SYRINGE APPARATUS FOR DISINFECTION OF CENTRAL LINE PORT NEEDLELESS CONNECTOR AND METHOD OF DISINFECTING A CENTRAL LINE PORT NEEDLELESS CONNECTOR
A syringe apparatus for disinfection of central line port needleless connector and method of disinfecting a central line port needleless connector. The syringe apparatus includes a syringe tip including a first O-ring including a disinfectant located in a first section of a tip cavity between an inner tip portion of the syringe tip and an outer tip portion of the syringe tip. The syringe tip preferably further includes one or more Luer lock sections and one or more additional O-rings. The syringe apparatus preferably also includes a cap including an inner layer including a disinfectant.
This application is a continuation of and claims priority to U.S. patent application Ser. No. 17/218,298 entitled “SYRINGE APPARATUS FOR DISINFECTION OF CENTRAL LINE PORT NEEDLELESS CONNECTOR AND METHOD OF DISINFECTING A CENTRAL LINE PORT NEEDLELESS CONNECTOR” invented by Jason Lakis and filed on Mar. 31, 2021, the entirety of which is incorporated herein by reference.
FIELDThis disclosure relates to the field of disinfection of central line port needleless connectors. More particularly, this disclosure relates to a syringe apparatus for disinfecting central line port needleless connectors and a method of disinfecting central line port needless connectors.
BACKGROUNDCentral intravenous lines (also known as central venous catheters) are a type of intravenous (IV) line that, instead of only being inserted peripherally with a small catheter, are inserted into a patient's arm or neck and have a much longer catheter length, often leading all the way up to the top of a patient's heart. Central IV lines are used regularly in the hospital setting to help manage sick patients. Central IV lines are preferred to peripheral IV lines because central lines are a safer route through which to receive medication, antibiotics, fluids, blood, and nutrition. Central IV lines are a much more versatile and a better long-term option than a simple peripheral IV line.
Luer locks are often used in association with central lines. Luer locks are fittings that are securely joined by means of a tabbed hub to a female fitting (needless connector) which screws into threads in a sleeve on a male fitting (often a Normal Saline flush tip). Needleless connectors (also referred to as access ports) are the access medium for central lines. Usually there are two or three port attachments per central line with Luer locks at the tips. When a Normal Saline syringe is screwed into a Luer lock of a port, a patient's bloodstream can be accessed. Connection of both ends of the Luer lock open the “highway” to the bloodstream. Normal Saline (NS) flushes often use 0.9% sodium chloride solution in a prefilled syringe that connects directly to a needleless connector via a Luer lock system. NS flushes are the primary source of initial access to a patient's bloodstream.
When a healthcare professional accesses a needleless connector on a central line, there are usually one or more cleaning protocols in place. Such protocols typically include cleaning the outside and the surrounding of the needless connector with an alcohol pad for a minimum period of time (often fifteen seconds). A next step is to twist a normal saline syringe (male end) into a needleless port (female end) locking into the luer locks. Next, the Normal Saline solution is injected into the central line. Key factors in cleaning the needleless connectors are (1) providing enough intense friction while twisting and engulfing the top and sides of the needleless connector with an alcohol pad and (2) dry time or allowing complete dryness of the needleless connector before use. Doing these steps often leads to a safe and direct access to a patient's bloodstream.
Central lines are incredibly useful for nurses who access them multiple times every shift to administer medications, nutrition, draw blood and a multitude of other interventions. Central lines are fast, easy, and extremely reliable. The biggest problem with central lines is often with the needleless connectors. When not in use, the needleless connectors are usually left dangling on patient's skin, inadvertently touched by hospital employees, dirty bed sheets, or other unclean surfaces. This creates biofilm growth over a needless connector and, if not cleaned properly before a NS flush connection, can push millions of bacteria cells directly into a patient's bloodstream. This can result in a patient getting a central line associated bloodstream infection (CLABSI). CLABSIs are serious infections due to bacteria entering into a patient's central line. Such infection infects a patient's blood, potentially leading to sepsis and eventual death through septic shock. It is believed that around 50% of all CLABSIs are from improper cleaning of the needless connectors prior to NS flushes. CLABSIs are treatable with antibiotics but such infections increase hospital stay length and create a more aggressive course of treatment. CLABSIs cost hospitals billions of dollars annually.
