阅读说明：本技术 具有增强移除力的iv套件针头 (IV set needle with enhanced removal force ) 是由 吉恩·梅森 乔治·曼苏尔 瑞安·卡拉汉 埃德蒙·于 于 2020-03-04 设计创作，主要内容包括：本文描述了IV针头。IV针头包括针头主体。针头主体可以由第一材料形成,并且可以包括会聚到一点的针头部分。IV针头进一步包括穿过针头主体形成的至少一个针头流动端口。IV针头进一步包括与至少一个针头流动端口流体连通的下流动端口。IV针头还可以包括围绕针头主体设置的包覆成型的接合特征,其中,包覆成型的接合特征包括第二材料,并且被构造成将IV针头保持在IV容器内。(IV needles are described herein. The IV needle includes a needle body. The needle body may be formed of a first material and may include needle portions that converge to a point. The IV needle further includes at least one needle flow port formed through the needle body. The IV needle further comprises a lower flow port in fluid communication with the at least one needle flow port. The IV needle may further include an overmolded engagement feature disposed about the needle body, wherein the overmolded engagement feature comprises a second material and is configured to retain the IV needle within the IV container.)

1. An IV needle comprising:

a needle body comprising a first material and a needle portion converging to a point;

at least one needle flow port formed through the needle body;

a lower flow port in fluid communication with the at least one needle flow port; and

an overmolded engagement feature disposed about the needle body, wherein the overmolded engagement feature comprises a second material and is configured to retain the IV needle within an IV container.

2. The IV needle of claim 1, wherein the first material comprises acrylonitrile butadiene styrene plastic.

3. The IV needle of claim 1, wherein the needle portion comprises a bevel.

4. The IV needle of claim 1, wherein the at least one needle flow port is disposed adjacent the needle portion.

5. The IV needle of claim 1, wherein the at least one needle flow port comprises a plurality of flow ports.

6. The IV needle of claim 1, wherein the second material comprises a greater coefficient of friction than the first material.

7. The IV needle of claim 1, wherein the second material comprises a thermoplastic elastomer or silicone.

8. The IV needle of claim 1, wherein the overmolded engagement feature extends along an axial length of the needle body.

9. The IV needle of claim 1, wherein the overmolded engagement feature comprises a cylindrical body.

10. The IV needle of claim 9, wherein the overmolded engagement feature is disposed circumferentially around the needle body.

11. The IV needle of claim 1, wherein the overmolded engagement feature extends radially away from the needle body.

12. The IV needle of claim 11, wherein the overmolded engagement feature comprises an upper barb having an upper distal radius and an upper proximal radius, wherein the upper distal radius is less than the upper proximal radius.

13. The IV needle of claim 12, wherein the overmolded engagement feature comprises a lower barb having a lower distal radius and a lower proximal radius, wherein the lower distal radius is greater than the lower proximal radius, and the lower barb is spaced apart from the upper barb.

14. The IV needle of claim 11, wherein the overmolded engagement feature comprises an axial retention feature having a central height extending radially away from the needle body.

15. An IV needle comprising:

a needle body comprising a needle portion converging to a point;

at least one needle flow port formed through the needle body;

a lower flow port in fluid communication with the at least one needle flow port; and

an engagement feature extending radially away from the needle body, wherein the engagement feature is configured to retain the IV needle within an IV container.

16. The IV needle of claim 15, wherein the engagement feature comprises an upper barb having an upper distal radius and an upper proximal radius, wherein the upper distal radius is less than the upper proximal radius.

17. The IV needle of claim 16, wherein the engagement feature comprises a lower barb having a lower distal radius and a lower proximal radius, wherein the lower distal radius is greater than the lower proximal radius, and the lower barb is spaced apart from the upper barb.

18. The IV needle of claim 15, wherein the engagement feature comprises an axial retention feature having a central height extending radially away from the needle body.

