U.S. patent application number 11/528913 was filed with the patent office on 2008-04-03 for low profile catheter assembly.
This patent application is currently assigned to Tyco Healthcare Group LP. Invention is credited to Richard Braga, Robert Frechette, Brett Haarala.
Application Number | 20080082079 11/528913 |
Document ID | / |
Family ID | 38739917 |
Filed Date | 2008-04-03 |
United States Patent
Application |
20080082079 |
Kind Code |
A1 |
Braga; Richard ; et
al. |
April 3, 2008 |
Low profile catheter assembly
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.
Inventors: |
Braga; Richard; (Taunton,
MA) ; Frechette; Robert; (Lakeville, MA) ;
Haarala; Brett; (Framingham, MA) |
Correspondence
Address: |
Kendall (CDFS)
445 BROAD HOLLOW ROAD, SUITE 225
MELVILLE
NY
11704
US
|
Assignee: |
Tyco Healthcare Group LP
|
Family ID: |
38739917 |
Appl. No.: |
11/528913 |
Filed: |
September 28, 2006 |
Current U.S.
Class: |
604/523 |
Current CPC
Class: |
A61M 39/284 20130101;
A61M 25/0026 20130101; A61M 1/3653 20130101; A61M 1/3659 20140204;
A61M 25/00 20130101; A61M 25/0097 20130101 |
Class at
Publication: |
604/523 |
International
Class: |
A61M 25/00 20060101
A61M025/00 |
Claims
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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 5 including
means for releasably securing the movable member in the second
position.
7. The medical catheter assembly according to claim 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 to claim 1 wherein the
first and second clamp sections are connected by a tether.
9. The medical catheter assembly according to claim 1 including
first and second extension tubes connectable to the catheter
hub.
10. The medical catheter apparatus according to claim 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 to claim 10 wherein the first
and second extension conduits are arranged in side by side
relation.
12. The medical apparatus according to claim 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 to claim 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 to claim 10 including first and
second adapters mounted to each of the first and second extension
tubes.
15. The medical apparatus according to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 29 wherein the step of passing
the catheter includes at least partially exposing the catheter hub
through the second opening.
37. The method according to claim 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 to claim 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.
Description
BACKGROUND
[0001] 1. Technical Field
[0002] 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.
[0003] 2. Description of the Related Art
[0004] 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.
[0005] 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
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] A method for performing a surgical procedure is also
disclosed. The method includes the steps of:
[0014] 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;
[0015] accessing an underlying tissue site through an opening in
the skin of a patient;
[0016] advancing a distal end of the elongated catheter through the
tissue site and into the patient;
[0017] creating a surgical tunnel from the tissue site and out
through a second opening in the skin remote from the first
opening;
[0018] 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
[0019] fluidly coupling the at least one longitudinal lumen of the
catheter with an external fluid source.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Preferred embodiments of the disclosure will be better
understood with reference to the accompanying drawings wherein:
[0021] FIG. 1 is a perspective view of the low-profile catheter of
the system in accordance with the principles of the present
disclosure;
[0022] FIG. 2 is a perspective view with parts separated
illustrating the components of the low-profile catheter of FIG.
1;
[0023] FIG. 3 is a side cross-sectional view of the low-profile
catheter;
[0024] FIG. 4 is a perspective view of an alternate embodiment of
the catheter hub of the low profile catheter;
[0025] FIGS. 5-6 are perspective views illustrating the leading end
of the low profile catheter;
[0026] FIG. 7 is a side plan view of the leading end of the low
profile catheter system taken along the lines 7-7 of FIG. 1;
[0027] FIG. 8 is a cross-sectional view of the low profile catheter
taken along the lines 8-8 of FIG. 1;
[0028] FIG. 9 is a perspective view of the clamp of the low-profile
catheter;
[0029] FIGS. 9A-9B are each perspective views illustrating the
clamp of FIG. 9 in a non-assembled condition;
[0030] FIG. 9C is a view of an area of detail identified in FIG. 3
illustrating the clamp positioned about the extension tube and in a
first open position;
[0031] FIG. 9D is a view similar to the view of FIG. 9C
illustrating the clamp in a second closed position;
[0032] FIGS. 10A and 10B are perspective views of alternate
embodiments of the clamp;
[0033] FIG. 11 is a side plan view of the low profile catheter with
the clamps removed;
[0034] FIG. 12 is a side plan view similar to the view of FIG. 11
with the extension tubes twisted prior to insertion within the
surgical site;
[0035] FIG. 13 is a side plan view illustrating a tunneling
instrument and the extension tube adapter;
[0036] 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
[0037] FIG. 15 is a perspective view illustrating an embodiment of
the sheath of FIG. 14;
[0038] 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
[0039] 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
[0040] 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.
