Abstract:
A system for absorbing blood and bodily fluids during surgical procedures includes an elongated, flexible element having a proximal end and a distal end, a weight secured to the distal end of the elongated, flexible element, and a plurality of absorbent elements attached to the elongated, flexible element. The absorbent elements are spaced from or connected to one another along the length of the elongated, flexible element. The absorbent elements, such as sponges or cotton balls, are adapted for soaking up blood and bodily fluids at a surgical site. A tab is secured to the proximal end of the elongated, flexible element for extracting the absorbent elements from the surgical site.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application claims benefit of U.S. Provisional Application Ser. No. 61/800,645 filed Mar. 15, 2013, the disclosure of which is hereby incorporated by reference herein. 
    
    
     BACKGROUND OF THE INVENTION 
     Field of the Invention 
     The present application is generally directed to surgical instruments and surgical procedures, and is more particularly related to systems, devices and methods for controlling and collecting blood and bodily fluids at surgical sites and cleaning surgical instruments in situ at a surgical site. 
     Description of the Related Art 
     During surgery, and particularly during laproscopic and endoscopic surgeries, large quantities blood and bodily fluids accumulate at the surgical site. The blood and bodily fluids must be collected and removed from the surgical site so that it remains clear of blood and bodily fluids, and to maintain good visibility for the surgeon. 
     A number of devices and methods have been developed for removing fluids from a surgical site. A first method involves using a vacuum to suction blood and bodily fluids from a surgical site, however, using a vacuum during laproscopic or endoscopic surgeries can result in deflation of the cavity. As a result, using a vacuum during these types of procedures is not viewed as a safe and effective choice by many surgeons. 
     Another procedure involves using gauze to swab and/or blot up the blood and bodily fluids present at a surgical site. Although gauze is relatively easy to use during open surgical procedures, it is much more difficult to use during laproscopic surgeries. A typical drawback involves the gauze bunching up or sticking inside the trocar as it is pushed toward the surgical site. Another drawback involves attempting to push a sufficient quantity of gauze through the trocar port, which is somewhat similar to pushing a rope down an enclosed tube. Typically, the gauze gets jammed in the trocar and cannot be pushed, in which case the trocar may need to be removed, which could traumatize the patient. Yet another drawback to using separate gauze sheets or balls is that the gauze inserted into the patient may become lost or be left behind at the end of the surgery. Leaving gauze inside a patient can cause myriad problems including infection, post-surgery complications, and an increased potential for costly malpractice claims. Yet another complication associated with using gauze is that the volume of fluid that may be absorbed is limited. 
     Moreover, since gauze expands or swells as it soaks up fluids, when the gauze is removed through the trocar, it is compressed, whereby the fluid in the blood soaked gauze drips back into the body through the trocar, allowing collected fluids back into the surgical field. These fluids that drip back into the surgical site could contain dead tissue, old blood, removed tissue particles, and saline mixed with blood, all of which must be removed from the patient to limit post surgical adhesions and minimize the possibility of infection. 
     In addition, when removing bloody gauze from a surgical site, the trocar or other instruments may become bloody and/or contains tissue particles that can soil the instruments and optical lenses, requiring more time during the surgery to clean the trocar and the associated instrument. 
     In view of the above, there remains a need for systems, devices and methods for reliably and efficiently removing blood and bodily fluids from surgical sites during surgical procedures. There also remains a need for systems, devices and methods that are capable of cleaning surgical instruments, such as a trocar, of blood and tissue during surgical procedures. 
     SUMMARY OF THE INVENTION 
     In one embodiment, a system for absorbing blood and bodily fluids during surgical procedures preferably includes an elongated, flexible element having a proximal end and a distal end, a weight secured to the distal end of the elongated, flexible element, and one or more absorbent elements, such as sponges or cotton balls, attached to the elongated, flexible element, whereby the one or more absorbent elements are adapted for soaking up blood and bodily fluids at a surgical site. 
     In one embodiment, the one or more absorbent elements include a plurality of absorbent elements attached to the elongated, flexible element, whereby the absorbent elements are spaced from one another along the length of the elongated, flexible element. 
