WO2008102382A1 - Dispositif polyvalent servant à insérer un cathéter veineux ou artériel au moyen d'un système de sécurité jetable - Google Patents

Dispositif polyvalent servant à insérer un cathéter veineux ou artériel au moyen d'un système de sécurité jetable Download PDF

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Publication number
WO2008102382A1
WO2008102382A1 PCT/IT2007/000112 IT2007000112W WO2008102382A1 WO 2008102382 A1 WO2008102382 A1 WO 2008102382A1 IT 2007000112 W IT2007000112 W IT 2007000112W WO 2008102382 A1 WO2008102382 A1 WO 2008102382A1
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WO
WIPO (PCT)
Prior art keywords
needle
plunger
container
venous
cursor
Prior art date
Application number
PCT/IT2007/000112
Other languages
English (en)
Inventor
Michela Facco
Original Assignee
Michela Facco
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 Michela Facco filed Critical Michela Facco
Priority to PCT/IT2007/000112 priority Critical patent/WO2008102382A1/fr
Publication of WO2008102382A1 publication Critical patent/WO2008102382A1/fr

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Classifications

    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies

Definitions

  • the present patent relates to percutaneous venous and arterial catheters used in anesthesia or to administer medication; it particularly concerns a new all-purpose device for inserting a venous or arterial catheter using a disposable safety system.
  • Percutaneous catheters are routinely inserted in major blood vessels, having become an important, even essential part of the procedure for the proper implementation of numerous therapeutic actions, such as venous or arterial pressure measurement, the injection of anesthetics or the administration of medication in difficult settings.
  • the operator punctures the skin with a syringe, penetrating far enough to reach the artery or vein and aspirating a minimal quantity of blood to ensure that the needle has entered the blood vessel.
  • a Seldinger wire is then inserted through the suitably-perforated plunger of the syringe, and the wire is driven forward in the blood vessel until it reaches the required position.
  • the operator then removes the syringe and a dilator consisting of a rigid cannula suitable for dilating the path from the skin to the artery or vein is slidingly inserted along the Seldinger wire in order to facilitate the subsequent insertion of the catheter.
  • a dilator consisting of a rigid cannula suitable for dilating the path from the skin to the artery or vein is slidingly inserted along the Seldinger wire in order to facilitate the subsequent insertion of the catheter.
  • the dilator is then removed and the catheter is slidingly inserted along the Seldinger wire until it penetrates inside the blood vessel and reaches the required position. Finally, the Seldinger wire is also removed, sliding it out through the inside of the catheter, which can then be connected to the bottles of pharmaceutical and/or anaesthetic solution.
  • a needle and a dilator with an aspirating structure for inserting central venous and arterial catheters that consist of a needle applied to a plunger, the two being combined together and integrated with each other, both slidingly contained inside a container that is equipped with a dilator at one end and with a lateral aspiration device and a mechanism for feeding the Seldinger wire.
  • Such devices serve the purpose of facilitating the above-described operations, making the procedure for inserting the catheter far more rapid, effective and safe.
  • Said known devices thus comprise a cylindrical container housing a needle attached to a plunger. Both the needle and the plunger are axially perforated to enable the passage of the Seldinger wire.
  • a cursor connected to the plunger and lying on the outside of the container enables the operator to slide said plunger inside the cylindrical container, thereby slidingly displacing the needle.
  • Said cylindrical container is fixed to a tank with a piston, i.e. an aspiration or injection device, that communicates with the plunger and consequently with the needle by means of a hole obtained in said plunger.
  • a piston i.e. an aspiration or injection device
  • the combined device also comprises a dilator for the purpose of expanding the path so as to facilitate the subsequent insertion of the catheter.
  • Said dilator is situated at the front end of the cylindrical container and is axially perforated and positioned in such a way as to enable the passage of the needle and of the Seldinger wire.
  • the dilator consists of a cannula whose internal diameter is sufficient to contain the needle, and whose external diameter is comparable with that of the catheter being inserted. A part of the length of said dilator has a slightly tapered shape to enable the connection of the needle to the front end of the cylindrical container.
  • Said known devices thus enable the Seldinger wire to be installed in the required position inside the patient's blood vessel and, at the same time, they dilate the path along which the catheter will subsequently be inserted.
  • Said known devices thus enable the Seldinger wire to be installed in the required position inside the patient's blood vessel and, at the same time, they dilate the path along which the catheter will subsequently be inserted.