[0041] 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.
[0042] 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.
[0043] 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, the hemodialysis
catheter 10 in accordance with the principles of the system of the
present disclosure. Catheter 10 includes several components
assembled together, namely, catheter hub or housing 12, elongated
catheter member 14 extending distally from the catheter hub 12 and
first and second extension tubes 16, 18 extending proximally from
the catheter hub 12. Catheter system 10 further includes a pair of
clamps 20 which are mountable about each of extension tubes 16,
18.
[0044] With reference now to FIGS. 1-3, catheter hub 12 is
advantageously dimensioned for engagement by the clinician.
Moreover, catheter hub 12 defines a reduced profile particularly
when viewed along the longitudinal housing axis "k" (FIG. 2) of the
catheter hub 12. Housing axis "k" is in general alignment with axis
"m" of catheter member 16. Catheter hub 12 includes proximal or
trailing housing section 22 adjacent extension tubes 16, 18 and
distal or leading housing section 24 adjacent catheter member 16.
As best depicted in FIG. 3, proximal housing section 22 defines
first and second internal extension conduits 26, 28 extending along
the housing axis "k" and separated by septum wall 30 of catheter
hub 12. First extension conduit 26 is in general parallel relation
with the housing axis "k". Second extension conduit 28 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
of first extension conduit 16 coupled with the slight oblique
arrangement of second extension conduit 28 significantly reduces
the profile of catheter hub 12 particularly compared to
conventional catheter hub designs which employ a v-or t-shaped
shaped conduit connection areas.
[0045] First and second extension conduits 26, 28 are adapted to
receive respective first and second extension tubes 16, 18 in
secured relation therewith. In one preferred embodiment, extension
tubes 16, 18 are secured within the respective extension conduits
26, 28 via an interference or frictional fit. It is also envisioned
that cements or adhesives may be utilized to secure extension tubes
16, 18 within their respective extension conduits 26, 28. Distal or
leading housing section 24 of catheter hub 12 defines central
opening 32 which receives catheter member 14. Catheter member 14
may be secured within central opening 32 of distal housing section
24 via an interference or frictional fit, and, possibly
supplemented with cements and adhesives or the like.
[0046] Catheter hub 12 may further include a pair of opposed suture
wings 34 along its outer surface. Suture wings 34 define openings
36 dimensioned for receiving sutures which may be utilized in
securing catheter hub 20 relative to the subject. In an alternative
embodiment depicted in FIG. 4, catheter hub 20 may have an annular
groove 36a in its outer wall in lieu of suture wings 34. A suture
may be wrapped within annular groove 36a and subsequently secured
relative to the subject.
[0047] Referring now to FIGS. 5-8, in conjunction with FIG. 3,
elongated catheter member 16 will be discussed. Catheter member 16
is preferably a dual lumen catheter having first and second
longitudinal lumens 38,40 separated by a septum wall 42 which
extends the length the catheter member 16 (FIG. 3). Each of the
first and second longitudinal lumens 38, 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 wall 42 of
catheter member 16 preferably abuts septum wall 30 of catheter hub
20 in the assembled condition of the components. Thus, with this
arrangement, low profile catheter 10 defines a dual lumen catheter,
inclusive of a first lumen including extension conduit 26 and first
longitudinal lumen 38 of catheter member 14, and a second lumen
inclusive of extension conduit 28 and second longitudinal lumen 40.
