Mechanical food intake restriction device

• US 6,067,991 A
• Filed: 08/13/1998
• Issued: 05/30/2000
• Est. Priority Date: 08/13/1998
• Status: Expired due to Term

• Current Assignee: Obtech Medical AG (Johnson & Johnson)
• Original Assignee: Peter Forsell
• Inventors: Forsell, Peter
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): Wingood, Pamela
• Application Number:
  US09/133,320
• Time in Patent Office: 656 Days
• Field of Search: 600/593, 600/30, 600/31, 600/38, 600/40, 606/151, 606/157, 604/97, 604/99, 604/51, 604/28, 128/898, 128/899
• US Class Current: 128/899
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61F 5/0053 remotely adjustable
• CPC Class Codes: A61F 5/0066 Closing devices for gastric bands

Abstract

A food intake restriction device for surgical application in the abdomen of a patient for forming a stoma opening in the stomach or esophagus of the patient comprises an elongated non-inflatable restriction member, a forming device for forming the elongated restriction member into at least a substantially closed loop around the stomach or the esophagus to define a restriction opening, and a post-operation non-invasive adjustment device for mechanically adjusting the restriction member in the loop to change the size of the restriction opening. The components are of bio-compatible material and are effective for treating morbid obesity over an extended period of time always in a non-invasive manner.

Claims

1. A food intake restriction device for surgical application in the abdomen of a patient for forming a stoma opening in the stomach or esophagus of the patient, the device comprising:

an elongated non-inflatable restriction member,

forming means for forming said elongated restriction member into at least a substantially closed loop around the stomach or the esophagus, said loop defining a restriction opening, and

a post-operation non-invasive adjustment device which mechanically adjusts said restriction member in said loop to change the size of said restriction opening.

2. The device according to claim 1, wherein said adjustment device adjusts said longitudinal extension of said elongated restriction member in said loop.

3. The device according to claim 2, wherein said restriction member comprises a main portion and two elongated end portions, and said adjustment device establishes a longitudinal relative displacement between said end portions of said restriction member, so that the size of said restriction opening is adjusted.

4. The device according to claim 3, wherein said adjustment device comprises a movement transferring member in engagement with at least one of said end portions of said restriction member and operable to displace said one end portion relative to said other end portion of said restriction member;

wherein the movement transferring member comprises a drive wheel; and

wherein said drive wheel is in engagement with both of said end portions of said restriction member and is operable to displace said end portions relative to each other; and

further comprising an elongated flexible drive shaft operatively connected to said drive wheel; and

further comprising a motor remote from said restriction member, said elongated flexible drive shaft operatively connecting said motor to said drive wheel; and

wherein said drive wheel comprises a pulley in frictional engagement with said restriction member; and

wherein a gear rack is formed on at least one of said end portions of said restriction member and said drive wheel comprises a gear wheel in mesh with said gear rack; and

wherein said movement transferring member comprises at least one cylinder and a piston, which is movable therein and is connected to one of said end portions of said restriction member, said piston being operable to longitudinally displace said one end portion of said restriction member relative to said other end portion of said restriction member; and

wherein said movement transferring means may comprise two interconnected cylinders and two pistons in said respective cylinders connected to said end portions, respectively, of said restriction member, said pistons being operable to longitudinally displace said end portions of said restriction member relative to each other; and

further comprising a motor, which is fixed relative to said main portion of said restriction member and has a rotating drive shaft operatively connected to said movement transferring member, said motor being positioned relative to said elongated restriction member so that said drive shaft extends transverse thereto, or substantially tangentially to said loop of said restriction member.

5. The device according to claim 2, wherein said elongated restriction member is longitudinally resilient and said adjustment device comprises a contraction means which longitudinally contracts said resilient restriction member;

and wherein said elongated restriction member comprises a substantially nonresilient main portion and an end portion forming an elongated helical spring, which is contractable by said contraction means; and

wherein said contraction means comprises an elongated flexible pulling member connected to said main portion of said restriction member and extending through said helical spring to contract said helical spring against an arresting member, which is fixed relative to said main portion of said restriction member; and

further comprising an elongated tube joined at one end thereof to said arresting member, said pulling member extending in said tube; and

further comprising a motor remote from said restriction member and attached to said other end of said elongated tube, said motor being adapted to pull said pulling member through said tube to contract said helical spring.