     In one embodiment, an anchor tab, such as a pull ring, is secured to the proximal end of the elongated, flexible element. In one embodiment, the anchor tab or pull ring is sized so that it is larger than the inner diameter of the trocar so that the tab or ring may not fall into the trocar and become lost inside a patient&#39;s body. The larger relative size of the tab or ring desirably insures that the tab or ring will remain outside the body and cannot fit into the trocar. When it is desirably to remove the absorbent elements from the trocar, the tab or ring is pulled for retrieving the absorbent elements. In one embodiment, the absorbent elements are attached to the elongated, flexible element at positions that are closer to the weight (i.e., the distal end) than the anchoring tab (i.e., the proximal end). The anchor tab may have a code provided thereon for auditing and accountability purposes. 
     In one embodiment, a sealing element covers a distal end of one or more of the absorbent elements, such as a distal-most one of the plurality of absorbent elements. In one embodiment, a sealing element may have a grip element located at a distal end of the sealing element that is adapted to be held by a surgical tool for being moved about a surgical site for absorbing blood and bodily fluids. In one embodiment, the sealing element has a proximal end having a cup shape that covers the distal end of the distal-most absorbent element, and the grip element protrudes from the distal end of the cup shaped proximal end. In one embodiment, a sealing element covers a distal end of each of the absorbent elements. The sealing elements are preferably more rigid than the absorbent elements. 
     In one preferred embodiment, a cup shaped proximal end of a sealing element has an elongated reservoir that is located distal to an absorbent element thus creating a space for the collection of fluids between the distal end of the absorbent element and the proximal face of the elongated reservoir of the cup shaped sealing element. In one embodiment, the reservoir volume may be adjusted in response to the degree of fluid management that is required. In one embodiment, a sealing element preferably includes a relatively thin, flexible protruding membrane located near the proximal rim of the sealing element. The protruding membrane may be perpendicular or may be angled in the proximal direction so as to further cup and collect dripping fluids as the absorbent elements are being removed from a trocar. The thin, flexible protruding membrane may also serve to effectively communicate with a range of potentially larger trocar ports for enabling the removal of swollen absorbent components with reduced fluid loses. 
     In one embodiment, a system includes a surgical tool, such as a trocar, having an elongated, tubular opening (e.g., a trocar opening) with an inner diameter. In one embodiment, a sealing element preferably has an outer diameter that communicated with the inner diameter of the elongated, tubular opening. 
     In one embodiment, a method of using the system disclosed herein desirably includes inserting the trocar into a surgical opening and advancing a distal end of the trocar to a surgical site, introducing the weight secured to the distal end of the elongated, flexible element into the trocar opening, and lowering the weight and the absorbent elements attached to the elongated, flexible element through the trocar opening until the weight and the absorbent elements are advanced beyond the distal end of the trocar and are disposed adjacent the surgical site. In one embodiment, the absorbent elements are advanced through a trocar and positioned at a surgical site as seen fit by a surgeon. 
     In one embodiment, the method may include using a surgical instrument for engaging the weight secured to the distal end of the elongated, flexible element for pulling the elongated, flexible element and the absorbent elements through the trocar opening and from the distal end of the trocar, using the surgical instrument for engaging the gripping element located at the distal end of the sealing element for manipulating the absorbent element at the surgical site for absorbing blood and bodily fluids at the surgical site, and using the tab secured to the proximal end of the elongated, flexible element for pulling the elongated, flexible element, the absorbent elements and the weight toward the proximal end of the trocar opening for removing the absorbent elements from the surgical site. 
     In one embodiment, a system for absorbing blood and bodily fluids during surgical procedures desirably includes an elongated, flexible element, such as a flexible core, having a proximal end and a distal end, a weight secured to the distal end of the elongated, flexible element, a plurality of absorbent elements (e.g., sponges or cotton balls) attached to the elongated, flexible element, whereby the absorbent elements are spaced from one another along the length of the elongated, flexible element, and whereby the absorbent elements are adapted for soaking up blood and bodily fluids at a surgical site, and a tab secured to the proximal end of the elongated, flexible element. 