Single or triple lumen catheters are also envisioned.
[0048] With particular reference to FIGS. 5-7, leading or distal
end 44 of catheter member 16 will be discussed. The arrangement of
catheter distal end 44 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 end 44 of catheter
member 16 includes a pair of opposed openings 46,48 arranged in its
outer wall in diametrical relation and in fluid communication with
respective first and second longitudinal lumens 38,40. Each opening
46,48 is characterized by having an arcuate recessed wall surface
50 to define a partial generally arcuate opening as shown. Openings
46,48 are symmetrically arranged about the longitudinal axis "m" of
catheter member 14. Preferably, septum wall 42 of catheter member
16 extends distally beyond catheter member 16. Catheter member 16
further includes a pair of polygonal or parallelepiped openings 52
in fluid communication with first and second longitudinal lumens
38, 40 and openings 46, 48. Openings 52 are disposed proximal of
openings 46, 48 as shown. Openings 46,48 and proximal openings 52
permit passage of fluids during the surgical procedure. Further
details regarding distal end 44 of catheter member 16 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.
[0049] Catheter member 16 is preferably flexible and may be formed
by conventional injection molding or extrusion means. The wall of
catheter member 16 may include reinforcing material if desired.
Catheter member 16 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 member 16 may be devoid of any normally
curved orientation.
[0050] Referring again to FIGS. 1-3, catheter member 16 may further
include at least one cuff 54 on its outer surface. Cuff 54 may
include a fabric material and functions to be a site for tissue
ingrowth for long term securing of catheter 10 in an indwelling
position. For example, cuff 54 may reside in the tunnel formed
during the tunneling procedure. More than one cuff 54 may also be
provided. Catheter member 16 may also include radiopaque markings
or strips to facilitate the location of catheter within the body
with a fluoroscope.
[0051] First and second extension tubes 16,18 may be any suitable
tubing adapted to supply or withdrawal fluid to or from a body
vessel. First and second extension tubes 16,18 preferably include a
compressible material whereby the tubes 16,18 may be selectively
compressed via clamps 20 to substantially close the opening within
the tubes 16,18. The free or trailing ends of extension tubes 16,18
remote from catheter hub 12 have adapters 56 mounted thereto.
Adapters 56 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 or cam 58 for securing to a fluid source. Adapters
56 may be secured to extension tubes 16,18 by any of the
aforementioned means including friction or tolerance fit,
adhesives, cements, or the like.
As best depicted in FIGS. 1-2, adapters 56 each include outer walls
having a pair of recessed surfaces 60. Recessed surfaces 60 are
ergonomically designed to be engaged by the clinician thereby
facilitating manipulation of the catheter 10 about the operative
site.
[0052] First tube extension 16 may define a length which is less
than second tube extension 18. In one preferred embodiment, the
overall effective length of first extension tube 16 and its
attached adapter 56 is less than the corresponding overall
effective length of second extension tube 18 and its adapter 56. As
a further preference, the overall effective length of first
extension tube 16 and its adapter 56 is less than or equal to the
length of second extension tube 18. With this arrangement, first
extension tube 16 and its adapter 56 may be placed in juxtaposed or
side-by-side relation with the second extension tube 18 to
substantially reduce the profile presented by the first and second
extension tubes 16, 18. The significance of this feature will be
appreciated from the description provided hereinbelow. First and
second extension tubes 16,18 may define the same lengths if
desired.
[0053] Referring now to FIGS. 9-9D, in conjunction with FIG. 3,
clamps 20 will be discussed. Clamps 20 are mounted about first and
second extension tubes 16,18. Each clamp 20 is adapted to move from
a first open position in non compressive engagement with the
respective extension tube 16,18 (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. Each clamp 20 defines a
longitudinal clamp axis "t" and longitudinal opening or passage 62
for reception of extension tube 16,18. Longitudinal passage 62 is
inclusive of first and second openings 64,66 within opposed end
walls 68,70 of the clamp 20 and the central interior of the clamp
20.
