Abstract:
The present invention relates to a family of medical device packages designed and fabricated to provide instantaneous recognition as to the source and origin of a sterilized medical device stored therein and for passively retaining said medical device and related items in a desired manually accessible location within the package. The invention provides apparatus and methods for safely transporting, storing, identifying source and origin of, opening, packing and unpacking, evenly balanced packages containing sterilized implantable medical devices (IMDs). The packages and methods of the invention also are designed with features and structures that efficiently enhance the mechanical stability of one or more of the packages when stored in inventory at a clinic, in transport, and on an initial packaging site, and promote ease of handling and complement implant procedure efficiency in the operating room.

Description:
FIELD OF THE INVENTION  
       [0001]     The invention relates to a family of medical device packages designed and fabricated to provide instantaneous recognition as to the source and origin of a sterilized medical device stored therein and for passively retaining said medical device and related items in a desired manually accessible location within the package.  
       BACKGROUND OF THE INVENTION  
       [0002]     Containers designed for storing and transporting medical devices and surgical equipment are well known in the art. Generally, these types of containers include a container and a cover with sufficient volume to hold medical devices and components securely.  
         [0003]     One of the general requirements for medical device containers is the need to maintain physical protection for a sterilized device package. Specifically, the primary features of most sterilized medical device packages are to provide protection and maintain sterility of the device until final delivery to an operating room.  
         [0004]     Due at least in part to the proliferation of diverse device devices a wide variety of different medical device packages populate the inventory of many hospitals and clinics. The different packages must be stored in a readily accessible manner but currently popular so-called ergonomic (or non-prismatic) shaped packages do not easily stack together and a clinician must oftentimes physically remove a package in order to determine the features and the model of the device and/or the manufacturer of the device. In addition, once a prior art package is opened the package does not typically provide a stable platform for the package or the device itself.  
         [0005]     There is, therefore, a need to provide apparatus and methods for safely transporting, storing, identifying source and origin of, and opening and utilizing stable, well-balanced packages containing sterilized implantable medical devices (IMDs), with features and structures that efficiently enhance the mechanical stability of one or more of the packages when stored in inventory at a clinic, in transport, and on an initial packaging site, promote ease of handling and complement implant procedure efficiency in the operating room.  
       SUMMARY OF THE INVENTION  
       [0006]     The present invention relates to a family of medical device packages designed and fabricated to provide instantaneous recognition as to the source and origin of a sterilized medical device stored therein and for passively retaining said medical device and related items in a desired manually accessible location within the package. The invention provides apparatus and methods for safely transporting, storing, identifying source and origin of, opening, packing and unpacking, evenly balanced packages containing sterilized implantable medical devices (IMDs). While diverse IMDs can be securely conveyed within the inventive package, without limitation, the inventive package can be used for implantable pulse generators, implantable cardioverter-defibrillators, drug pumps, neurological, muscle and deep-brain stimulation devices, medical electrical leads, stents, and the like. The packages and methods of the invention also are designed with features and structures that efficiently enhance the mechanical stability of one or more of the packages when stored in inventory at a clinic, in transport, and on an initial packaging site, and promote ease of handling and complement implant procedure efficiency in the operating room.  
         [0007]     In addition, the inventive packaging optionally includes package tracking features including wireless resonant antenna, g-force data logging and/or impingement of forces that exceed a predetermined threshold (e.g., using a uni- or multi-axis accelerometer or the like), optically encoded device information (e.g., universal product code), and/or automated shelf-life indicating means (e.g., a tactile, visual, and/or auditory signal or flag) that either automatically operate upon initial product release, during a given prescribed shelf-life, or following expiration of the prescribed shelf-life and/or intermittently indicates shelf-life status when the IMD package is handled or moved.  
         [0008]     The package optionally includes apertures to enable a gradual but continuous release of sterilization gas residues and provide for equalization of pressure during, for example, a pressure excursion encountered during transit.  
         [0009]     The apertures provide an exit for gases such as ethylene oxide, hydrogen peroxide or the like that might otherwise accumulate in the interior of the package which could render the package and the IMD unacceptable in certain jurisdictions with strict emission standards.  
         [0010]     The package optionally includes one or more security seal members or structures that indicates that the package has been opened for the first time, thus providing visible proof if the package was tampered with, opened, or otherwise possibly compromised. One type of member includes a short segment or segments of adhesive tape (e.g., fabricated from PVC or other more environmentally friendly materials). Another type of member includes a dual purpose package wrap covering all or a portion of exposed surfaces of the package and optionally including one or decorative source-identifying symbols, logos, trademarks and the like.  
