Catheter position indicator and related systems and methods

Abstract

The present disclosure relates to a catheter assembly, a vascular access device, and related methods. The catheter assembly can include a catheter adapter having a catheter extending from a distal end thereof. The catheter can include a proximal end, a tip, and a tube segment between the proximal end and the tip. The tube segment can include one or more position indicators to indicate a position of the catheter relative to the vasculature. The catheter assembly can include a guide needle extending through the tube segment and including a sharp distal tip configured to introduce the catheter into the vasculature.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to vascular access devices and related systems and methods. BACKGROUND

[0002] Catheters are commonly used for a variety of infusion therapies. For example, catheters can be used to infuse fluids, such as saline solution, various medicinal drugs, and total parenteral nutrition, into a patient's body. Catheters can also be used to withdraw blood from a patient.

[0003] A common type of catheter is an over-the-needle peripheral intravenous catheter. As the name implies, an over-the-needle catheter can be mounted over an introducer needle having a sharp distal tip. The catheter and introducer needle can be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the bevel of the needle facing away from the patient's skin. The catheter and introducer needle are typically inserted into the patient's vein at a shallow angle through the skin.

[0004] To verify that the introducer needle and / or catheter is properly placed in the blood vessel, the clinician typically confirms the presence of blood "flashback." Thus, the clinician can visualize blood, thereby confirming placement of the introducer needle within the vasculature. Once placement of the needle has been confirmed, the clinician can temporarily occlude blood flow in the vein and remove the introducer needle, leaving the catheter in place and secured for future blood withdrawal and / or infusion therapy.

[0005] However, in some instances, the catheter can become dislodged or "walked off" due to improper securement or, more commonly, due to application of forces greater than the securement method was designed to withstand. For example, catheter walk-off can occur when a patient rolls over in bed, hangs on their tubing on a bed rail, transfers between beds, fidgets, or intentionally pulls on their tubing.

[0006] At a minimum, catheter walk-off can require restarting of the intravenous catheter, which places the clinician at increased risk of potential sharps injuries and blood or drug exposure. Additionally, intravenous catheter restarts can be both inconvenient and uncomfortable for the patient. In more serious cases, such as when walk-off results in loss of peripheral vein site integrity, the patient can be required to use a more invasive central line, which increases the risk of phlebitis, infiltration, and infection, as well as longer treatment times. Potential worst-case scenarios can include hemorrhage, air embolism, and blood stream infection, and associated risk of patient death.

[0007] The subject matter claimed herein is not limited to implementations that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is included as merely illustrative of one example technological area where some implementations described herein can be practiced. SUMMARY

[0008] The present disclosure relates generally to vascular access devices and related systems and methods. As previously noted, catheter dislodgement can be caused by improper securement, or more commonly, dislodgement caused by a patient rolling over in bed, hanging their line on a bed rail, being transferred to a different bed, fidgeting, or intentionally pulling on their line.

[0009] Such dislodgement can require line restarts, which are often both inconvenient and uncomfortable. In some cases, it can be necessary to install a more invasive central line in the patient, which is associated with increased risk of phlebitis, infiltration, infection, and longer treatment times. Worst case scenarios can include hemorrhage, air embolism, and blood stream infection, increasing the risk of patient death. Embodiments described herein can provide early indication of catheter movement, thereby reducing the risk of dislodgement and its associated complications.

[0010] In some embodiments, the catheter assembly can include a catheter adapter having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end. In some embodiments, a catheter can extend from the distal end of the catheter adapter. In some embodiments, the catheter can include a proximal end, a tip, and a tube segment between the proximal end and the tip of the catheter. In some embodiments, the tube segment can include at least one position indicator to indicate a position of the catheter relative to a vasculature of a patient.

[0011] Some embodiments can include a guide needle extending through the tube segment. In some embodiments, the guide needle can include a sharp distal tip configured to introduce the catheter into the vasculature.