19. A method of transferring fluid from an IV container to a drip chamber, the method comprising:

engaging an engagement feature of the IV needle against a septum of the IV container; and

flow is directed from the IV container through the IV needle to a drip chamber.

20. The method of claim 19, further comprising:

piercing an IV container by advancing the IV needle through a septum of the IV container; and

advancing the IV needle through the IV container.

Technical Field

The present disclosure relates generally to IV needles and, more particularly, to IV needles having engagement features.

Background

Medical treatment typically involves the infusion of a medical fluid (e.g., saline or a liquid medication) to a patient using an Intravenous (IV) catheter that is connected to a fluid source, such as an IV container, bag or bottle, through an arrangement of flexible tubing and fittings (commonly referred to as an "IV set"). The IV set may include an IV needle to pierce a septum of the IV container to allow medical fluid to flow out of the IV container. Once the IV needle is advanced through the septum of the IV container, medical fluid may flow through the IV needle to the IV set.

In some applications, the IV container may be a blow molded polyethylene bottle. Blow molded bottles may have a thin wall thickness and low compliance. In certain applications, the IV needle may be inadvertently removed from the IV container during use of the IV set.

Disclosure of Invention

The disclosed subject matter relates to IV needles having engagement features. In some embodiments, the IV needle comprises: a needle body comprising a first material and a needle portion converging to a point; at least one needle flow port formed through the needle body; a lower flow port in fluid communication with the at least one needle flow port; and an overmolded engagement feature disposed about the needle body, wherein the overmolded engagement feature comprises a second material and is configured to retain the IV needle within the IV container.

In some embodiments, the IV needle comprises: a needle body comprising a first material and a needle portion converging to a point; at least one needle flow port formed through the needle body; a lower flow port in fluid communication with the at least one needle flow port; and an engagement feature extending radially away from the needle body, wherein the engagement feature is configured to retain the IV needle within the IV container.

In certain embodiments, a method of transferring fluid from an IV container to a drip chamber, comprises: engaging an engagement feature of the IV needle against a septum of the IV container; and directing flow from the IV container through the IV needle to the drip chamber.

It is understood that various configurations of the subject technology will become readily apparent to those skilled in the art from this disclosure, wherein it is shown and described by way of illustration. As will be realized, the subject technology is capable of other and different constructions and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the summary, drawings, and detailed description are to be regarded as illustrative in nature and not as restrictive.

Drawings

The accompanying drawings, which are included to provide a further understanding and are incorporated in and constitute a part of this specification, illustrate disclosed embodiments and together with the description serve to explain the principles of the disclosed embodiments. In the drawings:

fig. 1 is a front view of an IV set according to various aspects of the present disclosure.

Fig. 2 is a front view of an IV needle for use with the IV set of fig. 1 in accordance with aspects of the present disclosure.

Fig. 3 is a top view of the IV needle of fig. 2 according to aspects of the present disclosure.

Fig. 4 is a front view of the IV needle of fig. 2, in accordance with aspects of the present disclosure.

Fig. 5 is a perspective view of an IV needle for use with the IV set of fig. 1 in accordance with aspects of the present disclosure.

Fig. 6 is a perspective view of an IV needle for use with the IV set of fig. 1 in accordance with aspects of the present disclosure.

Fig. 7 is a perspective view of an IV needle for use with the IV set of fig. 1 in accordance with aspects of the present disclosure.

Detailed Description

The disclosed IV needle incorporates features for engaging and sealing against various types of IV containers. The IV needle may engage a portion of the IV container to retain the IV needle within the IV container. The detailed description set forth below is intended as a description of various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. It will be apparent, however, to one skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the subject technology. To facilitate understanding, like parts are labeled with like element numbers. Reference numerals may have an additional alphabetic suffix to indicate different instances of a common element, while common elements are generally referred to by the same number without the suffix letter.