     In one embodiment, sealing elements cover the distal ends of each of the absorbent elements. The sealing elements may be more rigid than the absorbent elements. In one embodiment, the absorbent elements are preferably closer to the distal end of the elongated, flexible element than the proximal end of the elongated, flexible element so that the proximal end of the elongated, flexible element remains outside of the trocar when the absorbent elements are positioned at the surgical site, thereby insuring that none of the absorbent elements are left behind at the surgical site at the end of a surgical procedure. 
     In one embodiment, a flexible absorbent sealing system preferably includes a flexible, elongated cord having a proximal end with a pull ring or grip and a distal end with a weight. The flexible absorbent system preferably has one or more absorbent elements (e.g., sponges, cotton balls) that are attached to the flexible cord and spaced from one another along the length of the flexible cord. The absorbent elements are designed to soak up blood and bodily fluids inside a patient at a surgical site. The absorbent elements may have various shapes (e.g., spherical, bullet, square, rectangular), various sizes (e.g., small, medium and large), and various absorbent properties and/or qualities. In one embodiment, at least one of the absorbent elements has a distal end seal having an outer diameter that substantially matches or communicates with the inner diameter of a cannulated surgical instrument, such as a trocar. As the absorbent element passes through the trocar, the distal end seal preferably retains fluid as it wipes the inner diameter of the instrument for cleaning the instrument of blood, tissue, and/or debris so as to provide good visibility for the surgeon. In one embodiment, the distal end seal may have an elongated reservoir that provides a space between the distal end of the absorbent element and the proximal face of the cup shaped portion of the sealing element. In one embodiment, a proximal rim of a cup shaped portion of the distal end seal may include a thin, flexible membrane that extends outwardly or proximally toward the proximal end of the flexible, elongated cord. 
     In one embodiment, the flexible absorbent sealing system may have one or more absorbent-sealing elements along the length of the cord to increase absorbency without increasing the difficulty of removing a large absorbent element and incurring dripping back into the body cavity. The flexible absorbent sealing system preferably minimizes repetitive motions of constant sponge replacement into a single combined motion. The system disclosed herein also desirably reduces the risk of leaving a sponge, gauze, or absorbing element, because all of the absorbent elements are attached to the flexible cord, which has a proximal end with that remains outside the body at all times. 
     In one embodiment, the present invention provides a system for preventing collected blood and fluids from re-entering the body upon gauze removal during endoscopy surgery. 
     In one embodiment, the flexible absorbent sealing system disclosed herein enables surgical personnel to use a single device to both remove one or more used absorbent elements through a trocar and simultaneously clean the trocar during removal of the used absorbent elements. 
     The present invention also prevents a new, clean gauze or absorbent element from getting dirty upon entry into a dirty trocar. 
     The present invention also preferably eliminates the need for a separate cleaning operation to clean a trocar after a used, bloody absorbent element has been removed from the trocar. 
     The system disclosed herein enables surgical personnel to maximize the volume of blood and fluid retrieved by using numerous smaller connected absorbent elements that each fit into a properly sized trocar, while limiting the release of the absorbed blood and fluid. 
     In one embodiment, the flexibility of the cord enables the individual absorbent elements to be positioned where needed inside the body. The flexibility of the cord enables two or more absorbent elements to be packed together to absorb blood and fluids, or to function as a dam to halt the flow of blood and fluids. 
     In one embodiment, a system may have absorbent elements having different sizes to accommodate different sized trocars and instruments. 
     In one embodiment, the system may include radio opaque material that is detectable with radiology. In one embodiment, at least one of the absorbent elements includes a radio opaque material. 
     In one embodiment, the distal end of the flexible cord has a weight that may be lowered into the trocar and grasped by a clamping element for pulling the absorbent elements through the trocar and into a body cavity. As such, the absorbent elements on the flexible cord may be selectively pushed or pulled through the trocar in either direction. 
     In one embodiment, larger sized absorbent elements may be used when increased absorbency is required. 
     In one embodiment, flexible cords having different lengths may be utilized to provide for systems that are short, medium and long. 
     In one embodiment, at least one of the absorbent elements has a spherical shape adjacent to a trocar seal. 
