# US 2025/0065077 A1 · Medical access sheaths

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- Number: US 2025/0065077 A1
- Document ID: US20250065077A1
- Status: Published application
- Kind: A1
- Application number: 18/947,203
- Filed: 2024-11-14
- Published: 2025-02-27
- Earliest claimed: 2022-05-25
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Michael G. Valdez; Daniel James Murray; Hien T. Nguyen; Steven Park
- Web page: https://patentgrep.com/patent/US20250065077A1

## CPC

- A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)}
- A61M 25/0662: {Guide tubes}
- A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure}
- A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked}
- A61M 25/0074: {Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable}
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61M 25/09041: {Mechanisms for insertion of guide wires}
- A61M 2025/0188: {having slitted or breakaway lumens}
- A61M 2025/09116: {Design of handles or shafts or gripping surfaces thereof for manipulating guide wires}
- A61M 2025/09125: {Device for locking a guide wire in a fixed position with respect to the catheter or the human body}
- A61M 2025/1045: {for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations}
- 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 tapered medical access sheath can comprise an access sheath hub and an access sheath shaft extending distally from the access sheath hub. The access sheath shaft can comprise a first delivery lumen extending from a proximal end of the access sheath shaft to a side opening on a distal portion of the access sheath shaft, the first delivery lumen having a width configured to slidably receive a distal portion of a medical device disposed around a guidewire. The access sheath shaft can comprise a tapered distal end portion disposed distally of the side opening. A recess can extend along a longitudinal dimension of the tapered distal end portion from a proximal end to a distal end of the tapered distal end portion. The recess can be in fluid communication with the first delivery lumen and have a width smaller than the diameter of the first delivery lumen.

## Claims

### Claim 1

A tapered medical access sheath comprising:
an access sheath hub; and
an access sheath shaft extending distally from the access sheath hub, the access sheath shaft comprising:
a first delivery lumen extending from a proximal end of the access sheath shaft to a side opening on a distal portion of the access sheath shaft, the first delivery lumen having a diameter configured to slidably receive a distal portion of a medical device disposed around a guidewire;
a tapered distal end portion disposed distally of the side opening; and
a recess extending along a longitudinal dimension of the tapered distal end portion from a proximal end to a distal end of the tapered distal end portion, the recess being in fluid communication with the first delivery lumen and having a width smaller than the diameter of the first delivery lumen.

### Claim 2 (depends on 1)

The sheath of claim 1, wherein:
an inner lumen wall portion defining a portion of the first delivery lumen adjacent to the side opening comprises a ramp configured to guide an exit trajectory of the distal portion of the medical device through the side opening; and
the recess extends from at least a portion of the ramp to a distal slit on a distal end of the access sheath shaft.

### Claim 3 (depends on 1)

The sheath of claim 1, wherein:
the recess comprises a width configured to slidably receive at least a portion of a guidewire;
the first delivery lumen comprises a diameter configured to slidably receive at least a portion of a medical device, and the width of the recess being sized to provide a portion of the medical device remaining disposed through the side opening while the medical device is in a deployed state.

### Claim 4 (depends on 1)

The sheath of claim 1, wherein:
the recess comprises a width configured to accommodate a proximal portion of a medical device, the proximal portion of the medical device having a smaller diameter than that of a distal portion of the medical device;
the first delivery lumen comprises a diameter configured to accommodate the distal portion of the medical device, and the width of the recess being sized to slidably receive the proximal portion of the medical device while the distal portion of the medical device is disposed distally of the access sheath shaft.

### Claim 5 (depends on 1)

The sheath of claim 1, wherein the tapered distal end portion is distal of and adjacent to a distal edge of the side opening.

### Claim 6 (depends on 1)

The sheath of claim 1, wherein a sidewall portion of the access sheath shaft defining a proximal edge of the side opening extends around a portion of a circumference of the distal portion of the access sheath shaft.

### Claim 7 (depends on 6)

The sheath of claim 6, wherein the sidewall portion of the access sheath shaft defining a proximal edge of the side opening extends around a half of the circumference of the distal portion of the access sheath shaft.

### Claim 8 (depends on 1)

The sheath of claim 1, further comprising a protrusion along an exterior surface of a sidewall portion of the access sheath shaft defining a proximal edge of the side opening, the protrusion being configured to be pushed against an inner lumen wall of an expandable distal end portion of an introducer sheath while the access sheath shaft is slidably disposed through an introducer sheath delivery lumen and translated distally relative to the introducer sheath.

