Embodiments of the subject matter described herein relate generally to fluid infusion devices for delivering a medication fluid to the body of a user. More particularly, embodiments of the subject matter relate to the use of a gas trapping filter in the medication fluid flow path.
Certain diseases or conditions may be treated, according to modern medical techniques, by delivering a medication fluid or other substance to the body of a patient, either in a continuous manner or at particular times or time intervals within an overall time period. For example, diabetes is commonly treated by delivering defined amounts of insulin to the patient at appropriate times. Some common modes of providing insulin therapy to a patient include delivery of insulin through manually operated syringes and insulin pens. Other modern systems employ programmable fluid infusion devices (e.g., continuous insulin infusion devices such as insulin pumps) to deliver controlled amounts of insulin or other drugs to a patient.
A fluid infusion device suitable for use as an insulin pump may be realized as an external device or an implantable device, which is surgically implanted into the body of the patient. External fluid infusion devices include devices designed for use in a generally stationary location (for example, in a hospital or clinic), and devices configured for ambulatory or portable use (to be carried by a patient). External fluid infusion devices may establish a fluid flow path from a fluid reservoir to the patient via, for example, a suitable hollow tubing. The hollow tubing may be connected to a hollow fluid delivery needle that is designed to pierce the patient's skin to deliver an infusion fluid to the body. Alternatively, the hollow tubing may be connected directly to the patient's body through a cannula or set of micro-needles.
It is desirable to reduce the amount of air bubbles in a medication fluid before delivering the fluid to the patient. Small bubbles may be introduced into the medication fluid during a reservoir filling operation, for example, when the fluid reservoir is filled from a vial using a syringe. Although patients are instructed to eliminate air from a filled reservoir, some micro bubbles may remain.
Accordingly, it is desirable to have an assembly, system, or component that is designed to mitigate the effects of air bubbles within a medication fluid flow path. In addition, it is desirable to have an assembly, system, or component that reduces the presence of air bubbles in a fluid flow path while also filtering particulates and/or unwanted substances from the medication fluid. Furthermore, other desirable features and characteristics will become apparent from the subsequent detailed description and the appended claims, taken in conjunction with the accompanying drawings and the foregoing technical field and background.
Disclosed herein is a fluid conduit assembly for delivery of a medication fluid. An exemplary embodiment of the fluid conduit assembly includes a structure defining a flow path for the medication fluid and a gas trapping filter coupled to the structure. The gas trapping filter is positioned in the flow path to filter particulates from the medication fluid and retain gas bubbles from the medication fluid.
A fluid delivery system is also disclosed herein. An exemplary embodiment of the system includes: a fluid infusion pump to provide a medication fluid; a fluid conduit assembly coupled to the fluid infusion pump; and a gas trapping filter. The fluid conduit delivers the medication fluid to a user, and the fluid conduit assembly defines a flow path for the medication fluid. The gas trapping filter is positioned in the flow path to filter particulates from the medication fluid and retain gas bubbles from the medication fluid.
Also disclosed herein is a fluid conduit assembly for delivery of a medication fluid. An exemplary embodiment of the fluid conduit assembly includes a body section to receive a fluid reservoir, and a flow path defined in the body section. The flow path carries fluid from the fluid reservoir when the body section is coupled to the fluid reservoir. The fluid conduit assembly also has a length of tubing extending from the body section and in fluid communication with the flow path. The length of tubing carries fluid from the body section during a fluid delivery operation. The fluid conduit assembly also has a partially or predominantly hydrophilic gas trapping filter positioned in the flow path to filter particulates from the medication fluid and retain gas bubbles from the medication fluid.
This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
A more complete understanding of the subject matter may be derived by referring to the detailed description and claims when considered in conjunction with the following figures, wherein like reference numbers refer to similar elements throughout the figures.
The following detailed description is merely illustrative in nature and is not intended to limit the embodiments of the subject matter or the application and uses of such embodiments. As used herein, the word “exemplary” means “serving as an example, instance, or illustration.” Any implementation described herein as exemplary is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.
