WO2016128976A1

WO2016128976A1 - Efficient subcutaneous tissue treatment

Info

Publication number: WO2016128976A1
Application number: PCT/IL2016/050159
Authority: WO
Inventors: Daniela SHEMI
Original assignee: Shemi Daniela
Priority date: 2015-02-10
Filing date: 2016-02-10
Publication date: 2016-08-18

Abstract

Apparatus and method for treating tissue under a patient's skin, the apparatus comprising - - a handheld assembly that includes a surface, configured to be intermittently movable in contact with the skin and having openings therethrough, and an array of hypodermic needles, configured to be movable normally to the surface so that the tips of the needles pass through the openings and penetrate through the skin into the tissue while the surface is in contact with the skin and stationary; - one or both of a fluid dispenser and a suction device, switchably in fluid communication with the needles and operative, while the needles penetrate the skin, to cause, respectively, a fluid to be injected into, or fluid to be suctioned from, the tissue; - one or both of a heating device and a vibration device. The surface is preferably the cylindrical surface of a roller.

Description

Efficient subcutaneous tissue treatment

TECHNICAL FIELD

The field of the invention is the treatment of subcutaneous tissue and particularly - apparatus for conveniently and efficiently applying any of several methods to reduce fatty tissue.

BACKGROUND ART

There is a widespread need to reduce the amount of lipids and other fatty components in subcutaneous tissues - for both health related and aesthetic reasons. Many different methods, each utilizing specific apparatus, are known for directly achieving such reduction; it is noted that systemic means for reduction, such as diets and medicines, are outside the scope of the invention and the present discussion. In general, each reduction method comprises two major functions - (a) softening or liquefying the lipids and (b) disposing the softened or liquefied lipids. Function 'a' generally involves either administering a solvent to the tissue or heating the tissue. Function 'b' generally involves either suction or natural absorption by the body's lymphatic system. Thus each of the methods is characterized by a particular choice of techniques for each of the two functions and by particular apparatus.

More specifically, any method that combines injection of a solvent with natural disposal by the lymphatic system is known as Liposys; injection is generally administered by a hypodermic needle that is repeatedly inserted over the area to be treated. A prevalent method, known as liposuction and aimed particularly at large concentrations of fatty tissue, involves injection of a solvent and suction, using a cannula that is inserted through one or more incisions and manipulated to reach various regions of the tissue. In methods that use heating for softening the lipids, any of a number of energy sources, such as a heated pad, infrared radiation, radio waves, ultrasound and laser are variously used; those that employ suction for lipid disposal, generally use a suitable hypodermic needle that, again, is repeatedly inserted over the area to be treated. An alternative method, known as

cryotherapy, rather than softening the fatty tissue or lipids, breaks it up by freezing, then lets the fractions be disposed by the body. The various methods are variously aimed at specific body parts and specific ranges of sizes of affected tissue; the latter may vary from very large bulks of fatty tissue down to miniature subcutaneous folds. They also differ from each other along a number of parameters, including the type of professional skill required, patient's comfort and the need for anesthesia, length and number of treatment sessions and recuperation time. Another significant difference between them is the quality of the achieved results - mainly the evenness of the reduction over the treated area; in some cases the resulting skin appears lumpy.

Often, a fat reduction procedure needs to be accompanied or followed by a treatment of the skin over the affected region - both to cosmetically tighten it over its new smaller area and to heal the effects of hypodermic intrusions. Some of the known fat reduction methods, particularly those employing heat, do enable such treatment; others require it to be administered separately.

Aside from specific limitations mentioned above, all known methods and apparatus for fatty tissue reduction have, in common, several major drawbacks:

(a) They generally require a relatively high degree of practitioner skill - both absolutely and relative to the quality of results (the quality being measured mainly in the evenness and thoroughness of tissue reduction).

(b) The procedure is usually lengthy, since only one element of a tissue is addressed at a time (e.g. penetration by a single hypodermic needle).

