Patent Publication Number: US-2017348477-A1

Title: Container for enclosing a medical device

Description:
TECHNICAL FIELD 
     The present invention relates to a container for enclosing a medical device, and more specifically, and in a first form of the invention, to a single-use flexible container which impedes, or substantially prevents unauthorized access and potential tampering with the medical device which is enclosed as a patient undergoes a clinician directed, and supervised medical treatment, and/or inhibits dust, debris and other biological contamination from coming into contact with the medical device during a treatment regimen. 
     BACKGROUND OF THE INVENTION 
     Those skilled in the art will recognize that assorted clinician directed medical procedures include, as a part of a given treatment plan, the introduction of various medicines, and fluids by means of vascular infusion. In order to accomplish this treatment, assorted vascular infusion systems have been developed, over time. It should be understood that an infusion system is the process by which an infusion device, and associated disposables (Vascular Access Devices (VAD&#39;s)), are used to deliver fluids or drugs, in solution, to a patient by intravenous subcutaneous, epidural, or enternal routes. Such vascular infusion systems for the delivery of these fluids or other medicines may include monitors, controllers, syringe driver/pumps, general-purpose/volumetric pumps, PCA pumps, ambulatory pumps, and the like. Still further these vascular infusion systems also cooperate with tubing of various lengths and diameters; filters; taps; anti-siphon and free-flow prevention valves; clamps; and catheters of assorted designs, and which are used and matched to the infusion system which has been selected by skilled medical personnel. 
     For example, a peripherally inserted central catheter [PICC or PIC catheter] is a form of vascular access device that can be used for a prolonged period of time such as for chemotherapy regimens, extended antibiotic treatment or total parenteral nutrition. Such catheters can also be used for the administration of substance that should not be done peripherally. This particular catheter enters the body through the skin at a peripheral site, and extends to the superior vena cava, and stays in place for days or even sometimes weeks. PIC lines or catheters often are coupled in fluid receiving relation relative to a PICC hub and which allows a clinician to gain access to the PIC line or catheter to introduce various fluids at given time intervals during the treatment regimen which has been selected. Other designs of VAD are, of course, available. 
     As of late, many clinicians have noted an increase in the number of incidents within a clinical or treatment setting where a patient, or individuals acquainted with a patient have gained improper and unauthorized access to a Vascular Access Device for purposes of trying to introduce or inject unauthorized substances through the VAD into the vascular system of the patient being treated. Sometimes the motivation underlying the unauthorized access is due, in part, to the mental state of the patient undergoing treatment. On other occasions, the motivation for the unauthorized access is for other nefarious purposes. Apart from the aforementioned patient population, other patient groups such as home health patients; pediatric; hemodialysis; psychiatric; and patients in extended care facilities could benefit from a product which would prevent access or contamination to a medical device being utilized. While clinicians, and their support staff often closely monitor patients undergoing infusion or other medical therapies to prevent such unauthorized access, or unintended contamination, indeed, such unauthorized access and contamination does, unfortunately, occur, and the results of introducing unauthorized fluids (whether liquid or gas) through a VAD may result in infections or other serious medical conditions from developing and which may lead even to the death of the patient. 
     While attempts have been made by treating clinicians, healthcare workers, clinics and hospitals to educate both patients and other care givers regarding the dangers associated with tampering with VADs and related peripherals, such as PIC lines or catheters and PICC hubs, the problem has persisted. On the one hand, patients undergoing such therapies usually need some privacy while such therapies are conducted. However, this privacy often contributes to the undetected and unauthorized access and sometimes inadvertent contamination of these VAD assemblies. Moreover, in view of possible medical exigencies, clinicians must have ready access to both the infusion equipment, and the peripherals, in the event that emergency medical treatment must take place. In addition to the foregoing, and in light of the possible serious health consequences which may result from tampering with, or contamination of an infusion system, any inappropriately effected VAD warrants immediate attention, and intervention as soon as any tampering or contamination has been detected. 
     Consequently, those skilled in this art field have sought after a means for both inhibiting the unauthorized access to and contamination of VADs, and which further provides a means for quickly identifying when possible tampering and/or contamination has taken place, so that immediate medical intervention may be employed to prevent serious harm from happening to the patient undergoing therapy. Therefore, a means which achieves the objectives, noted above, is the subject matter of the present invention. 
