US20050126948A1 - Package for surgical implant - Google Patents

Abstract

A package for storing an implantable medical device during storage and shipping includes a containment region for containing the device, a flange surrounding the containment region, and lidstock sealed against this flange. A recess in the containment region permits insertion of a surgical gripping tool below the device support surface. The package may further include ribs that facilitate steadying or gripping the package during removal of the lidstock, and a separate receptacle for holding the device after removal from the containment region. The device is preferably a device implantable in the human eye.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This is a continuation of application Ser. No. 10/183,804 filed Jun. 26, 2002.
BACKGROUND OF THE INVENTION
• This invention relates to a package for containing a surgical implantable device, particularly an ophthalmic device for implanting in the human eye. Various devices for implanting in the eye are known. As examples, devices for sustained delivery release of a pharmaceutically active ingredient into the back-of-the-eye are disclosed in the following patents, the disclosures of which are incorporated herein by reference: U.S. Pat. Nos. 6,375,972; 5,773,019; 5,378,475; 6,001,386; and 6,217,895.
DESCRIPTION OF THE DRAWINGS
• FIG. 1 is an exploded top perspective view of a package according to various preferred embodiments of this invention, including a medical device and lidstock.
• FIG. 2 is a bottom schematic perspective view of the package shown inFIG. 1.
• FIG. 3 is a top perspective view of the package ofFIG. 1 including lidstock.
• FIG. 4 is side view of the package ofFIG. 1.
• FIG. 5 is a top view of the package ofFIG. 1.
• FIG. 6 is a cross-section view taken along line6-6 ofFIG. 5.
• FIG. 7 is a top perspective view of a second package.
• FIG. 8 is a top perspective view of a third package.
• FIG. 9 is a top perspective view of a fourth package.
• FIG. 10 is a top perspective view of a fifth package.
• FIG. 11 is a top view of a medical device shown inFIG. 1.
• FIG. 12 is a side view of the device ofFIG. 11.
SUMMARY OF THE INVENTION
• This invention provides a package for storing an implantable medical device during storage and shipping. The package comprises a first flange extending upwardly from an upper surface and defining a containment region for containing the device, wherein the containment region includes a support surface for supporting the device in the containment region. The package further comprises a second flange extending upwardly from the upper surface, wherein the second flange completely surrounds the first flange and includes an upper surface for sealing of lidstock thereto.
• According to preferred embodiments, the package comprises a recess extending below the device support surface in the containment region, such that the recess permits insertion of a surgical gripping tool below this device support surface. The first flange may have the form of two protrusions extending upwardly from the package upper surface and defining the containment region, for example, the recess may then have the form of an elongated groove in the package upper surface that separates the two protrusions and extends transversely to the containment region. Preferably, these two protrusions are both arcuate.
• The package may further include ribs that facilitate steadying or gripping the package during removal of the lidstock. The ribs may extend upwardly from the same upper surface from which the second flange extends, or the ribs may extend from a second package upper surface at a different elevation than the first package upper surface.
• According to preferred embodiments, the package includes a holding receptacle for holding the device after removal from the containment region. For example, the holding receptacle may have the form of a groove formed in the package upper surface and located between the ribs.
• The device is preferably a device implantable in the human eye, wherein the containment region is sized to contain such a device while preventing excessive movement of the device during storage and shipping. Accordingly, the containment region preferably has a maximum length of 10 mm. For packages including two first flange protrusions, the maximum length between inner surfaces of the two protrusions is 10 mm, and the maximum width between inner surfaces of an individual protrusion is 10 mm, more preferably 5 mm.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
• FIGS.1 to6 illustrate apackage100 according to various preferred embodiments.Package100 includes a topplanar surface101 with front and rearvertical sidewalls102,103 extending downwardly fromplanar surface101 and serving to support the package on a work surface.
• The package is designed to contain asterile device10 during shipping and storage, wherein sterility of the device is maintained and the device is protected from damage.Outer flange105 extends upwardly fromplanar surface101. For the embodiment shown in FIGS.1 to6,flange105 is generally diamond-shaped with rounded corners.Flange105 includes anupper surface106. After placingdevice10 in the package,lidstock20 is hermetically sealed againstsurface106, so that the package assembly assumes the configuration shown inFIG. 3.Surface106 may be flat or arcuate. Thelidstock20 may be hermetically sealed againstsurface106 by conventional heat sealing. Representative materials forlidstock20 include vapor and moisture impermeable materials such as plastics or metallic laminates. Lidstock20 will generally be slightly larger than the outer perimeter offlange106 so that portions of thelidstock overhand flange106. Such overhanging portions oflidstock20 allow a user to grip the overhanging portion when removing thelidstock20 to access the device. An advantage of the diamond-shaped flange106 in FIGS.1 to6 is that the lidstock may be pulled from multiple points, i.e., from each corner of the flange, depending on the preference of the user. The embodiment shown in FIGS.1 to6 includesribs107,108 protruding upwardly fromsurface101. A user may place a thumb or fingers on these ribs while removinglidstock20 with the other hand in order to steady the package on a support surface.
