Abstract:
A manually manipulatable tool for removing a fecal impaction, the tool is adapted for insertion into a patient&#39;s rectum to engage and penetrate the impaction. The tool is fitted with flexible, arcuately configured elements collapsible at least partially during insertion into the rectum and penetration of the fecal impaction, withdrawal of the tool deploying the elements to exert traction on the impaction thus facilitating withdrawal of at least portions of the impaction. A body member of the tool is preferably elongated and can optionally be provided with a longitudinally extending lumen for introduction of an enema solution concurrently with or independently of impaction removal.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention relates generally to tools for removal of fecal impactions and particularly to such a tool configured for ease of useage and safety of operation for rapid and reliable removal of a fecal impaction. 
     2. Description of the Prior Art 
     Patients often present in clinical settings with impacted stools that can only be evacuated spontaneously with extreme difficulty if at all. Such blockages are typically referred to as fecal impactions and result from the inability to spontaneously empty the rectum of accumulated stool. A fecal impaction occurs due to excessive and continuing fecal mass accumulation in the rectal vault such that the large and growing fecal bolus cannot be readily passed through the anus. The impaction worsens as additional stool is produced and typically hardens with drying of distal portions of the impacted stool, thereby creating an increasingly uncomfortable and potentially dangerous emergency condition. Medical intervention is often required for removal of the impaction from the rectum especially once the density and mass of the accumulating stool precludes passage spontaneously. 
     While fecal impactions can occur in otherwise healthy individuals, those suffering from certain medical conditions including neuromuscular diseases and severe debilitation as well as those in the general geriatric population are susceptible to the spontaneous development of fecal impactions. Accordingly, fecal impaction is a commonly encountered condition in patients not only presenting in an emergency situation at a medical facility but also for patients hospitalized for other conditions. 
     Current clinical practice typically relies on repeated insertions of a finger of a medical practitioner through the anus and into the rectum of a patient for removal of the impaction. Practitioners called upon to accomplish this task include nurses, paramedics, medical technicians as well as physicians. As presently practiced, a clinician inserts a gloved finger through the patient&#39;s anus and into the rectum in an effort to manually dislodge the stool mass either entirely or in fragments. The gloved finger probes the fecal mass in an effort to break up the mass followed by retrieval of fragmented portions of the mass. The patient may become capable of spontaneous defecation once a sufficient portion of the mass has been removed manually. Removal of such sufficient portions or of the entire mass usually necessitates repeated manual interventions coupled with supplemental use of one or more fluid enemas. Hospital admission may be required for more intensive efforts to free an impaction. 
     Manual manipulation of an impacted fecal mass is subject to failure since utilization of a single, gloved finger weighs against application to the impaction of a mechanical advantage sufficient to relieve the condition. A finger is simply not configured to grasp the fecal mass or to gain attachment thereto due to the shape of a finger and the inability to frictionally engage the mass. Probing of the fecal mass with the finger of a clinician involves blind sweeps and stirring motions that are not easily directed advantageously and thus can prove ineffective. Patient discomfort is often increased by attempts of the attending clinician to curl the inserted finger in an effort to improve connection with the fecal mass. This flexion motion, though essential to the effort to grasp a portion of the fecal mass, causes further distention of an already distended bowel. Pain thus unavoidably accompanies inefficiency during attempts to remove the impaction and often results in the necessity to abort the procedure. Once an ineffective manual procedure is discontinued, hospitalization for repeated enema treatment becomes necessary with reliance then being placed on hydrodynamic dissolution of the impaction. 
