# US 5,707,086 A · Tubing connectors and parts for receiving the connectors

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- Number: US 5,707,086 A
- Document ID: US5707086A
- Status: Granted
- Kind: A
- Application number: 08/559,834
- Filed: 1996-03-14
- Granted: 1998-01-13
- Earliest claimed: 1995-02-13
- Assignees: Aksys, Ltd.
- Inventors: Dennis M. Treu; Kenneth E. Pawlak; Wayne F. Adolf
- Web page: https://patentgrep.com/patent/US5707086A

## CPC

- B01D 65/102: {Detection of leaks in membranes}
- A61L 2/04: Heat (radiation A61L2/08)
- A61L 2/18: Liquid substances
- A61M 1/16: with membranes
- A61M 1/1607: {before use, i.e. upstream of dialyser}
- A61M 1/1609: {after use, i.e. downstream of dialyser}
- A61M 1/1649: {with pulsatile dialysis fluid flow}
- A61M 1/165: {with a dialyser bypass on the dialysis fluid line}
- A61M 1/1656: {Apparatus for preparing dialysates}
- A61M 1/166: {Heating (for sterilisation A61M1/1686)}
- A61M 1/1662: {with heat exchange between fresh and used dialysate}
- A61M 1/1666: {by dissolving solids}
- A61M 1/1668: {Details of containers}
- A61M 1/1672: {using membrane filters, e.g. for sterilising the dialysate}
- A61M 1/1682: {both machine and membrane module, i.e. also the module blood side}
- A61M 1/1684: {Checking the module characteristics before reuse}
- A61M 1/1686: {by heat}
- A61M 1/1688: {with recirculation of the sterilising fluid}
- A61M 1/169: {using chemical substances}
- A61M 1/1692: {Detection of blood traces in dialysate}
- A61M 1/1694: {with recirculating dialysing liquid}
- A61M 1/288: {Priming (priming in extracorporeal blood circuits A61M1/3643)}
- A61M 1/3434: {with pre-dilution and post-dilution}
- A61M 1/3437: {downstream of the filter, e.g. post-dilution with filtrate}
- A61M 1/3465: {using dialysate as substitution fluid}
- A61M 1/3468: {using treated filtrate as substitution fluid}
- A61M 1/3609: {Physical characteristics of the blood, e.g. haematocrit, urea}
- A61M 1/3622: {with a cassette forming partially or totally the blood circuit}
- A61M 1/36224: {with sensing means or components thereof}
- A61M 1/36226: {Constructional details of cassettes, e.g. specific details on material or shape}
- A61M 1/362263: {Details of incorporated filters}
- A61M 1/3626: {Gas bubble detectors}
- A61M 1/3627: {Degassing devices; Buffer reservoirs; Drip chambers; Blood filters}
- A61M 1/3629: {degassing by changing pump speed, e.g. during priming}
- A61M 1/3639: {Blood pressure control, pressure transducers specially adapted therefor}
- A61M 1/3641: {Pressure isolators}
- A61M 1/3643: {Priming, rinsing before or after use}
- A61M 1/3644: {Mode of operation}
- A61M 1/3646: {Expelling the residual body fluid after use, e.g. back to the body}
- A61M 1/3647: {with recirculation of the priming solution}
- A61M 1/3649: {using dialysate as priming or rinsing liquid}
- A61M 1/365: {through membranes, e.g. by inverted trans-membrane pressure [TMP]}
- B01D 61/02: Reverse osmosis; Hyperfiltration {; Nanofiltration}
- B01D 61/025: {Reverse osmosis; Hyperfiltration}
- B01D 61/04: Feed pretreatment
- B01D 61/12: Controlling or regulating
- B01D 61/32: Controlling or regulating
- B01D 65/022: {Membrane sterilisation}
- B01D 65/104: {Detection of leaks in membrane apparatus or modules}
- C02F 1/441: {by reverse osmosis}
- F16K 17/0453: {the member being a diaphragm}
- A61M 1/1658: {Degasification}
- A61M 39/16: having provision for disinfection or sterilisation {(A61M39/143 takes precedence)}
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2205/15: Detection of leaks
- A61M 2205/17: with redundant control systems
- A61M 2205/18: with alarm
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3324: PH measuring means
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/3368: Temperature
- A61M 2205/3382: Upper level detectors
- A61M 2205/3386: Low level detectors
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/6072: Bar codes
- A61M 2205/705: Testing of filters for leaks
- A61M 2205/707: Testing of filters for clogging
- A61M 2205/7554: with means for unclogging or regenerating filters
- A61M 2205/7581: with means for switching over to a fresh filter on clogging or saturation
- A61M 2206/11: Laminar flow
- A61M 2230/65: Impedance, e.g. conductivity, capacity
- B01D 2311/04: Specific process operations in the feed stream; Feed pretreatment
- B01D 2321/04: Backflushing
- B01D 2321/16: Use of chemical agents
- B01D 2321/32: By heating or pyrolysis
- Y10S 210/929: Hemoultrafiltrate volume measurement or control processes
- Y10S 215/03: Medical
- Y10T 137/7722: Line condition change responsive valves
- Y10T 137/7794: With relief valve
- Y10T 137/7796: Senses inlet pressure
- Y10T 137/7799: Liquid transfer
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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)}
- C02F: TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE (separation in general B01D; special arrangements on waterborne vessels of installations for treating water, waste water or sewage, e.g. for producing fresh water, B63J; adding materials to water to prevent corrosion C23F; treating radioactively-contaminated liquids G21F9/04; regeneration of reactants for recirculation into processes, see the relevant places for the processes)
- F16K: VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING {(devices for emptying and evacuating the excess liquid in valves or conduits F16L55/07)}
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A connector for a tube and a port construction for sealingly and securely receiving the connector. The connector has a male luer comprising a locking hub and a cylindrical tubing port. The cylindrical tubing port receives the free end of the tube. A second piece is provided that envelops the male luer, comprising a elongate cylindrical housing having a interior surface. The male luer and the tube are snugly inserted within the interior surface of the second piece to form a unitary connector. The port receives the connector and has a housing having a first end and a second end and an open interior region defining first and second chambers and a housing axis. The first and second chambers are disposed within the first and second ends of the housing, respectively. A locking knob is movably mounted on the first end of the port apparatus and movable along the housing axis relative to the first end between first and second positions. The knob is rotatable in the second position relative to the first end into a locking engagement with the housing. When the connector is inserted into the first chamber of the port, the user rotates the knob to one side to securely retain the connector. The connector is pressed into sealing contact with an O-ring disposed in the interior region of the first chamber, thereby preventing any leakage around the connector and port. Various alternative tubing connectors are disclosed.

