Prismatic source-indicating medical device packaging

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

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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

FIG. 1 depicts a perspective view of an opened package according to an embodiment of the present invention.

FIG. 2 depicts a perspective view of the interior of the opened package according to an embodiment of the invention.

FIG. 3 depicts a perspective view of the interior of the opened package according to an embodiment of the invention.

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).

FIG. 5 is a plan view of the interior major planar surfaces of the opened package according to an embodiment of the invention.

FIG. 6 is a plan view of the exterior major planar surfaces of the opened package according to an embodiment of the invention.

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”).

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”).

FIG. 9 is a view taken along line A-A of FIG. 5.

FIG. 10 is enlarged area A from FIG. 7.

FIG. 11 is enlarged area B from FIG. 8.

FIG. 12 is enlarged area C from FIG. 8.

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

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.

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.

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).

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.

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.

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).

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

Claims

1. A source-identifying package for transporting a sterilized medical device, comprising:

a first major cover having an exterior and an interior, wherein the interior has three walls and an open side wall location;

a minor cover member coupled to the first major cover with a first hinge at the open side wall location of the first major cover;

a second major cover having an exterior and an interior, wherein the interior has four wall members and the second major cover having a hinged coupling to the minor cover and wherein said four wall members are configured to slide inside the three walls of the first major cover;

a source-identifying color or indicia disposed on at least one of the first major cover, the second major cover and the minor cover member; and

at least a pair of cooperating interlocking structures disposed on one of the three walls and one of the four walls in opposing locations so that when the package is closed together the structures releasably retain the respective walls together.

2. A package according to claim 1, further comprising:

an aperture formed in at least one of: the minor cover member, the first major cover, the second major cover.

3. A package according to claim 1, further comprising:

a pair of rib members disposed on opposing ends of the minor cover member and configured to provide a biasing force to a corresponding one of the four side wall members.

4. A package according to claim 1, wherein at least three of the four wall members are fabricating with between about one half of a degree and three degrees of draft.

5. A package according to claim 4, further comprising:

at least two crowned regions located where at least two of the four wall members abut.

6. A package according to claim 1, further comprising:

a manual access cut-out feature in one of the three side walls.

7. A package according to claim 6, wherein the cut-out is disposed on the wide wall opposing the open side wall location.

8. A package according to claim 7, wherein the cut-out is configured with one of a geometric configuration and an irregular configuration.

9. A package according to claim 1, wherein the sterilized medical device comprises an implantable pulse generator (IPG).

10. A package according to claim 1, wherein the sterilized medical device comprises an implantable cardioverter-defibrillator (ICD)

11. A package according to claim 10, wherein the sterilized medical device further comprises at least one medical electrical lead for the ICD.

12. A package according to claim 1, wherein the sterilized medical device comprises an implantable drug pump.

13. A package according to claim 1, wherein the sterilized medical device comprises an implantable neurological stimulator.

14. A package according to claim 1, wherein the sterilized medical device comprises an implantable stent.

15. A package according to claim 1, wherein the sterilized medical device comprises an implantable orthopedic structure.

16. A package according to claim 1, further comprising:

a mechanical impact sensor.

17. A package according to claim 1, wherein the mechanical impact sensor comprises one of a single-axis accelerometer and a multiple-axis accelerometer and including wireless telemetry for conveying signals to a remote unit and wherein said remote unit includes data logging and impact memory storage.

18. A package according to claim 1, wherein the sterilized medical device further includes a product information label having symbols that can be read with a machine vision device.

19. A package according to claim 1, wherein the sterilized medical device comprises one of a wireless radio frequency (RF) identification circuitry and an optical scanner identification label.

20. A source-identifying package for transporting a sterilized medical device, comprising:

a generally prismatic container devoid of protruding external surface features when in a closed configuration, said container including a major first cover and a major second cover each radially hinged to a minor cover disposed between the major first and second covers, and wherein the exterior of the container includes at least one indicia from the group: a trademark, a logo, a slogan, a trade dress feature, a service mark, a name of a commercial entity, a trade name, an icon;

wherein at least one of the first major cover, the second major cover, and the minor cover are predominantly colored consistent with a characteristic tradedress color of the owner of said at least one indicia; and

wherein when the container is disposed in an open configuration the major first and the major second cover and the intermediate cover assume a substantially coplanar relationship.