     Such manual techniques while imperfect are commonly used in spite of the existence in the prior art of devices of varying complexity intended to address the task of fecal impaction removal. Examples of such devices include the apparatus disclosed by Klingenstein in U.S. Pat. No. 5,730,726, the disclosed apparatus comprising a shaft having flexible spines that can be bowed away from the shaft to engage the fecal mass after insertion into a patient&#39;s rectum. Smith, in U.S. Pat. No. 4,243,037, discloses a fecal impaction removal device comprising a plunger assembly adopted for introduction into the rectum of a patient and having prongs intended to engage an impacted fecal mass. In U.S. Pat. No. 3,316,912, Whitaker discloses a device insertable into the rectum followed by extension of a hinged scoop-like element intended to capture a portion of an impaction for removal. Sourwine, in U.S. Pat. No. 833,759, discloses a double loop handle connected to a distal and proximal dilator as well as expandable blade elements intended to permit more ready insertion and engagement of the impaction. Sims, in U.S. Pat. No. 1,448,158, discloses blades disposed closely along a shaft for insertion into the rectum with spreading of the blade after insertion to engage the fecal mass. The patents to Sourwine and Smith further disclose use of central channels in the respectively disclosed devices for introduction of enema solutions while said devices are contained within the rectal vault. 
     While fecal disimpaction devices have previously been suggested in the art, the art still experiences a need for a simple, inexpensive, safe and efficacious tool for removal of fecal disimpactions, the fecal disimpaction tool disclosed herein meeting these needs long-felt in the art through provision of a tool having distal and proximal dilators facilitating insertion into and withdrawal from the anus of a patient as well as flexible, arcuately configured finger-like elements formed of a flexible though non-elastic material collapsible against a central shaft during insertion and opening once within the rectal vault to engage the fecal mass for removal. The fecal disimpactor of the invention is shown to produce the functions and advantages thus referred to as is shown and described herein. 
     SUMMARY OF THE INVENTION 
     The invention provides a fecal impaction removal tool capable of use with maximum effectiveness and minimal patient discomfort. A preferred embodiment of the invention comprises an elongated shaft having a central lumen extending longitudinally therethrough, the lumen being provided proximally with a connection mechanism such as a Luer lock or similar coupling mechanism adapted for connection to a water jet or enema administration system that could comprise a syringe or the like. A handle such as can be comprised of twin loops can be integrally formed on the shaft adjacent the proximal opening of the lumen. The shaft of the tool terminates distally in a shaped dilator permitting ease of insertion into the anus of a patient suffering from a fecal impaction. A second dilator spaced from said first dilator along the shaft facilitates withdrawal of the tool from the patient, a series of flexible, arcuately configured grappling elements being disposed between the first and second dilators. The elements are preferably formed of a resinous material having a lower durometer relative to that of the resinous material forming the shaft, the dilator and remaining portions of the tool. 
     The grappling elements are shaped to cant backwardly from the first dilator and toward the second dilator, insertion of the tool into the anus of a patient causing the elements to compress inwardly behind the first dilator as the tool advances into the rectum to penetrate the fecal compaction. The tool is inserted sufficiently to cause the second dilator to be inserted through the anus of the patient so that the first and second dilators as well as the series of elements are disposed completely within the patient&#39;s rectal vault and have essentially pierced the fecal impaction. The tool can then be manipulated such as by twisting and by inward and outward movements of the tool short of withdrawal of the second dilator from the anus so that the impaction can be loosened and portions thereof can be fractured or subjected to a grasping action by the elements which extend outwardly of the shaft on manipulation such as can include partial back and forth movements of the tool within the rectal vault. Alternatively, the tool can simply be withdrawn after insertion as aforesaid thereby to cause outward extension of the elements and engagement between the elements and the fecal impaction prior to complete withdrawal of the tool through the patient&#39;s anus to thereby remove at least portions of the fecal impaction engaged with the elements and subject to loosening and fragmentation by the actions of the tool. 
     Practice of the invention can include use of the disimpaction tool more than once after cleaning. The use of more than one tool is desired since the procedure proceeds more rapidly if cleaning is not practiced. The tool of the invention is therefore preferably manufactured as a disposable item. 
     As noted herein, the shaft can be formed with a centrally disposed lumen terminating proximally in an opening adapted to be fitted with a conventional lock configured to be connected to a reservoir of enema fluids including gently pressurized fluid, fluid flow through the hollow shaft and exiting the shaft via ports located in the shaft between the first and second dilators resulting in contact between and entry of enema fluid into the fecal mass to facilitate loosening and fragmentation of the mass such that the grappling elements of the tool can grasp at least portions of the mass for removal. 
