WO2009098666A1

WO2009098666A1 - Medical injection apparatus

Info

Publication number: WO2009098666A1
Application number: PCT/IB2009/050496
Authority: WO
Inventors: Antoine Assaf; Valerio Frigo
Original assignee: Zelig - Servicos De Consultadoria Lda
Priority date: 2008-02-05
Filing date: 2009-02-06
Publication date: 2009-08-13
Also published as: SM200800007B; AR070556A1; EP2249901A1; SM200800007A; WO2009098666A8

Abstract

An apparatus for intradermal and subcutaneous injection of a filler material comprises a pistol-shaped frame (2) with a handle portion (3) and a housing portion (4) defining a longitudinal axis (L) and designed to house a syringe (S) so that the needle (N) is substantially parallel to said axis (L), electromechanical actuator means (5) susceptible of interacting with the plunger (P) to promote an axial translational motion (t) thereof and facilitate controlled ejection of the filling material. The apparatus comprises oscillator means (7) adapted to cause oscillations (ϖ) of the needle (N) in at least one first plane of oscillation (π) parallel to said longitudinal axis (L).

Description

MEDICAL INJECTION APPARATUS

Field of the invention

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.

Background art

Various types of procedures are known in plastic and cosmetic surgery, which involve intradermal or subcutaneous injection of a drug, a biostimulating agent or other biocompatible materials, commonly known as "fillers", with the purpose of correcting body defects.

For example, in procedures for cosmetic correction of the face or other parts of the human body by filling skin creases, the filler material, generally hyaluronic acid or collagene, is introduced through a syringe that is manually handled by the surgeon.

In such procedures, 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.

Nevertheless, the quality of the procedure is strictly associated with the operator's skill and high accuracy and expertise is required for particular skin detachments, to avoid undesired complications. Additional problems arise when determining the depth to be reached by the needle and the amount of filler material to be injected.

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. One example of such device is disclosed in US patent 5 300 029.

Nevertheless, 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.

Therefore, they cannot be easily adapted to those skin filling procedures in which the needle has to penetrate the skin as tangentially as possible to the skin.

Moreover, these devices only allow a longitudinal reciprocating motion of the syringe, possibly at a variable frequency, and cannot provide the above mentioned undulatory motion used to stimulate the skin tissue.

Disclosure of the invention

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.

These and other objects, as better explained hereafter, are fulfilled by 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.

Thanks to this particular configuration, 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.

Advantageously, 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.

Conveniently, 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.

Due to this additional feature, 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.

Advantageously, 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.

This will allow the apparatus to adapt its operation to each patient's needs, and to save and store the operating parameters of each procedure.

Brief description of the drawings

Further features and advantages of the invention will be more readily apparent upon reading of the detailed description of a preferred non exclusive embodiment of an injection apparatus of the invention, which is shown as a non limiting example with the help of the annexed figures, in which:

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.

Detailed description of one preferred embodiment

Referring to the above figures, the apparatus of the invention, generally designated by numeral 1 , 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.

As shown in Fig. 1 , 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.

According to a peculiar feature of the present invention, oscillator means are provided, which are adapted to cause oscillations τπ of the needle N of the syringe S in at least one first plane of oscillation π parallel to the longitudinal axis L.

Thanks to this feature, during the filling procedure, 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.

As shown in Fig. 2, in which the dashed lines indicate two different positions of the needle N during an oscillation m, the oscillation angle α 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.

Most advantageously, the oscillatory movements xπ 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.

Thus, under the action of the oscillator means 7, the housing portion 4 may be set into a first oscillatory motion xπ about the first axis Y orthogonal to the plane of oscillation π and a second oscillatory motion ζ about a second transverse axis Z in another plane π' orthogonal to the former π. Both oscillatory motions τπ and ζ will have respective predetermined amplitudes and frequencies, possibly adjustable and not necessarily coincident.

In a preferred, non exclusive configuration of the present invention, as shown in Figs. 6 and 7, the oscillator means 7 may include a first electric motor 12 or an equivalent motor drive.

In a preferred, non exclusive configuration of the invention, the first electric motor 12 may be a micromotor with an epicyclic reduction gear, with a driving shaft 13 having first cam means 14.

These may be designed to operate on the support plate 6 and impart the first oscillatory motion τσ in the plane π. For example, 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.

Furthermore, 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 ζ.

Once again, the 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.

Equivalent results may be obtained if the motor drive of the oscillator means 7 consists of servomotors or power-assisted motors, to allow feedback speed control even under load variation conditions.

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 τσ, ζ.

In an alternative configuration, not shown herein, the oscillator means 7 may be controlled by a hydraulic, pneumatic, mechanical or the like servosystem.

In yet another embodiment, also not shown, 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.

In a particular preferred but not exclusive embodiment of the invention, 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.

Also, 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.

Furthermore, 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.