6. The device according to claim 2, wherein said restriction member comprises an elongated helical spring having a free end, and a body to which said spring is nonrotatably secured at its opposite end, said adjustment device rotates said helical spring in one direction to enlarge said coils of said helical spring to longitudinally contract said elongated helical spring and to rotate said helical spring in said opposite direction to reduce said size of said coils of said helical spring to longitudinally extend said helical spring;

and wherein said restriction member comprises a further elongated helical spring having a free end and nonrotatably secured to said body at its opposite end, and said adjustment device comprises a drive shaft having two opposite end portions connected to said helical springs, respectively, at their free ends, said helical coils forming left and right hand helices, respectively, or said adjustment device comprises a gearing having an input shaft and two opposite aligned output shafts connected to said helical springs, respectively, at their free ends, said input shaft being connected to said output shafts such that said output shafts rotate in said opposite directions upon rotation of said input shaft, said helical coils forming said same helices.

7. The device according to claim 1, wherein said restriction member forms a radially innermost circumferential confinement surface in said loop of said restriction member, and said adjustment device mechanically adjusts said restriction member so that at least a portion of said confinement surface is substantially radially displaced in said loop.

8. The device according to claim 7 wherein said restriction member comprises an elongated voltage responsive element forming part of said confinement surface and capable of bending into a bow in response to a voltage applied across said element, said radius of curvature of said bow being adjustable by changing said level of said voltage, or said restriction member comprises an elastic annular element forming said confinement surface, and said adjustment means is adapted to change said diameter of said elastic annular element in which case said forming means comprises a substantially rigid outer annular element coaxially surrounding said elastic annular element, and said adjustment device comprises means for pulling said elastic annular element radially outwardly towards said outer annular element to expand said elastic annular element, and said pulling means comprises a plurality of threads secured to said elastic annular element along said circumference thereof and running from said elastic element via guide members attached to said outer annular element;

or wherein said forming means comprises a substantially rigid outer annular element, and said restriction member comprises an elongated helical spring extending internally along said outer annular element and contacting said latter, said helical spring forming part of said circumferential confinement surface and having a free end, and a body to which said spring is nonrotatably secured at its opposite end, said adjustment device rotating said helical spring in one direction to enlarge said coils of said helical spring to contract said circumferential confinement surface and rotating said helical spring in said opposite direction to reduce the size of said coils of said helical spring to expand said circumferential confinement surface, or said forming means comprises a substantially rigid outer annular element, and said restriction member comprises a first and a second elongated helical spring extending internally along said outer annular element and contacting the latter, said helical springs forming part of said circumferential confinement surface, said first and said second spring, respectively, having a free end, and a body to which said first and said second spring, respectively, is nonrotatably secured at its opposite end, said adjustment device rotating said first and said second spring, respectively, in one direction to enlarge said coils of said spring to contract said circumferential confinement surface and rotating said first and said second spring, respectively, in said opposite direction to reduce the size of said coils of said spring to expand said circumferential confinement surface.

9. The device according to claim 1, wherein said restriction member comprises at least two separate elements, at least one of which is pivoted so that it may turn in a plane in which said loop of said restriction member extends, and said adjustment device turns said pivoted element to change the size of said restriction opening;

and wherein said restriction member comprises a plurality of separate pivoted elements disposed in series, each pivoted element being turnable in said plane, and said adjustment device turns all of said pivoted elements to change the size of said restriction opening; and

wherein said pivoted elements comprise lamellae arranged like said adjustable aperture mechanism of a camera.

10. The device according to claim 1, wherein said restriction member comprises at least two frame elements which are foldable towards each other by said adjustment device;

and wherein said foldable frame elements comprise two substantially semi-circular frame elements which are hinged together such that said semi-circular elements are swingable relative to each other from a fully open state in which they form a circle to a fully folded state in which they form a semi-circle.

11. The device according to claim 1, wherein said elongated restriction member is elastic and varies in thickness as seen in a cross-section therethrough, and said adjustment device turns the restriction member around said longitudinal extension thereof;

and wherein said elongated restriction member comprises an elastic belt.

12. The device according to claim 1, further comprising a motor operatively connected to said adjustment device;

and wherein said motor is fixed to said restriction member, or said motor is remote from said restriction member and is connected to said adjustment device by a power transmission conduit, such as a flexible power transmission conduit; and

wherein said motor is a manually activatable electric motor.

