Patent Grant
11938087
The present invention relates to an intramuscular stimulation needling device, and more particularly the present invention relates to a variable speed intramuscular stimulating needling device for treating muscular pain.
Intramuscular stimulation (IMS) is a known method for treating musculoskeletal pain by inserting a needle into affected muscle tissue. Intramuscular stimulation was described by Gunn, “Dry Needling of Muscle Motor Points for Chronic Low-Back Pain: A Randomized Clinical Trial with Long-Term Follow-up”, Spine, Vol. 5, No. 3, pp. 279-291 (1980). Since then, the intramuscular stimulation method has become quite common for relief in chronic musculoskeletal pains. The musculoskeletal pain caused by tightening of the muscle can be treated by intramuscular stimulation. The tightness of the muscle tends to apply severe pressure or pinching forces to the nerve fibers within the muscle, thereby causing chronic pain. Repeated intramuscular stimulation treatments can make the contracted muscle relax, thereby the pain eventually subsides.
Typically, intramuscular stimulation involves the insertion of a fine needle, similar to an acupuncture needle, into the affected muscle. The needle is driven to reciprocate stimulating the muscle by repeatedly moving the needle back and forth linearly within the muscle. This needle can be reciprocated repeatedly for the desired number of times at different points in several muscular sites. For brevity, such needle manipulation will be referred to as “poking” in the remainder of this disclosure. The frequency of the treatment depends on the severity of the muscle contraction. A severely contracted muscle will require more frequent treatments over longer periods, whereas the required frequency will be less for the lightly injured muscles. Intramuscular stimulation treatment is usually performed at multiple muscle points.
The needle is generally driven by a motorized needling instrument that can reciprocate the needle within a muscle at preset velocity. A person administering the treatment can hold the instrument steadily at the desired treatment site while the motor provides controlled, uniform back and forth linear motion to the needle within a fixed stroke length. For extended intramuscular stimulation treatment sessions, a mechanical swivel arm is provided to hold the stimulator needling instrument, and a footswitch is also provided to remotely turn the motor on and off. In this way, intramuscular stimulation treatments can be performed with minimal physical effort, helping to avoid muscle injury to the person administering the treatment.
U.S. Pat. No. 5,735,868A describes an intramuscular stimulator used for treating patients suffering from musculoskeletal pain such as low back pain, sciatica, shoulder pain, neck pain, headache, etc. It consists of a control unit and a hand piece. The hand piece is a linear actuator that is controlled by the control unit for reciprocating movement of the needle. To operate the device, a sterile disposable needle is first mounted onto the hand piece. A practitioner holds the hand piece and inserts the needle beneath the skin manually to stimulate the target muscle. This mechanical stimulation is performed at a specific muscle region called the trigger points. The trigger points encompass a tight region of a muscle that contains a lot of contraction knots. The contraction knots can result from a muscular injury and/or the nerve irritation due to an accident, lifestyle, or professional hazard. When a trigger point is stimulated mechanically, a sudden muscle contraction called local twitch response (LTR) is elicited sometimes, which relaxes a certain part of the muscle. When local twitch responses are obtained for different parts of an affected muscle, the muscle as a whole relaxes and the pain symptoms subside.
The known needling instruments have been effective in treating chronic muscular pains. However, in some chronic pains, the trigger point zone expands and becomes ‘rock-like’ hard. For such muscles, needling with an intramuscular stimulator becomes difficult if not impossible. The needle often bends or is unable to penetrate the ‘rock-like’ muscle zone at all. Naturally, it is very difficult to obtain local twitch responses from such ‘rock-like’ zones with the intramuscular stimulators of the prior art.
Moreover, the intramuscular stimulators of the prior art have a pre-programmed constant speed and the stroke length of the linear actuator. The known intramuscular stimulators can operate only at a constant speed. This is the biggest drawback of the known intramuscular stimulators.
Thus, a desire is there for an improved intramuscular stimulator that can be effective for treating a range of chronic muscular pains including needling the ‘rock-like’ muscle zone.
The following presents a simplified summary of one or more embodiments of the present invention in order to provide a basic understanding of such embodiments. This summary is not an extensive overview of all contemplated embodiments and is intended to neither identify key or critical elements of all embodiments nor delineate the scope of any or all embodiments. Its sole purpose is to present some concepts of one or more embodiments in a simplified form as a prelude to the more detailed description that is presented later.
It is, therefore, a principal object of the present invention for a stronger needling action.
It is another object of the present invention that the treatment time can be reduced.
It is still another object of the present invention that very rigid muscle tissues can be needled quickly and easily.
In one aspect, disclosed is an intramuscular stimulation needling device that can include a stepper motor, a needle, and a control unit. The needle can poke an affected muscle tissue, the needle can be operably coupled to the stepper motor, wherein the stepper motor reciprocates the needle within the affected muscle tissue, wherein in each needling cycle, the needle moves a pre-determined distance (stroke length) forwardly in the first half cycle and retracts to the original position in the second half cycle. The control unit can be operably coupled to the stepper motor, wherein the control unit can accelerate the needle one or more times in the first half cycle at spaced intervals and decelerate the needle in the second half cycle in a pattern reverse to the acceleration of the needle in the first half cycle.
