Closing system and electronic control method

• US 20050240144A1
• Filed: 11/19/2002
• Published: 10/27/2005
• Est. Priority Date: 11/20/2001
• Status: Active Grant

• Current Assignee: Dieter Jocham, Helmut Wassermann
• Original Assignee: Dieter Jocham, Helmut Wassermann
• Inventors: Schostek, Sebastian, Ho, Chi-Nghia, Wassemann, Helmut
• Granted Patent: US 7,217,237 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61F 2/004 inflatable

Abstract

A closing system is described and a correspondingly suitable method for the selective opening and closing of a tubular body organ, comprising a closing element and a regulating system controlling the closing element. Furthermore described are a method and a system for the electronic control of an artificial fine-sensory sphincter implant, with at least one sensor signal or, respectively, sensor value acting—in the method or, respectively, in the system—analog to the difference between the internal bladder pressure and the cuff pressure, and being converted in an analog or digital electronic circuit by means of calculator and comparator functions or, respectively, calculator and comparator elements and being compared with reference values such that an actuator system will be controlled such that the cuff pressure or, respectively, the differential pressure between cuff and urinary bladder moves either in a low area limited by two threshold values or above a specific safety pressure or below that in case of miction.

Claims

1. A closing system, preferably an implantable closing system, for the selective closing and opening of a tubular body organ, comprising a closing element and a regulating system controlling the closing element, with the regulating system setting a first condition of the closing system and returning a deviation from the first condition in a self-regulating manner back to the first condition.

2. A closing system according to claim 1, with the regulating system together with the closing element presenting a closed circuit.

3. A closing system according to any one of the claims 1 or 2, the regulating system having a first reservoir and sensor elements being in connection with a control unit, and the connecting line from the closing element dividing into a first feed line and a second feed line, with the first feed line having a pump device and a first shutoff valve and the second feed line having a second shutoff valve between the first reservoir and the closing element.

4. A closing system according to any one of the claims 1 to 3, with a sensor element being provided as a first sensor unit on the closing element, a second sensor unit between the first shutoff valve and the closing element, and a third sensor unit on the pump device.

5. A closing system according to any one of the claims 1 to 4, with the pump device being a quick-action pump.

6. A closing system according to any one of the claims 1 to 5, with the pump device being a feed pump which is connected with a second reservoir via a third shutoff valve.

7. A closing system according to claim 1, with the regulating system controlling the closing element via a fluid.

8. A closing system according to any one of the claims 1 to 7, with the sensor units being pressure sensors.

9. A process for the selective opening and closing of a tubular body organ, in particular with the use of the closing system according to any one of the claims 1 to 7 which has the following steps:

a) Providing a closing element for the tubular body organs and a regulating system

b) Setting a first condition of a closing system through the regulating system

c) A self-regulating return of the closing system to the first condition in case of a deviation from the first condition.

10. A process according to claim 9, with the first condition being set by providing a reservoir, from which—

via a pump device—

pressure is applied on the closing element and the pressure is held on the closing element by closing a shutoff valve.

11. A process according to claim 9 or 10, with a pressure increase in the tubular body organ being registered via a sensor unit and short-term counteracting by increasing the pressure on the closing element.

12. A method for the electronic control of an artificial fine-sensory sphincter implant, characterized in that—

in the method—

a sensor signal or, respectively, sensor value (1) acting analog to the difference between internal bladder pressure (11) and the cuff pressure (4) in an analog or digital electronic circuit, being converted by means of calculator and comparator functions such and compared with reference values that an actuator system will be controlled such that the cuff pressure or, respectively, the differential pressure between cuff and urinary bladder either moves in a low range limited by two threshold values or above a certain safety pressure or, respectively, below that in case of miction.