While the following description is directed to the administration of medical fluids to a patient by medical personnel using the disclosed IV needle, it is to be understood that this description is merely an example of use and does not limit the scope of the claims. The various aspects of the disclosed IV needle may be used in any application where it is desirable to prevent accidental removal of an IV needle.

The disclosed IV needle overcomes several challenges found with respect to the operation and arrangement of certain IV sets. One challenge with some conventional IV needles is that they may have a low removal force (less than one pound-force) to remove from IV containers of varying or different configurations. Because some conventional IV needles may be removed with little force, some conventional IV needles may be inadvertently or accidentally removed from the IV container, thereby interrupting medical treatment.

Thus, it would be advantageous in accordance with the present disclosure to provide an IV needle as described herein that can securely engage within different IV containers. The disclosed IV needle provides engagement features for engagement with various IV containers. Advantageously, the disclosed IV needle allows a clinician to consistently and reliably use the IV needle without inadvertently removing the IV needle from the IV container. In addition, the disclosed IV needle may be reliably used with a variety of IV containers, including polyvinyl chloride (PVC) IV bags and/or blow-molded polyethylene infusion bottles. In addition, the IV needle may seal against the IV container to prevent leakage.

Examples of IV needles that can be engaged with various IV containers are now described.

Fig. 1 is a front view of an IV set 100 according to various aspects of the present disclosure. In the example shown, the IV set 100 may provide medical fluid to a patient from an IV container, bag or vial 102.

As shown, the IV needle 110 facilitates the transfer of fluid from the IV container 102 to the patient via the drip chamber 104. During operation, the IV needle 110 is advanced through the IV container 102 to pierce the septum of the sealed IV container 102. As the IV needle 110 is advanced, the septum of the IV container 102 is displaced. The engagement feature of the IV needle 110 retains the IV needle 110 within the IV container 102 after the IV needle 110 is introduced. In addition, the engagement feature of the IV needle 110 may seal the IV needle 110 against the IV container 102.

As shown, the IV container 102 may be any suitable container for storing medical fluids. In some embodiments, the IV container 102 is a PVC IV bag. In some applications, such as some developing countries, the IV container 102 may be different in construction from a PVC IV bag. For example, the IV container 102 may be a blow molded polyethylene infusion bottle. Additionally, the IV container 102 may have a thinner wall construction or lower compliance than a PVC IV bag.

Advantageously, the engagement feature of the IV needle 110 may engage with the IV container 102, which has a thinner wall construction or lower compliance than a PVC IV bag to ensure that the IV needle 110 is securely engaged. Alternatively, the IV needle 110 may be used with a PVC IV bag.

After the IV needle 110 is introduced into the IV container 102, medical fluid from the IV container 102 is allowed to flow through the IV needle 110 to the drip chamber 104 and to the patient.

Fig. 2 is a front view of an IV needle 110 for use with the IV set 100 of fig. 1 in accordance with aspects of the present disclosure. In the illustrated embodiment, the IV needle 110 may be advanced through a septum of the IV container to allow medical fluid within the IV container to flow out.

In the example shown, the needle body 120 pierces and displaces a septum of an IV container. Needle body 120 extends from base portion 126 and converges to needle portion 122. In some embodiments, the needle body 120 is a generally elongate member. Alternatively, the needle body 120 may have a generally cylindrical shape. The needle body 120 may be formed of a substantially rigid material including, but not limited to, Acrylonitrile Butadiene Styrene (ABS) plastic.

As shown, the needle portion 122 converges to a point or more generally to a reduced radius portion relative to the needle body 120. Optionally, the needle portion 122 may have a bevel 124. During operation, as the IV needle 110 is advanced, the needle portion 122 may pierce or rupture a septum of the IV container, allowing the needle body 120 to displace and advance the septum into the IV container.

Once the needle body 120 ruptures the septum and advances into the IV container, the overmold 140 may retain the IV needle 110 within the IV container. For example, overmold 140 may engage the edge of an IV container or septum surrounding IV needle 110.

