Filter needle assembly with seal plug

Abstract

A filter needle assembly for use in administering a liquid payload, comprising a needle and connector portion, a filter needle body cap, a sealing plug, and a filter. The sealing plug initially lacks a needle channel, so that the distal end of the hollow needle must be pushed through the distal end of the sealing plug while the sealing plug is held by a holding tool with a hollow wire of sufficient depth to receive the protruding end of the hollow needle. Attempts to reuse the filter needle assembly by inserting the hollow needle into the filter needle assembly for a second time will not work because the distal end of the hollow needle will push the sealing plug distally rather than passing through it.

Description

[Technical Field]

[0001] This application incorporates by reference commonly assigned U.S. Patent No. 9,669,164 B2, issued June 6, 2017, for "Filtering Needle Cap Having a Sealing Sleeve Around a Needle." To the extent that the teachings or terminology found in the '164 patent differ from this application, the usage in this application controls. [Background technology]

[0002] Field of the Disclosure The present disclosure generally relates to a filter needle assembly for safely administering medications or other liquid payloads that require filtration prior to administration to a patient. The filter needle assembly may be used with human patients, in veterinary applications for animals, and in other applications that benefit from filtration of the liquid payload before delivery. In this disclosure and the claims that follow, the term needle should be understood to mean a hypodermic needle or similar needle with an open distal end and an internal lumen to allow for the transfer of liquid.

[0003] Liquid medications are typically stored in sealed glass ampoules (often spelled ampoules) or other known storage devices. In the case of glass ampoules, to access the medication, the ampoules are opened by snapping off the glass neck. In doing so, debris in the form of glass shards can be generated, which must be removed from the medication before administration. The debris is typically removed by drawing the medication through a filtered cannula or straw fixed to the end of a syringe.

[0004] The most common use of a syringe for delivering liquids is to deliver liquid medications, but other liquid payloads can be drawn from a reservoir through a filter to remove debris before delivering the filtered liquid payload through a needle connected to the syringe.

[0005] Examples of uses beyond pharmaceuticals include the infusion of some nutritional supplements into patients. Some public health agencies offer needle exchanges for people addicted to illegal drugs as a way to limit the spread of disease, and filter needles can be effective in this application. Some blood products, such as PCC (prothrombin complex C), use filter needles. The list of uses should not be considered a limitation on the scope of the claims, as one of ordinary skill in the art will be able to adapt the teachings of the present disclosure for use with a particular liquid payload and filtration needs.

[0006] Methods for removing debris include two-stage and one-stage processes. In a two-stage process, the needle or straw has a filter element secured within the needle and connector portion. As the liquid payload is drawn into the syringe, the filter captures the debris and removes it from the administered liquid payload. The filter straw or needle is then removed from the syringe and discarded. Care must be taken to remove and discard the filter needle to avoid inadvertently administering a contaminated liquid payload to a patient. In addition to the risk of accidentally administering a contaminated liquid payload to a patient, a two-stage process can involve the use of specially adapted, expensive disposable equipment.

[0007] Relevant prior art includes commonly assigned U.S. Patent No. 9,669,164 to Carr et al., issued June 6, 2017, for "Filtering Needle Cap Having Sleeve Sealing Around a Needle." This filter needle cap featured a sleeve inserted into the filter needle cap from the open end toward the distal / filter end to seal around the outer diameter of the hollow needle. The placement of the sleeve within the filter needle cap limited the dead volume of liquid payload that would be drawn through the filter and into the filter needle cap, but not into the distal tip of the hollow needle.

[0008] Commonly assigned U.S. Patent No. 10,512,728 to Carr et al. issued on December 24, 2019, for a "Filtering Needle Cap with a Seal Around a Needle." The '728 patent was the result of a divisional application claiming priority to the '164 patent. While the '728 patent shared a common purpose with the '164 patent, it differed in that the '164 patent relied on a sleeve to seal a portion of the outer diameter of a hollow needle, while the '728 patent did not use a separate sleeve component. Instead, '728 teaches an intermediate portion of the filter needle cap between the distal open end of the filter needle cap and the proximal open end of the filter needle cap, the intermediate portion being sized such that when the filter needle cap is attached to the hub, insertion of the distal tip of the hollow needle through the intermediate portion of the filter needle cap substantially seals circumferentially around the outer diameter of the hollow needle closer to the distal end of the hollow needle than to the proximal end of the hollow needle, thereby preventing the liquid payload from being drawn into the fluid fitting and down the outer diameter of the hollow needle within the filter needle cap, so that the liquid payload is drawn into a lumen within the hollow needle.

[0009] Disposable medical devices should be used only once.

[0010] The filter needle assembly is intended for single use. The filter needle cap taught in U.S. Pat. No. 9,669,164 (discussed above) or U.S. Pat. No. 10,512,728 (discussed above) is intended for single use. Once the hollow needle is removed from the filter needle cap, the filter needle cap should be discarded. However, filter needle caps as taught in the '164 or '728 patents can be reused because there is nothing to prevent the distal tip of the hollow needle from being reinserted back into the filter needle cap through the sleeve or sealed intermediate portion.

[0011] Even though packaging and user instructions prohibit it, there is always the temptation to reuse equipment. Sometimes this is an attempt to save money by using a single-use item several times, as there are many needs to draw the same liquid payload from a series of identical ampoules.

[0012] A staff member may have obtained a filter needle cap and used the filter needle cap in the prescribed manner. After removing the hollow needle from the filter needle cap, the staff member may want to aspirate additional liquid payload from the ampoule but may not want to go to the supply cabinet to obtain another filter needle cap. Perhaps the staff member did not aspirate the entire amount of liquid payload needed for the patient.

[0013] If there was no time difference because the staff member immediately realized that the amount of liquid payload required was greater than the amount drawn into the syringe, the second use could be harmless. However, if the staff member placed the used filter needle cap in a non-sterile location, this is a problem. Because staff members only have two arms, there is a greater than 50% chance that the used filter needle cap will be placed somewhere.

[0014] The risk is much higher if a staff member attempts to provide an additional liquid payload from a different ampoule several hours later and finds it easier to reuse the used filter needle cap than to retrieve a new one from the supply cabinet down the hall. While it is unclear how often such a problem might arise, the prior art, including the '164 and '728 patents, does not preclude attempts to use a filter needle cap a second time.