In one implementation of the intramuscular stimulation needling device, the needle can be accelerated once during the first half cycle or the needle can be accelerated twice during the first half cycle, or the needle can be accelerated thrice during the first half cycle, or the needle can be accelerated n times during the first half cycle. The point where the acceleration occurs is arbitrary. The acceleration of the needle can be achieved by shortening the delay time between subsequent pulses that are delivered to the stepper motor. The control unit can include one or more inputs, such a push buttons, for accelerating the needle one or more times.
In one aspect, disclosed is a method for intramuscular stimulation by needling as a therapeutic modality using the disclosed intramuscular stimulation needling device. The needle can be inserted subcutaneously to a desired depth. The control unit can have an option for accelerating the needle by a desired number of times in the first half of a needling cycle. The needle in the second half cycle can be decelerated in a pattern reverse to the acceleration of the needle.
In one implementation of the method, the selected option can be to accelerate the needle once during the first half needling cycle, or to accelerate the needle twice during the first half needling cycle, or to accelerate the needle thrice during the first half needling cycle. The option can be provided as one or more inputs, such as push buttons, in the control unit for accelerating the needle one or more times, wherein each input of the one or more inputs correspond to the number of accelerations.
These and other objects and advantages of the embodiments herein and the summary will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.
The accompanying figures, which are incorporated herein, form part of the specification and illustrate embodiments of the present invention. Together with the description, the figures further explain the principles of the present invention and to enable a person skilled in the relevant arts to make and use the invention.
Subject matter will now be described more fully hereinafter with reference to the accompanying drawings, which form a part hereof, and which show, by way of illustration, specific exemplary embodiments. Subject matter may, however, be embodied in a variety of different forms and, therefore, covered or claimed subject matter is intended to be construed as not being limited to any exemplary embodiments set forth herein; exemplary embodiments are provided merely to be illustrative. Likewise, a reasonably broad scope for claimed or covered subject matter is intended. Among other things, for example, the subject matter may be embodied as methods, devices, components, or systems. The following detailed description is, therefore, not intended to be taken in a limiting sense.
The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments. Likewise, the term “embodiments of the present invention” does not require that all embodiments of the invention include the discussed feature, advantage, or mode of operation.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of embodiments of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise”, “comprising,”, “includes” and/or “including”, when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.
The following detailed description includes the best currently contemplated mode or modes of carrying out exemplary embodiments of the invention. The description is not to be taken in a limiting sense but is made merely for the purpose of illustrating the general principles of the invention, since the scope of the invention will be best defined by the allowed claims of any resulting patent.
To operate the intramuscular stimulation needling device, the needle can be first mounted onto the shaft of the stepper motor (18 in
A linear actuator can be a programmable stepper motor in which its axis movement speed is controlled by the input step pulse rate. The input step pulse rate is programmable by adjusting the delay time between subsequent pulses. Shorter delay time results in faster linear velocity while longer delay time results in a slower velocity. Suppose the axis of a linear actuator moves 0.1 mm per step pulse input. Then, it will take 100 pulses to move the axis by 10 mm. If a delay time of 1 msec is used, then it will take 100 msec for 10 mm movement of the axis, and therefore, the speed will be 100 mm/s (neglecting the time for the pulse width). If the delay time is 10 msec, the speed will be 10 mm/s. A velocity accelerator 37, shown in
The disclosed velocity accelerator can increase the needling velocity during the first half of the needling cycle i.e., between D0 to D1. It can be increased once, twice, or as many times as desired. For a one-time increase, the initial velocity V1 can be increased to V2 in the middle of the half-cycle as shown by trace 39. For two increases, the initial velocity V1 can be increased to V2 and then to V3 in the middle of the first half cycle, respectively, as shown by trace 40 of
In one exemplary embodiment, the needle tip can initially move with a velocity V1 after it is inserted under the skin to a depth of D0. D0 can be any depth as chosen by the practitioner. When the needle tip reaches a depth of D1m (refer to
The results of velocity acceleration are stronger penetration force due to the acceleration of velocity and shorter period of needling compared with the intramuscular stimulator of constant velocity. The stronger penetration force enables penetration of the needle into ‘rock-like’ trigger point zones to obtain LTRs. The shorter periods mean shorter treatment time—a significant advantage for both the patient and the practitioner. The upper limit for the velocity acceleration is the speed limit set by the linear actuator specification. As the speed of a linear actuator increases the thrust force of the motor decreases. Therefore, usable high velocity is limited.
Another advantage of the velocity acceleration is that LTRs tend to be elicited more frequently when the needle tip velocity increases during needling. It has been well known from the manual needling method that LTRs tend to come out more readily when the needle is manipulated in a ‘pecking’ motion. The ‘pecking’ is like a bird moving its beak rapidly toward the target food. In such a case, the velocity increases as the beak approach the food. Needling with increasing velocity is closer to this ‘pecking’ motion.
