Patent Application
20250228696
Colostomy plates typically consist of a square adhesive plate usually made of corya gum which is placed on the skin of the patient. The colostomy or the ileostomy protrudes through a central hole through the center of the plate and the colostomy bag is attached to/detached from the plate using a clip-on plastic device similar to a Zip-Lock bag. Colostomy plates are difficult to attach and remain attached to the skin of the patient especially if the skin is moist or if the skin becomes infected or irritated from the spillage of the stool. At this point, adhesives or glues are used in an attempt to stick the plate to the skin. Frequently, the plates fall off or the bag falls off and stool leaks onto the abdominal wall causing inconvenience and distress.
This application extends the work described in PCT/US2021/34619 to Armstrong, filed May 27, 2021, entitled “Endoluinal Stoma Devices,” which claims priority to U.S. provisional patent application 63/031,285 filed May 28, 2020 to Armstrong, entitled “Endoluminal Stoma Devices,” both of which are incorporated herein by reference.
The current device avoids the need for colostomy plates, glues and adhesives. A self-retaining endoluminal colostomy device is provided which avoids the traditional stoma plates and adhesives. The device incorporates a flexible or semi-rigid plastic sleeve which is generally cylindrical in shape. A ring, which can be made of plastic or polymer or other springy material, is located at each end of the sleeve. The inner ring, which is generally deformable with return to or close to its original shape upon deformation and release, is inserted into the lumen of the stoma using an introducer or flexible endoscope. Once inserted, the inner ring unfolds and adopts its original circular form. By gently pulling on the outer ring, the inner ring is then pulled to the sub-fascial space where it becomes lodged. The outer ring can then be secured around the outer tip of the stoma to secure the channel through the device for ultimate collection of waste. In some embodiments, the outer ring is rolled over upon itself which shortens the plastic sleeve while securing the device around the stoma. The outer ring protects the stoma and forms a stable base to attach stoma devices such as colostomy bags or occlusive devices. The cylindrical sleeve, the inner ring and the outer ring therefore create a self-retaining device to attach stoma bags, occlusive plates, voiding tubes, or other suitable structures thereto. This design can avoid the use of plates, adhesives, or the like, and therefore avoids inflammation and/or ulceration of the peri-stomal skin.
The two rings may be equal or unequal in size and/or shape. There may also be a plurality of “inner rings”, to improve traction of the device within the bowel lumen. The inner ring may have the same diameter, or a slightly larger diameter than the diameter of the inner lumen of the small or the large bowel, so enabling it to become lodged in the sub-fascial space. The diameter of the outer ring may be slightly larger than the diameter of a conventional stoma, so therefore sized to provide for covering the external stoma. The sleeve membrane or a portion thereof may be fenestrated or contain perforations to allow mucous secretions into the lumen of the bowel.
In a first aspect, the invention pertains to an endoluminal stoma channel comprising a resilient deformable inner ring, an outer ring, a flexible polymer sleeve connected to the inner ring and the outer ring to form a flow channel and comprising a biocompatible polymer, and a tether comprising a cord and a knob. In general, the cord is attached to the inner ring, and the knob has a position such that the cord can extend along the sleeve, in the interior or exterior of the sleeve, past the outer ring with the outer ring pulled away from the inner ring such that the sleeve is taut. The words sleeve and membrane are used interchangeably herein for convenience.
In a further aspect, the invention pertains to a method for controlling release from a stoma through an endoluminal stoma channel comprising a resilient deformable inner ring, an outer ring, and a flexible polymer sleeve connected to the inner ring and the outer ring to form a flow channel and comprising a biocompatible polymer. The method comprises engaging an outer cover with a clamp onto the outer ring of the endoluminal stoma channel, wherein the inner ring is located within the patient with the flexible polymer sleeve extending outward from the stoma with the outer ring positioned outside the stoma, wherein the outer cover provides closure of the stoma or a controlled pathway for releases from the stoma.
In another aspect, the invention pertains to a stoma discharge control system comprising:
In yet another embodiment, the current device includes an outer flexible ring and an inner flexible ring interconnected by a thin transparent membrane. The inner ring is configured for insertion into a stoma (colostomy, ileostomy, urostomy) underneath the inner aspect of the abdominal wall of a patient. The outer ring is configured so that it may be folded inward or outward to shorten the plastic membrane making the inner ring snug underneath the abdominal wall. The outer ring may also take the form of various cross-sectional shapes to keep the ring from unfolding when folded inward or outward. The inner ring may also take the form of various cross-sectional shapes to enable the inner ring to be folded to adjust the length of the circular membrane, for instance shortened in a thin emaciated individual, or lengthened for instance in a morbidly obese individual. Once folded, the membrane can maintain its circular form as a result of the cross-sectional shape of the inner ring.
In a further embodiment the inner ring is made of a softer and more malleable material in order to minimize pressure on the underlying small bowel or large bowel mucosa and to prevent erosions or ischemia of the bowel wall.
In a still further embodiment, the inner ring contains circumferential protrusions, such as ribs, bumps, ridges, or other suitable shapes, and/or a textured surface in order to increase contact between the inner ring and the small or large bowel, to prevent the inner ring from slipping out of the stoma.
A third modification involves the circular membrane interconnecting the inner and outer ring being transparent in order to visualize the color of the stoma ensuring that it remains pink and viable and not dusky and ischemic. A further embodiment involves the dynamic nature of the circular membrane between the inner and outer rings, the circular membrane being operable to dampen any excessive intra-abdominal force such as during sudden coughing or sneezing (i.e., being operable to reversibly absorb, store, and return the energy used to deflect or distort the intra-abdominal force). This dynamic, elastic configuration acts in a similar way as a shock absorber. Any sudden increase in intra-abdominal pressure will put immediate pressure on the outer cap of the device. This will transiently increase tension in the plastic membrane interconnecting the inner and outer ring cushioning any sudden increase in pressure, in effect acting as a shock absorber between the inner and outer ring. This will reduce the chances of the inner ring being extruded.
