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
  • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
• • 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
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion

Definitions

• the present invention generally finds application in the field of equipment for medical use and relates to an apparatus for intradermal and subcutaneous injection of a filler material, particularly for cosmetic surgery.
• the filler material generally hyaluronic acid or collagene
• a syringe that is manually handled by the surgeon.
• the needle is caused to penetrate the skin tangentially or at a very small angle, and an undulatory motion may be imparted thereto to stimulate the skin tissue and facilitate its dilation and detachment.
• Electromechanical devices commonly known as “pistols” are currently available, which may be either manual or automatic and are designed to be connected to a syringe for guiding the sliding plunger and allow controlled injection of the filler material.
• a syringe for guiding the sliding plunger and allow controlled injection of the filler material.
• such devices which are particularly employed in mesotherapy procedures, are designed to guide the needle in a substantially longitudinal direction parallel to the needle axis and at least partially orthogonal, or at large angles, to the surface of the body at the area thereof subjected to treatment.
• the object of the present invention is to overcome the above drawbacks, by providing an electromechanical medical injection apparatus that is highly efficient and relatively cost-effective.
• a particular object is to provide a portable apparatus that can impart an oscillatory motion to the syringe with which the apparatus is connected.
• a further object is to provide a highly ergonomic apparatus, which may be used by both left- and right-handed operators, and allows the needle to be oriented through a wide range of angles relative to the part of the human body being treated.
• Yet another object of the invention is to provide an apparatus that allows adjustment of all operating parameters and customized configuration according to the person undergoing surgery.
• Another important object of the present invention is to provide an apparatus that allows saving and storage of the operating parameters of each procedure.
• an electromechanical portable injection apparatus as defined in claim 1 , comprising a pistol-shaped frame with a handle portion and a housing portion defining a longitudinal axis and designed to house a syringe so that the needle is substantially parallel to said axis, electromechanical actuator means susceptible of interacting with the plunger to impart translation thereto in a longitudinal direction and facilitate controlled ejection of the filler material.
• the invention is characterized in that it comprises oscillator means adapted to cause oscillations of the needle in at least one first oscillation plane parallel to said longitudinal axis.
• the apparatus of the invention may be used to impart oscillatory motion to the needle of the syringe associated therewith, as required for simple and sage skin detachment.
• the oscillator means may include a first electric motor with first cam means, for imparting a first oscillatory motion of predetermined and adjustable amplitude and frequency.
• the oscillator means may include a second electric motor with second cam means, for imparting a second oscillatory motion of predetermined and adjustable amplitude and frequency about an axis parallel to the plane of oscillation.
• the apparatus may be oriented at various angles relative to the body part being treated, and may be easily handled by both right- and left-handed operators.
• the apparatus may include control and adjustment means having a logic controller for controlling the oscillator means and/or the actuator means and interface means for customized configuration of the operating parameters thereof.
• FIG. 1 is a side view of an apparatus of the invention
• FIG. 2 is a top view of the apparatus of Fig. 1 ;
• FIG. 3 is a front view of the pistol-shaped frame belonging to the apparatus of Fig. 1 , as taken along the plane /-/;
• FIG. 4 is a front view of the frame, as taken along the plane // - // of Fig. 2;
• FIG. 5 is a side view of the apparatus of Fig. 1 , partially cut away to reveal some of its interior parts;
• FIG. 6 is a perspective view of a first detail of the oscillator means of an apparatus of the invention.
• FIG. 7 is a perspective view of a second detail of the oscillator means of the apparatus of the invention.
• FIG. 8 is a perspective view of a detail of the actuator means belonging to the apparatus of the invention, and associated with a syringe.
• the apparatus of the invention may be used in cosmetic or plastic surgery for subcutaneous or intradermal injection of a filler material F, through a syringe 1 of special or traditional type, mounted to the apparatus 1.
• the apparatus 1 will be particularly suitable for use in the correction of face defects, such as wrinkles, naso-labial folds, naso-genian folds and the like, by injecting a liquid or semisolid filler material therein.