[0015] The goal of preventing a second use of a disposable medical device is not unique to filter needle assemblies. See, for example, U.S. Patent No. 5,261,880, issued November 16, 1993, for "Single Use Syringes with Second Use Lockout." The improvement patented in the '880 patent was a modification to a disposable hypodermic syringe that would lock the syringe after a single use.

[0016] vocabulary

[0017] One (A, An).

[0018] In this application, and in the claims that follow, the term one or a single item identification should be read as at least one unless such a construction is impossible within the context of the specification as a whole. For example, use of the term "solo," "only," or the phrase "not more than one" will indicate that a single item is intended.

[0019] Chamber.

[0020] The term chamber is used below to describe the portion of the interior pathway through which the liquid payload passes. In some uses of the word chamber, the chamber may be sealed by closing a door (such as a bedroom or a judge's chamber), but in this context, a chamber is a partially enclosed space with an inlet and an outlet.

[0021] Gne and Gnes.

[0022] To avoid unwieldy singular uses of "he / she" and "his / her," or potentially confusing "they" and "their," this application uses the gender-neutral pronoun -gne, the possessive pronoun -gnes, the reflexive pronoun -gneself, and the objective case -gnerm.

[0023] Or.

[0024] Unless indicated to the contrary, the term "or" should be construed as an inclusive or rather than an exclusive or. Thus, the default meaning of "or" would be the same as the more unwieldy "and / or."

[0025] Proximal and distal.

[0026] The terms proximal and distal are commonly used when describing medical devices. For purposes of this application and the claims that follow, proximal refers to the end that is typically held by the end user, and distal is the opposite end. Thus, in the case of a hypodermic needle, the end of the needle that is injected into the patient or IV bag would be the distal end, and the syringe end that is manipulated by the user would be the proximal end. For a holding tool that holds a sealing plug, the proximal end would be the end that is inserted into the filter needle cap body, consistent with considering the syringe end of the assembly the proximal end.

[0027] Seal.

[0028] In this disclosure and the claims that follow, the term seal, as used in the teachings of this disclosure, requires creating a seal between the outer periphery of the needle and the inner periphery of the opening created in the sealing plug so that the syringe can effectively aspirate a liquid payload through the interior of the needle and into the open distal end of the needle without drawing air past the seal. Similarly, there is a seal between the exterior of the sealing plug and the interior of the filter needle cap. A seal sufficient for this purpose may not be a seal sufficient to maintain a more dramatic pressure differential across the seal or to maintain a seal against a more moderate pressure gradient for any significant period of time. Thus, in this context, the noun and verb seal refers to a seal sufficient to allow the syringe to aspirate a liquid payload.

[0029] set.

[0030] Unless indicated to the contrary, the term "set" should be construed as a group of one or more items.

[0031] Step.

[0032] The term step may be used in descriptions within this disclosure. For clarity, one distinct operation or step may be described before proceeding with the description of another distinct operation or step. The term step should not be construed to imply any particular order among the various steps disclosed unless a particular order of individual steps is explicitly indicated.

[0033] Essentially.

[0034] Often, when describing an industrial process, it is useful to note that a given parameter is substantially satisfied. Examples would be substantially parallel, substantially perpendicular, substantially uniform, and substantially flat. In this context, substantially X means that for the purposes of the industrial process, it is X. Therefore, something that may not be absolutely parallel, but is practically parallel, is substantially parallel. Similarly, a mixed air stream with a substantially uniform temperature will have temperature deviations that are insignificant to the industrial process.

[0035] As recognized in CEEquipment Co. v. United States, 13 USPQ2d 1363, 1368 (Cl.Ct.1989), the word "substantially" in a patent claim creates some definitional discretion—thus, the word "substantially" may prevent circumvention of infringement by minor variations that do not affect the results sought to be achieved. Summary of the Invention [Problem to be solved by the invention]

[0036] Aspects of the teachings contained within this disclosure are addressed in the claims filed with this application upon filing, and rather than adding a redundant restatement of claim subject matter, these claims should be considered incorporated by reference into this Summary.

[0037] This Summary is intended to introduce the concepts disclosed herein, rather than to be an exhaustive list of the numerous teachings and variations on those teachings provided in the broad description within this disclosure, and therefore, the contents of this Summary should not be used to limit the scope of the claims that follow.

[0038] The inventive concepts are illustrated in a series of examples, with some examples illustrating more than one inventive concept. Individual inventive concepts can be implemented without implementing all the details provided in a particular example. Those skilled in the art will understand that the inventive concepts illustrated in various examples can be combined together to address specific applications, so it is not necessary to provide examples of all possible combinations of the inventive concepts provided below. [Means for solving the problem]

[0039] Some aspects of the teachings of the present disclosure can be expressed as a filter needle assembly for use in administering a liquid payload, the filter needle assembly including a needle and connector portion, a filter needle cap body, a seal plug, and a filter. The needle and connector portion includes a hollow needle with a distal tip of the hollow needle having an opening to a lumen extending through the hollow needle. The needle and connector portion also includes a hub, which in turn includes an open proximal end adapted to reversibly engage a fluid fitting; and The distal end of the hub engaged with the proximal end of the hollow needle Includes.

[0040] The filter needle cap body includes an open distal end in fluid communication with the open proximal end of the filter needle cap body via an internal channel, the open proximal end of the filter needle cap body being sized to receive the distal end of the hub within the open proximal end of the filter needle cap body and reversibly engage with the hub when the distal end of the hollow needle is inserted into the internal channel.

[0041] The filter needle cap also includes a filter adapted to remove debris from the liquid payload as it is drawn into the fluid fitting, through the filter and filter needle cap, and into the lumen within the hollow needle.

[0042] The filter needle assembly also includes a seal plug for surrounding the distal portion of the hollow needle after the distal tip of the hollow needle is pushed through the seal plug to form a seal between the seal plug and the distal portion of the hollow needle, so that the liquid payload is drawn into the fluid fitting and is prevented by the seal plug from passing down the outer diameter of the hollow needle within the filter needle cap, causing the liquid payload to be drawn into the lumen within the hollow needle.

[0043] In this type of filter needle assembly, removing the hollow needle from the sealing plug precludes reliable reinsertion of the hollow needle through the sealing plug, as subsequent contact of the distal end of the hollow needle pushes the sealing plug toward the distal open end of the filter needle cap body, precluding a second use of the filter needle assembly.