13. A method according to claim 12, characterized in that the calculator function of the electronic circuit comprises:

(a) a differentiator function whose output signal or, respectively, output value (14) is equivalent to the differentiation of the curve of the sensor signal or, respectively, the sensor value (1);

(b) an adding function with a monostable offset signal or, respectively, offset value whose output signal or, respectively, output value (12) is equivalent to the output signal or, respectively, output value (14) of the differentiator function, increased by the monostable offset signal or, respectively, the monostable offset value;

(c) an integrator function with a monostable reference signal or, respectively, a monostable reference value (5) and a constant starting value where selectively

(i) the monostable reference signal or, respectively, the monostable reference value (5) is not equal to the monostable offset signal or, respectively, offset value of the adding function and will be selected such that the output signal or, respectively, the output value (12) of the adding function upon activity crosses the monostable reference signal or, respectively, the monostable reference values, with the integrator function continuously or numerically integrating the difference between the output signal or, respectively, the output value (12) of the adding function and the monostable reference signal or, respectively, the monostable reference value (5) such that—

upon low activity of the output signal or, respectively, the output value (14) of the differentiator function—

the output signal or, respectively, the output value (13) of the integrator function moves away from the starting value of the integrator function of the starting value, and in case of high activity of the output signal or, respectively, the output value (14) of the differentiator value will move toward the starting value,

or

(ii) the monostable reference signal or, respectively, the monostable reference value (5) is unequal to the output signal or, respectively, the output value (14) of the differentiator function upon low activity and is selected such that the output signal or, respectively , the output value (14) of the differentiator function upon activity will cross the monostable reference signal or, respectively, the monostable reference value (5), with the integrator function continuously or numerically integrating the difference between the output signal or, respectively, the output value (14) of the differentiator function and the monostable reference signal or, respectively, the monostable reference value (5) such that—

upon low activity of the output signal or, respectively, the output value (14) of the differentiator function, the output signal or, respectively, the output value (13) of the integrator function will continuously move away from the starting value and—

upon high activity of the output signal or, respectively the output value (14) of the differentiator function—

will move towards the starting value;

(d) a comparator function with a bistable threshold signal or, respectively, threshold value (3), whereby—

in the event of parity or, respectively, crossing of the sensor signal or, respectively, sensor value (1) with the bistable threshold signal or, respectively, the bistable threshold value (3)—

this threshold signal or, respectively, this threshold value (3) will be decreased or, respectively, increased by the amount due to the hysteresis and a signal is thus triggered which causes the actuator system to decrease (16) the cuff pressure (4) until—

by renewed parity or, respectively, renewed crossing of the sensor signal (1) with the bistable threshold signal or, respectively, the bistable threshold value (3), a signal will be triggered which causes the actuator system to terminate the decrease (16) of the cuff pressure (4) and increasing or, respectively, decreasing the bistable threshold signal or, respectively, the bistable threshold value (3) by the amount due to the hysteresis;

and

(e) a comparator function with a monostable threshold signal or, respectively, threshold value (2), whereby—

in the event of parity or, respectively, crossing of the sensor signal or, respectively, the sensor value (1) with the monostable threshold signal or, respectively, the monostable threshold value (2), a signal is triggered which causes the actuator system to terminate the increase (15) of the cuff pressure (4) and activates the integrator function such that, upon activation, the output signal or, respectively, the output value (13) of the integrator function is in accordance with the constant starting value.

14. A method according to claim 13, characterized in that the sensor signal or, respectively the sensor value (1) is compared with the output signal or, respectively, the output value (12) of the adding function such that—

in the event of parity or, respectively, crossing of the sensor signal or, respectively, the sensor value (1) with the output signal or, respectively, the output value (12) of the adding function, a signal is triggered which causes the actuator system to increase (15) the cuff pressure (4) and suspend the comparator function according to claim 13 (d).

15. A method according to claim 13, characterized in that—

in the event of parity or, respectively, crossing of the output signal or, respectively, the output value (13) of the integrator function with the monostable threshold signal or, respectively, threshold value (6), a signal is triggered which causes the actuator system to decrease (16) the cuff pressure (4) and/or activates the comparator function according to claim 13 (d).

16. A method according to any one of the claims 13 to 15, characterized in that a delaying function is furthermore provided which is activated upon triggering a pressure compensation between an admission pressure reservoir (29) and a cuff (25) by a comparator function and triggers a signal when reaching the set delay time, which causes the actuator system to terminate the pressure compensation between the admission pressure reservoir (29) and the cuff (25) and activates the integrator function such that, upon activation, the output signal or, respectively, the output value (13) of the integrator function is equivalent to the constant starting value.

