Stoma coupler

Abstract

A system for removing bodily fluids from a stoma of a patient. The system comprises a stoma coupler configured to be installed within an interior of a bowel segment of the patient. The stoma coupler comprises a cylindrical main body having an interior and an exterior and a valve positioned with the interior of the main body. An exterior surface of the stoma coupler comprises a textured pattern configured to be in contact with the interior of the bowel segment. The stoma coupler presents a primary opening extending through the stoma coupler through which fluid from the patient's body is configured to pass. The system further comprises a bag configured to be removably coupled with the stoma coupler.

Description

STOMA COUPLERCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims the priority benefit of U.S. Provisional Application Serial No. 63 / 679,299, filed August 5, 2024, entitled “STOMA COUPLER,” and incorporated by reference in its entirety herein.FIELD OF THE INVENTION

[0002] Embodiments of the present invention relate to medical devices. More particularly, embodiments of the present invention relate to a stoma coupler and method of using the stoma coupler.BACKGROUND OF THE INVENTION

[0003] An ostomy is a surgical procedure in which one end of a bowel segment is surgically connected to the patient’s abdominal wall. As such, the stoma is an opening in the body of a patient (e.g., formed through an incision) through which bodily waste fluids, such as feces and urine, can pass. Commonly a stoma bag will be connected to the stoma to receive the bodily fluids for disposal. For example, stoma bags are generally attached to the skin of the patient by adhesive tape around the stoma. As can be appreciated, attachment in this common manner often leads to unwanted leakage, patient irritations, and possible infections.SUMMARY

[0004] Embodiments of the present invention include a system for removing bodily fluids from a stoma of a patient. The system comprises a stoma coupler configured to be installed within an interior of a bowel segment of the patient. The stoma coupler comprises a cylindrical main body having an interior and an exterior and a valve positioned with the interior of the main body. An exterior surface of the stoma coupler comprises a textured pattern configured to be in contact with the interior of the bowel segment. The stoma coupler presents a primary opening extending through the stoma coupler through which fluid from the patient’s body is configured to pass. The system further comprises a bag configured to be removably coupled with the stoma coupler.

[0005] Embodiments of the present invention additionally include a stoma coupler comprising a cylindrical main body having an interior and an exterior and a valve positioned with the interior of the main body. An exterior surface of the stoma coupler comprises a textured pattern configured to be in contact with the interior of the bowel segment. The stoma coupler is configured to be received within an interior of a bowel segment of a patient. The stoma coupler presents a primary opening extending through the stoma coupler through which fluid from the patient’s body can pass. The stoma coupler is configured to releasably couple with a stoma bag to receive the fluid from the patient’s body.

[0006] Embodiments of the present invention further include a stoma bag for receiving bodily fluids from a stoma of a patient. The stoma bag comprises a container, and a coupling head secured around an opening in the container. The coupling head includes a tubular projection extending from the container. The bag includes one or more connection tabs extending radially outward from the coupling head. The bag is configured to be securely engaged with a stoma coupler associated with the stoma of the patient by inserting the tubular projection within the stoma coupler and rotating the bag with respect to the stoma coupler. Upon the bag being securely engaged with the stoma coupler, the tubular projection is configured to maintain a valve of the stoma coupler in an open position such that fluid from the patient is allowed to pass through the stoma coupler and into the container of the stoma bag.

[0007] This summary is not intended to identify essential features of the present invention, and is not intended to be used to limit the scope of the claims. These and other aspects of the present invention are described below in greater detail.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Embodiments of the present invention are described in detail below with reference to the attached drawing figures, wherein:

[0009] FIG. 1 is a perspective view of a distal end of a stoma coupler according to embodiments of the present invention;

[0010] FIG. 2 is a cross-section of the stoma coupler of FIG. 1 ;

[0011] FIG. 3 is an exploded view of the stoma coupler of FIGS. 1 and 2;

[0012] FIG. 4 is a cross-section of the stoma coupler of FIG. 1 inserted within a stoma of a patient and with a stoma bag coupled with the stoma coupler;

[0013] FIG. 5 is a pattern design of a mesh from the stoma coupler of FIG. 1 ;

[0014] FIG. 6 is another pattern design of a mesh from the stoma coupler of FIG. 1 ;

[0015] FIG. 7 is a perspective view of a cap configured to be coupled with the stoma coupler of FIG. 1 ;