Any increase in tension on the circular membrane will also increase pressure on the inner ring forcing it to become more securely positioned on the inner aspect of the stoma and the underside of the fascial surface of the anterior abdominal wall. This increased pressure will therefore increase the seal between the inner ring, the inner aspect of the stoma and the anterior abdominal wall, thereby preventing leaks of liquids around the inner ring and the outer surface of the inner membrane.
This dynamic system will act like a shock absorber for any sudden increase in the intra-abdominal pressure to prevent leaks from the device. A further aspect of the current invention involves the mechanical stability between the inner and outer rings provided by gentle traction on the circular membrane which gently squeezes the inner aspect of the stoma and the abdominal wall keeping the stoma device securely in place. This contrasts with the adynamic and rigid configuration of the cylindrical stoma device described in U.S. Pat. No. 4,137,918 to Bogert, which would be easily “shot” out of the stoma with a sudden increase in intra-abdominal pressure, such by a sudden cough or sneeze.
The current embodiment also includes the provision of an inner colostomy bag made of thin pliable plastic or latex, similar to a large condom or balloon. This inner colostomy bag is detachably attached to the outer ring using a snap-on mechanism, (similar to a Zip-Lock bag or conventional colostomy attachment) or a slip-on mechanism, in the case of the condom or balloon embodiment. Once attached to the outer ring, the inner colostomy bag is gently delivered into the inner aspect of the plastic membrane of the device, and the outer cover is attached to the outer ring securing the inner bag in the inner aspect of the stoma device.
When the patient feels the need to defecate, the outer cover is removed from the outer ring and the stool begins to fill the inner colostomy bag. As the inner colostomy bag fills, it's extruded to the outer aspect of the stoma device, similar to a conventional outer colostomy device. Once the colostomy bag is at least partially full it can be removed from the outer ring and the waste disposed of with minimal spillage of stool. The inner colostomy bag prevents the free spillage of stool from the stoma device once the outer cover is removed and permits clean and controlled delivery of stool into the bag which can then be disposed of cleanly.
In a further embodiment the inner colostomy bag may include a malleable colostomy ring positioned at a mouth (or opening) of the inner colostomy bag. The malleable colostomy ring is compressible and when compressed can be inserted inside the inner aspect of membrane below the outer ring. Upon release of compression, the colostomy ring returns to or close to its original shape and becomes sealingly engaged with the outer ring to prevent leakage of stool and gas. The inner colostomy bag may then be inserted in the inner aspect of the device and the outer cover attached to the outer ring. In some embodiments, the inner colostomy bag may further include a gas releasing mechanism. In one embodiment, the gas releasing mechanism includes an air release tube having an upper opening and a lower opening, the tube secured within a port in the inner colostomy bag such that the tube's lower opening is positioned in the inner aspect of the stoma device and the tube's upper opening is positioned in the outer aspect of the device. In one embodiment, the upper opening may be sealed or closed via a removable cap or by a valve and gas may be released through the tube's upper opening by removing the cap or opening the valve.
In yet a further embodiment, a tab or string may be positioned on the periphery of the colostomy ring to assist in removing or venting the inner colostomy bag and/or to release gas from the lumen of the bowel in the event of gas build-up. In some embodiments, the tab or string may further protrude through an opening on the outer cover when the outer cover is attached to the outer ring. Traction on the tab or string when the colostomy ring is sealingly engaged with the outer ring will cause the colostomy ring to deform thereby breaking the seal between the colostomy ring and the outer ring allowing for the removal or venting of the inner colostomy bag and/or release of gas from the lumen of the bowel. In a further embodiment, the tab or string may be positioned on the periphery of the colostomy ring and further detachably attached to the periphery of the cap and traction on the tab or string occurs by at least partially removing the cap from the outer ring. In one embodiment, the tab or string may be positioned on the periphery of the colostomy ring at a 12 o'clock position to preferentially allow for the escape of gas or flatus, rather than the escape of liquids or stool.
A prior art colostomy plate 1 with the lumen of the colon 2 which is located in a hole 3 located in the middle of the colostomy plates. Around the periphery of the hole 3, a plastic ring 4 is located where the colostomy bag may be detachably attached to the stoma plate and replaced for emptying and cleaning, etc.
A transverse view of a colostomy showing the colostomy plates 1 which are adherent to the skin of the abdominal wall 6. The bowel [colon or ileum] is tunneled 7 through the abdominal wall 8 to create a colostomy or ileostomy 9. The point where the colostomy 9 enters the abdominal wall tunnel is referred to as the sub-fascial space 10 and is typically the tightest and most narrowed part of the stoma.
The device is generally a flexible, elastic generally cylindrical sleeve 11 with two rings attached at each end made of flexible, or malleable or semi-rigid plastic or polymer. An inner ring 12 is located within the lumen of the stoma and lodges in the sub-fascial space 10. The inner ring 12 may be rolled upon itself so shortening the length of the sleeve 11. The inner ring 12 may be prevented from “unrolling” by a “split ring” configuration having a non-circular cross-section area similar to a figure of 8 or other shape illustrated in B1-B7. In a further embodiment both the outer ring 13 and the inner ring 12 may be rolled upon itself so shortening the length of the sleeve membrane 11.
