Continent ostomy device

Abstract

A continent ostomy device and method of sealing and evacuating an ostomy. The device eliminates the need to always wear an ostomy pouch through a series of components and a flexible conduit. The flexible conduit can extend through the stoma and anchor in the lumen of a patient's bowel. The other end of the conduit passes through a wafer adapter and a conduit adapter. The wafer adapter is configured to engage an ostomy wafer and the conduit adapter is configured to engage the conduit and rotatably engage the wafer adapter. When the conduit adapter rotatably engages the wafer adapter, the conduit twists to create a seal, thus eliminating the need to always wear an ostomy pouch.

Description

[0001] CONTINENT OSTOMY DEVICE

[0002] PRIORITY INFORMATION

[0003] This nonprovisional application claims priority to provisional application No. 63639978, entitled “Continent Ostomy Device,” filed 4 / 29 / 2024 by the same inventors.

[0004] BACKGROUND OF THE INVENTION

[0005] 1. Field of the Invention

[0006] This invention relates, generally, to medical devices. More specifically, it relates to continent ostomy devices.

[0007] 2. Brief Description of the Prior Art

[0008] An ostomy is an externally facing, surgically diverted segment of a small or large bowel created by a surgeon that forms a temporary or permanent stoma. A stoma is the portion of the digestive tract that is brought through the abdominal wall, serving as the bridge between the internal and external environment and allowing waste to be diverted out of the body. Fig. 1 provides an image of a typical stoma 10.

[0009] Common diagnoses that require an ostomy include colon or rectal cancer, small bowel cancer, ulcerative colitis, or obstruction of the bowel. Current methods aiding in the collection of waste from the stoma 10 include the usage of an externally hanging ostomy pouch 12, which is a heavy-duty plastic bag connected to an adhesive wafer 14 that is applied and adhered to the skin around the stoma 10. Fig. 2 depicts an ostomy wafer 14 around a stoma 10 with an ostomy pouch 12 being attached to the wafer 14. The pouch 12 collects waste 16 that periodically spills from the stoma 10 as depicted in Fig. 3.

[0010] Currently, there exist an ostomy device that employs a flexible conduit, which is described in US Publication Number 2023 / 0218424 A1 . However, that device has various shortcomings. For example, the device lacks an adapter for securely attaching the conduit to the wafer, the device lacks an adapter for securely attaching a conventional ostomy pouch prior to untwisting the conduit, the device lacks any indication as to when it has been sufficiently rotated to create a seal, and the device must be untwisted and manually clamped by the user to create a seal and prevent spillage prior to attaching an ostomy pouch.

[0011] Accordingly, what is needed is an improved system that is easier to use and reduces leakage and malodor. However, in view of the art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the field of this invention how the shortcomings of the prior art could be overcome.

[0012] All referenced publications are incorporated herein by reference in their entirety. Furthermore, where a definition or use of a term in a reference, which is incorporated by reference herein, is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.

[0013] While certain aspects of conventional technologies have been discussed to facilitate disclosure of the invention, Applicants in no way disclaim these technical aspects, and it is contemplated that the claimed invention may encompass one or more of the conventional technical aspects discussed herein.

[0014] The present invention may address one or more of the problems and deficiencies of the prior art discussed above. However, it is contemplated that the invention may prove useful in addressing other problems and deficiencies in a number of technical areas. Therefore, the claimed invention should not necessarily be construed as limited to addressing any of the particular problems or deficiencies discussed herein.

[0015] In this specification, where a document, act or item of knowledge is referred to or discussed, this reference or discussion is not an admission that the document, act or item of knowledge or any combination thereof was at the priority date, publicly available, known to the public, part of common general knowledge, or otherwise constitutes prior art under the applicable statutory provisions; or is known to be relevant to an attempt to solve any problem with which this specification is concerned.

[0016] BRIEF SUMMARY OF THE INVENTION

[0017] The present invention includes continent ostomy device and method of sealing an ostomy of a patient. The continent ostomy device includes a flexible conduit having a first end and a second end, with a retention device located proximate the first end. The conduit is configured to twist about itself to create a seal. A wafer adapter is configured to engage an ostomy wafer and includes an internal aperture through which the conduit passes when the wafer adapter engages the ostomy wafer. A conduit adapter is configured to engage the conduit and also includes an internal aperture through which the conduit passes. A conduit retainer is further provided to engage the conduit. The conduit adapter is configured to operably engage the wafer adapter and rotate relative to the ostomy wafer, such that rotation of the conduit adapter twists the conduit to create a seal between the first and second ends of the conduit. In some embodiments, the conduit adapter rotatably engages the wafer adapter.

[0018] Some embodiments further include a pouch adapter that rotatably engages the conduit retainer via a rotational direction opposite to the direction required to engage the conduit adapter to the wafer adapter. In these embodiments, the pouch adapter may be configured to engage an ostomy pouch and to rotate in order to untwist the conduit while the ostomy pouch is secured to the pouch adapter. The device may also include a cap configured to at least partially cover the second end of the conduit by engaging at least the conduit retainer.

