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WO2010141563A2 - Appareil en ligne fermé et méthode d'aspiration de fluide - Google Patents

Appareil en ligne fermé et méthode d'aspiration de fluide Download PDF

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Publication number
WO2010141563A2
WO2010141563A2 PCT/US2010/037043 US2010037043W WO2010141563A2 WO 2010141563 A2 WO2010141563 A2 WO 2010141563A2 US 2010037043 W US2010037043 W US 2010037043W WO 2010141563 A2 WO2010141563 A2 WO 2010141563A2
Authority
WO
WIPO (PCT)
Prior art keywords
syringe
fluid
valve mechanism
line
fluid chamber
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.)
Ceased
Application number
PCT/US2010/037043
Other languages
English (en)
Other versions
WO2010141563A3 (fr
Inventor
Yair Mendels
Matan Shamir
Marco Orga
Eldad Gabriel Rubinstein
Vered Aframian
Elad Uziel
Yehonatan Gershuni
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.)
Biometrix Ltd
Original Assignee
Biometrix Ltd
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 Biometrix Ltd filed Critical Biometrix Ltd
Publication of WO2010141563A2 publication Critical patent/WO2010141563A2/fr
Publication of WO2010141563A3 publication Critical patent/WO2010141563A3/fr
Priority to US13/296,327 priority Critical patent/US9357950B2/en
Priority to IL216436A priority patent/IL216436A/en
Anticipated expiration legal-status Critical
Priority to US14/206,469 priority patent/US20140194778A1/en
Ceased legal-status Critical Current

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
    • A61B5/150992—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
    • A61B5/150007—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
    • A61B5/155—Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals

Definitions

  • the present invention relates to the field of sampling devices.
  • the present invention relates to an in-line sampling device and method for introducing fluid to and withdrawing (aspirating) fluid from an infusion or arterial tube that is connected to a catheterize patient.
  • the present invention relates to a syringe for either manually or automatically, introducing and aspirating a fluid in a closed sterile environment, sealed from the ambient air, and which reduces the risk of error during the aspiration process due to its simplicity of operation.
  • Some prior art blood sampling systems comprise a syringe comprising the dual function of introducing an upstream sterile fluid (e.g. saline solution) to a patient located downstream, and drawing back (aspirating) downstream fluid into the syringe in a sealed sterile manner.
  • an upstream sterile fluid e.g. saline solution
  • drawing back (aspirating) downstream fluid into the syringe in a sealed sterile manner.
  • a small amount of infused fluid runs through the blood sampling line to the patient, when the line is not in use. This enables the blood sampling line to maintain in a clear, unblocked/unclogged condition.
  • the fluid is aspirated beyond the sampling site so that a clean blood sample may be withdrawn.
  • US 5,324,266 discloses an in-line sampling system having a blood sampling device, with a fluid storage mechanism and a fluid draw element.
  • the aspiration is performed manually, similar to all prior art syringes.
  • the design of the device allows overshooting of fluid, such that over-aspiration may occur.
  • the proposed sealing of the fluid chamber from the external surrounding air is achieved by a fairly large harmonica-like cylinder made of resilient material, which is difficult to keep in a tight and completely sealed stage during the aspiration of the fluid. This increases the risk of exposing the aspirated fluid to the contaminated hospital ward environment.
  • the length of the syringe is almost doubled at the maximum volume of the fluid chamber, and therefore cumbersome to operate when the syringe is positioned on the patient's arm or next to the patient.
  • US 5,961,472 discloses a closed, one-handed blood sampling system which allows fluid do be drawn from a patient to a reservoir and returned thereto, but requires two independent squeezing motions.
  • the blood sampling system comprises a spring-based drawback mechanism.
  • the design of the device allows overshooting of fluid, such that over- aspiration may occur.
  • the proposed sealing of the fluid chamber is attempted by use of a harmonica-like resilient material, which is difficult to seal on the plastic portion of the syringe, and can be easily perforated. This would expose the fluid to the ambient contaminated hospital ward environment.
  • the length of the syringe is almost doubled at the maximum volume of the fluid chamber, and therefore cumbersome to operate when the syringe is positioned on the patient's arm or next to the patient.
  • US 5,374,401 discloses a blood sampling apparatus that allows the accumulator of blood and infusion solution mixtures remain sterile, for multiple uses.
  • the apparatus comprises a screw-like transmission design, wherein a housing is closed off by a rotatable cover, which, in turn, seals off the housing with a rotatable seal.
  • the cover and seal are threadingly connected via outer and inner threads.
  • the screw-like transmission design results in a low sensitivity to changes in resistance during the aspiration process. Thus, if an occlusion occurs, this will not be felt during aspiration. Moreover, it is not possible to determine the volume of aspirated fluid with the un-scaled fluid chamber. Furthermore, the existing design of the apparatus does not teach of an in-line device.
  • US 6,159,164 discloses a blood sampling system for sampling blood through an intravenous or intra- arterial tube.
  • the system comprises a plunger for drawing fluid from a fluid from the tube into a chamber, and for expelling the fluid from the chamber in to the tube.
  • the plunger creates a vacuum in the chamber, thereby causing fluid to be aspirated into the chamber.
  • Aspirating action causes fluid in the patient to be drawn up to the sampling site.
  • the elevation of the plunger is accomplished via an actuator connected to a stick-like handle. This system is operable by one hand. However, due to the design of the actuator, the force required to elevate and lower the handle is not the same along the distance of the handle.
  • the design of the device allows overshooting of fluid, such that over-aspiration may occur, similar to that described with the above prior art. Moreover, it is not possible to determine the volume of aspirated fluid with the un-scaled fluid chamber. Furthermore, the existing design of the apparatus does not teach of an in-line device.
  • the foregoing objects are accomplished by an apparatus and method that consists of an in-line sampling syringe for selectively introducing a fluid to and aspirating a fluid from a downstream fluid conduit connected to a catheterized patient.
  • the syringe comprises a fluid chamber into which fluid is aspirated.
  • a volume regulator is provided for adjusting the volume of the fluid chamber.
  • a fluid line through which fluid flows through said syringe connects to a downstream fluid conduit.
  • a valve mechanism is provided for selectively either allowing fluid flow along said fluid line or preventing fluid flow along said fluid line while simultaneously aspirating a fluid. This latter effect is achieved by selectively shifting the volume regulator to adjust the volume of the fluid chamber.
  • a housing joins the fluid chamber, the fluid line, the valve mechanism, the volume regulator and the control mechanism.
  • An electronic control apparatus is provided for operating said valve mechanism.
  • the method comprises operating the in-line sampling system for selectively introducing fluid to and aspirating a fluid from a downstream fluid conduit connected to a catheterized patient as described above and includes a syringe as described.
