CA1325365C - Dual-lumen catheter-connecting system - Google Patents
Dual-lumen catheter-connecting systemInfo
- Publication number
- CA1325365C CA1325365C CA000599573A CA599573A CA1325365C CA 1325365 C CA1325365 C CA 1325365C CA 000599573 A CA000599573 A CA 000599573A CA 599573 A CA599573 A CA 599573A CA 1325365 C CA1325365 C CA 1325365C
- Authority
- CA
- Canada
- Prior art keywords
- catheter
- extension tubes
- pair
- tubes
- dual
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
- A61M5/1582—Double lumen needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
- A61M1/3659—Cannulae pertaining to extracorporeal circulation
- A61M1/3661—Cannulae pertaining to extracorporeal circulation for haemodialysis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
- A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/0246—Holding devices, e.g. on the body fixed on the skin having a cover for covering the holding means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/0028—Multi-lumen catheters with stationary elements characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Cardiology (AREA)
- Urology & Nephrology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- External Artificial Organs (AREA)
Abstract
ABSTRACT
A dual-lumen catheter assembly comprising a dual-lumen catheter, a Y connector having one end fastened to the proximal end of the catheter, and a pair of extension tubes each having one end fastened to the opposite end of the connector from the catheter, each of the extension tubes being bent back toward the distal end of the catheter, extending along opposite sides of the connector.
A dual-lumen catheter assembly comprising a dual-lumen catheter, a Y connector having one end fastened to the proximal end of the catheter, and a pair of extension tubes each having one end fastened to the opposite end of the connector from the catheter, each of the extension tubes being bent back toward the distal end of the catheter, extending along opposite sides of the connector.
Description
Field of The Invention 13 2 5 3 6 5 The present invention relates qenerally to extracorporeal .~blood treatment systems and, more particularly, to an improved ~, method and apparatus for connecting a dual-lumen catheter to the ~5 long flexible tubes which carry blood in both directions between ;the catheter and an extracorporeal blood treatment unit. This iinvention is particularly concerned with such a method and apparatus which permits the catheter to be positioned in c~nvenient anatomical sites durin~ the periods between successive treatments ~-lO to avoid patient discomfort and accidental displacement of the tt~h.~catheter, and to facilitate sterile attachment of the catheter to the patient during such periods.
Back~roun~ Of The Invention Dual-lumen catheters have come into widespread use for extracorporeal blood purification procedures such as hemodialysis.
Blood is withdrawn from the patient through one of the lumens of the catheter and supplied to a hemodialysis unit where the blood is purified, and thQ resulting purl~ied blood is then returned ~o the patient through the other lumen of the catheter. Examples of such catheters are shown in U.S. Patents Nos. 4,134,402; 4,583,968: and 4,682,978. .
Although these catheters were originally intended ~or acute hemodialysis treatments, the catheters havQ proven to be so satisfactory that they are typically allowed to remain in patients 25 ~or several weeks, and sometimes for several month~. ~he cathet~rs are used for the hemodialysis treatments that such patients receive approxi~ately every three days, and during the interdialytic , c~ , , -'.
,- .
periods the catheter remains inser~ed 15n and attached to the patient Dual-lumen hemodialysis catheters are normally supplied with certain auxiliary components permanently pre-attached to the '~ 5 catheter. These auxiliary components facilitate the connection o~
the two lumens of the catheter (which are extremely small within the catheter) to a pair of long flexible tubes which carry blood to and from the hemodialysis unit. The auxiliary components include a . .:
Y-shaped hub which receives the proximal end of the catheter at one ~i` 10 end of the hub, and a pair of extension tubes which are fastened to the opposite end of the hub and carry a pair of clamps, female luer ~ fittings for connection to male luer fittings on the long tubes ;j leading to the hemodialysis unit, and a pair of caps ~usually with : in~ectable elastomeric ports) closing the openings of the luer ,,~; lS fittings.
.~
The hub and portions of the extension tubes affixed to the catheter are normally used to secure the catheter to the patient, by the use of sutures and by applying tape or an adhesive-coated bandage across the hub and/or the extension tubes and adhering the ~3 20 tape or bandage to the sX$n of the patient on opposite sides of the hub. Sometimes the hub forms either ~ suture groove or a suture ~; web or ~wingn to facilitate attachment to the patient by suturing.
; Because of the length of the extension tubes and the other - :~3 auxiliary components, the extracorporeal part o~ the cath~ter assembly usually extends beyond the patient's body. As a result, tho catheter is continually disturbed by movements of the patient and/or people and equipment around the patient, or by clothing -which is pQriodically donned or removed by the patient. It is not .~ , ~, . ~ , .. , .. - ,.. . . ~. . . . .. ... ...
132~365 unusual for such movements to cause the catheter to become ^ dislodged entirely from the patient. Even when the catheter is not dislodged, continual movement of the catheter within tha vein ~r., causes discomfort and pain to the patient, and can lead to damage -~ 5 to the vein in which the catheter is inserted.
~r` For example, when the catheter is inserted in a jugular vein, the extension tubes normally extend upwardly along the neck and ear of the patient. This not only makes it difficult to attach the !'~" catheter to the patient (sometimes the hub or extension tubes are taped to the ear or even around the entire neck or ~ead of the patient), but also places both the hub and the extension tubes in ~; the direct path of movement of the patient's head. When the catheter is inserted into a subclavian vein, which is located under ~ the clavicle, the extension tubes typically project upwardly or ;~ 15 outwardly beyond the shoulder of the patient.
Regardless of where the catheter i8 located on the pati~nt's ~ body, the weight of the long tubes leading to the dialysis unit, ; which typically have a larger cross section than the extension tubes, often exerts pulling forces on the extension tubes and the catheter, which o~ course tend~ to withdraw th~ cat~eter ~rom the : .
patient's body. These forces are also applied to the sutures, causing dlscom~ort and pain to the patient, and can cause the catheter to pivot back and forth within the vein, thereby irritating the walls of the vein. Such catheter movements can also cause suction forces to be exerted on the vein walls.
,, ~ . .
,.
Back~roun~ Of The Invention Dual-lumen catheters have come into widespread use for extracorporeal blood purification procedures such as hemodialysis.
Blood is withdrawn from the patient through one of the lumens of the catheter and supplied to a hemodialysis unit where the blood is purified, and thQ resulting purl~ied blood is then returned ~o the patient through the other lumen of the catheter. Examples of such catheters are shown in U.S. Patents Nos. 4,134,402; 4,583,968: and 4,682,978. .
Although these catheters were originally intended ~or acute hemodialysis treatments, the catheters havQ proven to be so satisfactory that they are typically allowed to remain in patients 25 ~or several weeks, and sometimes for several month~. ~he cathet~rs are used for the hemodialysis treatments that such patients receive approxi~ately every three days, and during the interdialytic , c~ , , -'.
,- .
periods the catheter remains inser~ed 15n and attached to the patient Dual-lumen hemodialysis catheters are normally supplied with certain auxiliary components permanently pre-attached to the '~ 5 catheter. These auxiliary components facilitate the connection o~
the two lumens of the catheter (which are extremely small within the catheter) to a pair of long flexible tubes which carry blood to and from the hemodialysis unit. The auxiliary components include a . .:
Y-shaped hub which receives the proximal end of the catheter at one ~i` 10 end of the hub, and a pair of extension tubes which are fastened to the opposite end of the hub and carry a pair of clamps, female luer ~ fittings for connection to male luer fittings on the long tubes ;j leading to the hemodialysis unit, and a pair of caps ~usually with : in~ectable elastomeric ports) closing the openings of the luer ,,~; lS fittings.
.~
The hub and portions of the extension tubes affixed to the catheter are normally used to secure the catheter to the patient, by the use of sutures and by applying tape or an adhesive-coated bandage across the hub and/or the extension tubes and adhering the ~3 20 tape or bandage to the sX$n of the patient on opposite sides of the hub. Sometimes the hub forms either ~ suture groove or a suture ~; web or ~wingn to facilitate attachment to the patient by suturing.