[0019] In some variations, the conduit retainer and conduit adapter interconnect through one or more keyed joints. In addition, the wafer adapter may include a thread on an external surface, and the conduit adapter may include a corresponding thread on an internal surface to engage the wafer adapter. Further, the conduit retainer may include a thread on an external surface that is directionally opposite the thread on the internal surface of the conduit adapter, thereby facilitating unthreading upon attachment of the pouch adapter.

[0020] Another aspect of the invention provides a method of sealing an ostomy of a patient. The method includes inserting a first end of a conduit through a stoma until a retention device reaches the intraabdominal portion of the bowel. A second end of the conduit is passed through an internal aperture in a wafer adapter, and the wafer adapter is secured to an ostomy wafer. The second end is also passed through an internal aperture in a conduit adapter and folded back over an external surface of the conduit adapter. A conduit retainer is then slid over the folded-back portion of the conduit, and the conduit adapter is threaded onto the wafer adapter, causing the conduit to twist and form a seal between its first and second ends.

[0021] Some embodiments of the method include rotatably engaging the conduit adapter to the wafer adapter. In some cases, a pouch adapter is rotatably engaged to the conduit retainer in the opposite rotational direction. An ostomy pouch may then be secured to the pouch adapter. As the conduit retainer and the conduit adapter conjointly rotate relative to the pouch adapter, their rotation causes the conduit to untwist, thereby allowing the contents of the bowel to flow into the pouch. When the ostomy pouch is disconnected, a cap may be secured to the conduit retainer. In some implementations, the conduit adapter and conduit retainer are interconnected using keyed joints to ensure a secure connection.

[0022] These and other important objects, advantages, and features of the invention will become clear as this disclosure proceeds.

[0023] The invention accordingly comprises the features of construction, combination of elements, and arrangement of parts that will be exemplified in the disclosure set forth hereinafter and the scope of the invention will be indicated in the claims.

[0024] BRIEF DESCRIPTION OF THE DRAWINGS

[0025] For a fuller understanding of the invention, reference should be made to the following detailed description, taken in connection with the accompanying drawings, in which:

[0026] Fig. 1 is an image of a typical stoma.

[0027] Fig. 2 is an image of a conventional ostomy wafer around a stoma with a conventional ostomy pouch to be secured to the wafer.

[0028] Fig. 3 is an image of a conventional ostomy pouch having collected waste.

[0029] Fig. 4 is an exploded perspective view of an embodiment of the present invention.

[0030] Fig. 5 is a perspective view of an embodiment of the present invention.

[0031] Fig. 6 is an exploded perspective view of an embodiment of the present invention. Fig. 7 is a perspective view of an embodiment of the present invention.

[0032] Fig. 8 depicts an embodiment of the flexible conduit.

[0033] Fig. 9 depicts an embodiment of the flexible conduit having passed through a patient's abdominal wall. The bowel and stoma were omitted to aid in clarity.

[0034] Fig. 10 depicts an embodiment of the flexible conduit having passed through a patient's abdominal wall and an ostomy wafer. The bowel and stoma were omitted to aid in clarity.

[0035] Fig. 11 depicts an embodiment of the flexible conduit having passed through a patient's abdominal wall, an ostomy wafer, a wafer adapter, and a conduit adapter. The bowel and stoma were omitted and the wafer adapter is shown in spaced relation to the wafer to aid in clarity.

[0036] Fig. 12 depicts an embodiment of the flexible conduit having passed through a patient's abdominal wall, an ostomy wafer, a wafer adapter, and a conduit adapter with the conduit folded back over the conduit adapter. The bowel and stoma were omitted and the wafer adapter is shown in spaced relation to the wafer to aid in clarity.

[0037] Fig. 13 depicts the same components as Fig. 12 with the conduit retainer secured to the conduit adapter. The bowel and stoma were omitted and the wafer adapter is shown in spaced relation to the wafer to aid in clarity.

[0038] Fig. 14A is a rear perspective view of an embodiment of the wafer adapter.

[0039] Fig. 14B is a front perspective view of an embodiment of the conduit adapter.

[0040] Fig. 14C is a front perspective view of an embodiment of the conduit retainer.

[0041] Fig. 15 depicts the same components as Fig. 13 with the conduit adapter secured to the wafer adapter. The bowel and stoma were omitted and the wafer adapter is shown in spaced relation to the wafer to aid in clarity.

[0042] Fig. 16 depicts the same components as Fig. 15 with a cap / cover secured to the device. The bowel and stoma were omitted and the wafer adapter is shown in spaced relation to the wafer to aid in clarity.

[0043] Fig. 17 depicts the same components as Fig. 16 with the cap / cover removed prior to securing the pouch adapter. The bowel and stoma were omitted and the wafer adapter is shown in spaced relation to the wafer to aid in clarity.

