Apparatus and method for minimizing pain perception

Surgery: kinesitherapy – Kinesitherapy – Vibrator

Reexamination Certificate

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Details

C606S181000, C606S182000, C600S573000, C600S583000

Reexamination Certificate

active

06231531

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is directed to an apparatus and method for minimizing a subject's pain perception during a medical procedure and, more specifically, to a modular system for obtaining a blood sample from a subject while minimizing pain perception.
2. Description of the Related Art
Due to the pain often associated with invasive medical procedures, such as blood sampling and the like, many people are reluctant to visit a doctor or to obtain needed diagnostic tests and other beneficial medical procedures. This is particularly true in the case of children, who, if traumatized, may develop a lasting fear of doctors and/or medical procedures that can persist into adolescence or even adulthood. This reluctance is often aggravated in situations where multiple punctures must be made to obtain the necessary quantity of blood or other bodily fluid. In this regard, data published by H. Fruhstorfer, et al. in
Practical Diabetes International
, Vol. 12, No. 4, July/August 1995, demonstrated that increasing penetration depth provides more blood from a single puncture. Unfortunately, however, increased penetration depth often increases pain perception during the procedure.
Previous attempts to reduce pain perception during invasive procedures include various devices and methods for introducing a local anesthetic, such as Lidocaine® or ethylchloride, prior to piercing. For example, transdermal electrode patches have been used to drive a local anesthetic by ionic transport into the dermal tissue layer before intravenous line placement. Transcutaneous electrical nerve stimulation (TENS) has also been used to relieve both acute and chronic pain. TENS involves the application of a constant current to the skin for durations ranging from a few minutes to as long as 30 minutes.
Another method and apparatus for reducing pain perception was disclosed by McCann in U.S. Pat. No. 2,258,857. The apparatus includes a vibrating unit having a contacting element adapted to contact a patient's face during a dental procedure. In operation, the patient activates the vibrating unit and holds the unit in place on his face, proximate the ear. The vibrations purportedly distract and confuse the patient's nerve functions, thereby lessening pain perception by preventing the patient's nerve sense from locating the exact point of the pain. Also, the noise produced by the unit purportedly overcomes all noises produced by other instruments during the dental procedure, thereby further distracting the patient from the dental procedure.
A device for reducing pain perception during injections was disclosed by Kravitz in U.S. Pat. No. 3,620,209. The device includes a casing adapted to be pressed against a patient's skin, a strap for securing the casing to the patient, and vibratory means positioned within the casing. In operation, the casing is secured to the patient, and the vibratory means is actuated. After the patient's skin is vibrated sufficiently to stimulate the pain center of the skin, a needle (which does not form part of the device) is injected into the patient, proximate the device, and the pain of the injection is purportedly minimized by the vibration.
Another device for reducing pain perception associated with injections was disclosed by Pokras in U.S. Pat. No. 5,647,851. The device is a portable, hand held vibrating injection device including an injection needle and a housing enclosing a vibrator. In operation, the vibrator vibrates the needle as it penetrates the patient's skin, thereby purportedly lessening the amount of pain and discomfort experienced by the patient. The vibration of the needle also purportedly accelerates migration of the injected medication into the subcutaneous tissue and away from the puncture site.
Various other approaches and apparatus have been proposed to reduce the perception of pain while drawing blood samples, such as those disclosed in U.S. Pat. No. 4,462,405, U.S. Pat. No. 5,035,704 and WO 97/28741.
SUMMARY OF THE INVENTION
The present invention is directed to an apparatus and method for minimizing a subject's pain perception during an invasive medical procedure, such as blood sampling and the like. The unique configuration of the apparatus of the present invention allows invasive procedures to be performed on a subject with minimal discomfort.
The apparatus includes a receiving surface constructed to contact a portion of the subject's skin and a vibratory mechanism associated with the receiving surface such that the vibratory mechanism transmits vibrations through the receiving surface and to the subject's skin. An invasive sharp is substantially permanently supported and moveably disposed with respect to the receiving surface such that the invasive sharp can reciprocate between a first position in which the sharp is spaced from the receiving surface, away from the subject's skin, and a second position in which at least a portion of the sharp protrudes through an opening in the receiving surface.
In various alternative embodiments, it is contemplated that the apparatus may further include a roller unit moveably disposed relative to the invasive sharp such that the roller unit applies a force on the sharp that moves the sharp from the first position to the second position. The roller unit may contain a roughened roller so that movement of the roller transmits vibrations through the receiving surface. The apparatus may also include a resilient member associated with the invasive sharp such that the resilient member moves the sharp from the second position to the first position when the force applied by the roller unit is removed. If desired, a spring or an elastomeric sheet may serve as the resilient member.
Another aspect of the invention includes a modular system for obtaining a blood sample from a subject with minimal pain perception. The system includes a housing and a removable module disposed within the housing. The module has a receiving surface constructed to contact a portion of the subject's skin. An invasive sharp is moveably disposed within the removable module such that the sharp reciprocates between a first position in which the sharp lies below the receiving surface and a second position in which at least a portion of the invasive sharp protrudes through an opening in the receiving surface. A vibratory mechanism associated with the receiving surface transmits vibrations through the receiving surface and to the subject's skin.
In alternative embodiments, the system may include a channel adapted to receive a body fluid from the subject and to direct the body fluid to a point of use. The channel may include a capillary tube. The system may further include a roller unit moveably disposed within the housing such that the roller unit applies a force on the sharp that moves the sharp from the first position to the second position. The roller unit may contain a roughened roller so that movement of the roller transmits vibrations through the receiving surface. The apparatus may also include a resilient member associated with the invasive sharp such that the resilient member moves the sharp from the second position to the first position when the force applied by the roller unit is removed.
In another aspect of the present invention, a method is provided for minimizing a subject's pain perception during a medical procedure. The method includes supporting an invasive sharp with respect to a receiving surface having an opening therethrough. The receiving surface is vibrated while a portion of the surface is in contact with the subject's skin. The subject's skin is pierced with the sharp while the skin is contacting the receiving surface. The sharp is then withdrawn from the skin.
In various alternative embodiments, the piercing may be accomplished by actuating a roller unit moveably disposed relative to the invasive sharp such that the roller unit applies a force on the sharp that moves it from a first position to a second position in which

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