[0012] In some embodiments, the at least one position indicator can include at least one marker disposed on an outer surface of the tube segment. Some embodiments of the at least one marker can include a colored band, a symbolic marker, or a graduated marker. In some embodiments, the at least one marker includes a plurality of non-uniformly spaced markers. In other embodiments, the at least one marker includes a plurality of uniformly spaced markers.

[0013] In some embodiments, the distance between non-uniformly spaced markers can decrease proximate the distal end of the catheter adapter. In some embodiments, the at least one marker can indicate a distance from a distal end of the catheter. In some embodiments, the at least one marker can indicate dislodgement of the catheter relative to the vasculature. Some embodiments of the at least one position indicator can include a first position indicator located proximate a tip of the catheter and a second position indicator located proximate a proximal end of the catheter.

[0014] In some embodiments, a vascular access device for detecting a catheter position within a vasculature can include a catheter including a proximal end, a tip, and a tube segment between the proximal end and the tip. In some embodiments, a position indicator can be disposed on an outer surface of the tube segment and can be configured to indicate a position of the catheter within the vasculature.

[0015] In some embodiments, the position indicator can include at least one marking printed on an outer surface of the tube segment. In some embodiments, the position indicator can include a plurality of markings. In some embodiments, each of the plurality of markings can be uniformly spaced apart.

[0016] In some embodiments, each of the plurality of markings can include a non-uniform characteristic. The non-uniform characteristic can include, for example, color, width, length, and / or spacing. In some embodiments, the position indicator can be a colored band, a marker, or a scale marking.

[0017] In some embodiments, the position indicator can include a first plurality of markings located proximate to the tip of the catheter and a second plurality of markings located proximate to the proximal end of the catheter. In some embodiments, each of the first plurality of markings can be uniformly spaced apart from another of the first plurality of markings. Likewise, each of the second plurality of markings can be uniformly spaced apart from another of the second plurality of markings.

[0018] Some embodiments can include a method for detecting a catheter position. In some embodiments, the method can include providing a catheter assembly to introduce a catheter into a vasculature of a patient. Some embodiments of the catheter assembly can include a catheter adapter including a proximal end, a distal end, and a lumen extending between the proximal end and the distal end. A catheter can extend from the distal end. In some embodiments, the catheter can include a proximal end, a tip, and a tube segment between the proximal end and the tip. Some embodiments of the tube segment can include a position indicator to indicate a position of the catheter relative to the vasculature.

[0019] In some embodiments, a guide needle can extend through the tube segment. Some embodiments of the guide needle can include a sharp distal tip to introduce the catheter into the vasculature at a vasculature access site of the patient. In some embodiments, the catheter can be secured such that the position indicator is aligned with the vasculature access site. Some embodiments of the method can further include automatically monitoring a position of the position indicator relative to the vasculature access site to detect a catheter dislodgement.

[0020] In some embodiments, the position indicator can include a plurality of markings printed on an outer surface of the tube segment. In some embodiments, the method can further include automatically activating an alarm in response to the position of the position indicator being misaligned with the vasculature access site.

[0021] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure claimed. It should be understood that various embodiments are not limited to the arrangements and instrumentalities shown in the attached drawings. It should also be understood that the embodiments can be combined, or that other embodiments can be utilized, and structural changes can be made without departing from the scope of the various embodiments of the present disclosure, unless so claimed. Accordingly, the following detailed description should be taken as illustrative and not restrictive. BRIEF DESCRIPTION OF DRAWINGS

[0022] The exemplary embodiments will be described and explained with additional specificity and detail by the use of the accompanying drawings in which:

[0023] Figure 1A is a top perspective view of an example catheter assembly according to some embodiments;

[0024] Figure 1B is a cross-sectional view of the catheter assembly of Figure 1A

[0025] Figure 2 is a top perspective view of an example catheter according to some embodiments showing a plurality of position indicators;

[0026] Figure 3A is a top perspective view of an example catheter according to some embodiments;

[0027] Figure 3B is a top perspective view of an example catheter according to some embodiments;

[0028] Figure 3C is a top perspective view of an example catheter according to some embodiments;

