Bandage-Based Traction Device with Integrated Tourniquet for Improved Blood Collection
The catheter assembly with a bandage and tourniquet system addresses occlusions by applying controlled traction, improving blood collection and fluid delivery through IV catheters.
Patent Information
- Application Number
- JP2024540885
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-01-05
- Filing Date
- 2023-01-04
- Publication Date
- 2025-01-24
AI Technical Summary
Existing indwelling IV catheters often become occluded at the tip due to fibrin sheaths, blood clots, or vein walls, limiting their functionality for fluid injection and aspiration, including blood collection, and current methods of uncontrolled manipulation can increase removal incidence and shorten catheter life.
A catheter assembly with a bandage and tourniquet system that applies directional inward pressure to release occlusions, featuring arms or wings that couple with the catheter adapter and bandage, allowing controlled traction to clear obstructions and improve blood collection.
The system effectively relieves occlusions by applying radial inward pressure, enhancing blood withdrawal and fluid delivery through the catheter while minimizing catheter removal and extending its indwelling life.
Smart Images

Figure 2025502062000001_ABST
Abstract
Description
[Technical field]
[0001] The present disclosure relates generally to intravenous (IV) catheter assemblies, and more particularly to an IV catheter assembly with a traction device and tourniquet for improved blood collection via an indwelling catheter. [Background technology]
[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 296,702, entitled "Bandage-Based Traction Device with Integrated Tourniquet for Improved Blood Collection," filed January 5, 2022, the entire disclosure of which is incorporated herein by reference.
[0003] Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids, such as saline, various medications, and total parenteral nutrition, into a patient. Catheters may also be used to withdraw blood from a patient.
[0004] A common type of IV catheter apparatus is what is called an "over-the-needle" catheter. As the name suggests, an over-the-needle catheter may be fitted over an introducer needle with a sharp distal tip. The IV catheter device may include a catheter adapter, a catheter extending distally from the catheter adapter, and an introducer needle extending through the catheter. The catheter and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the needle bevel pointing away from the patient's skin. The catheter and introducer needle are typically inserted at a shallow angle through the skin into the patient's vascular system, and the catheter is left in place as an indwelling catheter.
[0005] Over time, indwelling IV catheter devices may become occluded at or near the tip of the catheter due to the presence of fibrin sheaths, thrombi, vein walls, or valves. The occlusion may limit the catheter's ability to infuse and / or aspiration, including successfully obtain blood from a patient. Current catheters may be manually manipulated to allow blood collection, but doing so in an uncontrolled manner may increase the incidence of dislodgement and shorten the indwelling catheter's lifespan. Thus, there is a need in the art for improved devices, systems, and methods for manipulating indwelling catheters to free the catheter tip to allow blood collection and fluid delivery therefrom or through. [Prior art documents] [Patent documents]
[0006] [Patent Document 1] International Publication PCT / US2021 / 36859 Brochure Summary of the Invention
[0007] Provided herein is a catheter assembly having a catheter adapter having a proximal end, a distal end, and a lumen extending along a first longitudinal axis therebetween; a catheter extending from the distal end of the catheter adapter; a bandage having a first end, a second end, and first and second sides extending therebetween, defining a second longitudinal axis and configured to cover at least a portion of the catheter adapter at a penetration site into a patient's vasculature, the bandage further having an upper surface and a lower surface, the lower surface configured to contact the patient's skin; and a blood vessel configured to apply radially inward pressure to the patient's limb proximate the penetration site, the bandage being a blood vessel configured to couple with the bandage.
[0008] According to one embodiment of the present invention, the tourniquet includes one or more arms configured to couple with a bandage.
[0009] According to an embodiment of the invention, the one or more arms are configured to be coupled with a dressing at one or more locations along the arm.
[0010] According to one embodiment of the present invention, the dressing further includes one or more pegs disposed on the upper surface.
[0011] According to an embodiment of the invention, the one or more pegs are disposed along a second longitudinal axis of the dressing, the second longitudinal axis being parallel to the first longitudinal axis.
[0012] According to one embodiment of the invention, the one or more pegs include at least one peg disposed along the first side and at least one peg disposed along the second side.
[0013] According to an embodiment of the invention, the one or more arms are configured to releasably couple to one or more pegs.
[0014] According to an embodiment of the invention, one or more of the arms include a plurality of apertures, the apertures configured to releasably couple to one or more pegs.
[0015] According to an embodiment of the present invention, the one or more arms are connected to the tourniquet at multiple locations.
[0016] According to an embodiment of the invention, one or more arms are associated with the dressing at a single location.
[0017] According to an embodiment of the present invention, one or more of the arms includes a tensioning assembly.
[0018] According to an embodiment of the invention, the one or more arms are coupled to a dressing adjacent the proximal end of the catheter adapter.
[0019] According to an embodiment of the invention, the one or more arms are coupled to a dressing adjacent a distal end of the catheter adapter.
[0020] According to an embodiment of the present invention, the arm or arms are formed of a flexible material.
[0021] According to one embodiment of the invention, the one or more arms are formed from an elastomeric material.
[0022] According to an embodiment of the present invention, the arm or arms are formed of a rigid material.
[0023] According to one embodiment of the invention, the dressing includes an adhesive disposed on the lower surface.
[0024] According to an embodiment of the present invention, the housing is configured to cover at least a portion of the catheter adapter.
[0025] According to one embodiment of the present invention, the tourniquet includes a fastener configured to allow the tourniquet to be shortened and lengthened, thereby allowing different amounts of radially inward pressure to be applied to the patient's limb.
[0026] According to an embodiment of the invention, the second tourniquet is configured to apply radially inward pressure to the patient's limb proximate the penetration site, and the second tourniquet is configured to couple with the bandage.
[0027] According to one embodiment of the invention, the second tourniquet includes one or more second arms configured to couple with the bandage.
[0028] Also provided herein is a catheter assembly including a catheter adapter including a proximal end, a distal end, and a lumen extending along a first longitudinal axis therebetween, a catheter extending from the distal end of the catheter adapter, and a tourniquet configured to apply radially inward pressure to a patient's limb proximate a penetration site, the tourniquet configured to be coupled to the catheter adapter.
[0029] According to an embodiment of the present invention, the tourniquet includes one or more first arms.
[0030] According to one embodiment of the present invention, the catheter adapter includes a pair of wings disposed about the lumen.
[0031] According to one embodiment of the present invention, the adapted catheter further includes one or more pegs disposed on its upper surface.
[0032] According to one embodiment of the present invention, one or more pegs are disposed on a pair of wings.
[0033] According to an embodiment of the invention, the one or more first arms are configured to releasably couple to one or more pegs.
[0034] According to an embodiment of the invention, the one or more first arms include a plurality of apertures, the apertures configured to releasably couple to one or more pegs.
[0035] According to an embodiment of the invention, the one or more first arms couple to a proximal end of the catheter adapter.
[0036] According to an embodiment of the invention, the one or more first arms couple to a distal end of the catheter adapter.
[0037] According to an embodiment of the invention, the one or more first arms are coupled to a catheter adapted for multiple positions.