     Embodiments of the invention can conveniently be provided with three to four sets of the grappling elements, the sets of elements either being oriented identically along the shaft or rotated relative to adjacent sets to produce an interdigitated arrangement or even a “swirling” arrangement. The elements are preferably shaped with arcuate outer edges, each edge being disposed in opposing relation to the edge of said element located on the opposite side of the shaft. The elements are preferably formed with ridges extending at right angles to the shaft and disposed in proximity to edges of each element and on surfaces of the elements facing the proximal end of the tool, the ridges acting to engage the fecal mass more effectively. A reinforcing strut can be formed in each element set on proximal surfaces thereof and on portions of the elements on each side of the shaft. Pairs of ports communicating with the lumen of the hollow shaft are preferably formed in the shaft immediately proximally to each set of elements. 
     Accordingly, a primary object of the invention is to provide a reliable, inexpensive and easily and safely used tool for removing a fecal impaction, the tool having a shaped distal dilator facilitating insertion of the tool through the anus of a patient as well as for fragmentation of the impaction, the shaft being further formed with arcuately recurved grappling elements disposed proximally of the distal dilator and capable of compression toward the shaft during insertion and expansion into engagement with the impaction on full insertion into the rectal vault, the elements facilitating removal of at least portions of the impaction on removal of the tool through the patient&#39;s anus. 
     It is another object of the invention to provide a fecal impaction removal tool having a distal dilator and compressible or collapsible grappling elements located proximally of the dilator and formed on and with an elongated shaft, the shaft having an elongated lumen extending along the shaft from the anterior end of the shaft toward the distal dilator, the lumen being adapted to receive enema fluids therethrough, the fluids being vented from ports disposed near the distal dilator and into the fecal mass of the impaction to facilitate removal of the impaction. 
     It is a further object of the invention to provide a fecal impaction removal tool having a shaft, a handle disposed on a proximal end of the shaft to permit manipulation of the tool and sized to prevent loss of the tool into the rectal vault on insertion of the tool into the anus of a patient, and a distal dilator formed on the ends of the shaft opposite the handle, a proximal dilator also being formed on and with the shaft and spaced from the distal dilator, the shaft, the dilator and the handle being formed of a first relatively hard resinous “plastic” material and a series of compressible grappling elements formed on the shaft between the dilators and formed of a second “plastic” material of a reduced durometer or hardness relative to the durometer of the first material. 
     Further objects and advantages of the invention will become more readily apparent in light of the following detailed description of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of a first embodiment of the invention shown from a distal end of the invention; 
         FIG. 2  is a perspective view of the article shown in  FIG. 1  seen from an anterior end; 
         FIG. 3  is a side elevational view of the article seen in  FIG. 1 ; 
         FIG. 4  is a side elevational view of the article seen in  FIG. 3  and rotated ninety degrees about a longitudinal axis from the position seen in  FIG. 3 ; 
         FIG. 5  is a plan view of the article seen in  FIG. 1 ; 
         FIG. 6  is a bottom view of the article seen in  FIG. 1 ; 
         FIG. 7  is a side elevational view in section of the article as seen and as oriented in  FIG. 3 ; 
         FIG. 8  is a detail perspective view of the article seen in  FIG. 1 ; 
         FIG. 9  is a perspective view of a second embodiment of the invention; 
         FIG. 10  is a side elevational view of the article shown in  FIG. 9 ; 
         FIG. 11  is a side elevational view of the article seen in  FIG. 10  and rotated ninety degrees about a longitudinal axis from the position seen in  FIG. 10 ; 
         FIG. 12  is a plan view of the article seen in  FIG. 9 ; 
         FIG. 13  is a perspective view of a third embodiment of the invention; 
         FIG. 14  is a side elevational view of the article shown in  FIG. 13 ; 
         FIG. 15  is a side elevational view of the article seen in  FIG. 14  and rotated ninety degrees about a longitudinal axis from the position seen in  FIG. 14 ; 
         FIG. 16  is a plan view of the article seen in  FIG. 13 ; 
         FIG. 17  is a perspective view of a fourth embodiment of the invention; 
         FIG. 18  is a side elevational view of the article shown in  FIG. 17 ; 
         FIG. 19  is a side elevational view of the article seen in  FIG. 18  and rotated ninety degrees about a longitudinal axis from the position seen in  FIG. 18 ; and, 
         FIG. 20  is a plan view of the article seen in  FIG. 17 . 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring now to the drawings and particularly to  FIGS. 1 through 8 , a fecal impaction removal tool configured according to a first embodiment of the invention is seen at  10  to comprise an elongated shaft  12  preferably formed of a resinous or “plastic” material of a durometer imparting a desired rigidity such that a medical practitioner can insert distal portions of the tool  10  through the anus of a patient and into the rectal vault to engage an impacted fecal mass lodged therein. The flexible shaft  12  is sufficiently rigid to allow partial insertion of the tool  10  into the rectum as well as manipulation of the tool  10  while engaged with an impaction followed by withdrawal to remove at least fragments of an impaction created by manipulation of the tool  10 . 