     SUMMARY OF THE INVENTION 
     A first aspect of the present invention relates to a container for enclosing a medical device, and which includes a flexible sheet which is defined by opposite first and second sides, and a peripheral edge, and wherein the flexible sheet is sized so that it may be received about, and substantially completely encloses a medical device; an adhesive layer is deposited on one of the first or second sides of the flexible sheet, and in a narrow zone which is oriented near the peripheral edge of the flexible sheet, and wherein the adhesive layer is employed to adhere to one side of the flexible sheet so as to maintain the flexible sheet in an orientation where the flexible sheet completely encloses the medical device; and an adhesive layer release sheet is provided, and which is located in covering relation relative to the adhesive layer when the flexible sheet is not enclosing the medical device. 
     Still another aspect of the present invention relates to a container for enclosing a medical device and which includes a flexible, and at least partially transparent sheet which is defined by a first surface; an opposite, second surface; and a peripheral edge, and wherein the flexible sheet is sized so that when the flexible sheet is folded, at least in part onto itself, the folded, flexible sheet forms a cavity which receives, and encloses a medical device; a zone of adhesive deposited in a region of the second surface of the flexible sheet and which is adjacent to the peripheral edge thereof, and wherein the zone of adhesive is effective in adhesively securing a first portion of the second surface of the flexible sheet, to a second portion of the second surface when the flexible sheet is folded so as to form the cavity and which encloses the medical device, and wherein the zone of adhesive is located along the entire length of the peripheral edge so that the resulting cavity is substantially inaccessible once the medical device is received within the cavity; and an adhesive release sheet which is located in covering relation relative to the zone of adhesive and which is removed prior to the folding of the flexible sheet to form the cavity. 
     These and other aspects and forms of the present invention will be discussed in greater detail hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Preferred embodiments of the invention are described below with reference to the following accompanied drawings. 
         FIG. 1  is a perspective, environmental view of a portion of a typical infusion arrangement and which is employed to deliver a source of a fluid to a patient undergoing medical treatment. 
         FIG. 2  is a greatly enlarged, partial view of an infusion system utilizing Vascular Access Devices (VADs) which are coupled in fluid delivering relation relative to a line or tube which is inserted into a patient. 
         FIG. 3  is a graphical depiction of a PIC line or catheter which is coupled in fluid receiving relation relative to three PICC hubs which are coupled to same. The three PICC hubs, as illustrated, represent one type of medical device (VAD) which may be enclosed within the container for enclosing a medical device of the present invention. 
         FIG. 4  is a graphical depiction of a flexible sheet which forms a feature of the present invention, and wherein an adhesive layer release sheet is being removed from same to expose an adhesive layer which is located therebeneath. 
         FIG. 5  is a graphical depiction of one form of the present invention and which is now ready to enclose a medical device in a manner as seen in  FIG. 4 . 
         FIG. 6  is a plan view of still another form of the present invention and which displays a pull tab to assist in the opening of the container as described. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     This disclosure of the invention is submitted in furtherance of the constitutional purposes of the U.S. Patent Laws “to promote the progress of science and useful arts” (Article 1, Section 8). 
     One possible form of the present invention is generally indicated by the numeral  10 , and is best understood by a study of  FIGS. 3, 4 and 5  respectively. As best understood by a study of the environmental view of  FIG. 1 , the present invention  10 , as seen in  FIG. 3 , is useful when used for enclosing medical devices or peripheral features which are typically utilized in a general vascular infusion arrangement which is indicated by the numeral  11 . These vascular infusion arrangements  11  are well known, and often include the use of several individual infusion pumps  12  which can supply various fluids, and other medicines, and which further can then be delivered in a vascular manner to a patient, not shown. The individual infusion pumps  12  ( FIGS. 1 and 2 ) are coupled to an infusion given pathway which is generally indicated by the numeral  13 . The infusion given pathway  13  often includes tubing  14  which is then coupled in fluid flowing relation relative to a line or tube, and which is then inserted into the patient. One type of a Vascular Access Device (VAD) is a PIC line or catheter  15  as seen in  FIG. 3 . In this type of VAD the PIC line  15  is coupled in fluid flowing relation relative to a multiplicity of PICC hubs  16  as seen in  FIG. 3 . The respective PICC hubs  16  are well known, and their operation does not need to be described in the present application. However, those skilled in the art will recognize that a multiplicity of PICC hubs or other VADs may be utilized based upon the type of medical treatment or regimen that the patient is currently undergoing. 
     As was discussed earlier in this patent application, as of late, treating clinicians, and other healthcare workers have witnessed or otherwise experienced an increase in the number of incidents where tampering or other inadvertent contamination of VADs has been detected. To inhibit the tampering that has sometimes been detected or reported, and also to prevent potential serious health problems from arising with the patient from ambient contamination, the present invention  10  has been conceived. 