[0029] Figure 3D is a top perspective view of an example catheter according to some embodiments;

[0030] Figure 4 is a top perspective view of an example catheter of the catheter assembly of Figure 1A

[0031] Figure 5 is a top perspective view of the catheter assembly of Figure 1A disposed in a vasculature according to some embodiments. DETAILED DESCRIPTION

[0032] As used in this specification, the term "distal" refers to the direction farther from a clinician who contacts the device with a patient. The term "proximal" refers to the direction closer to the clinician who contacts the device with the patient. Thus, for example, the end of a catheter that first contacts the patient's body is the distal end, while the opposite end of the catheter is the proximal end of the catheter.​​

[0033] As mentioned earlier, catheters may become dislodged due to improper fixation or intentional or unintentional force applied to the catheter or catheter adapter. For example, catheter dislodgment may occur when a patient turns over in bed, hangs their tubing on the railing, moves between beds, fidgets, or deliberately pulls out their tubing.

[0034] Catheter removal may require catheter restart, placing clinicians at increased risk due to potential sharps injury and exposure to blood and / or medications. Intravenous catheter restart can also be inconvenient and uncomfortable for the patient. In more serious cases, such as when removal results in loss of peripheral venous site integrity, the patient may require a more invasive central catheter, increasing the risk of phlebitis, infiltration, and infection, as well as longer treatment times. Potential worst-case scenarios may include bleeding, air embolism, and bloodstream infection, along with associated patient mortality. The embodiments described herein can provide early indication of catheter displacement or removal, allowing clinicians to address the issue immediately without restarting the catheter.

[0035] Now for reference Figure 1A -1B, In some embodiments, the catheter system 10 may include a needle assembly 12 and a catheter assembly 14. Figure 1A -1B illustrates a catheter system in the insertion position, ready for insertion into a patient's vein, according to some embodiments. In some embodiments, catheter assembly 14 may include catheter adapter 16, which may include a distal end 18, a proximal end 20, and a lumen 21 extending therebetween. In some embodiments, catheter 22 may extend from the distal end 18. Some embodiments of catheter 22 may include a peripheral intravenous catheter (“PIVC”). In some embodiments, catheter 22 may include a proximal end 26, a tip 24, and a segment between the proximal end and the tip. In some embodiments, the proximal end 26 of catheter 22 may be secured within catheter adapter 16.

[0036] In some embodiments, the needle assembly 12 may include a needle hub 28 that can be removably coupled to the catheter adapter 16. In some embodiments, the needle assembly 12 may include a guide needle 30. In some embodiments, the proximal end of the guide needle 30 may be secured within the needle hub 28. In some embodiments, when the catheter 22 is ready for insertion into a patient's vein, the guide needle 30 may extend through the catheter segment, for example, as... Figure 1A As shown in -1B.

[0037] In some embodiments, the needle assembly 12 can include a needle grip 32 that a clinician can hold and move proximally to withdraw the introducer needle 30 from the vein once it is confirmed that the catheter 22 is placed within the vein. In some embodiments, the catheter assembly 14 can include an extension tube 34. In some embodiments, a distal end of the extension tube 34 can be coupled to the catheter adapter 16, and a proximal end of the extension tube 34 can be coupled to an adapter 36.

[0038] In some embodiments, when the introducer needle 30 is removed from the catheter assembly 14, a fluid infusion device can be coupled to the adapter 36 to deliver fluid into the patient's body through the catheter 22 inserted into the vein. In some embodiments, a blood collection device can be coupled to the adapter 36 to draw blood from the patient's body through the catheter 22 inserted into the vein.

[0039] In some embodiments, the catheter assembly 14 can be an integrated catheter system 10 having an extension tube 34 integrated within the catheter adapter 16, such as the BD NEXIVA TM Closed intravenous catheter system, BD NEXIVA TM DIFFUSICS TM Closed intravenous catheter system, BD PEGASUS™ TM Safety-Closed intravenous catheter system, or other integrated catheter systems. In Figure 1A One example of an integrated catheter system 10 is shown in FIG. 1B. In some embodiments, the catheter assembly 14 can be non-integrated, such that there is no extension tube 34.

