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WO2025076150A1 - Dispositif de collecte de sang et procédés d'utilisation - Google Patents

Dispositif de collecte de sang et procédés d'utilisation Download PDF

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Publication number
WO2025076150A1
WO2025076150A1 PCT/US2024/049677 US2024049677W WO2025076150A1 WO 2025076150 A1 WO2025076150 A1 WO 2025076150A1 US 2024049677 W US2024049677 W US 2024049677W WO 2025076150 A1 WO2025076150 A1 WO 2025076150A1
Authority
WO
WIPO (PCT)
Prior art keywords
slider
handle
catheter
cannula
distal end
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/US2024/049677
Other languages
English (en)
Inventor
Raul LEYTE-VIDAL
Amir Belson
Jason Ryan STATS
Daniel PICO
Paul Fenton
Ryan Patterson
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.)
Venocare Inc
Original Assignee
Venocare Inc
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 Venocare Inc filed Critical Venocare Inc
Publication of WO2025076150A1 publication Critical patent/WO2025076150A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150992—Blood 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub

Definitions

  • An extension port positioned adjacent to the distal end of the handle having a first end in communication with the handle interior portion and a second end configured to couple to a vacutainer assembly; a slider having a body with a pair of alignment features on an exterior surface of the body and an arm extending from the body wherein the slider is disposed within the interior portion of the handle with the arm extending through and moveable relative to the elongated slot; a slider lumen extending from a distal end of the slider body to a flow path opening along a portion of a sidewall the slider body; and a cannula having a proximal end and a distal end and a lumen extending from the distal end to the proximal end wherein the cannula lumen proximal end is coupled to the slider body so that the cannula lumen is in fluid communication with the flow path opening.
  • a length of slider movement along the elongated slot may be configured to advance the cannula distally a first distance without creating a fluid pathway through an attached catheter and then further distally a second distance that creates a fluid pathway through the attached catheter.
  • the protrusion comprises a tapered male luer proximal segment and an elongate extension distal to the male luer proximal segment.
  • the elongate extension may be positionable adjacent to a proximal end of a catheter lumen extending from the catheter hub.
  • the blood draw device can further comprise a seal sized and shaped to fit into the handle along the elongate slot to close off access to the interior portion, the seal having an angled slit along a length shaped to allow sliding movement of the slider arm.
  • the seal may further comprise a perimeter adapted to engage the opening of the elongated slot.
  • the angled slit adapted to reseal along the length of the angled slit distal to the slider arm and along the length of the angled slit proximal to the slider arm.
  • the device may further comprise a ratchet assembly with a first ratchet element positioned on an interior of the handle and a second ratchet feature positioned on the slider body, the second ratchet feature configured to engage the first ratchet feature when the slider is advanced distally within the handle.
  • the first ratchet feature may comprise a plurality of teeth along a length of the ratchet feature, wherein the plurality of teeth corresponds to a length of cannula deployment when the second ratchet feature is in communication with the first ratchet feature.
  • the first ratchet feature may have length configured to provide tactile indication of the slider body relative to the extension port.
  • the device may further comprise a visual or a tactile indicator along a surface of the handle adjacent to the elongate slot configured to indicate a length of cannula deployment, a relative position of the slider or the cannula with respect to a catheter hub coupled to the proximal end of the handle, or a relative position of the flow path opening on the slider body with respect to the extension port on the handle.
  • the visual or tactile indicator may be a tactile indicator is a ratchet system formed by an interaction between a ratchet element on the slider and a cooperating ratchet element along the elongated slot of the handle.
  • a first ratchet element comprises a plurality of teeth along a length of the ratchet feature, wherein the plurality of teeth correspond to a length of cannula deployment when the second ratchet feature is in communication with the first ratchet feature.
  • a second ratchet element may have a length configured to provide tactile indication of the cannula distal end to a distal most end of a catheter lumen coupled to the proximal end of the handle.
  • a third ratchet element may have a length configured to provide tactile indication of the cannula distal end to a full cannula extension length for an indicated catheter lumen length of a catheter coupled to the proximal end of the slider.
  • a method of coupling a coupler of a blood draw device to an indwelling catheter hub can comprise the steps of aligning a coupler at the distal end of a blood draw device with a proximal end of a catheter hub; and advancing the coupler over the exterior of the catheter hub until the catheter hub is docked with the coupler; and positioning a protrusion of the blood draw device within the catheter hub and adjacent to a proximal end of a catheter lumen extending from the catheter hub.
  • a blood collection device comprises a coupler having a protrusion configured to engage a catheter, the coupler positioned at the distal end of a handle.
  • An extension port positioned adjacent to the distal end of the handle; the extension port configured to couple to a vacutainer assembly.
  • a slider having a body disposed within an interior of the handle and an arm extending through an axial slot extending along a length of the handle, the slider body having a lumen extending through from a distal end of the slider body to a flow path opening along a length of the slider body.
  • a cannula extending from a distal end of the slider body, the cannula comprising a lumen extending from a distal end into the slider body.
  • a tube seal disposed within the interior of the handle, wherein the slider is configured to move axially through an interior of the tube seal.
  • the seal may be on the slider about the side port adapted and configured to remain in sealed relation to the handle interior during slider movement.
