Abstract:
A needle biopsy guide system is disclosed for attachment to an endoluminal ultrasound probe or like sonographic instrument. The device includes a biopsy-guide attachment that allows for trocar catheter placement for abscess drainage or like procedures, using the transvaginal or transrectal route under sonographic control. The device has a base portion, which is attachable to an ultrasound probe. A removable retainer is provided that slides into the base unit to hold a biopsy needle in place. A physician may locate the target area in the body with the ultrasound probe, insert the biopsy needle into the target area, and then remove the insert (retainer) from the base unit and ultrasound probe, and leave the biopsy needle in place in the body.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority from U.S. provisional application Ser. No. 60/885,342 filed on Jan. 17, 2007, incorporated herein by reference in its entirety. 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not Applicable 
     INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
     Not Applicable 
     NOTICE OF MATERIAL SUBJECT TO COPYRIGHT PROTECTION 
     A portion of the material in this patent document is subject to copyright protection under the copyright laws of the United States and of other countries. The owner of the copyright rights has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the United States Patent and Trademark Office publicly available file or records, but otherwise reserves all copyright rights whatsoever. The copyright owner does not hereby waive any of its rights to have this patent document maintained in secrecy, including without limitation its rights pursuant to 37 C.F.R. §1.14. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention pertains generally to a needle guide, and more particularly to a needle guide for attachment to a medical instrument such as an imaging probe. 
     2. Description of Related Art 
     Pelvic inflammatory disease affects nearly 1 million women in the United States annually, and approximately 85,000 of these women eventually have pelvic abscesses. Left untreated, pelvic abscesses are associated with acute morbidity, adhesion formation, impaired fertility, and chronic pelvic pain. Although many pelvic abscesses respond to antibiotic therapy, surgery is often needed when antibiotics fail. However, laparotomy for pelvic abscesses is one of the more technically difficult gynecologic procedures and has associated surgical and anesthetic risks, hospitalization costs, and prolonged recovery times. The definitive surgical treatment of a total hysterectomy and bilateral salpingo-oophorectomy is highly effective. However, the surgical treatment leaves patients infertile and devoid of ovarian hormones, which are major problems in the young premenopausual women who tend to be affected by pelvic abscesses. Total abdominal hysterectomy is the alternative to failed aspiration or drainage of these abscesses. 
     Pelvis Abscess may also be due to a number of other etiologies. Patients with appendicitis, diverticulitis or Crohn&#39;s disease may develop pelvis abscesses. Laparatomy is highly effective in the treatment of these pelvic abscesses. However, laparotomy is associated with both anesthesia and surgical risks, and prolonged recovery time. 
     Over the past decade, percutaneous image guided drainage of pelvic abscesses has shown to be an effective alternative to surgical techniques [1]. Various approaches have been advocated for drainage of these abscesses, including the transabdominal route, the transgluteal route [2], the transrectal route [3, 4] and the transvaginal route [5, 6]. CT or sonography has been used to guide the transabdominal and the transgluteal abscess drainage. Only sonography is used for guidance of transrectal or transvaginal abscess drainage. However, for sonographically guided transrectal or transvaginal trocar method of needle placement, the use of a punctured channel that is not open to allow the catheter to be free is a technical limitation for all current endorectal and endovaginal transducers. 
     Therefore, there have been modifications of different transrectal or transvaginal ultrasound probes to allow catheter placement. These have included the use of a catheter, which is placed through a peel-away sheet or catheters that are placed into a groove on the ultrasound probe and are fixed with rubber bands. These allow trocar catheter placement for transrectal or transvaginal drainage [7-10]. 
     Transrectal and/or transvaginal abscess drainage using sonographic technique has been shown to be an effective method in drainage of pelvic abscesses. While CT was previously the method that was utilized for drainage of these abscesses via the transgluteal and/or the transabdominal route, there have been a number of different manuscripts that have described the transrectal or transvaginal sonographic guidance of deep pelvic abscess. [5-10] 
     When using the transrectal or transvaginal route, aspiration alone has been shown to be as successful when compared with catheter placement. For instance, Lee [7] reported an overall success rate of 86%, using aspiration alone or 86% success rate for catheter placement. Van Sonnenberg [6] has shown an 88% success rate in patients with aspiration alone, compared to 83% with catheter placement. However, patients with aspiration alone may have smaller fluid collections, less loculations or less viscous fluid than those in which catheters are placed. Catheter placement allows repeated flushing of larger abscesses to help breakdown loculi and decrease the viscosity of the abscess contents. 
