Piercing connector for medical fluid containers

Abstract

The piercing connector assembly includes a valve and a piercing connector, the piercing connector comprising: a piercer received by the valve, the piercer including a spiked end and a lever, the lever including a protrusion; a shell extending around the piercer and the valve, the shell including a pre-activation opening and a post-activation opening; a spring that is held compressed during pre-activation by a tab of the lever being positioned in the pre-activation opening; and an actuator slidably engaged to the shell, the actuator including a protrusion, the actuator being translatable by a user such that the protrusion is aligned with the tab positioned in the opening, the user can push the protrusion into the pre-activation opening to disengage the tab from the opening, and the spring can decompress and translate the piercer such that the medical fluid container is accessed and the tab is positioned in the post-activation opening.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical fluid procedures and, more particularly, to accessing fluids from medical fluid containers such as peritoneal dialysis fluid bags. [Background technology]

[0002] (background) A variety of causes can cause a person's renal system to fail. Renal failure results in several physiological abnormalities. It is no longer possible to balance water and minerals or eliminate the daily metabolic load. Toxic end products of metabolism such as urea, creatinine, uric acid, etc. may accumulate in the patient's blood and tissues.

[0003] Reduced kidney function, particularly kidney failure, is treated by dialysis. Dialysis removes waste, toxins and excess water from the body that normally functioning kidneys would otherwise remove. Dialysis treatments for replacement of kidney function are vital for many people because the treatment is life-threatening.

[0004] One type of renal failure therapy is hemodialysis ("HD"), which generally uses diffusion to remove waste products from a patient's blood. Diffusion occurs because of a diffusion gradient across a semi-permeable dialyzer between the blood and an electrolyte solution called the dialysate or dialysis fluid.

[0005] Hemofiltration ("HF") is another renal replacement therapy that relies on convective transport of toxins from the patient's blood. HF is achieved by adding replacement or substitution fluid to the extracorporeal circuit during treatment. The replacement fluid, and fluid accumulated by the patient between treatments, is ultrafiltered during the course of the HF treatment, thereby providing a convective transport mechanism that is particularly beneficial for the removal of middle and large molecules.

[0006] Hemodiafiltration (HDF) is a treatment modality that combines convective and diffusive clearance. HDF uses dialysis fluid flowing through a dialyzer similar to standard hemodialysis to provide diffusive clearance. In addition, substitution solution is delivered directly to the extracorporeal circuit, thereby providing convective clearance.

[0007] Most HD, HF, and HDF treatments are performed in facilities. Today, there is a trend toward home hemodialysis ("HHD"), in part because HHD can be performed daily, thereby providing therapeutic benefits over in-center hemodialysis treatments, which are typically performed two or three times a week. Studies have found that more frequent treatments remove more toxins and waste products and have less interdialytic fluid overload than patients undergoing less frequent but perhaps longer treatments. Patients undergoing more frequent treatments do not experience as many down cycles (fluid and toxin fluctuations) as in-center patients who build up two or three days' worth of toxins before treatment. In certain areas, the nearest dialysis facility may be many miles away from the patient's home, resulting in door-to-door treatment times consuming a large portion of the patient's day. Treatments at facilities close to the patient's home may also consume a large portion of the patient's day. HHD may be performed at night or during the day, when the patient is relaxing, working, or otherwise productive.

[0008] Another type of renal failure therapy is peritoneal dialysis ("PD"), in which dialysis solution, also called dialysis fluid or PD fluid, is infused into a patient's peritoneal cavity via a catheter. The PD fluid contacts the peritoneal membrane within the patient's peritoneal cavity. Waste, toxins and excess water enter the PD fluid from the patient's bloodstream through the peritoneal capillaries due to diffusion and osmosis, i.e., an osmotic gradient across the membrane is created. An osmotic agent in the PD fluid creates the osmotic gradient. The spent PD fluid is pumped out of the patient, thereby removing the waste, toxins and excess water from the patient. This cycle may be repeated, for example, multiple times.

[0009] There are various types of peritoneal dialysis therapy, including Continuous Ambulatory Peritoneal Dialysis (CAPD), Automated Peritoneal Dialysis (APD), Tidal Peritoneal Dialysis, and Continuous Flow Peritoneal Dialysis (CFPD). CAPD is a manual dialysis procedure in which a patient manually connects an implanted catheter to a drain to allow spent PD fluid to flow out of the patient's peritoneal cavity. The patient then switches the fluid communication so that the patient catheter is in communication with a bag of fresh PD fluid to infuse the patient with fresh PD fluid through the catheter. The patient removes the catheter from the bag of fresh PD fluid, allowing the PD fluid to dwell in the patient's peritoneal cavity, where it transports waste, toxins, and excess water. After a dwell period, the patient repeats the manual dialysis procedure, for example, four times a day. Manual peritoneal dialysis requires significant time and effort from the patient and leaves significant room for improvement.

