig.14 The example shown in is a wired data hub 108 that allows a healthcare professional to connect a wired connection interface to the proximal end of the data hub 108. The use of an electrical interface 1427 allows the monitoring system to disconnect and reconnect when necessary to detect critical blood-based patient parameters. For example, the connection at the digital probe 106 allows such disconnection, such as for improved mobility for necessary patient removal.

[0112] Fig.15 Also shown is a wired connection 1529 for operatively coupling the data hub 108 of the vascular probe insertion assembly 100 to a monitoring system described in the present disclosure. The wired connection 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 1529 may also include a plug 1533 for completing the connection between the data hub 108 and the wired connection 1529 to the monitoring system. In some embodiments, the monitoring system may include a bedside monitoring system, a computer or computing device, a data cloud, or a combination thereof. In some embodiments, the monitoring system may be used 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 example embodiments.

[0113] Fig.16 is a top view of a digital probe 106, a data hub 108, and a wired connection 1529 according to some embodiments of the present disclosure. As described in the present disclosure, a vascular probe insertion assembly 100 may include a digital probe 106 operatively coupled to a data hub 108 via a strain relief 813. The digital probe 106 may include one or more sensors 815 operatively coupled to a nitinol core wire 817 to be inserted into a vascular anatomy of a patient. The data hub 108 may also include a stabilizing platform 919 for providing structural support to the data hub 108 and, in one embodiment, affixing the data hub 108 to an external anatomy of the patient via, for example, an adhesive.

[0114] As described in the present disclosure, the data hub 108 may include an electrical interface 1427. The electrical interface 1427 may be used by the data hub 108 to couple the data hub 108 to a monitoring system via a wired connection. In some embodiments, the electrical interface 1427 may include one or more contact pins that interface with corresponding wired connections that operatively couple the data hub 108 to the monitoring system. As described in the present disclosure, the data hub 108 may be a wireless data hub 108 or a wired data hub 108. Fig.14 The example shown in FIG. 1 is a wired data hub 108 that allows a healthcare professional to connect a wired connection interface to a proximal end of the data hub 108 .

[0115] Fig.16 Shows Fig.16The wired connection 1529 described in the present disclosure 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 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 1529 may also include a plug 1533 for completing the connection between the data hub 108 and the wired connection 1529 to the monitoring system. In some embodiments, the monitoring system may include a bedside monitoring system, a computer or computing device, a data cloud, or a combination thereof. In some embodiments, the monitoring system may be used to calculate, classify, process, send, 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 example embodiments.

[0116] Fig.17 1 is a perspective view of a vascular probe insertion assembly 100 with a wired connection 1529 according to some embodiments of the present disclosure. As described in the present disclosure, the data hub 108 may include a digital probe 106 for placing one or more sensors into a patient's vascular anatomy. The data hub 108 may also include a stabilizing platform 919 for giving the data hub 108 structural support and, in one embodiment, affixing the data hub 108 to the patient's external anatomy via, for example, an adhesive.

[0117] exist Fig.17 , the data hub 108 is further coupled to a wired connection 1529 for operatively coupling the data hub 108 to a monitoring system via the wired connection. In some embodiments, the wired connection 1529 is permanently coupled to the data hub 108 at the proximal end of the data hub 108. The wired connection 1529 may also 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 may dock with a USB port at the monitoring system. The length of the wired connection 1529 may vary, and in one embodiment may be long enough to reach the monitoring system from the patient.

[0118] Fig.18 A wired connection 1529 is shown permanently connected to the data hub 108. Fig.181 is a side view of a digital probe 106 with a wired connection 1529 according to some embodiments of the present disclosure. In some embodiments, the wired connection 1529 allows a healthcare professional to operably connect to a plug (not shown) to a monitoring system when the digital probe 106 is placed within the patient's vascular anatomy. In some embodiments, the wired connection 1529 can be disconnected from the digital probe 106 and the stabilizing platform 919 if necessary to allow for better patient mobility. The wired connection 1529 can then be reconnected as described in the present disclosure when those blood-based critical patient parameters are to be detected or monitored.