[0040] In some embodiments, the catheter assembly 14 can be vented to observe blood and to facilitate proximal flow of blood within the introducer needle 30 and / or the catheter 22. In some embodiments, the catheter assembly 14 can be vented in any suitable manner. For example, a vent plug 38 can be coupled to the adapter 36 during insertion of the catheter assembly 14 into the patient. In some embodiments, the vent plug 38 can be permeable to air but not blood. In some embodiments, the catheter 22, the catheter adapter 16, the extension tube 34, the adapter 36, and the vent plug 38 can be in fluid communication.

[0041] In some embodiments, in response to the introducer needle 30 being inserted into a vein of a patient, blood can flow through the sharp distal tip 40 of the introducer needle 30. The blood flow can cause a "flashback," or indicate to the clinician that the introducer needle 30 has entered the vein. After confirming that the sharp distal tip 40 is located within the vein of the patient, the clinician can lower the insertion angle and advance the catheter 22 a small distance to ensure that the distal end 24 of the catheter 22 is in the vein before withdrawing the catheter 22 from the introducer needle 30. The distal end 24 of the catheter 22 can be separated from the proximal end of the sharp distal tip 40 of the introducer needle 30 by a distance referred to as the "lie distance." In some embodiments, the length of the bevel extending from the sharp distal tip 40 can vary depending on the gauge size of the introducer needle 30. Thus, in some embodiments, the distance that the catheter 22 needs to travel from the sharp distal tip 40 into the vein can vary depending on the gauge and the lie distance. If the catheter 22 is withdrawn from the introducer needle 30 too early, the catheter 22 insertion can fail.

[0042] In some embodiments, the tube segment of the catheter 22 can include a position indicator 42 to indicate the position of the catheter 22 relative to the vasculature of the patient. The position indicator 42 can be one or more markings 44 disposed on the outer surface of the tube segment. Some embodiments of the one or more markings 44 can include one or more colored bands, indicia markings, or graduated markings. In some embodiments, the markings 44 can include a plurality of non-uniformly spaced markings 44. In other embodiments, the markings 44 can include a plurality of uniformly spaced markings 44.

[0043] In some embodiments, the position indicator 42 can include a plurality of markings 44 that can indicate to the clinician the depth of catheter 22 insertion into the vein. In some embodiments, the spacing between the markings 44 can be a portion of the lie distance. In some embodiments, the lie distance can depend on the gauge. In some embodiments, the clinician can advance the catheter 22 a few markings 44 before withdrawing the catheter 22 from the introducer needle 30. In some embodiments, the distance between the non-uniformly spaced markings 44 can decrease near the distal end 18 of the catheter adapter 16. In some embodiments, the one or more markings 44 can indicate the distance to the distal end 24 of the catheter 22. In some embodiments, the markings 44 can indicate the withdrawal of the catheter 22 relative to the vasculature. Some embodiments of the position indicator 42 can include a first position indicator 42 located near the tip 24 of the catheter 22 and a second position indicator located near the proximal end 26 of the catheter 22. In some embodiments, the first position indicator 42 can include a first plurality of markings 44 that are uniformly spaced from each other. Likewise, each of the second position indicators 42 can include a second plurality of markings 44 that are uniformly spaced from each other.

[0044] Reference is now made to Figure 1AIn some embodiments, the position indicator 42 can include markings 44 printed on the surface of the tube segment of the catheter 22. In some embodiments, the position indicator 42 can include a pattern or material applied to or adhered to the surface. In some embodiments, the markings 44 can be pad printed or etched onto the tube segment. In other embodiments, the markings 44 can be applied by any other suitable method, such as screen printing, digital printing, flexographic printing, UV-Litho printing, or laser printing. In some embodiments, the markings 44 can be printed in multiple colors or patterns.

