US20080103476A1 - Medical tubing connector assembly incorporating strain relief sleeve - Google Patents

Abstract

A connector assembly for interconnecting separate sections of tubing, e.g., medical tubing. Connector assemblies are, in one embodiment, a two-piece construction having a connector pin and a connector sleeve. An exemplary connector sleeve includes a first end, a second end, and a passageway extending between the first and second ends. The passageway, in one embodiment, is stepped, e.g., defined by both a bore of a first diameter and a bore of a second diameter.

Description

TECHNICAL FIELD
• The present invention relates generally to medical devices and, more particularly, to connector assemblies for joining two pieces of medical tubing, e.g., catheters, wherein the connector assemblies are operable to provide strain relief to the catheter connection.
BACKGROUND
• In many medical applications, it is necessary to connect one section of medical tubing, e.g., a catheter, with another. Generally speaking, it is important that these connections be relatively secure and stable so that the tubing does not separate or develop leaks at the connection point. Security and leak-resistance take on special importance in applications where the tubing sections are implanted in a human body.
• One procedure that necessitates implantation of medical tubing into the body involves the use of an implantable drug infusion pump. Such pumps are often used to control pain and/or spasticity, as well as to provide one or more drugs or fluid medications to a particular location within the body. For instance, a typical implant procedure may involve implanting a drug infusion pump into a cavity or subcutaneous pocket in the body and delivering a drug, via a catheter(s), to an epidural space or intrathecal space of the spinal column or to a particular location within the brain. In this exemplary application, a catheter assembly having two or more catheter sections, e.g., a thin-walled distal section (near the implantation site) and a thicker-walled proximal section (connected directly to the infusion pump), may be used to deliver the drug to the desired site.
• The distal catheter section may be positioned in the desired location in the body and then connected to the proximal catheter section by use of a medical tubing connector. The connection may be made by inserting one end or prong of the connector into a lumen of one catheter section (e.g., the proximal section) and the other end of the connector into the lumen of the other catheter section (e.g., the distal section) and then sliding both catheter sections towards one another (toward the middle of the connector). The proximal section may then be connected to the drug infusion pump.
• While adequate, difficulties have been encountered in the manufacture and use of such prior art medical connectors. For example, these connectors, which have been sized to fit within the lumens of the catheter tubing sections, are small and may be difficult to manipulate during implantation. Moreover, because some of these connectors fit entirely within the lumens of the respective catheter sections, it is often difficult for the implanting physician to be sure that the interface between catheter sections is positioned at, or even near, the center of the connector, i.e., it may be difficult to center the catheter sections on the connector. Misalignment of the connector can result in a weakened connection that is more likely to separate and/or develop leaks. Other potential problems include: lack of ability to adequately secure the catheters relative to one another; and inability to provide sufficient strain relief to the connection.
SUMMARY OF THE INVENTION
• Embodiments of the present invention provide connector assemblies and methods for connecting sections of medical tubing that may overcome some or all of the problems identified above. For example, in one embodiment, a connector assembly is provided having a connector pin. The connector pin includes: a first end portion, a second end portion, and a lumen extending between the first end portion and the second end portion; and a central portion located between the first end portion and the second end portion, wherein the central portion has an outer dimension that is larger than an outer dimension of both the first and second end portions. The assembly also includes a tubular connector sleeve comprising a first end, a second end, and a passageway extending between the first end and the second end. The passageway is stepped such that it has: a first diameter between the first end of the sleeve and a stop surface located in the passageway; and a second diameter between the stop surface and the second end of the sleeve, wherein the first diameter is greater than the second diameter.
• In another embodiment, a method of interconnecting sections of medical tubing is provided, wherein the method includes inserting a first end portion of a connector pin into a first medical tube. The connector pin includes: a second end portion, wherein a lumen extends between the first end portion and the second end portion; and a central portion located between the first and second end portions, wherein the central portion includes an outer dimension that is greater than an outer dimension of either of the first and second end portions. The method also includes: inserting the second end portion into a second medical tube; sliding a tubular sleeve over the first and second medical tubes and the connector pin; and engaging a first lock portion located within a passageway of the sleeve with a second lock portion of the connector pin.
• The above summary is not intended to describe each embodiment or every implementation of the present invention. Rather, a more complete understanding of the invention will become apparent and appreciated by reference to the following Detailed Description of Exemplary Embodiments and claims in view of the accompanying figures of the drawing.
BRIEF DESCRIPTION OF THE VIEWS OF THE DRAWING
• The present invention will be further described with reference to the figures of the drawing, wherein:
• FIG. 1 is a perspective view of a connector assembly in accordance with one exemplary embodiment of the invention, the connector assembly for use with coupling separate sections of medical tubing, e.g., catheters;
• FIG. 2 is a cross-sectional view of the connector assembly ofFIG. 1;
• FIG. 3 is a perspective view of a connector pin in accordance with one embodiment of the present invention;
• FIG. 4 is a perspective view of a connector pin in accordance with another embodiment of the present invention;
• FIG. 5 in a perspective view of a tubular connector sleeve in accordance with one embodiment of the invention;
• FIGS. 6-7 illustrate an exemplary method for assembling the connector assembly ofFIGS. 1 and 2; whereinFIG. 6 illustrates the connector pin during insertion into the tubular connector sleeve; andFIG. 7 illustrates the connector pin after complete insertion into the sleeve.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
• In the following detailed description of illustrative embodiments of the invention, reference is made to the accompanying figures of the drawing which form a part hereof, and in which are shown, by way of illustration, specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention. Unless stated otherwise herein, the figures of the drawing are rendered primarily for clarity and thus may not be drawn to scale.
• Generally speaking, the invention is directed to apparatus and methods for securely coupling two pieces of tubing to one another. While the invention may find application to most any type of tubing, it is especially well-suited to the joining of separate sections of medical tubing, e.g., catheters. For instance, connector assemblies in accordance with embodiments of the present invention may be used to couple a drug infusion catheter (extending from a drug infusion pump) to a brain infusion catheter located at a predetermined location within a human brain. Accordingly, while the following exemplary embodiments are described with reference to such infusion catheter couplings and methods, those of skill in the art will realize that the invention may find use with most any type of tubing application.
• FIGS. 1 and 2 illustrate a medicaltubing connector assembly50 in accordance with one embodiment of the invention. Theassembly50 may include a medical connector, e.g., connector pin100 (seeFIG. 2), and a strain relieving,tubular connector sleeve200. A first medical tubing section, e.g.,first catheter60, and a second tubing section, e.g.,second catheter70, may couple to theconnector pin100 as further described below. Once so coupled, thetubular sleeve200 may slide over theconnector pin100 and thecatheters60 and70 as shown, resulting in a secure and substantially leak-free coupling of the independent catheters.
• Moreover, as further explained below, theconnector assembly50 may provide strain relief for thecatheters60 and70. That is, thetubular connector sleeve200 may provide resistance to tearing of thecatheters60 and70 by the ends ofconnector pin100 and further resist forces that would tend to separate, or allow relative movement of, theconnector pin100 relative to thecatheters60 and70. Theconnector assembly50 may also include securing features, e.g.,suture grooves202 on an exterior surface of thesleeve200, to permit securing thesleeve200 over theconnector pin100 and for fixing of the assembly relative tolocal tissue82, e.g., with asuture80.
• FIG. 2 illustrates a cross section of theconnector assembly50. In this view, theconnector pin100 is illustrated as a generally longitudinal member having a first end portion102 (also shown inFIG. 3) operable to fit within alumen62 of thefirst catheter60 with a small clearance fit or, alternatively, an interference fit, and asecond end portion104 operable to fit within alumen72 of thesecond catheter70 with small clearance, or interference, fit. The fits between theconnector pin100 and thecatheters60 and70 may be sufficient to hold the catheters in place, relative to the connector pin, under normal operating circumstances.
• Theconnector pin100 may also include acentral portion106 positioned between thefirst end portion102 and thesecond end portion104. Thecentral portion106 has an outer or external dimension, e.g., adiameter108, that is preferably larger than at least one of: an outer or external dimension (e.g., a first diameter110) of thefirst end portion102; and an outer or external dimension (e.g., a second diameter112) of thesecond end portion104. Theconnector pin100 may also include alumen114 extending through the pin from thefirst end portion102 to thesecond end portion104. Thelumen114, in the illustrated embodiment, may pass completely through theconnector pin100 so as to permit fluid communication between thefirst catheter60 and thesecond catheter70.
• FIG. 3 is an enlarged perspective view of theexemplary connector pin100 ofFIG. 2. Theconnector pin100 may be made of most any biocompatable material including various metals and plastics, e.g., noble metals such as titanium. Moreover, theconnector pin100 may be an integral component or, alternatively, the enlargedcentral portion106 may be made of a secondary material which may, for example, be molded to a shaft formed by the first and second end portions. In the illustrated embodiments, thelumen114 may be generally concentric to the longitudinal axis of theconnector pin100.
• Theend portions102 and104 may extend a sufficient distance from thecentral portion106 to ensure adequate engagement with thecatheters60 and70. Moreover, while theend portions102 and104 may be most any shape, they are preferably cylindrical to correspond with the shape of the catheter lumens into which they are inserted. The enlargedcentral portion106 may also be of most any shape but is also preferably cylindrical to correspond to the shape of thetubular connector sleeve200 as further described below.