### Claim 9 (depends on 1)

The sheath of claim 1, wherein:
an inner lumen wall portion defining a portion of the first delivery lumen adjacent to the side opening comprises a ramp configured to guide an exit trajectory of a distal portion of a medical device through the side opening; and
a sidewall portion of the access sheath shaft defining a distal portion of the side opening extends along at least a portion of the ramp.

### Claim 10 (depends on 9)

The sheath of claim 9, wherein the sidewall portion defining the distal portion of the side opening extends along respective edges of the ramp.

### Claim 11

A method of delivering a medical device, the method comprising:
providing a tapered access sheath comprising an access sheath shaft having a tapered distal end portion, and the access sheath shaft further comprising:
a first delivery lumen extending from a proximal end to a side opening of the access sheath shaft; and
a recess extending through the tapered distal end portion and in fluid communication with the first delivery lumen, the recess having a width smaller than a diameter of the first delivery lumen;
providing a medical device comprising at least a portion disposed within the first delivery lumen;
providing a guidewire comprising corresponding portions disposed within a guidewire lumen of the medical device, the first delivery lumen and the recess of the access sheath shaft, and a bodily lumen;
advancing at least a portion of the access sheath shaft comprising the at least a portion of the medical device disposed therein along the guidewire into a bodily lumen; and
advancing the medical device distally relative to the access sheath shaft along the guidewire to position a distal portion of the medical device out of the first delivery lumen through the side opening and externally of the access sheath shaft, and to lift a corresponding portion of the guidewire out of the recess.

### Claim 12 (depends on 11)

The method of claim 11, wherein advancing the medical device distally relative to the access sheath shaft along the guidewire comprises positioning at least a portion of the distal portion of the medical device disposed externally of the first delivery lumen along an axis offset from a longitudinal axis of the recess; and the method further comprising maintaining a portion of the medical device disposed through the side opening after advancing the portions of the medical device out of the first delivery lumen through the side opening.

### Claim 13 (depends on 11)

The method of claim 11, wherein advancing the medical device distally relative to the access sheath shaft along the guidewire comprises:
advancing the medical device until a portion of the medical device fits within the recess;
positioning the portion of the medical device through the recess; and
disposing the distal portion of the medical device distally of a distal end of the access sheath shaft.

### Claim 14 (depends on 11)

The method of claim 11, further comprising positioning an introducer sheath into the bodily lumen, and wherein advancing at least a portion of the access sheath shaft comprising the at least a portion of the medical device disposed therein along the guidewire into a bodily lumen comprises advancing the at least a portion of the access sheath shaft and medical device through a sheath delivery lumen of the introducer sheath positioned into the bodily lumen.

### Claim 15 (depends on 14)

The method of claim 14, wherein advancing the at least a portion of the access sheath shaft and medical device through the introducer sheath comprises pushing a protrusion on an exterior surface of a side wall portion of the access sheath shaft defining a proximal edge of the side opening against an inner lumen wall portion of an expandable distal end portion of the introducer sheath to expand the expandable distal end portion.

### Claim 16

A method of delivering a medical device, the method comprising:
providing a tapered access sheath comprising an access sheath shaft having a first delivery lumen extending through the access sheath shaft to a side opening on a distal portion of the access sheath shaft, and a recess extending from the first delivery lumen to a distal end of the access sheath shaft;
providing a medical device comprising a guidewire lumen extending therethrough, the medical device comprising a distal portion disposed within the first delivery lumen;
providing a guidewire comprising corresponding portions disposed within the guidewire lumen of the medical device, and the first delivery lumen and the recess of the access sheath shaft; and
advancing the medical device along the guidewire to deploy the distal portion of the medical device through the side opening.

### Claim 17 (depends on 16)

The method of claim 16, wherein advancing the medical device to deploy the distal portion of the medical device comprises lifting a corresponding portion of the guidewire out of the recess.

### Claim 18 (depends on 16)

The method of claim 16, wherein advancing the medical device to deploy the distal portion of the medical device comprises advancing the distal portion of the medical device through the side opening and maintaining a portion of the medical device extending through the side opening while the distal portion is in a deployed state.

### Claim 19 (depends on 16)

The method of claim 16, wherein advancing the medical device to deploy the distal portion of the medical device comprises positioning a portion of the medical device through a distal slit at the distal end of the access sheath shaft to provide at least a portion of a proximal portion of the medical device slidably received within the recess and the distal portion of the medical device disposed distally of the distal end of the access sheath shaft.

### Claim 20 (depends on 19)

The method of claim 19, further comprising positioning the distal portion of the medical device distally of the access sheath shaft and along a path coaxial with a longitudinal axis of the recess.