     With the Seldinger technique, a needle is placed, and then a guide wire is placed through the needle after removal of the needle stylet. Thus the needle, the needle guide and the ultrasound probe are then removed. The guidewire is kept in place and the rest of the technique may be guided by fluoroscopy or by ultrasound. However, there may be difficulty in catheter placement via the Seldinger technique when using the endovaginal route. This is because of the difficulty with buckling of the guidewire when dilators or catheters are placed through the thick vaginal musculature. 
     Thus, the invention relates to providing a needle guide for attachment to a sonographic transducer, which allows the probe and needle guide to be detached and removed from the needle or trocar catheter and removed from the patient while the needle or trocar catheter remains in place within the abscess cavity. This will allow for a single step for catheter placement into a pelvic abscess using either the endovaginal or endorectal route. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention includes a needle biopsy guide system, which is configured to be attached to an endoluminal ultrasound probe or like sonographic instrument or imaging probe. The system has a biopsy-guide attachment that will allow for trocar catheter placement for abscess drainage, using the transvaginal or transrectal route under sonographic control. 
     The system has a base portion, which is attachable to an ultrasound probe. A removable insert or retainer is provided that slides into the base unit to hold a biopsy needle in place. In an exemplary preferred method, a physician may locate the target area in the body with the ultrasound probe, insert the biopsy needle into the target area, and then remove the insert (retainer) from the base unit and ultrasound probe, and leave the biopsy needle in place in the body. 
     An aspect of the invention is a needle guide for use with an imaging probe, such as an ultrasound transducer or the like. The needle guide includes an elongate guide body configured to mount to the imaging probe. The guide body has a groove running generally longitudinally along the length of the guide body. The groove is configured to guide translation of a needle along the guide body to a treatment location in a body lumen of a patient. The needle guide further includes a slot running adjacent to the groove, wherein the slot is configured to house a retainer. The retainer is configured to slideably mate with the slot such that the retainer may be removed from the guide body to expose the groove, thereby allowing the needle to be separated from the guide body and imaging probe while the needle remains located at the treatment location. 
     In an exemplary preferred embodiment, the guide body comprises an inner surface configured to conform to the shape of the imaging probe. The guide body may also have a fastening mechanism to secure the needle guide to the imaging probe. 
     In another embodiment, the guide body includes an outer surface opposite the inner surface, such that the groove opens longitudinally out into the outer surface via the slot. When the retainer is not installed in the needle guide, the needle may be laterally repositioned from the groove to a location outside the needle guide. 
     In another embodiment, the guide body has a proximal end and a distal end, wherein the slot is configured such that the retainer may be installed in the needle guide by positioning the retainer in a slot opening at the proximal end of the guide body, and sliding the retainer in the slot longitudinally along the guide body toward the distal end of the guide body. The slot may preferably terminate at a stop at the distal end of the guide body such that the retainer is restrained from forward motion past the stop and the distal end. 
     In one mode, the groove emanates at a proximal opening of the proximal end and continues through the guide body to terminate at a distal opening at the distal end. The guide body has a depression adjacent to the proximal opening of the groove to allow manipulation of the needle. 
     Another aspect of the present invention is a method for inserting a biopsy needle at a treatment location in a patient&#39;s body. The method includes the steps of attaching a needle guide to an imaging probe, positioning the needle guide and imaging probe at the treatment site in the patient&#39;s body, guiding the biopsy needle longitudinally along a groove in the needle guide to the treatment location, slideably removing a retainer from a stowed position in the needle guide to expose the groove, and separating the biopsy needle from the needle guide by laterally pulling it out of the exposed groove. The needle guide and biopsy probe may then be removed from the treatment location while the biopsy needle remains at the location. The biopsy needle, for example, may be guided to the treatment location in an endorectal procedure or an endovaginal procedure. 
     In one embodiment, the retainer, in the stowed position, is held in a groove adjacent to the slot, such that the biopsy needle is retained in the needle guide when the retainer is in the stowed position. In this configuration, the needle is free to laterally advance away from the needle guide when the retainer is in a retracted position. 
     Another aspect of the present invention is an apparatus for guiding a needle along an imaging probe to a treatment location in a patient&#39;s body. The apparatus has an elongate guide body configured to mount to the exterior surface of an imaging probe. The guide body includes a longitudinal groove spanning an exterior surface of the guide body, wherein the groove is configured to guide translation of a surgical needle longitudinally along the guide body to a treatment location in a body lumen of a patient. The apparatus may further include a slot spanning adjacent and exterior to the groove along the exterior surface of the guide body to house a retainer. The retainer may be configured to slideably mate with the slot such that the retainer may be removed from the guide body to expose the groove, thereby allowing the surgical needle to be separated from the guide body and imaging probe while the needle remains located at the treatment location. 