[0045] In some embodiments, each marking 44 can include a non-uniform characteristic. The non-uniform characteristic can include, for example, color, width, length, and / or spacing. In some embodiments, the markings 44 can be staggered or spaced apart in the longitudinal axis direction. In these embodiments, the placement of the markings 44 can facilitate a clinician's recognition of the depth of insertion of the tip 24 of the catheter 22. In these embodiments, the markings 44 can aid in confirming one or more positions of the catheter tip 24 relative to the vasculature or skin surface.

[0046] For example, in some embodiments, the markings 44 can indicate that the catheter 22 has entered a vein, that the catheter 22 has been fed further into the vein, and / or that the catheter 22 has been fully inserted into the vein. In some embodiments, the markings 44 can be configured to indicate that the tip 24 of the catheter 22 is within the vein. In some embodiments, the markings 44 can be configured to indicate that the tip 24 of the catheter 22 is withdrawn or partially withdrawn from the vein. In some embodiments, the markings 44 can facilitate a clinician's visualization of blood flashback, thereby confirming that the introducer needle 30 is inserted within the vasculature.

[0047] Referring now to Figure 2 In some embodiments, the markings 44 can be colored bands 46. In some embodiments, the colored bands 46 can have a uniform width. In other embodiments, the colored bands 46 can be non-uniform in width. Because it is often difficult to determine the position or depth of the catheter 22 at a glance, a contrasting color can be particularly useful. As the catheter 22 is further inserted into the vasculature or vein, the color visible at the skin surface can provide a more intuitive indication or reference of the depth of insertion of the catheter 22 into the vein. In some embodiments, the visible color can indicate the dislodgement of the catheter 22 after it has been previously positioned and secured, as will be explained in more detail below. In some embodiments, the color and width of the bands of the position indicator 42 can vary depending on the application of the catheter 22.

[0048] Referring now to Figure 3AIn some embodiments, the plurality of markers 44 can be uniform, or evenly spaced. In some embodiments, the markers 44 can include linear or notational markers 44 that are substantially perpendicular to the longitudinal axis of the catheter 22. In some embodiments, the notational markers 44 can be uniform, or can alternate between primary and secondary notational markers 44 to more accurately indicate the depth of the catheter 22 and help provide a clear visual reference. In some embodiments, the thickness and spacing of the markers 44 can vary depending on the application of the location indicator. In some embodiments, a clinician can insert the catheter 22 such that a particular marker 44 is aligned with, or flush with, the outer surface of the patient's skin. In some embodiments, a particular marker 44 or color band 46 can be aligned with the patient's skin to indicate to the clinician that the catheter 22 has been properly inserted into the vasculature or vein.

[0049] Referring now to Figure 3B and 3D In some embodiments, the location indicator 42 can include more than one plurality of markers 44. In some embodiments, one or more markers 44 can be located near the catheter tip 24. Likewise, in some embodiments, one or more markers 44 can be located near the proximal end 26 of the catheter 22. In these and other embodiments, the plurality of markers 44 can be evenly or unevenly spaced.

[0050] Referring now to Figure 3C In some embodiments, the location indicator 42 can include a first plurality of markers 48 and a second plurality of markers 50. In some embodiments, the first plurality of markers 48 can be located near the catheter tip 24 and the second plurality of markers can be located near the proximal end 26 of the catheter 22. In some embodiments, the first plurality of markers 48 and the second plurality of markers 50 can be evenly spaced. In other embodiments, the first plurality of markers 48 and the second plurality of markers 50 can be unevenly spaced. In at least one embodiment, the first plurality of markers 48 can include two markers 44 spaced apart by a first distance 52. In at least one embodiment, the first distance 52 can be approximately 2-3 mm. The second plurality of markers 50 can also include two markers 44 spaced apart by a second distance 54. In some embodiments, the second distance 54 can also be approximately 2-3 mm. In some embodiments, the first plurality of markers and the second plurality of markers can be spaced apart by a third distance 56. In one embodiment, the third distance 56 can be approximately 5-10 mm.

