US20080082079A1 - Low profile catheter assembly - Google Patents

Abstract

A medical catheter assembly includes a catheter hub, an elongate catheter member extending from the catheter hub and having at least one longitudinal lumen for passage of fluids, an extension tube extending from the catheter hub and defining an internal lumen in fluid communication with the at least one longitudinal lumen of the catheter member and a clamp positionable about the extension tube. The catheter hub defines a reduced profile. The clamp includes first and second clamp sections and defines a longitudinal clamp axis. The clamp has a longitudinal opening for passage of the extension tube and a movable member adapted to move from a first position to a second position to substantially close the internal lumen. The first and second clamp sections are separable to facilitate positioning of the extension tube within the longitudinal opening.

Description

BACKGROUND
• 1. Technical Field
• The present disclosure is directed to a catheter assembly, and, in particular, relates to a low-profile catheter system adapted for use in a subcutaneous tunneling catheterization procedure.
• 2. Description of the Related Art
• Catheters are flexible medical instruments intended for the withdrawal and introduction of fluids relative to body cavities, ducts, and vessels. Catheter instrumentation may have particular application in a hemodialysis procedure where blood is withdrawn from a blood vessel for treatment, and subsequently returned to the blood vessel for circulation. Known hemodialysis catheters include multiple lumens, such as dual lumen or triple-lumen catheters, permitting bi-directional fluid flow within the catheter whereby one lumen is dedicated for withdrawal of blood and the other lumen is dedicated for returning the treated blood to the vessel. During an exemplary hemodialysis procedure, a multiple lumen catheter is inserted into a body and blood is withdrawn through an arterial lumen of the catheter. The removed blood is directed to a hemodialysis unit which dialyzes, or purifies, the blood to remove waste, and toxins. The dialyzed blood is returned to the patient through a venous lumen of the catheter.
• Various techniques are employed for the insertion of hemodialysis catheters including, e.g., with the use of guidewires, introduction stylets or the like. Some of these known techniques include subcutaneous tunneling methodologies where a subcutaneous tunnel is formed between two spaced openings in the skin with the use of a trocar or the like. The catheter end is attached to the trocar and pulled though the tunnel to expose the catheter which is subsequently inserted into, e.g., the jugular vein and routed to the heart.
SUMMARY
• Accordingly, the present disclosure is directed to further improvements in hemodialysis catheters and systems used therewith. A medical catheter assembly includes a catheter hub having a reduced profile, an elongate catheter member extending from the catheter hub and having at least one longitudinal lumen for passage of fluids, an extension tube extending from the catheter hub and defining an internal lumen in fluid communication with the at least one longitudinal lumen of the catheter member and a clamp positionable about the extension tube. The clamp includes first and second clamp sections and defines a longitudinal clamp axis. The clamp has a longitudinal opening for passage of the extension tube and a movable member adapted to move from a first position to a second position to substantially close the internal lumen. The first and second clamp sections are separable to facilitate positioning of the extension tube within the longitudinal opening, e.g., subsequent to positioning the elongate catheter member within the subject. The first and second clamp sections may be releasably mounted to each other along the longitudinal clamp axis to facilitate lateral positioning of the extension tube within the longitudinal opening of the clamp. The first and second clamp sections may include a pin and corresponding slot mechanism for effecting releasable mounting of the first and second clamp sections. The first and second clamp sections may be connected by a tether.
• In one preferred embodiment, the clamp includes a clamp base defining the longitudinal opening and has the movable member mounted thereto. The movable member is pivotally mounted to the clamp base and is adapted to pivot relative to clamp base between the first and second positions thereof. Means for releasably securing the movable member in the second position may be provided. The clamp base may include an internal locking shelf dimensioned to engage the movable member to secure the movable member in the second position.
• The medical catheter assembly may include first and second extension tubes which are connectable to the catheter hub. The catheter hub defines first and second extension conduits for respectively receiving the first and second extension tubes. The first and second extension conduits may be arranged in side by side relation. Preferably, the first extension conduit is arranged about an axis in substantial parallel relation with a longitudinal hub axis of the catheter hub. The second extension conduit is arranged about an axis in oblique relation with the longitudinal hub axis of the catheter hub. First and second adapters may be mounted to each of the first and second extension tubes. The first extension tube and the first adapter define a first effective length which is substantially less than a corresponding second effective length of the second extension tube and the second adapter. Preferably, the first effective length is less than a length of the second extension tube to permit the first extension tube and the first adapter to be positioned in adjacent side by side relation with respect to the second extension tube thereby reducing the profile thereof to facilitate passage through tissue.
