SYSTEMS AND DEVICES FOR MONITORING NEGATIVE PRESSURE DEVICES
20220355017 ยท 2022-11-10
Inventors
Cpc classification
A61F5/0076
HUMAN NECESSITIES
A61M1/60
HUMAN NECESSITIES
A61M1/604
HUMAN NECESSITIES
A61B17/1114
HUMAN NECESSITIES
A61M1/73
HUMAN NECESSITIES
A61B2090/064
HUMAN NECESSITIES
A61F2/04
HUMAN NECESSITIES
International classification
Abstract
The present disclosure provides systems and devices for monitoring the pressure within a negative pressure system, such as a suction cannister. In one aspect, the system includes an anchor configured for positioning within an intestine of the patient at the anastomosis site and a source of negative pressure, such as a suction cannister, fluidly coupled to the anchor. A portable alarm device is coupled to the suction cannister and includes a trigger for detecting the pressure therein. A signal device emits a signal when this pressure is above a threshold level to ensure that the anchor remains securely in contact with the walls of the intestines at the anastomosis site. The alarm device includes a handle to allow a patient to grasp and carry the suction cannister, providing critical patient mobility during the recovery period.
Claims
1. An internal bypass system for a target site in a GI tract of a patient, the system comprising: an anchor configured for positioning within the GI tract of the patient at the target site; a negative pressure system having a source of negative pressure fluidly coupled to the anchor; an alarm device coupled to the negative pressure system and having a trigger for detecting a pressure from within the negative pressure system; and a signal device coupled to the trigger and configured to emit a signal.
2. The bypass system of claim 1, wherein the anchor comprises a flexible sheath having outer walls and an internal channel for allowing passage of matter through the sheath.
3. The bypass system of claim 2, wherein the anchor further comprises a stent coupled to the sheath and configured to provide an outward radial force to the sheath.
4. The bypass system of claim 2, wherein the negative pressure system comprises one or more tubes fluidly coupled to an outer wall of the sheath and at least one suction canister fluidly coupled to the one or more tubes.
5. The bypass system of claim 4, wherein the alarm device comprises a main body having a coupling device for removably attaching the main body to the suction canister.
6. The bypass system of claim 5, wherein the coupling device comprises a fastener sized to pass through an opening of the suction canister and an opening of the main body.
7. The bypass system of claim 5, wherein the trigger comprises a movable element coupled to an outer wall of the suction canister, the movable element being configured to move from a first position to a second position when a pressure of the suction canister reaches a threshold level.
8. The bypass system of claim 7, further comprising a tactile sensor having a contact surface configured to contact a surface of the movable element in the second position when the main body is coupled to the suction canister.
9. The bypass system of claim 8, wherein the tactile sensor is positioned such that the movable element contacts the tactile sensor when the pressure reaches the threshold level.
10. The bypass system of claim 9, wherein the tactile sensor is coupled to the signal device and configured to activate the signal device when the movable element contacts the tactile sensor.
11. The bypass system of claim 5, further comprising a second suction canister fluidly coupled to the one or more tubes, wherein the trigger is a first trigger and wherein the first trigger is configured to detect pressure within the first suction canister, the device further comprising a second trigger configured to detect pressure within the second suction canister.
12. The bypass system of claim 11, wherein the main body comprises an elongate portion and first and second opposing ends, wherein the opposing ends each comprise a coupling device for coupling the main body to the first and second suction canisters and the elongate body comprises a handle for grasping and carrying the main body and the suction canisters.
13. (canceled)
14. (canceled)
15. (canceled)
16. A portable alarm device for use with a negative pressure system, the device comprising: a main body configured for removable attachment to a suction cannister, the main body including a handle; at least one trigger coupled to the main body and configured to detect a pressure from an interior of the suction cannister; and a signal device coupled to the trigger and configured to emit a signal.
17. The device of claim 16, wherein the main body comprises a coupling device for removably attaching to the main body to the suction cannister.
18. The device of claim 17, wherein the coupling device comprises a fastener sized to pass through an opening of the suction cannister and an opening of the main body.
19. The device of claim 16, wherein the trigger comprises an expandable element coupled to an outer wall of the suction canister, the expandable element being configured to expand when a pressure of the suction canister reaches a threshold level.
