WO1993005832A1 - Automatic cannulation device - Google Patents

Automatic cannulation device Download PDF

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Publication number
WO1993005832A1
WO1993005832A1 PCT/US1992/007625 US9207625W WO9305832A1 WO 1993005832 A1 WO1993005832 A1 WO 1993005832A1 US 9207625 W US9207625 W US 9207625W WO 9305832 A1 WO9305832 A1 WO 9305832A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
needle
piston
penetration
blood vessel
Prior art date
Application number
PCT/US1992/007625
Other languages
French (fr)
Inventor
Filiberto P. Zadini
Giorgio C. Zadini
Original Assignee
Zadini Filiberto P
Zadini Giorgio C
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 Zadini Filiberto P, Zadini Giorgio C filed Critical Zadini Filiberto P
Priority to JP5506098A priority Critical patent/JP3050600B2/en
Priority to CA002118693A priority patent/CA2118693C/en
Priority to EP92919851A priority patent/EP0603300A4/en
Priority to AU25939/92A priority patent/AU667685B2/en
Publication of WO1993005832A1 publication Critical patent/WO1993005832A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0612Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585Needle inserters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1587Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body suitable for being connected to an infusion line after insertion into a patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1588Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3112Incorporating self-aspirating means, e.g. to provide flashback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0693Flashback chambers

Definitions

  • TECHNICAL FIELD This invention relates to blood vessel cannulation devices and is particularly directed to automatic means for catheter placement within blood vessels.
  • BACKGROUND ART Cannulating blood vessels is a common procedure in patient care, in order to administer fluids, drugs, blood or blood products.
  • catheter for accomplishing cannulation.
  • the needle is within the catheter; while in the other instance, the catheter is within the needle.
  • the needle serves to penetrate the skin and the wall of the blood vessel and, once the blood vessel has been entered, the catheter is advanced manually until an ade ⁇ quate position is reached.
  • manual catheter placement involves both of the operator's hands; one for stabilization of the needle, and the other for advancement of the catheter.
  • manual catheter placement is an extremely delicate procedure which can be
  • SUBSTITUTESHEET performed only by specially trained and highly skilled medical personnel and, even then, placement failure is not uncommon, due to such factors as failure to recognize penetration of the blood vessel, sequence delays, disrup ⁇ tion of the continuity of the blood vessel, patient anatom ⁇ ical variability, etc.
  • TITUTESH ⁇ ET improved catheter placement device which auto ⁇ matically advances the catheter, once the blood vessel has been penetrated, and which may be triggered one-handedly or, in a preferred embodiment, includes means for sensing penetration of a blood vessel and for automatically advanc ⁇ ing the catheter in response to such penetration.
  • an improved catheter placement device comprising a needle, a catheter concentric with the needle, resilient means urging said catheter to an advanced position, and means for triggering the resilient means upon penetration of the wall of a blood vessel.
  • the triggering means may be manual or may include means for sensing pene ⁇ tration of a blood vessel and for automatically advancing the catheter in response to such penetration.
  • Another object of the present invention is to provide an improved catheter placement device which permits one- handed insertion and placement of a catheter.
  • An additional object of the present invention is to provide an improved catheter placement device which permits automatic advancement of the catheter, once a blood vessel has been penetrated.
  • a specific object of the present invention is to provide an improved catheter placement device comprising a needle, a catheter concentric with the needle, self-pro ⁇ pelled, automatic means for catheter advancement, and means for triggering said means for self-propelled advancement upon penetration of the wall of a blood vessel.
  • the trig ⁇ gering means may be manual or may include means for sensing penetration of a blood vessel and for automatically advanc ⁇ ing the catheter in response to such penetration.
  • FIGURE 1 is a transverse section through a catheter placement device embodying the present invention
  • FIGURE 2 is a view, similar to that of FIG. 1, show ⁇ ing the catheter placement device is its unlocked position;
  • FIGURE 3 is a vertical section through the catheter placement device of FIG. 1, taken on the line 44 of FIG. 1;
  • FIGURE 4 is a plan view of the latch member of the catheter placement device of FIG. 1;
  • FIGURE 5 is a transverse section through an alterna ⁇ tive form of the catheter placement device of FIG. 1, shown in the unarmed condition;
  • FIGURE 6 is a view showing the catheter placement device of FIG. 5 in its armed condition, after penetration of the skin, but prior to penetration of a blood vessel;
  • FIGURE 7 is a view showing the catheter placement device of FIG. 5 immediately following penetration of a blood vessel
  • FIGURE 8 is a view showing the catheter placement device of FIG. 5 following advancement of the catheter;
  • FIGURE 9 is transverse section through another alternative form of the catheter placement device of FIG. 1, shown in its unarmed condition;
  • FIGURE 10 is a view showing the catheter placement device of FIG. 9 in its armed condition, after penetration of the skin, but prior to penetration of a blood vessel;
  • FIGURE 11 is a view showing the catheter placement device of FIG. 9 immediately after penetration of a blood vessel ;
  • FIGURE 12 is a view showing the catheter placement device of FIG. 9 following advancement of the catheter;
  • FIGURE 13 is a transverse section through a further alternative form of the catheter placement device of FIG. 1, shown in its unarmed condition;
  • FIGURE 14 is a view showing the catheter placement device of FIG. 13 in its armed condition, after penetration of the skin, but prior to penetration of a blood vessel;
  • FIGURE 15 is a view showing the catheter placement device of FIG. 13 in its armed condition, after penetration of the skin, but prior to penetration of a blood vessel;
  • FIGURE 16 is a view showing the catheter placement device of FIG. 13 following advancement of the cathe ⁇ ter;
  • FIGURE 17 is a view, similar to that of FIG. 1, showing another alternative form of the catheter placement device of FIG. 1;
  • FIGURE 18 is a view, similar to FIG. 5, showing another alternative form of the catheter placement device of FIG. 5;
  • FIGURE 19 is a view, similar to that of FIG. 5, showing an additional alternative form of the catheter placement device of FIG. 5;
  • FIGURE 20 is a view, similar to FIG. 9, showing a further alternative form of the catheter placement device of FIG.9;
  • FIGURE 21 is a view, similar to that of FIG. 20, showing the catheter placement device of FIG. 20 in its "armed" position;
  • FIGURE 22 is a view, similar to that of FIG. 9, showing another alternative form of the catheter placement device of FIG. 9;
  • FIGURE 23 is a view, similar to that of FIG. 22 showing the catheter placement device of FIG. 21 in its "armed" position;
  • FIGURE 24 is a view, similar to that of FIG. 22 showing the catheter placement device of FIG. 22 immediate ⁇ ly after penetration of a blood vessel;
  • FIGURE 25 is a view, similar to that of FIG. 22 showing the catheter placement device of FIG. 22 immediate ⁇ ly after release of the catheter;
  • FIGURE 26 is a view, similar to that of FIG. 9, showing an additional alternative form of the catheter placement device of FIG. 9;
  • FIGURE 27 shows an alternative form of the catheter placement device with an automatic arming rod
  • FIGURE 28 shows a cross-section of the automatic arming rod of FIG. 27
  • FIGURE 29 is a view, similar to that of FIG. 27, showing the catheter placement device of FIG. 27 after skin penetration and the beginning of the automatic arming process;
  • FIGURE 30 is a view, similar to that of FIG. 27, showing the catheter placement device of FIG. 27 after skin penetration, in a further stage of the arming process;
  • FIGURE 31 is a view, similar to that of FIG. 27, showing the catheter placement device of FIG. 27 immediate ⁇ ly after penetration of a blood vessel;
  • FIGURE 32 is a view, similar to that of FIG. 27, showing the catheter placement device of FIG. 27 immediate ⁇ ly after release of the catheter;
  • FIGURE 33 is a view, similar to that of FIG. 27, after the removal of the needle, showing connection of the catheter with the intravenous tubing;
  • FIGURE 34 shows an additional alternative form of the catheter placement device
  • FIGURE 35 is a view, similar to that of FIG. 34, showing the catheter placement device of FIG. 34 immediate ⁇ ly after skin penetration;
  • FIGURE 36 is a view, similar to that of FIG. 34, showing the catheter placement device of FIG. 34, immedi ⁇ ately after release of the catheter;
  • FIGURE 37 is a view, similar to that of FIG. 9,. showing an additional form of the catheter placement device of FIG.9;
  • FIGURE 38 is a view, similar to that of FIG. 5, showing an alternative form of the catheter placement device of FIG. 5 prior to skin penetration;
  • FIGURE 39 is a view, similar to that of FIG. 38, showing the catheter placement device of FIG. 38 immediate ⁇ ly after skin penetration;
  • FIGURE 40 is a view, similar to that of FIG. 38, showing the catheter placement device of FIG. 38 immediate- ly after blood vessel penetration;
  • FIGURE 41 is a view, similar to that of FIG. 38, showing the catheter of the catheter placement device of FIG. 38 placed intravenously;
  • FIGURE 42 shows the separate four components of a further alternative form of the catheter placement device
  • FIGURE 43 shows the device of fig 42 while being assembled
  • FIGURE 44 shows a further stage on the assembly of catheter placement device of fig. 42;
  • FIGURE 45 shows the assembled unit of fig. 2 prior to skin penetration
  • FIGURE 46 shows the assembled unit of fig.42 after penetration into a blood vessel
  • FIGURE 47 shows the disengaging of the propelling unit of fig. 42 from the catheter placed intravenously
  • FIGURE 48 shows an alternative form of the catheter placement device of fig.5;
  • FIGURE 49 shows a top view of the same catheter device of fig . 48 ;
  • FIGURE 50 shows the catheter placement device of fig.48 after blood vessel penetration
  • FIGURE 51 shows an alternative form of a semi-auto ⁇ matic catheter placement device
  • FIGURE 52 shows the catheter placement device of fig.51 after blood vessel penetration.
  • FIGURE 53 shows yet an alternative form of a fully automatic catheter placement device, where the means for sensing penetration are represented by an opto-electric source-sensor pair.
  • FIGURE 54 show an alternative form of the device of fig.53 where the represented sensors are temperature sen ⁇ sors.
  • FIGURE 55 show an alternative form of the device of fig. 53 where the represented sensors are sensors detecting the electrical conductivity properties of the blood.
  • FIGURE 56 shows an alternative form of the device of fig.53 in which the represented sensor is a flow detector sensor.
  • FIGURE 57 shows an alternative device of fig.53, where the represented sensor is an acoustic sensor.
  • FIGURE 58 shows yet an alternative form of the device of fig.53 in which the represented sensor is a pressure sensor.
  • FIGURE 59 shows yet an alternative form of the device of fig.53 in which the represented sensor is an illustra ⁇ tion of a sensor of chemical properties of the blood, such as a pH sensor, or of a sensor capable of sensing presence of blood by detecting presence of a component of the blood, such as oxygen.
  • the represented sensor is an illustra ⁇ tion of a sensor of chemical properties of the blood, such as a pH sensor, or of a sensor capable of sensing presence of blood by detecting presence of a component of the blood, such as oxygen.
  • a catheter placement device comprising a needle 12, having a tubular hollow shaft 14 projecting from a handle portion 16, and a flexible catheter 18 projecting from a hub 20.
  • the catheter 18 concentrically encircles the shaft 14 of the needle 12, while the catheter hub 20 telescopes over the forward portion of the needle handle portion 16.
  • the needle 12 may be made to concentrically telescope over the catheter 18.
  • the catheter hub 20 has a radial flange 22 formed adjacent the rear end 24 of the hub 20 and has a lever 26, formed of resilient material, projecting rearwardly from one side of the flange 22 and having an opening 28 formed adjacent the free end of the lever 26, as best seen in FIG. 4.
  • a bridge member 30 projects radially outward from the needle handle 16 and, as best seen in FIG.3, has an aperture 32 formed therein to receive the lever 26 and has a stud 34 project ⁇ ing into the aperture 32 which is mateable with the opening 28 of the lever 26 to releasably retain the lever 26 and, hence, the hub 20 and catheter 18 in the position shown in FIG. 1.
  • resilient means such a spring 36, is mounted between the rear end 24 of the catheter hub 20 and the front end 38 of the handle portion 16 of the needle 12 to urge the hub 20 and catheter 18 forwardly.
  • the catheter 18 and needle 12 are in the positions seen in FIG. 1, with the catheter 18 encircling the shaft 14 of the needle 12 and with opening 28 of lever 26 of the catheter 18 engaging the stud 34 of the bridge member 30 on the handle portion 16 of the needle 12 to releasably lock the catheter 18 in the position shown in FIG. 1.
  • the operator presses the lever 26 toward the handle portion 16 of the needle 12, causing opening 28 of the lever 26 to disengage from the stud 34 and allowing spring 36 to drive the catheter 18 forwardly and, thereby, to advance and position the catheter 18 within the blood vessel.
  • the needle 12 may be removed and the tubing containing the food, drugs or other desired material may be attached to the hub 20 of the catheter 18 for delivery of the desired material into the patient's blood vessel.
  • the lever 26 can be operated by the same hand which is holding the needle handle 16, thus, enabling the operator to position the needle 12, advance and place the catheter 18 and with ⁇ draw the needle 12 in a one-handed operation, leaving the operator's other hand free for other purposes.
  • FIGURES 5-8 show an alternative form, indicated generally at 39, of the catheter placement device 10 of. FIG. 1 which serves to automatically advance the catheter when the blood vessel is penetrated.
  • the catheter 40 encircles the needle shaft 42 and has a hub 44 formed with an annular recess 46 extending about the interior surface of the hub 44.
  • the needle 42 has a generally cylindrical hub 48 formed with openings 50 in the side walls 52 of the needle hub 48 to receive balls 54, to releasably lock the catheter hub 44 in the position shown in FIG. 5, as will be more fully ex ⁇ plained hereafter.