• The catheter hub may define a pair of suture wing holes for receiving a suture utilized in securing the catheter hub. Alternatively, the catheter hub defines an outer groove dimensioned for accommodating a suture utilized in securing the catheter hub.
• In another embodiment, a low profile catheter hub for an elongate dual lumen catheter includes a catheter hub member adapted for connection to a dual lumen catheter. The catheter hub member defines a longitudinal hub axis and has first and second conduits therein adapted for fluid connection to respective fluid supply and/or withdrawal tubing. The first fluid conduit is arranged about a first axis extending in substantial parallel relation with the longitudinal hub axis. The second fluid conduit is arranged about a second axis in oblique relation with the longitudinal axis.
• A clamp for closing compressible medical tubing is also provided. The clamp includes a clamp member defining a longitudinal clamp axis. The clamp member includes first and second clamp sections and has a longitudinal opening for passage of compressible tubing. The clamp member includes a movable member adapted to move from a first position to a second position to substantially close a lumen of the compressible tubing. The first and second clamp sections are releasably mountable to each other whereby the first and second clamp sections may be separable generally along the longitudinal clamp axis to permit access to the longitudinal opening to facilitate positioning of the compressible tubing within the longitudinal opening. The first and second clamp sections may be connected by a tether.
• The first and second clamp sections include a pin and corresponding slot mechanism for providing a releasable mounting of the first and second clamp sections. The clamp member may include a clamp base defining the longitudinal opening and having the movable member pivotally mounted thereto. The movable member is adapted to pivot relative to the clamp base between the first and second positions thereof. The clamp base may include an internal locking shelf dimensioned to engage the movable member to secure the movable member in the second position.
• A method for performing a surgical procedure is also disclosed. The method includes the steps of:
• providing a catheter including a catheter hub and an elongated catheter extending from the hub, the elongated catheter having at least one longitudinal lumen for passage of fluids;
• accessing an underlying tissue site through an opening in the skin of a patient;
• advancing a distal end of the elongated catheter through the tissue site and into the patient;
• creating a surgical tunnel from the tissue site and out through a second opening in the skin remote from the first opening;
• passing the catheter through the surgical tunnel by introducing the catheter hub through the first opening and advancing the catheter hub with the elongated catheter following there along within the surgical tunnel; and
• fluidly coupling the at least one longitudinal lumen of the catheter with an external fluid source.
BRIEF DESCRIPTION OF THE DRAWINGS
• Preferred embodiments of the disclosure will be better understood with reference to the accompanying drawings wherein:
• FIG. 1 is a perspective view of the low-profile catheter of the system in accordance with the principles of the present disclosure;
• FIG. 2 is a perspective view with parts separated illustrating the components of the low-profile catheter ofFIG. 1;
• FIG. 3 is a side cross-sectional view of the low-profile catheter;
• FIG. 4 is a perspective view of an alternate embodiment of the catheter hub of the low profile catheter;
• FIGS. 5-6 are perspective views illustrating the leading end of the low profile catheter;
• FIG. 7 is a side plan view of the leading end of the low profile catheter system taken along the lines7-7 ofFIG. 1;
• FIG. 8 is a cross-sectional view of the low profile catheter taken along the lines8-8 ofFIG. 1;
• FIG. 9 is a perspective view of the clamp of the low-profile catheter;
• FIGS. 9A-9B are each perspective views illustrating the clamp ofFIG. 9 in a non-assembled condition;
• FIG. 9C is a view of an area of detail identified inFIG. 3 illustrating the clamp positioned about the extension tube and in a first open position;
• FIG. 9D is a view similar to the view ofFIG. 9C illustrating the clamp in a second closed position;
• FIGS. 10A and 10B are perspective views of alternate embodiments of the clamp;
• FIG. 11 is a side plan view of the low profile catheter with the clamps removed;
• FIG. 12 is a side plan view similar to the view ofFIG. 11 with the extension tubes twisted prior to insertion within the surgical site;
• FIG. 13 is a side plan view illustrating a tunneling instrument and the extension tube adapter;
