Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
  • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
  • A61B5/1075—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions by non-invasive methods, e.g. for determining thickness of tissue layer
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/0048—Detecting, measuring or recording by applying mechanical forces or stimuli
  • A61B5/0053—Detecting, measuring or recording by applying mechanical forces or stimuli by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
  • A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
  • A61B5/442—Evaluating skin mechanical properties, e.g. elasticity, hardness, texture, wrinkle assessment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
  • A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
  • A61B5/443—Evaluating skin constituents, e.g. elastin, melanin, water
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4869—Determining body composition
  • A61B5/4872—Body fat
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
  • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
  • A61B5/6848—Needles
  • A61B5/6849—Needles in combination with a needle set
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Definitions

• the invention relates to methods of selecting a needle with an injection length suited for administration of a therapeutic agent in the subcutis at a body location.
• the subcutaneous route is one of the most versatile routes of administration in that it can be used for both short term and very long term therapies. Additional benefits of subcutaneous administration include favorable bioavailability and pharmacokinetic properties and ease of delivery independent of the consciousness or rationality of the patient. While the subcutaneous tissue is an important target of drug delivery, it can be difficult to determine the boundaries of the subcutis between the dermal layers and underlying muscle tissue. For many medications, accidental administration within the cutis or the muscle tissue can lead to side effects, incorrect dosage or leakage of the medication from the injection site.
• insulin accidentally injected into the muscle tissue will be absorbed more rapidly than if injected into the subcutaneous tissue and this is potentially dangerous as it may cause low levels of blood glucose.
• Other therapies such as immunoglobulins, can irritate mast cells if injected into the dermal layers.
• clearing the dermal layers is important to avoid reactions which can include swelling, redness, itching, pain, and in some cases, the drug leaking out of the injection sites due to the swelling surrounding the area.
• the injection into the subcutis can be controlled by the length of the needle used for the injection or infusion. However, it is often difficult to know the required length of needle needed to clear the cutis given the variability in body fat compositions at different locations in the body.
• the invention provides a method for selecting a needle with an injection length for subcutaneous injection of a therapeutic agent at a body location, comprising measuring body fat at the body location and selecting a needle with an injection length suited to position the anterior opening of the needle within the subcutis at the body location.
• the method may further include the step of correlating the body fat measurement with a depth of body fat at the body location.
• the body fat at a body location may be measured with a skinfold caliper.
• skinfold calipers include the Accu-Measure® Fitness 3000 Personal Body Fat Tester, Baseline Skinfold Caliper, Slim Guide Skinfold Caliper, and AccuFitness FatTrack II Digital Body Fat Caliper.
• the skinfold caliper is the Accu-Measure® Fitness 3000 Personal Body Fat Tester.
• the body location may be selected from the abdomen, thigh, arm, such as the back of the arm, and hip, such as the back of the hip.
• the body fat measurement may include an average of two or more measurements at a body location.
• the injection length of the needle may be the length of needle from the tip to the posterior end of the shaft or from the tip to a fixed point on the shaft.
• the fixed point may be a block to prevent injection past the block.
• the fixed point may be a bend in the needle to prevent injection past the bend, such as a bend of the needle at about a 90 degree angle.
• the injection length of the needle may be selected from between about 3 mm and about 20 mm.
• the injection length of the needle is selected from about 4 mm, about 6 mm, about 9 mm, about 12 mm and about 14 mm.
• the injection length of the needle may be selected from about 0.1 mm to about 5 mm greater than the depth of body fat at the body location.
• the injection length may be selected from about 1 mm to about 3 mm greater than the depth of body fat at a body location.
• the needle is a RMS High-Flo® needle.
• the invention includes the method for selecting a needle with an injection length for subcutaneous injection of a therapeutic agent at a body location, comprising measuring body fat at a body location with a skinfold caliper and selecting a needle with an injection length suited to position the anterior opening of the needle within the subcutis at the body location.
• the invention includes a method for selecting a needle with an injection length for subcutaneous injection of a therapeutic agent at a body location, comprising measuring body fat at a body location, correlating the body fat measurement with a depth of body fat at the body location, and selecting a needle length suitable to position the anterior opening of the needle within the subcutis at the body location.
• the invention further includes a method for subcutaneous injection of a therapeutic agent at a body location, comprising measuring body fat at a body location, selecting a needle with an injection length suited to position the anterior opening of the needle within the subcutis at the body location, inserting the needle at an angle perpendicular or approximately perpendicular to the skin surface to the extent that the anterior opening of the needle is within the subcutis at the body location, and injecting the therapeutic agent.
• the invention provides a skinfold caliper for selecting a needle with an injection length suited for positioning the anterior opening of the needle in the subcutis, wherein the skinfold caliper measures the width of a skin fold and outputs a suitable injection length or injection length range for a needle.