[0119] Fig.19 is a top view of the digital probe 106 and the data hub 108 according to some embodiments of the present disclosure. Fig.19 The data hub 108 is shown, which includes a tether connector 1935 that operatively couples the data hub 108 to the digital probe 106. In some embodiments, the length of the tether connector 1935 can vary depending on the level of mobility required by the patient. In some embodiments, the tether connector 1935 and the data hub 108 can also be secured to the patient's external anatomy to prevent the digital probe 106 from being displaced.

[0120] Fig. 20 is a top view of the digital probe 106 and the data hub 108 according to some embodiments of the present disclosure. Fig. 20 In the embodiment shown in , the data hub 108 can include a tether connector 1935 that operatively couples the data hub 108 to the digital probe 106. In some embodiments, the length of the tether connector 1935 can vary depending on the level of mobility required by the patient. In some embodiments, the tether connector 1935 and the data hub 108 can also be fixedly attached to the patient's external anatomical structure to prevent the digital probe 106 from being displaced.

[0121] In some embodiments, the stabilizing platform 919 may be operably coupled to the intermediate hub 2037 proximate to the digital probe 106. In some embodiments, the stabilizing platform 919 may be semi-rigid, which allows the data hub 108 to be placed against the external anatomical structure of the patient so that the data hub 108 does not rotate when the digital probe 106 is placed within the vascular anatomical structure of the patient, 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 external anatomical structure of the patient. In some embodiments, the stabilizing platform 919 may include a non-slip surface that creates greater friction between the stabilizing platform 919 and the external anatomical structure of the patient. In some embodiments, the stabilizing platform 919 may enhance the stability of the intermediate hub 2037 placed against the external anatomical structure of the patient. In some embodiments, the intermediate hub 2037 may include some of those elements that may be included in the data hub 108. In some embodiments, the intermediate hub 2037 may include one or more of a power supply, a PMU, and a microcontroller or other hardware processing device, and other circuits. Where these devices are included within the intermediate hub 2037 , the data hub 108 need not include these devices as the tether connector 1935 operatively couples the intermediate hub 2037 to the data hub 108 .

[0122] Fig.21 is a side perspective view of a vascular probe insertion assembly according to some embodiments of the present disclosure. Fig.21 The vascular probe insertion assembly 100 shown in FIG. 1 may be similar to Figure 1 The vascular probe insertion assembly 100 shown in FIG. 1 , wherein the syringe 2139 is operatively coupled to the slotted cannula 102 .

[0123] 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 forms a sidewall extending along the length of the slotted cannula 102, except at the slot, the sidewall coaxially maintains the digital probe 106 therein. Therefore, the digital probe 106 can coaxially run within the slotted cannula 102 until the slotted cannula 102 is removed from the patient's anatomical structure, 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 hub 108, so that when the digital probe 106 is inserted into the patient's vascular anatomical structure, the digital probe 106 can leave the digital probe channel 118 formed in the data hub 108.

[0124] In some embodiments, the digital probe 106 may include a core wire for structure and durability during advancement of the digital probe 106 through the 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 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 damage or complications in the patient's vein or artery.

[0125] In some embodiments, the digital probe 106 may be coated with a variety of coatings to improve the performance of the digital probe 106 and reduce the risk of complications such as thrombosis or probe-related bloodstream infection (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 any of an anti-thrombotic or antimicrobial coating and / or polymer additive.

[0126] The sensors present on the digital probe 106 may include any number or type of sensors that detect or measure parameters of the patient's vascular anatomy. These sensors may be placed along the digital probe 106 as individual sensors or sensor bundles. These sensors may include sensors that incorporate technologies capable of detecting or measuring the patient's blood pressure (venous or arterial), blood gas, blood pH level, and electrolyte presence, 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.

[0127] 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 for the beveled portion along the slotted cannula 102. This allows the sharp terminal end of the slotted cannula 102 to penetrate the patient's skin when the healthcare professional accesses the patient's vein or artery. The split sheath 104 also prevents the digital probe 106 from exiting the narrow slot formed along the slotted cannula 102 during the insertion of the vascular probe insertion assembly 100 into the patient's vascular anatomy.

[0128] 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 ( Fig.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.