• FIG. 14 is a side plan view illustrating the tunneling instrument mounted to the extension tube adapter and a sheath positioned about the connection location; and
• FIG. 15 is a perspective view illustrating an embodiment of the sheath ofFIG. 14;
• FIGS. 16-17 are views illustrating a methodology of insertion of the low profile catheter through a reverse tunneling procedure to access the right atrium of the heart; and
• FIG. 18 is a view illustrating at least partial removal or retraction of the sheath to expose the adapters for connection to a hemodialysis machine.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The exemplary embodiments of the catheter and methods of use disclosed are discussed in terms of medical catheters for the administration of fluids (withdrawal or introduction) relative to the body of a subject and, more particularly, in terms of a hemodialysis catheter. However, it is envisioned that the present disclosure may be employed with a range of catheter applications including surgical, diagnostic and related treatments of diseases and body ailments of a subject. It is further envisioned that the principles relating to the catheter disclosed include employment with various catheter related procedures, such as, for example, hemodialysis, cardiac, abdominal, urinary, intestinal, and in chronic and acute applications. Moreover, the catheter can be used for administration of fluids such as, for example, medication, saline, bodily fluids, blood and urine.
• In the discussion that follows, the term “proximal” or “trailing” will refer to the portion of a structure that is closer to a clinician, while the term “distal” or “leading” will refer to the portion that is further from the clinician. As used herein, the term “subject” refers to a human patient or other animal. The term “clinician” refers to a doctor, nurse or other care provider and may include support personnel.
• The following discussion includes a description of the catheter system, followed by a description of an exemplary method of operating the catheter in accordance with the principles of the present disclosure. For discussion purposes, the catheter will be discussed in terms of a hemodialysis catheter and the method of operation will be discussed in terms of a reverse tunneling procedure utilized for positioning the catheter during a dialysis procedure. However, those skilled in the art will appreciate the catheter has many other applications in addition to dialysis applications.
• Referring now to the figures wherein like components are designated by like reference numerals throughout the several views,FIGS. 1-2 illustrate in perspective views, thehemodialysis catheter10 in accordance with the principles of the system of the present disclosure.Catheter10 includes several components assembled together, namely, catheter hub orhousing12,elongated catheter member14 extending distally from thecatheter hub12 and first andsecond extension tubes16,18 extending proximally from thecatheter hub12.Catheter system10 further includes a pair ofclamps20 which are mountable about each ofextension tubes16,18.
• With reference now toFIGS. 1-3,catheter hub12 is advantageously dimensioned for engagement by the clinician. Moreover,catheter hub12 defines a reduced profile particularly when viewed along the longitudinal housing axis “k” (FIG. 2) of thecatheter hub12. Housing axis “k” is in general alignment with axis “m” ofcatheter member16.Catheter hub12 includes proximal or trailinghousing section22adjacent extension tubes16,18 and distal or leadinghousing section24adjacent catheter member16. As best depicted inFIG. 3,proximal housing section22 defines first and secondinternal extension conduits26,28 extending along the housing axis “k” and separated byseptum wall30 ofcatheter hub12.First extension conduit26 is in general parallel relation with the housing axis “k”.Second extension conduit28 is arranged at an acute angle “b” with respect to the housing axis “k”. Angle “b” may range from about 0 degrees to about 45 degrees relative to the housing axis “k”, more preferably, about 5 degrees to about 20 degrees relative to the housing axis “k”. This parallel arrangement offirst extension conduit16 coupled with the slight oblique arrangement ofsecond extension conduit28 significantly reduces the profile ofcatheter hub12 particularly compared to conventional catheter hub designs which employ a v-or t-shaped shaped conduit connection areas.
• First andsecond extension conduits26,28 are adapted to receive respective first andsecond extension tubes16,18 in secured relation therewith. In one preferred embodiment,extension tubes16,18 are secured within therespective extension conduits26,28 via an interference or frictional fit. It is also envisioned that cements or adhesives may be utilized to secureextension tubes16,18 within theirrespective extension conduits26,28. Distal or leadinghousing section24 ofcatheter hub12 definescentral opening32 which receivescatheter member14.Catheter member14 may be secured withincentral opening32 ofdistal housing section24 via an interference or frictional fit, and, possibly supplemented with cements and adhesives or the like.
• Catheter hub12 may further include a pair ofopposed suture wings34 along its outer surface.Suture wings34 defineopenings36 dimensioned for receiving sutures which may be utilized in securingcatheter hub20 relative to the subject. In an alternative embodiment depicted inFIG. 4,catheter hub20 may have anannular groove36ain its outer wall in lieu ofsuture wings34. A suture may be wrapped withinannular groove36aand subsequently secured relative to the subject.
