CA-3082094-C - BASKET FOR A CATHETER DEVICE

Abstract

The present disclosure relates to a basket for a catheter designed to be deployed in complex vasculature to optimally treat vascular and arterial disease conditions such as blood clots, blood emboli, and deep vein thrombosis. The basket may comprise a shaft with a plurality of cuts along a portion of its length to form a plurality of tines that provide support for a plurality of porous tubes to form the limbs of the basket. The limbs of the basket expand radially away from the longitudinal axis of the basket when the longitudinal length of the basket is reduced. The limbs may also be connected to a drug delivery system, and in this manner, baskets of the present disclosure allow for the use of both mechanical and pharmaceutical means of thrombolysis.

Inventors

• Nicholas Green

Assignees

• PEBBLE HILL PARTNERS, LLC

Dates

Publication Date

20260505

Application Date

20181109

Priority Date

20171109

Claims (20)

1. What is claimed: 1. A deployable infusion basket for an infusion catheter comprising: a shaft comprising a wall with an inner surface and an outer surface and a lumen extending between a distal end and a proximal end and defining a longitudinal axis, wherein a plurality of helical cuts along a portion of the shaft between the inner and outer surface of the wall form a plurality of tines; wherein the proximal end of the shaft is uncut; a plurality of tubes, each tube comprising a wall with an inner surface and an outer surface and a lumen extending between a distal end and a proximal end; wherein the plurality of tubes are melted together and to the outside of the shaft at the uncut proximal end of the shaft; wherein each of the plurality of tines of the shaft are disposed in the lumen of each of the plurality of tubes to form a plurality of limbs; wherein the plurality of tines independently support the limbs between the proximal and distal end of the tines; and wherein the distal end of each of the plurality of limbs are attached together.
2. 2. The basket of claim 1, wherein the limbs of the basket deploy from a first position to a second position when a longitudinal length of the basket is reduced.
3. 3. The basket of claim 2, wherein the limbs of the basket are in a closed state in the first position.
4. 4. The basket of any one of claims 1 to 3, wherein the shaft comprises a shape memory material.
5. 5. The basket of claim 4, wherein the shape memory material is a nickel-titanium nitinol alloy.
6. 6. The basket of any one of claims 1 to 5, wherein the plurality of cuts are formed by laser cutting.
7. 7. The basket of any one of claims 1 to 6, wherein the plurality of helical cuts have a Date re~ue/Date received 2024-05-24 rotation of at least 360 degrees over a length of the deployable infusion basket.
8. 8. The basket of claim 7, wherein the plurality of helical cuts have a rotation of at least 450 degrees over the length of the deployable infusion basket.
9. 9. The basket of any one of claims 1 to 8, wherein each of the plurality of tubes is porous.
10. 10. The basket of claim 9, wherein each of the plurality of tubes comprises a plurality of infusion ports extending between the inner surface and outer surface of the wall of the tube.
11. 11. The basket of claim 10, wherein the infusion ports are holes having diameters between 0.001 and 0.006 inches.
12. 12. The basket of any one of claims 1 to 11, wherein the deployable infusion basket is between three and eight inches in length.
13. 13. The basket of any one of claims 1 to 12, wherein the deployable infusion basket is six inches in length.
14. 14. The basket of any one of claims 1 to 13, further comprising a fiber optic material disposed within the lumen of at least one of the plurality of tubes.
15. 15. A catheter comprising: the basket of claim 1, and further comprising: an inner shaft comprising a wall with an inner surface and an outer surface and a lumen extending between a distal end and a proximal end, wherein the inner shaft is disposed coaxially within the lumen of the shaft and is attached to the distal end of the basket; an outer shaft comprising a wall with an inner surface and an outer surface and a lumen extending between a distal end and a proximal end, wherein the outer shaft is disposed coaxially around the inner shaft to form a fluid compartment between the inner surface of the outer shaft and the outer surface of the inner shaft; and 21 Date re~ue/Date received 2024-05-24 wherein the proximal end of the limbs of the basket are connected to the fluid compartment.
16. 16. The catheter of claim 15, wherein the connection between the proximal end of the limbs of the basket and the fluid compartment comprises a seal disposed between the inner shaft and the proximal end of the plurality of limbs.
17. 17. The catheter of claim 15 or 16, wherein the limbs of the basket deploy from a first position to a second position when the inner shaft is moved in a proximal direction.
18. 18. The catheter of any one of claims 15 to 17, wherein each of the plurality of tubes comprises a plurality of infusion ports extending between the inner surface and outer surface of the wall of the tube.
19. 19. The catheter of any one of claims 15 to 18, further comprising a fiber optic material disposed within the lumen of the inner shaft or at least one of the plurality of tubes.
20. 20. The catheter of any one of claims 15 to 19, wherein the basket further comprises an irradiation source. 22 Date re~ue/Date received 2024-05-24