  • the rear end 56 of the needle hub 48 carries a radial flange 58 and a cylindrical wall 60 ex ⁇ tends forwardly from the flange 58 to encircle and guide movement of the catheter hub 44, which is telescopically slideably between the needle hub 48 and the cylindrical wall 60.
  • a spring 59 is mounted within the cylindrical wall 60 rearwardly of the catheter hub 44 and serves to urge the catheter hub 44, and consequently, the catheter 40 forward ⁇ ly.
  • a wall member 62 divides the interior of the needle hub 48 and defines a forward chamber 64 and a rearwardly open ⁇ ing recess 66.
  • a piston 68 is slideably mounted and has an annular recess 70 extend ⁇ ing about the periphery of the piston 68, which serves to receive the balls 54 when the catheter 40 is released, as hereinafter described.
  • a spring 72 is located between the wall member 62 and the piston 68 to normally urge the piston 68 to seat against the forward end of the chamber 64, as seen in FIG. 5, so that the body 74 of the piston 68 serves to force the balls 54 to extend through openings 50 to engage the recess 46 of the catheter hub 44 and, hence, to releasably lock the catheter hub 44 in the position shown in FIG. 5, against the urging of spring 59.
  • the wall member 62 has a central opening 76 and a post-needle member 78 is mounted in the opening 76 and projects rearwardly as shown.
  • a capsule 80 is slideably mountable within the rearwardly opening recess 66 of the needle hub 48 and has a plug 82 closing the open end 84 of the capsule 80.
  • the capsule 80 contains a vacuum and the plug 82 is rupturable, when pressed against the post-needle member 78, to cause partial retraction of the piston 68, as more fully de ⁇ scribed below.
  • FIG. 5 shows the catheter placement device 39 in preparation for use, but prior to insertion.
  • FIG. 6 shows the catheter placement device 39 after the needle 42 has penetrated the skin 86 of a patient, but prior to penetra ⁇ tion of a blood vessel 88.
  • the operator presses the vacuum capsule 80 forwardly, causing the post-needle member 78 to pierce the plug 82.
  • This causes air from the forward chamber 64 of the needle hub 48 to enter the capsule 80, which creates a partial vacuum within the chamber 64 and serves to partial ⁇ ly retract piston 68 against the action of spring 72.
  • This creates a vacuum within the chamber 64 forwardly of the piston 68, as seen at region 90.
  • the body 74 of the piston 68 still serves to force the balls 54 into recess 46 to continue locking the catheter hub 44 in its retracted position, as seen in FIGS. 5 and 6.
  • the catheter placement device 39 is now "armed" to automatically advance the catheter 40.
  • the needle 42 has penetrated the wall 89 of the patient's blood vessel 88.
  • blood from the blood vessel 88 is drawn into region 90 by the vacuum in the region 90.
  • This drives the piston 68 rearwardly, against the action of spring 72, to the point that the annular recess 70 of the piston 68 becomes aligned with openings 50 of the side walls 52 of the needle hub 48. Consequently, balls 54 can move into the recess 70 of the piston 68 and out of the recess 46 of the catheter hub 44.
  • spring 59 drives the catheter hub 44 and catheter 40 forwardly, automatically, without any action by the operator, to advance and place the catheter 40, as seen in FIG. 8.
  • the catheter placement device 39 is initially in the position shown in FIG. 5, with the catheter 40 retracted and with piston 68 urged forwardly by spring 72, causing balls 54 to pass through openings 50 in the side walls 52 of the needle hub 48 to enter recess 46 of the catheter hub 44 and, hence, to lock the catheter 40 in its retracted position.
  • the operator presses the vacuum capsule 80 forward, causing the post- needle member 78 to penetrate the plug 82.
  • This causes air from chamber 64 of the needle hub 48 to enter the vacuum capsule 80 and serves to partially retract the piston 68 to create a vacuum within region 90 forward of the piston 68, as seen in FIG. 6, and thereby "arming" the catheter place ⁇ ment device 39.
  • the catheter placement device 39 provides simple and automatic, yet highly accurate placement of the catheter 40.
  • FIGURES 9-12 show another alternative form, indicated generally at 92, of the catheter placement device 10 of FIG.l comprising a needle shaft 94 projecting from a gener ⁇ ally cylindrical hub 96 having a flange 98 extending radi ⁇ ally outward from the rear end 100 of the needle hub 96 and having a cylindrical sleeve 102 extending forwardly from the flange 98 and spaced from the side wall 103 of the cylindrical hub 96 to define a space 104 therebetween.
  • a flexible tubular catheter 106 encircles the needle shaft 94 and projects forwardly from a generally cup-shaped catheter hub 108 having a side wall 110 which is telescopically slideable within the space 104 of the needle hub 96.
  • a spring 112 is positioned within the space 104 between the flange 98 of the needle hub 96 and the rear end of the side wall 110 of the catheter hub 108 and serves to urge the catheter hub 108 forwardly.
  • the side wall 110 of the cathe ⁇ ter hub 108 is formed with an internal annular recess 114 and the side wall 103 of the cylindrical needle hub 96 are formed with openings 116 and balls 118 are seated in the openings 116 and extend into the recess 114 to releasably lock the catheter hub 108 in its retracted position, as seen in FIGS. 9, 10 and 11.
  • a piston 120 is slideably mount ⁇ ed within the cylindrical needle hub 96 and is formed with an annular recess 122, located adjacent the forward end of the piston 120, and an axial recess 124, extending forward ⁇ ly from the rear end 125 of the piston 120.
  • the needle hub 96 has a stud 126 projecting radially outward adjacent the rear end 100 of the needle hub 96 and a trigger member 128 encircles the stud 126 and is slideably mounted thereon.
  • the trigger member 128 is formed with a pair of forwardly projecting flanges 130 and 132.
  • Flange 130 extends forward ⁇ ly from the inner edge 134 of the rear surface 136 of the trigger member 128 and a spring 127 is seated between the stud 126 and the trigger member 128 to urge the trigger member outward causing flange 130 of the trigger member 128 to normally engage the rear end 125 of the piston 120, as seen in FIG. 9, and serving to normally prevent rearward movement of the piston 120.
  • Flange 132 extends forwardly from the inner edge 138 of the front surface 140 of the trigger member 128.
  • a latch member 142 is supported by a resilient stem 143, which projects outwardly from the outer surface of the sleeve 102 of the needle hub 96 adjacent flange 132 of the trigger member 128.
  • the latch member 142 has an inclined rear surface 144, which is normally posi ⁇ tioned to partially underlie the end of flange 132 of the trigger member 128, as seen in FIG. 9.
  • a spring 146 is located within the cylindrical needle hub 96 for ⁇ wardly of the piston 120 to normally urge the piston 120 rearwardly.
  • the catheter placement device 92 is normally in the condition seen in FIG. 9 with the trigger member 128 urged outwardly by spring 127 urging trigger member 128 to its outward position wherein flange 130 engages piston 120 to hold the piston 120 in its forward position compressing spring 146 and forcing balls 118 through openings 116 of the needle hub 96 into recess 114 of the catheter hub 108 to releasably lock the catheter hub 108 in its retracted position.
  • the operator presses the trigger member 128 inward toward the cylindrical sleeve 102 of the needle hub 96, causing flange 130 of the trigger member 128 to disengage from piston 120 and to enter the axial recess 124 of the piston 120, which allows spring 146 to drive the piston 120 slightly rear ⁇ ward, as seen in FIG. 10, and creating a vacuum in the space 148 forward of the piston 120 within the cylindrical needle hub 96.
  • flange 132 of the trigger member 128 moves inwardly past the inclined surface 144 of the latch member 142, causing the latch member 142 to cam forwardly on the resilient stem 143.
  • FIGURES 13-16 show another alternative form, indicat ⁇ ed generally at 150, of the catheter placement device 10 of FIG. 1 comprising a needle shaft 152 projecting from a generally cylindrical hub 154 having a flange 156 extending radially outward from the rear end 158 of the needle hub 154 and having a cylindrical sleeve 160 extending forwardly from the flange 156 and spaced from the cylindrical hub 154 to define a space 162 therebetween.
  • a flexible tubular catheter 164 encircles the needle shaft 152 and projects forwardly from a generally cup-shaped catheter hub 165 having a side wall 166 which is telescopically slideable within the space 162 of the needle hub 154.
  • a spring 168 is positioned within the space 162 between the flange 156 of the needle hub 154 and the rear end of the side wall 166 of the catheter hub 165 and serves to urge the catheter hub 165 forwardly.
  • the side wall 166 of the catheter hub 165 is formed with an internal annular recess 170 and the cylin ⁇ drical needle hub 154 is formed with openings 172 and balls 174 are seated in the openings 172 and extend into the recess 170 to releasably lock the catheter hub 165 in its retracted position, as seen in FIGS. 13 and 14.
  • a piston 176 is slideably mounted within the cylindrical needle hub 154 and is formed with an annular recess 178, located adjacent the forward end of the piston 176, and a rearward- ly-opening recess 180, extending forwardly from the rear end 182 of the piston 176.
  • a generally U-shaped capsule 184 is slideably mountable within the rearwardly-opening recess 180 of the piston 176 and has a plug 186 closing the open end 188 of the capsule 184.
  • the capsule 184 contains a vacuum and the plug 186 is rupturable, when pressed against a post-needle member 190 carried by the piston 176 and projecting rearwardly therefrom, to create a vacuum within the space 194 which "arms" the catheter placement device 150.
  • the operator When the operator has inserted the needle shaft 152 into the skin of the patient, the operator presses the vacuum capsule 184 inward to cause the post-needle member 190 to pierce the plug 186 to "arm" the catheter placement device 150. Subsequently, the instant the needle 152 pene ⁇ trates the wall 89 of the blood vessel 88, the vacuum in the space 194 causes blood to flow into the space 194 and the vanishing of the vacuum due to the blood entering the space 194 drives the piston 176 to its fully retracted position, as seen in FIG.
  • FIG. 17 shows an alternative form, indicated general ⁇ ly at 196, of the catheter placement device 10 of FIG. 1.
  • the catheter placement device 196 is substantially identi ⁇ cal with that of the catheter placement device 10 of FIG. 1, except that the spring 36 of the catheter placement device 10 is replaced by a pair of magnets 198 and 200 mounted with like poles in opposing relation, as indicated by arrows 202. In this way, when lever 26 is released, the magnets 198 and 200 will serve to drive the catheter hub 20 away from the front end 38 of the needle 12 and, hence, will serve to automatically advance the catheter 18.
  • FIG. 18 shows an alternative form, indicated general ⁇ ly at 204, of the catheter placement device 39 of FIG. 5.
  • the catheter placement device 204 is substantially identi ⁇ cal with that the catheter placement device 39 of FIG. 5, except that the spring 59 of the catheter placement device 39 is replaced by a quantity of compressed gas which is supplied from a suitable source, such as capsule 206.
  • the catheter placement device 204 functions in sub ⁇ stantially the same manner as the catheter placement device 39, except that when the catheter hub 44 is unlocked the catheter 40 is automatically advanced by expansion of the compressed gas from capsule 206, rather than by expansion of spring 59.
  • FIG. 19 shows another alternative form, indicated generally at 208, of the catheter placement device 39 of FIG. 5.
  • the catheter placement device 208 is substantially identical with that the catheter placement device 39 of FIG. 5, except that the spring 59 of the catheter placement device 39 is replaced by a pair of magnets 210 and 212 mounted with like poles in opposing relation, as indicated by arrows 214.
  • the catheter placement device 208 functions in substantially the same manner as the catheter placement device 39, except that when the catheter hub 44 is unlocked, the magnets 210 and 212 will serve to automat ⁇ ically drive the catheter 40 forward for placement, rather than by expansion of spring 59.
  • FIGURES 20 and 21 show a further alternative form, indicated generally at 214, of the catheter placement device 92 of FIG. 9.
  • the catheter placement device 214 is substantially identical with that of the catheter placement device 92 of FIG. 9, except that the locking balls 118, openings 116 and advancing spring 112 of the catheter placement device 92 of FIG. 9 have been omitted.
  • a cylindrical chamber 216 is provided adjacent the rear end 100 of the needle hub, projecting inwardly from the side wall 103 of the needle hub 96.
  • the cylinder 216 has an opening 218 facing toward the rear end 125 of the piston 120 and a piston 220 is slideably mounted in the opening 218.
  • the rear end of the cylinder 216 is connected to a generally U-shaped duct 222 and a shaft 224 is carried by the rear end of the catheter hub 108 and projects into the end 226 of the duct 222.
  • the cylinder 216 and duct 222 are filled with a suitable hydraulic fluid 228.
  • button 128 When button 128 is pressed inwardly, it releases piston 120, which is driven partially rearward by spring 146. However, as the piston 120 moves rearwardly, it creates a vacuum within space 148 which prevents full rearward movement of the piston 120. Subsequently, as seen in FIG. 21, penetration of a blood vessel allows blood to flow into chamber 148 and the vanishing of the vacuum due to the entering of the blood into chamber 148 serves to drive the piston 120 rearward.
  • the piston ring 240 assures that the vacuum in space 148 will be maintained. Subse ⁇ quently, penetration of a blood vessel 88 by the needle 94, allows blood to flow into space 148. The vanishing of the vacuum due to the entering of the blood into space 148 drives piston 120 farther rearward, which allows piston ring 240 to expand out of recess 242 and enables spring 146 to drive piston 120 fully rearward causing the rear end 125 of piston 120 to engage piston 220 and to drive the piston 220 rearwardly within cylinder 216. This forces the hydrau ⁇ lic fluid 228 to flow through duct 222 and to drive shaft 228 forwardly to release the catheter hub 108.
  • FIGURES 22, 23, 24 and 25 show yet another alterna ⁇ tive form, indicated generally at 230, of the catheter placement device 92 of FIG. 9.
