Perforated connector for medical fluid container

Abstract

A perforated connector assembly includes: a valve; and a perforation connector, the perforation connector comprising: a perforator received by the valve, the perforator comprising a stapled end and a lever, the lever comprising a protrusion; a housing extending around the perforator and the valve, the housing including a pre-activation opening and a post-activation opening; the spring is kept compressed by a protruding part, located in the opening before starting, of the lever during the period before starting; and an actuator slidably engaged to the housing, the actuator including a projection, the actuator being translatable by a user such that the projection becomes aligned with the projection located within the opening, where the user is capable of pushing the projection into the pre-activation opening, and the actuator is capable of moving the projection into the pre-activation opening. The perforator is configured to displace the protrusion from the opening, and wherein the spring is configured to decompress and translate the perforator such that the medical fluid container is accessed and the protrusion becomes located within the post-activation opening.

Description

Technical Field

[0001] The present disclosure relates generally to medical fluid therapy, and in particular to accessing fluid from a medical fluid container, such as a peritoneal dialysis fluid bag. Background Art

[0002] Due to various reasons, a person's renal system may fail. Kidney failure produces several physiological disturbances. It is no longer possible to balance water and minerals or to secrete 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] Dialysis is used to treat reduced kidney function, especially kidney failure. Dialysis removes waste products, toxins, and excess water from the body that would otherwise be removed by a normally functioning kidney. Dialysis treatment to replace kidney function is vital to many people because the treatment is life-saving.

[0004] One type of renal failure treatment is hemodialysis ("HD"), which typically uses diffusion to remove waste products from a patient's blood. A diffusion gradient occurs across a semipermeable dialyzer between the blood and an electrolyte solution called dialysate or dialysis fluid to induce diffusion.

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

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

[0007] Most HD, HF and HDF treatments occur at centers. Today there is a trend toward home hemodialysis ("HHD"), in part because HHD can be performed every day, thereby providing treatment benefits superior to hemodialysis treatments in centers, which usually occur every 2 or 3 weeks. Studies have shown that more frequent treatments remove more toxins and wastes, and provide less interdialysis fluid overload, compared to patients who receive less frequent but potentially longer treatments. Patients who receive more frequent treatments do not experience as many down cycles (swings of fluids and toxins) as patients in centers that have accumulated toxins for two or three days before treatment. In some areas, the nearest dialysis center may be many miles away from the patient's home, resulting in door-to-door treatment time consuming most of the day. Treatment in a center near the patient's home may also consume most of the patient's day. HHD can be performed at night or during the day while the patient is relaxing, working or otherwise producing.

[0008] Another type of renal failure treatment is peritoneal dialysis ("PD"), which infuses a dialysis solution (also called dialysis fluid or PD fluid) into the patient's peritoneal compartment via a catheter. The PD fluid contacts the peritoneum in the patient's peritoneal compartment. Waste products, toxins, and excess water flow from the patient's blood through the capillaries in the peritoneum and enter the PD fluid due to diffusion and osmosis, i.e., an osmotic gradient occurs across the membrane. An osmotic agent in the PD fluid provides the osmotic gradient. Used PD fluid is drained from the patient, thereby removing waste products, toxins, and excess water from the patient. This cycle is repeated, for example, multiple times.

[0009] There are various types of peritoneal dialysis treatments, including continuous ambulatory peritoneal dialysis ("CAPD"), automated peritoneal dialysis ("APD"), tidal dialysis, and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis treatment. Here, the patient manually connects an implanted catheter to a drain to allow spent PD fluid to drain from the patient's peritoneal cavity. The patient then switches the fluid connection so that the patient's catheter is connected to a bag of fresh PD fluid to inject fresh PD fluid into the patient through the catheter. The patient disconnects the catheter from the bag of fresh PD fluid and allows the PD fluid to reside in the patient's peritoneal cavity, where transfer of waste, toxins, and excess water occurs. After the dwell period, the patient repeats the manual dialysis procedure, for example four times a day. Manual peritoneal dialysis requires a significant amount of time and effort from the patient, leaving ample room for improvement.

[0010] APD is similar to CAPD in that dialysis treatment includes a drain, fill, and dwell cycle. However, an APD machine typically performs the cycle automatically while the patient sleeps. An APD machine relieves the patient from having to manually perform treatment cycles and from having to deliver supplies during the day. The APD machine is 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 a dialysis fluid source through the catheter and into the patient's peritoneal compartment. The APD machine also allows the PD fluid to dwell within the chamber and allows for the transfer of waste, toxins, and excess water. The source can include multiple liters of dialysis fluid (including several bags of solution).