Particularly, there may be 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.

These 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.

Advantageously, as shown in Fig. 1, 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.

Particularly, the controller 29 may include a first electronic regulator for regulating the frequency of the first oscillatory motion tσ, a second electronic regulator for regulating the frequency of the second oscillatory motion ζ 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.

Also, the controller 29 may include user interface means 31 connected to the electronic regulators for customized configuration of the operating parameters.

For instance, there may be provided 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.

Thus, 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.

Furthermore, the controller 29 may be designed to communicate with an external computer, possibly having a screen for data display.

The above disclosure shows that 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.

Due to the provision of interface means 31 , 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.

The apparatus of the invention is susceptible of a many changes and variants within the inventive principle disclosed in the annexed claims. All the details thereof may be replaced by other technically equivalent parts, and the materials may vary depending on different needs, without departure from the scope of the invention.

While the apparatus has been described with particular reference to the annexed figures, the numerals referred to in the disclosure and claims are only used for the sake of a better intelligibility of the invention and shall not be intended to limit the claimed scope in any manner.

Claims

1. A medical injection apparatus, particularly for intradermal or subcutaneous injection of a filler material (F) in cosmetic surgery, wherein the filler material (F) is contained in a syringe (S) having a plunger (P) and a needle (N), comprising: a pistol-shaped frame (2) with a handle portion (3) and a housing portion (4) defining a longitudinal axis (L) and designed to house a syringe (S) with the needle (N) substantially parallel to said axis (L); electromechanical actuator means (5), which are susceptible of interacting with the plunger (P) to promote the axial translational motion (t) thereof and facilitate controlled ejection of the filler material; characterized by comprising oscillator means (7) adapted to cause oscillations (xπ) of the needle (N) in at least one first oscillation plane (π) substantially parallel to said longitudinal axis (L).

2. Apparatus as claimed in claim 1 , characterized in that said oscillator means (7) are designed to interact with the syringe (S) located in said housing portion (4).

3. Apparatus as claimed in claim 1 , characterized in that said housing portion (4) comprises a support plate (6) designed to support the syringe (S) and journalled on said frame (2) about a first oscillation axis (Y) substantially orthogonal to said first oscillation plane (π).

4. Apparatus as claimed in claim 3, characterized in that said oscillator means (7) include a first electric motor (12) having a driving shaft (13) with first cam means (14) designed to interact with said support plate (6) and impart said first oscillatory motion (w).

5. Apparatus as claimed in claim 4, characterized in that said support plate (6) is further pivoted on said frame (2) about a second oscillation axis (Z) substantially parallel to said first oscillation plane (π).

6. Apparatus as claimed in claim 5, characterized in that said oscillator means (7) include a second electric motor (15) having a driving shaft (16) with second cam means (17) designed to interact with said support plate (6) and impart a second oscillatory motion (τσ) in a second plane of oscillation (π¹) substantially orthogonal to the former (π).

7. Apparatus as claimed in claim 6, characterized in that said support plate (6) has an L shaped cross section to define a pair of orthogonal support surfaces (18, 19), for said first (14) and second (17) cam members.

8. Apparatus as claimed in one or more of the preceding claims, characterized in that said actuator means (5) include an epicycloidal gear (21) operatively associated to a third motor (22) and designed to operate on the free end of the plunger (P) to impart said axial translational motion (t).

9. Apparatus as claimed in one or more of the preceding claims, characterized by comprising locking means (20) for locking the syringe (S) in said housing portion (4).

10. Apparatus as claimed in one or more of the preceding claims, characterized in that it comprises means (24) for controlling and adjusting said oscillator means (7) and/or said actuator means (5), said control and adjustment means (24) being associated to said handle portion (3) for selective actuation of said oscillator means (7) and/or said actuator means (5).

11. Apparatus as claimed in claim 10, characterized in that said control and adjustment means (24) include first and second switches (25, 26) for selectively enabling said first and second motors (12, 15), an optional third switch (27) being provided for controlled operation of said third motor (22).

12. Apparatus as claimed in claim 10 or 11 , characterized in that said control and adjustment means (24) include an electronic controller (29) which is electrically connected to said oscillator means (7) and/or said actuator means (5) and having first and second electronic regulators for adjusting the frequencies of said first (D) and said second oscillatory motions (τπ) respectively, and a third electronic regulator for adjusting the speed of axial translation (t) of said actuator means (5).

13. Apparatus as claimed in claim 12, characterized in that said controller (29) includes user interface means (31) for customized configuration of the operating parameters of said oscillator means (7) and said actuator means (5) operably connected to said first, second and third electronic regulators.

14. Apparatus as claimed in claim 13, characterized in that said user interface means (30) comprise a data input unit for inputting speed, amplitude and frequency parameters into said first, second and third electronic regulators and a memory unit designed to be connected to said data input unit.