WO2008086631A1

WO2008086631A1 - Connectology system

Info

Publication number: WO2008086631A1
Application number: PCT/CA2008/000164
Authority: WO
Inventors: Joseph E. Dadson, Sr.; Belinda Y. H. Wong; Orson L. Bourne
Original assignee: Newsol Technologies Inc.
Priority date: 2007-01-19
Filing date: 2008-01-18
Publication date: 2008-07-24
Also published as: CA2574551A1

Abstract

The present invention provides a connectology system comprising a set of mating male connectors and female connectors, the connectors having one or more of the following features: a) two or more independent quarter-turn threads to engage and disengage the connectors; b) a tactile feedback mechanism to indicate completion of engagement and commencement of disengagement; c) flange elements to inhibit touch contamination of the connectors; and d) wing elements to permit application of torque for engagement and disengagement.

Description

CONNECTOI OGY SYSTEM

Field of the Invention

[0001] The present invention relates to the field of connectology. In particular, it relates to connectology systems for use with peritoneal dialysis (PD) machines. Background of the Invention

[0002] The natural kidneys function continuously 24 hours a day to maintain the body in a healthy state. They remove nitrogenous waste products and excess fluid, balance electrolytes and generate essential hormones for building red blood cells. When the kidney function drops below a level necessary to sustain life, a person is classified as reaching End Stage Renal Failure (ESRF).

[00031 Dialysis or kidney transplants are the only two accepted treatments for patients with ESRF. Dialysis is the process of transferring accumulated bio-waste from the blood stream into a disposable fluid. It is also used for removing excess fluid from the body and for correcting plasma electrolyte balance. There are two forms of kidney dialysis: Haemodialysis (HD) and Peritoneal Dialysis (PD).

[0004] HD is a complex but rapid procedure, and is the process to which most lay people refer when they speak of dialysis. However, the high annual operating cost and complex infrastructure required for HD make it unsuitable for home use. The ever-increasing demand for home-care and the need for cost containment are favouring the adoption of PD for home care.

[00051 PD makes use of the internal peritoneal membrane to purify the patients' blood. There are two major forms of PD, automated Peritoneal Dialysis (APD) and the manual modality known as CAPD. With both, the blood never leaves the patient's body. Instead, dialysate (dialysis solution) is instilled (FILL) directly into the peritoneal cavity of the patient through a catheter. The dialysate draws soluble waste and excess fluid from the blood contained in the numerous blood vessels in the peritoneal membrane. Osmosis and diffusion are the dominant mechanisms that facilitate this blood cleansing process. In addition, the dialysate balances electrolytes and corrects acidosis of the

_ J . File No 739₂7- I ₅(ODV) blood. This entire process takes place during a fixed time period known as the DWELL. At the end of this period the spent dialysate is removed from the peritoneal cavity (DRAIN) and discarded. This exchange action must be repeated several times during a 24-hour period because the body is continuously producing toxic wastes. [0006] PD is a very gentle modality. Its slow corrective action closely resembles that of the natural kidney. The operational simplicity, the safety, the elimination of the venipunctures and the low operational costs continue to encourage the growth of this modality. Since PD is not an extracorporeal system, there is no need for large heparinization; an advantage which favors diabetics. However, the need to adhere to a strict aseptic procedure to avoid infection is more important than with HD treatment. The peritoneum membrane is exposed to the external environment every time a catheter is connected to, or disconnected from the solution supply. Hence the potential for infection is high. This potential is a serious limitation to the wide spread acceptance of PD and the route of such infection can usually be traced back to the connectology practice associated with current PD machines.

[0007| Connectology is a dialysis term that describes the connection relationships between a patient's catheter, the machine disposable set (including the transfer set), and the solutions.

[0008) In PD, poor connectology is often the first culprit implicated in peritonitis infection-related events. Poorly designed connectors can lead to improper handling and can result in bacterial contamination and subsequent infection. Thus, the PD connectology is one of the key factors associated with infection control and infection reduction. Complications due to infection may be fatal to the patient and can easily triple the cost of the treatment. Although serious efforts are being centered to produce safe connectology, as yet there is no a single complete connectology system that effectively addresses all the interfaces of PD system in clinical use.

[0009] Two features found in the current connectology art are the use of spikes and threaded connectors. Spiking into dialysis solution bags has many drawbacks, the major one being solution contamination. The procedure of spiking a sterile solution bag can compromise the sterile integrity of the system. Contaminants on the spike are directly

_ 2 - File No.739₂7-15(ODV) and immediately introduced into the main solution bag. Once introduced into the bag, the glucose, warm temperature and light provide excellent growth environment for bacteria to multiply very quickly. Eventually the contaminants would be infused into the patient. Infection therefore happens very often if extra care is not exercised with spiking. A desirable attribute of a connectology system is to remove the need to spike the solution bag.

|0010] Starting from the patient and moving towards the APD machine there are a number of threaded connectors. The first of these is the bond to transfer set. This first threaded connector mates directly to an adapter (commonly made from titanium) that is inserted at the opening end of the patient's permanent catheter. A satisfactory non- leaking mating between the titanium adapter and this threaded connector should stay intact for 6 months or more. The connector further needs to be compatible with the many chemicals, electrolytes and medications used for PD treatments. The connector material should withstand high sterilization temperatures without deforming or shrinking. Its thread should not generate major friction and be easy to put on. It should not crack under pressure or deteriorate with time because of aging or chemical exposure. Additionally, the connector should come off very easily at the end of 6 months or more time of usage.

