APPARATUS AND METHOD FOR MEASURING HEMOSTATIC PROPERTIES OF PLATELETS

• US 3,712,293 A
• Filed: 07/27/1970
• Issued: 01/23/1973
• Est. Priority Date: 07/27/1970
• Status: Expired due to Term

• Current Assignee: Medical Research Institute (Jarrow Formulas Incorporated)
• Original Assignee: Clarence Harold Jr. Mielke
• Inventors: Mielke, Clarence Harold Jr.
• Primary Examiner(s): Howell, Kyle L.
• Application Number:
  US05/058,252
• Time in Patent Office: 911 Days
• Field of Search: 128/2R,2G,2B,305,314,316,325,333 30/293,294
• US Class Current: 600/369
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150977 Arrays of piercing elements for simultaneous piercing
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15155 Piercing elements which are specially shaped or are provided with fittings or attachments to facilitate nesting, stacking or joining together end-to-end or side-by-side
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use

Abstract

An apparatus and method for making a standardized reproducible blade incision in the subject'"'"''"'"'s forearm for the purpose of measuring his bleeding time. A blade is precisely mounted on the blade holder by use of a gauge block, and a flat template with standard thickness and standard length of slot is used to guide the blade and limit the depth and length of incision.

Claims

1. Apparatus for clinically testing the bleeding time of a human subject comprising, in combination:

a. a blade holder having a handle, a lower horizontal planar bearing surface, and a blade receiving portion open at said planar bearing surface;

b. means on said blade holder for mounting a cutting blade on said blade receiving portion at a predetermined, specific location;

c. a cutting blade having a pointed tip and an angled cutting edge extending away from said tip, said blade being mounted on said blade holder by said mounting means in a predetermined, specific position in which said blade tip protrudes beyond said horizontal, planar bearing surface of said blade holder by a predetermined, specific distance, the plane of said blade being perpendicular to said planar bearing surface; and

d. a template having parallel upper and lower horizontal planar surfaces, and walls forming a straight, vertical blade slit open at said upper and lower planar surfaces, the width of said slit being slightly greater than the width of said cutting blade, said blade tip being removably inserted through said template slit, and said blade holder planar bearing surface being slidably positioned flush against said template upper horizontal planar surface, whereby the tester may firmly press the template against the volar side of the subject'"'"''"'"'s forearm with one hand, grip the blade holder with the other hand, insert the blade tip vertically at one end of the template slit, pEnetrate the subject'"'"''"'"'s skin with the blade tip to a depth at which the blade holder planar bearing surface is positioned flush against the template upper horizontal surface, draw the blade along the length of the template slit to the other end of the slit, withdraw the blade vertically from the slit, remove the template, and measure the time which elapses until the resulting bleeding ceases.

2. Apparatus of claim 1 wherein said cutting blade has an aperture formed therein and said blade holder mounting means includes at least one bolt adapted to pass through said blade aperture into threadable engagement with said blade holder to immobilize said blade thereon.

3. A method for clinically testing the bleeding time of a human subject comprising the following steps:

a. mounting a cutting blade on a blade holder which has a lower horizontal planar bearing surface, said blade being mounted in a predetermined, specific position in which the cutting tip of said blade protrudes beyond said horizontal planar bearing surface of said blade holder by a predetermined, specific distance;

b. pressing a template against the volar side of the subject'"'"''"'"'s forearm, said template having a blade slit formed entirely therethrough, said blade slit having a predetermined, specific length and depth;

c. inserting said blade cutting tip through said template blade slit at one end of said slit, and vertically penetrating the subject'"'"''"'"'s skin by pressing said blade holder downwardly until said blade holder lower horizontal planar bearing surface is positioned flush against the upper horizontal surface of said template;

d. drawing said blade holder smoothly and rapidly along the length of said template blade slit to the other end of said slit to cause said blade to make an incision of a predetermined, specific, uniform length and depth in the subject'"'"''"'"'s skin;

e. withdrawing said blade vertically from the subject'"'"''"'"'s skin and removing said template from the subject'"'"''"'"'s skin; and

f. measuring the time which elapses between when the blade is withdrawn and when the resulting bleeding ceases.

4. The method of claim 3 including the following additional step:

blotting the incision bleeding with filter paper strips without touching the incision edges until blood no longer stains the filter paper.