Patent Publication Number: US-2021161701-A1

Title: Bowel waste management systems and methods for use

Description:
FIELD OF THE INVENTION 
     The present invention relates to bowel waste management systems based on collection members having inflatable retention cuffs. 
     SUMMARY 
     A method is disclosed, according to embodiments, of employing a bowel management system in the course of treatment of a human patient. The method comprises: (a) providing a waste transport device that includes (i) a collection member for bowel drainage, the collection member comprising a distal end, a proximal end and a collapsible transsphincteric zone, and (ii) an inflatable retention cuff mounted around the collection member, the cuff being distally displaced from the collapsible transsphincteric zone; and (b) deploying at least a distal portion of the collection member within the patient&#39;s rectum so that the mounted retention cuff is disposed therein and the collapsible transsphincteric zone is disposed across the patient&#39;s sphincter, wherein the mounted retention cuff is characterized by (i) having a maximum diameter greater than 30 mm when inflated in free space to a pressure of 10 cm H 2 O, and (ii) having a maximum diameter, when inflated in free space to a pressure of at least 25 cm H 2 O and at most 60 cm H 2 O, of at least 65 mm and/or at least 1.5 times a maximum diameter of said mounted retention cuff when inflated in free space to a pressure of at most 10 cm H 2 O. 
     In some embodiments of the method, the collection member can be sized for an adult human rectum. 
     In some embodiments of the method, it can be that when the cuff is inflated to a pressure of 10 cm H 2 O, and is deployed within the adult human rectum so that the collection member is co-axial with the human rectum, a widest portion of the cuff is in wrinkled contact with the rectum, and the cuff is unstretched at the wrinkled contact with the rectum. 
     In some embodiments of the method, when the mounted cuff is uninflated or inflated to a pressure of 10 cm H 2 O, and is deployed within the adult human rectum so that the collection member is co-axial with the human rectum, the diameter of the cuff at a widest portion of the cuff can be greater than 30 mm and less than 60 mm. 
     In some embodiments of the method, when the waste-transport device is in free space, it can be that the inflatable cuff cannot be air-inflated to a pressure of 60 cm H 2 O. 
     In some embodiments of the method, when the waste-transport device is in free space, it can be, that the inflatable cuff is operable to be air-inflated to a pressure of 35 cm H 2 O such that during a pressure ramp-up, after reaching a pressure of 20 cm H 2 O an additional 4 cc or an additional 5 cc or more of air is required in order to reach a pressure of 35 cm H 2 O. 
     In some embodiments of the method, it can be that when the mounted cuff is deployed within a rigid in-vitro enclosing tube having an inner diameter of at least 40 mm and not more than 50 mm so that (i) the collection member is co-axial with the rigid in-vitro enclosing tube and (ii) the tube-mounted cuff is uninflated or inflated to a pressure of 10 cm H 2 O, a portion of the mounted cuff is in wrinkled contact with an inner wall of the rigid in-vitro enclosing tube. 
     In some embodiments of the method, it can be that when the mounted cuff is deployed coaxially within the in-vitro enclosing tube and inflated to a pressure of 10 cm H 2 O, a ratio between (i) a length of a band of the cuff in wrinkle-free contact with the in-vitro enclosing tube and (ii) a length of a band of the cuff in wrinkled contact with the in-vitro enclosing tube, is at most 0.01 or at most 0.1 or at most 0.2. 
     In some embodiments of the method, it can be that when the mounted cuff is deployed coaxially within the in-vitro enclosing tube and inflated to a pressure of 40 cm H 2 O, a ratio between (i) a length of the cuff in wrinkle-free contact with the in-vitro enclosing tube and (ii) a length of the cuff in in wrinkled contact with the in vitro enclosing tube is at least 0.3 or at least 0.5 or at least 1. 
     In some embodiments of the method, it can be that throughout a 2-cm long portion of the cuff with a longitudinal center midway between the proximal and distal cuff attachment locations, a Shore A material-hardness value of the cuff material is at most 30 or at most 20 or at most 10. 
