EP0109657A1 — Improved catheter assembly

Claim 1

Independent Claim 92 words

An improved catheter assembly including a catheter hub and catheter comprising: a flexible catheter having a flared proximal end, and an axial bore extending therethrough; and a catheter hub having a lumen extending axially therethrough, said flexible catheter being fixedly positioned within said lumen, said catheter hub defining a chamber integrally formed therein, said flared proximal end of said catheter being tightly gripped and sealed by means of said catheter hub about the exterior of said flared proximal end, but allowing the flow of fluid through said lumen and said axial bore.

Claim 2

Dependent Claim 92 words

An improved catheter assembly including a catheter hub and catheter comprising: a flexible catheter having a flared proximal end, and an axial bore extending therethrough; and a catheter hub having a lumen extending axially therethrough, said flexible catheter being fixedly positioned within said lumen, said catheter hub defining a chamber integrally formed therein, said flared proximal end of said catheter being tightly gripped and sealed by means of said catheter hub about the exterior of said flared proximal end, but allowing the flow of fluid through said lumen and said axial bore.

Claim 3

Dependent Claim 59 words

The catheter assembly as disclosed in Claim 1 and further comprising: an annular projection integrally formed and circumferentially disposed about said catheter hub, said annular projection defining said chamber therein, wherein the wall thickness of said catheter hub about said flared proximal end and thereby the encapsulation of said flared proximal end within said chamber may be precisely controlled.

Claim 4

Dependent Claim 61 words

The catheter assembly as disclosed in Claim 1 and further comprising: a substantially tubular projection integrally formed and extending from the distal end of said catheter hub, said tubular projection being of a reduced wall thickness relative to the remainder of said catheter hub so as to reduce shrinkage during manufacture, thereby improving gripping of said catheter by said catheter hub.

Claim 5

Dependent Claim 62 words

The catheter hub and catheter of Claim 1 wherein the exterior of said flared proximal end is encapsulated by said walls of said chamber, but said axial bore of said catheter is unobstructed and open to said lumen of said catheter hub whereby flow of fluid through said lumen is facilitated and seepage of fluid around said flared proximal end is prevented.

Claim 6

Dependent Claim 54 words

The catheter hub and catheter as disclosed in Claim 1 wherein said lumen of said catheter hub decreases in inside diameter proximate said flared proximal end so that the area behind and around said flared proximal end is filled with the material of the wall of said chamber, thereby encapsulating said flared proximal end.

Claim 7

Dependent Claim 94 words

The insert molded catheter-hub and catheter of Claim 1 wherein said lumen conically tapers proximate the proximal end of said catheter hub so as to facilitate telescopic insertion of and connection to a tapered needle hub having a needle affixed. therein, said needle thereby being positioned through said catheter hub and said catheter with the point of said needle extending sufficiently from said catheter to align with the bevel of the distal end of said catheter thereby forming a smooth transition between said distal end of said catheter and said point of said needle.

Claim 8

Dependent Claim 36 words

The catheter hub as disclosed in Claim 1 and further comprising: a plurality of radial serrations axially disposed about the periphery of said catheter hub, constructed and arranged for gripping of said catheter hub during use.

Claim 9

Dependent Claim 56 words

The catheter hub as disclosed in Claim 1 wherein said catheter is from 18 to 26 gauge in thickness and said catheter hub ranges from .025 - .035" plus or minus .005 depending on gauge in wall thickness proximate said chamber so as to reduce shrinkage of said catheter hub away from said catheter following molding.

Claim 10

Dependent Claim 53 words

The catheter as disclosed in Claim 1 wherein said catheter is from 14-16 gauge in thickness and said catheter hub ranges from .025 - .035" plus or minus .005 depending on gauge in wall thickness proximate said chamber so as to reduce shrinkage of said catheter hub away from said catheter following molding.

Claim 11

Dependent Claim 37 words

The catheter hub as disclosed in Claim 8 wherein the wall thickness of said catheter hub minimizes shrinkage of said walls of said catheter hub away from said catheter following molding thereby improving gripping of said catheter.

Claim 12

Dependent Claim 37 words

The catheter hub as disclosed in Claim 9 wherein the wall thickness of said catheter hub minimizes shrinkage of said walls of said catheter hub away from said catheter following molding thereby improving gripping of said catheter.

Claim 13

Dependent Claim 21 words

The catheter hub as disclosed in Claim 1 wherein said catheter hub is injection molded of a medical grade thermoplastic material.

Claim 14

Dependent Claim 19 words

The catheter hub as disclosed in Claim 1 wherein said catheter is a medical grade tube of polyethylene terephthalate.

Claim 15

Dependent Claim 85 words

An improved catheter hub and catheter comprising: a flexible catheter having a flared proximal end and an axial bore extending therethrough; and a catheter hub having a lumen extending therethrough, said flexible catheter being fixedly positioned within said lumen, said catheter hub defining a chamber about said flared proximal end of said catheter being tightly gripped and sealed by means of said catheter hub about the periphery of said flared proximal end, but allowing the flow of fluid through said lumen and said axial bore.

