Implantation system with handle and catheter and method of use thereof

• US 9,414,943 B2
• Filed: 07/26/2013
• Issued: 08/16/2016
• Est. Priority Date: 08/24/2009
• Status: Active Grant

• Current Assignee: QualiMed Innovative Medizinprodukte GmbH
• Original Assignee: QualiMed Innovative Medizinprodukte GmbH
• Inventors: Mangiardi, Eric K., Schmitt, Martina
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US13/952,334
• Publication Number:
  US 20130310915A1
• Time in Patent Office: 1,117 Days
• Field of Search: 606/108, 604/131, 604/151, 604/155, 604/164.04, 604/164.07
• US Class Current: 1/1
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 17/2841 Handles
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/041 Bile ducts
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 : Guide tubes

Abstract

A system for deploying an implantable medical device into a body lumen is disclosed. The system comprises a catheter having functional zones for stability, protection, flexibility, trackability and pushability. The system further comprises a device for deploying an implantable medical device with the catheter. A method for deploying an implantable medical device into a body lumen using the system is also disclosed.

Claims

1. A method for deploying an implantable medical device comprising;

advancing a catheter into a body lumen, the catheter comprises;

an elongated body having a distal end and a proximate end, the elongated body further comprising;

a stabilization zone at the distal end;

a protection zone located between the stabilization zone and the proximate end, wherein the protection zone is adapted to carry an implantable device;

a flexibility zone located between the protection zone and the proximate end;

a trackability zone located between the flexibility zone and the proximate end;

a pushability zone located between the trackability zone and the proximate end;

a connector at the proximate end for connecting to an advancing device; and

the implantable medical device affixed to the protection zone;

attaching the proximal end of the catheter to the advancing device, the advancing device comprising;

a base member comprising a base handle; and

a deployment extension having a distal end and a proximate end, the proximate end is connected to the base handle, wherein the distal end of the deployment extension is configured to accommodate variable shafts to allow for interchangeability of varying catheter diameters;

a first tubular member that fits over the deployment extension and is longitudinally slidable over the deployment extension, the first tubular member comprising;

a first tubular body with a distal end and a proximal end; and

a first handle for controlling movement of the first tubular member, the first handle disposed between the first tubular body and the guiding extension; and

a second tubular member that fits over the first tubular member and is longitudinally slidable over the first tubular member, the second tubular member comprising;

a second tubular body with a distal end and a proximal end; and

a second handle for controlling movement of the second tubular member,

wherein the first handle is located between the base handle and the second handle and

wherein the distal ends of the deployment extension, the first tubular body, and the second tubular body are adapted to deploy an implantable medical device, and

retracting the first tubular member and the second tubular member towards the base member to deploy the implantable medical device in the body lumen.

2. The method of claim 1, wherein the implantable medical device is a stent.

3. The method of claim 1, further comprising attaching a viewing device to the base member.

4. The method of claim 3, wherein the viewing device is an endoscope.

5. The method of claim 1, wherein the body lumen is a blood vessel or a bile duct.

6. The method of claim 1, wherein the protection zone of the catheter comprises an inflatable balloon for deploying the implantable medical device.

7. The method of claim 1, wherein the tractability zone of the catheter is coated with or comprises an embedded radio-opaque substance.

8. The method of claim 1, wherein the stabilization zone of the catheter is coated with or comprises an embedded radio-opaque substance.

9. The method of claim 1, wherein the protection zone of the catheter is coated with or comprises an embedded radio-opaque substance.

10. The method of claim 1, wherein the flexibility zone of the catheter is coated with or comprises an embedded radio-opaque substance.

11. The method of claim 1, wherein the pushability zone of the catheter is coated with or comprises an embedded radio-opaque substance.

12. The method of claim 1, wherein the catheter further comprises a transition area resided between two adjacent zones of different flexibility, wherein the transition area has a flexibility that is intermediate between the flexibilities of the two zones.

13. The method of claim 1, wherein the catheter further comprises a strain relief area between the pushability zone and the connector.

14. The method of claim 1, wherein the stabilization zone and the protection zone of the catheter have a flexibility index of less than 3000 mN.

15. The method of claim 1, wherein the flexibility zone of the catheter has a flexibility index of less than 3500 mN.

16. The method of claim 1, wherein the trackability zone has a flexibility index of less than 4500 mN.

17. The method of claim 1, wherein the pushability zone of the catheter has a flexibility index of less than 6000 mN.

18. The method of claim 1, wherein the stabilization zone and the protection zone of the catheter have a flexibility index of less than 3000 mN, the flexibility zone of the catheter has a flexibility index of less than 3500 mN, the trackability zone of the catheter has a flexibility index of less than 4500 mN, and the pushability zone of the catheter has a flexibility index of less than 6000 mN.

19. The method of claim 1, wherein the diameters of the zones of the catheter are the same as one another.

20. The method of claim 1, wherein the diameters of the zones of the catheter are different from one another.

21. The method of claim 1, wherein the advancing device comprises a guiding extension connected to the base handle and extending in a direction parallel to the deployment extension, and

wherein the first handle comprises a stabilizing ring fitting over the guiding extension and longitudinally slidable thereover such that movement of the first tubular member is controlled and rotation of the first tubular member relative to the base member is prevented.