     Referring now to  FIGS. 3-5 , one possible form of a container  10  for enclosing a medical device  16 , such as a PICC hub  16 , is seen in these drawings. In this regard, the container  10  for enclosing a medical device is formed of a flexible, fluid impervious sheet  20  which is typically fabricated from a synthetic polymer having a thickness dimension of typically less than about 1 mm. The flexible sheet  20  as seen in these drawings is depicted as having a square, or rectangular shape, but the main body  21  may have different shapes including circular ( FIG. 6 ), oval and other irregular shapes depending upon the type, size, and shape of the medical device  16  which the flexible container  10  will enclose. The main body  21  of the flexible sheet  20  is at least, in part, transparent or translucent so that once the flexible container  10  is appropriately positioned or deployed to enclose a medical device  16 , a clinician or caregiver, not shown, can continue to view the medical device in the event that the medical device malfunctions or some other situation or event occurs which requires immediate clinician intervention. The flexible sheet  20  is usually fabricated of a material which will permit a user to write on the exterior or first surface as will be described, below. This will permit a clinician, for example, to make appropriate notes regarding when the flexible container was put into place, and by whom. The flexible sheet  20  is defined, in part, by a peripheral edge  22 . Still further, the flexible sheet  20  has a first surface or side  23 , and an opposite or second surface or side  24 . As illustrated in the drawings, and in one form of the invention, the flexible sheet  20  may be formed in a fashion where it has a preexisting or otherwise previously established medial fold line  25  which is formed therein. The medial fold line permits the flexible sheet to be easily folded, upon itself, in the manner which will be discussed, below. The medial fold line divides the second surface or side  24  into a first portion  26 , and a second portion  27 . This feature will also be discussed in greater detail in the paragraphs which follow. Still further the flexible sheet as seen in  FIG. 5 or 6  typically includes a weakened region, or area, which is generally indicated by the numeral  28 . The weakened region, as seen in the drawings is illustrated as being a scored line  29  which will allow a clinician or other attending and authorized healthcare worker to apply force in order to tear or otherwise rend open the container  10  when it is properly installed ( FIG. 3 ) so as to gain access to the medical device  16 , for appropriate medical purposes. In one form of the invention, this tearing or rending of the container  10  can be achieved by means of a pull tab  30  which is seen in  FIG. 6 . The pull tab  30 , as illustrated, extends circumferentially, outwardly relative to the peripheral edge  22 . By exerting a force on the pull tab  30  the scored line  29  separates to open the container  10 . This feature makes the present invention particularly useful when a gloved healthcare worker needs to have rapid access to the medical device  16  which is enclosed within the container. 
     As seen in the drawings ( FIGS. 5 and 6 ), the flexible sheet  20  includes an adhesive layer  40  which is applied to the second side or surface  24 . The adhesive layer  40  is applied in a narrow adhesive zone  41  which is located adjacent to the peripheral edge  22 . As depicted therein, the zone of adhesive  41  extends along the entire length of the peripheral edge  22 . However, in some forms of the invention, the adhesive zone may extend along only a portion of the length of the peripheral edge  22 . The adhesive layer  40  has a top surface  42  which when exposed, and placed in contact with either the main body  21  of the flexible sheet  20 , or with another portion of the zone of adhesive, creates a very strong adhesive bond which typically cannot be separated from the flexible sheet. The adhesive strength is selected so that the amount of force that would be applied to open the container  10  causes a distortion or tears the flexible sheet  20 . This adhesive is selected to be this strong so that any attempt to tamper with the medical device by applying force to the container  10  will cause such distortion to the flexible sheet that a clinician can easily visually detect the tampering attempt, and then can take immediate action. The top surface  42  of the adhesive layer  40  is initially covered with an adhesive layer release sheet  50 , ( FIG. 4 ) which covers the top surface  42  so that the flexible sheet  20  can be moved about in a clinical setting, prior to installation, without the flexible sheet adhering to other surfaces. When the flexible container  10  is installed to enclose the medical device  16  ( FIG. 3 ), the adhesive layer release sheet  50  is first removed ( FIG. 4 ) from the adhesive layer  40 , and thereafter, the flexible sheet  20  is folded or otherwise received about and substantially completely encloses the medical device  16  ( FIG. 3 ). 
     In another form of the invention, not shown, the container may take on the form of a rigid, transparent clam shell arrangement which can be folded onto itself to form an interior cavity  60  and which is sized so as to enclose the medical device  16  as seen in  FIG. 3 . In this other form of the invention the container  10  may be closed by means of the adhesive layer  40 , as earlier described, or by other well-known means including by a lock which is made integral with the container. 
