The present invention relates generally to a pen needle for coupling to a delivery device, such as a pen needle delivery device. The pen needle includes a plurality of needles or cannulas for delivering the substance to a patient and for piercing a septum of the delivery device. The pen needle is configured for coupling to the delivery device without rotating the needles or cannulas relative to the septum when the proximal end of the cannulas or needles pierce the septum of the delivery device.
Insulin and other injectable medications are commonly delivered with drug delivery pens, where a disposable pen needle hub is attached to the pen to facilitate access to the drug container and allow fluid egress from the container through the needle into the patient.
Various pen needle delivery devices are known in the art for dispensing the substance to the patient. The delivery devices often use a disposable needle hub having a cannula or needle extending from a patient end of the hub for inserting into the patient. A non-patient end of the hub is coupled to the pen delivery device for delivering the substance to the patient.
The needle hub assembly is often packaged in a container containing several loose needle hubs. A needle hub is selected from the package and attached to the pen needle delivery device for injecting the patient and then removed to be discarded. The needle hub package includes an outer cover that encloses the needle hub and a removable seal that is peeled from the outer cover to open the cavity so that the needle hub can be removed. The needle hub can have threaded non-patient end that is threaded onto the delivery device. The delivery device with the attached needle hub is then removed from the outer cover. An inner needle shield is attached to the needle hub to cover the cannula until the device is ready for use. The shield is removed to expose the cannula for use to deliver the substance to the patient. After use, the needle hub can be inserted back into the outer cover to enclose the exposed cannula. The pen delivery device is separated from the needle hub leaving the needle hub within the outer cover.
The pen needles often include a needle that extends from the proximal, non-patient end of the needle hub. The needle is positioned to pierce the septum of the delivery pen to access the drug or other medication. The pen needle is threaded onto the end of the delivery pen so that the needle pierces the septum as the needle hub advances onto the delivery pen. The needle typically has a thin diameter which can bend during the insertion into and though the septum, which interferes with the delivery of the drug to the patient.
Existing pen needle assemblies are disclosed in U.S. Patent Application Publication Nos. 2006/0229562 to Marsh et al. and 2007/0149924 to R. Marsh, the entire contents of both of which are hereby incorporated by reference.
Microneedles devices are known having a needle length of less than 5 mm for certain applications. The delivery device can have a single needle or multiple needles arranged in a selected pattern for introducing the medication to a patient.
Although the prior devices have been suitable for the intended use, there is a continuing need in the industry for improved pen needle devices and methods of connecting the pen needle to the delivery device.
The present invention relates generally to a pen needle for coupling to a delivery device such as a pen needle delivery device used for injecting a medication to a patient, such as insulin delivery injections. The pen needle includes a plurality of needles or cannulas for delivering the medication or substance to a patient. The pen needle includes a needle hub supporting the needles and a collar that is able to rotate with respect the needle hub. The collar has internal threads for coupling to the delivery device. The collar is able to rotate relative the needle hub so that the plurality of needles engage the septum in a linear direction and resist rotation of the needle hub and resist lateral force against the proximal end of the needles to prevent shearing, bending or damage to the proximal end of the needles.
The pen needle in one embodiment includes a hub with a plurality of needles extending through the hub and having a distal end for injecting and delivering a medication into a patient and a proximal end forming a non-patient end extending from a non-patient proximal end of the hub for piercing a septum of the delivery device to access the medication or other substance to be delivered to the patient. The pen needle is configured for coupling to the delivery device without rotating the needle hub with respect to the delivery device where the needle hub and the needles move in an axial direction so that the needles pierce the septum of the delivery device in an axial direction.
The needles are spaced apart a distance to provide multiple simultaneous injections to deliver the medication to the patient at a controlled depth and rate of delivery. The needles have a suitable exposed distal end extending from the distal end of the needle hub with a selected length and gauge depending on the desired depth of penetration and the volume of the medication to be delivered in a selected length of time. The needles in one embodiment have length of about 1 to 5 mm. In one embodiment, the exposed length of the distal end of the needles is about 2 to 10 mm. In one embodiment, the exposed distal end of the needle has a length of about 2-7 mm. In other embodiments, the needles can have a length of less than about 2 mm. In further embodiments, the needles have an exposed length extending from the distal end of the hub of about 1-2 mm where the needles have a length to deliver a medication subcutaneously or into the epidermis. The needles have a length to provide the exposed proximal end extending from the proximal end of the needle hub to enable the needles to pierce the septum of the delivery device to access the medication of the delivery device. The proximal end of the needles has a length of about 4 to 7 mm.
