The invention generally relates to devices, systems, and methods for performing surgical procedures, and more particularly, temporary, non implantable surgical sponge-pad devices, systems, and methods for the absorption of blood and body fluids, temporary packings, hydration of tissues, tissue protection, organ transportation, dressings and the like in an operative site used during medical and surgical procedures.
A surgical sponge 10 (see
Like other things used in surgery, surgical sponges 10 are designed to be sterile. They come in their own sterile packaging and can be safely autoclaved or terminally sterilized in multiple ways. Standard Lap sponges and Raytec also commonly carry lint and other particles and though they may be sterile, the material may come off and be retained inside the body or wound. In addition Raytec and lap sponges can be very abrasive and traumatize the skin and tissues.
Materials used in conventional surgical sponges 10 range from cotton, rayon and polyesters, from gauzes to non-wovens. Conventional surgical sponges are available in various sizes: e.g., 12″×12″ and upwards to 24″×24″; or 4″×18″ and upwards to 8″×36″ when they are open completely.
During a typical surgical procedure, a relatively large number of surgical sponges 10, e.g., exceeding thirty to forty, may be required. Conventional surgical sponges 10 are treated as single use items and disposed of after blood soaked or used because they become nonfunctional and become impregnated with blood and a patient's body fluids. As shown in
The sheer number of surgical sponges 10 that are conventionally used during a single surgical procedure also compounds the problem of accountability. Several techniques have been developed, e.g., counting all sponges 10 and instruments, sometimes with the assistance of a barcode scanner, or radio opaque markers, or radio-frequency identification devices (RFID), to reconcile the sponge count before wound closure, with the sponge count reconciliation at the end of a large surgical case often taking up to five minutes and the patient cannot be closed until the sponge needle and instrument count is correct. Inadvertent errors may occur, with a sponge 10 left within a surgical site when the wound is closed, termed a retained sponge. Sponges left behind may cause infection and serious complications. When the error is discovered, the surgeon must re-expose the surgical site and retrieve the sponge 10, causing undue further stress and trauma to the patient. In addition there are millions of dollars of litigation annually for a surgeon leaving a retained sponge inside a body cavity. Some institutions are now performing X-ray examination on all major cases where a chest or abdominal cavity is opened to further check for a retained sponge which also adds to operative time and exposes the patient to radiation.
The invention provides a new surgical-pad with a nearly unlimited number of new and improved uses that overcome many of the problems and limitations current sponges have in surgery. One specific application for our present invention would be for a surgical sponge-pad substitute. Our device, however, is up to 1500% more absorbent, much more durable, lint and particle free, washable and reusable within the same surgical case reusable. The surgical pad may even be used to clean instruments or placed as a dressing on the patient following the end of the procedure. The technical features of the surgical-pad, surgical sponge devices make possible unique surgical pad, sponge systems and methods that take advantage of the use, conditioning, and reuse of a single surgical sponge device again and again during the same surgical procedure. The invention provides surgical sponge-pad devices, systems, and methods that make possible a significant reduction in the number of sponge-pads needed for a given surgical procedure compared to prior art sponges, e.g. 2-3 sponge-pads of the present invention versus 30-40 prior art sponges per case, and also markedly shortening the surgical time along with a marked reduction in the time required for a sponge count or unnecessary surgical delays.
The surgical sponge-pad devices comprise a sterilizable, liquid-absorbent, and durable material that can be economically sized and configured for use and reuse during a given surgical procedure. The material is dust and lint free (that is, it does not flake or shed fibers or the like). This new material is soft, non-abrasive and does not traumatize skin or deep tissue that is often very friable from a disease process such as infection or cancer. The material possesses an enhanced liquid absorbing capacity up to 1500%, which can be a very desirable characteristic, e.g., by a capability of holding at least ten times its weight in liquid. It can be used in the operating field, where the absorbent character of the material quickly absorbs blood, body fluids, as well as water and other aqueous liquids in an operative site. It may also be utilized to sequester off bowel to limit fecal spillage and contamination an infection in open bowel cases. The material is sized and configured to be quickly reconditioned outside the operating field, where the material can be quickly rinsed and cleaned by immersion in an aqueous liquid (e.g., saline) on the back table, and residual liquid easily released by manual wringing and rinsing in saline, and at that time be immediately available for return and reuse in the operating field. The material is sufficiently durable so that it can rinsed, cleaned, and wrung to release residual liquid repeatedly and returned for repeated reuse in the operating field, over and over again during the course of a single surgical procedure. At the end of the surgical procedure, the material can be disposed of as medical waste, with much less bioburden to our world.