Claim 16

Dependent Claim 85 words

An improved catheter hub and catheter comprising: a flexible catheter having a flared proximal end and an axial bore extending therethrough; and a catheter hub having a lumen extending therethrough, said flexible catheter being fixedly positioned within said lumen, said catheter hub defining a chamber about said flared proximal end of said catheter being tightly gripped and sealed by means of said catheter hub about the periphery of said flared proximal end, but allowing the flow of fluid through said lumen and said axial bore.

Claim 17

Dependent Claim 20 words

The catheter hub as disclosed in Claim 13 wherein said catheter hub is bifurcated and is joined about said catheter.

Claim 18

Dependent Claim 19 words

The catheter hub as disclosed in Claim 13 wherein said flared proximal end is heat sealed to said chamber.

Claim 19

Dependent Claim 18 words

The catheter hub as disclosed in Claim 1 wherein said catheter is adhesively secured to said catheter hub.

Claim 20

Dependent Claim 65 words

The catheter hub as disclosed in Claim 1 and further including: .a pinched waist portion integrally formed in said catheter hub proximate and immediately behind said chamber, said pinched waist portion causing the rear portion of said chamber to be reduced in inside diameter thereby abutting against said flared proximal end of said catheter so as to prevent backward movement of said catheter during venipuncture.

Claim 21

Independent Claim 220 words

A method of manufacturing a catheter having a catheter hub insert molded about the proximal end thereof comprising: cutting a section of catheter tubing to a .desired length, thereby forming a catheter; abutting the proximal end of said catheter against a heated die having a flat base with a conical appendage extending substantially perpendicularly therefrom so as to cause said proximal end of said catheter to flare outward and to curl over; removing said catheter from contact with said heated die; mounting said catheter, flared end first, on a tapered core pin, said core pin-having an upper tubular section of substantially the same outside diameter as the inside diameter of said catheter and a lower tapered section of increasing outside diameter; inserting said catheter and core pin into an injection mold having a cavity shaped as a catheter hub and an enlarged chamber formed in said cavity proximate the flared proximal end of said catheter; closing said mold; introducing a quantity of heated plastic material thrugh a gate and into said cavity, and about said catheter; cooling said plastic material so as to form a catheter hub about said catheter which mechanically grips said catheter; opening said mold; removing said core pin, catheter hub and catheter from said mold; and removing said catheter hub and catheter from said core pin.

Claim 22

Independent Claim 220 words

A method of manufacturing a catheter having a catheter hub insert molded about the proximal end thereof comprising: cutting a section of catheter tubing to a .desired length, thereby forming a catheter; abutting the proximal end of said catheter against a heated die having a flat base with a conical appendage extending substantially perpendicularly therefrom so as to cause said proximal end of said catheter to flare outward and to curl over; removing said catheter from contact with said heated die; mounting said catheter, flared end first, on a tapered core pin, said core pin-having an upper tubular section of substantially the same outside diameter as the inside diameter of said catheter and a lower tapered section of increasing outside diameter; inserting said catheter and core pin into an injection mold having a cavity shaped as a catheter hub and an enlarged chamber formed in said cavity proximate the flared proximal end of said catheter; closing said mold; introducing a quantity of heated plastic material thrugh a gate and into said cavity, and about said catheter; cooling said plastic material so as to form a catheter hub about said catheter which mechanically grips said catheter; opening said mold; removing said core pin, catheter hub and catheter from said mold; and removing said catheter hub and catheter from said core pin.

Claim 23

Dependent Claim 80 words

The method as disclosed in Claim 18 and further comprising the steps of: positioning the gate of said injection mold at a 45° angle to said chamber so as to force said catheter upward on core pin and into its proper position against said tapered section when heated plastic is injected; encapsulating said flared proximal end of said catheter in said heated plastic material; and filling the chamber of said cavity with heated plastic material to form said catheter hub.

Claim 24

Dependent Claim 59 words

the method as disclosed in Claim 18 or 19 and further comprising the steps of: decreasing the inside diameter of said cavity proximate and immediately behind said chamber, thereby constricting the flow of heated plastic therethrough so as to compress said plastic about said flared proximal end, thereby causing said catheter hub to tightly grip said flared proximal end.

Claim 25

Dependent Claim 64 words

The method of manufacturing a catheter as disclosed in Claim 18 and further comprising: constructing said heated conical appendage in a hexagonal shape; and forming said flared periphery of said catheter into a hexagonal configuration by telescopic insertion of said first end of said catheter tubing over said conical appendage; said hexagonal configuration facilitating gripping of said flared proximal end of said catheter hub.

Claim 26

Dependent Claim 28 words

The catheter as disclosed in Claim 1 wherein said flared proximal end is formed in a hexagonal configuration so as to facilitate gripping thereof by said catheter hub.

Claim 27

Dependent Claim 39 words

The catheter hub as disclosed in Claim 1 wherein said flared proximal end is formed in a C configuration in cross section, so as to be encapsulated in said chamber, thereby preventing axial movement of said catheter during use.

Claim 28

Dependent Claim 46 words

The catheter as disclosed in Claim 1 wherein said flared proximal end further includes a thickened wall portion proximate said flared proximal end, said thickened wall portion being constructed and arranged to facilitate compression against the interior of said chamber, thereby more tightly gripping said catheter.

Improved catheter assembly

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