US20070049878A1 - Bowel management system - Google Patents
Bowel management system Download PDFInfo
- Publication number
- US20070049878A1 US20070049878A1 US11/553,731 US55373106A US2007049878A1 US 20070049878 A1 US20070049878 A1 US 20070049878A1 US 55373106 A US55373106 A US 55373106A US 2007049878 A1 US2007049878 A1 US 2007049878A1
- Authority
- US
- United States
- Prior art keywords
- patient
- catheter
- section
- balloon
- bowel
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M3/00—Medical syringes, e.g. enemata; Irrigators
- A61M3/02—Enemata; Irrigators
- A61M3/0279—Cannula; Nozzles; Tips; their connection means
- A61M3/0295—Cannula; Nozzles; Tips; their connection means with inflatable balloon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M3/00—Medical syringes, e.g. enemata; Irrigators
- A61M3/02—Enemata; Irrigators
- A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
- A61M3/0241—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being supplied by gravity
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M3/00—Medical syringes, e.g. enemata; Irrigators
- A61M3/02—Enemata; Irrigators
- A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
- A61M3/0254—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped
- A61M3/0262—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped manually, e.g. by squeezing a bulb
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/068—Faeces; Excretions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/10—Trunk
- A61M2210/1042—Alimentary tract
- A61M2210/1067—Anus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M3/00—Medical syringes, e.g. enemata; Irrigators
- A61M3/02—Enemata; Irrigators
- A61M3/027—Devices for holding the cannula in position, e.g. belts
Definitions
- the present invention relates generally to the field of devices for bowel maintenance, and, more particular, to a rectal catheter having multiple sections of varying durometer hardness and a retention balloon to retain the catheter within the rectum of incontinent patients.
- the new system (1) facilitates the collection of fecal matter for patients requiring stool management (2) provides access for colonic irrigation and (3) provides a conduit through which medications may be administered.
- the new bowel management system is composed generally of a rectal catheter having three distinct portions, each with different elasticity and durometer hardness.
- a retention balloon mounted on the outer diameter of the patient proximal catheter maintains the catheter in a position within the rectum that provides for atraumatic sealing and anchoring.
- An optional intralumenal balloon mounted on the inner diameter of the catheter assists in insertion of the device into a patient's rectum and also acts as an anti-reflux valve to obstruct the catheter's evacuation lumen during periods of bowel irrigation or following medication administration for the purpose of retaining the medications in the patient's rectum.
- a drainage tube extends outwardly from the external retention faceplate and functions as a conduit to transport waste and irrigation fluids away from the patient to a waste collection bag.
- a flush/sampling port is located on the drainage tube and provides access for catheter flushing (rinsing) and stool sampling.
- the catheter of the new system preferably includes three syringe connectors.
- One of the connectors is in fluid communication with the retention balloon and one of the connectors is in fluid communication with the intralumenal balloon. These connectors facilitate the inflation/deflation of the respective balloons.
- the third connector is in fluid communication with an optional irrigation lumen that exits the catheter at the patient proximal tip and is used for bowel irrigation and administration of medication solutions.
- the present invention is, briefly, a bowel management system for use in a patient.
- the new system includes a waste collection catheter having at least two distinct sections of varying durometer hardness.
- a first section which is patient proximal and which is disposed in the patient's rectum in normal use position, has a first end and a second end, and a durometer hardness in the range of about 50A to about 90A, so that the catheter patient proximal section is stiff enough to automatically maintain an open position for free flow of bowel waste when in normal use position with a retention balloon inflated.
- the first section is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of the patient.
- a second section has a first end connected to the second end of the patient proximal section, and a second end, and a durometer hardness in the range of about 5A to about 49A.
- the second section can be positioned and retained in the anal canal of the patient for extended periods without distending the sphincters or causing discomfort.
- the system also includes a selectively collapsible, substantially spherical retention balloon attached coaxially and exterior of the patient proximal first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most first end of the patient proximal first section of the waste collection catheter.
- the substantially spherical retention balloon has an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient's rectum without being so large as to trigger a defecatory response in the patient.
- the present invention is also, briefly, the combination of a bowel management system for use in a non-ambulatory patient and a waste collection bag.
- the bowel management system includes a waste collection catheter having at least two distinct sections of varying durometer hardness including a patient proximal first section, which is disposed in the patient's rectum in normal use position, having a first end and a second end.
- the durometer hardness of the first section is such that the catheter patient proximal section is stiff enough to automatically maintain an open position for free flow of bowel waste when in normal use position, yet is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of a patient.
- a second section has a first end connected to the second end of the patient proximal first section, and a second end sufficiently spaced from the first end that the second section can be positioned and retained in the anal canal of the patient and has a durometer hardness to permit the retention of the second section in the patient for extended periods without causing discomfort or lesions in the patient.
- a waste collection bag is adapted for secure, leak-proof connection to the waste collection catheter and is sized sufficiently large enough to receive fecal waste from the patient for extended periods, in the range of at least four hours.
- the invention is further, briefly, a method for inserting a bowel management system into a patient, the method including:
- a waste collection catheter having at least two distinct sections of varying durometer hardness including:
- a first section which is patient proximal and which is disposed in the patient's rectum in normal use position, having a first end and a second end, and a durometer hardness in the range of about 50A to about 90A, so that the catheter patient proximal section is stiff enough to automatically maintain an open position for free flow of bowel waste when in normal use position with retention balloon inflated, yet is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of a patient;
- a second section having a first end connected to the second end of the patient proximal section, and a second end, and a durometer hardness in the range of about 5A to about 49A, so that the second section can be positioned and retained in the anal canal of the patient for extended periods without distending the sphincters or causing discomfort;
- a selectively collapsible, substantially spherical retention balloon attached coaxially and exterior of the patient proximal first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most first end of the patient proximal first section of the waste collection catheter, the substantially spherical retention balloon having an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient's rectum without being so large as to trigger a defecatory response in the patient;
- the invention is further, briefly, a method for inserting a bowel management system into a patient, the method including:
- a waste collection catheter having at least two distinct sections of varying durometer hardness
- a first section which is patient proximal and which is disposed in the patient's rectum in normal use position, having a first end and a second end, and a durometer hardness in the range of about 50A to about 90A, so that the catheter patient proximal section is stiff enough to automatically maintain an open position for free flow of bowel waste when in normal use position with retention balloon inflated, yet is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of a patient;
- a second section having a first end connected to the second end of the patient proximal section, and a second end, and a durometer hardness in the range of about 5A to about 49A, so that the second section can be positioned and retained in the anal canal of the patient for extended periods without distending the sphincters or causing discomfort;
- a selectively collapsible, substantially spherical retention balloon attached coaxially and exterior of the patient proximal first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most first end of the patient proximal first section of the waste collection catheter, the substantially spherical retention balloon having an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient's rectum without being so large as to trigger a defecatory response in the patient;
- FIG. 1 is a schematic perspective view of a bowel management system constructed in accordance with and embodying the present invention and shown inflated in the use position.
- FIG. 2 is a schematic perspective view of the system of FIG. 1 , shown partially exploded.
- FIG. 3 is a schematic representation of the exterior of the rectal tube subassembly of the system of FIG. 1 .
- FIG. 3A is an exploded view of the subassembly of FIG. 3 .
- FIG. 4 is a side elevational view of the drainage tube assembly of FIG. 1 with a bag connector attached thereto.
- FIG. 5 is an exploded view of FIG. 4 .
- FIG. 6 is a schematic side view of the patient proximal end of the assembled bowel management system.
- FIG. 7 is a longitudinal section, enlarged, through the patient proximal end of the system of FIG. 1 taken on line 7 - 7 of FIG. 6 and further enlarged for clarity of detail.
- FIG. 8 is an enlarged schematic elevational view of the rectal tube of the assembly of FIG. 1 .
- FIG. 9 is a longitudinal sectional view taken on line 9 - 9 of FIG. 8 .
- FIG. 10 is a transverse sectional view taken on line 10 - 10 of FIG. 8 .
- FIG. 11 is an enlarged schematic sectional view of the tri-lumen tube of the assembly of FIG. 1 .
- FIG. 12 is an enlarged partial sectional view showing the lumens, taken from FIG. 9 .
- FIG. 13 is a left end elevational view of FIG. 3 , rotated.
- FIG. 14 is an enlarged sectional view taken from FIG. 13 showing the connection of the tri-lumen tube to the rectal tube.
- FIG. 15 is a schematic elevational view of a waste collection bag used with the system with its various tubes and connectors.
- a bowel management system generally designated 10 , includes a catheter 12 having a patient proximal end 14 and a patient distal end 16 and three distinct sections 18 , 20 , 22 therebetween.
- Rectal catheter section 18 is located at the proximal end 14 of the catheter, section 20 is a midsection and section 22 is toward the patient distal end 16 .
- a first balloon 24 which is inflatable, is mounted at the patient proximal end 14 of catheter 12 and a bag connector assembly 26 is mounted at the patient distal end 16 .
- Rectal catheter section 18 has a patient proximal opening that, when positioned for normal use, opens into the rectum of a patient and a second end or distal opening which connects to the second catheter section 20 .
- First catheter section 18 (shown enlarged in FIGS. 8, 9 , 10 and 12 ) is formed of a material having a durometer hard enough to maintain a sufficient opening at the first end of the tube, in order to avoid collapse and subsequent blocking of fecal outflow from the patient.
- An example of a suitable material is silicone rubber, 80 SH polydimethylsiloxane and fumed silica.
- the optimal durometer range is between 50A and 90A shore hardness.
- the proximal opening must be kept open, in order to effectively receive stool entering the first catheter section 18 .
- a relatively large lumen which runs longitudinally within the cylindrical wall of tube section 18 is indicated at number 30 in FIGS. 8, 9 , 10 and 12 .
- Smaller lumens 32 , 34 are located adjacent and parallel to lumen 30 on opposite sides thereof.
- Reference numeral 36 denotes an annular shoulder at the proximal end of catheter section 18 .
- the proximal end of bolster (“retention”) balloon 24 rests against shoulder 36 when in expanded, inflated use position.
- FIGS. 6 and 7 show enlargements of retention balloon 24 mounted to tube section 18 and show that the proximal end of the balloon 24 is adjacent to and tapers toward the proximal end of tube 18 .
- Retention balloon 24 is formed of a selectively collapsible and inflatable material and is mounted coaxially around the proximal end of section 18 so that the extreme ends of each element are substantially flush (or at least closely adjacent to) with one another.
- FIG. 7 is a longitudinal section of FIG. 6 , which illustrates internally of tube section 18 an optional intralumenal balloon 38 in a collapsed state.
- the intralumenal balloon 38 acts as a anti-reflex valve (ARV) and if inflated sufficiently so that the patient proximal end of balloon 38 protrudes slightly (as shown in phantom in FIG. 7 ) beyond the proximal end of tube section 18 , the intralumenal balloon also acts as an aid to insertion of the bowel management assembly into the patient's rectum.
- ARV anti-reflex valve
- This optional embodiment of the system includes an irrigation lumen 30 (described further herein), which exits the patient proximal end of the catheter section 18 and can be connected to an irrigation supply for inputting irrigant (such as saline) into the patient's rectum.
- irrigant such as saline
- FIGS. 3 and 3 A illustrate assembled and unassembled, respectively, the sub-assembly of the indwelling portion of the new system 10 .
- the patient proximal catheter section 18 extending just slightly beyond the retention balloon 24 and then the second catheter section 20 .
- Catheter section 20 is a cylindrical tube when completely open. It is formed with a very thin wall from a soft elastic material which results in a collapsible tube that when collapsed, such as by the anal sphincter muscles, creates a very small profile.
- the optimal durometer range for section 20 is between 5A to 49A shore hardness.
- a first, proximal, end of the second catheter section 20 is connected to the distal or second end of the first catheter section 18 .
- Catheter section 20 may be constructed as one unitary tube of singular durometer hardness, thickness and diameter.
- An example of a suitable material for making trans-sphincter catheter section 20 is silicone rubber, 30 SH polydimethylsiloxane and fumed silica.
- an optional faceplate 41 which mounts surrounding the tube 20 and has preferably at least two sections 42 extending therefrom. Each extension 42 can have loops or other connectors 44 thereon to facilitate attachment of the faceplate strap 40 to the patient to keep it in place.
- an extruded multi-lumen member 46 shown in enlarged perspective, in FIG. 11 ) for permitting inflation/deflation of the balloons and flushing of the rectum, if desired.
- An end view of assembly 10 is provided in FIG. 13 , showing the relative positions of the strap 40 and the multi-lumen catheter.
- An enlarged sectional view (rotated) in FIG. 14 better illustrates the connection of the multi-lumen member 46 with the assembly at catheter section 18 .
- An example of a suitable material for forming multi-lumen member 46 is silicone rubber, 57SH polydimethylsiloxane and fumed silica.
- FIG. 3A further elements of the subassembly are seen which are hidden or not clear in FIG. 3 .
- This view illustrates retention balloon 24 in its expanded state before application to catheter section 18 .
- the extensions 24 A of the symmetrical balloon on each end are annular.
- FIG. 7 it is seen more clearly how extensions 24 A are folded under and inwardly so as to seal flat against the exterior wall at opposite ends of catheter section 18 .
- the figures also show the substantially spherical shape of retention balloon 24 .
- This shape is important because it seats naturally in the patient's rectum to prevent leaking around the retention balloon.
- the shape of the balloon is important to prevent damage to the rectal wall and to achieve optimum sealing to prevent leakage and to effectively funnel fecal matter into the proximal opening of catheter section 18 .
- the shape needs to be substantially spherical, not elliptical or torrodial.
- the size of the balloon when inflated is not only critical to prevent leakage but also to prevent migration of the new system 10 out of the rectum.
- the optimal size for balloon 24 for the normal adult patient is between 44 cc and 69 cc. It has been shown in the literature that a volume of 90 cc is sufficient to trigger a defecatory response and thus the retention balloon should not be sized to reach this volume.
- the minimum of 44 cc is critical in order to prevent leakage and outward migration from the rectum of the patient.
- the size of the balloon as expressed by a length to diameter ratio is 0.75 at the low end of the inflation range, 44 cc, (i.e., the balloon length is 1.35 inches and the balloon diameter would then be 1.8 inches) and 0.61 at the upper end, 69 cc (i.e., a balloon length of 1.35 inches and a balloon diameter of 2.32 inches). It is to be understood that all sizes given herein are for an average adult patient and can be adjusted proportionally for other non-average patients.
- the retention balloon 24 is inflated via a lumen 34 , which opens into the balloon.
- the lumen is connected via a multi-lumen member 46 to an inflation device, such as a syringe, filled with air or saline or some other biocompatible fluid.
- the inflation device limits the volume of inflation medium infused to a volume that results n the inflation of the balloon to the desired range of 44 to 69 cc.
