catheter

Abstract

An example catheter includes a tubular body portion and a cuff. The tubular body portion has a proximal end portion and a distal end portion. The distal end portion defines a distal surface of the tubular body portion. The cuff is attached to the distal end portion and defines a distal surface of the cuff. In certain embodiments, the tubular body portion terminates within the cuff such that the distal surface of the body portion is proximal to the distal surface of the cuff. In certain embodiments, a pocket is formed between the cuff and the body portion. In certain embodiments, the body portion is more rigid than the cuff.

Description

CROSS-REFERENCE TO RELATED DISCLOSURES

[0001] The present disclosure claims the benefit of U.S. Application No. 63 / 173,814 filed on April 12, 2021 and U.S. Application No. 63 / 186,528 filed on May 10, 2021, the disclosures of which are incorporated herein in their entireties by reference. Technical Field

[0002] The present disclosure relates generally to catheters and related systems, and more particularly, but not by way of limitation, to defecation catheters and related systems. Background Art

[0003] Indwelling catheters for fecal management are often used to manage liquid or semi-liquid feces in non-ambulatory hospitalized patients. However, many existing fecal management catheters create pressure points when a patient is in a seated position.

[0004] U.S. Patent No. 7,727,188 discloses a balloon catheter in which the balloon is attached to the end of the catheter by way of forming a recess or pocket between the catheter wall and the balloon wall. The recess or pocket opens toward the proximal end of the catheter. The rigid end of an insertion element or a finger is received in the recess for attachment to the catheter. The distal end of the catheter is inserted into the intestine and positioned by manipulating the insertion element or the finger, with the end of the insertion element held in the recess. After the catheter has been properly positioned within the intestine, the insertion element or finger is withdrawn, and is removed from the catheter as the end of the insertion element slides out of the recess and out of the intestine. The balloon is inflated either before or after withdrawal of the insertion element, to fix the tip of the catheter in place within the intestine. Because the catheter at its distal end is entirely made of a soft and flexible material, soft tissue damage caused by use of the device does not occur even when the catheter remains in place within the body over an extended period of time.

[0005] Many existing approaches, including those described in the literature referenced above, may suffer from one or more drawbacks or limitations, such as those related to ease of insertion and / or the suppression of soft tissue damage. For these reasons in particular, further improvements are still needed in this field. [Overview of the project]

[0006] An example of a catheter includes a tubular body portion and a cuff. The tubular body portion has a proximal end portion and a distal end portion. The distal end portion defines the distal surface of the tubular body portion. The cuff is attached to the distal end portion and defines the distal surface of the cuff. In certain embodiments, the tubular body portion terminates within the cuff such that the distal surface of the body portion is located proximal to the distal surface of the cuff. In certain embodiments, a pocket is formed between the cuff and the body portion. In certain embodiments, the body portion is rigider than the cuff. Further forms, features, and embodiments of this application will become apparent by examining the drawings and description provided herein. [Brief explanation of the drawing]

[0007] [Figure 1] Figure 1 is a cross-sectional view of a catheter according to a specific embodiment. [Figure 2] Figure 2 is a perspective view of a cuff according to a specific embodiment. [Figure 3] Figure 3 is a cross-sectional view of the cuff shown in Figure 2. [Figure 4] Figure 4 is a cross-sectional view of the distal end of the catheter shown in Figure 1. [Figure 5] Figure 5 is a cross-sectional view along the line IV-IV in Figure 1. [Figure 6] Figure 6 shows a pocket according to a specific embodiment. [Figure 7] Figure 7 is another cross-sectional view along the line IV-IV in Figure 1. [Figure 8] Figure 8 shows the structure of a pocket according to a specific embodiment. [Modes for carrying out the invention]

[0008] While the concepts of this disclosure are subject to various modifications and alternative forms, specific embodiments are shown in the drawings as examples and described in detail herein. However, it should be understood that the concepts of this disclosure are not intended to be limited to the specific forms disclosed, but rather are intended to cover all modifications, equivalents, and alternatives that conform to the scope of this disclosure and the appended claims.

[0009] References to “one embodiment,” “one example embodiment,” and “exemplary embodiment” in this specification indicate that the described embodiments may include certain features, structures, or characteristics, but not all embodiments will include those specific features, structures, or characteristics. Furthermore, such expressions do not necessarily refer to the same embodiment. Furthermore, references to “preferred” components or features may indicate the desirability of certain components or features in a particular embodiment, but it should be further understood that this disclosure is not so limited with respect to other embodiments in which such components or features may be omitted. Furthermore, where certain features, structures, or characteristics are described in relation to an embodiment, whether expressly described or not, it is presented that implementing such features, structures, or characteristics in relation to other embodiments is within the knowledge of those skilled in the art.