• Referring now toFIGS. 5-8, in conjunction withFIG. 3,elongated catheter member16 will be discussed.Catheter member16 is preferably a dual lumen catheter having first and secondlongitudinal lumens38,40 separated by aseptum wall42 which extends the length the catheter member16 (FIG. 3). Each of the first and secondlongitudinal lumens38,40 may define a D-shaped opening in cross-section. Other lumen arrangements are also envisioned including circular, pie shaped or other shapes known in the art. Coaxial lumens are also envisioned.Septum wall42 ofcatheter member16 preferably abutsseptum wall30 ofcatheter hub20 in the assembled condition of the components. Thus, with this arrangement,low profile catheter10 defines a dual lumen catheter, inclusive of a first lumen includingextension conduit26 and firstlongitudinal lumen38 ofcatheter member14, and a second lumen inclusive ofextension conduit28 and secondlongitudinal lumen40. Single or triple lumen catheters are also envisioned.
• With particular reference toFIGS. 5-7, leading ordistal end44 ofcatheter member16 will be discussed. The arrangement of catheterdistal end44 is similar to an embodiment disclosed in commonly assigned U.S. Patent Application No. 2005/0267400 to Haarala et al., the entire contents of which are incorporated herein by reference. In particular,distal end44 ofcatheter member16 includes a pair ofopposed openings46,48 arranged in its outer wall in diametrical relation and in fluid communication with respective first and secondlongitudinal lumens38,40. Eachopening46,48 is characterized by having an arcuate recessedwall surface50 to define a partial generally arcuate opening as shown.Openings46,48 are symmetrically arranged about the longitudinal axis “m” ofcatheter member14. Preferably,septum wall42 ofcatheter member16 extends distally beyondcatheter member16.Catheter member16 further includes a pair of polygonal orparallelepiped openings52 in fluid communication with first and secondlongitudinal lumens38,40 andopenings46,48.Openings52 are disposed proximal ofopenings46,48 as shown.Openings46,48 andproximal openings52 permit passage of fluids during the surgical procedure. Further details regardingdistal end44 ofcatheter member16 may be ascertained by reference to the Haarala '400 publication. Other arrangements, e.g., as disclosed as alternate embodiments in the Haarala '400 publication, are also envisioned.
• Catheter member16 is preferably flexible and may be formed by conventional injection molding or extrusion means. The wall ofcatheter member16 may include reinforcing material if desired.Catheter member16 may have a pre-curved configuration in its normal state, i.e., have a preformed bend which it normally assumes in the absence of an external stressor to conform to a body cavity or vessel in which the catheter member is to be positioned. Alternatively,catheter member16 may be devoid of any normally curved orientation.
• Referring again toFIGS. 1-3,catheter member16 may further include at least onecuff54 on its outer surface.Cuff54 may include a fabric material and functions to be a site for tissue ingrowth for long term securing ofcatheter10 in an indwelling position. For example,cuff54 may reside in the tunnel formed during the tunneling procedure. More than onecuff54 may also be provided.Catheter member16 may also include radiopaque markings or strips to facilitate the location of catheter within the body with a fluoroscope.
• First andsecond extension tubes16,18 may be any suitable tubing adapted to supply or withdrawal fluid to or from a body vessel. First andsecond extension tubes16,18 preferably include a compressible material whereby thetubes16,18 may be selectively compressed viaclamps20 to substantially close the opening within thetubes16,18. The free or trailing ends ofextension tubes16,18 remote fromcatheter hub12 haveadapters56 mounted thereto.Adapters56 may be any conventional luer connector or adapter utilized in a surgical environment for administrating fluids. One suitable connection is a luer connector which may incorporate an external thread orcam58 for securing to a fluid source.Adapters56 may be secured toextension tubes16,18 by any of the aforementioned means including friction or tolerance fit, adhesives, cements, or the like.
• As best depicted inFIGS. 1-2,adapters56 each include outer walls having a pair of recessed surfaces60. Recessed surfaces60 are ergonomically designed to be engaged by the clinician thereby facilitating manipulation of thecatheter10 about the operative site.
• First tube extension16 may define a length which is less thansecond tube extension18. In one preferred embodiment, the overall effective length offirst extension tube16 and its attachedadapter56 is less than the corresponding overall effective length ofsecond extension tube18 and itsadapter56. As a further preference, the overall effective length offirst extension tube16 and itsadapter56 is less than or equal to the length ofsecond extension tube18. With this arrangement,first extension tube16 and itsadapter56 may be placed in juxtaposed or side-by-side relation with thesecond extension tube18 to substantially reduce the profile presented by the first andsecond extension tubes16,18. The significance of this feature will be appreciated from the description provided hereinbelow. First andsecond extension tubes16,18 may define the same lengths if desired.