     In one embodiment, at least one of the absorbent elements has at least one flat shape adjacent to a trocar seal 
     In one embodiment, at least one of the absorbent elements has at least one cylindrical shape, at least one bullet shape, or at least one egg shape adjacent to a trocar seal. 
     The flexible cord interconnecting the absorbent elements may include a colored or non-colored connection line attached to the absorbent elements and the trocar seal. 
     The system may be made of various bio-compatible surgical materials including but not limited to plastics, polymers, silicones, polyurethanes, composite polymers/monomers, stainless steels, of braided or monofilament structures as well as all known absorbent material including super absorbent materials, materials that react in the presence of blood or other fluids and other such materials known by those skilled in the art. 
     In one embodiment, a proximal end of the flexible cord has an anchor tab for being secured outside the body. The anchor tab may be coded for auditing and accountability purposes. 
     The distal end of the flexible cord may be weighted so that it falls freely down through the trocar, and so that the distal end of the cord may be easily seen and grasped. In one embodiment, a system may include a compressed absorbent both pre and post contact with fluids which may drop freely down a trocar prior to being exposed to fluids. As such, the device does not need to be pulled or pushed as described for other embodiments disclosed herein. 
     The distal seal may be made from any material that will prevent fluid dripping back into the trocar during removal of used absorbent elements. In one embodiment, the distal seal may have a grip member that can be used to grasp and position an absorbent element during surgery or to clean/wipe a specific surgical site or instrument during surgery. The distal seal may be made of materials including but not limited to silicone, rubber, polymers, non-absorbent cloth, etc. The seals may or may not have selective movability along the length of the flexible cord. 
     The flexible absorbent sealing system disclosed herein is preferably safer, more user friendly for both surgeons and patients, and more efficient at fluid management than can be obtained when using conventional un-tethered gauze or sponges in a closed surgical procedure. 
     The flexible absorbent sealing system disclosed herein has less fluid loss/drip upon removal through a trocar as compared to the same weight gauze pad or cotton balls with retained fluids. 
     These and other preferred embodiments of the present invention will be described in more detail below. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a flexible absorbent and sealing system including a flexible cord and absorbent elements attached to the flexible cord, in accordance with one embodiment of the present invention. 
         FIG. 2  shows a magnified view of the flexible cord and the absorbent elements shown in  FIG. 1 . 
         FIG. 3  shows a magnified view of a distal-most absorbent element shown in  FIG. 2  including a distal end seal covering a distal end of the absorbent element, in accordance with one embodiment of the present invention. 
         FIGS. 4A-4C  show the flexible absorbent and sealing system of  FIG. 1  being inserted into a trocar, in accordance with one embodiment of the present invention. 
         FIG. 5  shows the distal absorbent element of  FIG. 2  being gripped by a clamping device. 
         FIGS. 6A-6C  show the flexible absorbent and sealing system of  FIG. 1  being extracted from a trocar, in accordance with one embodiment of the present invention. 
         FIG. 7  shows a flexible absorbent and sealing system including a flexible cord and absorbent elements that are closely spaced from one another on the flexible cord, in accordance with one embodiment of the present invention. 
         FIG. 8  shows a flexible absorbent and sealing system including a flexible cord and absorbent elements that are widely spaced from one another on the flexible cord, in accordance with one embodiment of the present invention. 
         FIG. 9  shows a flexible absorbent and sealing system including a flexible cord and absorbent elements having a cylindrical shape, in accordance with one embodiment of the present invention. 
         FIG. 10  shows a flexible absorbent and sealing system including a flexible cord and absorbent elements having an egg shape, in accordance with one embodiment of the present invention. 
         FIG. 11  shows an absorbent element and a distal end seal having a flexible protruding membrane, in accordance with one embodiment of the present invention. 
         FIG. 12  shows an absorbent element and a distal end seal having an elongated reservoir, in accordance with another embodiment of the present invention. 