[0129] The vascular probe insertion assembly 100 may also include a data hub 108, which is operatively connected 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 transmission 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 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, for example, the data hub 108 is detecting a parameter of the patient's vascular anatomy because the digital probe 106 is 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 digital probe 106 (e.g., green LED illuminated), incorrect placement of digital probe 106 (e.g., red LED illuminated), or suboptimal placement of digital probe 106 (e.g., yellow LED illuminated). In some embodiments, data detected (or not detected) by digital probe 106 may be used by a microcontroller in data hub 108 to determine whether digital probe 106 has been correctly, incorrectly, or suboptimally inserted into the patient's anatomy.

[0130] exist Fig.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 121, 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 draw a certain amount 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 a 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 anatomical structure at those relatively more sensitive or more critical insertion sites.

[0131] During the operation of the vascular probe insertion assembly 100, the healthcare professional can address the patient's anatomical structure and determine the position where the digital probe 106 can be placed in the patient's vein or artery. Once the appropriate injection site is determined, the healthcare professional can insert the vascular probe insertion assembly 100, and specifically the slotted sleeve 102 and its digital probe 106 and the split sheath 104 into the patient's anatomical structure to the vein or artery. At this time, because the slotted sleeve 102 is fluidly connected to the syringe 2139, the healthcare professional can visually detect that the slotted sleeve 102 has reached the vein or artery by gently pulling the plunger 2141 out of the barrel 2143 of the syringe 2139. Because the barrel 2143 is made of, for example, transparent plastic, the healthcare professional can visually detect the filling of the barrel 2143.

[0132] 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 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 syringe 2139 in one hand and the data hub 108 / needle safety shield 114 with the other hand. While holding the data hub 108 / needle safety shield 114 in place, the healthcare professional can begin to pull the syringe 2139 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 ( Fig.21The healthcare professional may then begin cutting the split sheath 104 (not shown). This will continue until the beveled portion of the slotted cannula 102 is safely contained within the passage formed through the needle safety shield 114. This process may also include removing the data hub 108 from the needle safety shield 114. In some embodiments, the data hub 108 and the needle safety shield 114 may be operably coupled together via a track system so that when the healthcare professional pulls the slotted cannula 102 and the split sheath 104 through the passage formed through the needle safety shield 114, they may be slidably removed from each other.

[0133] 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 contacting and possibly injuring the healthcare professional. Additionally, the splittable sheath 104 that has been cut lengthwise along the length of the slotted cannula 102 can be separated from the slotted cannula 102 and thrown away with the syringe 2139, the slotted cannula 102 and the needle safety shield 114.

[0134] Additionally, when the slotted cannula 102 is pulled out of the patient's vascular anatomy, the digital probe 106 is retained. In some embodiments, when the slotted cannula 102 is inserted into the vascular anatomy, the supplementary 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 retain 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 / supplementary length 120 of the digital probe can exit the slotted cannula 102 because the splittable sheath 104 is cut and the slot formed in the slotted cannula 102 is used as an exit for the digital probe 106 to be removed from the slotted cannula 102.

[0135] When the slotted cannula 102, the splittable sheath 104, the needle safety shield 114, and the syringe 2139 have been removed from the digital probe 106 and the data hub 108, the 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 event that the healthcare professional has determined that the digital probe 106 is not inserted correctly, 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 determine a new insertion site. In the event that the healthcare professional has determined that the digital probe 106 is properly inserted, the healthcare professional can secure the data hub 108 to an external portion of the patient's anatomy (e.g., an arm) and apply a securement dressing ( Fig.21 ) to prevent the digital probe 106 from being displaced. In some embodiments, the healthcare professional can also apply a skin adhesive at the injection site where the slotted cannula 102 enters the patient's body to secure the digital probe 106 to the patient during the digital probe 106 indwelling period.

[0136] In the event that the healthcare professional no longer needs the digital probe 106 and the data 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 hub 108 and discard them. In some embodiments, the healthcare professional can do this by grasping the data 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.

