WO1999047193A1 - Seringue haute pression - Google Patents

Seringue haute pression Download PDF

Info

Publication number
WO1999047193A1
WO1999047193A1 PCT/US1999/005907 US9905907W WO9947193A1 WO 1999047193 A1 WO1999047193 A1 WO 1999047193A1 US 9905907 W US9905907 W US 9905907W WO 9947193 A1 WO9947193 A1 WO 9947193A1
Authority
WO
WIPO (PCT)
Prior art keywords
barrel
syringe
plunger
pressure
proximal
Prior art date
Application number
PCT/US1999/005907
Other languages
English (en)
Inventor
James Pokorney
Original Assignee
James Pokorney
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 James Pokorney filed Critical James Pokorney
Publication of WO1999047193A1 publication Critical patent/WO1999047193A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3135—Syringe barrels characterised by constructional features of the proximal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3137—Specially designed finger grip means, e.g. for easy manipulation of the syringe rod

Definitions

  • the present invention generally relates to syringes, and more particularly to high pressure control syringes.
  • High pressure syringes have been used in medical procedures for many years. To facilitate single hand retraction and injection motions, a high pressure syringe is typically designed with thumb and hand rings or grips to allow sufficient hand control in both the injection (depression of plunger) and the aspiration (retraction of plunger) modes.
  • radioimaging is done more frequently and elaborately during diagnostic procedures, where mapping of the anatomy is required for further evaluations.
  • dye injection is also needed during therapeutic procedures, such as angioplasty, in order to enable the physician to evaluate catheter location, condition of the lesion, nature of the stenosis, progress of the procedure, effectiveness of the dilatation, and location and orientation of stent placement, if necessary.
  • the interventionalist uses a hand-held syringe to inject a sufficient volume and flow rate of radiopaque dye to opacity the artery under study. Inadequately opacified vessels generally result in overestimation of stenosis severity due to contrast "streaming" as it forms a layer with unopacified blood.
  • the specific volume and rate of injection is controlled by the interventionalist by observing the fluoroscopic image. For instance, in the right coronary artery, 3-6 cm 3 of contrast are injected at a rate of 2-3 cm 3 per second, and in the left coronary artery, 4-7 cm 3 are injected at the same rate.
  • syringe pressures of 100 psi or more are often required. Such high pressure delivery is critical to create the appropriate contrast filling. If the dye is delivered with insufficient injection pressures, inadequately opacified vessels can result causing either incorrect fluoroscopic images or repeat injections. Repeating the injection subjects the patient to a higher risk of adverse side effects of the radiopaque dye and also increases the cost of the procedure. A major reason for inadequate injection volumes is the limitations on current syringes to deliver the necessary pressure, especially with users who do not possess above average hand strength.
  • Syringe Pressure Hand Force / Plunger Area (or barrel internal cross-section area)
  • One commercially available high pressure syringe Merit Medical, model CCS460 provides increased injection pressure by reducing the barrel cross- sectional area.
  • this decrease in the barrel's cross-sectional area requires a reduction in syringe volume from 10 cubic centimeters to 6 cubic centimeters to maintain a plunger stroke length that is ergonomically acceptable. This lower volume is undesirable in most interventional procedures.
  • a unique syringe design allows an increased stroke length within the ergonomic limitations of the average hand in conjunction with a lowered barrel cross-sectional area, thereby reducing the force required from the user without reducing delivery pressure or volume.
  • One embodiment of the present invention is a hand operated syringe for injecting a liquid which includes an elongated barrel having proximal and distal ends and an exit orifice at its distal end.
  • a pair of opposing finger grips are present at the proximal end of the barrel, each having a proximal inner portion defining a most proximal pressure point closely adjacent the barrel to which finger pressure is 4
  • the pressure points defining a plane substantially perpendicular to the barrel's axis.
  • a plunger is received in the barrel and it has a proximal end protruding from the barrel, the proximal end including a pressure surface adapted to receive manual pressure from, e.g., the thumb in an injection procedure.
  • the plunger is movable between retracted and fully inserted positions within the barrel to discharge a volume of liquid through the exit orifice.
  • the pressure surface of the plunger and the finger pressure points closely adjacent the barrel are arranged so that when the plunger is in its fully inserted position, its pressure surface is spaced distally of a plane defined by the finger pressure points which is substantially perpendicular to the barrel's axis.
  • the plunger pressure surface lies substantially in said plane when the plunger is in its fully inserted position.
