Fossa ovalis penetration

• US 10,500,371 B2
• Filed: 10/14/2015
• Issued: 12/10/2019
• Est. Priority Date: 10/14/2014
• Status: Active Grant

• Current Assignee: Transseptal Solutions Ltd.
• Original Assignee: Transseptal Solutions Ltd.
• Inventors: Sapir, Elad, Teichman, Eyal, Maisano, Francesco
• Primary Examiner(s): Rosen, Eric J
• Assistant Examiner(s): Restaino, Andrew P.
• Application Number:
  US15/518,126
• Publication Number:
  US 20170296781A1
• Time in Patent Office: 1,518 Days
• Field of Search: 623 111, 623 211
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00305 Constructional details of the flexible means
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/3454 Details of tips
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0089 : Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2205/0216 : Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/0233 : Conductive materials, e.g. antistatic coatings for spark prevention
• CPC Class Codes: A61M 2205/3317 : Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2210/125 : Heart
• CPC Class Codes: A61M 25/003 : characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/005 : with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0084 : being one or more injection needles
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A wall (39) of a catheter (38) (a) includes a braided portion (41) having an outer surface (45), an inner surface (47), and a braided interior (53) between the outer and inner surfaces (45, 47), and (b) is shaped to define first and second longitudinally-running channels (27a, 27b) therethrough. A distal portion of the catheter (38) is shaped to define first and second lateral openings (26a, 26b). An angle between (a) a first line (76) running between the first and second lateral openings (26a, 26b), and (b) a second line (78) that is parallel to a central longitudinal axis of the catheter (38) when the catheter (38) is straight, is between 30 and 150 degrees. A flexible longitudinal member (14) passes from a proximal portion of the catheter (38) to the distal portion via the first channel (27a), out of the first channel (27a) via the first lateral opening (26a), into the second channel (27b) via the second lateral opening (26b), and from the distal portion to the proximal portion via the second channel (27b).

Claims

1. Apparatus comprising:

a catheter shaped to define a catheter lumen,

wherein a wall of the catheter (a) comprises a braided portion, and (b) is shaped to define a first longitudinally-running channel through the wall and a second longitudinally-running channel through the wall, and

wherein a distal portion of the catheter is shaped to define a first lateral opening and a second lateral opening, and wherein an angle between (a) a first line running between the first and second lateral openings, and (b) a second line that is parallel to a central longitudinal axis of the catheter when the catheter is straight, is between 30 and 150 degrees;

a flexible longitudinal member that passes (a) from a proximal portion of the catheter to the distal portion of the catheter via the first channel, (b) out of the first channel via the first lateral opening, (c) into the second channel via the second lateral opening, and (d) from the distal portion of the catheter to the proximal portion of the catheter via the second channel;

a needle shaped to be slidably disposed within the catheter lumen;

a dilator element shaped to be slidably disposed within the catheter lumen, wherein the dilator element is shaped to define a dilator lumen; and

a dilator tip disposed at a distal end of the dilator element, wherein the dilator tip is configured to dilate an opening created by the needle.

2. The apparatus according to claim 1, wherein the angle between the first and second lines is between 60 and 120 degrees.

3. The apparatus according to claim 2, wherein the angle between the first and second lines is between 80 and 100 degrees.

4. The apparatus according to claim 1, wherein the first and second openings are separated from one another by an angle of 170-190 degrees measured along a circumference of the catheter.

5. The apparatus according to claim 1, wherein the needle is shaped to be slidably disposed within the dilator lumen.

6. The apparatus according to claim 1, wherein the flexible longitudinal member is mechanically resilient.

7. The apparatus according to claim 1, wherein a diameter of the flexible longitudinal member is between 0.1 and 0.5 mm.

8. The apparatus according to claim 1, wherein the flexible longitudinal member comprises a wire.

9. The apparatus according to claim 1, wherein the flexible longitudinal member comprises a material selected from the group consisting of:

nitinol, stainless steel, and chromium cobalt.