; Because of the length of the extension tubes and the other - :~3 auxiliary components, the extracorporeal part o~ the cath~ter assembly usually extends beyond the patient's body. As a result, tho catheter is continually disturbed by movements of the patient and/or people and equipment around the patient, or by clothing -which is pQriodically donned or removed by the patient. It is not .~ , ~, . ~ , .. , .. - ,.. . . ~. . . . .. ... ...
132~365 unusual for such movements to cause the catheter to become ^ dislodged entirely from the patient. Even when the catheter is not dislodged, continual movement of the catheter within tha vein ~r., causes discomfort and pain to the patient, and can lead to damage -~ 5 to the vein in which the catheter is inserted.
~r` For example, when the catheter is inserted in a jugular vein, the extension tubes normally extend upwardly along the neck and ear of the patient. This not only makes it difficult to attach the !'~" catheter to the patient (sometimes the hub or extension tubes are taped to the ear or even around the entire neck or ~ead of the patient), but also places both the hub and the extension tubes in ~; the direct path of movement of the patient's head. When the catheter is inserted into a subclavian vein, which is located under ~ the clavicle, the extension tubes typically project upwardly or ;~ 15 outwardly beyond the shoulder of the patient.
Regardless of where the catheter i8 located on the pati~nt's ~ body, the weight of the long tubes leading to the dialysis unit, ; which typically have a larger cross section than the extension tubes, often exerts pulling forces on the extension tubes and the catheter, which o~ course tend~ to withdraw th~ cat~eter ~rom the : .
patient's body. These forces are also applied to the sutures, causing dlscom~ort and pain to the patient, and can cause the catheter to pivot back and forth within the vein, thereby irritating the walls of the vein. Such catheter movements can also cause suction forces to be exerted on the vein walls.
,, ~ . .
,.
,, .
~ 132~365 -~ The present invention provides an improved dual-lumen catheter-connecting system which permits the catheter to remain relatively stable during the entire time the catheter remains inserted in the patient, even during long-term use of the catheter extending over numerous extracorporeal blood treatments. In this connection, the invention also provides such a catheter-` connecting system which significantly improves the comfort level ~- of the patient in whom the catheter is inserted, and which s~ greatly reduces the risk of venous damage.
~' 10 The invention again provides an improved dual lumen catheter system which enables the catheter to be secured to the body of the patient in natural anatomical depressions, or fossa, where the extracorporeal portions of the catheter assembly are shielded 1~ by the patient's body. In these regions the catheter is not -~ easily disturbed by movements of the patient or by movement of people and articles around the patient, regardless of the particular vein into which the catheter is inserted. In this connection, the lnvention provides such a system which facilitates the donning and removal of clothing by the patient, a~d which enables ambulatory patients to wear normal clothing, without any unsightly or embarrassing pro~ections, between successive extracorporeal blood treatments. -~
The lnvention further provides an improved hemodialysis catheter-connecting system which facilitates connection of the catheter and its attached auxiliary components to the long flexible tubes which lead to the dialysis unit, regardless of where the dialysis unit is positioned relative to the patient.
~, 30 The invention again eliminates the need to attach the auxiliary ~ components of a dual-lumen catheter, to the neck, ears or head of -; the patient when the catheter is inserted in a ~ugular vein, and which discourages the use of bandages or tape encircling the neck of the patient. -~
- ` 132~3g~
The invention again facilitates cormection of a dual-lumen hemodialysis catheter to a hemodialysis unit located anywhere around the patient.
he invention also provides an improved catheter-connecting system which to a large extent isolates the catheter from retracting forces and bending moments applied to the extension , tubes, thereby reducing movement of the catheter tip within the vein and consequently reducing initiation and suction forces on the vein walls. The invention also eliminates any pro~ection of the auxiliary components of the catheter beyond the extremity of ` the shoulder of the patient when the catheter is inserted into the subclavian vein of the patient.
The present invention further provides such a system which avoids ~; kinking of the extension tubes and helps prevent collapse and ~; maintain patency of the extension tubes.
The invention also avoids the exertion of pulling forces, due to the weight of the dialysis tubes, on the catheter, and to reduce such forces on the sutures attaching the catheter assembly to the patient.
'~' According to the present invention there is provided a dual-lumen catheter assembly comprising: a dual-lumen catheter having a distal end and a proximal end, flow diversion means having one end fastened to the proximal end of said catheter, and a pair of flexible extension tubes each having one end fastened to the opposite end of said flow diversion means from said catheter, each of said extension tubes being bent back toward the distal end of said catheter to form a bend having a predetermined shape, ~' each bend being adapted to flex and deform from sald , predetermined shape ln response to an external force and being adapted to return to said predetermined shape in response to ~ .
~,.... . . . . . .
1325~
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remov~l of said external force. Suitably said extension tubes, including the bends thereln, are flexible. Desirably wherein the bent extension tubes and the flow diversion means lie ln substantially the same plane. Suitably the catheter assembly of includes flow control means on each of said extension tubes, on the proximal sides of said bends in said tubes.
., ~ .
In one embodiment of the present invention the catheter assembly includes a pair of luer fittings fastened to the proximal ends of said extension tubes, and a closure cap on each of said luer , fittings.
, In another embodiment of the present invention said flow diversion means includes a pair of internal passageways communicating with the dual lumens of said catheter at said one end of said flow diversion means and with said extension tubes at said opposite end of said flow diversion means. Suitably wherein the bends in said extenslon tubes are generally U-shaped.
Desirably said dual-lumen catheter comprises a cylindrical body portion having an internal longitudinal septum forming a pair of ~; elongated lumens having D-shaped cross sections, the distal end of said body portion terminating in a smooth conical tapered tip, ~` one of said lumens extending longitudinally through said tip, and the other lumen terminating at an opening formed in the side wall of sald catheter proximally of the distal end of said tip.
The present invention also provides a dual-lumen catheter assembly comprising a dual-lumen catheter, and connectlng means attached to the proximal end of said catheter and forming a pair of internal passageways which communicate at one end thereof with ~ the dual lumens in said catheter, said passageways curving back .5~ toward the distal end of said connecting means at the other ends of said passageways will tend to move said catheter in a i3 35 direction opposite that of said exerted forces. Suitably said connecting means comprises a connector fastened to the proximal r .
.
.
- 132~365 :,, end of said catheter, and a pair of extension tubes fastened to said connector, said connector forming a pair of internal .~ passageways connecting each of the catheter lumens to one of said extension tubes, and said extension tubes forming said curved passageways. Desirably each of said curved passageways is U-shaped.
i' ... Advantages of the invention will become apparent upon reading the ~ 10 following detailed description and upon reference to the drawings ~ in which:
....
FIG. 1 ls a perspective view of a dual-lumen hemodialysis . catheter assembly embodying the present inventlon;
.:.
FIG. 2 is an enlarged longitudinal section taken along a diameter of the distal portion of the catheter of FIG. 1, perpendicular to the septum inside the catheter, as generally illustrated by line -; 2-2 in FIG. l;
. 20 FIG. 3 is an end elevation taken at the distal end of the catheter portion shown in FIG. 2 as lllustrated by line 3-3 ln FIG. 2;
FIG. 4 is a section taken generally along line 4-4 in FIG. 2;
.. ~ FIG. 5 is a section taken generally along line 5-5 in FIG. 2;
:, .
;,cl FIG. 6 is a sectlon taken generally along line 6-6 in ~IG. 2;
:1 FIG. 7 is a plan view of the y-shaped hub of the catheter assembly of FIG. l;
; -- .
