Pump clip for a fluid infusion device

A pump clip for a fluid infusion device is provided. The pump clip includes a clip base having a first end opposite a second end. The clip base defines an aperture through the clip base between the first end and the second end. The clip base is pivotable between a first position and a second position along a first pivot axis. The pump clip includes a clip pivot base coupled to the clip base along the first pivot axis. At least a portion of the clip pivot base is received within the aperture in the first position. The pump clip includes a clip coupled to the clip pivot base along a second pivot axis and the clip cooperates with the clip pivot base to receive an article.

TECHNICAL FIELD

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 a pump clip for a portable fluid infusion device that securely couples the fluid infusion device to the user and withstands accidental displacement of the fluid infusion device.

BACKGROUND

Certain diseases or conditions may be treated, according to modern medical techniques, by delivering a medication or other substance to the body of a user, 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 user at appropriate times. Some common modes of providing insulin therapy to a user include delivery of insulin through manually operated syringes and insulin pens. Other modern systems employ programmable fluid infusion devices (e.g., insulin pumps) to deliver controlled amounts of insulin to a user.

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 user. Generally, 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 user). External fluid infusion devices may establish a fluid flow path from a fluid reservoir to the user via, for example, a set connector of an infusion set, which is coupled to the fluid reservoir.

In the example of the external fluid infusion device as an insulin infusion device, the external fluid infusion device is intended to be used continuously and delivers insulin twenty-four hours a day according to a programmed plan unique to each pump wearer. A small amount of insulin, or a basal rate, is given continually. This insulin keeps the user's blood glucose levels in the desired range between meals and overnight. When food is eaten, the user programs the external infusion device to deliver a bolus of insulin matched to the amount of food that will be consumed. The user determines how much insulin will be given based on factors including insulin sensitivity, insulin duration, insulin-on-board, and the like. In many instances, external infusion devices include a processor that assists the user in making therapy decisions based on information provided by the user including blood glucose levels, carbohydrate intake, and/or information from the external infusion device.

In this instance, as the device is used continuously for delivering insulin twenty-four hours a day, it is desirable to secure the device to the body of the user. In certain instances, a pump clip can enable easy access to the external infusion device while allowing the fluid infusion device to be securely held in position while being discrete and inconspicuous. Given that a pump clip is often secured to a user's clothing, however, the fluid infusion device is susceptible to accidental displacement, caused by bumping/snagging on chairs, seat belts when exiting a vehicle, contact with door knobs/tables, etc. The accidental displacement may pull the pump clip away from the fluid infusion device, which may cause damage to the pump clip and/or the fluid infusion device. In addition, movement of the infusion set from accidental displacement of the fluid infusion device or tubing may adversely affect the delivery and efficacy of the infusion therapy.

Accordingly, it is desirable to provide a pump clip for a fluid infusion device that securely couples the fluid infusion device to the user while reducing a likelihood of damage to the pump clip and/or fluid infusion device from accidental or unintentional displacement of the fluid infusion device. 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.

BRIEF SUMMARY

According to various embodiments, provided is a pump clip for a fluid infusion device. The pump clip includes a mount. The mount includes wings defined on opposed sides of the mount, a first lock tab to couple the pump clip to the fluid infusion device and a lip. The pump clip includes a base coupled to the mount that defines a second lock tab that engages with the lip to retain the mount in a first position. The mount is pivotable about a first pivot axis into a second position in which the mount is spaced apart from the base. The pump clip includes a clip coupled to the base, the clip pivotable about a second pivot axis relative to the base between a first, clamped position and a second, released position to receive an article.

Further provided according to various embodiments is a portable fluid infusion device system. The portable fluid infusion device system includes a fluid infusion device having a pump clip interface that defines a pair of rails. The portable fluid infusion device system includes a pump clip coupled to the pump clip interface. The pump clip includes a mount. The mount includes wings defined on opposed sidewalls of the mount, a first lock tab and a lip. The wings cooperate with the pair of rails to position the pump clip on the fluid infusion device and the first lock tab cooperates with the pump clip interface to releasably couple the pump clip to the fluid infusion device. The pump clip includes a base coupled to the mount that defines a second lock tab that engages with the lip to retain the mount in a first position. The mount is pivotable about a first pivot axis into a second position in which the mount is spaced apart from the base. The pump clip includes a clip coupled to the base and the clip is pivotable about a second pivot axis relative to the base between a first, clamped position and a second, released position to receive an article.

Also provided according to various embodiments is a portable fluid infusion device system. The portable fluid infusion device system includes a fluid infusion device having a pump clip interface that defines a pair of rails and a notch. The portable fluid infusion device system includes a pump clip coupled to the pump clip interface. The pump clip includes a mount. The mount includes wings defined on opposed sidewalls of the mount, a first lock tab and a lip. The wings are configured to be slidably received within the pair of rails to position the pump clip on the fluid infusion device. The first lock tab cooperates with the notch of the pump clip interface to releasably couple the pump clip to the fluid infusion device. The pump clip includes a base coupled to the mount that defines a second lock tab that engages with the lip to retain the mount in a first position. The mount is pivotable about a first pivot axis into a second position in which the mount is spaced apart from the base. The pump clip includes a clip coupled to the base and the clip is pivotable about a second pivot axis relative to the base between a first, clamped position and a second, released position to receive an article.

According to various embodiments, provided is a pump clip for a fluid infusion device. The pump clip includes a clip base having a first end opposite a second end. The clip base defines an aperture through the clip base between the first end and the second end. The clip base is pivotable between a first position and a second position along a first pivot axis. The pump clip includes a clip pivot base coupled to the clip base along the first pivot axis. At least a portion of the clip pivot base is received within the aperture in the first position. The pump clip includes a clip coupled to the clip pivot base along a second pivot axis and the clip cooperates with the clip pivot base to receive an article.

Further provided according to various embodiments is a portable fluid infusion device system. The portable fluid infusion device system includes a fluid infusion device having a first end opposite a second end. The portable fluid infusion device system includes a pump clip coupled to the first end and to the second end. The pump clip includes a clip base having a first base end opposite a second base end. The clip base defines an aperture through the clip base between the first base end and the second base end. The clip base has a first base side opposite a second base side. The second base side is coupled to the fluid infusion device. The clip base is pivotable between a first position and a second position along a first pivot axis. The pump clip includes a clip pivot base coupled to the first base side of the clip base along the first pivot axis such that at least a portion of the clip pivot base is received within the aperture in the first position and the clip pivot base is spaced apart from the clip base in the second position. The pump clip includes a clip coupled to the clip pivot base along a second pivot axis and the clip cooperates with the clip pivot base to define a slot to receive an article.

Also provided according to various embodiments is a portable fluid infusion device system. The portable fluid infusion device system includes a fluid infusion device having a first end opposite a second end. The portable fluid infusion device system includes a pump clip coupled to the first end and to the second end. The pump clip includes a clip base having a first base end opposite a second base end. The clip base defines an aperture through the clip base between the first base end and the second base end. The clip base has a first base side opposite a second base side. The second base side is coupled to the fluid infusion device. The clip base is pivotable between a first position and a second position along a first pivot axis. The pump clip includes a clip pivot base coupled to the first base side of the clip base along the first pivot axis such that at least a portion of the clip pivot base is received within the aperture in the first position and the clip pivot base is spaced apart from the clip base in the second position. The pump clip includes a first biasing member coupled to the clip base that biases the clip base in the first position. The first biasing member includes a first leg coupled to the clip pivot base and a second leg coupled to the clip base. The pump clip includes a clip coupled to the clip pivot base along a second pivot axis and the clip cooperates with the clip pivot base to define a slot to receive an article.

DETAILED DESCRIPTION

As used herein, the term “axial” refers to a direction that is generally parallel to or coincident with an axis of rotation, axis of symmetry, or centerline of a component or components. For example, in a cylinder or disc with a centerline and generally circular ends or opposing faces, the “axial” direction may refer to the direction that generally extends in parallel to the centerline between the opposite ends or faces. In certain instances, the term “axial” may be utilized with respect to components that are not cylindrical (or otherwise radially symmetric). For example, the “axial” direction for a rectangular housing containing a rotating shaft may be viewed as a direction that is generally parallel to or coincident with the rotational axis of the shaft. Furthermore, the term “radially” as used herein may refer to a direction or a relationship of components with respect to a line extending outward from a shared centerline, axis, or similar reference, for example in a plane of a cylinder or disc that is perpendicular to the centerline or axis. In certain instances, components may be viewed as “radially” aligned even though one or both of the components may not be cylindrical (or otherwise radially symmetric). Furthermore, the terms “axial” and “radial” (and any derivatives) may encompass directional relationships that are other than precisely aligned with (e.g., oblique to) the true axial and radial dimensions, provided the relationship is predominately in the respective nominal axial or radial direction. As used herein, the term “transverse” denotes an axis that crosses another axis at an angle such that the axis and the other axis are neither substantially perpendicular nor substantially parallel.

