# US 12,599,748 B2 · Catheter tips for rapidly insertable central catheters and methods thereof

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- Number: US 12,599,748 B2
- Document ID: US12599748B2
- Status: Granted
- Kind: B2
- Application number: 18/076,169
- Filed: 2022-12-06
- Published: 2024-06-06
- Granted: 2026-04-14
- Earliest claimed: 2022-12-06
- Assignees: Bard Access Systems, Inc.
- Applicants: Bard Access Systems, Inc.
- Inventors: Glade H. Howell; Juan Sepulveda
- Web page: https://patentgrep.com/patent/US12599748B2

## CPC

- A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure}
- A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)}
- A61M 25/0069: {Tip not integral with tube}
- A61M 25/008: {Strength or flexibility characteristics of the catheter tip}
- A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters}
- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- 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 rapidly inserted central catheter can include a catheter tube, a catheter hub, and one or more extension legs. The catheter tube can include a single-piece catheter tip coupled to a distal end portion of the catheter tube having a first section, a second section, and a third section. The first section of the catheter tip can have a uniform taper over an outer diameter thereof for dilating tissue around a needle tract from a size commensurate with an outer diameter of a needle shaft to a size commensurate with an outer diameter of the second section of the catheter tip. The third section of the catheter tip can have a non-uniform taper over an outer diameter thereof for dilating the tissue from the size commensurate with the outer diameter of the second section of the catheter tip to a size commensurate with an outer diameter of the catheter tube.

## Claims

### Claim 1

A rapidly insertable central catheter (“RICC”), comprising:
a catheter tube including a catheter-tube portion of a primary lumen of the RICC having an inner diameter;
a single-piece catheter tip coupled to a distal end portion of the catheter tube having a first section, a second section, and a third section, wherein:
the first section of the catheter tip has a uniform taper over an outer diameter of the first section for dilating tissue around a needle tract from a size commensurate with an outer diameter of a needle shaft of an introducer needle to a size commensurate with an outer diameter of the second section of the catheter tip;
the second section of the catheter tip has a uniform taper for dilating the tissue from a size commensurate with the outer diameter of the first section of the catheter tip to a size commensurate with an outer diameter of the third section of the catheter tip, each successive transverse cross section of the second section of the catheter tip approximating a larger concentric annulus in a proximal direction along the second section of the catheter tip and a smaller concentric annulus in a distal direction along the second section of the catheter tip, and each concentric annulus of the larger concentric annulus and the smaller concentric annulus defined by the outer diameter of the second section of the catheter tip and the inner diameter of the catheter-tube portion of the primary lumen of the RICC, thereby providing the uniform taper of the second section of the catheter tip; and
the third section of the catheter tip has a non-uniform taper over the outer diameter of the third section for dilating the tissue from the size commensurate with the outer diameter of the second section of the catheter tip to a size commensurate with an outer diameter of the catheter tube;
a catheter hub coupled to a proximal portion of the catheter tube; and
one or more extension legs, each extension leg of the one or more extension legs coupled to the catheter hub by a distal portion thereof.

### Claim 2 (depends on 1)

The RICC of claim 1, wherein each successive transverse cross section of the first section of the catheter tip approximates a larger concentric annulus in a proximal direction along the first section of the catheter tip and a smaller concentric annulus in a distal direction along the first section of the catheter tip, each concentric annulus of the larger concentric annulus and the smaller concentric annulus defined by the outer diameter of the first section of the catheter tip and the inner diameter of the catheter-tube portion of the primary lumen of the RICC, thereby providing the uniform taper of the first section of the catheter tip.

### Claim 3 (depends on 1)

The RICC of claim 1, wherein each successive transverse cross section of the third section of the catheter tip approximates a larger eccentric annulus in a proximal direction along the third section of the catheter tip and a smaller eccentric annulus in a distal direction along the third section of the catheter tip, each eccentric annulus of the larger concentric annulus and smaller eccentric annulus defined by the outer diameter of the third section of the catheter tip and the inner diameter of the catheter-tube portion of the primary lumen of the RICC, thereby providing the non-uniform taper of the third section of the catheter tip.

