The invention relates to a packaging tray for a medical device, and in particular to a packaging tray for a surgical staple line reinforcement material having an adhesive or other coating agent disposed thereon.
Surgical stapler devices are designed to simultaneously cut and seal an extended segment of tissue in a patient. Typically, a surgical stapler comprises two stapler arms, one arm containing two or more lines of staples and a second arm containing an anvil structure to bend each of the staples into a closed position. For many applications, a surgical blade is included in the device to quickly sever tissue between the lines of staples. Those stapler devices employing a cutting blade are referred to as “anastomotic staplers” and those used without a cutting blade are referred to as “non-anastomotic staplers.”
For some procedures, the use of bare staples, with the staples in direct contact with the patient's tissue, is generally acceptable. The integrity of the tissue itself will normally prevent the staples from tearing out of the tissue and compromising the seam before healing has occurred. In certain circumstances, however, the tissue that is being sealed is too fragile to securely hold the staples in place. In these instances, the tissue will tend to rip at or near the staple lines, which may slow healing and possibly leading to serious complications.
One area where fragile tissue is of particular concern is the use of stapler devices in lung tissue, and especially lung tissue that is affected by emphysema or similar diseased conditions. Diseased lung tissue is very fragile and, in extreme cases, will readily tear through unprotected staple lines. With the growing use of surgical staplers in operations on diseased lung tissue such as bullectomies and volume reduction procedures, it has become increasingly important to develop some reliable means to protect fragile tissue from tissue tears due to surgical staples or surgical stapling procedures. Moreover, when staples are used, it is desirable to reduce any leakage around the staples.
One known protective measure involves the use of reinforcement or bolster material, wherein the staples are driven through both the reinforcement material and the patient's tissue. The reinforcement material inhibits tearing of the tissue or leakage around the staples. The use of staple line reinforcement is typically accomplished by temporarily affixing the reinforcement material to each arm of the stapler prior to stapling the patient's tissue. The staples are then driven through the reinforcement material and the patient's tissue, sandwiching the tissue between two layers of reinforcement material. An adhesive or other coating agent is often applied to the reinforcement material to help bond the reinforcement material to the tissue or perform some other task. Examples of staple line reinforcement materials are disclosed in US Publication No. 2004/0093029, entitled “Apparatus and Method for Producing a reinforced Surgical Staple Line”, and US Publication No. 2007/0027472, entitled “Medical Devices and Methods Useful for Applying Bolster Material”, the entire contents of which are hereby incorporated by reference.
An adhesive or other coating agent is often utilized to temporarily affix the reinforcement or bolster material to the arms of the stapler. The coating agent is typically supplied to the user separately from the reinforcement material as part of a kit. The user must then apply the coating agent to the reinforcement material just prior to affixing the material to the stapler arms. The task can be time consuming, and often results in contamination of the reinforcement material. In addition, the user may be unable to apply the coating agent to the reinforcement material uniformly or in the appropriate amount. Thus, it is desirable to pre-coat the reinforcement material at the time of manufacture, and prior to delivery to the end user. However, the pre-coated reinforcement material must be protected from inadvertent contact with packaging or other materials during transport, storage and delivery to the user. Thus, it is desirable to provide a packaging tray for a medical device, such as a pre-coated staple line reinforcement material, that protects the device from contamination and inadvertent contact with the packaging material prior to use. These and other purposes of the present invention will become evident from review of the following specification.
Accordingly, the present invention provides a packaging tray for a medical device having features that resolve or improve upon one or more of the above-described drawbacks.
In a first aspect of the present invention, the packaging tray is adapted to hold a medical device comprising a substantially flat configuration and having a portion of at least one surface thereof comprising a coating of an agent disposed thereupon. The medical device further comprises an uncoated portion thereof extending laterally from the portion of the at least one surface comprising the agent. In one particular embodiment, the medical device comprises an implantable material removably disposed on an applicator strip. The applicator strip comprises the laterally extending uncoated portion, and the coating of the agent is disposed on the implantable material.
The packaging tray comprises a container unit having a top portion and a bottom portion that defines a protective chamber therebetween configured to receive the coated portion of the medical device. The container unit is further configured to include an anchoring region disposed lateral to the protective chamber and between the top and bottom portions. When the medical device is disposed within the container unit, the uncoated portion is at least partially received and secured within the anchoring region, and the coated portion is maintained within the protective chamber, such that the at least one surface comprising the coating of the agent is prevented from contacting the top and bottom portions of the container unit. In one particular embodiment, the top and bottom portions of the container unit comprise separate and identical tray portions that are connected together by a plurality of attachment portions. The tray portions may also comprise a translucent material, such as transparent plastic, to permit viewing of a medical device disposed therein.