     Further aspects of the invention will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing preferred embodiments of the invention without placing limitations thereon. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) 
       The invention will be more fully understood by reference to the following drawings which are for illustrative purposes only: 
         FIG. 1  is a top view of the needle guide of the present invention installed on an ultrasound transducer. 
         FIG. 2  is a cross sectional view of the needle guide and transducer of  FIG. 1 , with a biopsy needle installed in the guide. 
         FIG. 3  is a top view of the needle guide and transducer of  FIG. 1 , with a biopsy needle installed in the guide. 
         FIG. 4  is a cross sectional view of the needle guide and transducer of  FIG. 1 , with the retainer removed. 
         FIG. 5  is a top view of the needle guide and transducer of  FIG. 1 , with the retainer removed. 
         FIG. 6  is a top view of the retainer of the present invention. 
         FIG. 7  is a perspective view of the distal end of the needle guide without the retainer. 
         FIG. 8  is a perspective view of the proximal end of the needle guide without the retainer. 
         FIG. 9A  is a side view of the needle guide and transducer of  FIG. 1  being inserted in a body lumen. 
         FIG. 9B  is a side view of the needle guide and transducer of  FIG. 1  being used to guide a biopsy needle to a treatment location in the body lumen. 
         FIG. 9C  illustrates removal of the retainer from the needle guide and transducer and separation of the biopsy needle from the needle guide and transducer while the needle remains at the treatment location in the body lumen. 
         FIG. 9D  illustrates removal of the needle guide and transducer from the body lumen while the needle remains at the treatment location in the body lumen. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring more specifically to the drawings, for illustrative purposes the present invention is embodied in the apparatus generally shown in  FIG. 1  through  FIG. 9D . It will be appreciated that the apparatus may vary as to configuration and as to details of the parts, and that the method may vary as to the specific steps and sequence, without departing from the basic concepts as disclosed herein. 
       FIG. 1  illustrates a top view of a needle guide  10  configured to attach to a diagnostic instrument  20 , such as an ultrasound probe (transducer) or the like. Needle guide  10  primarily includes a guide body  12  and a retainer  14  that is configured to slide longitudinally, i.e. along the length of the guide body  12 , into a slot  16  that runs along the top of guide body  12 . 
       FIG. 2  illustrates further detail of the guide body  12  in cross-sectional view with the retainer  14  inserted. As shown in  FIGS. 2 and 4 , the slot  16  is preferably configured to have sidewalls  34  that that are sloped to form an acute angle such that the retainer  14  is retained from moving upward when installed in the slot. Slot  16  is preferably sized to house retainer  14  without lateral play so as to maintain placement accuracy without frictional engagement that would impede removal of the retainer from the slot or placement of the retainer into the slot. 
     The body  12  also has groove  24  that runs below and generally longitudinal with slot  16 . As shown, groove  24  is generally circular in shape, however, groove  24  may comprise a variety of geometries to allow needle  30  to be freely inserted and directed. The term “needle” as used herein encompasses biopsy needles, trocar catheters or like hollow instruments for introducing material into or removing material from the body. In some embodiments, the present invention also may be used to guide other elongate medical instruments, which may or may not be hollow. Groove  24  of needle guide  10  is configured to position needle  30  in a longitudinal orientation in relation to instrument  20  when the retainer  14  is inserted in the guide body  12 . 
       FIG. 3  shows a top view of the needle guide  10  carrying a conventional needle  30  having a hub  32 . Those skilled in the art will appreciate that hub  32  prevents conventional needle carrier/transducer assemblies from being removed from a body cavity without engaging hub  32  and removing needle  30  at the same time. 
     As shown in  FIG. 3  (and in cross section in  FIG. 2 ), the presence of the retainer  14  in the slot  16  over groove  24  provides an enclosed, longitudinal path running generally axially down the length of the guide body  12  (and thus the instrument  20 ). Thus, for example, by inserting a needle, or trocar catheter  30  into the proximal end  18  of the groove  24 , the forward motion of the needle  30  is confined to be longitudinal along the groove, without obstruction, and precisely directed to the distal end  28  of the guide  10  and probe  20 . 
     Because the hub  32  has a generally larger profile than the groove  24 , it precludes the guide  10  (and instrument  20 ) from being backed away or separated from the needle  30  while the needle remains at the treatment site. To facilitate this, the retainer  14  is removed from the guide body  12  to expose the open end of groove  24 . 
