Device for treatment of aneurysm

• US 9,795,320 B2
• Filed: 10/10/2008
• Issued: 10/24/2017
• Est. Priority Date: 10/11/2007
• Status: Active Grant

• Current Assignee: Kirk Promotion Ltd.
• Original Assignee: Kirk Promotion Ltd.
• Inventors: Forsell, Peter
• Primary Examiner(s): YABUT, DIANE D
• Application Number:
  US12/682,501
• Publication Number:
  US 20100211092A1
• Time in Patent Office: 3,301 Days
• Field of Search: 606194, 606201, 600 16, 600 17, 600 18
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• 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 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/4393 Sexual arousal or erectile dysfunction evaluation, e.g. tumescence evaluation
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61F 2002/30668 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2002/3067 for data transfer
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0002 : for data transfer
• CPC Class Codes: A61M 60/268 : the displacement member being flexible, e.g. membranes, diaphragms or bladders
• CPC Class Codes: A61M 60/274 : the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/427 : the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/531 : using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/554 : of blood pressure
• CPC Class Codes: A61N 1/0556 : Cuff electrodes
• CPC Class Codes: A61N 1/37252 : Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/3787 : from an external energy source

Abstract

In a method, system and device a member is provided around an aneurysm enabling treatment and monitoring of the aneurysm. In accordance with one embodiment the device is adapted to be adjusted postoperatively. Hereby the treatment can be efficiently carried out without having to perform surgery when adjusting the member.

Claims

1. A device for treating a vascular aneurysm of a human or mammal patient, comprising:

an implantable member adapted to hold fluid, the implantable member being adapted to be placed against an outside of a blood vessel having the aneurysm and to exercise a pressure on the aneurysm to prevent or reduce an expansion of the aneurysm, wherein the implantable member comprises two or more segments that are arranged after each other in an axial direction of the blood vessel and individually adjustable in a radial direction of the blood vessel such that the implantable member can be adjusted to follow an outer contour of the aneurysm, and wherein said two or more segments are adapted to provide a pressure that is equal or less than the diastolic blood pressure of the human or mammal patient.

2. The device according to claim 1, wherein the device is adapted to monitor an expansion of the aneurysm.

3. The device according to claim 1, comprising a control unit and a sensor, wherein the control unit is adapted to control the pressure applied onto the aneurysm based on the signal generated by the sensor.

4. The device according to claim 1, wherein the implantable member is a Y-shaped member, and wherein the implantable Y-shaped member is adapted to be placed at the Aorta Bifurcation.

5. The device according to claim 1, further comprising a pressure regulator adapted to achieve a substantially even pressure affecting the aneurysm from the outside of the blood vessel.

6. The device according to claim 1, wherein the implantable member is an elastic member, and wherein the elastic member is adapted to apply a pressure onto the aneurysm and has an expansion interval wherein the pressure applied is substantially constant or within an interval for treating and reducing expansion of the aneurysm.

7. The device according to claim 1, wherein the implantable member is spring loaded.

8. The device according to claim 1, wherein the implantable member is adapted to exert an essentially constant pressure or a pressure reducing the pressure difference, caused by changes in blood pressure in the blood vessel, on the aneurysm.

9. The device according to claim 1, further comprising a control device adapted to increase the pressure on the blood vessel when the aneurysm expands and being implanted in the patient, the control device adapted to increase the pressure on the blood vessel when at least one of:

the aneurysm expands more than a predetermined value, and the aneurysm expands more than a predetermined value during a time period.

10. The device according to claim 1, further comprising logic circuitry for determining when the aneurysm is expanding based on a signal from a sensor or measuring device.

11. The device according to claim 1, further comprising an electrical pulse generator adapted to provide stimulation of the aneurysm wall via electrodes located on the inside of the implantable member, and a control unit adapted to vary the position of the electrical stimulation signals for stimulation of the aneurysm.

12. The device according to claim 1, further comprising a sensor or measuring device for sensing or measuring an expansion of the aneurysm, and a volume control unit adapted to directly or indirectly control the volume in the implantable member based on a signal generated by the sensor or measuring device for controlling an expansion of the aneurysm.