(c) Since, as pointed out above, methods differ in the locations and tissue sizes that they address, a clinic aiming to provide comprehensive service needs to acquire skills in multiple methods and to equip itself with multiple types of apparatus.

(d) The mode of lipid softening (i.e. heating vs. dissolving) and of lipid disposal (i.e.

suction vs. lymphoid absorption) is inherent to each particular method and apparatus, as pointed out above; however there may, in some particular cases, be an advantage to using the alternative mode - which would, again, require the acquisition of additional methods and apparatus.

US patent application US20080312648 (by Peterson) discloses an array of hypodermic needles, held in a pair of parallel plates, configured so that the needles may be driven into subcutaneous tissue while one plate is held in touch with the skin. Heat or heated fluid may pass through the needles into the tissue, to melt lipids. The needles may also be connected to a suction device to remove fluid (e.g. melted lipids) from the tissue. This apparatus and the method of its utilization overcome to some extent the drawbacks of prior-art methods, outlined above. In particular, this apparatus and method enable faster overall operation, provide some greater flexibility in the choice of modes for lipid softening and disposal and reduce the degree of skill required of the practitioner. They have, however, several disadvantages: The array of needles needs to be configured for each particular type, size and depth of tissue; controlling the depth of penetration, as well as the amount of fluid being supplied or removed, still require a relatively high skill level; when a region of tissue that is larger than the array is to be treated, the needle-holding plate needs to be carefully aligned in successive positions - which increases the required skill level. Another disadvantage is the relatively greater pain that a large number of needles penetrating the skin simultaneously may inflict on the patient. Furthermore, the disclosed apparatus and method do not provide for any cosmetic functions that may be desirable in conjunction with the fat reduction procedure.

DISCLOSURE OF THE INVENTION

The object of the present invention is to provide convenient means for administering an inexpensive and minimally invasive procedure of reducing fat (or lipids) in a fatty tissue, as well as for additional cosmetic treatment. The fat reduction procedure according to the present invention, in contradistinction from procedures of prior art, is mainly characterized by -

(a) access to the fatty tissue by shallow transdermal penetration at a plurality of regularly spaced points over an appropriate region of the skin;

(b) injection of solvent through the penetration points and application of vibration to break up fatty cells, to distribute the solvent and to ease the pain of penetration;

(c) letting dissolved fat be absorbed in the body at a natural pace;

(d) optionally sucking dissolved fat transdermally at a similar plurality of regularly spaced points - preferably after warming the region; and

(e) repeating steps 'a' through 'd' ad lib, thereby addressing progressively deeper layers of the fatty tissue.

Apparatus according to the invention that facilitates the above described procedure, as well as other subcutaneous tissue treatment procedures to be outlined below, comprises primarily a hand-held assembly that includes -

- a surface, configured to be placed in contact with a patient's skin and to intermittently move along it (by gliding or rolling), the surface having openings therethrough, and - an array of mutually parallel hypodermic needles, the array being disposed so that the needle tips are normally in air and is operative to be moved perpendicularly to said surface so that the tips of the needles pass through the openings in the surface and penetrate through the skin into the underlying tissue.

The depth of penetration is preferably controllable. The term "intermittently move" is used here to denote motion that is interrupted from time to time by periods of being stationary (to be termed "stationary periods"). It is only during stationary periods that the array of needles is allowed to move and penetrate the tissue.

The array of needles is readily replaceable and may be supplied in various configurations - notably, some suitable for injection, e.g. of a lipids solvent (or softener) or a filling material, and some suitable for suction, e.g. of dissolved fat and other fluids. The term "readily replaceable" denotes that it is replaceable by the practitioner prior to each procedure. The arrays in the various configurations may differ in one or more parameters, such as the number of needles, their thickness and their length; preferably the needles are arranged in a single row, across the path of motion, and their number does not exceed 8 (to reduce patient's discomfort). Preferably the arrays are disposable, i.e. used only once per procedure and then discarded.