These and other advantages, as well as the invention itself, will become apparent in the details of construction and operation as more fully described below. Moreover, it should be appreciated that several aspects of the invention can be used with packaging for other types of staple line reinforcement materials or medical devices.
Embodiments of the present invention will now be described by way of example with reference to the accompanying drawings, in which:
The invention is described with reference to the drawings in which like elements are referred to by like numerals. The relationship and functioning of the various elements of this invention are better understood by the following detailed description. However, the embodiments of this invention as described below are by way of example only, and the invention is not limited to the embodiments illustrated in the drawings. It should also be understood that the drawings are not to scale and in certain instances details have been omitted, which are not necessary for an understanding of the present invention, such as conventional details of fabrication and assembly.
In general,
One embodiment of the medical device 100 for use with the packaging tray 10 is illustrated in
In the particular embodiment illustrated, the medical device 100 comprises an implantable material 108 removably disposed on an applicator strip 110. The applicator strip 110 comprises a central portion 112, two laterally extending portions or wings 114, and a removable tab 116 extending from the rearward end thereof. The central portion 112 is sized and configured to support the implantable material 108 thereon, and is preferably sized and configured to align with the arms of a surgical stapler (not shown) or other device on to which the implantable material 108 is to be removably attached. In particular, the central portion 112 preferably has a width that is equal to that of the implantable material 108 and the arms of the surgical stapler.
The removable tab 116 is configured to engage slots 118 in the ends of the implantable material 108 so as to secure it to the applicator strip 110. In particular, the implantable material 108, which comprises a single strip of bolster material, is secured to the applicator strip 110 by first folding the bolster material over the central portion and then passing the slot 118 on each end of the bolster material over the tab 116. The implantable material 108 may subsequently be removed or separated from the applicator strip 110 by tearing or otherwise removing the tab 116 from the applicator strip 110. This typically occurs at the time the implantable material 108 is affixed to the arms of the surgical stapler.
The laterally extending wings 114 provide a grasping area for the user. In particular, the user may grasp the wings 114 and manipulate the position of the applicator strip 110 without engaging the or otherwise coming into contact with the implantable material 108. As will be explained in greater detail below, the laterally extending wings 114, which generally comprise the uncoated portion of the medical device 100, also provide a mechanism for securing the applicator strip 110 to the packaging tray 10. Although two laterally extending wings 114 are shown, fewer or more than two wings can be utilized. In addition, it should be appreciated that the shape of the laterally extending wings 114 is not critical to the present invention.
In the embodiment illustrated, the applicator strip 110 comprises a compressible material such as polymer foam (e.g., styrene or Styrofoam). A compressible material facilitates attachment of the implantable material 108 to the arms of the surgical stapler by allowing uniform pressure to be applied by the arms to the implantable material 108 during attachment thereof.
The implantable material 108 comprises a reinforcement or bolster material, such as a layer of dried, collagenous extracellular matrix (ECM) material, suitable for use with surgical staplers. The coating 104 of the agent is disposed on the exterior surface of the implantable material 108 (i.e., the surface that is opposite the surface that faces the central portion 112 of the applicator strip 110). One example of a preferred coating 104 is a dried, reversible gelatin based adhesive coating that is adapted to allow the implantable material 108 to be temporarily affixed to the arms of the surgical stapler. Other types of coatings 104 may include medicaments, pharmacologically active materials and/or biological materials. In addition, coatings 104 may also be applied to the interior surface of the implantable material 108 (i.e., the surface which faces or engages the central portion 112 of the applicator strip 110). As explained in background section above, it is preferable to apply the coating 104 to the implantable material 108 at the time the medical device 100 is manufactured. However, the coating 104 must be protected from contamination and prevented from coming into contact with packaging or other surfaces during transport, storage and delivery to the user. As will be explained in greater detail below, the packaging tray 10 of the present invention is configured to protect the coating 104, as well as the implantable material 108 and the applicator strip 110, subsequent to the initial manufacture of the medical device 100.
Additional details regarding the applicator strip 110, implantable material 108 and coating 104 are disclosed in US Publication No. 2007/0027472, entitled “Medical Devices and Methods Useful for Applying Bolster Material”, the entire contents of which are hereby incorporated by reference. Alternative configurations for these components are also disclosed in the above-referenced publication, as well as in US Publication No. 2004/0093029, entitled “Apparatus and Method for Producing a reinforced Surgical Staple Line”. It should be understood by those skilled in the art that the packaging tray 10 of the present invention may be modified or re-configured to accommodate one or more of these alternative configurations without departing from the scope of the invention. In addition, it should be understood by those skilled in the art that the packaging tray 10 of the present invention may be modified, re-configured or otherwise adapted to accommodate other types of medical devices 100 having coated portions that require protection from inadvertent contact with the packaging or other surfaces, and that the packing tray 10 of the present invention is not limited to medical devices 100 for use with surgical staplers.
