A stomal diverter device includes a catheter, a stoma rod, and a bracket. The catheter includes a first tube having an open end, a second tube spaced from the first tube having a closed end, and a drain tube. The stoma rod is positioned between the first and second tubes and includes structure to releasably attach the stoma rod to the abdomen of the patient. The bracket is supported on the catheter and the stoma rod and defines a locking feature that is configured to engage a mating feature of the stoma rod to secure the catheter between the stoma rod and the bracket.

BACKGROUND

1. Technical Description

The present disclosure is directed to a device and method for performing an ostomy procedure and, more particularly, to a stomal diverter device and method of using the stomal diverter device during an ostomy procedure.

2. Background of Related Art

During an ostomy procedure, a portion of an internal body vessel, such as the intestine or colon, is exteriorized to form a stoma. Stomas may be created in conjunction with an ostomy procedure by securing a bisected portion of the internal body vessel to the abdominal wall to provide internal access into the internal body vessel for collecting fecal matter. Ostomy surgery is sometimes performed on an emergency basis due to diverticulitis, trauma, radiation complications, volvulus, necrotic bowel, bowel perforation, etc. An ostomy may be temporary to allow for healing of the bowel or a decrease of inflammation at a surgical site. In some instances, an ostomy may be permanent.

In ostomy procedures, the internal body vessel is secured to the abdominal wall and/or cutaneous tissue of the abdomen. Securing the internal body vessel to the abdominal wall and/or the cutaneous tissue of the abdomen keeps the stoma in the desired location and prevents it from withdrawing back into the abdominal cavity. Typically, a colostomy bag is connected to the stoma site with an adhesive to collect waste materials from the internal body vessel. Although a stoma has no sensory nerve endings and is insensitive to pain, several complications can result at the stoma site where the colostomy bag is secured, such as leaks, skin irritation, infection, etc. As such, the condition of the stoma must be assessed regularly.

Thus, there is a continuing need in the medical arts for an alternative mechanism for collecting fecal matter or waste material from an internal body vessel that overcomes the above disadvantages and can improve the quality of life of patients requiring ostomy.

SUMMARY

One aspect of the disclosure is directed to a stomal diverter device that includes a catheter, a stoma rod, and a bracket. The catheter has a body defining a first tube having an open end, a second tube spaced from the first tube having a closed end, and a drain tube. The first tube is configured to be received within a first opening of a body vessel to receive bodily fluids. The second tube is configured to be received within a second opening of the body vessel. The drain tube has an open end that is configured to extend from an abdomen of a patient and is in fluid communication with the first and second tubes. The stoma rod is configured to be positioned between the first and second tubes and includes structure to releasably attach the stoma rod to the abdomen of the patient. The stoma rod also defines a mating feature. The bracket is supported on the catheter and the stoma rod and defines a locking feature that is configured to engage the mating feature of the stoma rod to secure the catheter between the stoma rod and the bracket to the abdomen of the patient.

In embodiments, the structure of the stoma rod includes a lower surface, an upper surface, and a pair of posts extending from the upper surface, wherein each post defines the mating feature.

In some embodiments, the lower surface of the stoma rod includes an adhesive pad configured to attach the stoma rod to the abdomen of the patient.

In certain embodiments, the structure of the stoma rod includes a plurality of flanges that extend from an outer surface thereof. Each flange defines a hole therethrough and each hole is configured to receive a fastener to secure the stoma rod to the abdomen of the patient.

In embodiments, the bracket includes an upper surface, a lower surface, and a central circular portion defining an opening. The opening is configured to receive the drain tube of the catheter. In embodiments, a pair of legs extends from the lower surface and each leg defines the locking feature.

In some embodiments, the locking feature of the bracket includes at least one protrusion and the mating feature of the stoma rod includes at least one recess.

In certain embodiments, the first tube includes an anchoring device on an outer surface thereof and the anchoring device is configured to secure the first tube to the first opening of the body vessel.

In embodiments, the anchoring device is at least one inflatable balloon that is selectively inflatable from a deflated position to an inflated position and selectively deflatable from the inflated position to the deflated position. The inflatable balloon is configured to anchor the first tube to the first body vessel in the inflated position.