  • the catheter placement device 230 is substantially identical to the catheter placement device 92 of FIG. 9, except that the locking balls 118 , openings 116 and advancing spring 112 of the catheter placement device 92 of FIG. 9 have been omitted and the advancing spring 112 is replaced by a cam 232 which is pivotally mounted in the side wall 103 of the needle hub 102.
  • the cam 232 has a trigger portion 234 and an actuator portion 236, which is engageable with the rear end 238 of the side wall 110 of the catheter hub 108.
  • a piston ring 240 is mounted in a recess 242 of the piston 120 and frictionally engages the side wall 103 of the needle hub 102.
  • the trigger button 128 In use, when, after skin penetration, the trigger button 128 is pressed, it moves arm 130 out of engagement with piston 120, which allows spring 146 to drive piston 120 partially rearward, to the position seen in FIG. 23. However, the movement of piston 120 creates a vacuum within space 148 which opposes the action of spring 146 and limits the rearward movement of the piston 120.
  • the piston ring. 240 assures that the vacuum in space 148 will be main ⁇ tained. Subsequently, penetration of a blood vessel 88 by the needle 94, allows blood to flow into space 148, as seen in FIG. 24.
  • FIG. 26 shows yet another alternative form, indi ⁇ cated generally at 244, of the catheter placement device 230 of FIGS. 22, 23, 24 and 25.
  • the catheter placement device 244 is substantially identical to the catheter placement device 230 of FIG.
  • a lever 246 is pivotally mounted on the forwardly extending arm 130 of the trigger button 128 and one side of the rearwardly extending portion 125 of piston 120 is omitted.
  • the lever 246 comprises a trigger portion 248, which extends into the path of movement of the rearwardly extending portion 125 of piston 120, and an actuator portion 250 which engages the rear end 238 of the side wall 110 of the catheter hub 108.
  • the catheter placement device 244 functions in substantially the same manner as the catheter placement device 230 of FIGS. 22, 23, 24 and 25.
  • the rearwardly extending position 125 of piston 120 engages the trigger portion 248 of the lever 246, causing the lever 246 to pivot, driving the trigger portion 248 rearwardly to the position seen in dotted lines in FIG. 26, and causing the actuator portion 250 of lever 246 to move forwardly, as seen in dotted lines in FIG. 26, to drive the rear end 238 of the catheter hub 108 forwardly to release and place the catheter 106.
  • FIGURES 27 - 33 show a fully automatic form of cathe ⁇ ter placement device, indicated generally at 260, wherein the means for arming the sensing means which responds to blood vessel penetration is automatically actuable upon skin penetration by the needle.
  • the catheter placement device 260 is essentially similar to the device of FIG. 9 with the following important differences: the arming means, which in FIG.
  • the trigger member 128 is represented in the device 260 by a cylinder 302 sur ⁇ rounding the catheter and telescopically slideable on the catheter, of sufficient thickness, particularly in corre ⁇ spondence of its distal end 304 to not be permitted to follow the needle shaft 308 and catheter shaft 306 at the site of skin penetration, and to be retained as soon as the distal end of the cylinder is in contact with the skin.
  • the retention of the cylinder, while the needle and catheter are being advanced inside the skin, will result in a back ⁇ ward movement of the cylinder relatively to the needle and the catheter.
  • Resilient hook 280 is the equivalent of the ball members of FIG. 9. The out ⁇ ward displacement of resilient hook 280 will result in a disengagement of the catheter hub 312, to which the hook 280 is anchored, from the needle hub 330.
  • FIGURES 34 - 36 show another alternative form of a catheter placement device, indicated generally at 320.
  • the catheter placement device 320 is essentially similar to the device of FIGS. 27 - 33 with the following important dif ⁇ ferences: the self-propelling catheter advancement is obtained by the expansion of expandable material 358 and the omission of catheter automatic arming.
  • the needle hub is essentially similar to the device of FIGS. 27 - 33 with the following important dif ⁇ ferences: the self-propelling catheter advancement is obtained by the expansion of expandable material 358 and the omission of catheter automatic arming.
  • chamber 342 of the needle 340 contains a chamber 356 filled with a thermally expandable material 358, such as mercury.
  • the blood at 37 degrees Centigrades or warmer, will cause the thermally expandable material 358 to expand, provoking the rapid advancement of piston 364 which, acting upon catheter hub surfaces 336, will push forward, via its flanges, catheter 338 further inside blood vessel 89.
  • FIG. 37 shows yet another alternative form, indi ⁇ cated generally at 400, of the catheter placement device of FIG. 9.
  • the catheter placement device 400 is essentially identical to the catheter placement device 92 of FIG. 9 except that a membrane 402 of defor able material is inter ⁇ posed between spring 146 and piston 120.
  • the dome 401 of membrane 402 is securely attached, via a screw or pin 404, to the anterior surface 403 of piston 120.
  • the lateral segments 406 of membrane 402 are airtightly fitting the space 408 between the sidewall 103 of needle hub 96 and hollow cylindrical structure 405,in order to create an air ⁇ tight compartment 407.
  • Catheter placement device 400 basi ⁇ cally functions as catheter placement device 92. When the catheter has penetrated the skin and the device is armed, spring 146 is released, causing deformation of dome 401 of membrane 402 and increasing the volume of the air-tight compartment 407, to create a vacuum within needle hub 92.
  • FIGURES 38 - 41 show yet another alternative form, indicated generally at 500, of the catheter placement device 39 of FIG. 5.
  • the propelling unit 510 is basically identical to needle hub 48 of catheter placement device 39 of fig. 5.
  • the difference between the two devices lies on the fact that the catheter hub 40 of device 39 of fig.9 has been replaced by a separate unit, the interface member 505, while catheter 540 has an ordinary hub 544.
  • Said interface member 505, of a generally cylindrical shape, has an adaptor 502 protruding from the front end 503 which fits into the ordinary catheter hub 544 to which is connected.
  • the needle 542 is still an integral, non detachable part of the propelling unit 510.
  • unit 500 The sequence of operations for unit 500 is similar to that described for catheter placement device 39 of fig.5.
  • a vacuum is created in front of piston 68 by the arming of the device carried out by forward pressing of vacuum capsule 80 against post needle member 78 with resulting piercing of plug 82 and rearward aspiration of piston 68 with partial retraction of said piston.
  • catheter 540 After catheter 540 is securely placed in blood vessel
  • propelling unit 510 with its interface member 505 is extracted and the catheter left in place as in fig. 41.
  • FIGURES 42-47 show another alternative form of cathe ⁇ ter placement device, indicated generally at 600, of the catheter placement device 39 of FIG.5.
  • needle 642 and catheter 640 with their respective ordinary hubs 648 and 644, are separate units from the propelling unit 610.
  • Propeller unit 610 is basically identical to needle hub 48 of device 39 of fig.5.
  • An interface member 605 has replaced catheter hub 44 of device 39 of fig.5.
  • Fig. 42 shows separately the four components of the device 600 prior to assembly and use.
  • Figures 43, 44 and 45 show progressive stages of the assembly process.
  • Fig. 43 shows needle 643 with ordinary hub 648 con ⁇ nected to adaptor 603 of propelling unit 610 via a screw type of mechanism 602, while member interface 605 and catheter 640 are shown in line ready to be connected.
  • Fig.44 shows catheter 640 and interface member 605 connected to each other via the fitting of the adaptor 608 of interface member 605 into ordinary catheter hub 644 of catheter 640.
  • Fig.45 shows the entire unit assembled and ready to be used.
  • the sequence of operation for the placement of catheter 640 into the blood vessel is the same as the one described for the device 39 of fig. 5 and device 500 of fig. 38-41.
  • Fig.46 shows the advancement of interface member 605 and catheter 640 upon blood vessel penetration.
  • Fig.47 shows the propelling unit 610 with interface member 605 extracted from the catheter 640 placed within the blood vessel.
  • Figures 48, 49, 50 show yet an alternative form of catheter placement device 39 of fig. 5.
  • the propelling unit 710 is a separate unit from the catheter 740 and the needle 742 with their respective ordinary hubs 744 and 748.
  • the separate propelling unit 710 can be applied to the catheter/needle assembly at the moment of use as needed by the operator.
  • Propeller unit 710 is basically identical to needle hub 48 of fig.5, and catheter hub 44 has been replaced by interface member 705.
  • Interface member 705 of general cylindrical hollow shape is interposed between outer wall 760 and inner wall 750 of propelling unit 710.
  • Inter ⁇ face member 705 has flange 712 to which two crossed studs 722 are pivoted by pin 720 on flange 712. Arms 724 of studs 722 are applied to catheter hub 744 maintaining a secure grip on catheter hub 744 via the pressure exerted by re ⁇ leased band spring 714 on proximal crossed segments of stud 722.
  • Fig.49 is a top view of device 700.
  • the crossed studs are visualized maintaining firm grip on catheter hub 744 via arms 724.
  • interface member 710 urged forward by the release of spring 59 upon blood vessel penetration, will carry forward crossed studs 722 which will advance catheter 740 into the blood vessel due to the grip of arms 724 on catheter hub 744.
  • the propelling unit 710 can be then removed from the catheter 740 releasing the grip of arms 724 on catheter hub 744 via approximating proximal segment of studs 722 against released band spring 714.
  • Fig.51 and fig.52 show an alternative form of the semiautomatic version of the catheter placement device generally indicated at 800.
  • catheter placement device 800 in ⁇ cludes a generally cylindrically shaped propelling unit 810 with an inner hollow cylinder 814 with a front end 816 supporting needle 840 and an outer cylinder 812, concentric to inner cylinder 814, bearing flange 822 and lever 844 and enclosing space 826 containing vacuum capsule 830.
  • Catheter placement device 800 includes also catheter 860 with ordinary catheter hub 862 and an interface member 850 interposed between outer cylinder 812 and inner cylin ⁇ der 824, provided with adaptor 852 fitting into ordinary catheter hub 862.
  • Fig.51 shows device 800 in its armed position after skin penetration. Arming is obtained by pressing forward vacuum capsule 830 against posterior segment 842 of needle 840 causing the piercing of plug 832 of capsule 830 by said posterior segment 842.
  • Fig. 52 shows device 800 after blood vessel penetra ⁇ tion.
  • vacuum 834 within capsule 830 will draw blood into transparent vacuum capsule . 830.
  • Presence of blood in capsule 830 will alert the operator of the occurred blood vessel penetration and he or she will promptly press handle 844 of lever 824 pivoted on fulcrum 846, causing disengagement of tooth 844 out of recess 856 of interface member 850.
  • tooth 844 Disengagement of tooth 844 will permit advancement of interface member 840 by action of spring 818 and placement of its connected catheter 860 within blood vessel 89.
  • Fig.53 through fig.58 show alternative types of catheter placement devices in which means of sensing pene- tration include electric or electronic means and are acti ⁇ vated by the vanishing of the vacuum occurring upon pene ⁇ tration of a blood vessel or by various physical properties of the blood rushing into the vacuum chamber upon penetra ⁇ tion of the needle into a blood vessel.
  • Fig.53 shows a schematic version of the device in which an optical-photosensor senses the occurred penetra ⁇ tion of the blood vessel by optically detecting the blood rushing into the vacuum chamber.
  • the optical-photosensor pair, source/sensor chosen for representation in fig.53 includes a light emitting device, 950, and a light sensor, 952.
  • Transduction of light stimuli captured by light sen ⁇ sors 952 in response to passage of the blood within vacuum chamber 928 may be variously obtained by various transduc ⁇ tion elements, like photovoltaic, photoconductive, photo- conductive junction, photoemissive.
  • Transducers will in turn activate electromagnet 925 to displace metal lever 932 of fig.53 by attraction toward its pole effacing the lever, disengaging in so doing lever 932 from its retainer 934, and permitting forward advancement of the catheter 918 by the resiliency of compressed spring 936 acting upon flange 938 of needle hub 940 and flange 922 of catheter hub 920.
  • the light sensor 952 of fig 53 may be placed on the same side as light emitting device 950. In that case the light sensor 952 will detect a beam reflected from the opposite wall of the vacuum chamber, which in that case acts as reflecting surface, or by the blood itself that will reflect the light beam by diffusion.
  • the light sensor 952 placed on the same side as the light emitting device.
  • Fig.54 shows a device substantially similar to device of fig.53, where temperature sensors, rather than optical sensors, sense the occurred penetration of the blood vessel by detecting the variation of temperature induced on temperature sensors 954 and 956 of fig.54 by the warm blood rushing into the vacuum chamber.
  • the temper ⁇ ature sensors chosen for representation in fig.54 are sensors responding to heat transfer method of conduction from blood to sensors, however temperature sensors acting upon heat transfer method of convection as well as sensors acting upon heat transfer method of radiation (such as infrared radiation emitters/ receivers) can also be used.
  • Transduction elements may be thermoelectric ele ⁇ ments (such as thermocouples) , resistive elements (such as resistance thermometers), oscillating crystals elements, and others.
  • Fig.55 shows a device substantially similar to device of fig.53, where sensors detecting blood as an electric conductor, rather than optical sensors, sense the occurred penetration of the needle into a blood vessel by detecting the appearance of an electrical conductor, such as blood, rushing into the vacuum chamber.
  • the sensors chosen in fig.55 to illustrate the detection of the physical property of conductivity of the blood include an electromagnet, 958.
  • Vacuum chamber 928 is between the poles of electromagnet 958.
  • the blood rushing into the vacuum chamber upon needle penetration of a blood vessel is detected by an application of the principle that a voltage proportionate to the rate of flow is induced in a conductor (in this case blood in the vacuum chamber) moving through a magnetic field at right angles to the magnetic lines of forces.
  • Transduction is achieved by inductance, capacitance, resistance.
  • Blood could also behave as a dielectric and as such the rushing of the blood into the vacuum chamber could be detected by capacitance transducers where the passage of blood results in changes of voltages at the electrodes of the capacitor.
  • Fig.56 shows a device substantially similar to device of fig.53, where sensors detect the physical property of the blood as a fluid.