One material that is particularly suited for use in the manner described is synthetic chamois. Such a material exhibits the above-noted desired characteristics; notably, an enhanced liquid absorbing and release/conditioning capacities, as well as the durability to withstand repeated reuse. A surgical sponge device comprising synthetic chamois can be repeatedly used to absorb blood, body fluids, as well as water and other aqueous liquids in an operative site, then quickly rinsed, wrung to release residual liquid, and returned for reuse in the operative field, again and again during the course of a given surgical procedure. Synthetic chamois can be made from, for example, polyvinyl alcohol, polyurethane, polyvinyl acetate, polypropylene, polyester, and polytetraflouroethylene (PTFE), polyglycolic acid and other like-based materials. Other suitable materials, such as polyester, cellulose materials, micro denier or other cleaning textiles, foam like materials or fabrics may also be used. The surgical sponge devices may also include coatings, e.g. anti-microbial and anti-fungal coatings, or soaked in such materials like antiseptics, antimicrobials and even antibiotic solutions.
The preferred materials for the surgical sponge-pad devices are highly absorbent compared to prior art sponges and pads. These new surgical sponge-pad devices have absorbency ranges of more than 100 percent increase of the traditional surgical sponges, to a 1000 percent increase absorbency compared to traditional sponges, and over 1500% increase in absorbency over some traditional sponges on the market and utilized in surgery every day. The surgical sponge-pad devices also have an increased absorption rate per area, with absorption rates of at least 0.70 g/in2 and up to and above 5.00 g/in2. This clinically equates to placing the pad on a table and placing a large amount of water on the table top with the water immediately being soaked into the pad-sponge.
A comparison of various surgical sponge devices according to the present invention and other commercially available non-surgical sponges is demonstrated in
The surgical sponge-pad devices just described make possible surgical sponge systems and methods that lead to a significant reduction in the number of surgical sponges needed for a given surgical procedure. The reduction in the number of sponge-pad device compared to prior art surgical sponges, in turn, makes possible significantly less environmental damage due to the reduction in medical waste, as well as contributing to markedly lower health care and disposable costs and bio burden. The systems and methods also lessen the problem of reconciling the surgical sponge count before wound closure, because there are fewer surgical sponge-pad devices to be accounted for again decreasing dramatically the operating times for sponge counts that may range over $100/minute.
The nature and scope of the invention may be best understood by reference to the following description, taken in conjunction with the accompanying drawings. Additional applications may include background material for vascular and microvascular anastomosis that may also be soaked in plain Lidocaine to help keep blood vessels from constricting helping to keep the vascular or microvascular anastomosis open. In addition, problems occur in surgery when open wounds maintain tissue hydration, as well as protecting the wound edges from retractors from general surgery procedures to cardiothoracic and chest procedures where the large chest wall retractors may be very traumatic to the wound edges and inhibit would healing. Also, in spine and Neurosurgery, the wicking action of the foam can absorb cerebrospinal fluid and keep the field dry so repairs and surgery may be performed more efficiently. Some additional applications will certainly arise and may include an improved transportation system for organ transplantation, plastic surgery applications of absorbing fluid from liposuction sites and as dressings following surgical procedures. A wide variety of liquids such as cardioplegic solution, antibiotics, antimicrobials, antiseptics, vasoconstrictors, vasodilators, wounds growth factors, clotting agents to name a few can be incorporated into the surgical pads. In addition the surgical pads will be valuable in the emergency room and for trauma patients to decrease bleeding and keep tissue well hydrated until surgical repair and treatment may be performed.
Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention, which may be embodied in other specific structure. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.
Each surgical sponge-pad device 18 is sized and configured for use as a surgical sponge-pad depending on the specific use and application. The surgical sponge-pad devices 18 can be made available in various sizes, e.g., upwards to 24″×24″, 4″×18″, or 8″×36″, for manipulation in conventional ways, e.g., using surgical forceps 12. An example of a particular sized sponge device 18 would have the dimensions of 4″×10″×½, as further depicted in
The surgical sponge-pad device 18 comprises surgical sponge material that is characterized according to the invention by a unique blend of physical characteristics that make it well suited for use and reuse as a surgical sponge in an operating room environment as well as a multifunctional device that is a single use and not designed to be retained inside the body, but disposed of following surgery or medical use. The material possesses a capability to quickly absorb blood, body fluids, as well as saline, water and other aqueous liquids found in or utilized in an operative site. The material also possesses the capability of being quickly rinsed clean after use by immersion in an aqueous solution such as sterile saline and residual liquid and or body fluids or blood and released by manual wringing. The material is sufficiently durable so that it can repeatedly rinsed, cleaned and wrung to release residual liquid and returned for reuse in an operating field.
Given these criteria, various materials can be identified by a person of ordinary skill in the art. A representative material having these characteristics is medical or surgical, intraoperative type of synthetic chamois. Synthetic chamois material is dust and lint free; that is, it does not flake or shed fibers or the like. Medical Synthetic chamois material can be sterilized, and it possesses a superior liquid absorbing capacity, e.g., a capability of holding up to fifteen times or greater (as noted above), its weight in liquid, and being up to 1500% more absorbent than current sponges used in surgery. Medical Synthetic chamois material is well suited for use in an operating environment, due to its capability to quickly absorb blood, body fluids, as well as water and other aqueous liquids in an operative site. Further, synthetic chamois material can be quickly reconditioned by immersion in a simple aqueous conditioning liquid (e.g., normal saline), where it can be quickly rinsed clean and then residual liquid easily released by manual wringing. After reconditioning, the surgical sponge-pad device 18 comprising synthetic chamois is immediately available to be returned for reuse in the operating field. The synthetic chamois material is sufficiently durable so that it can repeatedly rinsed cleaned and wrung to release residual liquid and returned for reuse in the operating field, over and over again during the course of a given surgical procedure. At the end of the surgical procedure, the synthetic chamois material can be economically disposed of as medical waste.