The following description relates to various embodiments of a pump clip. The geometry of the pump clip can be configured to accommodate a variety of different portable devices such as, but not limited to, portable external infusion systems. In one example, the pump clip is provided for use with a fluid infusion device of the type used to treat a medical condition of a user. The infusion device can be used for infusing 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 infused 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. For the sake of brevity, conventional features and characteristics related to infusion system operation, insulin pump and/or infusion set operation, fluid reservoirs, and fluid syringes 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. Patent Publication Nos. 2009/0299290 and 2008/0269687; 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; 7,621,893; 7,828,764; and 7,905,868; which are each incorporated by reference herein.

Generally, the pump clip configured to hold an external infusion device, such as a fluid infusion device, has various design challenges that generally are not present regarding many other portable electronic devices. For example, with some embodiments the infusion device is directly connected via tubing to an infusion set having a cannula inserted into the user. Thus, while pump clips for portable electronic devices can allow the electronic device to spin freely, if applied to a portable infusion device the free rotation could lead to tangled or displaced tubing and may displace the infusion set. Moreover, since the pump clip is in contact with the user, the size and geometry of the pump clip needs to be comfortable to wear, and the pump clip needs to be able to attach to a variety of areas on the user or to various articles or objects associated with the user to enable the fluid infusion device to be worn at various locations. Additionally, given the repeated contact with the user, the pump clip needs to be composed of a material resistant to exposure to chemicals, such as sun screen, body lotion, finger oils, and detergents to prolong a useful life of the pump clip.

With reference toFIG. 1, a pump clip100is shown coupled to a fluid infusion device102. InFIG. 1A, the pump clip100is shown removed from the fluid infusion device102. The pump clip100and the fluid infusion device102cooperate to define a portable fluid infusion device system99(FIG. 1). The fluid infusion device102may be any fluid infusion device known in the art, and thus, the fluid infusion device102will not be discussed in great detail herein. Generally, the fluid infusion device102is designed to be carried or worn by the user, and to be coupled to the user via the pump clip100. In one example, the fluid infusion device102is an insulin infusion device, such as the MiniMed Paradigm® 500 series Insulin Pump, which is commercially available from Medtronic MiniMed, Inc. of Northridge, Calif. The fluid infusion device102may leverage a number of conventional features, components, elements, and characteristics described in U.S. Pat. Nos. 6,485,465 and 7,621,893, the relevant content of which is incorporated by reference herein.

Briefly, with reference toFIGS. 1 and 1A, the fluid infusion device102includes a housing104. The housing104has a first end106and an opposite second end108. The first end106defines a slot110and a protrusion112(FIG. 1A). The slot110receives a portion of the pump clip100to assist in securing the pump clip100to the first end106of the fluid infusion device102. The slot110has a width W1(FIG. 1A), which is sized to receive the portion of the pump clip100. The slot110may have inward sloping sides to facilitate the alignment of the pump clip100with the slot110. With brief reference toFIG. 1A, the protrusion112extends outwardly from the slot110. The protrusion112cooperates with a portion of the pump clip100to retain the pump clip100on the housing104and coupled to the fluid infusion device102. The protrusion112generally comprises a rounded tab; however, the protrusion112may have any desired shape to cooperate with the pump clip100. With reference back toFIG. 1, as will be discussed, the second end108is received within a portion of the pump clip100.

The pump clip100includes a clip base120, a lock button122, a first biasing member or first spring124, a hinge pin126, a clip pivot base128, a second biasing member or second spring130, a clamp pin132and a clip134. With reference toFIG. 2, the pump clip100is shown detached from the fluid infusion device102. As shown, the clip base120is configured to receive the fluid infusion device102. The clip base120includes a first base side140opposite a second base side142, a first base end144opposite a second base end146and an aperture148. The clip base120is generally composed of a biocompatible polymeric material, including, but not limited to, copolyester (Tritan® TX1001 or Tritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortron® 1200L1), Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin® 500P, and Delrin® SC655), Polyurethane (Isoplast® 2531 or Isoplast® 2510) and polycarbonate. In one example, the clip base120is composed of Tritan® COPOLYESTER MX711. The clip base120may be formed using casting, printing, molding or another suitable technique.

With reference toFIG. 3, the first base side140includes or defines a first pin post150, a second pin post152and a spring cover154. The first pin post150and the second pin post152extend outwardly from the first base side140. The first pin post150and the second pin post152are rounded to provide a smooth contact surface against the user. The first pin post150defines a first bore150a, and the second pin post defines a second bore152a. The first bore150areceives a first end126aof the hinge pin126, and the second bore152areceives an opposite second end126bof the hinge pin126. The first pin post150and the second pin post152cooperate to retain the hinge pin126on the clip base120. The first bore150aand the second bore152aare defined in the respective first pin post150and the second pin post152along an axis A, which is substantially perpendicular to the longitudinal axis L1of the clip base120.

The spring cover154is arcuate, and may be substantially cylindrical. The spring cover154is defined on the first base side140so as to be substantially evenly spaced apart from the first pin post150and the second pin post152. Stated another way, the spring cover154is substantially centered on the first base body140between the first pin post150and the second pin post152. The spring cover154is spaced apart from the first pin post150and the second pin post152such that respective portions of the clip pivot base128may be received between the first pin post150and the spring cover154, and between the second pin post152and the spring cover154. The spring cover154protects the first spring124, and substantially encloses a portion of a body of the first spring124such that the first spring124is substantially concealed from view when the pump clip100is assembled (FIG. 2). The spring cover154defines a spring aperture154a, which cooperates with the second base side142to receive the first spring124.

With reference toFIG. 4, the second base side142is shown in greater detail. The second base side142is substantially flat or planar for being positioned against the fluid infusion device102(FIG. 1) when the fluid infusion device102is coupled to the pump clip100. The second base side142includes a spring guide156, a spring recess158, a first pocket or relief160and a second pocket or relief162. The spring guide156is defined as a concave notch on the second base side142, which extends between the spring recess158and the aperture148. The spring guide156receives a portion of the first spring124. The spring recess158is in communication with the spring cover154and cooperates with the spring cover154to receive the first spring124. The first relief160is defined on the second base surface142so as to be substantially opposite the second pin post152(FIG. 3). The second relief162is defined on the second base surface142so as to be substantially opposite the first pin post150(FIG. 3). The first relief160and the second relief162may provide a mass savings and may aid in the manufacture of the clip base120.

With reference toFIG. 5, the first base end144includes a coupling flange164. The coupling flange164extends outwardly form the first base end144, and generally extends along an axis A1, which is substantially perpendicular to the longitudinal axis L1of the clip base120(FIG. 3). The coupling flange164has a width W2, which is substantially equal to the width W1of the slot110(FIG. 1) so that the coupling flange164may be received onto the fluid infusion device102. The coupling flange164may also include one or more protrusions, such as a first protrusion164aand a second protrusion164b. The first protrusion164aand the second protrusion164bextend outwardly from a respective side164c,164dof the coupling bore166and cooperate with mating features defined in the slot110to assist in coupling the pump clip100to the fluid infusion device102. In one example, the first protrusion164aand the second protrusion164bcooperate to form a dovetail with the slot110(FIG. 1A).

The coupling flange164also defines a coupling bore166, which receives the lock button122. The coupling bore166includes a plurality of ridges168, which are spaced apart about a circumference of the coupling bore166. Each of the plurality of ridges168cooperate with a respective one of a plurality of reliefs170defined on the lock button122(FIG. 3) to retain the lock button122within the coupling bore166. In this example, each of the plurality of ridges168include a bulbous portion168a, which assists in retaining the lock button122within the coupling bore166. Each of the plurality of ridges168are defined about a perimeter of the coupling bore166and extend radially inward toward a center of the coupling bore166. The coupling flange164may also include one or more graphical indicators172, such as a lock symbol172aand an unlock symbol172b, as shown inFIGS. 12A and 12D, if desired. The lock symbol172aand the unlock symbol172bprovide a visual indicator of a lock position and an unlock position, respectively, for the pump clip100relative to the fluid infusion device102, as will be discussed further herein.

With reference toFIG. 3, the second base end146is substantially C-shaped to fit around the second end108of the fluid infusion device102(FIG. 1). The second base end146includes a coupling portion174and a lip176. The coupling portion174extends outwardly away from the clip base120along an axis A2. The axis A2is substantially parallel to the axis A1, and is substantially perpendicular to the longitudinal axis L1. The coupling portion174defines a channel178. The channel178is sized to be adjacent to the second end108of the fluid infusion device102(FIG. 1) to couple the fluid infusion device102to the pump clip100. Generally, the channel178enables the pump clip100to clear a bumper defined on a bottom of the housing104of the fluid infusion device102. The lip176extends outwardly away from the coupling portion174along an axis A3. The axis A3is substantially perpendicular to the axis A2, and substantially parallel to the longitudinal axis L1of the clip base120. A curved surface180is defined between the lip176and the coupling portion174to assist in coupling the fluid infusion device102to the pump clip100. The lip176and the curved surface180cooperate to guide the fluid infusion device102into the coupling portion174.

