Abstract:
An umbilical catheterization device that allows a physician to prepare an umbilical cord and apply appropriate retraction to widen vessels to introduce a catheter. The device comprises a base and a plurality of arms. The arms may include retraction devices or may be compatible with independent retraction devices, including but not limited to sutures. The retraction devices are attached to the umbilical cord, and used to provide retraction.

Description:
BACKGROUND 
     1. Technical Field 
       [0001]    Umbilical catheterization is often performed as a life-sustaining measure in neonates that require resuscitation or monitoring (John P Magnan. 2014.  Umbilical Vein Catheterization. Medscape Reference . Accessed on 8 Jan. 2015.). Catheterization can be performed through either of the two arteries or the vein. Umbilical venous catheterization is most commonly performed for resuscitation and central venous measurement, while arterial catheterization is performed for arterial blood-gas measurements and intravascular delivery of medications (Taylor L Sawyer. 2013.  Umbilical Artery Catheterization. Medscape Reference . Accessed on 8 Jan. 2015.). An estimated 120,000 patients receive umbilical catheterizations each year at neonatal intensive care units (NICU) around the US (2012  National Statistics on Umbilical Vein Catheterizations.  2012.  U.S. Department of Health and Human Services: Healthcare Cost and Utilization Project.  Accessed on 8 Jan. 2015, 2012  National Statistics on Artery Catheterizations.  2012.  U.S. Department of Health and Human Services: Healthcare Cost and Utilization Project.  Accessed on 8 Jan., 2015.). The procedure is either performed immediately after the patient is brought into the ICU, or within a week of admission (because vessels remain patent for up to a week). A large number of these procedures are performed under emergency situations, particularly when resuscitation is required. 
         [0002]    Before beginning the procedure, the patient is placed supine. The procedure involves grasping the umbilical cord, identifying the necessary vessel, dilating the vessel, introducing a flexible catheter, and guiding it to the appropriate location for the intervention. Imaging is then performed (usually x-ray) to confirm placement. There are a number of complications associated with this procedure, however, the biggest concern with this procedure is the low success rate, which ranges from 48% to 88% (R. Haase, M. Hein, V. Thale, C. Vilser, N. Merkel. 2011.  Umbilical Venous Catheters—Analysis of Malpositioning over a  10- Year Period.  Z Geburtshilfe  Neonatol,  215 (1), 18-22, Vijay Gupta, Naresh Kumar, Atanu Kumar Jana, Niranjan Thomas. 2014.  A Modified Technique for Umbilical Arterial Catheterization. Indian Pediatrics,  51 (8), 672). Introducing the catheter into the vessel is a major contributor to the low success rate. Further, the procedure requires 1-2 assistants to aid with cord retraction to introduce the catheter. These assistants would also need to be sufficiently sterilized for the procedure. Therefore there appears to be a need for a method to introduce a catheter into the umbilical cord without additional assistance, and with a higher rate of success. Improving the success rate of umbilical catheterizations will save lives, reduce treatment costs due to extended resource utilization, and minimize the occurrence of lengthened patient stay caused by complications. 
       SUMMARY OF INVENTION 
       [0003]    The device is intended to allow a physician to prepare an umbilical cord by applying appropriate retraction and widening vessels (arteries and veins) to introduce the catheter. The device can be placed on the patient&#39;s abdomen, where it may or may not surround the umbilical cord. Once the device is placed, the umbilical cord can be retracted through a number of methods, all compatible with the device. This provides retraction as per the physician&#39;s requirements, without the need for any assistants. The device is indicated for use on neonates who require umbilical procedures, including but not limited to umbilical vascular catheterizations. The device is indicated for securing the umbilical cord during catheterization, and providing retraction. The device is also indicated for use in any facility where umbilical catheterizations are performed. The device is also indicated for use to retract other organs. 
