Filtering Needle Assembly with Seal Plug that Must be Held for Needle Penetration

Abstract

A filtering needle assembly for use in administering a liquid payload, including: a needle and connector portion; a filtering needle body cap; a seal plug, and a filter: The seal plug initially lacking a needle channel so that a distal end of a hollow needle must be forced through the distal end of the seal plug while the seal plug is retained by a holding tool with a hollow midline of adequate depth to receive the protruding end of the hollow needle. An attempt to reuse the filtering needle assembly with a second insertion of a hollow needle into the filtering needle assembly will not work as the distal end of the hollow needle will push the seal plug distally rather than traverse the seal plug.

Claims

1. A filtered needle assembly (100), comprising: a needle and connector portion (110) including a hollow needle (150) having a distal tip (154); a filtering needle cap (200) having a proximal end (204) and a distal end (208), the proximal end configured to receive the needle and connector portion; a seal plug (300) positioned within the filtering needle cap, the seal plug having: a proximal face (308); a closed distal end (306); a hollow interior (316); and at least one rib ring (344) extending radially outward; wherein the at least one rib ring provides a compression fit within the filtering needle cap; wherein the distal tip of the hollow needle is configured to push rather than penetrate the closed distal end of the seal plug unless the seal plug is constrained from movement by a holding tool (500) as the compression fit from the at least one rib ring is insufficient resistance to allow the distal tip of the hollow needle to penetrate the seal plug; and the filter assembly further comprising a filter, positioned within the distal end of the filtering needle cap after the holding tool is no longer needed to allow for penetration of the seal plug by the distal tip of the hollow needle.

2. The filtered needle assembly of claim 1, wherein the seal plug includes a first rib ring and a second rib ring.

3. The filtered needle assembly of claim 2, wherein the first rib ring and the second rib ring have different shapes.

4. The filtered needle assembly of claim 1, wherein the seal plug includes hemispheric protrusions (330) on the proximal face of the seal plug.

5. The filtered needle assembly of claim 1, wherein the hollow interior of the seal plug has a diameter greater than an outer diameter of the hollow needle.

6. The filtered needle assembly of claim 1, wherein the filter is a sintered filter.

7. The filtered needle assembly of claim 1 wherein the filter is wholly within the distal end of the filtering needle cap (200).

8. The filtered needle assembly of claim 1 wherein the filter is not wholly within the distal end of the filtering needle cap (200).

9. The filtered needle assembly of claim 1 wherein the distal tip of the hollow needle is of a type selected from the group consisting of beveled tipped needles, sharp ended hypodermic needles, and blunt tip needles.

10. A filtered needle assembly, comprising: a filtering needle cap (100) having a proximal chamber (212), a distal chamber (230), and an annular shoulder (220) separating the proximal chamber and the distal chamber; a seal plug (300) positioned within the distal chamber; wherein the seal plug is configured to: allow penetration by a distal tip (154) of a hollow needle (150) but only when the seal plug is held against the annular shoulder by a holding tool (500); and be displaced within the distal chamber when the distal tip of the hollow needle is applied without the seal plug being held against the annular shoulder, thereby precluding a second use of the filtering needle assembly; and the filtered needle assembly further comprising a filter, positioned within the distal end of the filtering needle cap after use of the holding tool.

11. The filtered needle assembly of claim 10, wherein the seal plug includes at least one rib ring that creates a compression fit within the distal chamber.

12. The filtered needle assembly of claim 10, wherein the seal plug has a hollow interior that is closed at the distal end prior to penetration by the hollow needle.

13. The filtering needle assembly of claim 10 wherein the second use is an attempt to reuse the hollow needle of the filtering needle assembly.

14. A filtering needle assembly (100), comprising: a needle and connector portion (110) including a hollow needle (150) having a distal tip (154); a filtering needle cap (200); and a seal plug (300) positioned within the filtering needle cap, the seal plug configured to be penetrated by the distal tip of the hollow needle to form a seal, the seal plug penetrable only when precluded from distal movement.

15. The filtering needle assembly of claim 14 wherein: the filtering needle cap has a proximal chamber (212) and a distal chamber (230) separated by an annular shoulder (220; the seal plug is positioned within the distal chamber, and the distal tip of the hollow needle is configured to penetrate the seal plug only when the seal plug is held against the annular shoulder.