[0010] APD is similar to CAPD in that the dialysis treatment includes a drain cycle, a fill cycle, and a dwell cycle. However, APD machines typically perform the cycles automatically while the patient sleeps. APD machines free the patient from having to manually perform the treatment cycles and from having to transport supplies during the day. APD machines are fluidly connected to an implanted catheter, a source or bag of fresh PD fluid, and a fluid drain. The APD machine pumps fresh PD fluid from the dialysis fluid source through the catheter and into the patient's peritoneal cavity. The APD machine also allows the PD fluid to dwell in the cavity, allowing transport of waste, toxins, and excess water to occur. The source may contain multiple liters of dialysis fluid, including several solution bags.

[0011] The APD machine pumps spent PD fluid from the patient's peritoneal cavity and out through the catheter. As with the manual process, several drain, fill, and dwell cycles occur during dialysis. A "final fill" may occur at the end of an APD treatment. The final fill fluid may remain in the patient's peritoneal cavity until the start of the next treatment, or it may be manually emptied at some point during the day.

[0012] Any of the above treatment modalities may operate with pre-made, e.g., bagged, solutions. Bagged solutions are typical for any type of PD (CAPD or APD). Bagged solutions may also be used for HD, particularly HHD (see, e.g., U.S. Pat. No. 8,029,454, assigned to the assignee of the present application). Continuous renal replacement therapy ("CRRT") is an acute form of HD, HF, or HDF, and typically uses bagged dialysis fluid.

[0013] Prefabricated, e.g., bagged, solutions for any of the above modalities are typically sterilized after filling and then stoppered to maintain the medical fluid in a sterile state until use. There are various methods for accessing the sterile solution at the time of use. One method is to spike or pierce a connector on the bag at the time of use to establish flow of the medical fluid between the bag and the patient or the point of use, such as a disposable cassette.

[0014] There are problems with the existing bag piercing connector. One container using the existing piercing connector has shown issues with activation and piercing the film of the container or bag. A root cause analysis ("RCA") of failures over multiple years of use in the field indicates that the issues are primarily due to lack of application of the correct piercing force in the correct manner and at the correct speed by the user, film stiffness, and weaknesses in the existing piercing connector material / design.

[0015] Therefore, a need exists for an improved pierce connector. [Prior art documents] [Patent documents]

[0016] [Patent Document 1] U.S. Patent No. 8,029,454 Summary of the Invention [Means for solving the problem]

[0017] (overview) The present disclosure involves the use of a piercing connector assembly to access a medical fluid or solution located in a solution container or bag operable in any type of dialysis treatment, including any type of peritoneal dialysis ("PD") treatment, hemodialysis ("HD") treatment, hemofiltration ("HF") treatment, hemodiafiltration ("HDF") treatment, or continuous renal replacement therapy ("CRRT") treatment. It should be understood that the piercing connector of the present disclosure may be used in any type of medical treatment having bagged or otherwise stored medical fluid that needs to be aseptically opened for use. Thus, the piercing connector may further be used with any type of bagged medical infusion or intravenous fluid, saline, lactated Ringer's, and the like.

[0018] The piercing connector assembly in one embodiment includes a valve for operation with the piercing connector, which may be a flexible plastic or rubber piece that is welded, e.g., ultrasonically sealed, heat sealed, or solvent bonded, to a medical fluid bag, e.g., a PD fluid bag. The valve may be a cylindrical plastic or rubber piece with a circular flanged bottom to increase the welding surface for a fluid-tight seal to the bag.

[0019] The piercing connector, in one embodiment, includes a piercer / spike that mates with or is o-ring-formed with an o-ring that provides sealed, movable communication within the valve such that the medical fluid, e.g., PD fluid, once accessed, cannot flow from the bag into the valve and around the outside of the piercer / spike. The piercer / spike is actuated within the valve to puncture the medical fluid bag, e.g., PD fluid bag, to access the medical or PD fluid.

[0020] The piercing connector further comprises a shell, e.g., a cylindrical shell in one embodiment, that is external to the valve and the perforator / spike to center / align the movement of the perforator / spike within the valve. The shell is, e.g., formed with a pair of openings, e.g., molded. The perforator / spike comprises an elongated cylindrical body, one end of which is a spiked end and the other end of the cylinder includes a connector for connecting to a tube, such as a flexible tube for carrying medical fluid, e.g., PD fluid, from the piercing connector. The lever extends from the elongated tubular body, e.g., molded with the tubular body. The lever in one embodiment extends from a circular lever wall, which extends from the elongated tubular body.

[0021] A tab is provided at the end of the lever and extends outward. The tab of the lever of the perforator / spike is initially (prior to activation) in the pre-activation opening of the shell. Such engagement prevents the perforator / spike from moving or being moved relative to the shell valve or medical fluid bag, e.g., PD fluid bag. A second opening or post-activation opening in the shell sets an end-of-travel position for the perforator / spike, where the tab is in the post-activation opening of the shell after activation (bag spike).

