Patent Description:
Indwelling fecal management catheters are often utilized to manage the liquid or semi-liquid fecal matter of non-ambulatory hospital patients. However, many existing fecal management catheters provide a pressure point when the patient is in the sitting position.

<CIT> is considered the closest prior art to the invention and discloses a balloon catheter in which the balloon is mounted on the end of the catheter in a manner that creates a recess or pocket between the catheter wall and balloon wall. The recess or pocket opens toward the proximal end of the catheter. The rigid end of an introducer element or finger is received in the recess to attach it to the catheter. The distal end of the catheter, with the end of the introducer element in the recess, is inserted and positioned within the bowel by manipulating the introducer element or finger. After the catheter is properly positioned in the bowel, the introducer element or finger is withdrawn, detaching it from the catheter as the end of the introducer element slides out of the recess and then out of the bowel. The balloon is inflated prior to or after the withdrawal of the introducer element to anchor the end of the catheter in position within the bowel. Since the distal end of the catheter is made entirely of soft, compliant material, no soft tissue damage can occur from use of the device, even when the catheter remains in place within the body over an extended time period.

Many existing approaches, including those set forth in the above-referenced document, may suffer from one or more drawbacks or limitations, such as those relating to ease of insertion and/or discouraging soft tissue damage. For these reasons among others, there remains a need for further improvements in this technological field.

<CIT> relates to a device for emptying stool from the rectum of a patient by means of a shaft body which is introduced into the bowel via the anus. <CIT> relates to devices for draining or closing a natural or artificial bladder outlet by means of a balloon body. <CIT> relates to a drainage appliance and includes a distal portion with a distensible retention cuff for retaining the distal portion in the rectum. <CIT> relates to a balloon catheter that may include a catheter shaft having a proximal end and a distal end. <CIT> relates to a method of removing material from the stomach of a patient in which a collapsible funnel at the end of a catheter is placed into the stomach. <CIT> relates to a device for transanally introducing an infusion into the rectum or colon of a patient.

According to a first aspect of the present invention, there is provided a cuff in accordance with claim <NUM>. According to a second aspect of the present invention, there is provided a catheter in accordance with claim <NUM>. In certain embodiments, the tubular body portion terminates within the cuff such that the distal face of the body portion is positioned proximally of the distal face of the cuff. In certain embodiments, the body portion is more rigid than the cuff. Further forms, features, and embodiments of the present application will become apparent from review of the drawings and descriptions provided herewith.

Although the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and will be described herein in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives consistent with the present disclosure and the appended claims.

It should further be appreciated that although reference to a "preferred" component or feature may indicate the desirability of a particular component or feature with respect to an embodiment, the disclosure is not so limiting with respect to other embodiments, which may omit such a component or feature. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to implement such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.

Additionally, it should be appreciated that items included in a list in the form of "at least one of A, B, and C" can mean (A); (B); (C); (A and B); (B and C); (A and C); or (A, B, and C). Similarly, items listed in the form of "at least one of A, B, or C" can mean (A); (B); (C); (A and B); (B and C); (A and C); or (A, B, and C). Items listed in the form of "A, B, and/or C" can also mean (A); (B); (C); (A and B); (B and C); (A and C); or (A, B, and C). Further, with respect to the claims, the use of words and phrases such as "a," "an," "at least one," and/or "at least one portion" should not be interpreted so as to be limiting to only one such element unless specifically stated to the contrary, and the use of phrases such as "at least a portion" and/or "a portion" should be interpreted as encompassing both embodiments including only a portion of such element and embodiments including the entirety of such element unless specifically stated to the contrary.

In the drawings, some structural or method features may be shown in certain specific arrangements and/or orderings. However, it should be appreciated that such specific arrangements and/or orderings may not necessarily be required. Rather, in some embodiments, such features may be arranged in a different manner and/or order than shown in the illustrative figures unless indicated to the contrary. Additionally, the inclusion of a structural or method feature in a particular figure is not meant to imply that such feature is required in all embodiments and, in some embodiments, may be omitted or may be combined with other features.