  • the sensor chosen in fig.56 to illustrate detection of blood as a flowing fluid is mechanical flow sensing element 966, whose angular displacement is caused by the rushing of the blood into vacuum chamber 928.upon blood vessel penetration.
  • Such a displacements may activate a switch which in turn will activate electromagnet 926.
  • sensor detecting the physical property of the blood as a fluid can be used, such as other types of flow sensors, fluid density sensors, humidity and moistures sensors, hygrometers,and others.
  • Transduction elements are of most various types and depend upon the type of sensing element used.
  • Fig.57 shows a device substantially similar to device of fig.53, where sensors detecting static and dynamic acoustic properties of the blood.
  • the sensors chosen in fig 57 illustrate the presence of the blood via detecting the sound generated by the blood rushing into vacuum chamber 928 by acoustic sensor 974.
  • Sensors based on ultrasound/sonar technics can also be used to detect blood rushing into vacuum chamber upon blood vessel penetration.
  • Fig. 58 shows pressure/vacuum transducers, 980, activated by the change in pressure in vacuum chamber 928 occurring upon blood vessel penetration.
  • the pressure transducers may be of various types: capacitative, inductive, piezoelectric, potentiomentric, reluctive, strain-gage, servo-type, of vibrating elements, and others.
  • Fig. 59 shows yet an alternative form of the device of fig.53 in which the represented sensor 990 is an illus ⁇ tration of a sensor of chemical properties of the blood, such as a sensor able to detect certain ranges of pH, characteristic of the blood.
  • the represented sensor 990 is an illus ⁇ tration of a sensor of chemical properties of the blood, such as a sensor able to detect certain ranges of pH, characteristic of the blood.
  • Blood could also be detected by detecting blood components with the use of appropriate sensors analyzers, such as the 02 sensor 990 of fig.59.
  • Sensors analyzers could identify blood presence by any of the technics used to analyze blood components.
  • the blood components that can be used for blood detection are all the blood components which can be quickly identified by analyzers.

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Abstract

An improved catheter placement device (92), comprising a needle (94), a catheter (106) concentric to the needle, and self-propelling means (146) for moving said catheter (106) to an advanced position upon penetration of the wall (89) of a blood vessel (88). The self-propelling means may be actuated manually or may include means for sensing penetration of a blood vessel and for automatically advancing the catheter in response to such penetration.

Description

AUTOMATIC CANNULATION DEVICE
BACKGROUND
TECHNICAL FIELD This invention relates to blood vessel cannulation devices and is particularly directed to automatic means for catheter placement within blood vessels.
BACKGROUND ART Cannulating blood vessels is a common procedure in patient care, in order to administer fluids, drugs, blood or blood products. Heretofore, there .have been two basic types of catheter for accomplishing cannulation. In one instance, the needle is within the catheter; while in the other instance, the catheter is within the needle. In both cases, the needle serves to penetrate the skin and the wall of the blood vessel and, once the blood vessel has been entered, the catheter is advanced manually until an ade¬ quate position is reached. Unfortunately, such manual catheter placement involves both of the operator's hands; one for stabilization of the needle, and the other for advancement of the catheter. Furthermore, manual catheter placement is an extremely delicate procedure which can be
SUBSTITUTESHEET performed only by specially trained and highly skilled medical personnel and, even then, placement failure is not uncommon, due to such factors as failure to recognize penetration of the blood vessel, sequence delays, disrup¬ tion of the continuity of the blood vessel, patient anatom¬ ical variability, etc.
A search in the United States Patent Office has revealed the following references:
PATENT NO. INVENTOR ISSUED
4,767,407 S.J. Foran Aug. 30, 1988
4,904,240 R.L. Hoover Feb. 27, 1990
4,944,728 M. . Carrell et al Jul. 31, 1990
4,966,589 J.M. Kaufman Oct. 30, 1990
Each of these references requires manual advancement of the catheter and, hence, is subject to the disadvantages discussed above. Thus, none of the prior art catheter placement devices has been entirely satisfactory.
BRIEF SUMMARY AND OBJECTS OF INVENTION
These disadvantages of prior art catheter placement devices are overcome with the present invention and an
TITUTESHξET improved catheter placement device is proposed which auto¬ matically advances the catheter, once the blood vessel has been penetrated, and which may be triggered one-handedly or, in a preferred embodiment, includes means for sensing penetration of a blood vessel and for automatically advanc¬ ing the catheter in response to such penetration.
The advantages of the present invention are prefera¬ bly attained by providing an improved catheter placement device comprising a needle, a catheter concentric with the needle, resilient means urging said catheter to an advanced position, and means for triggering the resilient means upon penetration of the wall of a blood vessel. The triggering means may be manual or may include means for sensing pene¬ tration of a blood vessel and for automatically advancing the catheter in response to such penetration.
Accordingly, it is an object of the present invention to provide an improved catheter placement device.
Another object of the present invention is to provide an improved catheter placement device which permits one- handed insertion and placement of a catheter.
An additional object of the present invention is to provide an improved catheter placement device which permits automatic advancement of the catheter, once a blood vessel has been penetrated. A specific object of the present invention is to provide an improved catheter placement device comprising a needle, a catheter concentric with the needle, self-pro¬ pelled, automatic means for catheter advancement, and means for triggering said means for self-propelled advancement upon penetration of the wall of a blood vessel. The trig¬ gering means may be manual or may include means for sensing penetration of a blood vessel and for automatically advanc¬ ing the catheter in response to such penetration.
These and other objects and features of the present invention will be apparent from the following detailed description, taken with reference to the figures of the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWING
FIGURE 1 is a transverse section through a catheter placement device embodying the present invention;
FIGURE 2 is a view, similar to that of FIG. 1, show¬ ing the catheter placement device is its unlocked position;
FIGURE 3 is a vertical section through the catheter placement device of FIG. 1, taken on the line 44 of FIG. 1;
FIGURE 4 is a plan view of the latch member of the catheter placement device of FIG. 1;
FIGURE 5 is a transverse section through an alterna¬ tive form of the catheter placement device of FIG. 1, shown in the unarmed condition;
FIGURE 6 is a view showing the catheter placement device of FIG. 5 in its armed condition, after penetration of the skin, but prior to penetration of a blood vessel;
FIGURE 7 is a view showing the catheter placement device of FIG. 5 immediately following penetration of a blood vessel;
FIGURE 8 is a view showing the catheter placement device of FIG. 5 following advancement of the catheter;
FIGURE 9 is transverse section through another alternative form of the catheter placement device of FIG. 1, shown in its unarmed condition;
FIGURE 10 is a view showing the catheter placement device of FIG. 9 in its armed condition, after penetration of the skin, but prior to penetration of a blood vessel;
FIGURE 11 is a view showing the catheter placement device of FIG. 9 immediately after penetration of a blood vessel ; FIGURE 12 is a view showing the catheter placement device of FIG. 9 following advancement of the catheter;
FIGURE 13 is a transverse section through a further alternative form of the catheter placement device of FIG. 1, shown in its unarmed condition;
FIGURE 14 is a view showing the catheter placement device of FIG. 13 in its armed condition, after penetration of the skin, but prior to penetration of a blood vessel;
FIGURE 15 is a view showing the catheter placement device of FIG. 13 in its armed condition, after penetration of the skin, but prior to penetration of a blood vessel;
FIGURE 16 is a view showing the catheter placement device of FIG. 13 following advancement of the cathe¬ ter;
FIGURE 17 is a view, similar to that of FIG. 1, showing another alternative form of the catheter placement device of FIG. 1;
FIGURE 18 is a view, similar to FIG. 5, showing another alternative form of the catheter placement device of FIG. 5; FIGURE 19 is a view, similar to that of FIG. 5, showing an additional alternative form of the catheter placement device of FIG. 5;
FIGURE 20 is a view, similar to FIG. 9, showing a further alternative form of the catheter placement device of FIG.9;
FIGURE 21 is a view, similar to that of FIG. 20, showing the catheter placement device of FIG. 20 in its "armed" position;
FIGURE 22 is a view, similar to that of FIG. 9, showing another alternative form of the catheter placement device of FIG. 9;
FIGURE 23 is a view, similar to that of FIG. 22 showing the catheter placement device of FIG. 21 in its "armed" position;
FIGURE 24 is a view, similar to that of FIG. 22 showing the catheter placement device of FIG. 22 immediate¬ ly after penetration of a blood vessel;
FIGURE 25 is a view, similar to that of FIG. 22 showing the catheter placement device of FIG. 22 immediate¬ ly after release of the catheter; FIGURE 26 is a view, similar to that of FIG. 9, showing an additional alternative form of the catheter placement device of FIG. 9;
FIGURE 27 shows an alternative form of the catheter placement device with an automatic arming rod;
FIGURE 28 shows a cross-section of the automatic arming rod of FIG. 27;
FIGURE 29 is a view, similar to that of FIG. 27, showing the catheter placement device of FIG. 27 after skin penetration and the beginning of the automatic arming process;
FIGURE 30 is a view, similar to that of FIG. 27, showing the catheter placement device of FIG. 27 after skin penetration, in a further stage of the arming process;
FIGURE 31 is a view, similar to that of FIG. 27, showing the catheter placement device of FIG. 27 immediate¬ ly after penetration of a blood vessel;
FIGURE 32 is a view, similar to that of FIG. 27, showing the catheter placement device of FIG. 27 immediate¬ ly after release of the catheter;
FIGURE 33 is a view, similar to that of FIG. 27, after the removal of the needle, showing connection of the catheter with the intravenous tubing;
FIGURE 34 shows an additional alternative form of the catheter placement device;
FIGURE 35 is a view, similar to that of FIG. 34, showing the catheter placement device of FIG. 34 immediate¬ ly after skin penetration;
FIGURE 36 is a view, similar to that of FIG. 34, showing the catheter placement device of FIG. 34, immedi¬ ately after release of the catheter;
FIGURE 37 is a view, similar to that of FIG. 9,. showing an additional form of the catheter placement device of FIG.9;
FIGURE 38 is a view, similar to that of FIG. 5, showing an alternative form of the catheter placement device of FIG. 5 prior to skin penetration;
FIGURE 39 is a view, similar to that of FIG. 38, showing the catheter placement device of FIG. 38 immediate¬ ly after skin penetration;
FIGURE 40 is a view, similar to that of FIG. 38, showing the catheter placement device of FIG. 38 immediate- ly after blood vessel penetration;
FIGURE 41 is a view, similar to that of FIG. 38, showing the catheter of the catheter placement device of FIG. 38 placed intravenously;
FIGURE 42 shows the separate four components of a further alternative form of the catheter placement device;
FIGURE 43 shows the device of fig 42 while being assembled;
FIGURE 44 shows a further stage on the assembly of catheter placement device of fig. 42;
FIGURE 45 shows the assembled unit of fig. 2 prior to skin penetration;
FIGURE 46 shows the assembled unit of fig.42 after penetration into a blood vessel;
FIGURE 47 shows the disengaging of the propelling unit of fig. 42 from the catheter placed intravenously;
FIGURE 48 shows an alternative form of the catheter placement device of fig.5;
FIGURE 49 shows a top view of the same catheter device of fig . 48 ;
FIGURE 50 shows the catheter placement device of fig.48 after blood vessel penetration;
FIGURE 51 shows an alternative form of a semi-auto¬ matic catheter placement device;
FIGURE 52 shows the catheter placement device of fig.51 after blood vessel penetration.
FIGURE 53 shows yet an alternative form of a fully automatic catheter placement device, where the means for sensing penetration are represented by an opto-electric source-sensor pair.
FIGURE 54 show an alternative form of the device of fig.53 where the represented sensors are temperature sen¬ sors.
FIGURE 55 show an alternative form of the device of fig. 53 where the represented sensors are sensors detecting the electrical conductivity properties of the blood.
FIGURE 56 shows an alternative form of the device of fig.53 in which the represented sensor is a flow detector sensor. FIGURE 57 shows an alternative device of fig.53, where the represented sensor is an acoustic sensor.
FIGURE 58 shows yet an alternative form of the device of fig.53 in which the represented sensor is a pressure sensor.
FIGURE 59 shows yet an alternative form of the device of fig.53 in which the represented sensor is an illustra¬ tion of a sensor of chemical properties of the blood, such as a pH sensor, or of a sensor capable of sensing presence of blood by detecting presence of a component of the blood, such as oxygen.
DETAILED DESCRIPTION OF THE INVENTION In that form of the present invention chosen for pur¬ poses of illustration in FIG. 1, a catheter placement device, indicated generally at 10, is shown comprising a needle 12, having a tubular hollow shaft 14 projecting from a handle portion 16, and a flexible catheter 18 projecting from a hub 20. As shown, the catheter 18 concentrically encircles the shaft 14 of the needle 12, while the catheter hub 20 telescopes over the forward portion of the needle handle portion 16. However, it will be apparent to those skilled in the art that, if desired, the needle 12 may be made to concentrically telescope over the catheter 18. The catheter hub 20 has a radial flange 22 formed adjacent the rear end 24 of the hub 20 and has a lever 26, formed of resilient material, projecting rearwardly from one side of the flange 22 and having an opening 28 formed adjacent the free end of the lever 26, as best seen in FIG. 4. A bridge member 30 projects radially outward from the needle handle 16 and, as best seen in FIG.3, has an aperture 32 formed therein to receive the lever 26 and has a stud 34 project¬ ing into the aperture 32 which is mateable with the opening 28 of the lever 26 to releasably retain the lever 26 and, hence, the hub 20 and catheter 18 in the position shown in FIG. 1. Finally, resilient means, such a spring 36, is mounted between the rear end 24 of the catheter hub 20 and the front end 38 of the handle portion 16 of the needle 12 to urge the hub 20 and catheter 18 forwardly.