An embodiment of the packaging tray 10 of the present invention is illustrated in FIGS. 1 and 3-8, wherein
In the particular embodiment illustrated, the top and bottom portions 14, 16 of the container unit 12 comprise separate and identical tray portions 22 that are connected together by a plurality of attachment portions 24. In particular, and as best seen in
In the particular embodiment illustrated, each tray portion 22 comprises a pair of circular shaped male attachment members 32 along one side thereof, a pair of octagon shaped female attachment sockets 34 along the opposite edge thereof, a single elongate male attachment member 36 adjacent to one edge of the protective chamber 18, and a single elongate female attachment socket 38 along the opposite edge of the protective chamber 18. Thus, the pair of circular shaped male attachment members 32 of one tray portion 22 is configured to engage the pair of octagon shaped female attachment sockets 34 of the other tray portion 22. Likewise, the single elongate male attachment member 36 of one tray portion 22 is configured to engage the single elongate female attachment socket 38 of the other tray portion 22. The arrangement provides a total of six attachment portions 24 for connecting the two tray portions 22 together.
Of course, it should be understood that fewer or additional attachment portions 24, or differently shaped attachments portions 24, may be utilized to connect the tray portions 22 together. Likewise, the attachment portions 24 may comprise a non-mechanical mechanism such as an adhesive for connecting the tray portions 22 together. Furthermore, the top and bottom portions 14, 16 of the container unit 12 may be formed as a unitary structure as opposed to a plurality of components that have been assemble together. Finally, it should be understood that the top and bottom portions 14, 16 do not need to be formed from identical tray portions 22, but may alternatively comprise different shaped tray portions 22. For example, all of the male attachment members 28 may be formed on one tray portion 22 (e.g., the top portion 14), while all of the female attachment sockets 30 may be formed on the other tray portion 22 (e.g., the bottom portion 16).
As best seen in
As best seen in
As best seen in
As best seen in
In the embodiment illustrated, the tray portions 22 comprise a translucent material, such as transparent plastic, to permit viewing of a medical device 100 disposed therein. In particular, the tray portions 22 comprise transparent co-polyester that has been tinted with a light blue coloring. An example of a suitable co-polyester material is “Eastar 6763 PETG”, manufactured by the Eastman Chemical Company. Other suitable materials include ABS, Styrene, Vinyl, Olefin, Nylon and Urethane. The tray portions 22 are preferably formed by an injection molding process. However, it should be understood that the particular type of material and method of manufacture are not critical to the present invention. For example, the tray portions 22 may be formed of an opaque material, such as opaque plastic. An opaque material may have the advantage of protecting the medical device 100 from exposure to UV light, which may adversely affect the medical device 100 (e.g. by activating or drying out the adhesive coating 104). In addition, the tray portions 22 may further comprise release agents and other coatings such as silicone. Other types of medical devices 100 may require the use other materials or manufacturing methods. Other suitable materials and methods of manufacturing the packaging tray 10 are well known to those skilled in the art.
The tray portions 22 may comprise other features that improve the strength or handling of the packaging tray 10. For example, the tray portions 22 may include depressions or raised portions, such as those shown adjacent to the protective chamber 18, that are configured to increase the strength thereof and/or prevent planar surfaces of the tray portions 22 from excessive bending or flexing. Similarly, the tray portions 22 may comprises roughened surfaces to improve the tactile handling of the packaging tray 10. Such features are well known to those skilled in the art.
As discussed above, the illustrated embodiment of the packaging tray 10 of the present invention is manufactured by injection molding two identical tray portions 22. As shown in
Any other undisclosed or incidental details of the construction or composition of the various elements of the disclosed embodiment of the present invention are not believed to be critical to the achievement of the advantages of the present invention, so long as the elements possess the attributes needed for them to perform as disclosed. The selection of these and other details of construction are believed to be well within the ability of one of even rudimentary skills in this area in view of the present disclosure. Illustrative embodiments of the present invention have been described in sufficient detail for the purpose of disclosing a practical, operative structure whereby the invention may be practiced advantageously. The designs described herein are intended to be exemplary only. The novel characteristics of the invention may be incorporated in other structural forms without departing from the spirit and scope of the invention.
Unless otherwise indicated, all ordinary words and terms used herein shall take their customary meaning as defined in The New Shorter Oxford English Dictionary, 1993 edition. All technical terms shall take on their customary meaning as established by the appropriate technical discipline utilized by those normally skilled in that particular art area. All medical terms shall take their meaning as defined by Stedman's Medical Dictionary, 27th edition.
This application claims the benefit of U.S. Provisional Application Ser. No. 60/992,964, filed Dec. 6, 2007, entitled “Medical Device Packaging Tray”, the entire contents of which are incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60992964 | Dec 2007 | US |