     In some embodiments of the method, it can be that wherein throughout a 2-cm long portion of the cuff with a longitudinal center midway between the proximal and distal cuff attachment locations, a Shore A material-hardness value of the cuff material is at least 4 or least 5. 
     According to embodiments disclosed herein, a bowel management system comprises: (a) a waste-transport device including a collection member for bowel drainage, the collection member comprising (i) a distal end and a proximal end, and (ii) a collapsible transsphincteric zone, the collection member being configured such that during normal use, the distal end of the collection member is disposed within a patient&#39;s rectum and the collapsible transsphincteric zone is disposed across the patient&#39;s sphincter; and (b) an inflatable retention cuff mounted around the collection member so as to define fixed proximal and distal cuff-attachment locations on the surface of the collection member, the proximal cuff-attachment location being distally displaced from the transsphincteric zone and the distal cuff-attachment location being at, or proximally displaced from, the distal end, wherein: (i) when the mounted cuff is inflated to a pressure of 10 cm H 2 O in free space, a maximum diameter of the cuff is greater than 30 mm; and (ii) when the mounted cuff is inflated in free space to a pressure of at least 25 cm H 2 O and at most 60 cm H 2 O, a maximum diameter of the cuff is at least 65 mm, and/or at least 1.5 times the maximum diameter of the cuff when inflated in free space to a pressure of at most 10 cm H 2 O. 
     In some embodiments, the collection member can be sized for an adult human rectum. 
     In some embodiments, it can be that when the cuff is inflated to a pressure of 10 cm H 2 O, and is deployed within the adult human rectum so that the collection member is co-axial with the human rectum, a widest portion of the cuff is in wrinkled contact with the rectum, and the cuff is unstretched at the wrinkled contact with the rectum. 
     In some embodiments, it can be that when the mounted cuff is uninflated or inflated to a pressure of 10 cm H 2 O, and is deployed within the adult human rectum so that the collection member is co-axial with the human rectum, the diameter of the cuff at a widest portion of the cuff is greater than 30 mm and less than 60 mm. 
     In some embodiments, it can be that when the waste-transport device is in free space, the inflatable cuff cannot be air-inflated to a pressure of 60 cm H 2 O. 
     In some embodiments, it can be that when the waste-transport device is in free space, the inflatable cuff is operable to be air-inflated to a pressure of 35 cm H 2 O such that during a pressure ramp-up, after reaching a pressure of 20 cm H 2 O an additional 4 cc or an additional 5 cc or more of air is required in order to reach a pressure of 35 cm H 2 O. 
     In some embodiments, it can be that when the mounted cuff is deployed within a rigid in-vitro enclosing tube having an inner diameter of at least 40 mm and not more than 50 mm so that (i) the collection member is co-axial with the rigid in-vitro enclosing tube and (ii) the tube-mounted cuff is uninflated or inflated to a pressure of 10 cm H 2 O, a portion of the mounted cuff is in wrinkled contact with an inner wall of the rigid in-vitro enclosing tube. 
     In some embodiments, it can be that when the mounted cuff is deployed coaxially within the in-vitro enclosing tube and inflated to a pressure of 10 cm H 2 O, a ratio between (i) a length of a band of the cuff in wrinkle-free contact with the in-vitro enclosing tube and (ii) a length of a band of the cuff in wrinkled contact with the in-vitro enclosing tube, is at most 0.01 or at most 0.1 or at most 0.2. 
     In some embodiments, it can be that when the mounted cuff is deployed coaxially within the in-vitro enclosing tube and inflated to a pressure of 40 cm H 2 O, a ratio between (i) a length of the cuff in wrinkle-free contact with the in-vitro enclosing tube and (ii) a length of the cuff in in wrinkled contact with the in vitro enclosing tube is at least 0.3 or at least 0.5 or at least 1. 