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

[0012] Any of the above treatment modalities can be operated with pre-made, e.g., bagged solutions. Bagged solutions are typical for any type of PD (CAPD or APD). Bagged solutions can 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] Pre-made (e.g., bagged) solutions for any of the above methods are typically sterilized after filling and then capped to maintain the medical fluid in a sterile condition until use. There are different ways to access the sterile solution at the time of use. One way is to pierce or perforate the connector of the bag at the time of use, thereby establishing medical fluid flow between the bag and the point of use (such as a patient or a disposable box).

[0014] There appear to be problems with existing bag piercing connectors. One container using an existing piercing connector showed problems with priming and piercing the membrane of the container or bag. Root cause analysis ("RCA") of failures used in the field for many years showed that the problems were primarily due to: lack of correct piercing force applied by the user in the correct manner and at the correct speed, stiffness of the membrane, and fragility of the existing piercing connector material / design.

[0015] Therefore, there is a need for an improved piercing connector. Summary of the invention

[0016] The present disclosure relates to the use of a perforated connector assembly for accessing a medical fluid or solution located within a solution container or bag that can be operated with 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 perforated connector of the present disclosure can be used for any type of medical treatment with bagged or otherwise stored medical fluids that need to be aseptically opened for use. Therefore, the perforated connector can be used in addition with any type of bagged medical infusates or intravenous fluids, saline, lactated Ringer's solution, etc.

[0017] In one embodiment, the piercing connector assembly includes a valve for operating with the piercing connector, wherein the valve can be a flexible plastic or rubber piece that is welded, such as ultrasonically sealed, heat sealed, or solvent bonded to a medical fluid (e.g., PD fluid) bag. The valve can be a cylindrical plastic or rubber piece with a rounded, flanged bottom for increasing the weld surface for fluid-tight sealing to the bag.

[0018] In one embodiment, the piercing connector includes a piercer / spike fitted or formed with an O-ring that provides sealed and movable communication within the valve so that once accessed, the medical fluid (e.g., PD fluid) cannot flow from the bag, within the valve, and around the outside of the piercer / spike. The piercer / spike is actuated within the valve to pierce the medical fluid (e.g., PD fluid) bag and access the medical or PD fluid.

[0019] The perforating connector also includes a housing (e.g., a cylindrical housing in one embodiment) that resides on the outside of the valve and the perforator / nail and centers / aligns the movement of the perforator / nail in the valve. The housing is formed with, for example, a pair of openings molded therein. The perforator / nail includes an elongated cylindrical body, one end of which is a nail-end, and the other end of which includes a connector for connecting to a tube, such as a flexible tube for carrying a medical fluid (e.g., PD fluid) from the perforating connector. The lever extending from the elongated tubular body is, for example, molded together with the tubular body. In one embodiment, the lever extends from a circular lever wall, which in turn extends from the elongated tubular body.

[0020] The projection is disposed at the end of the lever and extends outwardly. The projection of the lever of the perforator / nail initially (before activation) resides in the pre-activation opening of the housing. This engagement prevents the perforator / nail from moving or being moved relative to the housing valve or the medical fluid (e.g., PD fluid) bag. The second or post-activation opening of the housing sets the end-of-stroke position of the perforator / nail. Here, after activation (bag piercing), the projection resides in the post-activation opening of the housing.

[0021] The piercing connector in one embodiment includes a compression spring that is initially compressed between a circular lever wall of the piercer / nail and an internal ledge of the housing disposed at or near the distal end of the housing. The spring is sized, for example, to have a coil diameter such that the spring provides sufficient force when decompressed to cause the piercer / nail to pierce the PD fluid bag. When a protrusion on the lever of the piercer / nail is pushed under and out of the initial or pre-activation opening of the housing, the spring is able to expand and translate the piercer / nail.

[0022] The piercing connector of the present disclosure further includes an actuator or a slider, which is press-fitted into a groove disposed in the housing and is therefore constrained by these grooves so as to be able to translate back and forth in only one direction. In one embodiment, the groove is provided by a member extending radially outward from the housing. Then, the actuator or the slider may include legs extending inwardly, which engage the groove formed by the member to keep the slider slidingly engaged to the housing. In one embodiment, the actuator or the slider is elongated so that its end covers the pre-startup opening formed in the housing, which accommodates the outwardly extending protrusion of the lever of the puncher / nail in the pre-actuation condition or state. In this way, the actuator or the slider prevents (i) the user from actuating the piercing connector assembly prematurely and (ii) the outwardly extending protrusion, for example, from moving prematurely during shipment. The actuator or the slider is also provided with, for example, a protrusion molded with a downwardly extending protrusion extending from the middle or off-center portion of the actuator or the slider. The downwardly extending protrusion is used to push the outwardly extending projection of the lever from the front opening for activation.