- retention balloon 24 An example of a suitable material from which to form retention balloon 24 , in order to achieve the desired results is silicone rubber, 30SH polydimethylsiloxane and fumed silica.
- the retention balloon material itself could limit the size if a material or structure was used that would only expand to the optimum size.
- An example of such material would be polyimide.
- An example of such a structure would be a stiff mesh impregnated into an otherwise elastic material such as silicone that would mechanically limit the retention balloon size when inflated.
- FIG. 3A to the right of the retention balloon 24 is shown a second balloon 38 which is illustrated in its collapsed position. Balloon 38 is also illustrated in FIG. 7 collapsed in solid lines and inflated in broken lines. When inflated, balloon 38 fills the lumen of catheter section 18 to block reflux and facilitates insertion of the system into a patient.
- catheter section 18 is shown then to the right of balloon 38 .
- two small TEFLON tubes 48 which interconnect paired small lumen in the multi-lumen catheter 46 to corresponding openings to paired lumen in rectal catheter section 18 .
- An optional radiopaque marker 50 is preferably annular and is useful for accurately determining the location of and position of the assembly portion within the rectum of the patient. Marker 50 is formed for example of material such as a tungsten silicone mixture, which is biocompatible, but easily detected by radiograph.
- the trans-sphincter catheter section 20 To the right of radiopaque marker 50 in FIG. 3A is shown the trans-sphincter catheter section 20 , the midsection of catheter 12 .
- FIG. 3 and 3 A also illustrate the positioning of the faceplate 40 as it is mounted by a through hole onto the patient distal end of mid-catheter section 20 .
- a bridge section or drain tube connector band 52 is illustrated to the right of element 40 in FIG. 3A and also is visible in FIG. 3 .
- Bridge section 52 permits the third, patient distal segment of catheter 12 , segment 22 to be connected in abutting relationship with midsection 20 , by a slip fit of the sections 20 , 22 over (or optionally, under) the segment 52 .
- Extruded multi-lumen member 46 is illustrated at the right of FIG. 3A and is shown in part, enlarged in FIG. 11 for clarity. In this embodiment, the multi-lumen member 46 is relatively flat and elongated and bears a large central lumen 30 flanked by two smaller lumen 32 , 34 on opposite sides of lumen 30 , as previously discussed.
- FIGS. 1 and 2 illustrate three ports (for example, luer-style connectors), which are connectable to the various lumens in multi-lumen member 46 .
- the larger central port 54 attaches to large lumen 30 A in the multi-lumen member and is used for connection of a syringe or other infusion device in order to infuse irrigants or medications.
- An optional port 56 connects to one of the small optional lumens (e.g., 32 a ) in the multi-lumen member 46 for inflation and deflation of the optional intralumenal balloon 38 with a syringe or other appropriate device.
- the other small optional port 58 connects to small lumen 34 a , in the multi-lumen member 46 in order to inflate and deflate the retention balloon with a syringe or other appropriate device.
- FIGS. 4 and 5 illustrate the subassembly of the third catheter segment 22 .
- Segment 22 connects at a patient proximal end 22 A to the distal end of the trans-sphincter mid-segment 20 and the opposite, patient distal end 22 B to a connector 66 , which is adapted for connection to a collection bag for example as illustrated at 60 in FIG. 15 .
- the third catheter section 22 is formed of a non-collapsible tube constructed of a material that is stiff enough to maintain its shape to minimize kinking and facilitate drainage of the tube, but soft enough to be “milked” by a care professional to force trough fecal material.
- Optional application of a coating to the exterior of section 2 can facilitate milking thereof and optional internal coating of section 22 facilitates flow-through of feces by decreasing friction against the internal side wall.
- Catheter 22 as shown has an optional sampling/flushing port 62 (shown most clearly in FIG. 5 ) to provide access to the lumen of section 22 for taking fecal samples or for flushing to clean the catheter.
- an optional sampling/flushing port 62 shown most clearly in FIG. 5
- a cover for port 62 , 63 of any suitable variety is also desirable.
- the connector assembly 66 illustrated at end 22 B of catheter 22 includes a sleeve 64 spacedly along the length of catheter 22 to receive and retain the connector assembly, which attaches 22 B to collection bag 60 . It may be a heat-shrinkable band or other suitable retention means as desired. As shown in FIG. 5 connector assembly 66 fits into the end 22 B and then is adapted, also with an optional O-ring (e.g. 67 ), to connect in a sealing manner to the bag. A closure portion 68 is also desirable for closing off the connector assembly 64 preventing leakage when the bag is separated from catheter portion 22 . If desired, the closure portion 68 may be connected by a string, strip, cord or other piece 70 to end 26 .
- FIG. 15 illustrates waste collection bag 60 , which is considerably larger than what would ordinarily be used for a colostomy or urinary bag and the bag may be left in place for long periods of time without having to be emptied. It is expected that bag 60 will have approximately a three liter capacity, and be provided with a hook 72 for hanging on the bed or chair and of course a connector 73 for connection to the catheter connector assembly 64 in a sealing manner.
- the waste bag 60 also optionally carries a drain tube holster 74 , such as the U-shaped connector illustrated, for example, and a clamp 76 for sealing off the collection bag drain tube 82 .
- Clamp 76 desirably carries a button 78 or other connector, which slips into holster 74 or otherwise attaches to bag 60 .
- Closure portion 75 is also desirable for preventing leakage from the bag connector 73 when the bag is not connected to the catheter portion 22 of the bowel management system 10 .
- An outlet tube 82 is also provided for draining out the contents of the bag. It is preferred that the bag 60 be suitable for folding up because it is rather long; in order to prevent it from dragging on the floor.
- Clamp 76 carrying the button holster connector 78 is useful for sealing off collection bag drain tube 82 by pinching it.
- Cap 80 which is preferably attached to the holster 74 is useful for blocking the open tip (not shown) of bag drain tube 82 .
- a faceplate which would serve as a retention mechanism to prevent internal migration of the bowel management system 10 , as well as to prevent rotation of the trans-sphincter catheter section 20 of the device.
- a faceplate 41 can be mounted on the bridge section 52 as illustrated, in FIGS. 1 and 2 , as one useful example.
- the faceplate can take the form of a strap, wedge, donut, etc. and would preferably be made of silicone, foam or other soft material to avoid irritation of the patient's skin.
- FIGS. 1 and 2 also illustrate a clip assembly 21 for attachment of the assembly 10 to a sheet, bedclothes, etc. It is to be understood that the illustrated embodiment is merely one useful assembly for accomplishing this task. As shown, an elastomeric band surrounds a simple pinch clip for gripping fabric or other thin material for the purpose of holding the assembly in position. Other useful stabilizing devices are conceived.
- bowel management system 10 For insertion of bowel management system 10 into a non-ambulatory patient it is preferred that the patient be in the left side down position, if possible, although other positions may be utilized if necessary due to the patient's clinical condition.
- the procedure for insertion is performed using recognized aseptic techniques as appropriate.
- a device is selected with the appropriate trans-sphincter catheter section length, usually 4 cm for a female patient, or 6 cm for a male patient. And the rectum of the patient is examined to confirm no rectal impaction and to be sure that no lesions or strictures exist which would preclude use of the device.
- a 60 cc syringe is filled with 35 cc-40 cc water and a 30 cc syringe is filled with 20 cc water.
- the 30 cc syringe is attached to the intralumenal balloon connector and the intralumenal balloon 38 is filled with the 20 cc's of fluid.
- Lubricant is applied to patient proximal end of the device including the protruding intralumenal balloon 38 , the deflated retention balloon 24 and the patient's anus.
- the protruding end of the intralumenal balloon as an introducer, the patient proximal end of catheter section 18 is guided through the anus and into the distal rectum.
- the 60 cc syringe is attached to the retention balloon connector 58 and the retention balloon 24 is inflated with the syringe contents (in this example, 35 cc-40 cc water).
- the catheter connector assembly 66 is connected to the waste collection bag connector 73 and bag 60 is positioned at bedside so that the catheter drainage tube 22 is not twisted or kinked. This allows for unobstructed fecal matter flow from the catheter 22 into bag 60 .
- the 30 cc syringe is used to completely aspirate the 20 cc of water (or air) from intralumenal balloon 38 .
- the 30 cc syringe is disconnected from the intralumenal balloon connector.
- the patient is placed in a slight head up position to promote drainage, the gravity irrigation or enteral feeding bag is filled with one liter of warm tap water and hung from an IV pole two to three feed above the height of patient's anus.
- the irrigation bag administration set is connected to the catheter irrigation port 54 .
- gravity irrigation is begun. Large stool pieces are broken up by a combination of irrigating and manual douching (i.e. constricting outflow and squeezing the drainage tube repeatedly). Irrigation is discontinued when stool pieces are no longer present in the effluent.
- Irrigation of the patient's rectum can be performed using a gravity bag or by using a syringe.
- the gravity bag method it is necessary to provide a waste collection bag with at least two liters of available volume.
- a standard gravity irrigation or enteral feeding bag with pre-attached administration set is used to infuse about a liter of warm tap water into the patient's anus at a flow rate of about one liter in six to ten minutes.
- the irrigation bag administration set is connected to the catheter system irrigation port and the 30 cc syringe (filled with 20 cc of fluid) is attached to the intralumenal balloon connector and the intralumenal balloon 38 is filled with the 20 cc's of fluid.
- the flow control valve on the irrigation bag set is opened and fluid is allowed to drain by gravity into the rectum and colon. If leakage occurs past the retention balloon during irrigation more water is injected into the retention balloon up to a maximum inflation volume of 50 cc.
- the infused irrigant is permitted to remain as long as prescribed by physician. Then the 20 cc volume of fluid with which the intralumenal balloon was inflated is removed via syringe and the mixed fluid and feces are allowed to drain out of the rectum and colon. If necessary, the patient's position is modified to slight head up. Once irrigation is complete the administration set is disconnected from the catheter irrigation port. Any additional fluid that was injected into the retention balloon is removed by syringe via the retention balloon connector. If necessary the retention balloon may be completely aspirated and refilled to normal use volume (about 35 to about 40 cc).
- a syringe is prepared with about 60 cc of warm tap water.
- a 30 cc syringe is prepared with about 20 cc of air or water and attached to the intralumenal balloon connector and the intralumenal balloon is inflated.
- the syringe is connected to the catheter irrigation port. With the patient in a slight head down position the irrigant is slowly injected into the rectum and colon. As with the gravity bag irrigation method, any leakage can be handled by further inflating the retention balloon.
- irrigant is permitted to dwell for a prescribed time and then the fluid is aspirated from the intralumenal balloon with a syringe to allow drainage of fluid and feces out of the rectum and colon. If necessary the patient's position can be modified. Again, if extra fluid was introduced into the retention balloon it can now be released and the waste bag emptied if necessary.
- the system irrigation port can be useful for administering medications or enema solutions.
- the port is preferably flushed first with about 10 cc to about 20 cc of water before and after administration of enema/medication solution.
- a syringe is filled with the desired solution to be introduced and a 30 cc syringe is filled with about 20 cc of air or water.
- the solution is injected and the catheter irrigation lumen is flushed as indicated.
- the syringe is then disconnected from the irrigation port and the solution is permitted to dwell for the prescribed time.
- the intralumenal balloon is then deflated, preferably by use of a 30 cc syringe, as previously described.
- the flush/sampling port of the system can also be used to draw samples of fecal mater by use of a catheter tip syringe attached to the flush/sampling port. This can be very useful for monitoring a patient's progress and for testing purposes.
Abstract
A bowel management system includes a waste collection catheter having at least two distinct sections. The first section is patient proximal when disposed in the patient's rectum and has durometer hardness in the range of about 50A to about 90A. The second catheter section is connected to the first section and has durometer hardness in the range of about 5A to about 49A. A selectively collapsible, substantially spherical retention balloon is attached coaxially and exterior of the first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most end of the first section of the waste collection catheter, the substantially spherical retention balloon having an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient's rectum without being so large as to trigger a defecatory response in the patient.
Description
- The present invention relates generally to the field of devices for bowel maintenance, and, more particular, to a rectal catheter having multiple sections of varying durometer hardness and a retention balloon to retain the catheter within the rectum of incontinent patients.
- Many circumstances can result in an individual becoming incontinent for an extended period of time. Examples of such circumstances include head or spinal cord trauma, disabling strokes, microbial caused illness, broken lower limbs or pelvic bones, digestive disorders, intensive care stays, and as side effects of administration of various pharmaceuticals. Incontinent patients and their caretakers face a great burden in the maintenance of the bowel and its functions. Such patients often suffer from constipation, but can also experience boughts of diarrhea, which impose even greater nursing problems. Constipation or stool impaction can be painful and require messy bowel irrigations and/or manual disimpaction to break up the impacted stool. Diarrhea, on the other hand, can result in perianal skin breakdown, which in turn can lead to open wounds and infections. The proper treatment of perianal wounds, whether caused by exposure to feces (i.e. diarrhea) or other etiology, can be especially difficult if the wound is continually being contaminated by feces. A great deal of time is necessary to cleanse contaminated wounds, change bedding and treat infections. Thus, there is a great need for devices and methods to improve the function of the bowel in incontinent patients. This need is
- Previously, efforts to address these problems included a variety of devices, such as bags or plugs adhered to or inserted into the anus of non-ambulatory patients. These methods are limited in their effectiveness, in part due to leakage around the devices and the resultant effluent that remains in contact with the perianal skin and, in part, due to the complexities of the anal canal anatomy that can interfere with the use of such devices. Because of the ineffectiveness of the available methods for managing fecal evacuation in bed-ridden patients, physicians are frequently forced to construct a stoma in those individuals where enough intact perianal skin does not remain or where the occurrence of an infection would be life threatening.
- Thus, it is among the advantages and features of the present invention that it can be used as a bowel maintenance system in a wide variety of incontinent patients for diversion of fecal matter to a receptacle to minimize contact of such fecal matter with patient skin. The new system (1) facilitates the collection of fecal matter for patients requiring stool management (2) provides access for colonic irrigation and (3) provides a conduit through which medications may be administered.
- Thus, it was with the above disadvantages and limitations in mind that the new bowel management system was developed. The new system is composed generally of a rectal catheter having three distinct portions, each with different elasticity and durometer hardness. A retention balloon mounted on the outer diameter of the patient proximal catheter maintains the catheter in a position within the rectum that provides for atraumatic sealing and anchoring. An optional intralumenal balloon mounted on the inner diameter of the catheter assists in insertion of the device into a patient's rectum and also acts as an anti-reflux valve to obstruct the catheter's evacuation lumen during periods of bowel irrigation or following medication administration for the purpose of retaining the medications in the patient's rectum. An optional faceplate that can be anchored to the patient with tape prevents migration of the retention balloon too far into the rectum. A drainage tube extends outwardly from the external retention faceplate and functions as a conduit to transport waste and irrigation fluids away from the patient to a waste collection bag. A flush/sampling port is located on the drainage tube and provides access for catheter flushing (rinsing) and stool sampling.