[0044] Some aspects of the teachings of the present disclosure can be expressed as a method for loading a quantity of a filtered liquid payload into a syringe and associated hollow needle and disabling loading of a second quantity of a filtered liquid payload into a second syringe and associated second hollow needle. Obtaining a reservoir of liquid payload, and Obtaining a syringe attached to a filter needle assembly, the filter needle assembly including a needle and connector portion and a filter needle cap body. Includes.

[0045] The needle and connector are a hollow needle having a distal tip thereof with an opening to a lumen extending through the hollow needle; a hub including an open proximal end adapted to reversibly engage a fluid fitting, and a distal end of the hub engaged with a proximal end of a hollow needle; Includes.

[0046] The filter needle cap body is a distal open end in fluid communication with the proximal open end of the filter needle cap body via an internal channel; a proximal open end of the filter needle cap body sized to receive a distal end of the hub within the proximal open end of the filter needle cap body to reversibly engage the hub when the distal end of the hollow needle is inserted into the internal channel; a filter adapted to remove debris from the liquid payload as the liquid payload is drawn into the fluid fitting and through the filter needle assembly into the lumen in the hollow needle; and a seal plug for surrounding the distal end of the hollow needle after the distal end of the hollow needle is threaded through the seal plug to form a seal between the seal plug and the distal portion of the hollow needle such that the liquid payload is prevented from passing down the outer diameter of the hollow needle within the filter needle cap body by the seal plug and the liquid payload is drawn into the lumen within the hollow needle; Includes.

[0047] Because the sealing plug can be moved distally away from the distal end of the hollow needle unless it is held in place by the tool, when the distal tip of the hollow needle is moved through the sealing plug, the sealing plug is held in place by the tool, and therefore the second hollow needle cannot be used to load a second amount of a second filtered liquid payload into the second syringe after removal of the hollow needle from the sealing plug.

[0048] A method for loading a quantity of filtered liquid payload into a syringe using a syringe to aspirate the liquid payload from a liquid payload reservoir also includes using the syringe to aspirate the liquid payload from the liquid payload reservoir, the liquid payload passing through a filter before entering an opening in the distal end of the hollow needle before removing the hollow needle from the filter needle assembly to expose the distal tip of the hollow needle.

[0049] Some aspects of the teachings of the present disclosure can be expressed as a method of assembling a filter needle assembly, the method comprising: Needle and connector parts, Filter needle cap body, Seal plugs, and Filters This includes obtaining

[0050] The method includes pushing a sealing plug into the open distal end of the filter needle cap body until the sealing plug comes to rest against an annular shoulder at the distal end of a proximal chamber between the annular shoulder and the open proximal end of the filter needle cap body.

[0051] The method includes holding the seal plug against an annular shoulder with a holding tool having an opening midline while the distal tip of the hollow needle advances through the seal plug, so that the distal tip of the hollow needle extends beyond the distal end of the seal plug and into the opening midline of the holding tool.

[0052] The method then calls for removing the holding tool after the distal tip of the hollow needle extends beyond the distal end of the sealing plug.

[0053] The method then calls for inserting a filter into the distal end of the filter needle cap body and securing the filter to the distal end of the filter needle cap body.

[0054] Some aspects of the teachings of the present disclosure can be expressed as a method for preventing a filter needle assembly from operating with a hollow needle. While designing to fail is counterintuitive, this prevents a second use of the filter needle assembly, thus protecting the patient from inadvertent second use of the filter needle assembly. The method can be summarized as loading a syringe with a liquid payload through the filter needle assembly and then retaining the filter needle assembly rather than discarding it.

[0055] The distal tip of the hollow needle is then inserted into the open proximal end of the filter needle assembly and the distal tip of the hollow needle is advanced through the proximal chamber of the filter needle assembly and into the hollow interior of the sealing plug.

[0056] The method also requires advancing the distal tip of the hollow needle until it contacts the sealing plug and pushing the sealing plug distally into the distal chamber of the filter needle assembly without passing through the sealing plug. The result is that because the distal tip of the hollow needle cannot pass through the sealing plug without a retention tool holding the sealing plug against the annular shoulder at the distal end of the proximal chamber, someone attempting to use the filter needle assembly will ultimately not be able to easily draw liquid into the hollow needle because the distal tip of the hollow needle is not within the distal chamber.

[0057] Additional aspects of the teachings of the present disclosure include: Needle and connector parts, Filter needle cap body, Seal plugs, and Filters The present invention may be expressed as a method of assembling a filter needle assembly, comprising obtaining

[0058] The method also includes pushing the sealing plug into the open distal end of the filter needle cap body until the sealing plug comes to rest against the annular shoulder at the distal end of the proximal chamber located between the annular shoulder and the open proximal end of the filter needle cap body.

[0059] Thereafter, while the distal tip of the hollow needle is advanced through the sealing plug, the sealing plug is held against the annular shoulder with a holding tool having an opening midline such that the distal tip of the hollow needle extends beyond the distal end of the sealing plug and into the opening midline of the holding tool.

[0060] The retention tool is then removed after the distal tip of the hollow needle extends beyond the distal end of the sealing plug and before the filter is inserted into the distal end of the filter needle cap body and secured to the distal end of the filter needle cap body. [Effects of the Invention]

[0061] Other systems, methods, features and advantages of the disclosed teachings will be, or will become, immediately apparent to one with skill in the art upon examination of the following figures and detailed description, and it is intended that all such additional systems, methods, features and advantages be included within the scope of and protected by the accompanying claims.

