Patent Application
20150320584
The present invention relates generally to devices and methods for reducing the volume of sound emanating from a stoma, an artificial hole in an abdomen, in patients such as those that have undergone a colostomy, ileostomy or jejunostomy.
Bowel-related diseases and other medical issues are sometimes treated through surgical procedures such as colostomy, ileostomy or jejunostomy. During these surgical procedures the patient's bowel is redirected out of his or her abdomen through a hole known as a stoma. Body waste such as stool, flatus or gas and other fluids exit through this hole rather than the rectum. The stoma does not have a sphincter under voluntary muscular control by the patient. Because the patient's intestinal motion is an involuntary action, contractions that cause the expulsion of stool and gas are not able to be suppressed by the patient. A sealed waste collection device, commonly referred to as an ostomy bag, is therefore placed around and attached to the stoma to collect the waste. The bag is typically attached to the patient's skin around the stoma with tape or glue sealant, and is periodically changed.
Patients are usually able to put the bag under their existing clothing to cover and prevent the visual appearance of the bag. Unfortunately, the inability to control noises or sounds made when waste such as stool and gas exits the stoma unexpectedly presents continuing problems. For example, some patients report not wanting to engage in social interactions or to attend routine social events such as religious services and family gatherings because of embarrassment caused by these noises at inopportune times. These situations can negatively affect the quality of life, and sometimes even cause significant emotional distress, in patients that might otherwise be able to enjoy a fulfilling life free from other complications associated with the surgery.
Devices that function as patient-controlled valves to manually block the stoma are known. These devices can be actuated or otherwise controlled by the patient to release the waste at times selected by the patient. One such device, known as the Comfort-63, is commercially available from Stomabags of Miami, Fla.
There remains, however, a continuing need for devices and methods that alleviate certain complications such as those described above associated with the use of ostomy bags.
Embodiments of the invention include devices and methods to reduce undesirable noise-related complications related to the use of ostomy bags. One embodiment of the invention includes a sleeve of sound absorbing material configured to surround substantially all or part of an ostomy bag. Some embodiments include a bag opening that is closable by a zipper to removably receive the ostomy bag. Other embodiments include a stoma-coupling opening to enable a patient's stoma to be coupled to the ostomy bag. Yet other embodiments include a pocket for releasably holding an active noise cancellation device.
An ostomy silencer 10 in accordance with one embodiment of the invention is illustrated in
The embodiment of the ostomy silencer 10 shown in
Noise cancellation device 12 includes an enclosure 50 containing a battery compartment 52, sound cancellation electronics 54, speaker 56 and microphone 58. Speaker 56 can be mounted to face a first side of enclosure 12, and positioned on the enclosure at a location causing it to be positioned adjacent to the speaker opening 32 on the pocket 30. Speaker 56 is thereby configured to effectively broadcast outwardly from the pocket 30 and away from the patient. Microphone (mic) 58 is mounted to face a second, opposite side of the enclosure 50 in the illustrated embodiment, and is positioned on the enclosure at a location causing it to be positioned adjacent to the microphone opening 34 in the pocket 30. The microphone 58 is thereby configured to efficiently detect sounds emanating from the stoma (i.e., and present in the ostomy bag). Battery compartment 53 can be enclosed by a cover 60. Sound cancellation electronics 54 can include threshold detector 62. As shown in
Noise cancellation device 12 is an active device that cancels noise emanating from the stoma. The device 12 uses known approaches to provide this result. Briefly, microphone 58 detects sounds emanating from the stoma and couples signals representative of those sounds to the sound cancellation electronics 54. Sound cancellation electronics 54 produce an output signal having a frequency content that is generally the same as that of the signal from the microphone, but one hundred and eighty degrees out of phase with the microphone signal. The speaker 56 thereby produces a sound similar to, but one hundred and eighty degrees out of phase with, the sound detected by the microphone 58. The sound cancellation electronics also causes the sound produced by the speaker 56 to have an amplitude or volume similar to that of the sound detected by the microphone 58. Automatic or other volume control methodologies can provide this function. Because the sound waves produced by the speaker 56 are generally the same as those emanating from the stoma, but of opposite phase, the sound waves produced and broadcast by the speaker effectively cancel the sound waves emanating from the stoma. This effect of the noise cancellation device 12 is enhanced because the speaker 56 is located close to the source of the undesired sounds. Sounds associated with stool, fluids and gas exiting the stoma are thereby substantially reduced in volume or effectively eliminated. Although shown and described in connection with the passive sound reduction functionality produced by the sleeve 14, noise cancellation device 12 is used independently of the sleeve in other embodiments of the invention. For example, the noise cancellation device 12 can be functionally coupled to the patient and his or her ostomy bag by other structures or approaches.
Sound cancellation electronics 54 can be implemented in any of a wide variety of known or otherwise conventional approaches such as a programmed microprocessor, an ASIC (application specific integrated circuit) or using discrete circuit components. The illustrated embodiment of sound cancellation electronics 54 includes threshold detector 62 that causes the electronics to generate an output signal to the speaker 56 only when the detected sounds reach or exceed a certain threshold (e.g., volume) level. The threshold level can be selected by the patient in some embodiments of the invention. By not responding to relatively low level stoma-related sounds that might not be sufficiently audible to be of concern to the patient, more efficient battery use can be achieved. Other embodiments of the invention do not include the threshold detector 62.
