The subject matter disclosed herein relates to devices and methods for providing enemas to a patient.
Spina bifida, which literally means “cleft spine”, is characterized by the incomplete development of the brain, spinal cord, and/or the meninges (the protective covering around the brain and spinal cord). Patients with spina bifida have damaged nerves that affect the bowel and the anal sphincter muscle. In particular, both the bowel and the sphincter have low muscle tone, leading to the combined problems of constipation and bowel movements at unexpected times, i.e., bowel incontinence. The constipation is because the bowel cannot effectively evacuate stool and the bowel incontinence is because the anal sphincter is relatively weak and cannot hold the stool. The end result is called neurogenic bowel and is common in spina bifida and other neurological conditions, such as but not limited to spinal cord injury, multiple sclerosis, stroke, transverse myelitis, and others. Therefore, in the spina bifida population and other patients with neurogenic bowel, daily high-volume enemas are needed to fully the evacuate the bowel and prevent both of these problems.
Cone enemas, in which the enema is delivered to the bowel using a tapered, or cone-shaped tip for the enema insertion is used because, if held firmly to the weak anal sphincter, it can provide a water tight seal. However, the current cone enema systems do not allow for a reproducibly water tight seal between the cone and the bowel, since skill and practice are needed for effective self-administration of these devices. Delivering the enemas can be challenging, especially for pediatric patients and their care givers. The delivery of the enema and evacuation of the bowel may take from 45 minutes to an hour. Naturally, such skill (not to mention patience) is more difficult for pediatric patients. The result is that leakage occurs during administration of the enema fluid, which results in inadequate administration of the enema fluid, as well as waste of the fluid, and low adherence to the bowel evacuation regimen.
The current solution to this problem is that the enemas are administered with assistance from a caregiver. Thus, the patients and their families experience high stress related to need for these enemas. The patients are also frustrated due to lack of independence.
Other efforts to solve this problem are summarized in the following documents:
P. Midrio, et al., Peristeen® transanal irrigation in paediatric patients with anorectal malformations and spinal cord lesions: a multicentre Italian study, Colorectal Dis. 2016 January; 18(1):86-93; doi: 10.1111/codi.13101 discloses a system involving involves a semi-rigid catheter with a balloon to hold the device in place. The problem with this system is that because spina bifida patients have poor anal sphincter muscle tone, the balloon is often expelled by the patient before the enema is complete, therefore a caregiver must hold the catheter in. In addition, the device is not disclosed to be suitable to attach to a toilet.
US Patent Application Publ. No. US 2004/0148689 A1 discloses a bidet attachment for a toilet. It is not disclosed to be suitable for providing a water tight seal to provide an enema to a person having poor anal sphincter muscle tone.
US Patent Application Publ. No. US 2005/0223482 A1 discloses an irrigation system that can be used while sitting on the toilet. The device is not disclosed to be suitable for providing a water tight seal to provide an enema to a person having poor anal sphincter muscle tone.
US Patent Application Publ. No. US 2019/0224412 A1 discloses a trans-anal irrigation device. It is not disclosed to be suitable to attach to a toilet.
U.S. Pat. No. 4,205,402 A discloses bidet attachment for a toilet. It is not disclosed to be suitable for providing a water tight seal to provide an enema to a person having poor anal sphincter muscle tone.
U.S. Pat. No. RE38,690 E discloses a toilet attachment for an enema, douche or colonic irrigation. The device has an irrigation tip that further has a delimiter to prevent the tip from being inserted too far into a body cavity. The tip is not disclosed to be suitable for providing a water tight seal in a person having poor anal sphincter muscle tone.
U.S. Pat. No. 6,964,653 B2 discloses a bacteria inhibiting hygienic device for vaginal/colon cleansing. The device is not disclosed to be attachable to a toilet, nor is it disclosed to be suitable for providing a water tight seal in a person having poor anal sphincter muscle tone.
Accordingly, there remains a need for a device that effectively and reproducibly holds the cone enema systems in place, without need for assistance.
Four exemplary embodiments of an enema assist device are described herein. The enema assist device is intended to help patients having a weak anal sphincter muscle become independent with respect to enema administration. In particular, all of the embodiments are intended to hold a fluid delivery tip for an enema system in place above a toilet so that a patient in need of such an enema assist device can adjust the position of the fluid delivery tip as necessary, and then simply sit on the fluid delivery tip to create a water tight seal between the fluid delivery tip and the weak anal sphincter muscle. Accordingly, all of the embodiments as disclosed herein are capable of holding a fluid delivery tip for an enema system in a fixed position when the fluid delivery tip is sat on.