[0023] Any component of the piercing connector assembly of the present disclosure may be formed, for example, by molding, from a thermoplastic such as polyetherimide ("PEI"), polyethersulfone ("PES"), polyamide / nylon ("PA"), acrylonitrile butadiene styrene ("ABS"), polycarbonate ("PC"), polyetheretherketone ("PEEK"), or polyvinyl chloride ("PVC"). The valve and / or O-ring (if provided separately) may alternatively be formed (e.g., molded) from an elastomer such as ethylene propylene diene monomer ("EPDM") rubber, neoprene, silicone rubber, thermoplastic vulcanizate ("TPV"), or thermoplastic elastomer ("TPE")). The compression spring may be formed from a suitable spring metal so as to provide a desired amount of opening force.

[0024] In one embodiment, the spring-activated perforating connector assembly is activated as follows. Before activation, the outwardly extending projection of the perforator / nail resides in the housing opening before activation, which prevents the pre-wound spring from unfolding and prevents the perforator / nail from being translated relative to the rest of the assembly. Here, the sharp end of the spliced ​​tip of the nail resides substantially at the base of the valve. In one embodiment, it is important that the distal end of the actuator or slider is extended so that it covers and shields the projection of the perforator / nail that resides in the housing opening before activation, thereby preventing premature activation.

[0025] During activation of the piercing connector assembly, the user touches and translates the actuator or slider so that its downwardly extending protrusion meets the upwardly extending protrusion of the piercer / nail residing in the pre-activation housing opening. The user then presses the protrusion into the pre-activation opening, which forces the piercer / nail protrusion to leave the opening, which in turn allows the spring to unfold, thereby translating the piercer / nail including the lever in one direction, so that the nailed end of the piercer / nail pierces the medical fluid (e.g., PD fluid) bag to open, thereby allowing access to the medical fluid or PD fluid therein. During activation, the unfolded spring translates the piercer / nail until the protrusion on the lever of the piercer / nail meets the post-activation housing opening. When this happens, the lever, which is biased to spring upward during activation, automatically snaps into the post-activation opening, thereby preventing the piercer / nail from being further translated.

[0026] After actuation of the piercing connector assembly, in the event that a medical fluid (e.g., PD fluid) bag is pierced, the medical fluid or PD fluid can flow from the medical or PD fluid bag through the interior lumen of the piercer / spike into the medical or PD therapy fluid line. The outwardly extending protrusion of the lever arm of the piercer / spike remains within the post-activation housing opening, so that: the spiked end of the piercer / spike continues to extend into the medical or PD fluid bag while the bag is emptied.

[0027] According to the disclosure set forth herein, and without limiting the present disclosure in any way, in a first aspect that may be combined with any other aspect or portion thereof, a piercing connector assembly comprises: a valve for sealing to a medical fluid container and a piercing connector, the piercing connector comprising: a piercer sealingly received by the valve, the piercer comprising a spiked end and a lever, the lever comprising a protrusion; a housing extending around the piercer sealingly received by the valve, the housing comprising a pre-activation opening and a post-activation opening; a spring, the spring being actuated by the lever of the piercer located within the housing during pre-activation and an actuator slidably engaged to the housing, the actuator including a protrusion, the actuator being configured to be translated by a user such that the protrusion becomes aligned with the protrusion located within the pre-activation opening, wherein the user is then able to push the protrusion into the pre-activation opening to disengage the protrusion from the pre-activation opening, and wherein the spring is then able to decompress and translate the perforator such that the medical fluid container is pierced open by the spiked end and the protrusion becomes located within the post-activation opening.

[0028] In a second aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the valve comprises a flanged bottom for enhancing a weld between the valve and the medical fluid container.

[0029] In a third aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the perforator is sealingly received by the valve via an O-ring, and wherein the O-ring is formed together with the perforator and the valve, or the O-ring is a separate O-ring.

[0030] In a fourth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the end of the piercer includes a connector for connecting to a tube configured to transport the medical fluid from the medical fluid container.

[0031] In a fifth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the perforator comprises an elongated cylindrical body and a circular wall extending from the body, wherein the lever extends from the circular wall, and wherein the spring is held compressed by the circular wall.

[0032] In a sixth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the housing comprises an internal ledge, and wherein the spring is also held compressed by the internal ledge.

[0033] In a seventh aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the distal end of the actuator is extended so that during pre-activation, the distal end covers the protrusion of the lever of the punch located within the pre-activation opening of the housing.