• Suitable materials may be, for instance, hyaluronic acid or mixtures thereof, collagen, amino acids or other vitalizing or biostimulating products of common use in cosmetic medicine, or adipose tissue in lipostructure techniques.
• an apparatus of the invention comprises a frame 2 having a handle portion 3, adapted to be held by an operator for comfortable handling of the frame 2, and a housing portion 4 defining a longitudinal axis L and suitable for axially housing the needle N of the syringe S.
• the frame 2 may have the shape of a pistol or the like, for ensuring high ergonomic quality and allowing a comfortable and safe grasp by both right- and left-handed operators.
• the housing portion 4 may have, for example, a tubular shape, or a cradle shape, for accommodating syringes S of different diameters and lengths.
• the apparatus 1 further includes electromechanical actuator means 5, which are susceptible of interacting with the plunger P of the syringe S and impart an axial translational motion t thereto with a predetermined speed to facilitate controlled ejection of the filler material F.
• oscillator means are provided, which are adapted to cause oscillations ⁇ of the needle N of the syringe S in at least one first plane of oscillation ⁇ parallel to the longitudinal axis L.
• the operator may impart controlled oscillatory movements to the whole syringe S or to its needle N only, with no particular skill being required from the operator.
• the oscillation angle ⁇ may fall in a relatively narrow range, e.g. from -30° to +30° relative to the axis L, although the oscillation amplitude may be adjusted to a larger value.
• the frequency values will probably be of the order of a few Hertz but may be adjusted to any value with no limitation except practical and functional restrictions.
• the oscillatory movements x ⁇ transmitted to the needle N which is introduced more or less deep into the patient's skin, will cause a first skin detachment effect, while stimulating fibrosis formation.
• a first defect attenuation effect will be thus obtained without even using any filler material F, which may be employed in much smaller amounts and provide more effective and long-lasting effects.
• Figs. 3 and 4 show that the housing portion 4 may include a support plate 6 for supporting the syringe S, which is movably mounted to the frame 2.
• the plate 6 is preferably mounted to the frame 2 to pivot about a pair of orthogonal axes of oscillation Y and Z, defined by a pair of substantially transverse specially shaped pivots 8, 9 designed to be received in corresponding complementary recesses 10, 11 or slots formed in the frame 2.
• the housing portion 4 may be set into a first oscillatory motion x ⁇ about the first axis Y orthogonal to the plane of oscillation ⁇ and a second oscillatory motion ⁇ about a second transverse axis Z in another plane ⁇ ' orthogonal to the former ⁇ .
• Both oscillatory motions ⁇ and ⁇ will have respective predetermined amplitudes and frequencies, possibly adjustable and not necessarily coincident.
• the oscillator means 7 may include a first electric motor 12 or an equivalent motor drive.
• the first electric motor 12 may be a micromotor with an epicyclic reduction gear, with a driving shaft 13 having first cam means 14.
• the first cam means 14 may include a first cam member 14' whose center axis W is longitudinally offset to the axis Y of the pivot 8, thereby minimizing the resistant torque opposing the first electric motor 12.
• the oscillator means 7 may include a second electric motor 15, possibly similar to the former 12 and also having a driving shaft 16 associated with second cam means 17, with a second cam member 17' designed to operate on the support plate 6 and impart the second oscillatory motion ⁇ .
• center axis X of the second cam member 17' may be conveniently transversely offset to the axis Z of the second pivot 9, to minimize the resistant torque opposing the second electric motor 15.
• the oscillator means 7 may be also associated with elastic return means, which are only schematically shown in the annexed figures and designated by numeral 34, for cooperating with the cam means 14, 17 to impart the oscillations ⁇ , ⁇ .
• the oscillator means 7 may be controlled by a hydraulic, pneumatic, mechanical or the like servosystem.
• the oscillator means 7, possibly as described above, may be associated with the frame 2 in such a manner as to directly operate on part of the syringe S.
• the support plate 6 may have a substantially L cross section to define a pair of orthogonal support surfaces 18 and 19, for the first and second cam members 14', 17' respectively.
• the support plate 6 so designed will define appropriate housings, not shown, with the frame 2, for receiving the micromotors 13, 15 thereby providing as compact and handy a pistol 2 as possible.
• the housing portion 4 may have such a longitudinal length I as to allow the needle N of the syringe S to at least partially project out of the frame 2.
• Locking means 20 may be provided in the housing portion 4 for locking the syringe S, and may be common easy operable linkages or nut and screw assemblies, preferably associated with the housing portion 4 to uniquely define the position of the needle N.
