Methods and apparatuses for flow restoration and implanting members in the human body

• US 9,039,749 B2
• Filed: 10/01/2010
• Issued: 05/26/2015
• Est. Priority Date: 10/01/2010
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Shrivastava, Sanjay, Cam, Anh
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): OBU, KENDRA NNEAMAKA
• Application Number:
  US12/896,707
• Publication Number:
  US 20120083868A1
• Time in Patent Office: 1,698 Days
• Field of Search: 606191-192, 606/194, 606/200, 623 111- 112, 623 115- 117, 623/1.2, 623 122- 123, 623/1.35
• US Class Current: 623/1.11
• 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 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures

Abstract

A medical device for blood flow restoration and/or for use as an implantable member in a human vessel includes a self-expanding member, a guidewire, and a connection mechanism. The self-expanding member includes a plurality of cells and filaments having specific ranges of thicknesses, widths, and heights. The self-expanding member can take on a volume-reduced coiled form with overlapped edges, and can generate optimal radial forces against a vessel wall and/or thrombus when deployed and expanded.

Claims

1. A medical device comprising:

a guidewire having a proximal end and a distal end, the distal end comprising a stem;

a connection mechanism comprising (a) the stem, (b) a ball attached directly to the stem, (c) a keyway structure configured to receive the stem and the ball, (d) a sleeve surrounding the keyway structure, the stem, and the ball, and (e) an adhesive between (i) the sleeve and (ii) the stem and the ball, the stem and the ball positioned in the keyway, and the ball being unreleasable from the keyway and the sleeve; and

a self-expanding member attached to the distal end of the guidewire via the connection mechanism, the self-expanding member having a mesh configuration and comprising;

the keyway structure,

a proximal portion having a first plurality of cells, the proximal portion being tapered along a longitudinal portion of its length;

a distal portion having a second plurality of cells, the distal portion forming a generally tube-like configuration having a central, longitudinal axis; and

a seam along a longitudinal axis of the distal portion, the seam forming two edges extending generally longitudinally along the self-expanding member;

wherein the self-expanding member can be modified into a volume-reduced form having a generally coiled, tubular configuration for insertion within a microcatheter, the edges of the distal portion being overlapped in the volume-reduced, coiled configuration such that in the volume-reduced, coiled configuration the self-expanding member has multiple layers in at least one radial direction;

wherein a distal end of the distal portion further comprises filaments that include distal elements, the filaments and distal elements of the distal end being bent radially inwardly towards the central longitudinal axis;

wherein the first plurality of cells comprises filaments having a filament thickness of between 0.045 mm and 0.080 mm, and a filament width of between 0.040 mm and 0.090 mm;

wherein the second plurality of cells comprises filaments having a filament thickness of between 0.040 mm and 0.075 mm, and a filament width of between 0.038 mm and 0.082 mm;

wherein the second plurality of cells comprises cells having a width of between 3.50 mm to 5.50 mm and a height of between 2.50 mm to 4.5 mm;

wherein the self-expanding member has a radial force measurement greater than or equal to 0.0010 N/mm and a chronic outward force of less than or equal to 0.026 N/mm as measured using a thin film method of testing, and a radial force measurement of between approximately 6 to 37 gf/in as measured using a two-pin method of testing.

2. The medical device of claim 1, wherein the connection mechanism comprises a detachable mechanism for detaching the self-expanding member from the guidewire.

3. The medical device of claim 2, wherein the detachable mechanism comprises an electrolytically severable joint.

4. The medical device of claim 1, wherein the self-expanding member has a dislodgment force that ranges between 0.010 N and 0.700 N, the dislodgment force being measured by determining the force required to cause a fully deployed self-expanding member to slip axially along an in vitro model simulating an artery by pulling the self-expanding member along a specified length and recording the force at which slippage occurs.

5. The medical device of claim 1, wherein the self-expanding member has a total filament length and wherein the self-expanding member is configured to engage and remove thrombi of a particular range of length such that a ratio of the total filament length of the self-expanding member to the thrombus length in the particular range is between 10 to 15.

6. The medical device of claim 5, wherein the self-expanding member has a total filament length of 255 mm, a ratio of 12.75, and is configured to engage and remove thrombi that range up to approximately 20 mm in length.