16. The filtering needle assembly of claim 15 wherein the seal plug is precluded from distal movement when held against the annular shoulder by a holding tool (500).

17. The filtering needle assembly of claim 15 wherein the seal plug has a hollow interior (316) along a portion of a midline of the seal plug.

18. The filtering needle assembly of claim 15 wherein the seal plug has at least one rib ring (344).

19. The filtered needle assembly of claim 14 wherein the distal tip of the hollow needle is of a type selected from the group consisting of beveled tipped needles, sharp ended hypodermic needles, and blunt tip needles.

20. In a filtered needle assembly for use in administering a liquid payload, the filtered needle assembly comprising: a connector portion and a filtering needle cap, the connector portion comprising: a hollow needle with a distal end of the hollow needle having an opening to a lumen running through the hollow needle; and a hub comprising: an open proximal end adapted to reversibly engage a fluid fitting; and a distal end of the hub engaged with a proximal end of the hollow needle; and the filtering needle cap comprising: a distal open end in fluid communication via an internal channel with a proximal open end of the filtering needle cap; the proximal open end of the filtering needle cap sized to receive the distal end of the hub within the proximal open end of the filtering needle cap to reversibly engage the hub when the distal end of the hollow needle is inserted into the internal channel, and a filter element adapted for removing debris from the liquid payload as the liquid payload is drawn through the filtering needle cap into the lumen within the hollow needle as the liquid payload is drawn into the fluid fitting, wherein the improvement comprises: a seal plug positioned within the filtering needle cap, the seal plug having a hollow interior, and wherein the distal end of the hollow needle penetrates the seal plug, forming a seal between the hollow needle and the seal plug, but only when the seal plug is precluded from moving distally when the hollow needle is attempting to penetrate the seal plug; whereby the filtered needle assembly is suited for use to draw liquid payload into the lumen in the hollow needle and as the liquid payload is drawn into the fluid fitting, the liquid payload is blocked by the seal plug from traveling down an outside diameter of the hollow needle within the filtering needle cap.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0069] The disclosure can be better understood with reference to the following figures. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the disclosure. Moreover, in the figures, like reference numerals designate corresponding parts throughout the different views.

[0070] FIG. 1 illustrates the filtered needle assembly 100 in exploded perspective form.

[0071] FIG. 2 is a side and front perspective view of filtered needle assembly 100 which allows a view of the filter 400 within the distal end of the filtered needle assembly 100.

[0072] FIG. 3 is a cross section of filtered needle assembly 100.

[0073] FIG. 4 is a cross section of a side view of the seal plug 300.

[0074] FIG. 5 provides a front side perspective view of seal plug 300.

[0075] FIG. 6 provides a rear side perspective view of seal plug 300.

[0076] FIG. 7 illustrates process 1000 for loading a syringe with a liquid payload through a filtered needle assembly 100.

[0077] FIG. 8 illustrates process 2000 for precluding loading second syringe with a previously used filtered needle assembly 100.

[0078] FIG. 9 shows an enlarged partial cross section of the filter needle assembly 100 after a distal tip 154 of a hollow needle 150 has pushed against the seal plug 300 while not held by a holding tool.

[0079] FIG. 10 sets forth the key steps in the process 3000 to assemble a filtered needle assembly 100.

[0080] FIG. 11 provides a perspective view of holding tool 500, the filter needle cap body 250 and the seal plug 300.

DETAILED DESCRIPTION

[0081] The presently disclosed subject matter is described with specificity to meet statutory requirements. However, the description itself is not intended to limit the scope of this patent. Rather, the inventors have contemplated that the claimed subject matter might also be embodied in other ways, to include different steps or elements similar to the ones described in this document, in conjunction with other present or future technologies. Moreover, although the term step may be used herein to connote different aspects of methods employed, the term should not be interpreted as implying any particular order among or between various steps herein disclosed unless and except when the order of individual steps is explicitly described.

[0082] FIG. 1 illustrates the filtered needle assembly 100 in exploded perspective form. Introduced in FIG. 1 are: the needle and connector portion 110 and a filtering needle cap 200, which includes a seal plug 300, and a filter 400.