In use, the catheter 18 and needle 12 are in the positions seen in FIG. 1, with the catheter 18 encircling the shaft 14 of the needle 12 and with opening 28 of lever 26 of the catheter 18 engaging the stud 34 of the bridge member 30 on the handle portion 16 of the needle 12 to releasably lock the catheter 18 in the position shown in FIG. 1. When the shaft 14 of the needle 12 penetrates a desired blood vessel, the operator presses the lever 26 toward the handle portion 16 of the needle 12, causing opening 28 of the lever 26 to disengage from the stud 34 and allowing spring 36 to drive the catheter 18 forwardly and, thereby, to advance and position the catheter 18 within the blood vessel. Thereafter, the needle 12 may be removed and the tubing containing the food, drugs or other desired material may be attached to the hub 20 of the catheter 18 for delivery of the desired material into the patient's blood vessel. It will be apparent that the lever 26 can be operated by the same hand which is holding the needle handle 16, thus, enabling the operator to position the needle 12, advance and place the catheter 18 and with¬ draw the needle 12 in a one-handed operation, leaving the operator's other hand free for other purposes.
FIGURES 5-8 show an alternative form, indicated generally at 39, of the catheter placement device 10 of. FIG. 1 which serves to automatically advance the catheter when the blood vessel is penetrated. In this form of the present invention, the catheter 40 encircles the needle shaft 42 and has a hub 44 formed with an annular recess 46 extending about the interior surface of the hub 44. The needle 42 has a generally cylindrical hub 48 formed with openings 50 in the side walls 52 of the needle hub 48 to receive balls 54, to releasably lock the catheter hub 44 in the position shown in FIG. 5, as will be more fully ex¬ plained hereafter. The rear end 56 of the needle hub 48 carries a radial flange 58 and a cylindrical wall 60 ex¬ tends forwardly from the flange 58 to encircle and guide movement of the catheter hub 44, which is telescopically slideably between the needle hub 48 and the cylindrical wall 60. A spring 59 is mounted within the cylindrical wall 60 rearwardly of the catheter hub 44 and serves to urge the catheter hub 44, and consequently, the catheter 40 forward¬ ly. A wall member 62 divides the interior of the needle hub 48 and defines a forward chamber 64 and a rearwardly open¬ ing recess 66. Within the forward chamber 64, a piston 68 is slideably mounted and has an annular recess 70 extend¬ ing about the periphery of the piston 68, which serves to receive the balls 54 when the catheter 40 is released, as hereinafter described. A spring 72 is located between the wall member 62 and the piston 68 to normally urge the piston 68 to seat against the forward end of the chamber 64, as seen in FIG. 5, so that the body 74 of the piston 68 serves to force the balls 54 to extend through openings 50 to engage the recess 46 of the catheter hub 44 and, hence, to releasably lock the catheter hub 44 in the position shown in FIG. 5, against the urging of spring 59. The wall member 62 has a central opening 76 and a post-needle member 78 is mounted in the opening 76 and projects rearwardly as shown. A capsule 80 is slideably mountable within the rearwardly opening recess 66 of the needle hub 48 and has a plug 82 closing the open end 84 of the capsule 80. The capsule 80 contains a vacuum and the plug 82 is rupturable, when pressed against the post-needle member 78, to cause partial retraction of the piston 68, as more fully de¬ scribed below.
FIG. 5 shows the catheter placement device 39 in preparation for use, but prior to insertion. FIG. 6 shows the catheter placement device 39 after the needle 42 has penetrated the skin 86 of a patient, but prior to penetra¬ tion of a blood vessel 88. Once the needle 42 has entered the skin 86, the operator presses the vacuum capsule 80 forwardly, causing the post-needle member 78 to pierce the plug 82. This causes air from the forward chamber 64 of the needle hub 48 to enter the capsule 80, which creates a partial vacuum within the chamber 64 and serves to partial¬ ly retract piston 68 against the action of spring 72. This, in turn, creates a vacuum within the chamber 64 forwardly of the piston 68, as seen at region 90. However, the body 74 of the piston 68 still serves to force the balls 54 into recess 46 to continue locking the catheter hub 44 in its retracted position, as seen in FIGS. 5 and 6. The catheter placement device 39 is now "armed" to automatically advance the catheter 40.
In FIG. 1 , the needle 42 has penetrated the wall 89 of the patient's blood vessel 88. The instant that such penetration occurs, blood from the blood vessel 88 is drawn into region 90 by the vacuum in the region 90. This drives the piston 68 rearwardly, against the action of spring 72, to the point that the annular recess 70 of the piston 68 becomes aligned with openings 50 of the side walls 52 of the needle hub 48. Consequently, balls 54 can move into the recess 70 of the piston 68 and out of the recess 46 of the catheter hub 44. When this occurs, spring 59 drives the catheter hub 44 and catheter 40 forwardly, automatically, without any action by the operator, to advance and place the catheter 40, as seen in FIG. 8.
In use, the catheter placement device 39 is initially in the position shown in FIG. 5, with the catheter 40 retracted and with piston 68 urged forwardly by spring 72, causing balls 54 to pass through openings 50 in the side walls 52 of the needle hub 48 to enter recess 46 of the catheter hub 44 and, hence, to lock the catheter 40 in its retracted position. Once the operator has inserted the needle 42 into the skin 86 of the patient, the operator presses the vacuum capsule 80 forward, causing the post- needle member 78 to penetrate the plug 82. This causes air from chamber 64 of the needle hub 48 to enter the vacuum capsule 80 and serves to partially retract the piston 68 to create a vacuum within region 90 forward of the piston 68, as seen in FIG. 6, and thereby "arming" the catheter place¬ ment device 39. Subsequently, the instant the needle 42 penetrates the patient's blood vessel 88, as seen in FIG. 7, blood from the blood vessel 88 is drawn into region 90 of the needle hub chamber 64. This drives the piston 68 rearwardly, against the action of spring 72, until annular recess 70 of the piston 68 becomes aligned with openings 50 in the side walls 52 of the needle hub 48, which allows balls 54 to move out of recess 46 of the catheter hub 44. This automatically unlocks the catheter hub 44 and allows spring 59 to advance the catheter 40, as seen in FIG. 8. Because the advancement of the catheter 40 occurs automati¬ cally and instantly, in response to penetration of the blood vessel 88 by the needle 42, proper placement of the catheter 40 is assured and overpenetration or underpenetra- tion are avoided. Furthermore, pressing of the vacuum capsule 80 against the post-needle member 78, to "arm" the catheter placement device 39, can be accomplished by the operator as a one-handed operation. Thus, the catheter placement device 39 provides simple and automatic, yet highly accurate placement of the catheter 40.
FIGURES 9-12 show another alternative form, indicated generally at 92, of the catheter placement device 10 of FIG.l comprising a needle shaft 94 projecting from a gener¬ ally cylindrical hub 96 having a flange 98 extending radi¬ ally outward from the rear end 100 of the needle hub 96 and having a cylindrical sleeve 102 extending forwardly from the flange 98 and spaced from the side wall 103 of the cylindrical hub 96 to define a space 104 therebetween. A flexible tubular catheter 106 encircles the needle shaft 94 and projects forwardly from a generally cup-shaped catheter hub 108 having a side wall 110 which is telescopically slideable within the space 104 of the needle hub 96. A spring 112 is positioned within the space 104 between the flange 98 of the needle hub 96 and the rear end of the side wall 110 of the catheter hub 108 and serves to urge the catheter hub 108 forwardly. The side wall 110 of the cathe¬ ter hub 108 is formed with an internal annular recess 114 and the side wall 103 of the cylindrical needle hub 96 are formed with openings 116 and balls 118 are seated in the openings 116 and extend into the recess 114 to releasably lock the catheter hub 108 in its retracted position, as seen in FIGS. 9, 10 and 11. A piston 120 is slideably mount¬ ed within the cylindrical needle hub 96 and is formed with an annular recess 122, located adjacent the forward end of the piston 120, and an axial recess 124, extending forward¬ ly from the rear end 125 of the piston 120. The needle hub 96 has a stud 126 projecting radially outward adjacent the rear end 100 of the needle hub 96 and a trigger member 128 encircles the stud 126 and is slideably mounted thereon. The trigger member 128 is formed with a pair of forwardly projecting flanges 130 and 132. Flange 130 extends forward¬ ly from the inner edge 134 of the rear surface 136 of the trigger member 128 and a spring 127 is seated between the stud 126 and the trigger member 128 to urge the trigger member outward causing flange 130 of the trigger member 128 to normally engage the rear end 125 of the piston 120, as seen in FIG. 9, and serving to normally prevent rearward movement of the piston 120. Flange 132 extends forwardly from the inner edge 138 of the front surface 140 of the trigger member 128. A latch member 142 is supported by a resilient stem 143, which projects outwardly from the outer surface of the sleeve 102 of the needle hub 96 adjacent flange 132 of the trigger member 128. The latch member 142 has an inclined rear surface 144, which is normally posi¬ tioned to partially underlie the end of flange 132 of the trigger member 128, as seen in FIG. 9. Finally, a spring 146 is located within the cylindrical needle hub 96 for¬ wardly of the piston 120 to normally urge the piston 120 rearwardly.
In use, the catheter placement device 92 is normally in the condition seen in FIG. 9 with the trigger member 128 urged outwardly by spring 127 urging trigger member 128 to its outward position wherein flange 130 engages piston 120 to hold the piston 120 in its forward position compressing spring 146 and forcing balls 118 through openings 116 of the needle hub 96 into recess 114 of the catheter hub 108 to releasably lock the catheter hub 108 in its retracted position. Once the operator has caused the needle shaft 94 to penetrate the patient's skin 86, as seen in FIG. 10, the operator presses the trigger member 128 inward toward the cylindrical sleeve 102 of the needle hub 96, causing flange 130 of the trigger member 128 to disengage from piston 120 and to enter the axial recess 124 of the piston 120, which allows spring 146 to drive the piston 120 slightly rear¬ ward, as seen in FIG. 10, and creating a vacuum in the space 148 forward of the piston 120 within the cylindrical needle hub 96. At the same time, flange 132 of the trigger member 128 moves inwardly past the inclined surface 144 of the latch member 142, causing the latch member 142 to cam forwardly on the resilient stem 143. When flange 132 has past the inclined surface 144, the resilient stem 143 returns the latch member 142 to its original position, in which it now overlies flange 132 to lock the trigger member 128 in its "actuated" position, as seen in FIGS. 10, 11 and
12. When the operator causes the needle shaft 94 to pene¬ trate the wall 89 of a blood vessel 88, blood from the blood vessel is instantly drawn into the space 148 within the needle hub 96, due to the vacuum created therein when spring 146 drove the piston 120 to its partially retracted position, as seen in FIG. 10. The vanishing of the vacuum due to entering of the blood in the space 148 forces the piston 120 to its fully retracted position, as seen in FIG. 11, which causes the annular recess 122 of the piston 120 to become aligned with openings 116 of side wall 103 of the needle hub 96 and allowing balls 118 to move out of the annular recess 114 of the side wall 110 of the catheter hub 108. This unlocks the catheter hub 108 and allows spring 112 to drive the catheter hub 108 forward to advance and place the catheter 106, as seen in FIG. 12. Again, it will be apparent that the operator can use one hand to grasp and position the catheter placement device 92, during insertion of the needle 94 into the patient's skin 86 and to actuate the trigger member 128 to "arm" the catheter placement device 92 prior to penetration of the blood vessel 88, so that the catheter placement device 92 can instantly and automatically advance and place the catheter 106 upon penetration of the blood vessel 88, without additional effort by the operator.
FIGURES 13-16 show another alternative form, indicat¬ ed generally at 150, of the catheter placement device 10 of FIG. 1 comprising a needle shaft 152 projecting from a generally cylindrical hub 154 having a flange 156 extending radially outward from the rear end 158 of the needle hub 154 and having a cylindrical sleeve 160 extending forwardly from the flange 156 and spaced from the cylindrical hub 154 to define a space 162 therebetween. A flexible tubular catheter 164 encircles the needle shaft 152 and projects forwardly from a generally cup-shaped catheter hub 165 having a side wall 166 which is telescopically slideable within the space 162 of the needle hub 154. A spring 168 is positioned within the space 162 between the flange 156 of the needle hub 154 and the rear end of the side wall 166 of the catheter hub 165 and serves to urge the catheter hub 165 forwardly. The side wall 166 of the catheter hub 165 is formed with an internal annular recess 170 and the cylin¬ drical needle hub 154 is formed with openings 172 and balls 174 are seated in the openings 172 and extend into the recess 170 to releasably lock the catheter hub 165 in its retracted position, as seen in FIGS. 13 and 14. A piston 176 is slideably mounted within the cylindrical needle hub 154 and is formed with an annular recess 178, located adjacent the forward end of the piston 176, and a rearward- ly-opening recess 180, extending forwardly from the rear end 182 of the piston 176. A generally U-shaped capsule 184 is slideably mountable within the rearwardly-opening recess 180 of the piston 176 and has a plug 186 closing the open end 188 of the capsule 184. The capsule 184 contains a vacuum and the plug 186 is rupturable, when pressed against a post-needle member 190 carried by the piston 176 and projecting rearwardly therefrom, to create a vacuum within the space 194 which "arms" the catheter placement device 150. When the operator has inserted the needle shaft 152 into the skin of the patient, the operator presses the vacuum capsule 184 inward to cause the post-needle member 190 to pierce the plug 186 to "arm" the catheter placement device 150. Subsequently, the instant the needle 152 pene¬ trates the wall 89 of the blood vessel 88, the vacuum in the space 194 causes blood to flow into the space 194 and the vanishing of the vacuum due to the blood entering the space 194 drives the piston 176 to its fully retracted position, as seen in FIG. 15, wherein the annular recess 178 of the piston 176 is aligned with openings 172 in the side wall of the needle hub 154, which allows the balls 174 to move out of the annular recess 170 in the side wall 166 of the catheter hub 165. This "unlocks" the catheter hub 165 and allows spring 168 to drive the catheter hub 165 forward to advance and place the catheter 164 within the blood vessel 88, as seen in FIG. 16. Here, again, the operator can use one hand to insert the needle 152 into the patient's skin 86 and to press the vacuum capsule 184 inward to "arm" the catheter placement device 150. Subse¬ quently, upon penetration of a blood vessel 88, the cathe¬ ter placement device 150 will, instantly and automatically, advance and place the catheter 164 without any additional action by the operator. FIG. 17 shows an alternative form, indicated general¬ ly at 196, of the catheter placement device 10 of FIG. 1. The catheter placement device 196 is substantially identi¬ cal with that of the catheter placement device 10 of FIG. 1, except that the spring 36 of the catheter placement device 10 is replaced by a pair of magnets 198 and 200 mounted with like poles in opposing relation, as indicated by arrows 202. In this way, when lever 26 is released, the magnets 198 and 200 will serve to drive the catheter hub 20 away from the front end 38 of the needle 12 and, hence, will serve to automatically advance the catheter 18.