13. The device according to claim 12, wherein the volume control unit controls the volume in the implantable member for generating a signal corresponding to a parameter related to the aneurysm or the treatment of the aneurysm based on a signal indicative of at least one of:

a parameter that corresponds to the size of the aneurysm, flow of fluid from the implantable member to the first reservoir, volume in the first reservoir, and pressure in the fluid filled implantable member.

14. The device according to claim 1, further comprising a feed back alarm system based on the expansion of the aneurysm being controlled.

15. The device according to claim 1, further comprising an implantable internal energy source for powering implantable energy consuming components of the device.

16. The device according claim 15, further comprising a wireless energy-transmission device for non-invasively energizing implantable energy consuming components of the device with wireless energy.

17. The device according to claim 15, further comprising a feedback device for sending feedback information from inside the patient'"'"'s body to the outside thereof, the feedback information being related to at least one of a physical parameter of the patient and a functional parameter related to the device.

18. The device according to claim 15, further comprising (i) a sensor, (ii) a measuring device, or (iii) a sensor and a measuring device and an implantable internal control unit for controlling the device in response to information being related to at least one of:

a) a physical parameter of the patient sensed by the sensor or measured by the measuring device, and b) a functional parameter related to the device sensed by the sensor or measured by the measuring device.

19. The device according to claim 15, further comprising implantable electrical components, including (i) at least one voltage level guard, (ii) at least one constant current guard, or (iii) at least one voltage level guard and at least one constant current guard.

20. The device according to claim 15, further comprising an operation device for operating the device, the operating device comprising at least one of:

a) at least one motor, b) at least one motor comprising a servo designed to decrease the force needed for the motor to operate the device, instead the motor acting a longer way increasing the time for a determined action, and c) at least one pump for operating the device, wherein the pump is adapted to operate a hydraulic operation device for operating the device.

21. The device according to claim 15, further comprising an external data communicator and an implantable internal data communicator for communicating with the external data communicator, wherein (i) the internal communicator feeds data related to the device or the patient to the external data communicator, (ii) the external data communicator feeds data to the internal data communicator, or (iii) the internal communicator feeds data related to the device or the patient to the external data communicator and the external data communicator feeds data to the internal data communicator.

22. The device according to claim 1, further comprising an implantable injection port, adapted to, based on the expansion of the aneurysm being sensed or measured, move a liquid to calibrate the volume in a first reservoir to keep the first reservoir within a pressure regulation volume treatment interval, when the aneurysm expands.

23. The device according to claim 1, wherein said two or more segments are provided in at least one of the following ways:

axially along the blood vessel and radially along the blood vessel.

24. The device according to claim 1, wherein the implantable member is hydraulically adjustable.

25. The device according to claim 24, wherein the device comprises a hydraulic fluid reservoir and an implantable pump adapted to pump hydraulic fluid from the hydraulic fluid reservoir to the implantable member.

26. The device according to claim 24, wherein the device comprises a hydraulic fluid reservoir adapted to be pressurized for delivering a pressurized hydraulic fluid to the implantable member.

27. The device according to claim 26, wherein the pressurized hydraulic fluid reservoir is spring loaded.

28. The device according to claim 26, wherein the reservoir is adapted to be able to change its volume while keeping substantially the same pressure, such that the same pressure can be kept onto the aneurysm although the aneurysm expands.

29. The device according to claim 26, wherein the hydraulic fluid reservoir has a predetermined optimal pressure regulation volume treatment interval, and wherein a pressure regulator further comprises a second reservoir connected to the hydraulic fluid reservoir, the device being adapted to move liquid from the hydraulic fluid reservoir to the second reservoir to keep the hydraulic fluid reservoir within the regulation interval, when the aneurysm expands and liquid is moved from the implantable member into the hydraulic fluid reservoir.

30. The device according to claim 1, wherein the implantable member is mechanically adjustable.

31. The device according to claim 30, wherein the mechanically adjustable implantable member is adjustable by an adjustment screw.

32. The device according to claim 1, wherein the two or more segments comprises gel filled pads adapted to engage the blood vessel.

33. The device according to claim 32, wherein the gel filled pads are provided with different tilting angles.