Multi-lumen steerable catheter

• US 7,037,290 B2
• Filed: 12/16/2002
• Issued: 05/02/2006
• Est. Priority Date: 12/16/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gardeski, Kenneth C., Leners, Michael R., Torbert, Jesse T., Thomas, Ralph J.
• Primary Examiner(s): SIRMONS, KEVIN C
• Application Number:
  US10/318,624
• Publication Number:
  US 20040116848A1
• Time in Patent Office: 1,233 Days
• Field of Search: 604/95.01, 604/95.04, 604/528
• US Class Current: 604/95.01
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0158 with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials

Abstract

Elongated medical devices are disclosed adapted to be inserted through an access pathway into a body vessel, organ or cavity to locate a therapeutic or diagnostic distal segment of the elongated medical device into alignment with an anatomic feature of interest. Multi-lumen steerable catheters having a deflection lumen liner and a delivery lumen liner are adapted to be deflected by a deflection mechanism within or advanced through the deflection lumen liner to enable advancement of the catheter distal end through a tortuous pathway. At least one lumen liner is formed of a no yield elastomer.

Claims

1. An elongated multi-lumen steerable catheter comprising:

a catheter body extending between a catheter body proximal end and a catheter body distal end and having a proximal segment, a bendable intermediate segment and a distal segment, the catheter body further comprising;

an outer sheath extending between the catheter body proximal end and the catheter body distal end;

a deflection lumen extending within the outer sheath from a deflection lumen proximal end opening to the catheter body distal end; and

a delivery lumen extending within the outer sheath between a delivery lumen proximal end opening and a delivery lumen distal end opening at the catheter body distal end, the delivery lumen defined by a delivery lumen liner formed of an elastomer extending through the proximal segment, the bendable intermediate segment, and the distal segment of the catheter body;

a hub mounted to the catheter body proximal end; and

a deflection mechanism introduced within the deflection lumen selectively operable at the hub inducing a bend in the intermediate segment, wherein the outer sheath comprises a proximal outer sheath segment formed of a first thermoplastic material having a first flexural modulus extending the length of the catheter body proximal segment, an intermediate sheath segment formed of a second thermoplastic material having a second flexural modulus extending the length of the catheter body intermediate segment, and a distal sheath formed of a third thermoplastic material having a third flexural modulus lower than the first flexural modulus and second flexural modulus, the distal sheath extending the length of the catheter body distal segment.

2. The steerable catheter of claim 1, wherein the outer sheath distal segment embedding the distal segment of the delivery lumen liner has a flexural modulus ≦

1,300 psi.

3. The steerable catheter of claim 2, wherein the delivery lumen liner is formed having a 51D Shore durometer and a flexural modulus of about 25 ksi.

4. The steerable catheter of claim 1, wherein the catheter body further comprises:

a deflection lumen liner; and

a wire braid extending around and over the delivery lumen liner and the deflection lumen liner through the length of the proximal segment and the bendable intermediate segment of the catheter body.

5. The steerable catheter of claim 1, wherein the deflection mechanism comprises a stylet having a stylet wire adapted to be inserted through the deflection lumen to induce a bend in the intermediate segment of the catheter body corresponding to a bend in the stylet wire to steer the catheter body distal end through an access pathway of the body.

6. The steerable catheter of claim 1, wherein the deflection mechanism comprises a guidewire adapted to be passed through the deflection lumen to enable over-the-wire advancement of the steerable catheter through an access pathway of the body.

7. The steerable catheter of claim 1, wherein the deflection mechanism comprises a pull wire having a pull wire extending from the hub through the deflection lumen to the catheter body distal adapted to be retracted to induce a bend in the intermediate segment of the catheter body to steer the catheter body distal end through an access pathway of the body.

8. An elongated multi-lumen steerable catheter comprising:

a catheter body extending between a catheter body proximal end and a catheter body distal end and having a proximal segment, a bendable intermediate segment and a distal segment, the catheter body further comprising;

an outer sheath extending between the catheter body proximal end and the catheter body distal end;

a deflection lumen extending within the outer sheath from a deflection lumen proximal end opening to the catheter body distal end; and

a delivery lumen extending within the outer sheath between a delivery lumen proximal end opening and a delivery lumen distal end opening at the catheter body distal end, the delivery lumen defined by a delivery lumen liner formed of an elastomer extending through the proximal segment, the bendable intermediate segment, and the distal segment of the catheter body;

a hub mounted to the catheter body proximal end; and

a deflection mechanism introduced within the deflection lumen selectively operable at the hub inducing a bend in the intermediate segment, wherein the delivery lumen liner is formed having a 51D Shore durometer and a flexural modulus of about 25 ksi.