  • a fluid reservoir is provided for storing external fluid, and connected to the syringe via an upstream fluid conduit.
  • a catheter is provided for insertion into a patient, and connected to said syringe via a downstream fluid conduit.
  • a sampling port is situated along the downstream fluid.
  • the method further determines the presence of an occlusion along a patient side fluid conduit by the steps of providing in-line sampling as described, positioning the valve mechanism at a first position for allowing fluid flow along the fluid line, performing aspiration by shifting the position of the valve mechanism, measuring the increasing torque on the shaft of the motor connected to the syringe by one of taking constant measurements of the strain in the load cell and taking constant measurements of the current in the motor. From these measurements is can be determined whether an occlusion is present along the patient side fluid conduit. Additional objects and advantages of the present invention are described in detail herein below. Brief Description of the Figures
  • - Figs. Ia and Ib show an exploded perspective view (Fig. Ia) and an assembled perspective view (Fig. Ib) of a first embodiment of the present invention
  • - Figs. 2a and 2b show a cross-sectional first side view of the assembled first embodiment of the present invention of Fig. Ib, in an initial position (Fig. 2a) and a final position (Fig. 2b)
  • Fig. 3 shows a cross-sectional second side view of the first embodiment, shown in a 180 degree rotation about its horizontal longitudinal axis, as compared to that shown in Fig. 2a;
  • FIG. 4 shows a sampling system, comprising the syringe of the present invention in the initial position as shown in Fig. 2a;
  • Fig. 5 shows an alternative aspect of the first embodiment of the present invention in an exploded view;
  • - Figs. 6a and 6b show an alternative aspect of the first embodiment, in an initial position (Fig. 6a) and a final position (Fig. 6b);
  • Figs. 7a and 7b show an exploded perspective view of a second embodiment of the present invention (Fig. 7a) and an exploded view of the valve mechanism, the shifting mechanism and the motor coupling (Fig. 7b);
  • FIG. 8a and 8b show an assembled top perspective view of a sampling system (Fig. 8a) and an assembled bottom perspective view of the syringe (Fig. 8b) of the second embodiment;
  • Fig 8c shows a partially cutout perspective view of the syringe of the second embodiment
  • Figs. 9a, 9b and 9c show the plug element with the syringe in the pre- aspiration position (Fig. 9a), following initial aspiration (Fig. 9b) and after maximum aspiration (Fig. 9c);
  • Fig. 9d shows a bottom perspective view of the syringe of the second embodiment with the sealing plug removed from the housing;
  • FIG. 10a, 10b and 10c show one aspect of the sealing gasket, with the syringe in an initial position, pre-aspiration (Fig. 10a), following initial aspiration (Fig. 10b) and after maximum aspiration (Fig. 10c);
  • Fig. 10a, 10b and 10c show one aspect of the sealing gasket, with the syringe in an initial position, pre-aspiration (Fig. 10a), following initial aspiration (Fig. 10b) and after maximum aspiration (Fig. 10c);
  • - Fig. 1Od shows a perspective view of a first embodiment of the sealing gasket;
  • Figs. 11a, lib and lie show an alternative embodiment of the sealing gasket, with the syringe in an initial position, pre- aspiration (Fig. lla), following initial aspiration (Fig. lib) and after maximum aspiration (Fig. lie);
  • Fig. Hd shows a perspective view of a second embodiment of the sealing gasket
  • Figs. 12a-b show an exploded perspective view of the third embodiment of the present invention (Fig. 12a) and an exploded view of the components of the pressure system (Fig. 12b);
  • Fig. 12c shows a perspective view of a sampling system with the syringe of the third embodiment
  • Fig. 13 shows an assembled perspective view of the third embodiment of the present invention
  • - Fig. 14 shows a perspective view of the assembled syringe with the fluid chamber partially cutout
  • Figs. 15a-d show a top cut view of the third embodiment of the syringe of the present invention in a zeroing position (Fig. 15a), a fluid flow (open) position (Fig. 15b) a closed position with initial aspiration (Fig. 15c) and further aspiration (Fig. 15d); - Figs. 16a-d show cut perspective views of the syringe corresponding to Figs. 15a-d;
  • Figs. 17a-d shows an alternative aspect of the third embodiment, wherein the pressure transducer connects directly to a power source in a partially cut view (Fig. 17a), a bottom exploded view (Fig. 17b), a bottom assembled view (Fig. 17c), and showing the exploded components of the pressure system (Fig. 17d);
  • Figs. 18a-c show a fourth embodiment of the present invention in an assembled perspective view (Fig. 18a), in a partially cut perspective view (Fig. 18b) and a bottom perspective view (Fig. 18c);
  • Figs. 19a-b show a manually operable syringe with external dpt, connected to the arm of a patient (Fig. 19a) and with an internal dpt, connected to the arm of a patient (Fig. 19b);
  • Figs. 20a-b show a perspective view of the syringe of the second embodiment (Fig. 20a) and of the third embodiment (Fig. 20b);
  • Figs. 21a-b show an automatically operable syringe with an external pressure transducer (Fig. 21a) and an internal pressure transducer (Fig. 21b), mounted on a electronic control apparatus;
  • Figs. 22a-b show a front view of the electronic control apparatus and remote control device with the second embodiment of the syringe (Fig. 22a) and the third embodiment of the syringe (Fig.
  • Fig. 23 shows an exploded view of the electronic control apparatus
  • Fig. 24 shows an exploded view of the remote control device; - Figs. 25a-c show two aspects of the third embodiment of the syringe
  • Figs. 26a-d show sample pressure waveforms indicating different pressure conditions as measured by a pressure transducer;
  • Figs. 27 a-c show the gauge of a syringe of the present invention showing different positions of the valve with respect to Figs. 26a-d;
  • Figs. 28 a-c show a syringe of the second embodiment mounted on a electronic control apparatus showing different positions of the valve with respect to Figs. 26a-d;
  • Figs. 29a and 29b show torque load on the electronic motor shaft graphically represented as waveforms of non-occluded (Fig. 29a) and occluded (Fig. 29b) lines;
  • Figs. 30a and 30b shows a syringe in the open position, a syringe with the valve rotated, after aspiration has been performed along a non-occluded Fig. (30a) and occluded (Fig. 30b) line.
  • FIG. Ia A first embodiment of the in-line sampling syringe of the present invention is shown in Fig. Ia in an exploded view and in Fig. Ib in an assembled perspective view, and designated generally by numeral (100).
  • Syringe (100) selectively introduces a sterile fluid (e.g. saline solution) along a downstream fluid line (20) (e.g. an infusion or arterial tube) to a patient, and selectively withdraws the fluid from line (20) back into syringe (100).
