Abstract:
Intelligent needles comprise a needle for insertion into the skin to deposit a substance that causes plumping of the skin. The penetration depth of the needle may be adjusted automatically in conjunction with a sensor mechanism that determines a depth the needle can penetrate without contacting blood vessels. Methods of making and using the same for acupuncture and subcutaneous injection are also provided.

Description:
STATEMENT OF RELATED CASES 
       [0001]    This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application Ser. No. 61/012,137, filed Dec. 7, 2007, and U.S. Provisional Patent Application Ser. No. 61/012,174, filed Dec. 7, 2007, both of which are hereby incorporated by reference in their entireties. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This application generally relates to the field of acupuncture. More specifically, this application relates to acupuncture and intelligent needles for inserting substances subcutaneously for cosmetic purposes. 
       BACKGROUND 
       [0003]    Acupuncture has been used in facial rejuvenation to stimulate circulation, thereby reducing lines and wrinkles of aging or that are the result of injury. However, acupuncture does not currently include application of substances that may cause the skin to “plump” or swell because these substances should be placed below the skin, but not in a blood vessel. The swelling produced by the implanted substance can result in the reduced appearance of wrinkles. 
         [0004]    Therefore, there exists a need for apparatus and methods to administer substances by acupuncture that are effective to cause swelling in the region of application. 
       SUMMARY 
       [0005]    This patent application relates to advances that have been made in the use of sensors and very thin needles that are presently employed to draw blood, many in the field of diagnostics. 
         [0006]    In the development of blood capturing technologies, which are very important for diabetics, there is often a problem of numbing, associated with too many tests in a particular area. In order to solve this problem, several companies have developed thin needle technology and also have used measurement sensors to determine the minimal amount of depth needed in order to obtain a blood sample. The purpose of this equipment is to leave no traces on the skin, reduce pain and prevent associative physiological problems during diagnostic procedures. Suitable sensors of this type are known to those skilled in the art. The prior art thin sensor needles rely on a vacuum draw to capture blood. 
         [0007]    Various embodiments of the invention invert this process and, instead of having the vacuum draw associated with the sensor needles, have a pumping mechanism associated with the sensor and the needles. The purpose of the sensors, in this case, is the opposite of that in the diagnostic procedures. By aspects of the present invention, blood vessels can be avoided and the needle can stay within the confines of the skin layers, without going into any capillaries. Therefore, the sensors would set or reset the needles to go to a thinner level than would be used in the diagnostic equipment. 
         [0008]    Other aspects of the invention are directed to methods and apparatus to apply materials, such as silicone, under the skin, without entering the blood stream. This can be used to puff up the skin to avoid wrinkles for cosmetic purposes. Even though these materials will be absorbed or released from the skin in several days, this process will provide immediate cosmetic benefit at a lower cost than Botox or other injections that are presently used for cosmetic purposes. 
         [0009]    Additional aspects of the invention are directed to techniques for using acupuncture to reduce lines and wrinkles of aging or that are the result of injury. While acupuncture has been used in facial rejuvenation to stimulate circulation, the presence of a compound to inflate the skin, such as silicone or a stimulant, is not currently part of the practice of Acupuncture as it is used. 
         [0010]    Nevertheless, those trained in the techniques of needling and acupuncture are trained to place needles under the skin painlessly and without bleeding. By providing either coatings on the needles of substances that react when they are placed under the skin or deposits of such substances under the skin either through the manipulation of the needle, temperature or other mechanical means, the acupuncturist can deliver product exactly where it is needed for a person who wants to reduce the effects of aging or other cosmetic reasons. 
         [0011]    This technique involves substances that are non-toxic and can remain in place. The expertise of the acupuncturist in directing these materials subcutaneously can result in immediate results. The procedure is both simple and inexpensive. 