In some embodiments, the catheter includes a port that is in fluid communication with the at least one inflatable balloon. The port is connectable to one of a source of inflation fluid and a source of vacuum.

In certain embodiments, the second tube includes an anchoring device on an outer surface thereof. The anchoring device is configured to secure the second tube to the second opening of the body vessel.

In embodiments, the anchoring device includes a plurality of ribs.

In some embodiments, the stomal diverter device includes an inflatable balloon that is disposed on an inner surface of the first tube, wherein the inflatable balloon is inflatable from a deflated position to an inflated position and deflatable from the inflated position to the deflated position. The inflatable balloon is configured to obstruct the flow of digestive waste through the first tube in the inflated position.

In certain embodiments, the catheter includes a port that is in fluid communication with the inflatable balloon and is connectable to one of a source of inflation fluid or a source of vacuum.

In embodiments, the stomal diverter device includes a cap that is selectively attachable to the open end of the drain tube and is configured to obstruct the flow of bodily fluids through the open end of the drain tube.

Another aspect of the present disclosure is directed to a surgical method that includes: making an abdominal incision into an abdomen of a patient to provide access to an abdominal cavity of the patient; pulling a loop of a body vessel out of the abdominal cavity through the abdominal incision; positioning a stoma rod across the abdominal incision between the loop of the body vessel and the abdomen of the patient to prevent the loop of the body vessel from receding back into the abdominal cavity of the patient; making a first incision into the body vessel to define a first opening within the body vessel; making a second incision into the body vessel to define a second opening within the body vessel; inserting a first tube of a catheter into the first opening of the body vessel and a second tube of the catheter into the second opening of the body vessel such that a drain tube that is in fluid communication with the first and second tubes of the catheter extends out of the abdomen of the patient; and positioning a bracket over the catheter and the stoma rod and selectively engaging a locking feature of the bracket with a mating feature of the stoma rod to secure the first and second tubes within the first and second openings of the body vessel.

In embodiments, the method further comprises positioning a central portion of the bracket defining an opening therethrough over the drain tube and advancing the bracket towards the drain tube such that the drain tube is received within the opening.

In some embodiments, the method further comprises attaching a source of inflation fluid to a first port of the catheter and inflating an inflatable balloon disposed an on outer surface of the first tube and in fluid communication with the first port with the source of inflation fluid to secure the first tube to the first opening of the body vessel.

In certain embodiments, the method further comprises attaching a source of inflation fluid to a second port of the catheter and inflating an inflatable balloon disposed on an inner surface of the first tube and in fluid communication with the second port with a source of inflation fluid to obstruct the flow of bodily fluids through the first tube.

In embodiments, the method further comprises attaching a cap to an open end of the drain tube to obstruct the flow of bodily fluids therethrough.

In some embodiments, the method further comprises removing the cap from the open end of the drain tube and attaching a colostomy bag to the open end of the drain tube to permit the flow of bodily fluids into the colostomy bag.

In certain embodiments, the method further comprises removing the second tube from the second opening of the body vessel and inserting at least one of a camera, a surgical instrument, and a drug into the second opening to perform or a diagnostic and/or a therapeutic procedure within the second opening of the body vessel.

DETAILED DESCRIPTION OF EMBODIMENTS

The presently disclosed stomal diverter device will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. However, it is to be understood that the disclosed embodiments are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.

The presently disclosed stomal diverter device includes a catheter, a stoma rod, and a bracket. The catheter is configured to attach to first and second openings of a stoma and to permit and/or prohibit the discharge of digestive waste from the stoma. The stoma rod is selectively attachable to the abdomen of a patient and is securable between the abdomen of the patient and the stoma. The bracket is selectively attachable to the catheter and to the stoma rod to secure the catheter to the stoma. The stomal diverter device provides an interface between the stoma and a waste containment device, e.g., a colostomy bag, to prevent complications that are typically associated with colostomy bags attached directly to stoma sites (e.g., leaks, skin irritation, infections, etc.). In addition, the stomal diverter device allows a patient to obstruct the waste material from exiting the stoma when use of a colostomy bag is not desired.