[0051] In some embodiments, the first plurality of markers 48 can provide a reference for the depth of insertion of the catheter 22, while the second plurality of markers 50 can provide a reference for the penetration of the catheter 22 into the vein. In some embodiments, the second plurality of markers 50 can provide a reference for determining whether the catheter 22 has been dislodged. In some embodiments, the first plurality of markers 48 can be spaced apart from each other such that the first distance 52 is half the length of the needle bevel. In some embodiments, the first distance 52 can be the distance of the catheter hub. In some embodiments, the first distance 52 can be the length of the catheter cone 58. In some embodiments, the second plurality of markers 50 can be located at a distance of about 1 / 10 of the length of the catheter 22 measured from the catheter proximal end 26.

[0052] Referring now to Figure 4 Figure 5 In some embodiments, the position indicator 42 can indicate catheter dislodgement. In some embodiments, catheter dislodgement can be indicated by the exposure of markers 44 that were not previously visible. In other embodiments, catheter dislodgement can be indicated by a change in the position of the markers 44 relative to the surface of the skin. For example, after a clinician advances the catheter 22 into the vein several markers 44 prior to withdrawing the catheter 22 from the introducer needle 30, the markers 44 that are visible on the surface of the skin can be recorded on the catheter assembly 14 in the medical record, or in other suitable locations. In some embodiments, the annotations can indicate the markers 44 by the number of color bands, specific indicia markers, reference locations, or exposed markers 44 that are visible on the surface of the skin or under the skin.

[0053] In one example, the catheter 22 can include two markers 44 located near the proximal end 26 of the catheter 22. In some embodiments, the catheter 22 can be inserted into the vein and secured such that one of the markers 44 is exposed while the other marker 44 is under the surface of the skin. In some embodiments, if both markers 44 are exposed, the clinician can be alerted to possible dislodgement and can conduct further investigation to determine an appropriate response.

[0054] Some embodiments can include a method for detecting catheter position. In some embodiments, the method can include providing a catheter assembly to introduce a catheter into a patient's vasculature. Some embodiments of the catheter assembly can include a catheter adapter including a proximal end, a distal end, and a lumen extending therebetween. A catheter can extend from the distal end. In some embodiments, the catheter can include a proximal end, a tip, and a tube segment therebetween. Some embodiments of the tube segment can include a position indicator to indicate the position of the catheter relative to the vasculature.

[0055] In some embodiments, the guide needle may extend through a catheter segment. Some embodiments of the guide needle may include a sharp distal tip to introduce the catheter into the vascular system at the patient's vascular system entry site. In some embodiments, the catheter may be secured such that a position indicator is aligned with the vascular system entry site. Some embodiments of the method may also include automatically monitoring the position of the position indicator relative to the vascular system entry site to detect catheter dislocation.

[0056] In some embodiments, the position indicator may include a plurality of markings printed on the outer surface of the tube segment. In some embodiments, the method may also include automatically activating an alarm in response to a misalignment of the position indicator with the vascular system entry point.

[0057] Some embodiments may include a method for detecting the position of catheter 22. This method may include providing catheter assembly 14 to introduce catheter 22 into a vascular system. In some embodiments, catheter assembly 14 may include catheter adapter 16 including a proximal end 20, a distal end 18, and a lumen 21 extending therebetween. In some embodiments, catheter 22 may extend from the distal end 18. Catheter 22 may include a proximal end 26, a tip 24, and a segment therebetween. In some embodiments, the segment may include a position indicator 42 that indicates the depth at which catheter 22 is inserted into a vascular system or vein.

[0058] In some embodiments, the position indicator may include a mark 44 disposed on the outer surface of a segment of catheter 22. In some embodiments, a guide needle 30 may extend through the segment. Some embodiments of the guide needle 30 may include a sharp distal tip 40 for introducing catheter 22 into the vascular system at the patient's vascular system entry site. In some embodiments, catheter 22 may be advanced into the vascular system and secured such that the position indicator 42 is aligned with the vascular system entry site. In some embodiments, catheter 22 may be advanced through several marks 44 in the vascular system before being withdrawn from the guide needle 30.