With reference to <FIG>, illustrated therein is an indwelling catheter <NUM> according to certain embodiments. The illustrated catheter <NUM> extends along a longitudinal axis <NUM> defining a proximal direction (downward in <FIG>) and an opposite distal direction (upward in <FIG>), and generally includes a tubular body portion <NUM> having a proximal end portion <NUM> and an opposite distal end portion <NUM>, a cuff <NUM> positioned at the distal end portion <NUM> of the body portion <NUM>, a finger pocket <NUM> positioned between the body portion <NUM> and the cuff <NUM>, an inflation/deflation lumen <NUM> extending from the cuff <NUM> to an inflation/deflation port <NUM>, a first fitting <NUM> mounted to the inflation/deflation port <NUM>, and an evacuation passage <NUM> defined in part by the body portion <NUM> and in part by the cuff <NUM>. In the illustrated form, the indwelling catheter <NUM> is provided in the form of a fecal catheter, and the distal end portion <NUM> is configured for insertion into a patient's rectum. It is also contemplated that the catheter <NUM> may be provided in another form, such as that of a urinary catheter or an airway catheter.

The catheter body portion <NUM> extends from the proximal end portion <NUM> to the distal end portion <NUM>, and partially defines the inflation/deflation lumen <NUM> and the evacuation passage <NUM>. The distal end portion <NUM> includes a tubular wall <NUM> that is received in a central opening <NUM> of the cuff <NUM>, and has a distal face <NUM> defining a body portion inlet <NUM> having a body portion inlet diameter d116. In the illustrated form, the distal face <NUM> is positioned within the cuff <NUM> and proximally of an inlet <NUM> of the evacuation passage <NUM>. As described herein, the body portion <NUM> may be provided as a more rigid construction in comparison to the cuff <NUM>, and in certain forms is provided as a non-collapsible tube.

With additional reference to <FIG>, the cuff <NUM> is positioned at the distal end of the body portion <NUM>, and defines a chamber <NUM> and a funnel-shaped central opening <NUM>. The chamber <NUM> is configured to hold a fluid (e.g., air or saline) when the cuff <NUM> is in an inflated state, which fluid may be expelled to compress or deflate the cuff <NUM>. As illustrated in <FIG>, the central opening <NUM> includes a proximal portion <NUM> extending from a proximal face <NUM> of the cuff <NUM> and a distal portion <NUM> extending to a distal face <NUM> of the cuff <NUM>. The proximal portion <NUM> is sized and shaped to receive the distal end portion <NUM> of the body portion <NUM>, and is defined by a substantially annular wall <NUM> having a first inner diameter d127. The distal portion <NUM> is positioned distally of the proximal portion <NUM>, and is defined by a frustoconical wall <NUM> that expands from the first diameter d127 to a second diameter d154 greater than the first diameter d127. In the illustrated form, the wall <NUM> defining the distal portion <NUM> is substantially frustoconical, and tapers from the second diameter d154 to the first diameter d127 with a constant slope relative to the longitudinal axis <NUM>. It is also contemplated that the distal portion <NUM> have a convex or concave cross-section.

The cuff <NUM> has a total longitudinal length L120, which is comprised of a length L123 of the proximal portion <NUM> and a length L125 of the distal portion <NUM>. In the illustrated form, the proximal portion length L123 is slightly less than half (e.g., about <NUM>%) of the total length L120, and the distal portion length L125 is slightly more than half (e.g., about <NUM>%) of the total length L120. It is also contemplated that other ratios may be utilized. For example, the proximal portion length L123 may be between <NUM>% and <NUM>% of the total length L120. In the illustrated form shown in <FIG> and <FIG>, the distal body portion face <NUM> is offset from the distal cuff face <NUM> by the distal portion length L125, which may alternatively be referred to as the offset distance L125.

