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WO2025101702A1 - Blood draw device with kinking prevention of blood draw tube therein - Google Patents

Blood draw device with kinking prevention of blood draw tube therein Download PDF

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Publication number
WO2025101702A1
WO2025101702A1 PCT/US2024/054858 US2024054858W WO2025101702A1 WO 2025101702 A1 WO2025101702 A1 WO 2025101702A1 US 2024054858 W US2024054858 W US 2024054858W WO 2025101702 A1 WO2025101702 A1 WO 2025101702A1
Authority
WO
WIPO (PCT)
Prior art keywords
barrel
blood draw
barrels
distal end
nestable
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/054858
Other languages
French (fr)
Inventor
Michael Glen BEEMAN
Edwin JEYASEELAN A
Balaji Kannan
Mukilan BALAMURUGAN
Karthik Mr
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Becton Dickinson and Co filed Critical Becton Dickinson and Co
Publication of WO2025101702A1 publication Critical patent/WO2025101702A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150992Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; Blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings or valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes

Definitions

  • the present disclosure relates generally to blood draw devices for use with intravenous (IV) catheters and, more specifically, to blood draw devices that prevent kinking of a blood draw tube inserted into an indwelling IV catheter.
  • IV intravenous
  • VADs Vascular access devices
  • PIVCs peripheral intravenous catheters
  • PICCs peripherally inserted central catheters
  • CVCs central venous catheters
  • midline catheters The VAD may be indwelling for short term (days), moderate term (weeks), or long term (months to years).
  • Instrument delivery devices are often used with indwelling intravenous (IV) catheters to deliver an instrument into the IV catheter, with the instrument delivery device advancing the instrument beyond the tip of the indwelling catheter.
  • IV intravenous
  • the instrument delivery device can be in the form of a flexible blood draw tube or catheter, but the instrument may also be a guidewire, obturator, wire, electrical wiring, probe, or sensor(s), in other implementations.
  • the blood draw tube is advanced, it can encounter an obstruction, resulting in deflection of the tube.
  • obstructions include the friction of the seal within the delivery device, the torturous path within an integrated catheter, pinching of the catheter tubing as it dives into the skin, thrombus, fibrin, and valves.
  • the tube may kink.
  • the material and mechanical properties of the tube may be impacted, which can negatively impact performing of a blood draw.
  • kinking of the blood draw tube within the vein may cause irritation to the patient and/or require trials/attempts by a healthcare provider to insert the blood draw tube properly, which may again cause discomfort or inconvenience to the patient.
  • the housing or introducer thereof typically has a splithousing body with a large amount of internal space and an irregular (i.e. non- cylindrical/circular) inner surface.
  • the housing allows for a large amount of bending in the tube and the tube may potentially engage a feature of the irregular inner surface of the housing - which may lead to kinking and jamming of the blood draw tube.
  • the blood draw device includes a plurality of nestable barrels actuatable between an expanded state and a compressed state.
  • the plurality of nestable barrels includes an inner barrel defining an inner volume and having a proximal end and a distal end, with the inner barrel having a first diameter, an intermediate barrel defining an inner volume and having a proximal end and a distal end, the intermediate barrel having a second diameter greater than the first diameter, and an outer barrel defining an inner volume and having a proximal end and a distal end, the outer barrel having a third diameter greater than the first and second diameters.
  • the inner barrel is configured to advance distally into the intermediate barrel and the outer barrel to nest the inner barrel within the intermediate barrel and the outer barrel, and with both the intermediate barrel configured to nest within the outer barrel, so as to put the plurality of nestable barrels into the compressed state.
  • the blood draw device also includes a coupling device positioned at the distal end of the plurality of nestable barrels and configured to mate with an access connector of the catheter assembly and a blood draw tube positioned within the inner volumes of the plurality of nestable barrels, the blood draw tube having a proximal end and a distal end, with the proximal end joined to the proximal end of the inner barrel.
  • the inner barrel comprises a finger grip joined to the proximal end thereof via which a user can engage the blood draw device to actuate the plurality of nestable barrels from the expanded state to the compressed state.
  • the finger grip comprises a cylindrical member arranged concentrically with the inner barrel so as to be positioned about the proximal end of the inner barrel, with the finger grip having an open distal-facing end and a proximal-facing end that includes a small diameter opening.
  • the proximal end of the blood draw tube is secured within the small diameter opening of the finger grip.
  • the blood draw device further includes extension tubing that extends proximally from the inner barrel and the finger grip, the extension tubing having a distal end and a proximal end, with the distal end of the extension tubing secured to the inner barrel or the finger grip and in fluid communication with the blood draw tube, and with the proximal end of the extension tubing coupled to a connector, to allow for a medical device to be attached thereto.
  • the plurality of nestable barrels is arranged such that, when in the expanded state, the inner barrel is a proximal-most barrel, the intermediate barrel is a distal- most barrel, and the outer barrel is between the inner barrel and the intermediate barrel.
  • the inner barrel in transitioning from the expanded state to the compressed state, moves distally into the outer barrel until the finger grip abuts the proximal end of the outer barrel, and both the inner barrel and outer barrel subsequently move distally into the intermediate barrel.
  • a diameter of the finger grip is greater than the first diameter of the outer barrel, such that the outer barrel may be received within the open distal-facing end of the finger grip when the plurality of nestable barrels is actuated from the expanded state to the compressed state.
  • the proximal end of the intermediate barrel comprises an annular bump formed on an outer surface thereof and the distal end of the outer barrel comprises an annular ring formed on an inner surface thereof, the annular bump and the annular ring interacting to secure the intermediate barrel within the outer barrel and prevent disengagement therefrom.
  • the intermediate barrel includes a seal positioned at or adjacent the distal end thereof and that is configured to prevent a transfer of fluid between a catheter assembly and an inner volume of the intermediate barrel, with the blood draw tube passing through the seal.
  • the inner barrel includes a pair of extension legs at the distal end thereof, the pair of extension legs protruding outwardly from an outer profile of the inner barrel and configured to flex radially inward and outward, to enable assembly of the inner barrel with the outer barrel and lock the inner barrel within the outer barrel.
  • the plurality of nestable barrels is arranged such that, when in the expanded state, the inner barrel is a proximal-most barrel, the outer barrel is a distal-most barrel, and the intermediate barrel is between the inner barrel and the outer barrel.
  • the inner barrel in transitioning from the expanded state to the compressed state, moves distally into the intermediate barrel until the finger grip abuts the proximal end of the intermediate barrel, and both the inner barrel and intermediate barrel subsequently move distally into the outer barrel.
  • the outer barrel comprises an interior tubing positioned therein that defines a lumen, with the interior tubing joined to the distal end of the outer barrel and extending proximally therefrom into an inner volume of the outer barrel, and wherein the blood draw tube is positioned within the lumen and advances therethrough when the plurality of barrels is actuated from the expanded state to the compressed state.
  • the interior tubing has a fourth diameter that is less than the first diameter, such that when the plurality of barrels is actuated to the compressed position, the interior tubing is positioned within an inner volume of the inner barrel.
  • an inner diameter of the lumen of the interior tubing is less than an inner diameter of the inner barrel.
  • the outer barrel includes a seal positioned at or adjacent the distal end thereof and that is configured to prevent a transfer of fluid between a catheter assembly and an inner volume of the intermediate barrel, with the blood draw tube passing through the seal.