[0010] Furthermore, please understand that items in a list in the form of "at least one of A, B, or C" may 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" may mean (A), (B), (C), (A and B), (B and C), (A and C), or (A, B, C). Items listed in the form of "A, B, and / or C" may also mean (A), (B), (C), (A and B), (B and C), (A and C), or (A, B, and C). Furthermore, with respect to the claims, the use of phrases such as “one (a),” “one (an),” “at least a portion,” and / or “at least a portion” should not be interpreted as limiting such elements to only one unless otherwise stated, and the use of phrases such as “at least a portion,” and / or “a portion,” should be interpreted as encompassing both embodiments that include only a portion of such elements and embodiments that include the whole of such elements, unless otherwise stated.

[0011] In drawings, some structural or methodological features may be shown in a specific arrangement and / or order. However, it should be understood that such a specific arrangement and / or order is not necessarily required. Rather, in some embodiments, such features may be arranged in a different way and / or order than shown in the illustrative drawings, unless otherwise indicated. Furthermore, the inclusion of structural or methodological features in a particular drawing does not mean that such features are required in all embodiments, and may be omitted or combined with other features depending on the embodiment.

[0012] Referring to Figure 1, an indwelling catheter 100 according to a particular embodiment is shown. The illustrated catheter 100 extends along a longitudinal axis 101 defining a proximal direction (downward in Figure 1) and a distal direction (upward in Figure 1) opposite to it, and generally includes a tubular body portion 110 having a proximal end portion 112 and an opposite distal end portion 114, a cuff 120 positioned on the distal end portion 114 of the body portion 110, a finger pocket 130 positioned between the body portion 110 and the cuff 120, an inflatable / deflated lumen 140 extending from the cuff 120 to an inflatable / deflated port 102, a first attachment 104 attached to the inflatable / deflated port 102, and a drainage passage 150, partly defined by the body portion 110 and partly defined by the cuff 120. In the diagrammatic format, the indwelling catheter 100 is provided in the form of a fecal catheter, with the distal end portion 114 configured for insertion into the patient's rectum. It is also conceivable that the catheter 100 could be provided in other forms, such as a urethral catheter or an airway catheter.

[0013] The catheter body portion 110 extends from a proximal end portion 112 to a distal end portion 114, partially defining an inflatable / deflated lumen 140 and a drainage passage 150. The distal end portion 114 includes a tubular wall 117 that is received by the central opening 122 of the cuff 120 and has a distal surface 115 that defines a body portion inlet 116 having a body portion inlet diameter d116. In illustrative form, the distal surface 115 is positioned proximal to the inlet 154 of the drainage passage 150 within the cuff 120. As described herein, the body portion 110 is provided as a more rigid structure compared to the cuff 120 and, in certain forms, as a non-foldable tube.

[0014] Referring further to Figures 2 and 3, the cuff 120 is located at the distal end of the body portion 110 and defines a chamber 121 and a funnel-shaped central opening 122. The chamber 121 is configured to hold a fluid (e.g., air or saline) when the cuff 120 is in an inflated state, and this fluid can be discharged to compress or deflate the cuff 120. As shown in Figure 3, the central opening 122 includes a proximal portion 123 extending from the proximal surface 124 of the cuff 120 and a distal portion 125 extending to the distal surface 126 of the cuff 120. The proximal portion 123 is sized and shaped to receive the distal end portion 114 of the body portion 110 and is defined by a substantially annular wall 127 having a first inner diameter d127. The distal portion 125 is located distal to the proximal portion 123 and is defined by a conical wall 128 that expands from a first diameter d127 to a second diameter d154 which is larger than the first diameter d127. In the illustrated example, the wall 128 defining the distal portion 125 is substantially conical and tapers at a constant slope with respect to the longitudinal axis 101 from the first diameter d154 to the second diameter d127. The cross-section of the distal portion 125 may also be convex or concave.