     The shaft  12  is terminated proximally by a handle  14  formed of loops  16  each capable of receiving one of a practitioner&#39;s fingers for ease of use of the tool  10  such as by application of torque to the tool  10  and especially for withdrawal of the tool  10  from the patient. The loops  16  are preferably formed integrally with the shaft  12  with each loop  16  being disposed in opposed relation in proximity to the proximal end of the shaft  12 . The handle  14  is dimensioned to prevent entry of the entire tool  10  into the anus to prevent “loss” of the tool  10  into the rectum. As seen particularly in  FIGS. 2 and 6 , the shaft  12  terminates at it&#39;s proximal end in a locking adaptor  18  such as a conventional Luer lock. The locking adaptor  18  is disposed at the proximal end of a lumen  20  extending through the shaft  12  internally thereof thus forming a channel within the shaft  12  and causing the shaft  12  to be hollow through a substantial extent thereof from the proximal end inwardly toward a distal end of said shaft  12 . The lumen  20  serves as a conduit for delivery of fluids such as enema fluids under pressure, the locking adaptor  18  facilitating connection to an apparatus (not shown) acting as a reservoir of such fluids with the unshown apparatus providing a capability to deliver enema fluids into the lumen  20 . Such apparatus can comprise a syringe (not shown) or other device capable of secure coupling to the proximal end of the shaft  12  for delivery of an enema fluid into the lumen  20 . The fluids thus introduced into the interior of the hollow shaft  12  are chosen for facilitation of stool softening, lubrication and/or mechanical absorption of an impacted fecal mass disposed in a patient&#39;s rectum. Such fluids can be introduced concurrently with or independently of manipulation of an impaction such as prior to intended manipulation. 
     As is best seen in  FIGS. 1 ,  3  and  8 , the shaft  12  is formed with ports  22  disposed in spaced relation along the shaft  12  at locations along the shaft  12  near the distal end of said shaft. The ports  22  communicate the lumen  20  with an impaction or with the interior of the rectal vault so that enema solution introduced as aforesaid into the hollow shaft  12  is caused to contact an impacted fecal mass to facilitate softening and/or fragmentation of the mass either prior to or during manipulation of the tool  10  such as by application of torque by a practitioner manually grasping the loops  16  of the handle  12  and/or by a series of small inward and outward displacements of the tool  10 . The ports  22  are typically formed in the shaft  12  in pairs with one each of the ports  22  in a pair of ports being located oppositely across the width or diameter of the shaft  12 . As will be further described herein, the ports  22  are typically disposed immediately adjacent to and proximally of sets  24  of flexible, arcuately configured grappling elements formed on the shaft  12  as will be further described hereinafter. 
     The shaft  12  terminates distally in a first dilator  28  of a substantially ogive conformation with a rounded tip  30 , the dilator  28  preferably being formed integrally with the shaft  12 . The dilator  28  is formed distally in a cruciform configuration from a plurality of regularly spaced elements  32  that taper toward the tip  30  and join proximally to a substantially circular base  34  joined to the shaft  12 . The elements  32  as well as surfaces of the base  34  are relieved, that is, essentially rounded such that the dilator  28  can be inserted into and withdrawn from a patient&#39;s anus with ease and with minimal discomfort to the patient. The dilator  28  can be lubricated prior to insertion even though the material from which the dilator  28  as well as the shaft  12  inter alia is formed is chosen to exhibit low surface friction. The dilator  28  is shaped and sized such that insertion minimally distends an impacted fecal mass as well as the rectal vault to minimize patient discomfort. 