  • each of the inner barrel, the intermediate barrel, and the outer barrel comprises a cylindrical inner surface of the barrels that lowers resistance against the blood draw tube when moved from the first position to the second position.
  • the plurality of nestable barrels reduces or eliminates kinking of the blood draw tube as it moved from the first position to the second position.
  • a system that includes a catheter assembly having a catheter adapter and a catheter extending from a distal end of the catheter adapter and a blood draw device as previously described.
  • the blood draw device is connected to the catheter adapter via the coupling device, and wherein the blood draw device is operable to move the blood draw tube from the first position, in which the distal end of the blood draw tube is disposed within the plurality of nestable barrels or the coupling device, to the second position, in which the distal end of the blood draw tube is disposed beyond the distal end of the intermediate barrel and the coupling device, and into or through the catheter assembly.
  • the catheter assembly includes a connector coupled to the proximal end of the catheter adapter, so as to be positioned between the catheter adapter and the blood draw device, and an extension set integrated into or removably coupleable to the connector, the extension set including a fluid conduit comprising a luer connection at a proximal end thereof for connection to a fluid delivery device.
  • FIG. 1A is a perspective view of a system including a catheter assembly and an associated blood draw device useable therewith, with the blood draw device in an expanded state, according to a non-limiting embodiment described herein;
  • FIG. IB is a perspective view of the system of FIG. 1A in a compressed state
  • FIG. 2A is a cross-section view of a blood draw device included in the system of FIG. 1A, with the blood draw device in the expanded state, according to a non-limiting embodiment described herein;
  • FIG. 2B is a cross-section view of the blood draw device of FIG. 2A, with the blood draw device in the compressed state;
  • FIG. 3 is a cross-section view of a blood draw device included in the system of FIG. 1A, with the blood draw device in the expanded state, according to another non-limiting embodiment described herein;
  • FIG. 4A is a cross-section view of a blood draw device included in the system of FIG. 1A, with the blood draw device in the expanded state, according to another non-limiting embodiment described herein;
  • FIG. 4B is a cross-section view of the blood draw device of FIG. 4A, with the blood draw device between the expanded state and the compressed state;
  • FIG. 4C is a cross-section view of the blood draw device of FIG. 4A, with the blood draw device in the compressed state;
  • FIG. 5A is a perspective view of a system including a catheter assembly and an associated blood draw device useable therewith, with the blood draw device in an expanded state, according to another non-limiting embodiment described herein; and
  • FIG. 5B is a perspective view of the system of FIG. 5A in a compressed state.
  • proximal and distal refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient.
  • distal end the end of a device first touching the body of the patient
  • proximal end of the device the end of a device first touching the body of the patient
  • catheter assembly 10 may include a catheter adapter 12, which may include a distal end 14 and a proximal end 16.
  • the proximal end 16 includes a port 18 - with the catheter adapter 12 including a lumen 20 extending through the distal end 14 and the proximal end 16 and in fluid communication with the port 18.
  • the catheter assembly 10 may also include a catheter 22 extending from the distal end 14 of catheter adapter 12.
  • the catheter 22 may include a peripheral intravenous catheter, a midline catheter, or a peripherally-inserted central catheter.
  • Catheter 22 may be formed of any suitable material and may be of any useful length, as known to those of skill in the art.
  • a luer connector 32 may be provided at port 18.
  • blood draw device 110 may be reversibly coupleable to the luer connector 32.
  • blood draw device 110 includes a plurality of telescopic tubes or barrels 112, 114, 116 that may be selectively nested during use of the device 110. Via nesting of the telescopic barrels 112, 114, 116, the device 110 may be actuated from an expanded state to a compressed state, for purposes of advancing blood draw tubing into the catheter assembly 10, including into the catheter 22 and/or out past a distal tip of the catheter 22 to facilitate a blood draw from a patient.
  • the telescopic barrels 112, 114, 116 include an intermediate barrel 114, an outer barrel 116, and an inner barrel 112, as ordered from distal to proximal with the device 110 in its expanded state.
  • the outer barrel 116 has a proximal end 120 and a distal end 122
  • the intermediate barrel 114 has a proximal end 124 and a distal end 126
  • the inner barrel 112 has a proximal end 128 and a distal end 130.
  • each of the barrels 112, 114, 116 has a different diameter, so as to provide for nesting of the barrels, with the outer barrel 116 having a first diameter, the intermediate barrel 114 having a second diameter less than the first diameter, and the inner barrel 112 having a third diameter less than both the first diameter and the second diameter.
  • the inner barrel 112 is thus sized to fit within an inner volume of the intermediate barrel 114 and an inner volume of the outer barrel 116, while the intermediate barrel 114 is sized to also fit within the inner volume of the outer barrel 116.
  • the inner barrel 112 is configured as a telescopic cylinder of uniform diameter that defines an inner volume and that includes an opening at its distal end 130 and an opening at its proximal end 128.
  • a finger grip 132 is provided at the proximal end 128 of inner barrel 112 and may be integrally formed with the inner barrel 112 or affixed thereto.
  • the finger grip 132 may be configured as a cylindrical member arranged concentrically with the inner barrel 112, with the finger grip 132 positioned about the proximal end 128 of the inner barrel 112.
  • the finger grip 132 may have an open distal-facing end, with a diameter of the finger grip 132 being greater than the first diameter of outer barrel 116, such that the outer barrel 116 may be received within the finger grip 132 when the device 110 is actuated from its expanded state to its compressed state.
  • the proximal-facing end of the finger grip 132 includes a small diameter opening 134 aligned with the proximal opening of the inner barrel 112. The finger grip 132 provides a means by which a user can engage the device 110 and initiate use thereof to actuate the device 110 from the expanded state to the compressed state, as explained further below.
  • blood draw device 110 includes a blood draw tube 150 having a proximal end 152 and a distal end 154.
  • blood draw tube 150 may be formed of a polymer, such a polyimide-containing material, nylon, polyurethane, and other suitable polymeric material.
  • the blood draw tube 150 includes a base material and a low-friction coating applied on an outer surface of the base material, the low-friction coating having a lower coefficient of friction than the base material.
  • the proximal end 152 of blood draw tube 150 is secured to the finger grip 132 at the proximal end 128 of inner barrel 112.
  • the blood draw tube 150 is positioned within the small diameter opening of the finger grip 132 and is secured therein, such as by ultrasonic welding, adhesive, or another suitable bonding means.
  • the blood draw tube 150 extends distally from its attachment point to finger grip 132, with the blood draw tube 150 having a length such that it extends through inner barrel 112, through outer barrel 116 and to the distal end of intermediate barrel 114.
  • the intermediate barrel 114 is configured as a telescopic cylinder of uniform diameter that defines an inner volume and that includes an opening at its distal end 126 and an opening at its proximal end 124.
  • the proximal end 124 is configured to be positioned within outer barrel 116 and includes an annular ring or bump 156 that serves to secure the intermediate barrel 114 within outer barrel 116 and prevent disengagement therefrom.
  • the distal end 126 is configured to be coupled with a coupling device 158 that provides for engagement of the device to the catheter assembly.
  • coupling device 158 is exemplified as a male luer connection that mates with a female luer connection of connector 32, with the male luer connection of coupling device 158 having an elongated member 160 surrounded by a rotating collar 162.
  • the rotating collar 162 may be rotated to threadingly engage the male luer connection to the female luer connection of connector 32.
  • alternative embodiments of blood draw device 110 may include a coupling device 158 of another type to secure blood draw device 110 to catheter assembly 12, including luer connections, clips, blunt plastic cannulae, blunt metal cannulae, hybrid luers (e.g., with a cannula) friction fits, and the like.
