Abstract:
An abdominal tissue support for supporting excess abdominal adipose tissue away from the femoral crease to facilitate the maintenance of a sterile field for femoral puncture procedures. The abdominal tissue support may generally include a waist belt, at least one support apron affixed to the waist belt and a strap arrangement. The abdominal tissue support may also include a movable support apron slidable along the length of the waist belt. The strap arrangement may be securable at a patient&#39;s shoulders or to a fixture located near the patient&#39;s head.

Description:
FIELD OF THE INVENTION 
   The present invention relates generally to the field of maintaining a sterile field for surgical procedures. More particularly the invention relates to supporting parts of the body clear of the sterile field and the femoral crease while performing a femoral puncture procedure. 
   BACKGROUND OF THE INVENTION 
   Many medical procedures entail inserting a catheter into an artery to gain access to the body&#39;s vasculature to perform various medical or surgical procedures. A preferred location for accessing the femoral artery is at the femoral crease where the upper thigh joins the groin. In order to avoid introducing pathogenic microorganisms into the body&#39;s vasculature or blood stream, it is necessary to maintain a sterile field in the vicinity of the puncture that is made to access the femoral artery. 
   It is estimated that about forty million Americans are obese and an even larger number are overweight. Patient&#39;s that are obese are at higher risk of vascular disease including coronary artery disease as well as other health problems. An increasing number of patients that present for procedures that utilize a femoral puncture are overweight or obese. 
   Between five and fifteen percent of patients who present for femoral puncture procedures to insert a catheter are obese or overweight to the point that they have excess abdominal tissue that covers the artery access site. In order to gain access to the femoral artery at the femoral crease and to maintain a sterile field for the femoral puncture it is necessary that the excess abdominal tissue be repositioned away from the femoral crease. Current procedure in preparing the patient for femoral puncture calls for taping the excess abdominal tissue with surgical tape in an attempt to move it away from the femoral access site. Utilizing surgical tape to support the excess abdominal tissue requires preparing the skin for application of the tape. Preparation can include shaving hair from the skin in the areas where the tape must adhere to the body. When the procedure is completed the tape must be removed from the patient&#39;s body, which can be painful for the patient. Because the effectiveness of this approach will necessarily vary from patient to patient, the potential for the tape to give way during the surgical procedure is a significant problem. 
   Generally when there is excess abdominal tissue that must be moved away from the access site, two caregivers must work together to lift the excess tissue and apply the tape so as to allow access to the femoral artery. The requirement of two caregivers is inefficient and also requires that two care providers initially prepare the patient by taping the abdominal tissue and then proceed to scrub to maintain the sterile field. 
   An improved method and apparatus for supporting abdominal tissue away from the femoral puncture site will provide benefits to both the patient and the physician. 
   SUMMARY OF THE INVENTION 
   The abdominal tissue support of the invention solves many of the above discussed problems. The present invention generally includes a waist belt, at least one support apron affixed to one side of the waist belt, and a shoulder strap arrangement. Optionally the invention may include a second movable support apron, slideable along the length of the waist belt for positioning on the other side of the waist belt relative to the first support apron 
   In a preferred embodiment, the waist belt may be at least partially covered with a hook and loop fastener material such as Velcro® with the loop portion of the fastener material arranged to face the patient&#39;s skin for patient comfort. The first support apron is operably fixedly secured to the waist belt and the waist belt extends through a sleeve formed at the bottom of the movable support apron. The exterior of the waist belt may be at least partially covered with a hook material of the hook and loop fastener to engage and attach to the loop portion of the hook and loop fastener on the interior of the waist belt. 
   In one embodiment, the first support apron is secured to a first end of the waist belt such as by stitching. The first support apron may be substantially triangular in shape and may include a vertical strap and a diagonal strap that provides additional structural support generally proximate a lower and outer portion. The first support apron may include a fabric apron portion, which fills in the space between the vertical strap, the diagonal strap and the waist belt. Alternately, the space enclosed by the vertical strap, the diagonal strap and the waist belt may be left open or may be partially filled with mesh or a matrix of straps. The first support apron preferably includes a shoulder strap extending upwardly and away from the first support apron. The shoulder strap may be an extension of the vertical strap and may be formed from a hook and loop fastener type material such as Velcro®. The shoulder strap may be adapted to support the waist belt by passing over the patient&#39;s shoulder or neck or may be adapted to be secured to a fixture that is mounted on a procedure table in the vicinity of the patient&#39;s head or at another convenient location within the procedure suite. 
   The movable support apron, if present, is slideably secured to the waist belt such as by a sleeve located along the bottom edge of the movable support apron. The movable support apron may include a vertical strap and a diagonal strap generally proximate a lower and outer portion and may be substantially triangular in shape with the sides of the triangle being generally formed by the sleeve, the vertical strap, and the diagonal strap. The movable support apron may include a fabric filling in the space surrounded by the vertical strap and the diagonal strap and the sleeve or may be partially filled or may be left open. The movable support apron may include a pad of hook fastener material in the vicinity of the meeting of the vertical strap and the diagonal strap. 