  • a sterile fluid e.g. saline solution
  • a downstream fluid line (20) e.g. an infusion or arterial tube
  • syringe (100) is understood to be a closed, sealed to the ambient air, in-line aspirating device.
  • Syringe (100) comprises a fluid chamber (110) into which an infused fluid is aspirated from a downstream fluid conduit (20), a volume regulator (120) for adjusting the volume capacity of fluid chamber (110), a fluid line (130) along which fluid flows through syringe (100) towards a patient, and a valve mechanism (150) for regulating the fluid flow along fluid line (130) by selectively allowing fluid to flow along fluid line (130) towards a patient when desired, and preventing fluid to flow along fluid line (130) when aspirating the downstream fluid.
  • Valve mechanism (150) additionally selectively shifts volume regulator (120) to adjust the volume of fluid chamber (110).
  • Syringe (100) further comprises a housing (160) for joining fluid chamber (110), fluid line (130), valve mechanism (150) and volume regulator (120).
  • syringe (100) are preferably designed to be compact and small in size in order to be user friendly and to avoid potential risks during use as well as complications caused by the complexity of the procedure, which might normally be present in the prior art when such a device is mounted on the arm of a patient, or mounted on a bed or table near the patient.
  • FIG. Ia Also shown in Fig. Ia is a section of an upstream fluid conduit (10) for connecting to a fluid reservoir (not shown in this figure) and a section of a downstream fluid conduit (20) for contact with the patient (not shown).
  • a connector (22) joins downstream fluid conduit (20) with distal opening (112) of syringe (100) located at a first longitudinal (distal) end (111) of fluid chamber (110).
  • fluid chamber (110) is shown in a preferred cylindrical shape, but may alternatively comprise any other suitable shape, depending on design, mechanical and/or other considerations.
  • distal opening (112) of syringe (100) is located at first longitudinal end (111) of fluid chamber (110).
  • a second longitudinal (proximal) end (113) of fluid chamber (110) comprises an opening in communication with the fluid line (130), as described herein below.
  • the opening at second longitudinal end (113) is preferably larger than the opening at first longitudinal end (111), and enables at least a portion of volume regulator (120) to shift therethrough, as described further herein below.
  • housing (160) When syringe (100) is assembled, the open end (169) of housing (160) is coupled with longitudinal end (113) of fluid chamber (110).
  • the coupling of housing (160) with fluid chamber (110) may be accomplished by any suitable fastening means such as threading, clips, etc.
  • FIG. 4 shows a sampling system (101), comprising syringe (100) in the initial position as shown in Fig. 2a, a fluid reservoir (12) (e.g. an infusion bag) for storing, for example, saline solution, connected to syringe (100) via upstream fluid conduit (10), and a catheter (14), for insertion into a patient, connected to distal opening (112) of syringe (100) via downstream fluid conduit (20) and connector (22).
  • a fluid reservoir (12) e.g. an infusion bag
  • Connector (22) is shown threadingly coupled with opening (112), however, any form of a removably connectable coupling may be used to join connector (22) with opening (112).
  • a sampling port (16) is situated along downstream fluid conduit (20) for removing a blood sample at the site of the port via a blood sampling syringe (see Fig. 4).
  • Fluid line (130) is shown in one aspect of the first embodiment comprised of flexible tubing, as indicated illustratively by a bending (131), for instance, in Fig. 2a. It is understood that fluid line (130) preferably extends essentially straight, with minor bending, when fluid chamber (110) is in its initial position, as described herein.
  • valve mechanism (150) in the initial position of syringe (100), valve mechanism (150) is shown in an open position for allowing fluid to flow downstream through fluid line (130).
  • the first end (142) of opening (140) in valve mechanism (150) serves as an inlet and is in communication with an elongated port (162) located at the proximal end (164) of syringe (100).
  • valve mechanism (150) runs from valve mechanism (150) through the body (161) of housing (160), towards a first longitudinal (proximal) end (164) of housing (160).
  • the second end (144) of opening (140) valve mechanism (150) serves as an outlet and is in communication with the second end (134) of fluid line (130) through aperture (163) located in body (161) of housing (160).
  • Valve mechanism (140) is rotatingly disposed within a matching frame (166) in body (161) of housing (160), as described herein below.
  • Volume regulator (120) (see Fig. Ia and Fig. 2b) comprises a sealing gasket (122) for preventing leakage of fluid out of fluid chamber (110), and a drive portion (124) for shifting sealing gasket (122) within fluid chamber (110).
  • Sealing gasket (122) is connected via coupling member (126) at the first longitudinal end (125) of drive portion (124).
  • Sealing gasket (122) comprises an internal radial groove (121) (see Fig. 2a) within which a radial disk (127) of coupling member (126) is disposed.
  • the geometrical shape of coupling member and the corresponding shape of sealing gasket (122) is not limited to that shown herein, and may comprise an alternate design while performing essentially the same function as the components shown herein.
  • An anti-microbial vent (165) (see Fig. Ia), comprising a filter, is preferably located in an opening in housing (160) of syringe (100).
  • the filtered vent (165) prevents bacteria and/or other undesirable microorganisms from entering into syringe housing (160) when air is expelled out of vent (165) during the aspiration process, wherein sealing gasket (122) is shifted within fluid chamber (110), as well as when air is sucked into housing (160) through vent (165) when the syringe returns to the line-open position.
  • Vent (165) or at least a portion thereof also is preferably treated with an anti-microbial agent, such as silver ions.
  • fluid chamber (110) is in contact with the inner surface of first longitudinal end (111) of fluid chamber (110). In this position, fluid chamber (110) is at its minimum volume capacity, wherein preferably essentially zero amount of fluid may be accommodated therein, and fluid flows from fluid reservoir (12), shown in figure 4, through valve mechanism (150) and fluid line (130), and out of syringe (100) via distal opening (112).
  • Drive portion (124) comprises a shifting mechanism (152) (see Fig. Ia) for allowing drive portion (124) to shift sealing gasket (122) within fluid chamber (110).
  • Shifting mechanism (152) is comprised of a rack (154) and pinion (156) pair of gears for translating the rotational motion of the handle (151) into linear motion of drive portion (124), as described herein below, but may alternatively comprise any suitable mechanism for enabling the shifting of sealing gasket (122).
  • Fig. 3 shows a cross-sectional second side view cut longitudinally along syringe (100), seen from the perspective of the second side (i.e. the side facing into the paper in Fig. 2a).
  • syringe (100) is shown in Fig. 3 after a 180 degree rotation about its longitudinal axis, such that, for instance, rack gear (154) is shown vertically below pinion gear (156) in Fig. 2a, and vertically above pinion gear (156) in Fig. 3, relative to the correct orientation of the page.