Referring toFIG. 1, the presently disclosed stoma diverter device is shown generally as10and includes a catheter20, a stomal rod80, and a bracket100. The catheter20includes a body22defining a first tube24, a second tube26, and a drain tube28. The catheter20of the stomal diverter device10is generally configured for attachment to a stoma site “ST.”

Referring also toFIG. 5, the first tube24of the catheter20inner surface32defining a first channel30, an outer surface34, and an open end36. The inner surface32of the first tube24supports an inflatable balloon40that is connected to a fluid line42, which is in communication with a first port44. The first port44is disposed on the body22of catheter20and is connectable to an inflation source (not shown) to selectively inflate the inflatable balloon40from a deflated position (FIG. 5) to an inflated position (FIG. 6). The first port44is also connectable to a vacuum source to deflate the inflatable balloon40from the inflated position to the deflated position. The outer surface34of the first tube24also supports one or more inflatable balloons46,48. The inflatable balloons46,48are connected to a fluid line50, which is in communication with a second port52. The second port52is disposed on the body22of the catheter20and is connectable to an inflation source to facilitate inflation of the inflatable balloons46,48from a deflated position to an inflated position (FIGS. 5 and 6). The second port52is connectable to a vacuum source (not shown) to selectively deflate the inflatable balloons46,48from the inflated position to the deflated position.

The second tube26includes an inner surface62defining a second channel60, an outer surface64, and a closed end66. The outer surface64of the second tube26defines a plurality of anchoring elements or ribs68. The second tube26may be oriented transversely relative to the first tube24such that the first tube24and the second tube26define a bifurcated configuration.

The drain tube28includes an inner surface72defining a discharge channel70that is in fluid communication with the first channel30of the first tube24and the second channel60of the second tube26. The drain tube28also includes an outer surface74and an open end76. The open end76of the drain tube28may be configured to receive a valve or cap78(FIG. 5) for obstructing the flow of digestive waste through the open end76of the drain tube28. The cap78can be removed to allow for the flow of digestive waste through the open end76of the drain tube28. With the cap78removed from the open end76of the drain tube28, a waste containment device, e.g., a colostomy bag “C” (FIG. 6), may be secured to the open end76of the drain tube28, as will be described below.

In embodiments, the outer surface34of the first tube24may include a plurality of ribs (e.g., similar to the ribs68of the second tube26), clips, or the like, in lieu of, or in addition to the inflatable balloons46,48for securing the first tube24to a stoma “ST.” Likewise, the outer surface64of the second tube26may include inflatable balloons in lieu of, or in addition to ribs68. It should be appreciated that any number of anchoring devices in, or on first tube24, second tube26, and drain tube28are contemplated.

With continued reference toFIGS. 1 and 5, the stoma rod80has an upper surface82and a lower surface84. The upper surface82includes a first post84, and a second post86. Each of the first and second posts84,86includes a mating feature or recess84a,86a. The lower surface84of the stoma rod80has a flared portion84band a reduced width portion84c. The lower surface84of the stoma rod80supports one or more adhesive pads90. In embodiments, each adhesive pad90may have a generally C-shaped cross section and include an inner surface92, an upper surface94, a side surface96, and a tissue contacting surface98. The inner surface92of each adhesive pad90receives a reduced width portion84cof stoma rod80, and the upper surface94of each adhesive pad90supports a flared portion84bof the stoma rod80. The side surfaces96of the adhesive pads90include one or more fastening ears99. Each fastening ear99defines a hole99athat is configured to receive a fastener (not shown).

In embodiments, the stoma rod80may have any suitable cross-sectional shape such as a semi-circular, circular, square, rectangular, or the like. In some embodiments, the stoma rod80may be formed from pliable, semi-rigid, or rigid material, such as a plastic, a polymer, a metal, or the like. In certain embodiments, each adhesive pad90may be a flat sheet, sticker, tape, or the like. In embodiments, the adhesive pads90may include any type of biocompatible adhesive (e.g., glue). In some embodiments, the lower surface84of the stoma rod80may optionally include an adhesive coating in lieu of the adhesive pads90.