[0137] The vascular probe insertion assembly 100 described in the present disclosure allows for direct intravascular measurement of hemodynamic and blood-based key patient parameters with minimal footprint on the patient's body. The vascular probe insertion assembly 100 also allows for 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. Further, the risks associated with other systems for completing measurements that can be achieved with the vascular probe insertion assembly 100 are eliminated. 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 key vascular-based parameters.

[0138] Fig. 22 is a side perspective view of a vascular probe insertion assembly 100 according to some embodiments of the present disclosure. Fig. 22 The vascular probe insertion assembly 100 shown in FIG. Fig.21 The vascular probe insertion assembly 100 shown in FIG. Fig. 22 In the embodiment shown in FIG. 2 , the digital probe 106 and the data hub 108 have been removed from the slotted cannula 102 , the needle safety shield 114 , and the syringe 2139 . Fig.21 The splittable sheath 104 shown in FIG. Fig. 22 104 , because movement of the needle safety shield 114 toward the beveled distal end of the slotted cannula 102 causes the needle safety shield cutting blade of the needle safety shield 114 to cut away the splittable sheath 104 , exposing the slotted cannula 102 , as described in the present disclosure.

[0139] like Fig. 22 , the needle safety shield 114 may include a plurality of attachment surfaces 201 that interface with complementary connection surfaces formed on the digital probe 106. 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 during insertion of the slotted cannula 102 into the patient's vascular anatomy. As described in the present disclosure, after the slotted cannula 102 has been inserted into a vein or artery of the patient, it may subsequently be removed while the digital probe 106 and the data hub 108 remain in place. In embodiments of the present disclosure, removal of the slotted cannula 102 allows the digital probe 106 to remain within the patient's vein or artery while the data hub 108 (operatively coupled to the digital probe 106) remains with the patient. The needle safety shield 114, slotted cannula 102, and syringe 2139 are removed away from the data hub 108 by sliding the needle safety shield 114 laterally 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 syringe 2139 can be thrown away or otherwise treated as a biohazard, taking appropriate disposal steps to dispose of them as such.

[0140] The data hub 108 can remain with the patient and can be later secured to the outer surface of the patient's anatomical structure (such as an arm). As described in the present disclosure, the digital probe 106 can include a supplemental length 120 of the digital probe that allows the healthcare professional to advance the digital probe 106 further into the patient's anatomical structure and, if necessary, into a vein or artery. This advancement of the digital probe 106 using the supplemental length 120 of the digital probe can be achieved when the slotted cannula 102 is within a vein or artery. Therefore, during the removal of the slotted cannula 102, the length of the supplemental length 120 of the digital probe can be changed depending on whether the healthcare professional deems it necessary to further pass the digital probe 106 into the patient's vein or artery.

[0141] Fig.23 is a side perspective view of the digital probe 106 inserted into a vascular anatomy 407 according to some embodiments of the present disclosure. Fig.23 Shown in healthcare professionals have removed e.g. Fig.21 and Fig. 22 2139, the digital probe 106 in the installed position after the slotted cannula, splittable sheath, needle safety shield, and syringe 2139 are installed. As described in the present disclosure, when the slotted cannula is pulled out of the patient's vascular anatomy 407, the digital probe 106 remains. 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, 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 407 before the slotted cannula is removed, for example, to retain 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 supplemental length 120 of the digital probe may exit the slotted cannula as the splittable 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.

[0142] In some embodiments, the data hub 108 may be affixed to an external anatomical structure 409 of the patient. The external anatomical structure 409 to which the data hub is affixed may vary depending on the vascular anatomy 407 into which the digital probe 106 is inserted. For example, where the vascular anatomy 407 is a vein within the patient's arm, the data hub 108 may be affixed to the patient's arm near where the digital probe 106 penetrates the patient's skin.

[0143] As described in the present disclosure, the vascular probe insertion assembly 100 may also include a data hub 108, which is operatively connected 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 transmission 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 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, for example, the data hub 108 is detecting a parameter of the patient's vascular anatomy because the digital probe 106 is 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 digital probe 106 (e.g., green LED illuminated), incorrect placement of digital probe 106 (e.g., red LED illuminated), or suboptimal placement of digital probe 106 (e.g., yellow LED illuminated). In some embodiments, data detected (or not detected) by digital probe 106 may be used by a microcontroller in data hub 108 to determine whether digital probe 106 has been correctly, incorrectly, or suboptimally inserted into the patient's anatomy. In some embodiments, 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 by a 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 devices may be selectively removable such that when it is no longer necessary to monitor the patient's vascular anatomy 407, 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.