         [0011]     While multiple embodiments of the present invention are described, depicted, and claimed herein still other embodiments of the invention will become apparent to those skilled in the art following review of the instant patent document. All such embodiments are intended to be expressly covered hereunder. Also the invention can be modified in various insubstantial ways without departing from the scope of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive wherein common elements are sometimes identified in the various views by common reference numerals and the elements depicted are not rendered to scale.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0012]      FIG. 1  depicts a perspective view of an opened package according to an embodiment of the present invention.  
         [0013]      FIG. 2  depicts a perspective view of the interior of the opened package according to an embodiment of the invention.  
         [0014]      FIG. 3  depicts a perspective view of the interior of the opened package according to an embodiment of the invention.  
         [0015]      FIG. 4  depicts a perspective view of the opened package according to an embodiment of the invention having a pair of additional enlarged views of one form of interlocking corner engagement structures depicted alongside  FIG. 4  (views D,E).  
         [0016]      FIG. 5  is a plan view of the interior major planar surfaces of the opened package according to an embodiment of the invention.  
         [0017]      FIG. 6  is a plan view of the exterior major planar surfaces of the opened package according to an embodiment of the invention.  
         [0018]      FIG. 7  is an elevational view of one end of a package according to the invention and featuring an area to be enlarged for ease of review (denoted as “SEE DETAIL A”).  
         [0019]      FIG. 8  is an elevational view of one side of a package according to the invention depicting the package in the fully opened configuration and featuring two areas to be enlarged for ease of review (denoted as “SEE DETAIL B” and “SEE DETAIL C”).  
         [0020]      FIG. 9  is a view taken along line A-A of  FIG. 5 .  
         [0021]      FIG. 10  is enlarged area A from  FIG. 7 .  
         [0022]      FIG. 11  is enlarged area B from  FIG. 8 .  
         [0023]      FIG. 12  is enlarged area C from  FIG. 8 .  
         [0024]      FIG. 13  schematically illustrates several additional optional features of a package according to the invention; namely, impact data logging module, wireless scanner module, and printed product identification code field.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0025]      FIG. 1  depicts a perspective view of the external major surfaces  110 ,  112  of an opened package  100  according to an embodiment of the present invention. Major surfaces  110 ,  112  are coupled to external minor surface  111  by a pair of hinges  102 ,  104 . An optional set of apertures  108  are formed in minor surface  111  and provide a venting function for the interior of the package  100 . The hinges  102 ,  104  are depicted as continuous linear regions having a relatively thinner cross section that the surfaces  110 ,  111 ,  112  although different structures can be used. However, as depicted the package  100  is formed as a unitary injection molded part the hinges  102 ,  104  are formed simply as relatively thinner having beveled lateral side walls adjacent the surfaces  110 ,  111 ,  112  so that if one of the hinges  102  or  104  are opened to a maximum degree then the beveled lateral side walls of that portion function as a mechanically stop. The hinges  102 ,  104  cooperate so that when the package  100  is opened the major surfaces  110 ,  112  and the minor surface  111  are substantially coplanar and thus provides a firm foundation for the package  100  and the contents disposed therein.  
         [0026]     On an area of the external major surface  112  preferably source-identifying indicia  106  is displayed and as depicted the indicia  106  forms an integral part of the major surface  112  (i.e., the indicia  106  is included in the mold for the package  100  and is formed during injection of resin material into the mold). One of the inventive aspects of the present invention includes the foregoing source-identifying indicia  106  and either in lieu of or in addition to indicia  106  the resin or other material used to fabricate the package  100  (or at least one externally visible portion of the package  100 ) is colored per a trade dress color, a trademark color, of the sponsor, manufacturer or other source of the articles carried within the package  100 . For example, in one embodiment of the invention the indicia  106  comprises one or more logos, trademarks or service marks owned by Medtronic, Inc. of Minneapolis, Minn., U.S.A. and the resin utilized to fabricate the package  100  is PMS code number 301 (blue) as identified by the Pantone Matching System (PMS) codes distributed by Pantone, Inc. of 590 Commerce Boulevard, Carlstadt, N.J., U.S.A. In another example the indicia comprises a logo, trademark or service mark of Vitatron B. V. a subsidiary of Medtronic, Inc. that operates with a relatively newly released source identifying trademark color for its products a green hue or hues corresponding to PMS code number 376 (primary) and/or PMS code number 382 (secondary). That is, more than one color can be utilized, as appropriate depending on the trademarks or trade dress of the person or firm who supply the devices or materials provided along with the source-identifying package  100 .  