       FIGS. 4 and 5  provide further detail of the guide body  12  in cross-sectional view with the retainer  14  removed. As shown in  FIG. 4 , the upper end of groove  24  opens into slot  16 , such that needle  30  may be separated from the guide body  12  via a lateral, or non-longitudinal, motion of the guide body  12  with respect to the needle  30 . Once the needle  30  is outside the confines of the slot  24 , the guide  10  and instrument  20  may be longitudinally extracted from the treatment site while the needle  30  remains in place. 
       FIG. 6  illustrates a top view of the retainer  14 . The retainer  14  is a generally elongate member that is configured to extend the length of slot  16  so that a portion of the proximal end  60  of the retainer preferably extends past the proximal end of the guide body  12 . The distal tip  54  of the retainer is preferably tapered to allow it to be readily placed into slot  16  with minimal guidance. The remainder of the retainer  14 , out to the proximal end  60 , then takes a profile that generally matches the internal walls of the slot  16 , such that the retainer is restrained from lateral motion once inside the slot  16 , but freely moves longitudinally inside slot  16 . As shown in the cross section of  FIG. 2 , the sides of the retainer  14  may generally form a trapezoidal shape, in part to match the walls of the slot  16 . However, it is appreciated that the retainer may be configured to conform to a number of different shapes, e.g. circular, semi-circular, elliptical, etc., with corresponding matching internal walls for slot  16 . 
     The retainer  14  also may comprise a pull ring  56  that is retained inside a bore  58  of the retainer  14 . The pull ring  56  facilitates digital maneuvering of the retainer  14  in and out of the slot  16 . 
     Referring now to  FIG. 7 , the slot  16  terminates at stop  52  just short of the distal tip  28  of the guide body  12 . Stop  52  prevents forward motion of the retainer  14  with respect to the guide body  12  once the retainer has been installed along the length of the slot  16 . Thus, when the retainer  14  has been fully installed in guide body  12 , it is only free to move in one direction, i.e. it can only move longitudinally outward from the proximal end  18  of the guide. 
     Referring now to  FIG. 8 , the proximal end  18  of the guide body  12  has a recess  50  emanating from the exit point of groove  24  and slot  16 . Recess  50  allows the needle  30  and hub  32  to be deflected downward so that the retainer may clear the hub  32  and be removed from the guide body  12 . 
     Referring back to  FIG. 2 , guide  10  preferably may be coupled to instrument  20  by a coupling means, such as a ring shaped fastener  40 , which is positioned at the proximal end  18  of the guide body  12 . It will be appreciated that any number of rings, including a second ring at the distal end  28  (not shown), could be used as well without departing from the scope of the invention. Instrument  20  fits within rings  40 , and the longitudinal position of the apparatus in relation to instrument  20  is held fixed by locking means  42 , that has a cam-type latch  46  which may be used to secure the guide  10  to the instrument  20 . To release the guide  10  from the instrument  20 , the latch  46  may be pulled back to allow the ring to rotate open along hinge  44 . 
     The guide body  12  with ring  40  generally comprises an internal surface  22  that conforms to the shape of the instrument  20 , and may be configured to accommodate a variety of instruments and geometries. Referring to  FIG. 7 , the distal tip may have a pair of protrusions  64  located on the internal surface. The protrusions  64  may be used to lock into a groove or other feature of the instrument  20 . 
     Additionally, the locking means  42  could alternatively comprise a set screw or any other type of fastener, although it is preferred that the fastener be of a type that allows the ring to be disconnected or disengaged from the transducer. It will also be appreciated that other detachable coupling means, such as slotted joints (e.g., dovetail or dado-like joints), adjustable circumference bands or the like, could be employed to fasten needle guide  10  to instrument  20  instead of using ring  40 . 
       FIGS. 9A-9B  illustrate a method of guiding a needle into a body lumen, e.g. for transrectal or transvaginal pelvic abscess drainage. As shown in  FIG. 9A , the needle guide  10  of the present invention is installed on the ultrasound transducer  20  and inserted (e.g. endovaginally or endorectally) into the body cavity  100 . The ultrasound probe  20  (or other similar device known in the art) is used to guide placement of the distal tip  28  of the guide to the appropriate region, i.e. treatment area  102  where the abscess is located. The needle guide  10  is preferably long enough so that the proximal end  18  of the guide body  12 , bearing the groove  24 , and retainer  14 , is external to the patient for access by the physician. 
     Referring now to  FIG. 9B , after localizing the abscess cavity and ensuring there are no large vessels in its path for example by using color flow, a trocar catheter  30  (or similar device) is then placed through groove  24  of the needle guide  10  at the proximal end  18 , guiding the biopsy needle to a treatment location  102  in the body lumen  100 . The catheter or needle  30  exits the guide  10  at the distal end  28  and into the treatment location. Once the trocar catheter  30  has been placed, the inner stylet (not shown) is removed and the fluid is aspirated. If purulent fluid is aspirated, then the catheter  30  may be pushed from the stiffening canula into the fluid collection. The Cope loop of the catheter is then tightened. 