   The shoulder strap, which extends upwardly from the first support apron and may be an extension of the vertical strap of the first support apron, preferably is formed of a loop portion of a hook and loop fastener material and is adapted to interconnect with the hook material pad on the movable support apron. 
   The first support apron and the movable support apron may be formed of a non-woven fabric. It is preferred that the fabric used to form the first support apron and movable support apron be a non-shedding fabric with limited stretch that does not produce significant lint fibers and/or other particulate matter that may interfere with the maintenance of a sterile surgical field. The fabric used to form first support apron and movable support apron may be an inexpensive or biodegradable fabric in order to allow for disposable use of the abdominal tissue support. The abdominal tissue support is primarily intended for use on a patient who is positioned supine, typically on a surgical table. 
   In operation, the abdominal tissue support is preferably placed on the table prior to the patient being positioned on the table, with the waist belt disconnected and the movable support apron positioned to one side of the patient while the first support apron is positioned to the other side of the patient. Once the patient is positioned supine, lying on top of the waist belt with the first support apron on one side and the movable support apron on the other side. The waist belt is wrapped around the patient as low on the abdomen as possible, in the vicinity of the femoral crease. The waist belt may then be secured to the first support apron and to itself by engagement of the pads of hook and loop fastener material for example. The hook and loop fastener material may extend a substantial distance along the waist belt in order to provide a secure attachment, even if a large amount of tissue is to be supported as well as to allow adjustability. 
   The first support apron preferably should be positioned so as to be above one thigh of the patient. The movable support apron can then be slid along the waist belt to position it above the other thigh of the patient. The shoulder strap is then placed under tension and routed up over the patient&#39;s torso and over one of the patient&#39;s shoulders. In this embodiment, the route of the shoulder strap continues down diagonally across the back and out under one of the patient&#39;s armpits and is then extended to be attached to the hook material pad on the movable support apron. Alternately, the shoulder strap may be attached to a fixture located near the head of the patient. The shoulder strap and the movable support apron are both placed under tension in a direction upward and away from the femoral crease in order to lift the excess abdominal tissue away from the femoral crease. Once the first support apron and the movable support apron are in the desired position, supporting the excess abdominal tissue away from the femoral crease, the shoulder strap is secured relative to the movable support apron so that the excess abdominal tissue is held up and away from the femoral crease to allow access for the femoral puncture. The location of the shoulder strap attachment may be on the movable support apron as well and the location of the hook pad for attaching the shoulder strap, for example, may be reversed to be on the first support apron if desired. 
   Once the femoral puncture procedure is completed, the shoulder strap may be released from its attachment on the movable support apron. The waist belt may be released and the surgical tissue support may be discarded. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a plan view of a surgical tissue support in accordance with the present invention viewed from the inside; 
       FIG. 2  is a plan view of the surgical tissue support viewed from the outside 
       FIG. 3  is a perspective view of a first step of the application of a surgical tissue support to a patient in accordance with the present invention; 
       FIG. 4  is a perspective view of a second step of the application of the surgical tissue support to a patient; 
       FIG. 5  is a perspective view of a third step of the application of the surgical tissue support to a patient; 
       FIG. 6  is a perspective view of a fourth step of the application of the surgical tissue support to a patient; 
       FIG. 7  is a perspective view of a surgical tissue support in accordance with the present invention with a waist belt and a shoulder strap arrangement coiled and not connected; and 
       FIG. 8  is a perspective view of a surgical tissue support with the waist belt and shoulder strap arrangement extended and attached as they would be when applied to a patient. 
   

   DETAILED DESCRIPTION OF THE INVENTION 
   Referring to  FIGS. 1 ,  2 ,  7  and  8 , the abdominal tissue support  10  of the present invention generally includes waist belt  12 , first support apron  14 , optional second movable support apron  16 , and shoulder strap  18 . 
   Waist belt  12  generally includes secured end  20  and free end  22 . Secured end  20  is operably secured to first support apron  14  such as by stitching, adhesive, fusing, riveting, stapling or other methods known to those skilled in the art. Waist belt  12  is preferably formed of a flexible stretch resistant material, such as fabric, that includes the hook portion of a hook and loop type fastener. In an exemplary embodiment, waist belt  12  may have a width of approximately five centimeters and a length of approximately two meters. The width and length of waist belt  12  may be adjusted as necessary to accommodate patients of different sizes. 