  • Pinion gear (156) is positioned axially with, and behind frame (166) (as seen in Fig. 3) of body
  • valve mechanism (150) comprises a handle (151), and an elongated insertion member (158) rotatable about its central longitudinal axis.
  • Elongated insertion member (158) comprises a tip (159) shaped for disposing within slot (157) of pinion gear (156).
  • Opening (140) is essentially a through hole extending through elongated insertion member (158).
  • Valve mechanism (150) shifts between the open position as shown in Fig. 2a and a closed position as shown in Fig. 2b (as described herein below), by rotation of handle (151). The rotation between positions may be accomplished in a single motion, thereby reducing the steps required to be performed by the operator.
  • This design is not only simple to operate but also avoids the need for opening and closing of additional valves or clamps, thereby reducing the risk of error during the aspiration process.
  • valve mechanism (150) When valve mechanism (150) is in the closed position, fluid flow from upstream fluid conduit (10) is stopped, and fluid is aspirated from downstream (patient side) fluid conduit (20).
  • syringe (100) preferably further comprises a measuring gauge (168) for indicating the volume capacity of fluid chamber (HO) according to the position of volume regulator (120).
  • Gauge (168) is a semi-circular indicator, comprising a flat scale numbered from 0-6cc.
  • the rotation of handle (151) adjusts the volume capacity of fluid chamber (110) by shifting sealing gasket (122), as described herein below.
  • the position of handle (151) along gauge (168) indicates the volume capacity of fluid chamber (HO), wherein when handle (151) is oriented towards the "zero" indicia, fluid chamber (110) is at the minimum volume capacity (or, the initial position), and when handle (151) is oriented towards the "six" indicia, fluid chamber (110) is at the maximum volume capacity (or, the final position).
  • gauge (168) the measuring units and range used in gauge (168), as well as the geometric shape of gauge (168), depends on conventional measuring standards, the size of syringe (100), as well as other factors known by the man skilled in the art. Moreover, the size of syringe (100) may be designed according to the age/size of the patient. For instance, a smaller aspiration volume is needed in the fluid chamber for neonates.
  • gauge (168) in which the measuring units are shown on the front of gauge (168), and in which rotation of handle (151) for filling fluid chamber (110) is performed in a single motion, is advantageous when syringe (100) is mounted on the arm of a patient or situated on a bed or table near the patient, in that such a design reduces the need for the practitioner who is operating syringe (100) to be involved in more than one action while performing the withdrawing operation. This reduces the risk of incorrect operation of syringe (100) as well as injury to the patient.
  • the initial rotation of handle (151) of valve mechanism (150) in the first embodiment simultaneously rotates opening (140) as well as pinion gear (156), for both preventing fluid flow downstream through fluid line (130) and drawing a fluid into fluid chamber (110) via a vacuum created within fluid chamber (110).
  • opening (140) as well as pinion gear (156)
  • pinion gear (156) for both preventing fluid flow downstream through fluid line (130) and drawing a fluid into fluid chamber (110) via a vacuum created within fluid chamber (110).
  • the process between the initial shifting of handle (151) and the maximum rotation of handle (151) may be accomplished in a single motion.
  • flexible fluid line (130) shown partially cut
  • valve mechanism (150) in the final position of syringe (100), valve mechanism (150) is shown in a closed position. Fluid chamber (110) is at the maximum volume capacity, wherein, although not shown in Fig. 2b, handle (151) is oriented at the "six" position, as described herein above.
  • a constant resistance force is present during the rotation of handle (151) and translation into a linear aspiration.
  • An increase of resistance during the rotation of handle (151) may indicate an occlusion along fluid conduit (20).
  • An alternative aspect of the first embodiment is shown in an exploded view in Fig. 5, similar to that of Fig. Ia, wherein the fluid line (130') is comprised of two line sections (132a), (132b), telescopically arranged within syringe (100').
  • FIG. 6a A cross-sectional side view (similar to the view shown in Fig. 2a) of the second aspect of the assembled syringe (100') is shown in Fig. 6a, wherein fluid chamber (110) is at the minimum volume capacity (or, the initial position), as seen enlarged in Detail A.
  • Fluid line (130') extends essentially from distal opening (112) of syringe (100'), to second end (144) of opening (140) of the valve mechanism (not seen).
  • the first end (134b) of the second line section (132b) of fluid line (130') is disposed telescopically within the second end (134a) of the first line section (132a) of fluid line (130').
  • O-ring (135), situated on line section (132b), is for preventing leakage between telescopic line sections (132a) and 132b).
  • Fig. 6b shows the drawing of Fig. 6a, wherein fluid chamber (110) is at the maximum volume capacity (or, the final position), as seen enlarged in Detail B, wherein first line section (132a) telescopically overlaps first line section (132b).
  • FIG. 7a A second embodiment of the syringe of the present invention is shown in Fig. 7a in an exploded view, in Fig 8a in an assembled top perspective view as part of a sampling system (201), and in Fig. 8b in an assembled bottom perspective view, referred to generally by numeral (200), and comprises all of the essential features of the first embodiment, mutatis mutandis, with the differences described herein below.
  • syringe (200) comprises a fluid chamber (210) for withdrawing (aspirating) a fluid therein from a downstream fluid conduit, a volume regulator (220) for adjusting the volume capacity of fluid chamber (210), a rigid fluid line (230) along which fluid flows through syringe (200) towards a patient, and a valve mechanism (250) which allows fluid to flow along fluid line (230) towards a patient, and prevents fluid flow along fluid line (230) when withdrawing the downstream fluid.
  • Valve mechanism (250) selectively alternates the orientation of opening (240) as well as selectively shifts volume regulator (220) to adjust the volume of fluid chamber (210).
  • Syringe (200) further comprises a housing (260) for joining fluid chamber (210), fluid line (230), valve mechanism (250) and volume regulator (220) to form a single unit.
  • Rigid fluid line (230) is preferably prevented from bending and/or coiling, or otherwise adjusting in length, such as telescopically, as opposed to the fluid line according to the first embodiment of the present invention. This provides a mechanically more simple aspiration process than that of the first embodiment.
  • the distal opening (212) of syringe (200) is located at first longitudinal end (211) of fluid chamber (210).
  • a second longitudinal (proximal) end (213) of fluid chamber (210) comprises an opening in communication with the fluid line (230), as described herein below.
  • the opening at second longitudinal end (213) is preferably larger than the opening at first longitudinal end (211), and enables at least a portion of volume regulator (220) to shift therethrough.
  • fluid chamber (210) When assembled, as seen in Figs. 8a and 8b, the open end (269) (Fig. 7a) of housing (260) is coupled with second longitudinal end (213) of fluid chamber (210). Additionally, fluid chamber (210) comprises wings (218) that fit into opposing slots (267) in housing (260), thereby providing additional connecting means between fluid chamber (210) and housing (260).