~, FIG. 8 is a section taken generally along line 8-8 in FIG. 7;
~'~ 35 FIG. 9 is a section taken generally along line 9-9 in FIG. 7;
- 6a -/
~. ` 1325365 FIG. 10 is a fragmentary side elevation of the catheter assembly ~ Of FIG. 1, illustrating the extension tubes in three different :- positions;
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6b -' 13253~
FIG. 11 is a par~ial side elevation and partial sectional view of one of the extension tubes and the auxiliary components associated therewith in the catheter assembly of FIG. l;
s FIG. 12 is a diagrammatic Vi~!W Of a portion of a human body with the catheter of FIG. 1 inserted in a subclavian vein;
^~. FIG. 13 is a diagrammatic view of a portion of a human body ; having the catheter of FIG. 1 inserted in a jugular vein;
FIG. 14 is a diagrammatic view of a portion of a human body -~^ having the catheter o~ FIG. 1 inserted in a femoral vein:
~'?~ 10 FIG. 15 is a perspective view of the first tier of a two-tier . .: .
~; attachment system for the catheter assembly o~ FIG. l;
FIG. 16 is a perspective view of a two-tier attachment system . for the catheter of FIG. 1, including the first tier shown in ~IG.
15;
~ 15 FIG. 17 is a partial side elevation and partial sectional ~ view o~ an alternative attachment system for th~ cath~ter of FIG.
1; and FIG. 18 is a partial side elevation and partial sQctional view of the attachment system ~hown in FIG. 17 with the catheter assembly in a closed condition.
While the invention is susceptible to various modi~icat~ons . . and alternative ~orms, specific embodiments thereo~ have been shown by way of example in the drawings aDd will herein be : described ln detail. It should be understood, however, that it is not intended to limit the invention to the particular forms disclosed, but on the contrary, the lntention i8 to cover all modlr1cation~, qyival-nts, and alternativ ~ ralling ~ithln th-:, ' ` :~ 132536~
spirit and scope of the invention as defined by the appended claims.
`'' Detailed Description Of Preferre~l Embodiments Turning now to the drawings and referring first to FIG. 1, there is shown a dual-lumen hemodialysis catheter lO of the type describ~d in Mahurkar U.S. Patent No. 4,583,968, issued April 22, .
1986 for ~Smooth Bore Double Lumen Catheter". This catheter lo has a cylindrical body portion 11 which is hollow except for a flat, longitudinal, diametral septum 12 which divides the interior of the hollow cylinder into two parallel lumens 13 and 14, each having a D-shaped cross section (FIGS. 2 and 3). As illustrated by the ~-~ arrows in FIG. 2, the lumen 13 is the blood-intake lumen, and the lumen 14 is the blood-return lumen.
At the distal end of the catheter, the exterior surface of the cylinder 11 merges into a smoothly tapered conical tip 15. on the $nside, the blood return lumen 14 extends longitudinally all the way through the tip 15, bending slightly as its passes through the tip so that it opens at 16 near the center of the distal end of the ¢onical tip, as can be seen in FIGS. 2 and 3. Within the tip 15, the cross-sectional shape of the lumen 14 gradually changes from ~: D-~haped at the proximal end of the tip 15 (see FIG. 5) to circular at the distal end o~ the tip (see FIG. 3). An intermediate con~iguration of the transition from D to circular is shown in the i sectional view in FIG. 4.
2S In addition to the opening 16 at the distal end of the blood-return lumen 14, a pair of additional apertures 17 and 18 are ~ormed in the side wall of the return lumen. These two aper~ures '~
,..... .
13253~5 17 and 18 are spaced longitudinally away from the distal opening 16 toward the proximal end of the catheter. These apertures ensure the flow of blood through the return lumen 14 even in situations where the distal opening 16 might become wholly or partially blocked.
In order to provide a longitudinal spacing between the distal openings of the two lumens 13 and 14, the blood intake lumen is terminated at an opening 20 in the side wall of the catheter. A
second opening 21 spaced longitudinally from the opening 20 permits blood to enter the lumen 13 in the event of a blockage of the lo opening 20 against the wall of the vein into which the catheter 10 i5 inserted.
At the proximal end of the catheter 10, the two D-shaped lumens 13 and 14 open into a Y-shaped connector or hub 30 which *orms two internal passageways 31 and 32 (see FIGS. 7-9) communicating with the proximal ends of the catheter lumens. As can be seen in FIGS. 7 and 8, the distal ends o~ the hub passageways 31 and 32 are D-shaped and are separated by a thin gap 33 ~or receiving the septu~ 12 of the catheter. The walls of the catheter lumens are expanded at the proxi~al end of the catheter to ~it over th~ corresponding portions of the hub 30, as ~hown in FIG.
1, and the inside walls of the cathet~r lumens are preferably bonded to the m~ting walls of the hub 30. The passageways 31 and 32 then divergQ from each other and assume a circular cross section (see FIG. 9) as they extend toward the proximal end of the hub, and thQy also increase in cross-sectional area, as can be seen in FIG.
7. At the proximal end of the hub 30, the hub passageways 31 and 32 open into a pair of ~errules 34 and 35 formed as integral parts of the hub.
13253~5 To facilitate connection of the catheter hub 30 to the conventional tubes leading to a dialysis unit, and also to accommodate a pair of clamps for opening and closing the blood intake and return passageways, a pair of extension tubes 40 and 41 are attached to the ferrules 34 and 3s on the proximal end of the hub 30. These extension tubes 40 and 41 are typically formed of a polymeric material such as silicone, and are long enough to receive a pair of conventional clamps 42 and 43 for opening and closing the respective tubes. The clamps 42 and 43 serve as on-off valves or lo flow control devices for controlling the flow of blood between the catheter and the dialysis unit.
The distal ends of the extension tubes 40 and 41 are permanently attached to the Y connector, and the proximal ends of the tubes are permanently bonded to a pair of ~emale luer ~ittings 44 and 45 which match the male luer Pittings conventionally provided on tha ends of the tubes leading to the dialysis unit.
The mating luer ~ittings serve as coupling means for coupling thQ
proximal ends of the extension tubes to the flexible tubes leading to the extracorporeal blood treatment unit. The extension tubes 40 and 41 are relatively soft and flexible, 80 that they can be easily manipulated and also easily closed by the pressure o~ the clamps 42 and 43.
In accordance with one important aspect of the present invention, the extension tubes are bent back toward the distal end of the catheter, preferably extending along the sides of the catheter and the Y-shaped hub. ~y providing these U-bends in the extension tubes, the auxiliary connecting elements attached to the proximal end of the catheter can be accommodated in a small area ~.
,i " ,,",. ",, ,., ";,,;, ,,..,, ~.,", ~ "~ "
. . .
~2~365 S around the access site on the patient's bocly. Consequently, the entire connecting assembly for the catheter, including the luer fittings on the proximal ends of the extension tubes, can be located on a protected portion of the patient's body.
There are no projections to interfere with movements of the patient, or wi~h themo~ement of people and articles around the patient. It is also easy for the patient to don and remove clothing, and norma1 clothing can be worn by the patient du~ing interdialytic pedods vnthout any uDsightl~ or emba~assing projec~ng portions of the catheter assembly.
Perhaps even more importantly, any forces exerted on the proximal ends of the actension tubes tend to move the catheter iD the same direction as the applied force. Thus, when pulling forces are exerted on the exter~sion tubes by the long and relatively heavy tubes leading to the dialy3is unit, for examplè, those forces tend to push the catheter into the patient to hold it in place, rather than withdrawing the catheter. Consequently, the ~isk of accidental dislodgement of the catheter is greatly reduoed, as is the ~isk of vein irritation and damage.
In the particular embodiment illustrated in the drawings, the U-bend in each extension tube 40 and 41 begins at a point just slightly beyond the pro~malend of the hub ferrule 34 or 3S (see Fla 1l). ~e bend is exactly 180D, and terminates in a straight length of tubing 40a or 41a which is long enough to receive one of the clamps 42 and 43 and the stem of the luer fitting 44 or 45 and its cap 46 (see ~;IG. 11).
In accordance with one particular aspect of the invention, the U-bends are permanently formed in the extension tubes 40 and 41.