  • the known devices nonetheless have certain drawbacks, the First of which is that they carry the risk of air entering the device - and consequently also the patient's blood vessel, through the channel in the needle, when the Seldinger wire is inserted. Moreover, these known devices have to be removed ⁇ whenever the operator needs, for instance, to check the patient's arterial or venous blood pressure, with the previously- mentioned consequent risks of infection and related discomfort.
  • the main aim of the present invention is to make the operation for inserting the catheter extremely safe, rapid and effective, reducing the number of instruments required.
  • Another object of the present invention is to carry out a closed system, that is, a system capable of preventing any air from entering the device and, as a result, the patient's artery or vein, after the needle has been inserted in the patient's blood vessel.
  • a closed system that is, a system capable of preventing any air from entering the device and, as a result, the patient's artery or vein, after the needle has been inserted in the patient's blood vessel.
  • Another object of the present invention is to enable the measurement of the patient's arterial or venous blood pressure with no need to remove said device.
  • a further object of the present invention is to protect both the operator and the patient from accidental puncture, injury, infection, etc., thereby ensuring the maximum safety for operator and patient.
  • Another important object of the present invention is to prevent any reuse of the device once it has been used.
  • Another important object of the invention is to prevent the removal of the needle once the device has been used.
  • a further object of the present invention is to carry out an extremely safe, self-locking device capable of preventing any accidental hazardous slipping and thereby complying with the standards on Needlestick-Prevention Devices (NPD).
  • NPD Needlestick-Prevention Devices
  • the above and other direct and complementary objects are achieved by the new all- purpose device for inserting venous or arterial catheters with a disposable safety system that is completely closed to prevent any air from entering the device, with combined needle and dilator, and with a valve for directly and immediately monitoring the arterial or venous pressure in the patient's blood vessel, as well as being capable of preventing any accidental slipping at the end of the needle's stroke.
  • the new device mainly consists of a substantially cylindrical container in which an axially perforated needle is slidi ⁇ gly contained, said needle being attached to a plunger that is also axially perforated.
  • said plunger slides inside the container parallel to its longitudinal axis, thereby inducing the simultaneous sliding of said needle.
  • said cylindrical container is provided with a cannula serving as a dilator, while there is provision for an aspiration zone either in a back position, opposite the needle, or alongside the container and communicating with the inside of the needle by means of a valve or channel integral with said plunger.
  • said aspiration zone lies in a back position and communicates with the inside of the needle by means of at least one valve situated to the rear of said plunger.
  • the operator uses a cursor or other appendage on the outside of the cylindrical container, solidly attached to said plunger, said cursor comprising one or more antireflux valves to enable the insertion of the Seldinger wire and the connection of means for monitoring the patient's arterial or venous blood pressure.
  • Said sealing septum prevents any air from entering the device before, during and after the insertion of said Seldinger wire.
  • the channel for inserting the Seldinger wire is preferably in the form of a curve with a wide radius of curvature in order to avoid it interfering with the insertion and passage of said Seldinger wire through said channel.
  • Said channel in the cursor comprises at least one branch wherein the outer opening in the second branch of said channel contains a further antireflux valve for directly and immediately monitoring the arterial or venous pressure in the patient's blood vessel.
  • said valve enables the connection of the transducer of a blood pressure measuring device.
  • the operator extracts the needle by sliding the cursor towards the front part of the container, then inserts the needle in the patient's artery or vein.
  • the operator punctures the septum in the valve on the cursor with the tip of the wire and then slides the wire through the channel until it emerges from the tip of the needle previously inserted in the patient's artery or vein.
  • the operator can monitor the patient's venous/arterial blood pressure throughout the procedure by connecting the transducer of the pressure measuring device to the valve provided for said purpose in the cursor.
  • the new device can include at least one syringe lying alongside and attached to said container such that the syringe's tank is placed in communication with the inside of the container by means of a hole or hollow channel obtained in said tank and/or said container.
  • the inside of said syringe's tank can also be placed in communication with the inside of said needle by means of a channel provided in said plunger such that, when the plunger is in a given forward position, said channel in the plunger is in communication with said hollow channel in the container.
