# US 10,765,837 B2 · Method and device for sheathless arterial catheterization

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- Number: US 10,765,837 B2
- Document ID: US10765837B2
- Status: Granted
- Kind: B2
- Application number: 14/868,988
- Filed: 2015-09-29
- Published: 2016-03-31
- Granted: 2020-09-08
- Earliest claimed: 2014-09-30
- Assignees: Cardinal Health Switzerland 515 GmbH
- Applicants: Cordis Corporation
- Inventors: Kintur A. Sanghvi
- Web page: https://patentgrep.com/patent/US10765837B2

## CPC

- A61M 25/09041: {Mechanisms for insertion of guide wires}
- 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)}
- A61M 2025/0183: {Rapid exchange or monorail catheters}
- 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 dilator for sheathless access to a vessel of a patient, having a distal portion with a maximal outer diameter that extends from a distal end to a guidewire exit port and a proximal portion with a reduced profile that extends from the guidewire exit port to the proximal end and a lumen that extends between the distal end and the guidewire exit port. A first guidewire may be positioned within the vessel and the dilator advanced over the guidewire. A guide catheter may then be advanced over the dilator.

## Claims

### Claim 1

A kit for gaining access to a vessel of a patient, comprising:
a first dilator having an elongated body with proximal and distal ends, a distal portion with a maximal outer diameter having a cylindrical configuration that extends from the distal end to a guidewire exit port, a proximal portion with a reduced profile having a semi-cylindrical configuration that extends from the guidewire exit port to the proximal end and a lumen defined by an inner wall that extends between the distal end and the guidewire exit port, wherein a portion of the inner wall continues to extend through the proximal portion; and
a second dilator having an elongated body with proximal and distal ends, a distal portion with a maximal outer diameter having a cylindrical configuration that extends from the distal end to a guidewire exit port, a proximal portion with a reduced profile having a semi-cylindrical configuration that extends from the guidewire exit port to the proximal end and a lumen defined by an inner wall that extends between the distal end and the guidewire exit port, wherein a portion of the inner wall continues to extend through the proximal portion;
wherein the first dilator is configured to be inserted into a radial artery, and the second dilator is configured to be inserted into the radial artery upon removal of the first dilator;
wherein the lumen of the first dilator has a smaller inner diameter than the lumen of the second dilator; and
wherein the maximal outer diameter distal portion of the first dilator has an outer diameter the same as the maximal outer diameter distal portion of the second dilator.

### Claim 2 (depends on 1)

The kit of claim 1, wherein the maximal outer diameter of the first dilator is about 1.80 mm.

### Claim 3 (depends on 1)

The kit of claim 1, further comprising a marker positioned on the proximal portion of the first dilator.

### Claim 4 (depends on 1)

The kit of claim 1, wherein the lumen of the first dilator has a diameter of about 0.58 mm and the lumen of the second dilator has a diameter of about 0.88 mm.

### Claim 5 (depends on 1)

The kit of claim 1, wherein the reduced profile proximal portion of the first dilator has a cross sectional area at least 40% smaller than a cross sectional area of the maximal outer diameter distal portion of the first dilator.

### Claim 6 (depends on 5)

The kit of claim 5, wherein the reduced profile proximal portion of the first dilator has a cross sectional area at least 50% smaller than a cross sectional area of the maximal outer diameter distal portion of the first dilator.

### Claim 7 (depends on 1)

The kit of claim 1, wherein the semi-cylindrical configuration of the proximal portion of the first dilator is configured to receive a guidewire therein and the cylindrical configuration of the distal portion of the first dilator is configured to receive the guidewire in the lumen therein.

### Claim 8 (depends on 1)

The kit of claim 1, wherein the maximal outer diameter of the second dilator is about 1.80 mm.

### Claim 9 (depends on 1)

The kit of claim 1, wherein the distal end of the first dilator is tapered.

### Claim 10 (depends on 9)

The kit of claim 9, wherein the tapered distal end of the first dilator has a hydrophilic coating.

### Claim 11 (depends on 1)

The kit of claim 1, wherein the distal end of the second dilator is tapered.

### Claim 12 (depends on 11)

The kit of claim 11, wherein the tapered distal end of the second dilator has a hydrophilic coating.

### Claim 13 (depends on 1)

The kit of claim 1, wherein the first and second dilators are formed from a polymeric material.

### Claim 14

A method for gaining access to a radial artery of a patient, comprising:
providing a first dilator having an elongated body with proximal and distal ends, a distal portion with a maximal outer diameter having a cylindrical configuration that extends from the distal end to a guidewire exit port, a proximal portion with a reduced profile having a semi-cylindrical configuration that extends from the guidewire exit port to the proximal end and a lumen that extends between the distal end and the guidewire exit port;
positioning a first guidewire within the radial artery of the patient;
advancing the first dilator over the first guidewire into the radial artery without being inserted through a sheath;
advancing a first guide catheter over the first dilator;
removing the first dilator;
providing a second dilator having an elongated body with proximal and distal ends, a distal portion with a maximal outer diameter having a cylindrical configuration that extends from the distal end to a guidewire exit port, a proximal portion with a reduced profile having a semi-cylindrical configuration that extends from the guidewire exit port to the proximal end and a lumen that extends between the distal end and the guidewire exit port; and
introducing the second dilator through the first guide catheter and positioning a distal end of the second dilator at a desired region of the radial artery, wherein the lumen of first dilator has a smaller inner diameter than a lumen of the second dilator;
wherein the maximal outer diameter distal portion of the first dilator has an outer diameter the same as the maximal outer diameter distal portion of the second dilator.

### Claim 15 (depends on 14)

The method of claim 14, further comprising preloading the first dilator into the first guide catheter before advancing the first dilator.

### Claim 16 (depends on 14)

The method of claim 14, further comprising introducing a second guidewire through the first guide catheter and positioning a distal end of the second guidewire at a desired region of the radial artery, wherein the second guidewire has a larger diameter than the first guidewire.

### Claim 17 (depends on 16)

The method of claim 16, further comprising performing at least a portion of a procedure with the first guide catheter.

### Claim 18 (depends on 17)

The method of claim 17, further comprising:
withdrawing the first guide catheter;
advancing the second dilator over the second guidewire into the vessel without being inserted through a sheath;
advancing a second guide catheter over the second dilator; and
removing the second dilator.

### Claim 19 (depends on 18)

The method of claim 18, further comprising preloading the second dilator into the second guide catheter before advancing the first dilator.

### Claim 20 (depends on 19)

The method of claim 19, further comprising performing at least a portion of the procedure with the second guide catheter.