The apparatus further comprises a dispenser of injection fluid (to be referred to as fluid dispenser), connected by flexible tubing to the array of needles and operative to deliver, upon command, a given quantity of the fluid; that quantity is preferably selectable or controllable. The apparatus preferably also includes a suction device, alternatively connectable by flexible tubing to the array of needles (which array would generally have different parameters from the array that serves for injection) and operative to draw, upon command, a given quantity of fluid or for a given period of time; the quantity or period is preferably selectable or controllable. Generally the apparatus is arranged so that injection of a fluid, or a suction action, through the hypodermic needles occurs when, and only when, the tips of the needles are within the fatty tissue. The hand-held assembly is configured to be moved by a practitioner (e.g. a surgeon) progressively over the patient's skin, stopping it at successive positions to effect needle penetration, followed by injection or suction, over a segment of the skin defined by the array.

Preferably the assembly comprises also a vibration device and/or a heating device for, respectively, vibrating or warming the underlying tissue. More preferably, these devices are arranged so that, during the above described procedure, they, respectively, vibrate the tissue after injection or warm it ahead of suction. They may, however, be used also for other treatment functions, such as tightening or relaxing the skin. It is noted that, more generally, the apparatus of the invention may be used also for purposes other than fat reduction, such as smoothing the skin or reshaping underlying tissue, as the apparatus enables injection of appropriate fluids, such as filling materials, at precisely chosen locations, while optionally applying heat.

In preferred configurations, said surface is the cylindrical surface of a hollow roller, attached to the assembly through suitable bearings and rotatably rollable over the patient's skin; the needles array is disposed within the roller and movable radially. The intermittent motion, parallel to the skin, is then that of the assembly and of the roller's axis of rotation and is commensurate with the roller's rotational motion, while its surface is rollingly in contact with the skin. Radial motion of the array is allowed, by appropriate

synchronization, only during stationary periods and while the openings in the roller's surface are in rotational positions that allow the needles to pass therethrough. The assembly preferably includes a handle, by which the practitioner may hold it and maneuver the roller over desired segments of the patient's skin.

The apparatus preferably also comprises one or more mechanisms and control devices, which may be variously configured to be operable in corresponding modes of operation. In a first configuration (aimed at "manual" operation), for example, the roller is free to rotate while the practitioner guides it along, and in touch with, the patient's skin. Preferably a set of indicator lights is arranged to continuously signal whether or not the openings in the roller's surface are in an angular position that allows the needles to pass through them. In normal operation, whenever an opening is in such a position and at the appropriate location over the skin, the practitioner would stop the roller's motion and would activate the apparatus, in that he would push a suitable control button, or pull a trigger lever, with the effect of causing the array of needles to move radially into the position of penetration. He may then similarly cause the fluid dispenser to deliver the preset, or chosen, amount of fluid to the needles, or cause the suction device to operate for a preset, or selected, period of time, as the case may be. When the termination of the latter operation is indicated (e.g. by another light), the practitioner would cause the array of needles to be retracted and, after confirmation of the latter operation, would roll the roller to a new location on the skin and repeat the described operations. Preferably the radial motion of the array is effected by means of a suitable array drive mechanism and controller.

In a second configuration (aimed at "semi-automatic" operation), for example, arrangements and operations are similar to those of the first configuration, except that the step of delivery of injection fluid, or activation of suction, follows automatically the step of moving the needles into the skin and the termination of the injection or suction operation is

automatically followed by the retraction of the needles; this would be enabled by means of an array drive mechanism and controller.. Thus a single control activation by the practitioner at any one roller position causes the entire cycle described above to take place automatically.