• In the embodiment illustrated inFIG. 3, enlargedcentral portion106 may include anouter surface116 bounded bystop surfaces118 and120, which are generally perpendicular to a longitudinal axis of theconnector pin100. The stop surfaces118 and120 may provide a positive stop against which the ends of thecatheters60 and70, respectively, abut when theconnector pin100 is inserted therein. By providing the stop surfaces118 and120, the physician may ensure that each catheter is properly engaged with theconnector pin100. Thestop surface120 may also assist the physician in locating thetubular connector sleeve200 relative to theconnector pin100 as further described below.
• Thecentral portion106 may further include a lock portion (a portion operable to positively lock with another component) operable to secure theconnector pin100 to thetubular connector sleeve200. In the illustrated embodiments, the lock portion may be formed by a recess, e.g., acircumferential lock groove122, formed in theouter surface116 of thecentral portion106. Thelock groove122 may engage a corresponding lock portion associated with thetubular connector sleeve200 as further described below.
• Analternative connector pin130 illustrated inFIG. 4 (which is similar in many respects to theconnector pin100 described above) may include endportions132 and134 that haveaxial tapers136 and138, respectively. Theaxial tapers136 and138 may assist in insertion of theend portions132 and134 into receiving ends of the medical tubing. Theend portions132 and134 may also include circumferentiallydepressed sections140 and142, respectively. The circumferentially depressedsections140 and142 may assist in securing the medical tubing to theend portions132 and134. That is, since medical tubing is typically made of a generally compliant material, the inner surface of the tubing (e.g.,catheters60 and70 ofFIG. 2) will generally comply with the surface of the end portions of theconnector pin130, including thedepressed sections140 and142. Other connector pin embodiments may be similar to those described in U.S. Pat. No. 5,405,339 to Kohnen et al.
• FIG. 5 illustrates the exemplarytubular connector sleeve200 ofFIGS. 1 and 2. Theconnector sleeve200 may be made of a flexible and resilient material operable to receive thecatheters60 and70 and theconnector pin100 therein. Once assembled, theconnector sleeve200 may provide not only secure coupling of the mating components, but also strain relief to the catheter ends.
• Theconnector sleeve200 may include apassageway208 extending from afirst end204 of the sleeve to asecond end206. In the illustrated embodiment, thepassageway208 is cylindrical and stepped. The step may be defined, for example, by providing afirst section209 of thepassageway208 extending from thefirst end204 of thesleeve200 to astop surface212 located within thepassageway208. Thepassageway208 may, in thefirst section209, have a first interfacing dimension, e.g., may be defined by afirst diameter210. Thepassageway208 may also include asecond section211 that extends from thestop surface212 to thesecond end206 of thesleeve200. Thesecond section211 may have a second interfacing dimension, e.g., may be defined by asecond diameter214. The first interfacing dimension of thepassageway208 may be greater than the second interfacing dimension, e.g., thefirst diameter210 may be greater than thesecond diameter214.
• As used herein, the term “diameter” may refer to the length of the longest straight line segment passing through the center of a cross-section of a respective object, e.g., thepassageway208, and terminating at the object periphery, e.g., at the walls of the passageway. Thus, the term “diameter” may be used to describe an effective diameter of any component of the present invention (e.g., sleeve, sleeve passageway, connector pin, lumen, and tubing section) whether it has a circular or non-circular cross-sectional shape, e.g., oval.
• While the shape of thepassageway208 is described and illustrated herein as including two generally uniform stepped bores, the actual shape of the passageway and, for that matter, the shape of theconnector sleeve200 itself, may be altered without departing from the scope of the invention.
• Thefirst section209 of thesleeve200 may be defined by aninner surface216. The inner surface orwall216 may include a lock portion, e.g., an inwardly extendingprotrusion218. Theprotrusion218 is preferably circumferential and operable to engage a mating lock portion, e.g., the lock groove122 (seeFIG. 3) of theconnector pin100, when the latter is correctly positioned within the connector sleeve (seeFIG. 2).
• Theconnector sleeve200 may also includesuture grooves202. In the illustrated embodiment, theconnector sleeve202 may include twoseparate suture grooves202 defined by outwardly extendingcircumferential protrusions203.
• The material used to make theconnector sleeve200 is preferably flexible and resilient. While various polymers are suitable, materials that achieve these objectives may include silicone and polyurethane. In other embodiments, thesleeve200 could be made of a less compliant, e.g., relatively rigid, material.
• Assembly of the connector assembly ofFIGS. 1 and 2 will now be described with reference toFIGS. 6 and 7. These figures are cross-sectional views of theexemplary connector assembly50 ofFIGS. 1 and 2 in various stages of assembly. The connector assembly is described herein with respect to a drug or fluid medication delivery system using an implanted drug pump (not shown) operable to deliver drugs to a location within the brain. As stated above, however, this application is not limiting.
• A catheterization procedure may begin with the placement of a distal catheter section (e.g., thecatheter70 ofFIG. 2). This section of catheter may be inserted in a manner known to those skilled in the art. Before, during, or after proper placement of the distal section of thecatheter70 has been verified, a subcutaneous pump pocket may be prepared at the desired anatomical location within a patient's body. A proximal catheter section, e.g.,catheter60 ofFIG. 2, may then be tunneled from the distal catheter section to the pump pocket. At this point in the procedure, the adjacent ends of the distal and proximal catheter sections, e.g., the coupling ends ofcatheters60 and70 that are shown in the Figures, may be connected using the connector assembly described herein.