The aperture148is defined through the first base side140and the second base side142and extends from the near the first base end144to the second base end146. The aperture148has a thickness T1, which is sized and shaped to correspond to a portion of the clip pivot base128. The aperture148is in communication with the spring guide156.

As will be discussed, the lock button122is received within the coupling bore166and retains the pump clip100on the fluid infusion device102. The lock button122may be optional, in that the pump clip100may be snap-fit around the fluid infusion device102, if desired. In this example, with reference toFIG. 1, the lock button122includes a first end182and an opposite second end184. The lock button122is generally cylindrical in shape, and is composed of a biocompatible polymeric material, including, but not limited to, copolyester (Tritan® TX1001 or Tritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortron® 1200L1), Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin® 500P, and Dekin® SC655), Polyurethane (Isoplast® 2531 or Isoplast® 2510) and polycarbonate. In one example, the lock button122is composed of Tritan® COPOLYESTER MX711. The lock button122may be formed using casting, printing, molding or another suitable technique. The first end182includes a key slot186. The key slot186has a concave bottom surface186athat is shaped to receive an implement for moving or rotating the lock button122between a lock position and an unlock position. In one example, the instrument is a coin; however, the instrument may include a screwdriver, fingernail, or other device capable of being received in the key slot186and applying a force to move or rotate the lock button122within the coupling bore166.

With reference toFIG. 6, the second end184of the lock button122includes a first lock190spaced apart from a second lock192and the plurality of reliefs170. The plurality of reliefs170are defined about a perimeter or circumference of the lock button122near the first end182, and cooperate with the plurality of ridges168to retain the lock button122on the coupling flange164.

The first lock190is spaced apart from the second lock192about the perimeter or circumference of the lock button122. In one example, the first lock190is substantially opposite the second lock192about the circumference of the lock button122. The first lock190and the second lock192include a lock guide196and a lock protrusion198. The lock guide196guides the lock button122about the protrusion112of the fluid infusion device102(FIG. 1) to position the lock protrusion198into contact with the protrusion112(FIG. 1). The contact between the lock protrusion198and the protrusion112retains the pump clip100on the fluid infusion device102and inhibits the pump clip100from sliding off of the fluid infusion device102. The lock guides196are received through the coupling bore166, and once the lock button122is rotated past the one of the plurality of ridges168, the lock guides196retain the lock button122within the coupling bore166. Stated another way, the lock guides196sit under the plurality of ridges168, while the lock protrusions198slide over a top surface of the plurality of ridges168.

The first spring124is received within the clip base120and enables the clip base120to rotate relative to or away from the clip pivot base128upon the application of a torque greater than the first spring torque of the first spring124. Thus, the first spring124enables the clip base120to move from a first position (FIG. 2) to a second position and positions in-between (FIG. 10) upon the application of a torque to the fluid infusion device102greater than the first spring torque of the first spring124. As shown, in the first position the clip base210is adjacent to or next to the clip pivot base128, and in the second position, the clip base210is spaced apart from the clip pivot base128. In one example, the first spring torque applied by the first spring124is about 4.3 inch-ounces (in.-oz.) at the first position (fully closed position), and is about 17.5 inch-ounces (in.-oz.) at the second position (fully open position).

The first spring124biases the clip base120in the first position, and upon removal of a torque that has moved the clip base120towards the second position, the first spring124returns the clip base120to the first position. Thus, the first spring124enables the pump clip100to withstand torques caused by the fluid infusion device102contacting external factors without damaging the fluid infusion device102and/or the pump clip100, and without impacting an infusion set coupled percutaneously to the user. The first spring124also enables the user to apply a torque to rotate the fluid infusion device102without damaging the fluid infusion device102and/or the pump clip100, and without impacting an infusion set coupled percutaneously to the user. In one example, the first spring124withstands a torque acting on the fluid infusion device102that is less than about 4.3 inch-ounces (in.-oz.). Thus, a torque applied to the fluid infusion device102that is greater than about 4.3 inch-ounces (in.-oz.) causes the clip base120to move or rotate toward the second position. The first spring124is composed of a biocompatible metal or metal alloy, such as a nickel coated music wire. The first spring124may be formed through any suitable technique, such as extrusion, casting, etc. In this example, the first spring124is a helical torsion spring, and includes a first spring leg200and a second spring leg202, which extend from opposite sides of a helical coil body204. Thus, the first spring leg200is at a first end of the helical coil body204, and the second spring leg202is at a second end of the helical coil body204.

The first spring leg200is coupled to the clip pivot base128. In one example, the first spring leg200may be received within a pivot spring guide206defined on a portion of the clip pivot base128. With reference toFIG. 7, a portion of the first spring leg200may be substantially covered by the clip134when the pump clip100is assembled to assist in retaining the first spring leg200within the pivot spring guide206.

With reference toFIG. 4, the second spring leg202is coupled to the clip base120. In this example, the second spring leg202is coupled to the spring guide156of the second base side142of the clip base120. The helical coil body204is received within the spring recess158. With reference toFIG. 2, the spring cover154substantially encloses the helical coil body204to protect the helical coil body204and to protect the user from the helical coil body204. The helical coil body204defines an internal passage204athat receives the hinge pin126therethrough.

With reference toFIG. 2, the hinge pin126defines a first pivot axis P1for the movement or rotation of the clip base120relative to the clip pivot base128. The first pivot axis P1is a first pivot axis for the pump clip100, and the first pivot axis P1is substantially perpendicular to a longitudinal axis L2of the pump clip100. With reference back toFIG. 3, the hinge pin126has the first end126athat is received within the first pin post150, and the opposite second end126bthat is received within the second pin post152. The hinge pin126is composed of a biocompatible material, and in one example, is composed of a biocompatible metal or metal alloy. In this example, the hinge pin126is composed of a biocompatible sheet of metal or metal alloy, such as a stainless steel, which is rolled into a spiral cylinder. By providing the hinge pin126as cylindrical rolled sheet metal, the hinge pin126is easily inserted into the first pin post150, through a portion of the clip pivot base128, the first spring124and into the second pin post152, and once inserted, the hinge pin126expands to provide a radial force that retains the hinge pin126within the first pin post150and the second pin post152.

The clip pivot base128is coupled to the clip base120and to the clip134. The clip pivot base128is composed of a biocompatible polymeric material, including, but not limited to, copolyester (Tritan® TX1001 or Tritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortron® 1200L1), Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin® 500P, and Dekin® SC655), Polyurethane (Isoplast® 2531 or Isoplast® 2510) and polycarbonate. In one example, the clip pivot base128is composed of Tritan® COPOLYESTER MX711. The clip pivot base128may be formed using casting, printing, molding or another suitable technique. The clip pivot base128includes a first clip side210opposite a second clip side212and a first clip end214opposite a second clip end216. A wall218interconnects the first clip side210and the second clip side212. Generally, the wall218is received wholly within the aperture148when the clip base120is in the first position, such that a primary surface S of the first clip side210is substantially flush with a primary surface Si of the first base side140. The wall218has a thickness T2, which is substantially equal to the thickness T1of the aperture148. The primary surface S of the first clip side210is substantially flat or planar and smooth, to receive a portion of an article associated with a user of the pump clip, such as a belt, shirt, pants, etc.

The first clip side210includes a first pivot arm220, a second pivot arm222, a spring retainer224and a clip recess226. The first pivot arm220and the second pivot arm222are spaced apart on the first clip side210near and at the first clip end214. The first pivot arm220includes a first clip post228, the pivot spring guide206and an arm230that defines a first pivot bore232. The first clip post228defines a first clip bore234, which receives a first end132aof the clamp pin132. The first clip post228also defines a flange relief236, which enables a portion of the clip134to be received over the first clip post228. In one example, the flange relief236is a portion of the first clip post228adjacent to the wall218that is removed for receipt of the portion of the clip134. The first pivot arm220defines a sloped surface220athat transitions from the first clip post228to the arm230. The sloped surface220aprovides clearance for a movement or rotation of the clip134and acts as a guide for the rotation of the clip134.

The pivot spring guide206is defined between the first clip post228and the first pivot bore232along a side230aof the arm230. The pivot spring guide206may extend along an axis that is transverse or oblique to a longitudinal axis L3of the clip pivot base128to aid in retaining the first spring leg200. The arm230extends a distance D1above the wall218so that the arm230may rest upon a portion of the first base side140to enable the first pivot bore232to be coupled to the hinge pin126. As the distance D1for the arm230of the first pivot arm220is the same as the distance D1for an arm240of the second pivot arm222, the distance D1is shown inFIG. 3associated with the arm240with the understanding that the distance D1for the arm230is the same. The arm230has a width that is sized to be received on the first base side140between the first pin post150and an end of the spring cover154. The first pivot bore232is defined at a distalmost or terminal end of the arm230. The first pivot bore232receives a portion of the hinge pin126therethrough to pivotally couple the clip pivot base128to the clip base120(FIG. 7).