In a third configuration (aimed at "automatic" operation), for example, the roller is arranged to be driven by a suitable rotation drive mechanism ("rotation driver", for short). A controller is cooperative with that mechanism to intermittently rotate the roller by a preset or selected angle and cooperative with an array drive mechanism, during each stationary period, to cause, in sequence, the array of needles to move into a skin penetration position, the dispenser to deliver a preset or selected amount of injection fluid or, alternatively, the suction device to operate for a preset or selected period of time and the array of needles to retract. In operation, the practitioner would normally initiate and terminate this automatic multi-cycle operation, during which he would merely guide the roller in a desired path along the skin.

Clearly, "semi-automatic" and "automatic" configurations are also provided with facilities for overall and overriding control by the practitioner. It is noted that the apparatus may be fabricated to be selectively operational in any two or more configurations.

Operation in any of the modes, with any of the configurations, would normally proceed with the practitioner guiding the roller sequentially over pre-determined, generally parallel and contiguous, strip-like segments of the skin area. Such multi-strip operation would normally be carried out in one session. Additional sessions may be conducted at certain intervals, each session operating on the remainder of the fatty tissue under the treated skin area. If disposal of lipids by suction is chosen, sequential sessions would preferably invoke alternatingly injection and suction. Preferably the array of needles is disposable and a new array is mounted in the assembly prior to each session. As mentioned above, the array may be selected from a variety of configurations, each applicable to certain regions of a patient's body and to certain conditions and dimensions of the treated tissue, as well as to the mode of treatment. For example, a large number of needles (possibly in multiple rows) may be used when a large bulk of tissue is to be treated; conversely, a single needle may be used when treating, for example, a skin fold, in which case the path is along the fold. Also as mentioned, treatment may involve, for example, injection of filling material (rather than lipids solvent) - for which, again, certain array configurations may be applicable.

It will be appreciated that the disclosed apparatus and the procedures associated with its use provide significant advantages over apparatuses and methods of prior art, which include:

• Fast operation (due to the simultaneous operation of a plurality of needles);

• Ease of operation (due to the convenient transporting and positioning of the needles array and due to their at least semi-automatic operation);

• Relatively little discomfort and little trauma for the patient (due to the moderate number of needles and fast operation);

• Uniformity and accurate coverage of the injection or suction effects;

• Applicability to a variety of tissue treatment methods, including filling;

• Flexibility as to the body parts and tissue conditions that may be treated;

• Capability of applying heat simultaneously with the injection procedure - both for

softening lipids and for tightening the skin;

• Capability of applying vibration simultaneously or alternatingly with the injection- or suction procedure - to hasten the process and ease pain.

Specifically the present invention, in one aspect, is of apparatus for treating tissue under a patient's skin, comprising -

- a handheld assembly that includes a surface, configured to be intermittently movable in contact with the skin along a first axis and having openings therethrough, and a replaceable array of hypodermic needles, configured and operative to be movable normally to said surface so that the tips of the needles pass through the openings and penetrate through the skin into the tissue while the surface is in contact with the skin and stationary;

- one or both of a fluid dispenser and a suction device, switchably in fluid communication with the needles and operative, while the needles penetrate the skin, to cause, respectively, a fluid to be injected into, or fluid to be suctioned from, the tissue. The apparatus additionally comprises -

- an array driving mechanism, operative to cause the needles to automatically move in a complete cycle of penetrating into the tissue and retracting therefrom and

- a controller, operative to control the operation of the array driving mechanism and to cause the fluid dispenser or the suction device to move a given amount of fluid through all the needles while they penetrate the skin.

Preferably the motion of the needles is in synchronism with stationary periods in the motion of the surface.

Preferably the depth of penetration by the needles into the tissue is controllably variable.

Preferably the array is selectable from a plurality of arrays, at least two of which differs from each other in any of -

- the number of needles,

- the length of the needles,

- the thickness of the needles.

In some configurations, the apparatus further comprises one or both of a heating device and a vibration device, attached to the handheld assembly and configured to transmit heat or vibration, respectively, to the tissue while the surface is in contact with the skin.