With reference toFIG. 1, the bracket100includes an upper surface102and a lower surface104. The upper surface includes a circular central portion106that defines a circular opening108. The lower surface104of the bracket100supports a pair of spaced legs110,112. Each of the pair of legs110,112includes a distal portion having a mating feature or protrusion110a,112athat is configured to engage with a respective one of the mating features or recesses84a,86aof the stoma rod80. In embodiments, the bracket100may be formed from any suitable material, such as plastic, ceramic, metal, composite, or the like.

With reference toFIGS. 2 and 3, in use, for example, in a loop ostomy procedure (e.g., a diverting sigmoid loop colostomy, loop ileostomy, etc.), an incision is made into a patient's abdomen at an incision site “I.” A portion or loop “L” of the body vessel is pulled outwardly through the incision site “I” such that the loop “L” extends out of the patient's abdomen. In order to prevent the loop “L” from receding through the incision site “I” and back into the abdominal cavity, the stoma rod80is positioned centrally between the loop “L” and the patient's abdomen (e.g., at skin level). The tissue contacting surfaces98of the adhesive pads90of the stoma rod80are brought into contact with the patient's abdomen adjacent the incision site “I” to secure the stoma rod80to the patient's abdomen. In embodiments, fasteners (not shown) can be driven through holes(s)99aof the fastening ears99of the adhesive pads90through the patient's abdomen or skin, to further secure the stoma rod80to the patient. With the tissue contacting surface98of the adhesive pad90of the stoma rod80secured to the patient's abdomen and the stoma rod80secured between loop “L” and the abdominal wall, the body vessel “B” is prevented from receding back into the abdominal cavity.

With reference also toFIGS. 5 and 6, a first incision is made into a body vessel “B” to create a first opening therein. In embodiments, the body vessel “B” may include the bowel, e.g., small or large intestine, colon, or rectum. For example, the first opening may be formed in the upstream portion of the large intestine. A second incision is made into the body vessel to create a second opening therein. The second opening may be formed within the body vessel, such as, e.g., the downstream portion of the intestine. The first and second openings define the stoma “ST” (FIGS. 3 and 4). Each of the first and second openings is then affixed or sutured to the abdomen (e.g., at skin level) using one or more sutures “S” (FIGS. 3-6). The catheter20is then attached to the stoma “ST.” Specifically, the first tube24of the catheter20is inserted into the first opening of the stoma “ST” and the second tube26of the catheter20is inserted into the second opening of the stoma “ST.” With the catheter20attached to the stoma “ST,” the drain tube28of the catheter20extends outwardly from patient's abdomen.

With reference toFIG. 4, the bracket100is advanced towards the catheter20such that the central circular portion106of the bracket100aligns with the drain tube28. Specifically, the bracket100is advanced toward the catheter20, until the outer surface74of the drain tube28is received within the opening108of the bracket100. The mating features110a,112aof the bracket100are then engaged with the respective mating features84a,86aof the stoma rod80. With the drain tube28received within the opening108of the bracket100, and with the mating features110a,112aof the bracket100engaged with the mating features84a,86aof the stoma rod80, the catheter20is further secured to the stoma “ST” and is prevented from slipping or backing out of the patient.

Referring toFIG. 5, to further secure catheter20to the stoma “ST,” an inflation source may be connected to the second port52to send inflation fluid through the fluid line50(FIG. 6) into the inflatable balloons46,48. As the inflatable balloons46,48are inflated, the first tube24is anchored within the first opening of the stoma “ST.” Likewise, the ribs68on the outer surface74of the second tube26serve to anchor or secure the second tube26within the second opening of the stoma “ST.” In embodiments, other anchoring mechanisms, such as clips, fasteners, mechanical anchors, etc., may be used to secure the catheter20within the first and second openings within the “ST.”