[0083] The needle and connector portion 110 has a proximal end 114 which may be in the form of a hub 118. The hub 118 may be adapted to work with a Luer fitting sometimes called a Luer Taper. Luer fittings include those known as Luer-Lock and Luer-Slip (sometimes slip tip). While various Luer fittings are very common connections for medical devices, the teachings of the present disclosure are not limited to any specific fitting as other connections could be used.

[0084] Frequently, but not always, the connection between the hollow needle 150 and the hub 118 is augmented by an adhesive component. Such an adhesive component is conventional and not a point of focus for the present disclosure. Thus, details of this adhesive component are not provided. The adhesive component may be considered a part of the hub 118 for the purposes of this disclosure and the claims that follow.

[0085] The 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 fluid communication with a needle lumen 156. As discussed below, this application teaches sealing around a distal portion 158 of the hollow needle 150. The distal portion 158 includes the distal tip 154 but also a nearby portion of the hollow needle 150 so that the distal tip 154 extends beyond the sealed portion of the distal portion 158 of the hollow needle 150.

[0086] The filtering needle cap 200 has a filter needle cap body 250 with a distal portion 204 which is open, and a proximal end 208 which is also open. The filtering needle cap 200 also has a seal plug 300 and a filter 400 which are inserted into the open distal portion 204 of the filter needle cap body 250 during assembly.

[0087] FIG. 2 is a side and front perspective view of filtered needle assembly 100 which allows a view of the filter 400 within the distal end of the filtered needle assembly 100.

[0088] A distal portion of the hub 118 is designed to be secured within the open proximal end 208 of the filtering needle cap 200.

[0089] FIG. 3 is a cross section of filtered needle assembly 100. FIG. 3 shows that the distal tip 154 of the hollow needle 150 may be inserted distally into the open proximal end 208 of the filtering needle cap 200 and advanced through the proximal chamber 212. As the distal tip 154 moves distally, the cross section of the proximal chamber 212 diminishes via inwardly sloped walls 216. Eventually, the distal tip 154 reaches an annular shoulder 220 that limits the proximal movement of the seal plug 300. The annular shoulder 220 is the proximal end of the distal chamber 230.

[0090] FIG. 4 is a cross section of a side view of the seal plug 300. Seal plug 300 has a distal end 304 that is originally closed but later punctured by the distal tip 154 of the hollow needle 150. The seal plug 300 has a proximal face 308 with an opening 312 to a hollow interior 316 that is initially closed at the distal end 306. Optionally, the diameter 320 of most of the hollow interior 316 is greater than the outer diameter of the hollow needle 150 so the distal tip 154 (FIG. 3) of the hollow needle 150 can traverse most of the hollow interior 316 without resistance.

[0091] The annular proximal face 308 has a series of hemispheric protrusions 330 which make contact with the annular shoulder 220 of the filtering needle cap 200. These hemispheric protrusions 330 assist in ejecting the molded parts from the mold.

[0092] The seal plug 300 has a first rib ring 344 and a second rib ring 348. A careful observer will note that in this instance, the first rib ring 344 is not the same shape as the second rib ring 348. Both rib rings (344 and 348) have a maximum outer diameter 346 that is larger than outer diameter 336. The maximum outer diameter 346 of the rib rings (344 and 348) is larger than the inner diameter 236 of distal chamber 230 (FIG. 3). Thus, when seal plug 300 is loaded into the distal chamber 230 before the addition of the filter 400, a holding tool can be used to push the seal plug 300 proximally as the rib rings (344 and 348) compress to fit within inner diameter 236 of distal chamber 230. This compression fit retains the seal plug 300 in proximity to the annular shoulder 220 at the proximal end of the distal chamber 230.

[0093] The holding power of this compression fit is not sufficient to resist force imposed by a distal tip 154 of a hollow needle 150 if the hollow needle 150 is advanced distally. The hollow needle 150 pushes the seal plug 300 distally away from the annular shoulder 220 at the proximal end of the distal chamber 230.