  • a blood collection device may further comprise a plurality of stabilizing mounts arranged on an exterior surface of the slider positioned to maintain the seal in apposition with the handle interior while moving the slider along the slot.
  • a blood collection device may further comprise a seal coupled to the housing so as to close off the housing interior.
  • a blood collection device may further comprise a tubular seal within the interior of the handle the tubular seal can be adapted and configured to releasably seal the slot in response to movement of the slider along the slot.
  • FIG. 3 shows yet anther detailed perspective view of the distal end of the handle and male luer coupled thereto. Similar to the previous figure, the position of the cannula distal segment is seen in the stowed position as it is not extending beyond the male luer protrusion in this ready-to-use configuration. Also shown here is an example of a disengagement button on the top and the protrusion feature on the distal end. The male luer is transparent to show the cannula extending through the male luer but not out of the distal end. [0032] FIGS.
  • 4A to 4E show an example of a male luer in various views to highlight the coupling features configured to engage the distal end of a blood collection device handle as well as the proximal configuration adapted to couple with a catheter assembly including an example of a catheter assembly disengagement mechanism.
  • FIG. 7 shows an expanded view of the distal end of a blood collection device as illustrated in the previous figure with additional detail of examples for coupling between the male luer and the blood collection device handle as well as coupling of the male luer proximal side to a catheter assembly.
  • FIG. 14 illustrates a proximal perspective view of the blood collection device handle with the slider again in the proximal and stowed position to highlight the slider slot along the handle configure to guide the slider from the proximal position through distal advancement when in use.
  • FIG. 24 shows a cross-section side elevation view of a blood collection device configured for multiple-catheter length use with the slider advanced from the proximal position to the distal portion of the handle and engaged with the ratchet system.
  • the crosssection view highlights an example of a flow path through the slider plunger body.
  • FIG. 28 is a cross-section view of the previous figure to highlight the arrangement of the flow path as established by the distal positioning of the slider in the handle.
  • the slider is distally advanced to be in fluid communication with the extension set and vacutainer assembly.
  • FIG. 29 shows another example of the blood collection device from the previous figure used with a 1.75” catheter length and the slider is positioned proximal relative to the blood collection device example used with a 2.30” catheter, while maintaining fluid communication with the extension set port and vacutainer assembly.
  • FIG. 30 shows the cross section of the previous figure with the slide plunger continuing to maintain fluid communication with the extension port with yet a smaller catheter length.
  • FIG. 55 shows the blood collection device and catheter assembly of the previous figure in a perspective view from the proximal side with the slide plunger in the stowed position and arm extending through the proximal opening of the tube seal.
  • the blood collection device is shown aligned with the catheter hub ready for insertion.
  • FIG. 57 shows a perspective view of the cross-section example and configuration of the blood collection device from the previous figure.
  • this may be a single-catheter length configuration for a set catheter length.
  • the male luer is coupled to the distal end of the handle and is an intermediate element between the distal end of the handle and the catheter assembly that is shown docked to the blood collection device in this view.
  • the slide plunger is in the stowed position and cannula has not been advanced through the catheter assembly.
  • FIG. 58 shows a cross section of a blood collection device in a deployed configuration.
  • the blood collection device may be a single-catheter length configuration for a set catheter length (e.g., 1.30”).
  • the flow path is visible and has been established or completed from the distal end of the cannula extended beyond the distal end of the catheter.
  • the cannula would be within the vessel and flow through the cannula through the slide plunger body (e.g., manifold) that is now in communication with the tube seal opening and extension port of the handle to the vacutainer assembly.
  • the slide plunger body e.g., manifold
  • FIG. 59 shows the complete blood collection device of the previous figure where the cannula has been extended as the slide plunger is in the distal most position within the slot and tube seal slit.
  • the slide arm is now extending through the distal opening axially aligned with the tube seal slit.
  • the opening is accommodating he slide arm while the remaining length of the tube seal slit is sealed proximally from the slide plunger.
  • FIG. 68 shows the complete perspective view of the blood collection device from the previous figure adapted to accommodate the 1.75” catheter length with the same blood collection device.
  • FIG. 70 shows the blood collection device of the previous figure from the proximal perspective with details of the slide arm extending through the tube seal distal opening as well as the tube seal slit in a sealed configuration along the entire length of the slit from the proximal opening to the distal opening.
  • the devices described herein are configured to engage the proximal end or end of a catheter (e.g., catheter hub) to facilitate a blood draw through the catheter from the proximal end of the hub.
  • the distal end of the devices described herein can have a coupling mechanism (e.g., male luer 125) adapted to couple with the catheter including a protrusion or other feature configured to be positioned within the catheter hub and direct or support the passage of the cannula through the in-dwelling catheter into the vessel for the blood draw.
  • the arrangement of the device relative to the proximal end of the catheter can provide a direct flow path of blood through the cannula to the vacutainer when the cannula is deployed into the vessel as it may be during use.
  • This male luer may be configured to engage a catheter or catheter assembly (e.g., catheter hub of a catheter assembly) in a releasable engagement.
  • catheter coupling element 265b may be configured to engage a corresponding element on a catheter hub (not shown).
  • FIG. 3 shows yet another detailed perspective view of the distal end of the handle and male luer coupled thereto, as shown in FIG. 2.
  • the position of the cannula distal segment is seen in the stowed position as it is not extending beyond the male luer protrusion 270 in this ready-to-use configuration.