[0022] The piercing connector in one embodiment includes a compression spring that is initially compressed between a circular lever wall of the perforator / spike and an internal ledge of the shell at or near the distal end of the shell. The spring is sized, e.g., with a coil diameter, such that upon decompression it provides sufficient force to cause the perforator / spike to pierce the PD fluid bag. When a tab on the lever of the perforator / spike is pressed below and out of the initial or pre-activation opening of the shell, the spring expands, allowing the perforator / spike to translate.

[0023] The piercing connector of the present disclosure further includes an actuator or slider that is press-fit into a slot in the shell and is therefore constrained by the slot in the shell so that it can translate back and forth in only one direction. The slot, in one embodiment, is provided by a member extending radially outward from the shell. The actuator or slider may then include an inwardly extending leg that engages with the slot formed by the member to hold the slider in slidable engagement with the shell. The actuator or slider, in one embodiment, is elongated such that its end covers a pre-activation opening formed in the shell that receives the outwardly extending tab of the lever of the piercer / spike in a pre-activated condition or state. In this way, the actuator or slider (i) prevents a user from prematurely activating the piercing connector assembly and (ii) prevents the outwardly extending tab from being displaced prematurely, e.g., during shipping. The actuator or slider is further provided, e.g., molded, with a downwardly extending protrusion extending from a central or eccentric portion of the actuator or slider. The downwardly extending protrusion is used to push the outwardly extending tab of the lever out of the pre-activation opening.

[0024] Any of the components of the piercing connector assembly of the present disclosure may be formed, e.g., molded, from a thermoplastic resin such as polyetherimide ("PEI"), polyethersulfone ("PES"), polyamide / nylon ("PA"), acrylonitrile butadiene styrene ("ABS"), polycarbonate ("PC"), polyetheretherketone ("PEEK"), or polyvinyl chloride ("PVC"). If provided separately, the valve and / or O-ring may be formed, e.g., molded, from an elastomer such as ethylene propylene diene monomer ("EPDM") rubber, neoprene rubber, silicone rubber, thermoplastic bulk vinyl ester ("TPV"), or thermoplastic elastomer ("TPE"). The compression spring may be formed from a suitable spring metal to provide the desired amount of opening force.

[0025] Activation of the spring activated piercing connector assembly occurs in one embodiment as follows: Prior to activation, the outwardly extending tabs of the perforator / spike reside within the pre-activation shell opening, preventing the pre-coiled spring from extending and the perforator / spike from translating relative to the remainder of the assembly, with the sharp end of the mating tip of the spike essentially residing at the base of the valve. It is important in one embodiment that the distal end of the actuator or slider extends over and shields the perforator / spike tabs that reside within the pre-activation shell opening to prevent premature actuation.

[0026] During activation of the piercing connector assembly, a user contacts the actuator or slider and translates it so that its downwardly extending protrusion aligns with the upwardly extending tab of the perforator / spike present in the pre-activation shell opening. The user then pushes the protrusion into the pre-activation opening, thereby pushing the perforator / spike tab out of the opening, causing the spring to expand and translate the perforator / spike including the lever in an orientation such that the spiked end of the perforator / spike pierces and opens the medical fluid bag, e.g., PD fluid bag, thereby allowing access to the medical or PD fluid therein. During activation, the payout spring translates the perforator / spike until the tab on the perforator / spike lever aligns with the post-activation shell opening. When this occurs, the lever, which is biased to spring up during activation, automatically snaps into the post-activation opening, preventing the perforator / spike from being translated further.

[0027] After activation of the piercing connector assembly, a medical fluid bag, e.g., a PD fluid bag, is pierced and medical or PD fluid can flow from the medical or PD fluid bag through the internal lumen of the perforator / spike and into the medical or PD treatment fluid line. The outwardly extending tab of the lever arm of the perforator / spike remains within the shell opening after activation, such that the spiked end of the perforator / spike continues to extend into the medical or PD fluid bag while the bag is being emptied.

[0028] In a first aspect, which in light of the disclosure set forth herein is in no way limiting of the disclosure but may be combined with any other aspect or portion thereof, a piercing connector assembly includes a valve for sealing against a medical fluid container, a piercing connector, the piercing connector including a piercer sealingly received by the valve, the piercer including a spiked end and a lever, the lever including a tab, a shell extending around the piercer sealingly received by the valve, the shell including a pre-activation opening and a post-activation opening, and a tab of the lever of the piercer. the spring being compressed and held during pre-activation by being positioned within a pre-activation opening of the shell, and an actuator slidably engaged to the shell, the actuator including a protrusion, the actuator being configured to be translated by a user such that the protrusion is aligned with a tab positioned within the pre-activation opening, the user can then push the protrusion into the pre-activation opening to disengage the tab from the pre-activation opening, and the spring can then decompress and translate the perforator such that the medical fluid container is punctured and opened by the spiked end and the tab is positioned within the post-activation opening.

[0029] In a second aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the valve includes a flanged bottom for enhancing a weld between the valve and the medical fluid container.

[0030] In a third aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the perforator is sealingly received by the valve via an O-ring, the O-ring being formed with the perforator, the valve, or the O-ring being a separate O-ring.