Use of a Holding Tool

[0094] While a wide range of holding tools could be used to move the seal plug 300 proximally within the distal chamber 230, a holding tool with an open midline may be used to retain the seal plug 300 against the annular shoulder 220 at the proximal end of the distal chamber 230 as the distal tip 154 of the hollow needle 150 is pushed against the initially closed distal end 306 of the hollow interior 316 of the seal plug 300.

[0095] With an appropriate holding tool holding the seal 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 drive the distal tip 154 through the remainder of seal plug 300 and out the distal end 304 of the seal plug 300 so that a seal is formed around distal portion 158 (FIG. 3) of the hollow needle 150.

[0096] After removing the holding tool and inserting the filter 400, one has a filtered needle assembly 100 as shown in FIG. 2 and FIG. 3.

Additional Views of Seal Plug

[0097] FIG. 5 provides a front side 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 visible at the distal end 304 is simply a flat portion of the domed distal end 304.

[0098] FIG. 6 provides a rear side perspective view of seal plug 300. Visible in this view are proximal face 308, opening 312, a portion of hollow interior 316, and the set of hemispheric protrusions 330. Also visible in this view are first rib ring 344 and second rib ring 348

Process for Use

[0099] FIG. 7 illustrates process 1000 for loading a syringe with a liquid payload through a filtered needle assembly 100.

[0100] Step 1004Add Filtered Needle Assembly to Syringe. The filtered needle assembly 100 such 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.

[0101] Step 1008OptionalRemove Outer Cap. Often, the filter needle assembly 100 is shipped with an outer cap (not shown here). The outer cap is removed. Note this step is optional as in some instances the filter needle may be delivered in sterile packaging such as a blister pack without an outer cap. In many instances the filter needle assembly will be delivered with the needle and connector portion 110 factory inserted into the filtering needle cap 200 and with the outer cap covering a portion of the filtering needle cap 200. In order to minimize the chances that the filtering needle cap 200 will be separated from the needle and connector portion 110 when intending to merely remove the outer cap, the components may be designed so that the force needed to remove the filtering needle cap 200 from the needle and connector portion 110 may be significantly more than the force needed to remove the outer cap from the filtering needle cap 200. In this context, significantly more would include at least double. The difference in required force may be achieved by having different degrees of interference fits, or use of different materials or surface treatments. Other ways of increasing or decreasing the requisite removal force will be apparent to those of skill in the art.

[0102] Step 1012Draw Payload into Syringe. The filter element 400 is immersed in an ampoule or suitable receptacle for a liquid payload such as a pharmaceutical or other liquid. As the syringe plunger is withdrawn in a known manner, the liquid payload is drawn up in order to fill the syringe through a pathway through: [0103] the filter element 400; [0104] the distal chamber 230; and [0105] the interior of the hollow needle 150 that extends beyond the seal plug 300 into the distal chamber 230.

[0106] The suction force for drawing up the liquid payload is confined to the pathway by the seal plug 300 which substantially seals the distal chamber 230. The seal plug 300 prevents the flow of air in a distal direction from entering the distal chamber 230 from along the outer perimeter of the hollow needle 150 such that the syringe may effectively draw in liquid payload. As the syringe is loaded, any debris in the receptacle initially holding the liquid payload is precluded by the filter element 400 from entry into the distal chamber 230.

[0107] Step 1016Remove Filtered Needle Assembly from Syringe. Once the syringe is loaded, the filtering needle cap 200 is removed from the needle and connector portion 110 by sliding the filtering needle cap 200 distally until the distal tip 154 of the hollow needle 150 is free of the filtering needle cap 200. The filtering needle cap 200 may then be discarded along with any debris captured in the filter 400.

[0108] Step 1020Loaded Syringe is Ready for Use. The syringe is loaded with the desired amount of liquid payload which has been filtered as the liquid passed through filter 400. The distal tip 154 of the hollow needle 150 is exposed and ready for use. Depending on the application, the distal tip 154 of the hollow needle 150 may be inserted as appropriate into a patient's body, to a port with a septum for use with IV therapy, or to some other location.

Process For Precluding Second Use

[0109] FIG. 8 illustrates process 2000 for precluding loading second syringe with a previously used filtered needle assembly 100.

