Special receptacle or package – For body treatment article or material – Ligatures
Reexamination Certificate
2002-03-22
2004-05-25
Mohandesi, Jila M. (Department: 3728)
Special receptacle or package
For body treatment article or material
Ligatures
C206S227000, C206S380000
Reexamination Certificate
active
06739450
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to packages for sutures, and, more particularly, to packages for multiple double-armed sutures wherein each suture may include a pledget centered thereon and is removable from the package without tangling or knotting.
BACKGROUND OF THE INVENTION
Double-armed sutures, i.e., a surgical suture with a needle at each end, are well known and commonly used, e.g., in cardiovalve replacement surgery. This type of suture is optionally manufactured with a pre-centered pledget, i.e., a cushioning pad that prevents the suture from cutting into sutured tissue. Such sutures are frequently packaged in sets to supply an adequate number to advance the surgery without requiring opening and handling multiple packages. The sutures are typically arranged in the package with the needle ends of each suture grouped together such that the two ends of each suture can be identified. The sutures are provided in at least two different colors to aid in visually identifying each suture. It is preferable for the suture package to facilitate dispensing each suture by grasping one or both of the associated needles with a needle holder.
During surgery, a rhythm is developed between the scrub nurse and the surgeon in passing the sutures to the surgeon. If a suture becomes tangled upon removal from the package, this rhythm is interrupted and lengthens the surgery, which poses a danger to the patient. Accordingly, it remains an objective in this field to provide suture packaging that minimizes the chances of suture tangling.
Various suture winding and packaging schemes are now known for facilitating suture storage and dispensing from a package holding a plurality of sutures. For example, U.S. Pat. No. 6,029,806 entitled “PACKAGE FOR DOUBLE ARMED SUTURES” and owned by the present Assignee is incorporated by reference herein for its teachings concerning the storage of multiple sutures in a suture package having a plurality of pockets with plural compartments stacked in the Z direction.
Surgeons variously prefer to handle either a single needle holder, which is sequentially used to grasp a first needle of the suture then the second needle, or a pair of needle holders, which are used for simultaneously grasping both needles. It is desirable for each needle to be presented in the package with adequate space around it for the scrub nurse to readily grasp each needle individually with a needle holder. Spatial separation of the needles must not disturb their functional grouping, i.e., it must be apparent which two needles are connected to the same suture. It is also desirable for the sutures to be visually distinct. Furthermore, spatial separation of the needles and other beneficial features cannot be allowed to appreciably enlarge the needle package to the degree that it becomes unwieldy or that it cannot be accommodated in the standard storage devices present in the operating room and supply cabinets.
Owing to the conflicting objectives of storing greater numbers of sutures in smaller packaging, instances of compression and bending of the sutures and pledgets occur. With respect to pledgets, it is beneficial that they be delivered to the surgical site as flat as possible so that the contact surface area thereof relative to the sutured tissue is maximized to realize maximum force distribution. It is beneficial if the sutures are free of folds and flats along their entire length.
Because there are a variety of suture packages made by various manufacturers, in addition to a great variety of different kinds of sutures, it would be beneficial to have a convenient and effective means of communicating information concerning the sutures and/or the suture package to the surgeon and/or the scrub nurse at the time of suture use. Suture packages having identification and/or use information printed on sleeves that are separated from the package when it is opened require the printed material to be separately positioned on a crowded Mayo stand, e.g., juxtaposed next to the portion of the package holding the sutures. Accordingly, it would be beneficial for identification and/or use information to be printed on a part of the suture package that remains attached to the portion holding the needles.
It is therefore an object of the present invention to provide a new and improved package for multiple double-armed sutures that provides greater suture discrimination and ease of arming while preventing tangling of the sutures and, on sutures so supplied, keeping a pledget protected and centered on the suture upon withdrawal from the package. It is also desirable to have a package that is easy to handle, yet is capable of holding multiple sutures. Another object of the invention is to provide a package that applies minimal compression pressure to the sutures, such that the sutures are not flattened or folded, are loose within the package, and are therefore easy to remove. Yet another objective is to realize the foregoing objectives in a manner that is efficient and economical.
SUMMARY OF THE INVENTION
The limitations of known suture packages are addressed by the present invention which includes a suture package with a base panel and a first needle park attached to a front surface of the base panel for holding a first needle. The first needle is attached to a first suture and a pocket having a plurality of compartments is disposed on the front surface of the base panel. A first of the plurality of compartments receives the first suture. A second panel, smaller than the base panel is coupled to the base panel substantially parallel thereto with the first suture disposed between the second panel and the base panel. A second needle park is attached to a front surface of the second panel for holding a second needle, which is attached to a second suture. A second of the plurality of compartments receives the second suture.
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Porras Elizabeth
Roshdy Constance E.
Ethicon Inc.
Moh'andesi Jila M.
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