• the output of the skinfold caliper may be selected from digital or analog.
• the needle may be inserted at an angle perpendicular or approximately perpendicular to the skin surface.
• Figure 1 depicts a needle within the tissue layers of the skin and the positioning of the anterior opening of a needle in the subcutis. Description of the Invention
• the invention provides a method of selecting a needle with an injection length for subcutaneous injection of a therapeutic agent at a body location.
• To select the appropriate length needle the body fat at the body location is measured.
• the measurement of body fat at the body location is used to select a needle with an injection length suited to position the anterior opening of the needle within the subcutis at the body location.
• the measurement of body fat at a body location generally refers to a measurement of the depth of body fat and dermal tissue in the dermal layers.
• the cutis or cutaneous portion of the skin includes the epidermis and dermis while the subcutis or subcutaneous tissue is located between the cutis and muscle tissue.
• the amount of body fat in the dermal layers may vary dramatically from one individual to another and at one location on the body to another location on the same individual.
• the depth of body fat at a location in the abdomen may vary by multiple millimeters relative to the depth of body fat measured in the thigh.
• the depth of body fat at one location in the abdomen may vary relative to another position of the abdomen of the same individual. In some instances there will be no body fat in the dermal layers and the measurement of body fat will afford the depth of the dermal tissue.
• One way to measure the amount of body fat at a body location is to use a skinfold caliper.
• the body fat measured by a skinfold caliper at a body location may be used to select a needle for subcutaneous injection.
• the skinfold caliper measures a fold of the skin tissue which is greater than the depth of fat in the cutis at a body location.
• the invention provides a correlation between the skin fold measurement at a body location and depth of body fat at that location.
• the depth of body fat is the depth of body fat and dermal tissue in the dermal layers. In cases where there is no body fat in the dermal layers at a body location, the depth of body fat is the depth of the dermal layers.
• the depth of body fat determined using a skinfold caliper may then be used to select a needle appropriate for administration of a therapeutic agent into the subcutis.
• the caliper measurement of body fat is used to select a needle length without intermediate correlation to depth of body fat.
• a table provides a correlation between skin fold measurements and suitable needle length at the body location.
• Exemplary skinfold calipers include the Accu-Measure® Fitness 3000 Personal Body Fat Tester, Baseline Skinfold Caliper, Slim Guide Skinfold Caliper, and AccuFitness FatTrack II Digital Body Fat Caliper.
• the skinfold caliper is the Accu-Measure® Fitness 3000 Personal Body Fat Tester.
• the skinfold caliper used in methods of the invention is generally operated in a fashion consistent with its use in the field of body fat measurement. Measurement technique may vary slightly by body location, by operator or by other considerations. In general, a fold of skin is gathered between the thumb and forefinger of one hand. In some measurements, the skin fold may be slightly pulled away from the underlying muscle. Holding the calipers in the other hand, jaws of the caliper are positioned to clasp the skin fold about 1 ⁇ 4" from the fingers holding the fold. The trigger of the caliper is released so that the force of the jaws is on the skin fold. The skin fold may be concurrently held with the thumb and forefinger during the release of the caliper trigger.
• the measurement may be taken immediately or the measurement may be taken after passage of a short period of time, e.g., 10-20 seconds.
• a delay in measurement may allow the fold of skin to settle or adjust in the clasp of the calipers which may lead to a more accurate reading.
• Some skinfold calipers require that the measurement be read while the caliper is clasped around the skin fold.
• Other more preferable skinfold calipers allow for reading of the measurement following removal of the calipers from the skin fold.
• the procedure for measuring body fat at a body location may be repeated multiple times at a body location. In certain embodiments, the measurement is taken multiple times, such as two, three four or five times, and the measurements averaged.
• the invention provides a method of correlating body fat at a body location with an appropriate length needle for subcutaneous injection.
• the invention provides a conversion factor or table for converting a body fat measurement at a body location and thereby selecting an appropriate length needle for subcutaneous injection.
• the invention provides a method of correlating body fat at a body location with a body fat depth which may then be correlated with an appropriate length needle for subcutaneous injection.
• a skinfold caliper is graduated with needle lengths or has a digital output of a needle length, such that no correlation or table is required by the user to convert a body fat measurement to an appropriate needle length.
• a body fat measurement may be taken with a caliper at a body location but the output on the caliper is a needle length rather than the skin fold width generally read from the skinfold caliper.
• the skinfold caliper clasps the skin fold at a location in the abdomen and the measurement on the caliper reads 9 mm needle, such that a 9 mm needle is a suitable needle length to try for subcutaneous injection at that body location.
• the method of the invention further comprises the step of inserting the needle through the dermal tissue into the subcutis.
• the method comprises measuring the body fat at a body location, selecting a needle with a length suitable to position the needle in the subcutis and inserting the selected needle into the subcutis.