[0062] The present disclosure can be better understood with reference to the following figures. The components in the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the present disclosure. Moreover, in the figures, like reference numbers designate corresponding parts throughout the different views. [Brief explanation of the drawings]

[0063] [Figure 1] The filter needle assembly 100 is shown in exploded perspective format. [Figure 2] 1A and 1B are side and front perspective views of a filter needle assembly 100 allowing a view of a filter 400 within the distal end of the filter needle assembly 100. [Figure 3] 1 is a cross-section of a filter needle assembly 100. [Figure 4] 1 is a cross-sectional side view of a seal plug 300. FIG. [Figure 5] 1 provides a front perspective view of a seal plug 300. [Figure 6] 1 provides a rear perspective view of the seal plug 300. [Figure 7] A process 1000 for loading a syringe with a liquid payload through a filter needle assembly 100 is shown. [Figure 8] 20 illustrates a process 2000 for disabling loading a second syringe with a previously used filter needle assembly 100. [Figure 9] 1 shows an enlarged partial cross section of filter needle assembly 100 after distal tip 154 ​​of hollow needle 150 has pushed seal plug 300 while not being held by a holding tool. [Figure 10] The key steps in the process 3000 for assembling the filter needle assembly 100 are described. [Figure 11] 1 provides a perspective view of the holding tool 500, the filter needle cap body 250 and the seal plug 300. DETAILED DESCRIPTION OF THE INVENTION

[0064] The subject matter disclosed herein is described with particularity to satisfy statutory requirements. However, the description itself is not intended to limit the scope of the patent. Rather, the inventors contemplate that the claimed subject matter may be embodied in other ways to include different steps or elements similar to those described in this document, as well as other current or future technologies. Moreover, although the term "step" may be used herein to include different aspects of the method employed, the term should not be construed to imply any particular order among the various steps disclosed herein unless and except when the order of individual steps is explicitly described.

[0065] 1 shows in exploded perspective format a filter needle assembly 100. Illustrated in FIG. 1 are a needle and connector portion 110, as well as a filter needle cap 200, including a seal plug 300 and a filter 400.

[0066] Needle and connector portion 110 has a proximal end 114 that may be in the form of a hub 118. Hub 118 may be adapted to operate with a luer fitting, sometimes called a luer taper. Luer fittings include those known as luer locks and luer slips (sometimes slip tips). While various luer fittings are very common connections for medical instruments, other connections can be used, and the teachings of the present disclosure are not limited to any particular fitting.

[0067] Frequently, but not necessarily, the connection between hollow needle 150 and hub 118 is reinforced by an adhesive component. Such adhesive components are conventional and are not the focus of this disclosure. Therefore, details of this adhesive component are not provided. The adhesive component may be considered part of hub 118 for purposes of this disclosure and the claims that follow.

[0068] A hollow needle 150 is secured to the hub 118 of the needle and connector portion 110. The hollow needle 150 has a distal tip 154 ​​that is in fluid communication with a needle lumen 156. As described below, the present application teaches a seal around the distal portion 158 of the hollow needle 150. The distal portion 158 includes not only the distal tip 154 ​​but also a proximal portion of the hollow needle 150, such that the distal tip 154 ​​extends beyond the sealed portion of the distal portion 158 of the hollow needle 150.

[0069] The filter needle cap 200 has an open distal portion 204 and a filter needle cap body 250 with a similarly open proximal end 208. The filter needle cap 200 also has a seal plug 300 and a filter 400 that are inserted into the open distal portion 204 of the filter needle cap body 250 during assembly.

[0070] FIG. 2 is a side and front perspective view of filter needle assembly 100 allowing a view of filter 400 within the distal end of filter needle assembly 100. FIG.

[0071] The distal portion of the hub 118 is designed to be secured within the open proximal end 208 of the filter needle cap 200 .

[0072] Figure 3 is a cross-section of filter needle assembly 100. Figure 3 shows that distal tip 154 ​​of hollow needle 150 can be inserted distally into open proximal end 208 of filter needle cap 200 and advanced through proximal chamber 212. As distal tip 154 ​​moves distally, the cross-section of proximal chamber 212 decreases due to inwardly sloping wall 216. Eventually, distal tip 154 ​​reaches an annular shoulder 220 that limits proximal movement of seal plug 300. Annular shoulder 220 is the proximal end of distal chamber 230.

[0073] 4 is a cross-section of a side view of sealing plug 300. Sealing plug 300 has a distal end 304 that is originally closed but is later pierced by distal tip 154 ​​of hollow needle 150. Sealing plug 300 has a proximal face 308 with an opening 312 to a hollow interior 316 that is initially closed at distal end 306. Optionally, a diameter 320 of a majority of hollow interior 316 is larger than the outer diameter of hollow needle 150, so that distal tip 154 ​​(FIG. 3) of hollow needle 150 can pass through a majority of hollow interior 316 without resistance.

[0074] The annular proximal face 308 has a series of hemispherical projections 330 that contact the annular shoulder 220 of the filter needle cap 200. These hemispherical projections 330 aid in ejection of the molded part from the mold.

[0075] The sealing plug 300 has a first ribbed ring 344 and a second ribbed ring 348. A careful observer will notice that, in this case, the first ribbed ring 344 is not the same shape as the second ribbed ring 348. Both ribbed rings (344 and 348) have a maximum outer diameter 346 that is larger than the outer diameter 336. The maximum outer diameter 346 of the ribbed rings (344 and 348) is larger than the inner diameter 236 of the distal chamber 230 ( FIG. 3 ). Thus, when the sealing plug 300 is installed within the distal chamber 230 prior to adding the filter 400, a retention tool can be used to push the sealing plug 300 proximally as the ribbed rings (344 and 348) compress to fit within the inner diameter 236 of the distal chamber 230. This compressive fit holds the sealing plug 300 adjacent to the annular shoulder 220 at the proximal end of the distal chamber 230.

[0076] The holding force of this compression fit is not sufficient to resist the force applied by the distal tip 154 ​​of the hollow needle 150 as the hollow needle 150 advances distally, which pushes the sealing plug 300 distally, away from the annular shoulder 220 at the proximal end of the distal chamber 230.

[0077] Using the Retention Tool

[0078] While a wide variety of holding tools can be used to move the sealing plug 300 proximally within the distal chamber 230, a holding tool with an open midline can be used to hold the sealing plug 300 against the annular shoulder 220 at the proximal end of the distal chamber 230 when the distal tip 154 ​​of the hollow needle 150 is pressed against the initially closed distal end 306 of the hollow interior 316 of the sealing plug 300.

[0079] When a suitable holding tool is used to hold the sealing plug 300 against the annular shoulder 220 at the proximal end of the distal chamber 230, sufficient force can be applied to the hollow needle 150 to move the distal tip 154 ​​through the remainder of the sealing plug 300 and out of the distal end 304 of the sealing plug 300, thereby forming a seal around the distal portion 158 (FIG. 3) of the hollow needle 150.

[0080] After removing the holding tool and inserting the filter 400, one has the filter needle assembly 100 as shown in FIGS.