[0054] Each clamp 20 includes two sections, namely, first clamp
section 20a and second clamp section 20b which is releasably
mountable to the first clamp section. In one preferred arrangement,
first clamp section 20a includes openings 72 in side wall 74.
Second clamp section 20b includes pins 76 extending in transverse
relation from side wall 78. Pins 76 are advantageously dimensioned
to be received in the openings 72 of first clamp section 20a in
snap relation therewith whereby, upon mounting of the second clamp
section 20b to the first clamp section 20a, the clamp 20 becomes a
single unit. Preferably, in use, the respective extension tube
16,18 is positioned through the cutaway portions 80,82 (FIG. 9A)
leading to respective openings 14,16 of the first clamp section
20a. Thereafter, second clamp section 20b is mounted to first clamp
section 20a as discussed hereinabove.
[0055] Clamp 20 further includes internal wedge surfaces 84,86
arranged in opposed relation as shown. Upon movement of clamp 20
from the first open position of FIG. 9C to the second closed
position of FIG. 9D, wedge surfaces 84,86 engage extension tube 16,
18 in a manner to close the opening within the extension tube 16,
18 to thereby prevent passage of fluid within the tube 16,18. Clamp
20 further includes a locking mechanism to secure clamp 20 in the
in the second closed position. The locking mechanism preferably
includes locking surface 88 disposed on the cantilevered section of
clamp 20 which engages locking ledge 90 to secure the clamp 20 in
the second closed position. In general, clamp 20 includes clamp
base 92 having wedge surface 86 and movable member 94 having wedge
surface 84 mounted via a pivoting, hinge, living hinge, or
cantilever arrangement to the clamp base 92. Movable member 94 is
adapted to move or pivot between the first open position and the
second closed position of FIGS. 9C, 9D respectively.
[0056] FIG. 10A illustrates an alternate embodiment of the clamp.
Clamp 20 is substantially similar to the clamp 20 described in
connection with FIGS. 9-9D. However, in accordance with this
embodiment, clamp 20 further includes tether 95 connected to clamp
sections 20a,20b. Tether 95 may be integrally connected to clamp
sections 20a,20b or monolithically formed with the clamp sections
20a,20b. Tether 95 functions to operatively couple clamp components
20a,20b to facilitate manipulation and/or connection of the clamp
components at the operative site.
[0057] FIG. 10B illustrates an alternate embodiment of clamp 20.
Clamp 96 is substantially similar to clamp 20 discussed
hereinabove, but is a single piece component. Clamp 96 further
defines cut away portions 97,99 on opposed lateral sides of clamp
96 in communication with openings 64,66 respectively. It is also
envisioned that cut away portions 97,99 may be on the same side of
clamp 96. Thus, clamp 96 may be mounted about an extension tube
16,18 by passing the tube between movable member 94 and base member
92 through spacing 98 with clamp 96 in the open position of FIG.
10B. Sections of the respective tubing 16,18 may be passed through
cut away portions 97,99 for reception within openings 64, 66. In
one embodiment, portions 97a,99a of clamp base 92 defining
respective cut away portions 97,99 are relatively narrow adjacent
one lateral side to facilitate retention of the tube upon
positioning of the tube within longitudinal passage 62 of clamp 20.
Clamp 96 functions substantially in a similar manner to that
described in connection with clamp 20.
[0058] The components of catheter 10 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 of
catheter 10 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.
[0059] Catheter 10 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, catheter 10 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.
[0060] With initial reference to FIG. 11, extension tubes 16,18
with clamps 20 removed are placed in juxtaposed side by side
relation as shown. As indicated hereinabove, the effective length
of extension tube 16 and its adapter 56 is substantially equal to
or less than the length of extension tube 18 such that the tubes
16,18 may be placed in side by side relation as shown in FIG. 11.