As will be evident from the various uses discussed below, the surgical sponge-pad device 18 not only can be reused during a surgical procedure, the same surgical sponge-pad device 18 can be used for differing procedures concurrently. The surgical sponge-pad device 18 can be sterilized during a surgical procedure and further be used for cleaning procedure, such as sterilizing the surgical equipment or operating table, which minimizes the number of different classifications of sponges or other devices that need to be supplied for an operating room or hospital. The surgical sponge-pad device 18 can be sterilized for intraoperative surgical uses, which greatly reduces waste and time, as the same surgical sponge-pad device 18 can be in multiple fashions.
Synthetic chamois can be made from, for example, polyvinyl alcohol, polyurethane, polyvinyl acetate and other like-based materials. Other suitable materials, such as polyester, micro denier or other cleaning textiles or fabrics may also be used.
Due to these beneficial characteristics, the surgical sponge-pad system 16 need include only a prescribed, limited number of surgical sponge-pad devices 18 for a given surgical procedure would be required. The limited number of surgical sponge-pad devices 18 selected for a given surgical procedure will vary according to the application and nature of the procedure and the number of personnel present in the operating room, anticipated amount of fluid production or bleeding. As will be described in greater detail later, as few as two surgical sponge-pad devices 18 may be required in an orderly repetition during a given surgical procedure. This stands in stark contrast to the numerous conventional surgical sponges that are typically deemed required by conventional medical wisdom.
In support of the limited number of surgical sponge-pad devices 18 provided, the surgical sponge-pad system 16 provides the aqueous conditioning liquid 20 (e.g., normal saline) for the surgical sponge-pad devices 18, which is shown packaged in a container 22 prior to use in the operating room (see
The unique functional features of each surgical sponge-pad device 18, as described, make possible a unique method of using only a limited number of surgical sponges during a given surgical procedure.
The method includes (see
The method further includes (see
The method further includes (see
The method further includes (see
As
As
If necessary, the surgical sponge-pad devices 18 can be dried (xii) (see
The above-described sequence is repeated as necessary through the remainder of the surgical procedure. While the surgeon reuses a surgical sponge-pad device 18 in the operating field, the assistant reconditions a previously used surgical sponge device 18 for reuse. The surgeon and assistant repeatedly exchange a currently used surgical sponge-pad device 18 for a reconditioned previously used surgical sponge-pad device 18, enabling each surgical sponge-pad device 18 to be reconditioned and reused again and again during the course of the procedure.
The method can further include (see
As
The surgical sponge-pad device 18 of the present invention can be utilized in a wide range of surgical procedures. For example
In
As
The surgical sponge-pad device 18 of the present invention can be of varying sizes and shapes, as is evident in
As shown in
The multifunctional surgical sponge-pad will have significant and brand new applications in surgery for the protection and hydration of tissues, transmission of antibiotics and antimicrobials and other solutions, barriers in surgery and even use in transfer of transplanted organs as well as many other future medical and surgical uses yet to be determined. For example, the sponge-pad devices can be used in emergency room (ER) applications for open wounds to absorb blood and other bodily fluids, as well as keeping an area covered, clean, and moist when a trauma patient comes into the ER and must wait before being seen. Such similar uses could be used on the battlefield and in first aid trauma situations, wherein the sponge-pad device may keep the area clean and moist, as well as possibly delivering medicines to the patient, e.g. epinephrine, coagulants, antimicrobials, and antibiotics.
The adaptability and use of the present invention is further demonstrated in
As previously noted, the surgical sponge-pad device 18 could further incorporate antimicrobial or antifungal features. The surgical sponge-pad device 18 could also incorporate cleaners, soaps, waxes, etc., which would be beneficial when using the surgical sponge device 18 in general cleaning, as demonstrated in
Likewise, the sponge-pad device 18 could be used for sterilization of surgical equipment, as shown in FIG. 27. Because of the durability of the sponge-pad devices 18, the sterilization could be done before and after a procedure, as well as using the sponge-pad device 18 during the procedure. Because the sponge-pad device 18 can be resterilized and reused during the procedure, biowaste is greatly reduced compared to prior art sponges. Further, the multiple uses for the present surgical sponge-pad device 18 significantly provides an advantageous device over prior art sponges, as it can be utilized in varying ways while retaining its integrity for each of the particular uses.
The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.
This application claims the benefit of provisional application Ser. No. 61/454,840 filed 21 Mar. 2011.
Number | Date | Country | |
---|---|---|---|
61454840 | Mar 2011 | US |