Occlusion Bypassing Apparatus With A Re-Entry Needle and a Distal Stabilization Balloon

• US 20170100141A1
• Filed: 10/07/2015
• Published: 04/13/2017
• Est. Priority Date: 10/07/2015
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Morero, Massimo, Nicoli, Giampiero, Guala, Carlo, Scalvini, Giovanni, Miliani, Marco, Saputo, Michele, Vimercati, Claudia, Compagnoni, Ludwig, Zanetti, Davide, Silvestro, Claudio, Argentine, Jeffery
• Granted Patent: US 10,327,791 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61M 2025/0092 Single injection needle protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

An occlusion bypassing apparatus for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The apparatus includes an outer shaft component, a needle component, and an inflatable balloon. The outer shaft component has a side port proximal to a distal end thereof and a needle lumen there-through that includes a curved distal portion that terminates at the side port of the outer shaft component. The needle component is configured to be slidably disposed within the needle lumen of the outer shaft component. The inflatable balloon includes a body portion that is disposed distal to the side port of the outer shaft component, and the body portion of the balloon has a flattened profile in an inflated state with first and second chambers that laterally extend from opposing sides of the outer shaft component for stabilizing the apparatus within a subintimal space.

Claims

1. An apparatus for bypassing an occlusion in a blood vessel comprising:

an outer shaft component having a side port proximal to a distal end thereof, the outer shaft component including a needle lumen there-through that includes a curved distal portion that bends from a longitudinal axis of the apparatus and terminates at the side port of the outer shaft component and an inflation lumen there-through configured to receive inflation fluid;

a needle component configured to be slidably disposed within the needle lumen of the outer shaft component and removable therefrom; and

an inflatable balloon disposed at the distal end of the outer shaft component and in fluid communication with the inflation lumen of the outer shaft component, the balloon including a body portion that is disposed distal to the side port of the outer shaft component, the body portion of the balloon having a flattened profile in an inflated state with first and second chambers that laterally extend from opposing sides of the outer shaft component for stabilizing the apparatus within a subintimal space.

2. The apparatus of claim 1, wherein the body portion of the balloon has a circular profile in a deflated state for maneuvering the apparatus through a vasculature.

3. The apparatus of claim 1, wherein at least one weld extends over the body portion of the balloon to form the first and second chambers thereof.

4. The apparatus of claim 3, wherein first and second welds extend over opposing sides of the body portion of the balloon to form the first and second chambers thereof.

5. The apparatus of claim 1, wherein the balloon includes an elongated proximal neck and a distal neck, the body portion of the balloon extending between the elongated proximal neck and the distal neck, and the elongated proximal neck of the balloon is disposed proximal and distal to the side port of the outer shaft component.

6. The apparatus of claim 5, wherein a proximal cone extends between the elongated proximal neck and the body portion of the balloon and a distal cone extends between the distal neck and the body portion of the balloon, each of the proximal and distal cones extending between a 30 and 40 degree angle relative to the longitudinal axis of the apparatus.

7. The apparatus of claim 6, wherein the distal cone extends at a 30 degree angle relative to the longitudinal axis of the apparatus and the proximal cone extends at a 40 degree angle relative to the longitudinal axis of the apparatus.

8. The apparatus of claim 1, wherein the outer shaft component also includes a guidewire lumen that extends along at least a portion of the outer shaft component and terminates at a distal port at the distal end of the outer shaft component, the guidewire lumen of the outer shaft component being configured to slidingly receive a guidewire there-through.

9. The apparatus of claim 8, wherein a reinforced tubular component is disposed adjacent to the distal end of the outer shaft component and the reinforced tubular component defines a lumen in fluid communication with the guidewire lumen of the outer shaft component, the reinforced tubular component distally extending beyond the distal end of the outer shaft component through the balloon.

10. The apparatus of claim 9, wherein the reinforced tubular component includes a coiled element embedded within a polymer tube.

11. The apparatus of claim 1, wherein a needle housing is disposed within the outer shaft component and the needle housing includes a curved distal portion that defines the curved distal portion of the needle lumen and a transition proximal portion that has a variable flexibility along its length that decreases in a distal direction.