         [0027]      FIG. 2  depicts a perspective view of the interior of the opened package  100  according to an embodiment of the invention. Optionally, at least one aperture  108  couples the interior of the package  100  (when closed) to ambient atmosphere. As depicted the aperture  108  comprises five discrete apertures formed in minor surface  111 , although other locations can be suitably utilized. The aperture  108  allows diverse vapors from sterilization materials to escape the package  100  (even through a layer of clear heat shrink film or the like).  
         [0028]      FIG. 3  depicts a perspective view of the interior of the opened package  100  according to an embodiment of the invention.  FIG. 3  illustrates that two cooperating structures populate the interior of the package  100 ; namely, a region  118  surrounded on three sides by opposing walls  115  and end wall  114 . End wall  114  optionally includes a cut-out portion having a radius that promotes manipulation of the package  100  when opening and closing same. The device-retaining location is denoted by reference numeral  116  that is surrounded on all four sides by opposing walls  117 , wall  119  and wall  119 ′. The walls  117 ,  119 , and  119 ′ are described in greater detail hereinbelow.  
         [0029]     Also depicted in  FIG. 3  are a pair of ribs  122  disposed on the interior of minor surface  111 . The ribs  122  provide a biasing force to the wall  119 ′ and can be designed to seal the opposing ends of the package  100  when in the closed configuration. The biasing force helps support the wall  119 ′ and, for appropriately-sized objects disposed in the location  116  (e.g., sterile device envelope or inner package, documentation, etc.), tends to retain same during transport and storage.  
         [0030]      FIG. 4  depicts a perspective view of the opened package  100  according to an embodiment of the invention having a pair of additional enlarged views of one form of interior interlocking corner engagement structures  124 ,  126  depicted alongside  FIG. 4  (denoted as enlarged views D,E). The structures  124 ,  126  provide reversible positive mechanical engagement when the package  100  is closed. Thus, the structures  124 ,  126  each include an elongated raised part and an elongated recessed part and provide an appreciable (i.e., audible and/or tactile confirmation when the package  100  is firmly closed). The package  100  is designed and constructed so that when the package  100  is closed the structures  124 ,  126  are not visible; in fact, other than required labeling, the exterior of package  100  in the exemplary embodiment is devoid of ornamentation (save for the trademark or trade dress color or colors of the package or portions thereof and the indicia  106 ). Of course, other forms and types of interior interlocking structures  124 ,  126  can be utilized along the lines of the foregoing description, but the depicted structure lend themselves to thermoplastic injection molding. Also depicted in enlarged view E of  FIG. 4  is a lower peripheral shelf  128 . Shelf  128  provides a mechanical stop to the opposing top edge of wall  114  (except for cut out region  120 ) and in conjunction with cut out region  120  provide an effective manual access location when opening the package  100 . In fact, in the depicted embodiment the area defined by region  120  and shelf  128  provide the only readily manually accessible location on the package  100  (when closed).  
         [0031]      FIG. 5  is a plan view of the interior major planar surfaces of an opened package  100  according to an embodiment of the invention. The three-walled region  118  and four-sided region  116  are of course of comparable area and spaced apart by minor surface  111  (without the hinges  102 ,  104  depicted). The ribs  122  are shown in relationship to lateral sides of minor surface  111 . An optional manufacturing code  109  is depicted as disposed on the surface  111  provides information related to the fabrication, use, dates, configuration, etc. for the package  100 . While not specifically depicted, the four walls surrounding the region  116  and/or the three walls surrounding the region  118  can be inclined slightly (from an orthogonal relationship) with a draft of approximately between one half degree and about three degrees. The magnitude of the draft can change depending on the desired relationship or mechanical friction to be encountered when closing the package  100 . Also, the amount of draft can be adjusted to decrease or eliminate the surface scratching that sometimes occurs when an injection molded part is ejected from its mold. This is important at least in the context of one exemplary embodiment of the invention in which the majority of externally visible surfaces include a fine surface finish or complexion which includes just enough texture to increase the ease of manipulation during use (including use with latex or sterilized gloves or the like). The draft can also serve to retain a sterile device package, literature or the like residing within the region  116 .  
         [0032]      FIG. 6  is a plan view of the exterior major planar surfaces of an opened package  100  according to an embodiment of the invention. In this view of a package  100  the venting apertures  108  on surface  111  are bounded by hinges  102 ,  104 . The indicia  106  (albeit inverted in  FIG. 6 ) is displayed on the major surface  112  but could be displayed on major surface  110  alone or on both  110  and  112 .  