- The catheter of the new system preferably includes three syringe connectors. One of the connectors is in fluid communication with the retention balloon and one of the connectors is in fluid communication with the intralumenal balloon. These connectors facilitate the inflation/deflation of the respective balloons. The third connector is in fluid communication with an optional irrigation lumen that exits the catheter at the patient proximal tip and is used for bowel irrigation and administration of medication solutions.
- Accordingly, in furtherance of the above goals, the present invention is, briefly, a bowel management system for use in a patient. The new system includes a waste collection catheter having at least two distinct sections of varying durometer hardness. A first section, which is patient proximal and which is disposed in the patient's rectum in normal use position, has a first end and a second end, and a durometer hardness in the range of about 50A to about 90A, so that the catheter patient proximal section is stiff enough to automatically maintain an open position for free flow of bowel waste when in normal use position with a retention balloon inflated. However, the first section is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of the patient. A second section has a first end connected to the second end of the patient proximal section, and a second end, and a durometer hardness in the range of about 5A to about 49A. The second section can be positioned and retained in the anal canal of the patient for extended periods without distending the sphincters or causing discomfort. The system also includes a selectively collapsible, substantially spherical retention balloon attached coaxially and exterior of the patient proximal first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most first end of the patient proximal first section of the waste collection catheter. The substantially spherical retention balloon has an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient's rectum without being so large as to trigger a defecatory response in the patient.
- The present invention is also, briefly, the combination of a bowel management system for use in a non-ambulatory patient and a waste collection bag. The bowel management system includes a waste collection catheter having at least two distinct sections of varying durometer hardness including a patient proximal first section, which is disposed in the patient's rectum in normal use position, having a first end and a second end. The durometer hardness of the first section is such that the catheter patient proximal section is stiff enough to automatically maintain an open position for free flow of bowel waste when in normal use position, yet is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of a patient. A second section has a first end connected to the second end of the patient proximal first section, and a second end sufficiently spaced from the first end that the second section can be positioned and retained in the anal canal of the patient and has a durometer hardness to permit the retention of the second section in the patient for extended periods without causing discomfort or lesions in the patient. A waste collection bag is adapted for secure, leak-proof connection to the waste collection catheter and is sized sufficiently large enough to receive fecal waste from the patient for extended periods, in the range of at least four hours.
- The invention is further, briefly, a method for inserting a bowel management system into a patient, the method including:
- (a) providing a bowel management system, the system having:
- a waste collection catheter having at least two distinct sections of varying durometer hardness including:
- a first section which is patient proximal and which is disposed in the patient's rectum in normal use position, having a first end and a second end, and a durometer hardness in the range of about 50A to about 90A, so that the catheter patient proximal section is stiff enough to automatically maintain an open position for free flow of bowel waste when in normal use position with retention balloon inflated, yet is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of a patient;
- a second section having a first end connected to the second end of the patient proximal section, and a second end, and a durometer hardness in the range of about 5A to about 49A, so that the second section can be positioned and retained in the anal canal of the patient for extended periods without distending the sphincters or causing discomfort; and
- a selectively collapsible, substantially spherical retention balloon attached coaxially and exterior of the patient proximal first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most first end of the patient proximal first section of the waste collection catheter, the substantially spherical retention balloon having an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient's rectum without being so large as to trigger a defecatory response in the patient;
- (b) folding the patient proximal first end of the waste collection catheter longitudinally;
- (c) inserting the folded patient proximal first end of the waste collection catheter into the patient's rectum sufficiently far that the selectively collapsible, substantially spherical retention balloon is entirely within the patient's rectum; and
- d) securing the waste collection catheter in the position to which it has been inserted so that the catheter does not become separated from the patient during an extended period of time, in the range of hours, while the patient's body waste is permitted to drain out of the patient's body through the waste collection catheter.
- The invention is further, briefly, a method for inserting a bowel management system into a patient, the method including:
- (a) providing a bowel management system, the system having:
- a waste collection catheter having at least two distinct sections of varying durometer hardness including
- a first section which is patient proximal and which is disposed in the patient's rectum in normal use position, having a first end and a second end, and a durometer hardness in the range of about 50A to about 90A, so that the catheter patient proximal section is stiff enough to automatically maintain an open position for free flow of bowel waste when in normal use position with retention balloon inflated, yet is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of a patient;
- a second section having a first end connected to the second end of the patient proximal section, and a second end, and a durometer hardness in the range of about 5A to about 49A, so that the second section can be positioned and retained in the anal canal of the patient for extended periods without distending the sphincters or causing discomfort; and
- a selectively collapsible, substantially spherical retention balloon attached coaxially and exterior of the patient proximal first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most first end of the patient proximal first section of the waste collection catheter, the substantially spherical retention balloon having an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient's rectum without being so large as to trigger a defecatory response in the patient;
- b) inflating an intralumenal balloon in the patient proximal end of the waste collection catheter to the extent that the intralumenal balloon extends slightly beyond the proximal-most end of the catheter, to thereby provide a curved tip for ease of introduction of the catheter into the patient's rectum
- (c) inserting the patient proximal first end of the waste collection catheter into the patient's rectum sufficiently far that the selectively collapsible, substantially spherical retention balloon is entirely within the patient's rectum; and
- (d) securing the waste collection catheter in the position to which it has been inserted so that the catheter does not become separated from the patient during an extended period of time, in the range of hours, while the patient's body waste is permitted to drain out of the patient's body through the waste collection catheter; and
- (e) deflating the intralumenal balloon in the patient proximal end of the waste collection catheter to permit free flow of body wastes from the patient.
- These and other objects and advantages will be in part apparent and in part pointed out herein below.
-
FIG. 1 is a schematic perspective view of a bowel management system constructed in accordance with and embodying the present invention and shown inflated in the use position. -
FIG. 2 is a schematic perspective view of the system ofFIG. 1 , shown partially exploded. -
FIG. 3 is a schematic representation of the exterior of the rectal tube subassembly of the system ofFIG. 1 . -
FIG. 3A is an exploded view of the subassembly ofFIG. 3 . -
FIG. 4 is a side elevational view of the drainage tube assembly ofFIG. 1 with a bag connector attached thereto. -
FIG. 5 is an exploded view ofFIG. 4 . -
FIG. 6 is a schematic side view of the patient proximal end of the assembled bowel management system. -
FIG. 7 is a longitudinal section, enlarged, through the patient proximal end of the system ofFIG. 1 taken on line 7-7 ofFIG. 6 and further enlarged for clarity of detail. -
FIG. 8 is an enlarged schematic elevational view of the rectal tube of the assembly ofFIG. 1 . -
FIG. 9 is a longitudinal sectional view taken on line 9-9 ofFIG. 8 . -
FIG. 10 is a transverse sectional view taken on line 10-10 ofFIG. 8 . -
FIG. 11 is an enlarged schematic sectional view of the tri-lumen tube of the assembly ofFIG. 1 . -
FIG. 12 is an enlarged partial sectional view showing the lumens, taken fromFIG. 9 . -
FIG. 13 is a left end elevational view ofFIG. 3 , rotated. -
FIG. 14 is an enlarged sectional view taken fromFIG. 13 showing the connection of the tri-lumen tube to the rectal tube. -
FIG. 15 is a schematic elevational view of a waste collection bag used with the system with its various tubes and connectors. - Throughout the drawings like elements are indicated by like element numbers.
- With reference to the figures, and particularly
FIGS. 1 and 2 , a bowel management system, generally designated 10, includes acatheter 12 having a patientproximal end 14 and a patientdistal end 16 and threedistinct sections Rectal catheter section 18 is located at theproximal end 14 of the catheter,section 20 is a midsection andsection 22 is toward the patientdistal end 16. Afirst balloon 24, which is inflatable, is mounted at the patientproximal end 14 ofcatheter 12 and abag connector assembly 26 is mounted at the patientdistal end 16. These elements will be described in further detail hereafter. -
Rectal catheter section 18 has a patient proximal opening that, when positioned for normal use, opens into the rectum of a patient and a second end or distal opening which connects to thesecond catheter section 20. First catheter section 18 (shown enlarged inFIGS. 8, 9 , 10 and 12) is formed of a material having a durometer hard enough to maintain a sufficient opening at the first end of the tube, in order to avoid collapse and subsequent blocking of fecal outflow from the patient. An example of a suitable material is silicone rubber, 80 SH polydimethylsiloxane and fumed silica. The optimal durometer range is between 50A and 90A shore hardness. The proximal opening must be kept open, in order to effectively receive stool entering thefirst catheter section 18. A relatively large lumen which runs longitudinally within the cylindrical wall oftube section 18 is indicated atnumber 30 inFIGS. 8, 9 , 10 and 12.Smaller lumens Reference numeral 36 denotes an annular shoulder at the proximal end ofcatheter section 18. The proximal end of bolster (“retention”)balloon 24 rests againstshoulder 36 when in expanded, inflated use position. -
FIGS. 6 and 7 show enlargements ofretention balloon 24 mounted totube section 18 and show that the proximal end of theballoon 24 is adjacent to and tapers toward the proximal end oftube 18.Retention balloon 24 is formed of a selectively collapsible and inflatable material and is mounted coaxially around the proximal end ofsection 18 so that the extreme ends of each element are substantially flush (or at least closely adjacent to) with one another. -
FIG. 7 is a longitudinal section ofFIG. 6 , which illustrates internally oftube section 18 anoptional intralumenal balloon 38 in a collapsed state. When inflated theintralumenal balloon 38 acts as a anti-reflex valve (ARV) and if inflated sufficiently so that the patient proximal end ofballoon 38 protrudes slightly (as shown in phantom inFIG. 7 ) beyond the proximal end oftube section 18, the intralumenal balloon also acts as an aid to insertion of the bowel management assembly into the patient's rectum. This optional embodiment of the system includes an irrigation lumen 30 (described further herein), which exits the patient proximal end of thecatheter section 18 and can be connected to an irrigation supply for inputting irrigant (such as saline) into the patient's rectum. -
FIGS. 3 and 3 A illustrate assembled and unassembled, respectively, the sub-assembly of the indwelling portion of thenew system 10. From the lower left to the upper right ofFIG. 3 there is seen the patientproximal catheter section 18 extending just slightly beyond theretention balloon 24 and then thesecond catheter section 20.Catheter section 20 is a cylindrical tube when completely open. It is formed with a very thin wall from a soft elastic material which results in a collapsible tube that when collapsed, such as by the anal sphincter muscles, creates a very small profile. As this section of the catheter is left in place for very extended periods of time in the patient's anal region this collapsibility is important to prevent loss of the patient's sphincter tone, as could result over time if a large diameter rigid tube where in such place. The optimal durometer range forsection 20 is between 5A to 49A shore hardness. A first, proximal, end of thesecond catheter section 20 is connected to the distal or second end of thefirst catheter section 18.Catheter section 20 may be constructed as one unitary tube of singular durometer hardness, thickness and diameter. An example of a suitable material for making trans-sphincter catheter section 20 is silicone rubber, 30 SH polydimethylsiloxane and fumed silica. - Toward the patient distal end of
catheter section 20 there is mounted anoptional faceplate 41 which mounts surrounding thetube 20 and has preferably at least twosections 42 extending therefrom. Eachextension 42 can have loops orother connectors 44 thereon to facilitate attachment of thefaceplate strap 40 to the patient to keep it in place. Finally, inFIG. 3 , at the patient distal end ofcatheter section 20 there is connected an extruded multi-lumen member 46 (shown in enlarged perspective, inFIG. 11 ) for permitting inflation/deflation of the balloons and flushing of the rectum, if desired. An end view ofassembly 10 is provided inFIG. 13 , showing the relative positions of thestrap 40 and the multi-lumen catheter. An enlarged sectional view (rotated) inFIG. 14 better illustrates the connection of themulti-lumen member 46 with the assembly atcatheter section 18. An example of a suitable material for formingmulti-lumen member 46 is silicone rubber, 57SH polydimethylsiloxane and fumed silica. - In the exploded view,
FIG. 3A , further elements of the subassembly are seen which are hidden or not clear inFIG. 3 . This view illustratesretention balloon 24 in its expanded state before application tocatheter section 18. The extensions 24A of the symmetrical balloon on each end are annular. InFIG. 7 it is seen more clearly how extensions 24A are folded under and inwardly so as to seal flat against the exterior wall at opposite ends ofcatheter section 18. - The figures also show the substantially spherical shape of
retention balloon 24. This shape is important because it seats naturally in the patient's rectum to prevent leaking around the retention balloon. The shape of the balloon is important to prevent damage to the rectal wall and to achieve optimum sealing to prevent leakage and to effectively funnel fecal matter into the proximal opening ofcatheter section 18. Thus, the shape needs to be substantially spherical, not elliptical or torrodial. - The size of the balloon when inflated is not only critical to prevent leakage but also to prevent migration of the
new system 10 out of the rectum. The optimal size forballoon 24 for the normal adult patient is between 44 cc and 69 cc. It has been shown in the literature that a volume of 90 cc is sufficient to trigger a defecatory response and thus the retention balloon should not be sized to reach this volume. The minimum of 44 cc is critical in order to prevent leakage and outward migration from the rectum of the patient. The size of the balloon as expressed by a length to diameter ratio is 0.75 at the low end of the inflation range, 44 cc, (i.e., the balloon length is 1.35 inches and the balloon diameter would then be 1.8 inches) and 0.61 at the upper end, 69 cc (i.e., a balloon length of 1.35 inches and a balloon diameter of 2.32 inches). It is to be understood that all sizes given herein are for an average adult patient and can be adjusted proportionally for other non-average patients. Theretention balloon 24 is inflated via alumen 34, which opens into the balloon. The lumen is connected via amulti-lumen member 46 to an inflation device, such as a syringe, filled with air or saline or some other biocompatible fluid. The inflation device limits the volume of inflation medium infused to a volume that results n the inflation of the balloon to the desired range of 44 to 69 cc. - An example of a suitable material from which to form
retention balloon 24, in order to achieve the desired results is silicone rubber, 30SH polydimethylsiloxane and fumed silica. Alternatively, the retention balloon material itself could limit the size if a material or structure was used that would only expand to the optimum size. An example of such material would be polyimide. An example of such a structure would be a stiff mesh impregnated into an otherwise elastic material such as silicone that would mechanically limit the retention balloon size when inflated. In turning toFIG. 3A , to the right of theretention balloon 24 is shown asecond balloon 38 which is illustrated in its collapsed position.Balloon 38 is also illustrated inFIG. 7 collapsed in solid lines and inflated in broken lines. When inflated,balloon 38 fills the lumen ofcatheter section 18 to block reflux and facilitates insertion of the system into a patient. - Further with reference to