• Package10 includesinner flanges110, protruding upwardly fromsurface110 and contained inside the boundary defined byouter flange106, serving to closely containdevice10 while stored in the container. In other words,inner flanges110 form a containment region and preventdevice10 from moving excessively during shipping and storage, thus minimizing the risk ofdamaging device10. Also,inner flanges110 ensure that thedevice10 is presented in a predetermined configuration after removing thelidstock20 from the package, this configuration best seen inFIG. 5. For the illustrated embodiment,flanges110 are arcuately shaped. Arepresentative device10 is illustrated inFIGS. 11 and 12. For the illustrated embodiment,device10 has asustained release portion12 in which a drug is encased, and a suture tab portion including asuture hole15. The length of the device is indicated by “L” and the width of the device is indicated by “W”. It is preferred that the maximum length of the containment region bounded by the inner surfaces of the twoflanges110 is no greater than 2.5 mm of the length of the device (more preferably no greater than 2 mm), and/or the maximum width of this containment region bounded with the inner surfaces of eachflange110 is no greater than 2.5 mm of the width of the device (more preferably no greater than 2 mm), in order to protect the device from excessive movement. It is further preferred that at least one of the length and width is no greater than 1 mm than the respective length or width of the implant device. As an example, for a device implantable in the eye having a length of about 5.3 mm, the maximum length of the containment region between the inner surfaces of the twoflanges110 should be no greater than 7.8 mm (7.2 mm being suitable); for such a device having a width of about 2.0 mm, the maximum width of the containment region between the inner surfaces of anindividual flange110 should be no greater than 4.5 mm (2.8 mm being suitable). If desired, thelidstock20 may be also sealed against upper surfaces ofinner flanges110.
• In this embodiment,package100 includes arecess112 extending downwardly fromsurface110, contained inside the boundary defined byouter flange106 and extending betweeninner flanges110. In other words,device10 rests on a pair of surfaces definingdevice support surface115, best seen inFIG. 6, bounded withinflanges110. In removing thedevice10 from the package, a surgeon will typically grip the device with tweezers or another type of surgical gripping tool. Recess112 permits the surgeon to insert the tweezers or tool below the device anddevice support surface115 on which the device rests. Stated differently, the surgeon is not required to grip the device with the very tip of the tweezers or tool. In contrast, in various other packages for small medical devices, the devices rest entirely on a flat or concave surface, requiring the surgeon to access the device with the tool tip. It has been found that providing access below the device is less awkward and facilitates easier removal and handling. In the illustrated embodiment,recess112 is an elongated groove extending transversely to device support surfaces115 and separatinginner flanges110 from each other.
• For the embodiment illustrated in FIGS.1 to6, thepackage100 further includes areceptacle120 for holding the device after removing it from the containment region. After removing the device, a surgeon may wish to temporarily set down the device, andreceptacle120 provides a convenient receptacle for doing so. Also, as explained in more detail below, theentire package100 is preferably sterile, soreceptacle120 provides a sterile surface for placing the device. In the illustrated embodiment, after removing thedevice10 from the containment region, the surgeon will add sutures to thesuture tab12 on the device, the sutures for suturing the device to eye tissue.FIG. 5, in addition to illustrating device in the containment region resting onpedestal surface115, illustratesdevice10 inreceptacle120 with the added sutures13 resting onribs107,108. The device may be held inreceptacle20 while the surgeon readies the eye for implantation of the device. In this embodiment,receptacle120 has the form of a generally rectangular groove extending belowsurface101 and located betweenribs107 andribs108.
• Package100 may be molded from a plastic such as polycarbonate, polypropylene or polystyrene. In packaging thedevice10 inpackage100, thedevice10 is placed in the containment region of the package, andlidstock20 is sealed againstflange105, so that the assembly assumes the configuration shown inFIG. 3. Then, the entire assembly is sterilized, for example, with heat. It is preferred that the assembly is then placed in a sterile pouch conventionally used to store surgical instruments.
• FIG. 7 illustrates an alternate embodiment ofpackage700. In this embodiment, thepackage700 is supported on a work surface by a singlevertical sidewall702 extending downwardly from topplanar surface701. Also, this embodiment lacks ribs in the vicinity ofreceptacle720.
• FIG. 8 illustrates another alternate embodiment ofpackage800. In this embodiment, thepackage800 is supported on a work surface by front andrear legs802,803 extending downwardly from topplanar surface801.
• FIG. 9 illustrates an alternate embodiment ofpackage900. In this embodiment, thepackage900 includesribs907 to facilitate a user steadying the package while removing lidstock, but lacks a holding receptacle in the vicinity ofribs907. Also, this embodiment includes a chevron-shaped lidstock-sealingflange905. For this embodiment, it would be recommended that a user remove lidstock by gripping the lidstock in the vicinity of the pointed end of the chevron-shaped flange and pulling the lidstock backward.
• FIG. 10 illustrates an alternate embodiment ofpackage600. In this embodiment, theflange605 and rearvertical wall603 extend from a firstplanar surface601, whereas holdingreceptacle620,ribs607,608, and frontvertical wall602 extend from a second planar surface630.
• While the invention has been described with reference to various preferred embodiments, other alternate embodiments and variations will be evident to a person of ordinary skill in the art.