The outer ring 13 may be prevented from “unrolling” by a “split ring” configuration having a non-circular cross-section area similar to a figure of 8 or other shape illustrated in A1-A7. The sleeve 11 may be transparent to visualize the bowel mucosa to ensure it is pink and viable or opaque, non-elastic or elastic.
Referring to
The cylindrical sleeve 11 is made shorter by rolling the outer ring 13 and/or inner ring 12 upon itself. The diameter of the outer ring 13 is sufficient to cover the external ileostomy or colostomy and facilitates the placement of colostomy bags, occlusive plates and irrigation systems. Sleeve 11 may be made of transparent plastic material to ensure the bowel is pink and viable, and not dusky and ischemic.
In a further embodiment, inner ring 12 is made of a softer and more malleable material in order to minimize pressure on the underlying small bowel or large bowel mucosa and to prevent erosions or ischemia on the bowel wall.
In a further embodiment the inner ring 12 contains circumferential protrusions 14 such as ribs, bumps, ridges, or other suitable shape in order to increase contact between the inner ring 12 and the small or large bowel, to prevent the inner ring 12 from slipping out of the stoma.
Referring to
The sleeve 11 may be transparent, translucent, or opaque in order to visualize the color of the stoma ensuring that it remains pink and viable and not dusky and ischemic.
In a further embodiment inner ring 12 and/or outer ring 13 are made of a softer and more malleable material in order to minimize pressure on the underlying small bowel or large bowel mucosa and to prevent erosions or ischemia on the bowel wall.
The sleeve 11 may be non-elastic or elastic, although the sleeve 11 is generally flexible and tear resistant. Elastic or “stretchable” membranes facilitate deployment and securing the device. The sleeve 11 may comprise a biocompatible polymer. Various biocompatible polymers are known in the art, such as latex, polyesters, polyamines, vinyl polymers, and the like. The sleeve 11 may be fenestrated or contain perforations or holes to allow mucous to enter the lumen of the bowel. The length of the endoluminal device between planes of the rings with the inner and outer rings gently pulled away from each other may be about 0.5-20 cm, in some embodiments about 3-18 cm and in further embodiments about 5-16 cm total length. The cross-sectional diameter of the individual inner and outer rings may be about 0.05-2 cm, in other embodiments about 0.1-1 cm and in further embodiments about 0.25-0.5 cm. A person of ordinary skill in the art will recognize that additional ranges of dimensions within the explicit ranges above are contemplated and are within the present disclosure.
The inner ring 12 and the outer ring 13 interconnected by the sleeve 11 functions like a shock absorber. Any sudden increase in intra-abdominal pressure 16 is transmitted through the center 17 of the device to the outer cover 15 placing transient tension 19 on the elastic sleeve 11.
Referring to
Transverse section of a stoma with the device located in the lumen. The bowel 34 is tunneled through the abdominal wall 8 to make an external stoma 36 which protrudes above the skin level. The inner ring 12 of the device is located within the lumen of the bowel 34 and gently pulled distally until it lodges in the sub-fascial space 10. The outer ring 13 is rolled over upon itself so shortening the length of the sleeve or membrane 11 which keeps the inner ring 12 secured in the sub-fascial space 10. The outer ring 13 also covers the external stoma 36 to protect it, and to facilitate attachment of the bags or other structures described herein to the outer ring 13.
In obese individuals with thick abdominal walls 8, or when the sub-fascial space 10 is abnormally wide, as in para-stomal hernias, the inner ring 12 may deploy at a narrowing of the bowel 34 closer to the surface in the lumen than the sub-fascial space 10, or anywhere within the boundaries of the abdominal wall 8. The endo-luminal device therefore creates a tunnel 22 through the abdominal wall 8 and provides a stable platform to place bags or other structures.
Any increase in intra-abdominal pressure 16, such as by coughing or sneezing, increases the efficiency of the seal between the inner ring 12, the inner circumference of the stoma 20, and the underside of the abdominal wall 21 decreasing the chance of leakage from around the inner ring 12 and spillage of stool from the stoma.
Referring to
A further aspect of the current invention involves the mechanical stability between the inner ring 12 and outer ring 13 provided by gentle traction on the circular membrane 11 which gently squeezes the inner aspect of the stoma 20 and the underside of the abdominal wall 21 keeping the stoma device securely in place. The inner ring 12 and outer 13 ring of the device, together with tension in the membrane 11 sandwich the abdominal wall, creating a stable mechanical configuration. This creates a seal between the inner ring 12 and the circumference of the stoma 20 immediately beneath the abdominal wall. This contrasts with the adynamic and rigid configuration of the cylindrical stoma device described in U.S. Pat. No. 4,137,918 to Bogert, which would be easily “shot” out of the stoma during a sudden increase in intra-abdominal pressure, such as during a cough or sneeze.
The device may be generally cylindrical in form or alternatively conical. The inner ring 12 may be smaller than the outer ring 13, so creating an inverted conical shape 25. The inner ring 12 is located within the lumen of the bowel and the outer ring 13 is located on the abdominal wall of the patient.
In an alternative scenario, the inner ring 12 may be larger than the outer ring 13. This then forms a cone shape 28.
In an alternative embodiment, the membrane 11 may be tapering at its center 30 with a thinner central waist compared to the inner ring 12 and the outer ring 13.
The inner ring 12 is delivered into the lumen of the bowel by folding the inner ring 12 into an elliptical form, or twisting into a figure of 8 and again upon itself to form a circular form. The inner ring 12 is then inserted into the lumen of the bowel. A portion of the membrane 11 and the outer ring 13 remains above the abdominal wall.