  • Fig. 8a shows sampling system (201), comprising syringe (200), a fluid reservoir (12) connected to syringe (200) via upstream fluid conduit (10), and a catheter (14), for insertion into a patient, connected to distal opening (212) of syringe (200) via downstream fluid conduit (20) and connector (22).
  • a sampling port (16) is situated along downstream fluid conduit (10) for removing a blood sample at the site of the port via a blood sampling syringe (not shown).
  • Fig. 8c shows a partially cutout perspective view of syringe (200), cut along housing (260) a fluid chamber (210).
  • a sealing plug (265) is shown in the back wall of housing (260). Sealing plug (265) is best seen in Fig. 8b, and described further herein below.
  • an opening (not shown) in housing (260) allows air to be expelled when sealing gasket (222a) shifts within fluid chamber (210).
  • An anti-microbial vent is present in housing (260) of syringe (200), similar to that described in the first embodiment.
  • syringe (200) instead of a vent, syringe (200) comprises a sealing plug (265) disposed in an opening (see Fig. 9d) in housing (260), for maintaining a totally closed environment, sealed from the ambient air and for preventing any contamination that might otherwise occur with the presence of a vent.
  • Sealing plug (265) comprises an elastic membrane cover (271) situated at the outer end thereof, for preventing air from entering into and being released from housing (260).
  • membrane (271) expands outward due to pressure buildup of air within housing (260).
  • Fig. 9c shows membrane (271) fully expanded when syringe (200) is in the final position of maximum aspiration.
  • a bottom perspective view of syringe (200) is shown in Fig. 9d with sealing plug removed from housing (260).
  • Syringe (200) further comprises means for setting a predefined maximum volume of fluid chamber (210).
  • the means comprises at least one protrusion (202) (five protrusions are shown in the figures) extending outward, orthogonally from gauge (268), and a stopper
  • a predetermined rotational limit may be set for handle (251).
  • stopper (204) is joined with syringe (200), such as, at handle (250) via cord (205), or any alternative joining means.
  • the means for setting a predefined maximum volume of fluid chamber (210) comprises indentations within gauge (268) and a stopper for positioning thereat.
  • fluid chamber (210) It is advantageous to set a predefined maximum volume of fluid chamber (210), as this prevents excess fluid aspiration, particularly when only a limited amount of fluid is desired to be drawn into fluid chamber (210), such as in cases of severe blood loss as well as in newborn infants.
  • a coupling (275) is provided in order to accommodate the shaft of a motor (not shown), for enabling valve (250) to rotate via the motor, as described herein below.
  • Coupling (275) comprises a cavity portion (276) (Fig. 8b) for receiving the shaft of a motor (not shown) therein, and a coupling- shaft portion (277), which is coupled to tip (259) of elongated insertion member (258) via slot (257) in pinion (256).
  • the coupling component for accommodating the shaft of a motor may be present in all embodiments of the present invention, mutatis mutandis.
  • Rotation of valve (250) may be accomplished manually, or by a motor of a electronic control apparatus as further described herein below with regards to alternative embodiment but relates to the second embodiment, mutatis mutandis.
  • the advantages of rotating valve (250) via a motor include maintaining the sterile environment of syringe (200) by reducing potential contamination that could occur during manual handling of syringe (200).
  • the rotation of valve (250) via a motor enables the measuring of resistance of the movement of handle (251), as described further herein below. This allows the operator to determine possible occlusion in a more precise manner than simply attempting to "measure" the resistance by hand.
  • a partial cutout of a first side of fluid chamber (210) of the assembled syringe (200) is taken along a portion of fluid chamber (210), distally towards distal opening (212), and shown in Fig. 10a wherein syringe (200) is in the initial position, in which fluid flows through fluid line (230) and no aspiration is performed; in Fig. 10b, in which an initial aspiration is performed; and in Fig. 10c, in the final position in which maximum aspiration is performed.
  • Sealing gasket (222a) shown in a perspective view in Fig 1Od comprises a protruding ring element (228) located at the opening of gasket (222a), which is positioned around fluid line (230), as seen enlarged in Detail C in Fig. 10a.
  • Protruding ring element enables a laminar blood flow, which thereby reduces the potential of hemolysis from occurring as the blood flows from fluid line (230)
  • Ring element (228) is preferably an integral portion of gasket (222a).
  • gasket (222b) An alternative embodiment of gasket (222b) is shown in Figs, lla-d, and enlarged in Detail D, wherein in Fig. 11a syringe (200) is in the initial position, in which fluid flows through fluid line (230) and no aspiration is performed, in Fig. lib an initial aspiration is performed, and in Fig. lie, the final position in which maximum aspiration is performed.
  • sealing gasket (222b) is shown without the ring element of Figs. lOa-c, which simplifies the manufacturing process and reduces costs.
  • a third embodiment of the syringe of the present invention is shown in an exploded view in Fig. 12a, and in an assembled view in Fig. 13, referred to generally by numeral (300), and comprises all of the essential features of the previous embodiments, mutatis mutandis, with the following differences.
  • syringe (300) comprises - as integral components thereof - a blood pressure measuring system for continuously measuring a patient's blood pressure, as well as a flushing mechanism (380) flushing the line before and/or after sampling takes place.
  • the components of the blood pressure measuring system is shown in an exploded view in Fig. 12b, and described herein below.
  • Syringe (300) is shown as a component of a sampling system (301) in Fig. 12c, as described herein above with respect to the previous embodiments.
  • a sterile fluid such as saline is typically introduced to a patient along a fluid conduit in order to prevent blockage of the conduit.
  • blockage may nevertheless occur.
  • a change in the blood pressure reading it must be determined whether the change is due to an actual change in the physiological status of the patient, or due to a blockage or crimp in the fluid conduit joining the patient with the blood pressure reader, or any other glitch in one of the components of the system.
  • the components of the third embodiment of the present invention enable the practitioner to determine the source of a change in blood pressure reading, as described herein below.
  • Another means for indicating an occlusion is a change in the resistance while withdrawing fluid into the fluid chamber, as mentioned herein above.
  • the interlocking toothed relationship between the gears of the pinion and rack preferably enables a relatively fast linear displacement of the volume regulator. This allows a sensitivity to even a slightly higher resistance than usual during the displacement process.
  • Flushing mechanism (380) of the present invention is situated upstream of proximal port (362), and is connected with an upstream coupler (11) for connecting to upstream conduit (10).
  • a sealing plunger (388), for selectively allowing and preventing fluid flow is enclosed by a housing (391) and cover (392). Flushing mechanisms are standard features in the field, and have various designs that are well known in the known in the art.