With additional reference to <FIG>, the pocket <NUM> is positioned in the proximal portion <NUM> of the opening <NUM> of the cuff <NUM>, and generally includes an open proximal end <NUM> and a closed distal end <NUM>. The pocket <NUM> is positioned between the annular wall <NUM> and the tubular wall <NUM> of the distal end portion <NUM>, and may, for example, be adhered to the annular wall <NUM> and/or the tubular wall <NUM>. The pocket <NUM> provides an area for receiving a finger or insertion tool to facilitate insertion of the distal portion of the catheter <NUM> into a patient's orifice (e.g., rectum). In the illustrated form, the pocket <NUM> is provided as a separate component that is between the annular wall <NUM> and the distal end portion <NUM>. More particularly, the pocket <NUM> comprises a first flap <NUM> that is secured by a sealing <NUM>' on three sides along its periphery <NUM> to the tubular wall <NUM> of the body portion <NUM> such that an inner side of the pocket <NUM> is defined by the wall <NUM> and an outer side of the pocket <NUM> is defined by the flap <NUM>, which is glued to the wall <NUM>. It is also contemplated that the pocket <NUM> may be defined at least in part by the distal end portion <NUM>. As one example, the open proximal end <NUM> may be created by omitting a portion of the sealing <NUM> between the flap <NUM> and the tubular wall <NUM> of the body portion <NUM>. Additionally or alternatively, the flap <NUM> may be secured to the tubular wall <NUM> of the distal end portion <NUM> in a manner analogous to that in which the illustrated flap <NUM> is secured to the annular wall <NUM>.

The inflation/deflation lumen <NUM> has a distal end <NUM> that is open to the chamber <NUM>, a proximal end <NUM> connected with the inflation/deflation port <NUM>, and optionally, a second elongated lumen <NUM> extending between and connecting the distal end <NUM> and the proximal end <NUM> such that the chamber <NUM> is in fluid communication with the inflation/deflation port <NUM>. As a result, the cuff <NUM> is operable to be inflated and deflated via the first fitting <NUM>, which may be provided as a normally closed check valve and can be activated into an open passage with a mating syringe.

The evacuation passage <NUM> is configured to permit fluid (e.g., air, liquid, or semi-liquid) to flow from the inlet <NUM> to the outlet <NUM>. For example, in the illustrated form, effluent will flow from the inlet <NUM> to the outlet <NUM> for discharge from the outlet <NUM>. In certain embodiments, such as those in which the catheter <NUM> is utilized as an airway catheter, the passage <NUM> may further facilitate the flow of fluid (e.g., air) from the outlet <NUM> to the inlet <NUM>, for example during inhalation by the patient.

In the illustrated form, the evacuation passage inlet <NUM> is defined by the distal face <NUM> of the cuff <NUM> and has an inlet diameter d154, and the evacuation passage outlet <NUM> is defined by the proximal face of the body portion <NUM> and has an outlet diameter d154 less than the inlet diameter d154. More particularly, the evacuation passage <NUM> narrows in a distal-to-proximal direction (downward in <FIG> and <FIG>) from the inlet diameter d154 to a third diameter d127 due to the tapered or curved nature of the wall <NUM>, and steps from the third diameter d127 to the outlet diameter d154 due to the thickness t110 of the body portion <NUM>. It is also contemplated that the evacuation passage <NUM> may narrow in the distal-to-proximal direction in another manner. It has been found that providing the evacuation passage <NUM> with a larger inlet <NUM> may aid in enhancing the collection of effluent to be diverted from the patient's cavity.

As noted above, the illustrated catheter body portion <NUM> is a more rigid construction than the cuff <NUM>, and is optionally provided to not extend all the way to the inlet <NUM>. This offset distance L125 between the distal body portion face <NUM> and the distal cuff face <NUM> may reduce the potential pressure point when the patient is in the sitting position.

As also noted above, in the illustrated form, there is a finger pocket <NUM> in an open envelope, which can be created between the cuff <NUM> and the catheter body <NUM> by omitting a portion of the sealing <NUM> all around the perimeter of the joint between the two components. This finger pocket <NUM> with an open space recess between the cuff <NUM> and the catheter body <NUM> allows a finger or insertion tool to be positioned therein during the insertion of the cuff <NUM>, and may provide the added benefit of not extending a more rigid catheter body <NUM> all the way to the inlet <NUM>. This feature may likewise minimize the potential pressure point when the patient is in the sitting position. A device without a finger pocket may require a rigid catheter body tip all the way to the distal end in order to facilitate the shuffle of cuff insertion into a body cavity.