12. The apparatus of claim 11, wherein the needle component has a curved distal end with the same curvature as the curved distal portion of the needle lumen of the outer shaft component and a distal tip of the needle component is configured to penetrate a wall of the vessel.

13. The apparatus of claim 12, wherein in a first configuration of the apparatus the curved distal end of the needle component is held in a straightened form within the needle housing and wherein in a second configuration of the apparatus the curved distal end of the needle component extends from the side port of the outer shaft component and bends from the longitudinal axis of the apparatus.

14. The apparatus of claim 12, wherein the needle component includes a straight segment disposed between the curved distal end and the distal tip.

15. The apparatus of claim 11, wherein a distal tip of the needle housing includes a skive cut forming an opening configured to embed into the outer shaft component.

16. An apparatus for bypassing an occlusion in a blood vessel comprising:

an outer shaft component having a side port proximal to a distal end thereof, the outer shaft component including a needle lumen there-through that includes a curved distal portion that bends from a longitudinal axis of the apparatus and terminates at the side port of the outer shaft component and an inflation lumen there-through configured to receive inflation fluid;

a needle component configured to be slidably disposed within the needle lumen of the outer shaft component and removable therefrom; and

an inflatable balloon disposed at the distal end of the outer shaft component and in fluid communication with the inflation lumen of the outer shaft component, the balloon including an elongated proximal neck, an body portion, and a distal neck, wherein the elongated proximal neck of the balloon is disposed proximal and distal to the side port of the outer shaft component and the body portion of the balloon is disposed distal to the distal end of the outer shaft component, the body portion of the balloon having a flattened profile in an inflated state with first and second chambers that laterally extend from opposing sides of the outer shaft component for stabilizing the apparatus within a subintimal space, wherein at least one weld extends over the body portion of the balloon to form the first and second chambers thereof.

17. The apparatus of claim 16, wherein first and second welds extend over opposing sides of the body portion of the balloon to form the first and second chambers thereof.

18. An apparatus for bypassing an occlusion in a blood vessel comprising:

an outer shaft component having a distal port at a distal end thereof and a side port proximal to the distal end thereof, the outer shaft component including a needle lumen there-through that includes a curved distal portion that bends from a longitudinal axis of the apparatus and terminates at the side port of the outer shaft component, an inflation lumen there-through configured to receive inflation fluid, and a guidewire lumen that extends along at least a portion of the outer shaft component and terminates at the distal port of the outer shaft component, the guidewire lumen of the outer shaft component being configured to slidingly receive a guidewire there-through;

a needle housing disposed within the needle lumen of the outer shaft component, the needle housing including a curved distal portion that defines the curved distal portion of the needle lumen and a transition proximal portion that has a variable flexibility along its length that decreases in a distal direction;

a needle component configured to be slidably disposed within the needle lumen of the outer shaft component and removable therefrom;

an inflatable balloon disposed at the distal end of the outer shaft component and in fluid communication with the inflation lumen of the outer shaft component, the balloon including a body portion that is disposed distal to the distal end of the outer shaft component, the body portion of the balloon having a flattened profile in an inflated state with first and second chambers that laterally extend from opposing sides of the outer shaft component for stabilizing the apparatus within a subintimal space; and

a reinforced tubular component disposed adjacent to the distal end of the outer shaft component, the reinforced tubular component distally extending beyond the distal end of the outer shaft component through the balloon, wherein the reinforced tubular component defines a lumen in fluid communication with the guidewire lumen of the outer shaft component.

19. The apparatus of claim 18, wherein the needle component has a curved distal end with the same curvature as the curved distal portion of the needle lumen of the outer shaft component and a distal tip of the needle component is configured to penetrate a wall of the vessel, and wherein in a first configuration of the apparatus the curved distal end of the needle component is held in a straightened form within the needle housing and wherein in a second configuration of the apparatus the curved distal end of the needle component extends from the side port of the outer shaft component and bends from the longitudinal axis of the apparatus.

20. The apparatus of claim 19, wherein the needle component includes a straight segment disposed between the curved distal end and the distal tip.