[0031] In a fourth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the end of the perforator includes a connector for connecting to a tube configured to transport medical fluid from a medical fluid container.

[0032] In a fifth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the perforator includes an elongated cylindrical body and a circular wall extending from the body, a lever extending from the circular wall, and a spring held in compression by the circular wall.

[0033] In a sixth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the shell includes an internal bulge, and the spring is also held in compression by the internal bulge.

[0034] In a seventh aspect of the present disclosure, which may be combined with any other aspect or portion thereof, a distal end of the actuator is extended to cover a tab of a lever of the perforator whose distal end is positioned within a pre-activation opening of the shell during pre-activation.

[0035] In an eighth aspect of the present disclosure that may be combined with any other aspect or portion thereof, the tab extends radially outward from the lever into the pre-activation opening and into the post-activation opening.

[0036] In a ninth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the lever is bent by a tab contacting an inner surface of the shell while the lever is moved between the pre-activation opening and the post-activation opening, and the bending of the lever urges the lever to snap-engage with the post-activation opening upon reaching the post-activation opening.

[0037] In a tenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the protrusion extends radially inward from the actuator, allowing a user to push the protrusion into the pre-actuation opening to disengage the tab from the pre-actuation opening.

[0038] In an eleventh aspect of the present disclosure that may be combined with any other aspect or portion thereof, the shell includes an outer extending member defining at least one slot, and the actuator includes at least one leg configured to engage the at least one slot such that the actuator is constrained to translate relative to the shell.

[0039] In a twelfth aspect of the present disclosure that can be combined with any other aspect or portion thereof, a piercing connector includes a perforator including a spiked end and a lever, the lever including a tab, a shell extending around the perforator, the shell including a pre-activation opening and a post-activation opening, a spring that is compressed and held during pre-activation by the tab of the lever of the perforator being positioned within the pre-activation opening of the shell, and an actuator slidably engaged to the shell, the actuator including a protrusion, the actuator configured to be translated by a user such that the protrusion is aligned with the tab positioned in the pre-activation opening, the user can then push the protrusion into the pre-activation opening to disengage the tab from the pre-activation opening, and the spring can then decompress and translate the perforator such that the medical fluid container is punctured and opened by the spiked end and the tab is positioned in the post-activation opening.

[0040] In a thirteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the actuator is radially adjacent to the shell such that the actuator tends not to become entangled with external structures.

[0041] In a fourteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, at least one of a coil diameter of the compression spring and a material of the compression spring is selected such that the compression spring provides sufficient force to puncture and open the medical fluid container by the spiked end of the perforator.

[0042] In a fifteenth aspect of the present disclosure which may be combined with any other aspect or part thereof, the protrusion is provided at a central or eccentric portion of the actuator or slider.

[0043] In a sixteenth aspect of the present disclosure that may be combined with any other aspect or portion thereof, a method for accessing a medical fluid includes providing a perforator including a spiked end and a lever, the lever including an outwardly extending tab; providing a shell extending around the perforator, the shell including an opening that holds the tab of the lever prior to accessing the medical fluid; providing a spring that is compressed by the perforator and the shell prior to accessing the medical fluid; and providing an actuator, the actuator allowing a user to translate the actuator relative to the shell such that an inwardly extending protrusion of the actuator aligns with the tab of the lever that is held in the opening of the shell, the user can press the actuator such that the protrusion removes the tab from the opening, and the spring allows the spring to decompress and translate the perforator such that the medical fluid container is punctured resulting in an open perforator.

[0044] In a seventeenth aspect of the present disclosure that may be combined with any other aspect or portion thereof, a method includes providing a valve with a medical fluid container, the perforator sealingly moving within the valve.

[0045] In an eighteenth aspect of the present disclosure that may be combined with any other aspect or portion thereof, the shell extends around the outside of the valve.

[0046] In a nineteenth aspect of the present disclosure which may be combined with any other aspect or portion thereof, the medical fluid container is a PD fluid container.

[0047] In a twentieth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the method includes preventing the actuator from being translated in an out-of-alignment direction relative to the shell, and releasably preventing the actuator from being translated in an aligned direction relative to the shell.

[0048] In a twenty-first aspect of the present disclosure that may be combined with any other aspect or portion thereof, any of the features, functions, and alternatives described in connection with any one or more of Figures 1 to 10 may be combined with any of the features, functions, and alternatives described in connection with any other of Figures 1 to 10.

[0049] Thus, in light of the above aspects and the disclosure described herein, an advantage of the present disclosure is to provide a piercing connector having a user-advanced actuator or slider that does not extend radially far from the shell, which helps combat premature activation and damage to the slider during shipping and prior to use.

[0050] Another advantage of the present disclosure is to provide a piercing connector that has a user-advanced actuator or slider that is extended prior to use to cover the opening used to translate the perforator or spike, thereby further preventing premature activation.

[0051] A further advantage of the present disclosure is to provide a piercing connector that uses spring force to pierce or spike a medical fluid container or bag so that the user does not have to overcome the puncture resistance of the container or bag.