         [0004]    The device has two main components: a base and arms that are attached to the base. In some embodiments, the arms include a refraction element that is attached to the umbilical cord. The tension in the retraction element can be adjusted to enable appropriate retraction. In some embodiments, the arms and base include a retraction device-securing element that can attach to an independent retraction device. This independent retraction device is then attached to the umbilical cord and enables appropriate retraction. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0005]    The device and methods described herein are further described in terms of preferred embodiments. These preferred embodiments are described in detail with reference to the drawings. These embodiments are non-limiting preferred embodiments, in which like reference numerals represent similar structures throughout the several views of the drawings, and wherein: 
           [0006]      FIG. 1A-C  depict isometric views of the first preferred embodiment of the present invention; 
           [0007]      FIG. 2  depicts independent retraction devices working with the first preferred embodiment of the present invention; 
           [0008]      FIG. 3A-B  depict isometric views of the second preferred embodiment of the present invention; 
           [0009]      FIG. 4  depicts independent retraction devices working with the second preferred embodiment of the present invention; 
           [0010]      FIG. 5  depicts an isometric view of the third preferred embodiment of the present invention; 
           [0011]      FIG. 6A-B  depict isometric views of bending arms of the third preferred embodiment of the present invention; 
           [0012]      FIG. 7A-B  depict independent retraction devices working with the third preferred embodiment of the present invention; 
           [0013]      FIG. 8A-C  depict isometric views of the fourth preferred embodiment of the present invention; 
           [0014]      FIG. 9  depicts independent retraction devices working with the fourth preferred embodiment of the present invention; 
           [0015]      FIG. 10  depicts the fifth preferred embodiment of the present invention; 
           [0016]      FIG. 11  depicts the fifth preferred embodiment of the present invention retracting the umbilical cord; 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0017]      FIG. 1A  is a general view of the first embodiment of the umbilical catheterization device  100 . The umbilical catheterization device  100  includes a base  105  to which a plurality of vertical arms  110  is attached. The vertical arms  110  afford the physician a plurality of retraction angles. The vertical arms  110  each comprise a proximal end  115  and distal end  120 , with the proximal end  115  connected to the base  105 . The vertical arms  110  further comprise a proximal surface  125  and distal surface  130  (see  FIG. 1C ), bound by the proximal end  115  and distal end  120 . The distal end  120  of the vertical arm  110  comprises the first retraction device-securing element  135 . The first retraction device-securing element  135  is an opening that extends from the proximal surface  125  to distal surface  130  of the vertical arm  110 . 
         [0018]    The first embodiment of the umbilical catheterization device  100  further includes a plurality of horizontal arms  140  which are attached to the base  105 . The horizontal arms  140  each comprise a proximal end  145  and distal end  150 , with the proximal end  145  of the horizontal arm  140  attached to the base  105 . The distal end  150  of the horizontal arm  140  comprises a second retraction device-securing element  155 . The second retraction device-securing element  155  comprises two vertical columns  160 , each with a proximal end  165  and distal end  170 . The proximal end  165  of the vertical column  160  is attached to the distal end  150  of the horizontal arm  140 . The second retraction device-securing element  155  further comprises a horizontal column  175 , which is attached at either end to the vertical columns  160  at their distal ends  170 . 
         [0019]      FIGS. 1B and 1C  show alternate views of the first preferred embodiment of the umbilical catheterization device as described in  FIG. 1 . 
         [0020]      FIG. 2  is a general view of the first embodiment of the umbilical catheterization device  100  as described in  FIG. 1 , working with an independent retraction device  180 . A proximal end  185  of the independent retraction device  180  may attach to an umbilical cord  190 , while a distal end  195  of the independent retraction device  180  may attach to the first retraction device-securing element  135 . Alternatively, the distal end  195  of the independent retraction device  180  may pass through the first retraction device-securing element  135  and may attach to the second retraction device-securing element  155 . The tension in the independent retraction device  180  may be adjusted to exert appropriate retraction on the umbilical cord  190 . 
         [0021]    The first retraction device-securing element  135  enables the physician to attach an independent retraction device  180  that would aid in retracting the umbilical cord  190 . The first retraction device-securing element  135  further enables the physician to pass the independent retraction device  180  though the vertical arm  110  in order to attach the independent retraction device  180  to the second retraction device-securing element  155 , thus increasing tension-induced retraction on the umbilical cord  190 . The first embodiment of the umbilical catheterization device  100  may be constructed from a number of materials, which include, but are not limited to, polymers, metals, and composites. In some embodiments, the umbilical catheterization device  100  comprises a mechanism to attach the base  105  to the patient, or to drapes applied on top of the patient. 
         [0022]    In some embodiments, the umbilical catheterization device  100  may be formed as one piece, for example, by injection molding, casting, or machining In some embodiments, the umbilical catheterization device  100  may be formed by assembly of multiple parts, each formed by, for example, injection molding, casting, or machining In some embodiments, the umbilical catheterization device  100  is a once used disposable device. In some embodiments, the umbilical catheterization device  100  may be sterilized and reused. 
