1. Technical Field
The present disclosure relates to a method for manufacturing a multi-lumen catheter and, more particularly, to a method for manufacturing a multi-lumen catheter having a separated tip section.
2. Background of Related Art
Catheters for supplying and/or withdrawing fluids into and/or from the body are well known in the art and may be employed for medication delivery, urine removal and blood treatment, e.g., hemodialysis, to name a few. Single and multilumen catheters are well known. Typically, catheters used for hemodialysis are multilumen catheters and include a body which defines an arterial lumen and a venous lumen. During an exemplary hemodialysis procedure, a distal portion of a multilumen catheter is inserted into a patient and blood is withdrawn through the arterial lumen of the catheter. The withdrawn blood is supplied to a hemodialysis unit which purifies the blood by removing waste and toxins from the blood. Thereafter, the purified blood is returned to the patient through the venous lumen of the catheter.
One problem associated with multilumen dialysis catheters is the potential for recirculation of blood from the distal end of the venous lumen through the distal end of the arterial lumen. In an effort to minimize blood recirculation, catheters have been developed in which the arterial lumen and the venous lumen openings are laterally spaced. These catheters minimize blood recirculation by distancing the arterial lumen distal opening from the venous lumen distal opening.
Catheters can be manufactured using a variety of different techniques including, for example, thermoforming, extrusion, blow molding, rotational molding and injection molding. However, the manufacturing of dual lumen catheters with laterally spaced or separated tip sections complicates known catheter manufacturing processes.
Accordingly, a continuing need exists in the medical arts for a simpler, cost effective method for manufacturing a catheter having a separated tip section.
This disclosure relates to a method of manufacturing a multilumen catheter having a separate tip section. In one embodiment, the method comprises the following steps:
i) forming a dual lumen catheter body having a proximal end and a distal end and defining a first lumen and a second lumen, the dual lumen catheter body defining a first longitudinal axis;
ii) forming a first distal tip member defining a first distal lumen portion; and
iii) assembling the first distal tip member to the distal end of the catheter portion such that the first distal lumen portion is in fluid communication with the first lumen.
In one embodiment, the assembling step includes using adhesives to secure the first distal tip member to the distal end of the dual lumen catheter body. Alternatively, the assembling step includes using heat to secure the first distal tip member to the distal end of the dual lumen catheter body.
In one embodiment, the first distal tip member defines a second longitudinal axis and the assembling step includes positioning the second longitudinal axis of the distal tip member at an angle β in relation to the first longitudinal axis of the dual lumen catheter body. Angle β is greater than 0 degrees and may be about 5 degrees or greater. Alternatively, angle β may be about 10 degrees or greater.
In another embodiment, the method further includes the following steps:
iv) forming a second distal tip member defining a second distal lumen portion; and
v) assembling the second distal tip member to the distal end of the catheter portion such that the second distal lumen portion is in fluid communication with the second lumen of the dual lumen catheter body.
As discussed above, the assembling steps may include using adhesives or heat to secure the first and second distal tip members to the distal end of the dual lumen catheter body.
In one embodiment, the first distal tip member defines a second longitudinal axis and the second distal tip member defines a third longitudinal axis, and the assembling steps include securing the first and second distal tip members to the dual lumen catheter body such that the second longitudinal axis is disposed at an angle β to the third longitudinal axis. The angle β may be about 5 degrees or greater. Alternatively, the angle β, may be about 10 degrees or greater.
In another embodiment, the second longitudinal axis is substantially parallel to the first longitudinal axis. Alternatively, the second and the third longitudinal axes are both disposed at an angle in relation to the first longitudinal axis.
Various embodiments of the presently disclosed method for manufacturing a multilumen catheter having a separated tip configuration are disclosed herein with reference to the drawings, wherein:
Embodiments of the presently disclosed method of manufacturing split-tip multilumen catheters will now be described in detail with reference to the drawings wherein like reference numerals designate identical or corresponding elements in each of the several views.
The exemplary embodiments of the catheter disclosed herein 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.
Each tip member 20a and 20b defines a tip lumen 28 and 30, respectively, which has an open distal end 28a and 30a, respectively. Lumen 28 of tip member 20a is in fluid communication with lumen 14a (
As illustrated in
In an alternative embodiment of the presently disclosed method shown in
Referring to
As illustrated in
Referring again to
Although specific features of the disclosure are shown in some drawings and not in others, this is for convenience only as each feature may be combined with any or all of the other features in accordance with the disclosure.