  • said channel in the plunger comprises a branch that also leads to the outside of the device, suitable for the insertion and passage of the Seldinger wire, at the inlet of which there is a valve closed with a septum in self-sealing material that can be perforated with the end of the
  • the new disposable device has several design features and safety systems intended to protect both operators and patients against the risk of injury, accidental puncture, etc.
  • the dilator is long enough to completely cover the needle when the device is closed, i.e. when the cursor rests up against the rear end of the container and the needle is completely withdrawn.
  • said dilator is stably attached to the end of the container, so that it cannot be accidentally dislodged from its position.
  • said dilator is stably attached to the end of the container by means of suitable locking wings engaging in corresponding seats in said container, so that the dilator cannot be accidentally dislodged from its position.
  • the rear part of the container is closed with a locking element that is perforated to give access to the aspiration valve at the rear end of the plunger.
  • Said locking element serves the dual purpose of preventing the cursor, plunger and needle from sliding out of the rear end of the container, and of stopping their sliding action at the end of the cursor's stroke once the new device has been used for the first time, thereby preventing the plunger and needle from sliding forward again and consequently preventing the needle from re-emerging from the front end of the dilator.
  • the needle can no longer be extracted; it remains engaged in a fully retracted position, preventing any risk of accidental puncture.
  • said cursor on the plunger can comprise a locking system consisting, for instance, of a small pin that, when lowered, engages in corresponding enclosed seats obtained in the walls of the cylindrical container so that the cursor, and consequently the needle, cannot be displaced from the established positions.
  • Said seats for containing the pin of the locking device may be obtained, for instance, in the vicinity of the two ends of the container, thereby determining the needle's two end- of-stroke positions.
  • the pin when the disposable device is closed, the pin fits into a seat obtained in the vicinity of the rear end of the cylindrical container, so that the device retains the needle in a fully retracted position inside the container and inside the dilator, so that neither the operator nor the patient can be accidentally punctured by the pointed tip of the needle.
  • said locking device is opened, i.e. the pin is lifted by taking action on the corresponding release device, the needle can slide inside the container until it emerges from the container and from the dilator, and can consequently be used.
  • the cylindrical container comprises a further seat in which the pin of the locking device can engage, said seat being obtained in the vicinity of the front end of the cylindrical container, so that the needle can be locked in its fully extended position and the device can be used without the risk of the needle becoming dislodged from the required position.
  • Figure la-a shows a cross-section along the line identified as a-a in Figure 1.
  • Figures 3, 4 and 5 respectively show views from below and the side, and a three- dimensional view of the rear locking element (C).
  • Figures 6, 7 and 8 respectively show rear, top and three-dimensional views of the plunger (S) and cursor (K) assembly.
  • Figure 6a-a shows a lateral cross-section of the plunger (S) and cursor (K) assembly along the line identified as a-a in Figure 6.
  • Figure 9 shows the new device fully assembled, in the position with the needle (A) completely retracted (1) and with the needle (A) completely extended (2).
  • Figure 9a-a shows a lateral cross-section of the fully-assembled new invention along the line identified as a-a in Figure 9.
  • Figure 9b shows a detail of the system for engaging the plunger (S) in the rear locking element (C).
  • Figure 10 shows a three-dimensional view of the fully-assembled new device.
  • Figures 11 and 12 respectively show a front view and a side view of the new device complete with the syringe (L) alongside, which comprises a tank (Ll) and a piston (L2).
  • Figures 13a and 13b show cross-sections of the new device with the syringe (L) alongside, respectively with the needle (A) completely retracted ( Figure 13a) and with the needle (A) fully extended outside the container (I) ( Figure 13b).
  • Figure 13c shows a cross-section of the new device with the syringe (L) alongside, with the needle (A) completely retracted and no longer extractable because it is retained in position (3) by the locking device (B), which works as illustrated schematically in
  • the container (I) has a substantially cylindrical shape and slidingly contains an axially perforated needle (A), the rear end (Al) of which is inserted in and attached to a plunger (S) that is also contained inside said container (I).
  • Said plunger (S) is solidly attached to a cursor (K) outside the container (I), designed to enable the operator to make the plunger (S), and consequently also the needle (A), slide inside the container (I).
