PREFORMED STYLET FOR GUIDING A LEAD TO CONTACT THE SEPTUM

• US 20100004662A1
• Filed: 06/18/2009
• Published: 01/07/2010
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Sorin CRM SAS
• Inventors: OLLIVIER, Jean-Francois
• Granted Patent: US 10,071,228 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61M 2025/09133 having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09016 with mandrils
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems

Abstract

Preformed guiding stylet for introducing a septal lead in contact with the septum or other intra-corporal device in contact with body tissue. This stylet include a flexible wire (10), to be introduced by its distal end in a central lumen of the lead, and a control handle (18). The wire is elastically deformable in bending and has sufficient rigidity in torsion to enable transmission by the handle rotation of a rotational movement over the entire length of the wire. In the unstressed status, the wire comprises successively in its distal part (12), a first curvilinear portion (C1), a first straight portion (D1), a second curvilinear portion (C2) and optionally a second straight portion (D2). The first and second curvilinear portions extend in respective planes (P1, P2) making an angle (φ3) between them defining a dihedral (Δ) which axis (φ) comprises the first straight portion (D1). The total length of the first curvilinear portion, the first straight portion and the second curvilinear portion is between 82 and 195 mm, this so as to coincide with the anatomical curvature of the venous system in which the lead equipped with its stylet will be introduced.

Claims

1. A guiding stylet, for introducing a septal lead to contact an atrial or ventricular septum wall, comprising:

a flexible wire having a proximal end and a distal end suitable for passage in the central lumen of said septal lead, and

a control handle fixed to the proximal end of the wire and rotatable about an axis;

Said wire being elastically deformable in bending and having in an unstressed state, at its distal end, successively;

a first curvilinear portion (C1), a first straight portion (D1), and a second curvilinear portion (C2);

wherein the wire has a rigidity in torsion to allow transmission along its length of a rotational movement by a rotation of the handle;

the first curvilinear portion (C1) and the second curvilinear portion (C2) extend in respective planes (P1, P2) that make a angle (D3) between them that define a dihedral (A) that includes the first straight portion (D1);

wherein the total length of the first curvilinear portion, first straight portion and the second curvilinear portion is between 82 and 195 mm; and

,

wherein said distal end comprises a shape and corresponding to an anatomical curvature of the venous system in which the lead equipped with said stylet will be introduced.

2. The stylet of claim 1, wherein the first curvilinear portion (C1) and the second curvilinear portion (C2) are configured in relation to one another and the first straight portion (D1) to extend away from each other on opposite sides of a half-plane containing the first straight portion (D1), said stylet being designated to be introduced into the venous system via the right cephalic vein (22).

3. The stylet of claim 2, wherein the control handle (18) further comprises a marking (32) indicating that said stylet is designated to be introduced inside the venous system via the right cephalic vein (22).

4. The stylet of claim 1, wherein the first curvilinear portion (C1) and the second curvilinear portion (C2) are configured in relation to another and the first straight portion (D1) to extend in mutual alignment on the same side of a half-plane containing the first straight portion (D1), said stylet being designated to be introduced into the venous system via the left cephalic vein (30).

5. The stylet of claim 4, wherein the control handle (18) further comprises a marking (32) indicating that said stylet is designated to be introduced inside the venous system via the left cephalic vein (30).

6. The stylet of claim 1, wherein the wire further comprises a second straight portion (L2) positioned distal of the second curvilinear portion (C2).

7. The stylet of claim 6, wherein the second straight portion (L2) further comprises a length less than or equal to 15 mm.

8. The stylet of claim 1, wherein the dihedral angle is less than 45°

.

9. The stylet of claim 8, wherein the dihedral angle is between 10°

and 30°

.

10. The stylet of claim 1, wherein the first curvilinear portion (C1) has a radius of curvature (R1) less than or equal to 200 mm.

11. The stylet of claim 10, wherein the first curvilinear portion (C1) has a radius of curvature (R1) between 40 and 60 mm.

12. The stylet of claim 1, wherein the first curvilinear portion (C1) provides an opening angle (φ

1) of at least 10°

.

13. The stylet of claim 12, wherein the first curvilinear portion (C1) provides an opening angle (φ

1) of between 70° and

110°

.

14. The stylet of claim 1, wherein the first straight portion (R1) has a length of at least 10 mm.

15. The stylet of claim 14, wherein the first straight portion (R1) has a length between 30 and 70 mm.

16. The stylet of claim 1, wherein the second curvilinear portion (C2) has a radius of curvature (R2) between 10 and 15 mm.

17. The stylet of claim 1, wherein the second curvilinear portion (C2) provides an opening angle (φ

2) of between 20° and

40°

18. A kit for the introduction into the venous system, and for the direction and guidance of the distal end of a probe until contact with the wall of the atrial or ventricular septum, comprising:

a preformed guiding stylet according to the configuration of claim 1.

19. A kit for the introduction in the venous system, and for the direction and guidance of the distal end of a lead until contact with the atrial or ventricular septum wall, comprising:

A guiding stylet comprising a not preformed wire that is essentially straight in an unstressed state, and

a template for forming said wire to have successively;

a first curvilinear portion (C1), a first straight portion (D1), and a second curvilinear portion (C2);

wherein the wire has a rigidity in torsion to allow transmission along its length of a rotational movement by a rotation of the handle;

the first curvilinear portion (C1) and the second curvilinear portion (C2) extend in respective planes (P1, P2) that make a angle (φ

3) between them that define a dihedral (Δ

) that includes the first straight portion (D1);

wherein the total length of the first curvilinear portion, first straight portion and the second curvilinear portion is between 82 and 195 mm; and

,

wherein said distal end comprises a shape and corresponding to an anatomical curvature of the venous system in which the lead equipped with said stylet will be introduced.

20. The kit of claim 19, said kit further comprises a packaging for containing said stylet wherein said template further comprises a relief formed on said packaging of the stylet.