  • This detailed view also provides an example of the protrusion distal end 271 configured to complement and support insertion of the male luer into a catheter hub.
  • the coupling mechanism e.g., male luer
  • the coupling mechanism may be adapted to engage the proximal end of a catheter hub or an in-dwelling catheter.
  • the cannula, and male luer protrusion may be axially aligned such that the male luer can align a lumen therethrough with the catheter lumen to provide a path for the cannula to be advanced through the catheter and into the blood vessel.
  • 4D illustrates another distal perspective view to highlight additional exemplary elements of a disengagement mechanism including the disengagement button 265 and catheter engagement feature 290 as another element of a disengagement mechanism of the male luer.
  • This catheter engagement feature may be adapted to receive a corresponding element of a catheter hub for a positive engagement and locking the catheter to the device, when in use.
  • the male luers (e.g., coupling mechanisms) of devices described herein may comprise a protrusion having a proximal segment and a distal extension.
  • the male luer comprises a proximal luer segment 270c and a distal extension segment 270d.
  • the proximal segment may be configured to complement a standard female luer configuration of a catheter hub or other port.
  • a proximal luer segment may be a standard ISO luer taper or configuration to be used with a standard catheter hub.
  • the distal end may be configured to have a geometry that is complementary to the interior geometry of a catheter hub, such that when the blood draw device is coupled to a catheter, the male luer may be positionable within the catheter hub and extend adjacent or substantially adjacent to the proximal end of a catheter lumen.
  • the position of the distal end of a male luer e.g., coupling mechanism
  • the extension of distal segment 270d can provide additional support for the cannula and reduce the distance or gap from the distal end 270 to the proximal end of a catheter lumen.
  • the cannular can be extended or deployed out of the handle 105 through the proximal segment 270c and through the distal segment or extension 270d out of the distal tip 270b then through the catheter lumen (not shown).
  • a friction-fit engagement may include one or more detent engagement features 283 and 282 for facilitate communication with the proximal end of a catheter hub docked therein.
  • male luers described herein may have alignment features corresponding to alignment of a catheter for coupling with the device.
  • the male luer may comprise the proximal luer segment (e.g., 270c in FIG. 4D) with or without a distal extension (e.g., 270d in FIG. 4D).
  • the male luers described herein may comprise a protrusion that can have a consistent cross-sectional geometry along a length of the protrusion.
  • the geometry, dimensions, or other features of the male luers may be configured to complement, engage with, or otherwise support the insertion and positioning of the male luer within the catheter hub.
  • Gather hubs described herein may also comprise locking features 305 configured to engage the disengagement mechanism of the male luer or devise described herein. These additional locking features may be configured to facilitate a positive engagement between the device and the catheter assembly.
  • the catheter is not shown. However, the distal hub opening 310 is shown where the catheter may extend from or be coupled to. On the proximal end a catheter hub proximal surface 300c may be configured to communicate with the distal interior surface of the male luer when docked.
  • FIG. 10 shows an example of a distal segment of a blood collection device in a side elevation view with details of the ratchet system and male luer configurations at the distal end of the handle
  • blood collection devices described herein may comprise a ratchet system 250 configured to engage the slider when it is advanced distally in the handle 105.
  • the ratchet system 250 may have a series of teeth 250a, 250b, and 250c.
  • tooth 250a is positioned at a distal end of the ratchet system 250 and may provide an indicator for the distal positioning of the slider when advanced in the handle 105.
  • tooth 250b is positioned at the proximal side of the ratchet system 250 and may provide an indication of initial contact between the ratchet system 250 and the slider (not shown).
  • the distance between the proximal side and distal side o the ratch system may include one or more additional teeth (e.g., 250c).
  • the number and configuration of the ratchet system teeth may be configured to provide an indicator of the position of a slider and the length of cannula 120 advancement when in use.
  • the proximal side of the ratchet system 250 may indicate a first length of cannula advancement.
  • additional ratchet system teeth may indicate extended lengths of deployment.
  • catheter lengths may be any length.
  • catheter lengths may include 1.00”, 1.30”, 1.50”, 1.75”, 2.30” or more or less or any length therebetween.
  • the device adapted to be used with any catheter length may comprise an extended handle length, cannula length, etc. with a slider adapted to be advanced to multiple positions distally within the handle corresponding to the different catheter lengths.
  • the cannulas described herein may have a length from a proximal end extending out of the slider body to a distal end.
  • cannula lengths may be less than 1” to more than 5” or any length therebetween.
  • FIG. 1 IB shows the slider seal 155 in communication with the slider 110.
  • the seal flow path opening 156 is aligned with the slider flow path opening and the axial seal feature is accordingly aligned with the perimeter of the slider flow path opening.
  • Both the seal flow path opening 156 and slider flow path opening provide the proximal end of the flow path extending distally through the cannula 120.
  • the slider 110 is shown with the slider seal 155 in position at the handle proximal end 107.
  • the circumferential seal features are in contact with the interior of the handle to support the alignment of the slider 100 and the cannula 120 axially positioned within the handle.
  • FIG. 11C variations in the geometry of the seal features (e.g., the circumferential seal features 158) are shown where the exterior surface of the circumferential seal feature 158 is pointed as opposed to the rounded example 157. In some examples, the rounded circumferential seal features 157 may provide increased surface area contact with the interior surface of the handle.