## Claims

### Claim 1

A connector for a tube, comprising, in combination:
a male luer, said male luer comprising (a) a locking hub and (b) a cylindrical tubing port, said cylindrical tubing port receiving a free end of said tube thereover;
a second piece slidable over said tube and snugly enveloping said cylindrical tubing port and free end of said tube, said second piece comprising an elongate cylindrical housing having an interior surface and said male luer and said tube snugly inserted within said interior surface of said second piece, said interior surface frictionally engaging said free end of said tube received on said tubing port to form a unitary connector; said elongate cylindrical housing further comprising a circumferential sealing shoulder region displaced axially from said locking hub when said second piece is installed over said male luer to form said unitary connector.

### Claim 2 (depends on 1)

The connector of claim 1, wherein said cylindrical housing further comprises a circumferentially disposed notch portion between said circumferential sealing shoulder region and a first end of said housing axially opposite from said male luer.

### Claim 3 (depends on 1)

The connector of claim 1, wherein said second piece comprises means projecting inwardly from said interior surface for securely gripping said free end of said tube received on said cylindrical tubing port of said male luer.

### Claim 4

Connection apparatus for a hemodialysis machine comprising:
a connector terminating a blood line of an extracorporeal circuit, said connector having an end portion and a circumferential shoulder sealing surface axially displaced from said end portion;
a port for receiving said connector, said port comprising:
a knob and a housing having a first end and a second end and an open interior region defining first and said chambers and a housing axis, said first and second chambers within said first and second ends of said housing, respectively, said housing further comprising projection means for locking said knob to said housing;
said knob movably mounted on said first end, said knob movable along said axis relative to said first end between first and second positions and rotatable in said second position relative to said first end into a locking engagement with said projection means;
said first end having a plurality of apertures with bearings placed therein, said knob covering said bearings and urging said bearings towards said open interior region when said knob is in said second position;
biasing means for biasing said knob to said first position; and
an O-ring disposed in said interior region of said housing between said first and second chambers;
said connector being insertable into said first chamber with said circumferential should sealing surface making sealing engagement with said O-ring and securely maintained in place by said knob and said bearings when said knob is rotated into locking engagement with said projection means.

### Claim 5 (depends on 4)

The apparatus of claim 4, wherein said projection means comprises a pair of oppositely located projections extending outwardly from said first end of said housing.

### Claim 6 (depends on 5)

The apparatus of claim 5, wherein said knob further comprises a pair of race regions for accomdating said pair of oppositely located projections.

### Claim 7 (depends on 4)

The apparatus of claim 4, further comprising an optical sensor placed adjacent said housing for detecting the presence of said connector within said first or said second chamber.