• As represented inFIG. 6, theconnector sleeve200 may first be slid over the coupling end of thesecond catheter70. The sleeve may be slid sufficiently onto thesecond catheter70 to permit the physician unimpeded access to the coupling end of the second catheter. Thesecond end portion104 of the connector pin100 (in some embodiments, theconnector pin100 may be symmetrical such that thefirst end portion102 is identical to the second end portion) may be inserted into thelumen72 ofsecond catheter70. Thefirst end portion102 may be similarly inserted into thelumen62 of thefirst catheter60.
• Theend portions102 and104 of theconnector pin100 are preferably inserted into theirrespective catheter sections60 and70 until they contact the respective tubing stop surfaces118 and120. In practice, the implanting physician may effect the catheter connections by grasping the enlargedcentral portion106 of theconnector pin100.
• The outer diameter of eachend portion102 and104 may be slightly larger than the undeflected diameter of the lumens of therespective catheters60 and70. Alternatively, the outer diameters of theend portions102 and104 may be the same as, or slight less than, the diameters of the lumens of the respective catheters. The resulting fit between the components may result in not only secure connection of thecatheters60 and70, but may also provide substantially leak-free flow of fluid between the catheters.
• Once thecatheters60 and70 are coupled to theconnector pin100 as generally illustrated inFIG. 6, thetubular connector sleeve200 may be slid over theconnector pin100 in thedirection220 until thesecond stop surface120 of theconnector pin100 contacts thestop surface212 of theconnector sleeve200 as shown inFIG. 7. Prior to reaching the position illustrated inFIG. 7, thecircumferential protrusion218 of thesleeve200 may traverse thecentral portion106 of theconnector pin100 until theprotrusion218 reaches thelock groove122, whereby the protrusion engages the lock groove as shown inFIG. 7.
• The outer diameters of thecatheters60 and70 may be slightly larger than theundeflected diameters210 and214 of the connector sleeve200 (seeFIG. 5). Similarly, thediameter210 may be sized to receive thecentral portion106 of thepin connector100 therein as shown in the figures. In other embodiments, thediameters210 and214 may be the same as, or slightly larger than, the correspondingcatheters60 and70 and thecentral portions106. The resulting fit between the sleeve and thecatheters60 and70 andpin connector100 assists in securing the sleeve in place. Moreover, the abutting relationship of the stop surface120 (of the connector pin100) with the stop surface212 (of the connector sleeve200) provides means to ensure proper longitudinal positioning, e.g., self-location, of the sleeve relative to the pin. Still further, the engagement of theprotrusion218 of thesleeve200 with thegroove122 of theconnector pin100 provides positive feedback to the physician during connection and further prevents longitudinal separation, e.g., pulling apart, of thecatheters60 and70.
• While thestop surface212 is shown herein as being generally perpendicular to the axis of thesleeve200, other embodiments may provide other surface configurations. For example, a tapered surface may be used to form the stop surface.
• Once theconnector assembly50 has been assembled as shown inFIG. 7, it may be secured to surrounding tissue, e.g., sutured or ligated to scalp tissue, using thesuture grooves202. Preferably, asuture groove202 is located over each side of thecentral portion106, such that each catheter is effectively ligated by a suture.
• The size of medicaltubing connector assembly50 may vary depending upon the size of the particular tubing to be connected. In one exemplary embodiment, thecatheters60 and70 may have an undeflected lumen diameter of about 0.02 to about 0.03 inches (in), e.g. about 0.024 in (0.61 millimeters (mm)). Theconnector pin100 may have a length of about 0.5 in (13 mm), while the outer diameter of eachend portion102 and104 may be about 0.024 in (0.61 mm). The outer diameter of the enlargedcentral portion106 may be about 0.085 in (2.16 mm), while the outer diameter of thefirst catheter60 and thesecond catheter70 may be about 0.089 in (2.26 mm) and 0.041 in (1.04 mm), respectively. Thesleeve200 may have length of about 0.6 to about 1 in, e.g., about 0.8 in (20 mm), a first outer diameter (proximate the first end204) of about 0.125 in (3.17 mm), a firstinner diameter210 of about 0.080 to about 0.10 in, e.g., about 0.094 in (2.4 mm), a second outer diameter (proximate the second end206) of about 0.088 in (2.23 mm), and a secondinner diameter214 of about 0.035 to about 0.050 in, e.g., about 0.046 in (1.17 mm).
• Connector assemblies in accordance with embodiments of the present invention may provide a secure method and apparatus for connecting separate sections of medical tubing by using a two-piece connector assembly (connector pin and connector sleeve). Moreover, connector sleeves in accordance with embodiments of the present invention provide not only secure coupling, but also strain relief to the catheter connection. For instance, when assembled, thesleeve200 preferably extends afirst distance222 beyond the end of thefirst end portion102 of the pin connector100 (seeFIG. 7) and asecond distance224 beyond thesecond end portion104. That is, a longitudinal length of theconnector sleeve200 is preferably greater than a longitudinal length of theconnector pin100. This construction may reduce the chance of thepin connector100 puncturing the catheters.
• The complete disclosure of the patents, patent documents, and publications cited in the Background, the Detailed Description of Exemplary Embodiments, and elsewhere herein are incorporated by reference in their entirety as if each were individually incorporated.
• Exemplary embodiments of the present invention are described above. Those skilled in the art will recognize that many embodiments are possible within the scope of the invention. Other variations, modifications, and combinations of the various components and methods described herein can certainly be made and still fall within the scope of the invention. Thus, the invention is limited only by the following claims and equivalents thereto.