• Referring now toFIGS. 9-9D, in conjunction withFIG. 3, clamps20 will be discussed.Clamps20 are mounted about first andsecond extension tubes16,18. Eachclamp20 is adapted to move from a first open position in non compressive engagement with therespective extension tube16,18 (FIG. 9C) to a second substantially closed position to compress the respective extension tube (16,18) and close the lumen within the tube (FIG. 9D) thereby preventing fluid flow in either direction. Eachclamp20 defines a longitudinal clamp axis “t” and longitudinal opening orpassage62 for reception ofextension tube16,18.Longitudinal passage62 is inclusive of first andsecond openings64,66 withinopposed end walls68,70 of theclamp20 and the central interior of theclamp20.
• Eachclamp20 includes two sections, namely,first clamp section20aandsecond clamp section20bwhich is releasably mountable to the first clamp section. In one preferred arrangement,first clamp section20aincludesopenings72 inside wall74.Second clamp section20bincludespins76 extending in transverse relation fromside wall78.Pins76 are advantageously dimensioned to be received in theopenings72 offirst clamp section20ain snap relation therewith whereby, upon mounting of thesecond clamp section20bto thefirst clamp section20a, theclamp20 becomes a single unit. Preferably, in use, therespective extension tube16,18 is positioned through thecutaway portions80,82 (FIG. 9A) leading torespective openings14,16 of thefirst clamp section20a. Thereafter,second clamp section20bis mounted tofirst clamp section20aas discussed hereinabove.
• Clamp20 further includes internal wedge surfaces84,86 arranged in opposed relation as shown. Upon movement ofclamp20 from the first open position ofFIG. 9C to the second closed position ofFIG. 9D, wedge surfaces84,86 engageextension tube16,18 in a manner to close the opening within theextension tube16,18 to thereby prevent passage of fluid within thetube16,18.Clamp20 further includes a locking mechanism to secureclamp20 in the in the second closed position. The locking mechanism preferably includes lockingsurface88 disposed on the cantilevered section ofclamp20 which engages lockingledge90 to secure theclamp20 in the second closed position. In general,clamp20 includesclamp base92 havingwedge surface86 andmovable member94 havingwedge surface84 mounted via a pivoting, hinge, living hinge, or cantilever arrangement to theclamp base92.Movable member94 is adapted to move or pivot between the first open position and the second closed position ofFIGS. 9C,9D respectively.
• FIG. 10A illustrates an alternate embodiment of the clamp.Clamp20 is substantially similar to theclamp20 described in connection withFIGS. 9-9D. However, in accordance with this embodiment, clamp20 further includestether95 connected to clampsections20a,20b.Tether95 may be integrally connected to clampsections20a,20bor monolithically formed with theclamp sections20a,20b.Tether95 functions to operatively coupleclamp components20a,20bto facilitate manipulation and/or connection of the clamp components at the operative site.
• FIG. 10B illustrates an alternate embodiment ofclamp20.Clamp96 is substantially similar to clamp20 discussed hereinabove, but is a single piece component.Clamp96 further defines cut awayportions97,99 on opposed lateral sides ofclamp96 in communication withopenings64,66 respectively. It is also envisioned that cut awayportions97,99 may be on the same side ofclamp96. Thus, clamp96 may be mounted about anextension tube16,18 by passing the tube betweenmovable member94 andbase member92 through spacing98 withclamp96 in the open position ofFIG. 10B. Sections of therespective tubing16,18 may be passed through cut awayportions97,99 for reception withinopenings64,66. In one embodiment,portions97a,99aofclamp base92 defining respective cut awayportions97,99 are relatively narrow adjacent one lateral side to facilitate retention of the tube upon positioning of the tube withinlongitudinal passage62 ofclamp20.Clamp96 functions substantially in a similar manner to that described in connection withclamp20.
• The components ofcatheter10 are fabricated from materials suitable for medical applications, such as, for example, polymerics or metals. Suitable metals include titanium or stainless steel, depending on the particular catheter application and/or preference of a practitioner. Semi-rigid and rigid polymerics are contemplated for fabrication, as well as resilient materials, such as molded medical grade polyurethane, and silicone. The sealing components ofcatheter10 may be fabricated from low friction property materials such as, polytetrafluoroethylene (PTFE) coated, PTFE impregnated and/or internally lubricated elastomers. One skilled in the art, however, will realize that other materials and fabrication methods suitable for assembly and manufacture, in accordance with the present disclosure, also would be appropriate.
• Catheter10 may be installed in a subject through a subcutaneous tunneling procedure as disclosed in U.S. Pat. No. 4,832,687 to Smith, III and U.S. Pat. No. 5,944,732 to Raulerson, the entire contents of each of the '687 patent and the '732 patent being incorporated herein by reference. In one preferred embodiment,catheter10 in implanted within a major vein of a patient via the reverse tunneling method disclosed in U.S. Pat. No. 5,509,897 to Twardowski, the entire contents of the '897 patent being incorporated herein by reference.