The microcontroller chip 47 of
The specification of a stepper motor can give how long the motor axis moves per step input pulse, for example, 0.1 mm per pulse. If such a motor receives 100 pulses, the needle moves 10 mm in one direction determined by the DIR logic level 46. The microcontroller chip 47 can send 100 pulses to the stepper motor so that the needle can move 10 mm in one direction. After that, a direction change signal (which is a logic level change) is sent to the stepper motor via the DIR port of the stepper motor driver 44.
Subsequent 100 pulses move the motor axis in reverse direction completing one cycle i.e., a half-cycle in the forward direction and a half-cycle in the rearward direction. This one complete cycle is repeated resulting in the reciprocating motion of the needle.
When the push-button switch connected to port A1 is pressed, velocity acceleration pattern 1 can be executed. When the push button switch connected to port A2 is pressed, velocity acceleration pattern 2 can be executed. When the push button switch connected to port A3 is pressed, velocity acceleration pattern 3 can be executed. Likewise, when the push button switch connected to port A4 is pressed, velocity acceleration pattern 4 can be executed. When none of the four push-button switches is pressed, constant velocity needling can be executed.
Ultimately, for 100 pulses, the delay time can be decreased 99 times—i.e., after each pulse. This means the velocity will be increased 99 times. V1 to V2, V2 to V3, . . . V99 to V100. However, there is a practical upper limit for the velocity increase for a given motor because as the motor speed increases, the pushing force weakens. Similarly, there can also be a lower limit for the delay time. As the number of accelerations increases, the delay time is decreased in a smaller amount after each segment. For example, if there are 11 accelerations and the delay time range is 0.01 sec to 0.005 sec, the delay time is decremented 0.005/10 sec after each segment. For example, it would be like, 0.01 sec, 0.0095 sec, 0.0090 sec, . . . , 0.0055 sec, and 0.005 sec. For 10 acceleration changes, the needling pattern can become more gradual like the one shown by profile 41 of
It is to be understood that different velocity accelerations patterns can be programmed as when desired. For example, a software application can be provided on a mobile device, such as a smartphone that can be used to program the microcontroller. The software application can also be used to trigger the desired velocity pattern instead of buttons on the microcontroller chip 47. The mobile device can be connected to the disclosed velocity accelerometer by a wired or wireless connection. Examples of wireless connections can include Bluetooth.
The key elements in generating velocity acceleration patterns are: (1) the number of velocity changes, (2) the velocity values, and (3) the point where each velocity change occurs. The velocity is determined by the delay time in between subsequent pulses. To determine the point where the velocity change occurs, the total number of pulses corresponding to the needling depth is needed. There are two key design parameters: the distance the needle tip moves during the one-half cycle—this is called the needling depth or the stroke length—and the distance the linear actuator moves along its axis per one step pulse. The former is chosen by the designer of the device in consultation with the practitioner while the latter is obtained from the specification of the linear activator.
Suppose the stroke length is 10 mm and the axis moves 0.1 mm per step pulse. The number of velocity changes is 2, the three velocity values are 40 mm/sec, 50 mm/s, and 60 mm/sec; and the point where each velocity change occurs is at ⅓ and ⅔ of the half-cycle. The total number of pulses corresponding to the stroke length of 10 mm is 10 mm/0.1 mm or 100. The exact points where velocity changes are step 33 and step 66 (precisely, it has to be 33.3 and 66.6, but integers are needed for programming). The number of steps for 40 mm/s is 40 mm/0.1 mm or 400 steps/sec. A speed of 400 steps/sec is equivalent to 1 step per 0.0025 sec. So, the delay time DT1 for 40 mm/s velocity is 0.0025 sec or 2.5 msec; likewise, the delay time DT2 for 50 mm/sec velocity is 2 msec, and the delay time for 60 mm/s velocity is 1.67 msec. The velocity acceleration program proceeds as follows: (1) send out a direction logic level corresponding to ‘forward’ direction via port D2 of the microcontroller chip 47 of
With this acceleration of needling velocity, the following can be achieved: (1) LTRs can be obtained more frequently than for the case of single velocity; (2) ‘rock-like’ dense trigger point zone can be needled effectively, and (3) overall treatment time is shortened significantly compared with the case of single velocity intramuscular stimulators. A greater number of LTRs means enhanced treatment effectiveness and a shorter needling period means shorter treatment time for both patients and practitioners.
While the foregoing written description of the invention enables one of ordinary skill to make and use what is considered presently to be the best mode thereof, those of ordinary skill will understand and appreciate the existence of variations, combinations, and equivalents of the specific embodiment, method, and examples herein. The invention should therefore not be limited by the above-described embodiment, method, and examples, but by all embodiments and methods within the scope and spirit of the invention as claimed.
| Number | Name | Date | Kind |
|---|---|---|---|
| 5735868 | Lee | Apr 1998 | A |
| 6117156 | Richter | Sep 2000 | A |
| 20140114279 | Klinghoffer | Apr 2014 | A1 |
| Number | Date | Country | |
|---|---|---|---|
| 20210378911 A1 | Dec 2021 | US |