10. The apparatus according to claim 1,

wherein the flexible longitudinal member is configured to be deployed such that, in an absence of any force applied to the deployed portion of the flexible longitudinal member by an element that is not part of the apparatus, a deployment angle of the flexible longitudinal member is between 10 and 80 degrees, and

wherein the deployment angle is between (a) a vector that is (i) tangent to the flexible longitudinal member at an exit point of the flexible longitudinal member from the catheter, and (ii) directed away from the catheter, and (b) a distally-directed vector that is parallel to a longitudinal axis of the catheter at the exit point.

11. The apparatus according to claim 10, wherein the flexible longitudinal member is configured to be deployed such that, in the absence of any force applied to the deployed portion of the flexible longitudinal member by an element that is not part of the apparatus, the deployment angle is between 30 and 60 degrees.

12. The apparatus according to claim 1, wherein the flexible longitudinal member is radiopaque.

13. The apparatus according to claim 1, further comprising a plurality of radiopaque markers coupled to the flexible longitudinal member.

14. Apparatus comprising:

a catheter shaped to define a catheter lumen,

wherein a wall of the catheter (a) comprises a braided portion, and (b) is shaped to define a first longitudinally-running channel through the wall and a second longitudinally-running channel through the wall, and

wherein a distal portion of the catheter is shaped to define a first lateral opening and a second lateral opening, and wherein an angle between (a) a first line running between the first and second lateral openings, and (b) a second line that is parallel to a central longitudinal axis of the catheter when the catheter is straight, is between 30 and 150 degrees;

a flexible longitudinal member that passes (a) from a proximal portion of the catheter to the distal portion of the catheter via the first channel, (b) out of the first channel via the first lateral opening, (c) into the second channel via the second lateral opening, and (d) from the distal portion of the catheter to the proximal portion of the catheter via the second channel; and

a needle shaped to be slidably disposed within the catheter lumen,

wherein the needle is hollow, and comprises (a) a proximal portion, and (b) a helical distal portion, and

wherein the apparatus further comprises a fluid-impermeable cover surrounding the helical distal portion of the needle.

15. Apparatus comprising:

a catheter shaped to define a catheter lumen,

wherein a wall of the catheter (a) comprises a braided portion, and (b) is shaped to define a first longitudinally-running channel through the wall and a second longitudinally-running channel through the wall, and

wherein a distal portion of the catheter is shaped to define a first lateral opening and a second lateral opening, and wherein an angle between (a) a first line running between the first and second lateral openings, and (b) a second line that is parallel to a central longitudinal axis of the catheter when the catheter is straight, is between 30 and 150 degrees;

a flexible longitudinal member that passes (a) from a proximal portion of the catheter to the distal portion of the catheter via the first channel, (b) out of the first channel via the first lateral opening, (c) into the second channel via the second lateral opening, and (d) from the distal portion of the catheter to the proximal portion of the catheter via the second channel; and

a needle shaped to be slidably disposed within the catheter lumen,

wherein the needle is hollow, and comprises (a) a proximal portion, and (b) a distal portion that is more flexible than the proximal portion, and

wherein the apparatus further comprises a fluid-impermeable cover surrounding the distal portion of the needle.

16. The apparatus according to claim 15, further comprising:

a dilator element shaped to be slidably disposed within the catheter lumen, wherein the dilator element is shaped to define a dilator lumen; and

a dilator tip disposed at a distal end of the dilator element, wherein the dilator tip is configured to dilate an opening created by the needle.