A “potty training” embodiment works with a cone irrigator device used in the spina bifida and neurogenic bowel population to deliver high volume enemas for daily bowel management. A potty-training toilet seat is adapted with a support to hold the fluid delivery tip that allows a patient, in particular a child, to sit on the device to create a water tight seal thereby eliminating the need for parents to reach over and behind the child to hold the fluid delivery tip in place. In another embodiment, this system has also been adapted for adults—no training seat.
Another embodiment is for an older child/adolescent or adult that enable the fluid delivery tip to be attached to the end of a curved metal bar that enables the patient to place the tip in the anatomically correct position and push down with their body weight to create a water tight seal. In all of these embodiments, the common element is that the fluid delivery tip is cone shaped and that the tip is supported over the toilet bowl, such that the body weight of the patient is used to affect a water tight seal of the conical fluid delivery tip to the weak anal sphincter.
In the fourth embodiment, the fluid delivery tip may be attached on the end of a curved metal bar. In this embodiment as in the other three, the end of the curved metal bar may be equipped with a platform and/or wedge that is capable of angling the fluid delivery tip so as to alter the delivery angle to best seal the tip to a user's anal sphincter. In this embodiment, the curved metal bar may be simply cantilevered on the edge of the toilet bowl and the user only need apply a downward force on a handle portion of the curved metal bar to achieve suitable resistance to their body weight to hold the tip in the sealed position.
It should be understood that the wedges described in this fourth embodiment may be used with any of the embodiments disclosed herein.
An enema assist device is provided. The enema assist device includes a support. The support has a front, a back, a bottom surface, and a top surface, wherein the support is configured to be placed on a toilet bowl such that the support front is oriented towards the front of the toilet bowl. The support is further configured to support a fluid delivery tip such that the fluid delivery tip is disposed on the top surface of the support and protrudes at least partially beyond a plane defined by a top of the toilet seat.
According to another embodiment, the fluid delivery tip may include a conic section that has a top with an upper diameter and a bottom with a lower diameter. The upper diameter is smaller than the lower diameter, and the bottom of the conic section is disposed on the top surface of the support. In an embodiment, the top surface of the support may slope at an angle α, relative to the plane defined by the top of the toilet seat, thereby angling the fluid delivery tip at the angle α.
According to a further embodiment, the support may further include at least one angled wedge section on the top surface thereof. The angled wedge section is interposed between the fluid delivery tip and the support, the wedge having an angle α, relative to the plane defined by the top of the toilet seat, thereby imparting the angle α to the top of the support and thus angling the fluid delivery tip at the angle α. The angled wedge may further have a rotational angle β relative to an axis along the length of the support. The top surface of the support may slope downward from back to front at an acute angle α, thereby positioning the fluid delivery tip at an angle toward the toilet front. The support may include a platform, the platform having a first side and an opposing second side, such that the first side and the second side of the platform are placed under opposing sides of the toilet seat, and the support front is oriented towards the toilet front.
In an embodiment the enema assist device may include a removable toilet seat configured to be placed on top of a fixed toilet seat on a toilet bowl.
According to another embodiment, the support may include a rigid cantilever. The rigid cantilever may also include an adjustable attachment system, a first end and a second end, such that the first end is attached to a toilet bowl under the toilet seat with the adjustable attachment system and the second end is attachable to the fluid delivery tip. The adjustable attachment system may include at least one clamp configured to attach to the toilet bowl, and an adjustment clip fixedly attached to the at least one clamp. The adjustment clip may include a lower receptacle configured to hold the first end and an upper arm pivotally attached to the lower receptacle and configured to pivot between an open position and a closed position. The adjustment clip also includes a spring attached to the lower receptacle and to the upper arm. In operation, when the upper arm is in the open position, the first end can be placed in the lower receptacle and be moved from front to back relative to the toilet bowl, and when the upper arm is in the closed position, the spring urges the upper arm against the first end, such that the first end is attached to the toilet bowl. According to an embodiment, the rigid cantilever may be a curved bar. According to an embodiment, the second end may further include at least one angled wedge section on the top surface thereof and interposed between the fluid delivery tip and the second end. The wedge has an angle α, relative to the plane defined by the top of the toilet seat. When the wedge is place, it serves to impart the angle α to the top of the top surface of the second end and thus angling the fluid delivery tip at the angle α.