[0044] Fig. 18 depicts the same components as Fig. 17 with the pouch adapter aligned with the other components. The bowel and stoma were omitted and the wafer adapter is shown in spaced relation to the wafer to aid in clarity.

[0045] Fig. 19 depicts the same components as Fig. 18 with the pouch adapter secured to the conduit retainer. The bowel and stoma were omitted and the wafer adapter is shown in spaced relation to the wafer to aid in clarity. Fig. 20 is an exploded view of an embodiment of the present invention.

[0046] Fig. 21 is an illustration of the embodiment in Fig. 20 with the conduit secured and sealed.

[0047] Fig. 22A depicts a top view of an embodiment of the wafer adapter.

[0048] Fig. 22B depicts a side view of an embodiment of the wafer adapter.

[0049] Fig. 23A depicts a top view of an embodiment of the wafer adapter.

[0050] Fig. 23B depicts a side view of an embodiment of the wafer adapter.

[0051] Fig. 24 depicts an embodiment of a conduit adapter in the form of an iris retractor with the leaflets in a partially closed configuration.

[0052] Fig. 25 depicts an embodiment of a conduit adapter in the form of an iris retractor with the leaflets in an open configuration.

[0053] Fig. 26 is a side view of an embodiment of the present invention in which the conduit includes a removal component and the wafer adapter includes a slot for securing the removal component.

[0054] DETAILED DESCRIPTION OF THE INVENTION

[0055] In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings, which form a part thereof, and within which are shown by way of illustration specific embodiments by which the invention may be practiced. It is to be understood that other embodiments may be utilized, and structural changes may be made without departing from the scope of the invention.

[0056] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and / or” unless the context clearly dictates otherwise.

[0057] All numerical designations, such as measurements, efficacies, physical characteristics, forces, and other designations, including ranges, are approximations which are varied up or down by increments of 1.0 or 0.1 , as appropriate. It is to be understood, even if it is not always explicitly stated that all numerical designations are preceded by the term “about.” As used herein, “about” or “approximately” refers to being within an acceptable error range for the particular value as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined. As used herein, the term “about” refers to ±10% of the numerical; it should be understood that a numerical including an associated range with a lower boundary of greater than zero must be a non-zero numerical, and the term “about” should be understood to include only non-zero values in such scenarios.

[0058] Various embodiments of the present invention provide for a wide range of technical effects, advantages, and / or improvements to devices and methods for collectino waste expelled from an ostomy. In the following description, for explanatory purposes, numerous specific details are set forth to provide a thorough description of the embodiments of the present invention. It will be apparent to one of ordinary skill in the art that some embodiments may be practiced without some of these specific details. For the sake of brevity and clarity, the present invention is described in reference to a continent ostomy device, however, embodiments of the present invention are equally applicable to other situations in which a device patient needs to an airtight and effluent-tight system that allows users to control the expulsion of fluids from the body.

[0059] The phrases “in some embodiments,” “according to some embodiments,” “in the embodiments shown,” “in other embodiments,” and the like generally mean the particular feature, structure, or characteristic following the phrase is included in at least one implementation. In addition, such phrases do not necessarily refer to the same embodiments or different embodiments.

[0060] The present invention includes a continent ostomy device and method of use that improves upon current systems and methods for collecting and disposing of fecal waste by eliminating the need to always wear an ostomy pouch. The present invention includes a low-profile, discreet device that creates an airtight and effluent-tight seal when the ostomy pouch is not secured. In addition, the user can control the expulsion of gas and fecal matter, thus reducing leakage and malodor. The solution addresses the aesthetic drawbacks and social challenges of having an ostomy, offering a more discreet and dignified solution that improves users’ quality of life.

[0061] Referring now to Figs. 4-7, some embodiments of the present invention includes a flexible conduit 102, a wafer adapter 104, a conduit adapter 106, and a conduit retainer 108. As will be explained in subsequent paragraphs, these components are designed to integrate and connect with existing ostomy wafers 110 and ostomy pouches 112. Through these components the present invention is configured to create a temporary seal between the patient’s bowel and stoma.

[0062] Referring now to Figs. 8-10, the flexible conduit 102 has a first end 114 with a retention device 116, a second end 118 opposite of the first end 114, and a flexible body 120 therebetween. The first end 114 and the retention device 116 are configured to pass through the patient's stoma (not depicted for clarity) and abdominal wall 122 as shown in Fig. 9. To ensure that the retention device 116 can pass through the narrow opening in the stoma and abdominal wall 122, the retention device 116 is configured to elastically deform during insertion and then revert back to its original shape, or close to its original shape, in the larger cavity in the bowel. Once the retention device 116 is in the bowel, it functions as an anchor to prevent the conduit 102 from unintentional extraction from the patient.