The subject matter described here relates to certain assemblies, components, and features of a fluid infusion system of the type used to treat a medical condition of a patient. The fluid infusion system is used for infusing a medication fluid into the body of a user. The non-limiting examples described below relate to a medical device used to treat diabetes (more specifically, an insulin pump), although embodiments of the disclosed subject matter are not so limited. Accordingly, the medication fluid is insulin in certain embodiments. In alternative embodiments, however, many other fluids may be administered through infusion such as, but not limited to, disease treatments, drugs to treat pulmonary hypertension, iron chelation drugs, pain medications, anti-cancer treatments, medications, vitamins, hormones, or the like. Moreover, the gas trapping filter described below could be utilized in the context of other fluid delivery systems if so desired.
For the sake of brevity, conventional features and technologies related to infusion system operation, insulin pump and/or infusion set operation, and other functional aspects of the fluid infusion system (and the individual operating components of the system) may not be described in detail here. Examples of infusion pumps and/or related pump drive systems used to administer insulin and other medications may be of the type described in, but not limited to, U.S. Pat. Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653; 5,505,709; 5,097,122; 6,485,465; 6,554,798; 6,558,351; 6,659,980; 6,752,787; 6,817,990; 6,932,584; and 7,621,893; which are herein incorporated by reference.
The fluid infusion device 102 may be provided in any desired configuration or platform. In accordance with one non-limiting embodiment, the fluid infusion device is realized as a portable unit that can be carried or worn by the patient. In this regard,
The illustrated embodiment of the infusion set component 204 includes, without limitation: a tube 210; an infusion unit 212 coupled to the distal end of the tube 210; and a connector assembly 214 coupled to the proximal end of the tube 210. The fluid infusion device 202 is designed to be carried or worn by the patient, and the infusion set component 204 terminates at the infusion unit 212 such that the fluid infusion device 202 can deliver fluid to the body of the patient via the tube 210. The fluid infusion device 202 may leverage a number of conventional features, components, elements, and characteristics of existing fluid infusion devices. For example, the fluid infusion device 202 may incorporate some of the features, components, elements, and/or characteristics described in U.S. Pat. Nos. 6,485,465 and 7,621,893, the relevant content of which is incorporated by reference herein.
The infusion set component 204 defines a fluid flow path that fluidly couples the fluid reservoir to the infusion unit 212. The connector assembly 214 mates with and couples to the neck region of the fluid reservoir, establishing the fluid path from the fluid reservoir to the tube 210. The connector assembly 214 (with the fluid reservoir coupled thereto) is coupled to the housing of the fluid infusion device 202 to seal and secure the fluid reservoir inside the housing. Thereafter, actuation of the fluid infusion device 202 causes the medication fluid to be expelled from the fluid reservoir, through the infusion set component 204, and into the body of the patient via the infusion unit 212 at the distal end of the tube 210. Accordingly, when the connector assembly 214 is installed as depicted in
The base plate 306 is designed to be temporarily adhered to the skin of the patient using, for example, an adhesive layer of material. After the base plate is affixed to the skin of the patient, a suitably configured insertion device or apparatus may be used to insert a fluid delivery needle or cannula 308 into the body of the patient. The cannula 308 functions as one part of the fluid delivery flow path associated with the fluid infusion device 302. In this regard, the cannula 308 may be considered to be one implementation of the fluid conduit assembly 104 shown in
The fluid delivery systems 200, 300 described here are merely two exemplary embodiments that can include a fluid conduit assembly outfitted with a gas trapping filter. In this regard,
The fluid conduit assembly 400 is suitably configured to accommodate the delivery of a medication fluid such as insulin. The fluid conduit assembly 400 includes a structure 404 (or structures) defining a flow path 406 for the medication fluid. In
The flow path 406 is defined by the interior space of the structure 404. The gas trapping filter 402 may be coupled to the structure 404 and positioned in the flow path 406 such that the medication fluid passes through the gas trapping filter 402 during fluid delivery operations.