     In some embodiments, it can be that throughout a 2-cm long portion of the cuff with a longitudinal center midway between the proximal and distal cuff attachment locations, a Shore A material-hardness value of the cuff material is at most 30 or at most 20 or at most 10. 
     In some embodiments, it can be that throughout a 2-cm long portion of the cuff with a longitudinal center midway between the proximal and distal cuff attachment locations, a Shore A material-hardness value of the cuff material is at least 4 or least 5. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention will now be described further, by way of example, with reference to the accompanying drawings, in which the dimensions of components and features shown in the figures are chosen for convenience and clarity of presentation and not necessarily to scale. Also, in some drawings the relative sizes of objects, and the relative distances between objects, may be exaggeratedly large or small for the sake of convenience and clarity of presentation. In the drawings: 
         FIG. 1  is a perspective view of a bowel waste management system according to embodiments of the present invention. 
         FIG. 2  shows a diagrammatic cross-section of portions of a human&#39;s anatomy, having portions of a bowel waste management system superimposed thereupon, according to embodiments of the present invention. 
         FIGS. 3-5  are schematic drawings of a retention cuff deployed on a distal portion of a waste transport device, the cuff inflated under a variety of conditions, according to embodiments of the present invention. 
         FIG. 6  illustrates a relationship between a contact length and a pressure parameter according to embodiments of the present invention. 
         FIG. 7  shows a flowchart of a method of employing a bowel management system in the course of treatment of a human patient, according to embodiments of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS 
     The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. Throughout the drawings, like-referenced characters are generally used to designate like elements. 
     For convenience, in the context of the description herein, various terms are presented here. To the extent that definitions are provided, explicitly or implicitly, here or elsewhere in this application, such definitions are understood to be consistent with the usage of the defined terms by those of skill in the pertinent art(s). Furthermore, such definitions are to be construed in the broadest possible sense consistent with such usage. 
     The terms ‘distal’ and ‘proximal’ are to be understood as follows: the end of a collection member intended for insertion into a human patient&#39;s rectum is the distal end of the member, and the opposite end is the proximal end.  FIGS. 3-5  show distal direction  951  and proximal direction  901  with respect to a distal portion of collection member  106 , both of these directions being in keeping with the preceding explanation. 
     There is a need for a bowel waste management system having a collection tube with an inflatable cuff that has improved pressure stability and/or good contact even at low pressure, for example to handle the fact that (a) the rectum is not a perfect cylinder and (b) there is some variance in the diameter of human rectums. 
     Embodiments of the present invention relate to apparatus and methods for deploying an inflatable rectal retention cuff achieving a relatively stable cuff pressure, within the range of 25-60 cm H 2 O, under varying volume on the order of 10% of the cuff volume. 
     Unlike previously known art of bowel waste tube retention cuffs, the present invention introduces cuffs that behave significantly different when inflated within an enclosing tube compared with free space inflation. The cuffs&#39; pressure curve is different when inflated within different tube diameters. 
     For the present disclosure and as shown in the figures, it is assumed that when drain tube  106  is in enclosing tube  108  (i.e. either a human rectum or an in-vitro enclosing tube), the drain tube is co-axial with the enclosing tube  108 . For the present disclosure, any feature disclosed with respect to a human rectum may also be provided with respect to an external ‘in vitro’ rigid straight enclosing (i.e. perfectly cylindrical) test tube whose interior width matches that of an adult human rectum similar in size to an in vitro&#39; rigid straight (i.e. perfectly cylindrical) test tube whose interior width/diameter is 50 mm. +/−1 mm or +/−2 mm or +/−3 mm. 