     Operation 
     The operation of the described embodiment of the present invention is believed to be readily apparent, and is briefly summarized at this point. In its broadest aspect, the present invention relates to a container  10  for enclosing a medical device  16 , and which is formed of a flexible sheet  20  which is defined by opposite first and second sides  23  and  24 , respectively, and which has a peripheral edge  22 . The flexible sheet  20  is sized so that it may be received about, and substantially completely encloses the medical device  16 . The present invention further includes an adhesive layer  40  which is deposited on one of the first or second sides  23  and  24 , respectively, of the flexible sheet  20 , and in a narrow zone  41  which is oriented near the peripheral edge  22  of the flexible sheet  20 . The adhesive layer  40  is employed to adhere to one side of the flexible sheet  20  so as to maintain the flexible sheet  20  in an orientation where the flexible sheet completely encloses the medical device  16 . The present invention  10  further includes an adhesive layer release sheet  50  which is located in covering relation relative to the adhesive layer  40  when the flexible sheet  20  is not enclosing the medical device  16 . 
     In one form of the invention as seen in the drawings, the container  10  is fabricated of a synthetic substrate, and wherein the flexible sheet  20  is at least partially transparent. Still further, the flexible sheet  20 , in one form of the invention, may be weakened  28 , so as to facilitate an opening of the container by an application of a predetermined amount of physical force. Still further, the weakened region  28  of the flexible sheet may be defined, in one form of the invention, by a scored line  29 . In one form of the invention, as depicted, the adhesive layer  40  has an adhesive strength which resists separation from the flexible sheet  20  to such a degree that the flexible sheet  20  is visibly distorted when force is applied to open same. In the arrangement as seen in the drawings the flexible container  10  of the present invention is a single-use container. Still further, the flexible sheet  20  is substantially fluid impervious. As illustrated in the drawings the container encloses a medical device  16  which, in the form of the invention, as illustrated, permits selective vascular access to an individual undergoing a clinician&#39;s supervised medical treatment. As noted earlier, the container  10  may also be useful in inhibiting contamination of the medical device  16  from sources which come from the immediate ambient environment. Further, and as seen in the drawings, the flexible container  10 , and the medical device  16  may include at least one VAD  16  which is coupled in fluid flowing relation relative to a catheter line or tube  15 . As earlier discussed, the distortion and tearing of the flexible sheet  20  which forms the container  10  indicates a potential tampering with the medical device  16  which is enclosed within the flexible container  10 . 
     More specifically, the present invention relates to a container  10  for enclosing a medical device  16 , and which includes in one form, a flexible, and at least partially transparent sheet  20  which is defined by a first surface  23 ; an opposite second surface  24 ; and a peripheral edge  22 , and wherein the flexible sheet  20  is sized so that when the flexible sheet  20  is folded, at least in part, onto itself the folded flexible sheet  20  forms a cavity  60  which receives an enclosed medical device  16 . The container  10  includes a zone of adhesive  41  which is deposited in a region of the second surface  24  of the flexible sheet  20 , and which is located adjacent to the peripheral edge  22  thereof. The zone of adhesive  41  is effective in adhesively securing a first portion  26  of the second surface  24  of the flexible sheet  20  to a second portion  27  of the second surface  24  when the flexible sheet  20  is folded, so as to form a cavity  60 . The cavity  60  encloses the medical device  16 . The zone of adhesive  41  is located along the entire length of the peripheral edge  22  so that the resulting cavity  60  is substantially inaccessible once the medical device is received within the cavity  60 . An adhesive release sheet  50  is provided, and which is located in covering relation relative to the zone of adhesive  41 , and which is removed prior to the folding of the flexible sheet to form the cavity  60  ( FIG. 4 ). 
     Again, as was previously discussed, the flexible sheet is weakened  28 , so as to facilitate an opening of the container  10  by an application of a predetermined amount of physical force. This force can be transmitted to the weakened region  28  by means of the pull tab  30  as seen in  FIG. 6 . Because of its single-use nature, clinicians can readily visually determine whether unauthorized individuals have attempted to tamper with the medical device  16  which is enclosed in the cavity  60 . 
     Therefore, it will be seen that the present invention provides an easy and convenient means whereby a clinician can secure a medical device  16  against tampering or unauthorized access, and further provides a means whereby unintended contamination may be avoided. The present invention, when utilized properly, impedes possible blood infections or other health hazards, and can further prevent the unauthorized access to a medical device as described earlier in this application. 
     In compliance with the statute the invention has been described in language more or less specific as to structural and methodological features. It is to be understood, however, that the invention is not limited to the specific features shown and described since the means herein disclosed comprise the preferred forms of putting the invention into effect. The invention is therefore claimed in any of its forms or modifications within the proper scope of the appended Claims appropriately interpreted in accordance with the Doctrine of Equivalents.