METHODS AND DEVICES FOR CLOTS AND TISSUE REMOVAL

• US 20180014840A1
• Filed: 01/21/2017
• Published: 01/18/2018
• Est. Priority Date: 07/12/2016
• Status: Active Grant

• Current Assignee: CardioProlific Inc. (Koninklijke Philips N.V.)
• Original Assignee: CardioProlific Inc. (Koninklijke Philips N.V.)
• Inventors: Panian, Justin P.
• Granted Patent: US 10,980,555 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/320766 eccentric
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 1/75 Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• CPC Class Codes: A61M 1/81 Piston pumps, e.g. syringes
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32

Abstract

The present invention provides devices and methods for removal clots and other obstructive tissue and materials from humans located inside or outside of the patient'"'"'s endovascular system using aspiration alone, and in combination with rotational maceration and aspiration.

Claims

1. A clot removal device, comprising:

an aspiration catheter having at least one axial lumen;

a rotational device having a rotating shaft having a distal end, and an expandable braid attached to the distal end of the shaft and extending through the lumen of the aspiration catheter, wherein the expandable braid is delivered to a treatment site where blood clots are located from a first delivery position to a second clot engagement position, wherein in the first delivery position the expandable braid is in an unexpanded state inside the aspiration catheter having a first diameter, and wherein in the second position, the expandable braid is in a partially expanded position, having a second diameter that is greater than the first diameter when deployed outside the aspiration catheter and into clots, wherein the braid expands outwardly during rotations and macerates surrounding clots as the braid expands to its expanded state, and wherein the braid rotates concentrically along its longitudinal axis and expands radially as the braid rotates.

2. The device of claim 1, wherein the expandable braid has a distal end that has a distal tip thereat, and the distal tip prevents the distal end of the expandable braid from distally opening when deployed from the aspiration catheter, and wherein the distal tip is made of one of the following materials:

metal, polymer, rubber, adhesive or a combination thereof.

3. The device of claim 1, wherein the expandable braid has a cross-sectional shape that includes one of the following configurations:

circular, non-circular or a combination of both.

4. The device of claim 1, wherein the expandable braid has a diameter that is at least 1.5 times larger in its fully expanded state than in its unexpanded state when inside the aspiration catheter.

5. The device of claim 1, wherein the expandable braid comprises between 3-48 strands formed from a plurality of Nitinol wires having an outside diameter between 0.001 inches and 0.020 inches, wherein the outside diameter of the expandable braid is between 1-40 mm when in the expanded state.

6. The device of claim 1, wherein the expandable braid is formed from a plurality of Nitinol wire strands having variable wire dimensions braided into a tubular shape using one of the following:

circular wire, oval wire, flat wire or a combination thereof.

7. The device of claim 1, wherein the rotational device rotates in one of the following directions:

clockwise, anti-clockwise and a combination of both.

8. The device of claim 1, wherein the expandable braid comprises one continuous braid having at least two different outside dimensions.

9. The device of claim 1, wherein the expandable braid has a distal end, the rotating shaft is attached to the distal end of the expandable braid, and wherein the expandable braid has a proximal expandable braid section that is freely movable over the rotating shaft.

10. A clot removal device, comprising:

an aspiration catheter having at least one axial lumen;

a rotational device having a rotating shaft having a distal end, and an expandable braid attached to the distal end of the shaft and extending through the lumen of the aspiration catheter, wherein the expandable braid is delivered to a treatment site where blood clots are located from a first delivery position to a second clot engagement position, wherein in the first delivery position the expandable braid is in an unexpanded state inside the aspiration catheter having a first diameter, wherein in the second position, the expandable braid is in a partially expanded position, having a second diameter that is greater than the first diameter when deployed outside the aspiration catheter and into clots, wherein the braid expands outwardly during rotations and macerates surrounding clots, and wherein the braid rotates eccentrically along its longitudinal axis and expands radially as the braid rotates.

11. The device of claim 10, wherein the expandable braid has a distal end and a proximal end, and the distal end and the proximal end of the expandable braid rotate adjacent to the longitudinal axis of the braid.

12. A device for removing obstructive material, comprising:

an aspiration catheter having at least one axial lumen;

a constraining wire

a rotational device comprising an expandable braid having a distal end, and a rotational tubular member attached to the distal end of the expandable braid, wherein the proximal end of the expandable braid is movable over the constraining wire, wherein the rotational device is delivered through the lumen of the aspiration catheter, and wherein a stopper element is positioned on the constraining wire to prevent the expandable braid against over expansion while allowing stretching of the expandable braid when the expandable braid is moved distally.

13. The device of claim 12, wherein the stopper element maintains a predetermined size for the expandable braid.

14. The device of claim 12, wherein the rotational shaft has one of the following configurations:

solid wire, rod, cable, coil, tube or a combination thereof.

15. A device for removing obstructing matter from human body, comprising:

an aspiration catheter having at least one lumen, a distal end and a proximal end;

a liquid diaphragm pump attached to the proximal end of the aspiration catheter, wherein the speed at which the diaphragm reciprocates within the pump is higher than 2000 RPM, wherein the diaphragm stroke is more than 0.010″

, wherein the liquid pump produces instantaneous maximum pressure within less than 15 seconds from activation of the pump.

16. The device of claim 15, further including a rotational member having a distal end and a proximal end that can be rotated and longitudinally moved back and forth within the aspiration catheter, wherein the distal end of the rotational member has a bent shape, and wherein the rotational member is at least partially positioned within the aspiration catheter.

17. The device of claim 15, further including a syringe attached to the proximal end of the aspiration catheter.

18. A clot removal device, comprising:

an aspiration catheter having at least one axial lumen, a distal end and a proximal end;

a liquid aspiration pump having a non-return valve attached to the proximal end of the aspiration catheter; and

a syringe attached to the proximal end of the aspiration catheter, wherein vacuum applied by the syringe increases aspiration pressure within the aspiration catheter above a level provided by the liquid aspiration pump regardless of whether the pump is ON or OFF.

19. The device of claim 18, wherein the liquid pump is a diaphragm pump that is primed with saline flush before use.

20. The device of claim 18, wherein the liquid aspiration pump is sterile and is adapted for use within a patient adjoining sterilized field.