     As shown in  FIG. 9C , the retainer  14  is removed from the needle guide  10  by sliding it out from the slot  16 . Pulling on loop  56  may facilitate this. With the retainer  14  removed, the upper end of groove  24  opens to allow separation of the catheter  30  from the needle guide  10  and transducer  20 , allowing the catheter  30  to remain at the treatment location  102  in the body lumen. 
     Referring now to  FIG. 9D , the needle guide  10  and transducer  20  may then be removed from the body lumen  100  while the catheter  30  remains at the treatment location  102  in the body lumen. 
     Test Setup and Results 
     Nine patients, in whom a new biopsy guide was used for endorectal or endovaginal drain, are presented. The pelvic abscesses in all patients were non-responsive to antibiotics. Most patients received double antibiotic treatment or triple antibiotic therapy (see Table I). The indication for abscess drainage, includes patients who were septic after suspected abscess after appendectomy (n=3) post surgical, (n=2) diverticulitis, (n=2) and tubal ovarian abscess (n=2). Catheters were placed via the trocar method, using the transrectal route in 6 cases and in the endovaginal route in 3 cases. All patients had received deep conscious sedation with Midazolam hydrochloride (Versed; Hoffman-LaRoche, Inc., Nutley, N.J.) with fentanyl citrate (Abbott Laboratories, Abbott Park, Ill.) using an endovaginal probe CEV-8C4 EC7-Acuson (Acuson, Inc., Mountain View, Calif.). 
     A biopsy guide  10  as shown in  FIGS. 1-9D  was used, and included a central groove  24  for catheter placement and a removable retainer  14  that could be detached from guide  10  after catheter placement. The biopsy guide  10  was large enough to allow trocar placement of a 6.7 French-McGahan catheter (Cook Surgical, Bloomington, Ind.). Once the ultrasound probe was placed, either into the vagina or to the rectum, the trocar technique was used to place the catheter in the fluid collection. 
     When placing the catheter via the endovaginal or the endorectal technique, color flow Doppler ultrasound was utilized to avoid vessels in the intervening path. The inner stylet of the trocar catheter was removed after entering the fluid collection, and fluid aspiration was performed. In all cases, the catheter was then placed after aspiration of turbid or purulent fluid and the fluid was completely drained. The catheter was then placed to a Jackson-Pratt bulb syringe. The catheter was irrigated every shift with normal saline. 
     Patients continued with antibiotic therapy, which was followed and adjusted based upon the results of the culture. The catheter was removed after patients became afebrile for 24 hours, had a normal white count in drainage less than 10 mls per day, and showed a decrease in abscess cavity on CT. The patients were then followed, clinically, after catheter removal. 
     Eight of 9 patients had successful aspiration and drainage of fluid collections under ultrasound guidance using the method of the present invention. In one patient, the catheter was successfully placed into a suspected pelvic hematoma that did not decrease significantly in size with drainage. Turbid or purulent fluid was obtained in 8 of 9 patients. The cultures of these abscesses are shown in Table 1. 
     All patients improved clinically and were later discharged from the hospital. One patient (#8) with an infected hematoma did not respond to catheter drainage and required surgery. Catheter removal occurred from 2 to 11 days not counting the one unsuccessful drainage of a pelvic hematoma. No complications were encountered in any of these patients. 
     The following references are incorporated by reference in their entirety:
     1. Casola G, vansomenberg E, D′Agostino H B, Harker C P, Varney R R, Smith D. Percutaneous drainage of tubo-ovarian abscesses. Radiology. 1992 February; 182(2):399-402   2. Butch R J, Mueller P R, Fermcci J T Jr, Wittenberg J, Simeone J F, White E M, Brown A S. Drainage of pelvic abscesses through the greater sciatic foramen. Radiology. 1986 February; 158(2):487-91.   3. Alexander P L P L, Eschelman D J, Nazarian L N, Bonn J. Transrectal sonographically guided drainage of deep pelvic abscesses. AJR Am J Roentgenol. 1994 May; 162(5): 1227-30; discussion 123 1-2.   4. Kuligowska E, Keller E, Fermcci J T. Treatment of pelvic abscesses: value of one-step sonographically guided transrectal needle aspiration and lavage. AJR Am J. Roentgenol. 1995 January; 164(1):201-6   5. McGahan J P, Brown B, Jones C D, Stein M. Pelvic abscesses: transvaginal US-guided drainage with the trocar method. Radiology. 1996 August; 200(2):579-81.   6. Vansomenberg E, D′Agostino H B, Casola G, Goodacre B W, Sanchez R B, Taylor B. US-guided transvaginal drainage of pelvic abscesses and fluid collections. Radiology. 1991 October; 181(1):53-6.   7. Lee B C, McGahan J F, Bijan B. Single-step transvaginal aspiration and drainage for suspected pelvic abscesses refractory to antibiotic therapy. J Ultrasound Med. 2002 July; 21(7):731-8.   8. Hovsepian D M, Steele J R, Skinner C S, Maiden E S. Transrectal versus transvaginal abscess drainage: survey of patient tolerance and effect on activities of daily living. Radiology. 1999 July; 212(1): 159-63.   9. Nielsen M B, Torp-Pedersen S. Sonographically guided transrectal or transvaginal one-step catheter placement in deep pelvic and perirectal abscesses. AJR Am J Roentgenol. 2004 October; 183(4): 1035-6.   10. Varghese J C, O&#39;Neill M J, Gervais D A, Boland G W, Mueller P R. Transvaginal catheter drainage of tuboovarian abscess using the trocar method: technique and literature review. AJR Am J Roentgenol. 2001 July; 1 77(1): 139-44. Review.   11. Eschelman D J, Sullivan K L. Use of a Colapinto needle in US-guided transvaginal drainage of pelvic abscesses. Radiology. 1993 March, 186(3):893-4.   