[0011] The next connector is bonded to the opposite end of the transfer set. It is a particularly critical connector. This connector must maintain satisfactory mating characteristics during its entire life time. For example, during 6 months time under a CAPD modality of 5 exchanges a day, this connector undergoes screw-in and screw-out a minimum of 5,400 times. It must withstand chemical, electrolyte and medication reactions, withstand stress and strain during connect and disconnect, withstand heat sterilization, provide satisfactory bonding to the transfer set tube, and above all, its performance should withstand aging and discoloration.

|0012] There are many medical connecting systems in use today. The majority employ different connectors of different shapes, different threads, and different sizes for certain applications and/or different components of the same treatment system. For example, one PD system uses an ordinary semi-rigid tube for the outlet of the solution bags. This outlet is mated with a spike transfer set or a spike cassette set. The transfer set is mated

. 3 . File No.73927-15(ODV) with a multi-turn luer lock connector of different shapes and sizes. The luer lock transfer set connector has exposed fluid path that is susceptible to touch contamination. The transfer set tubing is made of silicone (a material normally used for long life transfer sets). The second connector of the transfer set is made of PVC, ABS and/or polycarbonate. Since silicone cannot be effectively glued to any of these materials, ultrasonic welding is used to attach the second connector to the silicone tubing. However, the connector (hard material) and the silicone tubing (soft and flexible material) have different durometers. Therefore ultrasonic welding does not produce reliable bonding between the connector and the tubing. To compensate a shrinkable overlay is applied over the welding to help secure the tubing to the connector. This bonding technique often fails because of aging and repeated mechanical stress and strain forces during connecting and disconnecting of the transfer set during the six months use and disinfectants have been known to gradually degrade the bonding between the connector and the tubing. A desirable attribute to improve the current art is a more robust method of chemically and mechanically joining the transfer tube to the connector and having an enclosed fluid path that is not susceptible to touch contamination.

|0013| The threading of the second connector of the currently available transfer set requires two or more complete rotations to fully engage and properly seal to the patient line of the dialysis disposable set. The twisting caused by screwing and unscrewing procedure, if not done well, transmits twists to the transfer set and the catheter as well. Mechanical stresses to the catheter due to these manipulations and/or pulling may cause trauma to the exit site of the catheter. This may result in exit-site infection, which is also a major problem of peritoneal access. For safety, the exit-site should be disturbed as little as possible. Trauma to the exit-site may cause leaks of dialysis solution. [0014] The disposable sets are complemented by disinfecting caps that allow patients to disconnect from and connect to the machine during treatment or at the end of treatment without risk of infection. Disinfecting caps should mate well with the connectors. The cap should ensure that the disinfectant does not dry up during storage and/or between patient disconnections. The caps should come off very easily when being removed. The cap should withstand pressure and stress. The cap should be smooth and small enough to provide comfort to patients wearing it for 6 months or more. The cap should be large

_ 4 _ File No.73927-15(ODV) enough to provide easy handling and be removed with minimum force. The design of the cap should be such that the patients do not touch the tip and/or the fluid path during handling (to prevent touch-contamination). Moreover it should be easy for the elderly and vision limited patients to operate safely. Preferably the mating should produce a positive feedback for the patient to know that the cap is properly seated onto the connector. Therefore an effective connectology system should incorporate disposable sets that are complemented by disinfecting caps to allow patients to knowingly disconnect and reconnect safely from the machine without risk of infection during and after treatment. |0015| It is an object of this invention to partially or completely fulfill one or more of the above-mentioned needs.

Summary of the Invention

[0016] According to an aspect of the present invention there is provided a connectology system comprising a set of mating male connectors and female connectors, the connectors having one or more of the following features: a) two or more independent less than complete turn threads to engage and disengage the connectors; b) a tactile feedback mechanism to indicate completion of engagement and commencement of disengagement; c) flange elements to inhibit touch contamination of the connectors; and d) wing elements to permit application of torque for engagement and disengagement. 10017 J Preferably, the male connectors and female connectors are comprised of an inner tube and an outer tube, wherein the inner tube forms a fluid path for the system and the outer tube shields the inner tube from contact and touch contamination.

[0018] Also preferably, the system further includes a set of male connector caps and female connector caps to cover the male connectors and female connectors when not in use. The system may additionally further include a set of male disinfectant caps and female disinfectant caps to cover and disinfect the male connectors and female connectors when not in use.