Upon insertion of the needle body 120 into the IV container, the overmold 140 may conform sufficiently to elastically deform to compress through the puncture site and/or expand past the puncture site. As a result, overmold 140 may have a greater surface area in contact with the septum of the IV container. In some embodiments, overmold 140 may expand to seal and/or minimize a small gap between IV needle 110 and the septum of the IV container, thereby preventing or reducing leakage, effectively functioning as a gasket. Alternatively, the edge of the septum of the IV container may be bonded or "embedded" into the compliant material of overmold 140.

In the example shown, overmold 140 may be formed from a compliant material, such as a soft polymer, a thermoplastic elastomer (TPE), and/or silicone. In some embodiments, overmold 140 may be formed from a material that is more compliant (lower durometer) than the material of needle body 120.

Further, overmold 140 may have a sufficient coefficient of friction to frictionally engage overmold 140 against the septum of the IV container. In some embodiments, the coefficient of friction of the material of overmold 140 is greater than the coefficient of friction of the material of needle body 120.

As shown, overmold 140 is cylindrically and/or circumferentially formed on needle body 120. In some embodiments, overmold 140 is formed on needle body 120 as a cylinder or as a skin. Optionally, overmold 140 may extend along the axial length of needle body 120. Overmold 140 may be formed during the molding of IV needle 110 by a "second shot".

Optionally, overmold 140 may constitute a physical barrier preventing IV needle 110 from being removed from the IV container. For example, an edge of overmold 140 may engage a septum of an IV container to prevent IV needle 110 from being removed from the IV container.

Fig. 3 is a top view of the IV needle 110 of fig. 2, in accordance with aspects of the present disclosure. Fig. 4 is a front view of the IV needle 110 of fig. 2, in accordance with aspects of the present disclosure. Referring to fig. 2-4, after the IV needle 110 is introduced into the IV container, the IV needle 110 may facilitate the flow of medical fluid from the IV needle to the patient via the drip chamber.

In the example shown, medical fluid flows from the needle flow port 130, through the needle body 120, and exits the IV needle 110 via the lower flow port 112. As shown, the needle flow port 130 can be formed adjacent to or through the needle portion 122 of the needle body 120. Alternatively, the needle flow port 130 may have an elliptical cross-sectional profile. In some embodiments, a needle flow port 130 is disposed above overmold 140 to allow medical fluid and air to flow through needle flow port 130. In the example shown, the needle flow port 130 is formed to continue through the needle body 120. The IV needle 110 may include one or more needle flow ports 130. For example, the IV needle 110 may include three needle flow ports 130.

As shown, needle flow port 130 is in fluid communication with lower flow port 112. The lower flow port 112 allows fluid to flow from the IV needle 110 to the drip chamber. The drip chamber may be coupled to an IV needle via a drip chamber connector 114.

Fig. 5 is a perspective view of an IV needle 210 for use with the IV set 100 of fig. 1 in accordance with aspects of the present disclosure. In the example shown, IV needle 210 includes a retention feature 242 that constitutes a physical barrier that prevents IV needle 210 from being removed from the IV container.

In some embodiments, the retention feature 242 extends radially away from the needle body 220. In the example shown, the retention feature 242 has a tapered or barb shape that allows the retention feature 242 to pass through the puncture site. As shown, the retention features 242 may be axially spaced apart. In the example shown, each retention feature 242 includes a distal radius 242a and a proximal radius 242 b. The retention feature 242 may taper between a distal radius 242a and a proximal radius 242 b. As shown, distal radius 242a is smaller than proximal radius 242 b.

Upon insertion of IV needle 210, proximal radius 242b of retention feature 242 may engage against a septum of an IV container. Advantageously, the proximal radius 242b of the retention feature 242 may provide a greater surface area to engage the septum of the IV container, thereby preventing the IV needle 210 from being removed from the IV container. In some applications, the retention feature 242 may enlarge the puncture site as the IV needle 210 is introduced.