20. The device of claim 19, further comprising a tactile sensor having a contact surface configured to contact a surface of the expandable element of the suction canister when the main body is coupled to the suction cannister.
21. The device of claim 20, wherein the tactile sensor is positioned such that the expandable element contacts the tactile sensor when the pressure reaches the threshold level.
22. The device of claim 21, wherein the tactile sensor is coupled to the signal device and configured to activate the signal device when the expandable element contacts the tactile sensor.
23. The device of claim 16, wherein the main body comprises an elongate body having opposing ends configured for removable attachment to first and second suction cannisters.
24. The device of claim 23, wherein the trigger is a first trigger and wherein the first trigger is configured to detect pressure within the first suction cannister, the device further comprising a second trigger configured to detect pressure within the second suction cannister.
25. (canceled)
26. (canceled)
27. (canceled)
28. (canceled)
29. A portable device for use for use with a negative pressure system, the device comprising: an elongate body with first and second opposing ends, wherein the first and second ends are configured for removable attachment to first and second suction canisters; a first trigger configured to detect a pressure from an interior of the first suction canister and a second trigger configured to detect a pressure from an interior of the second suction canister; and a signal device coupled to each trigger and configured to emit a signal
30. (canceled)
31. (canceled)
32. (canceled)
33. (canceled)
34. (canceled)
35. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the disclosure and together with the description, serve to explain the principles of the disclosure.
[0034]
[0035]
[0036]
[0037]
[0038]
[0039]
[0040]
[0041]
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0042] Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely exemplary of the disclosure and that the disclosure may be embodied in various forms. 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. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in any unnecessary detail. It should be understood also that the drawings are not drawn to scale and are not intended to represent absolute dimensions or relative size. Instead, the drawings help to illustrate the concepts described herein.
[0043] The present disclosure provides systems and devices for creating an internal bypass within a target area of the GI tract of a patient to allow feces and other waste matter to pass through the target area without contacting the walls of the GI tract at the target area. The target area may be, for example, an anastomosis site in the colon, rectum or anal passage created after bowel resection surgery to treat certain blockages and diseases, such as colorectal cancer, diverticulitis, severe bleeding, obstructions and the like. The bypass device may be secured to the anastomosis site with a negative pressure system, such as one or more suction cannisters coupled to the bypass device via suitable medical tubing, or the like. The present disclosure further provides a portable alarm device that responds to the pressure from within the suction cannister(s) and produces an alert signal to the health care professional when the pressure reaches a threshold level that would no longer be sufficient to secure the bypass device to the anastomosis site.
[0044] The portable alarm device is coupled to one or more suction cannisters and provides a handle for grasping and holding the cannister(s). This design allows the storage canisters to be portable to allow the patient to walk within their recovery room or about the halls of the hospital, as their normal mobility is restored, without disrupting the continuous application of negative or vacuum pressure to the bypass device.
[0045] Referring now to
[0046] Anchor 10 further comprises a stent 14 coupled to sheath 12 and configured to provide an outward radial force against sheath 12 or against the walls of the intestines. Stent 14, in combination with the negative pressure system described below, functions to hold open the target area within the GI tract such that feces and other waste matter will pass through sheath without contacting the walls around the anastomosis site. A more complete description of a suitable sheath and stent for use in bypass device 10 can be found in U.S. Pat. No. 9,339,272, the complete disclosure of which is incorporated herein by reference for all purposes.
[0047] Bypass device 10 further comprises one or more suction tubes 16, 18 extending along the outer periphery of sheath 12. Suction tubes 16, 18 have proximal ends that are coupled to a negative or vacuum pressure system for providing a negative pressure around the walls of sheath 12 and/or stent 14. This negative pressure functions to suction the outer walls of sheath 12 and stent 14 within a vacuum chamber area 20 to the inner walls of the intestines. In certain embodiments, bypass device may further include a distal covering ring 30 and one or more sealing rings 26, 28 extending around stent 14 to securely fasten stent 14 to the distal end of sheath 12. In addition, device 10 may include distal and/or proximal retrieval loops 22, 24 for facilitating removal of the device 10 after the anastomosis has fully healed.