[0110] Step 2004Load a syringe with a liquid payload through a filtered needle assembly 100 including a filtering needle cap 200 as described in process 1000 but do not discard the filtering needle cap 200 after removing the hollow needle 150 from the filtering needle cap 200.

[0111] Step 2008Insert a distal tip of a hollow needle into the open proximal end of the filtering needle cap 200. This distal tip of a hollow needle may be the same distal tip of the hollow needle used in process 1000 or may be a new distal tip of a new hollow needle attached to a new syringe.

[0112] Step 2012Advance the distal tip of the hollow needle through the proximal chamber of the filtering needle cap and into the hollow interior 316 of the seal plug 300.

[0113] Step 2016Continue to advance the distal tip of the hollow needle distally.

[0114] Step 2020Contact the distal tip 154 of the hollow needle 150 with the seal plug 300. As the opening formed by forcing the first distal tip of the first hollow needle across the seal plug 300 while the seal plug 300 was precluded from distal movement by an appropriate holding tool has substantially closed after withdrawal of the hollow needle from the seal plug 300, there is resistance even if the second distal tip 154 is perfectly aligned with the prior path taken by the first distal tip 154.

[0115] Step 2024Push the seal plug 300 distally within the distal chamber without traversing the seal plug 300. As the force needed to penetrate and traverse the seal plug is greater than the friction force holding the seal plug 300 adjacent to the annular shoulder 220 by the compression fit of the rib rings (344 and 348) within the distal chamber 230, the continued distal movement of the distal tip 154 of the hollow needle 150 pushes the seal plug 300 distally within the distal chamber without traversing the seal plug 300. See FIG. 9 which shows an enlarged partial cross section of the filter needle assembly 100 after a distal tip 154 of a hollow needle 150 has pushed against the seal plug 300 while not held by a holding tool. The seal plug 300 has slid distally within distal chamber 230.

[0116] Step 2028Fail to easily draw in liquid payload through filter 400 as the distal tip 154 of the needle 150 has not traversed the seal plug 300. It is possible that some liquid payload may eventually be drawn through the prior needle path in the seal plug 300 but it is likely that air from the proximal end of the filter needle assembly 100 would travel down to the distal tip 154 of the hollow needle 150 as the distal tip is on the proximal side of the seal and nothing would block air from entering the distal tip and satisfying the suction pull from the syringe body. This would not be a satisfactory process and the staff member would not try this a second time. Thus the design precludes making a habit of loading second syringe with a previously used filtered needle assembly 100 as the hollow needle displaces rather than traverses the seal plug and does not work well to obtain liquid payload.

[0117] The process set forth above precludes insertion of a second hollow needle connected to a second syringe to draw up a second payload liquid. In this context, the filtering needle cap 200 cannot recognize that the inserted hollow needle 150 is the same hollow needle 150 that was recently withdrawn from the filtering needle cap 200. Once the hollow needle 150 is removed from the filtering needle cap 200, the hollow needle becomes a stranger and thus a second hollow needle connected to a second syringe seeking to obtain a second liquid payload. The process would work the same when a different hollow needle was inserted. That hollow needle would also be treated as a prohibited second hollow needle.

Process for Assembling a Filtered Needle Assembly

[0118] FIG. 10 sets forth the key steps in the process 3000 to assemble a filtered needle assembly 100.

[0119] Step 3004Obtain: the needle and connector portion 110, a filtering needle cap body 25, a seal plug 300, and a filter 400.

[0120] Step 3008Push the seal plug 300 into the open distal end of the filtering needle cap body 250 and continue moving the seal plug 300 until the seal plug rests against the annular shoulder 220 at the end of the proximal chamber 212.

[0121] Step 3012Hold the seal plug while the distal tip traverses the seal plug. More specifically, hold the seal plug 300 against the annular shoulder with a holding tool that has an open midline while advancing the distal tip 154 of the hollow needle 150 all the way into the hollow interior 316 of the seal plug 300 and then push the distal tip 154 through the remaining portion of the seal plug 300 while the seal plug 300 is precluded from distal movement by the holding tool so that the distal tip 154 extends beyond the distal end 304 of the seal plug 300 and into the empty midline of the holding tool.

[0122] Step 3016Remove the holding tool from the distal portion 204 of the filtering needle cap after the distal end of the hollow needle extends beyond the distal end of the seal plug.