In the example shown, the retention features 242 may be overmolded or formed by a compliant material, such as a soft polymer, a thermoplastic elastomer (TPE), and/or silicone. In some embodiments, the retention feature 242 may be formed of a material that is more compliant (lower durometer) than the material of the needle body 220.

Alternatively, the retention feature 242 may be formed from the same or similar material as the needle body 220. In some embodiments, the retention feature 242 is integrally formed with the needle body 220.

Fig. 6 is a perspective view of an IV needle 310 for use with the IV set 100 of fig. 1 in accordance with aspects of the present disclosure. In the example shown, the IV needle 310 includes an upper retention feature, barb, or chamfered surface 344 and a lower retention feature, barb, or chamfered surface 346 that collectively constitute a physical barrier that prevents removal of the IV needle 310 from the IV container.

In some embodiments, upper and lower retention features 344, 346 extend radially away from needle body 320. In the example shown, the upper and lower retention features 344, 346 each have a tapered shape. As shown, the upper and lower retention features 344, 346 may be axially spaced apart.

In the example shown, the upper retention feature 344 includes an upper distal radius 344a and an upper proximal radius 344 b. The upper retention feature 344 may taper between an upper distal radius 344a and an upper proximal radius 344 b. As shown, the superior distal radius 344a is less than the superior proximal radius 344 b. In some embodiments, the smaller upper distal radius 344a of the upper retention feature 344 allows the upper retention feature 344 to pass through the puncture site.

Similarly, lower retention feature 346 includes a lower distal radius 346a and a lower proximal radius 346 b. Lower retention feature 346 may taper between a lower distal radius 346a and a lower proximal radius 346 b. As shown, the inferior distal radius 346a is greater than the inferior proximal radius 346 b.

Upon insertion of the IV needle 310, the upper proximal radius 344b of the upper retention feature 344 may engage against a septum of an IV container. Similarly, lower distal radius 346a of lower retention feature 346 may engage against the opposite side of the septum of the IV container, allowing the septum to be retained between upper retention feature 344 and lower retention feature 346 (constituting a "hard stop") to prevent IV needle 310 from being removed from the IV container. In some embodiments, the use of upper and lower retention features 344, 346 allows for reuse of the IV container with IV needle 310.

In the example shown, the upper and lower retention features 344, 346 may be overmolded or formed by a compliant material, such as a soft polymer, a thermoplastic elastomer (TPE), and/or silicone. In some embodiments, the upper and lower retention features 344, 346 may be formed of a material that is more compliant (lower durometer) than the material of the needle body 320.

Alternatively, the upper and lower retention features 344, 346 may be formed of the same or similar material as the needle body 320. In some embodiments, upper and lower retention features 344, 346 are integrally formed with needle body 320.

Fig. 7 is a perspective view of an IV needle 410 for use with the IV set 100 of fig. 1 in accordance with aspects of the present disclosure. In the example shown, the IV needle 410 includes an axial retention feature 448 that constitutes a physical barrier that prevents removal of the IV needle 410 from the IV container.

In some embodiments, the axial retention feature 448 extends axially along the needle body 420 and radially away from the needle body. In the example shown, the axial retention feature 448 has a ribbed shape that smoothly tapers to a central radial height 448a, which allows the axial retention feature 448 to pass through a puncture site. In some embodiments, the axial retention features 448 may be radially spaced apart.

The taper of the axial retention feature 448 may engage against a septum of an IV container when the IV needle 410 is inserted. Advantageously, the axial retention feature 448 may provide a greater surface area to engage the septum of the IV container, thereby preventing the IV needle 410 from being removed from the IV container.

In the example shown, the axial retention features 448 may be overmolded or formed by a compliant material, such as a soft polymer, a thermoplastic elastomer (TPE), and/or silicone. In some embodiments, the axial retention feature 448 may be formed of a material that is more compliant (lower durometer) than the material of the needle body 420.