A delivery device or introducer 35 may comprise a generally tubular device, which may be non-flexible or flexible. Alternatively, a flexible endoscope or the like may be used to insert the inner ring 12. The inner ring 12 is folded into a figure of 8 and compressed, and is inserted into the distal opening of the introducer 35 or around the end of the introducer. 35. The outer ring 13 and membrane 11 are located around the outside of the circumference of the delivery device or endoscope 35. Furthermore, forceps or the like can grip the inner ring 12 in a reduced profile for insertion into the stoma. The delivery device or endoscope 35 is then inserted into the colostomy and proximal to the sub-fascial space. The inner ring 12 is then gently pushed from the lumen of the delivery device or endoscope 35 for instance using a pusher, or rod, the ring 12 unfolds to form a circular form, and the delivery device 35 is removed.
The inner ring can be provided as an inflatable ring 101 that can be inserted in an uninflated state where the ring is manipulatable. As in
The delivery device may be a tubular introducer 50. The inner ring 12 is folded and compressed and inserted into the distal opening of the tubular introducer 50. The outer ring 13 and membrane 11 are located outside of the distal opening of the tubular introducer 50. The tubular introducer 50 is then inserted into the colostomy and proximal to the sub-fascial space. The inner ring 12 is then gently pushed from the tubular introducer 50 using a moveable pusher device, such as a plunger, releasably held at the proximal opening of the tubular introducer 50, the inner ring 12 unfolds to form a circular form, and the tubular introducer 50 is removed.
The inner ring 12 of the device may be introduced into the bowel by applying traction on the inner ring so deforming it into an oval shape. This may be performed by a simple rod shaped device, with a “V” shaped tip 38, passed into the outer ring 13 and sleeve 11 or by applying traction to the pull-string (not shown) of the inner ring 12, for instance by using biopsy forceps of a conventional flexible endoscope inserted into the outer ring 13 and sleeve 11. The inner ring 12 or rings are placed under traction using the V tipped device 38 or by traction on the pull-string which deforms the inner ring 12 or rings into an elliptical shape, which facilitates their placement into the stoma without trauma or pressure, and then released. The biopsy forceps of a conventional endoscope passed through the outer ring 13 and sleeve 11 may be used to grasp the “pull-string” of the inner ring and pull the inner ring into the sub-fascial-space
The inner ring 12 is deployed into the lumen of the bowel and it resumes its previous circular form. It is then gently pulled up into the sub-fascial space 10 where it lodges. Having removed the introducer, the outer ring 13 is then rolled upon itself until it reaches the skin of the anterior abdominal wall 6 and covers or protects the external stoma 36.
A plurality of inner rings 12, of equal diameter, are configured in parallel along the sleeve 11, in order to increase traction within the lumen of the bowel 34, to diminish the chances of perforation of the bowel wall.
In a further configuration, the diameter of the inner rings 12 may decrease progressively toward the sub-fascial space. In this configuration peristalsis of the bowel 34 tends to compress the rings together, forming a pyramidal or conical form, so maintaining the inner rings 12 with more stability within the lumen.
An embodiment of an endoluminal stoma channel comprises an outer ring 113, inner ring 112, and membrane 111 connecting outer ring 113 and inner ring 112. Tether 115 is connected to inner ring 112 in a configuration to run along the outside of membrane 111. Tether 115 has a knob 114 at its end.
Alternative embodiment of an endoluminal stoma channel comprises a tether 115 attached to inner ring 112 in a configuration to extend within membrane 111 and to pass through outer ring 113. This embodiment also has a knob 114 at the end of tether 115.
The removal of the endoluminal stoma channel of
The removal of the endoluminal stoma channel of
An embodiment of an attachable bag 51 is shown separate from the colostomy attachment device, endoluminal stoma channel 52. Bag 51 is designed for attachment to the outer ring 53. Bag 51 has a fastener 54 that can comprise a clamp or seal element with a releasable lever to attach and remove the bag or a snap-type design or the like similar to conventional colostomy bags. Bag 51 can have a closable drain 55 with a hook and loop closure or a clamp closure or the like, although in other embodiments the bag is sealed on its end for disposal and replacement of the bag rather than drainage.
An embodiment adapted from the device of
In a further embodiment, an inflatable balloon is 59 provided, attached to a fluid conduit 60, which is inflated in a similar manner as the balloon on a Foley catheter. The deflated balloon is inserted through the lumen 61 of the deployed device 62 and positioned proximal to the inner ring 12 of the deployed device. The balloon 59 is then inflated with fluid via the fluid conduit 60. The fluid conduit has a valve 65, such as a luer lock valve, which maintains pressure within the balloon and prevents leakage from the balloon 59.
The inflated balloon 59 is pulled gently toward the inner ring 12 of the device to form a seal between the inflated balloon and the inner ring of the device, similar to a “Ball valve” device. The inflated balloon 59 prevents stool, liquid and gas from exiting through the device and creates a stable mechanical seal between the balloon 59 and the inner ring 12. The inflatable fluid conduit 60 may be secured at the outer ring 13 or the plate attached to the outer ring by a slot or key-hole type configuration 67 which secures the balloon 59 at the inner ring 12 and maintains the seal between the balloon 59 and the inner ring 12.
The outer cover 15 with clasps 72 is shown adjacent an outer ring 13 configured for connection onto outer cover 15. Optional valve 75 and optional vent 76 are depicted on the surface of cap 70.
An alternative embodiment of the outer cover 15 having a hinge 74 connecting outer cover 15 to outer ring 13.
The outer cover 15 includes a drain tube 77 extending through valve 75.