[0015] The cuff 120 has a total longitudinal length L120, consisting of a proximal portion 123 with a length L123 and a distal portion 125 with a length L125. In the illustrated example, the length L123 of the proximal portion is slightly less than half of the total length L120 (e.g., about 45%), and the length L125 of the distal portion is slightly more than half of the total length L120 (e.g., about 55%). Other ratios may also be used. For example, the length L123 of the proximal portion may be 40% to 60% of the total length L120. In the illustrated examples shown in Figures 1 and 3, the surface 115 of the distal body portion is offset from the distal cuff surface 126 by the length L125 of the distal portion, which is sometimes referred to as the offset distance L125.

[0016] Referring further to Figures 4-6, the pocket 130 is located in the proximal portion 123 of the opening 122 of the cuff 120 and generally includes an open proximal end 132 and a closed distal end 134. The pocket 130 is located between the annular wall 127 and the tubular wall 117 of the distal end portion 114 and may be fixed to the annular wall 127 and / or the tubular wall 117, for example. The pocket 130 provides an area for receiving a finger or insertion tool to facilitate insertion of the distal portion of the catheter 100 into the patient's opening (e.g., the rectum). In the illustrated example, the pocket 130 is provided as a separate component located between the annular wall 127 and the distal end portion 114. More specifically, the pocket 130 includes a first flap 136 fixed to the tubular wall 117 of the main body portion 110 by a seal 109' along its periphery 137, such that the inside of the pocket 130 is defined by the wall 117 and the outside of the pocket 130 is defined by the flap 136 adhered to the wall 127. It is also conceivable that a portion of the pocket 130 is defined at least by the distal end portion 114. As an example, an open proximal end 132 may be created by omitting a portion of the seal 109 between the flap 136 of the main body portion 110 and the tubular wall 117. In addition, or instead, the flap 136 may be fixed to the tubular wall 117 of the distal end portion 114 in a similar manner to how the illustrated flap 136 is fixed to the annular wall 127.

[0017] The inflatable / deflated lumen 140 has a distal end 142 that opens to the chamber 121, a proximal end 144 connected to the inflatable / deflated port 102, and optionally a second elongated lumen 146 that extends between the distal end 142 and the proximal end 144, connecting the distal end 142 and the proximal end 144, so that the chamber 121 is in fluid communication with the inflatable / deflated port 102. As a result, the cuff 120 may be provided as a normally closed check valve and can be operated using a fitting syringe to open the passage, and is operable to inflate and deflate via a first fitting 104.

[0018] The discharge passage 150 is configured to allow a fluid (e.g., air, liquid, or semi-liquid) to flow from the inlet 154 to the outlet 152. For example, in the illustrated example, wastewater flows from the inlet 154 to the outlet 152 and is discharged from the outlet 152. In certain embodiments, such as when the catheter 100 is used as an airway catheter, the passage 150 can further facilitate the flow of fluid (e.g., air) from the outlet 152 to the inlet 154, for example, during inhalation by the patient.

[0019] In the illustrated example, the discharge passage inlet 154 is defined by the distal surface 126 of the cuff 120 and has an inlet diameter d154, and the discharge passage outlet 152 is defined by the proximal surface of the main body portion 110 and has an outlet diameter d154 smaller than the inlet diameter d154. More specifically, the discharge passage 150 narrows from the inlet diameter d154 to a third diameter d127 (downward in Figures 1 and 4) due to the tapered or curved nature of the wall 128, and a step is formed from the third diameter d127 to the outlet diameter d154 by the thickness t110 of the main body portion 110. It is also conceivable that the discharge passage 150 may narrow from distal to proximal in another way. Providing a large inlet 154 in the discharge passage 150 has been shown to help enhance the recovery of fluids diverted from the patient's body cavity.

[0020] As described above, the catheter body portion 110 shown in the figure has a more rigid structure than the cuff 120 and is arbitrarily positioned so as not to extend to the inlet 154. This offset distance L125 between the distal body portion surface 115 and the distal cuff surface 126 can reduce potential pressure points when the patient is seated.

[0021] Furthermore, as described above, in the illustrated example, there is an open-surround finger pocket 130, which can be formed between the cuff 120 and the catheter body 110 by omitting a portion of the seal 109 around the entire circumference of the connection between the two components. This finger pocket 130, which has an open space recess between the cuff 120 and the catheter body 110, allows a finger or an insertion tool to be placed therein during insertion of the cuff 120, and can provide the additional advantage that the more rigid catheter body 110 does not need to be extended to the inlet 154. This feature can also minimize potential pressure points when the patient is in a sitting position. For devices without a finger pocket, a rigid catheter body tip extending all the way to the distal end may be required to facilitate insertion of the cuff into a body cavity.