[0038] According to an embodiment of the present invention, the one or more first arms are formed of a flexible material.
[0039] According to one embodiment of the invention, the one or more first arms are formed from an elastomeric material.
[0040] According to an embodiment of the present invention, the one or more first arms are formed of a rigid material.
[0041] According to one embodiment of the present invention, the catheter adapter includes one or more second arms integral with the pair of wings, the one or more arms configured to couple to a tourniquet.
[0042] Also provided herein is a catheter assembly including a catheter adapter having a proximal end, a distal end, and a lumen extending along a first longitudinal axis therebetween, a catheter extending from the distal end of the catheter adapter, an extension tube extending from the proximal end of the catheter adapter, and a tourniquet configured to apply radially inward pressure to a patient's limb proximate a penetration site, the tourniquet configured to couple with the extension tube at one or more locations along a length of the extension tube.
[0043] According to an embodiment of the invention, the bandage is configured to cover at least a portion of the catheter adapter at a penetration site into the patient's vasculature, including a proximal end, a distal end, first and second sides disposed between the proximal end and the distal end, the proximal end, the distal end, and first and second sides defining a second longitudinal axis, and is configured to cover the penetration site into the patient's vasculature, an upper surface, a lower surface configured to contact the patient's skin, and a wire configured to couple with the extension tube.
[0044] According to an embodiment of the invention, a catheter adapter includes a pair of wings disposed about a lumen, one or more of the wings configured to mate with an extension tube.
[0045] According to one embodiment of the invention, the dressing is configured to couple with an extension tube.
[0046] According to one embodiment of the invention, the tourniquet, wings, and / or bandages couple to the extension tube via a snap fit.
[0047] Also provided herein is a method of withdrawing blood from a patient's vascular system, comprising attaching a catheter assembly according to any one of claims 1 to 40 to a limb of a patient, applying radially inward compression to the limb using a tourniquet, and attempting to withdraw blood from the catheter.
[0048] According to an embodiment of the invention, if blood cannot be collected from the catheter, the method includes applying a traction force to the catheter assembly to attempt to collect blood from the catheter a second time.
[0049] According to an embodiment of the invention, if blood cannot be collected from the catheter during the second attempt, the method includes applying traction to the catheter assembly with a tourniquet and attempting to collect blood from the catheter a third time. [Brief description of the drawings]
[0050] [Figure 1] FIG. 1 is a perspective view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Diagram 2] FIG. 2 is a perspective view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Diagram 3] FIG. 3 is a perspective view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 4] FIG. 4 is a perspective view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 5A] FIG. 5A is a top view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 5B] FIG. 5B is a side view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 5C] FIG. 5C is a side view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 6A]FIG. 6A is a top view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 6B] FIG. 6B is a top view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 7] FIG. 7 is a perspective view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 8] FIG. 8 is a top view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 9] FIG. 9 is a top view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 10] FIG. 10 is a top view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 11A] FIG. 11A is a top view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 11B] FIG. 11B is a side view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 12] FIG. 12 is a top view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 13] FIG. 13 is a top view of a catheter assembly according to a non-limiting embodiment or aspect described herein. [Figure 14] FIG. 14 is a perspective view of a catheter assembly according to non-limiting embodiments or aspects described herein. [Figure 15] FIG. 15 is a perspective view of a catheter assembly according to non-limiting embodiments or aspects described herein. [Figure 16] FIG. 16 is a top view of a catheter assembly according to a non-limiting embodiment or aspect described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0051] The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.
[0052] For purposes of explanation hereinafter, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "longitudinal" and their derivatives refer to the invention as oriented in the drawings. It is understood, however, that the invention may be subject to various alternative modifications unless expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. As such, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.
[0053] It should be understood that any numerical range recited herein is intended to include all subranges subsumed therein. For example, a range "from 1 to 10" is intended to include all subranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, i.e., ranges having a minimum value of 1 or more and a maximum value of 10 or less.
[0054] Provided herein is a catheter assembly that allows a user to apply traction to an indwelling IV catheter to free its tip from an obstruction that may prevent the withdrawal of blood from the catheter or the injection of a composition through the catheter. The traction force may be applied in a manner equivalent in time to the application of a tourniquet, which may also improve the withdrawal of blood through the catheter.
[0055] 1, a non-limiting embodiment of a catheter assembly 100 is shown, which may include a catheter adapter 110 having a proximal end 112, a distal end 114, and a lumen (not shown) therebetween and fluidly connecting the proximal end 112 and the distal end 114. The proximal end 112 and the distal end 114 of the catheter adapter may define a first longitudinal axis. The catheter adapter 110 may include a catheter 118 at its distal end 114 configured to be disposed within the vasculature of a patient and in fluid communication with the lumen. A catheter adapter 110 useful in the assemblies described herein may include any number of features known to those of skill in the art, such as a luer connection or needleless access connector at its proximal end 112, and / or one or more side ports providing fluid communication between an extension set and the lumen of the catheter adapter 110, and other similar features. Needleless access connectors are known to those skilled in the art and are commercially available, for example, from Becton, Dickinson and Company under the trade names SmartSite® and Q-SYTE®. Extension sets are known to those skilled in the art and are commercially available, for example, from Becton, Dickinson and Company under the trade names MAXPLUS®, MAXZERO®, NEUTRACLEAR®, Q-SYTE, and SmartSite. Catheter 118 can be a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter.
[0056] With continued reference to FIG. 1, the catheter assembly 100 may include a bandage 120 having a first end, a second end, and first and second sides therebetween that define a second longitudinal axis that may be substantially parallel to the first longitudinal axis of the catheter adapter 110. The bandage 120 is illustrated in the accompanying drawings as being substantially square or rectangular in shape, but one of ordinary skill in the art will appreciate that any shape may be used so long as the bandage 120 can include the features described herein. With reference to the non-limiting embodiment of FIG. 1, the ends and sides of the bandage 120 define a perimeter, and when in position on a patient, the bandage 120 covers at least a portion of the catheter adapter 110 such that at least a portion of the catheter adapter 110 is disposed within the perimeter. The bandage 120 includes a top surface and a bottom surface, the bottom surface configured to contact the patient's skin. In a non-limiting embodiment, the bandage 120 includes an adhesive on the bottom surface to improve adhesion to the skin. Suitable dressings may also include antimicrobial compositions to increase resistance to infections that may be common with indwelling catheters.
[0057] The catheter assembly 110 may further include a tourniquet 130, which may be configured as a removably attachable component of the catheter assembly 110, configured to encircle a patient's limb and substantially or completely occlude blood flow through one or more blood vessels thereof. The tourniquet 130 may be formed of any suitable material, such as an elastomeric material, a fabric material, a woven or nonwoven material, and / or a film-like material. In a non-limiting embodiment, the tourniquet 130 is an inflatable device, optionally a reversibly inflatable device, that when inflated compresses one or more blood vessels beneath the skin at the application site, thereby substantially or completely occluding blood flow therethrough. The tourniquet 130 may include a fastener 138, such as a hook-and-loop fastener, a pin-and-hole fastener, a releasable adhesive layer, a wrap-and-tie, or other similar fastener, allowing a user to adjust the length of the tourniquet and provide a radial compressive force to the patient to occlude one or more blood vessels. Without wishing to be bound by theory, it is believed that application of a tourniquet downstream of the catheter 118 causes occlusion of the blood vessel, causing distension of the vessel as blood collects, making it much easier to withdraw blood from the vessel in which the catheter 118 is placed. The tourniquet 130 may be releasably or permanently coupled to the dressing 120 and / or catheter adapter 110, as shown in the accompanying figures. In a non-limiting embodiment, multiple tourniquets may be included in the catheter assembly 100, for example, as shown in FIG. 6.