[0059] In some embodiments, catheter 22 may be inserted such that a plurality of first markers 48 are positioned within the vascular system and a plurality of second markers 50 are aligned with or flush with the outer surface of the patient's skin. In some embodiments, in response to the alignment of the second markers 50 with the outer surface of the patient's skin, catheter 22 may be inserted to a second depth, which may correspond to complete insertion of catheter 22 into a vein. In some embodiments, the plurality of second markers 50 may be close to the patient's skin surface. In some embodiments, position indicator 42 may include a plurality of markers 44 spaced approximately 2–3 mm apart at a distance of approximately 1 / 10 of the length of catheter 22 from its proximal end.

[0060] In some embodiments, the catheter adapter 14 can be secured to the patient. In some embodiments, a change in the position of the one or more markers 44 relative to the skin surface can indicate a potential catheter dislodgement. In this manner, some embodiments can facilitate early detection of catheter 22 dislodgement and enable corrective action to be taken.

[0061] Some embodiments of the method can also include automatically monitoring the position of the position indicator 42 relative to the venous access site to detect catheter 22 dislodgement. In some embodiments, the image processor 62 or other device 60 can automatically monitor the position of the position indicator 42 relative to the catheter insertion site. In some embodiments, the image processor can be coupled to the proximal end 20 of the catheter adapter 16 and / or secured to the patient.

[0062] In some embodiments, the image processor 62 can be configured to record one or more images of the insertion site relative to the markers 44. In some embodiments, the image processor can also be configured to analyze the relative position of the catheter 22 and / or the markers 44 to detect dislodgement of the catheter 22 and automatically activate an alarm.

[0063] In some embodiments, the image processor 62 can detect the markers 44 and capture the images by any suitable means. In some embodiments, the image processor 62 can be configured to detect a color contrast of the exposed markers 44. Embodiments of the image processor 62 can be combined with any other embodiments disclosed herein to facilitate placement of the catheter 22 within the vasculature and / or to detect dislodgement of the catheter 22.

[0064] In some embodiments, an alarm 64 can be activated in response to determining that the catheter 22 has been dislodged. In some embodiments, the alarm can be located on the image processor 62 or any other suitable device 60. In some embodiments, the alarm 64 can be automatically activated in response to the tip 24 of the catheter 22 being dislodged, or fully or partially withdrawn, or in response to the position indicator 42 being misaligned with the venous access site. In some embodiments, the alarm 64 can be activated locally or remotely. In some embodiments, the alarm 64 can include a visual, tactile, and / or audible alarm. In some embodiments, one or more alarms 64 can change or cease in response to the introducer needle 30 being removed from the vein, the catheter 22 or catheter tip 24 being removed from the vein, or the catheter 22 being at least partially withdrawn from the vein.

[0065] All examples and conditional language recited herein are intended to be construed to cover all equivalents falling within the spirit and scope of the disclosure and inventive concepts presented herein and are intended to encompass all alternatives, modifications, and variations falling within the scope of the disclosure. Although the present disclosure has been described in detail with reference to certain illustrative embodiments, it should be understood that various changes, substitutions, and alterations can be made hereto without departing from the spirit and scope of the present disclosure.