  • FIG. 12 shows a side elevation view of select elements of a blood collection device including a coupled catheter assembly, male luer, and slider coupled to the cannula with the handle removed to highlight an exemplary flow path, as described herein.
  • the handle removed, an example of alignment between the cannula 120, slider 110, male luer 125, and catheter assembly can be seen.
  • the slider 110 is in a proximal position with the cannula 120 not extended beyond the catheter distal tip 131a.
  • cannula length 120a would be disposed within the handle and available to be advanced through the catheter into a vessel during use.
  • alignment features of sliders described herein may support axial alignment and prevent unintentional buckling or misalignment of the slider and cannula during advancement and deployment in use.
  • Additional alignment elements such as the ratchet system alignment channel (e.g., 175) can also support the path available for the slider through the handle.
  • it may be beneficial to provide additional support for the slider in this manner to prevent the cannula from buckling when it is advanced into a vessel and possibly contacting obstructions or occlusions in the vasculature.
  • Another feature of the devices described herein may be minimizing the interior volume of the handle. For example, the interior diameter of a handle may be minimized by the slider and seal configurations to support slider alignment and prevent buckling, kinking, or unintentional non-linear displacement of the cannula during advancement and use.
  • FIG. 16A and 16B provide cross section views showing a first side 215e and 215f of the slider slot seal slit 215d as the portion of the slider slot seal contacting the slider arm 113 is only open around the slider arm 113.
  • FIG. 17 shows an example of a blood collection device from FIG. 16 with expanded views of the handle distal end in a top-down view to highlight the ratchet system 250 features and the positioning of the extension set port 135 extending from the blood collection device handle. A distal portion of the slider slot seal can also be seen with the slider not shown and in the proximal position in the slider slot 115.
  • the slider slot seal may be coupled to a device handle described herein.
  • the slider slot seal may be adapted to cover the slider slot of a handle and provide a sealed interior while allowing the slider arm to extend therethrough between the slider tab and slider plunger (e.g., slider body).
  • the slider slot seal may have one or more features to facilitate transition of the slider from a proximal or stowed position to a distal or deployed position.
  • the seal flow path opening 163 has a length and perimeter configured to communicate with the slider flow path opening.
  • the length of the seal 160 is long enough to provide an extended flow path opening 163 allowing a fluid communication in a deployed configuration when the flow path opening 163 is in communication with an extension set port (not shown) from the distal end to the proximal end of the flow path opening.
  • Annular elements 162 are positioned along a length of the seal and configured to support alignment and seal of the slider 170 in the handle.
  • the number of annular elements 162 may be one or more between a proximal annular element 162a to a distal annular element 162b.
  • Sliders described herein having a flow path opening such as flow path opening 163 in FIG. 21C or flow path opening 156 in FIG. 11C may have a length from the distal end of the flow path opening to the proximal end of the flow path opening to accommodate a fluid coupling between the flow path opening and the extension port of a handle when the cannula is in a deployed configuration.
  • the length of the flow path opening in the slider body can provide for a length of cannula deployment while maintaining a fluid coupling or fluid communication with the handle extension port for more than a single length of cannula deployment.
  • fluid communication or a flow path may be established when the distal end of a slider flow path opening is aligned with the handle extension port and the fluid communication is maintained through additional slider advancement as the slider flow path opening remains in alignment with the extension port along the length of the flow path opening.
  • the length of a slider flow path opening may be less than .1” to greater than 2” or any length therebetween.
  • the sliders illustrated in FIG. 1 IB to 1 ID may have a flow path opening 156 with a length of .15”, .16”, .17”, .18”, .19”, .20”, .21”, .22”, .23”, .24”, ,25”.26”, .27”.
  • FIGS. 26A to 26C provide additional details of the slider and handle arrangement as described in FIG. 21 A to 21C.
  • the entire device 200 is shown in FIG. 26A to illustrate the slider 170 in the proximal and stowed position in the handle 205.
  • the slider teeth 167 are proximal to the ratchet system 250 and the flow path opening 195 is not in communication with the extension set port 135. Accordingly, this may be the ready-to-use configuration (e.g., stowed configuration) as the cannula 120 is entirely within the device 200.
  • FIG. 26B and 26C highlight details of the slider 170 with the proximal section of device 200 from FIG.
  • FIG. 26A showing the slider 170 and flow path opening 195 sealed against the interior of the handle 205.
  • FIG. 26C removed the handle to show the slider 170 and movable slider seal 160 with wiper-style seal features 166.
  • the slider arm 173 is configured to extend through the handle and may be adapted to open a segment or portion of the slider slot seal (not shown).
  • the movable seal configuration of devices may be used by advancing the slider from a proximal position in the handle to a distal position such that the cannula extending from the slider is deployed into a vessel.
  • the slider distal advancement can advance the distal end of a cannula beyond a coupled catheter assembly and into the vessel to establish a flow of blood from the vessel, through the cannula, through the slider, and into a vacutainer assembly in communication with the device.
  • FIGs. 27 to 37 illustrate examples of a sequence for the devices described herein during use. These figures highlight the position of the slider and arrangement of the different components as the slider is advanced for a single catheter length device or a multiple catheter length device configuration.