FIG. 3A ,catheter section 18 is shown then to the right ofballoon 38. To the right ofcatheter section 18 are shown twosmall TEFLON tubes 48 which interconnect paired small lumen in themulti-lumen catheter 46 to corresponding openings to paired lumen inrectal catheter section 18. An optionalradiopaque marker 50 is preferably annular and is useful for accurately determining the location of and position of the assembly portion within the rectum of the patient.Marker 50 is formed for example of material such as a tungsten silicone mixture, which is biocompatible, but easily detected by radiograph. To the right ofradiopaque marker 50 inFIG. 3A is shown the trans-sphincter catheter section 20, the midsection ofcatheter 12.FIGS. 3 and 3 A also illustrate the positioning of thefaceplate 40 as it is mounted by a through hole onto the patient distal end ofmid-catheter section 20. A bridge section or draintube connector band 52 is illustrated to the right ofelement 40 inFIG. 3A and also is visible inFIG. 3 .Bridge section 52 permits the third, patient distal segment ofcatheter 12,segment 22 to be connected in abutting relationship withmidsection 20, by a slip fit of thesections segment 52. Extrudedmulti-lumen member 46 is illustrated at the right ofFIG. 3A and is shown in part, enlarged inFIG. 11 for clarity. In this embodiment, themulti-lumen member 46 is relatively flat and elongated and bears a largecentral lumen 30 flanked by twosmaller lumen lumen 30, as previously discussed. -
FIGS. 1 and 2 illustrate three ports (for example, luer-style connectors), which are connectable to the various lumens inmulti-lumen member 46. The largercentral port 54 attaches to large lumen 30A in the multi-lumen member and is used for connection of a syringe or other infusion device in order to infuse irrigants or medications. Anoptional port 56 connects to one of the small optional lumens (e.g., 32 a) in themulti-lumen member 46 for inflation and deflation of theoptional intralumenal balloon 38 with a syringe or other appropriate device. The other smalloptional port 58 connects tosmall lumen 34 a, in themulti-lumen member 46 in order to inflate and deflate the retention balloon with a syringe or other appropriate device. -
FIGS. 4 and 5 illustrate the subassembly of thethird catheter segment 22.Segment 22 connects at a patient proximal end 22A to the distal end of the trans-sphincter mid-segment 20 and the opposite, patient distal end 22B to aconnector 66, which is adapted for connection to a collection bag for example as illustrated at 60 inFIG. 15 . Thethird catheter section 22 is formed of a non-collapsible tube constructed of a material that is stiff enough to maintain its shape to minimize kinking and facilitate drainage of the tube, but soft enough to be “milked” by a care professional to force trough fecal material. Optional application of a coating to the exterior of section 2 can facilitate milking thereof and optional internal coating ofsection 22 facilitates flow-through of feces by decreasing friction against the internal side wall. -
Catheter 22 as shown has an optional sampling/flushing port 62 (shown most clearly inFIG. 5 ) to provide access to the lumen ofsection 22 for taking fecal samples or for flushing to clean the catheter. In order to prevent bacterial contamination of the catheter and to also aid in reduction of odor to fecal build up in the catheter, frequent flushing through the optional sampling/flushingport 62 is preferred. A cover forport - The
connector assembly 66 illustrated at end 22B ofcatheter 22 includes asleeve 64 spacedly along the length ofcatheter 22 to receive and retain the connector assembly, which attaches 22B tocollection bag 60. It may be a heat-shrinkable band or other suitable retention means as desired. As shown inFIG. 5 connector assembly 66 fits into the end 22B and then is adapted, also with an optional O-ring (e.g. 67), to connect in a sealing manner to the bag. Aclosure portion 68 is also desirable for closing off theconnector assembly 64 preventing leakage when the bag is separated fromcatheter portion 22. If desired, theclosure portion 68 may be connected by a string, strip, cord orother piece 70 to end 26. -
System 10catheter section 22 empties into acollection bag 60, which can be hung by the bedside to collect fecal waste matter.FIG. 15 illustrateswaste collection bag 60, which is considerably larger than what would ordinarily be used for a colostomy or urinary bag and the bag may be left in place for long periods of time without having to be emptied. It is expected thatbag 60 will have approximately a three liter capacity, and be provided with ahook 72 for hanging on the bed or chair and of course aconnector 73 for connection to thecatheter connector assembly 64 in a sealing manner. Thewaste bag 60 also optionally carries adrain tube holster 74, such as the U-shaped connector illustrated, for example, and aclamp 76 for sealing off the collectionbag drain tube 82.Clamp 76 desirably carries abutton 78 or other connector, which slips intoholster 74 or otherwise attaches to bag 60.Closure portion 75 is also desirable for preventing leakage from thebag connector 73 when the bag is not connected to thecatheter portion 22 of thebowel management system 10. Anoutlet tube 82 is also provided for draining out the contents of the bag. It is preferred that thebag 60 be suitable for folding up because it is rather long; in order to prevent it from dragging on the floor.Clamp 76 carrying thebutton holster connector 78 is useful for sealing off collectionbag drain tube 82 by pinching it. Also,Cap 80, which is preferably attached to theholster 74 is useful for blocking the open tip (not shown) ofbag drain tube 82. - Another optional feature of the new bowel management system is the provision of a faceplate which would serve as a retention mechanism to prevent internal migration of the
bowel management system 10, as well as to prevent rotation of the trans-sphincter catheter section 20 of the device. Such afaceplate 41 can be mounted on thebridge section 52 as illustrated, inFIGS. 1 and 2 , as one useful example. The faceplate can take the form of a strap, wedge, donut, etc. and would preferably be made of silicone, foam or other soft material to avoid irritation of the patient's skin. -
FIGS. 1 and 2 also illustrate aclip assembly 21 for attachment of theassembly 10 to a sheet, bedclothes, etc. It is to be understood that the illustrated embodiment is merely one useful assembly for accomplishing this task. As shown, an elastomeric band surrounds a simple pinch clip for gripping fabric or other thin material for the purpose of holding the assembly in position. Other useful stabilizing devices are conceived. - Use of the New Bowel Management System:
- For insertion of
bowel management system 10 into a non-ambulatory patient it is preferred that the patient be in the left side down position, if possible, although other positions may be utilized if necessary due to the patient's clinical condition. The procedure for insertion is performed using recognized aseptic techniques as appropriate. - A device is selected with the appropriate trans-sphincter catheter section length, usually 4 cm for a female patient, or 6 cm for a male patient. And the rectum of the patient is examined to confirm no rectal impaction and to be sure that no lesions or strictures exist which would preclude use of the device. A 60 cc syringe is filled with 35 cc-40 cc water and a 30 cc syringe is filled with 20 cc water. The 30 cc syringe is attached to the intralumenal balloon connector and the
intralumenal balloon 38 is filled with the 20 cc's of fluid. - Lubricant is applied to patient proximal end of the device including the protruding
intralumenal balloon 38, the deflatedretention balloon 24 and the patient's anus. Using the protruding end of the intralumenal balloon as an introducer, the patient proximal end ofcatheter section 18 is guided through the anus and into the distal rectum. - The 60 cc syringe is attached to the
retention balloon connector 58 and theretention balloon 24 is inflated with the syringe contents (in this example, 35 cc-40 cc water). Thecatheter connector assembly 66 is connected to the wastecollection bag connector 73 andbag 60 is positioned at bedside so that thecatheter drainage tube 22 is not twisted or kinked. This allows for unobstructed fecal matter flow from thecatheter 22 intobag 60. - After the catheter system is inserted into the patient's rectum and connected to the drainage bag, the 30 cc syringe is used to completely aspirate the 20 cc of water (or air) from
intralumenal balloon 38. The 30 cc syringe is disconnected from the intralumenal balloon connector. - Catheter/bowel lumenal patency is confirmed by performing the following procedure:
- The patient is placed in a slight head up position to promote drainage, the gravity irrigation or enteral feeding bag is filled with one liter of warm tap water and hung from an IV pole two to three feed above the height of patient's anus. The irrigation bag administration set is connected to the
catheter irrigation port 54. After the caretaker verifies the connection to the correct catheter port, gravity irrigation is begun. Large stool pieces are broken up by a combination of irrigating and manual douching (i.e. constricting outflow and squeezing the drainage tube repeatedly). Irrigation is discontinued when stool pieces are no longer present in the effluent. - Irrigation of the patient's rectum can be performed using a gravity bag or by using a syringe. In the gravity bag method it is necessary to provide a waste collection bag with at least two liters of available volume. A standard gravity irrigation or enteral feeding bag with pre-attached administration set is used to infuse about a liter of warm tap water into the patient's anus at a flow rate of about one liter in six to ten minutes. The irrigation bag administration set is connected to the catheter system irrigation port and the 30 cc syringe (filled with 20 cc of fluid) is attached to the intralumenal balloon connector and the
intralumenal balloon 38 is filled with the 20 cc's of fluid. - With the patient in a slight head down position the flow control valve on the irrigation bag set is opened and fluid is allowed to drain by gravity into the rectum and colon. If leakage occurs past the retention balloon during irrigation more water is injected into the retention balloon up to a maximum inflation volume of 50 cc.
- The infused irrigant is permitted to remain as long as prescribed by physician. Then the 20 cc volume of fluid with which the intralumenal balloon was inflated is removed via syringe and the mixed fluid and feces are allowed to drain out of the rectum and colon. If necessary, the patient's position is modified to slight head up. Once irrigation is complete the administration set is disconnected from the catheter irrigation port. Any additional fluid that was injected into the retention balloon is removed by syringe via the retention balloon connector. If necessary the retention balloon may be completely aspirated and refilled to normal use volume (about 35 to about 40 cc).
- If irrigation is performed using a syringe instead of a gravity bag preparations are similar, ensuring that sufficient space is available in the waste collection bag, and then a syringe is prepared with about 60 cc of warm tap water. A 30 cc syringe is prepared with about 20 cc of air or water and attached to the intralumenal balloon connector and the intralumenal balloon is inflated. The syringe is connected to the catheter irrigation port. With the patient in a slight head down position the irrigant is slowly injected into the rectum and colon. As with the gravity bag irrigation method, any leakage can be handled by further inflating the retention balloon. Similarly, irrigant is permitted to dwell for a prescribed time and then the fluid is aspirated from the intralumenal balloon with a syringe to allow drainage of fluid and feces out of the rectum and colon. If necessary the patient's position can be modified. Again, if extra fluid was introduced into the retention balloon it can now be released and the waste bag emptied if necessary.
- The system irrigation port can be useful for administering medications or enema solutions. In this case, the port is preferably flushed first with about 10 cc to about 20 cc of water before and after administration of enema/medication solution. A syringe is filled with the desired solution to be introduced and a 30 cc syringe is filled with about 20 cc of air or water. After inflating the intralumenal balloon, the solution is injected and the catheter irrigation lumen is flushed as indicated. The syringe is then disconnected from the irrigation port and the solution is permitted to dwell for the prescribed time. The intralumenal balloon is then deflated, preferably by use of a 30 cc syringe, as previously described.
- The flush/sampling port of the system can also be used to draw samples of fecal mater by use of a catheter tip syringe attached to the flush/sampling port. This can be very useful for monitoring a patient's progress and for testing purposes.
- In view of the foregoing, it will be seen that the several objects of the invention are achieved and other advantages are attained. Although the foregoing includes a description of the best mode contemplated for carrying out the invention various modifications are conceivable.
- As various modifications could be made in the constructions herein described and illustrated without departing from the scope of the invention it is intended that all matter contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative rather than limiting.
Claims (33)
1. A bowel management system comprising:
a first section of the catheter having a patient proximal opening that, when in position for normal use, is in a patient's rectum to receive bowel waste,
a second section of the catheter located distal to the first section that, when in position for normal use, can be collapsed by a patient's anal sphincter muscles;
the first section being sufficiently pliable to permit folding for insertion into a patient's rectum but following insertion permits flow of bowel waste through the patient proximal opening;
the second catheter section permitting passage of bowel waste from the patient and being sufficiently soft to permit retention within a patient's anal canal for extended periods of time; and
a retainer for retaining the patient proximal opening in a position for normal use where it opens into the rectum of the patient.
2. The bowel management system of claim 1 wherein the retainer is a balloon extending outward relative to the patient proximal opening for retaining the patient proximal opening in a position for normal use to permit passage of bowel waste through the patient proximal opening.
3. The bowel management system of claim 2 wherein the balloon is attached coaxially about and exteriorly of the first catheter section.
4. The bowel management system of claim 2 wherein the balloon has an inflated size so as to be sufficiently large to retain the patient proximal opening of the first catheter section in a position for normal use where it opens into the rectum of a patient without being so large as to trigger a defecatory response in the patient.
5. The bowel management system of claim 2 further including a lumened member substantially smaller in diameter than the first catheter section and having a first end in communication with the balloon and a second end connectable to a port for introduction or removal of a fluid to or from the balloon.
6. The bowel management system of claim 5 including a second lumened member substantially smaller in diameter than the first catheter section and having a first end in communication with a patient's rectum and a second end connected to an irrigation port for administering substances.
7. The bowel management system of claim 6 wherein the administered substances include at least one of a medication or an enema solution.
8. The bowel management system of claim 2 wherein the balloon has an inflated volume of about 44 cc to about 69 cc.
9. The bowel management system of claim 2 wherein the balloon has an inflated length to diameter ratio in the range of about 0.75 to about 0.61.
10. The bowel management system of claim 1 further comprising a third catheter section positioned distal to the second catheter section and coated internally with a substance to facilitate passage of bowel waste.
11. The bowel management system of claim 1 wherein at least one of the first catheter section and the second catheter section includes silicone.
12. The bowel management system of claim 1 further comprising a third catheter section positioned distal to the second catheter section and coated externally with a substance to facilitate milking.
13. The bowel management system of claim 1 wherein the retainer includes a strap.
14. The bowel management system of claim 13 wherein the strap is provided on a faceplate, the faceplate being mountable to an exterior of a third catheter section positioned distal to the second catheter section.
15. The bowel management system of claim 1 and further comprising an intralumenal balloon mounted to an interior of the first catheter section.
16. A waste collection catheter having at least two sections for receiving, carrying and removing bowel waste from a patient, comprising:
a rectal catheter section having a patient proximal opening that, when in a position for normal use, opens into a patient's rectum to receive bowel waste;
the rectal catheter section being sufficiently pliable to permit folding longitudinally for ease of insertion into a patient's rectum while also being sufficiently stiff following insertion to maintain an open position in a patient's rectum for free flow of bowel waste through the patient proximal opening;
a trans-sphincter catheter section distal to the rectal catheter section that can be collapsed by a patient's anal sphincter muscles when in a position for normal use;
the trans-sphincter catheter section being sufficiently soft to be retained in a patient's anal canal for extended periods without distending a patient's anal sphincter muscles or otherwise causing discomfort and extending from internally of a patient, through the anal sphincter muscles, to externally of a patient; and
means for retaining the patient proximal opening of the rectal catheter section in a position for normal use where it opens into a patient's rectum.
