# US 11,992,645 B2 · Integrated hemostasis bypass valve

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- Number: US 11,992,645 B2
- Document ID: US11992645B2
- Status: Granted
- Kind: B2
- Application number: 17/668,542
- Filed: 2022-02-10
- Published: 2023-08-10
- Granted: 2024-05-28
- Earliest claimed: 2022-02-10
- Assignees: St. Jude Medical, Cardiology Division, Inc.
- Applicants: St. Jude Medical, Cardiology Division, Inc.
- Inventors: Tracee Eidenschink; Mathias C. Glimsdale
- Web page: https://patentgrep.com/patent/US11992645B2

## CPC

- A61M 39/06: Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)}
- A61B 2017/00579: {Barbed implements}
- A61B 2017/00592: {Elastic or resilient implements}
- A61B 2017/00623: {Introducing or retrieving devices therefor}
- A61B 2017/00632: {Occluding a cavity, i.e. closing a blind opening}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/3425: {for internal organs, e.g. heart ports}
- A61M 2039/0258: {for vascular access, e.g. blood stream access}
- A61M 2039/0279: {for introducing medical instruments into the body, e.g. endoscope, surgical tools}
- A61M 2039/0282: {with implanted tubes connected to the port}
- A61M 2039/0626: {used with other surgical instruments, e.g. endoscope, trocar}
- 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)

## Abstract

According to one aspect of the disclosure, a delivery device may include a handle, a catheter sheath extending distally from the handle, and a hemostasis valve positioned within the handle. The hemostasis valve may be located proximal the catheter sheath and distal to a proximal end of the handle. The delivery device may also include a hemostasis bypass assembly coupled to the handle. The hemostasis bypass assembly may include a bypass tube coupled to an actuator. The actuator may be configured to be transitioned between a first condition in which a distal end of the bypass tube is positioned proximal to the hemostasis valve and the hemostasis valve is closed, and a second condition in which the distal end of the bypass tube traverses the hemostasis valve and the hemostasis valve is opened.

## Claims

### Claim 1

A delivery device for a collapsible and expandable medical device, the delivery device comprising:
a handle;
a catheter sheath extending distally from the handle;
a hemostasis valve positioned within the handle, the hemostasis valve being located proximal the catheter sheath and distal to a proximal end of the handle; and
a hemostasis bypass assembly coupled to the handle, the hemostasis bypass assembly including a bypass tube coupled to an actuator, the actuator configured to be transitioned between a first condition in which a distal end of the bypass tube is positioned proximal to the hemostasis valve and the hemostasis valve is closed, and a second condition in which the distal end of the bypass tube traverses the hemostasis valve and the hemostasis valve is opened,
wherein the hemostasis valve is part of a hemostasis valve assembly, the hemostasis valve assembly including a main body extending proximal of the hemostasis valve and a hub extending distally of the hemostasis valve, the main body and the hub maintaining the hemostasis valve therebetween,
wherein the actuator is a rotatable knob,
wherein the main body includes one or more protrusions extending radially outwardly from the main body, and the rotatable knob includes one or more curved recesses on an interior surface thereof, the one or more protrusions received within a corresponding one or more curved recesses on the interior surface of the rotatable knob, such that rotation of the rotatable knob translates the bypass tube toward or away from the hemostasis valve,
wherein the hemostasis bypass assembly includes a retaining ring that overlies the main body of the hemostasis valve assembly, a proximal end of the retaining ring being coupled to a distal end of the rotatable knob,
wherein in an assembled condition of the delivery device, the retaining ring is fixed to the rotatable knob wherein the retaining ring includes one or more recesses being sized and spaced to align with the one or more protrusions.

### Claim 2 (depends on 1)

The delivery device of claim 1, wherein the hemostasis bypass assembly is integrated with the handle.

### Claim 3 (depends on 2)

The delivery device of claim 2, wherein the hemostasis bypass assembly is coupled to the proximal end of the handle.

### Claim 4 (depends on 1)

The delivery device of claim 1, wherein the hemostasis valve is formed of urethane or silicone.

### Claim 5 (depends on 1)

The delivery device of claim 1, wherein the main body of the hemostasis valve assembly includes an interior flange defining a central aperture, and when the actuator is in the first condition, the distal end of the bypass tube is received within the central aperture.

### Claim 6 (depends on 5)

The delivery device of claim 5, wherein the bypass tube is coaxial with the central aperture, the hemostasis valve, and the catheter sheath.

### Claim 7 (depends on 1)

The delivery device of claim 1, further comprising a bypass hub at the proximal end of the actuator, the bypass hub coupled to the bypass tube, the bypass hub and the bypass tube including a continuous lumen extending therethrough.

### Claim 8 (depends on 7)

The delivery device of claim 7, wherein the bypass hub includes external threading.

### Claim 9 (depends on 1)

The delivery device of claim 1, wherein the hemostasis valve includes a proximal section and a distal section, a first group of four slits formed in the proximal section and extending a first depth toward the distal section, and a second group of four slits formed in the distal section and extending a second depth toward the proximal section.

### Claim 10 (depends on 9)

The delivery device of claim 9, wherein the first group of four slits are formed at about 90 degrees relative to each other in a first “X”-configuration, and the second group of four slits are formed at about 90 degrees relative to each other in a second “X”-configuration, the first “X”-configuration being offset by about 45 degrees relative to the second “X”-configuration.

### Claim 11 (depends on 10)

The delivery device of claim 10, wherein the first depth overlaps with the second depth to form a pathway from the first group of four slits to the second group of four slits.

### Claim 12 (depends on 1)

The delivery device of claim 1, further comprising a deflection knob coupled to the handle, the deflection knob being rotatable about a longitudinal axis of the handle to activate one or more pull wires coupled to a distal tip of the catheter sheath to deflect the distal tip of the catheter sheath.

### Claim 13 (depends on 1)

The delivery device of claim 1, wherein in a pre-assembled condition of the delivery device, the retaining ring is configured to slide over the main body while the one or more recesses are aligned with the one or more protrusions, and in the assembled condition of the delivery device, the one or more recesses are not aligned with the one or more protrusions to prevent the retaining ring from sliding off the main body.

### Claim 14 (depends on 1)

The delivery device of claim 1, wherein in the assembled condition of the delivery device, the retaining ring is fixed to the rotatable knob by adhesives or ultrasonic welding.

### Claim 15 (depends on 1)

A medical device system, comprising:
the delivery device of claim 1; and
the collapsible and expandable medical device, the medical device configured to be received within the delivery device in a collapsed condition and configured to pass through the delivery device while in the collapsed condition, the medical device having a first column strength in the collapsed condition that is less than a column strength of the bypass tube.

### Claim 16 (depends on 15)

The medical device system of claim 15, wherein the medical device is a left atrial appendage occlusion (“LAAO”) device.

### Claim 17 (depends on 16)

The medical device system of claim 16, wherein the LAAO device is formed of a braided mesh of metal strands.

### Claim 18 (depends on 17)

The medical device system of claim 17, wherein the metal strands are formed of a nickel titanium alloy.