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US 2023/0041626 A1Published application
Method and device for intermittently triggering a reflex-coordinated defecation
OwnerFred Göbelinventor
Life of this patent
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Abstract
The invention relates to a method for filling an inflatable catheter balloon of a device for transanally introducing an infusion into the rectum or colon of a patient by means of a filling device, wherein a fill volume or a filling pressure prevailing in the catheter balloon is increased in two or more steps until there occurs a gradual, user-controllable, pneumatically initiated expansion of portions of the bowel wall, thus triggering a coordinated defecation reflex, wherein the timing and intensity of the triggering stimulus can be determined to the greatest possible extent by the user.
Claims44
A method for intermittently triggering a coordinated defecation reflex in the rectum or colon of a user with an individual anatomy of the rectum or colon and a current reflex status, comprising the following steps:
- providing a catheter, the catheter comprising:
- a catheter shaft, and
- a catheter balloon surrounding the catheter shaft and being fixed to it, wherein the catheter balloon comprises a balloon envelope:
- which has a tubular or an annular geometry with two ends which are fixed to the catheter shaft at two fixation points in a fluid-tight manner in order to encompass a fluid-tight fillable compartment, wherein the distal fixation point of the catheter balloon is near the distal end of the catheter shaft, and
- which surrounds the catheter shaft between the two ends of the balloon in a freemoving manner, as the balloon envelope is not attached or fixed to the catheter shaft at any third location between the two fixation points of the ends of the balloon envelope at the catheter shaft, and
- which, during manufacturing of the catheter balloon, is preshaped to a reference dimension (VREF) of a balloon filling volume (VBF) as a maximum filling volume of the compartment in the balloon, which is achievable by inflation, but without any stretching of the balloon envelope, and which reference dimension (VREF) of the balloon filling volume (VBF) corresponds to a dimension of the rectum or colon of the user, and
- which is manufactured from a material which, although being flexible, is non-stretchable or only slightly stretchable so that, at or above the reference dimension (VREF), the ballon filling volume (VBF) of the catheter balloon instantly assumes or asymptotically approximates an unvarying dimension limit (VUDL) at a pressure in the range of 10 to 120 mbar applied to the interior of the balloon:
- VUDL>VREF;
- in a first step, inserting the catheter in the rectum or colon of the user and providing an initial fill volume (VIF,1) or an initial filling pressure (pIF,1) of air or another fluid in the catheter balloon in order to inflate the catheter balloon below the reference dimension (VREF) of the balloon filling volume (VBF) thereof in a pressure-neutral manner, i.e. wherein the initial filling pressure (pIF,1) inside the catheter balloon is equal to a physiologically acting intra-rectal acting pressure (pIR) that is prevailing in the rectum of the user, producing a sealing and anchoring effect without any stretching of the envelope of the catheter balloon and causing neither a trans-mural pressure (pTM,1) beyond the physiologically intra-rectally acting pressure (pIF) nor a reflex triggering expansion of portions of the lateral rectal wall exposed to the catheter balloon, according to the following formulas:
- pIF,1=pTM,1=pIR,
- and wherein the initial fill volume (VIF,1) of the catheter balloon is below the reference dimension of the balloon filling volume (VREF):
- VIF,2<VREF;
- so that the envelope of the balloon is not stretched;
- and
- in a second step, increasing such initial fill volume (VIF,1) or such initial filling pressure (pIF,1) to an increased fill volume (pIF,2) or an increased filling pressure (pIF,2) by pumping, squeezing or injecting air or another fluid into the catheter balloon by the user until there occurs a gradual, user-controllable expansion of portions of the lateral rectal wall exposed to the catheter balloon in such a way that the degree of filling of the balloon is best adapted to the individual anatomy, allowing for an even distribution of the trans-mural pressure (pTM,2) exerted by the balloon onto the exposed rectal structures, gradually increasing from the physiologically acting intra-rectal pressure (pIR) to a force level suited for triggering a coordinated physiological defecation reflex of the individual user, according to the following formula:
- pIF,2=pTM,2>pIR,
- and wherein the increased fill volume (VIF,2) of the catheter balloon is still below the reference dimension of the balloon filling volume (VREF):
- VIF,2<VREF;
- so that the envelope of the balloon is not stretched.