[0063] To ensure that the retention device 116 anchors the conduit 102, the retention device 116 has a lateral expanse greater than the lateral expanse of the passageway through the patient's abdominal wall 122. In some embodiments, the retention device 116 has a lateral expanse of between approximately 1 and 6 cm. In some embodiments, the lateral expanse of the retention device 116 is at least 1 cm. Moreover, while the retention device 116 is depicted as having a circular shape, alternative shapes can be used so long as the retention device 116 maintains its ability to pass through the opening in the patient and function as an anchor.

[0064] Both the retention device 116 and the flexible body 120 are comprised of biocompatible material(s), such as the non-limiting example of polyurethane. Like the retention device 116, the flexible conduit 102 may also be comprised of elastic material to prevent tearing. In addition, the conduit 102 is comprised of a fluid and gas impermeable material to prevent gas and / or stool from seeping to the external environment of the abdomen.

[0065] The conduit 102 is configured to extend out of the patient and engage a conduit adapter 106 at the second end 118. To ensure that the flexible body 120 can accommodate patients of varying thickness, the conduit 102 has a length between 1 and 30 cm. In some embodiments, the length of the conduit 102 is at least 1 cm and can be cut to a desired length as needed.

[0066] In some embodiments, the second end 118 is a free end. Put another way, it is an extension of the flexible body 120 and free of any additional objects or structures. More specifically, in some embodiments, the second end 118 does not include a second retention device as used in the device in US Publication Number 2023 / 0218424 A1.

[0067] The conduit 102 may be configured to be reusable indefinitely or for a predetermined period, such as 3 days. The conduit 102 can be disposed of or cleaned and reused based on the durability of the conduit 102.

[0068] In some embodiments, the conduit 102 includes a removal component 124, such as the string exemplified in Fig. 26. The removal component 124 includes a first end secured to the retention device 116, or to the first end of the conduit 102, and a second free end. The removal component 124 has a length extending between the two ends that is equal to or greater than the length of the conduit 102 to ensure that the removal component 124 will extend outside of the patient allowing the patient or another individual to grasp and pull the removal component 124 in an external direction to aid in the removal of the conduit 102 from the patient’s bowel. The free end may include a knot, protuberance, mass, or other object 125 that is integrated with or attached to the free end to provide a large cross-sectional area to aid in securing the free end within a slot 128 in the wafer adapter 104 or other component.

[0069] The removal component 124 can be configured to remain external from the conduit 102 and is thus comprised of biocompatible material. In addition, the removal component 124 has a minimal cross section to avoid irritating the patient's tissue.

[0070] Embodiments of the present invention include or are configured to be used with ostomy wafers 110, such as those typically found in the art. Figs. 4-7 depict examples of these wafers 110. The ostomy wafers 110 include an adhesive surface configured to adhere to a patient’s skin and a passageway 126 through which the stoma passes. As best shown in Fig. 10, the conduit 102 of the present invention passes through the passageway 126 in the ostomy wafer 110.

[0071] The external surface 128 — the surface opposite of the adhesive surface — includes an attachment mechanism 130 to which an ostomy pouch 112 is typically secured. The attachment mechanism 130 is typically a flange configured to temporarily engage a corresponding flange 131 on the ostomy pouch 112. With respect to the present invention, the attachment mechanism 130 engages the wafer adapter 104 rather than the ostomy pouch 112.

[0072] The wafer flange 130 may include an outwardly extending locking ridge or bead, while the wafer adapter 104 includes an attachment mechanism 133, which may be in the form of a flange similar to the flange 131 on ostomy pouch 112 (see e.g., Fig. 14A). Attachment mechanism 133 defines a corresponding groove or receiving channel dimensioned to snap-fit over a locking ridge established by attachment mechanism 130. The engagement between the ridge and channel provides a detent-type mechanical interface, ensuring axial retention of the wafer adapter 104 relative to the ostomy wafer 110.

[0073] During assembly, the attachment mechanism 133 of the wafer adapter 104 is axially aligned with the attachment mechanism 130 of ostomy wafer 110 and then pressed toward the ostomy wafer 110. As the flanges are urged together, the receiving channel deforms slightly to permit passage of the locking ridge and then resiliently returns to its original form once the ridge is seated within the groove, thereby generating an audible or tactile "click.” This feature serves as a positive indication of full engagement and secure attachment.

[0074] In some embodiments, the attachment mechanism 133 of the wafer adapter 104 is rotatable relative to the attachment mechanism 130 of ostomy wafer 110 after engagement, facilitating angular positioning of the wafer adapter 104. This may be enabled by a circular interface geometry with low-friction contact surfaces or by incorporating a ratcheting or indexing feature into the design.

[0075] In further embodiments, the attachment mechanisms 130 and 133 are fabricated from thermoplastic materials such as polyethylene or polypropylene, selected for their balance of flexibility and dimensional stability. The interface between attachment mechanisms 130 and 133 may also include sealing features, such as a circumferential lip or compression ring, to enhance fluid-tightness and mitigate odor or effluent leakage.