  • the blood pressure measuring system comprises a differential pressure transducer (372) located within fluid chamber (310), for measuring pressure along fluid line (330) and a stopcock valve (350) for selectively allowing and preventing fluid flow along fluid line (330), as well as for opening fluid line (330) to atmospheric pressure for calibration of pressure transducer (372) via outlet (381), as described herein below.
  • Pressure transducer (372) is at least partially enclosed by casing (370), having an atmospheric air inlet (375).
  • Atmospheric air inlet (375) is open to the atmosphere for allowing an internal membrane (not shown) within pressure transducer (372) to flex to enable pressure to be measured along fluid line (330).
  • a cable (373) and connector (374) extend from pressure transducer (372) for connecting to a power supply.
  • a clip (371) is shown for mounting syringe (300) on a mounting board (not shown).
  • Detail E shown in Fig. 13, is an enlargement of the portion of syringe (300), illustrating a clamp (311) which secures cable (373) extending out of syringe (300) at the seam at which fluid chamber (310) and housing (360) are joined together.
  • the outer tip of atmospheric air inlet (375) is shown extending out of clamp (311).
  • FIG. 15a-d A top view of syringe (300) is shown in a partial cross-section in Figs. 15a-d, showing fluid chamber (310) partially cut along fluid line (330), as well as a cross-section of outlet (381). Syringe (300) is in the zeroing position in Fig. 15a, in the fluid flow (also referred to herein as pre-aspiration) position in Fig. 15b, in the initial aspiration position, wherein fluid line (310) is closed, in Fig. 15c, and in a further aspiration position in Fig. 15d. Figs.
  • valve (350) in order to zero the pressure transducer (372), stopcock valve (350) is turned to the "zero" indicia, in which the longitudinal axis of opening (340) is rotated such that fluid is prevented from flowing through fluid line (330), while simultaneously allowing communication between pressure transducer (372) and the atmosphere via outlet (381).
  • valve (350) comprises an air-flow conduit (353) for enabling air flow between fluid line (330) and outlet (381).
  • Apertures (332) located near the closed tip (333) of fluid line (330), through which fluid flows, are covered by ring element (328) of gasket (322) (see Fig. 15a) when zeroing pressure transducer (372), thereby blocking air-flow communication with the patient.
  • fluid line (330) is a solid line (i.e. without apertures (332)), and open at its tip, wherein a cap, comprising apertures around its periphery is fixedly positioned on the tip
  • a second end of pressure transducer (372) is in communication with the atmosphere via atmospheric air inlet (375) (see Fig. 14) extending from pressure transducer (372), and open to the atmosphere.
  • the differential pressure is measured as zero, and indicated as zero pressure.
  • stopcock valve (350) is then turned to the "open" indicia, in which the longitudinal axis of opening (340) and the longitudinal axis of fluid line (330) are aligned. Ring element (328) shifts away from and thereby uncovers apertures (332), and fluid is allowed to flow from a fluid reservoir (not shown) to the patient (not shown). Pressure measurement can then be performed.
  • Outlet (381) is preferably covered with cap (383) when zeroing is not taking place.
  • Outlet (381) preferably comprises an antibacterial filter, such as that described herein above
  • valve (350) when it is desired to perform aspiration, valve (350) is turned to the "closed” indicia, in which the longitudinal axis of opening (340) is rotated such that fluid is prevented from flowing through fluid line (330), and simultaneously, an initial amount of fluid is aspirated into fluid chamber (310).
  • Figs. 15d and 16d show further aspiration of fluid into fluid chamber (310).
  • the pressure transducer system comprises the pressure transducer (372') within fluid chamber (310).
  • the components of the pressure transducer system of the alternative aspect of the third embodiment are shown in an exploded view in Fig. 17d.
  • Pressure transducer (372') is disposed within casing (370'), wherein casing (370') (see Fig. 17b) comprises a connector (374') having contacts that connect directly into a power supply (i.e. without a cable).
  • Connector (374') extends out of the back (i.e. bottom) of syringe, although may be designed differently according to alternative specifications. Atmospheric air inlet (375') is positioned between the contacts of connector
  • a fourth embodiment of the present invention is shown in an assembled perspective view in Fig. 18a, in a partially cut out perspective view in Fig. 18b and in a bottom perspective view in Fig. 18c, referred to generally by numeral (400), and comprises all of the essential features of the third embodiment, mutatis mutandis, with the following differences.
  • the components of the blood pressure measuring system are situated outside of fluid chamber (410) of syringe (400).
  • pressure transducer (472) is positioned downstream from fluid chamber (410).
  • Zeroing valve (485) selectively allows and prevents fluid flow from the fluid line within syringe (400) to the downstream fluid conduit (not shown in the figure). In the figures, zeroing valve (485) is closed, for preventing fluid flow.
  • Stopcock valve (374) is additionally joined with an outlet (481) to the atmosphere, directed away from syringe (400), for communication between pressure transducer (472) and the atmosphere for zeroing purposes, as described herein above regarding the third embodiment.
  • Fig. 19a shows a manually operable syringe (200) of the second embodiment of the present invention (shown conveniently enlarged in Fig. 20a) (or, alternatively, syringe (100) of the first embodiment) attached to the arm (50) of a patient, with infusion bag (12) for introducing sterile fluid through syringe (200).
  • External pressure transducer (72) is connected to syringe (200), and measurement readings are displayed on monitor (80).
  • Fig. 19b shows a manually operable syringe (300') of the third embodiment (shown conveniently enlarged in Fig.
  • Fig. 21a automatically operable syringe (200) of the second embodiment is mounted on an electronic control apparatus (60) which is attached to the bedside (54) of a patient (52), and an infusion bag (12) for introducing sterile fluid through syringe (200).
  • Remote control device (90) for controlling electronic control apparatus (60) is positioned as shown in Fig.
  • remote control device (90) is positioned on top of electronic control apparatus (60) (see Fig. 22a).
  • electronic control apparatus 60
  • Fig. 22a external pressure transducer (72) is connected to syringe (200). The pressure transducer should be positioned at the level of the measured organ. Measurement readings are displayed on monitor (80).
  • automatically operable syringe (300') of the third embodiment is mounted on an electronic control apparatus (60) which is attached to the bedside (54) of a patient (52), and an infusion bag (12) for introducing sterile fluid through syringe (300').
  • Remote control device (90) for controlling electronic control apparatus (60) is positioned in a way that will enable the pressure transducer inside syringe 300' to be on the same horizontal plane of the organ that is monitored for pressure measurements.
  • remote control device (90) is positioned on top of electronic control apparatus (60) (see Fig. 22b).
  • the internal pressure transducer is situated within fluid chamber (310) of syringe (300'), and measurement readings are displayed on monitor (80).
