Interventional catheter system and methods

• US 10,226,598 B2
• Filed: 06/05/2017
• Issued: 03/12/2019
• Est. Priority Date: 02/05/2008
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Chou, Tony M., Garrison, Michi E., Hyde, Gregory M., Renati, Richard J., Schaer, Alan K.
• Primary Examiner(s): Stransky, Katrina
• Assistant Examiner(s): Mendoza, Michael
• Application Number:
  US15/613,891
• Publication Number:
  US 20170361072A1
• Time in Patent Office: 645 Days
• CPC Class Codes: A61B 34/30 Surgical robots
• 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 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

An interventional catheter is adapted for treating a blood vessel. In an embodiment, the catheter includes an elongate shaft sized for insertion in a blood vessel and a stent positioned on a distal region of the elongate shaft. An expandable dilation member is coupled to a distal region of the elongate shaft. The expandable dilation member is adapted to expand outward. A stent containment member is positioned over the elongate shaft and the stent to contain the stent in a collapsed state.

Claims

1. A method of treating a blood vessel, comprising:

transcervically inserting a catheter system into a carotid artery, the catheter system comprising;

a distal section forming part of a reverse flow path of an embolic protection system;

a proximal extension outside of the reverse flow path and connected to the distal section by a connector;

an elongate shaft sized for insertion through the access sheath positioned transcervically in the carotid artery;

a self-expanding stent positioned on a distal region of the elongate shaft;

a retractable stent containment member slidably positioned over the elongate shaft and the stent to contain the stent in a collapsed state, wherein the retractable stent containment member is configured to be retracted from the elongate shaft a first length of the distal region exposing the self-expanding stent and wherein the stent containment member is longer than the elongate shaft;

a control mechanism on a proximal region of the elongate shaft, wherein the control mechanism is coupled to the stent containment member and can be used to retract the stent containment member; and

a flow shunt fluidly connected to the access sheath and forming a part of the reverse flow path of the embolic protection system, wherein the flow shunt comprises two or more parallel flow paths and a valve to open or close one or more of the parallel flow paths selectively directing blood flow through the one or more of the parallel flow paths to adjust a state of flow through the flow shunt; and

retracting the stent containment member from the elongate shaft to withdraw the stent containment member from the distal section and into the proximal extension proximal to the connector.

2. A method as in claim 1, wherein the first length is approximately 25 cm.

3. A method as in claim 1, wherein the stent containment member is completely retractable from the elongate shaft while the shaft is positioned in the carotid artery.

4. A method as in claim 1, wherein the stent containment member adds resistance to reverse flow through the reverse flow path in the access sheath and retraction of the stent containment member from the distal section of the access sheath into the proximal extension removes the resistance to reverse flow through the reverse flow path and increases the level of reverse flow during stent expansion.

5. A method as in claim 1, wherein the connector connects the reverse flow path to the flow shunt.

6. A method as in claim 1, wherein one of the two or more parallel flow paths comprises a main lumen and a secondary lumen having a flow resistance that is higher than a flow resistance of the main lumen.

7. A method as in claim 6, wherein the secondary lumen is longer and/or has a smaller diameter than the main lumen.

8. A method as in claim 7, wherein a pressure drop is created in the main lumen across an inlet and outlet of the secondary lumen.

9. A method as in claim 6, wherein the valve is configured to block flow through the main lumen and divert all flow to the secondary lumen increasing flow resistance and reducing rate of flow.

10. A method as in claim 9, wherein the valve is configured to block flow through the secondary lumen and divert all flow to the main lumen decreasing flow resistance and increasing the rate of flow.