[0058] With further reference to FIG. 1 , the tourniquet may include one or more arms 132 extending therefrom. The one or more tourniquet arms 132 may be formed of the same material as the tourniquet or may be a different material. The arms 132 may be flexible, elastomeric, rigid, semi-rigid, may provide tension and / or compression, may be releasably or permanently coupled to the tourniquet 130, may be loaded in terms of providing or preventing axial or rotational displacement, and / or may be loaded in terms of the amount of force (tension or compression) they provide, and may be passively or actively adjustable. In a non-limiting embodiment, the tourniquet 130 and / or arms 132 are configured to apply tension and / or compression to the bandage 120 and / or catheter adapter 110 based on tightening or loosening of the tourniquet 130. In a non-limiting embodiment, one or more tourniquet arms 132 can be reversibly or permanently coupled to the dressing 120 and / or catheter adapter 110 as shown in the accompanying figures.
[0059] 2-4, one or more tourniquet arms 132 may be reversibly or permanently coupled to the bandage 120 and / or catheter adapter 110 at one or more connection points 140. In a non-limiting embodiment, one or more tourniquet arms are coupled to one or more connection points at one or more locations along their length, thereby allowing for the adjustment of the amount of tension and / or compression (both shown as F in FIG. 2 and FIG. 9) and the application of traction to the catheter 118. As used herein, "traction" refers to the displacement of the catheter 118 at a distance either upstream or downstream from a rest position. In a non-limiting embodiment, the catheter 118 is displaced in a range of about 0 to about 0.5 inches, including all subranges and values therebetween. In a non-limiting embodiment, the catheter 118 is displaced about 0.125 inches. Without wishing to be bound by theory, it is believed that by applying force (e.g., tension and / or compression) to the catheter adapter 110, the tourniquet 130 and / or tourniquet arms 132 may be coupled directly to the catheter adapter 110 or to the dressing 130 (which itself may be directly or indirectly coupled to the catheter adapter 110) to displace the tip of the catheter 118, thereby freeing or repositioning the catheter from a potential obstruction (e.g., fibrin sheath, thrombus, vein wall, and / or valve). Although not shown in Figures 2-4, one skilled in the art will appreciate that the catheter adapter may be used with a variety of accessories, such as stabilization devices, devices that help adjust the angle at which the catheter adapter is placed relative to the patient's skin, and / or anchor pads, such as those commercially available from Becton, Dickinson and Company under the trade name STATLOCK®. Those skilled in the art will understand that the tourniquets and tourniquet arms described herein can be coupled to such devices to apply tension and / or compression, and thus traction, to the catheter, in a manner similar to the coupling to the catheter adapters and bandages described herein.
[0060] In a non-limiting embodiment, the one or more connection points 140 are releasable connection points for the tourniquet 130 and / or the arms 132, such as hook and loop connections, adhesive connections, etc. In a non-limiting embodiment, the one or more connection points 140 are pegs that extend radially outward (relative to the longitudinal axis of the catheter adapter 110) away from the patient's skin. The connection points 140, such as pegs, may be integrated into the dressing 130 and / or the catheter adapter 110. In a non-limiting embodiment, the connection points 140 may be provided as separate elements, removably or permanently attached to the dressing 130 and secured thereto by adhesives, welding, loop and hook fasteners, stitches, or other suitable attachments. The connection points 140 may include any features suitable to prevent the tourniquet 130 and / or the arms 132 from inadvertently separating from the connection points 140 during application of tension or compression to the dressing 120 and / or the catheter adapter 110.
[0061] In a non-limiting embodiment, for example, as shown in FIGS. 5A-5C, one or more tourniquet arms 132 may include one or more openings 134 therein for coupling by receiving one or more connection points 140. The connection points may be arranged in any suitable configuration to provide tension or compression to the bandage 120 and / or catheter adapter, thereby applying traction to the catheter 118. For example, the connection points 140 may be located at one or more locations along one or both sides of the bandage 120, for example, along the second longitudinal axis, as shown in FIG. 3. In a non-limiting embodiment, the one or more connection points 140 may be located along one or both ends and / or sides of the bandage 120. In a non-limiting embodiment, the one or more connection points 140 may be located on the catheter adapter 110, for example, on the proximal end 112, the distal end 114, and / or the wings 116. For example, as shown in Figure 4, one or more arms 132 mate with a connection point 140 located at the proximal end 112 of the catheter adapter 110. In the embodiment shown in Figure 4, the one or more arms 132 are arranged as a loop that mates with the connection point 140 to provide equal tension or compression along both sides of the catheter adapter 110 and reduce rotational displacement of the catheter 118.
[0062] 4, in a non-limiting embodiment, the catheter assembly 100 can include a housing 150 configured to cover at least a portion of the dressing 120 and / or the catheter adapter 110. In a non-limiting embodiment, the housing 150 is a vacuum dome configured to allow application of a vacuum, e.g., via a vacuum pump, at or adjacent to the catheter placement site, thereby creating a negative pressure environment below the dome to improve blood withdrawal via the catheter 118.
[0063] 5A-5C, non-limiting embodiments of a tourniquet 130 and arms 132 for use with the catheter assemblies described herein are shown. In the illustrated embodiment, the tourniquet 130 includes a fastener 138 in the form of a pin and hole connection that includes arms 132 that include several openings 134 along their length. The different openings 134 allow for variable levels of tension or compression to be applied to the bandage 120 or catheter adapter (as shown in FIGS. 5B and 5C), based at least in part on which openings 134 are utilized along with the pin connection and the material from which the tourniquet 130 and / or arms 132 are made, thereby applying a traction force to the catheter. Optionally, as shown in FIGS. 5A and 5C, for example, the tourniquet 130 includes a housing 150, such as a vacuum dome.
[0064] 6A and 6B, a non-limiting embodiment of a catheter assembly 100 is shown that includes a catheter adapter 110, a bandage 120, and multiple tourniquets 130, one disposed downstream of the catheter 118 and one disposed upstream of the catheter 118. The use of a second tourniquet 130 provides the catheter assembly 100 with several different features. The use of a second tourniquet 130 allows for traction in both directions (e.g., pushing and pulling the catheter 118). This can be accomplished without (FIG. 6A) or with (FIG. 6B) one or more arms 132 that couple the tourniquet 130 to the bandage 120 and / or catheter adapter 110. In a non-limiting embodiment as shown in FIG. 6, the tourniquet 130 and the bandage 120 and / or catheter adapter 110 can be coupled such that tightening the tourniquet 130 in preparation for blood collection can simultaneously apply traction to the catheter 118.