[0081] Additional diagram of seal plug

[0082] 5 provides a front perspective view of seal plug 300. Visible in this view are distal end 304, first rib ring 344, and second rib ring 348. The circle seen at distal end 304 is simply a flattened portion of dome-shaped distal end 304.

[0083] 6 provides a rear perspective view of seal plug 300. Visible in this view are proximal face 308, opening 312, a portion of hollow interior 316, and set of hemispherical projections 330. Also visible in this view are first rib ring 344 and second rib ring 348.

[0084] Process for use

[0085] FIG. 7 illustrates a process 1000 for loading a syringe with a liquid payload through a filter needle assembly 100.

[0086] Step 1004—Add filter needle assembly to syringe: The filter needle assembly 100, as shown in FIG. 2, is secured to the end of a syringe (not shown) or other fitting by engagement with the hub 118 at the proximal end 114 of the needle and connector portion 110.

[0087] Step 1008—Optional—Remove Outer Cap. Often, the filter needle assembly 100 is shipped with an outer cap (not shown here). The outer cap is removed. Note that in some cases, the filter needle may be shipped in sterile packaging, such as a blister pack, without the outer cap, so this step is optional. Often, the filter needle assembly will be shipped with the needle and connector portion inserted into the filter needle cap 200 at the factory and with the outer cap covering a portion of the filter needle cap 200. To minimize the possibility of the filter needle cap 200 becoming separated from the needle and connector portion 110 when attempting to remove only the outer cap, the components may be designed so that the force required to remove the filter needle cap 200 from the needle and connector portion 110 can be significantly greater than the force required to remove the outer cap from the filter needle cap 200. In this context, significantly greater would include at least twice as great. The difference in the required force can be achieved by having different degrees of interference fit or by using different materials or surface treatments. Other methods of increasing or decreasing the required removal force will be apparent to those skilled in the art.

[0088] Step 1012—Aspirate Payload into Syringe. The filter element 400 is placed in an ampoule or other suitable container for a liquid payload, such as a drug or other liquid. When the syringe plunger is withdrawn in a known manner, the liquid payload is drawn into the syringe. Filter element 400, a distal chamber 230, and The interior of the hollow needle 150 extending beyond the sealing plug 300 into the distal chamber 230 is drawn through the passage through the syringe to fill it.

[0089] The suction force for drawing up the liquid payload is confined to a path by the sealing plug 300, which substantially seals the distal chamber 230. The sealing plug 300 prevents distal airflow from entering the distal chamber 230 around the periphery of the hollow needle 150, so the syringe can effectively draw up the liquid payload. When the syringe is loaded, any debris within the container initially holding the liquid payload is prevented from entering the distal chamber 230 by the filter element 400.

[0090] Step 1016—Remove filter needle assembly from syringe. Once the syringe is loaded, the filter needle cap 200 is removed from the needle and connector portion 110 by sliding the filter needle cap 200 distally until it clears the distal tip 154 ​​of the hollow needle 150. The filter needle cap 200 may then be discarded along with any debris trapped within the filter 400.

[0091] Step 1020—Loaded syringe is ready for use. The syringe is loaded with a desired amount of liquid payload that is filtered as the liquid passes through filter 400. The distal tip 154 ​​of hollow needle 150 is exposed and ready for use. Depending on the application, the distal tip 154 ​​of hollow needle 150 can be inserted into a patient's body as needed, into a port with a septum for use in IV therapy, or into some other location.

[0092] Process to prevent second use

[0093] FIG. 8 illustrates a process 2000 for disabling loading a second syringe with a previously used filter needle assembly 100.

[0094] Step 2004—Load the syringe with the liquid payload through the filter needle assembly 100 including the filter needle cap 200 as described in process 1000, but without discarding the filter needle cap 200 after removing the hollow needle 150 from the filter needle cap 200.

[0095] Step 2008—Insert the distal tip of the hollow needle into the open proximal end of the filter needle cap 200. This distal tip of the hollow needle may be the same distal tip of the hollow needle used in process 1000, or it may be a new distal tip of a new hollow needle attached to a new syringe.

[0096] Step 2012 - The distal tip of the hollow needle is advanced through the proximal chamber of the filter needle cap and into the hollow interior 316 of the sealing plug 300.

[0097] Step 2016—Continue to advance the distal tip of the hollow needle distally.

[0098] Step 2020—Bringing the distal tip 154 ​​of the hollow needle 150 into contact with the sealing plug 300. Because the opening formed by intersecting the first distal tip of the first hollow needle with the sealing plug 300 while the sealing plug 300 is prevented from distal movement by a suitable holding tool is substantially closed after the hollow needle is withdrawn from the sealing plug 300, there is resistance even though the second distal tip 154 ​​perfectly matches the path previously taken by the first distal tip 154.

[0099] Step 2024—Push the sealing plug 300 distally within the distal chamber without passing through it. Because the force required to penetrate and pass through the sealing plug is greater than the frictional force holding the sealing plug 300 adjacent the annular shoulder 220 within the distal chamber 230 due to the compressive fit of the ribbed rings (344 and 348), continued distal movement of the distal tip 154 ​​of the hollow needle 150 pushes the sealing plug 300 distally within the distal chamber without passing through it. See FIG. 9 , which shows an enlarged partial cross-section of the filter needle assembly 100 after the distal tip 154 ​​of the hollow needle 150 has pushed against the sealing plug 300 while not being held by a holding tool. The sealing plug 300 is sliding distally within the distal chamber 230.

[0100] Step 2028—Because the distal tip 154 ​​of the needle 150 has not passed through the seal plug 300, the liquid payload cannot be easily aspirated through the filter 400. While it is possible that some liquid payload may eventually be aspirated through the previous needle path within the seal plug 300, it is possible that air from the proximal end of the filter needle assembly 100 will make its way down to the distal tip 154 ​​of the hollow needle 150 because the distal tip is on the proximal side of the seal and there is nothing to prevent air from entering the distal tip and satisfying suction being drawn from the syringe body. This is not a satisfactory process, and staff members are unlikely to attempt it again. Therefore, the design makes it impossible to routinely load a second syringe with a previously used filter needle assembly 100, because the hollow needle would not work well to retrieve the liquid payload, moving it rather than passing through the seal plug.