Claims (22)

1-19. (canceled)

20. A method of interconnecting sections of medical tubing, the method comprising:

inserting a first end portion of a connector pin into a first medical tube, the connector pin comprising:

a second end portion, wherein a lumen extends between the first end portion and the second end portion; and

a central portion located between the first and second end portions, the central portion comprising an outer diameter that is greater than an outer diameter of either of the first and second end portions, and wherein the central portion is bound by stop surfaces perpendicular to a longitudinal axis of the connector pin;

inserting the second end portion into a second medical tube;

sliding a tubular sleeve over the first and second medical tubes and the connector pin, wherein the tubular sleeve comprises a first end and a second end and further defines a passageway extending between the first end and the second end, the passageway forming a stop surface that is perpendicular to an axis of the tubular sleeve such that the passageway is defined by: a uniform bore having a first diameter extending between the first end of the sleeve and the stop surface of the passageway; and a uniform bore having a second diameter extending between the stop surface of the passageway and the second end of the sleeve, wherein the first diameter is greater than the second diameter; and

engaging a first lock portion located within the passageway of the sleeve with a second lock portion of the connector pin.

21. The method ofclaim 20, further comprising sliding the sleeve over the first medical tube prior to inserting the first end portion of the connector pin therein.

22. The method ofclaim 20, wherein the first and second medical tubes are catheters.

23. The method ofclaim 20, further comprising securing the sleeve to tissue.

24. The method ofclaim 23, wherein securing the sleeve to tissue comprises suturing the sleeve to the tissue.

25. The method ofclaim 20, further comprising delivering a substance from the first medical tube to the second medical tube through the connector pin.

