Abstract:
A subsurface wound measuring device and method are provided for measuring a subsurface wound or cavity of a patient, the device including a flexible strip having a first and second section, said sections having a first and second ends respectively with an intermediate bend being located between the first and second ends. The first end is adapted for being located internally to a patient, the second end being adapted for being located externally to the patient. The first and second sections have generally concave-shaped cross-sections with measuring indicia being located along at least one of the sections. The device also optionally includes a measuring strip and a receiver mounted on the second end for receiving the measuring strip, where the measuring strip and the flexible strip form complementary structure for measuring a subsurface wound or cavity.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     The present invention relates generally to medical measuring devices and methods, and in particular to wound modeling and treatment applications of same.  
         [0003]     2. Description of the Related Art  
         [0004]     In the medical field, wound treatment encompasses a wide variety of procedures, pharmacologicals, devices and equipment. Health care institutions and other providers commonly devote substantial resources to wound treatment. Treating open wounds, such as those associated with decubitus pressure ulcers and other chronic conditions, can be particularly challenging. For example, wound care facilities commonly specialize in the treatment of open, slow-healing wounds.  
         [0005]     Certain types of open wounds exhibit subdermal voids and pockets whereby intact skin areas are undermined by infected and necrotic tissue. Such subdermal conditions can be difficult to treat because they are not readily observable and do not respond to surface-applied treatment protocols. For example, an undermined wound may appear to be closing at the epidermis, when in fact subdermal conditions are actually worsening. Determining the extent of subsurface wounds is an important aspect of monitoring treatment progress and selecting appropriate treatment protocols.  
         [0006]     The related art includes devices and procedures for measuring and modeling open and subsurface wounds. For example, US Marketing Services Worldwide (USMS) of Miami, Florida offers a Wound Stick™ Measuring System with calibrated rulers adapted for measuring open wounds and a Wound Stick Tunneler™ for insertion into undermined pressure wounds. The measurements can be used to produce a WoundMap™ record, which documents the extent of subsurface injury. Another related art device is shown in Japanese Patent Abstract Publication No. 2004-073,769, which discloses a decubitus pocket measure including a probe and a measure, which enable marking the skin surface above the undermined portion of the wound. The use of this device is described in Kosaka, M. et al., “Pocket Measure”: an Exclusive Tool for Measuring and Recording Pressure Ulcer Pockets,  Journal of Plastic and Reconstructive Surgery,  August 2004, pp. 644-25.  
         [0007]     A wound measuring device for open and subsurface wounds would ideally be adapted for obtaining multiple measurements of irregular shapes, such as undermined wounds, and using such measurements for generating two-dimensional or three-dimensional models. Patient comfort and use of operation are additional considerations. The present invention addresses these considerations. Heretofore there has not been available a medical measuring device and method with the advantages and features of the present invention.  
       SUMMARY OF THE INVENTION  
       [0008]     In the practice of one aspect of the present invention, a wound measurement device is provided, which includes a flexible strip adapted for bending at an elbow whereby first and second sections with respective first and second ends are formed. The strip includes an upper surface with a measuring structure and a configuration adapted for inserting, guiding and manipulating same within a wound. Alternative embodiment measuring devices include different end constructions, guide and measuring strips adapted for cooperative, sliding engagement, and other optional features. In the practice of one aspect of the method of the present invention, multiple dimensions corresponding to the size and shape of the wound are determined whereby it can be modeled in two or three dimensions. The method can include monitoring the patient&#39;s progressive healing and response to treatment.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]      FIG. 1  is a perspective view of a subsurface wound measuring device embodying the present invention.  
         [0010]      FIG. 2  is a cross-section of a wound, with the measuring device partly inserted therein.  
         [0011]      FIG. 3A  is a cross-section of another wound, with the measuring device partly inserted therein.  
         [0012]      FIG. 3B  is another cross-section of the wound shown in  FIG. 3A , showing additional measurements being taken with the measuring device partly inserted in another orientation.  
         [0013]      FIG. 4  is a perspective view of a subsurface wound measuring device comprising an alternative embodiment of the present invention.  
         [0014]      FIG. 5  is a fragmentary, perspective view of a subsurface wound measuring device comprising another alternative embodiment of the present invention.  
         [0015]      FIGS. 6A and 6B  are perspective views of a subsurface wound measuring device comprising an alternative embodiment of the present invention.  
         [0016]      FIG. 7  is a perspective view of a measuring strip thereof.  
         [0017]      FIGS. 8 and 9  are perspective views of a subsurface wound measuring device comprising another alternative embodiment of the present invention.  
         [0018]      FIG. 10  is a perspective view of a subsurface wound measuring device comprising another alternative embodiment of the present invention.  
         [0019]      FIG. 11  is a fragmentary, perspective view thereof, taken generally within circle  11  in  FIG. 10 .  
         [0020]      FIG. 12  is a fragmentary, longitudinal cross-sectional view thereof, taken generally along line  12 - 12  in  FIG. 11 .  
         [0021]      FIG. 13  is a fragmentary, perspective view of a subsurface wound measuring device comprising another alternative embodiment of the present invention.  