17. Apparatus comprising:

a catheter shaped to define a catheter lumen,

wherein a wall of the catheter (a) comprises a braided portion, and (b) is shaped to define a first longitudinally-running channel through the wall and a second longitudinally-running channel through the wall, and

wherein a distal portion of the catheter is shaped to define a first lateral opening and a second lateral opening, and wherein an angle between (a) a first line running between the first and second lateral openings, and (b) a second line that is parallel to a central longitudinal axis of the catheter when the catheter is straight, is between 30 and 150 degrees;

a flexible longitudinal member that passes (a) from a proximal portion of the catheter to the distal portion of the catheter via the first channel, (b) out of the first channel via the first lateral opening, (c) into the second channel via the second lateral opening, and (d) from the distal portion of the catheter to the proximal portion of the catheter via the second channel; and

a needle shaped to be slidably disposed within the catheter lumen,

wherein the needle is hollow, and comprises (a) a proximal portion, and (b) a distal portion comprising a wall that is shaped to define a plurality of openings that pass completely therethrough, and

wherein the apparatus further comprises a fluid-impermeable cover surrounding the distal portion of the needle.

18. Apparatus comprising:

a catheter shaped to define a catheter lumen,

wherein a wall of the catheter (a) comprises a braided portion, and (b) is shaped to define a first longitudinally-running channel through the wall and a second longitudinally-running channel through the wall, and

wherein a distal portion of the catheter is shaped to define a first lateral opening and a second lateral opening, and wherein an angle between (a) a first line running between the first and second lateral openings, and (b) a second line that is parallel to a central longitudinal axis of the catheter when the catheter is straight, is between 30 and 150 degrees;

a flexible longitudinal member that passes (a) from a proximal portion of the catheter to the distal portion of the catheter via the first channel, (b) out of the first channel via the first lateral opening, (c) into the second channel via the second lateral opening, and (d) from the distal portion of the catheter to the proximal portion of the catheter via the second channel; and

a needle shaped to be slidably disposed within the catheter lumen,

wherein the needle is hollow, and comprises (a) a proximal portion, and (b) a distal portion comprising an elastomeric tube having an outer surface, an inner surface, and an interior portion between the outer and inner surfaces that is selected from the group consisting of;

a braided metal interior, and a coiled metal interior.

19. Apparatus comprising:

a catheter shaped to define a catheter lumen,

wherein a wall of the catheter (a) comprises a braided portion, and (b) is shaped to define a first longitudinally-running channel through the wall and a second longitudinally-running channel through the wall, and

wherein a distal portion of the catheter is shaped to define a first lateral opening and a second lateral opening, and wherein an angle between (a) a first line running between the first and second lateral openings, and (b) a second line that is parallel to a central longitudinal axis of the catheter when the catheter is straight, is between 30 and 150 degrees;

a flexible longitudinal member that passes (a) from a proximal portion of the catheter to the distal portion of the catheter via the first channel, (b) out of the first channel via the first lateral opening, (c) into the second channel via the second lateral opening, and (d) from the distal portion of the catheter to the proximal portion of the catheter via the second channel; and

a needle shaped to be slidably disposed within the catheter lumen,

wherein the needle is hollow, and comprises;

a proximal portion having an outer diameter between 0.7 and 3 mm, a length between 650 and 1200 mm, and a wall thickness between 0.1 and 0.3 mm; and

a distal portion at least partially made of nitinol, the distal portion having an outer diameter between 0.5 and 1.5 mm and a length between 30 and 200 mm.

20. Apparatus comprising:

a catheter shaped to define a catheter lumen,

wherein a wall of the catheter (a) comprises a braided portion, and (b) is shaped to define a first longitudinally-running channel through the wall and a second longitudinally-running channel through the walk and

wherein a distal portion of the catheter is shaped to define a first lateral opening and a second lateral opening, and wherein an angle between (a) a first line running between the first and second lateral openings, and (b) a second line that is parallel to a central longitudinal axis of the catheter when the catheter is straight is between 30 and 150 degrees;

a flexible longitudinal member that passes (a) from a proximal portion of the catheter to the distal portion of the catheter via the first channel (b) out of the first channel via the first lateral opening, (c) into the second channel via the second lateral opening, and (d) from the distal portion of the catheter to the proximal portion of the catheter via the second channel;

a needle shaped to be slidably disposed within the catheter lumen, wherein the needle is electrically conductive;

one or more conductors; and

a controller, which is coupled to the needle by the one or more conductors, and which is configured to drive the needle to apply energy capable of creating a hole through tissue.