It will be understood that various modifications may be made to the embodiments disclosed herein. For example, the various manufacturing processes disclosed to manufacture dual lumen catheters with expandable lumens may also be used to form a single lumen catheter with an expandable lumen where applicable. Therefore, the above description should not be construed as limiting, but merely as exemplifications of embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
This application is a continuation of U.S. patent application Ser. No. 12/835,170, filed Jul. 13, 2010, now U.S. Pat. No. 8,394,218, which claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 61/226,881, filed on Jul. 20, 2009. Each of these applications is incorporated herein by reference in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
4309994 | Grunwald | Jan 1982 | A |
4619643 | Bai | Oct 1986 | A |
4636272 | Riggs | Jan 1987 | A |
4925452 | Melinyshyn et al. | May 1990 | A |
5197976 | Herweck et al. | Mar 1993 | A |
5254084 | Geary | Oct 1993 | A |
5273534 | Knoepfler | Dec 1993 | A |
5476453 | Mehta | Dec 1995 | A |
5599304 | Shaari | Feb 1997 | A |
5624413 | Markel et al. | Apr 1997 | A |
5695457 | St. Goar et al. | Dec 1997 | A |
5704915 | Melsky et al. | Jan 1998 | A |
5718692 | Schon et al. | Feb 1998 | A |
5776111 | Tesio | Jul 1998 | A |
5800414 | Cazal | Sep 1998 | A |
5807311 | Palestrant | Sep 1998 | A |
5947953 | Ash et al. | Sep 1999 | A |
5957912 | Heitzmann | Sep 1999 | A |
5964796 | Imran | Oct 1999 | A |
6001079 | Pourchez | Dec 1999 | A |
6074374 | Fulton | Jun 2000 | A |
6117117 | Mauch | Sep 2000 | A |
6156016 | Maginot | Dec 2000 | A |
6190349 | Ash et al. | Feb 2001 | B1 |
6475207 | Maginot et al. | Nov 2002 | B1 |
6482169 | Kuhle | Nov 2002 | B1 |
6513527 | Abdel-Aziz | Feb 2003 | B1 |
6558356 | Barbut | May 2003 | B2 |
6585705 | Maginot et al. | Jul 2003 | B1 |
6638242 | Wilson et al. | Oct 2003 | B2 |
6682519 | Schon | Jan 2004 | B1 |
6695832 | Schon et al. | Feb 2004 | B2 |
6719749 | Schweikert et al. | Apr 2004 | B1 |
6723084 | Maginot et al. | Apr 2004 | B1 |
6743218 | Maginot et al. | Jun 2004 | B2 |
6758836 | Zawacki | Jul 2004 | B2 |
6872198 | Wilson et al. | Mar 2005 | B1 |
6881211 | Schweikert et al. | Apr 2005 | B2 |
6913601 | St. Goar et al. | Jul 2005 | B2 |
6916313 | Cunningham | Jul 2005 | B2 |
6921396 | Wilson et al. | Jul 2005 | B1 |
6966886 | Appling | Nov 2005 | B2 |
6997894 | Caresio | Feb 2006 | B2 |
7008412 | Maginot | Mar 2006 | B2 |
7013928 | Navis | Mar 2006 | B2 |
7018374 | Schon et al. | Mar 2006 | B2 |
RE39451 | Kuhle | Dec 2006 | E |
D550839 | Zawacki et al. | Sep 2007 | S |
7300430 | Wilson et al. | Nov 2007 | B2 |
7347852 | Hobbs et al. | Mar 2008 | B2 |
7381204 | Wilson et al. | Jun 2008 | B2 |
7393339 | Zawacki et al. | Jul 2008 | B2 |
8394218 | Sansoucy | Mar 2013 | B2 |
20020099326 | Wilson et al. | Jul 2002 | A1 |
20020133112 | Navis | Sep 2002 | A1 |
20030032918 | Quinn | Feb 2003 | A1 |
20030088213 | Schweikert et al. | May 2003 | A1 |
20030153898 | Schon et al. | Aug 2003 | A1 |
20040059314 | Schon et al. | Mar 2004 | A1 |
20040092863 | Raulerson et al. | May 2004 | A1 |
20040171997 | Wilson et al. | Sep 2004 | A1 |
20040172003 | Wilson et al. | Sep 2004 | A1 |
20040210187 | Zawacki | Oct 2004 | A1 |
20040243095 | Nimkar et al. | Dec 2004 | A1 |
20050054990 | Graft et al. | Mar 2005 | A1 |
20050059925 | Maginot et al. | Mar 2005 | A1 |
20050090844 | Patel et al. | Apr 2005 | A1 |
20050096585 | Schon et al. | May 2005 | A1 |
20050171469 | Cunningham | Aug 2005 | A1 |
20050187535 | Wilson et al. | Aug 2005 | A1 |
20050197624 | Goodson, IV et al. | Sep 2005 | A1 |
20050277862 | Anand | Dec 2005 | A1 |
20050283111 | Maurice | Dec 2005 | A1 |
20070005003 | Patterson et al. | Jan 2007 | A1 |
20070060866 | Raulerson et al. | Mar 2007 | A1 |
20070078438 | Okada | Apr 2007 | A1 |
20070106206 | Appling | May 2007 | A1 |
20070233042 | Moehle et al. | Oct 2007 | A1 |
20080009803 | Schon et al. | Jan 2008 | A1 |
20080009832 | Barron et al. | Jan 2008 | A1 |
20080021417 | Zawacki et al. | Jan 2008 | A1 |
20080033350 | Wilson et al. | Feb 2008 | A1 |
20080039774 | Zawacki et al. | Feb 2008 | A1 |
20080045886 | Hobbs et al. | Feb 2008 | A1 |
20080214980 | Anand | Sep 2008 | A1 |
20090143767 | Fentress et al. | Jun 2009 | A1 |
20090204052 | Nimkar et al. | Aug 2009 | A1 |
20090209940 | Nimkar et al. | Aug 2009 | A1 |
Number | Date | Country |
---|---|---|
WO 0132240 | May 2001 | WO |
WO 2009051967 | Apr 2009 | WO |
WO 2009051969 | Apr 2009 | WO |
Entry |
---|
European Search Report in corresponding European Application No. 10 16 9954 dated Oct. 27, 2010. |
Mexican Office Action dated Apr. 15, 2013 in copending Mexican Application No. MX/a/2010/007885. |
Number | Date | Country | |
---|---|---|---|
20140027041 A1 | Jan 2014 | US |
Number | Date | Country | |
---|---|---|---|
61226881 | Jul 2009 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 12835170 | Jul 2010 | US |
Child | 13750055 | US |