Current practice to minimize or otherwise prevent CLABSIs in hospitals include slogans like “Scrub the Hub” meaning clean the needleless connector for at least 15 seconds before connecting a NS syringe. This practice is intended to minimize/eliminate biofilm growth on a needless connector prior to introducing a NS flush to an access port. This slogan and practice is well intentioned but with nurses being stressed and rushed from patient to patient, properly scrubbing the hub does not happen every single time. Some nurses will sometimes use an alcohol pad for a few seconds to clean prior to port connection. Rarely will a nurse “scrub the hub” for the full 15 seconds or whatever is stipulated in their hospital's policy and procedures. This leads to a high number of CLABSIs which has very undesirable ramifications for patient prognosis and is extremely expensive to both the patient and the hospital. Needleless connector disinfection is frequently overlooked because of the immense workload of hospital practitioners paired with the high frequency in which needleless connector are accessed. Needless connector disinfection is variable at best and typically consists of a gentle wipe of an alcohol pad on the needleless connector before a flush is connected. CLABSIs then occur at a high rate.
One solution to help with this problem are Curos™ brand disinfecting caps for needleless connectors available from 3M based in Maplewood, Minn. These caps include disinfectant inside and can be attached to needleless connectors to clean them in a short period of time (i.e., a minute or so). Such caps can be kept on needleless connectors for up to seven days and keep needleless connectors clean. However, Curos caps are devices separate from needleless connectors and NS syringes. Curos caps still do not eliminate the variability of use.
What is needed, therefore, is a solution that does not require a separate cap or “scrub the hub” steps when engaging a NS syringe with a needleless connector of a central line. In this era of healthcare there is higher patient acuity and higher amounts of practitioner burnout and stress. In light of the COVID-19 pandemic, especially in the Intensive Care Units, practitioner time management and safe practice has never been as imperative. The variability of proper technique of disinfecting all intravenous needleless connectors needs to be taken out of practitioners hands and into a product that does it for them properly every single time.
SUMMARYThe above and other needs are met by a NS flush syringe apparatus that eliminates all the variables associated with improper or inadequate cleaning of a needleless port. The new NS flush described herein can be used with old protocols or stand alone as a new device to accomplish the same task.
In one aspect, a syringe apparatus is disclosed comprising a barrel; a plunger; and a syringe tip, the syringe tip further comprising an inner tip portion extending from a first end of the barrel to a distal end of the syringe tip; an outer tip portion concentrically positioned outside the inner tip portion, wherein the outer tip portion extends from a first end of the barrel to a distal end of the outer tip portion, and wherein the inner tip portion extends farther away from the barrel than the outer tip portion; a tip cavity formed between the inner tip portion and the outer tip portion, the tip cavity comprising a first section proximate to the distal end of the outer tip portion and a second section adjacent to the first section located closer to the barrel than the first section; a first O-ring inside the first section wherein the O-ring comprises a first disinfectant substance absorbed into the O-ring; and a first thread inside the second section extending inwardly and winding helically from an inner wall of the outer tip portion. Preferably, the outer tip portion flares outward along the distal end of the outer tip portion, preferably coinciding with the first section of the tip cavity. Preferably, saline solution is located inside the barrel.
The syringe tip preferably further comprises the tip cavity further comprising a third section adjacent to the second section and located closer to the barrel than the second section; and a second O-ring inside the third section wherein the second O-ring is dry. The syringe tip preferably further comprises the tip cavity further comprising a fourth section adjacent to the third section and located closer to the barrel than the third section; and a second thread inside the fourth section extending inwardly and winding helically from the inner wall of the outer tip portion.
In certain preferred embodiments, the syringe apparatus preferably further comprises a cap attached to the outer tip portion, the cap further comprising an outer shell; and an inner layer comprising a second disinfectant substance absorbed into the inner layer. The syringe preferably further comprises a seal ribbon wrapped around the interface between the cap and the outer tip portion, providing an air-tight seal that prevents drying of the first disinfectant substance in the cap and the second disinfectant substance in the first O-ring. In some embodiments, the first disinfectant substance comprises the second disinfectant substance. In some embodiments, the outer tip portion further comprises an outer ridge along the distal end of the outer tip portion, wherein the cap further comprises a bulge along a base of the cap, and wherein the seal ribbon is wrapped around the outer ridge and the bulge, sealing the cap to the outer tip portion.