_ 5 _ File No.73927-15(ODV) [0019] Most preferably, the disinfectant caps contain a disinfectant which is retained inside the disinfectant caps when not in use and released from the disinfectant caps when they are connected to the connectors.

[002Oj Thus the system of the preferred embodiments of the invention includes the highly beneficial feature of relying on a single rotation or less, preferably an approximately quarter turn, to securely engage a transfer set to the patient line of the peritoneal dialysis disposable set and/or the solution bags.

[0021] Other and further advantages and features of the invention will be apparent to those skilled in the art from the following detailed description thereof, taken in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0022] The invention will now be described in more detail, by way of example only, with reference to the accompanying drawings of preferred embodiments of the present invention, in which like numbers refer to like elements, wherein: Figure IA is a schematic drawing of an APD set up for performing dialysis treatment;

Figure IB is a schematic drawing of a set-up for performing CAPD or Manual peritoneal dialysis;

Figure 2 is a side view of preferred transfer set according to the present invention;

Figure 3 presents side views of the preferred female and male connectors and, the preferred female and male disinfectant caps;

Figure 4 shows elevation views of female and male covers, vented and non- vented, with the two O-Rings, big and small;

Figure 5A is a sectional view of a non-vented male connector cover and one embodiment of a female disinfectant cap;

_ 5 . File No 73927-15(ODV) Figure 5 B is a sectional view of a non- vented male connector cover and alternative embodiment of a female disinfectant cap;

Figure 6A is a sectional view of a non-vented female connector cover and one embodiment of a male disinfectant cap;

Figure 6B is a sectional view of a non-vented female connector cover and an alternative embodiment of a male disinfectant cap;

Figure 7 is a sectional view of the preferred embodiment of Luer Lock connector, with its associated retaining ring and Long Life tubing;

Figure 8 is an exploded sectional view of the female connector, and its associated small Oring, non-vented cover and retaining ring;

Figure 9 is an exploded sectional view of the male connector and its associated big O-ring and non-vented cover and retaining ring;

Figure 9A is a close-up section view of the male connector and retaining ring of Figure 9;

Figure 10 is a cross-sectional view of mated male and female connectors of Figs.

8 and 9, with tubing attached to the female connector;

Figure 1 1 is a perspective view of the female connector of Fig. 8;

Figure 1 IA is a front view of Figure 1 1;

Figure 1 1 B is a back view of Figure 1 1 ;

Figure 12A shows in cross-sectional view the male connector of Fig. 9 with attached tubing, and in process of being disinfected by capping with the female disinfectant cap of Figure 5A;

. 7 . File No.73927-15(ODV) Figure 12B shows in cross-sectional view the male connector with attached tubing, in process of being disinfected by capping the female disinfectant cap of Figure 5B;

Figure 13A shows in cross-sectional view the female connector with attached tubing, in process of being disinfected by capping with the male disinfectant cap of Figure 6A;

Figure 13B shows in cross-sectional view the female connector with attached tubing in process of being disinfected by capping with the male disinfectant cap of Figure 6B; and,

Figure 14 shows a cross-sectional view of the preferred embodiment of a reengaged male connector and female connector after said connectors have been disinfected using their respective mating disinfectant caps.

Detailed Description of the Preferred Embodiments

[0023J This invention comprises, in one embodiment, a connectology system for dialysis, that is a complete set of connectors, connector retaining rings, disinfectant caps and associated covers that are necessary for manufacturing, assembling, sterilizing the system and for administering all peritoneal dialysis treatments in a safe and reliable manner.

Other embodiments provide individual components of a connectology system for dialysis. A further embodiment is a kit of parts for assembly into a complete connectology system for dialysis. The preferred embodiment of the invention further teaches the art of attaching a connector to a tubing line to provide a reliable bonding structure that can withstand mechanical strains, electrolyte degradation, chemical agent attacks, sterilization methods (heat, gases, electron beam, gamma rays, etc.), disinfectant reactions and long-term applications. It is applicable to both CAPD and APD treatments and also to any medical treatment applications that rely on administering fluid to patients and/or removing fluid from patients.

[0024] Figure IA shows a typical APD interconnection system. The typical CAPD treatment system, as shown in Figure IB, differs only in the number and complexity of

_ g _ File No 73927- 15(ODV) parts unrelated to the connectology system. Key connectors 1, 10, 20, and 30 are used in the like manner as shown in this diagram.