[0052] Yet another advantage of the present disclosure is providing a pierce connector having a predetermined moving end for an actuator or slider that is advanced by a user.

[0053] Further features and advantages are described in and will be apparent from the following detailed description and drawings. The features and advantages described herein are not all-inclusive, and in particular many further features and advantages will be apparent to those skilled in the art in view of the drawings and description. Also, it is not necessary for any particular embodiment to have all the advantages described herein, and it is expressly contemplated that each advantageous embodiment may be separately claimed. Furthermore, it should be noted that the language used in this specification has been selected primarily for ease of reading and explanation, and is not intended to limit the scope of the inventive subject matter. [Brief description of the drawings]

[0054] [Figure 1] FIG. 1 is a perspective view of one embodiment of a valve for operation with the piercing connector of the present disclosure.

[0055] [Diagram 2] FIG. 2 is a side view of one embodiment of a piercer / spike of the piercing connector of the present disclosure.

[0056] [Diagram 3] FIG. 3 is a side view of one embodiment of a shell of the piercing connector of the present disclosure.

[0057] [Figure 4] FIG. 4 is a side view of one embodiment of a spring of the piercing connector of the present disclosure.

[0058] [Diagram 5] FIG. 5 is a perspective view of one embodiment of an actuator or slider of the piercing connector of the present disclosure.

[0059] [Figure 6] FIG. 6 is a side view of one embodiment of a piercing connector assembly of the present disclosure in a pre-activation condition or state.

[0060] [Figure 7]FIG. 7 is a side view of one embodiment of a piercing connector assembly of the present disclosure during activation.

[0061] [Figure 8] FIG. 8 is a side view of one embodiment of a piercing connector assembly of the present disclosure in a post-activation condition or state.

[0062] [Figure 9] FIG. 9 is a partial cross-sectional top view of one embodiment of an interference fit between the actuator and a member that releasably holds the actuator in place during sterilization prior to use, handling, packaging, shipping, and storage.

[0063] [Figure 10] FIG. 10 is a cross-sectional end view taken along line XX of FIG. 9 illustrating one embodiment for slidably restraining the slider relative to a member of the shell. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0064] (Detailed Description) Referring now to the drawings, and in particular to FIGS. 1-9, one embodiment of a piercing connector assembly 10 for use with a medical fluid container or bag 14 is shown. The piercing connector assembly 10 may be operable in any type of dialysis treatment, including any type of peritoneal dialysis ("PD") treatment, hemodialysis ("HD") treatment, hemofiltration ("HF") treatment, hemodiafiltration ("HDF") treatment, or continuous renal replacement therapy ("CRRT") treatment. It should be understood that the piercing connector assembly 10 may alternatively be used in any type of medical treatment that uses bagged or otherwise stored medical fluids that must be aseptically opened for use. Thus, the piercing connector assembly 10 may further be used with any type of bagged medical infusion, including intravenous fluids or medications, saline, lactated Ringer's, and the like.

[0065] 6-8 illustrate that the piercing connector assembly 10 in one embodiment includes a piercing connector 12 operating in conjunction with a valve 20 that is sealed to a medical fluid container or bag 14. The piercing connector 12 is formed from multiple components including a perforator / spike 30, a shell 50, a compression spring 70, and an actuator or slider 80. Any of the valve 20, the perforator / spike 30, the shell 50, and / or the actuator or slider 80 of the piercing connector assembly 10 may be formed, for example molded, from a thermoplastic material such as polyetherimide ("PEI"), polyethersulfone ("PES"), polyamide / nylon ("PA"), acrylonitrile butadiene styrene ("ABS"), polycarbonate ("PC"), polyetheretherketone ("PEEK"), or polyvinyl chloride ("PVC"). Valve 20 and / or a separate O-ring, if provided, may alternatively be formed, e.g., molded, from an elastomer, such as ethylene propylene diene monomer ("EPDM") rubber, neoprene rubber, silicone rubber, thermoplastic bulk vinyl ester ("TPV"), or thermoplastic elastomer ("TPE"). Compression spring 70 may be formed from materials configured to provide the desired spring force, including stainless steel, high carbon spring steel in wire or flat form, music wire, copper-based spring alloys, nickel-based spring alloys, and alloy spring steels such as chrome vanadium, silicon manganese, and chrome silicon.

[0066] FIG. 1 shows that the piercing connector assembly 10 in one embodiment includes a valve 20 for operation with the piercing connector 12, which may be a flexible plastic or rubber piece that is welded, e.g., ultrasonically sealed, heat sealed, or solvent bonded, to a medical fluid bag, e.g., a PD fluid bag 14. The valve 20 may be a cylindrical plastic or rubber piece having a circular flanged bottom 22 to increase the welding surface for a fluid-tight seal to the bag 14. The valve 20 may be provided with one or more O-ring seals 24, e.g., at its distal end and / or its base, to seal and / or center movement within the interior surface of the shell 50. Although not shown, the valve 20 may alternatively or additionally be provided with an inwardly extending O-ring seal on its interior surface to seal against the outer diameter of the perforator / spike 30.