According to another embodiment, the support is a rigid bar. In this embodiment, the rigid bar has a hand grip region located at the front of the rigid bar, an attachment region located on the top surface of the back of the rigid bar, and a pivot region located on the bottom surface and in between the front and the back of the rigid bar. The rigid bar is configured such that the fluid delivery tip is attachable to the attachment region. In use, the pivot region contacts the toilet bowl such that the hand grip region projects beyond an edge of the toilet bowl, the fluid delivery tip is positioned over a center region of the toilet bowl, and a user of the enema assist device grips the hand grip region and urges the hand grip region downward and thereby pivots the fluid delivery tip upward and urges the fluid delivery tip into the body orifice of the user. The fluid delivery tip attachment region may further include at least one angled wedge section on the top surface thereof and interposed between the fluid delivery tip and the support. The wedge section has an angle α, relative to the plane defined by the top of the toilet seat, thereby imparting the angle α to the top of the support and thus angling the fluid delivery tip at the angle α. The wedge section may also have a rotational angle β, measured relative to an axis along the length of the rigid bar. The rigid bar may also be curved.
Although the present disclosure makes reference to specific embodiments, the present disclosure is not intended to be limited to the details shown. Rather, various modifications may be made in the details within the scope and range of equivalents of the claims and without departing from the present disclosure.
Referring to
The top 20 of the fluid delivery tip 14 is constructed and arranged to be partially insertable into a body orifice of a user, i.e., an anal sphincter of a patient using the enema system 100. The bottom 22 of the fluid delivery tip 14 is constructed and arranged to provide a tight seal to the anal sphincter of a patient using the enema system 100, even if, and especially if, the anal sphincter has poor muscle tone. The upper outer diameter DU may be from 0.3 cm to 1 cm and the lower outer diameter DL may be from 1.5 cm to 3 cm. The fluid delivery tip 14 may have a bilayer construction in which an outer layer is comprised of a relatively soft material, such as silicone, plasticized polyvinylchloride (PVC) and the like, while an inner layer is a relatively rigid material, such as unplasticized PVC, polypropylene, high density polyethylene, polystyrene, polymerized acrylics, and the like. In this way, the fluid delivery tip 14 may conform to the anal sphincter of a patient during use of the enema, but the rigid interior provides a water tight seal to a weak anal sphincter when the fluid delivery tip 14 is in use.
In use, a patient in need of the enema assist device 1000 as disclosed herein, i.e. a person having weak muscle tone in the anal sphincter, would place the enema assist device 1000 under a toilet seat. The enema assist device 1000 may be moved backwards and forwards relative to the toilet seat, depending on the size of the toilet seat and the size of the patient. The patient would then sit on the toilet seat such that the fluid delivery tip 14 would partially enter their colon, since the fluid delivery tip protrudes beyond the plane of the toilet seat. In addition, the support 1002 is sufficiently rigid that it does not appreciably deflect due to the person's weight. Because the fluid delivery tip 14 is tapered, i.e., has a conical shape, and is soft on the outside, but comprises a rigid interior, a water tight seal is formed between the fluid delivery tip 14 and an anal sphincter having weak muscle tone. The enema assist device 1000 thus eliminates the need for a caregiver to reach over and behind the patient to hold the fluid delivery tip in place.
In use, a patient in need of the enema assist device 2000 as disclosed herein, i.e. a person having weak muscle tone in the anal sphincter, would place the removable toilet seat 2012 of the enema assist device 2000 on top of a fixed toilet seat on a toilet. The patient would then sit on the removable toilet seat 2012 such that the fluid delivery tip 14 would partially enter their colon, since the fluid delivery tip protrudes beyond the plane of the removable toilet seat. In addition, the support 2002 is sufficiently rigid that it does not appreciably deflect due to the person's weight. Because the fluid delivery tip 14 is tapered, i.e., has a conical shape, and is soft on the outside, but comprises a rigid interior, a water tight seal is formed between the fluid delivery tip 14 and an anal sphincter having weak muscle tone. The enema assist device 2000 thus eliminates the need for a caregiver to reach over and behind the patient to hold the fluid delivery tip in place.