         [0023]      FIG. 3A  is a general view of the second embodiment of the umbilical catheterization device  200 . The umbilical catheterization device  200  includes a base  205  to which a plurality of vertical arms  210  is attached. The vertical arms  210  afford the physician a plurality of retraction angles. The vertical arms  210  each comprise a proximal end  215  and distal end  220 , with the proximal end  215  connected to the base  205 . The vertical arms  210  further comprise a proximal surface  225  and distal surface  230 , bound by the proximal end  215  and distal end  220 . The distal end  220  of the vertical arm  210  comprises the first retraction device-securing element  235 . The first retraction device-securing element  235  is an opening that extends from the proximal surface  225  to distal surface  230  of the vertical arm  210 . 
         [0024]    The second embodiment of the umbilical catheterization device  200  further includes a second retraction device-securing element  240 . The second retraction device-securing element  240  is located on the distal surface  230  of the vertical arm  210 . The second retraction device-securing element  240  comprises a plurality of downward curving members  245 . The plurality of downward curving members  245  enable the physician to change the tension exerted. 
         [0025]      FIG. 3B  shows an alternate view of the second preferred embodiment of the umbilical catheterization device  200  as described in  FIG. 3A . 
         [0026]      FIG. 4  is a general view of the second embodiment of the umbilical catheterization device  200  as described in  FIG. 3A , working with an independent retraction device  250 . A proximal end  255  of the independent retraction device  250  may attach to an umbilical cord  260 , while a distal end  265  of the independent retraction device  250  may attach to the first retraction device-securing element  235 . Alternatively, the distal end  265  of the independent retraction device  250  may pass through the first retraction device-securing element  235  and may attach to the second refraction device-securing element  240 . The tension in the independent retraction device  250  may be adjusted to exert appropriate retraction on the umbilical cord  260 . 
         [0027]    The first retraction device-securing element  235  enables the physician to attach an independent retraction device  250  that would aid in refracting the umbilical cord  260 . The first retraction device-securing element  235  further enables the physician to pass the independent retraction device  250  though the vertical arm  210  in order to attach the independent retraction device  250  to the downward curving members  245 , thus increasing tension-induced retraction on the umbilical cord  260 . The second embodiment of the umbilical catheterization device  200  may be constructed from a number of materials, which include, but are not limited to, polymers, metals, and composites. 
         [0028]    In some embodiments, the umbilical catheterization device  200  may be formed as one piece, for example, by injection molding, casting, or machining In some embodiments, the umbilical catheterization device  200  may be formed by assembly of multiple parts, each formed by, for example, injection molding, casting, or machining In some embodiments, the umbilical catheterization device  200  is a once used disposable device. In some embodiments, the umbilical catheterization device  200  may be sterilized and reused. 
         [0029]      FIG. 5  is a general view of the third embodiment of the umbilical catheterization device  300 . The umbilical catheterization device  300  includes a base  305  to which a plurality of arms  310  is attached. The arms  310  afford the physician a plurality of retraction angles. The arms  310  each comprise a proximal end  315  and distal end  320 , with the proximal end  315  connected to the base  305 . The arms  310  further comprise a proximal surface  325  and distal surface  330  (see  FIG. 7B ), bound by the proximal end  315  and distal end  320 . The distal end  330  of the arm  310  comprises a retraction device-securing element  335 . The retraction device-securing element  335  is an opening that extends from the proximal surface  325  to distal surface  330  of the arm  310 . 
         [0030]      FIG. 6A-B  show a general view of the third embodiment of the umbilical catheterization device  300  as described in  FIG. 5 , with the arms  310  bent such that the retraction device-securing element  335  is raised above the base  305 . 
         [0031]      FIG. 7A  is a general view of the third embodiment of the umbilical catheterization device  300  as described in  FIG. 5 , working with an independent retraction device  340 . A proximal end  345  of the independent retraction device  340  may attach to an umbilical cord  350 , while a distal end  355  of the independent retraction device  340  may attach to the retraction device-securing element  335 . The arms  310  may be bent and/or adjusted to exert appropriate retraction on the umbilical cord  350 . 
         [0032]      FIG. 7B  is a general view of the third embodiment of the umbilical catheterization device  300  as described in  FIG. 5 , working with another type of independent retraction device  341 . A proximal end  346  of the independent retraction device  341  may attach to an umbilical cord  350 , while a distal end  356  of the independent retraction device  341  may attach to the retraction device-securing element  335 . The arms  310  may be bent and/or adjusted to exert appropriate retraction on the umbilical cord  350 . 
         [0033]    The retraction device-securing element  335  enables the physician to attach an independent retraction device  340  that would aid in retracting the umbilical cord  350 . The arms  310  normally lay flat, but may be raised or bent to apply tension to retract the umbilical cord  350 . The third embodiment of the umbilical catheterization device  300  may be constructed from a number of materials, which include, but are not limited to, polymers, metals, and composites. 