[0034] In an eighth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the protrusion extends radially outward from the lever into the pre-activation opening and the post-activation opening.

[0035] In a ninth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the lever is bent by the protrusion contacting the inner surface of the shell while the lever moves between the pre-start opening and the post-start opening, and the bending of the lever biases the lever to snap into the post-start opening when it reaches the post-start opening.

[0036] In a tenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the protrusion extends radially inward from the actuator to allow the user to push the protrusion into the pre-activation opening to disengage the projection from the pre-activation opening.

[0037] In an eleventh aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the housing comprises an outwardly extending member defining at least one slot, and wherein the actuator comprises at least one leg configured to engage the at least one slot such that the actuator is constrained to translate relative to the housing.

[0038] In a twelfth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, a piercing connector comprises: a piercer comprising a spiked end and a lever comprising a protrusion; a shell extending around the piercer, the shell comprising a pre-activation opening and a post-activation opening; a spring, which is held compressed by the protrusion of the lever of the piercer located within the pre-activation opening of the shell during pre-activation; and an actuator, which is slidably engaged to the shell, the actuator comprising a protrusion, the actuator being configured to be translated by a user so that the protrusion becomes aligned with the protrusion located within the pre-activation opening, wherein the user is then able to push the protrusion into the pre-activation opening to disengage the protrusion from the pre-activation opening, and wherein the spring is then able to decompress and translate the piercer so that the medical fluid container is pierced open by the spiked end and the protrusion becomes located within the post-activation opening.

[0039] In a thirteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the actuator resides radially adjacent to the housing such that the actuator tends not to become entangled with an outer structure.

[0040] In a fourteenth aspect of the present disclosure that may be combined with any other aspect or portion thereof, at least one of the coil diameter and material of the compression spring is selected so that the compression spring provides sufficient force to cause the medical fluid container to be pierced open by the spiked end of the piercer.

[0041] In a fifteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the protrusion is provided at a middle or offset portion of the actuator or slider.

[0042] In the sixteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, a method for accessing a medical fluid comprises: providing a perforator comprising a spike end and a lever, the lever comprising an outwardly extending protrusion; providing a shell extending around the perforator, the shell comprising an opening, the opening retaining the protrusion of the lever before accessing the medical fluid; providing a spring, the spring being compressed by the perforator and the shell before accessing the medical fluid; and providing an actuator, the actuator enabling a user to translate the actuator relative to the shell so that the inwardly extending protrusion of the actuator is aligned with the protrusion of the lever retained in the opening of the shell, wherein the user is able to push the actuator so that the protrusion removes the protrusion from the opening, thereby allowing the spring to decompress and translate the perforator so that the medical fluid container is pierced open by the perforator.

[0043] In a seventeenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the method includes providing the medical fluid container with a valve, wherein the piercer sealingly moves within the valve.

[0044] In an eighteenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the housing extends around an outside of the valve.

[0045] In a nineteenth aspect of the present disclosure that may be combined with any other aspect or a portion thereof, the medical fluid container is a PD fluid container.

[0046] In the twentieth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the method comprises: preventing the actuator from being translated in a non-alignment direction relative to the housing; and releasably preventing the actuator from being translated in a alignment direction relative to the housing.

[0047] In a twenty-first aspect of the present disclosure that may be combined with any other aspect or a part thereof, Figures 1 to 10 Any features, functions and alternatives described in any one or more of the figures may be combined with Figures 1 to 10 Any feature, function and alternative combination described in any other figure in the.

[0048] Based on the above aspects and the present disclosure set forth herein, an advantage of the present disclosure is to provide a piercing connector having an actuator or slider pushed by a user, which does not extend radially away from the housing, which helps prevent premature activation and damage to the slider during shipping and before use.

[0049] Another advantage of the present disclosure is to provide a piercing connector having an actuator or slider advanced by a user that is extended prior to use to cover an opening for translating the piercer or staple, thereby further preventing premature activation.

[0050] Another advantage of the present disclosure is to provide a piercing connector that uses spring force to pierce or puncture a medical fluid container or bag so that a user does not need to overcome the puncture resistance of the container or bag.

[0051] Yet another advantage of the present disclosure is to provide a piercing connector having a defined end of travel for an actuator or slider advanced by a user.

[0052] Additional features and advantages are described in and will be apparent from the following detailed description and accompanying drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the accompanying drawings and description. Moreover, it is not necessary for any particular embodiment to have all of the advantages listed herein, and it is expressly contemplated that each advantageous embodiment is individually claimed. In addition, it should be noted that the language used in this specification has been selected primarily for readability and guidance purposes rather than for limiting the scope of the subject matter of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Figure 1 is a perspective view of one embodiment of a valve for operation with the piercing connector of the present disclosure.