The second pivot arm222includes a second clip post242and the arm240that defines a second pivot bore244. The second clip post242defines a second clip bore246, which receives a second end132bof the clamp pin132. The first clip bore234of the first clip post228and the second clip bore246extend along an axis A3, which is substantially perpendicular to the longitudinal axis L2of the clip pivot base128. The second clip post242also defines the flange relief236, which enables a portion of the clip134to be received over the second clip post242. In this example, the flange relief236is a portion of the second clip post242adjacent to the wall218that is removed for receipt of the portion of the clip134. The second pivot arm222defines a second sloped surface222athat transitions from the second clip post242to the arm240. The second sloped surface222aprovides clearance for a movement or rotation of the clip134and acts as a guide for the rotation of the clip134.

The arm240extends the distance D1above the wall218so that the arm240may rest upon a portion of the first base side140to enable the second pivot bore244to be coupled to the hinge pin126. The arm240has a width that is sized to be received on the first base side140between an end of the spring cover154and the second pin post152. The second pivot bore244is defined at a distalmost or terminal end of the arm240. The second pivot bore244receives a portion of the hinge pin126therethrough to pivotally couple the clip base120to the clip pivot base128(FIG. 7). The arms230,240may also include a relief on an internal surface that is sized to enable the arms230,240to be positioned on either side of the spring cover154.

The spring retainer224extends outwardly or upwardly from the first clip side210. In one example, the spring retainer224is a post, which is cylindrical. The spring retainer224is coupled to the second spring130and a head224aof the spring retainer224may act as a stop to limit a compression of the second spring130.

The clip recess226is defined at or near the second clip end216and receives a portion of the clip134. The clip recess226cooperates with the clip134to define a tortuous path for clamping the pump clip100to an article of clothing, for example. In this example, the clip recess226is substantially rectangular; however, the clip recess226may have any desired shape. In this example, the clip recess226has an enclosed bottom surface226a, however, it should be understood that the clip recess226may comprise an aperture, which receives a portion of the clip134.

With reference toFIG. 4, the second clip side212is flush with the second base side142when the clip pivot base128is in the first position. The second clip side212is substantially flat or planar, and may include one or more recesses, which may aid in the manufacture of the clip pivot base128and may provide mass savings. With reference back toFIG. 3, the first clip end214includes the arms230,240, which pivotally couple the clip base120to the clip pivot base128. The second clip end216includes the clip recess226.

The second spring130is coupled to the clip pivot base128. In one example, the second spring130is a leaf spring and includes a first leaf250and a second leaf252interconnected by a substantially U-shaped body254. The second spring130is composed of a biocompatible metal or metal alloy, such as a stainless steel. The second spring130may be extruded, cast, stamped, machined or otherwise formed. The first leaf250is compressible by a force applied to the clip134to move the clip134from a first, clamped position to a second, release position. In one example, the force needed to overcome the second spring130to move the clip134from the first, clamped position (fully closed position) is about 1 pound-force (lbf.), and the force needed to move the clip134to the second, release position (fully opened position) is about 6 pound-force (lbf.). The second leaf252defines a spring bore256. The spring bore256receives the spring retainer224therethrough to couple the second spring130to the clip pivot base128. Generally, the spring bore256is circular; however, the spring bore256may have any shape that corresponds with the spring retainer224to retain the second spring130on the clip pivot base128. The body254couples the first leaf250to the second leaf252, and provides a second spring force that maintains the clip134in the first, clamped position.

With reference toFIG. 2, the clamp pin132defines a second pivot axis P2for the movement or rotation of the clip134relative to the clip pivot base128between the first, clamped position, the second, release position and various positions in-between. The second pivot axis P2is a second pivot axis for the pump clip100, and the second pivot axis P2is substantially perpendicular to the longitudinal axis L2of the pump clip100and substantially parallel to the first pivot axis P1. The second pivot axis P2is offset from or spaced apart from the first pivot axis P1along the longitudinal axis L2of the pump clip100. With reference back toFIG. 3, the clamp pin132has the first end132athat is received within the first clip bore234of the first clip post228, and the opposite second end132bthat is received within the second clip bore246of the second clip post242. The clamp pin132is composed of a biocompatible material, and in one example, is composed of a biocompatible metal or metal alloy. In this example, the clamp pin132is composed of a biocompatible sheet of metal or metal alloy, such as a stainless steel, which is rolled into a spiral cylinder. By providing the clamp pin132as cylindrical rolled sheet metal, the clamp pin132is easily inserted into the first clip post228, through a portion of the clip134, through the second spring130and into the second clip post242, and once inserted, the clamp pin132expands to provide a radial force that retains the clamp pin132within the first clip post228and the second clip post242.

The clip134cooperates with the primary surface S of the clip pivot base128to define a slot, generally indicated by reference numeral260inFIG. 2, for receipt of an article of clothing or item associated with the user, such as a shirt, belt, strap, etc. when the clip134is in the first, clamped position. The clip134is composed of a biocompatible polymeric material, including, but not limited to, copolyester (Tritan® TX1001 or Tritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortron® 1200L1), Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin® 500P, and Delrin® SC655), Polyurethane (Isoplast® 2531 or Isoplast® 2510) and polycarbonate. In one example, the clip134is composed of Tritan® COPOLYESTER MX711. The clip134may be formed using casting, printing, molding or another suitable technique. The clip134includes a first side262opposite a second side264, and a first end266opposite a second end268.

The first side262is substantially smooth, and includes an arcuate or curved surface270near and at the first end266. The curved surface270provides a location for a thumb of a user, for example, to apply a force to move the clip134to the second, release position. The second side264is substantially smooth, and includes a pair of clip hinge projections272, which extend outwardly from the second side264near the first end266. The clip hinge projections272are spaced apart from each other on the second side264. In this example, each of the clip hinge projections272includes a clip bore274, which receives a respective first end132aand second end132bof the clamp pin132.

The second side264also includes a clip projection276at the second end268. The clip projection276extends outwardly from the second side264, and is substantially U-shaped. With reference toFIG. 8, the clip projection276cooperates with the clip recess226to define a tortuous path for capturing an article of clothing or other item associated with the user to secure the pump clip100to the particular article of clothing or other item. Thus, the clip projection276enables the clip134to clamp onto an article of clothing or other item associated with the user, and the slot262also enables the pump clip100to be retained about a belt, strap, etc. associated with the user, if desired. Thus, it should be understood that the pump clip100is not limited to use just with belts or straps associated with a user. The second side264also has a recess278which is adjacent to the first leaf250of the second spring130. The second spring130is in compression in the assembly when the clip134is in the first, clamped position.

With reference toFIG. 11, when a force F is applied to the first end266of the clip134exceeds the spring force from second spring130, the clip134rotates about the second pivot axis P2defined by the clamp pin132and the second end268of the clip134is moved to the second, release position in which the clip134is open relative to the clip pivot base128. A width W3of the opening is at least about 0.4 inches (in.) wide for easy attachment and detachment of the pump clip100. Although not shown inFIG. 11, the clip pivot base128remains engaged with the clip base120when operating the clip134due to the first spring torque from the first spring124, and due to the application of the force to the clip134between the clamp pin132and the hinge pin126a moment is only created about the clamp pin132.

In one example, with reference toFIG. 3, in order to assemble the pump clip100, with each of the clip base120, the lock button122, the first spring124, the hinge pin126, the clip pivot base128, the second spring130, the clamp pin132and the clip134formed, the clip pivot base128may be positioned within the aperture148. With the first spring124received within the spring cover154, the first spring leg200of the first spring124may be positioned within the pivot spring guide206, and the second spring leg202may be positioned within the spring guide156. With the first pivot bore232and the second pivot bore244of the clip pivot base128coaxially aligned with the internal passage of the204aof the helical coil body204, the first bore150aof the first pin post150and the second bore152aof the second pin post152, the hinge pin126may be inserted through the first pin post150and through to the second pin post152to couple the clip pivot base128to the clip base120. The spring bore256of the second spring130may be coupled to the spring retainer224to couple the second spring130to the clip pivot base128. The clip hinge projections272may be positioned over the respective flange relief236such that the clip bores274, the first clip bore234and the second clip bore246are coaxially aligned. The clamp pin132is inserted through the clip hinge projections272such that the clamp pin132passes between the first leaf250and the second leaf252of the second spring130to couple the clip134to the clip pivot base128. The lock button122may be inserted into the coupling bore166of the coupling flange164.

With the pump clip100assembled, the pump clip100may be coupled to the fluid infusion device102. In one example, with reference toFIG. 9A, the pump clip100is shown in hands280of a user. In this example, an implement282is inserted into the key slot186and rotated in a counterclockwise direction to move the lock button122from the lock position to the unlock position. In the unlock position, the pump clip100is capable of being coupled to the fluid infusion device102, as shown inFIG. 9B. InFIG. 9B, the coupling portion174is coupled about the second end108of the fluid infusion device102.