Description

WO 2019/094 782 PCT/US2018/060115 BASKET FOR A CATHETER DEVICE CROSS~REFERENCE TO .RELATED APPLICATIONS This applicationelaims priority to US. Patent Application No. 15/808,649, filed Nov. 5 9,2017. FIELD OF THE INVENTION The present invention relates to mechanically deployable basket features for a catheter device, infusion.catheters, atld methods of treatment of pulmonary .embolism and deep vein thrombosis. DACKG.ROIJND OF THEINVENTION Conventional methods for catheter-directed thrombolysis involves infusing a dot dissolving medication via .a single lumen infusion catheter, which is typically much smaller in diameter t1:ran the vessel in which it is. placed. Additibnally, bec.ause the clot has. reduced o.r stopped the blood flow through the vessels, dispersion of the dot-dissolving :cnedic11tion is 15 impaired. Catheter.directed thrombolysis devices may additionally employ expandable baskets to mechanically open a blood clot, but these expandable baskets typically :function best in straight vessels .and ate not well adapted to the curved vascular. For example, in the case of a pulmonary embolism and the anaooroy of the pulmonary artery, 11;).rge blood clots are often lodged deep :in. the greater curvature ofthe artery and are dif:ficuU to treat. Concurrent 20 monitoring of important vital signs within the occluded vessel, such as blood pressure, is also not possible during deploymentof current cathetet~directed thro:rnbolysis devic!"ls. What. is needecl in the a:rt is i:i.n improved l?i'J.sket and infusion ci:\theter tha:t addresses the above limitations. SUMMARY OF THE INVENTION 25 The present invention addresses the need mentioned above by providing deployable baskets, infusion catheters and methods for the treatment of tlrrombus :in a blood vessel ln one aspect, the present disclosure provides a basket for an infusion catheter comprising a shaft comprising a wall with an inner surface and an outer surface and a lumen ex.tending betvveen a distal end and.a proximal eI14 and defining a loI1gitudinal axis, wherein a 30 plurality of cuts along atleast a portion of the shaft between the inner and outer surface .of the wall form a plurality of tines, a plurality of tubes, each tube comprising a wall with an inner 1 Date rec;ue/Date received 2024-05-24 WO 2019/094782 PCT/0S2018/060115 surface and an outer surface and a lumen extending between a distal end and a proximal end, wherein each of the plurality of tines of the shaft are disposed in the lumen of each of the plurality of tubes to form a plurality of limbs, and wherein the distal end of each of the plurality of limbs are attached and the proximal end of each of the plurality of limbs are 5 attached. In some embodiments, the present basket for an infusion catheter comprising a shaft comprising a wall with an inner surface and an outer surface and a lumen extending between a distal end and a proximal end and defining a longitudinal axis, wherein a plurality of helical cuts along a portion of the shaft between the inner and outer surface of the wall form a 10 plurality of tines; wherein the proximal end of the shaft is uncut; a plurality of tubes, each tube comprising a wall with an inner surface and an outer surface and a lumen extending between a distal end and a proximal end; wherein the plurality of tubes are melted together and to the outside of the shaft at the uncut proximal end of the shaft; wherein each of the plurality of tines of the shaft are disposed in the lumen of each of the plurality of tubes to 15 form a plurality of limbs; wherein the plurality of tines independently support the limbs without interconnection of tines between the promixal and distal end of the tines; and wherein the distal end of each of the plurality of limbs are attached together. In some embodiments, the limbs of the basket deploy from a first position to a second position when the longitudinal length of the basket is reduced. 20 In some embodiments, the limbs of the basket are in a closed state in the first position. In some embodiments, the limbs of the basket expand radially away from the longitudinal axis when the longitudinal length of the basket is reduced. In some embodiments, the shaft comprises a shape memory material. In some embodiments, the shape memory material is a nickel-titanium nitinol alloy. In some embodiments, the plurality of cuts are formed by laser cutting. In some embodiments, the plurality of cuts are helical and have a rotation of at least 360 degrees over the length of the deployable infusion basket. In some embodiments, the plurality of helical cuts have a rotation of at least 450 degrees over the length of the deployable infusion basket. In some embodiments, the plurality of cuts do not extend to the proximal end of the shaft. In some embodiments, each of the plurality of tubes is porous. In some embodiments, each of the plurality of tubes comprises a plurality of infusion ports extending between the inner surface and outer surface of the