[0065] Referring to FIG. 7, a non-limiting embodiment of a catheter assembly 100 is shown including a catheter adapter 110, a bandage 120, and a tourniquet 130. As previously described, the catheter adapter 110 can have a proximal end 112 and a distal end 114, with the catheter 118 extending from the distal end 114. As previously described, the tourniquet 130 can include a tourniquet arm 132. In the non-limiting embodiment shown in FIG. 7, the tourniquet arm 132 is coupled to the tourniquet 130 at multiple locations. Although FIG. 7 shows the tourniquet arm 132 coupled to the bandage 120 at a single location on its distal end 124, it should be understood that the tourniquet arm 132 can be coupled to the bandage 120 and / or the catheter adapter 110 at any suitable location. In the non-limiting embodiment of FIG. 7, the tourniquet arms 132 can be tensioned with a tensioning assembly 136 to provide traction to the catheter 118 by coupling the tourniquet arms to the bandage 120 and / or the catheter adapter 110.
[0066] Referring to FIG. 8, a non-limiting embodiment of a catheter assembly 200 is shown including a catheter adapter 210 having a first end 212 and a second end 214 defining a lumen (not shown) therebetween, and a catheter 218 at the second end 214. The catheter assembly 200 may include a tourniquet 230. In the non-limiting embodiment shown in FIG. 8, the catheter adapter 210 includes one or more wings 220 and one or more arms 222 extending therefrom. The one or more catheter adapter arms 222 may be reversibly coupled to or integral with the one or more wings 220 and may be coupled to the tourniquet 230 and / or tourniquet arms (not shown). In a non-limiting embodiment, the one or more catheter adapter arms 222 may be formed of the same material as the catheter adapter 210 or a different material than the catheter adapter 210. In a non-limiting embodiment, one or more catheter adapter arms 222 may be overmolded as part of the catheter adapter 210, for example as part of one or more catheter adapter wings 220. As noted above, here, coupling of the catheter adapter 210 through the arm 222 via the tourniquet 230 or tourniquet arm allows for tension and / or compression to be applied to the catheter adapter 210, and thus traction to the catheter 218.
[0067] 9, a non-limiting embodiment of a catheter assembly 300 is shown including a catheter adapter 310 having a proximal end 312 and a distal end 314 defining a longitudinal axis, including a lumen (not shown) therebetween and a catheter 318 at the distal end. The catheter assembly 300 may include a tourniquet 330 and a dressing 350 having a first end 352 and a second end 354. In the non-limiting embodiment of FIG. 9, the catheter assembly 300 includes an extension set including an extension tube 324 in fluid communication with the lumen (not shown) of the catheter adapter 310. As shown in FIG. 9, the extension tube 324 may be utilized to provide traction to the catheter 318 by coupling with the tourniquet 330. In this manner, various amounts of traction may be applied to the catheter 318, for example, by applying tension to the extension tube 324 by pulling the extension tube toward the tourniquet 330 and coupling the extension tube 324 with the tourniquet 330. In a non-limiting embodiment, a second extension tube (not shown) can be utilized and attached to a second tether and / or tourniquet to apply traction in multiple directions. The extension tube 324 can be coupled to the tourniquet 330 via any suitable type of connection, e.g., via a snap fit, friction fit, etc. In a non-limiting embodiment, the catheter assembly 300 can include an additional tether 358. The tether 358 can be formed of any useful material, such as those disclosed above, as suitable for the tourniquet arm or the catheter adapter arm. The tether 358 can be coupled to the dressing 350 and / or the catheter adapter 310, as previously described.
[0068] In a non-limiting embodiment, the tether 358 is coupled to the extension tube 324. In a non-limiting embodiment, the tether 358 is coupled to the extension tube 324 at one end and to the catheter adapter 310 at another end. The tether 358 may be coupled to the catheter adapter 310 at a location opposite the extension tube 324 such that the combination of the tether 358 and the extension tube 324 provides substantially equal tension and / or compression to the catheter adapter 310 when the extension tube 324 is coupled to the tourniquet, thereby providing a traction force to the catheter 318 without any significant rotational force being applied to the catheter 318, e.g., about the longitudinal axis of the catheter adapter 310. In a non-limiting embodiment, the tether 358 is at least partially embedded in the dressing 350.
[0069] 10, a non-limiting embodiment of a catheter assembly 400 is shown including a catheter adapter 410 having a proximal end 412 and a distal end 414 defining a longitudinal axis, including a lumen (not shown) therebetween and a catheter 418 at the distal end. The catheter adapter 410 may further include one or more wings 420. The one or more wings 420 may be arranged in any suitable manner, for example extending between the proximal end 412 and the distal end 414 of the catheter adapter 410. In the non-limiting embodiment of FIG. 10, the catheter assembly 400 includes an extension set including an extension tube 424 in fluid communication with the lumen (not shown) of the catheter adapter 410. Similar to the embodiment shown in FIG. 9, in the embodiment of FIG. 10, the extension tube 424 may be utilized to provide traction to the catheter 418 by coupling with a tourniquet 430. In this manner, various amounts of traction can be applied to the catheter 418, for example, by applying tension to the extension tube 424 by pulling the extension tube toward the tourniquet 430 and coupling the extension tube 424 to the tourniquet 430. The extension tube 424 can be reversibly or permanently coupled to one or more of the tourniquet 430, the catheter adapter 410, and / or a dressing (not shown) at one or more connectors 426 via any suitable type of connection, for example, via a snap fit, friction fit, etc. In a non-limiting embodiment, the extension tube 424 can be coupled to both the catheter adapter 410 and the tourniquet 430 at the connector 426. For example, as shown in FIG. 10, the extension tube 424 can be coupled to one or more wings 420 of the catheter adapter 410. The extension tube 424 can be coupled to the catheter adapter with its one or more wings 420, for example, via any suitable type of connection, for example, via a snap fit, friction fit, etc. In a non-limiting embodiment, the extension tube 424 can be coupled to the wing 420 of the catheter adapter 410 on a side opposite the side of the catheter adapter 410 to which the end of the extension tube 424 is coupled in fluid communication with the lumen.In this manner, the extension tube 424, when tensioned through its connection with the tourniquet 430, can provide substantially equal tension and / or compression to the catheter adapter 410, thereby providing a traction force to the catheter 418, e.g., about the longitudinal axis of the catheter adapter 410, without any significant rotational force being applied to the catheter adapter 410.
[0070] 11-16, there is shown a non-limiting embodiment of a catheter assembly 500 including a device for providing traction to a catheter 518 with one or more additional tourniquets 530. Such a traction device is disclosed in U.S. Patent No. 5,399,633, the contents of which are incorporated herein by reference in their entirety.
[0071] 11A-12, a non-limiting embodiment of a catheter assembly 500 configured to apply a traction force to a catheter 518 to create a clear path for fluid flow is shown. In some embodiments, the catheter assembly 500 may include a catheter adapter 510 having a proximal end 512, a distal end 514, and a lumen (not shown) extending along a longitudinal axis therebetween.
