Blood clot removal device

• US 8,998,946 B2
• Filed: 12/30/2008
• Issued: 04/07/2015
• Est. Priority Date: 12/30/2008
• Status: Active Grant

• Current Assignee: Invatec S.P.A. (Medtronic Plc)
• Original Assignee: Invatec S.P.A. (Medtronic Plc)
• Inventors: Morero, Massimo
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US13/140,403
• Publication Number:
  US 20110295305A1
• Time in Patent Office: 2,289 Days
• Field of Search: 606/113, 606/127, 606/159, 606/200, 604/508
• US Class Current: 606/200
• 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 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/2217 single wire changing shape to a gripping configuration

Abstract

A blood clot removal device (1), comprising a capture member (2) having a tubular body (3) of prevailing longitudinal extension and provided with a lumen (10) extending longitudinally in said tubular body (3), at least one proximal portion (4), at least one distal portion (5), an apical end (6) of said distal portion (5), and a tip (7); said at least one distal portion (5) of said capture member (2) having at least one helical length (8) provided, with coils (16) wrapped in a helical manner forming a pitch (p) therebetween in the longitudinal direction and adapted to the capture of blood clots (9); an inner cable (11) received in said longitudinal lumen (10) of said tubular body (3) so as to remain within said tubular body (3) helical length (8), said inner cable (11) comprising a proximal length (12) having a proximal maneuvering end (13) and a distal length (14) provided with a tip (15); wherein said tip (15) of said inner cable (11) is secured to said apical end (6) of said capture member (2) tubular body (3), said tip (15) being firmly secured to said apical end (6) so that, when said inner cable (11) is subjected to a relative movement relative to the capture member (2) in the proximal direction, said inner cable (11) brings the tubular body (3) apical end (6) closer to the proximal portion thereof, shortening the pitch (p) of said coils (16) of the helical length (8) of the blood clot (9) capture member (2).

Claims

1. A blood clot removal device, comprising:

a capture member having tubular body of prevailing longitudinal extension and provided with a lumen longitudinally extending in said tubular body, said tubular body having at least one proximal portion, at least one distal portion, an apical end of said distal portion, and a tip;

said at least one distal portion of said capture member having at least one helical length provided with coils wrapped in an helical manner forming a pitch (p) one relative to the other in the longitudinal direction, wherein the at least one distal portion of said capture member takes the at least one helical length when in a relaxed condition;

an inner cable received in said longitudinal lumen of said tubular body so as to extend through an entirety of said helical length of the tubular body, said inner cable comprising a proximal length having a proximal manoeuvring end and a distal length provided with a tip;

wherein at least one securing portion of said distal length of said inner cable is secured to said apical end of said tubular body of the capture member, said securing portion being firmly secured to said apical end so that, when said inner cable is subjected to a relative movement relative to the capture member in the proximal direction, said inner cable brings the apical end of the tubular body closer to the proximal portion thereof shortening the pitch (p) of said coils of the helical length of the capture member.

2. The device according to claim 1, wherein said securing portion of said inner cable is the cable tip, and said apical end of the tubular body is the tubular body tip.

3. The device according to claim 1 or 2, wherein said capture member, at least in the helical length thereof, is in a shape memory elastic material adapted to remain elastic also when stressed in an essentially rectilinear deployed configuration.

4. The blood clot removal device according to claim 1 or 2, wherein at least one proximal length of the capture member is in a first material adapted to support at least stresses adapted to retract said capture member to remove a blood clot, and at least one helical length of the capture member in a shape memory elastic material adapted to remain elastic also when stressed in an essentially rectilinear deployed configuration.

5. The device according to any one of the claims 1 to 2, wherein said helical length extends along a longitudinal axis (Y-Y) from a proximal end to a distal end, and comprises a plurality of coils which little by little approach said longitudinal axis (Y-Y) passing from said proximal end to said distal end, so as to constitute a receptacle or pocket transversally arranged to a vessel and forming a seat able to capture, at least partially contain, and retain, a blood clot to be removed.

6. The device according to claim 5, wherein said helical length has a dimension with a conical or frusto-conical shape.

7. The device according to any one of the claims 1 to 2, wherein said coils of said helical length have essentially a helical shape of a diameter decreasing from 5 mm at the proximal end of the helical length to a diameter of 1 mm at the distal end of the helical length.

8. The device according to any one of the claims 1 to 2, wherein said helical length has from 3 to 9 coils.

9. The device according to any one of the claims 1 to 2, wherein the coils of said helical length are arranged eccentrically relative to the proximal portion of the tubular body of the capture member so as to let that said helical length freely act to capture a blood clot.

10. The device according to any one of the claims 1 to 2, wherein a rectilinear further distal length ending in said tip is provided distally to said helical length.