     Although the description above contains many details, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention. Therefore, it will be appreciated that the scope of the present invention fully encompasses other embodiments which may become obvious to those skilled in the art, and that the scope of the present invention is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” All structural, chemical, and functional equivalents to the elements of the above-described preferred embodiment that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Moreover, it is not necessary for a device or method to address each and every problem sought to be solved by the present invention, for it to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed under the provisions of 35 U.S.C. 112, sixth paragraph, unless the element is expressly recited using the phrase “means for.” 
     
       
         
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                   
                   
                   
                   
                 Cx 
                 Abx 
                 Surg 
                   
                   
               
               
                 Pat # 
                 Hx 
                 Size 
                 Drains 
                 (transrectal/vag only) 
                 Pre-drain 
                 Post 
                 Pt Outcome 
                 Days 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 1 
                 s/p appy perf 
                 3.5 × 4   
                 1. transrectal deep pelvic 6.7F 
                 
                   Enterobacter cloacae 
                 
                 Ampicillin 
                 No 
                 CT significant 
                 8 
               
               
                   
                   
                   
                 2. LLQ 6F McGahon 
                 
                   Keibsiella pneumonia 
                 
                 Flagyl 
                   
                 improvement of 
               
               
                   
                   
                   
                 3. Low central abd 8F APD 
                 
                   Psuedomonas auruginosa 
                 
                 Gentamycin 
                   
                 pelvic abscess 
               
               
                 2 
                 s/p appy perf 
                 3 × 4 
                 Transrectal 6.7F McGahon 
                 