[0067] 2 shows that the piercing connector 12 includes a perforator / spike 30 in one illustrated embodiment that may be mated with or formed with an O-ring 32 that provides a sealed, movable communication within the valve 20 such that the medical fluid, e.g., PD fluid, once accessed, cannot flow from the PD fluid bag within the valve 20 and around the outside of the perforator / spike 30. Alternatively, the O-ring 32 may be a separate O-ring. The perforator / spike 30 is actuated within the valve 20 to puncture the medical fluid bag, e.g., PD fluid bag 14, to access the medical fluid, e.g., PD fluid.

[0068] The perforator / spike 30 of the illustrated embodiment includes an elongated cylindrical body 34 (on which the O-ring 32 may be formed or attached). One end of the cylindrical body 34 is a spiked end 34s, while the other end of the cylindrical body 34 is formed with or attached to a connector 34c for connecting to a tube (not shown), such as a flexible tube for carrying medical fluid, e.g., PD fluid, from the perforation connector 12. The connector 34c may be a threaded, e.g., luer, connector, or may be sized to permanently seal to the tube, e.g., via ultrasonic sealing, heat sealing, or solvent bonding.

[0069] A lever 36 extends from the elongated tubular body 34, e.g., molded therewith. The lever 36 in the illustrated embodiment extends from a circular lever wall 38, which extends from the elongated tubular body 34. The lever 36 may be cantilevered from the circular lever wall 38 such that it can bend downwardly or upwardly relative to the tubular body 34. A tab 40 is provided at the end of the lever 36, which in the illustrated embodiment extends radially outwardly.

[0070] 3 shows that the piercing connector 12 further includes a shell 50, e.g., a cylindrical shell in the illustrated embodiment, that resides outside the valve 20 and the perforator / spike 30 and that centers / aligns the movement of the perforator / spike 30 within the valve 20. The shell 50 is formed, e.g., molded, with a pair of openings 52, 54, including a pre-activation opening 52 and a post-activation opening 54.

[0071] The tab 40 of the lever 36 of the perforator / spike 30 is initially (prior to activation) in a pre-activation opening 52 in the shell 50. Such engagement prevents the perforator / spike 30 from moving or being moved relative to the shell 50, the valve 20, or the medical fluid bag, e.g., the PD fluid bag 14. A second or post-activation opening 54 in the shell 50 establishes an end of travel position for the perforator / spike 30. The tab 40 in the illustrated embodiment is in the post-activation opening 54 in the shell 50 after activation (bag spike).

[0072] 4 shows that the piercing connector 12 in one embodiment includes a compression spring 70 that is initially compressed between the circular lever wall 38 of the perforator / spike 30 and an internal ledge 56 (FIGS. 6-8) of the shell 50 at or near the distal end of the shell. The compression spring 70 is sized, for example with a coil diameter, and made of a desired material such that upon decompression, the spring provides sufficient force to cause the perforator / spike 30 to pierce the medical fluid bag, for example, the PD fluid bag 14. When the tab 40 on the lever 36 of the perforator / spike 30 is pressed down and out of the initial or pre-activation opening 52 of the shell 50, the compression spring 70 can expand to automatically translate the perforator / spike.

[0073] 5 shows that the piercing connector 12 of the present disclosure further includes an actuator or slider 80 that is press-fit into, and is thus constrained by, a slot provided in the shell 50 of FIG. 3 so that it can translate back and forth in only one direction. The slot 62 is provided by a member 60 that extends radially outward from the shell 50 in the illustrated embodiment. The actuator or slider 80 may then include inwardly extending legs 82 that engage with the slot 62 formed by the member 60 of the shell 50. FIG. 3 shows that one end of the member 60 extends at an angle to a flared head 66 that provides an interference fit with the slider 80 to hold it in place until actuation, as will be described in detail in connection with FIG. 9.

[0074] The actuator or slider 80 in the illustrated embodiment is elongated such that its distal end 84 covers the pre-activation opening 52 formed in the shell 50 that receives the outwardly extending tab 40 of the lever 36 of the perforator / spike 30 in a pre-activation condition or state of the assembly 10. In this manner, the distal end 84 of the actuator or slider 80 (i) prevents a user from prematurely activating the piercing connector assembly 10 and (ii) prevents the outwardly extending tab 40 from being prematurely displaced, for example during shipping. The actuator or slider 80 is further provided, e.g., molded, with a downwardly extending protrusion 86 that extends from a central or eccentric portion of the actuator or slider. The downwardly extending protrusion 86 is used to push the outwardly extending tab 40 of the lever 36 inwardly from the pre-activation opening 52.

[0075] 6-8 of the piercing connector assembly 10 show that the actuator or slider 80 resides radially near the outer diameter of the shell 50. Thus, the actuator or slider 80 does not pose a significant risk of getting caught or entangled on external structures that could interfere with the piercing connector assembly 10, such as moving the actuator or slider 80 relative to the rest of the piercing connector 12 during shipping.