17. A method according to any one of the claims 13 to 16, characterized in that the monostable offset signal or, respectively, the monostable offset value can be varied by the parameter variation from the outside.

18. A method according to any one of the claims 13 to 17, characterized in that the bistable threshold signal or, respectively, the bistable threshold value (3) can be varied by the parameter variation from the outside.

19. A method according to any one of the claims 13 to 18, characterized in that the monostable reference signal or, respectively, the monostable reference value (5) can be varied by the parameter variation from the outside.

20. A method according to any one of the claims 13 to 19, characterized in that the monostable threshold signal or, respectively, the monostable threshold value (2) can be varied by the parameter variation from the outside.

21. A method according to any one of the claims 17 to 20, characterized in that the parameter variation is effected by programming the electronics via infrared transmission from the outside.

22. A method for the control of miction of the electronic circuit according to any one of the preceding claims 12 to 21, characterized in that—

for activation of miction—

an external signal causes the actuator system to decrease the urethra closing pressure and deactivates the electronic circuit except for the comparator function according to claim 13 (d) and, for deactivation of miction, an external signal causes the actuator system to increase (15) the cuff pressure (4) until a signal is triggered which activates the electronic circuit in the event of parity or, respectively, crossing the sensor signal (1) with the bistable threshold signal or, respectively, threshold value (3).

23. A method according to claim 22, characterized in that the external signal for activation or deactivation of miction is transmitted by infrared transmission or by radio signals or by induction.

24. A method according to any one of the preceding claims 12 to 23, characterized in that the energy supply of the artificial fine-sensory sphincter implant is provided by induction from the outside.

25. A system for the electronic control of an artificial fine-sensory sphincter implant, characterized in that—

in the system—

at least one sensor signal or, respectively, sensor value (1) behaves analog to the difference between internal bladder pressure (11) and cuff pressure (4) being converted in an analog or digital electronic circuit by means of calculator and comparator elements such and compared with reference values such that an actuator system will be controlled such that the cuff pressure or, respectively, the differential pressure between cuff and urinary bladder either moves in a low range limited by two threshold values or above a specific safety pressure or, respectively, below that in case of miction.

26. A system according to claim 25, characterized in that the calculator element of the electronic circuit comprises:

(a) a differentiator element whose output signal or, respectively, output value (14) of the differentiation is equivalent to the curve of the sensor signal or, respectively, the sensor value (1);

(b) an adding element with a monostable offset signal or, respectively, offset value whose output signal or, respectively output value (12) is equivalent to the output signal or, respectively, output value (14) of the differentiator element increased by the monostable offset signal or, respectively, the monostable offset value;

(c) an integrator element with a monostable reference signal or, respectively, a monostable reference value (5) and a constant starting value, wherein selectively

(i) the monostable reference signal or, respectively, the monostable reference value (5) is not equal to the monostable offset signal or, respectively, the offset value of the adding element and is selected such that the output signal or, respectively, the output value (12) of the adding element upon activity crosses the monostable reference signal or, respectively, the monostable reference value (5), with the integrator element continuously or numerically integrating the difference between the output signal or, respectively, the output value (12) of the adding element and the monostable reference signal or, respectively, the monostable reference value (5) such that—

upon low activity of the output signal or, respectively, the output value (14) of the differentiator element—

the output signal or, respectively, the output value (13) of the integrator element will move away from the starting value and—

upon high activity of the output signal or, respectively, the output value (14) of the differentiator element—

will move towards the starting value,

or

(ii) the monostable reference signal or, respectively, the monostable reference value (5) is not equal to the output signal or, respectively, the output value (14) of the differentiator element upon low activity and is selected such that the output signal or, respectively, the output value (14) of the differentiator element upon activity crosses the monostable reference signal or, respectively, the monostable reference value (5) with the integrator element continuously or numerically integrating the difference between the output signal or, respectively, the output value (14) of the differentiator element and the monostable reference signal or, respectively, the monostable reference value (5) such that—

upon low activity of the output signal or, respectively, the output value (14) of the differentiator element—

the output signal or, respectively, the output value (13) of the integrator element will continuously move away from the starting value and—

upon high activity of the output signal or, respectively, the output value (14) of the differentiator element—

will move towards the starting value;