17. The waste collection catheter of claim 16 wherein the rectal catheter section and the trans-sphincter catheter section are formed of the same material.
18. The waste collection catheter of claim 17 wherein the material includes silicone.
19. The waste collection catheter of claim 16 including means for receiving, carrying and removing bowel waste from a patient, said means being associated with the trans-sphincter catheter section externally of a patient and cooperating with the retaining means for maintaining the waste collection catheter in a position for normal use.
20. The waste collection catheter of claim 16 wherein the retaining means is an inflatable balloon extending radially outwardly of the patient proximal opening for retaining the patient proximal opening in a position for normal use in an open position for flow of bowel waste through the patient proximal opening.
21. The waste collection catheter of claim 20 wherein the balloon is attached coaxially about and exteriorly of the rectal catheter section.
22. The waste collection catheter of claim 20 wherein the balloon has an inflated size so as to be sufficiently large to retain the patient proximal opening of the rectal catheter section in a position for normal use where it opens into a patient's rectum without being so large as to trigger a defecatory response in a patient.
23. The waste collection catheter of claim 20 further including a lumened member substantially smaller in diameter than the rectal catheter section and having a first end in communication with the balloon and a second end connectable to a port for introduction or removal of a fluid to or from the balloon.
24. The waste collection catheter of claim 23 including a second lumened member substantially smaller in diameter than the rectal catheter section and having a first end in communication with a patient's rectum and a second end connected to an irrigation port for administering substances.
25. The waste collection catheter of claim 24 wherein the administered substances include at least one of a medication or an enema solution.
26. The waste collection catheter of claim 20 wherein the balloon has an inflated volume of about 44 cc to about 69 cc.
27. The waste collection catheter of claim 20 wherein the balloon has an inflated length to diameter ratio in the range of about 0.75 to about 0.61.
28. The waste collection catheter of claim 16 further comprising a third catheter section positioned in normal use distal to the trans-sphincter catheter section, coated internally with a substance to facilitate flow through of bowel waste.
29. The waste collection catheter of claim 28 wherein the third catheter section includes a connector for connection to a collection bag.
30. The waste collection catheter of claim 28 wherein the third catheter section is sufficiently soft to be milked to force fecal matter through the third catheter section to a collection bag.
31. The waste collection catheter of claim 28 wherein the retaining means is a strap provided on a faceplate mountable to an exterior of the third catheter section.
32. The waste collection catheter of claim 16 wherein at least one of the rectal catheter section and the trans-sphincteral section includes silicone.
33. The waste collection catheter of claim 16 further comprising an intralumenal balloon mounted to an interior of the rectal catheter section.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/553,731 US20070049878A1 (en) | 2002-08-21 | 2006-10-27 | Bowel management system |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/225,820 US7147627B2 (en) | 2002-08-21 | 2002-08-21 | Bowel management system |
US11/553,731 US20070049878A1 (en) | 2002-08-21 | 2006-10-27 | Bowel management system |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/225,820 Continuation US7147627B2 (en) | 2002-08-21 | 2002-08-21 | Bowel management system |
Publications (1)
Publication Number | Publication Date |
---|---|
US20070049878A1 true US20070049878A1 (en) | 2007-03-01 |
Family
ID=31887082
Family Applications (7)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/225,820 Expired - Fee Related US7147627B2 (en) | 2002-08-21 | 2002-08-21 | Bowel management system |
US11/413,388 Expired - Fee Related US7722583B2 (en) | 2002-08-21 | 2006-04-28 | Bowel management system and waste collection bag therefor |
US11/553,731 Abandoned US20070049878A1 (en) | 2002-08-21 | 2006-10-27 | Bowel management system |
US12/245,484 Abandoned US20090030387A1 (en) | 2002-08-21 | 2008-10-03 | Bowel management system and waste collection bag therefor |
US12/245,463 Abandoned US20090030386A1 (en) | 2002-08-21 | 2008-10-03 | Bowel management system and waste collection bag therefor |
US12/369,572 Expired - Fee Related US8323255B2 (en) | 2002-08-21 | 2009-02-11 | Bowel management system |
US13/098,162 Expired - Fee Related US8801683B2 (en) | 2002-08-21 | 2011-04-29 | Bowel management system |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/225,820 Expired - Fee Related US7147627B2 (en) | 2002-08-21 | 2002-08-21 | Bowel management system |
US11/413,388 Expired - Fee Related US7722583B2 (en) | 2002-08-21 | 2006-04-28 | Bowel management system and waste collection bag therefor |
Family Applications After (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/245,484 Abandoned US20090030387A1 (en) | 2002-08-21 | 2008-10-03 | Bowel management system and waste collection bag therefor |
US12/245,463 Abandoned US20090030386A1 (en) | 2002-08-21 | 2008-10-03 | Bowel management system and waste collection bag therefor |
US12/369,572 Expired - Fee Related US8323255B2 (en) | 2002-08-21 | 2009-02-11 | Bowel management system |
US13/098,162 Expired - Fee Related US8801683B2 (en) | 2002-08-21 | 2011-04-29 | Bowel management system |
Country Status (11)
Country | Link |
---|---|
US (7) | US7147627B2 (en) |
EP (3) | EP2404630A3 (en) |
JP (4) | JP4260107B2 (en) |
AT (1) | ATE538823T1 (en) |
AU (3) | AU2003207608B2 (en) |
BR (1) | BR0305770A (en) |
CA (2) | CA2462570C (en) |
DE (1) | DE20321872U1 (en) |
DK (1) | DK1531884T3 (en) |
MX (1) | MXPA04003529A (en) |
WO (1) | WO2004018022A1 (en) |
Cited By (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2009015152A1 (en) * | 2007-07-22 | 2009-01-29 | C.R. Bard, Inc. | Waste management system |
US20090216206A1 (en) * | 2006-10-17 | 2009-08-27 | C. R. Bard, Inc. | Waste Management System |
WO2010057208A1 (en) | 2008-11-17 | 2010-05-20 | C. R. Bard, Inc. | Waste management system |
US20100234821A1 (en) * | 2007-10-30 | 2010-09-16 | Henrik Bork Bjerregaard | Intestinal irrigation device and method of using the device |
US20110015475A1 (en) * | 2009-07-14 | 2011-01-20 | Stimatix Gl Ltd. | Inflatable stomal implant |
WO2011138728A2 (en) | 2010-05-02 | 2011-11-10 | Stimatix Gi Ltd. | Ostomy port |
US8821465B2 (en) | 2009-07-14 | 2014-09-02 | Stimatix Gi Ltd. | Disposable ostomy assemblies |
US8998862B2 (en) | 2009-07-14 | 2015-04-07 | B. Braun Medical Sas | Ostomy containment device |
US9345612B2 (en) | 2012-05-10 | 2016-05-24 | B. Braun Medical Sas | Ostomy appliance |
USD783814S1 (en) | 2013-12-09 | 2017-04-11 | B. Braun Medical Sas | Adapter for flatus release |
USD796029S1 (en) | 2013-12-09 | 2017-08-29 | B. Braun Medical Sas | Colostomy appliance |
US11291579B2 (en) | 2013-05-09 | 2022-04-05 | B. Braun Medical Sas | Gas filter and release for ostomy appliance |
US11666696B2 (en) | 2019-03-25 | 2023-06-06 | Ellen McGrath | Enterostomy drainage methods and devices |
USD1012280S1 (en) | 2018-11-30 | 2024-01-23 | B. Braun Medical Sas | Ostomy device assembly |
Families Citing this family (84)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7361170B2 (en) | 2001-11-21 | 2008-04-22 | E-Z-Em, Inc. | Device, system, kit or method for collecting effluent from an individual |
US7147627B2 (en) | 2002-08-21 | 2006-12-12 | Hollister Incorporated | Bowel management system |
US7097637B2 (en) | 2003-08-27 | 2006-08-29 | C. R. Bard, Inc. | Safety needle with positive flush |
AU2011203584B2 (en) * | 2003-09-09 | 2013-07-11 | Convatec Technologies Inc. | Fecal management appliance and method and apparatus for introducing same |
US8016816B2 (en) | 2003-09-09 | 2011-09-13 | Convatec Technologies Inc. | Fecal management appliance and method and apparatus for introducing same |
US7727188B2 (en) | 2003-12-17 | 2010-06-01 | Convatec Technologies Inc. | Balloon catheter with positioning pocket |
US8079947B2 (en) * | 2004-07-26 | 2011-12-20 | Stillwagon Gary B | Internal radiation therapy device |
US20060025729A1 (en) * | 2004-07-30 | 2006-02-02 | Leiboff Arnold R | Transanal colorectal irrigators |
US8353860B2 (en) * | 2004-09-30 | 2013-01-15 | Boston Scientific Scimed, Inc. | Device for obstruction removal with specific tip structure |
US8075540B2 (en) * | 2004-11-09 | 2011-12-13 | Hollister Incorporated | Bowel management system with physiologic sensors |
US20060271087A1 (en) * | 2005-05-25 | 2006-11-30 | Bowel Management Systems, Llc | Fixed-volume inflation system for balloon catheters |
US7806850B2 (en) | 2005-10-24 | 2010-10-05 | Bracco Diagnostics Inc. | Insufflating system, method, and computer program product for controlling the supply of a distending media to an endoscopic device |
US20070149922A1 (en) * | 2005-12-28 | 2007-06-28 | Bowel Management Systems, Llc | Combined fixed volume retention cuff and relief valve |
AU2013202212B2 (en) * | 2006-10-17 | 2015-10-29 | C.R. Bard, Inc. | Waste management system |
US8323254B2 (en) * | 2006-10-26 | 2012-12-04 | Convatec Technologies, Inc. | Silicone based tube for transporting malodoriforous matter from the human body |
EP1946786A1 (en) * | 2007-01-19 | 2008-07-23 | Coloplast A/S | An irrigation system with a pump |
US8936583B2 (en) | 2007-09-28 | 2015-01-20 | Hollister Incorporated | Multi-layer catheter tubes with odor barrier |
US8734411B2 (en) | 2007-09-28 | 2014-05-27 | Hollister Incorporated | Multi-layer odor barrier tube, and combination odor barrier tube and odor barrier collection bag |
US8603029B2 (en) * | 2007-10-10 | 2013-12-10 | Hospi Corporation | Apparatuses and methods for medication administration |
EP3231402B1 (en) * | 2007-10-12 | 2021-09-29 | Implantica Patent Ltd. | Intestine stomy pump external |
EP2209416A4 (en) | 2007-10-15 | 2014-05-14 | Univ Maryland | Apparatus and method for use in analyzing a patient's bowel |
EP2211969A1 (en) * | 2007-11-13 | 2010-08-04 | University of Maryland, Baltimore | Apparatus and method for automating an enema with controlled distension |
US8529497B2 (en) * | 2007-12-04 | 2013-09-10 | Jae-Hwang Kim | Apparatus and method for controlling fecal diverting device |
WO2009131992A1 (en) * | 2008-04-22 | 2009-10-29 | Bristol-Myers Squibb Company | Temporary ostomy appliance |
AU2009242503B2 (en) * | 2008-05-01 | 2014-11-20 | Convatec Technologies Inc. | Rectal drain appliance |
US9744069B2 (en) | 2008-05-29 | 2017-08-29 | Advanced Medical Balloons Gmbh | Device for stool drainage |
ES2710359T3 (en) * | 2008-05-29 | 2019-04-24 | Advanced Medical Balloons Gmbh | Device for stool drainage |
US20090326490A1 (en) * | 2008-06-30 | 2009-12-31 | Mcmichael Donald Jay | Fecal incontinence collection device and method of use |
US9775980B2 (en) | 2008-09-23 | 2017-10-03 | Hospi Corporation | Valved enteral administration assembly |
US8092436B2 (en) * | 2008-10-17 | 2012-01-10 | Sterigear LLC | Bodily fluid drainage assembly |
WO2010045042A2 (en) | 2008-10-17 | 2010-04-22 | Sterigear LLC | Bodily fluid drainage assembly |
DE202009004536U1 (en) * | 2009-03-25 | 2010-08-12 | Marx, Karl-Heinz | Set for the creation of an artificial stomach entrance |
ITBO20090250A1 (en) * | 2009-04-22 | 2010-10-23 | Med Europ Europ Medical Supplie S S R L | KIT FOR WASHING ANATOMICAL DUCTS, OF THE TYPE OF INTESTINE AND SIMILAR. |
US8480640B2 (en) * | 2009-05-22 | 2013-07-09 | Robert J. Santimaw | Noninvasive bodily waste collection system and methods of use |
WO2011116108A1 (en) | 2010-03-16 | 2011-09-22 | Pelvalon, Inc. | Intra-vaginal device for fecal incontinence |
US9289278B2 (en) | 2010-03-16 | 2016-03-22 | Pelvalon, Inc. | Intra-vaginal devices and methods for treating fecal incontinence |
US8016802B1 (en) * | 2010-04-12 | 2011-09-13 | Schena Kenneth R | Method, apparatus and system for ostomy bag irrigation |
BR112013012846B1 (en) | 2010-11-24 | 2020-12-08 | Bracco Diagnostics Inc | insufflation system |