[0016] FIG. 8 is a cross-section of the stoma coupler of FIG. 1 inserted within a stoma of a patient and with the cap of FIG. 7 coupled with the stoma coupler;

[0017] FIG. 9 is a perspective view of a connection collar for a stoma coupler according to embodiments of the present invention, with the connection collar in the closed configuration;

[0018] FIG. 10 is a top plan view of the connection collar from FIG. 9 for a stoma coupler according to embodiments of the present invention, with the connection collar in the open configuration;

[0019] FIG. 11 is a perspective view of a back side of a stoma bag according to embodiments of the present invention;

[0020] FIG. 12 is a perspective view of a front side of the stoma bag from FIG. 11 ;

[0021] FIG. 13 is a perspective view of an insertion tool according to embodiments of the present invention;

[0022] FIG. 14 is a cross-section of the insertion tool from FIG. 13 integrated with the stoma coupler from FIG. 1 ;

[0023] FIG. 15 is a perspective view of a distal end of a stoma coupler according to additional embodiments of the present invention; and

[0024] FIG. 16 is a cross-section of the stoma coupler of FIG. 15.

[0025] The figures are not intended to limit the present invention to the specific embodiments they depict. While the drawings do not necessarily provide exact dimensions or tolerances for the illustrated structures or components, the drawings are to scale with respect to the relationships between the components of the structures illustrated in the drawings.DETAILED DESCRIPTION

[0026] The following detailed description of the present invention references various embodiments. The embodiments are intended to describe aspects of the invention in sufficient detail to enable those skilled in the art to practice the invention. Other embodiments can be utilized and changes can be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense. The scope of the present invention is defined only by the appended claims, along with the full scope of equivalents to which such claims are entitled.

[0027] Embodiments of the present invention are directed to a stoma coupler 10, as illustrated in FIGS. 1-3, configured to be implanted within an interior of a bowel segment of a patient as shown in FIG. 4. Because the stoma coupler 10 is implanted within an interior of the bowel segment, the stoma coupler 10 is configured to maintain the bowel segment in an open position, such that the bowel segment does not collapse upon itself.

[0028] Generally, the patient’s bowel segment will be brought through, and attached to a patient’s abdominal wall as a stoma. The bowel segment may be secured to the patient’s abdominal wall via sutures or other surgical methods. The stoma coupler 10 of embodiments of the present invention is configured to be inserted and retained within the interior of the patient’s bowel segment. With reference to FIGS. 1-3, the stoma coupler broadly comprises a main implant body 12, which may be formed from silicone and may have a hollow cylindrical shape. In certain embodiments, a polymer casing, such as silicone (e.g., Moldstar 31T), may be molded around the exterior of the main implant body 12.

[0029] Regardless, the stoma coupler 10 may have a generally cylindrical shape with a primary opening formed longitudinally through a center of the stoma coupler 10. Once the stoma coupler is integrated within a patient’s bowel (e.g., as shown in FIG. 4), bodily fluid may flow through the primary opening of the stoma coupler 10 from the proximal end of the stoma coupler to the distal end (i.e., the proximal end is the lower end shown in FIG. 4). As perhaps best shown in FIGS. 2 and 3, a valve 14 may be attached to the interior of the main implant body 12 and may selectively open and close the primary opening of the stoma coupler 10. FIGS. 2 and 3 show the valve 14 in the open position,while FIG. 4 shows the valve 14 in the closed position. In the open position, fluid can pass through the stoma coupler 10. In contrast, in the closed position, fluid is prevented from passing through the stoma coupler 10.

[0030] Turning to the structure of the main implant body 12 in more detail, the main implant body 12 may be formed from various plastics or resins, such as silicone or Formlabs Durable Resin. As perhaps best shown by the cross section of FIG. 2, the main implant body 12 comprises cylindrical main portion with a flange or shelf 20 that extends radially inward from the main portion into the primary opening of the stoma coupler 10. The valve 14 may be engaged with the main implant body 12 by way of a distal end of the valve 14 being engaged with a proximal surface of the shelf 20. In some embodiments, the valve 14 may be removably engaged with the main implant body 12. However, the valve 14 may, in other embodiments, be permanently engaged or integrated with the main implant body 12. In certain embodiments not shown in the drawings, the valve 14 may be removably secured in place with respect to the main implant body 12 via a locking ring that is configured to be snap fit into engagement with a proximal end of the main implant body 12, such that the circumferential portions of the valve 14 are securely held in place between the shelf 20 and the locking ring.