[0144] Fig.24is a schematic diagram of a vascular probe insertion assembly 100 docked with a data processing and cloud-based system 2445 according to some embodiments of the present disclosure. As described in the present disclosure, the vascular probe insertion assembly 100 can be operatively connected to the data processing and cloud-based system 2445 via a wired or wireless connection. In some embodiments, the vascular probe insertion assembly 100 can be operatively connected to a patient monitor 2447. In some embodiments, the patient monitor 2447 can be a bedside monitoring system present 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 can allow a healthcare professional to see real-time blood-based key patient parameters detected by the digital probe of the vascular probe insertion assembly 100.

[0145] In some embodiments, the vascular probe insertion assembly 100 may additionally or alternatively be operatively coupled to a cell phone 2449 or other handheld device within a 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 cell phone 2449 may provide a healthcare professional with real-time blood-based critical patient parameters detected by the digital probe of the vascular probe insertion assembly 100. In some embodiments, the cell phone 2449 may execute computer-readable program code of a monitoring application associated with the vascular probe insertion assembly 100.

[0146] In some embodiments, the vascular probe insertion assembly 100 is operably connected to a vital signs monitor 2451 within a data processing and cloud-based system 2445. In some embodiments, the vital signs monitor 2451 may be present at, for example, a nursing station or other remote desktop, where a healthcare professional can monitor the patient's blood-based key patient parameters 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 or all of the patient monitor 2447, the cell phone 2449, and / or the vital signs monitor 2451 can be used by a healthcare professional to view and monitor the patient's blood-based key patient parameters. Each of the patient monitor 2447, the cell phone 2449, and the vital signs monitor 2451 can be connected to each other so that communication is performed between these devices. Further, each of the patient monitor 2447, cell phone 2449, and vital signs monitor 2451 can be operably connected to a cloud network 2453 used, for example, by a hospital to maintain a record of the patient's blood-based key 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 can include a backend server 2455 for maintaining the data.

[0147] In some embodiments, the data processing and cloud-based system 2445 may include an artificial intelligence (AI) data algorithm and a computer-readable program code for detecting and predicting the onset of complications, treatment responses, health improvements, and / or changes in disease states of patients based on data received by the digital probe of the vascular probe insertion assembly 100. The execution of the computer-readable program code of the AI ​​data algorithm can be performed using a hardware processing device of any one of the patient monitor 2447, the mobile phone 2449, the vital signs monitor 2451, and / or the back-end server 2455, as described in the present disclosure. Therefore, based on the data received at the digital probe of the vascular probe insertion assembly 100, any of these devices can be used to detect and predict the onset of complications, treatment responses, health improvements, and / or changes in disease states of patients. Further, when any onset of complications, treatment responses, health improvements, and / or changes in disease states of patients are detected by executing the AI ​​data algorithm, a warning (e.g., a visual warning, an audible warning, etc.) can be triggered to a healthcare professional, indicating changes in key blood-based patient parameters, as described in the present disclosure.

[0148] Fig.25 is a side cross-sectional perspective view of a vascular probe insertion assembly 100 according to some embodiments of the present disclosure. Fig.25 shows the digital probe path (e.g., Figure 1 , 118 ) a cross-sectional view of the vascular probe insertion assembly 100 , showing the digital probe 106 as it passes through the data concentrator 108 prior to insertion into the slotted cannula 102 .

[0149] Fig.25Also shown is a needle hub 110 in fluid communication with the slotted cannula 102 and the splittable sheath 104. As described in the present disclosure, this allows a healthcare professional to detect when the slotted cannula 102 has been inserted into the patient's vascular anatomy. The healthcare professional detects this condition by visually monitoring 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 continue to remove these elements from the patient's vascular anatomy and from the data hub 108 by retracting the needle hub 110 away from the data hub 108 and the needle safety shield 114, as described in the present disclosure. Additionally, before 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 additional length 120 of the digital probe and advance it further into the digital probe channel 118 and into the slotted sleeve 102 / splittable sheath 104 to advance the digital probe 106 further into the patient's vascular anatomy. As described in the present disclosure, the healthcare professional can refer to the visual indicator ( Fig.25 ) to determine whether advancement of the supplemental length 120 of the digital probe into the patient's vascular anatomy results in proper placement of the digital probe 106.

