# US 10,500,028 B2 · Adjustable medical assembly for implant tension adjustment

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- Number: US 10,500,028 B2
- Document ID: US10500028B2
- Status: Granted
- Kind: B2
- Application number: 15/238,213
- Filed: 2016-08-16
- Published: 2016-12-08
- Granted: 2019-12-10
- Earliest claimed: 2012-02-22
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Mark Danna; Kristina Yim Jenkins
- Web page: https://patentgrep.com/patent/US10500028B2

## CPC

- A61F 2/0045: {Support slings}
- A61B 17/0401: {Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811)}
- A61B 17/06109: {Big needles, either gripped by hand or connectable to a handle}
- A61B 17/122: Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)}
- A61B 2017/00367: {Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like}
- A61B 2017/00805: {Treatment of female stress urinary incontinence}
- A61B 2017/0403: {Dowels}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0456: {Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor}
- A61B 2017/0461: {with features cooperating with special features on the suture, e.g. protrusions on the suture}
- A61B 2017/0464: {for soft tissue}
- A61F 2002/0072: {Delivery tools therefor}
- A61F 2210/0004: bioabsorbable
- A61F 2250/0007: for adjusting length
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- 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)

## Abstract

The present invention discloses a medical assembly and method to deliver and place a bodily implant inside a patient's body. The medical assembly includes an insertion tool such that a portion of the insertion tool defines a lumen. The medical assembly further includes a carrier configured to be coupled to the insertion tool and including a passageway. The medical assembly also includes a flexible elongate member configured to pass through the passageway of the carrier and the lumen. The elongate member is also configured to be coupled to the bodily implant such that a portion of the elongate member between the bodily implant and the carrier defines a length.

## Claims

### Claim 1

A medical assembly comprising:
an insertion tool configured to be inserted into a patient's body, the insertion tool having a proximal end portion and a distal end portion such that a portion between the distal end portion and the proximal end portion defines a lumen, the proximal end portion of the insertion tool defining a handle;
a carrier configured to be coupled to the distal end portion of the insertion tool and configured to be disposed within a bodily tissue upon placement, the carrier including a passageway; and
a flexible elongate member with a proximal end portion and a distal end portion, the elongate member being configured to be disposed within the lumen of the insertion tool and configured to pass through the passageway of the carrier, the elongate member further configured to be coupled to an implant such that a portion of the elongate member between the implant and the carrier defines a length of the elongate member,
wherein the insertion tool includes an adjustment mechanism configured to adjust the length of the elongate member between the implant and the carrier, the adjustment mechanism being disposed at the proximal end portion of the insertion tool, the adjustment mechanism includes a shaft that is partially disposed within the insertion tool and extends from a proximal end portion of the handle to a distal end portion of the handle,
the insertion tool further includes a locking mechanism configured to lock the elongate member within the insertion tool.

### Claim 2 (depends on 1)

The medical assembly of claim 1, wherein the carrier is a dart having a tip portion configured to be fixed to the bodily tissue and configured to anchor the implant with the bodily tissue upon placement.

### Claim 3 (depends on 1)

The medical assembly of claim 1, wherein the carrier is a clamp configured to be coupled to the distal end portion of the insertion tool at its proximal end portion, the clamp further including a jaw having flaps configured to clamp the bodily tissue.

### Claim 4 (depends on 3)

The medical assembly of claim 3, wherein the clamp further includes a locking member configured to lock the flaps of the jaw into the bodily tissue.

### Claim 5 (depends on 1)

The medical assembly of claim 1, wherein the insertion tool further includes a needle configured to be coupled to the carrier.

### Claim 6 (depends on 1)

The medical assembly of claim 1, wherein the passageway of the carrier includes a slot with a substantially circular cross section at one end and a rectilinear cross section at the other end such that the rectilinear cross section is narrower than the circular cross section.

### Claim 7 (depends on 1)

The medical assembly of claim 1, wherein the passageway of the carrier includes a slot, the carrier further including a teethed section having teeth configured to engage the elongate member that passes through the slot and the teethed section.