FIG. 18 shows an alternative form, indicated general¬ ly at 204, of the catheter placement device 39 of FIG. 5. The catheter placement device 204 is substantially identi¬ cal with that the catheter placement device 39 of FIG. 5, except that the spring 59 of the catheter placement device 39 is replaced by a quantity of compressed gas which is supplied from a suitable source, such as capsule 206. In use, the catheter placement device 204 functions in sub¬ stantially the same manner as the catheter placement device 39, except that when the catheter hub 44 is unlocked the catheter 40 is automatically advanced by expansion of the compressed gas from capsule 206, rather than by expansion of spring 59.
FIG. 19 shows another alternative form, indicated generally at 208, of the catheter placement device 39 of FIG. 5. The catheter placement device 208 is substantially identical with that the catheter placement device 39 of FIG. 5, except that the spring 59 of the catheter placement device 39 is replaced by a pair of magnets 210 and 212 mounted with like poles in opposing relation, as indicated by arrows 214. In use, the catheter placement device 208 functions in substantially the same manner as the catheter placement device 39, except that when the catheter hub 44 is unlocked, the magnets 210 and 212 will serve to automat¬ ically drive the catheter 40 forward for placement, rather than by expansion of spring 59.
FIGURES 20 and 21 show a further alternative form, indicated generally at 214, of the catheter placement device 92 of FIG. 9. The catheter placement device 214 is substantially identical with that of the catheter placement device 92 of FIG. 9, except that the locking balls 118, openings 116 and advancing spring 112 of the catheter placement device 92 of FIG. 9 have been omitted. Instead, a cylindrical chamber 216 is provided adjacent the rear end 100 of the needle hub, projecting inwardly from the side wall 103 of the needle hub 96. The cylinder 216 has an opening 218 facing toward the rear end 125 of the piston 120 and a piston 220 is slideably mounted in the opening 218. The rear end of the cylinder 216 is connected to a generally U-shaped duct 222 and a shaft 224 is carried by the rear end of the catheter hub 108 and projects into the end 226 of the duct 222. The cylinder 216 and duct 222 are filled with a suitable hydraulic fluid 228. In use, when button 128 is pressed inwardly, it releases piston 120, which is driven partially rearward by spring 146. However, as the piston 120 moves rearwardly, it creates a vacuum within space 148 which prevents full rearward movement of the piston 120. Subsequently, as seen in FIG. 21, penetration of a blood vessel allows blood to flow into chamber 148 and the vanishing of the vacuum due to the entering of the blood into chamber 148 serves to drive the piston 120 rearward. The piston ring 240 assures that the vacuum in space 148 will be maintained. Subse¬ quently, penetration of a blood vessel 88 by the needle 94, allows blood to flow into space 148. The vanishing of the vacuum due to the entering of the blood into space 148 drives piston 120 farther rearward, which allows piston ring 240 to expand out of recess 242 and enables spring 146 to drive piston 120 fully rearward causing the rear end 125 of piston 120 to engage piston 220 and to drive the piston 220 rearwardly within cylinder 216. This forces the hydrau¬ lic fluid 228 to flow through duct 222 and to drive shaft 228 forwardly to release the catheter hub 108.
FIGURES 22, 23, 24 and 25 show yet another alterna¬ tive form, indicated generally at 230, of the catheter placement device 92 of FIG. 9. The catheter placement device 230 is substantially identical to the catheter placement device 92 of FIG. 9, except that the locking balls 118 , openings 116 and advancing spring 112 of the catheter placement device 92 of FIG. 9 have been omitted and the advancing spring 112 is replaced by a cam 232 which is pivotally mounted in the side wall 103 of the needle hub 102. The cam 232 has a trigger portion 234 and an actuator portion 236, which is engageable with the rear end 238 of the side wall 110 of the catheter hub 108. Finally, a piston ring 240 is mounted in a recess 242 of the piston 120 and frictionally engages the side wall 103 of the needle hub 102.
In use, when, after skin penetration, the trigger button 128 is pressed, it moves arm 130 out of engagement with piston 120, which allows spring 146 to drive piston 120 partially rearward, to the position seen in FIG. 23. However, the movement of piston 120 creates a vacuum within space 148 which opposes the action of spring 146 and limits the rearward movement of the piston 120. The piston ring. 240 assures that the vacuum in space 148 will be main¬ tained. Subsequently, penetration of a blood vessel 88 by the needle 94, allows blood to flow into space 148, as seen in FIG. 24. The vanishing of the vacuum due to the entering of the blood into space 148 drives piston 120 farther rearward, which allows piston ring 240 to expand out of recess 242 and enables spring 146 to drive piston 120 fully rearward to engage the trigger portion 234 of cam 232, causing cam 232 to pivot and causing the actuator portion 236 of cam 232, as seen in FIG. 25 to drive the rear end 238 of side wall 110 of the catheter hub 108 forward to release and place the catheter 106. FIGURE 26 shows yet another alternative form, indi¬ cated generally at 244, of the catheter placement device 230 of FIGS. 22, 23, 24 and 25. The catheter placement device 244 is substantially identical to the catheter placement device 230 of FIG. 22, except that the cam 232 is omitted and, instead, a lever 246 is pivotally mounted on the forwardly extending arm 130 of the trigger button 128 and one side of the rearwardly extending portion 125 of piston 120 is omitted. The lever 246 comprises a trigger portion 248, which extends into the path of movement of the rearwardly extending portion 125 of piston 120, and an actuator portion 250 which engages the rear end 238 of the side wall 110 of the catheter hub 108.
In use, the catheter placement device 244 functions in substantially the same manner as the catheter placement device 230 of FIGS. 22, 23, 24 and 25. However, when the blood entering space 146 drives piston 120 rearwardly, the rearwardly extending position 125 of piston 120 engages the trigger portion 248 of the lever 246, causing the lever 246 to pivot, driving the trigger portion 248 rearwardly to the position seen in dotted lines in FIG. 26, and causing the actuator portion 250 of lever 246 to move forwardly, as seen in dotted lines in FIG. 26, to drive the rear end 238 of the catheter hub 108 forwardly to release and place the catheter 106. FIGURES 27 - 33 show a fully automatic form of cathe¬ ter placement device, indicated generally at 260, wherein the means for arming the sensing means which responds to blood vessel penetration is automatically actuable upon skin penetration by the needle. The catheter placement device 260 is essentially similar to the device of FIG. 9 with the following important differences: the arming means, which in FIG. 9 was represented by the trigger member 128, is represented in the device 260 by a cylinder 302 sur¬ rounding the catheter and telescopically slideable on the catheter, of sufficient thickness, particularly in corre¬ spondence of its distal end 304 to not be permitted to follow the needle shaft 308 and catheter shaft 306 at the site of skin penetration, and to be retained as soon as the distal end of the cylinder is in contact with the skin. The retention of the cylinder, while the needle and catheter are being advanced inside the skin, will result in a back¬ ward movement of the cylinder relatively to the needle and the catheter. The backward movement of the cylinder will force the tooth 298 against a non-steep side of the notch 310 where the tooth was resting in its initial position, displacing it outward. In turn, the tooth 298 will force the resilient hook 296 outwardly causing the disengagement of the piston 272, to which the resilient hook is anchored, from the edge 320 of a hole 294 formed in the front end of an anterior fold 322 of the needle hub connecting the internal needle hub 324 with the external needle hub 326. The piston 272, no longer retained, will be urged backward by the action of spring 290. However, the movement of piston 272 creates a vacuum within space 328 which opposes the action of spring 290 and limits the rearward movement of the piston. Subsequently, penetration of a blood vessel 88 by the needle 94 allows blood to flow into space 328, as seen in FIG. 31. The pressure of this blood drives piston 272 farther rearward, which allows flange 288 of piston 272 to outwardly displace the resilient hook 280, which is anchored to the catheter hub 312, out of the hole 278 formed in the external needle hub 330. Resilient hook 280 is the equivalent of the ball members of FIG. 9. The out¬ ward displacement of resilient hook 280 will result in a disengagement of the catheter hub 312, to which the hook 280 is anchored, from the needle hub 330. Such a disengage¬ ment will no longer retain the catheter hub 312 from the action of spring 266, and the catheter 306 will be pro¬ pelled into an advanced position relatively to the needle. In FIG. 33, the catheter 306 is shown in its final intrave¬ nous position, after the removal of needle 308 and needle hub 284, connected to adaptor 260 of intravenous tubing 263.
FIGURES 34 - 36 show another alternative form of a catheter placement device, indicated generally at 320. The catheter placement device 320 is essentially similar to the device of FIGS. 27 - 33 with the following important dif¬ ferences: the self-propelling catheter advancement is obtained by the expansion of expandable material 358 and the omission of catheter automatic arming. The needle hub
342 of the needle 340 contains a chamber 356 filled with a thermally expandable material 358, such as mercury. Chamber
356 has in its proximal portion a piston 364 with flanges
366 interposed between the inner face of the catheter hub
336 and the front of the needle hub 324. A lever 322 with its resilient segment 326 attached to flange 332 of piston
330 protrudes through an opening of catheter hub 372 and needle hub 370. This lever 322, in its resting position, locks piston 330 in its advanced position, not allowing spring 328 to displace the piston 330 rearwardly. Once the tip of the needle 340 penetrates skin 86, the lever 322 is lifted by the operator, thus disengaging piston 330 to a rearward position, resulting in creation of a vacuum within the hollow needle shaft 340 and spaces 374 and 360. Upon penetration of needle 340 into a blood vessel 89, blood will rush into the spaces 374 and 360, via the hollow needle shaft 340. The blood, at 37 degrees Centigrades or warmer, will cause the thermally expandable material 358 to expand, provoking the rapid advancement of piston 364 which, acting upon catheter hub surfaces 336, will push forward, via its flanges, catheter 338 further inside blood vessel 89.
Figure 37 shows yet another alternative form, indi¬ cated generally at 400, of the catheter placement device of FIG. 9. The catheter placement device 400 is essentially identical to the catheter placement device 92 of FIG. 9 except that a membrane 402 of defor able material is inter¬ posed between spring 146 and piston 120. The dome 401 of membrane 402 is securely attached, via a screw or pin 404, to the anterior surface 403 of piston 120. The lateral segments 406 of membrane 402 are airtightly fitting the space 408 between the sidewall 103 of needle hub 96 and hollow cylindrical structure 405,in order to create an air¬ tight compartment 407. Catheter placement device 400 basi¬ cally functions as catheter placement device 92. When the catheter has penetrated the skin and the device is armed, spring 146 is released, causing deformation of dome 401 of membrane 402 and increasing the volume of the air-tight compartment 407, to create a vacuum within needle hub 92.
Upon blood vessel penetration, the piston 120, with attached membrane 402, no longer retained by the-vacuum in space 407, will be carried rearwardly by the action of spring 146 until ball 118 enters annular recess 122. The catheter shaft 106, as described for catheter placement device 192 in FIGS.11 and 12, is free to be displaced forward within the blood lumen by spring 112.
FIGURES 38 - 41 show yet another alternative form, indicated generally at 500, of the catheter placement device 39 of FIG. 5. In this version, the propelling unit 510 is basically identical to needle hub 48 of catheter placement device 39 of fig. 5.The difference between the two devices lies on the fact that the catheter hub 40 of device 39 of fig.9 has been replaced by a separate unit, the interface member 505, while catheter 540 has an ordinary hub 544. Said interface member 505, of a generally cylindrical shape, has an adaptor 502 protruding from the front end 503 which fits into the ordinary catheter hub 544 to which is connected.
The needle 542, on the contrary, in this version, is still an integral, non detachable part of the propelling unit 510.
The sequence of operations for unit 500 is similar to that described for catheter placement device 39 of fig.5.
In summary, after needle 542 of unit 500 has pene¬ trated the skin 86, a vacuum is created in front of piston 68 by the arming of the device carried out by forward pressing of vacuum capsule 80 against post needle member 78 with resulting piercing of plug 82 and rearward aspiration of piston 68 with partial retraction of said piston.
Upon blood vessel penetration, blood from blood vessel 88 is drawn into vacuum space 90 in front of piston 68 causing vanishing of such vacuum and full rear¬ ward retraction of piston 68 to permit ball members 54 to enter recess 70 of piston 68. Interface member 505, not any longer retained by balls 54 engaged in annular recess
546 and opening 50, will be urged to advance by spring 59, driving catheter 540, via adaptor 502 connected to catheter hub 544, further into the blood vessel.
After catheter 540 is securely placed in blood vessel
88, propelling unit 510 with its interface member 505 is extracted and the catheter left in place as in fig. 41.
FIGURES 42-47 show another alternative form of cathe¬ ter placement device, indicated generally at 600, of the catheter placement device 39 of FIG.5.
In this version, needle 642 and catheter 640 with their respective ordinary hubs 648 and 644, are separate units from the propelling unit 610.
