Delivery system for medical devices

• US 20050090890A1
• Filed: 09/22/2004
• Published: 04/28/2005
• Est. Priority Date: 09/12/2003
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Fitzgerald, Keif, Wu, Patrick P., Klocke, Stephanie
• Granted Patent: US 7,993,384 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• CPC Class Codes: A61M 2025/0062 having features to improve the sliding of one part within another by using lubricants or surfaces with low friction coatings A61M2025/0046
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter

Abstract

The invention is directed to a delivery system for implantation a self-expanding medical device in a body which includes a control handle and a catheter portion. The catheter portion includes an outer restraining member which covers the collapsed, medical device, an inner catheter member having a distal end including a region upon which the medical device is mounted, and an outer sheath which is removably attached to the control handle. The outer sheath creates a conduit for the catheter portion to prevent the inner catheter member from moving axially when the outer restraining member is retracted. The control handle has a rotatable thumbwheel to actuate a retraction mechanism attached to the proximal end of the outer restraining member which moves the restraining member in a proximal direction to deploy the medical device.

Claims

1. A system for delivering and deploying a medical device within a patient, the system comprising:

a delivery catheter including an inner tubular member having a region for mounting the medical device thereon, a restraining member co-axially disposed over the inner tubular member and the medical device, the restraining member being adapted for axial movement with respect to the inner tubular member and an outer sheath which extends co-axially over a portion of the restraining member, the outer sheath being attachable to the entry point of the patient to provide a conduit for the delivery catheter to prevent the distal end of the inner tubular member from moving distally when the restraining member is retracted, each of the inner tubular member, restraining member and outer sheath having a side exit opening formed therein which cooperatively form a guide wire lumen for receiving a guide wire; and

a control handle attached to the delivery catheter and adapted to retract the restraining member sheath to uncover the medical device.

2. The delivery system of claim 1, wherein a passage is formed between the outer sheath and the retraining member to allow a guide wire to extend through the side exit opening of the restraining member and the side exit opening of the outer sheath.

3. The delivery system of claim 1, wherein the location of the side exit openings on the inner tubular member, retraining sheath and outer sheath are arranged to prevent a guide wire located in the guide wire lumen from moving when the restraining member is being retracted.

4. The delivery system of claim 3, wherein the end of the restraining member includes a distal portion adapted to cover the medical device, the diameter of the distal portion being larger than the diameter of the remainder of the restraining member and the outer sheath has a distal end which tapers towards the surface of the retraining member.

5. The delivery system of claim 4, wherein the distal end of the outer sheath is placed sufficiently away from the distal portion of the restraining member to prevent the distal portion from abutting against the distal end of the outer sheath as the restraining member is retracted.

6. The delivery system of claim 5, wherein the side exit openings have a longitudinal length which prevents a guide wire located in the guide wire lumen from moving as the restraining member is being retracted.

7. The delivery system of claim 1, wherein the proximal end of the outer sheath is attached to a strain relief member which is removably attached to the control handle.

8. The delivery system of claim 1, wherein each of the inner tubular member, restraining member and outer sheath have an outer surface and at least one of the surfaces is plastically deformed to create a treated surface having raised projections which decrease the amount of surface contact between the treated surface and a surface which is in sliding contact with the treated surface.

9. The delivery system of claim 8, wherein the outer sheath has a lumen through which the restraining member is disposed and the restraining member has a treated surface which contacts the surface which defines the lumen of the outer sheath.

10. The delivery system of claim 8, wherein the retraining member has a lumen through which the inner tubular member extends through and the inner tubular member has a treated surface which contacts the surface forming the lumen of the restraining member.

11. The delivery system of claim 9, wherein the retraining member has a lumen through which the inner tubular member extends through and the inner tubular member has a treated surface which contacts the surface forming the lumen of the restraining member.

12. The delivery system of claim 1, wherein each of the inner tubular member, restraining member and outer sheath have an outer surface and at least one of the surfaces is formed with raised projections which creates a formed surface that decrease the amount of surface contact between the formed surface and a surface which is in sliding contact with the formed surface.

13. The delivery system of claim 12, wherein the outer sheath has a lumen through which the restraining member is disposed and the restraining member has a formed surface which contacts the surface which defines the lumen of the outer sheath.

14. The delivery system of claim 12, wherein the retraining member has a lumen through which the inner tubular member extends through and the inner tubular member has a formed surface which contacts the surface forming the lumen of the restraining member.

15. The delivery system of claim 13, wherein the retraining member has a lumen through which the inner tubular member extends through and the inner tubular member has a formed surface which contacts the surface forming the lumen of the restraining member.

16. The delivery system of claim 12, wherein the material used to create the formed surface on the inner tubular member, restraining member or outer sheath is a thermoplastic.

17. The delivery system of claim 12, wherein the material used to create the formed surface on the inner tubular member, restraining member or outer sheath is a thermoset plastic.

18. A catheter system for delivering and deploying a medical device within a patient, the catheter system comprising:

an inner tubular member having a region for mounting the medical device thereon and a restraining member co-axially disposed over the inner tubular member and the medical device, the restraining member being adapted for axial movement with respect to the inner tubular member, wherein the inner tubular member and restraining member have an outer surface which is in sliding contact with each other and at least one of the outer surfaces is plastically deformed to create a treated surface having raised projections which decrease the amount of surface contact between the treated surface and the surface which is in sliding contact with the treated surface.

19. A catheter system for delivering and deploying a medical device within a patient, the catheter system comprising:

an inner tubular member having a region for mounting the medical device thereon and a restraining member co-axially disposed over the inner tubular member and the medical device, the restraining member being adapted for axial movement with respect to the inner tubular member, wherein the inner tubular member and restraining member have outer surfaces which come in sliding contact with each other, at least one of the surfaces having a formed outer surface having raised projections which decrease the amount of surface contact between the formed surface and the surface in sliding contact with the formed surface.

20. The catheter system of claim 19, wherein the material forming the inner member and restraining member is a tubing which is extruded to a size and shape which includes the formed surface.