### Claim 4 (depends on 1)

The RICC of claim 1, wherein the uniform taper of the first section of the catheter tip has a constant first taper angle and the non-uniform taper of the third section of the catheter tip has a variable third taper angle, the constant first taper angle greater than the variable third taper angle at a greatest taper angle of the variable third taper angle.

### Claim 5 (depends on 1)

The RICC of claim 1, wherein the uniform taper of the first section of the catheter tip has a constant first taper angle, the uniform taper of the second section of the catheter tip has a constant second taper angle, and the non-uniform taper of the third section of the catheter tip has a variable third taper angle, the constant first taper angle greater than the variable third taper angle at a greatest taper angle of the variable third taper angle, and the variable third taper angle greater than the constant second taper angle at the greatest taper angle of the variable third taper angle.

### Claim 6 (depends on 1)

The RICC of claim 1, wherein the second section of the catheter tip is about 4.0 to 5.0 times longer than the first section of the catheter tip.

### Claim 7 (depends on 1)

The RICC of claim 1, wherein the third section of the catheter tip is about 4.5 to 7.5 times longer than the second section of the catheter tip.

### Claim 8 (depends on 1)

The RICC of claim 1, wherein the catheter tip is of a first polymeric material and the catheter tube is of a second, softer polymeric material.

### Claim 9 (depends on 8)

The RICC of claim 8, wherein the first polymeric material is sufficiently stiff to prevent the catheter tip from collapsing, buckling, or otherwise appreciably deforming when a distal portion of the RICC is advanced into a blood-vessel lumen of a patient, the first polymeric material also being sufficiently pliable to prevent trauma to the blood-vessel lumen when the distal portion of the RICC is advanced farther into the blood-vessel lumen.

### Claim 10 (depends on 8)

The RICC of claim 8, wherein the RICC includes a set of three lumens including the primary lumen, a secondary lumen, and a tertiary lumen formed of fluidly connected portions of at least three catheter-tube lumens, three catheter-hub lumens, and three extension-leg lumens, the secondary lumen and the tertiary lumen terminating in the distal end portion of the catheter tube by at least some infill of melted polymeric material of the first polymeric material.

### Claim 11 (depends on 10)

The RICC of claim 10, wherein the primary lumen has a primary-lumen aperture in a distal end of the catheter tip, the secondary lumen has a secondary-lumen aperture in a side of the distal portion of the catheter tube, and the tertiary lumen has a tertiary-lumen aperture in the side of the distal end portion of the catheter tube but proximal of the secondary-lumen aperture.

### Claim 12

A method for forming a catheter tip of a rapidly insertable central catheter (“RICC”), comprising:
inserting a mandrel-mounted catheter tube into a cavity of a radiofrequency (“RF”)-welding die, a distal end of a mandrel of the mandrel-mounted catheter tube being short of an end of the cavity after inserting the mandrel-mounted catheter tube therein;
heating the RF-welding die to melt a first polymeric material in the cavity of the RF-welding die, molten polymeric material of the first polymeric material allowed to conform to the cavity around the mandrel during the heating of the RF-welding die to form, in a single piece, a nascent catheter tip coupled to a distal end portion of the catheter tube;
thrusting the distal end of the mandrel into the end of the cavity of the RF-welding die when the molten polymeric material exudes through an exit hole in the end of the cavity, excess polymeric material being cut from a distal end of the nascent catheter tip to form the catheter tip coupled to the distal end portion of the catheter tube with thrusting the distal end of the mandrel into the end of the cavity, wherein:
a first section of the catheter tip has a uniform taper over an outer diameter of the first section for dilating tissue around a needle tract from a size commensurate with an outer diameter of a needle shaft of an introducer needle to a size commensurate with an outer diameter of a second section of the catheter tip;
the second section of the catheter tip has a uniform taper for dilating the tissue from a size commensurate with the outer diameter of the first section of the catheter tip to a size commensurate with an outer diameter of a third section of the catheter tip, each successive transverse cross section of the second section of the catheter tip approximating a larger concentric annulus in a proximal direction along the second section of the catheter tip and a smaller concentric annulus in a distal direction along the second section of the catheter tip, and each concentric annulus of the larger concentric annulus and the smaller concentric annulus defined by the outer diameter of the second section of the catheter tip and an inner diameter of a catheter-tube portion of a primary lumen of the RICC, thereby providing the uniform taper of the second section of the catheter tip; and
a third section of the catheter tip has a non-uniform taper over the outer diameter of the third section for dilating the tissue from the size commensurate with the outer diameter of the second section of the catheter tip to a size commensurate with an outer diameter of the catheter tube.