[0150] Fig.26 26 is a block diagram of a method 2600 for manufacturing a vascular probe insertion assembly according to some embodiments of the present disclosure. The method 2600 may include inserting a digital probe into a slotted cannula at block 2605. As described in the present disclosure, the slot formed in the slotted cannula forms a sidewall extending along the length of the slotted cannula, except at the slot, the sidewall maintains the digital probe coaxially therein. Thus, the digital probe can run coaxially within the slotted cannula until the slotted cannula is removed from the patient's anatomical structure, as described in the present disclosure.

[0151] At block 2610, the method 2600 may further include forming a needle safety shield around the slotted cannula by passing the slotted cannula (and the digital probe) through a passage formed through the needle safety shield. The needle safety shield is formed 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 a healthcare professional. Additionally, in some embodiments, the needle safety shield may include a needle safety shield cutting blade for cutting the splittable sheath during extraction of the slotted cannula from the patient's vascular anatomy.

[0152] The method 2600 may also include, at block 2615, forming a splittable 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 splittable sheath may be made of a material that can be cut or otherwise split using a needle safety shield cutting blade of the needle safety shield.

[0153] The method 2600 may also include operatively connecting the 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 vein or artery of the patient. In some embodiments, this circuitry may include a radio or other transmission device that allows wireless transmission of data detected at the digital probe to, for example, a vascular monitoring system, as described in the present disclosure. Additionally, the data hub may include a power supply, a PMU, and a microcontroller or other hardware processing device and other circuitry. In some embodiments, the data hub may include one or more visual indicators for signaling to a healthcare professional that, for example, the data hub is detecting parameters of the patient's vascular anatomy because the digital probe is correctly inserted into the patient's vascular anatomy. These visual indicators may include a plurality of different colored LEDs that may indicate correct placement of the digital probe (e.g., green LED illuminated), incorrect placement of the digital probe (e.g., red LED illuminated), or suboptimal placement of the digital probe (e.g., 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.

[0154] Fig. 27 2700 is a block diagram of a method 2700 of inserting a digital probe of a vascular probe insertion assembly into a patient's anatomical structure according to some embodiments of the present disclosure. Method 2700 may begin at box 2705, with a healthcare professional inserting a slotted cannula, a digital probe, and a split sheath of a vascular probe insertion assembly into a patient's vascular anatomy. This may be performed after the healthcare professional has addressed the patient's anatomical structure in order to determine where the digital probe may be placed within a vein or artery of the patient. As described in the present disclosure, the vascular probe insertion assembly may include a slotted cannula, a digital probe, and a split sheath having a certain length. The length of the slotted cannula, the digital probe, and the split sheath inserted into the patient's anatomical structure and vascular anatomy may depend on the insertion location on the patient's body.

[0155] As described in the present disclosure, the slotted cannula may be in fluid communication with the fluid container of the needle hub. Thus, method 2700 may include determining at block 2710 whether the healthcare professional detects the presence of blood in the fluid container of the needle hub and whether the visual indicator of the data hub indicates correct insertion. Similarly, the healthcare professional may visually detect whether the slotted cannula has reached a vein or artery by the presence of blood in the fluid container. For example, because the needle hub is made of transparent plastic, the healthcare professional may visually detect the filling of the fluid container. Further, the data hub may include one or more visual indicators for sending a signal to the healthcare professional that, for example, the data hub is detecting a parameter of the patient's vascular anatomy because the digital probe is correctly inserted into the patient's vascular anatomy. These visual indicators may include a plurality of different colored LEDs that may indicate correct placement of the digital probe (e.g., green LED is on), incorrect placement of the digital probe (e.g., red LED is on), or suboptimal placement of the digital probe (e.g., yellow LED is on). 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.