The outer cover 15 includes a trapdoor 26 with a flap valve on the inner aspect of the trapdoor 26 to prevent leakage of stool or effluent.
When drainage tube 77 is inserted through the trapdoor 26, the trapdoor 26 is displaced allowing for the drainage of the contents within the sleeve.
An inner colostomy bag or condom 123 releasably attaches to the outer ring 13 to act as an “internal” colostomy bag.
Referring to
The inner colostomy bag 123 is releasably attached to or over, or within, the circumference of the outer ring 13 and gently inserted into the inner aspect 124 of the sleeve of the device.
Referring to
When the outer cap 15 is removed from outer ring 13, stool 125 slowly fills inner colostomy bag 123. The inner colostomy bag 123 is extruded to the outer aspect of the stoma device as the colostomy bag 123 fills, similar to a conventional outer colostomy device.
When the inner colostomy bag 123 is full (or at least partially full), it can be detached from the outer ring 13 and disposed of cleanly and without spillage. The inner colostomy bag 123 may be cleaned (or a new bag 12) and is then detachably attached to the outer ring 13 and the outer cover 15 is reattached to the outer ring 13. The inner colostomy bag 123 prevents the free spillage of stool 125 from the stoma device when the outer cap 15 is removed and permits clean and controlled delivery of stool 125 into the inner colostomy bag 123 which can then be disposed of cleanly.
A double-barreled ostomy device 129 is provided for loop colostomies and ileostomies. The device has two separate limbs 130, 131 one for each loop of the stoma. The inner rings 132, 133 of the two lumen device are inserted in the afferent and efferent limb of the stoma. The two lumens communicate with a common outer ring 134 which can be folded to the abdominal wall in the same manner as the single limb stoma device.
Referring to
Referring to
In a further embodiment, a tab or string 127 may be located on the periphery of the colostomy ring 126 to assist in removing or venting the inner colostomy bag 123. The tab 127 may also be used to release gas from the lumen of the bowel in the event of gas build-up. Applying traction on the tab 127 will deform the colostomy ring 126 breaking the seal between the colostomy ring 126 and the outer ring 13 and allowing for the release of gas or flatus. The colostomy ring can then be returned below the outer ring to sealingly engage the outer ring. Ideally, the tab 127 may be located at a 12 o'clock position on the colostomy ring 126 to preferentially allow for the escape of gas or flatus located on top of the stool surface rather than the escape of stool.
In still a further embodiment, the tab 127 may further be releasably attached to the periphery of the outer cover (not shown) such that partial removal of the outer cover will result in traction on the tab to compress the colostomy ring 126 and break the seal between the colostomy ring 126 and the outer ring 13 resulting in the release of gas. In yet a further embodiment the tab 127 may further protrude through an opening on the outer cover allowing the user to apply gentle traction on the tab 127 to compress the colostomy ring 126 and break the seal with the outer ring 13 resulting in the release of gas without having to remove the outer cover itself. Applying pressure to the tab 127 will return the colostomy ring 126 to the inner aspect 128 of the outer ring 13 to re-seal the inner colostomy ring 126 with the outer ring 13. These configurations would preferably be located at the 12 o'clock position on the colostomy ring 126 and outer cover to preferentially allow for the escape of gas, and not stool.
A 57 year old morbidly obese male undergoes a Hartmanns resection for perforated diverticulitis. Because of his obesity, and a 5 in deep abdominal wall, the end of the colostomy underwent ischemic necrosis, leaving a pencil thin “blow-hole+ fistula.
The device of the present disclosure was inserted into the “blow-hole” colostomy forming a stable platform for placement of a colostomy bag.
The device of the present disclosure was stable and remained in place and even applying significant traction to the device. The patient underwent a successful bowel prep to clean out the colon and had surgery to reverse the colostomy.
The devices described herein provide for secure interface with a stoma formed with a colon or ilium (small bowel) by placement of a sleeve extending from the stoma and secured with a ring anchored within the patient. The sleeve can be conveniently placed within the patient to provide a way to control output from the stoma without gluing something to the patient's skin. The ostomy device can be referred to as an endoluminal stoma channel, and these terms are used interchangeably herein for convenience. Various covers are described to secure onto an outer ring to provide desired control and controlled access. The endoluminal stoma channel and a cover as well as other possible components can be referred to as a stoma discharge control system, although the components can be referred to without specific reference to the system. The rings generally can have a circular shape in the plane of the ring, but other shapes can be effective too, especially for the outer ring. For example, the inner ring can have a minor oval shape. While an outer ring with a circular shape can fit snugly over the stoma, other shapes such as a square can also fit over the stoma and may provide different attachment modalities for covers and the like.
In contrast with the stoma anchored devices described herein, referring to
Referring to
Referring to
Referring to
In one embodiment, inner ring 12 is resilient and deformable with an outer surface that is generally flat around a circumference. In another embodiment, the inner ring 12 is resilient and deformable, and its undeformed configuration has an outer surface comprising contours and/or texture to present contact points of polymer having a shore durometer value of no more than 65 A. Thus, in one particular embodiment, the outer ring can comprise a polymer having a shore durometer value greater than 65 A and in further embodiments greater than about 30D. The contours and/or texture may take any form or shape as desired for the particular operation or intended use. For example, the outer surface of inner ring 12 may have one or more concave, ogee, French curve, arch, or hook regions. In other embodiments, the outer surface of inner ring 12 may be textured for example, it may comprise one or more nubs, bumps, ribs, or protrusions that may take any shape, such as round, square, circular/circle, rectangular/rectangle, triangular/triangle, cylindrical/cylinder, elliptical/ellipse, or (n)polygonal/(n)polygon where n is an integer of at least 5. In some embodiments, the contact points of polymer may have a shore durometer value of no more than about 60 A, or no more than about 55 A, or no more than about 50 A, or no more than about 45 A, or no more than about 40 A, or no more than about 35 A, or no more than about 30 A, or no more than about 25 A, or no more than about 20 A, or no more than about 15 A, or no more than about 10 A In one aspect of this embodiment, the contact points of polymer may have a shore durometer value in a range that includes and/or is between any two of the foregoing. For example, the contact points of polymer may have a shore durometer value Shore of about 10 A to about 65 A. A person of ordinary skill in the art will recognize that additional ranges of Shore duromater hardness within the explicit ranges above are contemplated and are within the present disclosure.