Thereafter, extension tubes 16,18 may be optionally twisted onto
each other to the configuration of FIG. 12. The twisting of
extension tubes 16,18 serves to effectively secure the extension
tubes 16,18 to each other thereby minimizing radial movement of the
extensions tubes 16,18 during passage through the subcutaneous
tunnel. In addition, with the extension tubes 16,18 secured, a
tunneling or trocar instrument may be attached to a leading adapter
56 to facilitate passage of both extension tubes 16, 18 through the
created tunnel.
[0061] With reference to FIG. 13, a tunneling or trocar instrument
100 is operatively connected to the proximal or free ends of
extension tubes 16,18 to effectively couple the tunneling
instrument to catheter 10. In one preferred embodiment, tunneling
instrument 100 includes mounting means in the form of, e.g., an
internal threaded or cam lock 102, which cooperates with
corresponding external thread 58 of adapter 56 to secure the
tunneling instrument 100 to catheter 10. As a further alternative,
a flexible sheath 200 may be positioned around the juncture or
connection area of tunneling instrument 100 and adapter 56,
preferably encompassing both adapters 56 as shown in FIG. 14.
Sheath 200 facilitates passage of tunneling instrument 100 and
catheter 10 through the subcutaneous tunnel by providing a smooth
and flexible outer member which may readily traverse the created
subcutaneous tunnel. Sheath 200 is preferably flexible and elastic
to stretch and tightly fit over the components. FIG. 15 illustrates
sheath 200 and with various features, for example, extension tab
202 which may be readily grasped to draw the sheath 200 back onto
extension tube 16,18 once exposed from the tunnel. Slits or notches
204 in the sheath 200 are also envisioned. A tear away capability,
for example along perforated or score line 206 may also be
incorporated with sheath 200.
[0062] The use of system 10 will now be discussed in terms of a
back end or reversed tunneling procedure in connection with
hemodialysis treatment. In this regard low profile catheter 10
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 of catheter 10 through the right jugular
vein for positioning of within the right atrium. As appreciated,
catheter 10 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.
[0063] Referring now to FIG. 16, an incision or entry opening 500
is made adjacent the midclavicular line, through the skin and the
subcutaneous tissue. The internal jugular vein 502 is punctured
using known techniques and leading end 44 of catheter 10 in
inserted through the internal jugular vein 502, the superior vena
cavity 504 and into the right atrium 506. The positioning of
leading end 44 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 or entry opening area
500 downwardly to a lower chest area. A small exit opening 508 is
made at the base of the subcutaneous tunnel. Thereafter, tunneling
instrument 100 with attached catheter 10 and sheath 200 of FIG. 14
is maneuvered through the tunnel which correspondingly draws
adapters 56, extension tubes 16,18, catheter hub 12 and the
proximal end of elongated catheter member 14 through the tunnel
toward the exit opening 508 as shown in FIG. 17. As appreciated,
the narrow profile of catheter hub 12 facilitates passage of the
catheter hub 12 through the subcutaneous tunnel. Tunneling
instrument 100 is removed from adapter 56. With adapters 56,
extension tubes 16,18 and catheter hub 12 exposed from the exit
opening 508, sheath 200 may be pulled back onto itself or removed
to expose adapters 56 for connection to the appropriate fluid
supply lines. FIG. 18 illustrates sheath 200 in the process of
being pulled back on itself to expose adapters 56. As indicated
hereinabove, extension tab 202 or notches 204 may be employed to
facilitate this procedural step. Also, sheath 200 may be removed or
separated from the components along, e.g., score line 206.
[0064] In a hemodialysis application, one adapter 56 may be
connected to the hemodialysis machine to withdraw blood through,
e.g., longitudinal lumen 38 and extension tube 16. The remaining
adapter 56 is intended to return the blood through extension tube
18 and longitudinal lumen 40 for delivery to the right atrium area.
Clamps 20 may be then mounted about extension tubes 16,18 and
assembled in the manner discussed hereinabove. Clamps 20 may be
manipulated between their respective first open and second closed
positions as desired.
[0065] 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.
* * * * *