     Referring now to the figures, and in particular  FIG. 1 , a bowel management system  100  according to embodiments comprises a waste-transport device which includes a collection member  106  for bowel drainage. The collection member comprises (i) a distal end  107  and a proximal end  102 , and (ii) a collapsible transsphincteric zone  160 . The collection member  106  is configured such that during normal use, the distal end  107  of the collection member  106  is disposed within a patient&#39;s rectum and the collapsible transsphincteric zone  160  is disposed across the patient&#39;s sphincter. The waste transport device additionally comprises an inflatable retention cuff  200  mounted around the collection member  106  so as to define fixed proximal and distal cuff-attachment locations  212 ,  211  (shown in  FIG. 3 ) on the surface of the collection member  106 . The proximal cuff-attachment location  212  is distally displaced from the transsphincteric zone  160 , and the distal cuff-attachment location  211  is either at the distal end  107  or proximally displaced therefrom. 
     A typical cuff inflation inlet  109  is shown, and can be used for air inflation and/or liquid inflation, e.g., by using tap water or saline solution. 
     In some embodiments, the bowel management system  100  can also include one or more inlets  109  for one or more optional lumens. 
     We refer now to  FIG. 2 , which shows a cross-sectional diagram of a human rectum and sphincter, with details of the collection member  106  superimposed thereupon. The collection member  106  is preferably sized for an adult human rectum. The retention cuff  200  is shown as suitably inflated for contact with the rectum wall  109 . 
     According to embodiments, an exemplary characteristic of the present invention is that when the retention cuff  200  is uninflated or inflated to a pressure of up to 10 cm H 2 O, and is deployed within an adult human rectum so that the collection member  106  is co-axial with the human rectum, a widest portion  431  of the retention cuff  200  is in wrinkled contact with a rectum wall  109 , and the retention cuff  200  is unstretched at the wrinkled contact with the rectum.  FIG. 3  illustrates the inflation of a retention cuff  200  (mounted on collection member  106 ), to 10 cm H 2 O in free space. A longitudinal center line  130  of the collection member is shown as a dotted line. Dashed lines show where the rectum walls  109  would be in the case of inflation within a rectum and not in free space. The measure ‘RR’ indicates the radius of a typical adult human rectum, i.e., being equal to the distance between tube centerline  130  and the dashed-line representation of the location of the rectum wall  108 . According to embodiments, when the mounted retention cuff  200  is uninflated or inflated to a pressure of 10 cm H 2 O, and is deployed within the adult human rectum so that the collection member  106  is co-axial with the human rectum, a maximum diameter of the cuff  200  (the diameter of the cuff  200  at a widest portion of the cuff  200 ) is greater than 30 mm and less than 60 mm. 
       FIG. 4  shows the retention cuff  200  of  FIG. 3 , once again inflated to 10 cm H 2 O, but this time within a solid cylindrical enclosing tube  108 , preferably one having an inner diameter of 50 mm or approximately 50 mm.  FIG. 4  thus illustrates the length of contact between the moderately inflated cuff  200  with the wall of the enclosing tube as RCP WRINKLED , i.e., wrinkled contact with the rectum contact portion. According to some embodiments, when the mounted retention cuff  200  is deployed coaxially within the in-vitro enclosing tube  108  and inflated to a pressure of 10 cm H 2 O, a ratio between (i) a length of a band of the cuff  200  in wrinkle-free contact with the in-vitro enclosing tube  108  and (ii) a length of a band of the cuff in wrinkled contact with the in-vitro enclosing tube  108 , is at most 0.01 or at most 0.1 or at most 0.2. According to some embodiments, when the mounted retention cuff  200  is deployed coaxially within the in-vitro enclosing tube  108  and inflated to a pressure of 40 cm H 2 O, a ratio between (i) a length of the cuff  200  in wrinkle-free contact with the in-vitro enclosing tube  108  and (ii) a length of the cuff  200  in wrinkled contact with the in vitro enclosing tube  108  is at least 0.3 or at least 0.5 or at least 1. 