13. The device according to claim 1, further comprising a hydraulic device which operates said adjustment device;

and wherein said hydraulic device is manually activatable or is powered by an electric motor, such as a manually activatable electric motor; and

further comprising a reservoir containing a predetermined amount of fluid for supplying said hydraulic device with fluid; and

wherein said reservoir defines a chamber for said predetermined amount of fluid and said hydraulic device changes he size of said chamber; and

wherein said hydraulic device comprises first and second wall portions of said reservoir, which are displaceable relative to each other to change the size of said chamber of said reservoir; and

wherein said first and second wall portions of said reservoir are designed to be displaceable relative to each other by manual manipulation thereof; and

wherein said first and second wall portions of said reservoir are displaceable relative to each other by manually pushing, pulling or rotating any of said wall portions in one direction, or wherein said first and second wall portions of said reservoir are displaceable relative to each other by magnetic means, or wherein said first and second wall portions of said reservoir are displaceable relative to each other by hydraulic means, or wherein said first and second wall portions of said reservoir are designed to be displaceable relative to each other by electric control means such as an electric motor; and

wherein said hydraulic device is adapted to operate said adjustment device with fluid from said reservoir in response to a predetermined first displacement of said first wall portion of said reservoir relative to said second wall portion of said reservoir, to increase the size of said restriction opening, and to operate said adjustment device with fluid from said reservoir in response to a predetermined second displacement of said first wall portion of said reservoir relative to said second wall portion of said reservoir, to decrease the size of said restriction opening.

14. The device according to claim 13 further comprising a hydraulic fluid reservoir;

and wherein said hydraulic device comprises an activatable pump for pumping fluid between said reservoir and said adjustment device; and

wherein said pump comprises a first activation member for activating said pump means to pump fluid from said reservoir to said adjustment device and a second activation member for activating said pump to pump fluid from said adjustment device to said reservoir; and

wherein said first and second activation members are operable by manual manipulation thereof or by magnetic means, or by hydraulic means, or by electric means such as an electric motor; and

wherein each of said first and second activation members are operable by manually pushing, pulling or rotation thereof in one direction; and

wherein at least one of said activation members operates when subjected to an external pressure exceeding a predetermined magnitude.

15. The device according to claim 14, wherein said hydraulic device comprises a servo means;

wherein said hydraulic device comprises first and second wall portions of said reservoir, and said servo means is adapted to provide relative displacement between said first and second wall portions of reservoir; and

wherein said servo means comprises magnetic means, electric means, or hydraulic means comprising a servo reservoir defining a chamber containing servo fluid and said hydraulic operation means comprises first and second wall portions of said servo reservoir, which are displaceable relative to each other to change the size of said chamber of said servo reservoir;

in response to a first displacement of the first wall portion of said servo reservoir relative to the second wall portion of the same reservoir, decrease the restriction opening via an indirect control of the adjustment device, and with a second displacement of the first wall portion relative to the second wall portion increase the size of the restriction opening; and

wherein said first and second wall portions of said servo reservoir are designed to be displaceable relative to each other by manual manipulation thereof, and wherein said first and second wall portions of said servo reservoir are designed to be displaceable relative to each other by manually pushing, pulling or rotating any of said wall portions of said servo reservoir in one direction;

wherein first and second wall portions of said servo reservoir are displaceable relative to each other by magnetic means, or said first and second wall portions of said servo reservoir are displaceable relative to each other by hydraulic means, or said first and second wall portions of said servo reservoir are displaceable relative to each other by electric control means such as an electric motor.

16. The device according to claim 1, further comprising a wireless remote control means for controlling said adjustment device, said remote control means comprising a separate signal transmitting means and a signal receiving means adapted to control said adjustment device in response to signals received from said signal transmitting means, and a motor for operating said adjustment device and an energizer unit for providing energy, and wherein said signal receiving means comprises a control unit powering said motor with energy provided by said energizer unit in response to signals received from said signal transmitting means;

and wherein said energizer unit comprises a power supply; and

wherein said control unit is adapted to power said motor with energy from said power supply, and wherein said power supply is an electric power supply such as a battery and said motor is an electric motor.

17. The device according to claim 16 wherein said signal transmitting means transmits electromagnetic wave signals and said energizer unit draws radiant energy from said electromagnetic wave signals as they are transmitted to said signal receiving means and transfer said radiant energy into electric energy for powering said electric motor.

18. The device according to claim 16, wherein said energizer unit comprises a rechargeable electric power supply for storing said electric energy and said control unit powers said electric motor with energy from said rechargeable electric power supply in response to signals received from said signal transmitting means.

19. The device according to claim 18 wherein said electric power supply comprises a capacitor, and wherein said electric motor is a stepping motor.