The gauge of the needles is typically about 32 gauge or smaller. In one embodiment, the needles are 34 gauge. The needles have a gauge that enables the distal end to pierce the skin of the patient a selected depth to deliver the medication and that enables the proximal end to pierce the septum without damaging or bending the needles during the penetration of the septum.
In one embodiment, the pen needle has a threaded collar and a needle hub where the collar can rotate relative to the needle hub supporting a plurality of needles. In one embodiment the needles extend through the hub and project from the distal end and from the proximal end of the hub. The collar is threaded onto a threaded end of the delivery device while the needle hub is configured to remain rotationally fixed relative to the collar and relative to the delivery device. The needle hub moves axially by the rotation of the threaded collar whereby the proximal, non-patient end of the needles move axially to pierce the septum of a delivery device without the needles rotating relative to the septum and the collar.
The needle hub includes a coupling to attach the needle hub to the collar where the collar can rotate independently of the needle hub. In one embodiment, the coupling between the collar and the needle hub is a flange on one of the needle hub or collar that mate with a recess on the other of the needle hub or collar. The collar can have an open end defined by an inwardly extending flange that is received in an annular recess in the needle hub.
In another embodiment, the coupling can be two spaced apart flanges extending outwardly from the needle hub to define an annular recess. The top distal end of the collar is received in the annular recess of the needle hub to allow rotation of the collar relative to the needle hub.
In a further embodiment, the coupling is a flange on the needle hub and at least one tab and typically a plurality of tabs projecting outwardly from the needle hub and spaced from the flange. The space between the flange and the tab captures the top end of the collar so that the collar can rotate relative to the needle hub.
The features of the pen needle are basically obtained by providing the pen needle with a collar having a side wall, an open proximal end, and a distal end, and a needle hub rotatably coupled to the distal end of the collar. The needle hub has a proximal end and a distal end. A plurality of needles are coupled to the needle hub where a distal end projects from the distal end of the needle hub and where a proximal, non-patient end of the needles extends from the proximal distal end of the needle hub. The proximal end of the needles are configured for piercing a septum of a delivery device when the pen needle is connected to the delivery device. The collar is rotatable independently of the needle hub and the needles so that the needle hub can remain rotationally fixed when the collar is rotated and attached to the delivery device. The needle hub is able to move axially with the axial movement of the collar where the proximal end of the needles pierce the septum of the delivery device.
The features are further obtained by providing a pen needle with a collar and a needle hub where the collar has a sidewall, an open proximal end having a coupling member, and a distal end. The needle hub has a proximal end and a distal end with a convex skin-contact surface with a proximal area at an outer edge of the skin-contact surface and a distal area centrally located and spaced axially from the proximal area. The proximal end of the needle hub has a coupling member coupled to the distal end of the collar where the collar is rotatable independently of the needle hub. A plurality of needles are coupled to the needle hub and have a distal end extending from the distal end of the needle hub, and a proximal end extending from the proximal end of the needle hub. The proximal end of the needles are configured for piercing a septum of a delivery device when the pen needle is attached to the delivery device.
The features of the invention are also obtained by providing a method of assembling a pen needle to a pen needle delivery device. The method comprises inserting the pen needle delivery device into a pen needle, where the pen needle includes a threaded collar having a proximal end and distal end, and a needle hub having a proximal end rotatably coupled to the distal end of the collar and a distal end with a plurality of needles extending from the distal end. The proximal end of the needles extend from the proximal end of the needle hub toward the proximal end of the needle hub. The collar rotates relative to the pen needle delivery device without rotating the needle hub so that the proximal end of the needles are able to pierce a septum on the pen needle delivery device
The objects, advantages, and salient features of the invention will become apparent from the following detailed description, which, taken in conjunction with the annexed drawings, discloses exemplary embodiments of the invention.