In preferred configurations of the apparatus, the movable surface is the cylindrical surface of a rotatable hollow roller, configured to be rollable in contact with the patient's skin. Preferably the motion of the needles is in synchronism with stationary periods in the rotation of the roller, which in turn are preferably in synchronism with given angular positions of the openings in the surface.

In some of the preferred configurations, the apparatus further comprises a rotation driving mechanism, coupled to the roller, wherein the controller is further operative to control the rotation driving mechanism so as to effect intermittent rotation of the roller, the cyclical motion of the needles being synchronized with stationary periods in the rotation.

In another aspect, the invention is of a method for treating tissue under a patient's skin, comprising the steps of

(a) providing apparatus as defined hereabove;

(b) intermittently moving the assembly along a first axis, while the surface is in contact with the skin,

(c) at each stationary period of the assembly motion, successively - - causing the array to move toward the skin until the tips of the needles penetrate through it into the tissue to a given depth,

- causing the fluid dispenser to inject a given quantity of fluid through the needles and

- causing the array to move away from the skin, thereby retracting the needles from the skin;

(d) as necessary, moving the assembly a given distance along a second axis, normal to the first axis, and repeating steps 'b' and 'c'.

Optionally the method further comprises the steps of -

(e) replacing the array of needles by a similar array and causing the suction device to be in fluid communication with the needles in that array,

(f) intermittently moving the assembly along a first axis, while the surface is in contact with the skin,

(g) at each stationary period of the assembly motion, successively -

- causing the array to move toward the skin until the tips of the needles penetrate through it into the tissue to a given depth,

- causing the suction device to draw a given quantity of fluid through the needles and

(h) as necessary, moving the assembly a given distance along a second axis, normal to the first axis and repeating steps 'f and 'g'.

Preferably steps 'c' and 'g' are performed automatically. When, in the provided apparatus, the movable surface is the cylindrical surface of a rotatable hollow roller, the moving in step 'b' includes rolling the roller in contact with the skin. When the provided apparatus includes a rotation driving mechanism, the moving in step 'b' includes causing said mechanism to controllably rotate the roller.

When the provided apparatus includes one or both of a heating device and a vibration device, steps 'b' or 'f may further include activating the heating device and/or the vibration device so as to transmit, respectively, heat and/or vibration to the tissue.

BRIEF DESCRIPTION OF DRAWINGS

Figure 1 is a trimetric schematic external view of a preferred configuration of a handheld assembly that is a part of the apparatus according to the present invention. Figures 2A and 2B are sectional schematic views of apparatus according to the present invention that incorporates the assembly of Fig. 1, showing an array of hypodermic needles in two typical position respectively.

EMBODIMENT OF THE INVENTION

A preferred embodiment of a roller-based configuration of the invention will now be described with reference to the schematic drawings in Figures 1 and 2, of which Figure 1 is a trimetric external view of a handheld assembly 2 and Figures 1A and IB are cross- sectional views of the overall system in respective different functional phases. Identical reference numbers in the three drawings refer to identical parts.

The handheld assembly 2 comprises three interconnected subassemblies -

(a) a rigid framework 10, comprising a handle 12, a forked frame 14, a pair of hubs 16 and a vertical rail 18 attached to each hub 16;

(b) a roller 20, rotationally attached to the hubs 16 by means of bearings 26 and having a cylindrical wall 22 with a plurality of elongated slots 24 therethrough, which are oriented parallel to the rotational axis, the outer surface of the wall 22 being finished for contact with a patient's skin; and

(c) an array 30 of hypodermic needles, comprising a block 32, a manifold compartment 34 on top of the block 32 and a plurality of regularly spaced vertically oriented hypodermic needles 36, which are held by block 32 with their top ends in fluid communication with manifold compartment 34 and their tips pointing downward. The needles may be arranged in one or more rows.