132~3~
That is, both the overall shape of the bend and the size of the interior passageway of the bend are set or nmemorizedn in the extension tube so that the tube always returns to that configuration. The U-bends are still flexible but are substantially stiffer than the straight end portions of the tubes, as a result of which any forces applied to the more flexible end portions of the tubes tend to simply pivot those flexible end portions about the relatively stiff bent portions. Consequently, the catheter is to a large extent isolated from bending moments applied to the end portions of the extension tubes. This greatly reduces pivoting and tilting movement of the catheter within the vein, thereby further reducing irritation of the vein walls and the attendant ris~ of venous damage.
The relatively stiff U-bends also form a fulcrum about which the proximal portions of extension tubes can be turned to facilitate connection to a dialysis unit located anywhere within a 360- circle around the patient. This flexibility of the catheter assembly is illustrated in FIG. 10, ~hich shows the extension tubes bent laterally to one side of the catheter in solid lines, to the other side ~n dashed lines, and in a direction away ~rom the catheter in phantom lines.
With certain siliGones and other polymeric ~a~erials, the extension tubes 40 and 41 may be set in the desired size and shape by simply heating each tube while holding it in the desired size and shape. One si~ple and effective way to accompllsh this is to slide the extension tube over a U-shaped wire or rod which defines the radius of the dssired bend and also the size of the interior passageway to be maintained within the bend. The curved portion of 13253~
the tube, with the wire still in place, is then dipped in a liquid heated to a temperatur~ sufficient to set, i.e., effect cross linking of, the polymer. Alternatively, the bent portions of the extension tubes can be molded or otherwise formed from a polymer that has a greater durometer than the straight sections of the tubes.
FIG. 12 illustrates the catheter of FIG. 1 inserted in a subclavian vein 50 of a patient. It can be seen that the access site for the catheter lo is located adjacent the clavi~le 51 of the patient, and the catheter is inserted in a direction generally parallel to the clavicle 51. Thus, the distal portions o~ the extension tubes 40 and 41 connected to the Y-shaped hub 30 extend outwardly from the hub 30 toward the outer extremity of the shoulder of the patient. Because of the U-bends in the extension tubes, however, the exten~ion tubes 40 and 41 curve bac~ toward the center of the patient's body before they reach the outer extremity of the shoulder. The luer connections to the long tubes leading to the dialysis unit are consequently located close to the access ;
s~te. As a result, the entire catheter assembly is nestled in a ~ -relatively small region around the access site, in the in~ra-clavicular fossa, where the catheter and its auxiliary components are sheltered by the body of the patient from peopIe and articles moving around th~ patient. No portion of the catheter assembly pro~ects beyond the body of the patient, nor interferes with movements of the patient. When th~ tubes leading to th~ dialysis unit are disconnected from the luer fittings on the catheter assembly, an ambulatory patient can move freely about with little ' - ~ . ' 132~36~
concern about snagging the catheter assembly on clothing or other article~.
- FIG. 13 illustrates a patient having the catheter assembly of FIG. 1 inserted in a jugular vein 70. It can be seen that the access site to the jugular vein 70 is located at the base of the neck of the patient, and the catheter 10 is inserted downwardly into the jugular vein. Consequently, the straight distal portions of the extension tubes 40 and 41 extend upwardly along the lower portion of the patient'~ neck. Because of the presence of the U-bends in the extension tubes, the straight proximal portions of theextension tubes 40 and 41 bend back down along the lower portion of the patient's necX so that the luer fittings are located near the access site. Here again, the entire catheter assembly ends up being located in a compact area where it is well protected in the cervical triangle of the patient's body.
FIG. 14 illustrates a patient having the catheter assembly of FIG. 1 inserted in a femoral vein 80. The catheter is inserted upwardly into the femoral vein 80 along the patient's thigh. The distal ends of the extension tubes 40 and 41 then extend downwardly along ths thigh but, because of the presence o~ the U-bendq ~n the extension tubes, the proximal ends of the tubes curve upwardly along the thigh. Consequently, the catheter assem~ly does not inter~ere with surrounding organs and leg movements o~ the patient.
Moreover, the catheter assembly remains snugly attached to th~
patient in the well protected femoral triangle region o~ the body~
FIGS. 15 and 16 illustrate a preferred two-tier arrangement ~or at~aching the catheter assembly to the patient. In thls arrangement, the access site, the hub 30, and the straight distal ., ! :.. : , . . .. i, . ' ' ' ; ~ "' ~ ",, ,:, ,,, ,"~ ,:," ;" ~"""~,,', ,, ', -132~3~5 portions of the extension tubes 40 and 41 are attached to the patient by an adhesiv~. bandage so as illustrated in FIG. 15. The straight proximal portions of the extension tubes, including the clamps and luer fittings carried thereby, are then placed on top of the bandage 90 and fastened by a second bandage 91 so that they are held securely in place on the top surface of the bandage 90. The bandage 90 is thus used to protect the patient from abrasion due to rubbing of the clamps and/or the luer fittings on the skin of the patient, and also isolates the Y connector from the movements of the extension tubes during dialysis.
FIGS. 17 and 18 illustrate an alternative attachment technigue which also seals the open ends of the luer fittings on the catheter assembly. As illustrated in FIG. 17, a ~irst length of tape 100 is applied along one side of the catheter assembly, with the U-bends in the extension tubes straightened out. Then when the extension tubes are allowed to relax, returning the extension tubes to their normal U-shaped configuration, the tape 100 bends on itself to hold the catheter assembly firmly in position in its relaxed condition.
Next, a second length of tape 101 i~ applied over the catheter assembly, w$th the portion of the tape 101 that extends beyond the luer fitt~ngs adhering to the first tape 100. This forms a relatively tight seal around the open ends of the Iuer fittings, preventing the entry of bacteria into the catheter assembly. The second length of tape 101 is adhered to the body o~ the patient to hold the entire catheter assembly securely in place in the desired location on the patient'æ body.
While the invention has been described with specific referenoe to ths Use of permanently bent extension tubes, the curved .
132~3~
passageways provided by those extension tubes may instead be fonned by a unita~y connecting member fastened to the pro~nmal end of the dual-lumen catheter. More speci~cally, the unitary connec~ng member may form two intemal U-shaped passageways, each of which is in communicacion w~th one of S the lumens of the catheter. The other ends of the passageways may tenninate in a pair of integral ferrules for direct connection to a pair of tubes leading to the diabsis unit, or the passageways may lead into a pair of straight extension tubes canging the conventional clamps and luer fittings. Because the internal passageways are U-shaped, curving back t~ward the distal end of the catheter, 10 any forces applied to the unitary connecting member by tubes leading to the dialysis uI~it will tend to move the catheter in the same direction as the ~pplied foroes. Consequently, pulling forces exerted on the connecting member will tend to hold an inserted catheter in place rather than withdra~g it.
k ... . . . . . ... . . . . ..... . . .
~ 132~365 -~ The present invention provides an improved dual-lumen catheter-connecting system which permits the catheter to remain relatively stable during the entire time the catheter remains inserted in the patient, even during long-term use of the catheter extending over numerous extracorporeal blood treatments. In this connection, the invention also provides such a catheter-` connecting system which significantly improves the comfort level ~- of the patient in whom the catheter is inserted, and which s~ greatly reduces the risk of venous damage.
~' 10 The invention again provides an improved dual lumen catheter system which enables the catheter to be secured to the body of the patient in natural anatomical depressions, or fossa, where the extracorporeal portions of the catheter assembly are shielded 1~ by the patient's body. In these regions the catheter is not -~ easily disturbed by movements of the patient or by movement of people and articles around the patient, regardless of the particular vein into which the catheter is inserted. In this connection, the lnvention provides such a system which facilitates the donning and removal of clothing by the patient, a~d which enables ambulatory patients to wear normal clothing, without any unsightly or embarrassing pro~ections, between successive extracorporeal blood treatments. -~
The lnvention further provides an improved hemodialysis catheter-connecting system which facilitates connection of the catheter and its attached auxiliary components to the long flexible tubes which lead to the dialysis unit, regardless of where the dialysis unit is positioned relative to the patient.