         FIG. 13  shows an absorbent element and a distal end seal having a flexible protruding membrane and an elongated reservoir, in accordance with still another embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     Referring to  FIG. 1 , in one embodiment, a flexible absorbent and sealing system  20  preferably includes a flexible cord  22  having a proximal end  24  and a distal end  26 . The system preferably includes a pull ring  25  attached to the proximal end  24  of the cord  22  and a weight  28  attached to the distal end  26  of the cord  22 . The system  20  desirable includes a plurality of absorbent elements  30 A- 30 D that are attached to the cord  22  and that are spaced from one another along the length of the cord  22 . In  FIG. 1 , five absorbent elements  30 A- 30 E are shown, however, other embodiments may have fewer or more spaced absorbent elements (e.g.,  20 ) and still fall within the scope of the present invention. 
     Referring to  FIGS. 1 and 2 , the absorbent elements  30 A- 30 E are adapted to absorb and soak up blood, bodily fluid, tissue, and other debris that is present at a surgical site. The absorbent elements are preferably made of materials that have the ability to soak up and absorb liquids such as cotton balls and sponges. The absorbent elements  30 A- 30 E are attached to and evenly spaced from one another along the length of the flexible cord  22 . The flexibility of the cord  22  enables the individual absorbent elements to be manipulated and moved relative to one another, yet remain attached to the flexible cord at all times. In one embodiment, the flexibility of the cord  22  enables two or more of the absorbent elements  30 A- 30 D to be bunched together to absorb a large pool of blood/fluid, or to form a dam at a surgical site to stop the flow of blood/fluid. 
     Referring to  FIGS. 2 and 3 , in one embodiment, the distal-most absorbent element  30 E on the flexible cord  22  has a seal/wipe element  32 , which has an outer diameter that preferably matches or communicates with the inner diameter of a trocar used with the system  20 . The size of the seal/wipe element  32  can be modified to match the inner diameter of a trocar. The seal/wipe element  32  is preferably used to wipe and/or seal the trocar as the distal-most absorbent element  30 E is pulled proximally through the torcar. The distal end of the seal/wipe element  32  has a grip element  34  that enables the distal-most absorbent element  30 E to be held between the jaws of a clamping tool. The grip element  34  enables the absorbent element  30 E to be held and moved around a surgical site as necessary to collect blood, fluid, tissue, etc. 
     Referring to  FIGS. 4A-4C , in order to deploy the absorbent elements  30 A- 30 E at a surgical site inside a patient, the distal end  26  of the flexible cord  22  may be passed through a trocar  36  having a proximal end  38 , a distal end  40 , and a trocar opening that extends from the proximal end to the distal end. The weight  28  attached to the distal end of the flexible cord  22  preferably enables the cord to easily pass through the trocar opening. Once the weight falls below the distal end  40  of the trocar  36 , a surgical tool  42 , such as a surgical grip, may be utilized to grasp the weight for pulling the flexible cord  22  and all of the absorbent elements  30 A- 30 E attached to the flexible cord beyond the distal end  40  of the trocar  36  in the direction Designated DIR 1 . Once the absorbent elements  30 A- 30 E have been pulled beyond the distal end  40  of the trocar  36 , the absorbent elements are preferably disposed inside a patient, adjacent a surgical site. 
     Referring to  FIG. 5 , in one embodiment, the surgical tool  42  is used to grab the grip element  34  ( FIG. 3 ) provided on the seal/wipe element  32 . In one embodiment, the absorbent element  30 E may be manipulated at the surgical site by holding the grip element  34  of the seal/wipe element  32 . By utilizing the grip element  34  on the seal/wipe element  32 , the absorbent portion of the absorbent element  30 E will not be squeezed and will not lose its contents (e.g., previously absorbed blood). The other absorbent elements  30 A- 30 D may also be moved to collect fluid by using the surgical grips  42  to grasp the respective grip elements  34 A- 34 D. 