[0031] The valve 14 may comprise a flexible one-way check valve. In a natural state where no forces are applied to the valve 14, the valve 14 may be in a closed position that restricts fluid flow through the stoma coupler 10. However, the valve 14 may be formed from a flexible material, such as silicone or rubber, which may allow the valve 14 to be selectively forced open from the closed position to an open position to permit waste to travel from the patient, through the implant body 12, to outside the patient, as will be described in more detail below.

[0032] In some embodiments, as perhaps best shown in FIGS. 1 and 3, a distal end of the main implant body 12 may be removably connected with a connection mechanism 24. In some embodiments, the connection mechanism 24 may be snap fit into the distal end of the main implant body 12. The connection mechanism 24 may be configured to facilitate the connection of various components attachments (e.g., bags or caps) to the main implant body 12, as will be described in more detail below.

[0033] When the connection mechanism 24 is secured to the main implant body 12, a receiving gap 26 is formed on the interior of the stoma coupler 10, between a distal end of the connection mechanism 24 and the shelf 20 of the main implant body 12. In addition, the distal end of the connection mechanism 24 may include one or more (e.g., a pair) of notches or slots 28 formed thereon. In certain embodiments, the slots 28 may be formed on opposite circumferential sides of the distal end of the connection mechanism 24 (e.g., 180 degrees offset from each other). As a result, when the connection mechanism 24 is coupled with the main implant body 12, the slots 28 communicate with the receiving gap 26, such that an object that passes through the slots 28 can be received within the receiving gap 26. Thus, as will be described in more detail below, the connection mechanism 24 provides for a sealing connection between various attachments and the stoma coupler 10. Such attachments include caps, stoma bags, etc.

[0034] As also shown in FIGS. 1 -3, the exterior of the stoma coupler 10 may additionally include a cylindrically-shaped section of mesh 30 that extends from adjacent the proximal end of the stoma coupler 10 distally along a central portion of the stoma coupler 10 toward a distal end of the stoma coupler 10. For example, as perhaps best shown in FIG. 2, the distal end of the stoma coupler 10 may have a radially enlarged portion that extends outward from the central portion of the stoma coupler 10 via a flanged surface. Similarly, the proximal end of the stoma coupler 10 may have a radially enlarged portion that extends outward from the central portion of the stoma coupler 10 via a flanged surface. As such, the mesh 30 may extend along the exterior of the entire central portion of the stoma coupler 10 between such flanged surfaces of the proximal and distal ends.

[0035] The mesh 30 of the stoma coupler 10 may be formed from metal (e.g., Nitinol alloy) and specifically designed with patterns to facilitate the ingrowth of mucosal tissue of the bowel segment within the mesh 30. In other embodiments, the mesh 30 may be formed from expanded polytetrafluoroethylene (ePTFE or Teflon) or polypropylene. Examples of mesh 30 design patterns are illustrated in FIGS. 5 and 6. In some embodiments, the mesh 30 may be formed by precision laser cutting to achieve specific design elements. Geometric patterning may be used to create two sets of pore sizes within the mesh 30. The larger hexagons / octagons of each design shown in FIGS. 5 and 6 may have an inscribed circle diameter of about 1 .9 mm. In FIG. 5, the triangular poresmay have an inscribed circular diameter of about 0.8 mm. In FIG. 6, the diamond shaped pores may have an approximate inner diameter of about 1.2 mm. It has been found beneficial for the mesh 30 to include at least two different pore types (e.g., with different shapes and / or sizes). These different pore shapes and sizes are particularly designed to elicit two different cellular growth mechanisms of the ingrowth of mucosal tissue of the bowel segment. As noted above, the mesh 30 may be integrated into the exterior of the stoma coupler 10, such that the ingrowth of the bowel’s mucosal tissue with the mesh 30 will function to secure the stoma coupler 10 to the bowel segment.

[0036] In some additional or alternative embodiments, an exterior surface of the stoma coupler 10 (e.g., of the main implant body 12) may comprise a textured surface. Such a texture surface may, for example, have design patterns similar to those shown FIGS. 5 and 6. Thus, the exterior surface of the stoma coupler 10 may be configured to elicit the ingrowth of mucosal tissue of the bowel segment into the stoma coupler 10 with or without a separate mesh 30 component.