Claims

1. A needle-type peripheral venous catheter assembly, characterized in that, The sheath-type peripheral venous catheter assembly includes: A catheter adapter, the catheter adapter including a proximal end, a distal end, and a lumen extending between the proximal and distal ends of the catheter adapter; A needle-type peripheral venous catheter extending distally from a catheter adapter, the needle-type peripheral venous catheter including a proximal end, a tip, and a segment between the proximal end and the tip, wherein the segment includes at least one position indicator to indicate the position of the needle-type peripheral venous catheter relative to a vascular system, wherein the at least one position indicator includes a first pair of markers and a second pair of markers, wherein the first pair of markers is disposed on the outer surface of the segment closer to the tip of the needle-type peripheral venous catheter than the distal end of the catheter adapter, wherein the second pair of markers... Markings are placed on the outer surface of the tubing segment closer to the distal end of the catheter adapter than the tip of the sheathed peripheral venous catheter, wherein a first and second mark in the first pair of markings are spaced apart, and wherein a first and second mark in the second pair of markings are spaced apart, wherein the first pair of markings provides a reference for the insertion depth of the sheathed peripheral venous catheter, and wherein the second pair of markings provides an indication of catheter removal by a change in the position of either the first or second mark relative to the patient's skin, wherein an unmarked portion of the tubing segment extends from the first pair of markings to the second pair of markings; and A guide needle extends through the segment of the sheath-type peripheral venous catheter and includes a sharp distal tip configured to introduce the sheath-type peripheral venous catheter into the vascular system, wherein the distance between the first and second marks in the first pair of marks is a Lai distance equal to the distance between the proximal end of the bevel of the guide needle and the tip of the sheath-type peripheral venous catheter.

2. The peripheral venous catheter assembly of claim 1, characterized in that, The first pair of marks is selected from a group consisting of color bands, symbol marks, and scale marks.

3. The peripheral venous catheter assembly of claim 1, characterized in that, The first pair of marks and the second pair of marks are evenly spaced apart.

4. The peripheral venous catheter assembly of claim 1, characterized in that, The second pair of markers is located at a distance of approximately 1 / 10 of the length of the catheter from the proximal end of the needle-type peripheral venous catheter.

5. The peripheral venous catheter assembly of claim 1, characterized in that, The distance between the first and second marks in the first pair of marks is half the length of the bevel of the guide pin.

6. The peripheral venous catheter assembly of claim 1, characterized in that, The first pair of markers consists of exactly two markers.

7. The peripheral venous catheter assembly of claim 1, characterized in that, The first and second marks in the first pair of marks are spaced apart by the length of the cone at the tip of the sheath needle peripheral venous catheter.

8. The peripheral venous catheter assembly of claim 1, characterized in that, The sheath-type peripheral intravenous catheter assembly further includes an image processor coupled to the sheath-type peripheral intravenous catheter assembly, wherein the image processor is configured to record an image of the insertion site of the sheath-type peripheral intravenous catheter assembly and analyze the position of the second pair of markers to detect the removal of the sheath-type peripheral intravenous catheter.

9. The peripheral venous catheter assembly of claim 8, characterized in that, The sheath-type peripheral intravenous catheter assembly also includes an alarm configured to be activated in response to the image processor detecting the removal.

10. A needle-type peripheral venous catheter assembly, characterized in that, The sheath-type peripheral venous catheter assembly includes: A sheathed peripheral venous catheter, the sheathed peripheral venous catheter comprising a proximal end, a tip, and a segment located between the proximal end and the tip of the catheter; Guide needle, the guide needle extending through the sheath-type peripheral venous catheter, wherein the guide needle includes an bevel; and A position indicator is disposed on the outer surface of a segment of the sheath-type peripheral venous catheter, the position indicator being configured to indicate the position of the sheath-type peripheral venous catheter within the vascular system. The position indicator includes a first pair of markers, which are positioned closer to the tip of the peripheral venous catheter than the proximal end of the catheter. The first pair of markers provides a reference for the insertion depth of the sheath-type peripheral venous catheter within the vascular system. Furthermore, the first and second marks in the first pair of marks are separated by a distance equal to the distance between the proximal end of the bevel and the tip of the needle-type peripheral venous catheter.

11. The peripheral venous catheter assembly of claim 10, characterized in that, The position indicator is printed on the outer surface of the pipe section.

12. The peripheral venous catheter assembly of claim 10, characterized in that, The first pair of marks are spaced 2-3 mm apart.

13. The peripheral venous catheter assembly of claim 12, characterized in that, The first pair of markers includes non-uniform characteristics selected from a group consisting of color, width, and length.

14. The peripheral venous catheter assembly of claim 10, characterized in that, Each of the first pair of marks is selected from the group consisting of a color band, a symbol mark, and a scale mark.

Images