[0076] The system may be adapted for various sizes and profiles, including low-profile versions for discreet wear, and may accommodate single-use or reusable components. Alternative embodiments may integrate gripping tabs or release levers to assist users with limited dexterity in detaching the components.

[0077] It should be noted that while the exemplary attachment mechanisms 130 and 133 are in the form of interconnecting flanges, alternative attachment mechanisms are considered, including those used with existing ostomy wafers and ostomy pouches. Non-limiting examples of alternative attachment mechanisms 130 and 133 include mechanical click-lock systems, adhesive coupling systems, floating flange designs, locking ring or lever mechanisms, and magnetic couplings.

[0078] The wafer adapter 104 further includes an annulus shape defining an internal aperture 132. The internal aperture 132 is configured to receive the conduit 102 once the conduit 102 passes through the passageway 126 in the ostomy wafer 110 as depicted in Fig. 11. The internal aperture 132 of the wafer adapter 104 is sufficiently sized to allow for passage of the conduit 102, allow for passage of stool, and avoid impacting the stoma when the wafer adapter 104 is secured to the ostomy wafer 110. In some embodiments, the diameter of the internal aperture 132 is between approximately 1 and 6 cm. In some embodiments, the diameter of the internal aperture 132 is at least 1 cm.

[0079] Once the conduit 102 passes through the internal aperture 132 in the wafer adapter 104, the attachment mechanism 133 of the wafer adapter 104 can engage the attachment mechanism 130 on the ostomy wafer 110 as best depicted in Fig. 7.

[0080] In some embodiments, such as the embodiment depicted in Figs. 4-19, the external surface of the wafer adapter 104 further includes a thread 134. The thread 134 provides a means for attaching a conduit adapter 106 to the wafer adapter 104. Some embodiments use alternative attachment mechanisms and devices to interconnect the conduit adapter 106 and the wafer adapter 104. Non-limiting examples of attachment mechanisms for securing the conduit adapter 106 and the wafer adapter 104 include snap-fit joints, bayonet couplings, magnetic attachments, interference fits, and twist-lock mechanisms.

[0081] As provided in Fig. 26, some embodiments of the wafer adapter 104 include a slot 128 configured to receive the removal component 124. The slot 128 is sized to create a friction fit with the removal component 124 to ensure that the removal component 124 remains in the slot 128 and helps prevent rotation of the first end of the conduit 102 within the bowel. The slot 128 may be linear or have a non-linear shape to aid in retaining the removal component 124 within the slot 128. The slot 128 can also extend to a location below the thread on the wafer adapter 104 so that the removal component 124 will not interfere with the threaded engagement of the conduit adapter 106 with the wafer adapter 104. Some embodiments of the wafer adapter 104 include multiple slots 128 to provide multiple attachment points for the removal component 124.

[0082] The conduit adapter 106 also has an annulus shape with an internal aperture 136. The internal aperture 136 is also configured to receive the conduit 102 once the conduit 102 passes through the ostomy wafer 110 and the wafer adapter 104 as depicted in Fig. 1 1. The internal aperture 136 of the conduit adapter 106 is sufficiently sized to allow for passage of the conduit 102 and stool while also engaging the conduit adapter 106. In some embodiments, the diameter of the internal aperture 136 of the conduit adapter 106 is between approximately 1 and 9 cm. In some embodiments, the diameter of the internal aperture 136 of the conduit adapter 106 is at least 1 cm.

[0083] The internal surface of the conduit adapter 106, as established by the internal aperture 136, includes a thread 138 configured to engage the thread 134 on the wafer adapter 104. In some embodiments, both threads 134 and 138 have the same directional orientation (e.g., both right- handed or both left-handed), allowing them to mate through rotation in a common tightening direction.

[0084] Prior to securing the conduit adapter 106 to the wafer adapter 104, the conduit 102 is fed through the internal aperture 136 in the conduit adapter 106. The conduit 102 is then secured to the conduit adapter 106. In some embodiments, the conduit 102 is attached to the conduit adapter 106 by folding the second end 118 of the conduit 102 back over the external surface of the conduit adapter 106 as shown in Fig. 12. To ensure a proper fit, the diameter of the external surface 132 of the conduit adapter 106 is sufficiently sized to enable a user to fold the conduit 102 back over the external surface of the conduit adapter 106.

[0085] Some embodiments further include a conduit retainer 108, which is configured to clamp the conduit 102 between the conduit adapter 106 and the conduit retainer 108 when the second end 118 of the conduit 102 is folded back over the external surface of the conduit adapter 106. Fig 13 depicts an embodiment of the conduit retainer 108 overlying the conduit 102. As illustrated, the conduit retainer 108 has an annulus shape with an internal aperture 140 configured to receive the conduit adapter 106.