         [0012]    Various aspects of the invention are directed to the addition of substances, including but not limited to silicone, that have the effect of “plumping” the skin. These substances can be either coated on the acupuncture needles or made a part of the needle (i.e., a filled syringe needle) such that they can be released by the acupuncturist either through mechanical manipulation of the needle, interaction with the body, heat applied from another source or a mechanical system operating with or contained within the needle. While this represents several embodiments of the concept, it is understood that there are many other ways in which these materials can be released subcutaneously, without departing from the spirit of the invention. Additional aspects are directed to processes of using acupuncture as a delivery system for these substances which cosmetically reduce wrinkles in the skin. 
         [0013]    Embodiments of the invention are directed to an intelligent needle for subcutaneous injection. The intelligent needle comprises a housing and a movable needle within the housing. The needle has a tip and is movable between a retracted position, where the needle tip is within the housing, to an extended position, where the needle extends from within the housing. The intelligent needle also has an adjustment mechanism coupled to the needle. The adjustment mechanism is operative to move the needle between the retracted position and the extended position. The intelligent needle also has a sensor operatively coupled to the adjustment mechanism. The sensor is adapted to determine a penetration depth, which is an amount the needle can penetrate the skin while avoiding blood vessels. 
         [0014]    The intelligent needle can further comprise a pump mechanism coupled to the needle and sensor. The pump mechanism is operable to pump contents of the needle into the skin upon receiving a signal from the sensor. 
         [0015]    The intelligent needle can further comprise a substance that causes plumping of the skin. In one embodiment, the substance is silicone. In one embodiment, the substance coats the needle. In other embodiments, the needle is prefilled with the substance. 
         [0016]    The substance may be released from the needle upon one or more of physical manipulation of the needle, mechanical manipulation of the needle, interaction with the body and applied heat. 
         [0017]    Other embodiments of the invention are directed to methods of administering acupuncture therapy. The methods comprise inserting a needle into the skin of a patient; and depositing a substance under the skin of the patient, the substance operative to cause plumping of the skin. 
         [0018]    In detailed aspects, the needle is inserted into the skin to a depth less than that which would be required to contact a blood vessel. In further detailed aspects, the insertion depth is determined by a sensor. In other embodiments, the substance is automatically deposited by a pump coupled to the needle, the pump being activated by the sensor detecting the needle inserted to the desired depth. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0019]    So that the manner in which the above recited features of the present invention can be understood in detail, a more particular description of the invention, briefly summarized above, may be had by reference to embodiments, some of which are illustrated in the appended drawings. It is to be noted, however, that the appended drawings illustrate only typical embodiments of this invention and are therefore not to be considered limiting of its scope, for the invention may admit to other equally effective embodiments. 
           [0020]      FIG. 1  shows an intelligent needle in accordance with one or more embodiments of the invention; 
           [0021]      FIG. 2  shows an intelligent needle in accordance with one or more aspects of the invention; 
           [0022]      FIG. 3  shows an intelligent needle in accordance with one or more aspects of the invention; 
           [0023]      FIG. 4  shows an intelligent needle with a coated needle tip in accordance with aspects of the invention; and 
           [0024]      FIG. 5  is an expanded view of the coated needle tip of  FIG. 4 . 
       
    
    
     DETAILED DESCRIPTION  
       [0025]    One or more embodiments of the invention are directed to intelligent needles for subcutaneous injection. The intelligent needle  10  of  FIG. 1  has a housing  12  which can be held by a person. A syringe  14 , or similar mechanism, is located within the housing  12  and has a needle  16  attached thereto. The needle  16  can be replaceable using, for example, Luer® type connectors, or other mechanisms. The needle can also be fixed in various embodiments. The needle  16  is of suitable gauge and sharpness to allow for subcutaneous insertion. The needle tip  18  can extend from within the housing  12  through a hole  20  in the housing  12 . 
