# US 10,441,449 B1 · Rotary handle stent delivery system and method

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- Number: US 10,441,449 B1
- Document ID: US10441449B1
- Status: Granted
- Kind: B1
- Application number: 15/993,291
- Filed: 2018-05-30
- Granted: 2019-10-15
- Earliest claimed: 2018-05-30
- Assignees: Vesper Medical, Inc.
- Applicants: Vesper Medical, Inc.
- Inventors: Michael A. Longo; Timothy W. O'Neil; Christopher John Turek
- Web page: https://patentgrep.com/patent/US10441449B1

## CPC

- A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61F 2/9517: {handle assemblies therefor}
- A61M 25/0113: {Mechanical advancing means, e.g. catheter dispensers}
- 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)}

## Abstract

A delivery device according to principles described herein includes a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft at least partially extending over the inner core and the outer sheath. A timing belt having a plurality of belt teeth on a surface of the timing belt is coupled to an outer sheath over a medical device or stent on the inner core such that movement of the timing belt link causes movement of the outer sheath from its position over the medical device or stent. The delivery device is actuated by rotation of a thumbwheel a thumbwheel coupled to a barrel having a plurality of teeth such that rotation of the thumbwheel causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the timing belt causing movement of the outer sheath.

## Claims

### Claim 1

A delivery device comprising:
a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft;
a flexible timing belt having a plurality of belt teeth on a surface of the flexible timing belt;
a timing belt link directly coupled to the flexible timing belt and coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath;
a barrel having barrel teeth corresponding to belt teeth for directly engaging the belt teeth;
a thumbwheel assembly having two thumbwheels, wherein at least a portion of the thumbwheel assembly is integral with the barrel such that rotation of the thumbwheel assembly causes movement of the barrel such that the barrel teeth directly engage the belt teeth to cause movement of the flexible timing belt and the timing belt link, causing movement of the outer sheath; and
a belt tensioner comprising a torsion spring, a tensioner arm and a tensioner pulley,
wherein the barrel is between the two thumbwheels and the flexible timing belt engages the barrel between the two thumbwheels; and
wherein the barrel and the two thumbwheels are rotatable about a common axis.

### Claim 2 (depends on 1)

The delivery device of claim 1, further comprising a housing, wherein a portion of the thumbwheel assembly is external to the housing, wherein the barrel is internal to the housing and the flexible timing belt is internal to the housing.

### Claim 3 (depends on 1)

The delivery device of claim 1, wherein the belt teeth are on an outer surface of the flexible timing belt.

### Claim 4 (depends on 1)

The delivery device of claim 1, further comprising at least one pulley, the flexible timing belt extending around the pulley such that the direction of rotation of the thumbwheel assembly imparts a desired direction of translation of the outer sheath.

### Claim 5 (depends on 1)

The delivery device of claim 1, the belt tensioner further comprising a tensioner arm axle and tensioner pulley axle.

### Claim 6 (depends on 1)

The delivery device of claim 1, wherein the three concentric shafts comprise:
the inner core sized to receive a medical device thereon;
the outer sheath sized to receive the medical device in an unexpanded state on the inner core therein and to hold the medical device, the outer sheath translatable coaxially over the inner core; and
the outer support shaft at least partially extending over the inner core and the outer sheath.

### Claim 7 (depends on 1)

The delivery device of claim 1, wherein the inner core and the outer support shaft are fixed with respect to a proximal end of the delivery device.

### Claim 8 (depends on 1)

The delivery device of claim 1, further comprising a metal shaft at an outer diameter of the inner core.

### Claim 9 (depends on 8)

The delivery device of claim 8, wherein the metal shaft is bonded to the outer diameter of the inner core.

### Claim 10 (depends on 8)

The delivery device of claim 8, wherein the metal shaft comprises stainless steel.

### Claim 11 (depends on 1)

The delivery device of claim 1, wherein the thumbwheel assembly is rotatable in a forward direction and a reverse direction such that the outer sheath translates in first direction when the thumbwheel assembly is rotated in the forward direction and the outer sheath translates in a second direction when the thumbwheel assembly is rotated in the reverse direction.