(d) a comparator element with a bistable threshold signal or, respectively, threshold value (3), whereby—

in the event of parity or, respectively, crossing of the sensor. signal or, respectively, sensor value (1) with the bistable threshold signal or, respectively, the bistable threshold value (3)—

this threshold signal or, respectively, this threshold value (3) is decreased or, respectively, increased by the amount due to the hysteresis and a signal is triggered thereby which causes the actuator system to decrease (16) the cuff pressure (4) until a renewed parity or, respectively, renewed crossing of the sensor signal (1) with the bistable threshold signal or, respectively, the bistable threshold value (3), a signal will be triggered which causes the actuator system to terminate the decrease (16) of the cuff pressure (4) and increases or, respectively decreases the bistable threshold signal or, respectively, the bistable threshold value (3) by the amount due to the hysteresis;

and

(e) a comparator element with a monostable threshold signal or, respectively, threshold value (2) whereby—

in the event of parity or, respectively, crossing of the sensor signal or, respectively, the sensor value (1) with the monostable threshold signal or, respectively, the monostable threshold value (2) a signal will be triggered which causes the actuator system to terminate the increase (15) of the cuff pressure (4) and activates the integrator element such that, upon activation, the output signal or, respectively, the output value (13) of the integrator element is equivalent to the constant starting value.

27. A system according to claim 26, characterized in that the sensor signal or, respectively, the sensor value (1) is compared with the output signal or, respectively, the output value (12) of the adding element such that—

in the event of parity or, respectively, crossing of the sensor signal or, respectively, the sensor value (1) with the output signal or, respectively, the output value (12) of the adding element, a signal will be triggered which causes the actuator system to increase (15) the cuff pressure (4) and deactivates the comparator element according to claim 26 (d).

28. A system according to claim 26, characterized in that—

in the event of parity or, respectively, crossing of the output signal or respectively, the output value (13) of he integrator element with the monostable threshold signal or, respectively, threshold value (6), a signal is triggered which causes the actuator system to decrease (16) the cuff pressure (4) and/or activates the comparator element according to claim 26 (d).

29. A system according to any one of the claims 26 to 28, characterized in that furthermore, a delaying element is provided which is activated upon triggering a pressure compensation between an admission pressure reservoir (29) and a cuff (25) by a comparator element, and upon reaching the set delay period, a signal is triggered which causes the actuator system to terminate the pressure compensation between the admission pressure reservoir (29) and the cuff (25) and activates the integrator element such that, upon activation, the output signal or, respectively, the output value (13) is in accordance with the integrator element of the constant starting value.

30. A system according to any one of the claims 26 to 29, characterized in that the monostable offset signal or, respectively the monostable offset value can be varied by the parameter variation from the outside.

31. A system according to any one of the claims 26 to 30, characterized in that the bistable threshold signal or, respectively the bistable threshold value (3) can be varied by the parameter variation from the outside.

32. A system according to any one of the claims 26 to 31, characterized in that the monostable reference signal or, respectively, the monostable reference value (5) can be varied by the parameter variation from the outside.

33. A system according to any one of the claims 26 to 32, characterized in that the monostable threshold signal or, respectively, the monostable threshold value (2) can be varied by the parameter variation from the outside.

34. A system according to any one of the claims 30 to 33, characterized in that the parameter variation is effected from the outside by programming the electronics via infrared transmission.

35. A system for miction control of the electronic circuit according to any one of the preceding claims 25 to 34, characterized in that—

for activating the miction—

an external signal causes the actuator system to decrease the urethra closing pressure and deactivates the electronic circuit except for the comparator element according to claim 26 (d), and for deactivation of miction, an external signal causes the actuator system to increase (15) the cuff pressure (4) until—

in the event of parity or, respectively, crossing the sensor signal (1) with the bistable threshold signal or threshold value (3)—

a signal is triggered which activates the electronic circuit.

36. A system according to claim 35, characterized in that the external signal for activation or deactivation of miction is transmitted via infrared transmission or by radio or by induction.

37. A system according to any one of the preceding claims 25 to 36, characterized in that the energy supply of the artificial fine-sensory sphincter implant is provided from the outside by induction.