The gas trapping filter 402 is formed from a suitable material, composition, or element such that the medication fluid can easily pass through the gas trapping filter 402 during fluid delivery operations. The gas trapping filter 402 can be formed from a hydrophilic, semi-hydrophilic, partially hydrophilic, or predominantly hydrophilic material. Although a truly hydrophilic material may be ideal, the material used for the gas trapping filter 402 can be partially or predominantly hydrophilic while exhibiting some amount of hydrophobicity. In practice, the gas trapping filter 402 can exhibit up to fifty percent hydrophobicity without adversely impacting the desired performance. For example, the gas trapping filter 402 may include or be fabricated from a hydrophilic membrane, a hydrophilic sponge material, or a hydrophilic foam material. As explained below, the gas trapping filter 402 also serves to filter particulates from the medication fluid during fluid delivery operations. Accordingly, the gas trapping filter 402 has a pore size that is small enough to inhibit the flow of particulates. In certain embodiments, the pore size is within the range of about 0.45 to 5.00 microns, which is suitable for most medical applications. Non-limiting examples of suitable materials for the gas trapping filter 402 include: polyacrylate; polyurethane; nylon; cellulose acetate; polyvinyl alcohol; polyethelene foam; polyvinyl acetate; polyester fiber felt; polyester (PET); polysulfone; polyethyl sulfone; collagen; polycaprolactone; or the like. It should be appreciated that the material or materials used to fabricate the gas trapping filter 402 can be treated to enhance the hydrophilic characteristics if so desired.
One function of the gas trapping filter 402 is to inhibit the downstream flow of air bubbles. Depending on the particular composition and configuration of the gas trapping filter 402, air bubbles 410 (depicted as small circles in the flow path 406 upstream of the gas trapping filter 402) can be blocked by the gas trapping filter 402 and/or retained within the gas trapping filter 402 as the liquid medication flows downstream. Thus, the gas trapping filter 402 may be realized as a gas impermeable membrane or material that also exhibits good hydrophilic properties. In some embodiments, the gas trapping filter 402 can be fabricated from material having micro-cavities formed therein for trapping and retaining gas bubbles from the medication fluid.
Another benefit of the gas trapping filter 402 relates to the volume accuracy of the fluid delivery system. In certain implementations, syringe pumps are calibrated to deliver a specified volume in response to a controlled mechanical actuation (e.g., movement of the syringe plunger in response to controlled rotation of an electric motor). Reducing or eliminating air from the fluid delivery path increases the accuracy of the volume calibrations.
In certain embodiments, the gas trapping filter 402 also serves to filter particulates from the medication fluid such that the particulate count of the downstream medication fluid is reduced. As mentioned above, the material used to fabricate the gas trapping filter 402 can be selected with a desired pore size to accommodate filtering of particulates having an expected size.
In some embodiments, the gas trapping filter 402 also serves to absorb and/or adsorb certain substances, chemicals, or suspended elements from the medication fluid. For example, the gas trapping filter 402 may include material that is configured or treated to absorb/adsorb lubricating or manufacturing oil that is associated with the manufacturing, assembly, or maintenance of one or more components of the fluid delivery system. In this regard, a fluid reservoir for insulin can be fabricated with a trace amount of silicone oil that serves as a lubricant for the plunger of the reservoir. Accordingly, the gas trapping filter 402 can include a material, layer, or treatment that reduces, traps, or otherwise removes some or all of the silicone oil from the medication fluid as it passes through the gas trapping filter 402.
In particular embodiments, the gas trapping filter 402 also serves as a drug depot during operation of the fluid delivery system. To this end, the gas trapping filter 402 can include a drug, medicine, chemical, or composition impregnated therein (or coated thereon, or otherwise carried by the gas trapping filter 402). A quantity of the drug is released into the medication fluid as the fluid flows through the gas trapping filter 402 during a fluid delivery operation. The wavy lines 414 in
Although
As mentioned above, the fluid conduit assembly that carries the gas trapping filter can be realized in a number of different forms. For example, the fluid conduit assembly may include or be realized as a fluid connector, where the gas trapping filter is integrated in the fluid connector. In this regard,
One or both of the connectors 506, 508 can be provided with a gas trapping filter having the characteristics and functionality described previously. For this particular embodiment, a unitary gas trapping filter 516 is integrated in the second connector 508. The gas trapping filter 516 is located within the body of the second connector 508, and it resides downstream from the septum 512. During a fluid delivery operation, the medication fluid exits the hollow needle 510, enters the second connector 508 (e.g., into a space that is upstream from the gas trapping filter 516), and is forced through the gas trapping filter 516 before it passes into the downstream section of tubing 504.