~, 30 The invention again eliminates the need to attach the auxiliary ~ components of a dual-lumen catheter, to the neck, ears or head of -; the patient when the catheter is inserted in a ~ugular vein, and which discourages the use of bandages or tape encircling the neck of the patient. -~
- ` 132~3g~
The invention again facilitates cormection of a dual-lumen hemodialysis catheter to a hemodialysis unit located anywhere around the patient.
he invention also provides an improved catheter-connecting system which to a large extent isolates the catheter from retracting forces and bending moments applied to the extension , tubes, thereby reducing movement of the catheter tip within the vein and consequently reducing initiation and suction forces on the vein walls. The invention also eliminates any pro~ection of the auxiliary components of the catheter beyond the extremity of ` the shoulder of the patient when the catheter is inserted into the subclavian vein of the patient.
The present invention further provides such a system which avoids ~; kinking of the extension tubes and helps prevent collapse and ~; maintain patency of the extension tubes.
The invention also avoids the exertion of pulling forces, due to the weight of the dialysis tubes, on the catheter, and to reduce such forces on the sutures attaching the catheter assembly to the patient.
'~' According to the present invention there is provided a dual-lumen catheter assembly comprising: a dual-lumen catheter having a distal end and a proximal end, flow diversion means having one end fastened to the proximal end of said catheter, and a pair of flexible extension tubes each having one end fastened to the opposite end of said flow diversion means from said catheter, each of said extension tubes being bent back toward the distal end of said catheter to form a bend having a predetermined shape, ~' each bend being adapted to flex and deform from sald , predetermined shape ln response to an external force and being adapted to return to said predetermined shape in response to ~ .
~,.... . . . . . .
1325~
. . ~
..
remov~l of said external force. Suitably said extension tubes, including the bends thereln, are flexible. Desirably wherein the bent extension tubes and the flow diversion means lie ln substantially the same plane. Suitably the catheter assembly of includes flow control means on each of said extension tubes, on the proximal sides of said bends in said tubes.
., ~ .
In one embodiment of the present invention the catheter assembly includes a pair of luer fittings fastened to the proximal ends of said extension tubes, and a closure cap on each of said luer , fittings.
, In another embodiment of the present invention said flow diversion means includes a pair of internal passageways communicating with the dual lumens of said catheter at said one end of said flow diversion means and with said extension tubes at said opposite end of said flow diversion means. Suitably wherein the bends in said extenslon tubes are generally U-shaped.
Desirably said dual-lumen catheter comprises a cylindrical body portion having an internal longitudinal septum forming a pair of ~; elongated lumens having D-shaped cross sections, the distal end of said body portion terminating in a smooth conical tapered tip, ~` one of said lumens extending longitudinally through said tip, and the other lumen terminating at an opening formed in the side wall of sald catheter proximally of the distal end of said tip.
The present invention also provides a dual-lumen catheter assembly comprising a dual-lumen catheter, and connectlng means attached to the proximal end of said catheter and forming a pair of internal passageways which communicate at one end thereof with ~ the dual lumens in said catheter, said passageways curving back .5~ toward the distal end of said connecting means at the other ends of said passageways will tend to move said catheter in a i3 35 direction opposite that of said exerted forces. Suitably said connecting means comprises a connector fastened to the proximal r .
.
.
- 132~365 :,, end of said catheter, and a pair of extension tubes fastened to said connector, said connector forming a pair of internal .~ passageways connecting each of the catheter lumens to one of said extension tubes, and said extension tubes forming said curved passageways. Desirably each of said curved passageways is U-shaped.
i' ... Advantages of the invention will become apparent upon reading the ~ 10 following detailed description and upon reference to the drawings ~ in which:
....
FIG. 1 ls a perspective view of a dual-lumen hemodialysis . catheter assembly embodying the present inventlon;
.:.
FIG. 2 is an enlarged longitudinal section taken along a diameter of the distal portion of the catheter of FIG. 1, perpendicular to the septum inside the catheter, as generally illustrated by line -; 2-2 in FIG. l;
. 20 FIG. 3 is an end elevation taken at the distal end of the catheter portion shown in FIG. 2 as lllustrated by line 3-3 ln FIG. 2;
FIG. 4 is a section taken generally along line 4-4 in FIG. 2;
.. ~ FIG. 5 is a section taken generally along line 5-5 in FIG. 2;
:, .
;,cl FIG. 6 is a sectlon taken generally along line 6-6 in ~IG. 2;
:1 FIG. 7 is a plan view of the y-shaped hub of the catheter assembly of FIG. l;
; -- .
~, FIG. 8 is a section taken generally along line 8-8 in FIG. 7;
~'~ 35 FIG. 9 is a section taken generally along line 9-9 in FIG. 7;
- 6a -/
~. ` 1325365 FIG. 10 is a fragmentary side elevation of the catheter assembly ~ Of FIG. 1, illustrating the extension tubes in three different :- positions;
, ;
;
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`,`5`',:
,'~
~,1',' ~, ~, ' ,.
, .
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'`~ `''' ' .~ ' ','' '~
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.~ .
, . .
. . ,' .
.~ " .
6b -' 13253~
FIG. 11 is a par~ial side elevation and partial sectional view of one of the extension tubes and the auxiliary components associated therewith in the catheter assembly of FIG. l;
s FIG. 12 is a diagrammatic Vi~!W Of a portion of a human body with the catheter of FIG. 1 inserted in a subclavian vein;
^~. FIG. 13 is a diagrammatic view of a portion of a human body ; having the catheter of FIG. 1 inserted in a jugular vein;
FIG. 14 is a diagrammatic view of a portion of a human body -~^ having the catheter o~ FIG. 1 inserted in a femoral vein:
~'?~ 10 FIG. 15 is a perspective view of the first tier of a two-tier . .: .
~; attachment system for the catheter assembly o~ FIG. l;
FIG. 16 is a perspective view of a two-tier attachment system . for the catheter of FIG. 1, including the first tier shown in ~IG.
15;
~ 15 FIG. 17 is a partial side elevation and partial sectional ~ view o~ an alternative attachment system for th~ cath~ter of FIG.
1; and FIG. 18 is a partial side elevation and partial sQctional view of the attachment system ~hown in FIG. 17 with the catheter assembly in a closed condition.
While the invention is susceptible to various modi~icat~ons . . and alternative ~orms, specific embodiments thereo~ have been shown by way of example in the drawings aDd will herein be : described ln detail. It should be understood, however, that it is not intended to limit the invention to the particular forms disclosed, but on the contrary, the lntention i8 to cover all modlr1cation~, qyival-nts, and alternativ ~ ralling ~ithln th-:, ' ` :~ 132536~
spirit and scope of the invention as defined by the appended claims.
`'' Detailed Description Of Preferre~l Embodiments Turning now to the drawings and referring first to FIG. 1, there is shown a dual-lumen hemodialysis catheter lO of the type describ~d in Mahurkar U.S. Patent No. 4,583,968, issued April 22, .
1986 for ~Smooth Bore Double Lumen Catheter". This catheter lo has a cylindrical body portion 11 which is hollow except for a flat, longitudinal, diametral septum 12 which divides the interior of the hollow cylinder into two parallel lumens 13 and 14, each having a D-shaped cross section (FIGS. 2 and 3). As illustrated by the ~-~ arrows in FIG. 2, the lumen 13 is the blood-intake lumen, and the lumen 14 is the blood-return lumen.
At the distal end of the catheter, the exterior surface of the cylinder 11 merges into a smoothly tapered conical tip 15. on the $nside, the blood return lumen 14 extends longitudinally all the way through the tip 15, bending slightly as its passes through the tip so that it opens at 16 near the center of the distal end of the ¢onical tip, as can be seen in FIGS. 2 and 3. Within the tip 15, the cross-sectional shape of the lumen 14 gradually changes from ~: D-~haped at the proximal end of the tip 15 (see FIG. 5) to circular at the distal end o~ the tip (see FIG. 3). An intermediate con~iguration of the transition from D to circular is shown in the i sectional view in FIG. 4.