  • intermediate barrel 114 may include a seal 164 that prevents unwanted fluid transfer between the catheter assembly 10 and the device 110, such as preventing blood or other fluids from leaking out of or entering the blood stream other than through the intended ports. That is, a fluid flow preventing seal 164 - such as a silicone septum - may be provided in or adjacent the coupling device 158 that is configured to prevent a transfer of fluid between the catheter assembly 10 and the inner volume of the intermediate barrel 114.
  • the outer barrel 116 is configured as a telescopic cylinder of generally uniform diameter that defines an inner volume and that includes an opening at its distal end 122 and an opening at its proximal end 120.
  • the distal end 122 is configured to be positioned about the proximal end 124 of intermediate barrel 114 and includes an annular ring or bump 166 that interacts with the annular bump 156 on the intermediate barrel 114 to prevent disengagement therefrom.
  • the proximal end 120 receives the distal end 130 of the inner barrel 112 therein.
  • the device 110 further includes extension tubing 168 that extends proximally from the inner barrel 112 and finger grip 132.
  • a distal end 170 of the extension tubing 168 is secured to the inner barrel 112 or finger grip 132, such as by ultrasonic welding, adhesive, or another suitable bonding means - with the extension tubing 168 joined such that it is placed in fluid communication with the blood draw tube 150.
  • a proximal end 172 of the extension tubing 168 is coupled to a connector 174, to allow for various medical devices to be attached thereto, with the connector 174 being a luer port according to one non-limiting example.
  • connector 174 allows for coupling of a fluid collection device (e.g., evacuated syringe) to receive fluid (i.e., blood) withdrawn from the vasculature.
  • a clamp 176 may be provided on the extension tubing 168 that is suitable for occluding fluid flow therethrough. Clamp 176 may be a slide clamp or a pinch clamp, according to embodiments.
  • the intermediate barrel 114, outer barrel 116, and inner barrel 112 are configured to provide for nesting of the barrels when the device 110 is transitioned from an expanded state to a compressed state.
  • the inner barrel 112 is slideably received within outer barrel 116, such that inner barrel 112 may be slideably received entirely, or almost entirely, within outer barrel 116
  • the intermediate barrel 114 is slideably received within outer barrel 116, such that intermediate barrel 114 may be slideably received entirely, or almost entirely, within outer barrel 116.
  • both the inner barrel 112 and the intermediate barrel 114 are positioned within outer barrel 116, the inner barrel 112 is also received within intermediate barrel 114.
  • Blood draw tube 150 is received within inner barrel 112 and may be advanced and/or retracted relative to intermediate barrel 114 and outer barrel 116 by displacement of the inner barrel 112 relative to the outer barrel 116 and displacement of both the inner barrel 112 and outer barrel 116 relative to intermediate barrel 114.
  • blood draw tube 150 may be advanced from a first positon as shown in FIGS. 1A and 2A, in which distal end 154 of blood draw tube 150 is within device 110, for example within intermediate barrel 114 and/or coupling device 158, to a second position as shown in FIGS. IB and 2B, in which a distal end 154 of blood draw tube 150 is positioned distally of coupling device 158 and, in embodiments in which device 110 is coupled to catheter assembly 10, optionally distally of catheter 22.
  • FIGS. 1A and 2A show device 110 in a first state, where blood draw tube 150 is in a first position, received within inner barrel 112, outer barrel 116, and intermediate barrel 114, and where inner barrel 112 is in a first position and outer barrel 116 is in a first position, with the inner barrel 112 extending proximally from outer barrel 116 and the outer barrel 116 extending proximally from intermediate barrel 114.
  • inner barrel 112 is coupled to or otherwise interacts with blood draw tube 150, such that as inner barrel 112 is advanced distally to a second position and outer barrel 116 is advanced distally to a second position, as shown in FIGS. IB and 2B, and blood draw tube 150 is moved to a second position, where a distal end 154 of blood draw tube 150 extends beyond intermediate barrel 114, coupling device 158, and/or catheter 22.
  • the inner barrel 112 may be advanced distally relative to the outer barrel 116 by way of a user grasping finger grip 132 and applying a distally-directed force thereto.
  • a distally-directed force to finger grip 132 advances both the inner barrel 112 and outer barrel 116 distally relative to the intermediate barrel 114 - until all three barrels 112, 114, 116 are nested together in the compressed position/state.
  • the blood draw tube 150 is caused to move to the second position, where the distal end 154 thereof extends beyond intermediate barrel 114, coupling device 158, and/or catheter 22.
  • the construction and arrangement of intermediate barrel 114, outer barrel 116, and inner barrel 112 provides for advancement of the blood draw tube 150 into the catheter while minimizing potential for kinking thereof during advancement.
  • the circular/cylindrical design profile of the inner surface of the barrels 112, 114, 116 offer less resistance to the blood draw tube 150, so as to enable small kinks in the blood draw tube 150 to be resolved/cleared and provide for pushing of the blood draw tube 150 into the catheter 22.
  • the inner surface of the barrels 112, 114, 116 provides a reduced diameter (i.e., inner diameter) as compared to existing instrument delivery devices, such that there is very limited play-around space (e.g., 0.25x of current play around space) in between the blood draw tube 150 and the internal surface of the barrels 112, 114, 116, thereby reducing kinking in the blood draw tube 150. Due to the reduced play-around space, the kink bent radius of blood draw tube 150 is lesser than the kink bent radius experienced in existing blood draw devices, thus minimizing the jamming of the blood draw tube 150.
  • play-around space e.g. 0.25x of current play around space
  • the distal end 130 of inner barrel 112 may further include thereon two extension legs 178 that protrude outwardly from the generally cylindrical outer profile of the inner barrel 112.
  • This extension leg 178 are configured to flex radially inward and outward, thereby helping to assemble the inner barrel 112 and outer barrel 116 (flexing inward during assembly) and lock the inner barrel 112 within the outer barrel 116 (flexing outward after assembly) - with the legs 178 locking at the end of outer barrel 116.
  • FIGS. 4A-4C an alternate embodiment of a blood draw device 180 is provided that is operable to introduce a blood draw tube 150 into an indwelling catheter. Similar to the embodiments of FIGS. 1A, IB, 2A, and 2B, the device 180 includes a plurality of telescopic barrels 112, 114, 116 that may be selectively nested during use of the device 180. However, in device 180, the barrels 112, 114, 116 are arranged with the outer barrel 116, intermediate barrel 114, and inner barrel 112 ordered from distal to proximal with the device 180 in its expanded state.
  • the inner barrel 112 may be advanced distally relative to the intermediate barrel 114 by way of a user grasping finger grip 132 and applying a distally-directed force thereto inner barrel 112.
  • a distally-directed force to finger grip 132 advances both the inner barrel 112 and intermediate barrel 114 distally relative to the outer barrel 116 - until all three barrels 112, 114, 116 are nested together in the compressed position/state.
  • the blood draw tube 150 is caused to move to the second position, where a distal end 154 thereof extends beyond intermediate barrel 114, coupling device 158, and/or catheter 22.
  • the outer barrel 116 has an interior tubing 182 formed integrally therein having a (fourth) diameter that is less than the first diameter of the inner barrel 112 such that - when device 180 is actuated fully to its compressed position, the interior tubing 182 is positioned within the inner volume of the inner barrel 112.