• With initial reference toFIG. 11,extension tubes16,18 withclamps20 removed are placed in juxtaposed side by side relation as shown. As indicated hereinabove, the effective length ofextension tube16 and itsadapter56 is substantially equal to or less than the length ofextension tube18 such that thetubes16,18 may be placed in side by side relation as shown inFIG. 11. Thereafter,extension tubes16,18 may be optionally twisted onto each other to the configuration ofFIG. 12. The twisting ofextension tubes16,18 serves to effectively secure theextension tubes16,18 to each other thereby minimizing radial movement of theextensions tubes16,18 during passage through the subcutaneous tunnel. In addition, with theextension tubes16,18 secured, a tunneling or trocar instrument may be attached to a leadingadapter56 to facilitate passage of bothextension tubes16,18 through the created tunnel.
• With reference toFIG. 13, a tunneling ortrocar instrument100 is operatively connected to the proximal or free ends ofextension tubes16,18 to effectively couple the tunneling instrument tocatheter10. In one preferred embodiment, tunnelinginstrument100 includes mounting means in the form of, e.g., an internal threaded orcam lock102, which cooperates with correspondingexternal thread58 ofadapter56 to secure thetunneling instrument100 tocatheter10. As a further alternative, aflexible sheath200 may be positioned around the juncture or connection area oftunneling instrument100 andadapter56, preferably encompassing bothadapters56 as shown inFIG. 14.Sheath200 facilitates passage oftunneling instrument100 andcatheter10 through the subcutaneous tunnel by providing a smooth and flexible outer member which may readily traverse the created subcutaneous tunnel.Sheath200 is preferably flexible and elastic to stretch and tightly fit over the components.FIG. 15 illustratessheath200 and with various features, for example,extension tab202 which may be readily grasped to draw thesheath200 back ontoextension tube16,18 once exposed from the tunnel. Slits ornotches204 in thesheath200 are also envisioned. A tear away capability, for example along perforated orscore line206 may also be incorporated withsheath200.
• The use ofsystem10 will now be discussed in terms of a back end or reversed tunneling procedure in connection with hemodialysis treatment. In this regardlow profile catheter10 functions as a hemodialysis catheter. However, it is envisioned that the system may be used for other surgical treatments and in other deployment procedures. The preferred method will be discussed in terms of deployment ofcatheter10 through the right jugular vein for positioning of within the right atrium. As appreciated,catheter10 may be implanted in the right atrium via the left jugular vein, the right atrium through the right subclavian vein, the right atrium through the left subclavian vein, or implanted in the femoral vein of the subject.
• Referring now toFIG. 16, an incision or entry opening500 is made adjacent the midclavicular line, through the skin and the subcutaneous tissue. The internaljugular vein502 is punctured using known techniques and leadingend44 ofcatheter10 in inserted through the internaljugular vein502, thesuperior vena cavity504 and into theright atrium506. The positioning of leadingend44 may be confirmed with an x-ray if desired. Thereafter, a subcutaneous tunnel is made with, e.g., a tunneling device or trocar from the first incision area orentry opening area500 downwardly to a lower chest area. Asmall exit opening508 is made at the base of the subcutaneous tunnel. Thereafter, tunnelinginstrument100 with attachedcatheter10 andsheath200 ofFIG. 14 is maneuvered through the tunnel which correspondingly drawsadapters56,extension tubes16,18,catheter hub12 and the proximal end ofelongated catheter member14 through the tunnel toward theexit opening508 as shown inFIG. 17. As appreciated, the narrow profile ofcatheter hub12 facilitates passage of thecatheter hub12 through the subcutaneous tunnel.Tunneling instrument100 is removed fromadapter56. Withadapters56,extension tubes16,18 andcatheter hub12 exposed from theexit opening508,sheath200 may be pulled back onto itself or removed to exposeadapters56 for connection to the appropriate fluid supply lines.FIG. 18 illustratessheath200 in the process of being pulled back on itself to exposeadapters56. As indicated hereinabove,extension tab202 ornotches204 may be employed to facilitate this procedural step. Also,sheath200 may be removed or separated from the components along, e.g.,score line206.
• In a hemodialysis application, oneadapter56 may be connected to the hemodialysis machine to withdraw blood through, e.g.,longitudinal lumen38 andextension tube16. The remainingadapter56 is intended to return the blood throughextension tube18 andlongitudinal lumen40 for delivery to the right atrium area.Clamps20 may be then mounted aboutextension tubes16,18 and assembled in the manner discussed hereinabove.Clamps20 may be manipulated between their respective first open and second closed positions as desired.
• Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, it is to be understood that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the disclosure.