  • FIG. 29 and 30 shows another example of the blood collection device from figure 27 used with a 1.75” catheter 401 and the slider 170 is positioned proximal relative to the blood collection device 200 example shown in FIGS. 27 and 28, while maintaining fluid communication with the extension set port 135 and vacutainer assembly 415.
  • the length 410b shows additional room for distal advancement of the slider 170.
  • the flow path opening 195 is still in fluid communication with the extension set port 135 now between the proximal and distal ends of the flow path opening 195.
  • the deployed cannula length 420 may be adaptable for a catheter length. For example, it may be longer or shorter as needed and controlled by positioning of the slider 170. Also shown is the slider slot seal 215. Referring to FIG.
  • FIG. 31 to FIG. 37 provide further examples of different distal advancement and positioning of a slider 170 within the blood collection device 200 including examples of different distances remaining distal of the slider 170 for continued advancement.
  • the length of the cannula 120 extending beyond the catheter shown in these figures may be adaptable.
  • the length of the cannula deployed in each example may be extended or retracted as needed to address occlusions, obstructions, or vessel tortuosity and establish a flow through the flow path including the cannula, slider, extension set port and vacutainer assembly. Referring to FIG.
  • the cross-section view shows an example of the slider position adapted to accommodate a 1.50” catheter 402.
  • the device 200 is shown in an arrangement to accommodate a 1.30” catheter 403.
  • FIG. 33 shows the cross-section view of the device in FIG. 32 and highlights the fluid communication relationship between the flow path opening 195 and the extension set port 135 as the extension set port 135 is in communication with the flow path opening 195 closer to the distal end of the flow path opening 195.
  • the device 200 is now coupled with a 1.00” catheter 404.
  • the cannula extends beyond the catheter with deployed length 120d that may be increased as remaining length 410e can accommodate additional distal advancement of the slider 170.
  • the multiple catheter length device configuration may be capable of deploying the cannula further beyond the catheter distal tip, as needed during use.
  • FIG. 35 the cross section of the blood collection device in FIG. 34 is shown with notable position of the extension set port 135 in communication with the distal end of the flow path opening 195. For example, if the slider 170 were retracted proximally from this position, the flow path would not longer be continuous and the flow path opening 195 would be sealed against the interior of the handle 205.
  • the slider 506 is shown here in the proximal position in a stowed or ready-to-use configuration.
  • the vacutainer assembly including the vacutainer 535, luer 530, tubing 516 are in communication with the extension set port 515 of the handle 505.
  • the cannula 525 extends through the center of the tube seal and through the male luer 520 including the male luer protrusion 521.
  • devices described herein having a static positioned tube seal may be configured for use with a single catheter length or configured for use with many catheter lengths in a single device.
  • the tube seal 510 is shown extending to the distal end of the handle and may contact an interior surface of the handle distal end or may be configured to contact the proximal end of the male luer 520. Also shown by this cross-section view is the flow path opening or interior of the slider 506a. In the proximal position (as shown), the flow path opening 506a may not be in communication with the extension set port.
  • the male luer 520 can have a disengagement mechanism configured to separate a catheter hub from being docked to the device 500 in use.
  • the disengagement button 522 can be depressed to lift the distal end of the disengagement mechanism and unlock the catheter coupled to the device.
  • a catheter hub may be docked and in communication with the device with one or more locking features engaged to disengagement feature 523 that may be released when the disengagement button 522 is actuated.
  • the male luer interior 520a may be configured to accommodate a catheter hub or portion of a catheter when the device 500 is in use.
  • male luers e.g., male luer 500
  • FIG. 41 shows a distal perspective view of the tube seal 510 without additional device elements.
  • the slider has been removed, but an example of the tube seal slit raised at segment 510d remains where the slide arm would pass through.
  • the tube seal slit 510c can remain sealed from the proximal side of the slide arm to the proximal end of the tube seal 510b and on the distal side of the slide arm extending through the tube seal slit.
  • the proximal end of the tube seal 510 includes an opening 513 configured to retain and accommodate the slider in the proximal (e.g., stowed or ready-to-use) configuration and maintaining a seal along the remainder of the distal length of the tube seal slit 510c.
  • the tube seal similar to the slider slot seal can be adapted to maintain and support a sterile environment for the interior of the devices described herein.
  • FIG. 42 shows a side elevation view of the slider 506 in the tube seal 510.
  • the slider 506 is positioned near a distal end 510a of the tube seal with the cannula extending through a center of the tube seal.
  • the handle and remaining device components are not shown, the length of the tube seal 510 proximal to the slider 506 show the slider 506 in a distal position.
  • the slider arm 508 is extending through the tube seal slit 510c with the proximal side of the slider arm 508a lifting or opening the tube seal slit 510c.
  • the slider can be configured to slide through the tube seal from a proximal end to a distal end.
  • the slider may be configured to transition from a proximal position to a distal position in the tube seal during use and corresponding to the deployment length needed for the cannula based on the catheter length.
  • FIG. 45 shows a detailed cross section of a perspective view at the distal end of the handle and proximal end of the male luer.
  • the slider 506 is in the distal most position and in communication with the proximal end of the male luer 520.
  • the cannula 525 is extending through the center of the male luer 520 with a potential flow path established including the cannula 525, slider interior 506a, extension set opening 514 through the tube seal 510 at the extension set port 515.