CN103370016B (en) | 2010-12-15 | 2016-10-19 | 科洛戈德有限公司 | For bypassing the system and method for anastomotic position |
EP2686031B1 (en) | 2011-03-17 | 2020-02-12 | ConvaTec Technologies Inc. | High barrier elastomer fecal catheter of ostomy pouch |
FR2978345B1 (en) | 2011-07-25 | 2013-08-30 | Charam Khosrovaninejad | SURGICAL DEVICE FOR ANCHOR CONTROL IN INTESTINES. |
GB201115160D0 (en) | 2011-09-02 | 2011-10-19 | Trio Healthcare Ltd | Discharge solidifier and malodour control |
WO2013044239A2 (en) | 2011-09-22 | 2013-03-28 | Pelvalon, Inc. | Intra-vaginal devices and methods for treating fecal incontinence |
AU2013200357B2 (en) | 2012-01-27 | 2014-09-18 | Hollister Incorporated | Multi-layer catheter tubes with odor barrier |
FR3001635B1 (en) * | 2013-02-05 | 2015-02-20 | Chru Lille | DEVICE FOR ALIMENTARY BOWL FLOW BETWEEN TWO STOMIES |
WO2014127295A1 (en) | 2013-02-14 | 2014-08-21 | Pelvalon, Inc. | Intra-vaginal devices and methods for treating fecal incontinence |
WO2014153077A1 (en) | 2013-03-14 | 2014-09-25 | Hollister Corporation | Bodily fluid collection devices, bodily fluid collection systems, and methods for removing bodily fluids |
US20140276501A1 (en) | 2013-03-14 | 2014-09-18 | Hollister Incorporated | Three-Dimensional Adhesive Patch |
CN103405297A (en) * | 2013-08-27 | 2013-11-27 | 林建江 | Complete flow turning type intestinal fistulization tube |
JP6407513B2 (en) * | 2013-09-24 | 2018-10-17 | 国立大学法人 東京大学 | Polymer for surface modification of medical materials |
US9993250B2 (en) * | 2013-12-19 | 2018-06-12 | Kyungpook National University Industry-Academic Cooperation Foundation | Device for protecting the rectal anastomosis |
WO2015117141A1 (en) | 2014-02-03 | 2015-08-06 | Hollister Incorporated | Inflationless retention cuff for fluid collection devices |
EP3206634B1 (en) | 2014-10-14 | 2019-07-03 | Colospan Ltd. | Apparatus for delivering a device to a hollow organ |
US11426302B2 (en) | 2014-11-03 | 2022-08-30 | Fistula Solution Corporation | Containment devices for treatment of intestinal fistulas and complex wounds |
JP6042948B2 (en) * | 2015-03-31 | 2016-12-14 | 国立研究開発法人国立がん研究センター | Transanal drain device |
CN108271347B (en) * | 2015-09-15 | 2021-04-20 | 萨维奇医疗股份有限公司 | Device and method for anchoring a sheath in a tissue cavity |
AU2016371351B2 (en) | 2015-12-17 | 2021-10-21 | Coloplast A/S | Emergency stop for a system and a method for anal and/or stomal irrigation |
CN105435323A (en) * | 2015-12-30 | 2016-03-30 | 夏周阳 | Operation flushing device for general surgery department |
KR20180102141A (en) | 2016-01-19 | 2018-09-14 | 윌마크 홀딩스, 엘엘씨 | A connector system for detachably connecting a fluid conduit |
US10022108B2 (en) | 2016-01-27 | 2018-07-17 | Elizabeth P. Ohler | Bowel care collection bag |
AU2017248237B2 (en) | 2016-04-08 | 2021-10-28 | Hollister Incorporated | Fecal collection device, system and method |
EP3481460B1 (en) | 2016-07-08 | 2020-05-13 | Hollister Incorporated | Wireless electronic pump design for a body cavity irrigation device |
WO2018009818A1 (en) | 2016-07-08 | 2018-01-11 | Hollister Incorporated | Body cavity irrigation integrated manual controller and pump device, system and method |
USD833011S1 (en) * | 2016-10-31 | 2018-11-06 | Dariush Nazarinasab | Surgical instrument |
EP3534863A1 (en) | 2016-11-03 | 2019-09-11 | Hollister Incorporated | Adjustable bowel treatment arm |
CN106512111B (en) * | 2016-11-22 | 2019-09-27 | 浙江省人民医院 | Intestinal tube interface arrangement and its accommodating device in art |
LT3554580T (en) | 2016-12-14 | 2020-11-25 | Hollister Incorporated | Transanal irrigation device and system |
US10271824B2 (en) * | 2017-08-14 | 2019-04-30 | Nooshin Jalili | Rectum gas passage analyzer |
WO2019038791A1 (en) * | 2017-08-22 | 2019-02-28 | Gnali Bocia S.R.L. | Cannula group for irrigation through natural body orifices, device and handle kit |
IT201700118289A1 (en) * | 2017-10-19 | 2019-04-19 | Sapi Med S P A | LIQUID INJECTOR FOR INTESTINAL CLISM |
FR3072557B1 (en) | 2017-10-19 | 2019-11-08 | Safeheal | COMPLEX SURGICAL DEVICE FOR THE PRODUCTION AND PROTECTION OF ANASTOMOSIS |
US11529154B2 (en) | 2018-08-08 | 2022-12-20 | Wilmarc Holdings, Llc | Stool management system |
US11839528B2 (en) | 2018-10-22 | 2023-12-12 | Medline Industries, Lp | Drypad with rapid absorption and liquid removal |
US11207097B2 (en) | 2019-02-13 | 2021-12-28 | Andrew Thomas Obst | Fluid management device for medical tubes and drainage incisions |
EP3946503A4 (en) | 2019-04-01 | 2023-03-15 | Sterigear LLC | Dual drainage bag, assemblies, and related methods |
US11523932B2 (en) | 2019-06-26 | 2022-12-13 | Andrew Thomas Obst | Enteric fistula, rectovaginal fistula, and ostomy effluent containment system, and devices and methods thereof |
US11103260B2 (en) * | 2019-07-18 | 2021-08-31 | Medline Industries, Inc. | Fecal impaction removal device |
US20210161701A1 (en) * | 2019-11-09 | 2021-06-03 | Airway Medix S.A. | Bowel waste management systems and methods for use |
DK202070353A1 (en) * | 2020-06-03 | 2022-01-14 | Mbh International As | An enema nozzle, and an enema device comprising said enema nozzle |
KR102389248B1 (en) * | 2020-07-08 | 2022-04-20 | 인제대학교 산학협력단 | Stoma bag for new born baby |
US20220047303A1 (en) * | 2020-08-17 | 2022-02-17 | Ebr Systems, Inc. | Systems and methods for delivering stimulation electrodes to endocardial or other tissue |
CN112057730B (en) * | 2020-10-10 | 2022-09-23 | 杜军 | Blocking type catheter fistulization external member |
US11103377B1 (en) | 2021-03-31 | 2021-08-31 | Lumopol, Llc | Irising drainage device and irising rectal catheter |
CN113289114A (en) * | 2021-06-28 | 2021-08-24 | 南通市第一人民医院 | Intestinal tract flushing device |
Citations (30)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US565531A (en) * | 1896-08-11 | Island | ||
US2457244A (en) * | 1943-06-22 | 1948-12-28 | Otis F Lamson | Medical appliance for control of enemata |
US2494393A (en) * | 1949-02-05 | 1950-01-10 | Otis F Lamson | Removable appliance for use as an artificial dam in cases of rectal incontinence |
US2813531A (en) * | 1955-09-26 | 1957-11-19 | Albert F Lee | Cannula |
US3459175A (en) * | 1966-04-08 | 1969-08-05 | Roscoe E Miller | Medical device for control of enemata |
US3548828A (en) * | 1968-06-14 | 1970-12-22 | John J Vasile | Excrement collecting appliance |
US3565386A (en) * | 1969-02-19 | 1971-02-23 | Gen Motors Corp | Mount for a body and coupling unit therefor |
US3938521A (en) * | 1972-06-22 | 1976-02-17 | M.E.D.S. Corporation | Collecting bag |
US4019515A (en) * | 1975-12-08 | 1977-04-26 | Daniel Kornblum | Enemata administering device |
US4030500A (en) * | 1974-12-16 | 1977-06-21 | Hadar Yngve Ronnquist | Fecal matter collector |
US4117847A (en) * | 1976-02-05 | 1978-10-03 | Clayton Ralph S | Colon catheter |
US4403982A (en) * | 1978-08-28 | 1983-09-13 | Clayton Ralph S | Colon cleansing system and technique |
US4496356A (en) * | 1982-09-29 | 1985-01-29 | Leon Lognion | Anal excretion collecting rectal catheter |
US4637814A (en) * | 1985-04-05 | 1987-01-20 | Arnold Leiboff | Method and apparatus for intestinal irrigation |
US4686985A (en) * | 1985-05-15 | 1987-08-18 | Lottick Edward A | Anal dilator and occluder |
US5342321A (en) * | 1993-05-18 | 1994-08-30 | Teleflex, Inc. | Low profile gastrostomy catheter |
US5520669A (en) * | 1994-07-19 | 1996-05-28 | Mulholland; Kevin J. | Intra-rectal drain and receptacle for fecal incontinence |
US5569216A (en) * | 1993-12-02 | 1996-10-29 | Kim; Jae H. | Multipurpose colostomy device having balloons on an end thereof |
US5766209A (en) * | 1993-02-19 | 1998-06-16 | Devonec; Marian A. | Prosthesis intended for the treatment of a natural lumen or tract, in particular an endo-urethral prosthesis |
US5782745A (en) * | 1995-11-13 | 1998-07-21 | Benderev; Theodore V. | Devices and methods for assessment and treatment of urinary and fecal incontinence |
US5904701A (en) * | 1994-02-14 | 1999-05-18 | Daneshvar; Yousef | Device for aiding procedural and therapeutic interventions of the gastrointestinal tract |
US5941860A (en) * | 1997-11-03 | 1999-08-24 | Wheeler; Alton D. | Fecal pouch and installation |
US5997546A (en) * | 1999-01-07 | 1999-12-07 | Ballard Medical Products | Gastric balloon catheter with improved balloon orientation |
US6342052B1 (en) * | 1999-11-02 | 2002-01-29 | Hector D. Allende | Anorectal apparatus |
US6468245B2 (en) * | 1996-11-27 | 2002-10-22 | Colorplast A/S | Irrigation device |
US20020173771A1 (en) * | 2001-05-17 | 2002-11-21 | La Tapachulteca Ii | Lesion restoration catheter for the colon and method for using same |
US6527755B1 (en) * | 2001-04-20 | 2003-03-04 | Fouad A. Salama | Feces control device |
US6716209B2 (en) * | 2002-02-22 | 2004-04-06 | Arnold Robert Leiboff | Loop ostomy device and methods for its use |
US6719709B2 (en) * | 2000-08-31 | 2004-04-13 | Abbeymoor Medical, Inc. | Diagnostic urethral assembly and method |
US20060189951A1 (en) * | 2002-08-21 | 2006-08-24 | Kim Jae H | Bowel management system and waste collection bag therefor |
Family Cites Families (167)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US594860A (en) * | 1897-12-07 | Apparatus for milking cows | ||
US565386A (en) * | 1896-08-04 | Rectal irrigating-dilator | ||
US2509884A (en) * | 1947-05-24 | 1950-05-30 | Hercules Powder Co Ltd | Tall oil treatment |
US3154077A (en) | 1962-06-04 | 1964-10-27 | Joseph P Cannon | Hemostatic device for anal surgery |
US3482576A (en) * | 1966-05-09 | 1969-12-09 | Kendall & Co | Easy deflatable retention catheter |
US3487837A (en) * | 1967-02-06 | 1970-01-06 | Roy A Petersen | Device for holding catheters in position |
US3509884A (en) * | 1967-09-13 | 1970-05-05 | William Bell | Rectal balloon catheter |
US3543744A (en) | 1968-11-29 | 1970-12-01 | Edwin Lepar | Equipment for administering enemas for radiological purposes |
US3802418A (en) * | 1971-02-16 | 1974-04-09 | R Clayton | Colon catheter |
US3884242A (en) * | 1971-03-29 | 1975-05-20 | Mpc Kurgisil | Catheter assembly |
US3766920A (en) * | 1971-07-21 | 1973-10-23 | Ezem Co | Enemata administering device |
US3726281A (en) | 1971-12-08 | 1973-04-10 | Bard Inc C R | Self-lubricating catheter |
US3828782A (en) * | 1972-04-10 | 1974-08-13 | S Polin | Temporary colostomy tube |
US3734100A (en) * | 1973-05-07 | 1973-05-22 | Medical Products Corp | Catheter tubes |
US3937224A (en) * | 1974-04-11 | 1976-02-10 | Uecker Ronald L | Colostomy catheter |
US3983879A (en) * | 1974-07-25 | 1976-10-05 | Western Acadia, Incorporated | Silicone catheter |
US3926705A (en) | 1974-07-25 | 1975-12-16 | Western Acadia | Silicone catheter and process for manufacturing same |
US4013077A (en) * | 1974-09-23 | 1977-03-22 | M.E.D.S. Corporation | Collecting device |
DE2447996A1 (en) | 1974-10-09 | 1976-04-22 | Hadar Y Roennqvist | Disposable sanitary faeces collection bag - includes disposable bag fitting into soft plastics tube constricted in centre |
GB1522391A (en) | 1975-02-12 | 1978-08-23 | Silvanov B | Method and apparatus for collecting human waste matter |
JPS5211435Y2 (en) * | 1975-03-25 | 1977-03-12 | ||
US4121589A (en) * | 1975-08-06 | 1978-10-24 | Mcdonnell Roy Edward | Ostomy appliance |
DE2643700A1 (en) | 1975-10-01 | 1977-04-14 | Ralph Stuart Clayton | CATHETER FOR FAST INTESTINE |
US4057065A (en) | 1976-06-21 | 1977-11-08 | Dow Corning Corporation | Percutaneous gastrointestinal tube |
US4182332A (en) * | 1978-02-17 | 1980-01-08 | Delaney Richard P | Rectal catheter |
US4381008A (en) | 1978-09-08 | 1983-04-26 | Johnson & Johnson | Methods of improving surface characteristics of extruded thermoplastic tubing and products produced thereby |
US4285341A (en) * | 1978-11-22 | 1981-08-25 | Pollack Charles N | Extracorporeal cannula apparatus with retractable intralumenal balloon and method for using same |
US4257421A (en) | 1979-01-10 | 1981-03-24 | Health Development Corporation | Gastro-intestinal tube guide and stiffener |
US4368739A (en) * | 1979-07-18 | 1983-01-18 | Nelson Jr Richard L | Long intestinal catheter |
US4381765A (en) * | 1981-04-02 | 1983-05-03 | Waters Instruments, Inc. | Ileostomy valve |
US4344434A (en) * | 1981-06-01 | 1982-08-17 | Santa Barbara Medical Foundation Clinic | Ileostomy appliance and method for implanting the same |
US4586927A (en) * | 1981-08-17 | 1986-05-06 | E. R. Squibb & Sons, Inc. | Irrigation sleeve and attachment therefor |