Claims (38)

1. A medical catheter assembly, which comprises:

a catheter hub;

an elongate catheter member extending from the catheter hub and having at least one longitudinal lumen for passage of fluids;

an extension tube extending from the catheter hub and defining an internal lumen in fluid communication with the at least one longitudinal lumen of the catheter member; and

a clamp including first and second clamp sections and defining a longitudinal clamp axis, the clamp having a longitudinal opening for passage of the extension tube and a movable member adapted to move from a first position to a second position to substantially close the internal lumen, the first and second clamp sections being separable to facilitate positioning of the extension tube within the longitudinal opening.

2. The medical catheter assembly according toclaim 1 wherein the first and second clamp sections are releasably mounted to each other along the longitudinal clamp axis to facilitate lateral positioning of the extension tube within the longitudinal opening of the clamp.

3. The medical catheter assembly according toclaim 2 wherein the first and second clamp sections include a pin and corresponding slot mechanism for effecting releasable mounting of the first and second clamp sections.

4. The medical catheter assembly according toclaim 1 wherein the clamp includes a clamp base defining the longitudinal opening and having the movable member mounted thereto.

5. The medical catheter assembly according toclaim 4 wherein the movable member is pivotally mounted to the clamp base and is adapted to pivot relative to clamp base between the first and second positions thereof.

6. The medical catheter assembly according toclaim 5 including means for releasably securing the movable member in the second position.

7. The medical catheter assembly according toclaim 5 wherein the clamp base includes an internal locking shelf dimensioned to engage the movable member to secure the movable member in the second position.

8. The medical catheter assembly according toclaim 1 wherein the first and second clamp sections are connected by a tether.

9. The medical catheter assembly according toclaim 1 including first and second extension tubes connectable to the catheter hub.

10. The medical catheter apparatus according toclaim 9 wherein the catheter hub defines first and second extension conduits for respectively receiving the first and second extension tubes.

11. The medical apparatus according toclaim 10 wherein the first and second extension conduits are arranged in side by side relation.

12. The medical apparatus according toclaim 11 wherein the first extension conduit is arranged about an axis in substantial parallel relation with a longitudinal hub axis of the catheter hub.

13. The medical apparatus according toclaim 12 wherein the second extension conduit is arranged about an axis in oblique relation with the longitudinal hub axis of the catheter hub.

14. The medical apparatus according toclaim 10 including first and second adapters mounted to each of the first and second extension tubes.

15. The medical apparatus according toclaim 14 wherein the first extension tube and the first adapter define a first effective length which is substantially less than a corresponding second effective length of the second extension tube and the second adapter.

16. The medical apparatus according toclaim 15 wherein the first effective length is less than a length of the second extension tube to permit the first extension tube and the first adapter to be positioned in adjacent side by side relation with respect to the second extension tube thereby reducing the profile thereof.

17. The medical apparatus according toclaim 1 wherein the catheter hub defines a pair of suture wing holes for receiving a suture utilized in securing the catheter hub.

18. The medical apparatus according toclaim 1 wherein the catheter hub defines an outer groove dimensioned for accommodating a suture utilized in securing the catheter hub.

19. A low profile catheter hub for an elongate dual lumen catheter, which comprises:

a catheter hub member adapted for connection to a dual lumen catheter, the catheter hub member defining a longitudinal hub axis and having first and second conduits therein adapted for fluid connection to respective fluid supply and/or withdrawal tubing, the first fluid conduit being arranged about a first axis extending in substantial parallel relation with the longitudinal hub axis, the second fluid conduit being arranged about a second axis in oblique relation with the longitudinal axis.