         [0034]    In some embodiments, the umbilical catheterization device  300  may be formed as one piece, for example, by injection molding, casting, or machining In some embodiments, the umbilical catheterization device  300  may be formed by assembly of multiple parts, each formed by, for example, injection molding, casting, or machining In some embodiments, the umbilical catheterization device  300  is a once used disposable device. In some embodiments, the umbilical catheterization device  300  may be sterilized and reused. 
         [0035]      FIG. 8A  is a general view of the fourth embodiment of the umbilical catheterization device  400 . The umbilical catheterization device  400  includes a base  405  to which a plurality of vertical arms  410  is attached. The vertical arms  410  afford the physician a plurality of retraction angles. The vertical arms  410  each comprise a proximal end  415  and distal end  420 , with the proximal end  415  connected to the base  405 . The vertical arms  410  further comprise a proximal surface  425  and distal surface  430 , bound by the proximal end  415  and distal end  420 . The distal end  420  of the vertical arm  410  comprises the first retraction device-securing element  435 . The first retraction device-securing element  435  is an opening that extends from the proximal surface  425  to distal surface  430  of the vertical arm  410 . 
         [0036]    The fourth embodiment of the umbilical catheterization device  400  further includes a second retraction device-securing element  440 . The second retraction device-securing element  440  comprises a shaft extending from the proximal surface  425  to distal surface  430  of a vertical arm  410 , with an opening towards the first retraction device-securing element  435 . 
         [0037]      FIG. 8B-C  show alternate views of the fourth preferred embodiment of the umbilical catheterization device  400  as described in  FIG. 8A . 
         [0038]      FIG. 9  is a general view of the fourth embodiment of the umbilical catheterization device  400  as described in  FIG. 8A , working with an independent retraction device  445 . The proximal end  450  of the independent retraction device  445  may attach to the umbilical cord  455 , while the distal end  460  of the independent retraction device  445  may attach to the first retraction device-securing element  435 . Alternatively, the distal end  460  of the independent retraction device  445  may pass through the first retraction device-securing element  435  and may be pulled down and secured within the second retraction device-securing element  440 . The tension in the independent retraction device  445  may be adjusted to exert appropriate refraction on the umbilical cord  455 . 
         [0039]    The first retraction device-securing element  435  enables the physician to secure an independent refraction device  445  that would aid in retracting the umbilical cord  455 . The first retraction device-securing element  435  further enables the physician to pass the independent retraction device  445  though the vertical arm  410  in order to pull down and secure the independent retraction device  445  within the second retraction device-securing element  440 , thus increasing tension-induced retraction on the umbilical cord  455 . The fourth embodiment of the umbilical catheterization device  400  may be constructed from a number of materials, which include, but are not limited to, polymers, metals, and composites. 
         [0040]    In some embodiments, the umbilical catheterization device  400  may be formed as one piece, for example, by injection molding, casting, or machining In some embodiments, the umbilical catheterization device  400  may be formed by assembly of multiple parts, each formed by, for example, injection molding, casting, or machining In some embodiments, the umbilical catheterization device  400  is a once used disposable device. In some embodiments, the umbilical catheterization device  400  may be sterilized and reused. 
         [0041]      FIG. 10  is a general view of the fifth embodiment of the umbilical catheterization device  500 . The fifth embodiment of the umbilical catheterization device  500  includes a base  505  to which a plurality of arms  510  is attached. The arms  510  afford the physician a plurality of retraction angles. The arms  510  each comprise a proximal end  515  and distal end  520 , with the proximal end  515  connected to the base  505 . The arms  510  further comprise a proximal surface  525  and distal surface  530 , bound by the proximal end  515  and distal end  520 . The distal end  520  of the arm  510  comprises a retraction device-securing element  535 . The retraction device-securing element  535  is an opening that extends from the proximal surface  525  to distal surface  530  (see  FIG. 11 ) of the arm  510 . 
         [0042]    The fifth embodiment of the umbilical catheterization device  500  further includes a retraction element  540 . The refraction element  540  comprises an integrated securement element, such as a hook  545  with a proximal end  550  (see  FIG. 11 ) and distal end  555  (see  FIG. 11 ). The proximal end  550  of the hook  545  is attached to the distal end  520  of the arm  510 . 
         [0043]      FIG. 11  is a general view of the fifth embodiment of the umbilical catheterization device  500  as described in  FIG. 10 . The arms  510  may be bent and/or adjusted such that the refraction element  540  is attached to the umbilical cord  560 , thus directly aiding in retraction of the umbilical cord  560 . 