In some embodiments, the syringe tip further comprises the tip cavity further comprising a third section adjacent to the second section and located closer to the barrel than the second section; and a second thread inside the third section extending inwardly and winding helically from the inner wall of the outer tip portion.
In another aspect, a method for disinfecting a needleless connector is disclosed, the method comprising inserting an inner tip portion of a syringe tip of a syringe apparatus into a receiving cavity of a needleless connector until a first end of the needleless connector reaches an outer tip portion of the syringe tip and compresses a first O-ring inside a tip cavity of the syringe tip defined between the inner tip portion and the outer tip portion to release disinfectant stored in the first O-ring onto the needleless connector; and twisting the syringe apparatus relative to the needleless connector to engage a first thread in the syringe tip with one or more connector ridges in the needleless connector. The method preferably further comprises pushing the syringe tip further into the receiving cavity to cause the one or more connector ridges to press against a second O-ring in the tip cavity of the syringe tip wherein the second O-ring is initially dry. The method preferably further comprises twisting the syringe tip relative to the needleless connector to engage a second thread in the syringe tip with one or more connector ridges in the needleless connector.
In another aspect, a method of injecting medicine into a patient through a central IV line is disclosed, the method comprising displacing liquid from a barrel of a syringe apparatus by pushing a plunger of the syringe inward; inserting a syringe tip of the syringe apparatus into a medicine vial; extracting medicine from the medicine vial using the syringe apparatus; disengaging the syringe apparatus from the medicine vial; inserting an inner tip portion of a syringe tip of a syringe apparatus into a receiving cavity of a needleless connector in fluid communication with a patient's bloodstream until a first end of the needleless connector reaches an outer tip portion of the syringe tip and compresses a first O-ring inside a tip cavity of the syringe tip defined between the inner tip portion and the outer tip portion to release disinfectant stored in the first O-ring onto the needleless connector; and injecting the extracted medicine from the syringe apparatus to the patient by injecting the extracted medicine to the needleless connector.
Preferably, the syringe tip used in the method comprises an inner tip portion extending from a first end of a barrel of the syringe apparatus to a distal end of the syringe tip; and an outer tip portion concentrically positioned outside the inner tip portion, wherein the outer tip portion extends from a first end of the barrel to a distal end of the outer tip portion a distance of length L, and wherein the inner tip portion extends away from the barrel than the outer tip portion a distance of more than the length L. The distal end of the syringe tip preferably comprises a multi-faceted blunt tip. Preferably, the inserting step d preferably further comprises twisting the syringe tip relative to the needleless connector to engage a first thread in the syringe tip with one or more connector ridges in the needleless connector. The inserting step d preferably further comprises pushing the syringe tip further into the receiving cavity to cause the one or more connector ridges to press against a second O-ring in the syringe tip. The inserting step d preferably further comprises twisting the syringe tip relative to the needleless connector to engage a second thread in the syringe tip with one or more connector ridges in the needleless connector.
The summary provided herein is intended to provide examples of particular disclosed embodiments and is not intended to cover all potential embodiments or combinations of embodiments. Therefore, this summary is not intended to limit the scope of the invention disclosure in any way, a function which is reserved for the appended claims.
Further features, aspects, and advantages of the present disclosure will become better understood by reference to the following detailed description, appended claims, and accompanying figures, wherein elements are not to scale so as to more clearly show the details, wherein like reference numbers indicate like elements throughout the several views, and wherein:
The figures are provided to illustrate concepts of the invention disclosure and are not intended to embody all potential embodiments of the invention. Therefore, the figures are not intended to limit the scope of the invention disclosure in any way, a function which is reserved for the appended claims.
