During surgery, a surgical drape is laid over a patient so as to cover a portion of the patient at or near a surgical field. A “surgical field”, which is also commonly referred to as a “surgical site”, is an operating field that is an isolated area where an invasive procedure or surgery is performed and that must be kept sterile by aseptic techniques. Surgical drapes are sterilized linens placed on the patient and around the surgical field in a manner that delineate sterile areas. Surgical appliances are placed on the surgical drape, such that the surgical appliances are within easy reach of the surgeon or the surgeon's assistant during surgery.
The surgical appliances used during surgery are typically scalpels for making incisions, retractors for holding open a portion of the body, forceps for holding organs and tissue, scissors for suturing and cutting, needle holders for holding needles while suturing tissue, tubing for allowing drainage or administration of fluids, staplers for closing the incisions, electrocautery devices for removing unwanted tissue or for sealing blood vessels, and other surgical appliances.
It is important that surgical appliances are contamination-free to reduce risk of patient infection. Contaminants (i.e., bioburden) that can cause infections include pathogens and microbial organisms, such as clostridia, streptococci, staphylococci, E. coli bacilli and other pathogens, bacterium and microbial organisms. Exogenous sources for these surgical field infectious pathogens, bacterium and microbial organisms include surgical personnel, the operating room environment, surgical instruments, and various materials brought to the surgical field. Such pathogens, bacterium and microbial organisms acquired by a patient while in the operating room can lead to serious post-operative, nosocomial (i.e., hospital-acquired) health complications, such as hepatitis, bronchitis, sepsis from intravenous sites, and even death. In the United States, approximately 780,000 of 30 million surgical procedures result in nosocomial surgical field infections. It has been estimated that nosocomial infections result in between 17,000 and 70,000 deaths annually in the United States.
Nosocomial patient infections may also result in medical malpractice tort liability for hospital personnel and/or the hospital facility, if medical personnel or the hospital fails to provide hygienic treatment and the infection is allowed to spread and cause further injury. In a 2005 study, it was estimated that the cost of jury awards for all medical malpractice cases in the United States was about 3.6 billion dollars. In 2006, the median medical malpractice award in the United States was $175,000.
In order to reduce risk of nosocomial patient infection during surgery, surgical appliances are routinely pre-sterilized. Especially in the case of re-usable surgical appliances, the surgical appliance is pre-soaked in a chemisteriliant solution and then hand scrubbed or subjected to ultrasonic cleaning. Pre-soaking, scrubbing and ultrasonic cleaning are performed so that any debris present on the surgical appliance cannot prevent direct contact between a sterilizing agent and microorganisms residing on the surgical appliance. In addition to pre-soaking, scrubbing and ultrasonic cleaning, pre-sterilization techniques also include chemical treatment, subjection to ionizing radiation, placement in a sterilizing chemical vapor or gas, and/or exposure to heat, as well as other pre-sterilization techniques. More specifically, chemical treatment may include use of chemicals with biocide capability, such as isopropyl alcohol, formaldehyde, bleach, tincture iodine, mercurochrome and other chemicals. Also, surgical appliances, especially surgical appliances having polymer components that cannot withstand elevated temperatures, can be exposed to a Cobalt-60 radiation source. The Cobalt-60 radiation source emits high-energy gamma ionizing radiation to kill microbial organisms. The radiation source can also be an electrical device that generates electron radiation in the form of an electron beam for killing microbial organisms. The chemical vapor or gas, which may be ethylene oxide gas, may also be used as a sterilizing agent. In the case of heat application, the surgical appliance is placed in an autoclave and subjected to moist heat in the form of pressurized steam or placed in an oven and subjected to dry heat. Dry heat may be applied at a predetermined elevated temperature, such as 320° F. (i.e., 160° C.), for a predetermined time duration, such as 60 minutes or wet heat may be applied at the same temperature of 320° F. (i.e., 160° C.), for a predetermined time duration, such as less than one minute. Use of the pre-sterilization techniques mentioned hereinabove reduces risk of patient infection when surgical appliances are delivered to and placed in the surgical field on the surgical drape.