         [0033]      FIG. 7  is an elevational view of one end of a package  100  according to the invention and featuring an area to be enlarged for ease of review (denoted as “SEE DETAIL A”) which appears as  FIG. 10  herein. The shelf  128  next to interlocking structures  124 , 126  and the cut-out region  120  of the opposing side of the package  100  are also depicted in  FIG. 7 .  
         [0034]      FIG. 8  is an elevational view of one side of a package  100  according to the invention depicting the package  100  in the fully opened configuration and featuring two areas to be enlarged for ease of review (denoted as “SEE DETAIL B” and “SEE DETAIL C”), which appear as  FIG. 11  and  FIG. 12  herein, respectively. The configuration of walls  115 ,  117  are depicted in  FIG. 8  (e.g., the relative height and shapes of the upper portions of the walls  115 ,  117 ).  
         [0035]      FIG. 9  is a view taken along line A-A of  FIG. 5  (i.e., the inner portion of wall  114 ). The specific nominal dimensions for an embodiment of the interlocking structure  126  are included in  FIG. 9  and the relative size of the cut-out region  120  is also depicted.  
         [0036]      FIG. 10  is enlarged area A from  FIG. 7  and depicts wall  119  and interlocking structure  124  and nominal dimensions for same disposed alongside shelf  128 . Juxtaposed in the view of  FIG. 10  is the wall  114  and the cooperating structure  126  disposed thereon when the package  100  is in a nearly-fully open configuration.  
         [0037]      FIG. 11  is enlarged area B from  FIG. 8  and illustrates the protruding portion of structure  124  coupled to wall  119  and also depicts the configuration or features of the upper corner of wall  117 , which is also visible in several of the other drawings. This upper corner provides mechanical strength and stability to the four walls surrounding region  116 . For example, the upper corner features provide improved alignment when the package  100  is just beginning to close, among other aspects.  
         [0038]      FIG. 12  is enlarged area C from  FIG. 8  in which the ribs  122  disposed on opposite sides of minor surface  111  in relation to walls  115  and  117 . While the ribs  122  appear rounded other shapes or cross sections can be utilized. In addition, the hinges  102 ,  104  are depicted in  FIG. 12 .  
         [0039]      FIG. 13  schematically illustrates several additional optional features of a package  100  according to the invention; namely, impact data logging module  200 , wireless scanner module  300  and printed product identification code field  400 . With respect to data logging module  200  includes an accelerometer or other mechanical sensor (e.g., single- or multi-axis unit) and wireless transmitting circuitry for providing a signal to a remote unit  250  regarding temporal and/or physical impact(s) upon the package  100  and thus, the device contained therein. For example, the module  200  can measure the amount of time since the package and/or device therein have remained closed and/or the magnitude and timing of any supra-threshold (or all) physical impact forces that impinge upon the package  100 . The remote unit  250  receives the signal and provides an alert (e.g., an illuminated of flashing light  252 , a text message  254 , a trace  258  on a data log screen  256  from a sensor or the like). The unit  250  can also include memory and transmitting circuitry to communicate with a central or other tracking equipment and the like. In addition or in lieu of the foregoing, the remote unit  250  can include time stamp  260 , a nominal or calibration indicia  262  and adjustable threshold or limit  264 .  
         [0040]     The package  100  can also include an RF or optical scanner-compliant label or similar  300 , for example, usable with a manual scanner  304  which emits optical or RF radiation  304  and contains memory and transmitting circuitry for collecting and correlating the scanned packages  100 . Such a capability improves inventory management and tracking of the package during transit, among other advantages.  
         [0041]     The package  100  can also include printed product identification code field  400  (e.g., a UPC-type code) as is known in the art and widely supported in many fields of endeavor, including many hospitals and clinics.  
         [0042]     While not depicted an embodiment of a self-supporting tray in which the implantable medical device may be stored. Tray is typically sterilized and may be made from foam or plastic material, including a hollow central interior portion with a flange extending thereabout for placing the medical device and other information therein. While also not specifically depicted, at least one breakaway strip can be adhered across a seam where the sides of package  100  overlap to provide a visible indication whether the package  100  has been opened (e.g., operates as a tamper-proof indicator). When the package  100  is opened a tensile force is exerted on breakaway strip that ultimately breaks to allow the package  100  to open. A broken strip serves as visible proof that package  100  has been opened and/or tampered with thus enabling the end user to reject the package  100 .  
         [0043]     While some selected and representative embodiments have been shown in accordance with the present invention, it should be clear to those skilled in the art that further embodiments may be made without departing from the scope of the present invention.