[0048] As shown in
[0049] Suction cannister 240 further comprises a projection 244 with an opening 245 on its top surface. In some embodiments discussed below, the main body of the portable device or accessory components to the portable device may comprise an insert, such as a fastener, which is sized to pass through opening 245. In the embodiment depicted in
[0050] The representative suction cannister 240 further comprises an inflow adaptor 242. Inflow adaptor 242 is capable of further attachment to medical tubing 340. In other embodiments of suction cannister 240, inflow adaptor 242 may be located elsewhere on the container instead of its top surface. For example, the location of inflow adaptor 242 may actually be somewhere near the bottom of the suction cannister. In some embodiments, it may be useful for the inflow adaptor 242 to comprise a control valve to allow for starting or stopping flow.
[0051]
[0052] Elongated portion 210 has a generally angular shape, like a rectangular block. The perpendicular cross-section of elongate portion 210, therefore, may be irregularly shaped and include sharp angles. In other embodiments, elongate portion 210 of main body 200 has a generally tubular or curvilinear shape, such as with a curved surface, similar to a standard bicycle handlebar. In these instances, the cross section of elongate portion 210 is generally circular or oval in nature. Main body 200 may alternatively be a combination of these shapes, with angular edges at opposing ends 350 of the device and tubular in the middle portion where the hand surrounds it. Main body 200 may be substantially rigid to be suitable for a robust grip. However, it may be at least partially covered with rigid or non-rigid padding to increase comfort while a patient holds it. The main body 200 may alternatively be covered at least in part by a material having roughness suitable for a non-slip hand grip. The covering could instead be a disposable liner. No matter the material, the surface of the device or the covering should be such that can be disposed of or easily disinfected with standard cleaning supplies used for cleaning medical equipment known in the art.
[0053] Elongate portion 210 of device 100 serves as a handle while opposing ends 350 include the coupling assemblies. In this embodiment, since opposing ends 350 are not constituents of the handle portion of the device, they may have a different shape altogether. For example, opposing ends 350 may include the coupling device and sensors and thus, may be modularly designed and irregularly shaped.
[0054] One embodiment of opposing ends 350 is shown in
[0055] Opposing end 350 may further include a base 352 that engages with the surface of suction cannister 240 and at least partially houses projection 244 of suction cannister 240. In some embodiments, as shown in
[0056] In some embodiments, suction cannister 240 comprises an expandable element 243 on a surface of cannister 240. Expandable element 243 may be in a contracted configuration as exemplified in the image of the right suction cannister 240 of
[0057] In an exemplary embodiment, expandable element 243 is configured to expand when the pressure within the suction cannister 240 reaches a threshold level. For example, if there is a loss of negative or suction pressure, the threshold pressure is reached, which causes expandable element 243 to move into the expanded configuration. In an exemplary embodiment, when expandable element 243 expands into its expanded configuration, its surface makes contact with the surface of a sensor element 307 of a tactile sensor 306 of device 100, as shown in the exploded portion of
[0058] The threshold pressure level that will trigger expandable element 243 may vary depending on the suction cannister used with the system. At a minimum, this threshold level will comprise a pressure that is high enough such that the internal bypass device is no longer capable of holding open the target area within the GI tract such that feces and other waste matter will pass through sheath without contacting the walls around the anastomosis site. In certain embodiments, the threshold pressure level will be based on an actual pressure value. A vacuum or suction pressure can generally be created with a pressure level below atmospheric pressure, or below about 760 mm Hg, which will vary based on the altitude of the suction canister, the temperature and other factors. In order to provide sufficient suction pressure to the internal bypass device, the pressure within the suction cannister is preferably at a level well below atmospheric pressure, e.g., about 480 mm Hg, or less. In certain embodiments, the threshold pressure level is a pressure greater than about 400 mm Hg, preferably greater than about 480 mm Hg.
[0059] In other embodiments, the threshold pressure level will be based on a percentage of the pressure level set by the individual suction canister. For example, certain commercial cannisters are set such that the trigger will expand when the pressure within the cannister is about 80% of the predetermined vacuum pressure within the system. In other cases, the pressure level may be set at other percentages, such as 90%, 75%, 50%, etc., depending on the capabilities of the individual suction cannister.