DETAILED DESCRIPTIONAs shown in
The syringe apparatus 100 preferably comes pre-packaged with saline solution in the barrel 108. In a preferred pre-packaged configuration before use, the syringe apparatus 100 includes a cap 142. The cap preferably further includes a bulge 143 along a base 144 of the cap 142. The cap 142 preferably further includes an outer shell 145 and an inner layer 146 that is preferably saturated with a disinfectant. The inner layer 146 is preferably a sponge-like material made of medical grade 100 PPI open cell polyurethane foam, but other materials with the ability to absorb and hold disinfectant can be used. The disinfectant liquid is preferably isopropyl alcohol (preferably 70% pure isopropyl alcohol plus 30% purified water by volume). Other disinfecting liquids, solutions, and mixtures known to a person having ordinary skill in the art can be used. When in the preferred pre-packaged form, the cap 142 covers an external section 148 of the inner tip portion 104 such that disinfectant is in constant contact with an outer surface 150 of the external section 148 of the inner tip portion 104. The external section 148 of the inner tip portion 104 is referred to as “external” because it extends out beyond the outer tip portion 106, preferably by about 3 mm to about 4 mm. When in the preferred pre-packaged form, the syringe apparatus 100 further includes a seal ribbon 152 as shown in
The first section 122A of the syringe tip 102 preferably angles or flares outward as shown in
Simpler embodiments of the syringe apparatus 100 are contemplated including a syringe apparatus that does not include the third section 122C (and associated second O-ring 134) or the fourth section 122D (and the associated second thread 140). For such an embodiment, the syringe tip 102 would only include the first section 122A (and associated first O-ring 124) and the second section 122B (and associated first thread 130).
In a related simpler embodiment of the syringe apparatus 100, the syringe apparatus does not include the fourth section 122D (and the associated second thread 140). For such an embodiment, the syringe tip 102 would only include the first section 122A (and associated first O-ring 124), the second section 122B (and associated first thread 130), and the third section 122C (and associated second O-ring 134).
The previously described embodiments of the present disclosure have many advantages. The early exposure of the disinfectant from the external section 148 of the inner tip portion 104 acts as a “scrubber” on top of any biofilm on the needleless connector 156. The disinfectant from the first O-ring 124 provides a means of properly disinfecting the entire needleless connector 156. The structure of the syringe apparatus 100 provides the most important factors in preventing CLABSIs, namely, friction and drying. Use of the syringe apparatus 100 avoids the need to “scrub the hub” and clean needleless connectors while providing the same benefits from traditional needleless connector cleaning steps. This is all done in less time with fewer steps to consider. After the cap 142 is removed from the syringe apparatus 100, the four steps to remember are push, twist, push, and twist. After these basic and simple steps, the Normal Saline fluid in the barrel 108 can be injected into a central IV line. Thus, the cleaning mechanism is part of the Normal Saline flush procedure which already requires connecting a syringe to a needleless connector by engaging Luer locks.
The foregoing description of preferred embodiments of the present disclosure has been presented for purposes of illustration and description. The described preferred embodiments are not intended to be exhaustive or to limit the scope of the disclosure to the precise form(s) disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiments are chosen and described in an effort to provide the best illustrations of the principles of the disclosure and its practical application, and to thereby enable one of ordinary skill in the art to utilize the concepts revealed in the disclosure in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the disclosure as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.
Any element in a claim that does not explicitly state “means for” performing a specified function, or “step for” performing a specific function, is not to be interpreted as a “means” or “step” clause as specified in 35 U.S.C. § 112, ¶6. In particular, the use of “step of” in the claims herein is not intended to invoke the provisions of 35 U.S.C. § 112, ¶6.
Claims
1. A syringe apparatus comprising:
- a. a barrel;
- b. a plunger; and
- c. a syringe tip, the syringe tip further comprising: i. an inner tip portion extending from a first end of the barrel to a distal end of the syringe tip; ii. an outer tip portion concentrically positioned outside the inner tip portion, wherein the outer tip portion extends from a first end of the barrel to a distal end of the outer tip portion, and wherein the inner tip portion extends farther away from the barrel than the outer tip portion; iii. a tip cavity formed between the inner tip portion and the outer tip portion, the tip cavity comprising a first section proximate to the distal end of the outer tip portion and a second section adjacent to the first section located closer to the barrel than the first section; iv. a first O-ring inside the first section wherein the O-ring comprises a first disinfectant substance absorbed into the O-ring; and v. a first thread inside the second section extending inwardly and winding helically from an inner wall of the outer tip portion.
2. The syringe apparatus of claim 1 wherein the outer tip portion flares outward along the distal end of the outer tip portion.
3. The syringe apparatus of claim 1 wherein the syringe tip further comprises:
- i. the tip cavity further comprising a third section adjacent to the second section and located closer to the barrel than the second section; and
- ii. a second O-ring inside the third section wherein the second O-ring is dry.
4. The syringe apparatus of claim 3 wherein the syringe tip further comprises:
- i. the tip cavity further comprising a fourth section adjacent to the third section and located closer to the barrel than the third section; and
- ii. a second thread inside the fourth section extending inwardly and winding helically from the inner wall of the outer tip portion.