         [0026]    The degree to which the needle tip  18  extends from the housing  12  can be controlled by an adjustment mechanism  22 ,  24 . The adjustment mechanism shown in  FIG. 1  consists of a rack  24  and pinion  22  type design. Other suitable mechanisms include, but are not limited to, screw threads, stepper motors, servos, solenoids, and piezoelectric devices. The adjustment mechanism  22 ,  24  is operative to move the syringe  14 , and therefore the needle  16  and needle tip  18 , between a retracted position and extended positions. In the retracted position, the needle tip  18  is within the housing  12  or flush with the housing  12 . In the extended positions, the needle tip  18  extends from the housing by an amount determined by the adjustment mechanism  22 ,  24  and associated sensor  26 . 
         [0027]    A sensor  26  is coupled through a processor  28  to the adjustment mechanism  22 ,  24 . The sensor  26  is connected to the processor  28  by connection  30 . The processor  28  is connected to the adjustment mechanism  22 ,  24  by adjustment connection  32 . The sensor  26  is adapted to determine the depth that the needle tip  18  can be inserted into the skin without contacting a blood vessel. The sensor  26  measures the skin properties and transmits this information to the processor  28  through connection  30 . The processor  28  calculates the proper depth and causes the adjustment mechanism  22 ,  24  to move the syringe  14  so that the needle tip  18  extends from the housing  12  by the calculated amount. 
         [0028]    According to some aspects of the invention, the intelligent syringe includes a pump mechanism. This mechanism can be a mechanical pump, air bladder, or other suitable mechanism operable to pump the contents of the syringe into the skin.  FIG. 1  shows an air bladder  34  type mechanism, which may be useful in single use devices. The air bladder  34  may also be refillable. A valve  36  can receive a signal from the processor  28  over connection  38  indicating that the needle tip  18  is in position. The sensor  26  may be adapted to sense when the housing  12  and needle tip  18  contact the skin and transmit a signal to the processor  28 . Upon receiving a signal from the processor  28 , the valve  36  opens, thereby releasing pressure from the air bladder  34 . The air travels through tubing  40  into the syringe  14  causing the plunger  42  to travel toward the needle tip  18 , expelling the substance  44  within the syringe. The valve  36  may be opened for a short duration so that only a small amount of the substance  44  is expelled. This intelligent needle  10  can therefore be used for repeated injections. 
         [0029]    Alternatively, the housing  12  of some aspects includes an actuator  41 , which can be a simple button. Pressing the actuator  41  sends a signal to the processor  28  through a connection (not shown). A signal can then be sent from the processor  28  to activate the valve  36 . 
         [0030]    Some aspects of the invention, as shown in  FIG. 1 , include a mechanism adapted to allow the user to adjust the volume of the substance  44  delivered. The mechanism may include a display  43  and an adjustment wheel  45 . Turning the adjustment wheel  45  can set the volume to be delivered, with the delivery volume being shown on the display  43 . The display can be, for example, a simple set of numerical wheels, as is common on laboratory micro-pipettes, or a liquid crystal display. The delivery volume is transmitted to the processor  28  which can then transmit one or more signals to the valve  36  instructing the valve  36  to open and close. 
         [0031]    In some aspects, the substance  44  is pre-filled in the syringe  14 . Other embodiments have the substance  44  separate from the syringe  14  so that the syringe  14  can be filled with the substance  44  or the needle tip  18  can be dipped into the substance  44 . 
         [0032]      FIG. 2  shows another embodiment of the intelligent needle  10 , where the contents of the syringe  14  can be ejected manually or automatically. Once the needle tip  18  has been inserted to the desired depth, the processor  28  sends a signal through connection  38  to an injection mechanism  48 ,  50 . The injection mechanism  48 ,  50  is illustrated as a rack  50  and pinion  48  type mechanism but can be any suitable system. Non-limiting examples include stepper motors, screw threads, servos, piezoelectric devices an solenoids. The injection mechanism  48 ,  50  is operative to cause the plunger  42  in the syringe  14  to be pushed toward the needle tip  18 , thereby emptying the substance  44  into the patient. Again, the plunger  42  may only be moved a small amount each time the injection mechanism  48 ,  50  is activated, allowing the intelligent needle  10  to be used multiple times on a single patient. 