The above benefits and other advantages of the various embodiments of the present invention will be more apparent from the following detailed description of exemplary embodiments of the present invention and from the accompanying figures, in which:
Throughout the drawings, like reference numbers will be understood to refer to like parts, components, and structures.
The present invention is directed to a pen needle for connecting to a delivery device such as a pen needle delivery device. The pen needle supports a plurality of needles or cannulas for delivering a substance to the patient where a proximal, non-patient end of the needles or cannulas are configured for piercing a septum on the delivery device when the pen needle is attached to the delivery device. Pen needle is configured so that a needle hub supporting the needles or cannulas move in a linear direction substantially without rotation of the needle hub relative to the delivery device for piercing the septum on the delivery device when the pen needle is attached to the delivery device.
Reference to embodiments of the present invention are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. The embodiments described herein exemplify, but do not limit, the present invention by referring to the drawings. The exemplary embodiments are presented in separate descriptions, although the individual features and construction of these embodiments can be combined in any number of ways to meet the needs of the user.
It will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein are capable of being modified, practiced or carried out in various ways. The term cannula and needle are used interchangeably. For purposes of this disclosure the term needle is used although it is understood that the term includes other devices such as a cannula that is able to pierce a patient for injecting and delivering a medication or other substance to a patient. It will be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms “connected,” “coupled,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled” and variations thereof are not limited to physical or mechanical connections or couplings. Further, terms such as up, down, bottom, and top are relative, and are employed to aid illustration, but are not limiting. The term “substantially” and “about” numerical ranges are understood as including a range that can encompass the specific or give value but not limited to the specific value and can encompass a range of equivalents. The term substantially can encompass a given value or characteristic and a value or characteristic that provides the intended function and/or purpose the value or characteristic. Features of the different embodiments can be combined with features of other embodiments so long as they are not inconsistent with each other.
Pen needle delivery device 10, as shown in
In standard pen needle devices the dosing and delivery mechanisms are all found within the outer sleeve 12 and is not described in greater detail as they are understood by those knowledgeable of the prior art. A medicament cartridge is typically attached to a standard pen injector housing by known attachment means. The distal movement of a plunger or stopper within the medicament cartridge forces the medication into the reservoir housing. The medicament cartridge is sealed by a septum and punctured by a septum penetrating needle cannula located within a reservoir or housing. Reservoir housing is preferably screwed onto the medicament cartridge although other attachment mechanism can be used. The pen needle delivery device can be a standard pen delivery device known in the industry so that the pen needle delivery device is not shown in detail. The pen needle 18 as shown in
The pen needle delivery device 10 is connected to needle hub 16 shown in
Referring to
As shown in
The distal end 40 of the sidewall 36 includes an end wall 46. In the embodiment shown, the end wall 46 extends inwardly from the sidewall 36 substantially perpendicular to the longitudinal axis of the collar 32. The end wall 46 has an inner edge 48 defining an opening 50 in the distal end 40 of the collar 32 as shown in
The needle hub 34 has a shape and configuration for supporting a plurality of needles 52 as shown in
The needles 52 have a length and gauge that can be used in pen needle devices. In one embodiment, the needle can have a distal end with an exposed length of about 1-10 mm although exposed length can be selected according to the intended use and intended depth of penetration into the skin of the patient. In one embodiment, the exposed length of the needle can be about 2-4 mm. In another embodiment, the exposed length of the needle can be about 1-5 mm. In one embodiment, the needle has an exposed distal end length of less than 2 mm. In the embodiment shown, the distal end of the needles has an exposed portion with a substantially uniform and equal length. In other embodiments, the needles can have different lengths to provide different injection depths into the skin for delivery of the medication.
In one embodiment, the needles are 34 gauge to reduce the discomfort of inserting the needles into the patient and reduce the perceived pain. The 34 gauge needles have smaller diameter lumen that can restrict the flow rate of the medication compared to larger diameter needles. The array of needles provides multiple delivery passages from the delivery device to deliver a standard dosage in a relatively short time without increasing the flow rate or pressure from the delivery device. The multiple needles also provide a delivery area that is larger than a single needle to promote improved delivery and absorption by the patient.