US4516578A (en) * | 1982-09-30 | 1985-05-14 | Luther Shuffield | Rectal device and method of inserting same |
US4471782A (en) * | 1982-09-30 | 1984-09-18 | Luther Shuffield | Medical implement for use in rectum and method for inserting same |
WO1984001513A1 (en) | 1982-10-08 | 1984-04-26 | David Hardcastle | Balloon catheter and process for the manufacture thereof |
FR2554353B2 (en) | 1982-11-17 | 1986-07-25 | David Noel | IMPROVEMENT TO RECTAL PROBES FOR BARYTES |
US4525156A (en) | 1983-02-16 | 1985-06-25 | Benusa John E | Method for stomach lavage |
US4583983A (en) * | 1983-10-25 | 1986-04-22 | Einhorn Carol J | Female urinary drainage device |
US4662890A (en) * | 1984-10-09 | 1987-05-05 | Waters Instruments, Inc. | Tubular medical prosthesis |
US4596554A (en) * | 1985-04-19 | 1986-06-24 | Dastgeer Ghulam M | Colo-rectal evacuator |
US4750902A (en) * | 1985-08-28 | 1988-06-14 | Sonomed Technology, Inc. | Endoscopic ultrasonic aspirators |
US4750488A (en) * | 1986-05-19 | 1988-06-14 | Sonomed Technology, Inc. | Vibration apparatus preferably for endoscopic ultrasonic aspirator |
IL78756A0 (en) * | 1986-05-12 | 1986-08-31 | Biodan Medical Systems Ltd | Catheter and probe |
JPH0728885B2 (en) | 1986-05-30 | 1995-04-05 | 株式会社メデイコン | Urine collection |
US4676778A (en) * | 1986-10-27 | 1987-06-30 | Nelson Jr Richard L | Long intestinal catheter with sump |
CA1264132A (en) | 1987-01-06 | 1990-01-02 | Gloria Ouellette | Colonic irrigator |
US4813422A (en) * | 1987-03-06 | 1989-03-21 | Healthcare Technological Resources, Inc. | Bowel control probe and method for controlling bowel incontinence |
US4826481A (en) * | 1987-05-27 | 1989-05-02 | Abbott Labs. | Enteral feeding device |
US4850986A (en) | 1987-09-18 | 1989-07-25 | Midwest Medical Co. | Incontinence device |
US5057073A (en) * | 1988-04-21 | 1991-10-15 | Vas-Cath Incorporated | Dual lumen catheter |
US4986822A (en) * | 1988-09-06 | 1991-01-22 | Anderson Irvin B | Rectal-colon dilator and collector assembly |
CA1329080C (en) | 1988-09-22 | 1994-05-03 | Aegis Medical, Inc. | Rectal insertion device and control valve means therefor |
US5053023A (en) * | 1988-10-25 | 1991-10-01 | Vas-Cath Incorporated | Catheter for prolonged access |
JPH02255155A (en) | 1989-03-30 | 1990-10-15 | Ogita Kazuhide | External urethral opening fixing type catheter to be retained in bladder |
US5041100A (en) * | 1989-04-28 | 1991-08-20 | Cordis Corporation | Catheter and hydrophilic, friction-reducing coating thereon |
CA1335777C (en) * | 1989-05-08 | 1995-06-06 | John E. Temple | Incontinence bag |
US4957486A (en) * | 1989-10-02 | 1990-09-18 | Davis Emsley A | Rectal-stomal insert apparatus and method |
US5295984A (en) * | 1989-12-07 | 1994-03-22 | Ultrafem, Inc. | Vaginal discharge collection device and intravaginal drug delivery system |
JPH0417161Y2 (en) | 1989-12-29 | 1992-04-16 | ||
US5098379A (en) | 1990-01-10 | 1992-03-24 | Rochester Medical Corporation | Catheter having lubricated outer sleeve and methods for making and using same |
US5269770A (en) | 1990-01-10 | 1993-12-14 | Rochester Medical Corporation | Microcidal agent releasing catheter with balloon |
JPH0515313Y2 (en) * | 1990-04-02 | 1993-04-22 | ||
FR2660561B1 (en) * | 1990-04-06 | 1994-05-13 | Technomed International | RECTAL PROBE. |
FR2660556B1 (en) | 1990-04-06 | 1994-09-16 | Rhone Poulenc Sante | MICROSPHERES, THEIR PREPARATION PROCESS AND THEIR USE. |
GB2243553B (en) | 1990-04-30 | 1994-03-09 | Squibb & Sons Inc | Rectal block |
JPH0422749Y2 (en) * | 1990-05-16 | 1992-05-26 | ||
JP3019990B2 (en) | 1990-06-15 | 2000-03-15 | 株式会社ジーシー | Dental unit |
US5279596A (en) * | 1990-07-27 | 1994-01-18 | Cordis Corporation | Intravascular catheter with kink resistant tip |
US5261898A (en) * | 1990-11-13 | 1993-11-16 | Polin Stanton G | Temporary colostomy apparatus |
US5080650A (en) * | 1991-01-28 | 1992-01-14 | Abbott Laboratories | Gastrostomy tube |
US5183464A (en) | 1991-05-17 | 1993-02-02 | Interventional Thermodynamics, Inc. | Radially expandable dilator |
CA2082315C (en) | 1991-11-13 | 1997-03-18 | Harold I. Pearsall | Catheter |
JP3071301B2 (en) | 1992-04-08 | 2000-07-31 | 新日本製鐵株式会社 | Evaluation method for liquefaction reaction activity of catalyst for coal liquefaction |
US5209726A (en) | 1992-05-04 | 1993-05-11 | Goosen Carl C | Self-lubricating urethral catheter and method for self-catheterization |
US5399164A (en) | 1992-11-02 | 1995-03-21 | Catheter Imaging Systems | Catheter having a multiple durometer |
KR960005818Y1 (en) | 1992-10-30 | 1996-07-16 | 우석형 | Paper guide fixing device |
JPH06197977A (en) | 1992-12-28 | 1994-07-19 | Japan Medical Dynamic Marketing Inc | Catheter |
CA2114697C (en) | 1993-02-08 | 2006-06-13 | Kenichi Shimura | Medical tool having lubricious surface in a wetted state and method for production thereof |
KR960005818B1 (en) | 1993-02-11 | 1996-05-01 | 김재황 | Catheter |
US6576008B2 (en) * | 1993-02-19 | 2003-06-10 | Scimed Life Systems, Inc. | Methods and device for inserting and withdrawing a two piece stent across a constricting anatomic structure |
WO1994023786A1 (en) | 1993-04-13 | 1994-10-27 | Boston Scientific Corporation | Prosthesis delivery system |
CN2174997Y (en) | 1993-04-26 | 1994-08-24 | 许如良 | Multi-purpose drainage tube for anal and bowels |
US5454798A (en) | 1993-05-14 | 1995-10-03 | Mentor Corporation | Disposable urine bag |
US5423764A (en) * | 1993-06-14 | 1995-06-13 | Fry; William A. | Lavage apparatus |
US5545149A (en) * | 1993-06-25 | 1996-08-13 | Medtronic, Inc. | Method of catheter segment attachment |
US5417657A (en) | 1993-10-06 | 1995-05-23 | Hauer; Carolyn | No-sepsis urinary drainage catheter |
US5425710A (en) | 1993-10-26 | 1995-06-20 | Medtronic, Inc. | Coated sleeve for wrapping dilatation catheter balloons |
US5538510A (en) | 1994-01-31 | 1996-07-23 | Cordis Corporation | Catheter having coextruded tubing |
US5911715A (en) * | 1994-02-14 | 1999-06-15 | Scimed Life Systems, Inc. | Guide catheter having selected flexural modulus segments |
US5569218A (en) * | 1994-02-14 | 1996-10-29 | Scimed Life Systems, Inc. | Elastic guide catheter transition element |
NL9401107A (en) * | 1994-07-01 | 1996-02-01 | Cordis Europ | Controlled bendable catheter. |
US5670558A (en) | 1994-07-07 | 1997-09-23 | Terumo Kabushiki Kaisha | Medical instruments that exhibit surface lubricity when wetted |
DE4436796C2 (en) * | 1994-07-15 | 2000-11-09 | Via Log Medikalprodukte Gmbh K | Closure means for closing a natural intestinal exit |
JP2844427B2 (en) | 1994-08-31 | 1999-01-06 | 重信 高根 | Method for producing rectal catheter |
US5509899A (en) | 1994-09-22 | 1996-04-23 | Boston Scientific Corp. | Medical device with lubricious coating |
US5624395A (en) | 1995-02-23 | 1997-04-29 | Cv Dynamics, Inc. | Urinary catheter having palpitatable valve and balloon and method for making same |
US6306144B1 (en) | 1996-11-01 | 2001-10-23 | Scimed Life Systems, Inc. | Selective coating of a balloon catheter with lubricious material for stent deployment |
US6406453B1 (en) * | 1995-04-26 | 2002-06-18 | Medtronic Xomed, Inc. | Composite ventilation tube |
JPH0938197A (en) * | 1995-07-25 | 1997-02-10 | Shigenobu Takane | Rectal catheter |
JP3297268B2 (en) * | 1995-09-28 | 2002-07-02 | テルモ株式会社 | catheter |
US5827304A (en) | 1995-11-16 | 1998-10-27 | Applied Medical Resources Corporation | Intraluminal extraction catheter |
US5860952A (en) * | 1996-01-11 | 1999-01-19 | C. R. Bard, Inc. | Corporeal access tube assembly and method |
US5697365A (en) | 1996-01-18 | 1997-12-16 | Pell; Donald M. | Endotracheal tube construction and method for intubating a patient |
BG62078B1 (en) | 1996-02-20 | 1999-02-26 | Traev Trajcho K | Rectal catheter |
GB9606012D0 (en) * | 1996-03-22 | 1996-05-22 | Brain Archibald Ian Jeremy | Laryngeal mask with gastric-drainage feature |
US5762996A (en) | 1996-04-15 | 1998-06-09 | Lucas; Daniel R. | Silicone balloon catheter |
US5785641A (en) * | 1996-05-08 | 1998-07-28 | Urocath Corporation | Male indwelling urethral catheter sizing system and insertion method |
US5807314A (en) * | 1996-10-11 | 1998-09-15 | Abbott Laboratories | Feeding tube and method for placing same |
CA2220285C (en) * | 1996-11-06 | 2006-10-03 | Archibald I.J. Brain | Endotracheal tube construction |
US5791036A (en) * | 1996-12-23 | 1998-08-11 | Schneider (Usa) Inc | Catheter transition system |
US5906605A (en) * | 1997-01-10 | 1999-05-25 | Cardiac Pathways Corporation | Torquable guiding catheter for basket deployment and method |
US5997517A (en) | 1997-01-27 | 1999-12-07 | Sts Biopolymers, Inc. | Bonding layers for medical device surface coatings |
US6132407A (en) * | 1997-02-06 | 2000-10-17 | C. R. Bard, Inc. | Outlet tube device for urinary drainage bag |
US5964732A (en) * | 1997-02-07 | 1999-10-12 | Abbeymoor Medical, Inc. | Urethral apparatus with position indicator and methods of use thereof |
US6050934A (en) | 1997-02-26 | 2000-04-18 | Cv Dynamics, Inc. | Urinary catheter having palpitatable discharge valve with protective shoulders |
CA2281885C (en) * | 1997-04-07 | 2007-10-30 | Cook Urological Inc. | Back-up retention member drainage catheter |
US6221467B1 (en) | 1997-06-03 | 2001-04-24 | Scimed Life Systems, Inc. | Coating gradient for lubricious coatings on balloon catheters |
US5971967A (en) * | 1997-08-19 | 1999-10-26 | Abbeymoor Medical, Inc. | Urethral device with anchoring system |
US5813531A (en) * | 1997-11-25 | 1998-09-29 | Kao; Jui-Chien | Tool box assembly |
SE9704712D0 (en) | 1997-12-17 | 1997-12-17 | Astra Ab | Medical device |
EP1049951A1 (en) * | 1997-12-22 | 2000-11-08 | Micrus Corporation | Variable stiffness fiber optic shaft |
US7008412B2 (en) * | 1998-01-06 | 2006-03-07 | Cathlogic, Inc. | Subcutaneous port catheter system and associated method |
US6228072B1 (en) | 1998-02-19 | 2001-05-08 | Percusurge, Inc. | Shaft for medical catheters |
US7087041B2 (en) * | 1998-02-25 | 2006-08-08 | Zassi Medical Evolutions, Inc. | Pad for use with continent ostomy port |
US6630215B1 (en) | 1998-03-09 | 2003-10-07 | Denki Kagaku Kogyo Kabushiki Kaisha | Medical Device |
US6090075A (en) | 1998-03-31 | 2000-07-18 | House; Jamie Glen | Disposable urinary catheterization assembly |
US6171296B1 (en) * | 1998-04-28 | 2001-01-09 | Microtherapeutics, Inc. | Flow directed catheter |
CN2325054Y (en) | 1998-04-30 | 1999-06-23 | 关怀敏 | Balloon catheter anal canal |
US5941669A (en) * | 1998-06-18 | 1999-08-24 | Southco, Inc. | Jack-out captivated screw |
WO2000003756A1 (en) * | 1998-07-16 | 2000-01-27 | Mark Cohen | Reinforced variable stiffness tubing |
GB9821771D0 (en) * | 1998-10-06 | 1998-12-02 | Brain Archibald Ian Jeremy | Improvements relating to laryngeal mask airway devices |
JP2000167041A (en) | 1998-12-02 | 2000-06-20 | Shigenobu Takane | Defacation device |
US6413228B1 (en) * | 1998-12-28 | 2002-07-02 | Pro Duct Health, Inc. | Devices, methods and systems for collecting material from a breast duct |
US6585705B1 (en) * | 1999-01-15 | 2003-07-01 | Maginot Catheter Technologies, Inc. | Retractable catheter systems |
US6743218B2 (en) * | 1999-01-15 | 2004-06-01 | Cathlogic, Inc. | Retractable catheter systems and associated methods |
US6475207B1 (en) * | 1999-01-15 | 2002-11-05 | Maginot Catheter Technologies, Inc. | Retractable catheter systems and associated methods |
US6171295B1 (en) * | 1999-01-20 | 2001-01-09 | Scimed Life Systems, Inc. | Intravascular catheter with composite reinforcement |
US6340465B1 (en) | 1999-04-12 | 2002-01-22 | Edwards Lifesciences Corp. | Lubricious coatings for medical devices |
US6176849B1 (en) | 1999-05-21 | 2001-01-23 | Scimed Life Systems, Inc. | Hydrophilic lubricity coating for medical devices comprising a hydrophobic top coat |
JP3477398B2 (en) | 1999-06-15 | 2003-12-10 | 株式会社精工タカネ | Rectal catheter and contrast agent enema device |
US6238383B1 (en) | 1999-07-20 | 2001-05-29 | Medical Device Solutions | Apparatus and method to facilitate intermittent self-catheterization by a user |
SE9903613D0 (en) * | 1999-10-06 | 1999-10-06 | Astra Ab | Rectal insertion device |
US7179849B2 (en) | 1999-12-15 | 2007-02-20 | C. R. Bard, Inc. | Antimicrobial compositions containing colloids of oligodynamic metals |
JP2001238956A (en) * | 1999-12-24 | 2001-09-04 | Toray Ind Inc | Catheter with balloon |
JP2001276228A (en) * | 2000-01-24 | 2001-10-09 | Toray Ind Inc | Catheter with balloon |