  • the remote control device and electronic control apparatus, as well as the monitor are connected via a wire.
  • a wireless remote control device for controlling the electronic control apparatus is utilized.
  • the wireless remote control device, electronic control apparatus and monitor are wireless communicatable with each other.
  • a local or remote control station (not shown in the figures) is optionally present for programming any one of the automatic operations described herein below to operate according to a predetermined routine based on preset instructions, such as time of day, length of operation, threshold limits, etc.
  • Figs. 22a and 22b show the front panel of remote control device (90), wherein device is positioned on top of electronic control apparatus (60).
  • the panel comprises an on/off button (93) and a selected volume display (94) with buttons for raising and lowering the setting. Buttons for automatic aspiration (95), line opening (96), zeroing (97), performing an occlusion test (98) and base line (99) are present on the panel.
  • a visual status lamp (57) of device (90) and automatic flushing button (not shown) are also preferably present.
  • Electronic control apparatus (60) and remote control device (90) are shown each in an exploded view in Fig. 23 and 24, respectively.
  • electronic control apparatus (60) comprises a casing base (61) and casing cover (62).
  • Casing cover (62) comprises an opening (64) through which shaft (65) of the gear (66a) engages with motor (79).
  • Upper and lower connectors (67a), (67b) are present for connecting the dpt connector of a syringe with the pressure transducer within the fluid chamber (connector
  • a syringe sensor (69) is a button sensor for determining whether no syringe is present, whether a large syringe is present, in which sensor (69) is pressed all the way into casing cover (62), and whether a small syringe is present, in which sensor (69) is partially pressed into casing cover (62).
  • the syringe is affixed to apparatus (60) via a pair of clips (70).
  • Switch (71) selectively turns electronics of casing on and off. Additionally or alternatively, a light indicator turns on when electronic control apparatus (60) is on and/or in use.
  • Casing base (61) comprises a connector (73) for the remote control wire, a connector (74) for the patient monitor output, a connector (75) for the dpt cable connector, and a DC power connector (76).
  • Connector (75) is adaptable to receive the connector at the end of a cable extending from the pressure transducer, as described herein above.
  • the remote control device is hingedly connectable to casing base (61) via hinges (77).
  • the internal components of electronic control apparatus (60) consist of a rechargeable battery (85), a motor (79), as mentioned herein above, a gear (66), a torque meter (66a) (seen in enlarged Detail F) and an encoder (78).
  • PCB (81) comprises a microprocessor (82) and buzzer (83), as well as a wireless module (84).
  • motor shaft (65) rotates the valve on the syringe of the present invention, as described herein above.
  • Remote control device (90) as seen in Fig. 24, comprises a casing base (85) and casing cover (86).
  • Casing base comprises a DC connector (87) and a connector (88) for communicating with the electronic control apparatus, and/or to a control station as mentioned herein above.
  • Internal components of remote control device (90) consist of battery (89), PCB (91) and a wireless module (92).
  • the front panel of casing cover (86) of remote control device is described herein above. It is understood that at least some of the features of electronic control apparatus (60) and remote control device (90) are optional and some features may be interchanged with alternatively similar or dissimilar features and elements.
  • Fig. 25a shows a side view of electronic control apparatus (60) having one aspect of syringe 300' of the third embodiment mounted thereon.
  • the pressure transducer is situated within fluid chamber (310), and a connector (374') connects directly into the upper connector of electronic control apparatus (60) (i.e. without a cable).
  • Shaft (65) of electronic control apparatus (60) is shown entering a coupling (275) (see Fig. 7b).
  • Fig. 25b shows a side view of electronic control apparatus (60) having syringe (400) of the fourth embodiment mounted thereon.
  • the pressure transducer is situated downstream of fluid chamber (410), and a connector (374) connects directly into the lower connector of electronic control apparatus (60).
  • Shaft (65) of electronic control apparatus (60) (see Fig. 23) is shown entering a coupling (275) (see Fig. 7b).
  • Fig. 25c shows a perspective view of electronic control apparatus (60) having one aspect of syringe (300) of the third embodiment mounted thereon.
  • a cable (373) and an appropriate connector extend from the pressure transducer for connecting to electronic control apparatus as shown.
  • Shaft (65) of electronic control apparatus (60) (see Fig. 23) is shown entering a coupling (275) (see Fig. 7b).
  • OTC occlusion test characteristic.
  • the BLC measurements are compared to the OTC measurements and it is determined whether the OTC measurements are within the predefined limits of the BLC. If yes, the shaft, and in turn, the valve, is rotated back to the open position. If no, an indicative alarm sounds, after which the valve is rotated back to the open position.
  • the valve is first rotated via the motor shaft to the zero indicia on the gauge, and remains in that position for the predetermined zeroing delay time (ZTD). The valve is then rotated back to the open position.
  • the shaft rotates the valve to the selected aspiration volume (AV) position.
  • the time-volume-pressure aspiration characteristics (AC) are measured and monitored, and a continuous comparison is made between the AC and OTC. If the measurements are not within the predefined limits, an indicative alarm is sounded and the shaft rotates the valve back to the open position. If the measurements are within the predefined limits, a sample is taken, and then the valve is rotated back to the open position, via the line opening operation as described herein below.
  • the motor shaft rotates the valve to the open position, to allow fluid to flow through the fluid line.
  • the line opening operation is either performed by the operator pressing the appropriate button on the control panel after the sample is take, or may be automatically set to be performed after a predefined amount of time (or maximum time limit) after the shaft is first rotated prior to taking the sample.
  • the “Flushing” operation comprises the flushing fork (plunger) being manipulated as desired by pressing and letting go and/or pressing and holding the appropriate button.
  • Figs. 26a-d show pressure wave diagrams indicating different pressure conditions as measured by a pressure transducer, for instance, with respect to syringe (300') of the third embodiment of the present invention, wherein the pressure transducer is within the fluid chamber.
  • the different positions of valve (350) are shown in gauge portion (368) in Figs. 27a, 27b', 27b" and 27c above the waveforms respectively, indicating a manual operation, and shown below the waveforms in Figs. 28a, 28b', 28b” and 28c respectively, mounted on electronic control apparatus (60), indicating automatic operation.
  • the x-axis measures time and the y-axis measure pressure.
  • Fig. 26a shows a normal arterial line blood pressure waveform (302a) prior to positioning valve (350) at the "zero” indicia on gauge (368), thereby calibrating the pressure to zero, as indicated by the zero'd waveform (303).
  • valve (350) is rotated manually; in Fig. 28a valve (350) is rotated by a motor shaft to the zero indicia on the gauge, and remains in that position for the predetermined zeroing delay time (ZTD), as described herein above.