[ 0025 j Thus in the assembled system according to an embodiment of the invention, in use, connector 1, most commonly a titanium adapter, is attached to the patient's catheter (not shown). Connector 10, which is a luer lock connector, and connector 20, which is a female tube connector, are attached to the opposite ends of the transfer set, illustrated in Figure 2 hereof. Connector 30, which is a male connector, is located when in use at the entrance of the patient tubing line of a cassette or the line that is attached to the dialysate solution bags. At the end of the tubing line (or lines) connected to the sterile fluid source, typically a dialysate solution bag, is another similar female tube connector 20a. At the outlet of the sterile solution bag (or bags, for multiple solution sources) is another similar male connector 30a. Alternatively, the solution bag outlet using connector 30a could be connected directly to the transfer set inlet female connector 20 to perform CAPD and/or any manual PD as it is currently practiced. (00261 Before the system is interconnected as shown in Figures IA or IB or in a similar manner for treatment, the individual tubing sets must be manufactured and sterilized. Each connector should be supplied with an appropriate connector cover. The constructions of the respective covers take a specific form depending on the kind of sterilization method used. Sterilization with ethylene oxide requires that the connector covers be vented to allow entry of the gases into the tubing set, and diffusion of the gases out of the tubing set after sterilization is completed. The alternative methods of electron beam and gamma sterilization do not require vented connector covers. For these two sterilization methods, tight fit non-vented connector covers are often preferred over vented connector covers. The connectology system of the preferred embodiment of the invention can use either vented or non-vented connector covers to allow for either type of sterilization to be used.

J0027] In addition to connector covers, matching disinfectant caps are provided in the preferred embodiment, to enable safe, easy and quick disconnection of mating connector parts and connector ends to be disinfected continuously during separations.

_ 9 _ File No 73927- 15(ODV) {0028] In Figures 2 - 9 and 11 of the accompanying drawings, the structure and features of the individual components of the connectology system of the preferred embodiment are illustrated and these will be described initially. In Figures 10 and 12 - 14, the assembly and various steps in the use of the components are illustrated, and this will be described after the structures of the components have been described.

[0029] Figure 2 shows a typical transfer set, comprising a luer lock connector 10 at one end, for mating with an adapter (typically a titanium adapter) of the catheter (not shown), a retaining ring 11, a long life tubing (typically silicone or polyurethane) 43, a retaining ring 40, a female connector 20, and a disinfectant cap 31 and its associated O-ring 34. This is an exit site connection and therefore construction and procedures aimed at inhibiting infections originating from mechanical wear and tear at the point of connection are desirable.

[0030] Figure 3 shows the female connector 20 and the male 30 adapted for connection thereto, in more detail. It also shows the corresponding disinfectant cap 21 adapted to mate with the male connector 30 for disinfecting purposes, and hence sometimes referred to herein as the female cap. It also shows the corresponding male cap 31, which is adapted to mate with the female connector 20 for disinfecting purposes. All the components are generally cylindrical. The male connector 30 and the disinfectant male cap 31 each include a large O-ring 34 for creating a seal as discussed below. During operations and/or at the end of treatment, when the male connector 30 is separated (disconnected) from the female connector 20, the respective disinfectant caps 21, 31 are used to protect the ends and the fluid paths of each connector. The female disinfectant cap 21 is a modification of female connector 20 and the male disinfectant cap 31 is a modification of male connector 30. The female connector 20 and the male connector 30 have respective outwardly protruding flanges 67 and 57. The disinfectant caps 21 and 31 have similar outwardly projecting flanges 67a and 57a respectively.

[00311 The male connector 30 is provided with a sealing face 58 against which the O- ring 34 is seated. The sealing face 58 is provided with a protuberance 51 at one isolated location. The female connector 20 has a cylindrical shield 62 axially in a direction away from the luer lock 10. A notch 61 is provided on the end edge 59 of the shield 62 to co-

. J O - File No.73927-15(ODV) operate with protuberance 51 on assembly. In similar manner, female cap 21 has a shield 62 and a notch 61. and male cap 31 has a sealing face 58 and a protuberance 51.

[0032] With reference to Figure 4, associated connector covers 22, 23, 32, and 33 are provided for temporary covering of the ends of the connectors while the connectors are joined to the tubing. Figure 4 also shows a small O-ring 24 and a large O-ring 34 for assembly with preferred embodiments of the connectors of the invention (Figures 3, 8 and 9). Connector covers 32 and 22 are respectively female and male vented connector covers, and have ribs 35, 25 respectively in their internal surfaces that allow gases to flow in and out of the connectors when the connectors are capped for gas sterilization. Connector cover 33 is a non-vented female cover and connector cover 23 is a non-vented male connector cover. These have no ribs, but instead have a smooth and tight fitting inner lumen that closes the connector's outer surfaces with air-tight seal for gamma and/or electron beam sterilizations. The connector cover 22 is also used to cover the female disinfectant cap 21, providing a leak proof cover. Likewise the connector cover 33 is used to cover male disinfectant cap 31. The large O-ring 34 sits at the outer circumference and at the end of the threads of both the tube connector 30 and the disinfectant cap 31. The small O-ring 24 is located inside of the female tube connector 20 only, as illustrated in Figure 8 described below.