[0086] The conduit retainer 108 is also configured to engage the conduit adapter 106. In some embodiments, the conduit retainer 108 engages the conduit adapter 106 in a manner sufficient to ensure that the conduit retainer 108 rotates as one with the conduit retainer 108. This corotation can be achieved through known approaches including but not limited to an inference fit, one or more keyed joints, splined interfaces, polygonal mating profiles (e.g., hexagonal or square), dovetail engagements, detent mechanisms, or interlocking tab-and-slot features.

[0087] As depicted in Figs. 14B-14C some embodiments include a key slot 142 is disposed within the external surface of the conduit adapter 106 and includes an offset locking channel 144. A key 146 is disposed in the internal surface of the conduit retainer 108. The key 146 is sized to fit within and travel along the key slot 142 as the conduit retainer 108 is slid into place. Once the key 146 reaches the end of the key slot 142, indicating that the conduit retainer 108 is fully seated onto the conduit adapter 106, the conduit retainer 108 is rotated slightly to move the key 146 into the locking channel 144. The conduit retainer 108 is then unable to translate relative to the conduit adapter 106 to effectively lock the two components together. It should be noted that while the key 146 is disposed on the conduit retainer 108 and the key slot 142 and locking channel 144 are disposed on the conduit adapter 106, the key 146 could be located on the conduit adapter 106 and the key slot 142 and the locking channel 144 could be disposed on the conduit retainer 108.

[0088] Once the conduit retainer 108 and conduit 102 are secured to the conduit adapter 106, the conduit adapter 106 can be threaded onto the wafer adapter 104. As the conduit adapter 106 is rotated onto the wafer adapter 104, the conduit 102 twists to create a seal similar to how bread bags are twisted to seal the bread within the plastic bag. This result is exemplified in Fig. 15, but it should be noted that Fig. 15 shows the wafer adapter 104 detached from the wafer 110. While functional in this manner, the wafer adapter 104 can be secured to wafer 110 prior to securing the conduit adapter 106 to the wafer adapter 104 to minimize slack in conduit 102.

[0089] The threaded connection between the conduit retainer 108 and the wafer adapter 104 is sufficient to ensure that the conduit retainer 108 completes between 1 and 6 rotations or at least 1 rotation. By achieving these thresholds, the conduit 102 twists a sufficient amount to maintain its seal under typical pressures experienced with ostomies.

[0090] In some embodiments, the external surface of the conduit retainer 108 also includes a thread 148. In some embodiments, the thread 148 is directionally opposite the thread 138 on the internal surface of the conduit adapter 106. Thus, an object can threadedly rotate onto the conduit retainer 108 and continued rotation will cause the conduit adapter 106 to unthread from the wafer adapter 104.

[0091] Referring now to Figs. 4, 5, and 16, some embodiments of the present invention further include a cap 150 that is configured to engage the conduit retainer 108. The cap 150 has a solid outer wall and an internal receiving area to house at least a portion of the conduit retainer 108. The internal surface as established by the receiving area may include a thread configured to engage the thread on the conduit retainer 108. In some embodiments, as best depicted in Fig. 16, the cap 150 fully encloses the conduit retainer 108, the conduit adapter 106, and the wafer adapter 104 to prevent unintentional detachment of the components. Again, it should be noted that Fig. 16 shows the wafer adapter 104 detached from the wafer 110 to aid in conveying the functionality of the components. While functional in this manner, the wafer adapter 104 can be secured to wafer 110 prior to securing the conduit adapter 106 to the wafer adapter 104 and the cap 150 to the conduit retainer 108 to minimize slack in conduit 102.

[0092] In some embodiments, the cap 150 has an absorbent, deodorizing, and disposable pad within the receiving area. The pad offers a second line of defense against any leakage through the twisted conduit 102. The cap 150 and absorbent, deodorizing pad also offer a method to deodorize and conceal any fecal remnants in the twist after excretion.

[0093] Referring now to Figs. 6-7 and 18-19, some embodiments of the present invention further include a pouch adapter 152. The pouch adapter 152 is configured to engage the conduit retainer 108. The pouch adapter 152 has an annulus shape with an aperture 156 established by an outer surface and an inner surface. The outer surface includes a flange 154, such as those typically found on ostomy wafers 110 and as described herein in relation to attachment mechanism 130. Flange 154 is configured to engage the corresponding flange on typical ostomy pouches 112. Like attachment mechanism 130, the flange 154 may have an alternative structure or use alternative attachment mechanisms that are configured to engage the attachment mechanism on the ostomy pouch 112. Non-limiting examples of alternative attachment mechanisms include mechanical click-lock systems, adhesive coupling systems, floating flange designs, locking ring or lever mechanisms, and magnetic couplings.

[0094] As depicted in Fig. 19, once the pouch adapter 152 is rotated onto the conduit retainer 108, continued rotation of the pouch adapter 152 will cause the conduit adapter 106 to unthread from the wafer adapter 104 due to the oppositely directed threads. The unthreading of the conduit adapter 106 in turn untwists the conduit 102 allowing stool to exit the patient's bowel and enter the ostomy pouch 112.