[0072] A catheter 518 may extend from the distal end 514 of the catheter adapter 510. In some embodiments, the catheter 518 may be used for blood sampling, fluid delivery, patient or device monitoring, or other clinical needs. In some embodiments, the catheter 518 may include a peripheral IV catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, the catheter 518 may be pre-inserted into the patient's vascular system and may remain within the vascular system.
[0073] In some embodiments, the bandage 550 may securely apply traction to the catheter 112 while the catheter 112 is positioned within the patient's vasculature. In some embodiments, the bandage 550 may include an adhesive 126 to secure the bandage 550 to the patient. In some embodiments, the bandage 550 may include a two-piece or two-section bandage 550 connected by an adjustment element 560. In some embodiments, the bandage 550 may include more than two sections and may be connected by one or more adjustment elements 560, such as adjustable tethers or other suitable fasteners or straps.
[0074] In some embodiments, each or some of the sections of bandage 550 may be spaced apart from one another by a distance. The distance between the sections of bandage 550 may be selected to optimize the application of traction to catheter 518. For example, during operation, some embodiments may apply traction to catheter 518 by adjusting the distance between two or more of the pieces or sections of bandage 550. In some embodiments, the distance between bandage 550 sections may be adjusted manually or automatically by adjustment element 560. In some embodiments, adjusting the distance between bandage 550 sections in this manner may exert tension between bandage 550 sections to apply traction to catheter 518.
[0075] In some embodiments, the bandage 550 may include a first section 552 adjustably coupled with a second section 554. In some embodiments, an adjustment element 560 may adjustably couple the first section 552 to the second section 554. The adjustment element 560 may include, for example, a tether, winch, ratchet, pulley, dial, screw, cable tie, or other suitable tensioning device or mechanism. Some embodiments of the adjustment element 560 may be releasable and / or removable to separate the first and second sections 116, 118.
[0076] In some embodiments, the first section 552 may be independent from the second section 554. Some embodiments of the first section 552 may be configured to fix and / or maintain the position of the catheter adapter 102 and / or catheter 518 to the patient, for example, via adhesive 126. In some embodiments, the first section 552 may include an opening 124 or other suitable feature or mechanism for maintaining the catheter adapter 102 and / or catheter 518 in a substantially fixed position relative to the patient.
[0077] In some embodiments, the second section 554 may be adjustably positioned and / or fixed relative to the first section 552 to apply traction to the catheter 518 within the vasculature. In some embodiments, the second section 554 may include an adhesive or other suitable device or mechanism for fixing and / or maintaining the position of the second section 554 relative to the patient. Some embodiments of the second section 554 may include a fixation device or mechanism for fixing and / or maintaining the position of the second section 554 relative to the first section 552.
[0078] In some embodiments, the position of the second section 554 relative to the first section 552 can be adjusted by an adjustment element 560. In some embodiments, as shown in FIG. 1, the adjustment element 560 can include one or more tethers 562 to couple the dressing 550 sections 552, 554 together. In some embodiments, a first end of the tether 562 can be coupled to the first section 552 and a second end of the tether 562 can be coupled to the second section 554.
[0079] In some embodiments, the tethers 562 may be configured such that each tether 562 is individually adjusted to pull traction on the catheter 518. In some embodiments, the tethers 562 may be configured such that they are collectively adjusted as a single unit to pull traction on the catheter 518. In some embodiments, each tether 562 may pull traction on the catheter 518 in either the proximal or distal direction.
[0080] In some embodiments, tightening tether 562 may pull the patient's skin so that the tip of catheter 518 may be reoriented within the vasculature. In some embodiments, repositioning the tip of catheter 518 within the vasculature in this manner may clear a fluid path for infusion of fluids or drugs or blood withdrawal. In some embodiments, adjustment element 560 may be automatically or manually adjusted or loosened to return dressing 550 to its initial position, thereby releasing the traction force on catheter 518.
[0081] 11A-12, a catheter assembly 500 may include one or more tourniquets 530 coupled with a traction device 560 and / or a bandage 550, as previously described. The combination of one or more tourniquets 530 and a traction device 560 may improve blood withdrawal or drug injection for reasons previously described.
[0082] In some embodiments, the adjustment element 560 may include one or more finger grips 564 to facilitate manual adjustment of the second section 554 of the bandage 550 relative to the first section 552 of the bandage 550. In some embodiments, the first finger grip 564 may be coupled to the first section 552 and the second finger grip 564 may be coupled to the second section 554. In some embodiments, the first section 552 and the second section 554 of the bandage 550 may be monolithically formed as a single unit. Some embodiments of the finger grips 564 may be coupled to the catheter adapter 510.
[0083] In operation, a user, such as a medical professional, can utilize a finger grip 564 to adjust or maintain the position of the first section 552 relative to the patient while utilizing another finger grip 564 to adjust or maintain the position of the second section 554 relative to the first section 552. In some embodiments, a finger grip 564 can be utilized to maintain the position of the first section 552 and the position of the second section 554 can be adjusted relative to the first section 552 via the other finger grip 564.
[0084] In some embodiments, a finger grip 564 may be utilized to adjust the position of the first section 552 in a proximal or distal direction, and the position of the second section 554 may be simultaneously adjusted in the opposite direction via another finger grip 564. In some embodiments, a finger grip 564 may be utilized to adjust the tilt, incline, or other position or orientation of the first section 552 relative to the second section 554. In some embodiments, utilizing one or more finger grips 564 to manually adjust the position of the first section 552 relative to the second section 554 in this manner can apply traction to the catheter 518 to reposition the tip of the catheter 518 within the vasculature, thereby opening a fluid pathway.
[0085] 13, in some embodiments, the catheter assembly 500 may include a dressing 550, with a first section 562 including a pad 600 for securing the catheter adapter 510 to the patient. The pad 600 may include openings, adhesive, and / or other suitable fastening features for receiving the catheter adapter 510 and securing the catheter adapter 510 to the pad 600 and the patient. In some embodiments, the catheter 518 may extend from the distal end 514 of the catheter adapter 510 through openings or other features of the pad 600 into the patient's vasculature. In some embodiments, the pad 600 may have a length sufficient to extend the length of the catheter 518 within the vasculature. In some embodiments, the pad 600 may include markings 608 indicating the approximate location of the catheter 112 under the pad 600.
[0086] In some embodiments, the second section 554 may include an isolation section of the dressing 550, such as a tab 606 coupled with a distal end of the pad 600. In some embodiments, the pad 600 and the tab 606 may be monolithically formed as a single unit. In operation, the tab 606 may be pulled distally relative to the distal end 514 of the catheter adapter 510 to apply traction to the catheter 518. In some embodiments, the tab 606 may include an adhesive or other suitable mechanism that allows the tab 606 to be selectively moved distally and secured in place to apply continuous traction to the catheter 518. In some embodiments, the markings and / or the tab 606 may facilitate blood collection by indicating a desired or optimal location for the clinician to apply pressure to draw blood.
[0087] 13, the catheter assembly 500 may include one or more tourniquets 530 coupled with tabs 606 of a bandage 550, as previously described. The combination of one or more tourniquets 530 and tabs 606 may improve blood withdrawal or drug infusion for reasons previously described.