20. The device according to claim 17, wherein said energizer unit comprises a battery, an electrically operable switch connecting said battery to said signal receiving means in an on mode when said switch is powered and to keep said battery disconnected from said signal receiving means in a standby mode when said switch is unpowered, and a rechargeable electric power supply for powering said switch;

and wherein said control unit powers said electric motor with energy from said battery in response to signals received from said signal transmitting means, when said switch is in its on mode; and

wherein said signal transmitting means transmits electromagnetic wave signals and said energizer unit draws radiant energy from said electromagnetic wave signals as they are transmitted to said signal receiving means and transfers said radiant energy into a current for charging said rechargeable electric power supply; and

wherein said rechargeable electric power supply is a capacitor, or wherein said energizer unit comprises a coil connected to said signal receiving means for inducing an alternating current as electromagnetic wave signals are transmitted through said coil to said signal receiving means and a rectifier for rectifying said alternating current.

21. The device according to claim 2, wherein said forming means comprises a spring material forming said elongated restriction member into said loop, such that said restriction opening has a predetermined size, and said adjustment device adjusts said restriction member against said spring action of said spring material;

and wherein said spring material is integrated in said restriction member.

22. The device according to claim 1, wherein said adjustment device comprise a servo means, such as a hydraulic device, an electric control means, or a magnetic means, or a manual manipulating means;

and wherein said hydraulic device is activated by manual manipulating means, said electric control means is activated by manual manipulating means, and said magnetic means is activated by manual manipulating means.

23. The device according to claim 22 wherein said servo means comprises a hydraulic operation means comprising a servo reservoir and a fluid supply reservoir connected in a closed system and containing a predetermined amount of fluid, and wherein said fluid supply reservoir defines a chamber for said predetermined amount of fluid and said hydraulic operation means changes the size of said chamber and thereby controls said servo reservoir;

and wherein said fluid supply reservoir comprises first and second wall portions of said fluid supply reservoir, which are displaceable relative to each other to change the size of said chamber; and

wherein said first and second wall portions of said fluid supply reservoir are displaceable relative to each other by manual manipulation means for pushing, pulling or rotating any of said wall portions in one direction;

or by magnetic means for pushing, pulling, or rotating any of said wall portions in one direction, or by electrical control means for pushing, pulling or rotating any of said wall portions in one direction, or by electrical control means for pushing, pulling or rotating any of said wall portions in one direction, or by hydraulic means for pushing, pulling or rotating any of said wall portions in one direction; and

wherein said fluid supply reservoir operates said servo reservoir with fluid from said fluid supply reservoir in response to predetermined first displacement of the first wall portion of said fluid supply reservoir relative to said second wall portions of said fluid supply reservoir to increase said amount of fluid in said servo reservoir and to operate said servo reservoir in response to a predetermined second displacement of said first wall portion of said fluid supply reservoir relative to said second wall portion of said fluid supply reservoir to decrease the amount of fluid in the servo reservoir.

24. A method of treating morbid obesity, comprising:

(a) surgically implanting in the abdomen of a patient with morbid obesity a food intake restriction device which forms a stoma opening in the stomach or esophagus, by forming an elongated non-inflatable restriction member into at least a substantially closed loop around the stomach or the esophagus of the patient, the loop defining a restriction opening; and

then

(b) when necessary for the patient'"'"'s health or desired progress, in a non-invasive procedure mechanically adjusting the restriction member to change the size of the restriction opening.

25. A method as recited in claim 24 wherein (a) is practiced by implanting a restriction member comprising a main portion and two elongated end portions;

and wherein (b) is practiced by establishing a longitudinal relative displacement between the end portions of the restriction member so that the size of the restriction opening is adjusted.

26. A method as recited in claim 24 wherein (a) is practiced by implanting a restriction member having a radially innermost circumferential confinement surface formed in the loop;

and wherein (b) is practiced by causing at least a portion of the confinement surface to be radially displaced in the loop.

27. A method as recited in claim 24 wherein (a) is practiced by:

(i) inflating the patient'"'"'s abdomen with gas by penetration of the patient'"'"'s skin, (ii) introducing at least one laparoscopic trocar into the abdomen to introduce the elongated restriction member and one or more medical instruments, and then (iii) forming the elongated restriction member into the at least substantially closed loop.

28. A surgical method for laparoscopically implanting a non-inflatable food restriction device for forming a stoma opening in the stomach or esophagus comprising:

(a) insufflating the abdomen of a patient to form a pneumoperitoneum;

(b) introducing at least one laparoscopic trocar into the abdomen;

(c) using a dissecting tool inserted through the laparoscopic trocar, dissecting the region of the esophagus or stomach adjacent or above the bursa omentalis; and

(d) introducing the non-inflatable food restriction device in the abdomen and applying the device in at least a substantially closed loop around the stomach or esophagus.

29. A method as recited in claim 28 further comprising, after (a)-(d), (e) post-operatively adjusting the restriction opening in a non-invasive procedure.