[0037] To further aid in ingrowth and connection with the bowel, in some embodiments not shown in the drawings, the exterior of the stoma coupler 10 may include sections (e.g., rings) of fiber batting. For example, the stoma coupler 10 may include a first ring of fiber batting (e.g., a first ring of Dacron) positioned around a proximal end of the stoma coupler 10, as well as a second ring of fiber batting (e.g., a second ring of Dacron) positioned around a middle portion or a distal end of the stoma coupler 10.

[0038] Regardless, as shown in FIG. 4, the stoma coupler 10 described above is configured to be inserted through the interior of a free end of a bowel segment 40 (e.g., the ileum) that has been partially extended through an incision in a patient’s abdominal wall 42 (and perhaps secured in place to the abdominal wall via sutures) to form a stoma. In more detail, the stoma coupler 10 is configured to be positioned within the bowel segment 40 such that the proximal end of the stoma coupler 10 is inserted entirely within the bowel segment 40 and at least a portion of the distal end of the stoma coupler 10 extends out, beyond the bowel segment 40 (and perhaps beyond the abdominal wall 42). The stoma coupler 10 can be secured in place within the bowel segment 40 via the mesh 30, which is configured to integrate with the interior portions of the bowel segment 40, as will be discussed in more detail below. In some embodiments, the stoma coupler 10 mayalso be secured to the inside of the bowel segment 40 with non-absorbable sutures. In some further embodiments, as will also be discussed in more detail below, the stoma coupler 10 may also include a connection collar 44 that fits around the bowel segment 40 to compress the bowel segment 40 between the connection collar 44 and the exterior of the main implant body 12 of the stoma coupler 10. In certain embodiments, the connection collar 44 will compress the bowel segment 40 between the connection collar 44 and the mesh 30 of the stoma coupler 10.

[0039] With the stoma coupler 10 engaged with the stoma, as described above, various external components or attachments can be releasably secured to the distal end of the stoma coupler 10, such as a stoma bag 50 for collecting bodily fluid flowing from the stoma, as shown in FIG. 4. Alternatively, a cap 52 may be secured to the stoma coupler 10, as shown in FIGS. 7 and 8, for blocking and sealing the flow of bodily fluid from the stoma.

[0040] As noted above, in certain embodiments, the stoma coupler 10 is also aided in being secured to the bowel segment 40 by way of the connection collar 44 shown in illustrations 4 and 8. When the stoma coupler 10 is inserted within the interior of the bowel segment 40, the connection collar 44 can be secured around the exterior of the bowel segment 40 to compress the bowel segment 40 between the connection collar 44 and the exterior of the stoma coupler 10 (e.g., between the connection collar 44 and the mesh 30). In some embodiments, as shown in FIG. 3, the connection collar 44 may be configured as a cable tie or a zip tie. Alternatively, certain embodiments of a connection collar 44(a) may have latching joint 56, as shown in FIGS. 9 and 10 that allows the connection collar 44(a) to be retained in a closed position around the bowel segment 40.

[0041] In some embodiments (not shown in the figures), an annular groove may be formed within the exterior of the stoma coupler 10 (e.g., the exterior of the mesh 30), such that the connection collar 44, 44a can be aligned with the annular groove when compressing the bowel segment 40. As a result, the bowel segment 40 can be further compressed between the connection collar 44, 44a and the annular groove formed in the stoma coupler 10.

[0042] In some embodiments, it may be preferrable for the connection collar 44, 44a is configured to provide between from 15 to 25%, from 18 to 23%, or about 20%radial compression of the total tissue thickness of the bowel segment 40 between the connection collar 44, 44a and the mesh 30 of the stoma coupler 10. In some of such embodiments, the main interior surface of the connection collar 44, 44a may be generally flat and / or uniform in shape. However, in some embodiments, the interior surface of the connection collar 44a may, as shown in FIGS. 9 and 10, be formed with a plurality of spaced apart protrusions or “spikes” 58 that extend outward from the main interior surface of the connection collar 44a. In some of such embodiments, the tips of the spikes 58 may be configured to provide from 40 to 60%, from 45 to 55%, or about 50% radial compression of the total tissue thickness of the bowel segment 40 between the spikes 58 of the connection collar 44a and the mesh 30 of the stoma coupler 10. Nevertheless, it is contemplated that the shape of the connection collar 44, 44a (and perhaps the annular groove formed in the stoma coupler 10) may be modified to provide uniform compression of the bowel segment 40. For example, the connection collar 44, 44a geometry may be configured to generally match that of any annular groove.

