# US 2017/0281142 A1 · Sheath-dilator system and uses thereof

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- Number: US 2017/0281142 A1
- Document ID: US20170281142A1
- Status: Published application
- Kind: A1
- Application number: 15/586,989
- Filed: 2017-05-04
- Published: 2017-10-05
- Earliest claimed: 2011-05-16
- Assignees: Vivasure Medical Limited
- Applicants: Vivasure Medical Limited
- Inventors: Christopher Martin; Damien Ryan; Gerard Brett
- Web page: https://patentgrep.com/patent/US20170281142A1

## CPC

- 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)}
- A61M 25/0662: {Guide tubes}
- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61B 5/0215: by means inserted into the body
- A61B 5/026: Measuring blood flow {(A61B3/1233, A61B3/1241 take precedence)}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00115: {with audible or visual output}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00654: {entirely comprised between the two sides of the opening}
- A61B 2017/00663: {the implement being a suture}
- A61B 2017/00672: {Locating means therefor, e.g. bleed back lumen}
- A61B 2090/062: {penetration depth}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked}
- A61M 25/0693: {Flashback chambers}
- A61M 2025/0002: {with a pressure sensor at the distal end}
- A61M 2025/0008: {having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type}
- A61M 2025/0166: {Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided}
- 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)}

## Abstract

A medical device includes a sheath having a proximal end and a distal end, the sheath having an opening at both the proximal end and the distal end, and a removable dilator having a distal end and a proximal end, the dilator having at least one blood detector disposed on a tapered portion of the distal end of the dilator, the dilator positionable within the sheath such that the tapered portion of the distal end of the dilator extends through the opening in the distal end of the sheath, the proximal end of the dilator extends through the opening in the proximal end of the sheath, and at least a portion of the at least one blood detector is adjacent to the distal end of the sheath.

## Claims

### Claim at position 1

1-37. (canceled)

### Claim 38

A medical device comprising:
a sheath having a proximal end and a distal end, the sheath having an opening at both the proximal end and the distal end;
a removable dilator having a distal end and a proximal end, the dilator having at least one blood detector disposed on the dilator, the dilator positionable within the sheath such that a tapered portion of the distal end of the dilator extends through the opening at the distal end of the sheath, the proximal end of the dilator extends through the opening at the proximal end of the sheath, and at least a portion of the at least one blood detector is adjacent to the distal end of the sheath;
a closure device for closing an aperture in a vessel; the closure device comprising:
a foot for engaging an internal surface of a wall of a vessel;
a plug for engaging an external surface of the wall of the vessel;
an anchor for engaging the plug; and
a suture;
wherein, upon deployment, the suture extends through the foot, the plug, and the anchor; and
wherein, upon engagement, the foot exerts a compressive force on the internal surface of the wall of the vessel, and the plug engages the external surface of the wall of the vessel, so that compression of the wall of the vessel on both sides of the aperture assists in closure of the aperture.

### Claim 39 (depends on 38)

The medical device according to claim 38, wherein the sheath comprises one or more depth indicators affixed thereto.

### Claim 40 (depends on 38)

The medical device according to claim 38, wherein the dilator comprises one or more location indicators affixed thereto.

### Claim 41 (depends on 38)

The medical device according to claim 38, wherein the dilator comprises a plurality of visual location indicators affixed thereto.

### Claim 42 (depends on 38)

The medical device according to claim 38, wherein the at least one blood detector includes a blood inlet opening in fluid communication with a blood outlet at the proximal end of the dilator.

### Claim 43 (depends on 38)

The medical device according to claim 38, wherein the at least one blood detector is a pressure sensor.

### Claim 44 (depends on 38)

The medical device according to claim 38, wherein the at least one blood detector is a flow sensor.

### Claim 45 (depends on 38)

The medical device according to claim 38, wherein the dilator includes a blood inlet opening disposed on the tapered portion.