• Fig. 8 shows a particular configuration of the actuator means 5, essentially consisting of a rack gear 21 driven by a third electric motor 22, such as a micromotor.
• the gear 21 has one end 23 designed for connection to the free end of the plunger P and susceptible of longitudinal translation to cause ejection of the filler material F and to empty the syringe S.
• the rack gear 21 may be equivalents replaced by any other epicyclic train.
• the actuator means 5 may include a proximity sensor, not shown, for detecting the fully retracted position of the rack 21 or an equivalent mechanism, corresponding to the maximum extension of the syringe S to define the position in which the syringe S will have to be replaced.
• Selective actuation of the oscillator means 7 and the actuator means 5 may be controlled by control and adjustment means 24.
• first, second and third pushbuttons or switches designated by numerals 25, 26 and 27 respectively, preferably located on the handle portion 3, adapted to selectively or simultaneously actuate the first, second and third electric motors 12, 15, 22 respectively.
• switches 25, 26, 27 may be either simple shunting switches or progressive switches or the like, or touch control devices and may possibly have an on/off operation.
• the handle portion 3 may also have optical means 28, such as LEDs or indicators electrically connected to the switches 25, 26, 27, indicating the operation of the oscillator means 7 and actuator means 5.
• optical means 28 such as LEDs or indicators electrically connected to the switches 25, 26, 27, indicating the operation of the oscillator means 7 and actuator means 5.
• power may be supplied to the apparatus 1 by a controller 29 external to the pistol 2 and adapted to be connected thereto by a common power cord 30 also designed for data transfer for controlling and monitoring the apparatus 1.
• the controller 29 also has the purpose of controlling the operation of the oscillator means 7 and/or the actuator means 5 and will be particularly designed for adjusting the oscillation frequency of the oscillator means 7 and/or the speed of longitudinal translation of the actuator means 5 and repositioning thereof.
• the controller 29 may include a first electronic regulator for regulating the frequency of the first oscillatory motion t ⁇ , a second electronic regulator for regulating the frequency of the second oscillatory motion ⁇ and a third electronic regulator for regulating the speed of translation t and positioning of the actuator means 5.
• the electronic regulators which are not shown because they are known per se, may be of analog or digital type and include respective electronic boards held within the box-like body of the controller 29.
• controller 29 may include user interface means 31 connected to the electronic regulators for customized configuration of the operating parameters.
• a data processing unit not shown, having a common microprocessor for entering and processing speed, amplitude and frequency parameters selected by the operator according to the particular procedure to be carried out and to the anatomic characteristics of the patient.
• the interface means 31 may also include an external display 32 or the like and a storage unit, not shown, designed to be connected to the data processing unit through a common connection port 33, such as a serial, parallel, USB or wireless, e.g. Bluetooth® or the like port.
• a common connection port 33 such as a serial, parallel, USB or wireless, e.g. Bluetooth® or the like port.
• the operator may save all the operating parameters of each procedure, as well as all procedure events and times to create a history for each patient and each type of procedure.
• the interface means 31 may also include a memory card, not shown, allowing storage of each patient's data, to be later displayed both on the display 32 and on another monitor connected to the controller 29, thereby simplifying the operator's tasks.
• controller 29 may be designed to communicate with an external computer, possibly having a screen for data display.
• the apparatus of the invention fulfils the intended objects and particularly meets the requirement of allowing oscillations to be imparted to the needle of the syringe that is used for the procedure, to facilitate skin detachment and improved skin crease filling, without requiring any particular skill from the operator.
• the apparatus will keep track of all the procedures that have been carried out, thereby providing a history for each patient, and affording an apparent advantage, particularly when a patient is to undergo further surgical procedures.

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)

Applications Claiming Priority (2)

Publications (1)

Family

ID=40651727

Family Applications (1)

Country Status (4)

Families Citing this family (16)

Family Cites Families (8)

• 2008
  • 2008-02-05 SM SM200800007A patent/SM200800007B/it unknown
• 2009
  • 2009-02-04 AR ARP090100359 patent/AR070556A1/es unknown
  • 2009-02-06 WO PCT/IB2009/050496 patent/WO2009098666A1/en not_active Ceased
  • 2009-02-06 EP EP09707917A patent/EP2249901A1/en not_active Withdrawn

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events