Special receptacle or package – For body treatment article or material – Ligatures
Reexamination Certificate
2000-05-23
2002-10-22
Yu, Mickey (Department: 3728)
Special receptacle or package
For body treatment article or material
Ligatures
C206S063500
Reexamination Certificate
active
06467612
ABSTRACT:
FIELD OF THE INVENTION
The field of the invention relates to suture reel dispensers and suture.
BACKGROUND OF THE INVENTION
For surgeons, an emphasis on working safely and quickly in the operating theatre is of paramount importance, as extra time spent during surgery can be dangerous to the patient. A patient remaining anesthetized for longer than is necessary endures more intraoperative and postoperative risks, including: atelectasis (lung collapse) which can lead to pneumonia, deep venous thrombosis (clots in the veins of the legs), pulmonary embolism (clots that leave the veins of the legs and lodge in the lung veins), stroke, myocardial infarction (heart attack), and even death. Manufacturers of equipment used during surgery strive to improve efficiency and safety.
Another major concern in the medical field is cost effectiveness. Wasting sterile instruments and equipment can be quite expensive. Any increase in cost a hospital accrues is translated into an inflated charge to individual patients. The future of medicine looks toward cost efficiency and patient safety.
By understanding the dynamics of the operating theatre, one realizes the importance of having materials and instruments ready prior to the surgeon asking for them. The basic allotment of people in the operating room involved with the surgery includes: (1) the patient; (2) the anesthesiologist; (3) the scrub nurse (sterile); (4) the surgeon (sterile); (5) a surgical assistant (sterile); and, (6) the circulating nurse (non-sterile). All instruments and materials, that the scrub nurse and the surgeon handle, must be sterile. All equipment is packaged so that while the outer cover is non-sterile, the inner package is sterile. Most equipment necessary to do a procedure is opened prior to an operation. Therefore, it is sterile and ready to use.
Moreover, in order to save money, the amount of equipment opened prior to the start of each individual operation is standardized. An estimate is made of how much material a surgeon will use during an individual procedure and the set-up is arranged so that there is, presumably, just enough material to complete a surgery. Very often during a surgery, the surgeon uses more material than what was pre-opened, requiring the surgeon to ask for more material. It is the circulating nurse's responsibility to acquire the necessary material and/or equipment, and then pass it to the scrub nurse in sterile fashion. Since the scrub nurse, the surgical assistant, and the surgeon are to remain sterile, only the circulating nurse is allowed to retrieve the necessary material and/or equipment. This makes the surgeon dependent upon the circulating nurse. Because the circulating nurse has other responsibilities, the surgeon is constantly waiting for her/him to retrieve the necessary material and/or equipment and hand it to the scrub nurse. These delays can be very lengthy. Suture, i.e., surgical thread, is one such material that the surgeon most often asks for.
Suture is a necessary material used to tie tissue and blood vessels in order to prevent hemorrhage (bleeding). Suture comes either fastened to a needle for sewing tissue, or free of needles used to tie clamped tissue. Sutures are made of different thickness, qualities (dissolvable, biodegradable, non-dissolvable), and solid colors (black, off-white, purple and others). Suture, not attached to needles, is packaged either wrapped around a spool (suture reel dispenser) or as multiple individual ties.
Suture reel dispensers were created to increase the efficiency of dispensing suture. Spooled suture allows the surgeon to draw suture from a larger one-unit supply each time a suture is needed, rather than reaching for individual ties, of limited length. The surgeon holds the suture reel dispenser in one hand and pulls the suture to the length needed with the other hand, and then ties the tissue or vessel. The surgical assistant then cuts the suture. With the reel remaining in the surgeon's hand, this procedure can be done over and over without needing to look away from the wound until the reel runs out of useable suture.
The medical supply companies that sell suture reels, wrap a standard amount of suture around the inner spool. A major disadvantage of prior suture and reel dispensers, is that the surgeon never knows how many ties he or she will have per reel so that he or she does not know when the suture will end until the last piece of useable suture is pulled out of the reel. Very often, the surgeon is left holding a piece of suture, which is too short to use. The surgeon must then ask for another suture reel, which often results in an unacceptable delay before another sterile reel is available for the surgeon. This delay can be detrimental to the patient's health. One way to prevent this dilemma would be to place more suture reels on the instrument table prior to surgery. Since it is never really known how much suture will be used during any individual operation; and, since any exposed, but, unused suture must be disposed of, this wasted material adds up to an increase in the cost of health care.
One would think that a suture reel (spool) made of clear plastic would enable the surgeon to look directly at the suture reel and, thereby, have an indication of the amount of suture remaining on the suture reel. This concept, in actuality, is not feasible for several reasons. First, the width of the prior suture reel is many times the diameter of the suture. As the suture is originally loaded around the suture reel spool, it wraps horizontally and then stacks vertically to a distance of about 2 mm, measured from the center of the suture reel. As the suture isdrawn from the dispenser, the suture reel rotates in reverse to the way the suture was loaded; horizontally, approximating one layer at a time, thereby vertically reducing the amount of previously loaded material. Several revolutions of the suture reel decreases the vertical distance of the suture from the center of the suture reel by a miniscule and practically unnoticeable amount. In order to observe the suture winding down, the surgeon would have to continuously look at the suture reel when pulling the suture out of the suture reel dispenser; by which action, would take the focus of the surgeon off the operation and, therefore, would be unacceptable. In reality and actual practice, surgeons keep his or her focus and attention directly on the operation and, therefore, looks away from the wound as little as possible.
Another disadvantage of the prior suture reel dispenser is difficulty in handling it. A suture reel dispenser must operate in a manner that allows the suture reel to rotate smoothly and freely, without a need to place undue tension on the suture in order to draw it from the suture reel dispenser. The prior suture reel dispenser contains a suture reel attached to a reel housing and is constructed so that the reel housing does not completely cover the suture reel. The apparatus is quite small, which makes it difficult to hold the suture reel dispenser without the surgeon's fingers touching the suture reel. Moreover, surgeons wear gloves, which makes this task even more arduous. Friction on the suture reel from the surgeon's fingers both increases the force necessary to pull the suture out of the suture reel dispenser and prevents the suture reel from turning freely. For example, at times, while the surgeon is pulling suture from the dispenser, the whole apparatus can become dislodged from the surgeon's grasp, caused by an abrupt stopping force or tension, when the suture reel does not rotate smoothly. Furthermore, the required smooth, rotating action of the suture reel, on its built-in axle, can easily be inhibited by any slight increase in friction on the reel body or by the lodging of the suture in the suture reel or dispenser, or by a combination of several of these factors. Any disruption of a normal, smooth dispensing action of the suture, results in the surgeon's attention being diverted away from the operating field; thereby causing an unacc
Arnold Troy
Fulbright & Jaworski
Yu Mickey
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