[0043] In some embodiments, the connection collars 44, 44a may be formed from the same material as the main implant body 12 (e.g., plastic or resin), but may be flexible enough to be secured around the bowel segment 40. As noted above, the connection collar 44, as shown in FIGS. 1-3, may be formed with a cable tie or zip tie connection. In contrast, the connection collar 44a, as shown in FIGS. 9 and 10, may be configured to flexibly open about the latching joint 56 which provides for the connection collar 44a to be flexed to an open position (when the latching joint 56 is unsecured) and securely held in a closed position (when the latching joint 56 is secured together). Specifically, FIG. 10 shows the connection collar 44a in an open position (with the latching joint 56 unsecured), such that the connection collar 44a can be moved and / or positioned around the bowel segment 40. And FIG. 9 shows the connection collar 44a in a closed position (with the latching joint 56 secured together), such that the connection collar 44a can be locked in position around the bowel segment 40. In some embodiments (not shown in the drawings), the connection collar 44, 44a may comprise a fabric batting (e.g., Dacron) positioned around the exterior of the connection collar 44, 44a (e.g., top, bott, and outer surfaces), to facilitate ingrowth of mucosal tissue of the bowel segment 40. The fabricbatting could be secured to the connection collar 44, 44a via adhesive, sutures, or combinations thereof.

[0044] In addition, the connection collar 44a may have various numbers of spikes 58 (e.g., from 15 to 30) spread apart around the main interior surface of the connection collar 44a. In addition, a spike angle of the spikes may vary (e.g., from 10 to 50° or about 30°). It should be noted that the spike angle is the angle of the exterior side of a given spike 58 relative to a radial centerline of the spike 58. However, it should be understood that the ideal configuration of the connection collar 44a and associated spikes 58 is one that provides appropriate compression to secure the stoma coupler 10 to the bowel segment 40, while minimizing the risk of tissue necrosis.

[0045] It should be understood, however, that in some embodiments, the connection collar 44, 44a may not be necessary for purposes of implanting the stoma coupler 10 within a patient’s bowel. For example, the stoma coupler 10 may be held in place within the bowel via sutures or other surgical methods.

[0046] As noted previously, once the stoma coupler 10 has been integrated with the stoma, various components can be operably coupled with the stoma via the stoma coupler 10. For example, the cap 52, as shown in FIG. 7, may be releasably attached to the distal end of the stoma coupler 10, as illustrated in FIG. 8. The cap 52 may be generally circular or disc shaped and may include a handle on its distal end and a gasket formed on its proximal end. The cap 52 may additionally comprise a pair of connection tabs 60, each extending radially from opposite sides of the main exterior surface of the cap 52. To securely engage the cap 52 with the stoma coupler 10, the connection tabs 60 of the cap can be inserted within the slots 28 formed in the connection mechanism 24, and the cap 52 can be rotated such that the connection tabs 60 are rotated through and securely held within the receiving gap 26 formed between the connection mechanism 24 and the main implant body 12 at the distal end of the stoma coupler 10. When facing the distal end of the stoma coupler 10, the cap 52 can be secured thereto via a clockwise rotation. The connection mechanism 24 may include barriers 62, as shown in FIGS. 2 and 3, that prevent improper rotation of the cap 52 when inserted within the distal end of the stoma coupler 10. The barriers 62 may also act as stops that ensure proper alignment of the connection tabs 60 and the slots 28 when the cap 52 is rotated in an oppositedirection (e.g., counter-clockwise) so as to facilitate efficient! removal of the cap 52 from the stoma coupler 10.

[0047] With the cap 52 securely engaged with the stoma coupler 10, the cap 52 will function as a stop or seal to prevent bodily fluid from exiting the stoma and external contamination from entering the stoma. The cap 52 provides a secure seal via the gasket, which may be formed from various types of appropriate elastomeric materials, such as polymer (e.g., rubber). In some embodiments, the cap 52 may comprise a filter that may function to provide pressure relief from gas build-up within the bowel. Furthermore, the cap 52 may include various sensors to provide data relative to the stoma coupler 10 and / or the patient. Such sensors may include, for example, pressure sensors to monitor the gas pressure within the stoma.

