Device for treating malignant, tumorous tissue areas

• US 6,245,057 B1
• Filed: 10/22/1999
• Issued: 06/12/2001
• Est. Priority Date: 04/23/1997
• Status: Expired due to Fees

• Current Assignee: Micronas Gmbh (TDK Corporation)
• Original Assignee: Micronas Intermetall GmbH (TDK Corporation)
• Inventors: Wolf, Bernhard, Sieben, Ulrich
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/425,598
• Time in Patent Office: 599 Days
• Field of Search: 604/65, 604/66, 604/890.1, 604/891.1, 604/20, 604/503, 424/422
• US Class Current: 604/891.1
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

A device (1) functions for treating malignant, tumorous tissue areas. The device has at least one measuring sensor for determining chemical or physical signal patterns in the immediate vicinity of the tumor cells or similar tissue part, a control unit and at least one treatment assembly, which has as an active agent release element for chemically influencing and/or treatment electrodes for physically influencing the tumorous tissue area to be treated. The sensor(s), the active agent release element, and the treatment electrodes are connected to the control unit for a physical and/or chemical treatment of the tumorous tissue area, controlled as a function of the measured values of the tumor cells. The device is constructed in the form of a swallowable capsule or dragée, and a sensor is provided for detecting release parameters. The control unit is designed with a threshold value switch for activating the active agent release element and/or the electrodes when a predetermined target value is exceeded.

Claims

1. A device (1, 1a, 1b, 1c, 1d) for treating malignant, tumorous tissue areas, comprising at least one measuring sensor (9) for determining chemical or physical signal patterns in an immediate vicinity of a tumorous tissue area, a control unit, and at least one treatment assembly having at least one active agent supply container (4), a dosing element with dosing control, and an active agent release element (6) for chemically influencing and/or treatment electrodes for physically influencing the tumorous tissue area to be treated, wherein the sensor(s)(9), the active agent release element(6) and/or the treatment electrodes (3) are connected to the control unit for controlling a physical and/or chemical treatment of the tumorous tissue area as a function of measured values of the tumor cells with continuous follow-up dosing of the active agent to be applied, wherein the device is constructed in a form of a swallowable capsule or a dragé

e and has a sheath (11) which at least covers the sensor(s)(9), the sheath being removable at least over a certain area under the influence of bodily fluid, wherein the control unit and a sensor for detecting release parameters are designed with a threshold value switch for activating the active agent release element and/or the electrodes when a predetermined target value is exceeded, and wherein at least one heat resistor (18) is provided within the active agent supply container (4) for heating up and release of the active agent.

2. The device according to claim 1, wherein at least for increasing the dwell time of the capsule or the dragé

e at a treatment location, the device has a sheath (21) with a filling material or foaming system (22), optionally on an enzymatic basis, which is designed for an immunobiochemical and/or immuno-enzymatic reaction upon reaching an area of inflammation or tumor.

3. The device according to claim 2, wherein besides the sensor(s)(9), a release position of the active agent release element(6), and optionally the treatment electrodes are covered by the sheath (11) in a starting condition.

4. The device according to claim 1, wherein the sheath (11) is dissolvable by the bodily fluid as a function of time and/or material.

5. The device according to claim 1, wherein the electrodes (3) include an outer side electrode having galvanic current generation upon contact with the bodily fluid.

6. The device according to claim 1, wherein the control unit, the treatment assembly, the active agent release element are connected to each other in a sandwich structure and form a complete functional unit.

7. The device according to claim 1, wherein individual structural groups are essentially constructed as chips and are connected to each other using flip-chip-Technology.

8. The device according to claim 1, wherein the active agent release element has at least one porous, structured membrane (7) and one active agent supply for the membrane, wherein the dosing element is located at the active agent supply.

9. The device according to claim 1, wherein the device has at least one pH-sensor (9) and optionally at least two electrodes for iontophoretic purposes, a voltage supply and a control unit.

10. The device according to claim 1, wherein the sensor(s)(9) and the active agent release element in a form of a porous membrane (7) function as a support and contact surface for the area of tissue to be treated.

11. The device according to claim 10, wherein the sensor(s)(9) are arranged in a vicinity of the membrane (7).

12. The device according to claim 10, wherein at least two of the treatment electrodes are provided for iontophoretic purposes at the support and contact area for the tissue area to be treated.

13. The device according to claim 1, including a pH-sensor (9) for determining acidification in an immediate vicinity of the tumor cells, the pH-sensor being based on a semiconductor or on a conductance and impedance measurement.

14. The device according to claim 13, wherein the pH sensor (9) comprises at least one ion-selective field effect transistor (IS-FET).

15. The device according to claim 13, further comprising at least one additional sensor which is an ion or molecular sensor.

16. The device according to claim 12, wherein within the support and contact area for the area of tissue to be treated on a circumferential area of the porous membrane (7), several of the sensors (9) are arranged spaced apart from each other.

17. The device according to claim 1, wherein the active agent supply container (4) is formed by an outer chip (14), an adjacent chip (15) having the heating resistor, and a spacer (17, 23) which encloses a container space and seals it off.

18. The device according to claim 17, wherein the spacer comprises a sealing ring (17) in a form of an O-ring.

19. The device according to claim 17, wherein one of the two adjacent chips has on its side facing the other chip a ring wall (23) constructed by etching, and a front side of the ring wall is sealingly connected with the other chip and bonded by eutectic bonding.

20. The device according to claim 17, wherein the spacer (17, 23) is spaced from an outer edge area of the two adjacent chips and connection contacts (20) are arranged between the two chips in the outer edge area outside of the spacer.

21. The device according to claim 1, wherein the active agent supply container (4) has at least one capillary tube (19) for release of active agent.