5. The syringe apparatus of claim 1 further comprising a cap attached to the outer tip portion, the cap further comprising:
- i. an outer shell; and
- ii. an inner layer comprising a second disinfectant substance absorbed into the inner layer.
6. The syringe of claim 5 further comprising a seal ribbon wrapped around the interface between the cap and the outer tip portion, providing an air-tight seal that prevents drying of the first disinfectant substance in the cap and the second disinfectant substance in the first O-ring.
7. The syringe apparatus of claim 6 wherein the first disinfectant substance comprises the second disinfectant substance.
8. The syringe apparatus of claim 6 wherein the outer tip portion further comprises an outer ridge along the distal end of the outer tip portion, wherein the cap further comprises a bulge along a base of the cap, and wherein the seal ribbon is wrapped around the outer ridge and the bulge, sealing the cap to the outer tip portion.
9. The syringe apparatus of claim 1 wherein the syringe tip further comprises:
- i. the tip cavity further comprising a third section adjacent to the second section and located closer to the barrel than the second section; and
- ii. a second thread inside the third section extending inwardly and winding helically from the inner wall of the outer tip portion.
10. The syringe apparatus of claim 5 further comprising a fluid in the barrel of the syringe apparatus wherein the fluid comprises a saline solution.
11. A method for disinfecting a needleless connector, the method comprising:
- a. inserting an inner tip portion of a syringe tip of a syringe apparatus into a receiving cavity of a needleless connector until a first end of the needleless connector reaches an outer tip portion of the syringe tip and compresses a first O-ring inside a tip cavity of the syringe tip defined between the inner tip portion and the outer tip portion to release disinfectant stored in the first O-ring onto the needleless connector; and
- b. twisting the syringe apparatus relative to the needleless connector to engage a first thread in the syringe tip with one or more connector ridges in the needleless connector.
12. The method of claim 11 further comprising pushing the syringe tip further into the receiving cavity to cause the one or more connector ridges to press against a second O-ring in the tip cavity of the syringe tip wherein the second O-ring is initially dry.
13. The method of claim 12 further comprising twisting the syringe tip relative to the needleless connector to engage a second thread in the syringe tip with one or more connector ridges in the needleless connector.
14. A method for injecting medicine into a patient through a central IV line, the method comprising:
- a. displacing liquid from a barrel of a syringe apparatus by pushing a plunger of the syringe inward;
- b. inserting a syringe tip of the syringe apparatus into a medicine vial;
- c. extracting medicine from the medicine vial using the syringe apparatus;
- d. disengaging the syringe apparatus from the medicine vial;
- e. inserting an inner tip portion of a syringe tip of a syringe apparatus into a receiving cavity of a needleless connector in fluid communication with a patient's bloodstream until a first end of the needleless connector reaches an outer tip portion of the syringe tip and compresses a first O-ring inside a tip cavity of the syringe tip defined between the inner tip portion and the outer tip portion to release disinfectant stored in the first O-ring onto the needleless connector; and
- f. injecting the extracted medicine from the syringe apparatus to the patient by injecting the extracted medicine to the needleless connector.
15. The method of claim 14 wherein the syringe tip used in the method comprises:
- i. an inner tip portion extending from a first end of a barrel of the syringe apparatus to a distal end of the syringe tip;
- ii. an outer tip portion concentrically positioned outside the inner tip portion, wherein the outer tip portion extends from a first end of the barrel to a distal end of the outer tip portion a distance of length L, and wherein the inner tip portion extends away from the barrel than the outer tip portion a distance of greater than the length L.
16. The method of claim 14 wherein the distal end of the syringe tip comprises a multi-faceted blunt tip.
17. The method of claim 14 wherein the inserting step d further comprises twisting the syringe tip relative to the needleless connector to engage a first thread in the syringe tip with one or more connector ridges in the needleless connector.
18. The method of claim 17 wherein the inserting step d further comprises pushing the syringe tip further into the receiving cavity to cause the one or more connector ridges to press against a second O-ring in the syringe tip.
19. The method of claim 18 wherein the inserting step d further comprises twisting the syringe tip relative to the needleless connector to engage a second thread in the syringe tip with one or more connector ridges in the needleless connector.
Type: Application
Filed: Oct 7, 2021
Publication Date: Oct 6, 2022
Inventor: Jason Lakis (La Mesa, CA)
Application Number: 17/495,962