|0033] Figure 5A shows a cut-away view of the female disinfectant cap 21 and the non- vented connector cover 23. One method of manufacturing female disinfectant cap 21 is to take female connector 20, remove the inner cylindrical tube, and extend the hole defined by 69 all the way through the body to terminate at the end of cylindrical tube 65 with a sealed end 66. A porous sponge 101 or similar material then retains disinfectant solution 102 inside female disinfectant cap 21. Similarly, Figure 6A displays a cut-away view of the male disinfectant cap 31, the non-vented cover 33, large O-Ring 34, disinfectant solution 102 and porous sponge 105. As with the female disinfectant cap 21, a male disinfectant cap 31 can be manufactured from a male connector 30 with the inner cylindrical hole 58 extended all the way through the whole body to create a single cavity, eliminating the inner cylindrical tubes 91 and 54 (as seen in Figure 9), and the single cavity created closed of at the end of 55 by end wall 56. This cavity is filled with disinfectant 102 and porous sponge 105 (or any appropriate material with a tiny hole or

. J ] _ File No.73927-15(ODV) holes in the material) is placed at the opening to contain the disinfectant inside the cavity. The outside large O-ring 34 is retained. It should be noted here that other kinds of disinfectants (gel, crystal, solid, powder etc.) could be equally used in the same fashion.

J0034] An alternative female disinfectant cap 21 is shown in Figure 5B. The porous sponge 101 (from Figure 5A) is replaced with a piston 106. The piston 106 maintains disinfectant 102 in place, and has a channel 108 to permit passage of disinfectant 102 As the male connector is coupled to the female disinfectant cap, piston 102 pushes inward, forcing disinfectant 102 through channel 108 and into the male connector to disinfect it. The equivalent, corresponding male disinfectant cap 31 is shown in Figure 6B. [0035] The piston 102 provides two advantages over the sponge 101. First, the piston action is much less likely to inadvertently release the disinfectant when not under pressure from the male connector. Second, the disinfectant 102 is under some degree of pressure, allowing it to travel further, including into the tubing to disinfect the tubing coupled to the connector as well. [0036) The corresponding disinfectant caps 21 and 31 are designed to provide effective disinfecting of both the fluid path and the surrounding protective shields during periods when connectors 20 and 30 are separated (disconnections). Touch contamination from handling the disinfectant caps 21 and 31 is reduced by two built-in features. The first is a circular flange 67 that prevents fingers from sliding forward to touch the outer shield of the connector during the connection phase. The second is that the fluid path and porous sponge 101, 105 are fully recessed inside an outer shield 62 to prevent contact between fingers and the fluid path and sponges. In addition, the flange 67 prevents individual disinfectant caps from accidentally rolling off sterile trays or surfaces.

|0037j Figure 7 shows the transfer set luer lock connector 10 that mates with titanium adapter 1 (shown in Figure IA) of the catheter (not shown). The long life tubing 43 passes through the retaining ring 11, and slides over the inner cylindrical tube of 10. The retaining ring 11 slides over the long life tubing 43 and is bonded to the inner surface of the outer cylindrical tube of 10. The retaining ring 11 locks into the inner part of the luer lock connector 10 and mechanically holds the tubing 43 in place with a strong bonding strength. The connector's specifications of the mating end, connector 10, the inner thread

. 12 - File No 73927-15(ODV) 13. inner luer taper 14, the fluid path 18 and the tube connector 17, are designed following luer lock standards and specifications.

[0038] In the known art of producing a transfer set, long life tubing line is slipped over the tail end 17 of the luer lock connector 10. Because the long life tubing materials (silicone, etc) do not bond very well to the luer lock plastic materials (PVC, ABS, Hytril, etc.) instead of using the standard bonding methods such as high strength glue, UV cured glue, or cyclohexanone, ultrasonic welding is often employed to weld the long life tubing 43 to the outer surface 17 of the tail end of the luer lock. A shrinkable sleeve is then applied over the welded area to protect the bond. Because the two plastic materials are of different durometers (hard and soft), the ultrasonic bonding is not necessarily as strong as would be desired for the intended long-term use of the long life transfer set. The luer lock connector often separates from the long life tubing line, causing leaks and creating means for bacterial contaminations. Therefore, users are encouraged to minimize movement of the welded joint. Regardless, it is common for the life of the weld to be shorter than the expected 6-months usage.

[0039] With reference to Figures 8 and 9, which show in more detail preferred embodiments of the female connector 20 and the mail connector 30 respectively,, each male connector 30 is constructed with an external quarter-turn thread 53 and female connector 20 is constructed with an internal quarter turn thread 63 to co-operate therewith, making it easy to achieve proper mating alignment and quick engagement of the connectors. This is of particular importance to reduction of catheter trauma at exit sites. The major complications of catheter exit-site separation are leaks followed by infections. Trauma and tension to exit-sites must be minimized to avoid separation of catheter from the skin. Therefore, the exit-site should be protected from even minimal mechanical disturbances. The quarter-turn threads 53 and 63 reduce twisting that normally generates mechanical strains on connector fittings, transfer sets, catheters and exit-sites.