[0088] 14, in some embodiments, a catheter assembly 500 includes a bandage 550 for receiving the catheter adapter 510 and a traction mechanism 560 coupled to the bandage 550 to consistently apply traction to a catheter 518 extending from the catheter adapter 510. In some embodiments, the bandage 550 may include a stabilization pad 700 having a contour for receiving and stabilizing the catheter adapter 510 and / or a stabilization element coupled thereto. Suitable stabilization pads are commercially available, for example, from Becton, Dickinson and Company under the trademark STATLOCK.
[0089] Some embodiments of the traction mechanism 560 may be coupled to the stabilization pad 700 at a location substantially corresponding to the location of the catheter 518. In some embodiments, the traction mechanism 560 may include an anchor point located on either side of the catheter 518 at or near its proximal end. In some embodiments, the traction arm 566 may extend distally from an anchor point parallel to the catheter 518. In some embodiments, a traction plate 568 extending substantially transversely to the traction arm 566 may be coupled or integral with the distal end of the traction arm 566. In some embodiments, the traction plate 568 may provide a distal anchor point for the traction mechanism 560.
[0090] During operation, in some embodiments, the traction arms 566 may be squeezed inward to straighten or deform the respective contours of the traction arms 566 in an inward direction relative to the catheter 518. In some embodiments, application of this force can apply a controlled traction force to the catheter 518 to open up fluid pathways within the vasculature.
[0091] 14, the catheter assembly 500 may include one or more tourniquets 530 coupled with a tow plate 568. The combination of one or more tourniquets 530 and a tow plate 568 may improve blood withdrawal or drug infusion for reasons previously discussed.
[0092] 15 and 16, in some embodiments, a first section 552 of bandage 550 may include contours, adhesive, and / or other features to hold catheter adapter 510 in a substantially fixed position relative to the patient. A second section 554 of bandage 550 may be spaced from first section 552 and substantially fixed relative to the patient via adhesive or other suitable device or mechanism. Thus, in some embodiments, a substantially fixed distance may separate first section 552 and second section 554.
[0093] In some embodiments, the traction mechanism 560 may be coupled to the first section 552 of the bandage 550 and may be configured to attach to and adjust the distance between the second section 554 of the bandage 114. In some embodiments, the traction mechanism 560 may include an adjustable snap feature 570 for adjusting the distance between the first section 552 and the second section 554. In this manner, some embodiments of the snap feature 570 may apply a consistent traction to the catheter 518.
[0094] 15, in some embodiments, the traction mechanism 560 may include a tension strap 572 coupled with the first section 552 of the bandage 550. In some embodiments, the tension strap 572 may be monolithically formed as a single unit with the first section 116 of the bandage 550. In some embodiments, the catheter adapter 510 and / or the stabilizing element may be coupled with the tension strap 572. In other embodiments, the tension strap 572 may substantially surround the catheter adapter 510 and / or the stabilizing element.
[0095] In any event, some embodiments of the tension strap 572 may include a snap feature 570 coupled or integrated with its distal end. In some embodiments, the snap feature 570 may include an extension or tab having one or more snap caps 1206 disposed along its length. In some embodiments, each snap cap 574 may be configured to couple to a socket 576 coupled or integrated with the second section 554 of the bandage 550. In some embodiments, the second section 554 may include multiple sockets 576 such that one or more snap caps 574 may be adjustably coupled with one or more sockets 576. In this manner, in some embodiments, the tension strap 572 may be tightened and / or loosened relative to the second section 554 of the bandage 550 to adjust the traction force applied to the catheter 518 in a controlled manner.
[0096] 15, the catheter assembly 500 may include one or more tourniquets 530 coupled with a bandage 550, such as second section 554. The combination of one or more tourniquets 530 and bandage 550 may improve blood withdrawal or drug infusion for reasons previously discussed.
[0097] 16, in some embodiments, the tension strap 572 or bandage 550 may include alternative connection features 580, such as clasps, buttons, hook and loop fasteners, adhesives, or other suitable fastening devices or features. As shown, in some embodiments, the connection feature 580 may include a first connector element 582 coupled with a first section 552 of the bandage 550 and a second connector element 584 coupled with a second section 554 of the bandage 550. In some embodiments, the first connector element 582 and / or the second connector element 584 may be adjustable to adjust the distance between the first section 552 of the bandage 550 and the second section 554 of the bandage 550. In some embodiments, the first connector element 582 and the second connector element 584 may be interlocked or otherwise coupled together to reduce the distance between the first section 552 and the second section 554, thereby applying traction to the catheter 510 in a consistent manner.
[0098] 16, the catheter assembly 500 may include one or more tourniquets 530 coupled with a bandage 550, such as second section 554. The combination of one or more tourniquets 530 and bandage 550 may improve blood withdrawal or drug infusion for reasons previously discussed.
[0099] Also provided herein are methods of withdrawing blood from a vascular access device, or repairing a failed vascular access device, or mitigating a potentially failed vascular access device. As described above, providing traction to a vascular access device, such as an indwelling catheter, can improve blood withdrawal and / or delivery of an agent through the catheter. Thus, in a non-limiting embodiment, a method of withdrawing blood includes providing a catheter assembly as described herein. A user, such as a medical professional, can tighten the tourniquet, thereby occluding one or more of the underlying blood vessels and causing blood to pool near the tip of the indwelling catheter. At this point, blood withdrawal can be attempted. If blood withdrawal is unsuccessful, traction can be applied to the catheter manually by the user, for example, by applying force with a finger. After application of traction, a second attempt to withdraw blood can be made. If the second attempt is unsuccessful, further traction can be applied to the catheter, for example, by increasing / decreasing tension or compression applied to the tourniquet arm, catheter arm, and / or tourniquet arm or catheter arm, or between the tourniquet and the dressing, catheter adapter, connecting feature, and / or traction mechanism, as described herein. If necessary, this step may be repeated until blood can be withdrawn. After successful withdrawal, the tourniquet may be loosened or removed.
[0100] While the present disclosure has been described in detail for purposes of illustration based on what are currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is for this purpose only, and that the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.