In use, a patient in need of the enema assist device 3000 as disclosed herein, i.e. a person having weak muscle tone in the anal sphincter, would use the clamps 3004 to clamp the enema assist device 3000 to a toilet bowl under a toilet seat. By using the adjustable clip as described above, the enema assist device 3000 may be moved backwards and forwards relative to the toilet seat, depending on the size of the toilet seat and the size of the patient. The patient would then sit on the toilet seat such that the fluid delivery tip 14 would partially enter their colon, since the fluid delivery tip protrudes beyond the plane of the toilet seat. In addition, the rigid cantilever 3002 is sufficiently rigid that it does not appreciably deflect due to the person's weight. Because the fluid delivery tip 14 is tapered, i.e., has a conical shape, and is soft on the outside, but comprises a rigid interior, a water tight seal is formed between the fluid delivery tip 14 and an anal sphincter having weak muscle tone. The enema assist device 3000 thus eliminates the need for a caregiver to reach over and behind the patient to hold the fluid delivery tip in place.
Another embodiment of the invention is shown in
The rigid bar 4002 is further also configured to support the fluid delivery tip 14 such that the fluid delivery tip is disposed on the top surface of the back of the rigid bar as may be seen in
In use, the pivot region 4016 contacts the toilet bowl such that the hand grip region 4012 projects beyond an edge of the toilet bowl and the fluid delivery tip 14 is over a center region of the toilet bowl. A user of the enema assist device 4000 grips the hand grip region 4012 and urges the hand grip region 4012 downward and thereby pivots the fluid delivery tip 14 upward and urges the fluid delivery tip 14 into the body orifice of the user. The hand grip region may be made of a neoprene foam tube 4011 for the patient to comfortably hold the device in place while administering the enema fluid. The pivot region may include a foot 4018 on the bottom of the rigid bar 4002 to help the patient hold the device 4000 in place. The foot 4018 thus contacts and provides a pivot point on the toilet seat or the toilet bowl and allows for adjusting the device 4000 tailored to a patient's need.
The fluid delivery tip attachment region 4014 may further include at least one angled wedge section 4020 on the top surface thereof and interposed between the fluid delivery tip and the rigid bar, the wedge section 4020 having an angle α, relative to the plane defined by the top of the toilet seat. The wedge section 4020 may also have a rotational angle β, relative to an axis along the length of the rigid bar. In this way, the wedge section 4020 imparts the angle α to the top of the rigid bar and thus angles the fluid delivery tip 14 at the angle α. The wedge section 4020 may be attached directly the rigid bar 4002 or may be attached to a platform 4022 attached to the back end 4006 of the rigid bar 4002. The platform 4022 may have grooves for placement of different angled wedges 4020. The wedges 4020 are designed to fit snuggly in place while allowing for a patient to fit the fluid delivery tip 14 in the appropriate anatomic arrangement. Wedges 4020 can be stacked on one another and may be made from a soft urethane material. The fluid delivery tip 14 fits on top of the platform 4022.
It will be understood that the terms and expressions used herein have the ordinary meaning as is accorded to such terms and expressions with respect to their corresponding respective areas of inquiry and study except where specific meanings have otherwise been set forth herein. Relational terms such as first and second and the like may be used solely to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms “comprises,” “comprising,” “includes,” “including,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises or includes a list of elements or steps does not include only those elements or steps but may include other elements or steps not expressly listed or inherent to such process, method, article, or apparatus. An element preceded by “a” or “an” does not, without further constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.
Unless otherwise stated, any and all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. Such amounts are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain. For example, unless expressly stated otherwise, a parameter value or the like may vary by as much as ±10% from the stated amount.
In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in various examples for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed examples require more features than are expressly recited in each claim. Rather, as the following claims reflect, the subject matter to be protected lies in less than all features of any single disclosed example. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.
While the foregoing has described what are considered to be the best mode and other examples, it is understood that various modifications may be made thereto and that the subject matter disclosed herein may be implemented in various forms and examples, and that they may be applied in numerous applications, only some of which have been described herein. It is intended by the following claims to claim any and all modifications and variations that fall within the true scope of the present concepts.
The present application claims priority to U.S. Provisional Patent Application No. 63/164,811, filed Mar. 23, 2021, entitled “ENEMA ASSIST DEVICE” the contents of which are incorporated herein by reference in their entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2022/021304 | 3/22/2022 | WO |
Number | Date | Country | |
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63164811 | Mar 2021 | US |