[0095] The present invention further includes a method of sealing a stoma and evacuating a patient's bowel. The method of sealing the stoma includes attaching an ostomy wafer 110 and inserting a flexible conduit 102 through the patient's stoma and into the patient's bowel. These steps can be performed using any of the components described herein. The externally residing portion of the conduit 102 is then passed through the wafer adapter 104 and the wafer adapter 104 is secured to the ostomy wafer 110. The conduit 102 is also passed through the conduit adapter 106 and folded back onto external surface of the conduit adapter 106. The conduit retainer 108 is then secured onto the conduit adapter 106. At this point, any excess conduit 102 can be trimmed and the conduit adapter 106 is secured to the wafer adapter 104 by threading the conduit adapter 106 onto the wafer adapter 104, which causes the conduit 102 to create a twist seal. In some embodiments, the conduit adapter 106 is rotated to create the twist seal and then secured to the wafer adapter 104. Optionally, a cap 150 can be secured to the conduit retainer 108.

[0096] The method of evacuating the patient's bowel includes attaching an ostomy pouch 112 directly to the conduit retainer 108 or through a pouch adapter 152. As the conduit retainer 180 and conduit adapter 106 conjointly rotate relative to the pouch adapter 152, their rotation causes the conduit 102 to untwist. The bowel is then free to evacuate waste into the pouch 112.

[0097] Referring now to Figs. 20-21 , some embodiments of the present invention include a wafer adapter 104 configured to clip onto the ostomy wafer 110 and the conduit 102 is configured to be folded back onto the wafer adapter 104. The conduit 102 may include an external ring 160 configured to fit tightly within a groove 162 in the wafer adapter 104. In such an embodiment, the user can manually rotate the conduit 102 to create the seal prior to folding the conduit 102 back over the external surface of the wafer adapter 104 or the user can rotate wafer adapter 104 when conduit 102 is already secured to wafer adapter 104. A cover 150 can then be secured over top of the conduit 102 and the wafer adapter 104. This embodiment may also include a pouch adapter 152. The pouch adapter 152 is configured to engage the wafer adapter 104 and the conduit 102 and includes an attachment component similar to that of the other designs described herein to engage the ostomy pouch 112. When the pouch adapter 152 is secured or when an ostomy pouch 112 is secured over top the wafer adapter 104, a user can remove the external ring 160 from the groove 162 and the conduit 102 will untwist and allow the content of the bowel to enter the ostomy pouch 112.

[0098] Referring now to Figs. 22-25, some embodiments include an alternatively designed wafer adapter 104 configured to attach to an ostomy wafer 110 as described in connection with other embodiments. Like previous versions, the wafer adapter 104 includes an internal aperture 132 through which the conduit 102 can pass. However, the wafer adapter 104 further includes a plurality of pin holes 164 arranged about its circumference.

[0099] In this embodiment, the conduit adapter 106 is in the form of an iris retractor. The iris retractor 106 includes slots 166 that receive the pins (not shown) which reside in the pin holes 164 and bolt holes 176 that receive bolts (not shown) secured to each leaflet 168. The pins also pass through leaflets 168. As iris retractor 170 is rotated relative to the wafer adapter 170, the pins slide along slots 166 thereby causing rotation of the leaflets 168 relative to the iris retractor 170.

[0100] This iris retractor 106 is similar to those known in the art and includes a plurality of leaflets 168 and an actuator 172 configured to occlude the central aperture 174 in the retractor 106. Alternative retractors are also considered where an actuator is configured to occlude an aperture through which the conduit 102 can pass. When the actuator 172 is in the open position (Fig. 25), fluid can flow through the conduit 102 passing through the central aperture 174. When the actuator is in the closed position (Fig. 24), the central aperture 174 is occluded by the leaflets 168 or other closure structures to seal the conduit 102.

[0101] The iris retractor 106 is configured to engage the wafer adapter 104 at a first end using any mechanisms and devices known in the art including those disclosed herein. At the second end, the iris retractor 106 is configured to engage a conduit retainer 108 once the conduit 102 is folded back over a portion of the iris retractor 106. The conduit retainer 108 is attached using any mechanisms and devices known in the art, including those disclosed herein, but does not interfere with the lever actuator. Like the other embodiments, the cap 150 and / or ostomy pouch 112 can be secured directly to the conduit retainer 108 or through an intermediate pouch adapter 152.

[0102] Some embodiments of the present invention further include a measuring system printed on the outside of the conduit 102 to allow the user to measure the correct conduit 102 length required for their specific anatomy and then cut off the remaining section of conduit 102.

[0103] The advantages set forth above, and those made apparent from the foregoing description, are efficiently attained. Since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

[0104] It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention that, as a matter of language, might be said to fall therebetween.