         [0022]      FIG. 13A  is a fragmentary, perspective view of a subsurface wound measuring device, which can be fitted with various end configurations, as shown in cross-sectional  FIGS. 14-16  taken generally along line  14 / 15 / 16  in  FIG. 13A .  
         [0023]      FIG. 17  is a fragmentary, top plan view of another alternative wound measuring device, which is adapted for retrieving tissue and fluid samples.  
         [0024]      FIG. 18  is a fragmentary, side elevational view thereof, shown in a tissue or fluid sample gathering position within a wound, taken generally along line  18  in  FIG. 17 .  
         [0025]      FIG. 19  is a fragmentary, cross-sectional view thereof, taken generally along line  19  in  FIG. 17 . 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
     I. Introduction and Environment  
       [0026]     As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure.  
         [0027]     Certain terminology will be used in the following description for convenience in reference only and will not be limiting. For example, up, down, front, back, right and left refer to the invention as oriented in the view being referred to. The words “inwardly” and “outwardly” refer to directions toward and away from, respectively, the geometric center of the embodiment being described and designated parts thereof. Forwardly and rearwardly are generally in reference to the direction of travel, if appropriate. Said terminology will include the words specifically mentioned, derivatives thereof and words of similar meaning.  
       II. Wound Measuring Device  2   
       [0028]     Referring to the drawings in more detail, the reference numeral  2  generally designates a subsurface wound measuring device embodying the present invention. Without limitation on the generality of useful applications of the device  2 , as shown in  FIG. 2 , it is particularly useful for obtaining linear dimensions corresponding to the size and configuration of an undermined subsurface wound cavity  4 , which includes an opening  5  at the skin layer  6 , a sidewall  7  with an inner portion  7   a  adjacent to a wound base  8  an outer portion  7   b  adjacent to the opening  5 . The sidewall inner portion  7   a  is larger than the outer portion  7   b,  whereby the wound cavity  4  undermines the patient&#39;s skin layer  6 . Such an undermined configuration presents difficulties in directly obtaining measurements since the sidewall inner portion  7   a  is largely obscured. The wound cavity  4  can extend to the fascia layer and beyond. The measuring device  2  is adapted for taking multiple linear measurements of a wound, not only of the skin opening but also of the irregular configuration of the undermined portion, including lengths, widths and depths. Such measurements can be used to generate a model of the wound in two or three dimensions.  
         [0029]     The measuring device  2  generally includes a flexible, upwardly-concave strip  10  with first and second ends  12 ,  14 . The first end  12  can be radiused as shown for patient comfort. The concavity of the strip  10  facilitates bending at an elbow  13  whereby first and second sections  20   a,    20   b  are formed adjacent to the ends  12 ,  14  respectively. The respective lengths of the sections  20   a,    20   b  can vary along the length of the strip  10 , depending upon where the elbow  13  is formed. A tubular sleeve  16  is mounted on the strip  10  adjacent to its second end  14 , and includes a sleeve passage  17 . The sleeve  16  is adapted for grasping, e.g. with the thumb and forefinger, whereby the device  2  can be positioned, guided and manipulated within the wound cavity  4 .  
         [0030]     The strip  10  includes an upper surface  18 , which can be provided with measuring structure comprising a printed scale  19  corresponding to suitable linear values represented by indicia  21 , such as centimeters. The scale  19  can extend for the length of the strip  10  and can originate at the first end  12 .  
         [0031]      FIG. 2  shows the device  2  placed in the wound cavity  4  for measuring same according to the method of the present invention. An elbow  13  can be formed with the strip first section  20   a  extending generally horizontally therefrom to a first point P 1  at its first end  12  on the cavity sidewall inner portion  7   a.  A first distance L 1  from the elbow  13  to P 1  can be measured, observed and recorded. The depth D, as measured from point P 3  to P 4  can be determined with the measuring device  2  ( FIG. 2 ). It will be appreciated a number of measurements can be taken, as appropriate for the nature of the wound, the precision requirements for measuring same, etc.  FIGS. 3A and 3B  show the measuring device  2  being used to obtain measurements of the wound  4  in a different area thereof. For example, the undermined, wound inner portion  7   a  can extend in multiple directions from the wound opening  5 . Thus, a first length measurement is taken to determine L 1  in a first undermined area, a second length measurement determines L 2  in a second undermined area and the third length measurement L 3  is taken across the opening  5 . The overall length of the wound  4  is thus the sum of L 1 +L 2 +L 3 . The depth D of the wound  4  can also be determined as shown. Additional measurements can be taken as needed, for example to determine distances between various opposite points on the wound sidewall. Given the generally irregular configurations of wounds, which configurations change with healing, it will be appreciated that multiple dimensional values may be required in order to accurately model a wound in two or three dimensions and monitor its healing progress.  