[0054] Figure 2 is a side view of one embodiment of a piercer / spike of a piercing connector of the present disclosure.

[0055] Figure 3 is a side view of one embodiment of a housing of a piercing connector of the present disclosure.

[0056] Figure 4is a side view of one embodiment of a spring of a piercing connector of the present disclosure.

[0057] Figure 5 is a perspective view of one embodiment of an actuator or slider of a piercing connector of the present disclosure.

[0058] Figure 6 is a side view showing one embodiment of a piercing connector assembly of the present disclosure in a pre-activation condition or state.

[0059] Figure 7 is a side view showing one embodiment of a piercing connector assembly of the present disclosure during startup.

[0060] Figure 8 is a side view showing one embodiment of a piercing connector assembly of the present disclosure in a post-activation condition or state.

[0061] Fig. 9 is a top partial cross-sectional view of one embodiment of an interference fit between an actuator and a component wherein the actuator is releasably held in place during sterilization, handling, packaging, shipping, and storage prior to use.

[0062] Fig.10 is along Fig. 9 XX, showing one embodiment of a member for slidably constraining a slider against a housing. DETAILED DESCRIPTION

[0063] Referring now to the drawings and in particular to Figures 1 to 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 is capable of operating with 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 can alternatively be used for any type of medical treatment using bagged or otherwise stored medical fluids that need to be aseptically opened for use. The piercing connector assembly 10 can therefore additionally be used with any type of bagged medical infusates, including intravenous fluids or medications, saline, lactated Ringer's solution, etc.

[0064] Figures 6 to 8The piercing connector assembly 10 in one embodiment is shown to include a piercing connector 12 that operates with a valve 20 that seals to a medical fluid container or bag 14. The piercing connector 12 is formed of a plurality of components, including: a piercer / spike 30; a housing 50; a compression spring 70; and an actuator or slider 80. Any of the valve 20, piercer / spike 30, housing 50, and / or actuator or slider 80 of the piercing connector assembly 10 may be formed (e.g., molded) from a thermoplastic such as polyetherimide ("PEI"), polyethersulfone ("PES"), polyamide / nylon ("PA"), acrylonitrile butadiene styrene ("ABS"), polycarbonate ("PC"), polyetheretherketone ("PEEK"), or polyvinyl chloride ("PVC"). The 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, silicone rubber, thermoplastic vulcanizate ("TPV"), or thermoplastic elastomer ("TPE"). The compression spring 70 may be formed from a material 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.

[0065] Figure 1 The piercing connector assembly 10 in one embodiment is shown to include a valve 20 for operating with the piercing connector 12, wherein the valve 20 can be a flexible plastic or rubber piece that is welded, such as ultrasonically sealed, heat sealed, or solvent bonded to a medical fluid (e.g., PD fluid) bag 14. The valve 20 can be a cylindrical plastic or rubber piece having a circular, flanged bottom 22 for increasing the weld surface for fluid-tight sealing to the bag 14. The valve 20 can be provided with one or more O-ring seals 24 (e.g., at the distal end of the valve 20 and / or at the base of the valve 20) for sealing and / or centering movement within the inner surface of the housing 50. Although not shown, the valve 20 can alternatively or additionally be provided with an inwardly extending O-ring seal on the inner surface of the valve 20 for sealing to the outer diameter of the piercer / spike 30.

[0066] Figure 2 In one illustrated embodiment, the piercing connector 12 includes a piercer / spike 30 that may be fitted or formed with an O-ring 32 that provides a sealed and removable connection within the valve 20 so that once accessed, the medical fluid (e.g., PD fluid) cannot flow from the PD fluid bag, within the valve 20, and outside around the piercer / spike 30. The O-ring 32 may alternatively be a separate O-ring. The piercer / spike 30 is actuated within the valve 20 to pierce the medical fluid (e.g., PD fluid) bag 14 and access the medical fluid (e.g., PD fluid).

[0067] The piercer / spike 30 in the illustrated embodiment includes an elongated cylindrical body 34 (to which an O-ring 32 may be formed or attached). One end of the cylindrical body 34 is a spike end 34s, while the other end of the cylindrical body 34 is formed with or attached to a connector 34c for connection to a tube (not shown) such as a flexible tube for carrying a medical fluid (e.g., PD fluid) from the piercing connector 12. The connector 34c may be a threaded connector such as a Luer connector, or may be sized to be permanently sealed to the tube, such as via ultrasonic sealing, heat sealing, or solvent bonding.