Claims

What is claimed is:1 . A continent ostomy device, comprising: a flexible conduit having a first end and a second end with a retention device located proximate the first end, wherein the conduit is configured to twist about itself to create a seal; a wafer adapter configured to engage an ostomy wafer, the wafer adapter including an internal aperture through which the conduit passes when the wafer adapter engages the ostomy wafer; a conduit adapter configured to engage the conduit, the conduit adapter including an internal aperture through which the conduit passes; a conduit retainer configured to engage the conduit; the conduit adapter configured to operably engage the wafer adapter and rotate relative to the ostomy wafer; wherein rotation of the conduit adapter twists the conduit to create a seal between the first end and the second end of the conduit.

2. The device of claim 1 , wherein the conduit adapter is configured to rotatably engage the wafer adapter.

3. The device of claim 2, further including a pouch adapter configured to rotatably engage the conduit retainer via a rotational direction opposite of a direction of rotation required to rotatably engage the conduit adapter to the wafer adapter.

4. The device of claim 3, wherein the pouch adapter is further configured to engage an ostomy pouch.

5. The device of claim 4, wherein the pouch adapter is configured to rotate to untwist the conduit while the ostomy pouch is secured to the pouch adapter.

6. The device of claim 1 , further including a cap configured to at least partially cover the second end of the conduit by engaging at least the conduit retainer.

7. The device of claim 1 , wherein the conduit retainer and the conduit adapter interconnect through one or more keyed joints.

8. The device of claim 1 , wherein the wafer adapter includes a thread on an external surface.

9. The device of claim 8, wherein the conduit adapter includes a thread on an internal surface that is configured to engage the thread on the wafer adapter.

10. The device of claim 9, wherein the conduit retainer includes a thread on an external surface that is directionally opposite of the thread on the internal surface of the conduit adapter.

11. A continent ostomy device, comprising: a flexible conduit having a first end and a second end with a retention device located proximate the first end, wherein the conduit is configured to twist about itself to create a seal; a wafer adapter configured to engage an ostomy wafer, the wafer adapter including an internal aperture through which the conduit passes when the wafer adapter engages the ostomy wafer; a conduit adapter, wherein the conduit adapter includes an internal aperture through which the conduit passes and an external surface configured to receive at least a portion of the conduit; a conduit retainer configured to secure the conduit between the conduit adapter and the conduit retainer; the conduit adapter configured to threadedly engage the wafer adapter and rotate relative to the ostomy wafer; wherein rotation of the conduit adapter in a first direction twists the conduit into a sealing orientation and rotation of the conduit adapter in a second direction untwists the conduit out of the sealing orientation.

12. The device of claim 11 , further including a pouch adapter configured to rotatably engage the conduit retainer via a rotational direction opposite of a direction of rotation required to rotatably engage the conduit adapter to the wafer adapter.

13. The device of claim 12, wherein the pouch adapter is further configured to engage an ostomy pouch.

14. The device of claim 13, wherein the pouch adapter is configured to rotate to untwist the conduit while the ostomy pouch is secured to the pouch adapter.

15. The device of claim 11 , further including a cap configured to at least partially cover the second end of the conduit by engaging at least the conduit retainer.

16. The device of claim 11 , wherein the conduit retainer and the conduit adapter interconnect through one or more keyed joints.

17. The device of claim 11 , wherein the wafer adapter includes a thread on an external surface.

18. The device of claim 17, wherein the conduit adapter includes a thread on an internal surface that is configured to engage the thread on the wafer adapter.

19. The device of claim 18, wherein the conduit retainer includes a thread on an external surface that is directionally opposite of the thread on the internal surface of the conduit adapter.

20. A method of sealing an ostomy of a patient, comprising: inserting a first end of a conduit through a stoma until a retention device of the conduit reaches an intraabdominal portion of the bowel of the patient; passing a second end of the conduit through an internal aperture in a wafer adapter and securing the wafer adapter to an ostomy wafer; passing the second end of the conduit through an internal aperture in a conduit adapter; folding the second end of the conduit back over an external surface of the conduit adapter; sliding a conduit retainer over the second end of the conduit that is folded back over the external surface of the conduit adapter; threading the conduit adapter onto the wafer adapter thereby causing the conduit to twist and create a seal between the first end and second end of the conduit.21 . The method of claim 20, further including rotatably engaging the conduit adapter to the wafer adapter.

22. The method of claim 21 , rotatably engaging a pouch adapter to the conduit retainer via a rotational direction opposite of a direction of rotation required to rotatably engage the conduit adapter to the wafer adapter.

23. The method of claim 22, further including securing an ostomy pouch to the pouch adapter.

24. The method of claim 23, wherein the conduit retainer and conduit adapter are configured to conjointly rotate relative to the pouch adapter to untwist the conduit while the ostomy pouch is secured to the pouch adapter.

25. The method of claim 23, further including securing a cap to the conduit retainer when the ostomy pouch is disconnected.

26. The method of claim 20, further including interconnecting the conduit retainer and the conduit adapter through one or more keyed joints.

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