7. The medical device of claim 1, wherein the second plurality of cells comprises filaments that have an average thickness of between 0.048 mm and 0.067 mm, and an average width of between 0.053 mm and 0.067 mm.

17. A method of blood flow restoration in the neurovasculature comprising:

inserting a balloon guide catheter into the neurovasculature;

inflating a balloon on a distal end of the balloon guide catheter;

inserting a microcatheter through the distal end of the balloon guide catheter;

inserting the medical device of claim 1 into the microcatheter such that the distal portion of the self-expanding member is located adjacent a thrombus in the neurovasculature;

withdrawing the microcatheter so as to expose and deploy the self-expanding member, the self-expanding member configured to expand against the length of the thrombus and engage the thrombus;

retrieving the thrombus by moving the microcatheter until the microcatheter covers a portion of the self-expanding device, and then withdrawing both the microcatheter and self-expanding member together proximally; and

providing aspiration through the balloon guide catheter to assist in removing the thrombus.

18. The method of claim 17, wherein at least partial blood flow restoration is restored immediately upon engagement of the self-expanding device with the thrombus.

19. The method of claim 17, further comprising withdrawing the thrombus at least partially into the microcatheter.

20. The method of claim 17, further comprising withdrawing the thrombus at least partially into the balloon guide catheter.

21. The method of claim 17, wherein the connection mechanism comprises an electrolytically severable joint, and wherein the method of blood flow restoration further comprises detaching the self-expanding member from the guidewire.

22. The method of claim 17, further comprising repositioning the self-expanding member prior to retrieving the thrombus.

23. A method of implanting a medical device in the neurovasculature comprising:

inserting a guide catheter into the neurovasculature;

inserting a microcatheter through the distal end of the guide catheter;

inserting the medical device of claim 1 through the microcatheter such that the distal portion of the self-expanding member is located adjacent a treatment site in the neurovasculature;

withdrawing the microcatheter so as to expose and deploy the self-expanding device, the self-expanding device configured to expand against and engage the treatment site;

detaching the self-expanding member via electrolytic disintegration of a portion of the connection mechanism.

24. The method of claim 23, wherein the treatment site comprises a stenosis.

25. The method of claim 23, wherein the treatment site comprises an aneurysm.

26. The method of claim 23, further comprising repositioning the self-expanding member prior to detachment.

27. The medical device of claim 1, further comprising an insulative coating on the stem and the ball.

28. The medical device of claim 1, wherein the keyway structure is monolithic with the self-expanding member.

8. A medical device comprising:

a guidewire having a proximal end and a distal end;

a self-expanding member attached to the distal end of the guidewire, the self-expanding member having a mesh configuration and comprising;

a proximal portion comprising a single piece forming (a) a first plurality of cells and (b) a part configured to receive at least one of (i) the distal end of the guidewire or (ii) a ball attached directly to the distal end of the guidewire, the proximal portion being tapered along a longitudinal portion of its length;

a distal portion having a second plurality of cells, the distal portion forming a generally tube-like configuration having a central, longitudinal axis; and

a seam along a longitudinal axis of the distal portion, the seam forming two edges extending generally longitudinally along the self-expanding member;

wherein the self-expanding member can be modified into a volume- reduced form having a generally coiled, tubular configuration for insertion within a microcatheter, the edges of the distal portion being overlapped in the volume- reduced, coiled configuration such that in the volume-reduced, coiled configuration the self-expanding member has multiple layers in at least one radial direction;

wherein a distal end of the distal portion further comprises filaments that include a plurality of distal elements, the filaments of the distal end being bent radially inwardly towards the central longitudinal axis;

a sleeve surrounding (a) the part configured to receive at least one of (i) the distal end of the guidewire or (ii) a ball attached to the distal end of the guidewire, and (b) the at least one of the distal end of the guidewire or the ball; and

an adhesive between (i) the sleeve and (ii) the at least one of the distal end of the guidewire or the ball;

and wherein the at least one of (i) the distal end of the guidewire or (ii) the ball is positioned in the part of the single piece of the proximal portion; and

wherein the at least one of (i) the distal end of the guidewire or (ii) the ball is unreleasable from the sleeve and the part of the single piece of the proximal portion.