[0068] The lever 36 extends from the elongated tubular body 34, for example, is molded with the tubular body. The lever 36 in the illustrated embodiment extends from a circular lever wall 38, which in turn extends from the elongated tubular body 34. The lever 36 can extend cantilevered relative to the circular lever wall 38 so as to be able to bend downward or upward relative to the tubular body 34. In the illustrated embodiment, a protrusion 40 is provided at the end of the lever 36 and extends radially outward.

[0069] Figure 3 The piercing connector 12 is shown to also include a housing 50, such as a cylindrical housing in the illustrated embodiment, which resides on the outside of the valve 20 and the piercer / spike 30 and centers / aligns the movement of the piercer / spike 30 within the valve 20. The housing 50 is formed with, such as molded with, a pair of openings 52, 54, including a pre-activation opening 52 and a post-activation opening 54.

[0070] The protrusion 40 of the lever 36 of the punch / spike 30 initially (prior to activation) resides in the pre-activation opening 52 of the housing 50. This engagement prevents the punch / spike 30 from moving or being moved relative to the housing 50, the valve 20, or the medical fluid (e.g., PD fluid) bag 14. The second or post-activation opening 54 of the housing 50 sets the end-of-travel position for the punch / spike 30. The protrusion 40 in the illustrated embodiment resides in the post-activation opening 54 of the housing 50 after activation (bag piercing).

[0071] Figure 4 The piercing connector 12 in one embodiment is shown to include a compression spring 70 that is initially compressed between the circular lever wall 38 of the piercer / nail 30 and the internal ledge 56 ( Figures 6 to 8). The compression spring 70 is sized, for example, to have a coil diameter and is made of a desired material so that the spring provides sufficient force when decompressed to cause the punch / spike 30 to pierce the medical fluid (e.g., PD fluid) bag 14. When the protrusion 40 on the lever 36 of the punch / spike 30 is pushed under the initial or activation front opening 52 of the housing 50 and pushed out from it, the compression spring 70 can expand and automatically translate the punch / spike.

[0072] Figure 5 The piercing connector 12 of the present disclosure is shown to further include an actuator or slider 80 that is press-fitted to a portion of the piercing connector 12 disposed on the Figure 3 The actuator or slider 80 is disposed in the slots 62 in the housing 50 and is thus constrained by these slots 62 so as to be able to translate back and forth in only one direction. In the illustrated embodiment, the slots 62 are provided by members 60 extending radially outward from the housing 50. The actuator or slider 80 may then include inwardly extending legs 82 that engage the slots 62 formed by the members 60 of the housing 50. Figure 3 The member 60 is shown to be angled outwardly at one end into a flared head 66 which forms an interference fit with the slider 80 to hold the slider in place until actuated (eg, in conjunction with the Fig. 9 discussed in detail).

[0073] The actuator or slider 80 in the illustrated embodiment is elongated so that its distal end 84 covers the pre-activation opening 52 formed in the housing 50, which accommodates the outwardly extending protrusion 40 of the lever 36 of the punch / nail 30 in the pre-activation condition or state of the assembly 10. In this way, the distal end 84 of the actuator or slider 80 prevents (i) the user from prematurely actuating the punch connector assembly 10 and (ii) the outwardly extending protrusion 40 from prematurely moving, for example, during shipping. The actuator or slider 80 is also provided with, for example, a downwardly extending protrusion 86 molded therein, which extends from the middle or offset portion of the actuator or slider. The downwardly extending protrusion 86 is used to push the outwardly extending protrusion 40 of the lever 36 inwardly from the pre-activation opening 52.

[0074] The piercing connector assembly 10 Figures 6 to 8 The actuator or slider 80 is shown residing radially close to the outer diameter of the housing 50. Thus, there is no significant risk of the actuator or slider 80 becoming caught or entangled with an outside structure, such as during shipping, which could damage the piercing connector assembly 10, such as by moving the actuator or slider 80 relative to the rest of the piercing connector 12.

[0075] In one embodiment, activation of the spring activated piercing connector assembly 10 occurs as follows. Figure 6It is shown that, prior to activation, the outwardly extending tab 40 supported by the lever 36 of the punch / nail 30 resides within the pre-activation housing opening 52, which prevents the pre-wound spring 70 from unwinding and prevents the punch / nail 30 from being translated relative to the rest of the assembly 10. Here, the spiked end 34s of the punch / nail 30 resides substantially at the base of the valve 20. Importantly in one embodiment, the distal end 84 of the actuator or slider 80 is extended so that it covers and shields the tab 40 of the punch / nail 30 that resides within the pre-activation housing opening 52 prior to activation, thereby preventing premature activation.