[0156] In the event that the healthcare professional has not detected the presence of blood in the fluid container, or the visual indicator on the data hub has detected incorrect or suboptimal placement of the digital probe ("No" at box 2710), then the method 2700 may continue to advance the slotted cannula (and the digital probe and the splittable sheath), and, if applicable, the additional length of the digital probe further into the patient's vascular anatomy at box 2715. The advancement of the cannula to the patient's anatomy may be performed to reach the patient's vascular anatomy until the healthcare professional detects blood in the fluid container of the needle hub. It should be appreciated that, in lieu of the needle hub, the vascular probe insertion assembly may include a syringe as described in the present disclosure for the healthcare professional to use to determine whether the slotted cannula has reached the patient's vascular anatomy. Additionally, in the event that 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 in the present disclosure. According to the method 2700, the healthcare professional may continue to monitor the presence of blood in the needle hub and confirm correct digital probe placement via the visual indicator until both are visually detected.

[0157] In the event that the presence of blood is detected and the visual indicator on the data hub indicates that the digital probe is properly placed, the method 2700 may include, at box 2720, the healthcare professional retracting the slotted cannula through a passage formed through the needle safety shield. This occurs when the needle safety shield cutting blade splits the splittable sheath to expose the narrow slot formed in the slotted cannula, as described in the present disclosure. In addition, by pulling the splittable sheath and the slotted cannula through the passage formed in the needle safety shield, the bevel and sharp point of the slotted cannula are retained within the needle safety shield so that the sharp point does not accidentally injure the healthcare professional. Further, at box 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.

[0158] The method 2700 may also include the healthcare professional discarding the needle safety shield, slotted cannula, split sheath, and needle hub at block 2730. Because they have been used, the needle safety shield, slotted cannula, and needle hub may be thrown away or otherwise treated as biohazards, taking appropriate disposal steps to dispose of them as such.

[0159] The method 2700 may also include securing the external portion of the digital probe and the data hub to the external anatomy of the patient at block 2735. It should be appreciated that any securing dressing may be used, including those with transparent windows (e.g., transparent film dressing) and any adhesive stabilizing platform for the data hub.

[0160] The vascular probe insertion assembly described in the present disclosure allows for direct intravascular measurement of hemodynamic and blood-based key 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, use of a vascular probe insertion assembly as 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 completing measurements that can be achieved with the vascular probe insertion assembly are eliminated. The vascular probe insertion assembly described in the present disclosure can be used for short-term or long-term monitoring of key vascular-based parameters while a digital probe is in place.

[0161] All examples and conditional language listed in this disclosure are intended for teaching purposes to help readers understand the inventions and concepts contributed by the inventors to promote the development of the art, and should be interpreted as not being limited to such specific examples and conditions. Although the embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions and modifications may be made thereto without departing from the spirit and scope of the disclosed embodiments.

Claims

1. A vascular probe insertion assembly, include: Slotted casing, comprising: a sharp tip configured to be inserted into a vascular anatomy of a patient; and a side wall extending proximally from the sharp tip, the side wall defining a slot; a splittable 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 proximally of the sensor tip; and A data hub is 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.

2. The vascular probe insertion assembly according to claim 1, further comprising: include: The vascular probe insertion assembly also includes a hub operatively coupled to the proximal end of the slotted cannula, the 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 vascular probe insertion assembly according to claim 1, further comprising: include: A needle safety shield comprising a passage through which a slotted cannula can pass, wherein the needle safety shield is operatively coupled to the data hub such that when the slotted cannula is removed from the patient's vascular anatomy, the sharp tip slides into and is received in a slide of the needle safety shield.

4. The vascular probe insertion assembly according to claim 3, further comprising: include: A needle safety shield cutting blade is formed in the passageway and is positioned to cut the splittable sheath when the vascular probe is retracted from within the patient's vascular anatomy.

5. The vascular probe insertion assembly according to claim 1, further comprising: include: A wireless transmitter is formed within the data hub to wirelessly transmit the sensor data to the monitoring system.