  • the interior tubing 182 may extend proximally from a distal end 122 of the outer barrel 116 and has a lumen formed therein through which the blood draw tube 150 is advanced.
  • the interior tubing 182 provides a reduced diameter through which the blood draw tube 150 is advanced - with the lumen providing an even smaller diameter than the device 110 of FIGS. 1A, IB, 2A, and 2B.
  • catheter assembly 10 may further include a connector 184 coupled to catheter adapter, along with an extension set 186 (integrated into or removably coupleable to connector 184, for example) including a fluid conduit 188.
  • Extension sets 186 are known to those of skill in the art and are commercially available from, for example, Becton, Dickinson and Company.
  • second fluid conduit 188 may include a luer connection 190 at an end thereof. The extension set 186 may enable a clinician to deliver medication to the patient when blood draw device 110 is not in use and prevent the clinician from having to disconnect the blood draw device 110 for medication delivery.
  • embodiments of the disclosure thus provide a blood draw device useable with an indwelling IV catheter that prevents kinking of a blood draw tube as it is inserted into the IV catheter.
  • the blood draw device(s) of the present disclosure reduces the play space for the blood draw tube within the inner volume thereof (i.e., the inner volume of the nestable barrels), such as by having an inner space of 0.25x that of existing blood draw devices.
  • the reduced play space minimizes the bend radius of any kinks that might form in the blood draw tube during advancement thereof, thereby reducing the risk of the blood draw tube jamming within the device.
  • the cylindrical/circular inner surface of the blood draw device i.e., of the nestable barrels

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Abstract

A blood draw device for use with a catheter assembly is provided that includes a plurality of nestable barrels actuatable between an expanded state and a compressed state and a coupling device the mates the nestable barrels to the catheter assembly. The nestable barrels includes an inner barrel, intermediate barrel, and outer barrel. The inner barrel is configured to advance distally into the intermediate barrel and the outer barrel to nest the inner barrel therein, while both the intermediate barrel and inner barrel are configured to nest within the outer barrel, so as to put the plurality of nestable barrels into the compressed state. A blood draw tube is positioned within the nestable barrels and is movable from a first position where its distal end is disposed within the nestable barrels to a second position where its distal end is advanced into or through the catheter assembly.

Description

BLOOD DRAW DEVICE WITH KINKING PREVENTION OF BLOOD DRAW
TUBE THEREIN
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application claims priority to United States Provisional Application No. 63/596,985 entitled “Blood Draw Device with Kinking Prevention of Blood Draw Tube Therein” filed November 8, 2023, the disclosure of which is hereby incorporated by reference in its entirety.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The present disclosure relates generally to blood draw devices for use with intravenous (IV) catheters and, more specifically, to blood draw devices that prevent kinking of a blood draw tube inserted into an indwelling IV catheter.
Description of Related Art
[0003] Vascular access devices (VADs) are used in the medical field to access peripheral vasculature of a patient for purposes of infusion therapy and/or blood withdrawal. Common types of VADs include over-the-needle peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. The VAD may be indwelling for short term (days), moderate term (weeks), or long term (months to years).
[0004] Instrument delivery devices are often used with indwelling intravenous (IV) catheters to deliver an instrument into the IV catheter, with the instrument delivery device advancing the instrument beyond the tip of the indwelling catheter. When the instrument delivery device is used to collect blood, as one example, the instrument can be in the form of a flexible blood draw tube or catheter, but the instrument may also be a guidewire, obturator, wire, electrical wiring, probe, or sensor(s), in other implementations. Often, when the blood draw tube is advanced, it can encounter an obstruction, resulting in deflection of the tube. Examples of obstructions include the friction of the seal within the delivery device, the torturous path within an integrated catheter, pinching of the catheter tubing as it dives into the skin, thrombus, fibrin, and valves. In some instances, if deflection or bending of the blood draw tube is excessively high, the tube may kink. When the blood draw tube experiences kinking, the material and mechanical properties of the tube may be impacted, which can negatively impact performing of a blood draw. Additionally, kinking of the blood draw tube within the vein may cause irritation to the patient and/or require trials/attempts by a healthcare provider to insert the blood draw tube properly, which may again cause discomfort or inconvenience to the patient.
[0005] In existing blood draw devices, the housing or introducer thereof typically has a splithousing body with a large amount of internal space and an irregular (i.e. non- cylindrical/circular) inner surface. Thus, when an obstruction is encountered and the blood draw tube begins to bend, the housing allows for a large amount of bending in the tube and the tube may potentially engage a feature of the irregular inner surface of the housing - which may lead to kinking and jamming of the blood draw tube.
[0006] Accordingly, it is desired to provide a blood draw device useable with an indwelling IV catheter that prevents kinking of a blood draw tube inserted into the IV catheter.
SUMMARY OF THE INVENTION
[0007] Provided herein is a blood draw device for use with a catheter assembly. The blood draw device includes a plurality of nestable barrels actuatable between an expanded state and a compressed state. The plurality of nestable barrels includes an inner barrel defining an inner volume and having a proximal end and a distal end, with the inner barrel having a first diameter, an intermediate barrel defining an inner volume and having a proximal end and a distal end, the intermediate barrel having a second diameter greater than the first diameter, and an outer barrel defining an inner volume and having a proximal end and a distal end, the outer barrel having a third diameter greater than the first and second diameters. The inner barrel is configured to advance distally into the intermediate barrel and the outer barrel to nest the inner barrel within the intermediate barrel and the outer barrel, and with both the intermediate barrel configured to nest within the outer barrel, so as to put the plurality of nestable barrels into the compressed state. The blood draw device also includes a coupling device positioned at the distal end of the plurality of nestable barrels and configured to mate with an access connector of the catheter assembly and a blood draw tube positioned within the inner volumes of the plurality of nestable barrels, the blood draw tube having a proximal end and a distal end, with the proximal end joined to the proximal end of the inner barrel. Nesting of the plurality of nestable barrels into the compressed state moves the blood draw tube from a first position, in which a distal end of the blood draw tube is disposed within the plurality of nestable barrels or the coupling device, to a second position, in which the distal end of the blood draw tube is disposed beyond a distal end of the plurality of nestable barrels and the coupling device, and into or through the catheter assembly. [0008] In some embodiments, the inner barrel comprises a finger grip joined to the proximal end thereof via which a user can engage the blood draw device to actuate the plurality of nestable barrels from the expanded state to the compressed state.
[0009] In some embodiments, the finger grip comprises a cylindrical member arranged concentrically with the inner barrel so as to be positioned about the proximal end of the inner barrel, with the finger grip having an open distal-facing end and a proximal-facing end that includes a small diameter opening.
[0010] In some embodiments, the proximal end of the blood draw tube is secured within the small diameter opening of the finger grip.
[0011] In some embodiments, the blood draw device further includes extension tubing that extends proximally from the inner barrel and the finger grip, the extension tubing having a distal end and a proximal end, with the distal end of the extension tubing secured to the inner barrel or the finger grip and in fluid communication with the blood draw tube, and with the proximal end of the extension tubing coupled to a connector, to allow for a medical device to be attached thereto.
[0012] In some embodiments, the plurality of nestable barrels is arranged such that, when in the expanded state, the inner barrel is a proximal-most barrel, the intermediate barrel is a distal- most barrel, and the outer barrel is between the inner barrel and the intermediate barrel.