### Claim 46 (depends on 38)

The medical device according to claim 38, wherein the dilator includes a blood inlet opening disposed on a cylindrical portion of the dilator.

### Claim 47 (depends on 38)

The medical device according to claim 38, wherein the at least one blood detector is a tissue type sensor.

### Claim 48 (depends on 38)

The medical device according to claim 38, wherein the sheath comprises a hub at the proximal end of the sheath and the dilator comprises a hub at the proximal end of the dilator, the sheath hub releasably engaged with the dilator hub.

### Claim 49 (depends on 48)

The medical device according to claim 48, wherein the blood outlet is in the dilator hub.

### Claim 50 (depends on 38)

The medical device according to claim 38, wherein the dilator comprises at least one opening at the distal tapered end, the at least one opening in fluid communication with one or more lumens within the dilator, the one or more lumens in fluid communication with a port in the dilator hub, whereby liquid is transferable between the opening in the distal tapered end of the dilator and the port in the dilator hub.

### Claim 51 (depends on 43)

The medical device according to claim 43, wherein the at least one sensor is connected to a control system and a display unit.

### Claim 52 (depends on 41)

The medical device according to claim 41, wherein the depth indicators include graduation marks.

### Claim 53 (depends on 48)

The medical device according to claim 48, comprising a luer connector extending from the port in the dilator hub, the luer connector creating a fluid pathway between the port and at least one of a 2 and 3 way tap.

### Claim 54 (depends on 38)

The medical device according to claim 38, wherein the dilator includes an internal lumen extending the entire length of the dilator and adapted for tracking over a guide wire.

### Claim 55 (depends on 38)

The medical device according to claim 38, wherein a transition between the distal end of the sheath and the dilator is substantially smooth.

### Claim 56 (depends on 38)

The medical device according to claim 38, comprising at least one sensor on an outer surface of the sheath.

### Claim 57 (depends on 38)

The medical device according to claim 38, comprising a linear array of sensors located along an outer surface of the sheath.

### Claim 58 (depends on 57)

The medical device according to claim 57, wherein the linear array of sensors is an array of tissue type sensors.

### Claim 59 (depends on 56)

A medical device according to claim 56, wherein the at least one sensor is a pressure sensor.

### Claim 60 (depends on 38)

The medical device according to claim 38, comprising one or more radiopaque markers positioned on the dilator.

### Claim 61 (depends on 38)

The medical device according to claim 38, wherein the plug comprises a soft fibre mesh component.

### Claim 62 (depends on 38)

The medical device according to claim 38, wherein the anchor comprises a rigid component.

### Claim 63 (depends on 38)

The medical device according to claim 38, wherein the foot and the plug comprise a bioabsorbable material.

### Claim 64 (depends on 63)

The medical device according to claim 63, wherein the bioabsorbable material is selected from the group consisting of polyglycolic acid (PGA), polylactic acid (PLA), polyethylene glycol (PEG), polydioxanone, bioabsorbable polyurethane, collagen, copolymers thereof, and combinations thereof.

### Claim 65

A method of positioning a medical device, comprising:
inserting a distal end of a dilator releasably engaged with a sheath having depth indicators thereon into a blood vessel, wherein the sheath comprises a sheath hub at a proximal end of the sheath and the dilator comprises a dilator hub at the proximal end of the dilator, the dilator releasably engaged with the sheath via a connection between the dilator hub and the sheath hub;
referencing a position of the sheath with respect to the blood vessel;
withdrawing the dilator from the sheath;
inserting a closure device into the sheath through the proximal end of the sheath;
moving the closure device distally along the sheath;
engaging the closure device with the sheath hub;
deploying a foot of the closure device for engaging an internal surface of a wall of the blood vessel, a plug of the closure device for engaging an external surface of the wall of the blood vessel, and an anchor of the closure device for engaging the plug; and
retracting the sheath and/or the closure device to position the foot against the internal surface of the wall of the blood vessel.