16 more elements
A device for intermittently triggering a coordinated defecation reflex in the rectum or colon of a user with an individual anatomy of the rectum or colon and a current reflex status, comprising a catheter, the catheter comprising:
- a catheter shaft, and
- a catheter balloon surrounding said catheter shaft and being fixed to it, wherein the catheter balloon comprises a balloon envelope:
- which has has a tubular or an annular geometry with two ends which are fixed to the catheter shaft at two fixation points in a fluid-tight manner in order to encompass a fluid-tight fillable compartment, wherein the distal fixation point of the catheter balloon is near the distal end of the catheter shaft, and
- which surrounds the catheter shaft between the two ends of the balloon in a freemoving manner, as the balloon envelope is not attached or fixed to the catheter shaft at any third location between the two fixation points of the ends of the balloon envelope at the catheter shaft, and
- which, during manufacturing of the catheter balloon, is preshaped to a reference dimension of a balloon filling volume as a maximum filling volume of the compartment in the balloon, which is achievable by inflation, but without any stretching of the balloon envelope, and which reference dimension of the balloon filling volume corresponds to a dimension of the rectum or colon of the user,
- which is laid in wrinkles if the balloon is inflated to a reference dimension of the filling volume below the preshaped reference dimension of the filling volume, and
- which is manufactured from a material which, although being flexible, is non-stretchable or only slightly stretchable so that, at or above the reference dimension, the ballon filling volume of the catheter balloon instantly assumes or asymptotically approximates an unvarying dimension limit at a pressure in the range of 10 to 120 mbar applied to the interior of the balloon;
- a manually operable pump, optionally with an integrated manometer for a pressure-controlled filling of the catheter balloon by the user, or a manually operable syringe element for a volume-controlled filling of the catheter balloon by the user:
- by providing an initial fill volume or an initial filling pressure to the catheter balloon in order to inflate it to a balloon filling volume below the reference dimension, which is sufficient to achieve an anchoring effect of the catheter balloon in the rectum or colon in a pressure-neutral manner, but without causing a reflex triggering expansion of portions of the bowel wall adjacent to the catheter balloon, and
- by pumping, squeezing or inserting air or another fluid into the catheter balloon in order to to increase said initial fill volume or said initial filling pressure to an increased fill volume or to an increased filling pressure until there occurs a gradual, user-controllable expansion of portions of the bowel wall adjacent to the catheter balloon, thus triggering a coordinated defecation reflex.
7 more elements
A method for intermittently triggering a coordinated defecation reflex in the rectum or colon of a user with an individual anatomy of the rectum or colon and a current reflex status, comprising:
- providing a catheter, the catheter comprising:
- a catheter shaft, and
- a catheter balloon surrounding the catheter shaft and being fixed to it, wherein the catheter balloon comprises a balloon envelope:
- which has a tubular or an annular geometry with two ends which are fixed to the catheter shaft at two fixation points in a fluid-tight manner in order to encompass a fluid-tight fillable compartment, wherein the distal fixation point of the catheter balloon is near the distal end of the catheter shaft, and
- which surrounds the catheter shaft between the two ends of the balloon in a freemoving manner, as the balloon envelope is not attached or fixed to the catheter shaft at any third location between the two fixation points of the ends of the balloon envelope at the catheter shaft, and
- which, during manufacturing of the catheter balloon, is preshaped to a reference dimension of a balloon filling volume as a maximum filling volume of the compartment in the balloon, which is achievable by inflation, but without any stretching of the balloon envelope, and which reference dimension of the balloon filling volume corresponds to a dimension of the rectum or colon of the user, and
- which is manufactured from a material which, although being flexible, is non-stretchable or only slightly stretchable so that, at or above the reference dimension, the ballon filling volume of the catheter balloon instantly assumes or asymptotically approximates an unvarying dimension limit at a pressure in the range of 60 to 120 mbar applied to the interior of the balloon;
- inserting the catheter in the rectum or colon of the user,
- providing an initial fill volume or an initial filling pressure of air in the catheter balloon in order to inflate the catheter balloon to a catheter balloon volume below its reference dimension without any stretching of the envelope of the catheter balloon, thereby achieving an anchoring effect of the catheter balloon in the rectum or colon of the user, and
- expanding portions of the bowel wall adjacent to the catheter balloon in order to trigger a coordinated defecation reflex by raising the initial filling pressure to an increased filling pressure in the range of 30 to 60 mbar, by additionally pumping, squeezing or inserting air or another fluid into the catheter balloon by the user until there occurs a gradual, user-controllable expansion of portions of the bowel wall adjacent to the catheter balloon in such a way that the degree of filling of the balloon is best adapted to the individual anatomy and current reflex status of the user in order to trigger the defecation reflex.
7 more elements
(canceled)
Dependencies are inferred from the claim text.