2S In addition to the opening 16 at the distal end of the blood-return lumen 14, a pair of additional apertures 17 and 18 are ~ormed in the side wall of the return lumen. These two aper~ures '~
,..... .
13253~5 17 and 18 are spaced longitudinally away from the distal opening 16 toward the proximal end of the catheter. These apertures ensure the flow of blood through the return lumen 14 even in situations where the distal opening 16 might become wholly or partially blocked.
In order to provide a longitudinal spacing between the distal openings of the two lumens 13 and 14, the blood intake lumen is terminated at an opening 20 in the side wall of the catheter. A
second opening 21 spaced longitudinally from the opening 20 permits blood to enter the lumen 13 in the event of a blockage of the lo opening 20 against the wall of the vein into which the catheter 10 i5 inserted.
At the proximal end of the catheter 10, the two D-shaped lumens 13 and 14 open into a Y-shaped connector or hub 30 which *orms two internal passageways 31 and 32 (see FIGS. 7-9) communicating with the proximal ends of the catheter lumens. As can be seen in FIGS. 7 and 8, the distal ends o~ the hub passageways 31 and 32 are D-shaped and are separated by a thin gap 33 ~or receiving the septu~ 12 of the catheter. The walls of the catheter lumens are expanded at the proxi~al end of the catheter to ~it over th~ corresponding portions of the hub 30, as ~hown in FIG.
1, and the inside walls of the cathet~r lumens are preferably bonded to the m~ting walls of the hub 30. The passageways 31 and 32 then divergQ from each other and assume a circular cross section (see FIG. 9) as they extend toward the proximal end of the hub, and thQy also increase in cross-sectional area, as can be seen in FIG.
7. At the proximal end of the hub 30, the hub passageways 31 and 32 open into a pair of ~errules 34 and 35 formed as integral parts of the hub.
13253~5 To facilitate connection of the catheter hub 30 to the conventional tubes leading to a dialysis unit, and also to accommodate a pair of clamps for opening and closing the blood intake and return passageways, a pair of extension tubes 40 and 41 are attached to the ferrules 34 and 3s on the proximal end of the hub 30. These extension tubes 40 and 41 are typically formed of a polymeric material such as silicone, and are long enough to receive a pair of conventional clamps 42 and 43 for opening and closing the respective tubes. The clamps 42 and 43 serve as on-off valves or lo flow control devices for controlling the flow of blood between the catheter and the dialysis unit.
The distal ends of the extension tubes 40 and 41 are permanently attached to the Y connector, and the proximal ends of the tubes are permanently bonded to a pair of ~emale luer ~ittings 44 and 45 which match the male luer Pittings conventionally provided on tha ends of the tubes leading to the dialysis unit.
The mating luer ~ittings serve as coupling means for coupling thQ
proximal ends of the extension tubes to the flexible tubes leading to the extracorporeal blood treatment unit. The extension tubes 40 and 41 are relatively soft and flexible, 80 that they can be easily manipulated and also easily closed by the pressure o~ the clamps 42 and 43.
In accordance with one important aspect of the present invention, the extension tubes are bent back toward the distal end of the catheter, preferably extending along the sides of the catheter and the Y-shaped hub. ~y providing these U-bends in the extension tubes, the auxiliary connecting elements attached to the proximal end of the catheter can be accommodated in a small area ~.
,i " ,,",. ",, ,., ";,,;, ,,..,, ~.,", ~ "~ "
. . .
~2~365 S around the access site on the patient's bocly. Consequently, the entire connecting assembly for the catheter, including the luer fittings on the proximal ends of the extension tubes, can be located on a protected portion of the patient's body.
There are no projections to interfere with movements of the patient, or wi~h themo~ement of people and articles around the patient. It is also easy for the patient to don and remove clothing, and norma1 clothing can be worn by the patient du~ing interdialytic pedods vnthout any uDsightl~ or emba~assing projec~ng portions of the catheter assembly.
Perhaps even more importantly, any forces exerted on the proximal ends of the actension tubes tend to move the catheter iD the same direction as the applied force. Thus, when pulling forces are exerted on the exter~sion tubes by the long and relatively heavy tubes leading to the dialy3is unit, for examplè, those forces tend to push the catheter into the patient to hold it in place, rather than withdrawing the catheter. Consequently, the ~isk of accidental dislodgement of the catheter is greatly reduoed, as is the ~isk of vein irritation and damage.
In the particular embodiment illustrated in the drawings, the U-bend in each extension tube 40 and 41 begins at a point just slightly beyond the pro~malend of the hub ferrule 34 or 3S (see Fla 1l). ~e bend is exactly 180D, and terminates in a straight length of tubing 40a or 41a which is long enough to receive one of the clamps 42 and 43 and the stem of the luer fitting 44 or 45 and its cap 46 (see ~;IG. 11).
In accordance with one particular aspect of the invention, the U-bends are permanently formed in the extension tubes 40 and 41.
132~3~
That is, both the overall shape of the bend and the size of the interior passageway of the bend are set or nmemorizedn in the extension tube so that the tube always returns to that configuration. The U-bends are still flexible but are substantially stiffer than the straight end portions of the tubes, as a result of which any forces applied to the more flexible end portions of the tubes tend to simply pivot those flexible end portions about the relatively stiff bent portions. Consequently, the catheter is to a large extent isolated from bending moments applied to the end portions of the extension tubes. This greatly reduces pivoting and tilting movement of the catheter within the vein, thereby further reducing irritation of the vein walls and the attendant ris~ of venous damage.
The relatively stiff U-bends also form a fulcrum about which the proximal portions of extension tubes can be turned to facilitate connection to a dialysis unit located anywhere within a 360- circle around the patient. This flexibility of the catheter assembly is illustrated in FIG. 10, ~hich shows the extension tubes bent laterally to one side of the catheter in solid lines, to the other side ~n dashed lines, and in a direction away ~rom the catheter in phantom lines.
With certain siliGones and other polymeric ~a~erials, the extension tubes 40 and 41 may be set in the desired size and shape by simply heating each tube while holding it in the desired size and shape. One si~ple and effective way to accompllsh this is to slide the extension tube over a U-shaped wire or rod which defines the radius of the dssired bend and also the size of the interior passageway to be maintained within the bend. The curved portion of 13253~
the tube, with the wire still in place, is then dipped in a liquid heated to a temperatur~ sufficient to set, i.e., effect cross linking of, the polymer. Alternatively, the bent portions of the extension tubes can be molded or otherwise formed from a polymer that has a greater durometer than the straight sections of the tubes.
FIG. 12 illustrates the catheter of FIG. 1 inserted in a subclavian vein 50 of a patient. It can be seen that the access site for the catheter lo is located adjacent the clavi~le 51 of the patient, and the catheter is inserted in a direction generally parallel to the clavicle 51. Thus, the distal portions o~ the extension tubes 40 and 41 connected to the Y-shaped hub 30 extend outwardly from the hub 30 toward the outer extremity of the shoulder of the patient. Because of the U-bends in the extension tubes, however, the exten~ion tubes 40 and 41 curve bac~ toward the center of the patient's body before they reach the outer extremity of the shoulder. The luer connections to the long tubes leading to the dialysis unit are consequently located close to the access ;
s~te. As a result, the entire catheter assembly is nestled in a ~ -relatively small region around the access site, in the in~ra-clavicular fossa, where the catheter and its auxiliary components are sheltered by the body of the patient from peopIe and articles moving around th~ patient. No portion of the catheter assembly pro~ects beyond the body of the patient, nor interferes with movements of the patient. When th~ tubes leading to th~ dialysis unit are disconnected from the luer fittings on the catheter assembly, an ambulatory patient can move freely about with little ' - ~ . ' 132~36~
concern about snagging the catheter assembly on clothing or other article~.