  • An additional embodiment of the present invention includes an elongated barrel that has proximal and distal ends and an exit orifice at its distal end.
  • This barrel defines a fluid reservoir that has a cross-sectional area A.
  • a pair of opposing finger grips are present at the proximal end of the barrel, each having a proximal inner portion defining a distally-facing pressure point to which finger pressure is applied proximally during operation of the syringe. These points lay in a plane substantially perpendicular to the barrel's axis.
  • a plunger is received in the barrel and has a proximal end protruding from the barrel, the proximal end including a proximally-facing pressure surface adapted to receive manual pressure.
  • the plunger is movable through a stroke length S between retracted and fully inserted positions within the barrel to discharge a volume V of fluid through the its exit orifice.
  • a stroke length S between retracted and fully inserted positions within the barrel to discharge a volume V of fluid through the its exit orifice.
  • its pressure surface is spaced distally of the plane by a distance L, where L is greater than or equal to 0.01 S and preferably greater than or equal to 0.02S.
  • Figure 1 is a cross-sectional view of one embodiment of the invention showing its plunger fully depressed;
  • Figure 2 is a cross-sectional view of the embodiment of Figure 1 with its plunger retracted;
  • Figure 3 is a side view of one embodiment of the invention showing the plunger in both its retracted (phantom line) and fully inserted positions;
  • Figure 4 is a side view of a commercially available syringe showing the plunger in both its retracted and fully inserted positions.
  • barrel body 10 is composed of a rigid clear polymer such as polycarbonate.
  • This body 10 defines an internal lumen or reservoir 16 adapted to hold the fluid to be injected.
  • a nozzle or exit orifice 20 At the distal end of the body 10 is a nozzle or exit orifice 20.
  • this orifice has a smaller diameter than the body 10, and is used to connect the syringe to extension tubing, catheter fittings, needles, and the like.
  • body 10 At the proximal end of body 10 opposite the orifice 20, body 10 has an opening designed to accept a plunger 12.
  • finger grips 24 are positioned at or adjacent the more proximal end of body 10 at or adjacent the more proximal end of body 10 at or adjacent the more proximal end of body 10 at or adjacent the more proximal end of body 10 at or adjacent the more proximal end of body 10 at or adjacent the more proximal end of body 10 at or adjacent the more proximal end of body 10 at or adjacent the more proximal end of body 10 at or adjacent the more proximal end of body 10 are a pair of opposing finger grips 24. These finger grips may be integrally formed with the syringe body 20 or otherwise attached. In a preferred embodiment these finger grips 24 are shaped to accommodate the comfortable gripping of the body 10 by the first and second (index and middle) fingers of the user's hand.
  • these grips 24 will define an opening 28 for the insertion of fingers.
  • these openings 28 to the proximal side of the grips 26, are distally-facing pressure points 46 to which finger pressure is applied proximally during the operation of the syringe.
  • Finger grips 24 are so positioned that the pressure points 46 extend proximally beyond the most proximal end of the body 10.
  • An additional embodiment of the invention provides additional ergonomic efficiencies by locating the finger pressure points as close to the barrel as possible while still allowing the plunger pressure surface to advance beyond the finger pressure points.
  • the pressure points 46 are closely adjacent to barrel 10. If finger grips adapted to allow more than one finger to simultaneously contact each grip are provided, the pressure points of the fingers closest to the barrel are the most closely adjacent pressure points.
  • additional finger grips 24 may be provided to afford substantially curved portions to the distal side of the finger grip 24, which may serve as an alternate gripping position 26.
  • a plunger 12 composed of a rigid polymer such as ABS (acrylonitrile- butadiene-styrene), is provided to control the aspiration and evacuation of the fluids delivered by the syringe.
  • This plunger 12 consists of a shaft 32 having a distal end 34.
  • a resilient seal 36 is placed at the distal end 34 of shaft 32. This resilient seal 36 helps provide an adequate vacuum for the aspiration of fluids into the body 10 as well as assisting in the complete evacuation of the same.
  • the seal 36 can be made of a number of materials including an elastic polymer such as polyisoprene.
  • the shaft 34 is spined to increase its column strength while providing a corresponding decrease in weight.
  • annular ridge 38 is provided near the distal end of shaft 32. This ridge 38 provides for the retention of the plunger 12 within the body 10 when used in conjunction with retaining ring 14.
  • the proximal end of plunger 12 is adapted to receive manual pressure.
  • this adaptation is in the form of a thumb ring 40.
  • This ring 40 defines an opening 42 for the insertion of a thumb.
  • the distal inside portion of ring 40 includes a pressure surface 48 where thumb pressure is applied during operation 7