The dynamic relationship between the sleeve 11 interconnecting the inner ring 12 and the outer ring 13 is depicted in
The outer ring 13 can be rolled upon itself and the length of the sleeve membrane 11 is thereby shortened. The outer ring 13 may have a diameter equal to or larger than the inner ring 12. The diameter of the outer ring is generally between about 1-12 cm, in some embodiments between about 2-10 cm in diameter, and in further embodiments between about 3-8 cm. A person of ordinary skill in the art will recognize that additional ranges of inner ring diameters and outer ring diameters within the explicit ranges above are contemplated and are within the present disclosure. As the outer ring 13 can be rolled upon itself, it deploys circumferentially around the outer stoma 36 so protecting it from drying or injury. The outer ring 13 then creates a stable platform where a stoma bag or occluding plate may be detachably attached using a clip mechanism or flip-on mechanism. The need for plates, glues and adhesives is therefore avoided, and erosion breakdown or ulceration of the skin which is often seen in current colostomies can be avoided.
For a configuration with a ring deployment not as deep in the stoma, referring to
Referring now to
A further aspect involves improved mechanical stability between the inner ring 12, outer ring 13 and sleeve 11. The outer ring 13 is configured to cover the external stoma and to provide an anchoring structure for the sleeve 11. The sleeve 11 is composed of an elastic biocompatible polymer having an intrinsic tension. Because the two rings 12 and 13 are integrated into the sleeve 11, each erect themselves proximally and distally to the sleeve due to the elastic intrinsic tension thereof. Thus, the outer ring 13, sleeve 11 and inner ring 12 in effect, sandwich the abdominal wall thereby creating a stable mechanical configuration.
Referring to a representative embodiment in
Referring to
Referring to
An embodiment with an inflatable inner ring 101 (uninflated ring 101′) is shown in
Referring to
Referring to
Referring to
In yet another configuration, the device may be released from the bowel by means of a “pull string”, which is attached to the most proximal flexible ring of the device and deployed within the inner sleeve of the device. The “pull string” is of sufficient length that it protrudes from the ostomy and is easily identifiable and accessible to the operator. Referring to
Gentle traction on the “pull string”, deforms the inner ring, and makes the diameter of the smaller dimension of the ring smaller, so making it simpler to pull through the stoma, and removing the entire device from the stoma, without trauma or pressure on the bowel. If the “pull string” or tether is deployed within the sleeve membrane, this ensures the inner ring is released and “pulled through” the inner lumen of the device, so potentially causing less pain to the patient. If the tether is located outside the inner and outer rings and the membrane, the tether would not interact with feces so the tether can remain cleaner, which would provide an advantage for this configuration. Referring to
In a further embodiment, the rings may be expandable, using an inner spring located within the hollow lumen of the inner ring, which allows the ring to expand and contract. In another configuration, the inner ring may be expandable wherein the ring is discontinuous or cut in a radial direction. One end of the cut ring is thinner and can be inserted into the wider end so expandable, in a similar manner as a snake swallowing its own tail. With respect to the inflatable embodiment of
The device is therefore a self-retaining endoluminal device which avoids the need for conventional stoma plates and glues. The outer ring makes a stable platform where colostomy bags or occlusive plates or irrigation devices may be secured. This avoids the need for adhesive plates, glues, and powders. Since the lumen is an endoluminal device, no external plate is required and excoriation, inflammation or ulceration of the skin around the stoma is avoided.
Referring to
Referring to the insert of
Referring to
Referring to
The fluid conduit 60 may be secured at the outer ring 13 or a plate or the like 67 attached to the outer ring by a slot or key-hole type configuration which secures the balloon at the inner ring 12 and maintains the seal between the balloon and the inner ring.
An occluding plate/outer cover or cap which is attached to the outer ring may take several forms. In one embodiment shown in
In a further embodiment, the occluding device incorporates a “gel” disc, similar to the commercially available “Gel Port” device (Applied Medical) used for laparoscopic abdominal surgery, and such gel disc products have been well described in the literature, see U.S. Pat. No. 7,736,306 and US 2020/0008792 to Becerra et al., entitled “Mechanical Gel Surgical Access Device,” both of which are incorporated herein by reference. The gel is a viscous, deformable jelly material which maintains its shape even when an object is inserted through the gel. Insertion is facilitated by a “cross-hairs” incision incorporated in the center of the gel. In this embodiment, a gel disc is detachably attached to the outer ring of the stoma device and can be used to access the lumen of the colon, via the device. The gel disc prevents leakage of stool liquid of gas from the colostomy but permits the insertion of objects such as drainage tubes. Such drainage tubes can be used to irrigate the colon, to empty it, or to drain accumulated fluids, such as in an ileostomy. The gel disc avoids the need to detach and reattach other occluding devices such as discs, plates, hinges plates, snap-on discs, clamp-on discs, ball valve devices, or valve devices.