- FIG. 13 illustrates a patient having the catheter assembly of FIG. 1 inserted in a jugular vein 70. It can be seen that the access site to the jugular vein 70 is located at the base of the neck of the patient, and the catheter 10 is inserted downwardly into the jugular vein. Consequently, the straight distal portions of the extension tubes 40 and 41 extend upwardly along the lower portion of the patient'~ neck. Because of the presence of the U-bends in the extension tubes, the straight proximal portions of theextension tubes 40 and 41 bend back down along the lower portion of the patient's necX so that the luer fittings are located near the access site. Here again, the entire catheter assembly ends up being located in a compact area where it is well protected in the cervical triangle of the patient's body.
FIG. 14 illustrates a patient having the catheter assembly of FIG. 1 inserted in a femoral vein 80. The catheter is inserted upwardly into the femoral vein 80 along the patient's thigh. The distal ends of the extension tubes 40 and 41 then extend downwardly along ths thigh but, because of the presence o~ the U-bendq ~n the extension tubes, the proximal ends of the tubes curve upwardly along the thigh. Consequently, the catheter assem~ly does not inter~ere with surrounding organs and leg movements o~ the patient.
Moreover, the catheter assembly remains snugly attached to th~
patient in the well protected femoral triangle region o~ the body~
FIGS. 15 and 16 illustrate a preferred two-tier arrangement ~or at~aching the catheter assembly to the patient. In thls arrangement, the access site, the hub 30, and the straight distal ., ! :.. : , . . .. i, . ' ' ' ; ~ "' ~ ",, ,:, ,,, ,"~ ,:," ;" ~"""~,,', ,, ', -132~3~5 portions of the extension tubes 40 and 41 are attached to the patient by an adhesiv~. bandage so as illustrated in FIG. 15. The straight proximal portions of the extension tubes, including the clamps and luer fittings carried thereby, are then placed on top of the bandage 90 and fastened by a second bandage 91 so that they are held securely in place on the top surface of the bandage 90. The bandage 90 is thus used to protect the patient from abrasion due to rubbing of the clamps and/or the luer fittings on the skin of the patient, and also isolates the Y connector from the movements of the extension tubes during dialysis.
FIGS. 17 and 18 illustrate an alternative attachment technigue which also seals the open ends of the luer fittings on the catheter assembly. As illustrated in FIG. 17, a ~irst length of tape 100 is applied along one side of the catheter assembly, with the U-bends in the extension tubes straightened out. Then when the extension tubes are allowed to relax, returning the extension tubes to their normal U-shaped configuration, the tape 100 bends on itself to hold the catheter assembly firmly in position in its relaxed condition.
Next, a second length of tape 101 i~ applied over the catheter assembly, w$th the portion of the tape 101 that extends beyond the luer fitt~ngs adhering to the first tape 100. This forms a relatively tight seal around the open ends of the Iuer fittings, preventing the entry of bacteria into the catheter assembly. The second length of tape 101 is adhered to the body o~ the patient to hold the entire catheter assembly securely in place in the desired location on the patient'æ body.
While the invention has been described with specific referenoe to ths Use of permanently bent extension tubes, the curved .
132~3~
passageways provided by those extension tubes may instead be fonned by a unita~y connecting member fastened to the pro~nmal end of the dual-lumen catheter. More speci~cally, the unitary connec~ng member may form two intemal U-shaped passageways, each of which is in communicacion w~th one of S the lumens of the catheter. The other ends of the passageways may tenninate in a pair of integral ferrules for direct connection to a pair of tubes leading to the diabsis unit, or the passageways may lead into a pair of straight extension tubes canging the conventional clamps and luer fittings. Because the internal passageways are U-shaped, curving back t~ward the distal end of the catheter, 10 any forces applied to the unitary connecting member by tubes leading to the dialysis uI~it will tend to move the catheter in the same direction as the ~pplied foroes. Consequently, pulling forces exerted on the connecting member will tend to hold an inserted catheter in place rather than withdra~g it.
k ... . . . . . ... . . . . ..... . . .
Claims (29)
1. A dual-lumen catheter assembly comprising:
a dual-lumen catheter having a distal end and a proximal end, flow diversion means having one end fastened to the proximal end of said catheter, and a pair of flexible extension tubes each having one end fastened to the opposite end of said flow diversion means from said catheter, each of said extension tubes being bent back toward the distal end of said catheter to form a bend having a predetermined shape, each bend being adapted to flex and deform from said predetermined shape in response to an external force and being adapted to return to said predetermined shape in response to removal of said external force.
a dual-lumen catheter having a distal end and a proximal end, flow diversion means having one end fastened to the proximal end of said catheter, and a pair of flexible extension tubes each having one end fastened to the opposite end of said flow diversion means from said catheter, each of said extension tubes being bent back toward the distal end of said catheter to form a bend having a predetermined shape, each bend being adapted to flex and deform from said predetermined shape in response to an external force and being adapted to return to said predetermined shape in response to removal of said external force.
2. The catheter assembly of claim 1 wherein said extension tubes, including the bends therein, are flexible.
3. The catheter assembly of claim 1 wherein the bent extension tubes and the flow diversion means lie in substantially the same plane.
4. The catheter assembly of claim 1 which includes a pair of luer fittings fastened to the proximal ends of said extension tubes, and a closure cap on each of said luer fittings.
5. The catheter assembly of claim 1 wherein said connector includes a pair of ferrules on said opposite end thereof, and said extension tubes are fastened to said ferrules.
6. The catheter assembly of claim 1 which includes flow control means on each of said extension tubes, on the proximal sides of said bends in said tubes.
7. The catheter assembly of claim 1 wherein said flow diversion means includes a pair of internal passageways communicating with the dual lumens of said catheter at said one end of said flow diversion means and with said extension tubes at said opposite end of said flow diversion means.
8. The catheter assembly of claim 1 wherein the bends in said extension tubes are generally U-shaped.
9. The catheter assembly of claim 1 wherein said dual-lumen catheter comprises a cylindrical body portion having an internal longitudinal septum forming a pair of elongated lumens having D-shaped cross sections, the distal end of said body portion terminating in a smooth conical tapered tip, one of said lumens extending longitudinally through said tip, and the other lumen terminating at an opening formed in the side wall of said catheter proximally of the distal end of said tip.
10. A blood treatment system comprising a dual-lumen catheter having a distal end and a proximal end, flow diversion means having one end fastened to the proximal end of said catheter, a pair of flexible extension tubes each having one end fastened to the opposite end of said flow diversion means from said catheter, each of said extension tubes being bent back toward the distal end of said catheter to form a bend having a predetermined shape, each bend being adapted to flex and deform from said predetermined shape in response to an external force and being adapted to return to said predetermined shape in response to removal of said external force, a blood treatment unit for receiving blood withdrawn from a patient through one of the lumens of said catheter, purifying the withdrawn blood, and returning the purified blood to the patient through the other lumen of said catheter, a pair of flexible tubes connecting said extension tubes to said blood treatment unit, flow control means for controlling the flow of blood between said catheter and said blood treatment unit, and coupling means for coupling the proximal ends of said extension tubes to said flexible tubes.
11. The system of claim 10 wherein said catheter is inserted into a patient and which includes a bandage fastening said flow diversion means to the skin of the patient, with the portions of said extension tubes on the proximal sides of said bends positioned on top of said bandage.
12. The system of claim 11 which includes means fastening to the top of said bandage the portions of said extension tubes on the proximal sides of said bends.
13. The system of claim 11 which includes flow control means and luer fittings installed, said extension tubes on the proximal sides of said bends.
14. The system of claim 10 wherein said extension tubes, including said bends, are flexible.
15. The system of claim 11 wherein the bent extension tubes and said flow diversion means lie in substantially the same plane.
16. The system of claim 10 which includes a pair of luer fittings fastened to the proximal ends of said extension tubes, and a closure cap on each of said luer fittings.
17. The system of claim 10 wherein said connector includes a pair of ferrules on said opposite end thereof, and said extension tubes are fastened to said ferrules.
18. The system of claim 10 which includes flow control means on each of said extension tubes, on the proximal sides of said bends in said tubes.