Block 32 is slidingly attached to the vertical rails 18, employing any means (not shown), such as a lead screw or a string and pulley, that enable an electric motor (not shown) to move the block and, with it, the entire array 30 up and down; alternatively, a hydraulic mechanism may be used. Any such arrangement will be referred to as an "array driving mechanism". When array 30 is in an up position, as illustrated in Fig. 2A, the tips of the needles 36 are entirely inside the roller and its cylindrical wall. However, When array 30 is in a down position, as illustrated in Fig. 2B, the needles protrude through a slot 24 in the cylindrical wall 22.

One or more sensors (not shown) are disposed so as to monitor the angular orientation of the roller and to detect each angle at which a slot 24 is at a bottom position, appropriate for penetration by the needles. In some embodiments of the handheld assembly there is a rotation driving mechanism (not shown), which includes a motor attached to the framework 10, whose rotor is coupled to the roller; it is operative to rotate the roller according to commands from a controller, as described below.

The hypodermic needles array 30 is readily replaceable by an identical or a similar array; that is, a practitioner may replace the array prior to, or during, a treatment session. There are preferably several types of arrays that may thus be interchangeably mounted, differing, for example, in the number of needles or in their thickness; some may be suitable for injection of various fluids while others may be suited for suction.

A flexible tube 38, a first end of which is in fluid communication with the manifold compartment 34, extends through the left-hand hub 16 to outside the assembly 2. A fluid dispenser 6 and/or a suction device 4 are alternately connectable, via respective tubes 7 and 5 to the second end of tube 38, each being, when thus connected, in fluid communication, through compartment 24, with the hypodermic needles 36. In some configurations, fluid dispenser 6 and/or suction device 4 are rigidly attached to framework 10; in other configurations they may be mounted on a stationary frame. In any case, fluid dispenser 6 is fluidly connected to a stationary solvent supply container (not shown) and suction device 4 is fluidly connected to a stationary disposal receptacle (not shown). Fluid dispenser 6 is operative to deliver, on command, a given quantity of solvent into the fluid path that begins with tube 7, continues through tube 38 and manifold 34 and ends with the needles 36, whence it is injected into the patient's tissue. Suction device 4 is operative to draw, on command, for a given period of time, fluid (such as containing dissolved fat) from the patient's tissue through a similar path that ends with tube 5 and to deliver the drawn fluid into the stationary receptacle.

There are preferably also provided a warming pad 19, in front of the roller, and/or a vibration pad 18, behind the roller - both attached to the rigid framework 10. The length of these pads is approximately that of the roller and they are positioned so that their bottom surfaces are flush with the bottom surface of the roller's cylindrical wall. Preferably the warming pad 19 is mounted in front of the roller and the vibration pad 18 - behind it (as shown in Fig. 1). The warming pad includes an electric heating element and, preferably, a controlling temperature sensor, but in other configurations it may include, or be replaced by, other types of heating devices, such as those using electromagnetic or ultrasonic energy. The vibration pad (which is a particular form of a vibration device) typically includes an electrically driven vibrating element.

A controller (not shown), including a digital processor, is provided for operating the entire system - preferably according to any of a number of different operational modes, some of which are described below. The controller incorporates sensors, such as the

aforementioned roller angular orientation sensor, sensors associated with the position of the needles array and those embedded in the fluid dispenser and the suction device, as well as in the supply container and in the disposal receptacle. The controller is likewise connected to control buttons and -switches, operatable by the practitioner (user of the apparatus), as well as to a display panel for displaying status- and operational data to the practitioner. Finally, the controller is operative to issue appropriate signals and commands to actuators and motors in the apparatus, to effect the desired operation.