[0022] With further reference to Figures 7 and 8, an alternative arrangement of the pocket 130 is illustrated. The flap 136 has a width W136 and a height H136, and is fixed by sealing 109' three sides between the cuff 120 of the body portion 110 and the distal end portion 114. Thus, an open proximal end 132 is created on the fourth side, which is the only non-adhered side.

[0023] A catheter 100 according to a specific embodiment of the present application comprises: a tubular body portion 110 having a proximal end portion 112 and a distal end portion 114, wherein the distal end portion 114 defines a distal body portion surface 115 of the tubular body portion 110; and a cuff 120 attached to the distal end portion 114 and defining a distal cuff surface 126 of the cuff 120, wherein the tubular body portion 110 terminates within the cuff 120 such that the distal body portion surface 115 is disposed proximal to the distal cuff surface 126.

[0024] In certain embodiments, the distal body portion surface 115 defines a body portion inlet 116 having a first diameter d116, the distal cuff surface 126 defines a cuff inlet 129 having a second diameter d154, and the first diameter d116 is smaller than the second diameter d154.

[0025] In certain embodiments, the tubular body portion 110 has higher rigidity than the cuff 120.

[0026] In certain embodiments, the catheter further comprises a pocket 130 radially positioned between the distal end portion 114 and the cuff 120, the pocket 130 having an open proximal end 132 and a closed distal end 134.

[0027] In a particular embodiment, the cuff 120 has a longitudinal length L120, and an offset distance L125 is defined between the distal body surface 115 and the distal cuff surface 126, wherein the offset distance L125 is 40% or more and 60% or less of the longitudinal length L120.

[0028] In a particular embodiment, the cuff 120 defines an opening 122 that includes a proximal portion 123 having a first diameter d127 and a distal portion 125 that expands from the first diameter d127 to a second diameter d154 in the proximal to distal direction.

[0029] In a particular embodiment of the present application, the present application relates to a catheter 100 defining a discharge passage 150, wherein the catheter 100 has an annular body portion 110 to which the discharge passage 150 is attached to a distal end portion 114, and a cuff 120 attached to the distal end portion 114 of the tubular body portion 110, the cuff 120 defining a distal inlet 154 of the discharge passage 150, the proximal outlet 152 having a first diameter d152, and the distal inlet 154 having a second diameter larger than the first diameter d152.

[0030] In certain embodiments, the opening 122 defined by the cuff 120 narrows from distal to proximal in the direction from a second diameter d154 to a third diameter d127 corresponding to the first diameter d152.

[0031] In a particular embodiment, the opening 122 has a distal portion 125 that narrows from a second diameter d154 to a third diameter d127 in the distal-to-proximal direction, and a proximal portion 123 having a third diameter d127.

[0032] In a particular embodiment, the proximal portion 123 has a third diameter d127 along its longitudinal length L123, the cuff 120 has a longitudinal length L120, and the longitudinal length L123 of the proximal portion 123 is 40% to 60% of the longitudinal length L120 of the cuff.

[0033] In certain embodiments, the tubular body portion 110 has higher rigidity than the cuff 120.

[0034] In certain embodiments, the catheter further has a pocket opening 132 defined at the interface between the tubular body portion 110 and the cuff 120.

[0035] In certain embodiments, the catheter further comprises a radially defined pocket 130 between the tubular body portion 110 and the cuff 120, the pocket 130 having an open proximal end 132.

[0036] A catheter 100 comprising a specific embodiment relating to the present application, comprising: a tubular body portion 110 having a proximal end portion 112 and a distal end portion 114; a cuff 120 defining an opening 122 having a proximal portion 123 and a distal portion 125, wherein the distal end portion 114 of the tubular body portion 110 is received by the proximal portion 123; and a pocket 130 disposed between the tubular body portion 110 and the cuff 120, wherein the tubular body portion 110 has a higher rigidity than the cuff 120.

[0037] In certain embodiments, the pocket 130 has an open proximal end 132 and a closed distal end 134.

[0038] In certain embodiments, the closed distal end 134 of the pocket 130 is positioned proximal to the proximal surface 126 of the cuff 120.

[0039] In a particular embodiment, the surface 115 of the distal body portion defined by the distal end portion 114 is positioned proximal to the distal cuff surface 126 of the cuff 120.