19. The system of claim 10 wherein said flow diversion means forms a pair of internal passageways communicating with the dual lumens of said catheter at said one end of the connector and with said extension tubes at said opposite end of the connector.
20. The system of claim 10 wherein the bends in said extension tubes are generally U-shaped.
21 21. A dual-lumen catheter assembly comprising a dual-lumen catheter, and connecting means attached to the proximal end of said catheter and forming a pair of internal passageways which communicate at one end thereof with the dual lumens in said catheter, said passageways curving back toward the distal end of said catheter so that forces exerted on said connecting means at the other ends of said passageways will tend to move said catheter in the same direction as said exerted forces.
22. The catheter assembly of claim 21 wherein said connecting means comprises a connector fastened to the proximal end of said catheter, and a pair of extension tubes fastened to said connector, said connector forming a pair of internal passageways connecting each of the catheter lumens to one of said extension tubes, and said extension tubes forming said curved passageways.
23. The catheter assembly of claim 21 wherein each of said curved passageways is U-shaped.
24. The catheter assembly of claim 21 wherein said dual-lumen catheter comprises a cylindrical body portion having an internal longitudinal septum forming a pair of elongated lumens having D-shaped cross sections, the distal end of said body portion terminating in a smooth conical tapered tip, one of said lumens extending longitudinally through said tip, and the other lumen terminating at an opening formed in the side wall of said catheter proximally of the distal end of said tip.
25. A blood treatment system comprising a dual-lumen catheter, connecting means attached to the proximal end of said catheter and forming a pair of internal passageways which communicate at one end thereof with the dual lumens in said catheter, said passageways curving back toward the distal end of said catheter so that forces exerted on said connecting means at the other ends of said passageways will tend to move said catheter in the same direction as said exerted forces, a blood treatment unit for receiving Wood withdrawn from a patient through one of the lumens of said catheter, purifying the withdrawn blood, and returning the purified blood to the patient through the other lumen of said catheter, and a pair of flexible tubes connecting said passageways to said blood treatment unit.
26. The system of claim 25 wherein said connecting means comprises a connector fastened to the proximal end of said catheter, and a pair of extension tubes fastened to said connector, said connector forming a pair of internal passageways connecting each of the catheter lumens to one of said extension tubes, and said extension tubes forming said curved passageways.
27. The system of claim 25 wherein each of said curved passageways is U-shaped.
28. The system of claim 25 wherein said dual-lumen catheter comprises a cylindrical body portion having an internal longitudinal septum forming a pair of elongated lumens having D-shaped cross sections, the distal end of said body portion terminating in a smooth conical tapered tip, one of said lumens terminating at an opening formed in the side wall of said catheter proximally of the distal end of said tip.
29. A catheter assembly comprising a dual-lumen catheter and connecting means attached to the proximal end of said catheter for connecting the dual lumens to a pair of tubes for carrying fluids into one of the lumens and out of the other lumen, a proximal portion of said catheter assembly being bent toward the distal end thereof so that forces exerted on said proximal portion of said catheter assembly will tend to move the distal end of said catheter assembly in the same direction as said exerted forces.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/194,143 US4895561A (en) | 1988-05-16 | 1988-05-16 | Dual-lumen catheter-connecting system |
| US194,143 | 1988-05-16 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1325365C true CA1325365C (en) | 1993-12-21 |
Family
ID=22716461
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000599573A Expired - Fee Related CA1325365C (en) | 1988-05-16 | 1989-05-12 | Dual-lumen catheter-connecting system |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US4895561A (en) |
| EP (1) | EP0346613B1 (en) |
| AT (1) | ATE79281T1 (en) |
| AU (1) | AU610723B2 (en) |
| CA (1) | CA1325365C (en) |
| DE (1) | DE68902428T2 (en) |
| ES (1) | ES2034485T3 (en) |
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| JP5713732B2 (en) | 2011-03-08 | 2015-05-07 | 日本コヴィディエン株式会社 | Catheter with valve |
| US10107022B2 (en) | 2011-06-07 | 2018-10-23 | Henniges Automotive Schlegel Canada, Inc. | Draft guard for window assembly having seals and integral fins |
| US20120311934A1 (en) | 2011-06-07 | 2012-12-13 | Steven Robert Abramson | Draft Guard |
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| US9402975B2 (en) * | 2011-08-31 | 2016-08-02 | Becton, Dickinson And Company | Systems and methods to increase rigidity and snag-resistance of catheter tip |
| US8747343B2 (en) | 2011-09-30 | 2014-06-10 | Covidien Lp | Hemodialysis catheter with improved side opening design |
| US9072867B2 (en) | 2011-09-30 | 2015-07-07 | Covidien Lp | Catheter with external flow channel |
| US10143822B2 (en) | 2012-07-05 | 2018-12-04 | Covidien Lp | Valved tip catheters |
| US9155862B2 (en) | 2012-09-28 | 2015-10-13 | Covidien Lp | Symmetrical tip acute catheter |
| US10252023B2 (en) | 2013-01-11 | 2019-04-09 | C. R. Bard, Inc. | Curved catheter and methods for making same |
| USD748252S1 (en) | 2013-02-08 | 2016-01-26 | C. R. Bard, Inc. | Multi-lumen catheter tip |
| WO2016011091A1 (en) | 2014-07-14 | 2016-01-21 | C. R. Bard, Inc. | Apparatuses, systems, and methods for inserting split tip catheters having enhanced stiffening and guiding features |
| EP3215211A4 (en) | 2014-11-07 | 2018-07-04 | C. R. Bard, Inc. | Connection system for tunneled catheters |
| US10610668B2 (en) | 2016-10-05 | 2020-04-07 | Becton, Dickinson And Company | Catheter with an asymmetric tip |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3256885A (en) * | 1963-06-26 | 1966-06-21 | Roehr Products Company Inc | Aspirating device |
| US3812851A (en) * | 1972-11-21 | 1974-05-28 | P Rodriguez | I. v. arm rest and support |
| US4098275A (en) * | 1975-11-28 | 1978-07-04 | Dante Vincent Consalvo | Dual flow cannula set |
| DE3048223C2 (en) * | 1980-12-20 | 1984-10-31 | Erich Prof.Dr.med. 8520 Erlangen Rügheimer | Connection system for gas lines with interlocking connecting elements for ventilation or anesthesia devices |
| US4626240A (en) * | 1981-11-06 | 1986-12-02 | Shiley Incorporated | Dual lumen subclavian cannula |
| CA1219785A (en) * | 1984-05-24 | 1987-03-31 | Geoffrey S. Martin | Dual lumen cannula |
| US4643711A (en) * | 1984-05-25 | 1987-02-17 | Cook, Inc. | Two lumen hemodialysis catheter |
-
1988
- 1988-05-16 US US07/194,143 patent/US4895561A/en not_active Expired - Lifetime
-
1989
- 1989-05-12 CA CA000599573A patent/CA1325365C/en not_active Expired - Fee Related
- 1989-05-12 DE DE8989108615T patent/DE68902428T2/en not_active Ceased
- 1989-05-12 AT AT89108615T patent/ATE79281T1/en not_active IP Right Cessation
- 1989-05-12 EP EP89108615A patent/EP0346613B1/en not_active Expired - Lifetime
- 1989-05-12 ES ES198989108615T patent/ES2034485T3/en not_active Expired - Lifetime
- 1989-05-15 AU AU34824/89A patent/AU610723B2/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| AU3482489A (en) | 1989-11-16 |
| DE68902428D1 (en) | 1992-09-17 |
| US4895561A (en) | 1990-01-23 |
| EP0346613B1 (en) | 1992-08-12 |
| DE68902428T2 (en) | 1993-02-18 |
| AU610723B2 (en) | 1991-05-23 |
| ATE79281T1 (en) | 1992-08-15 |
| EP0346613A1 (en) | 1989-12-20 |
| ES2034485T3 (en) | 1993-04-01 |
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| Date | Code | Title | Description |
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| MKLA | Lapsed |