  • Said plunger (S) comprises a channel (Sl) in communication with the rear end (Al) of the needle (A) and with an external opening (S2) for aspiration purposes closed with a valve (Vi) covered with a sealing septum or membrane (ViI) ( Figures 6-10), and/or a syringe (L), which in turn comprises a tank (Ll) with a sliding piston (L2) ( Figures 11- 14b).
  • Said channel (Sl) in the plunger is also in communication with at least one channel (Kl) obtained inside said cursor (K), wherein said channel has an external opening
  • Said channel (Kl) forms a curve and has a valve (Vk) over its external opening (K2), covered with a septum (VkI) made of a self-sealing material that can be perforated by the Seldinger wire and that serves the purpose of preventing any air from penetrating inside the device both during and after the insertion of said wire.
  • Vk valve
  • VkI septum
  • said channel (Kl ) in the cursor (K) comprises a branch (K3) that also leads to the outside of the device, at the external opening (K4) of which there is an antireflux valve (Vm), covered with a suitable membrane (Vm 1 ), and/or a plug.
  • Said valve (Vm) is shaped so as to allow for the connection of a transducer for measuring arterial and venous blood pressure when the needle (A) in the device is inserted in the patient's blood vessel.
  • the new device also comprises a syringe (L), which in turn comprises a substantially cylindrical tank (Ll) attached in a substantially parallel position alongside said container (I).
  • said channel (Sl) in said plunger (S) is designed so that when the plunger (S) is in position 2, ( Figure 13b), the opening in said channel (Sl) is opposite the opening in the hollow channel (L3) leading to the inside of said tank (Ll).
  • Said hollow channel (L3) also comprises a branch leading to the outside of the device, at the external opening of which there is an antireflux valve (Vm) covered with a suitable membrane.
  • Said valve (Vm) is shaped so as to enable the connection of a transducer for taking arterial and venous blood pressure measurements.
  • the inside of the needle (A) can be placed in communication with said transducer via the channel (S l) in the plunger and the channel (L3) that leads, via said valve (Vm), to the connection for said transducer.
  • the new device also comprises a cannula serving as a dilator (D) positioned at the front end (12) of the container (I), from where the needle (A) emerges.
  • One end (Dl) of the dilator (D) is at least partially tapered to enable the connection of the needle (A) to said dilator (D), said dilator being stably attached to the end of the container (I), e.g. by means of one or more locking wings (D2) and (D3) that engage in corresponding seats in said container (I), thereby preventing the dilator (D) from being accidentally dislodged from its position.
  • the new invention also comprises one or more safety and locking elements (C, B), attached to the rear of said container (I).
  • said container (1) to comprise a rear opening (II), closed with a locking element (C) that is perforated (Cf) to give access to the valve (Vi) on the plunger (S).
  • Said locking element (C) is consequently designed to be solidly attached to said container (I) and substantially serves the purpose of preventing the plunger (S), cursor (K) and needle (A) from sliding out of the rear opening (II) in the container (I).
  • Said locking element (C) comprises one or more tabs (Cl) suitable for engaging in corresponding grooves (13) provided in the walls of said container (I).
  • Said tabs (Cl) lie parallel to the walls of the container (I) and comprise wedge-shaped projections (C2) facing towards the inside of said container (I).
  • Said projections (C2) serve the purpose of engaging inside seats (Sb) provided in said plunger (S), said seats (Sb) occupying a position coinciding with said projections (C2) when said plunger (S) is in a completely withdrawn position (3), with the needle (A) also fully retracted, once the device has been used for the first time ( Figure 9a-a).
  • the needle (A) occupies a fully extended position (2). Once it has been used, the needle (A) is withdrawn and returns to position (1), and the plunger (S) is drawn further back to the rear of the container (I) enabling said projections (C2) to engage in said seats (Sb).
  • the new device comprises, for instance, a clip (B) suitable for closing Fixedly around a stud (Bl) solidly attached to the rear wall of the container (I).
  • said locking system (B2) may consist, for instance, of a pin (B22) that can be lowered to engage in corresponding enclosed seats (Fl) and (F2) obtained in the walls of the container (I) in the vicinity of the two ends of said container (I).
  • a pin (B22) of the locking system (B2) engages in one of said seats (Fl, F2), any sliding of the cursor (Pl), plunger (S) and needle (A) is prevented and the needle (A) remains locked in its fully-retracted position (1) or in its fully-extended position (2).
  • the locking system (B2) also comprises a suitable release device (B4) that makes said pin (B 22) emerge from the seat (Fl, F2) in which it is engaged.
  • a retaining device (B3) attached to the container (I) and/or to the tank (Ll) of the syringe (L) to prevent the cursor (K), and consequently the plunger (S) and needle (A), from becoming disengaged from the container (I), and/or to prevent the piston (L2) from sliding out.
  • Said retaining device (B3) also serves the purpose of ensuring the stable assembly of the new disposable device.