As another example, a fluid conduit assembly configured as described herein may include or be realized as an infusion set for a fluid infusion pump, where the gas trapping filter is integrated in the infusion set. In this regard,
The illustrated embodiment of the connector assembly 600 generally includes, without limitation: a body section 602; a flow path defined in the body section 602; a length of tubing 604 extending from the body section 602; and a gas trapping filter 606.
The lower body section 602b is suitably configured to receive a fluid reservoir, e.g., by a threaded engagement, a snap fit, tabs, or the like. The tubing 604 is physically and fluidly coupled to the upper body section 602b such that the tubing 604 is in fluid communication with the flow path. This allows the tubing 604 to carry fluid from the body section 602 during a fluid delivery operation. The flow path, much of which is hidden from view in
The gas trapping filter 606 is secured within the body section 602 such that it is positioned in the flow path of the medication fluid. During a fluid delivery operation, the medication fluid is forced out of the fluid reservoir and into the hollow needle (not shown in
The illustrated embodiment of the connector assembly 700 generally includes, without limitation: a body section 602 (having a lower body section 602a and an upper body section 602b); a venting membrane 702; a hollow needle 704; a gas trapping filter 706; and a reservoir membrane 708. These components can be assembled together in the manner generally described above for the assembly 600.
The venting membrane 702 can be affixed to the upper interior surface of the lower body section 602a such that the venting membrane 702 covers one or more vent holes 710 formed in the top portion of the lower body section 602a. The vent holes 710 facilitate venting of the reservoir chamber that resides in the housing of the fluid infusion device (see, for example,
The gas trapping filter 706 is secured within the body section 602 such that it is positioned in the flow path of the medication fluid. For the illustrated embodiment, the gas trapping filter 706 may be positioned between the reservoir membrane 708 and the downstream end 712 of the hollow needle 704. In certain embodiments, the gas trapping filter 706 is realized as a foam, sponge, or felt fiber composite material. Although not always required, the material used for the gas trapping filter 706 may include, without limitation: polyvinyl acetate (PVA); polyvinyl alcohol; polyester (PET); polycarbonate; polyurethane; polyethyl sulfone; collagen; polycaprolactone; or any combination thereof. In accordance with certain embodiments, a felt-based gas trapping filter 706 has a pore size within the range of about one to 100 microns, and preferably within the range of about 20 to 40 microns. In accordance with certain embodiments, a sponge-based gas trapping filter 706 has a pore size within the range of about 20 to 1000 microns. Regardless of its composition and configuration, the gas trapping filter 706 is suitably configured to reduce the amount of air bubbles in the downstream medication fluid, and to reduce the amount of particulates in the downstream medication fluid.
While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the described embodiment or embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope defined by the claims, which includes known equivalents and foreseeable equivalents at the time of filing this patent application.
This application is a continuation of U.S. patent application Ser. No. 16/368,630, filed Mar. 28, 2019, which is a continuation of U.S. patent application Ser. No. 14/508,934, filed Oct. 7, 2014 and issued on May 7, 2019 as U.S. Pat. No. 10,279,126.
