# US 2014/0276400 A1 · Reduced Material Tip for Catheter and Method of Forming Same

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- Number: US 2014/0276400 A1
- Document ID: US20140276400A1
- Status: Published application
- Kind: A1
- Application number: 14/212,919
- Filed: 2014-03-14
- Published: 2014-09-18
- Earliest claimed: 2013-03-15
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Abbott Cardiovascular Systems Inc.
- Inventors: Tram U. Le
- Web page: https://patentgrep.com/patent/US20140276400A1

## CPC

- A61M 25/1036: {Making parts for balloon catheter systems, e.g. shafts or distal ends (A61M25/1029 takes precedence)}
- A61M 25/001: {Forming the tip of a catheter, e.g. bevelling process, join or taper}
- A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure}
- A61M 25/1006: {Balloons formed between concentric tubes}
- A61M 25/1029: {Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril}
- A61M 25/1034: {Joining of shaft and balloon}
- B23K 26/36: Removing material (B23K26/55, B23K26/57 take precedence)
- B29C 57/00: Shaping of tube ends, e.g. flanging, belling or closing; Apparatus therefor {, e.g. collapsible mandrels}
- A61M 2025/1093: {having particular tip characteristics}
- B29C 2793/00: Shaping techniques involving a cutting or machining operation
- B29C 2793/009: after shaping
- B29K 2101/12: Thermoplastic materials
- B29L 2031/7542: {Catheters}
- B29L 2031/7543: {Balloon 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)}
- B23K: SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

Method for fabricating a catheter including providing an inner tubular member formed from a first polymeric material, the inner tubular member having a distal section, a distal end, and a lumen defined therein by a first inner diameter; necking down at least a portion of the distal section of the inner tubular member to form a necked tip having a second inner diameter; and removing a portion of polymeric material from an inner surface along the necked tip to define a third inner diameter for the necked tip. The method can include positioning the distal section of the inner tubular member in a balloon having a working length, a distal neck, and a distal leg, with the distal end of the inner tubular member extending distally beyond a distal end of the distal leg, and coupling the distal leg of the balloon to at least a portion of the distal section of the inner tubular member.

## Claims

### Claim 1

A method of fabricating a catheter, comprising:
providing an inner tubular member formed from a first polymeric material, the inner tubular member having a distal section, a distal end, and a lumen defined therein by a first inner diameter;
necking down at least a portion of the distal section of the inner tubular member to form a necked tip having a second inner diameter; and
removing a portion of polymeric material from an inner surface along the necked tip to define a third inner diameter for the necked tip.

### Claim 2 (depends on 1)

The method of claim 1, wherein the second inner diameter is less than the first inner diameter.

### Claim 3 (depends on 1)

The method of claim 1, wherein the third inner diameter is about equal to the first inner diameter.

### Claim 4 (depends on 1)

The method of claim 1, wherein the inner tubular member is necked down on a stepped mandrel having a first portion with a first outer diameter and a second portion having a second outer diameter, the second outer diameter being about equal to the second inner diameter.

### Claim 5 (depends on 1)

The method of claim 1, wherein the tubular member is necked down using a hot die having an inner diameter, wherein the necked tip has an outer diameter about equal to the inner diameter of the hot die.

### Claim 6 (depends on 1)

The method of claim 1, wherein the portion of polymeric material removed from the inner surface along the necked tip is removed by a rotary device.

### Claim 7 (depends on 1)

The method of claim 1, wherein the portion of polymeric material removed from the inner surface along the necked tip is removed by milling or laser ablation.

### Claim 8 (depends on 1)

The method of claim 1, further comprising monitoring the necked tip to determine a removal depth; and
terminating removing the portion of polymeric material from the inner surface along the necked tip when the removal depth reaches a predetermined threshold.

### Claim 9 (depends on 1)

The method of claim 1, wherein the polymeric material comprises a material selected from the group consisting of nylon, polyurethane, polyethylene, co-polyamide such as Pebax (polyether block amide), polyester, or co-polyester.

### Claim 10 (depends on 1)

The method of claim 1, wherein the inner tubular member is a multilayer tubular member comprising a first layer, a second layer, and a third layer, further wherein the second layer is an outer layer relative to the first layer and the third layer is an outer layer relative to the second layer.

### Claim 11 (depends on 1)

The method of claim 1, further comprising positioning the distal section of the inner tubular member in a balloon having a working length, a distal neck, and a distal leg, with the distal end of the inner tubular member extending distally beyond a distal end of the distal leg, and coupling the distal leg of the balloon to at least a portion of the distal section of the inner tubular member.

### Claim 12 (depends on 11)

The method of claim 11, wherein the balloon comprises a material selected from the group consisting of nylon, polyurethane, polyethylene, co-polyamide such as Pebax (polyether block amide), polyester, or co-polyester.

### Claim 13 (depends on 11)

The method of claim 11, further comprising forming the balloon by:
melt-extruding a thermoplastic polymeric material to form a tube having a tube lumen and cooling the extruded tube to a temperature less than an elevated temperature of the melt-extrusion;
placing the extruded tube within a capture member; and
biaxially orienting the polymeric material of the extruded tube by radially expanding the extruded tube with pressurized media in the tube lumen and axially stretching the extruded tube with a load applied to at least one end of the tube.

### Claim 14 (depends on 11)

The method of claim 11, wherein the balloon is a multilayer balloon comprising a first layer and a second layer, further wherein the second layer is an outer layer relative to the first layer.

### Claim 15 (depends on 14)

The method of claim 14, wherein the first layer comprises a first material having a first durometer hardness and the second layer comprises a second material having a second durometer hardness, the second duromoter hardness being greater that the first durometer hardness.

### Claim 16 (depends on 14)

The method of claim 14, wherein the first layer comprises a first material having a first durometer between about 55D and about 63D.

### Claim 17 (depends on 16)

The method of claim 16, wherein the first material comprises polyether block amide.

### Claim 18 (depends on 14)

The method of claim 14, wherein the second layer comprises a second material having a durometer between about 70D and 72D.

### Claim 19 (depends on 18)

The method of claim 18, wherein the second material comprises polyether block amide.

### Claim 20

A catheter having a monolithic distal tip prepared by a process comprising:
providing an inner tubular member formed from a first polymeric material, the inner tubular member having a distal section, a distal end, and a lumen defined therein by a first inner diameter;
necking down at least a portion of the distal section of the inner tubular member to form, a necked tip having a second inner diameter; and
removing a portion of polymeric material from an inner surface along the necked tip to define a third inner diameter for the necked tip.

### Claim 21 (depends on 20)

The catheter of claim 20, wherein the third inner diameter is about equal to the first inner diameter.

### Claim 22 (depends on 20)

The catheter of claim 20, wherein the first polymeric material comprises a material selected from the group consisting of nylon, polyurethane, polyethylene, co-polyamide such as Pebax (polyether block amide), polyester, or co-polyester.

### Claim 23 (depends on 20)

The catheter of claim 20, further comprising positioning the distal section of the inner tubular member in a balloon having a working length, a distal neck, and a distal leg, with the distal end of the inner tubular member extending distally beyond a distal end of the distal leg; and coupling the distal leg of the balloon to at least a portion of the distal section of the inner tubular member.