With the coupling portion174positioned about the second end108of the fluid infusion device102, with reference toFIG. 9C, the coupling flange164may be positioned over the first end106of the fluid infusion device102. The coupling flange164is advanced in the slot110until the second base side164contacts the housing104of the fluid infusion device102. In this position, the lock button122is positioned over the protrusion112defined on the housing104. With reference toFIG. 9D, with the pump clip100positioned about the fluid infusion device102, the implement282is re-inserted into the key slot186and rotated in a clockwise direction to move the lock button122from the unlock position to the lock position. In the lock position, the pump clip100is securely coupled to the fluid infusion device102.

With the pump clip100securely coupled to the fluid infusion device102, the pump clip100may be used to couple the fluid infusion device102to an article or object associated with the user. For example, with reference toFIG. 9E, the pump clip100is shown with a belt284received within the slot260defined between the clip134and the primary surface S of the clip pivot base128. In order to couple the belt284to the pump clip100, the user may apply a force F to the clip134to compress the second spring130and move the clip134to the second, release position. In this regard, the second spring130applies a second spring force FS2that acts against the clip134to maintain the clip134in the first, clamp position. Once the second spring force FS2is less than the force F, the clip134moves toward the second, release position. In the second, release position, the belt284may be positioned between the clip134and the clip pivot base128. Once the belt284is positioned between the clip134and the clip pivot base128, the user may remove the force F from the clip134, which causes the second spring130to move the clip134from the second, release position to the first, clamp position.

With the pump clip100and the fluid infusion device102coupled to the belt284, the clip base120is movable relative to the clip pivot base128to compensate for torques or forces encountered by the fluid infusion device102. In one example, if the fluid infusion device102encounters the torque TE, due to the fluid infusion device102contacting a seat belt, arm of a chair, door knob, a torque applied by a user, etc., the first spring124resists the torque TE until the torque TE overcomes the first spring torque FS1of the first spring124. Once the torque TE is greater than the first spring torque FS1, the clip base120moves or pivots from the first position (FIG. 9E), toward the second position as shown inFIG. 10or to a position between the first position and the second position. With reference toFIG. 10, in the second position, the clip base120is rotated about the hinge pin126away from the clip pivot base128, which enables the pump clip100to absorb the torque TE, without breaking the pump clip100and/or damaging the fluid infusion device102. By absorbing this torque TE, the pump clip100also ensures that the infusion set remains coupled to the user. Alternatively, the user may be the source of the torque TE, as the movement of the clip base120relative to the clip pivot base128enables the user to rotate the fluid infusion device102to view a screen of the fluid infusion device102without requiring a removal of the pump clip100from the belt284. In addition, the pump clip100is capable of withstanding a force of about 125 pound-force (lbf.) applied in the first pivot axis P1(in an instance where the pump clip100is unable to move to the second position) without damaging the pump clip100and/or fluid infusion device102. It should be noted that while the first spring124is described herein as being capable of absorbing the torque by moving the clip base126away from the clip pivot base128, the first spring124also absorbs forces, which are applied to the fluid infusion device102at a particular position or distance from the first spring124. Generally, a force of less than 1.0 pound-force (lbf.) acting upward on the fluid infusion device102can cause the clip pivot base128to rotate to deflect the force.

With reference toFIG. 11, in the second position, the clip base120is pivoted along the first pivot axis P1to an angle α, which in one example, is about 170 degrees to about 180 degrees. In this example, the angle α is about 180 degrees. The angle α represents a maximum angular displacement of the clip base120relative to the clip pivot base128. It should be understood that the clip base120may pivot to various other positions between the angle α and the first position (FIGS. 2 and 9E), depending upon an amount of the torque TE (FIG. 9E).

Thus, with reference toFIG. 11, a pivotal movement of the clip base120about the first pivot axis P1defined by the hinge pin126occurs when the first spring torque of the first spring124is overcome by the torque TE. The first spring torque of the first spring124is predetermined such that when the fluid infusion device102and/or pump clip100experiences the torque TE via pulling, snagging, bumping, etc., while the user is wearing the fluid infusion device102with the pump clip100, the fluid infusion device102and the clip base120rotate about the first pivot axis P1defined by the hinge pin126, which dissipates the energy from pulling, snagging, bumping, etc., so that it prevents damage to the pump clip100and/or the fluid infusion device102. Since the clip base120is mounted on the fluid infusion device102and the second spring130still holds the clip134in the first, clamped position onto the clip pivot base128, the fluid infusion device102remains attached to the user's clothing when the first spring torque of the first spring124is less than the torque TE during the pulling, snagging, bumping, etc. The first spring124returns the pump clip100to the first position once the torque TE is removed.

In addition, as shown inFIG. 11, the clip134is movable or pivotable about the second pivot axis P2to an angle β based on an application of the force F (FIG. 9E) to the first end266of the clip134, which in one example, may range from about 10 degrees to about 45 degrees. In this example, the angle β is about 16 degrees. The angle β represents an angular displacement of the clip134relative to the clip pivot base128. It should be understood that the clip134may pivot to various other positions between the maximum of the angle β of about 45 degrees and the first position (FIGS. 2 and 9E), depending upon an amount of the force F applied by the user (FIG. 9E).

It should be appreciated that the pump clip100may be constructed somewhat differently. With reference toFIG. 12, a pump clip100′ is shown. As this pump clip100′ is substantially similar to the pump clip100discussed with regard toFIGS. 1-11, the same reference numerals will be used to denote the same or similar components. As shown inFIG. 12, the pump clip100′ is coupled to a fluid infusion device102′. The pump clip100′ and the fluid infusion device102′ cooperate to define a portable fluid infusion device system99′. The fluid infusion device102′ may be any fluid infusion device known in the art, and thus, the fluid infusion device102′ will not be discussed in great detail herein. Generally, the fluid infusion device102′ is designed to be carried or worn by the user, and to be coupled to the user via the pump clip100′. In one example, the fluid infusion device102′ is an insulin infusion device, such as the MiniMed Paradigm® 700 series Insulin Pump, which is commercially available from Medtronic MiniMed, Inc. of Northridge, Calif. The fluid infusion device102′ may leverage a number of conventional features, components, elements, and characteristics described in U.S. Pat. Nos. 6,485,465 and 7,621,893, the relevant content of which is incorporated by reference herein.

Briefly, the fluid infusion device102′ includes a housing104′, which has a length LT, which is greater than a length LT1of the fluid infusion device102(FIG. 1). Thus, the pump clip100′ has a length LB, which is greater than a length LB1of the pump clip100(FIG. 1). The housing104′ has the first end106and the second end108. The first end106and the second end108are received within a portion of the pump clip100′.

The pump clip100′ includes a clip base120′, the lock button122, the first spring124, the hinge pin126, the clip pivot base128, the second spring130, the clamp pin132and the clip134. With reference toFIG. 13, the pump clip100′ is shown detached from the fluid infusion device102′. As shown, the clip base120′ is configured to receive the fluid infusion device102′. The clip base120′ includes the first base side140opposite a second base side142′, the first base end144opposite the second base end146and the aperture148. The clip base120′ is generally composed of a biocompatible polymeric material, including, but not limited to, copolyester (Tritan® TX1001 or Tritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortson® 1200L1), Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin® 500P, and Delrin® SC655), Polyurethane (Isoplast® 2531 or Isoplast® 2510) and polycarbonate. In one example, the clip base120′ is composed of Tritan® COPOLYESTER MX711. The clip base120′ may be formed using casting, printing, molding or another suitable technique.

The second base side142′ is shown in greater detail. The second base side142is substantially flat or planar for being positioned against the fluid infusion device102′ (FIG. 12) when the fluid infusion device102′ is coupled to the pump clip100. The second base side142′ includes the spring guide156, the spring recess158, the first relief160, the second relief162and a projection300. The projection300cooperates with the housing104′ to further secure the fluid infusion device102′ to the pump clip100′. In this example, the projection300is received within a recess defined in the housing104′ of the fluid infusion device102′ and cooperates with the recess to prevent the second base end146of the clip base120′ from sliding side to side on the fluid infusion device102′.

As the pump clip100′ is assembled the same way as the pump clip100, the assembly of the pump clip100′ will not be discussed in great detail herein. Moreover, as the pump clip100′ is coupled to the fluid infusion device102′ in the same manner that the fluid infusion device102is coupled to the pump clip100as described with regard toFIGS. 9A-9E, the coupling of the fluid infusion device102′ to the pump clip100′ will not be discussed in detail herein. With the pump clip100′ coupled to the fluid infusion device102′, the clip pivot base128is pivotable along the first pivot axis P1to the angle α to absorb the torque TE (the same as that shown with regard to the pump clip100ofFIGS. 9E and 11). In addition, the clip134is movable or pivotable about the second pivot axis P2to the angle β upon the application of a force to the first end266of the clip134(the same as that shown with regard to the pump clip100ofFIG. 11).