         [0033]    Alternatively, the intelligent needle  10  may include an externally accessible plunger rod  52 . This allows the user to depress the plunger rod  50 , forcing the plunger  42  toward the needle tip  18  and expelling the substance  44 . The manual plunger rod  52  and injection mechanism  48 ,  50  can be included and operate independently or cooperatively. For example, the injection mechanism  48 ,  50  may be triggered by pressure on the plunger rod  52 . 
         [0034]      FIG. 3  shows an aspect of the invention where the intelligent needle  10  is attached to an external pressure source  54 , such as a standard gas cylinder or compressor. A tube  56  can be connected to an inlet valve  58  on the intelligent needle  10 . Upon receiving a signal from the processor (not shown), the inlet valve  58  can open for a specified period of time, allowing pressure to push the substance from the syringe. The inlet valve  58  may also be manually triggered by an actuator button  41  on the syringe. The length of time that the inlet valve  58  is open can be customized depending on the desired application. 
         [0035]      FIG. 4  shows another embodiment of an intelligent needle  10  where a syringe is omitted and replaced with a needle  16 . The needle  16  has a tip  18  which can be adjusted to extend from or be recessed within the housing  12  using the previously described or similar mechanisms. The needle  16  can be coated with a substance  60  which can be released into the body upon insertion of the needle tip  18 , as shown in  FIG. 5 . 
         [0036]    The substance of various aspects of the invention is one that causes the skin to “plump” or swell. Non-limiting examples of substances include fats, silicone and stimulants. A specific aspect of the invention uses silicone as the substance. The substance is released from the needle upon one or more of physical manipulation of the needle, mechanical manipulation of the needle, by interaction of the substance with the body and by application of heat to either the needle or the region of the body. 
         [0037]    Additional embodiments of the invention are directed to methods of administering acupuncture therapy where a needle is inserted into the skin of a patient and a substance is deposited under the skin. The substance deposited may have the effect of plumping the skin, or causing localized swelling. 
         [0038]    The substance can be deposited by one or more of physical manipulation of the needle, mechanical manipulation of the needle, interaction of the substance with the body and application of heat to the target area of the body. In specific aspects, the substance is silicone. In other specific aspects, the substance is coated on the outside of a needle or within a syringe where the tip acts to puncture the skin. 
         [0039]    In some aspects, the needle is inserted into the skin to a depth less than that which would contact a blood vessel. In detailed aspects, the insertion depth is determined by a sensor system capable of evaluating the depth at which blood vessels are found. 
         [0040]    In further detailed aspects, the substance is automatically deposited by a pump mechanism coupled to the needle. The pump mechanism can be activated by the sensor system detecting that the needle has been inserted to the desired depth. Reference throughout this specification to “one embodiment,” “certain embodiments,” “one or more embodiments,” “an embodiment,” “one aspect,” “certain aspects,” “one or more embodiments” and “an aspect” means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the invention. Thus, the appearances of the phrases such as “in one or more embodiments,” “in certain embodiments,” “in one embodiment,” “in an embodiment,” “according to one or more aspects,” “in an aspect,” etc., in various places throughout this specification are not necessarily referring to the same embodiment or aspect of the invention. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments or aspects. The order of description of the above method should not be considered limiting, and methods may use the described operations out of order or with omissions or additions. 
         [0041]    It is to be understood that the above description is intended to be illustrative, and not restrictive. Many other embodiments will be apparent to those of ordinary skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. 
         [0042]    As used in this specification and the appended claims, the singular forms “a”, “an” and “the” include plural referents unless the context clearly indicates otherwise. For example, reference to a “substance” may also refer to more than one substance, and the like.