[0123] Step 3020Insert the filter 400 into the distal end of the filtering needle cap body 250. The filter may be held in position by various methods known to those of skill in the art including adhesives, compression fit, and others.

[0124] Step 3024Creating a sealed and sterilized package with the filtered needle assembly 100 inside the package.

Details

Choice of Filter Element

[0125] One design criterion for choice of a filter element on the distal end of the filtering needle cap versus a filter element contained internal in the filtering needle cap is whether collection of abnormal components within the liquid payload is relevant to the application. While all filter elements may be used to remove shards of glass, in some instances it may be useful to use a filter element on the distal end of the filtering needle cap as this distal surface will concentrate certain types of abnormal components. For example, some pharmaceuticals may partially crystalize from age or handling. While a small amount of crystallization may be tolerated, an unusual amount of crystallization may indicate that the pharmaceutical should be discarded rather than used. Likewise, some pharmaceuticals may have a small amount of sediment in the reservoir of the pharmaceutical such as an ampoule, but if a large amount of sediment appears on the outer surface of the filter element, the excessive sediment may indicate that the pharmaceutical is too old or has been compromised by handling.

[0126] The filter elements may be sintered filters which have a number of tortuous internal channels for liquid payload to traverse while capturing debris. Extending the thickness of the filter increases the distance that the liquid payload must travel but it also increases the number of possible paths for the liquid payload to travel. Thus, for some range of thicknesses, increasing the thickness decreases the overall resistance to flow.

[0127] One well-known vendor in the field of sintered filter material is the Porex Corporation located in Fairburn Georgia and at www.Porex.com (spaces inserted to avoid a live link).

Material for Plug

[0128] The choice of the material for use in the plug will be 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 liquids to be filtered, planned sterilization process, and desired shelf life. One suitable material is 50 durometer Chlorobutyl which is available from a number of vendors.

Retention of the Filter Element

[0129] In some of the examples set forth above, the filter element was retained by protrusions or detents that extended into the filter element to secure the filter element. Adhesives may be used to secure the filter element. Many designers may prefer a protrusion or other form of interference fit as the use of adhesives might cause adhesives to enter possible flow paths for liquid payload and thus partially impair the filter element. Those of skill in the art will recognize that other attachment methods may be used such at an ultrasonic bond, spin welding, heat welding, and press fit. Likewise, other suggested connections between components have been provided to provide a suitable example and those of skill in the art will recognize the many options for connecting two components together. The teachings of this present disclosure are not limited to any particular connection method for joining components unless specifically recited in the claims that follow.

Needle Types

[0130] The various figures discussed in connection with this disclosure have uniformly shown sharp distal ends for the needles. These needles have beveled tips. Sharp ended hypodermic needles are particularly adapted for injecting fluids directly into the body of the patient.

[0131] In many instances, the liquid payload is not delivered directly into the patient but is instead delivered to a bag of fluids used in intravenous therapy (IV therapy). A drip of liquid is provided into a vein of the patient to slowly provide a desired treatment. The IV fluids are typically in a bag. Ports with a self-sealing septum may be used to add pharmaceuticals to the liquid being provided in IV therapy. While a sharp tipped needle may be used to deliver a liquid payload through a septum, some prefer using a blunt tip needle. A blunt tip needle reduces the risk of a needle stick to the medical personnel and may be less damaging to the septum. While the variation of needle tips and the best uses for each type of needle tip are beyond the scope of the present disclosure, nothing in this present disclosure limits the teachings to applications with sharp point needles. Blunt tip needles will have openings on their distal portions and one of skill in the art can adapt the geometries of the filtering needle cap if needed to accommodate the geometry of various types of blunt tip needles.

Connection to the Hub

[0132] The examples in this disclosure referenced a distal end of a syringe engaging with the hub 118. This may be the most common interaction with the filter needle, but the teachings of this disclosure could be employed where there is a combination of components rather than a syringe. For some specific reasons, there may be a series of components including check valves, tubing, a syringe, or even a replacement for a syringe that may controllably intake and discharge liquid payload through the needle. The present disclosure may be used as long as there is an appropriate connection between the filtered needle and the remaining components via the distal fluid fitting of the remaining components.