[0076] Figure 7 It is shown that during activation of the piercing connector assembly 10, the user touches and translates the actuator or slider 80 so that its downwardly extending protrusion 86 meets the upwardly extending protrusion 40 of the piercer / nail 30 residing in the pre-activation housing opening 52. The user then presses the slider 80 and the protrusion 86 radially into the pre-activation opening 52, which forces the protrusion 40 of the piercer / nail 30 to leave the opening, which in turn allows the compression spring 70 to expand and automatically translate the piercer / nail 30 (including the lever 36) in one direction so that the spiked end 34s of the piercer / nail pierces the medical fluid (e.g., PD fluid) bag 14 to open, thereby allowing access to the medical fluid or PD fluid therein. During activation, the expansion of the compression spring 70 translates the piercer / nail 30 until the protrusion 40 on the lever 36 of the piercer / nail meets the post-activation housing opening 54. When this happens, the lever 36, which is biased to spring upward during actuation, automatically snaps upward into the post-actuation opening 54, thereby preventing further translation of the punch / nail 30. It should be understood that the compression spring 70 provides the piercing force required to overcome the tear resistance of the container or bag 14, so that the user does not have to provide such force.

[0077] Figure 8 It is shown that after actuation of the piercing connector assembly 10, with the medical fluid (e.g., PD fluid) bag 14 punctured, the medical or PD fluid can flow from the medical or PD fluid bag 14 through the interior lumen of the piercer / spike 30 into a medical or PD treatment fluid line or tube (not shown) attached to the connector 34c of the piercer / spike. The outwardly extending tab 14 of the lever 36 of the piercer / spike 30 remains within the post-activation opening 54 of the housing 54, so that the spiked end 34s of the piercer / spike 30 is securely retained within the medical fluid (e.g., PD fluid) bag 14 while the bag 14 is emptied.

[0078] Fig. 9 and Fig.10 One embodiment of an interference fit between the actuator or slider 80 and the member 60 of the housing 50 is shown. Figure 3 and Figure 5The member 60 is shown to define a groove 62 ( Figure 3 ), these grooves 62 frictionally but slidably receive the inwardly extending legs 82 of the slider 80 ( Figure 5 ). Fig. 9 It is shown that the member 60 may be additionally formed with or attached to a flared head 66 that is angled outwardly in a triangular manner from the remainder of the member 60. The flared head 66 forms an interference fit with the legs 82 of the actuator or slider 80, thereby preventing the actuator or slider from moving forward before and during actuation. Fig. 9 To actuate the piercing connector assembly 10, the user presses the slider 80 and moves the slider 80 in the Fig. 9 The slider 80 is slid from right to left in the slot 62 of the member 60 to overcome the retaining force of the interference fit between the flared head 66 and the leg 82 of the actuator or slider 80. Once the leg 82 slides to the left of the interference fit due to the flared head 66, the slider 80 can slide further to the left without significant interference. In one embodiment, the leg 82 of the slider 80 remains in the slot 62 of the member 60 throughout the travel of the member 60 so that the movement of the member 60 is always guided.

[0079] Although not in Fig. 9 8, but the member 60 may be additionally formed with protrusions / recesses that temporarily extend into or receive matching recesses / protrusions formed in the legs 82 of the slider 80. During sterilization, handling, packaging, shipping, and storage prior to use, the interference fit between the protrusions and recesses will additionally hold the actuator or slider 80 in place releasably against the member 60. To actuate the piercing connector assembly 10, the user will hereby press the slider 80 and cause it to Fig. 9 In the embodiment of the present invention, the slider 80 is slid from right to left in the projection / recess to overcome the retaining force of the interference fit between the projection and the recess. Once the leg 82 is slid to the left side of the projection / recess interference fit, the slider 80 can further slide to the left without significant interference.

[0080] Fig.10 An end view of an actuator or slider 80 slidably engaged to member 60 is shown, and further shown above in conjunction with Figure 3 and Figure 5 Specifically, member 60 defines slots 62 that receive legs 82 of an actuator or slider 80 so that the slider may not move upwardly away from member 60. As discussed, in one embodiment, legs 82 of slider 80 remain within slots 62 of member 60 throughout the travel of member 60 so that slider 80 cannot be disengaged from member 60 or housing 50 (regardless of the position of slider 80 relative to member 60).

[0081] 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. Therefore, it is intended that any or all such changes and modifications may be covered by the appended claims. For example, although the O-ring 32 is shown as being assembled or formed with the punch / nail 30, the O-ring may alternatively be provided with the valve 20.