Referring toFIG. 6, with the catheter20secured to the stoma “ST,” the stomal diverter device10, a containment device or colostomy bag “C” may be attached to the outer surface74of the drain tube28. As the patient undergoes normal digestive processes (e.g., excretion), digestive waste flows, in the direction indicated by arrow “A,” from the first opening of the stoma “ST” (e.g., the upstream portion of the intestine) through the first channel30of the first tube24, through the discharge channel70of the drain tube28, and into the colostomy bag “C.” The second tube26separates the second opening of the stoma “ST” from the first opening of the stoma ‘ST,” e.g., to keep the downstream portion of the intestine clean, and/or to allow for healing of the intestine. As such, no fluid can flow from the second tube26of the catheter20into the downstream portion of the intestine.

When use of the colostomy bag “C” is not desired, the patient or the clinician can remove the colostomy bag “C” and place the cap78(FIG. 5) on the open end76of the drain tube28. As such, digestive waste exiting the first opening of the stoma “ST” is prevented from exiting from the open end76of the drain tube28and out of the patient. To prevent digestive waste from further entering the catheter20, the patient or the clinician can connect an inflation source to the first port44to send inflation fluid from the inflation source through the fluid line42and into the inflatable balloon40to selectively inflate the inflatable balloon40. With the inflatable balloon40in the fully inflated position, the inflatable balloon40obstructs digestive waste from flowing through the first opening of the stoma “ST” and into drain tube28or the second tube26.

The patient or clinician can selectively deflate the inflatable balloon40by connecting the first port44to a vacuum source (not shown). With the inflatable balloon40deflated, digestive wastes can flow from the first opening of the stoma “ST” into the first channel30of the first tube24, and through the discharge channel70out of the open end76of the drain tube28(e.g., into a colostomy bag or other containment device, once cap78is removed).

If desired, the patient or the clinician can remove (e.g., by rotating, pulling, etc.) the second tube26from the second opening of the stoma “ST,” while leaving the first tube24secured to the first opening of the stoma “ST.” With the second opening of the stoma “ST” exposed, a clinician can insert one or more cameras, surgical instruments, drugs, therapies, etc., in the second opening of the stoma “ST” to perform a diagnostic (e.g., colonoscopy) or therapeutic procedure on the body vessel. Likewise, a clinician may leave the second tube26in place in the second opening of the stoma “ST” and remove the first tube24from the first opening of the stoma “ST,” and perform diagnostic and/or therapeutic procedures therein.

When complete removal of the stomal diverter catheter10is desired, the first and second tubes24,26are removed from the respective first and second openings of the stoma “ST.” The clinician or the patient can then gently detach the adhesive pad90of the stoma rod80from the patient's abdomen and remove the stoma rod80from the loop “L” of the body vessel. The clinician and/or the patient can then examine the stoma “ST.”

If needed or desired, the stomal diverter device10can then be re-attached to the stoma “ST” using the procedures described above. In order to prevent any possible skin irritation at the stoma “ST,” the adhesive pads90of the stoma rod80may be positioned at a different location than the original site of attachment to the patient's abdomen. For example, the stoma rod80may be rotated (e.g., from 45 degrees, 90 degrees, 120 degrees, etc.) relative to the original site of attachment to ensure that the adhesive pads90of the stoma rod80contact the patient's abdomen at a different location the original site of attachment. It should be appreciated that a clinician may install or remove stomal diverter device10from a patient, as necessary, e.g., in an outpatient setting. Additionally, a patient can perform installation or removal of stomal diverter device10, as necessary (e.g., at home).

Persons skilled in the art will understand that the structures and methods specifically described herein and shown in the accompanying figures are non-limiting exemplary embodiments, and that the description, disclosure, and figures should be construed merely as exemplary of particular embodiments. It is to be understood, therefore, that the present disclosure is not limited to the precise embodiments described, and that various other changes and modifications may be effected by one skilled in the art without departing from the scope or spirit of the disclosure. Additionally, the elements and features shown or described in connection with certain embodiments may be combined with the elements and features of certain other embodiments without departing from the scope of the present disclosure, and that such modifications and variations are also included within the scope of the present disclosure. Accordingly, the subject matter of the present disclosure is not limited by what has been particularly shown and described.