Claims (16)

1. A package for storing an implantable medical device during storage and shipping, comprising:

an upper surface;

a first flange extending upwardly from the upper surface and defining a containment region for containing the device, said containment region including a support surface for supporting the device in the containment region;

a second flange extending upwardly from the upper surface, said second flange surrounding the first flange and including an upper flange surface for sealing of lidstock thereto; and

at least one side wall extending downwardly from the upper surface and serving to support the package on a work surface.

2. The package ofclaim 1, further comprising a recess extending below the device support surface in the containment region.

3. The package ofclaim 2, wherein the recess permits insertion of a surgical gripping tool below the device support surface.

4. The package ofclaim 2, wherein the first flange comprises two protrusions extending upwardly from the upper surface and defining the containment region, and the recess has the form of an elongated groove separating the two protrusions and extending transversely to the containment region.

5. The package ofclaim 4, wherein the two protrusions are arcuate.

6. The package ofclaim 1, wherein the second flange is diamond shaped.

7. The package ofclaim 1, wherein the second flange is chevron shaped.

8. The package ofclaim 1, further comprising ribs on an upper surface thereof.

9. The package ofclaim 8, wherein the ribs extend upwardly from the same upper surface from which the second flange extends.

10. The package ofclaim 8, wherein the device further comprises a second upper surface at a different elevation than a first upper surface, the second flange extending upwardly from the first upper surface and the ribs extending upwardly from the second upper surface.

11. The package ofclaim 9, further comprising a holding receptacle for holding the device after removal from the containment region, the holding receptacle being a groove formed in the upper surface and located between the ribs.

12. A package for storing an implantable medical device during storage and shipping, comprising:

an upper surface;

a first flange extending upwardly from the upper surface and defining a containment region for containing the device, said containment region including a support surface for supporting the device in the containment region;

a second flange extending upwardly from the upper surface and including an upper flange surface for sealing of lidstock thereto; and

at least one side wall extending downwardly from the upper surface and serving to support the package on a work surface, the package further comprising a holding receptacle formed in the upper surface.

13. The package ofclaim 1, further comprising a vertical sidewall extending downwardly from the upper surface for supporting the device on a work surface.

14. The package ofclaim 1, comprising front and rear vertical sidewalls.

15. The package ofclaim 1, wherein the containment region has a maximum length of 10 mm.

16. The package ofclaim 4, wherein the maximum length between inner surfaces of the two protrusions is 10 mm.

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