  • the flow path continues through the extension set port lumen 515b and on to the vacutainer assembly (not shown). Additional details of the engagement elements 505a are shown at the distal end of the handle. These engagement features may be configured to provide improved engagement and manipulation for a user during use.
  • devices described herein are configured to couple with a catheter.
  • the male luer or handle distal end described herein may be configured to couple with a catheter, catheter hub, catheter assembly, etc.
  • the male luer may be adapted to couple with the catheter assembly via an engagement mechanism including features of the catheter hub and corresponding features configured to receive the catheter hub in the male luer.
  • the male luer may be adapted to facilitate a friction fit with a catheter (e.g., catheter hub).
  • the catheter hub may be adapted to couple with a male luer of a device described herein.
  • This interior geometry for the flow path through the slider can be adapted to reduce insult to cells traveling in the blood flow by reducing the impact of the cells on interior surfaces of flow path components (e.g., cannula, slider/slider plunger/extension port, etc.). Accordingly, the quality of cells in the drawn sample will improve due to a reduction in hemolysis.
  • flow path components e.g., cannula, slider/slider plunger/extension port, etc.
  • FIG. 46 shows a side elevation view of a catheter assembly configured to couple with a blood collection device described herein.
  • the catheter assembly 550 may have a catheter hub 555 with a proximal end 506 and a catheter 570 extending from a distal end of the catheter hub.
  • Stabilizing features 565 can provide stability and placement support for the catheter assembly when positioned in the patient.
  • the catheter hub may comprise an extension set including an extension port 559 coupled to tubing 575 that extends from the catheter hub extension port 559 to a luer 585.
  • a clamp 580 may be provided to control a flow through the catheter assembly extension set.
  • the catheter hub 555 may include one or more alignment features 557 configured to align the catheter assembly and blood collection device when coupling during use.
  • a locking feature 556 is also positioned on the catheter hub 555 and can be configured to support a connection with a male luer of a device described herein.
  • Catheter hub tab 558 may also be positioned on the catheter hub 555 and can be configured to support manipulation of the catheter during use. This tab 558 may also be configured to engage tape or other element configured to retain the catheter in position when placed and inserted into a patient’s vasculature.
  • the catheter hub proximal end 560 may be configured to receive the protrusion from a male luer described herein.
  • the distal end of the catheter hub 560 may comprise a seal or septum configured to allow for an intravascular access device (e.g., needle, guidewire, catheter, etc. to pass through the seal and through the catheter 570.
  • the seal may also be adapted to allow for passage of the male luer protrusions described herein to pass through the and into the catheter hub for blood collection, administration of medications, fluids, or interventional procedures without having to use the extension set of the catheter hub.
  • FIG. 47 to FIG. 49 show a sequence of the device 500 as it interacts and engages the catheter assembly 550.
  • the device 500 is aligned with the catheter assembly 550 such that the male luer 520 and male luer protrusion 521 are axially aligned with the catheter hub 550 with the male luer protrusion 560 approaching the seal at the catheter hub proximal end 560.
  • the cannula 525 is still stowed within the device 500 through the center of the tube seal 510 as the device is ready to engage the catheter assembly.
  • FIG. 48 now shows the device 500 coupled to the catheter assembly 550.
  • the catheter hub 555 is coupled with the male luer 520 with the disengagement mechanism 590 locked to the corresponding features of the catheter hub 555.
  • the cross-section view in FIG. 49 shows the coupled device of FIG. 48 with the male luer protrusion 521 in the catheter hub interior and contacting the distal interior surface 555a.
  • the male luer 521 may be configured to close the catheter assembly extension port when inserted.
  • the male luer protrusion may be positionable inside the catheter hub without closing the catheter hub extension set 559.
  • FIG. 50 shows a cross section of the blood collection device 500 from FIGS. 47 to 49 with the slider 506 in a distally advanced position within the handle 505 and tube seal 510.
  • the cannula 525 is now deployed and extending beyond catheter 570 to establish a flow path including the cannula 525, slider 506, slider flow pat opening 506a, tube seal extension set opening 514, extension set interior opening 515a to the tubing 516 and vacutainer (not show).
  • the slider 506 is not advanced to the distal most position as the distal end of the slider is not in communication with the proximal end of the male luer 520.
  • the devices described herein may be configured to be used with a single catheter length.
  • FIGS. 51 to 53B show cross section detailed views of engagement examples between a male luer and catheter assembly 550.Referring to FIG. 51, the distal portion of the handle 505 including the male luer 520 and catheter assembly 550 are shown in a cross section of a side view.
  • the male luer 520 has disengagement mechanism 590 including the disengagement button 595, disengagement distal end 600, opening 556 and internal disengagement feature with proximal side 595a and distal sider 595b.
  • the catheter assembly 555 is coupled to the male luer 520 with the catheter hub 555 inside the male luer and the male luer protrusion 521 extending into the catheter hub interior.
  • the catheter hub proximal surface 555b is in contact with the disengagement feature 595a.
  • the button 5959 has not been depressed and accordingly the catheter hub 555 is locked or docket to the male luer 520.
  • Locking feature 556 is positioned in the opening of the male luer disengagement mechanism 590.
  • FIGS. 53A and 53B show a sequence of disengagement of the catheter assembly 550 from the device 500 (e.g., male luer 520).