The needles 52 in the embodiment shown have a length to extend entirely though the needle hub to have an exposed distal end extending from the distal end of the needle hub with an exposed length for injecting a medication into the patient, and a proximal end extending from the proximal end of the needle hub with a length for piercing the septum. The needles in the embodiment shown in
In other embodiments, the distal end of the needle can have a diameter and/or gauge that is different from the proximal end. In this manner the distal end can have a needle gauge to provide the delivery of the medication to the patient with reduced discomfort to the patient. The proximal end of the needle can have larger diameter to resist bending or shearing when piercing the septum while providing the desired fluid flow of medication from the delivery device to the distal end of the needle.
The plurality of needles 52 are arranged on the distal end of the needle hub 34 to provide a selected needle pattern or array. The needles 52 are spaced apart a distance to enhance the injection of the medication into the patient without interfering without the penetration of an adjacent needle into the patient. In the embodiment shown, the needles 52 are arranged in a cluster, group or array that is substantially symmetrical so that the needles are spaced apart a substantially uniform distance. The dimensions of the pattern are selected to enable sufficient penetration of each of the needles into the patient. In one embodiment, the dimensions of the pattern correspond substantially to the dimensions of the distal face of the needle hub. In the embodiment show, the needles are arranged in an array having a substantially circular configuration having a diameter of about 2-4 mm and a surface area on the distal end of the needle hub of about 2-12 mm2. In one embodiment, the needle array covers a surface area on the distal face of the needle hub of about 2-4 mm2. In another embodiment, the surface area of the needle array has a diameter of about 3 to 5 mm. As shown, the needles are spaced apart laterally relative to the longitudinal axis of the needle and the needle hub.
In the embodiment shown, the needle hub 34 is formed by a sidewall 54 having an open proximal end 56 and a closed distal end 58. In the embodiment shown, the sidewall 54 has a substantially cylindrical configuration although other shapes and dimensions can be used. The distal end 58 of the needle hub 34 has an end wall 60 closing the distal end of the needle hub and defining a substantially convex skin contact surface for contacting the patient and limiting the depth of penetration of the needle during the delivery of the medication into the patient. In the embodiment shown, the end wall 60 has a distal face with a raised annular outer ring 62 and a raised inner circular shaped projection 64 spaced axially in a distal direction and spaced radially inward from the annular outer ring 62 forming a skin contact surface. A recessed area 66 is formed between the outer ring 62 and the inner projection 64 forming part of the skin contact surface of the needle hub. The contour and position of the inner and outer rings relative to each other and the recessed area 66 define a convex surface having a radius of curvature of about 4-8 mm to control the deformation of the skin when the needle is inserted into the patient and the skin contact surface is pressed against the skin by a common insertion force by the user. As shown in
In one embodiment, the contoured skin contact surface can have a radius of curvature of about 5-8 mm. In another embodiment, the distal face of the needle nub can have a radius of curvature of about 6-8 mm and a width of about 6-8 mm. The ratio of the diameter to the axial length of the distal surface of the needle hub forming the skin contact surface can be about 5:1 to about 8:1. The inner projection 64 can have an axial length of about 0.5 to 1.0 mm and a diameter of 2-3 mm with a surface area of about 3-5 mm2. The diameter of the skin contact surface of the distal end of the needle hub can be about 2 to 3 times the diameter of the inner projection.
The outer annular ring 62 has a distal surface forming a proximal area of the skin contact surface with a substantially conical shape corresponding to the radius of curvature of the skin contact surface of the needle hub. The projection 64 is spaced axially outward and radially inward from the annular outer ring 62 and has a dimension to support the needles in an array with a selected pattern to obtain the desired delivery and depth of penetration of the medication. The projection 64 has an outer surface forming a distal surface area 65 of the skin contact surface for receiving the needle array. The distal surface area 65 of the projection can have convex shape or a substantially flat surface extending in a plane perpendicular to the longitudinal axis of the needle hub.
The distal surface area 65 of the projection 64 is configured to support a selected number of needles in a selected array or pattern. In the embodiment shown, six needles are provided although the number of needles can vary depending on the medication, the desired volume of delivery, the desired depth of penetration, and the rate of delivery. The number of needles can range from about 4-12 and typically about 5-12. In one embodiment, the number needles in the array can be at least 5 and typically 6-8 needles.