[0013] In some embodiments, in transitioning from the expanded state to the compressed state, the inner barrel moves distally into the outer barrel until the finger grip abuts the proximal end of the outer barrel, and both the inner barrel and outer barrel subsequently move distally into the intermediate barrel.
[0014] In some embodiments, a diameter of the finger grip is greater than the first diameter of the outer barrel, such that the outer barrel may be received within the open distal-facing end of the finger grip when the plurality of nestable barrels is actuated from the expanded state to the compressed state.
[0015] In some embodiments, the proximal end of the intermediate barrel comprises an annular bump formed on an outer surface thereof and the distal end of the outer barrel comprises an annular ring formed on an inner surface thereof, the annular bump and the annular ring interacting to secure the intermediate barrel within the outer barrel and prevent disengagement therefrom.
[0016] In some embodiments, the intermediate barrel includes a seal positioned at or adjacent the distal end thereof and that is configured to prevent a transfer of fluid between a catheter assembly and an inner volume of the intermediate barrel, with the blood draw tube passing through the seal.
[0017] In some embodiments, the inner barrel includes a pair of extension legs at the distal end thereof, the pair of extension legs protruding outwardly from an outer profile of the inner barrel and configured to flex radially inward and outward, to enable assembly of the inner barrel with the outer barrel and lock the inner barrel within the outer barrel.
[0018] In some embodiments, the plurality of nestable barrels is arranged such that, when in the expanded state, the inner barrel is a proximal-most barrel, the outer barrel is a distal-most barrel, and the intermediate barrel is between the inner barrel and the outer barrel.
[0019] In some embodiments, in transitioning from the expanded state to the compressed state, the inner barrel moves distally into the intermediate barrel until the finger grip abuts the proximal end of the intermediate barrel, and both the inner barrel and intermediate barrel subsequently move distally into the outer barrel.
[0020] In some embodiments, the outer barrel comprises an interior tubing positioned therein that defines a lumen, with the interior tubing joined to the distal end of the outer barrel and extending proximally therefrom into an inner volume of the outer barrel, and wherein the blood draw tube is positioned within the lumen and advances therethrough when the plurality of barrels is actuated from the expanded state to the compressed state.
[0021] In some embodiments, the interior tubing has a fourth diameter that is less than the first diameter, such that when the plurality of barrels is actuated to the compressed position, the interior tubing is positioned within an inner volume of the inner barrel.
[0022] In some embodiments, an inner diameter of the lumen of the interior tubing is less than an inner diameter of the inner barrel.
[0023] In some embodiments, the outer barrel includes a seal positioned at or adjacent the distal end thereof and that is configured to prevent a transfer of fluid between a catheter assembly and an inner volume of the intermediate barrel, with the blood draw tube passing through the seal.
[0024] In some embodiments, each of the inner barrel, the intermediate barrel, and the outer barrel comprises a cylindrical inner surface of the barrels that lowers resistance against the blood draw tube when moved from the first position to the second position.
[0025] In some embodiments, the plurality of nestable barrels reduces or eliminates kinking of the blood draw tube as it moved from the first position to the second position.
[0026] Also provided herein is a system that includes a catheter assembly having a catheter adapter and a catheter extending from a distal end of the catheter adapter and a blood draw device as previously described. The blood draw device is connected to the catheter adapter via the coupling device, and wherein the blood draw device is operable to move the blood draw tube from the first position, in which the distal end of the blood draw tube is disposed within the plurality of nestable barrels or the coupling device, to the second position, in which the distal end of the blood draw tube is disposed beyond the distal end of the intermediate barrel and the coupling device, and into or through the catheter assembly.
[0027] In some embodiments, the catheter assembly includes a connector coupled to the proximal end of the catheter adapter, so as to be positioned between the catheter adapter and the blood draw device, and an extension set integrated into or removably coupleable to the connector, the extension set including a fluid conduit comprising a luer connection at a proximal end thereof for connection to a fluid delivery device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] FIG. 1A is a perspective view of a system including a catheter assembly and an associated blood draw device useable therewith, with the blood draw device in an expanded state, according to a non-limiting embodiment described herein;
[0029] FIG. IB is a perspective view of the system of FIG. 1A in a compressed state;
[0030] FIG. 2A is a cross-section view of a blood draw device included in the system of FIG. 1A, with the blood draw device in the expanded state, according to a non-limiting embodiment described herein;
[0031] FIG. 2B is a cross-section view of the blood draw device of FIG. 2A, with the blood draw device in the compressed state;
[0032] FIG. 3 is a cross-section view of a blood draw device included in the system of FIG. 1A, with the blood draw device in the expanded state, according to another non-limiting embodiment described herein;
[0033] FIG. 4A is a cross-section view of a blood draw device included in the system of FIG. 1A, with the blood draw device in the expanded state, according to another non-limiting embodiment described herein;
[0034] FIG. 4B is a cross-section view of the blood draw device of FIG. 4A, with the blood draw device between the expanded state and the compressed state;
[0035] FIG. 4C is a cross-section view of the blood draw device of FIG. 4A, with the blood draw device in the compressed state; [0036] FIG. 5A is a perspective view of a system including a catheter assembly and an associated blood draw device useable therewith, with the blood draw device in an expanded state, according to another non-limiting embodiment described herein; and
[0037] FIG. 5B is a perspective view of the system of FIG. 5A in a compressed state.
DESCRIPTION OF THE INVENTION
[0038] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, equivalents, variations, and alternatives are intended to fall within the spirit and scope of the present invention.
[0039] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting. [0040] As used in this specification, the words “proximal” and “distal” refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. Thus, for example, the end of a device first touching the body of the patient would be the distal end, while the opposite end of the device being manipulated by the user would be the proximal end of the device.
[0041] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.
[0042] Referring now to FIGS. 1A and IB, shown is a non-limiting embodiment of a system 8 including a catheter assembly 10 and a blood draw device 110 attachable thereto. Suitable catheter assemblies for use with blood draw devices described herein are commercially available, for example from Becton, Dickinson and Company under the trade name Nexiva. Catheter assembly 10 may include a catheter adapter 12, which may include a distal end 14 and a proximal end 16. In some embodiments, the proximal end 16 includes a port 18 - with the catheter adapter 12 including a lumen 20 extending through the distal end 14 and the proximal end 16 and in fluid communication with the port 18. [0043] The catheter assembly 10 may also include a catheter 22 extending from the distal end 14 of catheter adapter 12. The catheter 22 may include a peripheral intravenous catheter, a midline catheter, or a peripherally-inserted central catheter. Catheter 22 may be formed of any suitable material and may be of any useful length, as known to those of skill in the art. In some non-limiting embodiments or aspects, a luer connector 32 may be provided at port 18. As will be described below, blood draw device 110 may be reversibly coupleable to the luer connector 32.
[0044] With continuing reference to FIGS. 1A and IB and now also to FIGS. 2 A and 2B, blood draw device 110 includes a plurality of telescopic tubes or barrels 112, 114, 116 that may be selectively nested during use of the device 110. Via nesting of the telescopic barrels 112, 114, 116, the device 110 may be actuated from an expanded state to a compressed state, for purposes of advancing blood draw tubing into the catheter assembly 10, including into the catheter 22 and/or out past a distal tip of the catheter 22 to facilitate a blood draw from a patient. [0045] In accordance with aspects of the disclosure, the telescopic barrels 112, 114, 116 include an intermediate barrel 114, an outer barrel 116, and an inner barrel 112, as ordered from distal to proximal with the device 110 in its expanded state. The outer barrel 116 has a proximal end 120 and a distal end 122, the intermediate barrel 114 has a proximal end 124 and a distal end 126, and the inner barrel 112 has a proximal end 128 and a distal end 130. According to embodiments, each of the barrels 112, 114, 116 has a different diameter, so as to provide for nesting of the barrels, with the outer barrel 116 having a first diameter, the intermediate barrel 114 having a second diameter less than the first diameter, and the inner barrel 112 having a third diameter less than both the first diameter and the second diameter. The inner barrel 112 is thus sized to fit within an inner volume of the intermediate barrel 114 and an inner volume of the outer barrel 116, while the intermediate barrel 114 is sized to also fit within the inner volume of the outer barrel 116.