6. The vascular probe insertion assembly according to claim 1, further comprising: include: An electrical interface is 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, further comprising: include: A syringe coupling feature is 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, further comprising: include: A stabilizing platform is operatively coupled to the data hub to secure the data hub to an exterior surface of the patient's vascular anatomy while the digital probe is maintained within the patient's vascular anatomy.

9. A method of inserting a digital probe of a vascular probe insertion assembly into an anatomical structure of a patient, include: The slotted cannula is inserted into the patient's vascular anatomy and comprises: a sharp tip configured to be inserted into a vascular anatomy of a patient; a side wall extending proximally from the sharp tip, the side wall defining a slot; a splittable sheath shaped to surround at least a portion of the sidewall; a needle safety shield coaxially formed about the slotted sleeve; and a digital probe operatively coupled to the data hub, the digital probe coaxially disposed within the slotted sleeve and the splittable sheath; With the digital probe and data hub in place, retracting the slotted cannula through a passage formed through the needle safety shield, the needle safety shield cutting blade splitting the splittable sheath to expose a slot formed in the slotted cannula; and The needle safety shield is withdrawn from the data hub.

10. The method according to claim 9, further comprising: include: The vascular probe insertion assembly also includes a needle hub operatively coupled to the proximal end of the slotted cannula, the needle hub including a fluid container for a healthcare professional to determine when the slotted cannula is inserted into the patient's vascular anatomy.

11. The method according to claim 9, further comprising: include: The needle safety shield includes a needle safety shield cutting blade disposed within a passage formed through the needle safety shield that cuts the splittable sheath when the slotted cannula is retracted from within the patient's vascular anatomy.

12. The method according to claim 9, further comprising: include: The data hub includes a wireless transmitter that wirelessly transmits data received at the digital probe to a vascular monitoring system while the digital probe is maintained within the patient's vascular anatomy.

13. The method according to claim 9, further comprising: include: The data hub includes an electrical interface configured to receive a wired connection through which sensor data from the digital probe can be sent to a monitoring system.

14. The method according to claim 9, further comprising: include: The vascular probe insertion assembly includes a syringe coupling feature configured to secure a proximal end of the slotted cannula to a syringe to facilitate insertion of the slotted cannula into the patient's vascular anatomy.

15. The method according to claim 9, further comprising: include: A stabilization platform is operatively coupled to the data hub to secure the data hub to an exterior surface of the patient's vascular anatomy while the digital probe is maintained within the patient's vascular anatomy.

16. An indwelling vascular probe insertion assembly, include: A slotted cannula configured to facilitate insertion of the digital probe into a vascular anatomy of a patient, the slotted cannula comprising: a sharp tip configured to be inserted into a vascular anatomy of a patient; and a side wall extending proximally from the sharp tip, the side wall defining a slot; a splittable sheath coaxially formed on the outside of the slotted sleeve; A digital probe is coaxially formed in the slotted sleeve, the digital probe comprising: a sensor tip configured to generate sensor data indicative of operation of the vascular anatomy; and a shaft extending proximally of the sensor tip; and a data hub operatively coupled to the digital probe; and A needle hub is operatively coupled to the slotted cannula, the needle hub including a fluid reservoir to determine when the slotted cannula is inserted into the patient's vascular anatomy.

17. The indwelling blood vessel probe insertion assembly according to claim 16, further comprising: include: A needle safety shield comprising a passage through which a slotted cannula can pass, wherein the needle safety shield is operatively coupled to the data hub such that when the slotted cannula is removed from the patient's vascular anatomy, the sharp tip slides into and is received in a slide of the needle safety shield.

18. The indwelling blood vessel probe insertion assembly according to claim 17, further comprising: include: A needle safety shield cutting blade is formed within the passage formed through the needle safety shield to cut the splittable sheath when the digital probe is retracted from within the patient's vascular anatomy.

19. The indwelling blood vessel probe insertion assembly according to claim 16, further comprising: include: A wireless transmitter is formed within the data hub to wirelessly transmit the sensor data to a monitoring system.

20. The indwelling blood vessel probe insertion assembly according to claim 16, further comprising: include: An electrical interface is configured to receive a wired connection through which the sensor data can be sent to the monitoring system.

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