It should be appreciated that the pump clip100may be constructed somewhat differently, for use for a different type of fluid infusion device, for example. With reference toFIG. 14, a flip pump clip or pump clip400is shown. As this pump clip400is similar to the pump clip100discussed with regard toFIGS. 1-11, the same reference numerals will be used to denote the same or similar components. As shown inFIG. 14, the pump clip400is coupled to a fluid infusion device402. The pump clip400and the fluid infusion device402cooperate to define a portable fluid infusion device system399. The fluid infusion device402may be any fluid infusion device known in the art, and thus, the fluid infusion device402will not be discussed in great detail herein. Generally, the fluid infusion device402is designed to be carried or worn by the user, and to be coupled to the user via the pump clip400. In one example, the fluid infusion device402is an insulin infusion device, such as the MiniMed NGP series Insulin Pump, which is commercially available from Medtronic MiniMed, Inc. of Northridge, Calif. The fluid infusion device402may leverage a number of conventional features, components, elements, and characteristics described in U.S. Pat. Nos. 6,485,465 and 7,621,893, the relevant content of which is incorporated by reference herein.

Briefly, the fluid infusion device402includes a housing404. The housing104has a first end406and an opposite second end408. With reference toFIG. 15, the first end406defines a pump clip plate409, which includes a first rail410, a second rail412and a knob or notch414. The first rail410and the second rail412cooperate to form a pocket that receives a portion of the pump clip400to couple the pump clip400to the fluid infusion device402. In one example, the first rail410is opposite the second rail412, and each of the first rail410and the second rail412define a respective slot410a,412a. The slots410a,412aslidably receive the portion of the pump clip400to couple the pump clip400to the fluid infusion device402. In this example, the slots410a,412aextend for a length LT4, however, the first rail410and the second rail412may have any length that is suitable for receiving the portion of the pump clip400to couple the pump clip400to the housing404. The notch414provides tactile and audible feedback to the user that the pump clip400is coupled to the fluid infusion device402. The notch414is substantially U-shaped, and defines a notch recess414a. The notch recess414aincludes a stop surface414bthat contacts a portion of the pump clip400to provide tactile and audible feedback to the user.

With reference toFIG. 16, the pump clip400is shown detached from the fluid infusion device402. The pump clip400includes a mount420, a hinge pin422, a base424, a clamp pin426, the second spring130(FIG. 15) and a clip428. With reference back toFIG. 15, the mount420couples the pump clip400to the fluid infusion device402. The mount420is pivotable along a first pivot axis PA1defined by the hinge pin422between a first position (FIG. 16) and a second position (FIG. 19), and various positions in-between. The mount420is generally composed of biocompatible polymeric material, including, but not limited to, copolyester (Tritan® TX1001 or Tritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortron® 1200L1), Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin® 500P, and Delrin® SC655), Polyurethane (Isoplast® 2531 or Isoplast® 2510) and polycarbonate. The mount420may be formed using casting, printing, molding or another suitable technique. The mount420includes a first mount side430opposite a second mount side432, a first mount end434opposite a second mount end436, a first lock tab438and a pair of opposed wings440.

The first mount side430includes a first mount pin post442and a second mount pin post444defined at the first mount end434. The first mount pin post442and the second mount pin post444each define a respective mount pin bore442a,444a, which are coaxially aligned to receive the hinge pin422. The first mount pin post442and the second mount pin post444are rounded to provide a smooth surface in case of contact with the user. The first mount side430also defines a pair of sloped surfaces446a,446bthat extend from a respective one of the first mount pin post442and the second mount pin post444to a planar surface portion448of the first mount side430. The pair of sloped surfaces446a,446bre-inforce the first mount pin post442and the second mount pin post444.

The second mount side432defines a lip450at the second mount end436. The lip450cooperates with a portion of the base424via a snap-fit engagement to maintain the base424in a first position (FIG. 16). Upon release of the lip450by a force, the mount420is pivotable about the first pivot axis PA1defined by the hinge pin422to a second position (FIG. 19) and various positions in-between. In one example, a force acting on the fluid infusion device402that is greater than about 3 pound-force (lbf.) at the first rail410and the second rail412of the fluid infusion device402causes the release of the lip450and the pivoting of the mount420about the first pivot axis PA1. Thus, the snap-fit engagement between the lip450and the portion of the base424remains engaged for forces that are less than about 3 pound-force (lbf.), and the lip450disengages from the portion of the base424at forces that are greater than about 3 pound-force (lbf.). As shown, in the first position, the mount420is adjacent to or next to the base424, and in the second position, the mount420is spaced apart from the base424. Generally, with reference toFIG. 17, the lip450is defined by a relief on the second mount side432that extends inwardly from the second mount side432to receive a portion of the base424. With reference back toFIG. 15, in one example, the lip450has a width W4that is configured to withstand a predetermined amount of force before disengaging with the base424to enable the mount420to move toward the second position (FIG. 19).

In this regard, with reference toFIG. 19, a pivotal movement of the base424and the clip428against the mount420about the first pivot axis PA1defined by the hinge pin422occurs when the lip450disengages from the base424. The lip450disengages when the fluid infusion device402and/or pump clip400experiences a force F5via pulling, snagging, bumping, or a force applied by the user to view a screen of the fluid infusion device402, etc., that is greater than about 3 pound-force (lbf.) while the user is wearing the fluid infusion device402with the pump clip400. Once the lip450disengages, the fluid infusion device402and the mount420rotates about the first pivot axis PA1defined by the hinge pin422(SeeFIG. 20) which dissipates the energy from pulling, snagging, bumping, etc., so that it prevents damage to the pump clip400and/or pump clip plate409of the fluid infusion device402. Since the mount420is mounted on the fluid infusion device402and the second spring130still holds the clip428in the first, clamped position onto the base424, the fluid infusion device402remains attached to the user's clothing when the lip450disengages under the force during pulling, snagging, bumping, etc. With reference toFIG. 21, the pump clip400can return to the first position prior to the application of the force by applying a force F6the fluid infusion device402on a front surface402aof the fluid infusion device402to engage the lip450to a second lock tab498of the base424(SeeFIG. 21).

With reference back toFIG. 15, the second mount end436may also define a ramp surface452along a width of the second mount end436. The ramp surface452facilitates the engagement of the lip450with the portion of the base424. Generally, as will be discussed further herein, a movement of the first lock tab438toward the fluid infusion device402(FIG. 14) engages the lip450with the base424, and a movement of the first lock tab438away from the fluid infusion device402releases the lip450from the base424. Thus, the mount420and the base424are held together by the engagement of the lip450with the base424.

The first lock tab438extends beyond the first mount end434, and cooperates with the pump clip plate409to releasably couple the pump clip400to the fluid infusion device402. In addition, the first lock tab438cooperates with the notch414(FIG. 14) to provide tactile and audible feedback to the user that the pump clip400is coupled to the fluid infusion device402. In one example, the first lock tab438is defined on the mount420so as to be cantilevered with regard to the mount420. In this example, two channels439are defined through the first mount side432and the second mount side434on opposite sides of the first lock tab438to enable the first lock tab438to move or flex between a first, engaged position (FIG. 17) and a second, disengaged position (FIG. 19) to enable the user to couple the pump clip to the fluid infusion device402in the first, engaged position and to uncouple the pump clip400from the fluid infusion device402in the second, disengaged position.

With reference toFIG. 17, the first lock tab438includes a snap fit feature460, which engages with the notch414of the fluid infusion device402via a snap-fit engagement in the first, engaged position. The snap fit feature460, in one example, is a projection, which extends outwardly from the first lock tab438on the second mount side434. The snap fit feature460includes a stop or planar surface462and an inclined surface464. The planar surface462extends along an axis substantially perpendicular to a longitudinal axis L4of the pump clip400. The planar surface462abuts against the stop surface414bof the notch414(FIG. 14) when the pump clip400is assembled to the fluid infusion device402and provides the tactile and audible feedback to the user. The inclined surface464guides the first lock tab438into the notch414. The first lock tab438also includes a graspable portion466. The graspable portion466provides a contact surface for the user to remove or uncouple the pump clip400from the fluid infusion device402, as will be discussed further herein.

With reference toFIG. 15, the pair of opposed wings440are received within a respective one of the slots410a,412ato couple the pump clip400to the fluid infusion device402. It should be noted that the wings440are identical, and generally, the mount420is symmetric about the longitudinal axis L4(FIG. 17) of the pump clip400. Each of the wings440is substantially flat or planar. Each of the wings440extend outwardly from the mount420along opposed sidewalls420aof the mount420so as to be defined on the respective sidewall420abetween the first mount side432and the second mount side434. In one example, each of the wings440includes a tapered edge440a, which assists in positioning the wings440within the respective one of the slots410a,412a.