     Referring to  FIGS. 6A-6C , in one embodiment, after the absorbent elements  30 A- 30 E have been utilized to collect blood, fluid, tissue and debris at the surgical site, the absorbent elements may be pulled proximally through the trocar  36  for removal from the patient. In one embodiment, the pull ring  25  at the proximal end  24  of the flexible cord is pulled away from the proximal end  38  of the trocar  36  in the direction DIR 2 .  FIG. 6B  shows the flexible cord being pulled in the direction DIR 2  with the fourth absorbent element  30 D entering the trocar opening at the distal end  40  of the trocar  36 . As the fourth absorbent element  30 D is pulled through the trocar, it may clean the inside of the conduit extending through the trocar.  FIG. 6C  shows the distal absorbent element  30 E with the seal/wipe  32  upon reaching the opening at the distal end  40  of the trocar  36 . The seal/wipe  32  preferably has an outer diameter that closely matches or communicates with the inner diameter of the trocar opening for wiping clean the inside of the trocar opening as the seal/wipe  32  passes from the distal end to the proximal end of the trocar  36 . The tight seal between the seal/wipe element  32  and the trocar opening prevents fluid from dripping back inside the patient and wipes the trocar opening clean. 
     Referring to  FIGS. 7 and 8 , in one embodiment, the spacing between the absorbent elements may vary. In  FIG. 7 , a flexible absorbent sealing system  120  includes a first set of absorbent elements  130 A- 130 E that are spaced more closely together than a second set of absorbent elements  230 A- 230 E of a second flexible absorbent sealing system  220 , shown in the embodiment of  FIG. 8 . Alternately, the absorbent elements may each have a tubular core that allows them to move along the length of the flexible cord. There may, therefore, be no fixed spacing and the absorbent elements may move freely on the flexible cord having a space between or no space between each absorbent element. Although five absorbent elements are shown in each embodiment, the number of absorbent elements attached to a flexible cord may be as few as one or as many as twenty or more. 
     The absorbent elements may have a wide variety of geometric shapes. In the embodiment of  FIG. 9 , the absorbent elements  330 A- 330 E have a cylindrical shape. In the embodiment of  FIG. 10 , the absorbent elements  430 A- 430 E have an egg shape. 
     Referring to  FIG. 11 , in one embodiment, a flexible absorbent and sealing system  520  preferably includes at least one absorbent element  530  having a distal end seal  532  having a relatively thin, flexible protruding membrane  535  located near the proximal rim of the sealing element  532 . The protruding membrane  535  may be perpendicular to or may be angled in the proximal direction relative to the proximal end of a flexible cord. The protruding membrane  535  functions to further cup and/or collect dripping fluids as the absorbent elements are being removed from a trocar. The thin, flexible protruding membrane  535  may also serve to effectively communicate with a range of potentially larger trocar ports for enabling the removal of swollen absorbent elements with reduced fluid losses. 
     Referring to  FIG. 12 , in one embodiment, a flexible absorbent and sealing system  620  preferably includes at least one absorbent element  630  and a distal end seal  632  covering a distal end of the absorbent element  630 . In one preferred embodiment, a cup shaped proximal end of the distal end seal  632  preferably has an elongated reservoir  645  that is located distal to an absorbent element  630  thus creating a space  655  for the collection of fluids between the distal end  660  of the absorbent element  630  and the proximal face  662  of the elongated reservoir  645 . In one embodiment, the volume of the reservoir may be adjusted in response to the degree of fluid management that is required or desired. 
     Referring to  FIG. 13 , in one embodiment, a flexible absorbent and sealing system  720  preferably includes at least one absorbent element  730  and a distal end seal  732  that covers a distal end of the absorbent element  730 . The distal end seal preferably has a relatively thin, flexible protruding membrane  735  located near the proximal rim of the sealing element  732  and an elongated reservoir  745  that is located distal to an absorbent element  730  thus creating a space  755  for the collection of fluids between the distal end  760  of the absorbent element  730  and the proximal face  762  of the elongated reservoir  745 . 
     In one embodiment, a system may include a plurality of absorbent elements having distal end seals whereby one or more of the distal end seals has flexible protruding membranes and one or more of the distal end seals has elongated reservoirs. 
     Although one or more embodiments of the present application disclose using trocars, other embodiments of the present invention may utilize other devices having ports or elongated openings and still fall within the scope of the present invention. 
     While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, which is only limited by the scope of the claims that follow. For example, the present invention contemplates that any of the features shown in any of the embodiments described herein, or incorporated by reference herein, may be incorporated with any of the features shown in any of the other embodiments described herein, or incorporated by reference herein, and still fall within the scope of the present invention.