[0046] The inner barrel 112 is configured as a telescopic cylinder of uniform diameter that defines an inner volume and that includes an opening at its distal end 130 and an opening at its proximal end 128. A finger grip 132 is provided at the proximal end 128 of inner barrel 112 and may be integrally formed with the inner barrel 112 or affixed thereto. In some embodiments, the finger grip 132 may be configured as a cylindrical member arranged concentrically with the inner barrel 112, with the finger grip 132 positioned about the proximal end 128 of the inner barrel 112. The finger grip 132 may have an open distal-facing end, with a diameter of the finger grip 132 being greater than the first diameter of outer barrel 116, such that the outer barrel 116 may be received within the finger grip 132 when the device 110 is actuated from its expanded state to its compressed state. The proximal-facing end of the finger grip 132 includes a small diameter opening 134 aligned with the proximal opening of the inner barrel 112. The finger grip 132 provides a means by which a user can engage the device 110 and initiate use thereof to actuate the device 110 from the expanded state to the compressed state, as explained further below.
[0047] As indicated above, blood draw device 110 includes a blood draw tube 150 having a proximal end 152 and a distal end 154. In non-limiting embodiments, blood draw tube 150 may be formed of a polymer, such a polyimide-containing material, nylon, polyurethane, and other suitable polymeric material. In other embodiments, the blood draw tube 150 includes a base material and a low-friction coating applied on an outer surface of the base material, the low-friction coating having a lower coefficient of friction than the base material.
[0048] As shown best in FIGS. 2A and 2B, the proximal end 152 of blood draw tube 150 is secured to the finger grip 132 at the proximal end 128 of inner barrel 112. Specifically, the blood draw tube 150 is positioned within the small diameter opening of the finger grip 132 and is secured therein, such as by ultrasonic welding, adhesive, or another suitable bonding means. The blood draw tube 150 extends distally from its attachment point to finger grip 132, with the blood draw tube 150 having a length such that it extends through inner barrel 112, through outer barrel 116 and to the distal end of intermediate barrel 114.
[0049] The intermediate barrel 114 is configured as a telescopic cylinder of uniform diameter that defines an inner volume and that includes an opening at its distal end 126 and an opening at its proximal end 124. The proximal end 124 is configured to be positioned within outer barrel 116 and includes an annular ring or bump 156 that serves to secure the intermediate barrel 114 within outer barrel 116 and prevent disengagement therefrom. The distal end 126 is configured to be coupled with a coupling device 158 that provides for engagement of the device to the catheter assembly. In the illustrated embodiment, coupling device 158 is exemplified as a male luer connection that mates with a female luer connection of connector 32, with the male luer connection of coupling device 158 having an elongated member 160 surrounded by a rotating collar 162. The rotating collar 162 may be rotated to threadingly engage the male luer connection to the female luer connection of connector 32. However, it is appreciated that alternative embodiments of blood draw device 110 may include a coupling device 158 of another type to secure blood draw device 110 to catheter assembly 12, including luer connections, clips, blunt plastic cannulae, blunt metal cannulae, hybrid luers (e.g., with a cannula) friction fits, and the like. [0050] According to some embodiments, intermediate barrel 114 may include a seal 164 that prevents unwanted fluid transfer between the catheter assembly 10 and the device 110, such as preventing blood or other fluids from leaking out of or entering the blood stream other than through the intended ports. That is, a fluid flow preventing seal 164 - such as a silicone septum - may be provided in or adjacent the coupling device 158 that is configured to prevent a transfer of fluid between the catheter assembly 10 and the inner volume of the intermediate barrel 114. [0051] The outer barrel 116 is configured as a telescopic cylinder of generally uniform diameter that defines an inner volume and that includes an opening at its distal end 122 and an opening at its proximal end 120. The distal end 122 is configured to be positioned about the proximal end 124 of intermediate barrel 114 and includes an annular ring or bump 166 that interacts with the annular bump 156 on the intermediate barrel 114 to prevent disengagement therefrom. The proximal end 120 receives the distal end 130 of the inner barrel 112 therein.
[0052] According to embodiments of the disclosure, the device 110 further includes extension tubing 168 that extends proximally from the inner barrel 112 and finger grip 132. A distal end 170 of the extension tubing 168 is secured to the inner barrel 112 or finger grip 132, such as by ultrasonic welding, adhesive, or another suitable bonding means - with the extension tubing 168 joined such that it is placed in fluid communication with the blood draw tube 150. A proximal end 172 of the extension tubing 168 is coupled to a connector 174, to allow for various medical devices to be attached thereto, with the connector 174 being a luer port according to one non-limiting example. In some embodiments, connector 174 allows for coupling of a fluid collection device (e.g., evacuated syringe) to receive fluid (i.e., blood) withdrawn from the vasculature. In some embodiments, a clamp 176 may be provided on the extension tubing 168 that is suitable for occluding fluid flow therethrough. Clamp 176 may be a slide clamp or a pinch clamp, according to embodiments.
[0053] As indicated above, the intermediate barrel 114, outer barrel 116, and inner barrel 112 are configured to provide for nesting of the barrels when the device 110 is transitioned from an expanded state to a compressed state. In particular, the inner barrel 112 is slideably received within outer barrel 116, such that inner barrel 112 may be slideably received entirely, or almost entirely, within outer barrel 116, and the intermediate barrel 114 is slideably received within outer barrel 116, such that intermediate barrel 114 may be slideably received entirely, or almost entirely, within outer barrel 116. When both the inner barrel 112 and the intermediate barrel 114 are positioned within outer barrel 116, the inner barrel 112 is also received within intermediate barrel 114. [0054] Blood draw tube 150 is received within inner barrel 112 and may be advanced and/or retracted relative to intermediate barrel 114 and outer barrel 116 by displacement of the inner barrel 112 relative to the outer barrel 116 and displacement of both the inner barrel 112 and outer barrel 116 relative to intermediate barrel 114. In non-limiting embodiments, blood draw tube 150 may be advanced from a first positon as shown in FIGS. 1A and 2A, in which distal end 154 of blood draw tube 150 is within device 110, for example within intermediate barrel 114 and/or coupling device 158, to a second position as shown in FIGS. IB and 2B, in which a distal end 154 of blood draw tube 150 is positioned distally of coupling device 158 and, in embodiments in which device 110 is coupled to catheter assembly 10, optionally distally of catheter 22.
[0055] As can be appreciated, FIGS. 1A and 2A show device 110 in a first state, where blood draw tube 150 is in a first position, received within inner barrel 112, outer barrel 116, and intermediate barrel 114, and where inner barrel 112 is in a first position and outer barrel 116 is in a first position, with the inner barrel 112 extending proximally from outer barrel 116 and the outer barrel 116 extending proximally from intermediate barrel 114. In non-limiting embodiments, inner barrel 112 is coupled to or otherwise interacts with blood draw tube 150, such that as inner barrel 112 is advanced distally to a second position and outer barrel 116 is advanced distally to a second position, as shown in FIGS. IB and 2B, and blood draw tube 150 is moved to a second position, where a distal end 154 of blood draw tube 150 extends beyond intermediate barrel 114, coupling device 158, and/or catheter 22.