The hinge pin422movably or pivotally couples the base424to the mount420, and defines the first pivot axis PA1(FIG. 16). The first pivot axis PA1is substantially perpendicular to the longitudinal axis L4of the pump clip400(FIG. 16). In one example, the hinge pin422is a stepped pin, having a diameter at a first end422aand a second end422bthat is less than a diameter of the hinge pin422at a midsection422c. The stepped diameters along the hinge pin422reduces stress on the mount420and the base424, and provide a geometrical interference that assists in retaining the hinge pin422within the first mount pin post442, the second mount pin post444, and within a portion of the base424. The hinge pin422is composed of a biocompatible metal or metal alloy, such as a stainless steel. The hinge pin422may be formed through any suitable technique, such as extrusion, stamping, machining, casting, etc. The first end422aof the hinge pin422is received within a first pivot arm472of the base424and through the first mount pin post442; and the second end422bof the hinge pin422is received within a second pivot arm474of the base424and through the second mount pin post444. A pivot guide476rotates relative to the midsection422cof the hinge pin422.

The base424is generally composed of biocompatible polymeric material, including, but not limited to, copolyester (Tritan® TX1001 or Tritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortron® 1200L1), Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin® 500P, and Delrin® SC655), Polyurethane (Isoplast® 2531 or Isoplast® 2510) and polycarbonate. The base424may be formed using casting, printing, molding or another suitable technique. The base424includes a first base end480opposite a second base end482, and a first base side484opposite a second base side486.

With reference toFIG. 15, the first base end480includes the first pivot arm472, the second pivot arm474and the pivot guide476. The first pivot arm472, the second pivot arm474and the pivot guide476are spaced apart along the first base end480so that the first mount pin post442and the second mount pin post444may be received between the first pivot arm472, the second pivot arm474and the pivot guide476. In one example, the first mount pin post442is positioned between the first pivot arm472and an end of the pivot guide476; and the second mount pin post444is positioned between an opposite end of the pivot guide476and the second pivot arm474. The first pivot arm472defines a first pivot bore472a, which receives the first end422aof the hinge pin422. The second pivot arm474defines a second pivot bore474a, which receives the second end422bof the hinge pin422. With reference toFIG. 17, the pivot guide476defines a concave recess476a, which further guides the base424for rotation about the hinge pin422. In this example, the concave recess476acontacts the midsection422cof the hinge pin422for guiding the base424in rotation about the hinge pin422. The pivot guide476also defines a sloped surface476bon the second base side486. The sloped surface476bprovides clearance for the movement or flexing of the first lock tab438during coupling and uncoupling of the pump clip400from the fluid infusion device402. The first pivot arm472, the second pivot arm474and the pivot guide476also cooperate to serve as a stop for limiting a rotation of the clip428relative to the base424.

With reference back toFIG. 15, the second base end482includes a clip recess488. The clip recess488is defined at or near the second base end482and receives a portion of the clip428. The clip recess488cooperates with a portion of the clip428to define a tortuous path for clamping the pump clip400to an article of clothing, for example. In this example, the clip recess488is substantially rectangular; however, the clip recess488may have any desired shape. In this example, the clip recess488has an enclosed bottom surface490, however, it should be understood that the clip recess488may comprise an aperture, which receives a portion of the clip428. With reference toFIG. 17, in one example, the bottom surface490includes an indentation490a, which is configured to mate with the portion of the clip428to define the tortuous path. In this example, the indentation490ais triangular in shape; however, the indentation490amay have any desired shape that cooperates with the portion of the clip428to define the tortuous path.

The first base side484includes a pocket or recess495, a first clip pin post494and a second clip pin post496. The first base side484also defines a primary surface Si, which is substantially smooth for receiving an article of clothing, belt, strap, etc., associated with the user. The recess495is defined on the first base side484near the first base end480to receive the second spring130. The spring retainer224is defined in the recess495, and is coupled to the second spring130to retain the second spring130on the base424. In this example, an end or the second leaf252of the second spring130engages the recess495, or pocket, within the base424. The recess495, or pocket together with the post or the spring retainer224, securely holds the second leaf252of the second spring130.

The first clip pin post494and the second clip pin post496each extend outwardly and away from the first base side484. The first clip pin post494and the second clip pin post496are spaced apart from each other the first base side484such that the first clip pin post494and the second clip pin post496are on opposed sidewalls484aof the base424. Generally, the first clip pin post494and the second clip pin post496are spaced apart to enable the second spring130to be received between the first clip pin post494and the second clip pin post496. The first clip pin post494defines a first clip bore494a, and the second clip pin post496defines a second clip bore496a. The first clip bore494aand the second clip bore496aare coaxially aligned along axis A5to receive the clamp pin426therethrough to pivotally couple the clip428to the base424. Thus, the stepped hinge pin422is used to connect the mount420to the base424which allows for pivotal movement of the mount420relative to the base424. The stepped hinge pin422is inserted through the pair of mount pin bores442a,444aof the first mount pin post442and the second mount pin post444of the opposed sidewalls420aof the mount420and the pair of openings (first pivot bore472aand second pivot bore474a) of the first pivot arm472and the second pivot arm474of the opposed sidewalls484aof the base424.

With reference toFIG. 17, the second base side486defines the second lock tab498, a slot500and an elongated recess502. The second lock tab498cooperates with the lip450. In this regard, in the lock position, the lip450is received on or rests on the second lock tab498. In the unlock position, the lip450no longer contacts or is released from the engagement with the second lock tab498(FIG. 19). Generally, a thickness T4of the second lock tab498provides an interference onto which the lip450is received. In one example, the thickness T4is between about 0.01 inches (in.) to about 0.05 inches (in.). An angle γ is the snap-fit angle between the lip450and the second lock tab498. In one example, the angle γ is about 20 degrees to about 85 degrees. A thickness T5of the second lock tab498is about 0.05 inches (in.) to about 0.125 inches (in.). Each of the thickness T4, the thickness T5and the angle γ cooperate to determine the amount of force the mount420may withstand before moving toward the second position (FIG. 19). In one example, the mount420may withstand a force of 3 pound-force (lbf.) before the snap-fit between the lip450and the second lock tab498is released and the mount420moves toward the second position.

The slot500enables the second lock tab498to move or flex to release the lip450. The slot500may be defined between the second lock tab498and the elongated recess502. With reference toFIG. 20, the elongated recess502may defined through a portion of the second base side486near or adjacent to the slot500, and may extend from near or adjacent to the slot500to near or adjacent to the second base end482. The elongated recess502provides a mass savings. A bore504is defined through the elongated recess502, which assists in the formation of the base424via injection molding, for example. It should be noted that the bore504may be optional.

The clamp pin426movably or pivotally couples the clip428to the base424, and defines a second pivot axis PA2(FIG. 16). The second pivot axis PA2is substantially perpendicular to the longitudinal axis L4of the pump clip400(FIG. 16), and is substantially parallel to the first pivot axis PA1. Generally, the second pivot axis PA2is offset from or spaced apart from the first pivot axis PA1along the longitudinal axis L4of the pump clip400. In one example, the clamp pin426is a stepped pin, having a diameter at a first end426aand a second end426bthat is less than a diameter of the clamp pin426at a midsection426c. The stepped diameters along the clamp pin426reduces stress on the base424and the clip428, and provide a geometrical interference that assists in retaining the clamp pin426within the first clip pin post494, the second clip pin post496, and within a portion of the clip428. The clamp pin426is composed of a biocompatible metal or metal alloy, such as a stainless steel. The clamp pin426may be formed through any suitable technique, such as extrusion, stamping, machining, casting, etc. The first end426aof the clamp pin426is received within a first clip projection506(FIG. 20) of the clip428and through the first clip pin post494; and the second end426bof the clamp pin426is received within a second clip projection508of the clip428and through the second clip pin post496. The midsection426cof the clamp pin426is received through the second spring130.

The second spring130(FIG. 15) is coupled to the base424. The first leaf250is compressible by a force applied to the clip428to move the clip428from a first, clamped position to a second, release position. Thus, in this example, the second spring130is a leaf spring that is adapted to hold the clip428a closed position onto the base424and provide desired clip force to attach to a user. The spring bore256of the second leaf252receives the spring retainer224therethrough to couple the second spring130to the base424. The body254couples the first leaf250to the second leaf252, and provides a second spring force that maintains the clip428in the first, clamped position.

The clip428cooperates with the primary surface Si of the base424to define a slot, generally indicated by reference numeral510inFIG. 17, for receipt of an article of clothing or item associated with the user, such as a shirt, belt, strap, etc. when the clip428is in the first, clamped position. The clip428is composed of a biocompatible polymeric material, including, but not limited to copolyester (Tritan® TX1001 or Tritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortron® 1200L1), Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin® 500P, and Delrin® SC655), Polyurethane (Isoplast® 2531 or Isoplast® 2510) and polycarbonate. The clip428may be formed using casting, printing, molding or another suitable technique. The clip428includes a first side512opposite a second side514, and a first end516opposite a second end518.