The needles can be arranged in a suitable array or pattern to achieve the desired penetration into the patient and the desired delivery of the medication. As shown the drawings, the needles can be arranged in a substantially circular array or pattern around the distal face 65 of the projection 64. The needles are generally spaced apart a uniform distance from an adjacent needle and spaced inward from the peripheral edge of the post.
The distal face 65 of the projection 64 is generally circular and has a diameter of about 1-4 mm and generally a diameter of about 1.5-3.0 mm. The surface area of the distal face of the projection 64 can be about 3 to about 7 mm2. The area defined by the needle array can be about 3 to 7 mm2 and generally about 3-5 mm2.
The end wall 60 has a plurality of spaced apart axial passages 68 with a dimension for receiving a needle. The needles can be coupled to the needle hub by an adhesive, friction fit or other suitable attachment mechanism. The proximal end of the needles has a length greater than the longitudinal dimension of the side wall 54 of the needle hub 34 so that the proximal end of the needles extends into the collar as shown
Referring to
The proximal end 56 of the needle hub 34 is formed with a coupling for connecting the needle hub 34 to the collar 32 while allowing rotation between the needle hub and the collar. The coupling can be a flange on one of the collar and the needle hub and a complementing recess on the other of the collar and the needle hub. In the embodiment shown, the coupling is formed by an annular flange 88 extending radially outward from the proximal end of the sidewall 54 of the needle hub 34. The flange 88 has a peripheral edge 90 complementing the inner dimension of the collar 32. As shown in
The coupling mechanism in the embodiment shown also includes a second flange 96 extending radially outward from the sidewall 54 of the needle hub 34. The second flange 96 is spaced from the flange 88 a distance to form an annular recess corresponding substantially to the thickness of the end wall 46. The flange 96 has a radial dimension less than the radial dimension of the flange 88. The flange 96 has a top face with a chamfered edge 100. The chamfered edge 100 is able to slide over the inner edge of the opening 50 in the end wall 46 by a snap connection to couple the needle hub 34 to the collar 32. As shown in
The pen needle 30 is connected to the threaded end of the delivery device 10 as shown in
In another embodiment shown in
In another embodiment shown in
Needle hub 114 is similar to the needle hub in the previous embodiment having a sidewall 122 with a substantially cylindrical configuration with a proximal end and a distal end. An end wall 128 is formed at the distal end for supporting the needle 52 as in the previous embodiment. The end wall 128 in the embodiment shown has an inner projection and an outer ring forming the skin contact surface in a manner similar to the previous embodiment.
The proximal end of the sidewall 122 includes an outwardly extending flange 130 with a dimension complementing the inner dimension of the collar 112. The flange 130 has a bottom face for mating with the end of the delivery device and a top face for contacting the bottom face of the inwardly extending flange 118 of the collar 112. The needle hub 114 includes a post 144 extending axially from the end wall 128 for supporting the needles 52 as in the previous embodiment. The post 144 is substantially the same as in the previous embodiment.
The coupling between the collar 112 and needle hub 114 in the embodiment shown includes at least one and typically a plurality of tabs 136. The tabs 136 are formed by cutouts in the sidewall 122. As shown in
The foregoing embodiments and advantages are exemplary and are not to be construed as limiting the scope of the present invention. The description of an exemplary embodiment of the present invention is intended to be illustrative, and not to limit the scope of the present invention. Various modifications, alternatives, and variations will be apparent to those of ordinary skill in the art, and are intended to fall within the scope of the invention. It is particularly noted that the features of different embodiments and claims may be combined with each other as long as they do not contradict each other. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the appended claims and their equivalents.
This application is a continuation patent application of PCT International Patent Application No. PCT/US2020/063528 filed on Dec. 7, 2020, which claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 62/947,140 filed on Dec. 12, 2019, each of which are hereby incorporated by reference in their entireties.
Number | Date | Country | |
---|---|---|---|
62947140 | Dec 2019 | US |
Number | Date | Country | |
---|---|---|---|
Parent | PCT/US2020/063528 | Dec 2020 | US |
Child | 17836632 | US |