Typical operation of the apparatus described above will now be explained. In a so-called manual mode of operation, for example, the practitioner first marks and prepares a region of the patient's skin, then begins the injection phase of treatment, by switching on the controller, as well as the warming pad 19. Then, holding the assembly 2 by the handle 12, he proceeds to roll the roller along, and in contact with, the skin, whereby the warming pad imparts heat to the skin, in order to tighten it. When a "slot at bottom" indication is displayed, he stops the rolling motion and, by pushing a first button, causes the needles array, possibly by means of the array driving mechanism, to be lowered to its lowest position, whereby the needle tips penetrate the skin. Upon an indicated affirmation of that position, the practitioner pushes a second button, which causes device 6 to eject solvent into tube 7 and thus, as described above, to inject a given quantity of solvent through the needles to the underlying tissue. After a given period of time the needles array is automatically raised and an indication is displayed for the practitioner to resume rolling and the cycle is repeated until the end of the marked region on the skin is reached, other, parallel, strips of the region may then be similarly covered.

The resulting dissolved fat in the tissue may subsequently be left to be naturally dissipated by the body or else a second, suction, phase may be initiated after, say, half an hour, which phase proceeds as follows: The needles array used in the first phase is replaced by a similar needles array that is configured for suction and tube 38 is connected to tube 5 that leads to suction device 4. The practitioner now rolls the roller over the same region of the skin, in a pattern similar to that in the injection phase. However now, at each stop, after the array has been lowered, a push of a button signals the suction device 4 to draw a given quantity of dissolved fat from the tissue, as described above. During this phase the vibration pad 18 may be set in operation, to loosen the tissue and to allow the flow of dissolved fat into the needles, while also the warming pad 19 may be active. Optionally, the roller may be rolled over the entire region of the skin, prior to, or during, the above operation, without activating the needles array, but with only the warming pad and/or the vibration pad active.

A so-called semi-automatic mode of operation, for example, proceeds similarly to the manual mode, as described above, except that, upon receiving a "slot at bottom" indication, the practitioner pushes only one button, which results in the lowering of the needles array, followed automatically by the injection operation, during the first phase, or the suction operation, during the second phase. A so-called automatic mode of operation, for example, is possible if the handheld assembly includes a rotation driving mechanism and proceeds in general similarly to the other two modes described above except as follows: Upon an initial push of a button by the practitioner, the roller rotates by the action of the motor while the practitioner merely presses it onto the skin and guides it along the desired path. Whenever the controller senses a "slot at bottom" indication, it issues a command to lower the needles assembly and subsequently - a command to effect injection (during the first phase) or suction (during the second phase).

In general, the procedure described above would be repeated in subsequent sessions to similarly treat remaining layers of the fatty tissue. Similar procedures - primarily the injection phase - may be followed also for purposes other than fat reduction, such as to inject filling material.

INDUSTRIAL APPLICABILITY

The apparatus according to the invention consists of commercially available, or readily fabricatable, parts and can be manufactured in contemporary facilities by current skilled persons.

Claims

1. Apparatus for treating tissue under a patient's skin, comprising -

- a handheld assembly that includes a surface, configured to be intermittently movable in contact with the skin along a first axis and having openings therethrough, and an array of hypodermic needles, configured and operative to be movable normally to said surface so that the tips of said needles pass through said openings and penetrate through the skin into the tissue while said surface is in contact with the skin and stationary;

- one or both of a fluid dispenser and a suction device, switchably in fluid communication with said needles and operative, while said needles penetrate the skin, to cause, respectively, a fluid to be injected into, or fluid to be suctioned from, said tissue.

2. The apparatus of claim 1 wherein said array is configured as one or more rows, arranged along a second axis that is normal to said first axis, each row comprising one or more hypodermic needles.

3. The apparatus of claim 2 wherein the number of rows is 1 and the number of needles does not exceed 8.

4. The apparatus of claim 1 further comprising -

- a controller, operative to control the operation of the array driving mechanism and to cause said fluid dispenser or said suction device to move a given amount of fluid through all the needles while they penetrate the skin.

5. The apparatus of claim 4 wherein said motion of the needles is in synchronism with stationary periods in the motion of said surface.

6. The apparatus of claim 1, wherein said array is readily replaceable.

7. The apparatus of claim 6, wherein said array is selectable from a plurality of arrays, at least two of which differs from each other in any of -

- the number of needles,

- the length of the needles,

- the thickness of the needles.

