Thrombus removal system and process

• US RE47,376 E1
• Filed: 02/22/2016
• Issued: 05/07/2019
• Est. Priority Date: 04/01/2005
• Status: Expired due to Fees

• Current Assignee: Nexgen Medical Systems, Inc.
• Original Assignee: Nexgen Medical Systems, Inc.
• Inventors: Pokorney, James L., Finitsis, Stephanos, Kucharczyk, John
• Primary Examiner(s): Dawson, Glenn K
• Application Number:
  US15/050,442
• Time in Patent Office: 1,170 Days
• Field of Search: None
• CPC Class Codes: N/A

Abstract

A device capable of capturing and facilitating the removal of a thrombus in blood vessels (or stones in biliary or urinary ducts, or foreign bodies) uses a soft coil mesh with the aid of a pull wire or string to engage the surface of a thrombus, and remove the captured thrombus. The soft coil mesh is formed by an elongated microcoil element that forms the helical elements of a macrocoil element. The microcoil element provides a relatively elastic effect to the helical elements forming the macrocoil and allows for control of gripping forces on the thrombus while reducing non-rigid contact of the device with arterial walls. The use of multiple coil mesh elements, delivered through a single lumen or multiple lumens, preferably with separate control of at least one end of each coil, provides a firm grasp on a distal side of a thrombus, assisting in non-disruptive or minimally disrupted removal of the thrombus upon withdrawal of the device.

Claims

1. A device for retrieval of objects from within vessels of patients comprising:

a length of microcoil having approximately helical turns continuously or within adjacent sections of the length of microcoil and the helical turns have an average diameter, at least some of the continuous length or the segments sections in the length of microcoil having eyelets that extend beyond the average diameter extending outwardly from the helical turns and defining an axis offset from an axis of the helical turns, and a core wire passing through at least some adjacent eyelets from a distal end to a proximal end of the length of microcoil, the core wire being restrained near the distal end of the length of microcoil.

2. The device of claim 1 wherein the average diameter of the helical turns is less than 0.050 inches.

3. The device of claim 2 carried within a lumen of a microcatheter wherein the lumen internal diameter is greater than the average diameter of the helical turns of the length of microcoil.

4. The device of claim 2 wherein tension applied on the proximal end of the core wire will cause the length of microcoil to form loops outside of the average diameter of the length of microcoil.

5. A device for insertion into a vessel for the removal of at least one solid object from within the vessel, the device comprising:

a catheter having a lumen;

within the lumen of the catheter is at least;

a macrocoil elongate element having an axis and a length, multiple eyelets on the macrocoil elongate element that extend away outwardly from the macrocoil elongate element and define an axis offset from the axis of the macrocoil elongate element, and a core wire extending through at least two of the multiple eyelets;

wherein the core wire is attached at a distal point along the length of the macrocoil elongate element, wherein increasing tension on the core wire, which tension is in part guided by the core wire passing through multiple eyelets, causes the macrocoil elongate element to form loops, curves, bundles or a non-linear compressed shape.

6. The device of claim 5 wherein the macrocoil elongate element consists of a) a continuous length of microcoils or b) segments of microcoils separated by eyelets along the length of the macrocoil that elongate element, the continuous length of microcoils or the segments of microcoils add flexibility and conformability to the microcoil macrocoil elongate element.

7. The device of claim 6 wherein the macrocoil elongate element comprises a continuous length of microcoils.

8. The device of claim 7 wherein the eyelets are formed along the length of the macrocoil elongate element by dislocated microcoils extending away from the axis of the macrocoil elongate element and providing openings through which the core wire may pass passes.

9. The device of claim 6 wherein microcoils are positioned within the macrocoil elongate element so that an exterior surface of the microcoils positioned against a thrombus in a vessel will first engage an exterior surface of the thrombus.

10. The device of claim 5 wherein when tension is applied to the core wire, the macrocoil elongate element forms loops along the length of the macrocoil elongate element.

11. The device of claim 10 wherein at least some loops will be formed adjacent at least one eyelet.

21. The device of claim 5 wherein the catheter having the lumen consists of a single lumen, the macrocoil elongate element, the multiple eyelets on the macrocoil elongate element, and the core wire extending through at least two of the multiple eyelets within the single lumen.

12. A medical device for removing a thrombus from a blood vessel, comprising at least one elongated microcatheter lumen, wherein the medical device comprising at least one elongated flexible element microcatheter lumen comprising a) comprises at least one macrocoil comprising with a) a continuous segment of microcoils or b) at least two separate flexible element segments comprising microcoils therein, each the continuous segment or each flexible element segment of the at least one macrocoil being capable of conformation to at least one solid object after deployment from the at least one microcatheter lumen, each segment of the continuous segment or each flexible elements element segment having eyelets extending away from an axis of the continuous segment or the flexible element segments, respectively, and a core wire extending through the eyelets and along an outer surface of the continuous segment or the at least two separate flexible element segments, wherein tension on the core wire causes at least some adjacent eyelets to contract, forming a loop in the continuous segment of microcoils or a flexible element segment of the at least two separate flexible element segments, and the continuous segments or the flexible element segments, when deployed to a location outside of the microcatheter lumen, is capable of being withdrawn from the location outside the microcatheter lumen by withdrawal of the at least one microcatheter lumen.

13. The medical device of claim 12 wherein the at least one flexible element segment consists essentially of a continuous set of microcoils having an axis, the core wire and at least some eyelets are formed by microcoils extending away from the axis of the continuous set of microcoils.

14. The medical device of claim 12 wherein the eyelets are formed on the macrocoil by affixed attached eyelets extending away from the axis.

15. The medical device of claim 12 wherein the core wire is secured to passes through at least some adjacent eyelets.

16. A medical device for removing a thrombus from a blood vessel, comprising at least one microcatheter lumen, the at least one microcatheter lumen having at least one deployable flexible element comprising a macrocoil having sections of microcoils separated by offset microcoils that form eyelets, each section of microcoils being capable of conformation to at least one solid object after deployment from the microcatheter lumen, each eyelet extending away outwardly from the sections of microcoils and defining an axis offset from an axis of the sections of microcoils with a core wire extending through the eyelets, wherein tension on the core wire causes at least some adjacent eyelets to contract towards each other, forming a loop in the flexible element, the loop comprising microcoils, and each of the at least one deployable flexible elements, when deployed to a location outside of the microcatheter lumen, is capable of being withdrawn from the location by withdrawal of the lumen.

17. The medical device of claim 16 wherein the flexible element consists essentially of a continuous set of microcoils having an axis, the core wire and at least some eyelets are formed by microcoils extending away from the axis of the sections of microcoils.

18. The medical device of claim 16 wherein eyelets are form formed on the macrocoil by affixed attached eyelets extending away from the axis of the sections of microcoils.

19. The medical device of claim 16 wherein the core wire is secured to passes through at least some adjacent eyelets.

20. The device of claim 16 wherein microcoils are positioned within the macrocoil so that an exterior surface of the microcoils positioned against the thrombus in the blood vessel will first engage an exterior surface of the thrombus when the loop is drawn against the thrombus.

22. The medical device of claim 16 wherein a microcatheter having the microcathter lumen consists of a single lumen, the macrocoil, the multiple eyelets on the macrocoil, and the core wire extending through at least two adjacent ones of the multiple eyelets within the single lumen.