Propeller unit 610 is basically identical to needle hub 48 of device 39 of fig.5.
An interface member 605 has replaced catheter hub 44 of device 39 of fig.5.
Fig. 42 shows separately the four components of the device 600 prior to assembly and use.
Figures 43, 44 and 45 show progressive stages of the assembly process.
Fig. 43 shows needle 643 with ordinary hub 648 con¬ nected to adaptor 603 of propelling unit 610 via a screw type of mechanism 602, while member interface 605 and catheter 640 are shown in line ready to be connected.
Fig.44 shows catheter 640 and interface member 605 connected to each other via the fitting of the adaptor 608 of interface member 605 into ordinary catheter hub 644 of catheter 640.
Fig.45 shows the entire unit assembled and ready to be used.
The sequence of operation for the placement of catheter 640 into the blood vessel is the same as the one described for the device 39 of fig. 5 and device 500 of fig. 38-41.
Fig.46 shows the advancement of interface member 605 and catheter 640 upon blood vessel penetration.
Fig.47 shows the propelling unit 610 with interface member 605 extracted from the catheter 640 placed within the blood vessel.
Figures 48, 49, 50 show yet an alternative form of catheter placement device 39 of fig. 5.
In this version, generally indicated at 700, the propelling unit 710 is a separate unit from the catheter 740 and the needle 742 with their respective ordinary hubs 744 and 748.
The separate propelling unit 710 can be applied to the catheter/needle assembly at the moment of use as needed by the operator. Propeller unit 710 is basically identical to needle hub 48 of fig.5, and catheter hub 44 has been replaced by interface member 705. Interface member 705 of general cylindrical hollow shape is interposed between outer wall 760 and inner wall 750 of propelling unit 710. Inter¬ face member 705 has flange 712 to which two crossed studs 722 are pivoted by pin 720 on flange 712. Arms 724 of studs 722 are applied to catheter hub 744 maintaining a secure grip on catheter hub 744 via the pressure exerted by re¬ leased band spring 714 on proximal crossed segments of stud 722.
Fig.49 is a top view of device 700. The crossed studs are visualized maintaining firm grip on catheter hub 744 via arms 724.
The sequence of operation is identical to the one described for devices 39 of fig.5 and device 500 of figs. 38-41.
In fig.50 interface member 710 urged forward by the release of spring 59 upon blood vessel penetration, will carry forward crossed studs 722 which will advance catheter 740 into the blood vessel due to the grip of arms 724 on catheter hub 744. The propelling unit 710 can be then removed from the catheter 740 releasing the grip of arms 724 on catheter hub 744 via approximating proximal segment of studs 722 against released band spring 714.
Fig.51 and fig.52 show an alternative form of the semiautomatic version of the catheter placement device generally indicated at 800.
In this version catheter placement device 800 in¬ cludes a generally cylindrically shaped propelling unit 810 with an inner hollow cylinder 814 with a front end 816 supporting needle 840 and an outer cylinder 812, concentric to inner cylinder 814, bearing flange 822 and lever 844 and enclosing space 826 containing vacuum capsule 830.
Catheter placement device 800 includes also catheter 860 with ordinary catheter hub 862 and an interface member 850 interposed between outer cylinder 812 and inner cylin¬ der 824, provided with adaptor 852 fitting into ordinary catheter hub 862.
Fig.51 shows device 800 in its armed position after skin penetration. Arming is obtained by pressing forward vacuum capsule 830 against posterior segment 842 of needle 840 causing the piercing of plug 832 of capsule 830 by said posterior segment 842.
Fig. 52 shows device 800 after blood vessel penetra¬ tion.
Upon blood vessel penetration, vacuum 834 within capsule 830 will draw blood into transparent vacuum capsule. 830.
Presence of blood in capsule 830 will alert the operator of the occurred blood vessel penetration and he or she will promptly press handle 844 of lever 824 pivoted on fulcrum 846, causing disengagement of tooth 844 out of recess 856 of interface member 850.
Disengagement of tooth 844 will permit advancement of interface member 840 by action of spring 818 and placement of its connected catheter 860 within blood vessel 89.
Fig.53 through fig.58 show alternative types of catheter placement devices in which means of sensing pene- tration include electric or electronic means and are acti¬ vated by the vanishing of the vacuum occurring upon pene¬ tration of a blood vessel or by various physical properties of the blood rushing into the vacuum chamber upon penetra¬ tion of the needle into a blood vessel.
Fig.53 shows a schematic version of the device in which an optical-photosensor senses the occurred penetra¬ tion of the blood vessel by optically detecting the blood rushing into the vacuum chamber. The optical-photosensor pair, source/sensor chosen for representation in fig.53 includes a light emitting device, 950, and a light sensor, 952. Transduction of light stimuli captured by light sen¬ sors 952 in response to passage of the blood within vacuum chamber 928 may be variously obtained by various transduc¬ tion elements, like photovoltaic, photoconductive, photo- conductive junction, photoemissive. Transducers will in turn activate electromagnet 925 to displace metal lever 932 of fig.53 by attraction toward its pole effacing the lever, disengaging in so doing lever 932 from its retainer 934, and permitting forward advancement of the catheter 918 by the resiliency of compressed spring 936 acting upon flange 938 of needle hub 940 and flange 922 of catheter hub 920.
The light sensor 952 of fig 53 may be placed on the same side as light emitting device 950. In that case the light sensor 952 will detect a beam reflected from the opposite wall of the vacuum chamber, which in that case acts as reflecting surface, or by the blood itself that will reflect the light beam by diffusion.
The light sensor 952 placed on the same side as the light emitting device.
Fig.54 shows a device substantially similar to device of fig.53, where temperature sensors, rather than optical sensors, sense the occurred penetration of the blood vessel by detecting the variation of temperature induced on temperature sensors 954 and 956 of fig.54 by the warm blood rushing into the vacuum chamber. The temper¬ ature sensors chosen for representation in fig.54 are sensors responding to heat transfer method of conduction from blood to sensors, however temperature sensors acting upon heat transfer method of convection as well as sensors acting upon heat transfer method of radiation (such as infrared radiation emitters/ receivers) can also be used.
Transduction elements may be thermoelectric ele¬ ments (such as thermocouples) , resistive elements (such as resistance thermometers), oscillating crystals elements, and others.
Fig.55 shows a device substantially similar to device of fig.53, where sensors detecting blood as an electric conductor, rather than optical sensors, sense the occurred penetration of the needle into a blood vessel by detecting the appearance of an electrical conductor, such as blood, rushing into the vacuum chamber.
The sensors chosen in fig.55 to illustrate the detection of the physical property of conductivity of the blood include an electromagnet, 958. Vacuum chamber 928 is between the poles of electromagnet 958. The blood rushing into the vacuum chamber upon needle penetration of a blood vessel is detected by an application of the principle that a voltage proportionate to the rate of flow is induced in a conductor (in this case blood in the vacuum chamber) moving through a magnetic field at right angles to the magnetic lines of forces.
Transduction is achieved by inductance, capacitance, resistance.
Blood could also behave as a dielectric and as such the rushing of the blood into the vacuum chamber could be detected by capacitance transducers where the passage of blood results in changes of voltages at the electrodes of the capacitor.
Fig.56 shows a device substantially similar to device of fig.53, where sensors detect the physical property of the blood as a fluid.
The sensor chosen in fig.56 to illustrate detection of blood as a flowing fluid is mechanical flow sensing element 966, whose angular displacement is caused by the rushing of the blood into vacuum chamber 928.upon blood vessel penetration.
Such a displacements may activate a switch which in turn will activate electromagnet 926.
Other type of sensor detecting the physical property of the blood as a fluid can be used, such as other types of flow sensors, fluid density sensors, humidity and moistures sensors, hygrometers,and others.
Transduction elements are of most various types and depend upon the type of sensing element used.
Fig.57 shows a device substantially similar to device of fig.53, where sensors detecting static and dynamic acoustic properties of the blood.
The sensors chosen in fig 57 illustrate the presence of the blood via detecting the sound generated by the blood rushing into vacuum chamber 928 by acoustic sensor 974.
Sensors based on ultrasound/sonar technics can also be used to detect blood rushing into vacuum chamber upon blood vessel penetration.
Fig. 58 shows pressure/vacuum transducers, 980, activated by the change in pressure in vacuum chamber 928 occurring upon blood vessel penetration.
The pressure transducers may be of various types: capacitative, inductive, piezoelectric, potentiomentric, reluctive, strain-gage, servo-type, of vibrating elements, and others.
Fig. 59 shows yet an alternative form of the device of fig.53 in which the represented sensor 990 is an illus¬ tration of a sensor of chemical properties of the blood, such as a sensor able to detect certain ranges of pH, characteristic of the blood.
Other kinds of chemical properties of the blood are susceptible to be detected with the appropriate sensors, as well as physiological properties of the blood.
Blood could also be detected by detecting blood components with the use of appropriate sensors analyzers, such as the 02 sensor 990 of fig.59.
Sensors analyzers could identify blood presence by any of the technics used to analyze blood components.
The blood components that can be used for blood detection are all the blood components which can be quickly identified by analyzers.
Obviously, numerous other variations and modifica¬ tions can be made without departing from the spirit of the present invention. Therefore, it should be clearly under¬ stood that the forms of the present invention described above and shown in the figures of the accompanying drawing are illustrative only and are not intended to limit the scope of the present invention.

Claims

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14 WHAT IS CLAIMED IS :
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29 Claim 1. A catheter placement device comprising: a catheter and means for self-propelled advancement of said catheter to an advanced position.
Claim 2. The device of Claim 1 further compri- sing: a hollow needle, and said catheter being concentric with said needle,
Claim 3. The device of claim 2 wherein: said needle comprises a hub and a hollow shaft projecting forward from said hub.
Claim 4. The device of Claim 2 comprising: said catheter being concentric with said needle and projecting forwardly from a hub which is tele- scopically slideable about said needle.
Claim 5. The device of Claim 3 wherein: said catheter being concentric comprises a hub and a shaft projecting forwardly from said hub and is telescopically slideable about said needle.
(Definition of Self-propelled Means)
Claim 6. The device of claim 1 wherein: said self-propelled means is resilient.
Claim 7. The device of claim 1 wherein: said self-propelled means is magnetic.
Claim 8. The device of claim 1 wherein: said self-propelled means is pneumatic.
Claim 9. The device of claim 8 wherein: said pneumatic means employs compressed air.
Claim 10. The device of claim 1 wherein: said self-propelled means is hydraulic.
Claim 11. The device of claim 1 wherein: said self-propelled means is mechanical.
Claim 12. The device of claim 11 wherein: said self-propelled means is a cam mechanism.
Claim 13. The device of claim 11 wherein: said self-propelled means is a lever mechanism.
Claim 14. The device of claim 1 wherein: said self-propelled means is expandable material.
Claim 15. The device of claim 14 wherein: said expandable material is thermally expandable.
Claim 16. The device of Claim 2 wherein: said self-propelled means is actuable in response to penetration of a blood vessel by said needle.
Claim 17. The device of claim 2 wherein: said self-propelled means is manually actuable.
Claim 18. The device of claim 2 wherein: said self-propelled means is automatically actu- able in response to blood vessel penetration.
(Definition of sensing means)
Claim 19. The device of claim 2 further co pri- sing: means for identifying penetration of a blood ves* sel which automatically actuates said self-propelled means.
Claim 20. The device of claim 2 further compri- sing: means for sensing penetration of a blood vessel by said needle and for automatically advancing said catheter in response to such penetration.
Claim 21. The device of claim 2 further compri- sing: means for sensing pressure differential, occur- ring upon blood vessel penetration, between the pressure inside the blood vessel and the pressure within a defined space located rearward of said hollow needle and communicating with said hollow needle, said means being responsive thereto to automatically actuate said means for self-propelled advancement of said catheter.
Claim 22. The device of claim 3 further compri- sing: means for sensing pressure differential, occur- ring upon blood vessel penetration, between the pressure inside the blood vessel and the pressure within a defined space, within said needle hub, communicating with said hollow needle, said means being responsive thereto to automatically actuate said means for self- propelled advancement of said catheter.
Claim 23. The device of claim 22 further compri- sing: means for sensing pressure differential including a defined space within said needle hub communicating with said hollow needle shaft in which space the pressure is less than the pressure within the blood vessel.
Claim 24. The device of Claim 22 wherein: said means for sensing pressure differential includes a chamber communicating with said hollow needle shaft and located rearward of said needle, in which chamber the pressure is less then the pressure within a blood vessel.
Claim 25. The device of claim 24 wherein: said chamber is a vacuum chamber.
(Definition of means for creation of pressure differential)
Claim 26. The device of claim 22 wherein: said means for sensing pressure differential in- eludes means for creation of a pressure, within said defined space, below the pressure inside the penetrated blood vessel.
Claim 27. The device of claim 22 wherein: said means for sensing pressure differential in- eludes means for creation of a vacuum.
Claim 28. The device of claim 27 wherein: said means for creation of such vacuum comprises: a piston axially slideable contained in said needle hub, resilient means actuable subsequent to skin pene- tration by said hollow needle shaft and prior to penetration of a blood vessel for urging said piston rearwardly to a partially retracted position to create a vacuum forward of said piston, and latching means normally retaining said catheter in a retracted position and actuable by said piston moving fully rearward in response to vanishing of vacuum resulting from blood flowing into said needle to permit advancement of said catheter.
Claim 29. The device of claim 27 wherein: said means for the creation of a vacuum comprises: a wall extending across said needle hub to define a posterior chamber within said needle hub, a piston slideable within said needle hub defining the forward end of such chamber, a post-needle member extending through said wall and projecting rearwardly from said wall, a vacuum capsule mounted adjacent said wall and pierceable by said post-needle member after skin pene- tration by said needle shaft and prior to penetration of a blood vessel to allow air from said chamber to pass into said capsule to create a vacuum in said chamber to draw said piston partially rearward and so to create a vacuum within said needle hub forward of said piston to cause blood to flow into said needle immediately upon blood vessel penetration by said needle shaft.