9. An elongated multi-lumen steerable catheter comprising:

a catheter body extending between a catheter body proximal end and a catheter body distal end and having a proximal segment, a bendable intermediate segment and a distal segment, the catheter body further comprising;

an outer sheath extending between the catheter body proximal end and the catheter body distal end;

a deflection lumen extending within the outer sheath from a deflection lumen proximal end opening to the catheter body distal end; and

a delivery lumen extending within the outer sheath between a delivery lumen proximal end opening and a delivery lumen distal end opening at the catheter body distal end, the delivery lumen defined by a delivery lumen liner formed of an elastomer extending through the proximal segment, the bendable intermediate segment, and the distal segment of the catheter body;

a hub mounted to the catheter body proximal end; and

a deflection mechanism introduced within the deflection lumen selectively operable at the hub inducing a bend in the intermediate segment, wherein the catheter body further comprises;

a deflection lumen liner; and

a wire braid extending around and over the delivery lumen liner and the deflection lumen liner through the length of the proximal segment and the bendable intermediate segment of the catheter body.

10. An elongated multi-lumen steerable catheter comprising:

a catheter body extending between a catheter body proximal end and a catheter body distal end and having a proximal segment, a bendable intermediate segment and a distal segment, the catheter body further comprising;

an outer sheath extending between the catheter body proximal end and the catheter body distal end;

a deflection lumen extending within the outer sheath from a deflection lumen proximal end opening to the catheter body distal end; and

a delivery lumen extending within the outer sheath between a delivery lumen proximal end opening and a delivery lumen distal end opening at the catheter body distal end, the delivery lumen defined by a delivery lumen liner formed of an elastomer extending through the proximal segment, the bendable intermediate segment, and the distal segment of the catheter body;

a hub mounted to the catheter body proximal end; and

a deflection mechanism introduced within the deflection lumen selectively operable at the hub inducing a bend in the intermediate segment, wherein the deflection mechanism comprises a resistance heated shape memory alloy element disposed within the deflection lumen within the catheter body intermediate segment and electrical conductors extending through the deflection lumen to the resistance heated shape memory alloy element to apply electrical energy to and resistance heat the shape memory alloy element to induce a bend in the resistance heated shape memory alloy element to steer the catheter body distal end through an access pathway of the body.

11. An elongated catheter comprising:

a catheter body extending between a catheter body proximal end and a catheter body distal end, the catheter body comprises a stiff proximal segment, a flexible intermediate segment and a soft distal segment, the catheter body further comprising;

an outer sheath extending between the catheter body proximal end and the catheter body distal end; and

a catheter lumen liner extending within the outer sheath from a catheter lumen proximal end opening to a catheter lumen distal end opening at the catheter body distal end, the catheter lumen liner formed of an elastomer, and

a hub mounted to the catheter body proximal end, wherein the outer sheath comprises a proximal outer sheath segment formed of a first thermoplastic material having a first flexural modulus extending the length of the catheter body proximal segment, an intermediate sheath segment formed of a second thermoplastic material having a second flexural modulus extending the length of the catheter body intermediate segment, and a distal sheath formed of a third thermoplastic material having a third flexural modulus lower than the first flexural modulus and second flexural modulus, the distal sheath extending the length of the catheter body distal segment.

12. The steerable catheter of claim 11, wherein the outer sheath distal segment embedding the distal segment of the delivery lumen liner has a flexural modulus ≦

1,300 psi.

13. The steerable catheter of claim 12, wherein the catheter lumen liner is formed having a 51D Shore durometer and a flexural modulus of about 25 ksi.

14. The steerable catheter of claim 11, wherein the catheter body further comprises a wire braid extending around and over the catheter lumen liner through the length of the proximal segment and the bendable intermediate segment of the catheter body.

15. The steerable catheter of claim 11, wherein the catheter lumen liner is formed having a 51D Shore durometer and a flexural modulus of about 25 ksi.

16. An elongated catheter comprising:

a catheter body extending between a catheter body proximal end and a catheter body distal end, the catheter body comprises a stiff proximal segment, a flexible intermediate segment and a soft distal segment, the catheter body further comprising;

an outer sheath extending between the catheter body proximal end and the catheter body distal end; and

a catheter lumen liner extending within the outer sheath from a catheter lumen proximal end opening to a catheter lumen distal end opening at the catheter body distal end, the catheter lumen liner formed of an elastomer, and a hub mounted to the catheter body proximal end, wherein the catheter body further comprises a wire braid extending around and over the catheter lumen liner through the length of the proximal segment and the bendable intermediate segment of the catheter body.

17. An elongated catheter comprising:

a catheter body extending between a catheter body proximal end and a catheter body distal end, the catheter body comprises a stiff proximal segment, a flexible intermediate segment and a soft distal segment, the catheter body further comprising;

an outer sheath extending between the catheter body proximal end and the catheter body distal end; and

a catheter lumen liner extending within the outer sheath from a catheter lumen proximal end opening to a catheter lumen distal end opening at the catheter body distal end, the catheter lumen liner formed of an elastomer, and

a hub mounted to the catheter body proximal end, wherein the catheter lumen liner is formed having a 51D Shore durometer and a flexural modulus of about 25 ksi.