Deployment system incorporating application of adhesive

• US 10,219,792 B2
• Filed: 05/22/2015
• Issued: 03/05/2019
• Est. Priority Date: 05/23/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Edelman, Peter G., Christakis, Laura Elizabeth, Harris, Colby, Zarembo, Paul E.
• Primary Examiner(s): Stransky, Katrina
• Application Number:
  US14/720,105
• Publication Number:
  US 20150335321A1
• Time in Patent Office: 1,383 Days
• Field of Search: 623 136
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/00522 Sprayers
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/005 using adhesives

Abstract

The present disclosure is directed to a delivery catheter with a mechanism of discharging an adhesive during and/or immediately prior to deployment of the medical device by the delivery catheter.

Claims

1. A method of implanting a medical device in a body lumen comprising:

advancing a delivery catheter having the medical device disposed within an interior of the delivery catheter, through the body lumen to a deployment site, the medical device being selected from the group consisting of stents and valves, the delivery catheter defining at least one adhesive delivery channel having at least one discharge opening that either faces distally and extends through a distal end face of the delivery catheter to discharge adhesive in a distal direction distally beyond the distal end face, or that extends through a sidewall of the delivery channel and faces radially outward from the delivery channel relative to a longitudinal axis of the delivery catheter to discharge adhesive in a radially outward direction, for discharging the adhesive therefrom; and

thereafter, deploying the medical device from the delivery catheter at the deployment site while discharging an adhesive from the adhesive delivery channel in the delivery catheter during deployment of the medical device, the adhesive being discharged onto the medical device, a wall of the body lumen, or combinations thereof.

2. The method of claim 1, the adhesive delivery channel having a plurality of discharge openings for discharging the adhesive.

3. The method of claim 1, the adhesive delivery channel being a plurality of adhesive delivery channels.

4. The method of claim 3, wherein discharging the adhesive comprises depositing a plurality of lines of the adhesive from the plurality of adhesive delivery channels.

5. The method of claim 3, the delivery catheter comprising an outer sheath overlaying the medical device, the adhesive delivery channel secured to the outer sheath.

6. The method of claim 3, the delivery catheter comprising an outer sheath positioned over the medical device, the outer sheath defining the adhesive delivery channel;

wherein retracting the outer sheath from the medical device and discharging the adhesive are concurrent.

7. The method of claim 3, the delivery catheter comprising:

an inner sheath overlaying the medical device, the inner sheath comprising a distal end region and the plurality of adhesive delivery channels;

an outer sheath having a distal end and positioned over the inner sheath so that the distal end of the outer sheath is distal to the distal end region of the inner sheath;

wherein upon retraction of the outer sheath relative to the inner sheath, the plurality of adhesive delivery channels extend outward for discharging adhesive onto the wall of the body lumen during deployment of the medical device.

8. The method of claim 7, a circumference of the distal end region of the inner sheath being discontinuous.

9. The method of claim 7, the plurality of adhesive delivery channels comprising a shape memory polymer or an electroactive polymer.

10. The method of claim 1, wherein discharging the adhesive comprises spraying the adhesive.

11. The method of claim 10, the adhesive delivery channel comprising a nozzle for spraying the adhesive.

12. The method of claim 1, wherein the adhesive is discharged onto the medical device as the medical device is delivered from the distal end of the delivery catheter.

13. The method of claim 1, wherein the adhesive is discharged onto the wall of the body lumen.

14. The method of claim 1, the delivery catheter comprising an adhesive injection port positioned at a proximal region of the delivery catheter, the adhesive injection port in fluid communication with the adhesive delivery channel.

15. The method of claim 1, the delivery catheter comprising a catheter adhesive reservoir in fluid communication with the adhesive delivery channel.

16. A delivery catheter for a medical device comprising:

an inner shaft;

an inner sheath having a longitudinal axis and extending around the inner shaft, the inner sheath comprising a distal end region and defining at least one adhesive delivery channel comprising a discharge opening, the adhesive delivery channel forming the distal end region of the inner sheath; and

an outer sheath;

wherein the distal end region of the inner sheath is configured to move between a first configuration in which the at least one adhesive delivery channel extends along the longitudinal axis when the inner sheath is disposed within the outer sheath, to a second configuration in which the at least one adhesive delivery channel is moved radially outward relative to the inner shaft upon an initial retraction of the outer sheath.

17. A method of implanting a medical device in a body lumen comprising:

advancing a delivery catheter having the medical device disposed within an interior of the delivery catheter, through the body lumen to a deployment site, the delivery catheter comprising a distal tip, the delivery catheter defining an adhesive delivery channel having a discharge opening positioned in the distal tip;

thereafter, discharging an adhesive from the distal tip of the delivery catheter onto an inner surface of the body lumen at the deployment site; and

deploying the medical device from the delivery catheter in the body lumen at the deployment site immediately after discharging the adhesive.

18. The method of claim 17, the delivery catheter further comprising an inner shaft secured to the distal tip, the adhesive delivery channel further positioned in a wall of the inner shaft.

19. The method of claim 17, wherein the delivery catheter is moved in a first direction while discharging the adhesive and the delivery catheter is moved in a second direction opposite the first direction while deploying the medical device.

20. The method of claim 17, wherein the distal tip of the delivery catheter comprises an adhesive reservoir.