     A proximal dilator  36  is formed integrally with the shaft  12  in spaced relation to the distally disposed dilator  28 . The dilator  36  is conically shaped proximally to facilitate removal of the tool  10  once manipulation of an impacted fecal mass has occurred. The dilator  36  can be formed with smooth, low friction surfaces over the exterior thereof and can be formed in a cruciform configuration as is the dilator  28  is formed distally except with such cruciform shape extending in the direction of withdrawal of the tool  10 . The dilator  36  is intended to be received through the anus of a patient during insertion of the tool  10  and is therefore configured with an inwardly rounded annular shoulder  38  formed distally of the dilator  36 . The dilator  36  configured as aforesaid facilitates the atraumatic withdrawal of the tool  10  through dilation of the anus and relaxation of the anal sphincter. Such relaxation and dilation permit withdrawal of at least portions of an impacted fecal mass engaged with the tool  10  with minimal effort and with minimal discomfort to the patient. 
     The shaft  12  of the tool  10  is further seen to be configured with spaced sets  24  of the flexible, arcuately configured grappling elements  26  disposed between the distally disposed dilator  28  and the proximal dilator  36 . As is seen in  FIGS. 1 through 8 , the tool  10  is provided with three of the sets  24  while other drawings illustrate tools having three sets of grappling elements arranged in differing orientations as will be described hereinafter. The number of the sets  24  used in a particular tool configured according to the invention can vary and be other than is shown herein, the relative orientation between the sets  24  also varying as seen hereinafter and as is contemplated according to the invention. 
     Each of the grappling elements  26  comprising each one of the sets  24  can be identical and can comprise a substantially straight-edged inner body portion  27  having arcuate perimetric portions  29  at each end of said body portion  27 . The elements  26  are preferably formed on and about the shaft  12  by co-extrusion of a “plastic” or resinous material of lesser durometer than forms the shaft  12  during formation of the tool  10 . The material forming the elements  26  are thus preferably formed of a “softer” material to allow flexure of a sufficient degree to permit each element  26  of each arcuately-shaped set  24  to bend inwardly toward the shaft  12  on insertion of the tool  10  into the anus of a patient. The elements  26  can bend sufficiently to compress inwardly to positions wherein the perimetric portion  29  of each said element  26  virtually lies per se along the shaft  12  such that said element  26  need not create an entry path into the anus or into an impacted fecal mass. However, on full receipt into the fecal mass, compressing pressure on the elements  26  is either released due to restoring spring-like forces provided by the elements  26  per se and/or by manipulation of the tool  10  in one or more series of short inward and outward movements of the tool  10 . The elements  26  during engagement with a fecal mass thus extend outwardly of the shaft  12  to positions similar to those existing prior to insertion. The fecal mass is thus engaged by the elements  26  in a “hooking” action and can be fragmented while embedded within the mass. Ridges  31  formed on rearwardly facing surfaces of the elements  26  act to increase retention of at least portions of the fecal mass on the tool  10 . 
     As is best seen in  FIG. 8 , structural stability of the sets  24  is enhanced by integrally formed reinforcement struts  33  extending partially along a central axis of each of the elements  26  from the shaft  12 . Further structural contributions are provided by concentric and congruent annuli  35  and  37  formed integrally with each set  24  on that side of said set facing proximally of the tool  10 , the annulus  35  contiguous with the elements  26  being of greater diameter than the diameter of the annulus  37 . Both of the annuli  35  and  37  are formed about the shaft  12  with the annulus  37  extending outwardly of the larger annulus  35  and being carried thereby. Clearly, these structural elements can be formed other than as explicitly shown. 
     Each set  24  of the elements  26  are seen to be oriented in an aligned relation to adjacent sets  24  as seen in  FIGS. 1 through 8 . As will be described hereinafter, the sets  24  can be otherwise oriented. The orientations herein shown as well as other orientations and numbers of the sets  24  contemplated by the invention function to produce the intended result of removal of fecal impactions. 