### Claim 8 (depends on 1)

The medical assembly of claim 1, wherein the passageway of the carrier includes a slot with a substantially circular cross section at one end and a rectilinear cross section at the other end such that the rectilinear cross section is narrower than the circular cross section, the elongate member configured to pass the slot and includes a knot that is present at discrete locations on a portion of the elongate member.

### Claim 9 (depends on 1)

The medical assembly of claim 1, wherein the implant is a mesh based device configured to be coupled to the carrier and the insertion tool via the elongate member.

### Claim 10 (depends on 1)

The medical assembly of claim 1, wherein the carrier is made of a material comprising at least one of polypropylene, plastic, bio absorbable, radiopaque, medical grade stainless steel, acrylonitrile butadiene styrene, and polycarbonate.

### Claim 11 (depends on 1)

The medical assembly of claim 1, wherein the adjustment mechanism includes a knob configured to adjust the length of the elongate member by letting the elongate member in and out of the insertion tool.

### Claim 12 (depends on 1)

The medical assembly of claim 1, wherein the locking mechanism includes a gear and a push button, wherein the push button is configured to engage gear teeth when pushed externally.

### Claim 13 (depends on 1)

The medical assembly of claim 1, wherein the carrier is a first carrier configured to be attached to a first bodily tissue, the medical assembly further comprising a second carrier configured to be attached to a second bodily tissue.

### Claim 14

An insertion tool configured to deliver and place a bodily implant inside a patient's body, the insertion tool comprising:
a handle and a needle extending from the handle, wherein a portion of the handle and the needle defines a lumen, the lumen configured to receive a flexible elongate member, the elongate member configured to be coupled to the bodily implant;
an adjustment mechanism having an adjustment knob provided on a proximal end portion of the handle that is configured to adjust a length of the elongate member by letting a portion of the elongate member in or out of the lumen of the insertion tool, the adjustment mechanism includes a shaft that partially extends from the proximal end portion of the handle to a distal end portion of the handle; and
a locking mechanism including a button and a gear, the button configured to engage with the gear when pushed from a location external to the lumen.

### Claim 15

A method for placing a bodily implant in a patient's body, the method comprising:
adjusting a length of an elongate member between a carrier and the implant by operating a knob provided on a handle of an insertion tool such that operating the knob changes the length of the elongate member between the carrier and the implant by letting a portion of the elongate member in or out of the insertion tool, the knob including a shaft that extends at least from a proximal end portion of the handle to a distal end portion of the handle, wherein the carrier is configured to be disposed within a bodily tissue upon placement inside the body;
locking the elongate member within the insertion tool, after the length between the carrier and the implant is adjusted, by pressing a button provided on the insertion tool;
securing the length of the elongate member between the carrier and the implant to a carrier passageway provided in the carrier such that one end of the secured length is coupled to the carrier passageway and the other end is coupled to the bodily implant; and
placing the bodily implant and the carrier inside the body.

### Claim 16 (depends on 15)

The method of claim 15, further comprising a locking mechanism, wherein the locking mechanism includes a gear, the method further comprising engaging the gear with the button after the button is pressed.

### Claim 17 (depends on 15)

The method of treatment of claim 15, wherein the carrier is a clamp, the clamp further including a jaw having flaps configured to come in contact with one another, the method further comprising clamping the bodily tissue within the flaps by actuating the jaw with the use of the knob.

### Claim 18 (depends on 15)

The method of claim 15, wherein the securing of the length of the elongate member further comprises relocating a clamp along the length of the elongate member.

### Claim 19 (depends on 15)

The method of claim 15, further comprising placing the carrier into an obturator internus muscle through a single midline incision in a vaginal wall.

### Claim 20 (depends on 15)

The method of claim 15, wherein the carrier is a first carrier attached to a first end portion of the bodily implant and configured to be placed at a first bodily portion, the method further comprising placing a second carrier at a second bodily portion inside the patient's body, the second carrier attached to a second end portion of the bodily implant.