In a further embodiment, the patient may wish to personalize the surface of the occluding member. Options may include a skin colored surface to match the patient's skin color. Other possibilities include light-hearted shapes or art such as hearts, cartoon characters, or “no entry” signs.
In one embodiment, the inner colostomy bag comprises an elastic polymeric membrane having an elongation of at least 100% without breaking (i.e., an elongation at break of at least 100%). As used herein, “elongation at break” refers to the elongation recorded at the moment of rupture of the specimen, often expressed as a percentage of the original length; it corresponds to the breaking or maximum load, as measured by, for example, ASTM D-412 or ISO 37 and expressed as a percentage (%). In some embodiments, the elastic polymeric membrane has an elongation at break of at least about 150%, or at least about 200%, or at least about 250%, or at least about 300%, or at least about 350%, or at least about 400%, or at least about 450% or at least about 500%. In still other embodiments, the elastic polymeric membrane has an elongation at break of at least about 525%, or at least about 550%, or at least about 575%, or at least about 600%, or at least about 625%, or at least about 650%, or at least about 675%, or at least about 700%, or at least about 725%, or at least about 750%, or at least about 775%, or at least about 800%.
In another embodiment, the elastic polymeric membrane has a wall thickness of about 0.008 inches to about 0.025 inches, or about 0.010 inches to about 0.022 inches, or about 0.012 inches to about 0.020 inches, or about 0.014 inches to about 0.018 inches. A person of ordinary skill in the art will recognize that additional ranges of elongation and wall thickness within the explicit ranges above are contemplated and are within the present disclosure.
In one embodiment, the elastic polymeric membrane comprises a latex material, a natural rubbers, a thermoplastic polyolefin elastomer, a thermoplastic vulcanate, a thermoplastic polyurethane, a thermoplastic polyester, a thermoplastic co-polyester, a thermoplastic polyamide, a thermoplastic co-polyamide or a styrene block copolymer. Exemplary polymeric membranes include, but are not limited, to synthetic polyisoprene, butyl rubbers, polybutadiene, styrene-butadiene rubbers, chloroprene rubbers, polyacrylic rubbers, silicon rubbers, fluorosilicone rubbers, and nitrile rubbers such as Buna-N, hydrogenated nitrile rubbers, and nitrile butadiene rubber (NBR);
With reference now to
Referring now to
In another embodiment, the colostomy ring 126 may further include a tab 127 or string attached to the periphery of the colostomy ring 126. The tab 127 may have an essentially flat shape and extends between a first end which is secured to the ring 126 and a second end which is free and can be grasped by gripping so as to positively move the ring end part on which the tab 127 is mounted. In the event of gas build-up, the tab 127 may be used to release gas from the lumen of the bowel by gripping and applying traction to the tab 127 causing the colostomy ring 26 to deform thereby breaking the seal between the colostomy ring 126 and the outer ring 13 and allowing the gas or flatus to be released. Once the gas has been released, the colostomy ring 126 can be repositioned 28 below the outer ring 13 to sealingly engage the outer ring 13 by applying pressure to the tab 127 or string. Ideally, the tab 127 or string may be located at a 12 o'clock position on the colostomy ring 126 to preferentially allow the escape of gas or flatus located above the fluids or stool, rather than fluids or stool themselves.
In a further embodiment, the tab 127 or string may be detachably attached to the periphery of the outer cap 15, and partial removal of the outer cap 15 will result in the application of traction to the tab 127 or string causing the colostomy ring 126 to deform thereby breaking the seal between the colostomy ring 126 and outer ring 13 resulting in the release of gas or flatus. In still a further embodiment the tab 127 or string may protrude through an opening on the outer cap 15 allowing the user to grip and apply gentle traction on the tab 127 or string causing the colostomy ring 126 to deform the inner ring thereby breaking the seal between the outer ring 13 and colostomy ring 126 resulting in the release of gas or flatus, without removal of the outer cap 15 itself. The colostomy ring 126 may be returned to the previous sealingly engaged position by gripping and applying pressure to the tab 127 or string. These configurations are preferably located at the 12 o'clock position on the colostomy ring and cap, to preferentially allow the escape of gas, and not liquid
In still another embodiment, the inner colostomy bag 123 may further include a gas release mechanism (not shown). For example, the gas release mechanism may include an air release tube having an air release opening on its upper end an air intake opening on its lower end and is sized and configured to be received within a port on the inner colostomy bag 123 such that the air release opening is external to the inner colostomy bag 123 and the air intake opening is inside the inner colostomy bag 123. As those of skill in the art will recognize, gas is periodically expelled from the stoma and may cause colostomy bags to quickly fill with gas, rather than solid waste. In order to reduce the difficulty involved with releasing gas from the inner colostomy bag 123, embodiments are described, for example, of a gas release mechanism having an air release tube inserted into a port on the inner colostomy bag such that gas inside the colostomy bag 123 passes into the air intake opening and exits the air release opening.
In one embodiment, the air release tube may comprise a threaded portion that is configured to threadedly engage the port on the inner colostomy bag 123. The air release tube may be inserted into the inner colostomy bag by rotating the air release tube while applying pressure between the threaded portion and the correspondingly sized port in the inner colostomy bag 123.
The air release tube may comprise any type of tubing, such as flexible rubber tubing, plastic tubing, or metal tubing, and is configured for insertion into the inner colostomy bag 123 via the port. When the patient, or caregiver to the patient, desires to release gas from the inner colostomy bag 123, the air release tube may be inserted into the inner colostomy bag via the port, and when pressure is applied to the inner colostomy bag 123, gas within the inner colostomy bag 123 will exit the air release tube. Accordingly, the inner colostomy bag 123 may be used for an extended period of time due to the evacuation of gas that periodically accumulates within the inner colostomy bag 123.