[0060] It will be recognized by those skilled in the art that expandable element 243 may have a different structure than described above. For example, element 243 may be rectangular, circular, square, conical, or domed-shaped. In addition, element 243 may be designed to move from one position to another, or to simply translate or extend in one direction, when the threshold pressure has been reached in cannister 240 (rather than expanding).
[0061] In certain embodiments, sensor 306 is a type of pressure sensor, such as a tactile pressure sensor. In some embodiments, a surface of the tactile pressure sensor is configured to be contacted by the surface of expandable element 243 of
[0062]
[0063] In certain aspects, projection 244 of the suction cannister 240 is a tab which has opening 245. For example, the top surface of each of first and second suction cannisters 240 comprises a protruding tab with an opening 245 that allows for the insertion of a fastener. However, it is understood that the surface of the suction cannister may comprise a different structure. For example, suction cannister 240 may not have projection 244 and the coupling may be accomplished using something other than pin 303 or other type of fastener. For example, other types of connections may removably attach main body 200 to suction cannister 240. In one aspect, a clamp may be placed around the body or neck of suction cannister 240. The clasping end of the clamp may secure suction cannister 240 in place while the other end of the clamp may be attached to or inserted through main body 200 of device 100. In such aspects, the coupling of suction cannister 240 to portable alarm device 100 would be accomplished using something similar to pronged extension clamps that hold chemical flasks in place.
[0064] In a preferred embodiment, device 100 includes a coupling device 301 on each opposing end 350 for attaching device 100 to two separate suction cannisters 240. Main body 200 of device is configured such that the patient may grasp and carry device 100 with two suction canisters about the room or halls of the hospital without disrupting the suction pressure applied to bypass device 10.
[0065]
[0066] In an exemplary embodiment, an LED illumination window 223 can be seen which allows an LED unit 220 (see
[0067]
[0068] In some embodiments, there may be two LED units 220, a mute button 450, and a buzzer 452. It is understood that components of signal device 227 may be configured in multiple different ways. For example, a power supply 226 may be disposed external to main body 200 of alarm device 100. The battery of power supply 226 may be a small, rechargeable battery and circuit board 300 may be shaped so as to fit power supply 226 and accompanying electronics within another section of the device 100. For example, power supply 226 may be housed within opposing end 350 of
[0069] In use, bypass device 10 is introduced endoscopically through the patient's rectum and into the large intestines 400, and then advanced to the anastomosis site 402. Stent 14 is expanded through any suitable manner known in the art and suction tubes 16, 18 are coupled to one or more suction cannisters 240 via medical tubing 340. Suction pressure is then applied to sheath 12 via suction tubes 16, 18 (see
[0070] Portable alarm device 100 is coupled to each suction cannisters 240 by sliding projection 244 into base 352 such that protruding feet 353 are seated on the surface of the canister. In these embodiments, it is important that opening 245 of projection 244 aligns with open space 304 within the base 352. In this manner, pin 303 may be inserted through both openings and click into place when the quick-release button on its end reaches the housing space within opposing end 350 of device 100.
[0071] In a preferred embodiment, main body 200 and suction cannisters 240 are positioned by coupling device 301 such that element 307 of the tactile sensor is contactable by expandable element 243 of suction cannister 240 once pressure within the canister reaches a threshold value. Coupling device 301 is a unique and simple design that allows reproducibility in the precise configuration of suction cannisters 240 coupled to device 100. The coupling mechanism is also inherently lightweight and thus, does not further burden the patient.
[0072] If the pressure reaches a threshold value within the negative pressure system, element 243 expands, contacting element 307 of sensor 306 and signals the alarm as described above. This immediately alerts the patient or a healthcare practitioner that suction pressure has been lost and the system must be diagnosed or replaced to ensure that bypass device remains securely in place at the anastomosis site.
[0073] The devices in the present disclosure provide an easily graspable and lightweight design to enhance movement of the patient for personal needs or for performing exercises, such as for physical therapy. This allows the patient to be mobile during the recovery period, improving overall quality of life during the entire recovery window.
[0074] Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications, and variances. As well, one skilled in the art will appreciate further features and advantages of the present disclosure based on the above-described embodiments. Accordingly, the present disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.