Implantation device with handle and method of use thereof

• US 9,439,652 B2
• Filed: 08/24/2009
• Issued: 09/13/2016
• Est. Priority Date: 08/24/2009
• Status: Active Grant

• Current Assignee: QualiMed Innovative Medizinprodukte GmbH
• Original Assignee: QualiMed Innovative Medizinprodukte GmbH
• Inventors: Nissl, Thomas, Mangiardi, Eric K.
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US12/545,982
• Publication Number:
  US 20110046710A1
• Time in Patent Office: 2,577 Days
• Field of Search: 606/108, 623/1.11, 623/1.23, 604/164.01, 604/6.12, 604/38, 604/125, 124/65, 124/31, 254/134.3 R, 433/3, 433/46, 433/85, 433/159, 220/756, 220/757, 220/759, 222/326, 222/327, 222/323, 222/191, 222522- 52
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• 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: A61F 2/06 Blood vessels
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/041 Bile ducts

Abstract

An instrument for deploying an implantable medical device into a body lumen is disclosed. The instrument comprises a base member having a base handle and a deployment extension, a first tubular member having a first tubular body and a first handle, and a second tubular member having a second tubular body and a second handle. The first tubular member fits over the deployment extension and is longitudinally slidable over the deployment extension, and the second tubular member fits over the first tubular member and is longitudinally slidable over the first tubular member. The distal ends of the deployment extension, the first tubular body, and the second tubular body are adapted to hold and deploy the implantable medical device.

Claims

1. An instrument for deploying an implantable medical device in a body lumen, the instrument comprising:

a base member comprising a base handle;

a deployment extension having a distal end and a proximate end, the proximate end is connected to the base handle;

a guiding extension connected to the base handle and extending in a direction parallel to the deployment extension;

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 proximate end; and

a first handle disposed between the first tubular body and the guiding extension, the first handle containing 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; 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 proximate end; and

a second handle for controlling movement of the second tubular member, wherein the second tubular member is longitudinally slidable relative to the deployment extension and wherein the distal end of the second tubular body is configured such that a catheter can be removably attached,

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

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

wherein the distal ends in each of the deployment extension, the first tubular body and the second tubular body comprises a screw, luer or hub that is configured to facilitate removable attachment of a catheter to the distal ends in each of the deployment extension, the first tubular body and the second tubular body.

2. The instrument of claim 1, further comprising a viewing device, which is an endoscope.

3. The instrument of claim 1, wherein the deployment extension comprises means at the distal end for attachment of a catheter.

4. The instrument of claim 1, wherein the body lumen is a blood vessel.

5. The instrument of claim 1, wherein the body lumen is a bile duct.

6. The instrument of claim 1, wherein the first tubular member comprises interlocking means for attachment to the second tubular member.

7. The instrument of claim 6, wherein the interlocking means includes a locking tab on the first tubular body and a matching locking hole on the second tubular body.

8. The instrument of claim 1, wherein the base handle, the first handle and the second handle are beveled handles.

9. The instrument of claim 1, wherein the first tubular member has contoured sides to facilitate single-finger control of the first tubular member.

10. The instrument of claim 1, wherein the deployment extension of the base member further comprises a compression stopper to prevent the instrument from being over deployed.

11. The instrument of claim 1, wherein the implantable medical device is a stent.

12. A method for delivering an implantable medical device to a body lumen using the instrument of claim 1, attaching the first tubular member to the base member by sliding the first tubular body over the implantable medical device and the deployment extension;

attaching the second tubular member to the base member by sliding the second tubular body over the first tubular body;

attaching a proximate end of a catheter to the distal end of the second tubular body, wherein an implantable medical device is attached to a distal end of the catheter;

advancing the distal end of the catheter into the body lumen; 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.

13. The method of claim 12, wherein the retracting step includes:

(1) retracting the second tubular member towards the proximate end of the first tubular member; and

(2) retracting the first tubular member towards the proximate end of the base member.

14. The method of claim 12, wherein the retracting step includes:

(1) retracting the first tubular member towards the proximate end of the base member, and (2) retracting the second tubular member towards the proximate end of the first tubular member.

15. The method of claim 12, further comprising attaching an endoscope to the base member.

16. The method of claim 12, wherein said implantable medical device is attached to a distal end of said catheter.

17. The method of claim 12, wherein the implantable medical device is a stent.

18. The method of claim 12, wherein the body lumen is a blood vessel or a bile duct.

19. The instrument of claim 1, wherein said base member further comprises a coupling device for a viewing device, guide wire, or stabilization or attachment mechanism.

20. The instrument of claim 1, further comprising said deployment extension or said first tubular member having external measurement markers for the determination of retraction distance.

21. The instrument of claim 1, wherein the base member, the first tubular member and the second tubular member are molded from a plastic material and are interchangeable among different devices of different configurations.