Abstract

La présente invention concerne un nouveau dispositif utilisé pour insérer un cathéter veineux ou artériel. Le dispositif comprend un contenant dans lequel une aiguille et un piston, tous deux perforés dans la direction axiale, peuvent coulisser axialement, un élément de dilatation fixé solidement au contenant au niveau de l'extrémité d'où sort l'aiguille et un curseur situé sur l'extérieur du contenant qui est solidement fixé audit piston. Le curseur contient au moins un passage donnant accès à l'intérieur de l'aiguille, les ouvertures externes présentes dans lesdits passages étant fermées par une membrane et/ou un moyen d'obturation et/ou une seringue pour empêcher l'air de pénétrer dans le dispositif ou pour empêcher le sang du patient de s'écouler à l'extérieur lorsque l'aiguille est introduite dans le vaisseau sanguin du patient.
PCT/IT2007/000112 2007-02-19 2007-02-19 Dispositif polyvalent servant à insérer un cathéter veineux ou artériel au moyen d'un système de sécurité jetable WO2008102382A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IT2007/000112 WO2008102382A1 (fr) 2007-02-19 2007-02-19 Dispositif polyvalent servant à insérer un cathéter veineux ou artériel au moyen d'un système de sécurité jetable

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IT2007/000112 WO2008102382A1 (fr) 2007-02-19 2007-02-19 Dispositif polyvalent servant à insérer un cathéter veineux ou artériel au moyen d'un système de sécurité jetable

Publications (1)

Publication Number Publication Date
WO2008102382A1 true WO2008102382A1 (fr) 2008-08-28

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PCT/IT2007/000112 WO2008102382A1 (fr) 2007-02-19 2007-02-19 Dispositif polyvalent servant à insérer un cathéter veineux ou artériel au moyen d'un système de sécurité jetable

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Country Link
WO (1) WO2008102382A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102716542A (zh) * 2012-07-19 2012-10-10 郑州迪奥医学技术有限公司 侧部进丝的四合一导丝导入器
USD808013S1 (en) 2016-10-27 2018-01-16 Smiths Medical Asd, Inc. Catheter
US10675440B2 (en) 2016-02-18 2020-06-09 Smiths Medical Asd, Inc. Closed system catheter
CN114616014A (zh) * 2019-10-28 2022-06-10 麦迪.普罗有限责任公司 用于动脉通路的生物医学装置

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4030497A (en) * 1975-11-03 1977-06-21 The Kendall Company Syringe assembly
US5257979A (en) * 1992-07-27 1993-11-02 Ravindar Jagpal Instrument for catheterization
WO2003075995A1 (fr) * 2002-03-08 2003-09-18 Emmebi S.R.L. Dispositif mixte aiguille-dilatateur pour catherisation veineuse et arterielle centrale

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4030497A (en) * 1975-11-03 1977-06-21 The Kendall Company Syringe assembly
US5257979A (en) * 1992-07-27 1993-11-02 Ravindar Jagpal Instrument for catheterization
WO2003075995A1 (fr) * 2002-03-08 2003-09-18 Emmebi S.R.L. Dispositif mixte aiguille-dilatateur pour catherisation veineuse et arterielle centrale

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102716542A (zh) * 2012-07-19 2012-10-10 郑州迪奥医学技术有限公司 侧部进丝的四合一导丝导入器
US10675440B2 (en) 2016-02-18 2020-06-09 Smiths Medical Asd, Inc. Closed system catheter
USD808013S1 (en) 2016-10-27 2018-01-16 Smiths Medical Asd, Inc. Catheter
USD893711S1 (en) 2016-10-27 2020-08-18 Smiths Medical Asd, Inc. Catheter assembly
CN114616014A (zh) * 2019-10-28 2022-06-10 麦迪.普罗有限责任公司 用于动脉通路的生物医学装置
CN114616014B (zh) * 2019-10-28 2023-11-14 麦迪.普罗有限责任公司 用于动脉通路的生物医学装置

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