[0040] The female connector 20 includes an inner cylindrical tube 64 protruding beyond the end opposite from that adapted to receive the male connector 30, and terminating in a saw-toothed outer ring 60 for attachment to tubing 43

. 13 . File No.73927-15(ODV) |0041] Figure 8 shows an exploded view of the female connector 20, with internally placed small O-ring 24, the connector cover (vented 22 or non-vented 23 from Figure 4) and retaining ring 40 for securing the connector 20 to a tubing line. Figure 9 shows a similar exploded view of male connector 30, with externally placed large O-ring 34 and connector cover (vented 32 or non-vented 33 from Figure 4). The retaining ring 40 for securing the connector 20 to a tubing line is shown separated from the connector 20. The retaining rings could be of different materials, could take on other forms of constructions and other methods of attachments and/or bonding could be used to attach them to the respective connectors. A perspective view of the female connector 20 from the front end is shown in Figure 11.

10042] With reference to Figure 8, the female connector 20 to be secured to the opposite end of the long life tube 43 from that to which the luer lock connector 10 is attached has a tube connecting end of similar design to that of luer lock connector described above. Figure 8 shows an exploded view of the female connector 20, with internally placed small O-ring 24, the connector cover (vented 22 or non-vented 23 from Figure 4) and retaining ring 40 for securing the connector 20 to a tubing line. Figure 9 shows a similar exploded view of male connector 30, with externally placed large O-ring 34 and connector cover (vented 32 or non-vented 33 from Figure 4). The retaining ring 40 for securing the connector 20 to a tubing line is shown separated from the connector 20 in Figure 9A. The retaining rings could be of different materials, could take on other forms of constructions and other methods of attachments and/or bonding could be used to attach them to the respective connectors. A perspective view of the female connector 20 from the front end is shown in Figure 11.

[0043] The assembly and interconnection process, as well as the disinfecting, sterilizing process, of the system of the preferred embodiment of the present invention, will now be described with reference to the accompanying drawings.

J0044] To attach the long life tube 43 to the female connector 20, tube 43 (not shown in

Figure 8) is slipped over the saw-tooth outer ring 60 and over the entire outer surface of the inner cylindrical tube 64 until seated at the end. Using the same method explained above, the retaining ring 40 is slipped over long life tube 43, and forced into the inside of

_ 14 _ File No.73927-15(ODV) the outer cylindrical tube 65 until the inner ring 82 of the outer cylindrical tube 65 locks into the notch 42 and the notch 43 of the retaining ring 40 lines up with the saw tooth ring 60, trapping the long life tube 43 in place and the inner surface 45 of the retaining ring 40, compressing the long life tube 43 firmly against the outer end of the inner cylindrical tube 64. With the retaining ring 40 locked into the outer cylindrical tube 65, the outer surface 41 of the retaining ring 40 is ultrasonically welded to the inner surface of the inner surface 81 of the cylindrical tube 65 to form a strong and secure bond. Using this innovative method, all connectors are similarly bonded to their respective tubing accordingly. The retaining ring could also be bonded with glue to the inner side of the outer cylindrical surfaces of the connectors where the fabricating plastic materials are suitable to do so. For example, cyclohexanone may be used when PVC or ABS materials are used to fabricate the connectors 20, 30 and the corresponding retaining rings 40.

[0045J To mate the female connector 20 to the male connector 30, both connectors are easily held in the hand, with fingers safely behind the flanges 57 of the male connector 30 and 67 of the female connector 20, and the male connector 30 is inserted into the female connector 20 to engage the threading. By twisting the two connectors together for one quarter turn, the two connectors 20, 30 are firmly engaged with a tactile feedback click when the protuberance 51 of the male connector 30 locks into the notch 61 of the female connector 20 to provide a secure lock-in of the two connectors. This represents a further inventive feature, a tactile feedback mechanism that indicates to the user that the two parts of the connectors are appropriately mated.

[0046) As stated above, during separations of connectors 20 and 30 each mating connector 20. 30 is covered with corresponding disinfectant cap 21, 31. The cap design ensures that the internal fluid path, the external fluid path and the inside of the connector's outer shield are all exposed to adequate disinfectant solution without leaks. It is equally important that when the disinfected mating connectors are reunited, the flushing that follows immediately thereafter is effective to remove the disinfectant solutions from the fluid path before any solution is transfeiτed to the patient. The design of the connectors 20. 30 and disinfectant caps 21, 31 accomplish this important procedure effectively and still create a barrier to microorganisms.