Claim 30. The device of claim 27, wherein: said means for creation of a vacuum comprises: a piston slideable axially within said needle hub, a chamber defined by the hub of said needle and the anterior surface of said piston and communicating with said shaft of said needle, a hollow needle carried by said piston and projecting rearwardly from the piston, a vacuum capsule mounted on the rear end of said needle hub and having a plug pierceable by said hollow needle upon movement of said piston and said capsule toward each other to cause air to pass into said cap- sule from said needle hub rearward of said piston to cause partial rearward movement of said piston and so to create a vacuum within said chamber to cause blood to flow through said needle shaft into said chamber immediately upon penetration of a blood vessel by said needle shaft.
Claim 31. The device of claim 27 wherein: said means for creation of vacuum comprises: a defined space within said needle hub having a wall which is deformable to increase the volume of said defined space and so to create a vacuum within said space.
Claim 32. The device of claim 3 further compri- sing: means for sensing pressure differential occur- ring upon blood vessel penetration between the pressure inside the blood vessel and the pressure within a defined space located rearward of said hollow needle and communicating with said hollow needle, and means for manually actuating said means for self-propelled advancement of said catheter.
Claim 33. The device of Claim 32 wherein: said means for sensing pressure differential includes a defined space within said needle hub, communicating with said hollow needle shaft, in which the pressure is less than the pressure within a blood vessel.
Claim 34. The device of claim 33 wherein: said defined space is a vacuum chamber in communication with said hollow needle shaft. (Definition of Locking Means and Triggering means)
Claim 35. The device of Claim 2 further compri- sing: locking means releasably retaining said catheter in retracted position.
Claim 36. The device of Claim 35 wherein: said locking means is manually actuable.
Claim 37. The device of Claim 5 further compri- . sing: locking means releasably retaining said catheter in a retracted position.
Claim 38. The device of claim 37 wherein: said locking means comprises a bridge carried by one of said hubs and having a stud projecting from said bridge, and a lever carried by the other of said hubs and re- leasably engageable with said stud.
Claim 39. The device of claim 35 wherein: said locking means is automatically operable in response to blood vessel penetration by said hollow needle to actuate said means for self-propelled advancement of said catheter.
Claim 40. The device of Claim 35 wherein: said locking means is automatically operable in response to means sensing blood vessel penetration for releasing said catheter for advancement by said self- propelled means.
Claim 41. The device of Claim 35 wherein: said locking means, is automatically operable in response to means sensing pressure differential between the pressure within a blood vessel and the pressure within a defined space located, rearward of said hollow needle and communicating with said hollow needle, occurring upon blood vessel penetration.
Claim 42. The device of claim 37 further compri- sing: an annular recess extending about the interior of said catheter hub, said needle hub having at least one side wall formed with at least one opening therein. a piston axially movable within said needle hub formed with an annular recess located adjacent the for- ward end of said piston and having a body portion ex- tending rearward from said recess, at least one ball member movable into said recess of said catheter hub by engagement with said body por- tion of said piston to lock said catheter in a retrac- ted position and moveable into the recess of said pis- ton upon rearward movement of said piston to release said catheter for advancement.
Claim 43. The device of Claim 42 further co pri- sing: a wall extending across said needle hub to define a chamber containing said piston, a post-needle member mounted in an opening extend- ing through said wall and projecting rearwardly from said wall, and a vacuum capsule having a plug pierceable by said post-needle member to cause air to pass from said cham- ber into said capsule to cause rearward movement of said piston to a partially retracted position and to create a vacuum forward of said piston to cause blood to flow into said chamber immediately upon penetration of a blood vessel by said needle shaft to drive said piston by the vanishing of the vacuum resulting from the blood flowing into said chamber to its fully retracted position in which said ball member can enter the annular recess of said piston to release said catheter for advancement.
Claim 44. The device of Claim 42 further compri- sing: a post-needle member extending axially through said piston and projecting rearwardly from said piston and a vacuum capsule having a plug pierceable by said post-needle member to cause air to pass from said cham- ber into said capsule to cause rearward movement of said piston to a partially retracted position and to create a vacuum forward of said piston to cause blood to flow into said chamber immediately upon penetration of a blood vessel by said needle shaft to drive said piston by the vanishing of the vacuum to its fully retracted position in which said ball member can enter the annular recess of said piston to release said catheter for advancement.
Claim 45. The device of Claim 42 further compri- sing: a rearwardly opening recess extending axially of said piston, resilient means interposed between said piston and the front end of said needle hub to urge said pis- ton to a partially retracted position, a stud projecting radially outward from said needle hub, a trigger member engaging said stud and movable between a first position and a second position, a first flange carried by said trigger member ex- tending to a position engageable with said piston, when said trigger member is in said first position to lock said piston in its advanced position and moveable into said rearwardly opening recess when said trigger member is in its second position to allow said resili- ent means to move said piston to its fully rectracted position by the vanishing of the vacuum.
Claim 46. The device of claim 45 wherein: said ball member can enter the annular recess of said piston to release said catheter for advancement when said piston has moved to said partially retracted position thereby creating a vacuum within said needle hub forward of said piston to cause blood to flow into 6 said chamber instantly upon penetration of a blood ves- 7 sel by said needle shaft to drive said piston to its 8 fully retracted position. 9
Claim 47. The device of claim 2 further compri- 1 sing: 2 means for triggering said means for self-pro- 3 pelled advancement in response to penetration of the 4 wall of a blood vessel. 5
Claim 48. The device of claim 47 wherein: 1 said triggering means is manually actuable. 2
Claim 49. The device of claim 47 wherein: 1 said triggering means is automatically operable 2 in response to blood vessel penetration. 3
Claim 50. The device of claim 3 further compri- 1 sing: 2 means for triggering said means for self- 3 propelled advancement in response to penetration of 4 the wall of a blood vessel. 5
Claim 51. The device of claim 50 wherein: 1 said triggering means is manually actuable. 2
Claim 52. The device of claim 50 wherein: 1 said triggering means is automatically operable 2 in response to blood vessel penetration. 3
Claim 53. The device of claim 52 further compri- 1 sing: 2 a vacuum chamber being contained within said 3 needle hub and communicating with said needle shaft, 4 a piston slideably movable within said vacuum 5 chamber, 6 resilient means actuable by said triggering means 7 for urging said piston rearwardly within said chamber 8 to create a vacuum forward of said piston to limit 9 rearward movement of said piston, and 1 means operable upon full rearward movement of 1 said piston in response to blood entering said chamber 12 upon penetration of a blood vessel by said needle 13 shaft for actuating said self-propelled means to ad- 14 vance said catheter.
Claim 54. The device of claim 52 further compri- 1 sing: 2 a generally cylindrical chamber formed in said 3 needle hub and communicating with said shaft, 4 a piston slideably mounted within said chamber, 5 a wall closing the rear end of said chamber and 6 having a hollow cylindrical post-needle member projec- 7 ting through said wall and communicating with said 8 chamber, 9 a vacuum capsule movably mounted on said rear end 10 of said chamber having a plug pierceable by said 11 post-needle member upon movement of said capsule to 12 allow air within said chamber rearward of said piston 13 to flow into said capsule to cause partial rearward 14 movement of said piston and to create a vacuum in said 15 chamber forwardly of said piston, 16 locking means releasably securing said catheter 17 to said needle hub, and 18 means responsive to full rearward movement of 19 said piston in response to the pressure of blood enter- 20 ing said chamber forward of said piston for releasing 21 said locking means to allow advancement and placement 22 of said catheter. 23 (Definition of arming means)
Claim 55. The device of claim 2 further compri- 1 sing: 2 means for arming said means for self-propelled 3 advancement of said catheter. 4
Claim 56. The device of claim 20 further compri- 1 sing: 2 means for arming said means for sensing penetra- 3 tion of a blood vessel. 4
Claim 57. The device of claim 21 further compri- 1 sing: 2 means for arming said means for sensing pressure 3 differential. 4
Claim 58. The device of claim 26 further compri- 1 sing: 2 means for arming said means for creation of a 3 pressure, within said defined space, below the pressure 4 inside the penetrated blood vessel. 5
Claim 59. The device of claim 27 further compri- 1 sing: 2 means for arming said means for creation of a 3 vacuum. 4
Claim 60. The device of claim 57 wherein: 1 said arming means is manually actuable. 2
Claim 61. The device of claim 57 wherein: 1 said arming means is automatically actuable. 2
Claim 62. The device of claim 57 wherein: 1 said arming means is automatically actuable in 2 response to skin penetration. 3 (Definition of a device separated from catheter)
Claim 63. The device of Claim 1, wherein: said self-propelled means includes a propelling unit with a needle projecting forward from said propelling unit as an integral and undetachable part of said propelling unit
Claim 64. The device of Claim 63, wherein: 1 said propelling unit includes means for 2 manually operating said self-propelled means. 3
Claim 65. The device of Claim 63, wherein: 1 said propelling unit includes - 2 means for automatically operating said self- 3 propelled means in response to penetration of a blood 4 vessel. 5
Claim 66. The device of Claim 63, further compri- 1 sing: 2 an interface member between said 3 propelling unit and said catheter. 4
Claim 67. The device of Claim 1, wherein: 1 said self-propelled means includes 2 a propelling unit, a separate needle and 3 means of connection between said 4 propelling unit and said separate needle. 6
Claim 68. The device of Claim 67, wherein: 1 said propelling unit includes 2 means for manually operating said self-propelled 3 means. 4
Claim 69. The device of Claim 67, wherein: 1 said propelling unit includes 2 means for automatically .operating said self- 3 propelled means in response to penetration of a blood 4 vessel. 5
Claim 70. The device of Claim 67, further compri- 1 sing: 2 an interface member between said 3 propelling unit and said catheter. 4
Claim 71. A catheter placement device comprising: 1 a catheter, and 2 means for automatic advancement of said catheter 3
Claim 72. The device of Claim 71 further compri- 1 sing: 2 means for sensing penetration of a blood vessel 3 and responsive thereto to automatically advance 4 said catheter. 5
(Definition of additional sensing means)
Claim 73. The device of claim 20 wherein: 1 said means for sensing penetration comprise: 2 optical sensing means 3
Claim 74. The device of claim 20 wherein: 1 said means for sensing penetration comprise: 2 temperature sensing means 3
Claim 75. The device of claim 20 wherein: 1 said means for sensing penetration comprise: 2 means for sensing electrical properties of the 3 blood. 4
Claim 76. The device of claim 20 wherein: 1 said means for sensing penetration comprise: 2 means for detecting the physical properties 3 of the blood as a fluid. 4
Claim 77. The device of claim 20 wherein: 1 said means for sensing penetration comprise: 2 acoustic sensing means. 3
Claim 78. The device of claim 20 wherein: 1 said means for sensing penetration comprise: 2 means for sensing ultrasound. 3
Claim 79. The device of claim 20 wherein: 1 said means for sensing penetration comprise: 2 pressure sensing means. 3
Claim 80. The device of Claim 20 wherein: 1 said means for sensing penetration comprise: 2 means for detecting chemical properties of 3 the blood. 4
Claim 81. The device of Claim 20 wherein: 1 said means for sensing penetration comprise: 2 means for identifying blood by detecting blood 3 components. 4
Claim 82. The device of claim 20 wherein: 1 said means for sensing penetration actuates 2 an electromagnet to automatically advance said catheter. 3
PCT/US1992/007625 1991-09-13 1992-09-09 Automatic cannulation device WO1993005832A1 (en)

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EP92919851A EP0603300A4 (en) 1991-09-13 1992-09-09 Automatic cannulation device.
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US9005169B2 (en) 2007-10-16 2015-04-14 Cequr Sa Cannula insertion device and related methods
US9968747B2 (en) 2007-10-16 2018-05-15 Cequr Sa Cannula insertion device and related methods
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US9211378B2 (en) 2010-10-22 2015-12-15 Cequr Sa Methods and systems for dosing a medicament
US11253293B2 (en) 2011-03-09 2022-02-22 Olberon Limited Fluid vessel communication device
WO2015006383A3 (en) * 2013-07-09 2015-11-12 Farley Sean S Intravascular catheter insertion device
WO2018219842A1 (en) * 2017-05-31 2018-12-06 Fondazione Istituto Italiano Di Tecnologia Hand-held device for inserting a needle into a non-homogeneous material, particularly for intravenous catheterization
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IT201700059659A1 (en) * 2017-05-31 2018-12-01 Fondazione St Italiano Tecnologia Portable device for inserting a needle in a non-homogeneous material, particularly for intravenous catheterization.
US11752305B2 (en) 2017-05-31 2023-09-12 Fondazione Istituto Italiano Di Tecnologia Hand-held device for inserting a needle into a non-homogeneous material
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EP0705618A1 (en) 1996-04-10
EP1016428A3 (en) 2000-08-02
DE69232380D1 (en) 2002-03-14
DK0705618T3 (en) 2002-03-18
JPH07501459A (en) 1995-02-16
AU675904B2 (en) 1997-02-20
AU667685B2 (en) 1996-04-04
CA2118693C (en) 2000-11-21
CA2118693A1 (en) 1993-04-01
ATE212239T1 (en) 2002-02-15
JP3050600B2 (en) 2000-06-12
EP0603300A1 (en) 1994-06-29
US5312361A (en) 1994-05-17
AU3666895A (en) 1996-01-11
US5480388A (en) 1996-01-02
EP0705618B1 (en) 2002-01-23
EP1016428A2 (en) 2000-07-05
AU2593992A (en) 1993-04-27
JP3001476B2 (en) 2000-01-24
EP0603300A4 (en) 1995-01-11
JPH10151206A (en) 1998-06-09

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