[0048] In addition to the cap 52, embodiments of the present invention include the stoma bag 50, as illustrated in FIGS. 11 and 12, which can be removably coupled with the stoma coupler 10, as illustrated in FIG. 4, to receive and dispose of bodily fluids collected from the stoma. The stoma bag 50 may comprise a container 68 formed from a thin polyurethane sheet that has been laser cut to the appropriate size and shape. The stoma bag 50 includes a coupling head 70 that is secured to an opening formed in the stoma bag 50. The part of the coupling head 70 that is secured to the container 68 portion of the stoma bag 50 may include a plurality of knubs, ridges, or other similar projections that function to ensure that the adjacent inner surfaces of the polyurethane that form the container 68 do not adhere to each other. An opposite end of the coupling head 70 includes a tubular projection that is configured to be received within the primary opening of the stoma coupler 10. Finally, the coupling head 70 may also include a pair of connection tabs 72, which are configured to be securely engaged with the connection mechanism 24 and the main implant body 12 of the stoma coupler 10 to releasably secure the stoma bag 50 to the stoma coupler 10 in generally the same manner discussed above with respect to the cap 52.

[0049] For example, as shown in FIG. 4, the stoma bag 50 may be releasably attached to the distal end of the stoma coupler 10. The connection tabs 72 of the coupling head 70 of the stoma bag 50 can be inserted within the slots 28 formed in the connection mechanism 24 (not show in FIG. 4), and the coupling head 70 and / or stoma bag 50 canbe rotated such that the connection tabs 72 are rotated through and securely held within the receiving gap 26 formed between the connection mechanism 24 and the main implant body 12 at the distal end of the stoma coupler 10. When facing the distal end of the stoma coupler 10, the coupling head 70 and / or stoma bag 50 can be secured thereto via a clockwise rotation. Rotation in an opposite direction (e.g., counter-clockwise) may be used to remove the stoma bag 50 from the stoma coupler 10.

[0050] Notably, insertion of the coupling head 70 of the stoma bag 50 within the stoma coupler 10 may force open the valve 14 of the stoma coupler 10 to allow waste to pass through the patient’s stoma to the stoma bag 50. It is noted that prior to the coupling head 70 opening the valve 14, the valve 14 remains in a natural closed state to prevent bodily fluids and gasses from inadvertently passing from the patient and through the stoma coupler 10.

[0051] In more detail, upon the stoma bag 50 being attached to the stoma coupler 10, the coupling head 70 that is in the form of a tubular projection is inserted through the primary opening of the stoma coupler 10 (see, e.g., FIG. 4). The coupling head 70 is configured to force the valve 14 of the stoma coupler 10 to the open position (it is note that the valve 14 is normally in the closed position unless forced open by another object). The connection tabs 72 of the stoma bag 50 can, simultaneously, be received within the receiving gap 26 of the stoma coupler 10 (after passing through the slots 28). As such, the stoma bag 50 can be rotated clockwise to secure the stoma bag 50 into operable engagement with the stoma coupler 10. Specifically, with the stoma bag 50 attached to the stoma coupler 10, bodily fluid can pass through the stoma coupler 10 and be received within the interior of the stoma bag 50. Once full, the stoma bag 50 can be removed from the stoma coupler 10 and disposed or cleaned.

[0052] In some embodiments, the stoma bag 50 may include a filter 74, as shown in FIG. 11 , to allow for gas release from the stoma bag 50 while preventing fluid leakage. As such, the filter 74 may function a gas vent and liquid seal. The filter 74 may comprise a one-way filter formed from expanded polytetrafluoroethylene (ePTFE) in tandem with a charcoal filter. Specifically, the stoma bag 50 may comprise a combination of layers of ePTFE, polyurethane, and activated charcoal. ePTFE is capable of acting as a low- pressure barrier for gas release (e.g., a breathable barrier) while simultaneouslypreventing leakage when exposed to liquid. As such, gas can pass through an ePTFE layer, through the carbon filter, and through another ePTFE layer. The filter 74 may be attached to the bag via adhesive, heat sealing, or combinations thereof.