_ 15 _ File No 73927-I₅(ODV) [0047J In embodiments of this invention, a method to maintain integrity of attached tubing line to the connector is provided. These embodiments combine friction, tube line compression, a keyed saw tooth ring, and a glued and/or welded additional retaining ring to combat wear and tear at this joint. The tail end of the luer lock connector 10 of this invention is provided with an inner cylindrical tube 17, terminating with a saw-tooth ring 71, enclosed by a longer outer second cylindrical tube 15 that terminates with an inner ring 70. In assembly, the long life tube 43 is slipped all the way over the outer surface of the inner tube 17. The retaining ring 11, preferably made of the same material and/or similar material with the same durometer (hardness), is slipped over tube 43 and forced between the inner cylindrical tube 17 and the outer cylindrical tube 15, compressing tube 43 until the inner ring 70 of the outer tube 15 locks into notch 74 of the retaining ring 11. At the same time, notch 75 of the retaining ring 11 also aligns itself over the saw-tooth ring 71 of the inner tube 17, trapping the long life tube onto the saw-tooth ring 71 and the end 72. The outer surface 73 of the retaining ring 11 is then ultrasonic welded to the inner surface 16 of the outer cylindrical tube 15 to form a strong and long lasting permanent bond. The three mechanical forces, friction, compressive pressure and the keyed saw tooth lock, act in combination with the ultrasonic weld and seals to retain the long life tube in place. In addition the welded section is not exposed to the fluid carrying path and therefore removed from chemical attacks. [0048] With reference to Figure 8, the female connector 20 to be secured to the opposite end of the long life tube 43 from that to which the luer lock connector 10 is attached has a tube connecting end of similar design as that of luer lock connector described above. To attach the long life tube 43 to the female connector 20, tube 43 (not shown in Figure 8) is slipped over the saw-tooth outer ring 60 and over the entire outer surface of the inner cylindrical tube 64 until seated at the end. Using the same method explained above, the retaining ring 40 is slipped over long life tube 43, and forced into the inside of the outer cylindrical tube 65 until the inner ring 82 of the outer cylindrical tube 65 locks into the notch 42 and the notch 43 of the retaining ring 40 lines up with the saw tooth ring 60, trapping the long life tube 43 in place and the inner surface 45 of the retaining ring 40, compressing the long life tube 43 firmly against the outer end of the inner cylindrical tube 64. With the retaining ring 40 locked into the outer cylindrical tube 65, the outer

_ 1 6 _ File No 73927-I₅(ODV) surface 41 of the retaining ring 40 is ultrasonically welded to the inner surface of the inner surface 81 of the cylindrical tube 65 to form a strong and secure bond. Using this innovative method, all connectors are similarly bonded to their respective tubing accordingly. The retaining ring could also be bonded with glue to the inner side of the outer cylindrical surfaces of the connectors where the fabricating plastic materials are suitable to do so. For example, cyclohexanone may be used when PVC or ABS materials are used to fabricate the connectors 20, 30 and the corresponding retaining rings 40.

|0049] Figure 10 shows the internal structural details of the male connector 30 following mating connection to female connector 20. The female connector 20 has an attached tubing line held in place with a retaining ring 40. The retaining ring 40 is glued or ultrasonically welded to the inside of the female connector 20 as shown. Another tubing line (not shown here) is attached to male connector 30 using a retaining ring in the same manner. This figure also shows the alignment of the internal structures of the two connectors 30 and 20. [0050] The outer cylindrical cover 62 of the female connector 20 slides over the large O- ring 34 of the male connector 30, tightly sealing the inside of the mated connectors from the outside. The inner cylindrical tube 94 of the male connector 30 engages into the inner cylindrical tube 68 of the male connector 20 and compresses the small O-Ring 24 of the female connector 20 against the inner cylindrical step 27 of the female connector 20. The aligned internal cylindrical holes 90 of male connector 30 and 83 of female connector 20, define a sealed continuous internal fluid path.

|0051] Figure 12A shows a cross-section of a disconnected male connector 30 with an engaged female disinfectant cap 21. Screwing the female disinfectant cap 21 onto the opened end of the male connector 30 through one quarter turn twist-locks the two together with a tactile feedback click. The front 91 of the inner cylindrical tube 68 displaces inwards the porous sponge 101 of the disinfectant cap 21, thereby liberating sufficient disinfectant to enter the fluid path 90 of the male connector 30. At the same time, both the inner cylindrical tube 68 and the outer cylindrical tube 52 of the male connector 30, are disinfected accordingly, being continuously bathed in disinfecting fluid. The concentration of the disinfecting fluid surrounding the inner cylindrical tube 68 and

. 1 7 _ File No.73927-l ₅(ODV) the outer cylindrical tube 52 of the male connector 30 gets stronger with time as more disinfectant diffuses into the cylindrical space defined by the inner cylindrical surface of the female disinfectant cap 21. The large O-ring provides a secure seal to prevent leaks of fluid to the outside. The corresponding cross-section for a piston-based disinfectant cap is shown in Figure 12B.

[0052] Figure 13A shows in cross-sectional view a female connector 20 following disconnection from an engaged male disinfectant cap 31. During engagement, the inner cylindrical tube 69 pushes inward on the porous sponge 105 of the disinfectant cap 31, releasing disinfectant 102 into the cylindrical chambers and the fluid path 83 of the female connector 20. Diffusion of more disinfectant into the closed cylindrical spaces continues with time. The large O-ring 34 of the disinfectant cap 31 seals the disinfectant solution from the outside. The disinfectant cap 31 may stay connected on to the female connector 20 for as long as required. The corresponding cross-section for a piston-based disinfectant cap is shown in Figure 13B. |0053] The large O-ring 34 in a preferred embodiment also gives way easily to a minimum torque when the male disinfectant cap 31 and the female disinfectant cap 21 are being taken off from their respective female connector 20 and male connector 30.