20. A surgical clamp for closing compressible medical tubing, which comprises:

a clamp member defining a longitudinal clamp axis, the clamp member including first and second clamp sections and having a longitudinal opening for passage of a compressible tubing, the clamp member including a movable member adapted to move from a first position to a second position to substantially close a lumen of the compressible tubing, the first and second clamp sections being releasably mountable to each other whereby the first and second clamp sections may be separable generally along the longitudinal clamp axis to permit access to the longitudinal opening to facilitate positioning of the compressible tubing within the longitudinal opening.

21. The clamp according toclaim 20 wherein the first and second clamp sections include a pin and corresponding slot mechanism for providing a releasable mounting of the first and second clamp sections.

22. The clamp according toclaim 21 wherein the clamp member includes a clamp base defining the longitudinal opening and having the movable member pivotally mounted thereto, the movable member being adapted to pivot relative to the clamp base between the first and second positions thereof.

23. The clamp according toclaim 22 wherein the clamp base includes an internal locking shelf dimensioned to engage the movable member to secure the movable member in the second position.

24. The clamp according toclaim 20 wherein the first and second clamp portions are connected by a tether.

25. A surgical clamp for closing compressible medical tubing, which comprises:

a clamp member defining a longitudinal clamp axis, the clamp member including a clamp base defining a generally longitudinal opening for passage of a compressible tubing and a movable member, the clamp base having a first lateral opening in communication with the longitudinal opening to permit the compressible tubing to be positioned within the longitudinal opening from one lateral side of the clamp member and a second lateral opening in communication with the longitudinal opening to permit the compressible tubing to be positioned within the longitudinal opening from the other lateral side of the clamp member, the movable member adapted to move from a first position to a second position to substantially close a lumen of the compressible tubing.

26. The surgical clamp according toclaim 25 wherein portions of the clamp base defining the first and second lateral openings are dimensioned to substantially retain the compressible tubing within the longitudinal opening upon positioning of the compressible tubing therein.

27. A method for performing a surgical procedure, comprising the steps of:

providing a catheter including a catheter hub and an elongated catheter extending from the housing, the elongated catheter having at least one longitudinal lumen for passage of fluids;

accessing an underlying tissue site through an opening in the skin of a patient;

advancing a distal end of the elongated catheter through the tissue site and into the patient;

creating a surgical tunnel from the tissue site and out through a second opening in the skin remote from the first opening;

passing the catheter through the surgical tunnel by introducing the catheter hub through the first opening and advancing the catheter hub with the elongated catheter following there along within the surgical tunnel; and

fluidly coupling the at least one longitudinal lumen of the catheter with an external fluid source.

28. The method according toclaim 27 wherein the step of creating includes introducing a tunneler instrument and passing the tunneler between the tissue site and the second opening.

29. The method according toclaim 28 including the step of operatively connecting the catheter hub with the tunneler instrument and wherein the step of passing the catheter includes advancing the tunneler through the surgical tunnel to cause corresponding advancement of the catheter hub through the surgical tunnel.

30. The method according toclaim 29 wherein the catheter includes an extension tube extending proximally from the catheter hub and wherein the step of operatively connecting the catheter hub includes the step of coupling the extension tube with the tunneler instrument.

31. The method according toclaim 30 wherein the extension tube includes a fluid connector and wherein the step of coupling the extension tube includes coupling the tunneler instrument with the fluid connector.

32. The method according toclaim 31 wherein the fluid connector of the extension tube and the tunneler instrument include cooperative coupling means and wherein, during the step of coupling the tunneler instrument with the fluid connector, the cooperative coupling means are coupled.

33. The method according toclaim 30 wherein the catheter includes first and second longitudinal lumens and wherein the step of fluidly coupling includes fluidly coupling each of the first and second longitudinal lumens with an external fluid source.

34. The method according toclaim 33 wherein the catheter includes first and second extension tubes extending proximally from the catheter hub and in fluid communication with the first and second longitudinal lumens and including the step of fluid coupling the first and second extension tubes with at external fluid source.

35. The method according toclaim 34 including the step of positioning a sheath at least partially about the fluid connector of the extension tube and the tunneler instrument.

36. The method according toclaim 29 wherein the step of passing the catheter includes at least partially exposing the catheter hub through the second opening.

37. The method according toclaim 36 wherein the step of passing includes at least partially removing the catheter hub from the surgical tunnel through the second opening.

38. The method according toclaim 36 wherein the catheter includes an extension tube extending proximally from the catheter hub and including the step of mounting a clamp about the extension tube, the clamp adapted to move from a first position to a second position to substantially close a lumen of the extension tube.

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