  • the thumb ring may include an external, proximally facing surface 52 to facilitate the application of pressure by the hand palm.
  • a retaining ring 14 is placed on the proximal end of body 10.
  • this retaining ring 14 is made of an elastic polymer such as polypropylene, and is attached by snap fitting or bonding to body 10.
  • This elastic retaining ring 46 has an inside diameter slightly smaller than the outside diameter of the plunger's annular ridge 38, thereby providing resistance to the removal of plunger 12 from body 10.
  • the elastic nature of the ring 14 allows the plunger to "snap" into the barrel body 10 by exerting sufficient force to overcome the resistance provided by the elastic ring 14.
  • plunger 12 Once assembled, plunger 12, and more specifically seal 36, fit snugly within the lumen 16 to allow for the aspiration and evacuation of fluid during the operation of the syringe.
  • this syringe design significantly reduces the hand force necessary to generate high pressure injections without decreasing the injection volume V by reducing the barrel's cross-sectional area A while simultaneously increasing the plunger stroke length S to maintain the same injectate volume. This is achieved by positioning the finger grips 24 to allow the thumb to advance past the fingers at full plunger advancement. By doing this, the overall stroke length S is increased without requiring further hand extension. If desired, the thickness of the retainer ring may also be minimized.
  • Table 1 compares the invention, as shown in figure 3, to a popular syringe manufactured by NAMIC, Inc. (Glen Falls, New York Catalog No. 70085003) as shown in figure 4. 8
  • Plunger stroke S at full retraction is substantially lengthened in this invention, from 2.4 inches to 3.2 inches without lengthening the full hand extension E distance of 3.0 inches common to both designs.
  • Hand extension at full advancement L is defined as the distance measured distally from a plane substantially perpendicular to the barrel's axis defined by the most proximal pressure points 46 to the position assumed by the plunger pressure surface 48 when the plunger is fully inserted.
  • the distance L in a preferred embodiment is about 0.2 inches.
  • the negative value for L in the NAMIC example indicates that its pressure surface 48 lies on the proximal side of the plane.
  • the barrel 10 cross-sectional area A can be substantially reduced without decreasing volume V.
  • the barrel cross-sectional area A is reduced from 0.26 square inches to 0.19 square inches and the force required to generate 100 psi injection pressure is reduced from 26 pounds to 19 pounds.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Selon une réalisation, la présente invention porte sur une seringue manuelle permettant d'injecter un liquide et comprenant un corps allongé (10) doté d'extrémités proximale et distale, et d'un orifice d'évacuation au niveau de l'extrémité distale. Une paire d'éléments de préhension (24) opposés se trouvent à l'extrémité proximale du corps, chacun possédant une partie interne proximale qui forme un point (46) de pression se rapprochant du corps de la seringue lorsqu'on applique une pression lors de l'actionnement de la seringue. Ces points (46) forment un plan pratiquement parallèle à l'axe du corps. L'extrémité proximale d'un plongeur (12) ménagé dans le corps fait saillie du corps (10) et comporte une surface (48) de pression adaptée pour recevoir une pression manuelle. Le plongeur (12) peut se déplacer entre une position rétractée et une position totalement rentrée dans le corps (10) de façon à évacuer un volume de liquide par l'orifice d'évacuation. La surface (48) de pression du plongeur (12) et les points (46) de pression proches du corps sont agencés de sorte que, lorsque le plongeur (12) est en position totalement rentrée, sa surface de pression s'étende dans le plan.
PCT/US1999/005907 1998-03-20 1999-03-19 Seringue haute pression WO1999047193A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US4544198A 1998-03-20 1998-03-20
US09/045,441 1998-03-20

Publications (1)

Publication Number Publication Date
WO1999047193A1 true WO1999047193A1 (fr) 1999-09-23

Family

ID=21937880

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/005907 WO1999047193A1 (fr) 1998-03-20 1999-03-19 Seringue haute pression

Country Status (1)

Country Link
WO (1) WO1999047193A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2719413A1 (fr) * 2011-06-08 2014-04-16 Beijing DBT Medi-Tech Development Co., Ltd. Seringue à trois anneaux

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5226897A (en) * 1992-02-28 1993-07-13 Professional Medical Products, Inc. Manually driven piston syringe with frangibly mounted tube adapter

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5226897A (en) * 1992-02-28 1993-07-13 Professional Medical Products, Inc. Manually driven piston syringe with frangibly mounted tube adapter

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2719413A1 (fr) * 2011-06-08 2014-04-16 Beijing DBT Medi-Tech Development Co., Ltd. Seringue à trois anneaux
EP2719413A4 (fr) * 2011-06-08 2015-02-18 Beijing Dbt Medi Tech Dev Co Ltd Seringue à trois anneaux

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