• the needle may be inserted perpendicular or approximately perpendicular to the surface of the skin.
• the needle may be inserted at about a 90 degree angle relative to the skin surface.
• the needle is injected at an angle relative to the skin surface such as about a 10 degree angle or less to the skin surface, about a 20 degree angle or less to the skin surface, about a 30 degree angle or less to the skin surface, about a 40 degree angle or less to the skin surface, about a 50 degree angle or less to the skin surface, about a 60 degree angle or less to the skin surface, about a 70 degree angle or less to the skin surface, or about a 80 degree angle or less to the skin surface.
• the full injection length is inserted into the skin.
• a portion of the injection length is inserted into the skin.
• the anterior opening of the needle is below the cutis or substantially within the subcutis tissue.
• the method may further comprise injecting or infusing a therapeutic agent into the subcutis.
• the methods of the invention may be practiced at any location on the body in which subcutaneous injection is desired.
• the body location is selected from the abdomen, thigh, arm, such as the back of the arm, and the hip, such as the back of the hip.
• Body fat at different locations on the body may vary significantly such that measurement at one body location provides information on depth of fat and needle length specific to that measured location.
• the body fat measurement on the back of the upper arm may only provide guidance for selecting a needle length at that location on the body.
• the body fat measurement at one body location may provide guidance for needle length selection at other locations on the body.
• body fat measurement on the back of the right arm may be sufficient to determine needle length for the analogous position on the back of the left arm.
• the total length of a needle from the tip to the posterior end of the shaft may not correspond to the injection length of a needle.
• a needle may be bent at a 90 angle such that only the portion anterior to the angle is suited for injection into the body.
• the needle has a block on the shaft of the needle, such that injection cannot occur beyond the block in the needle.
• a block located around the shaft of the needle stops the needle from injection deeper into the body once the disk contacts the skin surface.
• the injection length of a needle 1 is measured from the anterior tip of the needle to the furthest injectable point on the shaft 6 of the needle ( Figure 1).
• the injection length of the needle may be measured from tip of the needle to posterior end of the shaft.
• the injection length is the length of the needle from the tip to a fixed point on the shaft such as a bend in the needle or a block 8 in the needle that prevents further injection beyond the block or the bend ( Figure 1).
• the needle is injected at an angle perpendicular or
• the shaft of the needle enters and traverses the skin layers at the shortest pathway to the subcutis at that position.
• the shaft of the needle may traverse the skin layers at an angled trajectory.
• the full extent of the injection length is injected into the body location.
• the full 9 mm of the needle is injected perpendicularly or approximately perpendicularly through the cutis and into the subcutis.
• a portion of the injection length is injected into the body location.
• 8 mm of the needle is injected perpendicularly or approximately perpendicularly through the cutis and into the subcutis and 1 mm of the injection length remains exterior to the body.
• the anterior opening of a needle 4 is generally positioned distal to the tip 5 of a needle ( Figure 1).
• a needle is selected with an injection length 1 such that the needle is suited to position the anterior opening of the needle 4 below the cutis and within the subcutis of the body location 3 ( Figure 1).
• a needle with an injection length suited to position the anterior opening 4 below the cutis may be longer than the distance required to clear the cutis and enter the subcutis ( Figure 1).
• the injection length suited to position the anterior opening of the needle below the cutis is 10 mm and the injection length of the needle is 11 mm.
• the full injection length may be inserted perpendicularly or approximately perpendicularly to the skin surface 7 to a point at which anterior opening resides further within the subcutis and closer to the muscle or alternatively 1 mm of the needle may remain exterior to the body (Figure 1).
• a needle is selected with an injection length suited to position the anterior opening of the needle substantially within the subcutis.
• Substantially within the subcutis includes, for example, when a portion of the anterior opening, such as about 5% or less, about 10% or less, about 20% or less, or about 30%> or less of the opening, is positioned in the cutis.
• the injection length of the needle is selected from between about 3 mm and about 20 mm.
• the injection length is selected from about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, about 11.5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, about 15 mm, about 15.5 mm, about 16 mm, about 16.5 mm, about 17 mm, about 17.5 mm, and about 18 mm.
• the injection length is selected from about 4 mm, about 4.5 mm, about 6 mm, about 6.5 mm, about 9 mm, about 9.5 mm, about 12 mm, about 12.5 mm, about 14 mm and about 14.5 mm.
• the needle is a RMS High-Flo® needle.
• the marketed needle length excludes the length of the tip 2 ( Figure 1).
• the needle is marketed as a 9 mm needle but the injection length is 9.5 mm.
• the method of the invention provides a correlation between measurement of body fat and depth of body fat in the cutis.
• a correlation is as follows: Depth of body fat SF
• SF skin fold measurement at a body location
• f(p) adjustment for pressure of compression
• F(SF)*SF factor for size adjustment.