       III. Alternative Embodiment Wound Measuring Devices  
       [0032]      FIG. 4  shows a measuring device  52  comprising an alternative embodiment of the present invention. The device  52  includes a removable tip  54  adapted for mounting on a strip  56  second end  58  to facilitate gripping, guiding, inserting and manipulating same.  FIG. 5  shows another alternative embodiment measuring device  60  of the invention with a collar  62  including an arcuate slot  64  slidably receiving the strip  10  or the strip  56  and adapted for gripping to facilitate inserting, positioning and guiding the strip  10  or  56 .  
         [0033]      FIGS. 6A, 6B  and  7  show another alternative embodiment wound measuring device  102 , including a measuring strip  110  with first and second ends  112 ,  114  associated with respective first and second sections  120   a,    120   b  separated by an elbow  113 . The measuring strip  110  has an arcuate, upwardly-concave configuration with an upper surface  118  including a measuring structure comprising a scale  119 . The measuring strip  110  is adapted for use in conjunction with the measuring device  2  described above, which in this configuration provides a guide strip  10  for guiding and directing the measuring strip  110  into and within the wound cavity  4 . As shown in  FIGS. 6A and 6B , the sleeve passage  17  telescopically and slidably receives the measuring strip  110 , which forms an elbow  113  adjacent to the elbow  13  whereby the measuring strip sections  120   a,    120   b  partly overlie the respective guide strip sections  20   a,    20   b.  The measuring strip  110  can thus be advanced into the wound cavity  4  and extended to engage its sidewalls  7   a,    7   b,  with the guide strip  10  providing a layer of protection and between the measuring strip  110  and the patient, particularly along the wound base  8 .  FIG. 7  shows the measuring strip  110  separated from the guide strip  10 . It will be appreciated that the guide and measuring strips  10  and  110  ( FIGS. 1 and 7  respectively) can be used together in the measuring device  102  configuration described above or independently.  
         [0034]      FIGS. 8 and 9  show the measuring strip  110  fitted with a movable sleeve  130  having a passage  132 , which telescopically and slidably receives the measuring strip  110 . The movable sleeve  130  is adapted for providing an index whereby a location along the length scale  119  can be marked for reference, e.g. when the measuring strip  110  is extracted. The strip  10  can also be fitted with the movable sleeve  130  for indexing particular locations along its length.  
         [0035]     The measuring strip  110  can be placed on the guide strip  10  of the measuring device  2 , and held digitally in place to mark a spot (e.g. the elbow  13  position) for a measurement, which can be readily read when the guide and measuring strips  10 ,  110  are extracted together from the wound cavity  4 . Alternatively, any relatively stiff, sterile available material, such as a cotton-tipped applicator, can be used with the guide strip  10  to obtain a measurement. The sleeve  130  shown in  FIGS. 8 and 9  can be freely movable and also require external fixation to hold and mark a position, or it can have an internal fixing and releasing device or spring.  
         [0036]      FIGS. 10-12  show an alternative embodiment measuring strip  222 , which includes a flat or blunt first end structure  224 , which is adapted for abutting a wound cavity surface. The blunt-ended configuration of the end structure  224 , which presents a relatively flat engagement face  226 , reduces or eliminates penetration into tissue within wound cavities, whereby relatively accurate length measurements can be taken with minimal patient discomfort. The end structure  224  includes a fillet  228 , which flares into the upper surface of the measuring strip  222 .  
         [0037]      FIG. 13  shows another alternative embodiment measuring strip  232 , which includes an arcuate, upwardly-concave lip  234  forming a first end structure  236  with a generally tubular configuration adapted for minimizing patient discomfort and providing accurate readings.  FIGS. 14-16  comprise fragmentary, cross-sectional views taken generally along line  14 / 15 / 16  in  FIG. 13A , which shows a portion of alternative embodiment measuring strips  242 ,  252  and  262  and the general location of end structures  246 ,  256  and  266  in relation thereto.  FIGS. 14-16  show the further alternative embodiment measuring strips  242 ,  252  and  262  respectively with the end structures  246 ,  256  and  266  including flanges  244 ,  254  and  264 . The end structure  246  is integrally formed with the measuring strip  242 . The end structures  256 ,  266  comprise separate clips attached to the measuring strips  252 ,  262  with the flanges  254 ,  264  depending downwardly and extending upwardly therefrom respectively.  
         [0038]      FIGS. 17-19  show another alternative embodiment biopsy/measuring device  302  comprising a measuring strip  310  with a first end  312  forming a distally-opened receptacle  330  adapted for receiving and extracting a tissue or fluid sample  332 , e.g. for culture purposes in connection with a biopsy. The device  302  can be used for sample collecting, measuring or both in one or more procedures. For example, in connection with measuring an undermined wound cavity, samples can be collected for analysis whereby treatment progress and potential pathogenic conditions can be monitored by analyzing the collected samples.  
         [0039]     It will be appreciated that various other end structures can be provided for the guide and measuring strips, including disposable tips and absorbable materials for applying pharmaceuticals or taking fluid samples. Moreover, the guide and measuring strip end structures can be modified by medical practitioners as necessary to accommodate a wide range of wound cavities among patients having unique conditions and treatment procedures.  
         [0040]     It is to be understood that the invention can be embodied in various forms, and is not to be limited to the examples discussed above. Other components and configurations can be utilized in the practice of the present invention.