[0076] Activation of the spring activated piercing connector assembly 10 occurs in one embodiment as follows. Figure 6 shows that prior to activation, the outwardly extending tab 40 supported by the lever 36 of the perforator / spike 30 resides within the pre-activation shell opening 52, thereby preventing the pre-coiled spring 70 from stretching and the perforator / spike 30 from translating relative to the remainder of the assembly 10. Here, the spiked end 34s of the perforator / spike 30 resides essentially at the base of the valve 20. In one embodiment, it is important that the distal end 84 of the actuator or slider 80 extends over and shields the tab 40 of the perforator / spike 30 that resides within the pre-activation shell opening 52 prior to activation, preventing premature activation.

[0077] 7 illustrates that during activation of the piercing connector assembly 10, a user contacts and translates the actuator or slider 80 so that its downwardly extending protrusion 86 coincides with the upwardly extending tab 40 of the perforator / spike 30 present within the pre-activation shell opening 52. The user then presses the slider 80 and protrusion 86 radially into the pre-activation opening 52, thereby pushing the tab 40 of the perforator / spike 30 out of the opening, causing the compression spring 70 to expand and automatically translate the perforator / spike 30, including the lever 36, in a direction such that the spiked end 34s of the perforator / spike pierces the medical fluid bag, e.g., the PD fluid bag 14, opening the bag 14 and allowing access to the medical or PD fluid therein. During activation, the expansion of the compression spring 70 translates the perforator / spike 30 until the tab 40 on the perforator / spike lever 36 is aligned with the post-activation shell opening 54. When this occurs, the lever 36, which is biased to spring up during activation, automatically snaps upward into the post-activation opening 54, preventing further translation of the perforator / spike 30. It should be appreciated that the compression spring 70 provides the puncturing force necessary to overcome the tear resistance of the container or bag 14, such that the user does not need to provide such force.

[0078] 8 illustrates that after activation of the piercing connector assembly 10, with the medical fluid bag, e.g., PD fluid bag 14, pierced, medical or PD fluid can flow from the medical or PD fluid bag 14 through the internal lumen of the perforator / spike 30 and into a medical or PD treatment fluid line or tubing (not shown) attached to the perforator / spike connector 34c. The outwardly extending tab 14 of the lever 36 of the perforator / spike 30 remains within the opening 54 after activation of the shell 54, thereby holding the spiked end 34s of the perforator / spike 30 fixedly within the medical fluid bag, e.g., PD fluid bag 14, while the bag is being emptied.

[0079] Figures 9 and 10 show one embodiment of an interference fit between an actuator or slider 80 and a member 60 of the shell 50. Figures 3 and 5 show that the member 60 defines a slot 62 (Figure 3) that frictionally but slidably receives an inwardly extending leg 82 (Figure 5) of the slider 80. Figure 9 shows that the member 60 may be formed with or attached to a flared head 66 that is angled in a triangular manner from the remainder of the member 60. The flared head 66 creates and interference fit with the leg 82 of the actuator or slider 80, preventing the actuator or slider from moving to the right or left of Figure 9 before and during actuation. To actuate the piercing connector assembly 10, the user presses on the slider 80 and slides it from right to left in FIG. 9 to overcome the retaining force of the interference fit between the flared head 66 and the legs 82 of the actuator or slider 80. Once the legs 82 have been slid to the left of the interference fit due to the flared head 66, the slider 80 can be slid further to the left without substantial interference. In one embodiment, the legs 82 of the slider 80 remain within the slots 62 of the member 60 throughout the entire course of the member's movement, thereby always guiding its movement.

[0080] Although not shown in FIG. 9, member 60 may further be formed with a protrusion / recess that temporarily extends into or receives a mating recess / protrusion formed in leg 82 of slider 80. The interference fit between the protrusion and the recess further releasably holds actuator or slider 80 in place relative to member 60 during sterilization prior to use, handling, packaging, shipping, and storage. To actuate piercing connector assembly 10, a user now presses slider 80, sliding it from right to left in FIG. 9 to overcome the retaining force of the interference fit between the protrusion and the recess. Once leg 82 is slid to the left of the protrusion / recess interference fit, slider 80 may be slid further to the left without substantial interference.

[0081] 10 shows an end view of actuator or slider 80 slidably engaged with member 60, further illustrating the structure and function previously described in connection with Figures 3 and 5. In particular, member 60 defines slots 62 that receive legs 82 of actuator or slider 80 such that the slider does not move upwardly off member 60. As previously described, legs 82 of slider 80, in one embodiment, remain within slots 62 of member 60 throughout the entire course of movement of the member, such that slider 80 cannot break free from member 60 or shell 50, regardless of the position of slider 80 relative to member 60.

[0082] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. It is therefore intended that any or all such changes and modifications may be covered by the appended claims. For example, although O-ring 32 is shown mated with or formed with perforator / spike 30, the O-ring may alternatively be provided with valve 20.