### Claim 8

A connector assembly, comprising:
(a) a connector for a tube, said connector comprising, in combination:
a male luer comprising (a) a locking hub defining a first opening and (b) an elongate cylindrical body portion receiving a free end of said tube thereover; and
a second piece insertable over said male luer, said second piece comprising an elongate cylindrical housing having a circumferentially disposed shoulder surface, and a circumferential notch, said second piece snugly inserted over said cylindrical body portion of said male luer and free end of said tube to form a unitary connector;
(b) port apparatus for receiving said connector, comprising:
a knob and a housing having a first end and a second end and an open interior region defining first and second chambers and a housing axis, said first and second chambers within said first and second ends of said housing, respectively, said housing further comprising projection means for locking said knob to said housing;
said knob movably mounted on said first end, said knob movable along said axis relative to said first end between first and second positions and rotatable in said second position relative to said first end into a locking engagement with said projection means;
said first end having a plurality of apertures with bearings placed therein, said knob covering said bearings and urging said bearings towards said open interior region when said knob is in said second position;
biasing means for biasing said knob to said first position; and
an O-ring disposed in said interior region of said housing between said first and second chambers;
said connector being insertable into said first chamber with said shoulder surface of second piece pressed into sealing engagement with said O-ring and maintained in place by said knob and said bearings pressing inwardly on said circumferential notch when said knob is locked in said second position.

### Claim 9 (depends on 8)

The connector assembly of claim 8, wherein said male luer of said connector is disposed within said second chamber when said connector is mounted to said port apparatus, thereby permitting disinfection of said male luer when disinfection fluids are circulated through said port apparatus.

### Claim 10 (depends on 9)

The connector assembly of claim 9, wherein said port apparatus further comprises an optical detector disposed about said second end for detecting the presence of said connector within said second chamber.

### Claim 11 (depends on 8)

The connector assembly of claim 8, wherein said projection means comprises a pair of projections spaced on opposite sides of said first end of said port apparatus housing, and wherein said knob further comprises a pair of races for accommodating said pair of projections.

### Claim 12 (depends on 8)

The connector assembly of claim 8, wherein said locking hub is integral with said cylindrical port.

### Claim 13 (depends on 8)

The connector assembly of claim 8, wherein said locking hub further comprises a hub portion and wherein said elongate cylindrical body portion having a longitudinal axis, wherein said hub portion is freely rotatable about said longitudinal axis relative to said elongate cylindrical body portion.

### Claim 14

A connector terminating a blood line of a hemodialysis machine, comprising a cylindrical housing having a first end and a second end, said second end comprising a locking hub and a first port, said connector having a tubing receiving portion disposed adjacent said first end for receiving said blood line thereover,
said cylindrical housing comprising a circumferentially disposed notch region adjacent said first end and a circumferentially disposed shoulder sealing region;
said circumferentially disposed shoulder region projecting radially outward from said cylindrical housing and positioned between said locking hub and said first end of said connector.

### Claim 15

A unitary connector for a blood line of a hemodialysis machine, comprising:
an elongate generally cylindrical housing having a first end and a second end, said first end connected to a free end of said blood line;
said second end comprising a locking hub for locking said connector to a patient's blood system access device, thereby permitting blood access between said patient and said blood line;
said housing further comprising a circumferential shoulder sealing portion disposed between said first end and said second end extending radially outward from said housing,
wherein said locking hub further comprises a hub portion and wherein said housing defines a longitudinal axis, wherein said hub portion is freely rotatable about said longitudinal axis relative to said housing.

### Claim 16

A unitary connector for a blood line of a hemodialysis machine, comprising:
an elongate generally cylindrical housing having a first end and a second end, said first end connected to a free end of said blood line;
said second end comprising a locking hub for locking said connector to a patient's blood system access device, thereby permitting blood access between said patient and said blood line;
said housing further comprising a circumferential shoulder sealing portion disposed between said first end and said second end extending radially outward from said housing,
wherein said locking hub is integral with said housing and wherein said locking hub further comprises a hub wall having at least one aperture passing therethrough for venting air within said locking hub.

### Claim 17

A connector and port apparatus for a blood line of a hemodialysis machine, comprising, in combination:
(a) a blood line connector comprising an elongate generally cylindrical housing having a first end and a second end, said first end connected to a free end of said blood line,
said second end comprising a locking hub for locking said connector to a patient's blood system access device, thereby permitting blood access between said patient and said blood line, said locking hub having an exterior diameter D;
said housing further comprising a circumferential shoulder sealing portion disposed between said first end and said second end extending radially outward from said housing; and
(b) a port placed in said hemodialysis machine for receiving said connector, comprising:
a housing having a first end and a second end and an open interior region defining first and second chambers, said first and second chambers within said first and second ends of said housing, respectively,
said second chamber having an interior surface having a diameter greater than said diameter D of said locking hub;
retaining means associated with said housing for securely retaining said connector to said housing such that said connector is received within said first chamber;
an O-ring disposed in said housing between said first and second chambers;
said connector being fully insertable into said first chamber and said circumferential shoulder sealing portion is pressed into sealing engagement with said O-ring and maintained in place by said retaining means, with said locking hub positioned within said second chamber of said housing, the differences in diameter in said locking hub and said second chamber creating a gap around said locking hub between said exterior surface of said locking hub and said interior surface of said second chamber.