Alternatively, the axial retention feature 448 may be formed from the same or similar material as the needle body 420. In some embodiments, the axial retention feature 448 is integrally formed with the needle body 420.

In some embodiments, the IV needles described herein may include one or more of the retention features described herein, or any combination thereof. Further, but not limited to, additional retention features may include O-rings, annular engagement features, knobs or engagement features, and/or spikes. Optionally, the IV needle may include a retention feature that is manipulated by the clinician or by introducing the IV needle into the IV container. For example, the IV needle may include a movable collar, a rotating cam assembly, or a movable oval retention feature. In some embodiments, the IV needle may include a retention feature that expands after the IV needle is inserted into the IV container. For example, the IV needle may include an expandable needle body, and/or a fluid absorbable retention feature. In some embodiments, the IV needle may include external retention features including, but not limited to, an external retainer that engages an external surface of the IV container and/or a hook that engages an external surface of the IV container.

The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The present disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

Reference to an element in the singular is not intended to mean "one and only one" unless specifically so stated, but rather "one or more. The term "some" means one or more unless specifically stated otherwise. A positive pronoun (e.g., his) includes negative and neutral genders (e.g., her and its), and vice versa. Headings and sub-headings, if any, are used for convenience only and do not limit the invention.

The word "exemplary" is used herein to mean "serving as an example or illustration. Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative constructions and operations described herein may be considered at least equivalent.

Phrases such as "an aspect" do not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. The disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. Phrases such as "an aspect," may refer to one or more aspects and vice versa. Phrases such as "an embodiment" do not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "an embodiment" may refer to one or more embodiments and vice versa. A phrase such as a "construct" does not imply that such construct is essential to the subject technology or that such construct applies to all constructs of the subject technology. The disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. Phrases such as "a configuration" may refer to one or more configurations and vice versa.

In one aspect, unless otherwise specified, all measured values, numerical values, nominal values, positions, sizes, dimensions and other specifications set forth in the following claims are approximate, and not precise, in this specification. In one aspect, they are intended to have a reasonable range, consistent with the functionality to which they pertain and with what is customary in the art to which they pertain.

In one aspect, the terms "coupled" and the like may refer to direct coupling. In another aspect, the terms "coupled" and the like may refer to an indirect coupling.

Terms such as "top," "bottom," "front," "back," and the like, if used in this disclosure, should be understood to refer to any frame of reference, not to the ordinary gravitational frame of reference. Thus, the top, bottom, front and rear surfaces may extend upwardly, downwardly, diagonally or horizontally in a gravitational frame of reference.

The various items may be arranged differently (e.g., arranged in a different order, or divided in a different manner), all without departing from the scope of the subject technology. All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. Elements of the claims are not to be construed according to the provisions of 35u.s.c § 112(f) sixth paragraph unless the element is explicitly recited using the phrase "means for … …", or in the case of method claims, the element is recited using the phrase "step for … …". Furthermore, to the extent that the terms "includes," "has," and the like are used, such terms are intended to be inclusive in a manner similar to the term "comprising" as "comprising" is interpreted when employed as a transitional word in a claim.

The title, background, summary, brief description of the drawings, and abstract of the disclosure are incorporated herein and provided as illustrative examples of the disclosure, not as a limiting description. They are not intended to limit the scope or meaning of the claims, which are submitted with such understanding. Furthermore, in the detailed description, it can be seen that this description provides illustrative examples, and that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed construction or operation. The following claims are hereby incorporated into the detailed description, with each claim standing on its own as a separately claimed subject matter.

The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language claims, and all legal equivalents are embraced therein. Notwithstanding, none of the claims are intended to encompass subject matter that fails to meet the requirements of 35u.s.c. § 101,102 or 103, nor should they be construed in such a manner.