### Claim 12

A system for delivery of an intraluminal stent, comprising:
a delivery device comprising:
a catheter having three concentric shafts including:
an inner core having the intraluminal stent thereon;
an outer sheath over the intraluminal stent in an unexpanded state on the inner core therein, the outer sheath holding the intraluminal stent in an unexpanded state, the outer sheath translatable coaxially over the inner core and the intraluminal stent; and
an outer support shaft at least partially extending over the inner core and the outer sheath;
a flexible timing belt having a plurality of belt teeth on a surface of the flexible timing belt;
a timing belt link directly coupled to the flexible timing belt and coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath to expose the intraluminal stent;
a barrel having barrel teeth corresponding to belt teeth;
a thumbwheel assembly having two thumbwheels, wherein at least a portion of the thumbwheel assembly is integral with the barrel such that rotation of the thumbwheel assembly causes movement of the barrel such that the barrel teeth directly engage the belt teeth to cause movement of the flexible timing belt and the timing belt link, causing movement of the outer sheath; and
a belt tensioner comprising a torsion spring, a tensioner arm and a tensioner pulley,
wherein the barrel is between the two thumbwheels and the flexible timing belt engages the barrel between the two thumbwheels; and
wherein the barrel and the two thumbwheels are rotatable about a common axis.

### Claim 13 (depends on 12)

The delivery device of claim 12, further comprising a housing, wherein a portion of the thumbwheel assembly is external to the housing, wherein the barrel is internal to the housing and the flexible timing belt is internal to the housing.

### Claim 14 (depends on 12)

The delivery device of claim 12, wherein the belt teeth are on an outer surface of the flexible timing belt.

### Claim 15 (depends on 12)

The delivery device of claim 12, further comprising at least one pulley, the flexible timing belt extending around the pulley such that the direction of rotation of the thumbwheel assembly imparts a desired direction of translation of the outer sheath.

### Claim 16 (depends on 12)

The delivery device of claim 12, the belt tensioner further comprising a tensioner arm axle and tensioner pulley axle.

### Claim 17 (depends on 12)

The delivery device of claim 12, further comprising a metal shaft at an outer diameter of the inner core.

### Claim 18 (depends on 17)

The delivery device of claim 17, wherein the metal shaft is bonded to the outer diameter of the inner core.

### Claim 19 (depends on 17)

The delivery device of claim 17, wherein the metal shaft comprises stainless steel.

### Claim 20 (depends on 17)

The delivery device of claim 17, wherein the thumbwheel assembly is rotatable in a forward direction and a reverse direction such that the outer sheath translates in first direction when the thumbwheel assembly is rotated in the forward direction and the outer sheath translates in a second direction when the thumbwheel assembly is rotated in the reverse direction.

### Claim 21 (depends on 12)

The delivery device of claim 12, wherein the outer support shaft and the inner core are fixed with respect to a proximal end of the delivery device.

### Claim 22

A method of delivering a medical device to a body using a delivery device comprising a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft; a flexible timing belt having a plurality of belt teeth on a surface of the flexible timing belt; a timing belt link coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath; a barrel having barrel teeth corresponding to belt teeth; a belt tensioner comprising a torsion spring, a tensioner arm and a tensioner pulley; a thumbwheel assembly having two thumbwheels, wherein at least a portion of the thumbwheel assembly is integral with the barrel such that rotation of the thumbwheel assembly causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the flexible timing belt and the timing belt link, causing movement of the outer sheath; and a medical device over an outer diameter of the inner core wherein the barrel is between the two thumbwheels and the flexible timing belt engages the barrel between the two thumbwheels and wherein the barrel and the two thumbwheels are rotatable about a common axis; the method comprising:
rotating the thumbwheel assembly in a predetermined direction to cause the flexible timing belt to move in direction associated with the predetermined direction of thumbwheel assembly rotation to cause the timing belt link to move the outer sheath in a desired direction; and
deploying the medical device from a distal end of the inner core to the body as the outer sheath moves in the desired direction.

### Claim 23 (depends on 22)

The method of claim 22, wherein the three concentric shafts comprise:
the inner core sized to receive a medical device thereon;
the outer sheath sized to receive the medical device in an unexpanded state on the inner core therein and to hold the medical device, the outer sheath translatable coaxially over the inner core; and
the outer support shaft at least partially extending over the inner core and the outer sheath.

### Claim 24 (depends on 22)

The method of claim 22, wherein the inner core and the outer support shaft are fixed with respect to a proximal end of the delivery device.

### Claim 25 (depends on 22)

The method of claim 22, further comprising a metal shaft at an outer diameter of the inner core.

### Claim 26 (depends on 25)

The method of claim 25, wherein the metal shaft is bonded to the outer diameter of the inner core.

### Claim 27 (depends on 25)

The method of claim 25, wherein the metal shaft comprises stainless steel.

### Claim 28 (depends on 25)

The method of claim 25, wherein the thumbwheel assembly is rotatable in a forward direction and a reverse direction such that the outer sheath translates in first direction when the thumbwheel assembly is rotated in the forward direction and the outer sheath translates in a second direction when the thumbwheel assembly is rotated in the reverse direction.