The first side512is substantially smooth, and includes a recessed surface520that extends from the first end516to the second end518. The recessed surface520provides a location for a removable graphical and/or textual indicator, such as a sticker, decal or decorative skin, which enables the user to personalize the pump clip400. The second side514is substantially smooth, and includes the first clip projection506and the second clip projection508, which extend outwardly from the second side512near the first end516. The first clip projection506and the second clip projection508are spaced apart from each other on opposed sidewalls514aof the clip428on the second side514. In this example, each of the first clip projection506and the second clip projection508includes a clip bore522, which receives a respective first end426aand second end426bof the clamp pin426. Thus, the clip428is rotatably mounted to the base424by the stepped clamp pin426inserted through the pair of the clip bores522of the first clip projection506and the second clip projection508that extend from opposed sidewalls514aof the clip428and the pair of the clip bores494a,496aof the first clip pin post494and the second clip pin post496, respectively, on the opposed sidewalls484aof the base424.

The second side514also includes a hook or clip projection524at the second end518. With reference toFIG. 17, the clip projection524extends outwardly from the second side264, and is substantially U-shaped. The clip projection524cooperates with the clip recess488to define a tortuous path for capturing an article of clothing or other item associated with the user to secure the pump clip400to the particular article of clothing or other item. In one example, the clip projection524includes a protrusion524a, which extends outwardly and away from a surface of the clip projection524. In this example, the protrusion524ais substantially triangular, and is shaped to be received within the indentation490aof the clip recess488. The engagement of the protrusion524aand the indentation490aassists the pump clip400in further clamping or gripping onto an article of clothing or item associated with the user, such as a shirt, belt, strap, etc. Thus, the clip projection524enables the clip428to clamp onto an article of clothing or other item associated with the user, and the slot510also enables the pump clip400to be retained about a belt, strap, etc. associated with the user, if desired. Thus, it should be understood that the pump clip400is not limited to use just with belts or straps associated with a user. In addition, it should be understood that the clip projection524need not include the protrusion524a, but rather, the clip projection524may be rounded similar to the clip projection276of the pump clip100ofFIGS. 1-11, if desired.

The second side514also has a recess526which engages the first leaf250of the second spring130. The second spring130is in compression in the assembly when the clip428is in the first, clamped position such that in the first, clamped position shown inFIG. 17, the clip projection524at the second end of the clip428is in compression resting in the clip recess488within the base424, which provides better attachment of the pump clip400on the article associated with the user, such as a shirt, belt, strap, etc. With reference toFIG. 18, when a force F4is applied to the first end516of the clip428exceeds the spring force from second spring130, the clip428rotates about the second pivot axis PA2defined by the clamp pin426and the second end518of the clip428is moved to the second, release position in which the clip428is open relative to the base424. A width W5of the opening is at least about 0.4 inches (in.) wide for easy attachment and detachment of the pump clip400. The lip450remains engaged with the base424when operating the clip428.

In one example, with reference toFIG. 15, in order to assemble the pump clip400, with each of the mount420, the hinge pin422, the base424, the second spring130, the clamp pin426and the clip428formed, the base424may be coupled to the mount420such that the lip450of the mount420engages the second lock tab498of the base424. With the first pivot bore472aand the second pivot bore474aof the base424coaxially aligned with the mount pin bore442aof the first mount pin post442and the mount pin bore444aof the second mount pin post444, the hinge pin422may be inserted through the first pivot arm472and through to the second pivot arm474to couple the base424to the mount420. The second spring130may be positioned within the recess495defined on the first base side484, and the spring bore256of the second spring130may be coupled to the spring retainer224to couple the second spring130to the base424. The clip bores522of the first clip projection506and the second clip projection508may be positioned over the base424such that the clip bores522, the first clip bore494aand the second clip bore496aare coaxially aligned. The clamp pin426is inserted through the clip bore522of the first clip projection506, the first clip bore494a, the second clip bore496aand the clip bore522of the second clip projection508such that the clamp pin426passes between the first leaf250and the second leaf252of the second spring130to couple the clip428to the base424.

With the pump clip400assembled, the pump clip400may be coupled to the fluid infusion device402. In one example, with reference toFIG. 22, with the pump clip plate409defined on the fluid infusion device402, the wings440on the mount420are aligned with the slots410a,412aof the rails410,412on the housing404. The wings440on the mount420are inserted into the rails410,412, such that the wings440slide in a direction D4along the slots410a,412auntil the snap fit feature460engages the notch414on the housing404of the fluid infusion device402. Once the snap fit feature460engages, a tactile and audible feedback is provided to the user to indicate the pump clip400is fully installed. With reference toFIG. 23A, the pump clip400is shown fully installed on the fluid infusion device402.

With the pump clip400fully installed on the fluid infusion device402, the pump clip400and the fluid infusion device402may be coupled to user. When coupled to the user, the mount420is movable relative to the base424to compensate for forces applied to the fluid infusion device402. In one example, with reference toFIG. 20, if the fluid infusion device402encounters a force FE, due to the fluid infusion device402encountering a seat belt, arm of a chair, door knob, a force applied by a user, etc., the lip450resists the force FE until the force FE overcomes the lip450and the lip450disengages with the base424. Once the lip450disengages from the base424, the mount420moves or pivots from the first position (FIG. 14), toward the second position as shown inFIG. 20or to a position between the first position and the second position. In the second position, the mount420is rotated about the hinge pin422away from the base424, which enables the pump clip400to absorb the force FE, without breaking the pump clip400and/or damaging the fluid infusion device402. By absorbing this force FE, the pump clip400also ensures that the infusion set remains coupled to the user. Alternatively, the user may be the source of the force FE, as the movement of the mount420relative to the base424enables the user to rotate the fluid infusion device402to view a screen of the fluid infusion device402without requiring a removal of the pump clip400from the user.

With reference toFIG. 20, in the second position, the mount420is pivoted along the first pivot axis PA1to an angle α1, which in one example, is about 170 degrees to about 180 degrees. In this example, the angle α1is about 180 degrees. The angle α1represents a maximum angular displacement of the mount420relative to the base424. It should be understood that the mount420may pivot to various other positions between the angle α1and the first position (FIGS. 14 and 17), depending upon an amount of the force FE (FIG. 20).

In addition, as shown inFIG. 18, the clip428is movable or pivotable about the second pivot axis PA2to an angle β1based on an application of the force F to the first end516of the clip428, which in one example, may range from about 10 degrees to about 45 degrees. In this example, the angle β1is about 17 degrees. The angle β1represents an angular displacement of the clip428relative to the base424. It should be understood that the clip428may pivot to various other positions between the maximum of the angle β1of about 45 degrees and the first position (FIGS. 14 and 17), depending upon an amount of the force F applied by the user (FIG. 18).

In order to remove the pump clip400from the fluid infusion device402, in one example, with reference toFIG. 23A, a force F7is applied by the user, which lifts up the first lock tab438. In example, the force F7is less than about 13.0 pound-force (lbf). With reference toFIGS. 23B and 23C, with the first lock tab438lifted up, a force F8is applied by the user to a rear surface438aof the first lock tab438to disengage the lip450with the second lock tab498of the base424. Once the lip450is disengaged, the pump clip400may be moved in the direction of the force F7(FIG. 23A) to slide the wings440toward the notch414. Once the wings440are removed or disengaged with the slots410a,412aof the rails410,412, the pump clip400is uncoupled or removed from the fluid infusion device402.

Thus, the pump clips100,100′,400each securely couple the respective fluid infusion device102,402to the user and absorb torques or forces acting on the respective fluid infusion device102,402, such as those encountered during an accidental displacement of the respective fluid infusion device102,402or during a user's rotation of the fluid infusion device102,402to view a screen associated with the fluid infusion device102,402, etc. In this regard, the rotation of the clip base120enables the respective pump clip100,100′ to absorb the torque without damaging the pump clip100,100′ and/or the respective fluid infusion device102. The rotation of the mount420enables the pump clip400to absorb the force without damaging the pump clip400and/or the respective fluid infusion device402. Moreover, by composing the pump clips100,100′,400of copolyester (Tritan® TX1001 or Tritan® COPOLYESTER MX711), Polyphenylene Sulfide (Fortron® 1200L1), Nylon (Zytel® ST801AW), Polyoxymethylene (Hostaform® MT12U03, Delrin® 500P, and Dekin® SC655), Polyurethane (Isoplast® 2531 or Isoplast® 2510) and polycarbonate; and metal or metal alloy, the pump clips100,100′,400are resistant to exposure to chemicals, such as sun screen, body lotion, finger oils, and detergents, which prolongs a useful life of the pump clips100,100′,400. Further, the smooth first side262of the clip134and the smooth first side512of the clip428provide comfort to the user during extended periods of wear.