Sterilization Choices

[0133] Those of skill in the art will recognize that the filtering needle cap with or without an outer cap may be sterilized prior to provision to the medical facility. Those of skill in the art will recognize that there are many different processes such as electron beam processing, gamma ray sterilization, or ethylene oxide gas. Those of skill in the art will recognize that medical devices may be adapted for use with a particular sterilization process to maximize effectiveness and throughput. The teachings of the present disclosure may be adapted for use with a variety of sterilization techniques and thus this aspect of the examples was not highlighted or discussed.

Optional Use of Outer Cap

[0134] As noted above, some applications may not use the outer cap but package the needle and connector portion along with the filtering needle cap in packaging such as a blister pack. The packaging would maintain the sterility of the items and would preclude even sterilized debris from becoming entrained in the filtering needle cap. Outer caps are well known to those of skill in the art. FIG. 1 of U.S. Pat. No. 9,669,164 shows an outer cap as element 12. FIG. 1 is incorporated by reference.

Alternatives and Variations

Locations of the Filter 400

[0135] While the figures used in the present disclosure show a filter 400 wholly within the

[0136] distal end of the filtering needle cap 200, this is not required in order to enjoy the benefits of the seal plug 300. U.S. Pat. No. 9,669,164 to Carr et al. for Filtering Needle Cap Having a Sleeve Sealing Around a Needle shows a range of suitable locations for the filter. The '164 patent is incorporated by reference in its entirety.

Number of Rib Rings

[0137] The example set forth above had a seal plug 300 with two rib rings 344 and 348. One of skill in the art will appreciate that the number of rib rings could be one, two, or more than two. What is needed is an ability to push the seal plug 300 into a slightly smaller diameter as the seal plug 300 deforms to fit and this compression fit increases the amount of force necessary to move the seal plug 300 but does not raise the required level sufficiently to allow a distal tip 154 of a hollow needle 150 to be driven through a seal plug 300 without the use of a holding tool.

Holding Tool

[0138] FIG. 11 provides a perspective view of holding tool 500, the filter needle cap body 250 and the seal plug 300. The holding tool 504 has a distal end 508 and a proximal end 504 which is inserted into the open distal portion 204 of the filter needle cap body 250 and then used to push and hold the seal plug 300 against the annular shoulder 220 (FIG. 3). While the seal plug 300 is held against the annular shoulder 220, the distal tip 154 of the hollow needle 150 (FIG. 3) may be forced to penetrate and transit the distal end 304 (FIG. 4) of the seal plug 300.

[0139] The proximal end 504 of the holding tool 500 needs a concavity of sufficient depth to receive the distal end of the hollow needle 150 that extends beyond the distal end 304 of the seal plug 300. One way to form this concavity is to have a holding tool 500 that is a hollow cylinder with an open midline from the proximal end 504 to the distal end 508. But this is not required. The opening at the proximal end 504 may end somewhere within the holding tool 500. The proximal end 504 of the holding tool may be a set of two or more fingers that hold the seal plug 300 against the annular shoulder 220 and provide adequate room for the distal end of the hollow needle 150. Those of skill in the art can work with the present disclosure to come up with a variety of holding tools in keeping with the purpose of the tool.

[0140] One of skill in the art will recognize that some of the alternative implementations set forth above are not universally mutually exclusive and that in some cases additional implementations can be created that employ aspects of two or more of the variations described above. Likewise, the present disclosure is not limited to the specific examples or particular embodiments provided to promote understanding of the various teachings of the present disclosure. Moreover, the scope of the claims which follow covers the range of variations, modifications, and substitutes for the components described herein as would be known to those of skill in the art.

[0141] Where methods and/or events described above indicate certain events and/or procedures occurring in a certain order, the ordering of certain events and/or procedures may be modified. Additionally, certain events and/or procedures may be performed concurrently in a parallel process, when possible, as well as performed sequentially as described above. The legal limitations of the scope of the claimed invention are set forth in the claims that follow and extend to cover their legal equivalents. Those unfamiliar with the legal tests for equivalency should consult a person registered to practice before the patent authority which granted this patent such as the United States Patent and Trademark Office or its counterpart.