   In a preferred embodiment, first support apron  14  is secured to waist belt  12  such as by stitching, fusing or adhesives. First support apron  14  may be a substantially triangular structure. Waist belt  12  has a front side  24  and a back side  26 . For the purposes of this application, front side  24  will be defined as the side of abdominal tissue support  10  that faces away from the patient&#39;s skin and back side  26  will be defined as the side of abdominal tissue support  10  that makes contact with the patient&#39;s skin. Throughout this application hook and loop fasteners will be described as preferred embodiments for making operably releasable connections between the various parts of abdominal tissue support  10 . It is to be understood that hook and loop fasteners may be replaced with buckles, snaps, adhesives or other forms of operably releasable connecting apparatus known to those skilled in the art and that this disclosure is intended to cover those types of operably releasable connecting apparatus as well as hook and loop fasteners. In addition, non-releasable fasteners such as adhesive may be utilized in which case the abdominal tissue support may be cut to release it from the patient for removal. 
   In one embodiment, fixed apron  14  includes waist belt portion  28 , vertical strap  30 , and diagonal strap  32 . Optionally first support apron  14  may include fabric panel  34 . If present, fabric panel  34  joins waist belt portion  28  to vertical strap  30  and diagonal strap  32  filling in the opening therebetween. First support apron  14  may also be secured to shoulder strap  18 . Shoulder strap  18  may be an extension of vertical strap  30  or diagonal strap  32 . Shoulder strap  18  may be secured in the vicinity where vertical strap  30  meets diagonal strap  32 . Alternately shoulder strap  18  may be secured to movable support apron  16  and be detachably securable to first support apron  14  or detachably secured to both movable support apron  16  and first support apron  14 . 
   Movable support apron  16  generally includes waist belt sleeve  36 , vertical strap  38  and diagonal strap  40 . Optionally, movable support apron  16  includes fabric panel  42  which occupies the space between waist belt sleeve  36 , vertical strap  38  and diagonal strap  40 . On front side  24 , movable support apron  16  may include shoulder strap securement  44 . Shoulder strap securement  44  may take the form of a hook and loop fastening material, a buckle, adhesive or other device for securing shoulder strap  18  to movable support apron  16 . Shoulder strap securement  44  may include shoulder strap pad  46  formed of hook and loop material. Shoulder strap securement  44  is desirably located in the area where vertical strap  38  joins diagonal strap  40 . 
   On the back side  26  of movable support apron  16  is waist belt pad  48 . Waist belt pad  48  may be formed of the loop side of hook and loop material or adhesive or other material for securing waist belt sleeve  36  to waist belt  12 . Waist belt sleeve  36  may include an extended portion  50 . Extended portion  50  may extend behind waist belt  12  and have on its back side  26 , waist belt pad  48 . 
   Waist belt portion  28  of first support apron  14  may include hook securement portion  52 . Hook securement portion  52  may be formed of a hook portion of a hook and loop type fastener and be adapted to receive waist belt pad  48  or hook and loop material secured to waist belt  12 . 
   In a preferred mode of operation, depicted in  FIGS. 3-6  abdominal tissue support  10  is placed on a procedure table so that waist belt  12  crosses the operating table and first support apron  14  is draped over one side of the operating table while movable support apron  16  is draped over the opposite side of the operating table. A patient is then placed on the procedure table, as depicted in  FIG. 3 , so that the patient is in a supine posture with waist belt  12  behind the patient&#39;s back at about the waist. Waist belt  12  is then adjusted in position, as depicted in  FIG. 4 , so that first support apron  14  is on the patient&#39;s abdomen just above the femoral crease and movable support apron  16  is on the patient&#39;s abdomen on the other side of the body just above the femoral crease. Referring to  FIG. 5 , waist belt  12  is secured about the patient snuggly by applying the hook and loop fastener material on waist belt  12  to hook and loop fastener material in the vicinity of waist belt portion  28  on first support apron  14 . 
   Alternately, abdominal tissue support  10  may be applied to patient while the patient is standing and then adjusted before or after the patient assumes a reclining posture on a procedure table. 
   Tension is then applied to shoulder strap  18  to lift excess tissue supported by first support apron  14 . Tension is applied on shoulder strap  18  substantially in the direction of the patient&#39;s head. Shoulder strap  18  is then routed over the ipsalateral shoulder to first support apron  14  around the back and emerges beneath the contralateral arm of the patient, as depicted in  FIG. 6 . Alternately, shoulder strap  18  is secured to a fixture near the patient&#39;s head. Shoulder strap  18  is further routed to shoulder strap securement  44  on movable support apron  16 . Tension is applied to movable support apron  16  in the direction of the patient&#39;s head to lift excess tissue away from the femoral crease. Shoulder strap  18  is then secured to shoulder strap securement  44  to support excess tissue via first support apron  14  and movable support apron  16  to provide access to the femoral crease with a femoral puncture procedure. 
   Once the femoral puncture procedure is completed, abdominal tissue support  10  may be removed and discarded. 
   The present invention may be embodied in other specific forms without departing from the central attributes thereof, therefore, the illustrated embodiment should be considered in all respects as illustrative and not restrictive, reference being made to the appended claims rather than the foregoing description to indicate the scope of the invention.