[0054] Figure 14 shows a cross-section of a male connector 30 following reconnection to female connector 20. It is to be noted that after internally flushing the reengaged connectors 30 and 20, disinfectant solution is removed from the aligned fluid paths 90 and 83. However, the small O-ring 24 of female connector 20, the internal cylindrical tube 94 of male connector 30, and the internal cylindrical tube of the female connector 20, seal off the fluid paths 90 and 83, from the surrounding disinfectant pool that continues to provide aseptic protection barrier to bacteria. The large O-ring 34 keeps the trapped disinfectant liquid from leaking outside the connectors.

[0055] This concludes the description of a presently preferred embodiment of the invention. The foregoing description has been presented for the purpose of illustration and is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of the above teaching

. ] g . File No.73927-15(ODV) and will be apparent to those skilled in the art. It is intended the scope of the invention be limited not by this description but by the claims that follow.

_ 19 _ File No.73927- I₅(ODV)

Claims

What is claimed is:

1. A connectology system, suitable for use in dialysis, comprising male connectors and female connectors, said connectors comprised of an inner tube and an outer tube, such that, when the male connectors and the female connectors are mated, said inner tubes form a fluid path for the system that is recessed from the top of the outer tubes and said outer tubes shield said inner tubes from contact and touch contamination.

2. The connectology system of claim 1, wherein said connectors have one of more of the following features:

one or more independent quarter-turn threads to engage and disengage said connectors;

a tactile feedback mechanism to indicate completion of engagement and commencement of disengagement;

flange elements to inhibit touch contamination of said connectors; and

wing elements to permit application of torque for engagement and disengagement.

3. The connectology system of claim 2, wherein said connectors have all of the following features: a) one or more independent quarter-turn threads to engage and disengage said connectors; b) a tactile feedback mechanism to indicate completion of engagement and commencement of disengagement; c) flange elements to inhibit touch contamination of said connectors; and d) wing elements to permit application of torque for engagement and disengagement.

4. The connectology system according to claims 1-3, wherein a means to maintain integrity of an attached tubing line to the connector combines any multiple combination of: friction, tube line compression, a keyed saw tooth ring, a glued retaining ring and a welded retaining ring.

. 20 - File No.73927-15(ODV)

5. The connectology system of claims 1-4, further including a set of male connector caps and female connector caps to cover said male connectors and said female connectors when not in use.

6. The connectology system of claim 5. wherein the connector caps are vented.

7. The connectology system of claim 5, wherein the set of male connector caps and female connector caps are disinfectant caps.

8. The connectology system of claim 7, wherein said disinfectant caps comprise a cavity containing disinfectant and a retaining element to which permits the disinfectant to be released from said cavity when said disinfectant caps are connected to said connectors.

9. The connectology system of claim 8, wherein the retaining element is a sponge which releases the disinfectant upon contact with the connector.

10. The connectology system of claim 8, wherein the retaining element is a piston containing a channel which allows passage of the disinfectant through the channel upon exertion of force upon the piston.

1 1. A kit having component parts capable of being assembled into a connectology system, comprising:

a) at least one male connector, each male connector comprised of an inner tube and an outer tube, and having one or more of the following features:

i) one or more independent quarter-turn threads to engage and disengage said connectors;

ii) a tactile feedback mechanism to indicate completion of engagement and commencement of disengagement;

iii) flange elements to inhibit touch contamination of said connectors; and

iv) wing elements to permit application of torque for engagement and disengagement,

- 2 1 - File No.73927- I₅(ODV) b) at least one male connector cap to cover said each male connector;

c) at least one female connector, each female connector comprised of an inner tube and outer tube, and having one or more of the following features:

iii) flange elements to inhibit touch contamination of said connectors; and

d) at least one female connector cap to cover said each female connector;

whereby the male connectors and the female connectors are mated to each other and said inner tubes form a fluid path for the connectology system that is recessed from the top of the outer tubes and said outer tubes shield said inner tubes from contact and touch contamination.

12. The kit of claim 1 1 , wherein the male connector caps and female connector caps are disinfectant caps.

13. The kit of claim 12, wherein said disinfectant caps comprise a cavity containing disinfectant and a retaining element to which permits the disinfectant to be released from said cavity when said disinfectant caps are connected to said connectors.

14. The kit of claim 13, wherein the retaining element is a sponge which releases the disinfectant upon contact with the connector.

15. The kit of claim 13, wherein the retaining element is a piston containing a channel which allows passage of the disinfectant through the channel upon exertion of force upon the piston.

_ 22 - File No 73927-15(ODV)

16. The kit of claims 1 1-15, further including at least one tubing line and said each male connector and said each female connector further includes a means to integrally attach said tubing line to said connector.

17. The kit of claim 16, wherein the means to integrally attach said tubing line to said connector combines any multiple combination of: friction, tube line compression, a keyed saw tooth ring, a glued retaining ring and a welded retaining ring.

_ 23 . File No.73927-15(ODV)