  • the catheter assembly is coupled in FIG. 53A, then the disengagement button 595 is depressed causing the distal end 600 of the disengagement mechanism to lift and release the catheter hub locking feature 556.
  • the catheter assembly may be pulled away from the device.
  • the interior disengagement feature proximal surface 595a can be adapted to bias the catheter hub 555 away from the device when the button 595 is depressed.
  • arrows 700-703 indicate an example of a disengagement sequence for separating a catheter hub from a blood draw device.
  • the disengagement button 595 is depressed causing the disengagement mechanism distal end 600 to lift above the catheter hub locking feature 556 while biasing the catheter hub 555 distally away from the blood draw device male luer 520 (e.g., coupling mechanism).
  • arrow 700 shows a step of depressing the disengagement button 595. Then the proximal end of the catheter hub 555 is contacted by the interior disengagement feature 595a. Contacting the proximal end of the catheter provides a distally biasing force to advance the catheter hub away from the male luer 520.
  • Depressing the disengagement button also causes the distal end of the disengagement feature to lift away from catheter hub exterior allowing the catheter hub locking feature to be free of the interferences of the disengagement mechanism, as shown at arrow 701. Then, advancing the catheter hub 555 as shown at arrow 702 and withdrawing or otherwise separating the male luer as indicated in arrow 703 support the disengagement of the blood draw device from the catheter hub, which can remain in the patient.
  • This simplified and direct flow path can reduce or eliminate damage to cells flowing through the flow path as there are fewer turns, angles, or other features of the flow path (e g., including the cannula, plunger, extension set to vacutainer).
  • hemolysis is reduced or eliminated thereby preserving the quality of cells in the sample drawn by the device.
  • the devices described herein including the capacity to couple with the proximal end of the catheter hub, provide a more direct flow path with fewer turns or angles compared to devices that require access to the catheter via an extension port on the catheter hub.
  • the axial alignment of the male protrusion, cannula, catheter lumen, and plunger provide a direct path for blood flow through the cannula lumen to the plunger where it is then directed to the vacutainer through the tubing and extension port on the handle.
  • the devices described herein, including devices with movable seals or nonmoving tube seal configurations may be used with a single predetermined catheter length or with many different catheter lengths using a single device.
  • variations in the length of the handle, cannula, slider, ratchet system, seals, tube seals, male luer, etc. can support for the variation between a single catheter length device or a device adapted to be used with multiple catheter lengths.
  • FIGS. 54 to FIG. 70 show examples of the device in use for both the single length configuration and multiple catheter length configurations of a device having a tube seal.
  • FIG. 56 and 57 show the device 500 of FIG. 54 now coupled to the catheter assembly 550.
  • the slider 506 is still in the proximal position ready to be deployed and deploy the cannula 525 through the catheter assembly 550.
  • the cross section shown in FIG. 57 reveals the discontinuous flow path as the slider flow path opening is not in communication with the extension port.
  • the view in FIG. 56 also illustrates and example of the position of the male luer within the catheter hub when the blood draw device is engaged or coupled with the catheter as it may be during use. In some examples, described herein, the male luer may extend past the extension port on the catheter hub.
  • the devices described herein can be configured to engage the catheter assembly (e.g., catheter hub) from the proximal end of the catheter and support a blood draw through the catheter hub rather than requiring additional configuration for vascular access through the extension port of the catheter.
  • the capacity for the device to perform a blood draw in this manner can reduce or prevent hemolysis by reducing the tortuosity of a flow path for the blood to travel from the blood vessel to the vacutainer.
  • FIGS. 58 and 59 show the device 500 of FIG. 54 now with the slider 506 advanced distally into the deployed configuration whereby the cannula 525 is deployed and extending beyond the distal end of catheter 570.
  • FIG. 60 shows additional advancement capacity of the single-catheter length configuration for the device 500.
  • This additional advancement is an incremental transition of the slider 506 after it has been distally advanced.
  • an optional additional advancement is possible to overcome any obstruction or occlusion contacted by the distal end of the cannula 525 when deployed.
  • vascular valves may otherwise prevent the cannula 525 from restabling a flow through the device 500.
  • the additional advancement feature and configuration can allow deployment of the cannula 525 beyond the obstruction even after the distal end of the cannula has been extended beyond the catheter 570.
  • the ratchet system may have a first deployed setting and a second obstruction clearance setting for the added advancement even in a single-catheter length device configuration.
  • FIGS. 61 to 70 illustrate a sequence of different positions for a device with a tube seal 510 and configured to be used with multiple catheter lengths.
  • the slider 606 is now extended with a flow path opening 606a having a distal end 606b and a proximal end 606c.
  • the length of the flow path opening 606a can be adapted to maintain fluid communication with a tube seal extension set opening and extension port with different catheter lengths.
  • the device 600 is coupled to a catheter assembly having a 1.00” catheter 625.
  • the flow path is established as the slider 606 is advanced and the cannula 625 extends beyond the catheter 625.
  • the extension port 615 is in fluid communication with the distal end of the flow path opening 606b.
  • the shortest length of catheter accommodated by a device may be associated with the length of the slider flow path opening.
  • FIG. 62 shows the device from FIG. 61 from a proximal perspective with the slider positioned between the distal end and proximal end of the handle 605.