[0101] The present invention includes the following embodiments: [Configuration 1] 1. A catheter assembly comprising: a catheter adapter including a proximal end, a distal end, and a lumen extending along a first longitudinal axis therebetween; a catheter extending distally from the distal end of the catheter adapter; a dressing including a first end, a second end and first and second sides extending therebetween, the dressing defining a second longitudinal axis and configured to cover at least a portion of the catheter adapter at a penetration site into a patient's vascular system, the dressing further including an upper surface and a lower surface, the lower surface configured to contact the patient's skin; a tourniquet configured to apply radially inward pressure to the patient's limb proximate the penetration site, the tourniquet configured to couple with the bandage. [Configuration 2] 2. The catheter assembly of claim 1, wherein the tourniquet comprises one or more arms configured to engage with the bandage. [Configuration 3] 3. The catheter assembly of configuration 2, wherein the one or more arms are configured to be coupled to the bandage at one or more locations along the arms. [Configuration 4] The catheter assembly of any one of configurations 1 to 3, wherein the bandage further comprises one or more pegs disposed on the upper surface. [ Configuration 5] The catheter assembly of configuration 4, wherein the one or more pegs are positioned along a second longitudinal axis of the bandage, the second longitudinal axis being parallel to the first longitudinal axis. [Configuration 6] The catheter assembly of configuration 4 or configuration 5, wherein the one or more pegs include at least one peg positioned along the first side and at least one peg positioned along the second side. [Configuration 7] 7. The catheter assembly of any one of configurations 4 to 6, wherein the one or more arms are configured to releasably couple to the one or more pegs. [Configuration 8] The catheter assembly of any one of configurations 4 to 7, wherein the one or more arms include a plurality of openings, the openings configured to releasably couple to the one or more pegs. [Configuration 9] The catheter assembly of any one of configurations 2-8, wherein the one or more arms are connected to the tourniquet at multiple locations. [Configuration 10] The catheter assembly of any one of configurations 2 to 9, wherein the one or more arms are coupled to the bandage at a single location. [Configuration 11] 11. The catheter assembly of any one of configurations 2-10, wherein the one or more arms include a tensioning assembly. [Configuration 12] 12. The catheter assembly of any one of configurations 2-11, wherein the one or more arms are coupled to the bandage adjacent the proximal end of the catheter adapter. [Configuration 13] 13. The catheter assembly of any one of configurations 2-12, wherein the one or more arms are coupled to the bandage adjacent the distal end of the catheter adapter. [Configuration 14] 14. The catheter assembly of any one of claims 2-13, wherein the one or more arms are formed from a flexible material. [Configuration 15] 15. The catheter assembly of any one of configurations 2-14, wherein the one or more arms are formed of an elastomeric material. [Configuration 16] 16. The catheter assembly of any one of configurations 2-15, wherein the one or more arms are formed from a rigid material. [Configuration 17] 17. The catheter assembly of any one of claims 1 to 16, wherein the bandage includes an adhesive disposed on the underside. [Configuration 18] 18. The catheter assembly of any one of claims 1 to 17, further comprising a housing configured to cover at least a portion of the catheter adapter. [Configuration 19] 19. The catheter assembly of any one of configurations 1-18, wherein the tourniquet includes a fastener configured to allow the tourniquet to be shortened and lengthened, thereby allowing different amounts of radially inward pressure to be applied to the patient's limb. [Configuration 20] 20. The catheter assembly of any one of claims 1-19, further comprising a second tourniquet configured to apply radially inward pressure to the patient's limb proximate the penetration site, the second tourniquet configured to couple with the bandage. [Configuration 21] 21. The catheter assembly of claim 20, wherein the second tourniquet comprises one or more second arms configured to couple with the bandage. [Configuration 22] 1. A catheter assembly comprising: a catheter adapter including a proximal end, a distal end, and a lumen extending along a first longitudinal axis therebetween; a catheter extending distally from the distal end of the catheter adapter; a tourniquet configured to apply radially inward pressure to a patient's limb proximate the penetration site, the tourniquet configured to mate with the catheter adapter. [Configuration 23] 23. The catheter assembly of claim 22, wherein the tourniquet comprises one or more first arms. [Configuration 24] 24. The catheter assembly of claim 22 or 23, wherein the catheter adapter comprises a pair of wings disposed about the lumen. [Configuration 25] 25. The catheter assembly of any one of Aspects 22-24, wherein the catheter further comprises one or more pegs disposed on an upper surface thereof. [Configuration 26] 26. The catheter assembly of claim 25, wherein the one or more pegs are disposed on the pair of wings. [Configuration 27] 27. The catheter assembly of configuration 25 or 26, wherein the one or more first arms are configured to releasably couple to the one or more pegs. [Configuration 28] 28. The catheter assembly of any one of configurations 25 to 27, wherein the one or more first arms include a plurality of openings, the openings configured to releasably couple to the one or more pegs. [Configuration 29] 29. The catheter assembly of any one of claims 23 to 28, wherein the one or more first arms couple to the proximal end of the catheter adapter. [Configuration 30] 30. The catheter assembly of any one of claims 23 to 29, wherein the one or more first arms are coupled to the distal end of the catheter adapter. [Configuration 31] 31. The catheter assembly of any one of configurations 23-30, wherein the one or more first arms are coupled to the catheter adapted for multiple positions. [Configuration 32] 32. The catheter assembly of any one of Aspects 23-31, wherein the one or more first arms are formed of a flexible material. [Configuration 33] The catheter assembly of any one of configurations 23-32, wherein the one or more first arms are formed of an elastomeric material. [Configuration 34] 34. The catheter assembly of any one of configurations 23-33, wherein the one or more first arms are formed of a rigid material. [Configuration 35] The catheter assembly of any one of claims 22 to 34, wherein the catheter adapter includes one or more second arms integral with the pair of wings, the one or more arms configured to couple with the tourniquet. [Configuration 36] 1. A catheter assembly comprising: a catheter adapter including a proximal end, a distal end, and a lumen extending along a first longitudinal axis therebetween; a catheter extending distally from the distal end of the catheter adapter; an extension tube extending from the proximal end of the catheter adapter; a tourniquet configured to apply radially inward pressure to a patient's limb proximate the penetration site, the tourniquet configured to couple to the extension tube at one or more locations along a length of the extension tube. [Configuration 37] a dressing configured to cover at least a portion of the catheter adapter at a site of entry into the patient's vascular system; A proximal end; A distal end. first and second side surfaces disposed between the proximal end and the distal end, the first and second side surfaces defining the proximal end, the distal end, and a second longitudinal axis, the first and second side surfaces configured to cover at least a portion of the catheter adapter at a penetration site into a patient's vasculature; The top surface and a lower surface configured to contact the patient's skin; and 37. The catheter assembly of claim 36, further comprising: a wire configured to couple to the extension tube. [Configuration 38] 38. The catheter assembly of configuration 36 or 37, wherein the catheter adapter includes a pair of wings disposed about the lumen, the one or more wings configured to mate with the extension tube. [Configuration 39] The catheter assembly of any one of configurations 37 to 38, wherein the dressing is configured to couple with the extension tube. [Configuration 40] 40. The catheter assembly of any one of configurations 36-39, wherein the tourniquet, wings, and / or bandage are attached to the extension tube via a snap fit. [Configuration 41] 1. A method of collecting blood from a patient's vascular system, comprising: Attaching the catheter assembly according to any one of configurations 1 to 40 to a limb of the patient; applying radially inward compression to the limb with the tourniquet; and attempting to withdraw blood from said catheter. [Claim 42] If no blood can be collected from the catheter, applying a traction force to the catheter assembly; 42. The method of embodiment 41, further comprising attempting to withdraw blood from the catheter a second time. [Configuration 43] If no blood can be collected from the catheter during the second attempt, applying traction to the catheter assembly using the tourniquet; 43. The method of claim 42, further comprising attempting to withdraw blood from the catheter a third time.
