# US 11,027,106 B2 · Dilating device and method for prostatic urethra

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- Number: US 11,027,106 B2
- Document ID: US11027106B2
- Status: Granted
- Kind: B2
- Application number: 16/403,632
- Filed: 2019-05-06
- Published: 2019-08-29
- Granted: 2021-06-08
- Earliest claimed: 2014-01-26
- Applicants: Butterfly Medical Ltd.
- Inventors: Yehuda Bachar
- Web page: https://patentgrep.com/patent/US11027106B2

## CPC

- 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)
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61B 1/307: for the urinary organs, e.g. urethroscopes or cystoscopes
- A61B 2018/00517: {Urinary bladder or urethra}
- A61F 2002/047: {Urethrae}
- A61M 2210/1096: Male
- 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)
- 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

A dilating device for the prostatic urethra comprising: Prostatic implant includes independently actuatable distal retractor incorporating and proximal retractor. Retractors may be connected via a spine member. System and method include implant manipulator detachably connected to implant, for manipulating and forcing implant into close proximity, for delivery into subject.

## Claims

### Claim 1

A method for dilating a prostatic urethra of a patient comprising:
Inserting a dilating device into the prostatic urethra of the patient said dilating device including a first elongated edge member having a first distally protruding nose portion and second elongated edge member having a second distally protruding nose portion symmetrically opposing each other across a spinal longitudinal axis, said first distally protruding nose portion and said second distally protruding nose portions protruding distally from the dilating device;
aligning the first elongated edge member and the second elongated edge member with posterolateral interlobar grooves of the prostatic urethra;
positioning said first distally protruding nose portion and said second distally protruding nose portion of the dilating device within the prostatic urethra on opposite lateral sides of a posterior portion thereof proximal to a bladder neck,
stretching laterally posterolateral sides of the prostatic urethra adjacent to the bladder neck with said first distally protruding nose portion and said second distally protruding nose portion;
preventing migration of the dilating device into a urinary bladder of the patient via said positioning and said stretching;
expanding said dilating device to an open configuration within said prostatic urethra and
exerting a radially outwards force on the prostatic urethra with said expanded dilating device to dilate the prostatic urethra.

### Claim 2 (depends on 1)

The method of claim 1, wherein said positioning of said first distally protruding nose portion is distal to a distalmost anterior portion of the dilating device.

### Claim 3 (depends on 1)

The method of claim 1, further comprising positioning said first distally protruding nose portion and said distally protruding nose portion in said prostatic urethra distal to a distalmost central portion of the dilating device.

### Claim 4 (depends on 1)

The method of claim 1, further comprising positioning said first distally protruding nose portion and said second distally protruding nose portion in said prostatic urethra distal to an anterior ridge of the dilating device.

### Claim 5 (depends on 1)

The method of claim 1, wherein aligning comprises transferring a torque applied to an alignment mechanism connected to the dilating deice.

### Claim 6 (depends on 1)

The method of claim 1, further comprising:
connecting an alignment mechanism to one or more proximally disposed protrusions of the dilating device.

### Claim 7 (depends on 1)

The method of claim 1, further comprising causing the dilating device to laterally compress and retreat within a deployment lumen when an alignment or a position of the dilating device is incorrect.

### Claim 8 (depends on 1)

The method of claim 1, wherein said stretching is from opposite lateral sides of a posterior side of the bladder neck.

### Claim 9 (depends on 1)

The method of claim 1, where said expanding includes extracting the dilating device from a deployment lumen entirely within the prostatic urethra of the patient.

### Claim 10 (depends on 1)

The method of claim 1, where said inserting includes extracting the dilating device from a deployment lumen into the urinary bladder and subsequently drawing the dilating device from the urinary bladder into the prostate urethra.

### Claim 11 (depends on 10)

The method of claim 10, wherein said drawing includes drawing the dilation device entirely into the prostatic urethra.

### Claim 12 (depends on 1)

The method of claim 1 further comprising:
engaging the dilating device with an anterior interlobar groove of the prostatic urethra.

### Claim 13 (depends on 1)

The method of claim 1, wherein said expanding is outward from said spinal longitudinal axis with a free end at said first and second elongated edge members like butterfly wings.

### Claim 14 (depends on 13)

The method of claim 13, wherein a posterior side of the dilating device is open.

### Claim 15 (depends on 1)

The method of claim 1, wherein said dilating device further includes a first proximal protrusion and second proximal protrusion and wherein a lateral width of between said first distally protruding nose portion and said second distally protruding nose portion is greater that a lateral distance between said first proximal protrusion and said second proximal protrusion.

### Claim 16 (depends on 1)

The method of claim 1, wherein said first distally protruding nose portion and said second distally protruding nose portion are L-shaped.

### Claim 17 (depends on 1)

The method of claim 1, further comprising:
impinging said first distally protruding nose portion and said second distally protruding nose portion against a cranial end of the prostatic urethra.

### Claim 18 (depends on 1)

The method of claim 1, further comprising:
resting said first distally protruding nose portion and said second distally protruding nose portion against a ledge formed by said stretching laterally of the posterolateral sides of the prostatic urethra.