Claims

1. 1. A piercing connector assembly comprising: a valve for sealing to a medical fluid container; Drilling connector and Equipped with The piercing connector comprises: a piercer sealingly received by the valve, the piercer including a spiked end and a lever, the lever including a tab; a shell extending around the perforator sealingly received by the valve, the shell including a pre-activation opening and a post-activation opening; a spring that is held compressed during pre-activation by the tab of the lever of the perforator being positioned within the pre-activation opening of the shell; an actuator slidably engaged with the shell; Equipped with 1. A piercing connector assembly, comprising: an actuator including a protrusion, the actuator configured to be translated by a user such that the protrusion is aligned with the tab positioned within the pre-activation opening; the user can then push the protrusion into the pre-activation opening to disengage the tab from the pre-activation opening; and the spring can then decompress and translate the perforator such that the medical fluid container is punctured and opened by the spiked end and the tab is positioned within the post-activation opening.

2. 10. The piercing connector assembly of claim 1, wherein the valve includes a flanged bottom for enhancing a weld between the valve and the medical fluid container.

3. 2. The piercing connector assembly of claim 1, wherein the piercer is sealingly received by the valve via an O-ring, the O-ring being formed with the piercer, the valve, or the O-ring being a separate O-ring.

4. The piercing connector assembly of claim 1 , wherein an end of the perforator includes a connector for connecting to a tube configured to transport medical fluid from the medical fluid container.

5. 2. The piercing connector assembly of claim 1, wherein the piercer includes an elongated cylindrical body and a circular wall extending from the body, the lever extending from the circular wall, and the spring being held in compression by the circular wall.

6. 6. The piercing connector assembly of claim 5, wherein the shell includes an internal ridge, the spring also being held in compression by the internal ridge.

7. 2. The piercing connector assembly of claim 1, wherein a distal end of the actuator extends over the tab of the lever of the piercer, the distal end of which is positioned within the pre-activation opening of the shell during pre-activation.

8. The piercing connector assembly of claim 1 , wherein the tab extends radially outward from the lever into the pre-activation opening and the post-activation opening.

9. 2. The piercing connector assembly of claim 1, wherein the lever is bent by the tab contacting an inner surface of the shell while the lever is moved between the pre-activation opening and the post-activation opening, the bending of the lever urging the lever to snap into engagement with the post-activation opening upon reaching the post-activation opening.

10. 2. The piercing connector assembly of claim 1, wherein the protrusion extends radially inward from the actuator to enable the user to press the protrusion into the pre-activation opening to disengage the tab from the pre-activation opening.

11. 2. The piercing connector assembly of claim 1, wherein the shell includes an outer extending member defining at least one slot, and the actuator includes at least one leg configured to engage the at least one slot such that the actuator is constrained to translate relative to the shell.

12. A piercing connector, a perforator including a spiked end and a lever, the lever including a tab; a shell extending around the perforator, the shell including a pre-activation opening and a post-activation opening; a spring that is held compressed during pre-activation by the tab of the lever of the perforator being positioned within the pre-activation opening of the shell; an actuator slidably engaged with the shell; Equipped with A piercing connector, wherein the actuator includes a protrusion, the actuator is configured to be translated by a user such that the protrusion is aligned with the tab positioned within the pre-activation opening, the user can then push the protrusion into the pre-activation opening to disengage the tab from the pre-activation opening, and the spring can then decompress and translate the perforator such that the medical fluid container is punctured and opened by the spiked end and the tab is positioned within the post-activation opening.

13. The piercing connector of claim 12 , wherein the actuator is radially adjacent to the shell such that the actuator tends not to entangle with external structure.

14. 13. The piercing connector of claim 12, wherein at least one of a coil diameter and a material of the compression spring is selected such that the compression spring provides sufficient force to puncture and open the medical fluid container by the spiked end of the perforator.

15. The pierce connector of claim 12, wherein the protrusion is provided on a central or eccentric portion of the actuator or slider.

16. 1. A method for accessing a medical fluid, comprising: providing a perforator including a spiked end and a lever, said lever including an outwardly extending tab; providing a shell extending around the perforator, the shell including an opening for retaining the tab of the lever prior to accessing the medical fluid; providing a spring that is compressed by the perforator and the shell prior to accessing the medical fluid; Providing an actuator; Including, The actuator allows a user to translate the actuator relative to the shell so that an inwardly extending protrusion of the actuator aligns with the tab of the lever held in the opening in the shell, and the user can press the actuator so that the protrusion removes the tab from the opening, allowing the spring to decompress and translate the perforator so that a medical fluid container is punctured to become an open perforator.

17. 17. The method of claim 16, including providing a valve with the medical fluid container, the perforator sealingly moving within the valve.

18. The method of claim 17 , wherein the shell extends around an exterior of the valve.

19. The method of claim 16 , wherein the medical fluid container is a PD fluid container.

20. 17. The method of claim 16, comprising: preventing the actuator from being translated in an out-of-alignment direction relative to the shell; and releasably preventing the actuator from being translated in an aligned direction relative to the shell.

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