[0101] The process described above precludes the insertion of a second hollow needle connected to a second syringe to draw a second payload liquid. In this context, the filter needle cap 200 cannot recognize that the inserted hollow needle 150 is the same hollow needle 150 that was recently withdrawn from the filter needle cap 200. Once the hollow needle 150 is removed from the filter needle cap 200, it becomes a stranger, and therefore a second hollow needle connected to a second syringe attempts to obtain a second liquid payload. The process would function the same as if a different hollow needle were inserted; that hollow needle would also be treated as a prohibited second hollow needle.

[0102] Process for Assembling a Filter Needle Assembly

[0103] FIG. 10 describes the key steps in a process 3000 for assembling the filter needle assembly 100.

[0104] Step 3004—Obtain: needle and connector portion 110 , filter needle cap body 25 , seal plug 300 , and filter 400 .

[0105] Step 3008 - Pressing the sealing plug 300 into the open distal end of the filter needle cap body 250 continues to move the sealing plug 300 until it comes to rest against the annular shoulder 220 at the end of the proximal chamber 212.

[0106] STEP 3012—Holding the sealing plug while the distal tip is threaded through it. More specifically, while the distal tip 154 ​​of the hollow needle 150 is advanced all the way into the hollow interior 316 of the sealing plug 300, the sealing plug 300 is held with a holding tool having an open midline against an annular shoulder, and then, while the sealing plug 300 is prevented from distal movement by the holding tool, the distal tip 154 ​​is pushed through the remainder of the sealing plug 300 so that the distal tip 154 ​​extends beyond the distal end 304 of the sealing plug 300 and into the open midline of the holding tool.

[0107] Step 3016—After the distal end of the hollow needle extends beyond the distal end of the sealing plug, remove the retention tool from the distal portion 204 of the filter needle cap.

[0108] Step 3020—Insert filter 400 into the distal end of filter needle cap body 250. The filter may be held in place by a variety of methods known to those skilled in the art, including adhesives, compression fit, and others.

[0109] Step 3024—Create a sealed and sterilized package with the filter needle assembly 100 in the package.

[0110] detail

[0111] Filter element selection

[0112] One design criterion for choosing a filter element on the distal end of a filter needle cap versus one contained within the filter needle cap is whether the collection of abnormal components within the liquid payload is appropriate for the application. While all filter elements can be used to remove glass debris, in some cases, using a filter element on the distal end of a filter needle cap can be useful because this distal surface concentrates certain types of abnormal components. For example, some medications may partially crystallize from age or handling. While a small amount of crystallization may be acceptable, an abnormal amount may indicate that the medication should be discarded rather than used. Similarly, some medications may have a small amount of sediment within the medication reservoir, such as an ampoule, but if a large amount of sediment appears on the outer surface of the filter element, excessive sediment may indicate that the medication is too old or has been spoiled by handling.

[0113] The filter element can be a sintered filter with several serpentine internal channels for the liquid payload to travel through while capturing debris. Increasing the thickness of the filter increases the distance the liquid payload must travel, but it also increases the number of possible paths for the liquid payload to travel. Thus, for a range of thicknesses, increasing the thickness decreases the overall flow resistance.

[0114] One well-known vendor in the field of sintered filter materials is Porex Corporation, Fairburn, Georgia, USA, at www.Porex.com (blanks inserted to avoid live link).

[0115] Plug material

[0116] The selection of material for use in the plug is a design choice and may be influenced by the type of needle being used and the geometry of the plug and other components. The material will need to be compatible with the liquid being filtered, the planned sterilization process, and the desired shelf life. One suitable material is 50 durometer chlorobutyl, available from several vendors.

[0117] Filter element retention

[0118] In some of the aforementioned examples, the filter element was held in place by protrusions or detents extending into the filter element to secure the filter element. Adhesives may be used to secure the filter element. Many designers prefer protrusions or other forms of interference fit because the use of adhesives can result in the adhesive entering potential flow paths for the liquid payload and thus partially damaging the filter element. Those skilled in the art will recognize that other attachment methods, such as ultrasonic bonding, spin welding, heat welding, and press fit, can be used. Similarly, other suggested connections between components are provided to provide suitable examples, and those skilled in the art will recognize many options for connecting two components together. The teachings of the present disclosure are not limited to any particular connection method for joining components, unless specifically recited in the claims that follow.

[0119] Needle Type

[0120] The various figures described in connection with this disclosure consistently show sharpened distal ends for needles. These needles have beveled tips. Sharp-tipped hypodermic syringes are particularly adapted for injecting fluids directly into a patient's body.

[0121] In many cases, liquid payloads are not delivered directly into a patient's body, but instead into a fluid bag used in intravenous therapy (IV therapy). A drip of liquid is delivered into a patient's vein to slowly provide the desired treatment. IV fluids are typically delivered within the bag. A port with a self-sealing septum can be used to add medication to the liquid being provided in IV therapy. While a pointed-tip needle can be used to deliver the liquid payload through the septum, some people prefer to use a blunt-tip needle. A blunt-tip needle may reduce the risk of needle sticks to medical personnel and cause less damage to the septum. Needle tip variations and the best use for each type of needle tip are beyond the scope of this disclosure, and nothing in this disclosure limits the teachings to applications with pointed-tip needles. Blunt-tip needles have an opening on their distal end, and those skilled in the art can adapt the geometry of a filter needle cap to accommodate the geometries of various types of blunt-tip needles, as needed.

[0122] Connection to the hub

[0123] The examples of this disclosure have referred to the distal end of a syringe engaging with hub 118. While this may be the most common interaction with a filter needle, the teachings of this disclosure may be employed when there is a combination of components other than a syringe. For some special reason, there may be a series of components including check valves, tubing, syringes, or even alternatives to syringes that can controllably intake and expel a liquid payload through the needle. This disclosure may be used as long as there is an appropriate connection between the filter needle and the remaining components via the distal fluid fittings of the remaining components.

[0124] Sterilization Selection

[0125] Those skilled in the art will recognize that filter needle caps, with or without outer caps, can be sterilized before being provided to a medical facility. Those skilled in the art will recognize that many different processes are possible, such as electron beam processing, gamma sterilization, or ethylene oxide gas. Those skilled in the art will recognize that medical instruments can be adapted for use with a particular sterilization process to maximize effectiveness and throughput. The teachings of the present disclosure can be adapted for use with a variety of sterilization techniques, and therefore, this aspect of the examples has not been emphasized or described.