[0053] In some additional embodiments, the stoma bag 50 may include one or more sensors 76, such as pressure sensors, configured to obtain data about the bag and / or the patient’s stoma. The sensors 76 may be positioned on and / or otherwise associated with the container 68 and / or the coupling head 70 of the stoma bag 50. In some embodiments, the sensors 76 may be incorporated with the filter 74 described above. Alternatively, or in addition, the sensors 76 may otherwise be incorporated with disc-shaped filters integrated with the container 68 of the stoma bag 50. Regardless, such sensors 76 may include pressure sensors configured to monitor gas pressures within the patient’s stoma and / or the stoma bag 50. The sensors 76 may include flow sensors configured to monitor liquid / solid flow within the patient’s stoma and / or the stoma bag 50. The sensors 76 may include temperature sensors configured to monitor a temperature of the patient, a temperature of the patient’s fluids within the stoma, and / or a temperature of the fluid within the stoma bag 50. The sensors 76 may include fill sensors configured to monitor an amount of fluid within the stoma bag 50. In some embodiments, the abovedescribed sensors 76 may be attached to and / or otherwise associated with the stoma coupler 10 instead of (or in addition to) the stoma bag 50. Furthermore, the sensors 76 may be powered by batteries, which may be incorporated within the stoma bag 50 and may be replaceable or rechargeable. Data from the sensors 76 may be transmitted to an external computing device (e.g., a mobile device) for review and further analysis.

[0054] Although the above description illustrates how the stoma bag 50 can receive bodily fluid from a patient and can be disposed when full, other embodiments of the present inventive stoma bag 50 may provide for the stoma bag 50 to have a secondary opening 78, as shown in FIG. 12, from which waste fluid can be removed from the container 68 of the stoma bag 50. As such, the stoma bag 50 may be reusable. In such embodiments, the secondary opening 78 may have multiple closing / sealing mechanisms to ensure that the fluid does not unwantedly escape from the stoma bag 50. For example, the stoma bag 50 may have a secondary opening 78 with multiple (e.g., two, three, or more) distinct closing / sealing mechanisms.

[0055] FIGS. 13 and 14 illustrate an insertion tool 80, which may be used by a surgeon to install the stoma coupler 10 in the bowel and / or stoma of a patient. The tool 80 may comprise an elongated rod or tube with a pair of connection tabs 82 at an end of the tool 80. The insertion tool 80 may have a length from 4 to 24 inches, from 6 to 20 inches, from 8 to 16 inches, or about 12 inches. As such, the insertion tool 80 may be securely engaged with the stoma coupler 10 in a similar manner as the stoma bag 50 and / or the cap 52 previously described. Upon connecting an end of the insertion tool 80 with the stoma coupler 10, the surgeon can use the tool 80 to more efficiently insert the stoma coupler 10 within the bowel and / or stoma of the patient. Specifically, the elongated length of the tool 80 provides increased maneuverability and leverage for the physician to adjust the position of the stoma coupler 10 when installing within the bowel and / or stoma of a patient.

[0056] In view of the above, embodiments of the present invention include a method of coupling a stoma bag 50 to a stoma coupler 10 that has been positioned within a bowel segment of a patient. For example, the stoma coupler 10 may have been inserted within the patient’s stoma by a surgeon using the insertion tool 80 described above. Regardless, the method may include a step of providing the stoma bag 50, which includes a container 68 and a coupling head 70. The coupling head 70 may include a tubular projection extending from an opening in the container 68. An additional step of the method may include coupling the stoma bag 50 with the stoma coupler 10 positioned within the bowel segment of the patient by removably engaging the coupling head 70 with the stoma coupler 10. In some embodiments, during the coupling step, the tubular projection of the coupling head 70 of the stoma bag 50 opens a valve 14 associated with the stoma coupler 10 such that fluid can flow from the patient, through the stoma coupler 10 and into the container 68 of the stoma bag 50. The tubular projection of the coupling head 70 is configured to maintain a valve 14 in the open position such that fluid from the patient is allowed to pass through the stoma coupler 10 and into the bag 50 as long at the bag 50 is properly coupled with the stoma coupler 10.

[0057] In certain embodiments, the method may include a further step of decoupling the stoma bag 50 from the stoma coupler 10. During such decoupling, the tubular projection of the coupling head 70 of the stoma bag 50 is removed from the stomacoupler 10 such that the valve 14 associated with the stoma coupler 10 closes. A still further step of the method may include coupling a cap 52 onto the stoma coupler 10 to prevent fluid from flowing out of the stoma coupler 10.

[0058] Although the invention has been described with reference to the one or more embodiments illustrated in the figures, it is understood that equivalents may be employed and substitutions made herein without departing from the scope of the invention as recited in the claims. For example, FIGS. 15 and 16 illustrate another embodiment of a stoma coupler 100. The stoma coupler 100 may be configured with similar components as the stoma coupler 10 previously described, such that the stoma coupler 100 may function similar to that of the stoma coupler 10. However, the stoma coupler 100 may have components with larger sizes than the corresponding components of the stoma coupler 10, such that the stoma coupler 100 may be used on patients with larger stomas or bowels.