26. The method ofclaim 20, wherein sliding the sleeve over the first and second medical tubes and the connector pin comprises sliding the sleeve over the first and second medical tubes and the connector pin until the stop surface of the passageway of the sleeve contacts one of the stop surfaces of the central portion of the connector pin.

27. The method ofclaim 20, wherein engaging the first lock portion located within the passageway of the sleeve with the second lock portion of the connector pin comprises deforming the sleeve sufficiently for an inwardly extending protrusion located within the passageway of the sleeve to engage a groove formed in the central portion of the connector pin.

28. The method ofclaim 20, wherein sliding the sleeve over the first and second medical tubes and the connector pin comprises sliding the sleeve until it extends longitudinally beyond first and second ends of the connector pin.

29-30. (canceled)

31. A method of interconnecting sections of medical tubing, the method comprising:

providing a connector pin comprising: a first end portion and a second end portion, wherein a lumen extends between the first end portion and the second end portion; and a central portion located between the first and second end portions, the central portion comprising an outer diameter that is greater than an outer diameter of one or both of the first and second end portions, and wherein the central portion is bound by stop surfaces perpendicular to a longitudinal axis of the connector pin;

inserting the first end portion into a first medical tube:

inserting the second end portion into a second medical tube;

sliding a tubular sleeve over the first and second medical tubes and the connector pin, wherein the tubular sleeve comprises a first end and a second end and further defines a passageway extending between the first end and the second end, the passageway comprising a stop surface that is perpendicular to an axis of the sleeve such that the passageway is defined by: a uniform bore having a first diameter extending between the first end of the sleeve and the stop surface of the passageway; and a uniform bore having a second diameter extending between the stop surface of the passageway and the second end of the sleeve, wherein the first diameter is greater than the second diameter;

contacting one of the stop surfaces of the central portion of the connector pin with the stop surface of the passageway of the sleeve; and

engaging a first lock portion extending inwardly from the uniform bore of the first diameter of the passageway with a second lock portion associated with the connector pin.

32. The method ofclaim 31, further comprising sliding the sleeve over the first medical tube prior to inserting the first end portion of the connector pin therein.

33. The method ofclaim 31, further comprising delivering a substance from the first medical tube to the second medical tube through the connector pin.

34. The method ofclaim 31, wherein sliding the sleeve over the first and second medical tubes and the connector pin comprises sliding the sleeve until it extends longitudinally beyond first and second ends of the connector pin.

35. The method ofclaim 31, wherein engaging the first lock portion with the second lock portion comprises engaging a protrusion formed in the passageway of the sleeve with a groove formed in the outer diameter of the central portion of the connector pin.

36. The method ofclaim 31, wherein the sleeve comprises a flexible material.

37. A method of interconnecting sections of medical tubing, the method comprising:

providing a connector pin comprising: a first end portion and a second end portion, wherein a lumen extends between the first end portion and the second end portion; and a central portion located between the first and second end portions, the central portion comprising an outer surface of a diameter that is greater than a diameter of both of the first and second end portions, and wherein the central portion is bound by stop surfaces perpendicular to a longitudinal axis of the connector pin;

inserting the first end portion into a first medical tube:

inserting the second end portion into a second medical tube;

sliding a tubular sleeve over the first and second medical tubes and the connector pin, wherein the tubular sleeve comprises a first end and a second end and further forms a stepped passageway extending between the first end and the second end, the stepped passageway defined by:

a first section comprising an inner surface defined by a bore of a first diameter, the bore of the first diameter extending both from an inwardly extending protrusion, formed along the inner surface of the first section, to the first end of the sleeve; and from the protrusion to a stop surface located within the stepped passageway; and

a second section comprising an inner surface defined by a bore of a second diameter, the bore of the second diameter extending from the stop surface of the stepped passageway to the second end of the sleeve, wherein the first diameter is greater than the second diameter; and

contacting one of the stop surfaces of the central portion of the connector pin with the stop surface located within the stepped passageway of the sleeve.

38. The method ofclaim 37, further comprising placing the inwardly extending protrusion of the stepped passageway into a groove formed in the outer surface of the central portion of the connector pin.

39. The method ofclaim 37, wherein the tubular sleeve comprises a flexible material.

40. The method ofclaim 37, wherein sliding the sleeve over the first and second medical tubes and the connector pin comprises sliding the sleeve until it extends longitudinally beyond first and second ends of the connector pin.

41. The method ofclaim 20, wherein the tubular sleeve comprises a flexible material.

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