Number | Name | Date | Kind |
---|---|---|---|
3003500 | Barton et al. | Oct 1961 | A |
3631654 | Riley et al. | Jan 1972 | A |
3650093 | Rosenberg | Mar 1972 | A |
3827562 | Esmond | Aug 1974 | A |
3882026 | McPhee | May 1975 | A |
3978857 | McPhee | Sep 1976 | A |
4004587 | Jess | Jan 1977 | A |
4013072 | Jess | Mar 1977 | A |
4116646 | Edwards | Sep 1978 | A |
4190426 | Ruschke | Feb 1980 | A |
4459139 | vonReis et al. | Jul 1984 | A |
4562751 | Nason et al. | Jan 1986 | A |
4571244 | Knighton | Feb 1986 | A |
4678408 | Nason et al. | Jul 1987 | A |
4685903 | Cable et al. | Aug 1987 | A |
4755173 | Konopka et al. | Jul 1988 | A |
4804360 | Kamen | Feb 1989 | A |
5080653 | Voss et al. | Jan 1992 | A |
5097122 | Colman et al. | Mar 1992 | A |
5183472 | Jaehrling et al. | Feb 1993 | A |
5195986 | Kamen | Mar 1993 | A |
5308333 | Skakoon | May 1994 | A |
5391250 | Cheney, II et al. | Feb 1995 | A |
5485408 | Blomquist | Jan 1996 | A |
5505709 | Funderburk et al. | Apr 1996 | A |
5522769 | DeGuiseppi | Jun 1996 | A |
5522803 | Teissen-Simony | Jun 1996 | A |
5665065 | Colman et al. | Sep 1997 | A |
5800420 | Gross et al. | Sep 1998 | A |
5807375 | Gross et al. | Sep 1998 | A |
5902281 | Kraus et al. | May 1999 | A |
5925021 | Castellano et al. | Jul 1999 | A |
5954643 | Van Antwerp et al. | Sep 1999 | A |
6017328 | Fischell et al. | Jan 2000 | A |
6186982 | Gross et al. | Feb 2001 | B1 |
6246992 | Brown | Jun 2001 | B1 |
6248067 | Causey, III et al. | Jun 2001 | B1 |
6248093 | Moberg | Jun 2001 | B1 |
6355021 | Nielsen et al. | Mar 2002 | B1 |
6376211 | Little, II et al. | Apr 2002 | B1 |
6379301 | Worthington et al. | Apr 2002 | B1 |
6471689 | Joseph et al. | Oct 2002 | B1 |
6485465 | Moberg et al. | Nov 2002 | B2 |
6544212 | Galley et al. | Apr 2003 | B2 |
6554798 | Mann et al. | Apr 2003 | B1 |
6558351 | Steil et al. | May 2003 | B1 |
6591876 | Safabash | Jul 2003 | B2 |
6641533 | Causey, III et al. | Nov 2003 | B2 |
6659980 | Moberg et al. | Dec 2003 | B2 |
6736797 | Larsen et al. | May 2004 | B1 |
6749587 | Flaherty | Jun 2004 | B2 |
6752787 | Causey, III et al. | Jun 2004 | B1 |
6766183 | Walsh et al. | Jul 2004 | B2 |
6801420 | Talbot et al. | Oct 2004 | B2 |
6804544 | Van Antwerp et al. | Oct 2004 | B2 |
6817990 | Yap et al. | Nov 2004 | B2 |
6932584 | Gray et al. | Aug 2005 | B2 |
7003336 | Holker et al. | Feb 2006 | B2 |
7029444 | Shin et al. | Apr 2006 | B2 |
7066909 | Peter et al. | Jun 2006 | B1 |
7137964 | Flaherty | Nov 2006 | B2 |
7303549 | Flaherty et al. | Dec 2007 | B2 |
7399277 | Saidara et al. | Jul 2008 | B2 |
7442186 | Blomquist | Oct 2008 | B2 |
7602310 | Mann et al. | Oct 2009 | B2 |
7621893 | Moberg et al. | Nov 2009 | B2 |
7647237 | Malave et al. | Jan 2010 | B2 |
7699807 | Faust et al. | Apr 2010 | B2 |
7727148 | Talbot et al. | Jun 2010 | B2 |
7785313 | Mastrototaro | Aug 2010 | B2 |
7806886 | Kanderian, Jr. et al. | Oct 2010 | B2 |
7819843 | Mann et al. | Oct 2010 | B2 |
7828764 | Moberg et al. | Nov 2010 | B2 |
7879010 | Hunn et al. | Feb 2011 | B2 |