[0126] Optional use of outer cap

[0127] As mentioned above, some applications may not use an outer cap, but the needle and connector portion may be packaged together with the filter needle cap in a package such as a blister pack. The package maintains the sterility of the item, making it impossible for even sterile debris to become trapped inside the filter needle cap. Outer caps are well known to those skilled in the art. Figure 1 of U.S. Patent No. 9,669,164 shows the outer cap as element 12. Figure 1 is incorporated by reference.

[0128] Alternatives and Variations

[0129] Filter 400 position

[0130] Although the illustrations used in this disclosure show the filter 400 completely within the distal end of the filter needle cap 200, this is not required to enjoy the benefits of the sealing plug 300. U.S. Patent No. 9,669,164 to Carr et al. for "Filtering Needle Cap Having a Sleeve Sealing Around a Needle" illustrates a range of suitable positions for the filter. The '164 patent is incorporated by reference in its entirety.

[0131] Number of ribbing

[0132] The examples described above had a sealing plug 300 with two rib rings 344 and 348. Those skilled in the art will understand that the number of rib rings can be one, two, or more than two. What is needed is the ability to compress the sealing plug 300 to a slightly smaller diameter, as the sealing plug 300 will deform to fit, and this compression fit increases the amount of force required to move the sealing plug 300, but does not increase the required level sufficiently to allow the distal tip 154 ​​of the hollow needle 150 to be advanced through the sealing plug 300 without the use of a retention tool.

[0133] Holding tool

[0134] 11 provides a perspective view of a retention tool 500, filter needle cap body 250, and sealing plug 300. Retention tool 504 has a distal end 508 and a proximal end 504 that is inserted into open distal portion 204 of filter needle cap body 250 and then used to press and hold sealing plug 300 against annular shoulder 220 (FIG. 3). While sealing plug 300 is being held against annular shoulder 220, distal tip 154 ​​(FIG. 3) of hollow needle 150 can be forced through distal end 304 (FIG. 4) of sealing plug 300.

[0135] The proximal end 504 of the retention tool 500 needs to have a concave surface deep enough to accommodate the distal end of the hollow needle 150, which extends beyond the distal end 304 of the sealing plug 300. One way to create this concave surface is to have the retention tool 500 be a hollow cylinder with an open midline from the proximal end 504 to the distal end 504. However, this is not required. The opening at the proximal end 504 can terminate anywhere within the retention tool 500. The proximal end 504 of the retention tool can have a set of two or more fingers that hold the sealing plug 300 against the annular shoulder 220 and provide sufficient room for the distal end of the hollow needle 150. Those skilled in the art can work with this disclosure to come up with a variety of retention tools that are consistent with the purpose of this tool.

[0136] Those skilled in the art will recognize that some of the alternative embodiments described above are generally not mutually exclusive, and that in some cases, additional embodiments can be created that employ two or more aspects of the variations described above. Likewise, the present disclosure is not limited to the examples or specific embodiments provided to facilitate understanding of the various teachings of the present disclosure. Moreover, the scope of the claims that follow covers the range of variations, modifications, and substitutions to the components described herein, as would be known to one of ordinary skill in the art.

[0137] While the methods and / or events described above may depict certain events and / or procedures occurring in a certain order, the ordering of certain events and / or procedures may be altered. Additionally, certain events and / or procedures may be performed simultaneously in parallel processes, even sequentially where possible, as described above. The legal limits of the scope of the claimed invention are set forth in the claims that follow and extend to include their legal equivalents. Persons unfamiliar with the legal aspects of equivalents should consult a person registered to practice before the patent authority that granted this patent, such as the U.S. Patent and Trademark Office or its equivalent.

Claims

1. A filter needle assembly (100) for use in administering a liquid payload, said filter needle assembly comprising a needle and connector portion (110), a filter needle cap body (250), a seal plug (300), and a filter (400); The needle and connector portion (110) a hollow needle (150) having a distal tip (154) of said hollow needle with an opening to a lumen (156) extending through said hollow needle; A hub (118), an open proximal end (114) adapted to reversibly engage a fluid fitting; and a distal end of the hub engaged with a proximal end of the hollow needle; Including the hub and Including, The filter needle cap body (250) a distal open end (204) in fluid communication with the proximal open end of the filter needle cap body via an internal channel; the proximal open end (208) of the filter needle assembly sized to receive the distal end of the hub within the proximal open end of the filter needle cap body for reversible engagement with the hub when the distal end of the hollow needle is inserted into the internal channel; Including, the filter (400) is adapted to remove debris from the liquid payload as the liquid payload is drawn into the fluid fitting, through the filter and the filter needle assembly, and into the lumen within the hollow needle; the sealing plug (300) surrounds the distal end of the hollow needle after the distal tip of the hollow needle is pushed through the sealing plug to form a seal between the sealing plug and the distal portion of the hollow needle, so that the liquid payload is drawn into the fluid fitting and prevented by the sealing plug from passing down the outer diameter of the hollow needle within the filter needle assembly, causing the liquid payload to be drawn into the lumen within the hollow needle; Upon removal of the hollow needle from the sealing plug, subsequent contact of the distal end of the hollow needle pushes the sealing plug toward the distal open end of the filter needle cap body, precluding a second use of the filter needle assembly and therefore precluding reliable reinsertion of the hollow needle through the sealing plug. A filter needle assembly (100).

2. 2. The filter needle assembly of claim 1, wherein the sealing plug is dome-shaped with a convex shape on the distal end (304) of the sealing plug and a hollow interior (316) that opens to a proximal face (308) of the sealing plug so that the distal tip of the hollow needle can advance through the hollow interior before being pushed through material between the distal end (306) of the hollow interior and the distal end (304) of the sealing plug.

3. 2. The filter needle assembly of claim 1, wherein the sealing plug has at least one rib ring (344, 348) such that an outer diameter of the sealing plug is not constant from the proximal end of the sealing plug to the distal end of the sealing plug, and the at least one rib ring forms a friction fit with the portion of the sealing plug within the filter needle cap body against which the sealing plug is held while the distal end of the hollow needle is pushed through the sealing plug, such that the liquid payload is substantially prevented from moving between the at least one rib ring and the portion of the sealing plug within the filter needle cap body.

