Expansible shearing catheters for thrombus removal

• US 6,652,548 B2
• Filed: 03/30/2001
• Issued: 11/25/2003
• Est. Priority Date: 03/31/2000
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Bacchus Vascular Incorporated (Medtronic Plc)
• Inventors: Leeflang, Stephen A., Evans, Michael A., Eversull, Christian S., Demarais, Denise M.
• Primary Examiner(s): Truong, Kevin T.
• Assistant Examiner(s): Bui, Vy Q.
• Application Number:
  US09/823,652
• Publication Number:
  US 20020010487A1
• Time in Patent Office: 970 Days
• Field of Search: 606/159, 606/170, 606/180, 606/181, 606/190, 606/191, 606/194, 606/195, 606/198, 606/108, 606/200, 623/1.11, 623/1.12, 623/1.13, 623/1.14, 623/1.15, 623/1.16, 623/1.17, 623/1.18, 623/1.19, 623/1.2, 430/311, 430/312-320
• US Class Current: 606/159
• 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 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2090/08021 of the patient or his organs

Abstract

Devices, methods, kits, and methods remove clot material from the vasculature and other body lumens. Expansible baskets may be used as cooperating radially expansible shearing members. Helically oriented struts of each basket may wind in a uniform circumferential direction. The struts can be independently flexible, allowing the shearing members to flex axially together. The inner basket may be rotatably driven and may use an axial pump extending proximally from the shearing members and/or a distal penetrator for advancing into an occlusion which inhibits guidewire access. The struts may slide substantially continuously across each other, and may be sufficiently aggressive for highly effective thrombectomy.

Claims

1. A thrombectomy catheter comprising:

a flexible tubular body having a proximal end and a distal end;

an outer shearing member attached near the distal end, the outer member having a perforate inner surface; and

an inner shearing member rotatably disposed within the outer member, the inner member having a proximal portion, a distal portion, and a circumferential series of struts extending therebetween, the struts sliding along the inner surface of the outer shearing member for shearing of clot material when the inner shearing member rotates,

wherein the struts are helically oriented and have a local pitch that increases toward the proximal and distal portions sufficiently to inhibit excessive separation between adjacent struts when the outer shearing member flexes axially, and

wherein the struts have protrusions which inhibit sliding of clot material axially between cooperating edges of the inner and outer shearing members.

2. The thrombectomy catheter of claim 1, wherein the inner member rotates about an axis, and wherein the inner and outer shearing bodies are sufficiently flexible to deflect the axis laterally when the outer shearing member engages a surrounding vessel and the inner member rotates therein.

3. The thrombectomy catheter of claim 1, wherein the struts uniformly coil distally toward a first circumferential orientation so that rotation of the inner shearing member toward the first circumferential orientation consistently urges sheared clot material proximally.

4. The thrombectomy catheter of claim 1, wherein the inner shearing member comprises tube material, the struts being separated by laser cut surfaces between adjacent tube material portions.

5. The thrombectomy catheter of claim 4, further comprising an expansible covering extending between adjacent struts of the outer basket to capture debris.

6. The thrombectomy catheter of claim 4, wherein the outer shearing member comprises outer tube material having a proximal outer portion, a distal outer portion and a circumferential series of outer struts extending helically therebetween, the struts being separated by laser cut outer surfaces between outer adjacent tube material portions.

7. The thrombectomy catheter of claim 1, wherein the struts are affixed together at the proximal portion and at the distal portion, and wherein the struts flex independently therebetween.

8. The thrombectomy catheter of claim 1, wherein at least one expansion actuator extends proximally from the shearing members so that the inner and outer shearing members can be radially expanded in situ.

9. The thrombectomy catheter of claim 8, wherein axial translation of an expansion actuator selectively radially expands the inner and outer shearing members concurrently.

10. The thrombectomy catheter of claim 1, further comprising a distally oriented clot penetrator adjacent the distal end.

11. The thrombectomy catheter of claim 10, wherein the occlusion penetrator comprises at least one end cutter that rotates with the inner shearing member and is exposed distally of the outer shearing member to advance the shearing members within a body lumen distally through clot material.

12. The thrombectomy catheter of claim 10, wherein the occlusion penetrator comprises a shaft extendable distally of the shearing members, the shaft axially cycleable through clot material without penetrating through a vessel wall.

13. The thrombectomy catheter of claim 1, further comprising an intravascular ultrasound sensor to measure of clot for removal.

14. A thrombectomy catheter comprising:

a flexible tubular body having a proximal end and a distal end;

a flexible drive shaft rotatably disposed within the tubular body;

an outer shearing member attached near the distal end of the tubular body, the outer member having a circumferential series of independent outer struts, the outer struts having inner surfaces; and

an inner shearing member rotationally driven by the drive shaft within the outer member, the inner member having a proximal portion, a distal portion, and a circumferential series of independent inner struts, the inner struts having outer surfaces which slide across the inner surfaces of the outer struts so as to shear clot material when the inner shearing member rotates, at least one member of the group comprising the inner struts and the outer struts being helically oriented and having a local pitch that increases toward the proximal and distal portions sufficiently to inhibit excessive separation between adjacent struts when the outer shearing member flexes axially,

wherein at least one member of the group comprising the inner struts and the outer struts have protrusions which inhibit sliding of clot material axially between cooperating edges of the inner and outer shearing members.

15. The thrombectomy catheter of claim 14, wherein the outer shearing member has an embolic debris capture coating.

16. The thrombectomy catheter of claim 14, wherein each of the inner and outer shearing members has a proximal portions and a distal portions, the struts of each shearing member affixed together at the proximal and distal portions and extending independently therebetween so that the shearing members flex axially primarily along the struts.

17. The thrombectomy catheter of claim 14, further comprising a proximal housing coupled to the tubular body, the housing having a motor drivingly engaging the drive shaft.

18. The thrombectomy catheter of claim 17, wherein the drive shaft engages the distal portion of the inner shearing member, wherein the drive shaft is axially translatable relative to the tubular body from adjacent the proximal housing, and wherein axial bearing surfaces of the outer and inner shearing members cooperate to effect concurrent radial expansion of the inner and outer shearing members when the drive shaft translates axially.