11. The device according to claim 10, wherein said further distal length comprises a folded portion towards the proximal portion of the tubular body starting from the apical end, preferably entering with a length of said folded portion between said helical coils of the helical length where the blood clot is received so as to at least partially insert said length of said folded portion in the blood clot and secure it to the device.

12. The device according to any one of the claims 1 to 2, wherein said inner cable is in an elastic material.

13. The device according to any one of the claims 1 to 2, wherein the tip of said inner cable comprises dimensions which are greater than those of the lumen of the tubular body of the capture member, and wherein the tip is adapted to be secured to the tubular body tip.

14. The device according to any one of the claims 1 to 2, wherein the inner cable tip is welded to the tubular body tip.

15. The device according to any one of the claims 1 to 2, wherein a securing portion of the inner cable is mechanically connected by interference fit to the tubular body apical end.

16. The device according to any one of the claims 1 to 2, wherein said inner cable has a tubular cable body defining a cable lumen.

17. The device according to any one of the claims 1 to 2, wherein the inner cable proximal manoeuvring end comprises indicating members configured to indicate the position of the cable relative to the tubular body.

18. The device according to any one of the claims 1 to 2, wherein the tubular body proximal end has a manoeuvring portion comprising an adjustable coupling with manoeuvring members configured to adjust the relative position of the proximal length of the inner cable and the proximal portion of the tubular body.

19. The device according to any one of the claims 1 to 2, wherein the device further comprises a micro-catheter having a tubular body defining a micro-catheter lumen of predefined transversal dimensions and adapted to receive said capture member which, when completely received in said micro-catheter lumen, unfolds the helical length bringing it to an essentially rectilinear configuration.

20. The device according to claim 19, wherein the device further comprises a catheter with tubular body comprising a lumen adapted to receive the micro-catheter with the capture member having the distal portion thereof with the helical length arranged with the coils thereof in a helical or deployed position for the capture of a blood clot.

21. The blood clot removal device according to any one of the claims 1 to 2, wherein said tip of said inner cable is secured to said apical end of said tubular body of the capture member so that, when said inner cable is subjected to a relative movement relative to the capture member in the distal direction, said inner cable moves the tubular body apical end away from the proximal portion thereof, increasing the pitch (p) of said coils of the helical length of the capture member.

22. An assembling method of a blood clot removal device, comprising the steps of:

providing a device according to any one of the claims 1 to 2,

inserting the inner cable in the lumen of the tubular body of the capture member, through the tip of the latter, starting from the proximal length thereof until brining the tip of the inner cable to the tubular body tip,

firmly securing a securing portion of the inner cable to the tubular body apical end, so that, when said inner cable is subjected to a relative movement relative to the capture member in the proximal direction, said inner cable brings the tubular body apical end closer to the proximal portion thereof, shortening the pitch (p) of said coils of the helical length of the blood clot capture member.

23. The assembling method according to claim 22, wherein the further step of making a portion of the inner cable proximal length to protrude from the tubular body (3) proximal end is provided.

24. The assembling method according to claim 22, wherein the further step of connecting a portion of the inner cable proximal length from the tubular body proximal end by means for allowing an adjustable relative movement is provided.

25. The assembling method according to claim 22, wherein the capture member with the inner cable is introduced in a micro-catheter.

26. The assembling method according to claim 22, wherein the capture member with the inner cable is introduced, with or without a micro-catheter, in a catheter.

27. A non-therapeutic and non-surgical method for the capture of an object, comprising the steps of:

providing a blood clot removal device according to any one of the claims 1 to 2;

arranging the capture member helical length distally to the object to be captured, leaving part of the tubular body proximal portion proximally to the object to be captured and with the proximal end thereof accessible for the handling thereof;

proximally returning the capture member, making so that the object to be captured is at least partially received in the helical length;

when the helical length, upon capturing and dragging the object to be captured elastically strains, increasing the pitch (p) of the coils, proximally returning the inner cable by moving the manoeuvring end thereof away from the tubular body proximal portion, so as to bring the tubular body apical end closer to the proximal portion thereof, shortening the pitch (p) of said coils of the capture member helical length.

28. The method according to claim 27, wherein there are provided the further steps of:

before arranging the helical length distally to the object to be captured, passing the object to be captured through or beyond by arranging the tubular body helical length in an essentially rectilinear position;

once the object to be captured has been passed beyond at least with the helical length, deploying the coils so that they take a helical shape distally to the object to be captured.

29. The method according to claim 27, wherein the capture member tubular body is brought to an essentially rectilinear position by introducing it with also the helical length thereof in a micro-catheter with a micro-catheter lumen of predefined transversal dimensions and adapted to receive said capture member which, when completely received in said micro-catheter, unfolds the helical length thus bringing it in an essentially rectilinear configuration.

30. The method according to claim 27, wherein the capture member tubular body is brought to an essentially rectilinear position by pushing the inner cable, the distal length of which is firmly secured to the tubular body apical end, in the tubular body lumen, and longitudinally moving the helical length coils away one from the other.