# US 10,500,371 B2 · Fossa ovalis penetration

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- Number: US 10,500,371 B2
- Document ID: US10500371B2
- Status: Granted
- Kind: B2
- Application number: 15/518,126
- Filed: 2015-10-14
- Published: 2017-10-19
- Granted: 2019-12-10
- Earliest claimed: 2014-10-14
- Assignees: Transseptal Solutions Ltd.
- Applicants: Transseptal Solutions Ltd.
- Inventors: Elad Sapir; Eyal Teichman; Francesco Maisano
- Web page: https://patentgrep.com/patent/US10500371B2

## CPC

- A61M 25/0084: {being one or more injection needles}
- A61B 17/12122: {within the heart (for closing a cardiac septal defect A61B17/0057)}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- 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)}
- A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/003: {Steerable}
- A61B 2017/00305: {Constructional details of the flexible means}
- A61B 2017/00323: {Cables or rods}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/1205: {Introduction devices}
- A61B 2017/3454: {Details of tips}
- A61B 2018/00357: {Endocardium}
- A61B 2018/00577: {Ablation}
- A61B 2018/00601: {Cutting}
- A61B 2018/1425: {Needle}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/08021: {of the patient or his organs}
- A61B 2090/0807: {Indication means}
- A61M 2025/004: {characterized by lumina being arranged circumferentially}
- A61M 2025/0089: {Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip}
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M 2205/0233: Conductive materials, e.g. antistatic coatings for spark prevention
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2210/125: Heart
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 2)

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

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 1)

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.

### Claim 11 (depends on 10)

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.

### Claim 12 (depends on 1)

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

### Claim 13 (depends on 1)

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

### Claim 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.

### Claim 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.

### Claim 16 (depends on 15)

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.

### Claim 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.

### Claim 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.

### Claim 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.

### Claim 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.