9. The medical device of claim 8, wherein the distal elements comprise marker bands.

10. The medical device of claim 8, wherein the distal elements have a hook-like configuration configured to aid in thrombus retention.

11. The medical device of claim 8, wherein the filaments of the distal end are bent radially inwardly at an angle between approximately ten to thirty degrees.

29. The medical device of claim 8, further comprising an insulative coating on at least one of the ball or the distal end of the guidewire.

30. The medical device of claim 8, wherein the sleeve comprises platinum.

12. A medical device comprising:

a guidewire having a proximal end and a distal end;

a connection mechanism comprising (a) the distal end of the guidewire, (b) at least one of a slit or an opening, (c) a sleeve surrounding (i) the at least one of a slit or an opening and (ii) the distal end of the guidewire, and (d) an adhesive between the sleeve and the distal end of the guidewire, wherein the distal end of the guidewire is positioned in the at least one of a slit or an opening, and the distal end of the guidewire is unreleasable from the sleeve and the at least one of a slit or an opening; and

a self-expanding member attached to the distal end of the guidewire via the connection mechanism, the self-expanding member having a mesh configuration and comprising;

a proximal portion comprising a single component having (a) a first plurality of cells and (b) the at least one of a slit or an opening, the proximal portion being tapered along a longitudinal portion of its length;

a distal portion having a second plurality of cells, the distal portion forming a generally tube-like configuration having a central, longitudinal axis; and

a seam along a longitudinal axis of the distal portion, the seam forming two edges extending generally longitudinally along the self-expanding member;

wherein the self-expanding member can be modified into a volume- reduced form having a generally coiled, tubular configuration for insertion within a microcatheter, the edges of the distal portion being overlapped in the volume- reduced, coiled configuration such that in the volume-reduced, coiled configuration the self-expanding member has multiple layers in at least one radial direction;

wherein the first plurality of cells comprises filaments having a filament thickness of between 0.045 mm and 0.080 mm, and a filament width of between 0.040 mm and 0.090 mm;

wherein the second plurality of cells comprises filaments having a filament thickness of between 0.040 mm and 0.075 mm, and a filament width of between 0.038 mm and 0.082 mm.

13. The medical device of claim 12, wherein the second plurality of cells comprises cells having a width of between 3.50 mm to 5.50 mm and a height of between 2.50mm to 4.5 mm.

14. The medical device of claim 12, wherein the connection mechanism comprises an electrolytically severable region for detaching the self-expanding member from the guidewire.

31. The medical device of claim 12, further comprising an insulative coating on the distal end of the guidewire.

15. A medical device comprising:

a guidewire having a proximal end and a distal end;

a ball attached directly to the distal end of the guidewire; and

a self-expanding member attached to the distal end of the guidewire, the self-expanding member having a mesh configuration and comprising;

a proximal portion having a first plurality of cells, the proximal portion being tapered along a longitudinal portion of its length, the proximal portion comprising an opening receiving the ball;

a distal portion having a second plurality of cells, the distal portion forming a generally tube-like configuration having a central, longitudinal axis; and

a seam along a longitudinal axis of the distal portion, the seam forming two edges extending generally longitudinally along the self-expanding member;

wherein the self-expanding member can be modified into a volume-reduced form having a generally coiled, tubular configuration for insertion within a microcatheter, the edges of the distal portion being overlapped in the volume-reduced, coiled configuration such that in the volume-reduced, coiled configuration the self-expanding member has multiple layers in at least one radial direction;

wherein the self-expanding member has a radial force measurement greater than or equal to 0.0010 N/mm and a chronic outward force of less than or equal to 0.026 N/mm as measured using a thin film method of testing, and a radial force measurement of between approximately 6 to 37 gf/in as measured using a two-pin method of testing;

a sleeve surrounding the ball and the opening of the proximal portion of the self-expanding member; and

an adhesive between the sleeve and the ball; and

wherein the ball is unreleasable from the sleeve and the opening of the proximal portion.

16. The medical device of claim 15, further comprising a detachable mechanism for detaching the self-expanding member from the guidewire.

32. The medical device of claim 15, further comprising an insulative coating on at least one of the ball or the distal end of the guidewire.