Implantation system with handle and catheter and method of use thereof

• US 10,485,685 B2
• Filed: 05/23/2016
• Issued: 11/26/2019
• 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:
  US15/162,167
• Publication Number:
  US 20160279387A1
• Time in Patent Office: 1,282 Days
• 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 kit comprising:

a catheter for deploying an implantable medical device, the catheter having a tip at its distal end and a connector at its proximal end, and

an advancing device, the advancing device comprising;

a base member comprising a base handle and a deployment extension having a distal end and a proximal end, the proximal end is connected to the base handle and a guiding extension having a distal end and a proximal end, the proximal end being connected to the base handle;

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; 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,

wherein the connector of the catheter is configured to be directly, removably, attached to the distal end of the deployment extension or the distal end of the first tubular body or the distal end of the second tubular body of the advancing device, and

wherein the first handle connects the first tubular body to the guiding extension, and wherein the base handle connects the deployment extension to the guiding extension.

2. The kit of claim 1, further comprising an implantable medical device.

3. The kit of claim 2, wherein the implantable medical device is a stent.

4. The kit of claim 1, further comprising a viewing device attachable to the base member.

5. The kit of claim 4, wherein the viewing device is an endoscope.

6. The kit of claim 1, wherein the catheter comprises a stabilization zone proximate to the tip, a protection zone proximate to the stabilization zone, a flexibility zone proximate to the protection zone, a pushability zone proximate to the flexibility zone and a strain relief area between the pushability zone and the connector.

7. The kit of claim 6, wherein the catheter further comprises a trackability zone located between the flexibility zone and the pushablility zone, wherein the trackability zone is coated with or comprises an embedded radio-opaque substance.

8. The kit of claim 7, wherein the trackability zone has a length of about 150 mm to about 250 mm.

9. The kit of claim 7, wherein the trackability zone has a flexibility index that is intermediate between the flexibility indices of the flexibility zone and the pushability zone.

10. The kit of claim 6, wherein the stabilization zone, the protection zone, the flexibility zone, the pushability zone, or a combination thereof are coated with or comprise an embedded radio-opaque substance.

11. The kit of claim 6, 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.

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

13. The kit of claim 6, wherein the stabilization zone has a length of between about 1 to about 5 mm.

14. The kit of claim 6, wherein the protection zone has a length of between about 100 to about 200 mm.

15. The kit of claim 6, wherein the flexibility zone has a length of between about 50 to about 150 mm.

16. The kit of claim 6, wherein the flexibility zone has a flexibility index that is higher than the flexibility index of the stabilization zone or the flexibility index of the protection zone.

17. The kit of claim 16, wherein the flexibility index of the flexibility zone is within a range of up to about 110% of the flexibility index of the stabilization zone or the flexibility index of the protection zone.

18. The kit of claim 6, wherein the pushability zone has a length of between about 100 to about 1020 mm.

19. The kit of claim 1, wherein the kit further comprises an introducer sheath.

20. The kit of claim 1, wherein the base handle, the first handle, and the second handle are structurally arranged so they can be pulled together with a single hand.

21. The kit of claim 1, 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.