     Once the tool  10  has been inserted into the anus of a patient and manipulated to abduct the elements  26  from a position folded toward and along the body of the shaft  12  as is caused by insertion, the impacted fecal mass is engaged and then manipulated through manual movement of the handle  14  by a practitioner, these movements being translated along the shaft  12  to the opposite end of the tool  10  carrying the dilators  28  and  36  as well as the sets  24  of grappling elements  26 . The length of the shaft  12  is chosen to be sufficient to efficiently permit insertion of the dilators  28  and  36  as well as the elements  26  and to effectively transmit forces exerted on the handle  14  to the distal end of the tool  10 . It is to be understood that the grappling elements  26  can be formed in alternate embodiments of a sufficiently rigid material, such as the material forming the shaft  12 , so that the sets  24  do not appreciably deform toward the shaft  12 . 
     The pairs of the oppositely aligned ports  22  can best be seen in  FIGS. 1 ,  3  and  8  to be disposed between adjacent sets  24  of the elements  26 , the elements  26  collapsing in preferred embodiments on insertion of the tool  10  as aforesaid such that the ports  22  are shadowed by portions of said elements  26  and are thus protected from fecal occlusion by the collapse of a portion of said elements  26  over each port  22 . However, fluid can exit the ports  22  while the elements  26  are collapsed thereover although abduction of the elements  26  after insertion permits pressurized fluid exiting the ports  22  to be more effectively directed against an impacted fecal mass. 
     Referring now to  FIGS. 9 through 12 , a second embodiment of the invention designated as tool  40  is seen to be essentially identical in all respects to the embodiment of  FIGS. 1 through 8  with the exception of the relative orientation of sets  42  of grappling elements  48 . The tool  40  is seen to be provided with distal and proximal dilators  44  and  46  respectively in a manner identical to the structure of the tool  10 . However, the sets  42  and the grappling elements  48  are seen to be rotated angularly relative to each other by approximately 45° which, for a tool having four sets  42  of the grappling elements  48  as does the tool  40 , produces a “swirling” arrangement of the sets  42 . The functions of the tool  40  are essentially identical to the functions of the tool  10  shown in  FIGS. 1 through 8  supra. 
     As is seen in  FIGS. 13 through 16 , a tool  60  is seen to be substantially identical to the tools  10  and  40  described herein with the common exception of the orientation of sets  52  of grappling elements  68 . The tool  60  is provided with distal and proximal dilators  64  and  66  respectively as is common to the tools  10  and  40 . However, the sets  62  of the grappling elements  68  are rotated at 90° angles relative to adjacent sets. The tool  60  is provided with four of the sets  62  as is seen best in  FIGS. 13 through 15 . The tool  60  functions as to results essentially identically to the function of the tools  20  and  40 . 
     Referring now to  FIGS. 17 through 20 , a tool  70  is seen to be substantially identical to the tools described above with the exception of the orientation of sets  72  of grappling elements  78 . The tool  70  is provided with distal and proximal dilators  74  and  76  respectively as is common to the tools described above. However, the second and third sets  72  of the grappling elements  78  from the tip of the tool  70  are rotated at 45 degree angles, the tool  70  having a total of three of the sets  72 . A complete “footprint” of the sets  72  is seen to be provided by the use of three of the sets  72  rotated as shown in  FIGS. 17 through 20 . The tool  70  functions as to results essentially identically to the function of the tools described above. 
     While the invention has been described herein in relation to particular embodiments thereof, it is to be understood that the invention can be configured other than as explicitly disclosed and described herein. In practice, the elements  26  can be configured other than as described herein, varying configurations of the elements  26  contemplated by the invention being intended to connect to, grasp, clasp, dig into and/or engage with an impacted fecal mass as disclosed herein and being capable of formation other than as detailed herein. The articles of the invention can further be formed of differing materials consistent with the function of the articles or portions thereof without departing from the scope of the invention. Accordingly, the scope of the invention is to be interpreted in light of the appended claims.