Any suitable noise cancellation circuit may be utilized in device 12. By way of example, embodiments of the device can include a circuit incorporating a microphone, a signal inverting amplifier, and a speaker, where said signal inverting amplifier inverts the phase of the signal from the microphone which is then output to a speaker in such a manner as to attenuate the sound from the original source with destructive wave interference. The circuit may also be modified with various filters, be limited to lower frequencies, include an amplifier on the output, incorporate the use of multiple microphones at different locations, incorporate a control for the separation between the noise source and cancellation speaker, include adaptable microprocessors with algorithms designed to actively adjust the speaker output, and the like. These modifications may have advantages with increasing the effective range, expanding the power band, and allow for cancellation of reverberations or echoes. Noise cancellation devices are disclosed, for example, in the Lueg U.S. Pat. No. 2,043,416, the Bergeron U.S. Pat. No. 8,189,803 and European Patent Application Publication No. 0 040 462, all of which are incorporated herein by reference in their entirety and for all purposes.
The illustrated embodiment of the support 252 includes an attachment portion 262 configured to extend around the stoma opening 206 on the back side 202 of the ostomy bag 200, and a mount portion 264 that extends from the attachment portion. One or both of the microphone 254 and speaker 256 are mounted to the mount portion 264. The mount portion 264 is configured to locate one or both of the microphone 254 and speaker 256 at a location that is not behind (i.e., is out from behind) the ostomy bag 200 when the bag and silencer 250 are worn by a patient. In some embodiments, the operation of the silencer 250 can be optimized when the mount portion 264 is configured to locate the microphone 254 and/or speaker 256 adjacent a front side of the ostomy bag 200, opposite the bag from the stoma, when the bag is worn by the patient.
Attachment portion 262 is a ring-shaped and annular member in the illustrated embodiment, although other embodiments take other shapes. The illustrated embodiment of the attachment portion 262 also includes a hinge 270 and clasp 272 that enables the attachment portion to be opened and closed to facilitate attachment to the ostomy bag 200. For example, the attachment portion 262 can be opened at the hinge 270, positioned around the seal 210 (e.g., between the base plate 204 and collection portion 201), and then closed with the clasp 272. Other embodiments of the attachment portion 262 have other structures to enable the attachment portion to be mounted to the ostomy bag 200 (e.g., the attachment portion 262 can be elastically expandable or formed of shape memory material). In still other embodiments the attachment portion 262 can be one piece or relatively rigid, and attached to the bag when the collection portion 201 is separated from the base plate 204 or by inserting the flexible collection portion through the attachment portion. Yet other embodiments of the invention have attachment portions that are not ring-shaped. For example, the attachment portion can be a clip that attaches to one of the tabs 213, on the ostomy bag 200.
The mount portion 264 is an elongated loop or handle in the embodiment illustrated in
Embodiments of the invention such as silencers 250 and 300 can be made relatively thin and have a low profile to minimize their physical size, and their contribution to the physical appearance of the ostomy bag when worn by the patient. For example, in embodiments the attachment portion 262 of silencer 250 and the body 302 of the silencer 300 can be 1 cm or less in thickness. Other embodiments of silencers 250 and 300 have other sizes.
Sound emanating from a patient's stoma sometimes has predominant or substantial sound components in different frequency bands, and relatively quiet components in other frequency bands. The frequency bands of the substantial components are sometimes separated from one another by the frequency bands of the relatively quiet sounds. For example, the sounds of solids flowing into the ostomy bag can be formed predominantly or largely of frequencies in a first and relatively low band, and the sounds of liquid flowing into the ostomy bag can be formed predominantly and largely of frequencies in a second and relatively high band that is spaced from the solids frequency band. The sounds emanating from the stoma may have relatively little frequency content in the range between the solids and liquids frequency bands. In embodiments of the invention, the sound cancellation electronics such as 54 described in connection with
Embodiments of the invention offer a number of important advantages. Embodiments that include a sleeve are convenient and easy to use and maintain. It is lightweight and comfortable to wear. Importantly, it also substantially reduces problematic stoma-related noises. The noise cancellation device can be a small and thin device. Embodiments of the invention that include this device or method are convenient to use. For example, the device can be conveniently mounted to the sleeve, ostomy bag cap or other structures near the stoma. Because it can removably mounted to the sleeve (e.g., in the pocket) in some embodiments, the noise cancellation device can be easily cleaned if it becomes soiled. The silencer requires no control actions or operation by the patient or physician. There is no physical interaction with the stoma itself, so the device presents no potential for medical complications associated with bowel obstruction. Sterility can be maintained and opportunities for infection transmission are minimized because the device does not directly contact the ostomy, stool, gas or other body fluids. The device is essentially universal, in that it can be used with a wide variety of types of ostomies, ostomy bags and related equipment. For these and other reasons it can have a significant positive impact on the quality of life of stoma patients.
Although the invention has been described with reference to preferred 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.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2013/057562 | 8/30/2013 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 61695024 | Aug 2012 | US |