[0056] In non-limiting embodiments, the inner barrel 112 may be advanced distally relative to the outer barrel 116 by way of a user grasping finger grip 132 and applying a distally-directed force thereto. Upon the inner barrel 112 advancing into outer barrel 116 and finger grip 132 coming into contact with the proximal end 128 of outer barrel 116, further application of a distally-directed force to finger grip 132 advances both the inner barrel 112 and outer barrel 116 distally relative to the intermediate barrel 114 - until all three barrels 112, 114, 116 are nested together in the compressed position/state. With the barrels 112, 114, 116 in the compressed position, the blood draw tube 150 is caused to move to the second position, where the distal end 154 thereof extends beyond intermediate barrel 114, coupling device 158, and/or catheter 22.
[0057] According to aspects of the disclosure, the construction and arrangement of intermediate barrel 114, outer barrel 116, and inner barrel 112 provides for advancement of the blood draw tube 150 into the catheter while minimizing potential for kinking thereof during advancement. First, the circular/cylindrical design profile of the inner surface of the barrels 112, 114, 116 offer less resistance to the blood draw tube 150, so as to enable small kinks in the blood draw tube 150 to be resolved/cleared and provide for pushing of the blood draw tube 150 into the catheter 22. Second, the inner surface of the barrels 112, 114, 116 provides a reduced diameter (i.e., inner diameter) as compared to existing instrument delivery devices, such that there is very limited play-around space (e.g., 0.25x of current play around space) in between the blood draw tube 150 and the internal surface of the barrels 112, 114, 116, thereby reducing kinking in the blood draw tube 150. Due to the reduced play-around space, the kink bent radius of blood draw tube 150 is lesser than the kink bent radius experienced in existing blood draw devices, thus minimizing the jamming of the blood draw tube 150.
[0058] Referring now to FIG. 3, in one embodiment of device 110, the distal end 130 of inner barrel 112 may further include thereon two extension legs 178 that protrude outwardly from the generally cylindrical outer profile of the inner barrel 112. This extension leg 178 are configured to flex radially inward and outward, thereby helping to assemble the inner barrel 112 and outer barrel 116 (flexing inward during assembly) and lock the inner barrel 112 within the outer barrel 116 (flexing outward after assembly) - with the legs 178 locking at the end of outer barrel 116.
[0059] Referring now to FIGS. 4A-4C, an alternate embodiment of a blood draw device 180 is provided that is operable to introduce a blood draw tube 150 into an indwelling catheter. Similar to the embodiments of FIGS. 1A, IB, 2A, and 2B, the device 180 includes a plurality of telescopic barrels 112, 114, 116 that may be selectively nested during use of the device 180. However, in device 180, the barrels 112, 114, 116 are arranged with the outer barrel 116, intermediate barrel 114, and inner barrel 112 ordered from distal to proximal with the device 180 in its expanded state. With this arrangement, the inner barrel 112 may be advanced distally relative to the intermediate barrel 114 by way of a user grasping finger grip 132 and applying a distally-directed force thereto inner barrel 112. Upon the inner barrel 112 advancing into intermediate barrel 114 and finger grip 132 coming into contact with the proximal end 124 of intermediate barrel 114, further application of a distally-directed force to finger grip 132 advances both the inner barrel 112 and intermediate barrel 114 distally relative to the outer barrel 116 - until all three barrels 112, 114, 116 are nested together in the compressed position/state. With the barrels 112, 114, 116 in the compressed position, the blood draw tube 150 is caused to move to the second position, where a distal end 154 thereof extends beyond intermediate barrel 114, coupling device 158, and/or catheter 22.
[0060] According to an aspect of the design, the outer barrel 116 has an interior tubing 182 formed integrally therein having a (fourth) diameter that is less than the first diameter of the inner barrel 112 such that - when device 180 is actuated fully to its compressed position, the interior tubing 182 is positioned within the inner volume of the inner barrel 112. The interior tubing 182 may extend proximally from a distal end 122 of the outer barrel 116 and has a lumen formed therein through which the blood draw tube 150 is advanced. Beneficially, the interior tubing 182 provides a reduced diameter through which the blood draw tube 150 is advanced - with the lumen providing an even smaller diameter than the device 110 of FIGS. 1A, IB, 2A, and 2B. Accordingly, there is very limited play-around space (e.g., 0.25x of current play around space) in between the blood draw tube 150 and the internal surface of the inner and intermediate barrels 112, 114 and in between the blood draw tube 150 and the interior tubing 182 of outer housing 116, thereby reducing kinking in the blood draw tube 150. Due to the less play-around space, the kink bent radius of blood draw tube 150 is lesser than the kink bent radius experienced in existing blood draw devices, thus minimize the jamming of the blood draw tube 150.
[0061] For each of the embodiments of FIGS. 1-4 described above, it is recognized that modifications could be made to the catheter assembly 10 to provide additional functionality thereto. In some non-limiting embodiments or aspects, and as shown in FIGS. 5A and 5B, catheter assembly 10 may further include a connector 184 coupled to catheter adapter, along with an extension set 186 (integrated into or removably coupleable to connector 184, for example) including a fluid conduit 188. Extension sets 186 are known to those of skill in the art and are commercially available from, for example, Becton, Dickinson and Company. In some non-limiting embodiments or aspects, second fluid conduit 188 may include a luer connection 190 at an end thereof. The extension set 186 may enable a clinician to deliver medication to the patient when blood draw device 110 is not in use and prevent the clinician from having to disconnect the blood draw device 110 for medication delivery.
[0062] Beneficially, embodiments of the disclosure thus provide a blood draw device useable with an indwelling IV catheter that prevents kinking of a blood draw tube as it is inserted into the IV catheter. As compared to existing blood draw devices, the blood draw device(s) of the present disclosure reduces the play space for the blood draw tube within the inner volume thereof (i.e., the inner volume of the nestable barrels), such as by having an inner space of 0.25x that of existing blood draw devices. The reduced play space minimizes the bend radius of any kinks that might form in the blood draw tube during advancement thereof, thereby reducing the risk of the blood draw tube jamming within the device. Additionally, the cylindrical/circular inner surface of the blood draw device (i.e., of the nestable barrels) offers less resistance to the blood draw tube and allows for small kinks to be cleared out during advancement of the blood draw tube into the catheter.
[0063] Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose 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 that are 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 may be combined with one or more features of any other embodiment.