  • Fig. 26b shows the normal arterial line blood pressure waveform (302a) following the initial opening of the valve.
  • Valve (350) is positioned at the "open" indicia (i.e. the "line opening” operation) manually in Fig. 27b' and automatically in Fig. 28b', in which fluid flow of saline through the syringe is allowed.
  • valve (350) is positioned at the "closed” indicia by manual rotation (Fig. 27b") and automatic rotation (Fig. 28b"), thereby preventing fluid flow through the fluid line, however pressure measurements may be taken.
  • Figs. 27c and 28c show the syringe after maximum aspiration.
  • fluid is aspirated into the fluid chamber of the syringe (300') as described herein above.
  • a fast recovery is shown (304) in Fig. 26c along the waveform (302c), indicating a non-occluded conduit.
  • a slow recovery (305) of the waveform (302c) occurs, as shown in Fig. 26d, this is an indication of a partial occlusion of the fluid conduit.
  • Figs. 29 and 30 show the torque based coagulation detection operation of the present invention, which is performed with the embodiments of the syringe that do not have the pressure sensor located within the fluid chamber, for instance, syringe (200) of the second embodiment.
  • the increase of resistance required to rotate the valve in order to aspirate fluid is an indication of an occluded fluid conduit.
  • the torque load on the electronic motor shaft is graphically represented as waveforms (202), (203) in Figs. 29a and 29b respectively, wherein the x-axis is a measurement of time and the y-axis is a measurement of torque.
  • Fig. 29a depicts the torque required to retract the syringe for a non-occluded downstream (i.e. patient side) fluid conduit
  • Fig. 29b depicts the torque developed in the shaft in an occluded or partially occluded downstream fluid conduit.
  • Fig. 30a' shows syringe (200) in the open position
  • Fig. 30a" shows syringe (200) with valve (250) rotated, after aspiration has been performed along a non-occluded line.
  • Fig. 30b' shows syringe (200) in the open position
  • Fig. 30b” shows syringe (200) with valve (250) rotated until the system stops the automatic drawing due to the torque valve reaching a
  • Electronic apparatus (60) constantly measures the developed torque on the shaft by measuring the strain in the load cell, or alternatively, the current in the motor. In order to prevent the creation of a vacuum in the syringe and patient side line, the torque load is not increased passed a a predefined upper limit value above the base line. If excessive torque is measured, this indicates a high degree of occlusion. The process stops and an alert message is activated.

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Abstract

La présente invention concerne un appareil d'échantillonnage en ligne et une méthode d'introduction sélective d'un fluide dans, et d'aspiration d'un fluide depuis, un conduit de fluide en aval raccordé à un patient cathétérisé. Ledit appareil consiste en une seringue qui possède une chambre de fluide, ledit fluide étant aspiré dans ladite chambre. Un régulateur de volume ajuste le volume de la chambre de fluide. Une conduite de fluide traverse la seringue jusqu'à une conduite de fluide en aval. Un mécanisme de valve laisse passer sélectivement le fluide le long de la conduite de fluide ou empêche le flux de fluide le long de la conduite de fluide tout en aspirant simultanément un fluide. En outre, ledit mécanisme déplace sélectivement le régulateur de volume pour ajuster le volume de la chambre de fluide. Un boîtier relie la chambre de fluide, la conduite de fluide, le mécanisme de valve, le régulateur de volume et le mécanisme de commande. Un appareil de commande électronique fait fonctionner le mécanisme de valve. Ladite méthode comprend la capacité de déterminer des occlusions dans la conduite.
PCT/US2010/037043 2009-06-03 2010-06-02 Appareil en ligne fermé et méthode d'aspiration de fluide Ceased WO2010141563A2 (fr)

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US13/296,327 US9357950B2 (en) 2009-06-03 2011-11-15 Apparatus and method of fluid aspiration
IL216436A IL216436A (en) 2009-06-03 2011-11-17 Sampling system on patient line
US14/206,469 US20140194778A1 (en) 2009-06-03 2014-03-12 Syringe enabled for aspirating blood into a sampling site in a closed manner and method

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US18388609P 2009-06-03 2009-06-03
US61/183,886 2009-06-03

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8034021B2 (en) 2002-11-19 2011-10-11 Biometrix Ltd. Manifold hub for patient fluid administration
US9074920B2 (en) 2009-06-03 2015-07-07 Biometrix Ltd. Apparatus and method for bedside collection of body fluids and automatic volume level monitoring
US9357950B2 (en) 2009-06-03 2016-06-07 Biometrix Ltd. Apparatus and method of fluid aspiration
US10362981B2 (en) 2007-08-23 2019-07-30 Flowsense Ltd. Diagnostic methods and systems based on urine analysis
CN110547812A (zh) * 2019-09-23 2019-12-10 江苏科华医疗器械科技有限公司 一种环绕浮动式采血装置
WO2023225139A1 (fr) * 2022-05-19 2023-11-23 Becton, Dickinson And Company Dispositif d'accès vasculaire à cathéter extensible

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107362402B (zh) * 2017-08-07 2020-08-21 广东省人民医院(广东省医学科学院) 单筒自动造影注射器

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6579263B1 (en) * 2002-01-11 2003-06-17 Milton Chernack Method and apparatus for the delivery of contrast fluid to a patient
US20070255167A1 (en) * 2004-03-01 2007-11-01 Wolfe Tory Medical, Inc. Apparatus for monitoring intra-abdominal pressure
US20050096627A1 (en) * 2003-11-03 2005-05-05 Howard Mark E. Fluid aspiration device

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8034021B2 (en) 2002-11-19 2011-10-11 Biometrix Ltd. Manifold hub for patient fluid administration
US8361011B2 (en) 2002-11-19 2013-01-29 Biometrix Ltd. Manifold hub for patient fluid administration
US10362981B2 (en) 2007-08-23 2019-07-30 Flowsense Ltd. Diagnostic methods and systems based on urine analysis
US9074920B2 (en) 2009-06-03 2015-07-07 Biometrix Ltd. Apparatus and method for bedside collection of body fluids and automatic volume level monitoring
US9357950B2 (en) 2009-06-03 2016-06-07 Biometrix Ltd. Apparatus and method of fluid aspiration
CN110547812A (zh) * 2019-09-23 2019-12-10 江苏科华医疗器械科技有限公司 一种环绕浮动式采血装置
CN110547812B (zh) * 2019-09-23 2022-05-27 江苏科华医疗器械科技有限公司 一种环绕浮动式采血装置
WO2023225139A1 (fr) * 2022-05-19 2023-11-23 Becton, Dickinson And Company Dispositif d'accès vasculaire à cathéter extensible

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WO2010141563A3 (fr) 2011-03-03
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