# US 11,998,438 B2 · Systems, devices, and methods for the accurate deployment of an implant in the prostatic urethra

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- Number: US 11,998,438 B2
- Document ID: US11998438B2
- Status: Granted
- Kind: B2
- Application number: 17/380,377
- Filed: 2021-07-20
- Published: 2022-03-17
- Granted: 2024-06-04
- Earliest claimed: 2016-12-09
- Assignees: Zenflow, Inc.
- Applicants: Zenflow, Inc.
- Inventors: Marcel Song Sicotte; Austin Michael Bly; Ben Collett-Nye; Shreya Mehta
- Web page: https://patentgrep.com/patent/US11998438B2

## CPC

- A61F 2/042: {Urinary bladders}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61F 2/04: Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts (A61F2/18, A61F2/20 take precedence; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95)
- A61F 2/885: {comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis}
- A61F 2/9517: {handle assemblies therefor}
- A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61M 27/008: {pre-shaped, for use in the urethral or ureteral tract}
- A61B 2017/00274: {Prostate operation, e.g. prostatectomy, turp, bhp treatment}
- A61F 2002/047: {Urethrae}
- A61F 2002/9665: {with additional retaining means}
- A61F 2250/001: for adjusting a diameter
- A61M 2025/1047: {having centering means, e.g. balloons having an appropriate shape}
- F16H 1/06: with parallel axes
- F16H 1/28: with gears having orbital motion
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}
- F16H: GEARING

## Abstract

Systems, devices, and methods are provided for the delivery of an implant into the prostatic urethra. Embodiments of delivery systems can include a delivery device for insertion into the patient and a proximal control device for use in controlling release of the implant from the delivery device.

## Claims

### Claim 1

A system for delivering an implantable device, comprising:
an implant;
a delivery device comprising a first elongate member having an inner lumen, an elongate grasper member slidable within the inner lumen comprising a recess for holding a proximal portion of an implant, and a distal control member comprising a recess for holding a distal portion of the implant; and
a proximal control device coupled with a proximal end region of the delivery device, the proximal control device comprising a user actuator, a housing, and a switch, wherein placement of the switch in a first position translates movement of the user actuator into movement of the implant in a first direction and placement of the switch in a second position translates the movement of the user actuator into movement of the implant in a second direction.

### Claim 2 (depends on 1)

The system of claim 1, wherein the proximal control device comprises a first gear assembly within the housing, the proximal control device being configured to translate movement of the user actuator into movement in the first gear assembly.

### Claim 3 (depends on 2)

The system of claim 2, wherein the switch selects between movement of the first gear assembly in a first direction and movement of the first gear assembly in a second direction.

### Claim 4 (depends on 3)

The system of claim 3, wherein the user actuator is coupled with a yoke that is coupled with a first pawl and a second pawl.

### Claim 5 (depends on 4)

The system of claim 4, wherein the switch selectively engages either the first pawl or the second pawl with a pinion gear.

### Claim 6 (depends on 5)

The system of claim 5, wherein the proximal control device is configured such that rotation of the pinion gear causes rotation of a face gear.

### Claim 7 (depends on 6)

The system of claim 6, wherein the proximal control device is configured such that rotation of the face gear causes rotation of a reel coupled with the elongate grasper member.

### Claim 8 (depends on 7)

The system of claim 7, further comprising:
an input gear engaged with the face gear; and
a reel gear engaged with the input gear, the reel gear coupled with or integrated with the reel.

### Claim 9 (depends on 8)

The system of claim 8, wherein the input gear is an interrupted gear, and wherein rotation of the reel gear by the input gear causes rotation of the reel and longitudinal movement of the elongate grasper member.

### Claim 10 (depends on 3)

The system of claim 3, wherein movement of the first gear assembly in the first direction causes distal movement of the elongate grasper member, and wherein movement of the first gear assembly in the second direction causes proximal movement of the elongate grasper member.

### Claim 11 (depends on 2)

The system of claim 2, wherein the proximal control device comprises a cam assembly within the housing, the proximal control device being configured to translate movement of the user actuator into movement in the cam assembly.

### Claim 12 (depends on 11)

The system of claim 11, wherein the cam assembly is coupled with the first elongate member.

### Claim 13 (depends on 12)

The system of claim 12, wherein the cam assembly is configured to move the first elongate member proximally with respect to the housing.

### Claim 14 (depends on 13)

The system of claim 13, wherein the cam assembly comprises a rotatable cam having a slot, the first elongate member being coupled with a guide member received within the slot.

### Claim 15 (depends on 14)

The system of claim 14, wherein the slot comprises a sloped slot portion and a radial slot portion.

### Claim 16 (depends on 14)

The system of claim 14, wherein the cam assembly comprises an inner tube having a longitudinal slot with the guide member received in the longitudinal slot.

### Claim 17 (depends on 11)

The system of claim 11, wherein the first gear assembly comprises a face gear having a first set of teeth that engage with teeth of another gear in the first gear assembly, wherein the face gear is coupled with the cam assembly such that movement of the face gear causes movement in the cam assembly.

### Claim 18 (depends on 11)

The system of claim 11, wherein the proximal control device comprises a second gear assembly.

### Claim 19 (depends on 18)

The system of claim 18, wherein movement in the cam assembly causes movement in the second gear assembly.

### Claim 20 (depends on 19)

The system of claim 19, wherein the second gear assembly is coupled with the first elongate member and is configured to rotate the first elongate member with respect to the housing.

### Claim 21 (depends on 20)

The system of claim 20, wherein the second gear assembly comprises a central gear having an aperture configured to receive the first elongate member such that rotation of the central gear causes rotation of the first elongate member.

### Claim 22 (depends on 21)

The system of claim 21, wherein the second gear assembly comprises an annular gear coupled with the cam assembly and coupled with the central gear by way of a planetary gear assembly.

### Claim 23 (depends on 22)

The system of claim 22, wherein the annular gear engages the planetary gear assembly such that rotation of the annular gear in a first direction causes first directional rotation of the central gear and rotation of the annular gear in a second direction causes second directional rotation of the central gear, the first directional rotation of the central gear being opposite to the second directional rotation.

### Claim 24 (depends on 2)

The system of claim 2, wherein the proximal control device comprises a releasable lock mechanism that prevents the proximal portion of the implant held by the elongate grasper member from exiting the inner lumen.

### Claim 25 (depends on 24)

The system of claim 24, wherein the lock mechanism comprises a movable tracking mechanism that interfaces with a groove in a face gear of the first gear assembly, the proximal control device configured such that movement of the face gear moves the tracking mechanism as the implant exits the inner lumen.

### Claim 26 (depends on 25)

The system of claim 25, wherein the proximal control device is configured such that the tracking mechanism is prevented from further motion prior to the proximal portion of the implant exiting the inner lumen.

### Claim 27 (depends on 26)

The system of claim 26, wherein the proximal control device comprises a release structure configured to be actuated by a user, wherein the release structure is configured to disengage the tracking mechanism from the face gear to allow the proximal portion of the implant to exit the inner lumen.

### Claim 28 (depends on 27)

The system of claim 27, wherein the release structure is a pull tab.

### Claim 29 (depends on 27)

The system of claim 27, wherein the release structure is coupled with the elongate grasper member.