7890295 | Shin et al. | Feb 2011 | B2 |
7892206 | Moberg et al. | Feb 2011 | B2 |
7892748 | Norrild et al. | Feb 2011 | B2 |
7901394 | Ireland et al. | Mar 2011 | B2 |
7942844 | Moberg et al. | May 2011 | B2 |
7946985 | Mastrototaro et al. | May 2011 | B2 |
7955305 | Moberg et al. | Jun 2011 | B2 |
7963954 | Kavazov | Jun 2011 | B2 |
7977112 | Burke et al. | Jul 2011 | B2 |
7979259 | Brown | Jul 2011 | B2 |
7985330 | Wang et al. | Jul 2011 | B2 |
8024201 | Brown | Sep 2011 | B2 |
8100852 | Moberg et al. | Jan 2012 | B2 |
8114268 | Wang et al. | Feb 2012 | B2 |
8114269 | Cooper et al. | Feb 2012 | B2 |
8137314 | Mounce et al. | Mar 2012 | B2 |
8181849 | Bazargan et al. | May 2012 | B2 |
8182462 | Istoc et al. | May 2012 | B2 |
8192395 | Estes et al. | Jun 2012 | B2 |
8195265 | Goode, Jr. et al. | Jun 2012 | B2 |
8202250 | Stutz, Jr. | Jun 2012 | B2 |
8207859 | Enegren et al. | Jun 2012 | B2 |
8226615 | Bikovsky | Jul 2012 | B2 |
8257259 | Brauker et al. | Sep 2012 | B2 |
8267921 | Yodfat et al. | Sep 2012 | B2 |
8275437 | Brauker et al. | Sep 2012 | B2 |
8277415 | Mounce et al. | Oct 2012 | B2 |
8292849 | Bobroff et al. | Oct 2012 | B2 |
8298172 | Nielsen et al. | Oct 2012 | B2 |
8303572 | Adair et al. | Nov 2012 | B2 |
8305580 | Aasmul | Nov 2012 | B2 |
8308679 | Hanson et al. | Nov 2012 | B2 |
8313433 | Cohen et al. | Nov 2012 | B2 |
8318443 | Norrild et al. | Nov 2012 | B2 |
8323250 | Chong et al. | Dec 2012 | B2 |
8343092 | Rush et al. | Jan 2013 | B2 |
8352011 | Van Antwerp et al. | Jan 2013 | B2 |
8353829 | Say et al. | Jan 2013 | B2 |
9901514 | Kavazov | Feb 2018 | B2 |
20020077598 | Yap et al. | Jun 2002 | A1 |
20020173748 | McConnell et al. | Nov 2002 | A1 |
20030032945 | Jayaraman | Feb 2003 | A1 |
20050161042 | Fudge et al. | Jul 2005 | A1 |
20060229530 | Hosoda et al. | Oct 2006 | A1 |
20060246272 | Zhang et al. | Nov 2006 | A1 |
20070123819 | Mernoe et al. | May 2007 | A1 |
20070125374 | Smith et al. | Jun 2007 | A1 |
20080097407 | Plishka | Apr 2008 | A1 |
20080105618 | Beckius et al. | May 2008 | A1 |
20100160861 | Causey, III et al. | Jun 2010 | A1 |
20100234824 | Christoph et al. | Sep 2010 | A1 |
20110184382 | Cady | Jul 2011 | A1 |
20130303987 | Esnouf | Nov 2013 | A1 |
20150112302 | Chattaraj et al. | Apr 2015 | A1 |
20160095987 | Chattaraj et al. | Apr 2016 | A1 |
20220031941 | Dang et al. | Feb 2022 | A1 |
20220409777 | Dang et al. | Dec 2022 | A1 |
20230108058 | Dang et al. | Apr 2023 | A1 |
Number | Date | Country |
---|---|---|
1583188 | Feb 2005 | CN |
1795932 | Jul 2006 | CN |
201969126 | Sep 2011 | CN |
103100131 | May 2013 | CN |
2229970 | Sep 2010 | EP |
2012033847 | Mar 2012 | WO |
2015061493 | Apr 2015 | WO |
2016057093 | Apr 2016 | WO |
Number | Date | Country | |
---|---|---|---|
20210338943 A1 | Nov 2021 | US |
Number | Date | Country | |
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Parent | 16368630 | Mar 2019 | US |
Child | 17374226 | US | |
Parent | 14508934 | Oct 2014 | US |
Child | 16368630 | US |