8. The apparatus of claim 1, wherein the depth of penetration by said needles into the tissue is controllably variable.

9. The apparatus of claim 1, further comprising one or both of a heating device and a vibration device, attached to said handheld assembly and configured to transmit heat or vibration, respectively, to said tissue while said surface is in contact with the skin.

10. The apparatus of claim 1 wherein said surface is the cylindrical surface of a rotatable hollow roller, configured to be intermittently rollable in contact with the patient's skin.

11. The apparatus of claim 10 further comprising -

- a controller, operative to cause said fluid dispenser or said suction device to move a controllable amount of fluid through all the needles while they penetrate the skin.

12. The apparatus of claim 11 wherein said motion of the needles is in synchronism with stationary periods in the rotation of said roller.

13. The apparatus of claim 12 wherein said stationary periods are in synchronism with given angular positions of said openings in the surface.

14. The apparatus of claim 11, further comprising a rotation driving mechanism, coupled to said roller, wherein said controller is further operative to control the rotation driving mechanism so as to effect intermittent rotation of the roller, said cyclical motion of the needles being synchronized with stationary periods in said rotation.

15. The apparatus of claim 10, wherein the depth of penetration by said needles into the tissue is controllably variable.

16. The apparatus of claim 10, further comprising one or both of a heating device and a vibration device, attached to said handheld assembly and configured to transmit heat or vibration, respectively, to the tissue while said surface is in contact with the skin.

17. A method for treating tissue under a patient's skin, comprising -

(a) providing -

- a handheld assembly that includes a surface, having openings therethrough, and a first array of hypodermic needles, configured and operative to be movable normally to said surface so that the tips of said needles pass through said openings and

- a fluid dispenser in fluid communication with the needles in said first array;

(b) intermittently moving said assembly along a first axis, while said surface is in contact with the skin,

(c) at each stationary period of said assembly motion, successively -

- causing said array to move toward the skin until the tips of the needles penetrate through it into the tissue to a given depth,

- causing said fluid dispenser to inject a given quantity of fluid through the needles and

- causing said array to move away from the skin, thereby retracting the needles from the skin;

(d) as necessary, moving said assembly a given distance along a second axis, normal to said first axis, and repeating steps 'b' and 'c'.

18. The method of claim 17, wherein step 'a' further includes providing -

- a second array of hypodermic needles, similar to said first array and configured to replace it, and

- a suction device

and further comprising the steps of -

(e) replacing said first array by said second array and causing said suction device to be in fluid communication with the needles in said second array,

(f) intermittently moving said assembly along a first axis, while said surface is in contact with the skin,

(g) at each stationary period of said assembly motion, successively -

- causing said suction device to draw a given quantity of fluid through the needles and

(h) as necessary, moving said assembly a given distance along a second axis, normal to said first axis and repeating steps 'f and 'g'.

19. The method of claim 17, wherein step 'c' is performed automatically.

20. The method of claim 17, wherein said surface is the cylindrical surface of a rotatable hollow roller and in step 'b' said moving includes rolling the roller in contact with the skin.

21. The method of claim 20, wherein step 'c' is performed automatically and in synchronism with the rotational positions of said openings.

22. The method of claim 21, wherein step 'a' further includes providing a rotation driving mechanism and in step 'b' said moving includes causing said mechanism to controllably rotate the roller.

23. The method of claim 17, wherein step 'a' further includes providing one or both of a heating device and a vibration device, attached to said assembly, and step 'b' further includes activating the heating device and/or the vibration device so as to transmit, respectively, heat and/or vibration to the tissue.

24. The method of claim 18, wherein step 'a' further includes providing one or both of a heating device and a vibration device, attached to said assembly, and step 'f further includes activating the heating device and/or the vibration device so as to transmit, respectively, heat and/or vibration to the tissue.

25. The method of claim 17, wherein said fluid is selectable from a group consisting of lipids solvent, lipids softener and filling material.