### Claim 13 (depends on 12)

The method of claim 12, further comprising:
sourcing or extruding the catheter tube of a second polymeric material softer than the first polymeric material, the catheter tube including a primary catheter-tube lumen, a secondary catheter-tube lumen, and a tertiary catheter-tube lumen corresponding to catheter-tube portions of a primary lumen, a secondary lumen, and a tertiary lumen of the RICC, respectively.

### Claim 14 (depends on 12)

The method of claim 12, wherein the first polymeric material of the catheter tip is sufficiently stiff to prevent the catheter tip from collapsing, buckling, or otherwise appreciably deforming when a distal portion of the RICC is advanced into a blood-vessel lumen of a patient, the first polymeric material of the catheter tip also being sufficiently pliable to prevent trauma to the blood-vessel lumen when the distal portion of the RICC is advanced farther into the blood-vessel lumen.

### Claim 15

A method of placing a rapidly insertable central catheter (“RICC”), comprising:
advancing a distal portion of the RICC over an access guidewire into a blood-vessel lumen of a patient, the distal portion of the RICC including a single-piece catheter tip of a first polymeric material having a first section, a second section, and a third section coupled to a distal end portion of a catheter tube of a second polymeric material, the first polymeric material of the catheter tip being sufficiently stiff to prevent the catheter tip from collapsing, buckling, or otherwise appreciably deforming while advancing the distal portion of the RICC over the access guidewire into the blood-vessel lumen; and
dilating tissue around a needle tract leading to the blood-vessel lumen while advancing the distal portion of the RICC into the blood-vessel lumen, wherein:
the first section of the catheter tip has a uniform taper over an outer diameter of the first section for dilating the tissue from a size commensurate with an outer diameter of a needle shaft of an introducer needle used to establish the needle tract to a size commensurate with an outer diameter of the second section of the catheter tip;
a second section of the catheter tip has a uniform taper for dilating the tissue from a size commensurate with the outer diameter of the first section of the catheter tip to a size commensurate with an outer diameter of the third section of the catheter tip, each successive transverse cross section of the second section of the catheter tip approximating a larger concentric annulus in a proximal direction along the second section of the catheter tip and a smaller concentric annulus in a distal direction along the second section of the catheter tip, and each concentric annulus of the larger concentric annulus and the smaller concentric annulus defined by the outer diameter of the second section of the catheter tip and an inner diameter of a catheter-tube portion of a primary lumen of the RICC, thereby providing the uniform taper of the second section of the catheter tip; and
the third section of the catheter tip having a non-uniform taper over the outer diameter of the third section for dilating the tissue from the size commensurate with the outer diameter of the second section of the catheter tip to a size commensurate with an outer diameter of the catheter tube.

### Claim 16 (depends on 15)

The method of claim 15, further comprising:
exchanging the access guidewire with a maneuver guidewire;
advancing a distal portion of the maneuver guidewire farther into the blood-vessel lumen to a lower ⅓ of a superior vena cava (“SVC”) of a heart of the patient;
advancing the distal portion of the RICC farther into the blood-vessel lumen over the maneuver guidewire to the lower ⅓ of the SVC, the first polymeric material also being sufficiently pliable to prevent trauma to the blood-vessel lumen while advancing the distal portion of the RICC over the maneuver guidewire farther into the blood-vessel lumen; and
withdrawing the maneuver guidewire leaving the catheter tube in place in the lower ⅓ of the SVC.