                   E. coli 
                 
                 Cefotaxime 
                 No 
                 CT drain in place, 
                 6 
               
               
                   
                   
                   
                   
                   Staphlococcus , coag(−) 
                 Flagyl 
                   
                 abscess significant 
               
               
                   
                   
                   
                   
                   
                   
                   
                 improvement 
               
               
                 3 
                 s/p appy perf 
                 5 × 6 
                 1. Transrectal 6.7F McGahon 
                 
                   Strep viridans 
                 
                 Unknown 
                 No 
                 Drain removed 
                 3 
               
               
                   
                   
                   
                 2. RLQ 10F Dawson-Meuller 
                   
                   
                   
                 prior to d/c 
               
               
                 4 
                 R TOA 
                 4 × 5 
                 Transvag 6.7F 
                 
                   E. coli 
                 
                 Clyndamycin 
                 No 
                 Cath removed by 
                 2 
               
               
                   
                   
                   
                   
                   Keibsiella  species 
                 Gentamycin 
                   
                 clin. Request for pt 
               
               
                   
                   
                   
                   
                   
                   
                   
                 d/c. US showed 
               
               
                   
                   
                   
                   
                   
                   
                   
                 improvement, but 
               
               
                   
                   
                   
                   
                   
                   
                   
                 fluid still 9.6 cm 
               
               
                 5 
                 s/p 
                  5 × 19 
                 Transvag 6.7F 
                   Staph , coag negative 
                 Unknown 
                 No 
                 CT resolved 
                 2 
               
               
                   
                 diverticulitis 
                   
                   
                   
                   
                   
                 abscess pt d/c 
               
               
                 6 
                 s/p MVA 
                   2 × 4.5 
                 1. Transrectal 6.7F 
                 
                   Psuedomonas auruginosa 
                 
                 Metronidazole 
                 No 
                 CT improvement, 
                 11 
               
               
                   
                 multiple 
                   
                 2. Midline 8F pigtail 
                   
                 Cipro 
                   
                 CT resolved. Drain 
               
               
                   
                 abscesses, 
                   
                 3. L subdiaphragmatic 8.2F 
                   
                 Fluconazole 
                   
                 still in place 
               
               
                   
                 feeding tube 
                   
                 pigtail 
                   
                 Tobramycin 
               
               
                   
                 misplace- 
               
               
                   
                 ment 
               
               
                 7 
                 s/p pelvic 
                 2.5 × 6   
                 1. Transrectal 7F loop (lamba) 
                 Gram(−) rod, lactulose+ 
                 Ampicillin 
                 No 
                 Drains removed 
                 9 
               
               
                   
                 surg 
                   
                 2. LLQ CT 12F loop (lamba) 
                   
                 Gentamycin 
               
               
                   
                   
                   
                   
                   
                 Flagyl 
               
               
                 8 
                 s/p 
                 4 × 6 
                 Transrectal 6.7F McGahon 
                 Nonsporeforming gram+ rod 
                 Unclear, 
                 Yes* 
                 Long Hospital 
               
               
                   
                 diverticulitis 
                   
                 into R pararectal 
                   Enterococcus  species 
                 started w/ 
                   
                 course, several 
               
               
                   
                 perf 
                   
                 infected hematoma 
                 
                   Bacteroides fragiles 
                 
                 Cefotaxime 
                   
                 surgeries, multiple 
               
               
                   
                   
                   
                   
                 
                   Clostridium 
                 
                 Flagyl Long 
                   
                 abscess drainages* 
               
               
                   
                   
                   
                   
                 
                   Psuedomonas auruginosa 
                 
                 Hospital 
                   
                 because 
               
               
                   
                   
                   
                   
                 
                   Lactobacillius 
                 
                 course-on 
                   
                 hematoma not 
               
               
                   
                   
                   
                   
                   Provotella / bacteroides   
                 many Abx 
                   
                 resolved 
               
               
                 9 
                 tubovarian 
                 5 × 9 
                 Transvag 6.7F McGahon into 
                 
                   Bacteroides uniformis 
                 
                 Unknown 
                 No 
                 US demonstrated 
                 8 
               
               
                   
                 abscess 
                   
                 peri ovarian abcess 
                 Mixed flora 
                   
                   
                 resolution