[0040] In a particular embodiment, the discharge passage inlet 154 defined by the opening 122 has a first diameter d154, and the diameter of the proximal portion 125 of the opening 122 decreases from the first diameter d154 to a second diameter d127 in the distal-to-proximal direction.

[0041] In a particular embodiment, the distal end portion 114 has a second diameter d127 as its outer diameter.

[0042] In certain embodiments, the tubular body portion 110 is more difficult to fold than the cuff 120.

[0043] A particular embodiment of the present application relates to a cuff 120 for a catheter 100, the cuff 120 having a proximal surface 124, a distal surface 126 facing the proximal surface 124 and defining an inlet 154 having a first diameter d154, and an opening 122 extending along a longitudinal axis 101 and penetrating the proximal surface 124 and the distal surface 126, wherein at least a portion of the opening 122 has a second diameter d127 smaller than the first diameter d154, and the opening 122 has a first portion 125 that opens to the inlet 154, the first portion 125 having an opening 122 that expands from the second diameter d127 to the first diameter d154 in the proximal to distal direction.

[0044] In certain embodiments, the opening further has a second portion 123 located proximal to the first portion 125, the second portion 123 having a second diameter d127 along the length L123 of the second portion.

[0045] In a particular embodiment, the cuff 120 has a longitudinal length L120, and the longitudinal length L123 of the second portion is 40% to 60% of the longitudinal length L120 of the cuff.

[0046] In certain embodiments, the cuff further comprises a pocket 130 located within the opening 122, the pocket 130 having an open proximal end 132.

[0047] In certain embodiments, the pocket 130 has a flap 136, the first portion of the flap 136's perimeter 137 being fixed to a wall 127 that partially defines the opening 122, and the second portion of the flap 136's perimeter 137 not being fixed to the wall 127, thereby defining the open proximal end.

[0048] In certain embodiments, the first portion 125 is frustum-shaped.

[0049] In certain embodiments, the cuff 120 further includes a chamber 121 that surrounds the opening 122 and is operable to receive a fluid for inflating the cuff 120.

[0050] A particular embodiment of this application relates to a catheter 100 having a cuff 120, wherein the catheter 100 further has a tubular body portion 110 connected to the cuff 120, the surface 115 of the distal body portion being positioned proximal to the distal surface 126 of the cuff 120.

[0051] In a particular embodiment, the distal end portion 114 of the tubular body portion 110 extends to the opening 122.

[0052] In certain embodiments, the tubular body portion has higher rigidity than the cuff 120.

[0053] Although the present invention is illustrated and described in detail in the drawings and the foregoing description, these are illustrative and not intended to be restrictive. However, only preferred embodiments are illustrated and described, and it is understood that it is desirable that all changes and modifications within the spirit of the invention be protected.

[0054] The use of words such as preferred, preferable, desirable, or more preferred in the above description indicates that a feature described in this way may be more preferable, but nevertheless, it may not be necessary, and embodiments lacking the same may be contemplated within the scope of the invention, but it should be understood that the scope is defined by the claims that follow. When reading the claims, if words such as "one (a)," "one (an)," "at least one," or "at least a portion" are used, it is intended that the claims are not intended to be limited to only one item unless otherwise stated in the claims. If the words "at least a portion" and / or "a portion" are used, unless otherwise stated in the claims, that item may include a portion and / or all of the items.

Claims

1. A tubular body portion having a proximal end portion and a distal end portion, wherein the distal end portion defines the surface of the distal body portion of the tubular body portion, and The cuff is attached to the distal end portion and defines the distal cuff surface of the cuff, The tubular body portion terminates within the cuff such that the surface of the distal body portion is located proximal to the distal cuff surface. The cuff has a length in the longitudinal direction, An offset distance is defined between the surface of the distal main body portion and the distal cuff surface. The offset distance is 40% or more and 60% or less of the length in the longitudinal direction. It is a fecal catheter. catheter.

2. The surface of the distal body portion defines an entrance to the body portion having a first diameter, The distal cuff surface defines a cuff entrance having a second diameter, The first diameter is smaller than the second diameter. The catheter according to claim 1.

3. The tubular body portion has higher rigidity than the cuff. The catheter according to claim 1.

4. It further has a pocket radially positioned between the distal end portion and the cuff, The pocket has an open proximal end and a closed distal end. The catheter according to claim 1.

5. The cuff defining the opening is A proximal portion having a first diameter, and It has a distal portion that expands from the first diameter to the second diameter in the direction from proximal to distal, The catheter according to claim 1.

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