Claims

1. A piercing connector assembly, comprising: a valve for sealing to a medical fluid container; as well as A perforating connector, the perforating connector comprising: a piercer sealingly received by the valve, the piercer comprising a spiked end and a lever, the lever comprising a projection; a housing extending around the perforator sealingly received by the valve, the housing including a pre-activation opening and a post-activation opening; a spring held compressed by the projection of the lever of the punch within the pre-activation opening of the housing during a pre-activation period; and an actuator slidably engaged to the housing, the actuator including a protrusion, the actuator being configured to be translated by a user such that the protrusion becomes aligned with the projection within the pre-activation opening, wherein the user can then push the protrusion into the pre-activation opening to disengage the projection from the pre-activation opening, and wherein the spring can then decompress and translate the piercer such that the medical fluid container is pierced open by the spiked end and the projection becomes positioned within the post-activation opening.

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

3. The piercing connector assembly according to claim 1, wherein: The perforator is sealingly received by the valve via an O-ring, and wherein the O-ring is formed together with the perforator and the valve, or the O-ring is a separate O-ring.

4. The piercing connector assembly according to claim 1, wherein: The end of the piercer includes a connector for connecting to a tube configured to deliver the medical fluid from the medical fluid container.

5. The piercing connector assembly according to claim 1, wherein: The punch includes an elongated cylindrical body and a circular wall extending from the body, wherein the lever extends from the circular wall, and wherein the spring is held in compression by the circular wall.

6. The piercing connector assembly according to claim 5, wherein: The housing comprises an internal ledge, and wherein the spring is also held in compression by the internal ledge.

7. The piercing connector assembly according to claim 1, wherein: The distal end of the actuator is extended so that during a pre-activation period, the distal end covers the protrusion of the lever of the punch that is located within the pre-activation opening of the housing.

8. The piercing connector assembly according to claim 1, wherein: The projection extends radially outward from the lever into the pre-activation opening and the post-activation opening.

9. The piercing connector assembly according to claim 1, wherein: The lever is bent by the protrusion contacting the inner surface of the housing while the lever moves between the pre-activation opening and the post-activation opening, and the bending of the lever biases the lever to snap into the post-activation opening when reaching the post-activation opening.

10. The piercing connector assembly according to claim 1, wherein: The protrusion extends radially inwardly from the actuator to allow a user to push the protrusion into the pre-activation opening to disengage the tab from the pre-activation opening.

11. The piercing connector assembly according to claim 1, wherein: The housing includes an outwardly extending member defining at least one slot, and wherein 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 housing.

12. A perforated connector, comprising: a punch including a spiked end and a lever including a protrusion; a housing extending around the punch, the housing including a pre-activation opening and a post-activation opening; a spring held compressed by the projection of the lever of the punch within the pre-activation opening of the housing during a pre-activation period; as well as an actuator slidably engaged to the housing, the actuator including a protrusion, the actuator being configured to be translated by a user such that the protrusion becomes aligned with the projection within the pre-activation opening, wherein the user can then push the protrusion into the pre-activation opening to disengage the projection from the pre-activation opening, and wherein the spring can then decompress and translate the piercer such that the medical fluid container is pierced open by the spiked end and the projection becomes positioned within the post-activation opening.

13. The penetration connector according to claim 12, wherein: The actuator resides radially adjacent to the housing such that the actuator tends not to become entangled with outboard structures.

14. The penetration connector according to 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 cause the medical fluid container to be pierced open by the spiked end of the piercer.

15. The penetration connector according to claim 12, wherein: The protrusion is provided at a middle or offset portion of the actuator or slider.

16. A method for accessing a medical fluid, comprising: providing a punch including a spiked end and a lever including an outwardly extending projection; providing a housing extending around the piercer, the housing including an opening that retains the protrusion of the lever prior to access to the medical fluid; providing a spring, the spring being compressed by the perforator and the housing prior to accessing the medical fluid; as well as An actuator is provided that enables a user to translate the actuator relative to the housing so that an inwardly extending protrusion of the actuator is aligned with the protrusion of the lever retained in the opening of the housing, wherein the user can push the actuator so that the protrusion removes the protrusion from the opening, thereby allowing the spring to decompress and translate the perforator so that the medical fluid container is pierced open by the perforator.

17. The method according to claim 16, comprising: A valve is provided for the medical fluid container, wherein the piercer sealingly moves within the valve.

18. The method according to claim 17, wherein: The housing extends around an outside of the valve.

19. The method according to claim 16, wherein: The medical fluid container is a PD fluid container.

20. The method according to claim 16, comprising: preventing the actuator from being translated relative to the housing in a non-registered direction; and releasably preventing the actuator from being translated relative to the housing in a registration direction.

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