[0059] Having thus described one or more embodiments of the invention, what is claimed as new and desired to be protected by Letters Patent includes the following:

Claims

What is claimed is:1 . A system for removing bodily fluids from a stoma of a patient, the system comprising: a stoma coupler configured to be installed within an interior of a bowel segment of the patient, wherein the stoma coupler comprises - a cylindrical main body having an interior and an exterior; and a valve positioned with the interior of the main body, wherein an exterior surface of the stoma coupler comprises a textured pattern configured to be in contact with the interior of the bowel segment, wherein the stoma coupler presents a primary opening extending through the stoma coupler through which fluid from the patient’s body is configured to pass; and a bag configured to be removably coupled with the stoma coupler.

2. The system of claim 1 , wherein the bag comprises a coupling head and one or more tabs extending from the coupling head, wherein the stoma coupler comprises a receiving gap configured to receive the tabs of the bag to securely couple the bag to the stoma coupler.

3. The system of claim 2, wherein the stoma coupler includes a connection mechanism engaged with a distal end of the main body, wherein the main body includes a shelf extending inward into the primary opening, and wherein the receiving gap is positioned between the connection mechanism and the shelf of the main body.

4. The system of claim 3, wherein the connection mechanism includes one or more slots in communication with the receiving gap, and wherein the one or more tabs are configured to be inserted through the one or more slots into the receiving gap.

5. The system of claim 3, wherein the valve is a positioned adjacent to the shelf of the main body opposite the receiving gap.

6. The system of claim 5, wherein the valve comprises a flexible valve.

7. The system of claim 6, wherein the valve is configured to be forced open by the coupling head of the bag upon the bag being coupled with the stoma coupler.

8. The system of claim 6, wherein the valve is formed from silicone.

9. The system of any one of claims 1-8, wherein the main body is formed from silicone.

10. The system of any one of claims 1-9, wherein the textured pattern is presented by a mesh positioned at least partly around the exterior of the main body, wherein the mesh is formed in a pattern of at least two different pore shapes or sizes that facilitates ingrowth of mucosal tissue of a bowel segment of the patient with the stoma coupler.11 . The system of claim 10, wherein the mesh comprises ePTFE.

12. The system of any one of claims 1-11 , wherein the stoma coupler further comprises a connection collar configured to compress the bowel segment against the main body of the stoma coupler.

13. The system of any one of claims 1-12, wherein the bag includes a filter configured to permit release of gas from the bag.

14. The system of claim 13, wherein the filter comprises ePTFE.

15. The system of claim 13, wherein the filter comprises activated charcoal.

16. The system of any one of claims 1 -15, wherein the bag includes a resealable secondary opening configured to selectively release bodily fluid from the bag.

17. The system of any one of claims 1 -16, further comprising a cap configured to be removably coupled with the stoma coupler, wherein the cap is configured to block fluid from passing through the stoma coupler and out of the patient.

18. The system of any one of claims 1 -17, further comprising an installation tool configured to be removably coupled with the stoma coupler, wherein the installation tool comprises an elongated rod.

19. A stoma coupler comprising: a cylindrical main body having an interior and an exterior; and a valve positioned with the interior of the main body, wherein an exterior surface of the stoma coupler comprises a textured pattern configured to be in contact with the interior of the bowel segment, wherein the stoma coupler is configured to be received within an interior of a bowel segment of a patient, and wherein the stoma coupler presents a primary opening extending through the stoma coupler through which fluid from the patient’s body can pass, wherein the stoma coupler is configured to be releasably coupled with a stoma bag to receive the fluid from the patient’s body.

20. A stoma bag for receiving bodily fluids from a stoma of a patient, the stoma bag comprising: a container; and a coupling head secured around an opening in the container, wherein the coupling head includes a tubular projection extending from the container. wherein the bag includes one or more connection tabs extending radially outward from the coupling head,wherein the bag is configured to be securely engaged with a stoma coupler associated with the stoma of the patient by inserting the tubular projection within the stoma coupler and rotating the bag with respect to the stoma coupler, wherein upon the bag being securely engaged with the stoma coupler, the tubular projection is configured to maintain a valve of the stoma coupler in an open position such that fluid from the patient is allowed to pass through the stoma coupler and into the container of the stoma bag.

Images