     In some embodiments, when the mounted retention cuff  200  is inflated in free space to a pressure of at least 25 cm H 2 O and at most 60 cm H 2 O, a maximum diameter of the cuff  200  is at least 65 mm. In some embodiments, a maximum diameter of the cuff  200  is at least 1.5 times the maximum diameter of the cuff  200  when inflated in free space to a pressure of at most 10 cm H 2 O (shown in  FIG. 3 ).  FIG. 5  illustrates the retention cuff  200  of  FIGS. 3 and 4  inflated to a pressure of 40 cm H 2 O in free space. 
     In embodiments, the inflatable retention cuff  200  is characterized by not being able to be air-inflated to a pressure of 60 cm H 2 O when the collection member  106  of the waste-transport device is in free space (or the waste-transport device is in free space). 
     In some embodiments, the inflatable retention cuff  200  is characterized by being operable to be air-inflated to a pressure of 35 cm H 2 O such that during a pressure ramp-up, after reaching a pressure of 20 cm H 2 O, an additional 4 cc or an additional 5 cc or more of air is required in order to reach a pressure of 35 cm H 2 O. 
     In embodiments, the inflatable retention cuff  200  is characterized by a material hardness such that throughout a 2-cm long portion of the cuff  200  with a longitudinal center  130  midway between the proximal and distal cuff attachment locations  211 ,  212 , a Shore A material-hardness value of the cuff material is at most 30 or at most 20 or at most 10. 
     In embodiments, the inflatable retention cuff  200  is characterized by a material hardness such that throughout a 2-cm long portion of the cuff  200  with a longitudinal center  130  midway between the proximal and distal cuff attachment locations  211 ,  212 , a Shore A material-hardness value of the cuff material is at least 4 or least 5. 
     According to embodiments of the invention, contact length between an inflated cuff  200  (e.g., inflated with air or with a liquid such as tap water or a saline solution) and the wall of an enclosed 50 mm tube  108  increases substantially linearly with pressure, i.e., when the cuff  200  is inflated while deployed in the enclosing tube  108 .  FIG. 6  shows a graph comparing the contact length-pressure curve of cuffs  200  according to the present invention (indicated by ‘Ultra-Soft’ in  FIG. 6 ) and a prior art cuff arrangement (indicated by ‘COV cuff’ in  FIG. 6 ). As shown by the graph, the increase in contact length vs. pressure is substantially greater in the case of the ‘Ultra-Soft’ cuffs, i.e., the cuffs of the present invention. 
     A method is now disclosed for employing a bowel management system in the course of treatment of a human patient. As illustrated in the flowchart of  FIG. 7 , The method comprises: 
     Step S 01  providing a waste transport device that includes (i) a collection member  106  for bowel drainage, the collection member  106  comprising a distal end  107 , a proximal end  109  and a collapsible transsphincteric zone  160 , and (ii) an inflatable retention cuff  200  mounted around the collection member  106 , the cuff  200  being distally displaced from the collapsible transsphincteric zone  160 ; and 
     Step S 02  deploying at least a distal portion of the collection member  106  within the patient&#39;s rectum so that the mounted retention cuff  200  is disposed therein and the collapsible transsphincteric zone  160  is disposed across the patient&#39;s sphincter. 
     According to the method, the mounted retention cuff  200  is characterized by (i) having a maximum diameter greater than 30 mm when inflated in free space to a pressure of 10 cm H 2 O, and (ii) having a maximum diameter, when inflated in free space to a pressure of at least 25 cm H 2 O and at most 60 cm H 2 O, of at least 65 mm and/or at least 1.5 times a maximum diameter of said mounted retention cuff  200  when inflated in free space to a pressure of at most 10 cm H 2 O. 
     The present invention has been described using detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the present invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the present invention that are described and embodiments of the present invention comprising different combinations of features noted in the described embodiments will occur to persons skilled in the art to which the invention pertains. 
     In the description and claims of the present disclosure, each of the verbs, “comprise”, “include” and “have”, and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of members, components, elements or parts of the subject or subjects of the verb. As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a marking” or “at least one marking” may include a plurality of markings.