4. 10. The filter needle assembly of claim 1, further comprising an outer cap having a closed distal end that can be placed over at least a portion of the filter needle assembly until the filter needle assembly is uncovered to filter the liquid payload as the liquid payload is drawn into the fluid fitting.

5. The open proximal end of the hub is adapted to be reversibly engaged with the fluid fitting on the distal end of a syringe, so that: operation of the syringe to take in the liquid payload, which is filtered by the filter and then passed through the hollow needle; Subsequent removal of the filter needle assembly to expose the distal end of the hollow needle allows administration of the filtered liquid payload through manipulation of the syringe.

10. The filter needle assembly of claim 1.

6. 10. The filter needle assembly of claim 1 provided in a kit with a reservoir of the liquid payload for administration to a patient using the hollow needle after the liquid payload has been filtered.

7. 1. A method for loading a quantity of a filtered liquid payload into a syringe and connected hollow needle (150) to prevent loading of a second quantity of a filtered liquid payload into a second syringe connected to a second hollow needle, comprising: obtaining a reservoir of liquid payload; attaching the syringe to a filter needle assembly (100), the filter needle assembly including a needle and connector portion (110) and a filter needle cap (200); The needle and connector portion (110) a hollow needle (150) having a distal tip (154) of said hollow needle with an opening to a lumen (156) extending through said hollow needle; It is a hub, an open proximal end (114) adapted to reversibly engage a fluid fitting; and a distal end of the hub engaged with a proximal end of the hollow needle; Including the hub and Including, The filter needle cap (200) a filter needle cap body (250) having a distal opening (204) in fluid communication with a proximal open end (208) of the filter needle cap body via an internal channel, a filter needle cap body (250), the proximal open end of the filter needle cap body being sized to receive the distal end of the hub within the proximal open end of the filter needle cap body for reversible engagement with the hub when the distal end of the hollow needle is inserted into the internal channel; a filter (400) adapted to remove debris from the liquid payload as it is drawn into the fluid fitting and through the filter needle assembly into the lumen in the hollow needle; a seal plug (300) for surrounding the distal end of the hollow needle after the distal end of the hollow needle is threaded through the seal plug to form a seal between the seal plug and a distal portion of the hollow needle so that the liquid payload is prevented by the seal plug from passing down the outer diameter of the hollow needle within the filter needle cap body and is drawn into the lumen within the hollow needle; Including, the sealing plug can be moved distally away from the distal end of the hollow needle unless secured in place by a retaining tool, such that when the distal tip of the hollow needle is moved through the sealing plug, the sealing plug is held in place by the retaining tool (500), such that after removal of the hollow needle from the sealing plug, a second hollow needle cannot be used to load a second amount of the filtered liquid payload into a second syringe; using the syringe to aspirate the liquid payload from the reservoir of the liquid payload, the liquid payload passing through the filter before entering the opening in the distal end of the hollow needle; removing the hollow needle from the filter needle assembly to expose the distal tip of the hollow needle; A method comprising:

8. 8. The method of claim 7, wherein once the hollow needle is removed from the sealing plug, the syringe with the coupled hollow needle becomes the second syringe with the second hollow needle, so that the second hollow needle is now unable to pass through the sealing plug.

9. 8. The method of claim 7, wherein the filter needle assembly is initially covered with an outer cap, and the force required to remove the outer cap from the filter needle assembly is less than half the force required to remove the needle and connector portion from the filter needle assembly to expose the distal end of the hollow needle.

10. 8. The method of claim 7, wherein the liquid payload is delivered through a septum for use in IV therapy.

11. A method of assembling a filter needle assembly (100), comprising: a needle and connector portion (110); Filter needle cap body (250), A seal plug (300), and Filter (400) and pushing the sealing plug into the open distal end (204) of the filter needle cap body (250) until the sealing plug rests against the annular shoulder (220) at the distal end of a proximal chamber (212) located between the annular shoulder and the open proximal end (208) of the filter needle cap body; holding the sealing plug against the annular shoulder with the holding tool (500) having an opening midline while the distal tip (154) of the hollow needle (150) is advanced through the sealing plug such that the distal tip of the hollow needle extends beyond the distal end (304) of the sealing plug and into the opening midline of the holding tool; removing the holding tool after the distal tip of the hollow needle extends beyond the distal end of the sealing plug; inserting the filter into the distal end of the filter needle cap body to secure the filter to the distal end of the filter needle cap body; A method for assembling a filter needle assembly (100), comprising:

12. 12. The method of assembling a filter needle assembly of claim 11, further comprising creating a sealed and sterilized package in which the filter needle assembly is placed in a sterile package.

13. 12. The method of assembling a filter needle assembly of claim 11, wherein the hollow needle advanced through the seal plug is a beveled pointed needle.

14. 12. The method of assembling a filter needle assembly of claim 11, wherein the hollow needle advanced through the seal plug is a blunt needle with an opening on the distal end of the hollow needle, but not the distal tip of the blunt needle.

15. 12. The method of assembling a filter needle assembly of claim 11, further comprising adding an outer cap over the filter needle assembly.

16. 12. The method of assembling a filter needle assembly of claim 11, wherein the retention tool is a cylinder that fits within the open proximal end of the filter needle cap body to hold the seal plug against the annular shoulder while the distal tip of the hollow needle is advanced through the seal plug.

17. 1. A method for rendering a filter needle assembly inoperable with a second hollow needle, comprising: loading a syringe with a liquid payload through said filter needle assembly (100); removing a first distal tip (154) of a first hollow needle (150) attached to the syringe from the open proximal end (208) of the filter needle assembly; thereafter, inserting a second distal tip (154) of the second hollow needle into the open proximal end (208) of the filter needle assembly; advancing the second distal tip of the second hollow needle through the proximal chamber (212) of the filter needle assembly and into the hollow interior (316) of a sealing plug (300); advancing the second distal tip of the second hollow needle distally until it contacts the sealing plug and pushes the sealing plug distally through the distal chamber (230) of the filter needle assembly without the second distal tip passing through the sealing plug; the second distal tip of the second hollow needle cannot pass through the sealing plug without a holding tool (500) holding the sealing plug against an annular shoulder (220) at the distal end of the proximal chamber (212), so the second distal tip of the second hollow needle is not within the distal chamber and liquid cannot be easily drawn into the hollow needle; A method comprising:

18. The invention is described and illustrated in this specification and the referenced drawings.

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