  • the tube seal 610 extends through the interior of the handle and sealing the interior of the handle from the flow of blood through the flow path that is established with the vacutainer assembly.
  • FIGS. 63 and 64 show the device 600 of FIG. 61 now coupled to a 1.30” catheter. In the cross-section view in FIG. 63, the slider is advanced distally relative to the example shown in FIG. 61.
  • the user can advance the slider and when the extension 1007 contacts the ratchet system 1008, this can indicate that the slider body opening is now aligned with the extension port and a flow-path has been established through the cannula and to the vacutainer.
  • the tactile positioning and alignment features of the handle can provide an indication of the slider position relative to the extension port.
  • the slider may still engage the positioning features on the exterior of the handle to indicate when the slider body opening is in fluid communication with the handle.
  • positioning features may include active features such as the ratchet system and active engagement with the slider.
  • positioning features may provide a passive tactile indication of the slider body alignment with the extension port by markers or other indicators on the handle exterior to indicate a relative position of the slider by to the handle extension port.
  • an intravascular catheter and guide placement structure may be adapted and configured specifically for use with a blood collection device or method described herein.
  • the catheter, the hub, or the lumen of an indwelling catheter may be modified for use with an embodiment of a guide element and a vascular access device.
  • aspects of the guide element and the vascular access device may be adapted and configured for use with a vascular catheter described herein.
  • a distal portion of the vascular access device may be adapted for ready coupling and uncoupling to a proximal aspect of the catheter hub, including passage through one or more valves or other structures based on specific configuration of the intravascular catheter.
  • a portion of the catheter lumen may be adapted or modified or reshaped so as to accommodate one or both or a combination of a vascular access needle and guide element.
  • the catheter lumen is modified to have a conformal shape configured for integral positioning and alignment with a distal portion of a guide element.
  • the vascular access device will have a distal end adapted to open one or more or any closure structure in a proximal aspect of the catheter hub of the catheter to be delivered using the vascular access device.
  • a proximal portion of the catheter hub may be adapted and configured for releasable engagement with either or both of the distal end of a blood collection device or a vascular access device.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
  • first and second may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element.
  • a first feature/element discussed below could be termed a second feature/element
  • a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
  • any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.
  • all numbers may be read as if prefaced by the word "about” or “approximately,” even if the term does not expressly appear.
  • a numeric value may have a value that is +/- 0.1% of the stated value (or range of values), +/- 1% of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc.
  • Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, then “about 10" is also disclosed.
  • any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points.

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Abstract

L'invention concerne un dispositif de collecte de sang comprenant un coupleur ayant une saillie conçue pour venir en prise avec un cathéter, le coupleur étant positionné au niveau de l'extrémité distale d'une poignée. Un orifice d'extension est positionné de manière adjacente à l'extrémité distale de la poignée, l'orifice d'extension étant conçu pour s'accoupler à un ensemble vacutainer. L'invention concerne un curseur ayant un corps agencé à l'intérieur de la poignée et un bras s'étendant à travers une fente axiale s'étendant le long d'une longueur de la poignée, le corps de curseur ayant une lumière s'étendant à travers une extrémité distale du corps de curseur jusqu'à une ouverture de trajet d'écoulement le long d'une longueur du corps de curseur, le curseur étant conçu pour se déplacer axialement le long d'une longueur de la poignée. Une canule s'étend à partir d'une extrémité distale du corps de curseur. La canule peut comprendre une lumière s'étendant d'une extrémité distale dans le corps de curseur. L'invention concerne également un joint mobile couplé au corps de coulisseau, le joint mobile étant conçu pour sceller la lumière de coulisseau contre l'intérieur de la poignée.
PCT/US2024/049677 2023-10-02 2024-10-02 Dispositif de collecte de sang et procédés d'utilisation Pending WO2025076150A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160022963A1 (en) * 2007-04-18 2016-01-28 Vascular Pathways, Inc. Intravenous Catheter Insertion And Blood Sample Devices And Method Of Use
US20190307986A1 (en) * 2011-01-31 2019-10-10 Vascular Pathways, Inc. Intravenous Catheter And Insertion Device With Reduced Blood Spatter
US20210113128A1 (en) * 2015-01-30 2021-04-22 Smiths Medical Asd, Inc. Needle assembly with diagnostic analysis provisions
US20210299429A1 (en) * 2020-03-31 2021-09-30 Becton, Dickinson And Company Catheter assembly with a slidable septum and related systems and methods

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160022963A1 (en) * 2007-04-18 2016-01-28 Vascular Pathways, Inc. Intravenous Catheter Insertion And Blood Sample Devices And Method Of Use
US20190022358A1 (en) * 2007-05-07 2019-01-24 Vascular Pathways, Inc. Intravenous Catheter Insertion and Blood Sample Devices and Method of Use
US20190307986A1 (en) * 2011-01-31 2019-10-10 Vascular Pathways, Inc. Intravenous Catheter And Insertion Device With Reduced Blood Spatter
US20210113128A1 (en) * 2015-01-30 2021-04-22 Smiths Medical Asd, Inc. Needle assembly with diagnostic analysis provisions
US20210299429A1 (en) * 2020-03-31 2021-09-30 Becton, Dickinson And Company Catheter assembly with a slidable septum and related systems and methods

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