         [0044]    The retraction device-securing element  535  enables the physician to attach an independent retraction device that would aid in retracting the umbilical cord  560 . The arms  510  may be raised or bent to apply tension to retract the umbilical cord  560 . Alternatively, the retraction element  540  may be attached to the umbilical cord  560  directly to enable retraction. The arms  510  normally lay flat, but may be raised or bent to apply tension to retract the umbilical cord  560 . The fifth embodiment of the umbilical catheterization device  500  may be constructed from a number of materials, which include, but are not limited to, polymers, metals, and composites. 
         [0045]    In some embodiments, the umbilical catheterization device  500  may be formed as one piece, for example, by injection molding, casting, or machining In some embodiments, the umbilical catheterization device  500  may be formed by assembly of multiple parts, each formed by, for example, injection molding, casting, or machining In some embodiments, the umbilical catheterization device  500  is a once used disposable device. In some embodiments, the umbilical catheterization device  500  may be sterilized and reused. 
       METHOD OF OPERATION 
       [0046]    The first embodiment of the umbilical catheterization device  100  may be used with other instruments currently employed to perform umbilical catheterizations. Prior to use, the patient is placed supine, and is appropriately sterilized. The umbilical cord  190  is cleaned, and appropriately prepared. Once the umbilical cord  190  has been prepared, the first embodiment of the umbilical catheterization device  100  is placed around the umbilical cord  190 , such that the umbilical cord  190  passes through the base  105  of the first embodiment of the umbilical catheterization device  100 . The first embodiment of the umbilical catheterization device  100  may adhere to the patient&#39;s skin through adhesives on the base  105 , or may be clamped to the cloth drapes placed around the umbilical cord  190  using standard surgical clamps. The first embodiment of the umbilical catheterization device  100  may also be secured to the patient&#39;s body through other means. The umbilical cord  190  should be cut at the required angle and height from abdomen, but this height should not exceed 2 cm, per current procedural guidelines. After bleeding has been controlled, the physician may choose the type of independent retraction device  180 . In the first embodiment of the umbilical catheterization device  100 , the proximal end  185  of the independent retraction device  180  may first be attached to the upper edge of the umbilical cord  190 . The distal end  195  of the independent retraction device  180  may then pass through the first retraction device-securing element  135 , and then may attach to the second retraction device-securing element  155 . Tension in the independent retraction device  180  may be altered as appropriate to induce required retraction on the umbilical cord  190 . Once the umbilical cord  190  has been held in place and retracted the required length and angle, the rest of the procedures involved in umbilical catheterization may be performed. 
         [0047]    The second embodiment of the umbilical catheterization device  200  has a similar method of operation as the first embodiment of the umbilical catheterization device  100 . After the proximal end  255  of the independent retraction device  250  is attached to the upper edge of the umbilical cord  260 , the distal end  265  of the independent retraction device  250  may then pass through the first retraction device-securing element  235 . The distal end  265  of the independent refraction device  250  may then attach to the downward curving members  245  on the second refraction device-securing element  240 . Tension in the independent retraction device  250  may be altered as appropriate to induce required retraction on the umbilical cord  260 , by, for example, selecting an appropriate one of the downward curving members  245 . 
         [0048]    The third embodiment of the umbilical catheterization device  300  has a similar method of operation as the first embodiment of the umbilical catheterization device  100 . Referring to  FIG. 7A  and  FIG. 7B , after the proximal end  345  or  346  of the independent retraction device  340  or  341  is attached to the upper edge of the umbilical cord  350 , the distal end  355  or  356  of the independent retraction device  340  or  341  may then attach to the retraction device-securing element  335 . The arms  310  may be bent and/or adjusted to exert appropriate retraction on the umbilical cord  350 . 
         [0049]    The fourth embodiment of the umbilical catheterization device  400  has a similar method of operation as the first embodiment of the umbilical catheterization device  100 . After the proximal end  450  of the independent retraction device  445  is attached to the upper edge of the umbilical cord  455 , the distal end  460  of the independent retraction device  445  may then pass through the first retraction device-securing element  435 . The distal end  460  of the independent retraction device  445  may then be pulled downwards to be secured within the second retraction device-securing element  440 . Tension in the independent retraction device  445  may be altered as appropriate to induce required retraction on the umbilical cord  455 . 
         [0050]    The fifth embodiment of the umbilical catheterization device  500  has the same method of operation as the first embodiment of the umbilical catheterization device  100 , with some modifications. After the umbilical cord  560  has been cut and prepared, the arm  510  may be bent and/or adjusted such that the retraction element  540  is attached to the umbilical cord  560 .