Claims
1. 1. A catheter assembly comprising: a catheter adapter including a proximal end, a distal end, and a lumen extending along a first longitudinal axis therebetween; a catheter extending distally from the distal end of the catheter adapter; a dressing including a first end, a second end and first and second sides extending therebetween, the dressing defining a second longitudinal axis and configured to cover at least a portion of the catheter adapter at a penetration site into a patient's vascular system, the dressing further including an upper surface and a lower surface, the lower surface configured to contact the patient's skin; a tourniquet configured to apply radially inward pressure to the patient's limb proximate the penetration site, the tourniquet configured to couple with the bandage.
2. The catheter assembly of claim 1 , wherein the tourniquet comprises one or more arms configured to couple with the bandage.
3. The catheter assembly of claim 2 , wherein the one or more arms are configured to be coupled with the dressing at one or more locations along the arm.
4. The catheter assembly of any one of claims 1 to 3, wherein the dressing further comprises one or more pegs disposed on the upper surface.
5. The catheter assembly of claim 4 , wherein the one or more pegs are disposed along the second longitudinal axis of the dressing, the second longitudinal axis being parallel to the first longitudinal axis.
6. 6. A catheter assembly according to claim 4 or claim 5, wherein the one or more pegs comprise at least one peg disposed along the first side and at least one peg disposed along the second side.
7. A catheter assembly according to any one of claims 4 to 6, wherein the one or more arms are configured to releasably couple to the one or more pegs.
8. A catheter assembly according to any one of claims 4 to 7, wherein the one or more arms include a plurality of openings, the openings configured to releasably couple to the one or more pegs.
9. A catheter assembly according to any one of claims 2 to 8, wherein the one or more arms are connected to the tourniquet at multiple locations.
10. A catheter assembly according to any one of claims 2 to 9, wherein the one or more arms are associated with the dressing at a single location.
11. The catheter assembly of any one of claims 2 to 10, wherein the one or more arms include a tensioning assembly.
12. A catheter assembly according to any one of claims 2 to 11, wherein the one or more arms are coupled to the dressing adjacent the proximal end of the catheter adapter.
13. A catheter assembly according to any one of claims 2 to 12, wherein the one or more arms are coupled to the dressing adjacent the distal end of the catheter adapter.
14. A catheter assembly according to any one of claims 2 to 13, wherein the one or more arms are formed from a flexible material.
15. A catheter assembly according to any one of claims 2 to 14, wherein the one or more arms are formed from an elastomeric material.
16. A catheter assembly according to any one of claims 2 to 15, wherein the one or more arms are formed from a rigid material.
17. A catheter assembly according to any preceding claim, wherein the dressing includes an adhesive disposed on the underside.
18. The catheter assembly of any one of claims 1 to 17, further comprising a housing configured to cover at least a portion of the catheter adapter.
19. 19. A catheter assembly according to any one of claims 1 to 18, wherein the tourniquet includes a fastener configured to allow the tourniquet to be shortened and lengthened, thereby allowing different amounts of radially inward pressure to be applied to the patient's limb.
20. 20. The catheter assembly of claim 1, further comprising a second tourniquet configured to apply radially inward pressure to the patient's limb proximate the penetration site, the second tourniquet configured to couple with the bandage.
21. The catheter assembly of claim 20 , wherein the second tourniquet comprises one or more second arms configured to couple with the bandage.
22. 1. A catheter assembly comprising: a catheter adapter including a proximal end, a distal end, and a lumen extending along a first longitudinal axis therebetween; a catheter extending distally from the distal end of the catheter adapter; a tourniquet configured to apply radially inward pressure to a patient's limb proximate the penetration site, the tourniquet configured to mate with the catheter adapter.
23. The catheter assembly of claim 22, wherein the tourniquet comprises one or more first arms.
24. 24. A catheter assembly according to claim 22 or claim 23, wherein the catheter adapter comprises a pair of wings disposed about the lumen.
25. A catheter assembly according to any one of claims 22 to 24, wherein the catheter further comprises one or more pegs disposed on an upper surface thereof.
26. The catheter assembly of claim 25, wherein the one or more pegs are disposed on the pair of wings.
27. 27. A catheter assembly according to claim 25 or claim 26, wherein the one or more first arms are configured to releasably couple to the one or more pegs.
28. A catheter assembly according to any one of claims 25 to 27, wherein the one or more first arms include a plurality of openings, the openings configured to releasably couple to the one or more pegs.
29. A catheter assembly according to any one of claims 23 to 28, wherein the one or more first arms are coupled to the proximal end of the catheter adapter.
30. A catheter assembly according to any one of claims 23 to 29, wherein the one or more first arms are coupled to the distal end of the catheter adapter.
31. A catheter assembly according to any one of claims 23 to 30, wherein the one or more first arms are associated with the catheter adapted for multiple positions.
32. A catheter assembly according to any one of claims 23 to 31, wherein the one or more first arms are formed of a flexible material.
33. A catheter assembly according to any one of claims 23 to 32, wherein the one or more first arms are formed from an elastomeric material.
34. A catheter assembly according to any one of claims 23 to 33, wherein the one or more first arms are formed of a rigid material.
35. A catheter assembly according to any one of claims 22 to 34, wherein the catheter adapter includes one or more second arms integral with the pair of wings, the one or more arms configured to couple with the tourniquet.
36. 1. A catheter assembly comprising: a catheter adapter including a proximal end, a distal end, and a lumen extending along a first longitudinal axis therebetween; a catheter extending distally from the distal end of the catheter adapter; an extension tube extending from the proximal end of the catheter adapter; a tourniquet configured to apply radially inward pressure to a patient's limb proximate the penetration site, the tourniquet configured to couple to the extension tube at one or more locations along a length of the extension tube.
37. a dressing configured to cover at least a portion of the catheter adapter at a site of entry into the patient's vascular system; A proximal end; A distal end. first and second side surfaces disposed between the proximal end and the distal end, the first and second side surfaces defining the proximal end, the distal end and a second longitudinal axis, the first and second side surfaces configured to cover at least a portion of the catheter adapter at a penetration site into a patient's vasculature; The top surface and a lower surface configured to contact the patient's skin; and and a wire configured to couple to the extension tube.
38. 38. A catheter assembly according to claim 36 or claim 37, wherein the catheter adapter includes a pair of wings disposed about the lumen, the one or more wings configured to mate with the extension tube.
39. 39. A catheter assembly according to claim 37 or claim 38, wherein the dressing is configured to couple with the extension tube.
40. A catheter assembly according to any one of claims 36 to 39, wherein the tourniquet, the wings and / or the bandage are attached to the extension tube via a snap fit.
41. 1. A method of collecting blood from a patient's vascular system, comprising: Attaching the catheter assembly of any one of claims 1 to 40 to a limb of the patient; applying radially inward compression to the limb with the tourniquet; and attempting to withdraw blood from said catheter.
42. If no blood can be collected from the catheter, applying a traction force to the catheter assembly; 42. The method of claim 41, further comprising attempting to withdraw blood from the catheter a second time.
43. If no blood can be collected from the catheter during the second attempt, applying traction to the catheter assembly using the tourniquet; 43. The method of claim 42, further comprising attempting to withdraw blood from the catheter a third time.
Citation Information
Patent Citations
PCT/US2021/36859