Device for performing a cutting-balloon intervention

• US 8,529,450 B2
• Filed: 01/19/2007
• Issued: 09/10/2013
• Est. Priority Date: 01/20/2006
• Status: Active Grant

• Current Assignee: Siemens Healthcare GMBH (Siemens AG)
• Original Assignee: Siemens AG
• Inventors: Maschke, Michael
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): REMALY, MARK DONALD
• Application Number:
  US11/655,972
• Publication Number:
  US 20070173919A1
• Time in Patent Office: 2,426 Days
• Field of Search: 60407-425, 604/31, 60433-471, 604/74, 604/76, 605/09, 606/7, 606/159, 606/191, 606/194, 600407-425, 600/431, 600433-471, 600/474, 600/476, 600/509
• US Class Current: 600/439
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/301 for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/7207 : of noise induced by motion artifacts
• CPC Class Codes: A61B 6/03 : Computed tomography [CT] echo-tomography A61B8/14
• CPC Class Codes: A61B 6/4417 : related to combined acquisition of different diagnostic modalities
• CPC Class Codes: A61B 6/5247 : combining images from an ionising-radiation diagnostic technique and a non-ionising radiation diagnostic technique, e.g. X-ray and ultrasound
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/42 : Details of probe positioning or probe attachment to the patient
• CPC Class Codes: A61F 2/958 : Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/1086 : having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/109 : having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

The invention relates to a device for performing a cutting-balloon intervention that includes a cutting-balloon catheter with an expandable balloon having axially arranged knives, with the cutting-balloon catheter having a pre-mounted stent.

Claims

1. A device for performing a cutting-balloon intervention on a patient, comprising:

a cutting-balloon catheter with an expandable balloon comprising an axially arranged knive;

a stent that is pre-mounted to the cutting-balloon catheter on a second expandable balloon; and

an integrated unit comprising an OCT sensor and an IVUS sensor located next to the expandable balloon for image monitoring;

a drive unit that advances or withdraws the cutting-balloon catheter and simultaneously rotating the OCT sensor and the IVUS sensor;

an OCT signal lead and an IVUS signal lead that connect the OCT sensor and the IVUS sensor to the drive unit respectively for rotating the OCT sensor and the IVUS sensor; and

a flexible drive shaft in which are the OCT signal lead and the IVUS signal lead,

wherein the flexible drive shaft does not rotate and only the OCT sensor and the IVUS sensor rotate to avoid a friction between the cutting-balloon catheter and a vessel wall of the patient.

2. The device as claimed in claim 1, wherein the expandable balloon is located on a tip of the cutting-balloon catheter and the second expandable balloon comprising the stent is located behind the expandable balloon.

3. The device as claimed in claim 1, wherein the stent is at least partially self-opening out.

4. The device as claimed in claim 1,

wherein a material of the stent is at least partially a metal, and

wherein the metal is selected from a group consisting of:

high grade steel, nitinol, and shape memory alloy.

5. The device as claimed in claim 1,

wherein a material of the stent is at least partially a bioresorbable material, and

wherein the bioresorbable material is selected from the group consisting of:

biologic material, magnesium, bio-engineering material, and plastic.

6. The device as claimed in claim 1,

wherein the stent comprises a coating for guiding the cutting-balloon catheter, and

wherein the coating is a nano coating or an active component coating.

7. The device as claimed in claim 1,

wherein the cutting-balloon catheter comprises a position sensor system, and

wherein the position sensor system is an electromagnetic sensor system.

8. The device as claimed in claim 1, wherein the cutting-balloon catheter comprises a device for pushing or pulling the cutting-balloon catheter.

9. The device as claimed in claim 1, wherein a physiological sensor is arranged on a tip of the cutting-balloon catheter.

10. The device as claimed in claim 1, wherein the cutting-balloon catheter comprises a coating for screening or reducing a frictional resistance in a vessel of the patient.

11. The device as claimed in claim 1,

wherein the cutting-balloon catheter comprises a lumen for injecting a contrast medium, and

wherein the contrast medium is an ultrasound contrast medium.

12. The device as claimed in claim 1, wherein the stent comprises an active component selected from the group consisting of:

Sirolimus, Paclitaxel, Everolimus, Rapamycin, and FK 506.

13. The device as claimed in claim 1, wherein the second expandable balloon comprising the stent is located on a tip of the cutting-balloon catheter and the expandable balloon is located behind the second expandable balloon.

14. An x-ray apparatus for performing a cutting-balloon intervention on a patient, comprising:

a radiation source that emits radiation to the patient;

a radiation detector that records an x-ray image data of the patient by detecting the radiation emitted from the radiation source;

a cutting-balloon catheter with an expandable balloon comprising an axially arranged knive that performs the cutting-balloon intervention;

a stent that is pre-mounted to the cutting-balloon catheter;

an integrated unit comprising an OCT sensor and an IVUS sensor located next to the expandable balloon for image monitoring; and

a drive unit that advances or withdraws the cutting-balloon catheter and simultaneously rotating the OCT sensor and the IVUS sensor;

an OCT signal lead and an IVUS signal lead that connect the OCT sensor and the IVUS sensor to the drive unit respectively; and

a flexible drive shaft in which are the OCT signal lead and the IVUS signal lead,

wherein the flexible drive shaft does not rotate and only the OCT sensor and the IVUS sensor rotate to avoid a friction between the cutting-balloon catheter and a vessel wall of the patient.

15. The x-ray apparatus as claimed in claim 14, further comprising an image correcting unit that corrects an image artifact of the x-ray image data due to the stent.

16. The x-ray apparatus as claimed in claim 14, further comprising a position sensor or an ECG sensor or combinations thereof.

17. The x-ray apparatus as claimed in claim 16, wherein the image data recorded by the x-ray apparatus and data recorded by the sensors are read out in a time sequence.

18. The x-ray apparatus as claimed in claim 16, wherein the x-ray image data recorded by the x-ray apparatus is combined or overlaid with an image data recorded by the IVUS sensor or the OCT sensor.

19. A method for performing a cutting-balloon intervention on a patient, comprising:

arranging a cutting-balloon catheter with an expandable balloon comprising an axially arranged knive;

pre-mounting a stent to the cutting-balloon catheter;

performing the cutting-balloon intervention on the patient using the cutting-balloon catheter and

monitoring the intervention by an integrated unit comprising an OCT sensor and an IVUS sensor located next to the expandable balloon;

advancing or withdrawing the cutting-balloon catheter and simultaneously rotating the OCT sensor and the IVUS sensor by a drive unit;

connecting the OCT sensor and the IVUS sensor to the drive unit by an OCT signal lead and an IVUS signal lead respectively;

integrating the OCT signal lead and the IVUS signal lead inside a flexible drive shaft; and

rotating only the OCT sensor and the IVUS sensor without rotating the flexible drive shaft to avoid a friction between the cutting-balloon catheter and a vessel wall of the patient.