• SF may be equal to a single skinfold measurement or SF may be the average of two or more measurements at a body location.
• the variable f(p) is an adjustment factor for tissue compression that may vary from one body location to another. For example, the compression of tissue at a location on the abdomen may be greater than the compression at the thigh due to differences in the tissue density resulting in the need for a larger adjustment for the abdomen.
• the f(p) may be selected from about 0.1 to about 4 mm, such as about 1 to about 3 mm. In certain embodiments, the f(p) may be zero.
• F(SF)*SF is an adjustment factor for inaccuracies that may exist for large skinfold measurements.
• F(SF) may be from about 0.01 to about 0.5, such as about 0.05 to about 0.3. In certain embodiments, the F(SF) may be zero.
• Depth of body fat may be correlated with the injection length of a needle.
• the injection length of the needle may be selected from about 0.1 mm to about 5 mm greater than the depth of body fat at the body location, such as from about 1.0 mm to about 3.0 mm greater than the depth of body fat.
• the injection length of the needle may be selected from between about 0.1 to about 1 mm greater than depth of body fat, about 1 mm to about 2 mm greater than the depth of body fat, about 2 mm to about 3 mm greater than the depth of body fat, about 3 mm to about 4 mm greater than the depth of body fat or about 4 mm to about 5 mm greater than the depth of body fat.
• subcutaneous injection of a therapeutic agent includes subcutaneous infusion of a therapeutic agent.
• Subcutaneous infusion or continuous subcutaneous infusion is a way to deliver one or more therapeutic agents over extended periods of time and is particularly useful for palliative care.
• Subcutaneous infusion is used in both the inpatient and outpatient settings, for example, for relief of malignant and non-malignant disease.
• the therapeutic agent of the method may be selected from any therapeutic agent suitable for subcutaneous administration.
• Exemplary therapies for subcutaneous administration include isotonic fluid replacement, immunizations, immunoglobulins, iron chelating treatment, insulin, heparin, hormones and growth factors, cytotoxic chemotherapy, sedation and narcotic drugs, and opioids.
• the therapeutic agent is an immunoglobulin.
• the invention further comprises a method for subcutaneous injection or infusion of a therapeutic agent at a body location, comprising measuring body fat at a body location, selecting a needle with an injection length suited to position the anterior opening of the needle within the subcutis at the body location, inserting the needle at an angle approximately perpendicular to the skin surface to the extent that the anterior opening of the needle is within the subcutis at the body location, and injecting or infusing the therapeutic agent.
• the injection or infusion is administered by a heathcare professional such as a nurse, nurse practitioner or doctor; self-administered; or administered by a third party such as a relative.
• Another aspect of the invention is a skinfold caliper for selecting a needle with an injection length suited for positioning the anterior opening of the needle in the subcutis, wherein the skinfold caliper measures the width of a skin fold and outputs a suitable injection length or injection length range for a needle.
• the output is the measurement read from the caliper.
• the output of the skinfold caliper may be digital, for example, the caliper may have a digital screen that reads a suitable needle length upon measuring the width of a skin fold.
• the output of the skinfold caliper may be analog, for example, the scale of the caliper is graduated with needle length measurements.
• the graduations on the caliper are needle lengths of 9 mm, 10 mm, 11 mm, etc, which are suitable needle lengths to try based upon the width of the skin fold at the body location.
• the needle is inserted into the skin at an angle perpendicular or approximately perpendicular to the skin surface.
• the invention further comprises a skinfold caliper for selecting a needle with an injection length suited for positioning the anterior opening of the needle in the subcutis, wherein the skinfold caliper measures the width of a skin fold and outputs the depth of body fat at the body location.
• the output of the skinfold caliper may be digital or analog.
• the output from the caliper may be used to select a needle with an injection length suited for positioning the anterior opening of a needle in the subcutis.
• the output of the skin fold measurement may be 10 mm, indicating that 11 mm is a suitable injection length to try to clear the cutis.
• the skinfold caliper of the invention may be any caliper used in the field of measuring body fat, wherein the improvement comprises an output of body fat depth, rather than skin fold width, at a body location or a suitable needle length at a body location for positioning the anterior opening of a needle in the subcutis at the body position.
• the output of the skinfold caliper may be a digital output or it may be an analog output.
• the present invention provides among other things methods of selecting needles with an injection length suited for subcutaneous administration of a therapeutic agent. While specific embodiments of the subject invention have been discussed, the above specification is illustrative and not restrictive. Many variations of the invention will become apparent to those skilled in the art upon review of this specification. The full scope of the invention should be determined by reference to the claims, along with their full scope of equivalents, and the specification, along with such variations.

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• 2014
  • 2014-08-27 EP EP14839103.0A patent/EP3038680B1/en active Active
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