Claims

THE INVENTION CLAIMED IS
1. A blood draw device for use with a catheter assembly, the blood draw comprising: a plurality of nestable barrels actuatable between an expanded state and a compressed state, the plurality of nestable barrels comprising: an inner barrel defining an inner volume and having a proximal end and a distal end, the inner barrel having a first diameter; an intermediate barrel having a proximal end and a distal end, the intermediate barrel defining an inner volume and having a second diameter greater than the first diameter; and an outer barrel having a proximal end and a distal end, the outer barrel defining an inner volume and having a third diameter greater than the first and second diameters; wherein the inner barrel is configured to advance distally into the intermediate barrel and the outer barrel to nest the inner barrel within the intermediate barrel and the outer barrel, and with both the intermediate barrel and the inner barrel configured to nest within the outer barrel, so as to put the plurality of nestable barrels into the compressed state; a coupling device positioned at the distal end of the plurality of nestable barrels and configured to mate with an access connector of the catheter assembly; and a blood draw tube positioned within the inner volumes of the plurality of nestable barrels, the blood draw tube having a proximal end and a distal end, with the proximal end joined to the proximal end of the inner barrel; wherein nesting of the plurality of nestable barrels into the compressed state moves the blood draw tube from a first position, in which a distal end of the blood draw tube is disposed within the plurality of nestable barrels or the coupling device, to a second position, in which the distal end of the blood draw tube is disposed beyond a distal end of the plurality of nestable barrels and the coupling device, and into or through the catheter assembly.
2. The blood draw device of claim 1, wherein the inner barrel comprises a finger grip joined to the proximal end thereof via which a user can engage the blood draw device to actuate the plurality of nestable barrels from the expanded state to the compressed state.
3. The blood draw device of claim 2, wherein the finger grip comprises a cylindrical member arranged concentrically with the inner barrel so as to be positioned about the proximal end of the inner barrel, with the finger grip having an open distal-facing end and a proximal-facing end that includes a small diameter opening.
4. The blood draw device of claim 3, wherein the proximal end of the blood draw tube is secured within the small diameter opening of the finger grip.
5. The blood draw device of claim 4, further comprising extension tubing that extends proximally from the inner barrel and the finger grip, the extension tubing having a distal end and a proximal end, with the distal end of the extension tubing secured to the inner barrel or the finger grip and in fluid communication with the blood draw tube, and with the proximal end of the extension tubing coupled to a connector, to allow for a medical device to be attached thereto.
6. The blood draw device of claim 3, wherein the plurality of nestable barrels is arranged such that, when in the expanded state, the inner barrel is a proximal-most barrel, the intermediate barrel is a distal-most barrel, and the outer barrel is between the inner barrel and the intermediate barrel.
7. The blood draw device of claim 6, wherein in transitioning from the expanded state to the compressed state, the inner barrel moves distally into the outer barrel until the finger grip abuts the proximal end of the outer barrel, and both the inner barrel and outer barrel subsequently move distally into the intermediate barrel.
8. The blood draw device of claim 6, wherein a diameter of the finger grip is greater than the first diameter of the outer barrel, such that the outer barrel may be received within the open distal-facing end of the finger grip when the plurality of nestable barrels is actuated from the expanded state to the compressed state.
9. The blood draw device of claim 6, wherein the proximal end of the intermediate barrel comprises an annular bump formed on an outer surface thereof and the distal end of the outer barrel comprises an annular ring formed on an inner surface thereof, the annular bump and the annular ring interacting to secure the intermediate barrel within the outer barrel and prevent disengagement therefrom.
10. The blood draw device of claim 6, wherein the intermediate barrel includes a seal positioned at or adjacent the distal end thereof and that is configured to prevent a transfer of fluid between a catheter assembly and an inner volume of the intermediate barrel, with the blood draw tube passing through the seal.
11. The blood draw device of claim 6, wherein the inner barrel includes a pair of extension legs at the distal end thereof, the pair of extension legs protruding outwardly from an outer profile of the inner barrel and configured to flex radially inward and outward, to enable assembly of the inner barrel with the outer barrel and lock the inner barrel within the outer barrel.
12. The blood draw device of claim 3, wherein the plurality of nestable barrels is arranged such that, when in the expanded state, the inner barrel is a proximal-most barrel, the outer barrel is a distal-most barrel, and the intermediate barrel is between the inner barrel and the outer barrel.
13. The blood draw device of claim 12, wherein in transitioning from the expanded state to the compressed state, the inner barrel moves distally into the intermediate barrel until the finger grip abuts the proximal end of the intermediate barrel, and both the inner barrel and intermediate barrel subsequently move distally into the outer barrel.
14. The blood draw device of claim 12, wherein the outer barrel comprises an interior tubing positioned therein that defines a lumen, with the interior tubing joined to the distal end of the outer barrel and extending proximally therefrom into an inner volume of the outer barrel, and wherein the blood draw tube is positioned within the lumen and advances therethrough when the plurality of barrels is actuated from the expanded state to the compressed state.
15. The blood draw device of claim 14, wherein the interior tubing has a fourth diameter that is less than the first diameter, such that when the plurality of barrels is actuated to the compressed position, the interior tubing is positioned within an inner volume of the inner barrel.
16. The blood draw device of claim 14, wherein an inner diameter of the lumen of the interior tubing is less than an inner diameter of the inner barrel.
17. The blood draw device of claim 12, wherein the outer barrel includes a seal positioned at or adjacent the distal end thereof and that is configured to prevent a transfer of fluid between a catheter assembly and an inner volume of the intermediate barrel, with the blood draw tube passing through the seal.
18. The blood draw device of claim 1, wherein each of the inner barrel, the intermediate barrel, and the outer barrel comprises a cylindrical inner surface of the barrels that lowers resistance against the blood draw tube when moved from the first position to the second position.
19. The blood draw device of claim 1, wherein the plurality of nestable barrels reduces or eliminates kinking of the blood draw tube as it moved from the first position to the second position.
20. A system comprising: a catheter assembly including a catheter adapter and a catheter extending from a distal end of the catheter adapter; and the blood draw device of claim 1, wherein the blood draw device is connected to the catheter adapter via the coupling device, and wherein the blood draw device is operable to move the blood draw tube from the first position, in which the distal end of the blood draw tube is disposed within the plurality of nestable barrels or the coupling device, to the second position, in which the distal end of the blood draw tube is disposed beyond the distal end of the intermediate barrel and the coupling device, and into or through the catheter assembly.
21. The system of claim 20, wherein the catheter assembly further comprises: a connector coupled to the proximal end of the catheter adapter, so as to be positioned between the catheter adapter and the blood draw device; and an extension set integrated into or removably coupleable to the connector, the extension set including a fluid conduit comprising a luer connection at a proximal end thereof for connection to a fluid delivery device.
PCT/US2024/054858 2023-11-08 2024-11-07 Blood draw device with kinking prevention of blood draw tube therein Pending WO2025101702A1 (en)

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US20190021640A1 (en) * 2017-07-19 2019-01-24 Becton, Dickinson And Company Extension housing a probe or intravenous catheter
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US20210268242A1 (en) * 2020-03-02 2021-09-02 Gyrus Acmi, Inc. Guide wire introducer
US20240358295A1 (en) * 2023-04-26 2024-10-31 Becton, Dickinson And Company Blood Draw Device and Method of Use Thereof for a Multi-Site Paired Blood Draw

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US20140364766A1 (en) * 2011-04-26 2014-12-11 Creative Vascular, Llc Systems and methods for phlebotomy through a peripheral iv catheter
US20190307962A1 (en) * 2016-06-09 2019-10-10 Novartis Ag Syringe and method for dispensing a liquid
US20190021640A1 (en) * 2017-07-19 2019-01-24 Becton, Dickinson And Company Extension housing a probe or intravenous catheter
US20210268242A1 (en) * 2020-03-02 2021-09-02 Gyrus Acmi, Inc. Guide wire introducer
US20240358295A1 (en) * 2023-04-26 2024-10-31 Becton, Dickinson And Company Blood Draw Device and Method of Use Thereof for a Multi-Site Paired Blood Draw

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