However, a surgical appliance can sometimes slip and fall from the surgical drape and land on the operating room floor. If this occurs, the pre-sterilized surgical appliance may become contaminated with infectious microbial organisms and may even break. In order to reduce the risk of patient infection and possible medical malpractice tort liability, the surgical appliance used during the surgical procedure must be replaced. In this case, the surgical procedure is interrupted, thereby causing more time to complete the surgical procedure. If sterilization of the surgical appliance is routinely performed inside the operating room, hospital personnel must repeat the previously mentioned sterilization procedures for the replacement surgical appliance. If the sterilized surgical appliance was delivered to the operating room contained in a package, another package containing a sterilized appliance must be obtained. Thus, re-sterilizing replacement surgical appliances in the operating room or obtaining another package containing a sterilized surgical appliance results in additional time to complete the surgical procedure, particularly if a sterile replacement surgical appliance is not immediately available. In addition, interruption of the surgical procedure can even pose a health risk to the patient. The health risk to the patient may arise because the surgeon will divert his eyes and attention away from the exacting surgery being performed in order to attend to replacing the surgical appliance. Therefore, it is important that surgical appliances are prevented from slipping from the surgical drape and falling to the operating room floor.
Various approaches have been attempted to address the issues mentioned hereinabove. For example, U.S. Pat. No. 4,944,311 titled “Surgical Instrument Retainer” and issued Jul. 31, 1990 in the names of Eldridge, Jr. et al. discloses a reusable, flexible surgical drape which is laid over a patient adjacent the surgical field and which retains surgical instruments thereon to facilitate access to the instruments. A plurality of magnets is embedded in the drape so as to retain magnetizable instruments placed on the drape by means of magnetic force. A non-megnetized portion is provided in the center of the drape for storage of non-magnetizable instruments. However, according to this patent, it appears that the non-magnetizable instruments are merely placed in the center of the drape rather than being securely attached to the center of the drape. Therefore, it appears possible that the non-magnetizable instruments can be inadvertently knocked or displaced from the center of the drape and fall to the operating room floor during the surgical procedure. Also, this patent appears directed to a surgical drape upon which surgical instruments are placed to facilitate access to the instruments and does not appear specifically directed to a surgical drape for preventing instruments from falling to the floor of the operating room.
Another approach is disclosed in U.S. Pat. No. 4,976,700 titled “Surgical Securing Tape” and issued Dec. 11, 1990 in the name of Dennis R. Tollini. The Tollini patent discloses a securing tape for securing to a patient's skin or to a support, a medical device such as tubing, a catheter, an intravenous needle, or the like. According to this patent, the securing tape includes an elongated tape having base portions and a central tab formed integrally therewith, The securing tape also includes pressure-sensitive tape on the base portions and on an exposed window of the tab. The securing tape further includes hook and pile fastener portions on opposite sides of the exposed adhesive on the tab and on the base portion facing the tape's exposed adhesive. However, it appears the Tollini patent is directed to securing tubes, catheters, intravenous needles, or the like and is not directed to securing larger surgical instruments of non-tubular shape, such as scalpels, retractors, forceps, scissors, staplers, and other larger, non-tubular instruments,
Yet another approach is disclosed in U.S. Pat. No. 5,315,985 titled “Endoscopic Instrumentation Kit And Package Therefor” and issued Mar. 21, 1994 in the names of Andre P. Decarie, et al. This patent discloses an endoscopic or laparoscopic instrumentation kit including at least one obturator and at least two sleeves forming a trocar assembly. An obturator is a removable plug used during insertion of tubular instruments. A trocar assembly is an assembly having a sharp-pointed instrument equipped with a cannula or tube and used to puncture the wall of a body cavity and withdraw fluid. The kit may also include a catheter, an endoscopic surgical instrument, tissue-gripping sleeve members and attachment devices for the trocar sleeves. The kit is packaged in a vacuum-formed enclosure having raised walls which correspond in size and shape to the instruments packaged therein for retaining and displaying the instruments. A method for utilizing the kit is also disclosed. Although Decarie, et al. disclose an endoscopic instrumentation kit and package therefor, the Decarie, et al. patent does not appear to disclose means for attaching the instruments to a surgical field.
Although the prior art approaches recited hereinabove may disclose (1) a surgical drape including a plurality of magnets embedded in the drape to place magnetizable instruments placed on the drape; (2) a securing tape for securing a tubular medical device such as tubing, catheters, intravenous needles, or the like to a patient's skin or to a support; and (3) an endoscopic or laparoscopic instrumentation kit, the prior art recited hereinabove do not appear to disclose the invention described and claimed hereinbelow.