With additional reference to <FIG>, illustrated therein is an alternative arrangement for the pocket <NUM>. The flap <NUM> has a width W136 and a height H136, and is secured on three sides between the cuff <NUM> and the distal end portion <NUM> of the body portion <NUM> by sealing <NUM>' those three sides. An open proximal end <NUM> is thus created on the fourth side, which is the only side that is not glued.

The present application relates to a cuff <NUM> for a catheter <NUM>, the cuff <NUM> comprising: a proximal face <NUM>; a distal face <NUM> opposite the proximal face <NUM> and defining an inlet <NUM> having a first diameter d154; and an opening <NUM> extending along a longitudinal axis <NUM> and through the proximal face <NUM> and the distal face <NUM>, at least a portion of the opening <NUM> having a second diameter d127 less than the first diameter d154 the opening <NUM> comprising a first portion <NUM> open to the inlet <NUM>, wherein the first portion <NUM> expands from the second diameter d127 to the first diameter d154 in a proximal-to-distal direction.

In certain embodiments, the opening further comprises a second portion <NUM> positioned proximally of the first portion <NUM>, the second portion <NUM> having the second diameter d127 along a second portion length L123.

In certain embodiments, the cuff <NUM> has a cuff longitudinal length L120; and wherein the second portion longitudinal length L123 is between <NUM>% of the cuff longitudinal length L120 and <NUM>% of the cuff longitudinal length L120.

The cuff further comprises a pocket <NUM> positioned within the opening <NUM>, the pocket <NUM> having an open proximal end <NUM>.

The pocket <NUM> comprises a flap <NUM>; wherein a first portion of a periphery <NUM> of the flap <NUM> is secured to a wall <NUM> that at least partially defines the opening <NUM>; and wherein a second portion of the periphery <NUM> of the flap <NUM> is not secured to the wall <NUM> to thereby define the open proximal end <NUM>.

In certain embodiments, the first portion <NUM> is frustoconical.

In certain embodiments, the cuff <NUM> further comprises a chamber <NUM> surrounding the opening <NUM> and operable to receive a fluid for inflation of the cuff <NUM>.

The present application relates to a catheter <NUM> comprising the cuff <NUM>, the catheter <NUM> further comprising a tubular body portion <NUM> connected to the cuff <NUM>, wherein a distal body portion face <NUM> is positioned proximally of the distal face <NUM> of the cuff <NUM>.

In certain embodiments, a distal end portion <NUM> of the tubular body portion <NUM> extends into the opening <NUM>.

In certain embodiments, the tubular body portion <NUM> is more rigid than the cuff <NUM>.

Claim 1:
A cuff (<NUM>) for a catheter (<NUM>), the cuff (<NUM>) comprising:
a proximal face (<NUM>);
a distal face (<NUM>) opposite the proximal face (<NUM>) and defining an inlet (<NUM>) having a first diameter (d154); and
an opening (<NUM>) extending along a longitudinal axis and through the proximal face (<NUM>) and the distal face (<NUM>),
wherein the cuff further comprises a pocket (<NUM>) positioned within the opening (<NUM>), the pocket (<NUM>) having an open proximal end (<NUM>), wherein the pocket (<NUM>) comprises a flap (<NUM>),
wherein the cuff (<NUM>) is characterized in that: at least a portion of the opening having a second diameter (d127) less than the first diameter (d154), the opening comprising a first portion open to the inlet, wherein the first portion expands from the second diameter (d127) to the first diameter (d154) in a proximal-to-distal direction,
and further characterized in that a first portion of a periphery (<NUM>) of the flap (<NUM>) is secured to a wall (<NUM>) that at least partially defines the opening (<NUM>); and in that a second portion of the periphery (<NUM>) of the flap (<NUM>) is not secured to the wall (<NUM>) to thereby define the open proximal end (<NUM>).