In one embodiment, the air release tube inserted into the inner colostomy bag may comprise a mechanism for releasably blocking the air release opening in the tube. For example, the air release tube comprises a blocking mechanism that may be used to block the opening of the air release tube in order to seal the contents of the inner bag colostomy bag 123. In order to reduce the risk of waste from the inner colostomy bag 123 escaping inadvertently through the air release tube, the blocking mechanism, when inserted into the air release opening of the air release tube, seals the air release tube thereby preventing passage of waste out of the air release opening. Other mechanisms for sealing an end of the air release tube, including valves, are also contemplated and are usable within the scope of the devices and methods described herein.
In another embodiment, the air release tube also comprises a threaded portion that provides a coupling between the air release tube and the port. In this embodiment, the air release tube may be inserted into the inner colostomy bag by rotating the air release tube while applying pressure between the threaded portion and the hole. The spiral threads on the threaded portion cause the air release tube to enter the inner colostomy bag through the port. Advantageously, the threaded portion provides an enhanced engagement of the air release tube and the inner colostomy bag. In other embodiments, other attachment means, such as protrusions or indentations on the air release tube, may be used in order to engage the air release tube to the inner colostomy bag 123.
In practice, the ostomy device can be used for an extended period of time or replaced at a recommended period, such as daily, weekly, monthly or other appropriate period. To this end, the device can be designed to be inserted and removed by a physician, an ostomy nurse, other health care profession or the patient themselves. Generally, the ostomy bag is emptied and/or replaced by the patient or a care provider on a time frame generally of multiple times a day on average.
Commercial devices such as the “Alexis” retractor is designed for short term use (typically 1-2 hours) as an abdominal wall retractor during surgical laparotomy, or as a skin retractor, as during breast biopsies. The membrane material is designed for contact with the patient's tissue for just the duration of the surgical procedure, for instance several hours, but no longer than 24 hours.
In the current devices, components of the device can remain in place for a much longer period of time, and the membrane and ring material can be biocompatible with the patient's tissues for days, or weeks. A patient with a prior art colostomy typically changes the palate 2 or 3 times a week, to avoid skin irritation, or fungal or bacterial overgrowth. With the current system, the device may be changed every week or two, or only when problems arise, such as dislodgement of the device or leakage from the device. This longer term contact with the patient's tissues can suggest the selection of a longer-term biocompatible material for the rings and sleeve components. Suitable polymers include, for example, polyamides (e.g., nylon), polyesters (e.g., polyethylene teraphthalate), polyacetals/polyketals, polyimide, polystyrenes, polyacrylates, vinyl polymers (e.g., polyethylene, polytetrafluoroethylene, polypropylene and polyvinyl chloride), polycarbonates, polyurethanes, poly dimethyl siloxanes, cellulose acetates, polymethyl methacrylates, polyether ether ketones, ethylene vinyl acetates, polysulfones, nitrocelluloses, natural and synthetic rubbers, similar copolymers and mixtures thereof. Suitable metals can include, for example, titanium, stainless steel, and alloys such as Nitinol and other spring metals.
Often patients with colostomies irrigate the stoma once a day, to empty the colon of liquid, gas and stool. After irrigating, these patients typically apply a large “band-aid” device over the stoma, to conceal the stoma, and minimize leakage. The current device allows for irrigation of the colon on a daily basis, and the occluding device (Plate, trapdoor, cap, gel-cap, valve or ball valve) is reapplied to prevent leakage.
Commercial retractors such as the Alexis retractor are designed to provide access to the abdominal cavity, Uterus (in Ceserian Sections) or skin, such as in breast biopsies, but these devices are not designed for longer term use or secure attachment to the patient away from supervision by a health care professional. The current system and associated device components has a plurality of designs and functions. A major function is to occlude a stoma and prevent leakage of stool gas and liquid. Various mechanisms are described herein which accomplish this: Using the ball-valve, hinged-plate, snap-on, a simple cap, screw on, gel-cap, or valve occluding devices. This function is distinct from vaguely similar commercial devices, which are designed to open access into a body cavity. A further function is to create a stable platform to attach colostomy bags, and to avoid the use of prior art colostomy plates and adhesives.
A 57 year old morbidly obese male underwent a “Hartman's resection” for perforated diverticulitis. After multiple post-operative complications including sepsis, respiratory and cardiac failure, he survived but was hospitalized for over a month. Because of his obesity, and a 5 in deep abdominal wall, the end of the colostomy underwent ischemic necrosis, leaving a pencil thin “blow-hole+ fistula (
The embodiments above are intended to be illustrative and not limiting. Additional embodiments are within the claims. In addition, although the present invention has been described with reference to particular embodiments, those skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the invention. Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. To the extent that specific structures, compositions and/or processes are described herein with components, elements, ingredients or other partitions, it is to be understand that the disclosure herein covers the specific embodiments, embodiments comprising the specific components, elements, ingredients, other partitions or combinations thereof as well as embodiments consisting essentially of such specific components, ingredients or other partitions or combinations thereof that can include additional features that do not change the fundamental nature of the subject matter, as suggested in the discussion, unless otherwise specifically indicated.
This application claims priority to U.S. Provisional Patent Application Ser. No. 63/270,863 filed Oct. 22, 2021. The noted application is incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2022/047461 | 10/21/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63270863 | Oct 2021 | US |