JP3071301U (en) | 2000-02-25 | 2000-08-29 | 株式会社オーセンティックスインターナショナル | Catheter for draining feces |
US7011622B2 (en) | 2000-03-15 | 2006-03-14 | Ams Research Corporation | Parylene coated components for artificial sphincters |
US6881209B2 (en) * | 2000-05-25 | 2005-04-19 | Cook Incorporated | Medical device including unitary, continuous portion of varying durometer |
US6743219B1 (en) * | 2000-08-02 | 2004-06-01 | Cordis Corporation | Delivery apparatus for a self-expanding stent |
JP4705715B2 (en) * | 2000-09-29 | 2011-06-22 | クリエートメディック株式会社 | Balloon catheter |
JP2002126094A (en) | 2000-10-24 | 2002-05-08 | Terumo Corp | Connector system |
US6663614B1 (en) | 2000-11-06 | 2003-12-16 | Advanced Cardiovascular Systems, Inc. | Catheter shaft having variable thickness layers and method of making |
US6682555B2 (en) | 2000-11-13 | 2004-01-27 | Wit Ip Corporation | Methods for treating the prostate and inhibiting obstruction of the prostatic urethra using biodegradable stents |
JP3639522B2 (en) * | 2000-11-22 | 2005-04-20 | クリエートメディック株式会社 | Rectal catheter |
JP3639523B2 (en) | 2000-11-22 | 2005-04-20 | クリエートメディック株式会社 | Rectal catheter |
US6575934B2 (en) * | 2000-12-21 | 2003-06-10 | Advanced Cardiovascular Systems, Inc. | Low profile catheter |
US6814718B2 (en) * | 2001-01-09 | 2004-11-09 | Rex Medical, L.P | Dialysis catheter |
ITTO20010274A1 (en) | 2001-03-23 | 2002-09-23 | Fiat Ricerche | CONTROLLED SHUTTER, WITH VARIABLE SECTION. |
US7077841B2 (en) * | 2001-03-26 | 2006-07-18 | Curon Medical, Inc. | Systems and methods employing a guidewire for positioning and stabilizing external instruments deployed within the body |
CN2489797Y (en) | 2001-04-20 | 2002-05-08 | 胡晓燕 | Balloon-type indwelling catheter for stool |
US6796960B2 (en) | 2001-05-04 | 2004-09-28 | Wit Ip Corporation | Low thermal resistance elastic sleeves for medical device balloons |
US20030065292A1 (en) | 2001-06-08 | 2003-04-03 | Darouiche Rabih O. | Ozonated medical devices and methods of using ozone to prevent complications from indwelling medical devices |
US6635047B2 (en) * | 2001-08-06 | 2003-10-21 | Scimed Life Systems, Inc. | Integrated polymer and braid for intravascular catheters |
US20030073963A1 (en) * | 2001-10-12 | 2003-04-17 | Falconer Malcolm Ian | Bowel irrigation system and probe therefor |
US6855137B2 (en) * | 2002-03-07 | 2005-02-15 | Visionary Biomedical, Inc. | Catheter shaft with coextruded stiffener |
US6837847B2 (en) | 2002-06-13 | 2005-01-04 | Usgi Medical, Inc. | Shape lockable apparatus and method for advancing an instrument through unsupported anatomy |
US7029467B2 (en) * | 2002-07-16 | 2006-04-18 | Edwards Lifesciences Corporation | Multiple lumen catheter having a soft tip |
-
2002
- 2002-08-21 US US10/225,820 patent/US7147627B2/en not_active Expired - Fee Related
-
2003
- 2003-01-17 MX MXPA04003529A patent/MXPA04003529A/en unknown
- 2003-01-17 DK DK03705823.7T patent/DK1531884T3/en active
- 2003-01-17 WO PCT/US2003/001594 patent/WO2004018022A1/en active IP Right Grant
- 2003-01-17 AT AT03705823T patent/ATE538823T1/en active
- 2003-01-17 EP EP11002970A patent/EP2404630A3/en not_active Withdrawn
- 2003-01-17 CA CA002462570A patent/CA2462570C/en not_active Expired - Fee Related
- 2003-01-17 EP EP03705823A patent/EP1531884B1/en not_active Expired - Lifetime
- 2003-01-17 AU AU2003207608A patent/AU2003207608B2/en not_active Ceased
- 2003-01-17 JP JP2004530762A patent/JP4260107B2/en not_active Expired - Fee Related
- 2003-01-17 EP EP09000391.4A patent/EP2044966B1/en not_active Expired - Lifetime
- 2003-01-17 DE DE20321872U patent/DE20321872U1/en not_active Expired - Lifetime
- 2003-01-17 CA CA2679454A patent/CA2679454C/en not_active Expired - Fee Related
- 2003-01-17 BR BR0305770-4A patent/BR0305770A/en not_active Application Discontinuation
-
2006
- 2006-04-28 US US11/413,388 patent/US7722583B2/en not_active Expired - Fee Related
- 2006-10-27 US US11/553,731 patent/US20070049878A1/en not_active Abandoned
-
2007
- 2007-03-07 AU AU2007201015A patent/AU2007201015C1/en not_active Ceased
-
2008
- 2008-05-02 JP JP2008120532A patent/JP2008212712A/en active Pending
- 2008-06-16 JP JP2008156533A patent/JP5134450B2/en not_active Expired - Fee Related
- 2008-10-03 US US12/245,484 patent/US20090030387A1/en not_active Abandoned
- 2008-10-03 US US12/245,463 patent/US20090030386A1/en not_active Abandoned
- 2008-12-12 AU AU2008255261A patent/AU2008255261B2/en not_active Ceased
-
2009
- 2009-02-11 US US12/369,572 patent/US8323255B2/en not_active Expired - Fee Related
-
2011
- 2011-04-29 US US13/098,162 patent/US8801683B2/en not_active Expired - Fee Related
-
2012
- 2012-07-23 JP JP2012162356A patent/JP2012228545A/en active Pending
Patent Citations (34)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US565531A (en) * | 1896-08-11 | Island | ||
US2457244A (en) * | 1943-06-22 | 1948-12-28 | Otis F Lamson | Medical appliance for control of enemata |
US2494393A (en) * | 1949-02-05 | 1950-01-10 | Otis F Lamson | Removable appliance for use as an artificial dam in cases of rectal incontinence |
US2813531A (en) * | 1955-09-26 | 1957-11-19 | Albert F Lee | Cannula |
US3459175A (en) * | 1966-04-08 | 1969-08-05 | Roscoe E Miller | Medical device for control of enemata |
US3548828A (en) * | 1968-06-14 | 1970-12-22 | John J Vasile | Excrement collecting appliance |
US3565386A (en) * | 1969-02-19 | 1971-02-23 | Gen Motors Corp | Mount for a body and coupling unit therefor |
US3938521A (en) * | 1972-06-22 | 1976-02-17 | M.E.D.S. Corporation | Collecting bag |
US4030500A (en) * | 1974-12-16 | 1977-06-21 | Hadar Yngve Ronnquist | Fecal matter collector |
US4019515A (en) * | 1975-12-08 | 1977-04-26 | Daniel Kornblum | Enemata administering device |
US4117847A (en) * | 1976-02-05 | 1978-10-03 | Clayton Ralph S | Colon catheter |
US4403982A (en) * | 1978-08-28 | 1983-09-13 | Clayton Ralph S | Colon cleansing system and technique |
US4496356A (en) * | 1982-09-29 | 1985-01-29 | Leon Lognion | Anal excretion collecting rectal catheter |
US4637814A (en) * | 1985-04-05 | 1987-01-20 | Arnold Leiboff | Method and apparatus for intestinal irrigation |
US4686985A (en) * | 1985-05-15 | 1987-08-18 | Lottick Edward A | Anal dilator and occluder |
US5766209A (en) * | 1993-02-19 | 1998-06-16 | Devonec; Marian A. | Prosthesis intended for the treatment of a natural lumen or tract, in particular an endo-urethral prosthesis |
US5342321A (en) * | 1993-05-18 | 1994-08-30 | Teleflex, Inc. | Low profile gastrostomy catheter |
US5569216A (en) * | 1993-12-02 | 1996-10-29 | Kim; Jae H. | Multipurpose colostomy device having balloons on an end thereof |
US5904701A (en) * | 1994-02-14 | 1999-05-18 | Daneshvar; Yousef | Device for aiding procedural and therapeutic interventions of the gastrointestinal tract |
US5520669A (en) * | 1994-07-19 | 1996-05-28 | Mulholland; Kevin J. | Intra-rectal drain and receptacle for fecal incontinence |
US5782745A (en) * | 1995-11-13 | 1998-07-21 | Benderev; Theodore V. | Devices and methods for assessment and treatment of urinary and fecal incontinence |
US6468245B2 (en) * | 1996-11-27 | 2002-10-22 | Colorplast A/S | Irrigation device |
US5941860A (en) * | 1997-11-03 | 1999-08-24 | Wheeler; Alton D. | Fecal pouch and installation |
US5997546A (en) * | 1999-01-07 | 1999-12-07 | Ballard Medical Products | Gastric balloon catheter with improved balloon orientation |
US6342052B1 (en) * | 1999-11-02 | 2002-01-29 | Hector D. Allende | Anorectal apparatus |
US6719709B2 (en) * | 2000-08-31 | 2004-04-13 | Abbeymoor Medical, Inc. | Diagnostic urethral assembly and method |
US6527755B1 (en) * | 2001-04-20 | 2003-03-04 | Fouad A. Salama | Feces control device |
US20020173771A1 (en) * | 2001-05-17 | 2002-11-21 | La Tapachulteca Ii | Lesion restoration catheter for the colon and method for using same |
US6716209B2 (en) * | 2002-02-22 | 2004-04-06 | Arnold Robert Leiboff | Loop ostomy device and methods for its use |
US20060189951A1 (en) * | 2002-08-21 | 2006-08-24 | Kim Jae H | Bowel management system and waste collection bag therefor |
US7147627B2 (en) * | 2002-08-21 | 2006-12-12 | Hollister Incorporated | Bowel management system |
US20090030386A1 (en) * | 2002-08-21 | 2009-01-29 | Hollister Incorporated | Bowel management system and waste collection bag therefor |
US20090030387A1 (en) * | 2002-08-21 | 2009-01-29 | Hollister Incorporated | Bowel management system and waste collection bag therefor |
US20090149824A1 (en) * | 2002-08-21 | 2009-06-11 | Hollister Incorporated | Bowel management system |
Cited By (36)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9855163B2 (en) | 2006-10-17 | 2018-01-02 | C. R. Bard, Inc. | Waste management system |
US8597266B2 (en) | 2006-10-17 | 2013-12-03 | C. R. Bard, Inc. | Waste management system |
US10660784B2 (en) | 2006-10-17 | 2020-05-26 | C. R. Bard, Inc. | Waste management system |
US8926577B2 (en) | 2006-10-17 | 2015-01-06 | C. R. Bard, Inc. | Waste management system |
US20090216206A1 (en) * | 2006-10-17 | 2009-08-27 | C. R. Bard, Inc. | Waste Management System |
US9463110B2 (en) | 2006-10-17 | 2016-10-11 | C. R. Bard, Inc. | Waste management system |
US9456920B2 (en) | 2006-10-17 | 2016-10-04 | C. R. Bard, Inc. | Waste management system |
US8070736B2 (en) | 2006-10-17 | 2011-12-06 | C. R. Bard, Inc. | Waste management system |
US8075539B2 (en) | 2006-10-17 | 2011-12-13 | C. R. Bard, Inc. | Waste management system |
US20090227970A1 (en) * | 2006-10-17 | 2009-09-10 | C.R. Bard, Inc. | Waste management system |
US8777912B2 (en) | 2007-07-22 | 2014-07-15 | C. R. Bard, Inc. | Waste management system |
WO2009015152A1 (en) * | 2007-07-22 | 2009-01-29 | C.R. Bard, Inc. | Waste management system |
US8574206B2 (en) * | 2007-10-30 | 2013-11-05 | Mbh-International A/S | Intestinal irrigation device and method of using the device |
US20100234821A1 (en) * | 2007-10-30 | 2010-09-16 | Henrik Bork Bjerregaard | Intestinal irrigation device and method of using the device |
WO2010057208A1 (en) | 2008-11-17 | 2010-05-20 | C. R. Bard, Inc. | Waste management system |
US8900116B2 (en) | 2009-07-14 | 2014-12-02 | Stimatix Gi Ltd. | Inflatable stomal implant |
US8845607B2 (en) | 2009-07-14 | 2014-09-30 | Stimatix Gi Ltd. | Ostomy port |
US8821464B2 (en) | 2009-07-14 | 2014-09-02 | Stimatix Gi Ltd. | Disposable ostomy assemblies |
US8821465B2 (en) | 2009-07-14 | 2014-09-02 | Stimatix Gi Ltd. | Disposable ostomy assemblies |
US8998862B2 (en) | 2009-07-14 | 2015-04-07 | B. Braun Medical Sas | Ostomy containment device |
US9314365B2 (en) | 2009-07-14 | 2016-04-19 | B. Braun Medical Sas | Ostomy port gas release mechanism |
US8864729B2 (en) | 2009-07-14 | 2014-10-21 | Stimatix Gi Ltd. | Ostomy closure |
US20110015475A1 (en) * | 2009-07-14 | 2011-01-20 | Stimatix Gl Ltd. | Inflatable stomal implant |
US10537461B2 (en) | 2009-07-14 | 2020-01-21 | B. Braun Medical Sas | Disposable ostomy assemblies |
US8858519B2 (en) | 2009-07-14 | 2014-10-14 | Stimatix Gi Ltd. | Disposable ostomy assemblies |
US9987160B2 (en) | 2009-07-14 | 2018-06-05 | B. Braun Medical Sas | Ostomy port |
WO2011138728A2 (en) | 2010-05-02 | 2011-11-10 | Stimatix Gi Ltd. | Ostomy port |
US10524953B2 (en) | 2012-05-10 | 2020-01-07 | B. Braun Medical Sas | Compact ostomy appliance |
US9883964B2 (en) | 2012-05-10 | 2018-02-06 | B. Braun Medical Sas | Ostomy appliance |
US9517157B2 (en) | 2012-05-10 | 2016-12-13 | B. Braun Medical Sas | Ostomy appliance |
US9345612B2 (en) | 2012-05-10 | 2016-05-24 | B. Braun Medical Sas | Ostomy appliance |
US11291579B2 (en) | 2013-05-09 | 2022-04-05 | B. Braun Medical Sas | Gas filter and release for ostomy appliance |
USD796029S1 (en) | 2013-12-09 | 2017-08-29 | B. Braun Medical Sas | Colostomy appliance |
USD783814S1 (en) | 2013-12-09 | 2017-04-11 | B. Braun Medical Sas | Adapter for flatus release |
USD1012280S1 (en) | 2018-11-30 | 2024-01-23 | B. Braun Medical Sas | Ostomy device assembly |
US11666696B2 (en) | 2019-03-25 | 2023-06-06 | Ellen McGrath | Enterostomy drainage methods and devices |
Also Published As
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US7722583B2 (en) | Bowel management system and waste collection bag therefor | |
US8777912B2 (en) | Waste management system | |
AU734209B2 (en) | An irrigation device | |
US20110282311A1 (en) | Waste management system | |
CN113384391A (en) | Controllable stoma belt cleaning device of flow |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |