JP2000237311A - Medicine send-out pen - Google Patents

Abstract

PROBLEM TO BE SOLVED: To enable safe use by providing a container retainer with a side part opening provided with a snap wing, holding a container inside the container retainer and then blocking the detachment of the container from a medicine send-out pen through a cam and a cam follower by a ratchet mechanism. SOLUTION: This medicine send-out pen 10 is provided with a pen injector main body 70 and the container retainer 40 for housing the container 30 thread cut as needed. The container 30 is provided with an end part 31 for holding a partition wall 35 by a cap 34 and a piston 33 for administering the medicine is freely slidably fitted inside. The container retainer 40 is provided with the side part opening 56 provided with the snap wing 57, a set of screw threads 43 for needle attachment are formed at the end part 41 and a plurality of cam tracks 45 are formed at the other end part 42. The cam track 45 is provided with an axial direction projection part 50 and a radial projection part 51 and many ratchet fingers 53 are also formed at the other end part 42.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

FIELD OF THE INVENTION The present invention relates to a ratchet having a specially designed opening in the wall of a container retainer for accommodating a standard or threaded container and joining the container retainer to the pen injector body of a drug delivery pen. Novel container retainer for a drug delivery pen having such means.

[0002]

2. Description of the Related Art Hypodermic syringes are used to deliver selected amounts of a drug to a patient. Conventional hypodermic syringes include a syringe barrel having opposite proximal and distal ends. A cylindrical chamber wall extends between the ends to define a chamber for containing a fluid. The proximal end of this conventional syringe barrel is substantially open and houses the plunger in a slidable and fluid tight engagement. At the end of this conventional syringe barrel,
A passage leading to the chamber is provided. A needle cannula is attached to the distal end of the barrel of the conventional syringe, and the lumen of the needle cannula communicates with the passage and the syringe barrel. When you move the plunger in the proximal direction,
Fluid is drawn into the chamber through the lumen of the needle cannula. As the plunger is moved distally, fluid is forced out of the chamber and flows through the lumen of the needle cannula.

[0003] Drugs to be injected by this conventional hypodermic syringe are often contained in a container having a pierceable elastic seal. The drug in this conventional container can be accessed by piercing an elastomeric seal with a needle cannula. By moving the plunger proximally a selected distance, a selected amount of drug is drawn into the chamber of the syringe barrel. The drug is injected into the patient by withdrawing the needle cannula from the container and moving the plunger distally.

[0004] Drugs such as insulin are self-injected. A typical diabetic patient needs several injections of insulin during the week or day. Insulin requirements vary from patient to patient, and each patient's requirements may vary over the course of the day and may vary from day to day. Each diabetic has established a regimen appropriate to his or her own physical conditions and his or her lifestyle. The regimen includes a combination of slow-acting or intermediate-acting insulin and fast-acting insulin. These regimens require that diabetics self-inject insulin at public places, such as at work or in restaurants. The handling of conventional standard hypodermic syringes and containers is inconvenient and cumbersome in these public environments.

[0005] Drug delivery pens have been developed to facilitate self-injection of drugs. One prior art drug delivery pen includes a container holder containing a container of insulin or other drug. The distal end of this conventional container holder is provided with mounting means for engaging a needle cannula having both ends. The base end is also provided with mounting means for engaging a drive / capacity setting device as described in detail below. The disposable container used with this conventional container holder has a distal end with a pierceable elastic seal pierced by one end of a needle cannula having both ends. The proximal end of this conventional container is provided with a plunger which is slidable in engagement with the cylindrical wall of the container to prevent fluid leakage. This conventional drug delivery pen is used by inserting a drug container into a container holder. The main body of the conventional pen is connected to the base end of the container holder. The pen body includes a dosage setting device that indicates the dosage to be delivered by the pen, and a drive that pushes the plunger of the container a distance corresponding to the selected dosage.

The user of the pen attaches a conventional double-ended needle cannula to the distal end of the container holder and pierces the resilient seal on the container with the cannula at the proximal end of the needle cannula. Next, the user selects a dosage and operates the pen to push the plunger to deliver the selected amount of drug. The user then removes and discards the needle cannula and stores the conventional drug delivery pen in a convenient location for the next required medication. The drug in the container will be consumed and consumed after several such doses. Empty containers are removed and discarded. A new container is inserted into the container holder, and the container holder and pen body are reassembled and used as described above.

[0007]

SUMMARY OF THE INVENTION The reusable drug delivery pen described above makes self-injection of drugs more efficient and more efficient than typical hypodermic syringes and separate drug containers. It becomes convenient. However, the drug delivery pen must be used with containers of a predetermined length and these containers need to be disassembled in order to be loaded into the drug delivery pen. As a result, it has been found that it is difficult for a user with motor skills and visual impairment to attach / detach the container to / from the drug delivery pen. It has turned out to be even more necessary to address this problem, as it is particularly common among diabetics to have complications that cause impaired motor skills. Therefore, there is a need to provide a drug delivery pen with a container retainer that provides improved flexibility by allowing the user to use many different length containers for the drug delivery pen. This is the same injection pre-filled syringe (injectio
n Prefill syringe) or provide the user with more freedom to choose the type of drug container or insulin while using the drug delivery pen.

Further, there is a need for a device that is easier and more intuitive to use than common drug delivery pens, and that also prevents a user from removing the container from the drug delivery pen after use, which is a contaminated container. It is important to prevent reuse. It would be desirable to have a device that has a fail-safe loading system that allows loading of the container without completely disassembling the drug delivery pen and prevents the user from loading the container incorrectly into the drug delivery pen.

[0009]

SUMMARY OF THE INVENTION The present invention is directed to a drug delivery pen having a container retainer that addresses the problems identified above. In particular, the container retainer has side openings with flexible snap wings to hold a standard or threaded container in the container retainer. The container retainer also includes improved means for attaching the container retainer to the pen syringe body, the improved means for removing the container from the drug delivery pen using a cam and cam follower designed with a ratchet mechanism. To prevent In another example, a release mechanism may be used so that the container is removed from the drug delivery pen.

[0010] Another feature of the present invention is a drug delivery pen having a container retainer for receiving and holding a container with an opening for receiving the container defined by a pair of flexible snap wings.

[0011]

FIG. 1 is a perspective view of a drug delivery pen 10 having a pen injector body 70 and a container retainer 40 for accommodating a standard container 30 or another example of a threaded container (described below). The container 30 includes a distal end 31 having a septum 35 held on the distal end 31 by a cap 34, and an open proximal end 32. Container 30
Includes an axially slidable piston 33 that seals the open proximal end 32 and is movable to dispense a drug from the container 30 during an injection procedure by the drug delivery pen 10. .

The container retainer 40 has a distal end 41 and a proximal end 42, the distal end 41 having a set of threads 43 for a needle attachment and extending from a shoulder 44 of the container retainer. The thread 43 for the needle attachment is intended to receive a standard pen needle with matching threads in its hub. These attachment means comprise a plurality of cam tracks 45 on the outer surface 46 of the container retainer 40. Each cam track 45 is defined by an axial portion 47 and a radial portion 48 extending around the circumference of the container retainer 40. Radial portion 48 has a ramp that varies from axial portion 47 to end wall 49, which provides sufficient force to attach container retainer 40 to pen injector body 70, as described below. The cam track 45 further comprises an axial projection 50 on the axial portion 47 and a radial projection 51 on the radial portion 48, which projections define a loading pocket 52 therebetween. Base end 42 of container retainer 40
Has a number of ratchet fingers 53 extending therein.

The container retainer 40 includes a central portion 54 disposed between the distal end 41 and the proximal end 42, the central portion 54 having an observation window 55 on one side and a larger side on the other side. An opening 56 is provided. Large side opening 56
Is defined by a pair of flexible snap wings 57 having a narrow portion 58 near the distal end of the opening 56 and a wide portion 59 near the proximal end of the opening 56, both of which have an ear shape. The opening 56 has a stress relief portion 60 at the base end of the wing 57 near the wide portion 59. The flexible snap wings 57 are designed to extend apart to receive and retain the container 30 within the opening 56 and within the container retainer 40, as described further below.

FIG. 2 shows a cross-sectional view of a pen injector body 70, which has an outer sleeve 72 and an inner sleeve 73 on the distal end 71 side. Inner sleeve 73
Is connected to an outer sleeve 72 by an inner wall 74, the outer sleeve 72 having a number of cam followers 75 on an inner surface 76 thereof. The inner sleeve 73 is spaced apart from the inner surface 76 of the outer sleeve 72 and includes a distal edge 77 and a radial ratchet 78 disposed on the outer surface 79 adjacent the inner wall 74 and includes a radial ratchet. 78 starts away from the distal edge 77 and near the cam follower 75 on the inner surface 76.

FIG. 3 and FIG.
FIG. 6 is a perspective view of the container retainer 40 showing a process of loading the container retainer 40 through the container retainer 40. In particular, FIG.
Shows the expanding action of a pair of flexible snap wings 57 for receiving and holding the container 30 in the side opening 56. Further, the end 31 of the container 30 is opened 5
6, the cap 34 and the septum 35 are clearly shown to be received in the distal end 41 of the container retainer 40 when inserted into the narrow portion 58 of FIG. The container 30 is the container retainer 4
5, the shoulder 37 of the container 30 is moved until it abuts the container retainer shoulder 44 on the container retainer 40, where it is clearly shown in FIG. Is assembled in the shipping position, the container 30 is fully loaded and the container retainer 4
0 is held in the side opening 56.

FIG. 6 is a cross-sectional view taken along the line AA shown in FIG. 5, and shows each cam follower 7 in each cam track 45.
5 is more clearly shown, in particular, each cam follower 75 is located within a loading pocket 52 defined by a radial projection 51 shown in FIG. 6 and an axial projection 50 shown in FIG. I have.

FIG. 7 is a partial cross-sectional view in the longitudinal direction along the line BB. FIG. 7 shows the relative position between the inner sleeve 73 having the outer sleeve 72 and the radial ratchet 78 and the proximal end 42 of the container retainer 40.

As shown in FIG. 5, the container retainer 40
Thereafter, it is rotated in the direction of the arrow while holding the pen injector body 70 so that each cam follower 75 is loaded.
ping) leaves pocket 52 and then, as shown in FIG.
The container retainer 40 moves through the radial portion 48 of each cam track 45 until it reaches the ready-to-use position. In the ready-to-use position, the distal edge 77 on the inner sleeve 73 of the pen injector body 70 and the proximal end 32 of the container 30
Each cam follower 75 has a predefined variation to provide sufficient axial force between the cam follower 75 and to fully seat the container shoulder 37 on the container retainer shoulder 44 within the container retainer 40. It traveled through a radial section 48 having a slope. The interaction between the distal edge 77 on the inner sleeve 73 and the proximal end 32 of the container 30 is illustrated in FIG.
Is more clearly indicated.

FIG. 9 shows the drug delivery pen 10 shown in FIG.
5 is a cross-sectional view taken along line AA of FIG. 5 and more clearly shows the interaction between the ratchet finger 53 of the proximal end 42 of the container retainer 40 and the radial ratchet 78 of the inner sleeve 73, both of which cams The cam follower 75 in the truck 45 is prevented from rotating backward or moving backward. Therefore, the ratchet fingers 53 and the radial ratchet 78 ensure that the force applied by the distal edge 77 to the proximal end 32 of the container 30 is constant and sufficiently holds the container 30 in place.

FIG. 10 is a cross-sectional view of another example of a drug delivery pen 10 having a release mechanism for releasing the force applied to the proximal end 32 of the container 30 by the distal edge 77 of the inner sleeve 73. . The release mechanism includes a release plunger 90, a spring 91, and an expandable collet 92. Release plunger 90 includes a thumb flange 93 extending from the main body with a distal extension 95 and a shoulder 96. The spring 91 is supported between the shoulder 96 and the inner wall 74 of the pen syringe body 70, and the extension 95 of the release plunger 90 is housed within the proximal end 98 of the collapsible collet 92. . The collapsible collet 92 includes a number of release fingers 99 extending from the distal end 97.

FIG. 11 is a cross-sectional view taken along the line AA showing the ratchet fingers engaged with the radial ratchet 78, for example, when the drug delivery pen 10 is in the ready-to-use position as described above. Is shown. Further, FIG.
And the corresponding position of the ratchet finger 53. Drug delivery pen 1 incorporating this release mechanism
0 indicates that the release plunger 90 moves distally against the force of the spring 91, and the extension 95 moves within the expandable collet 92 so that the expandable collet 92 releases the release finger 99. Pushing to release the ratchet finger 53 from the radial ratchet 78 will provide a release of the drug delivery pen from its ready-to-use position, such that the container 30 can be removed from the container retainer 40. This process will then allow the container retainer 40 to retract to a loading position where the container 30 can be removed from the side opening 56 in the opposite direction.

FIG. 12 shows the distal end 101 and the proximal end 10.
FIG. 9 is a perspective view of another container retainer 100 including a distal end 101, which does not include a threaded portion as in the previous embodiment. The unthreaded container retainer 100 includes a ring 104 and a plurality of fingers 105 extending therefrom.
And a front retainer clip 103 having For example, the retainer clip 103 may be made of stainless steel or polycarbonate and the container retainer 100
May consist of polypropylene. In any event, it is important that the retainer clip 103 be less flexible and made of the material used to make the wings 57 on the container retainer 100. Each finger 10
5 is housed in one of a number of holes 105 around the circumference of the distal end 101. Threadless container retainer 100
Is used with a threaded container 120, which has an internally molded or attached thread, as shown in FIG. The container 120 is inserted into the side opening 56 and held in the non-threaded retainer 100 as described above in the previous embodiment.

FIGS. 13 and 14 show the container retainer 24.
11 shows another example of a drug delivery pen 100 having different means of attaching a 0 to the pen injector body 270. All other features and features of drug delivery pen 200 are the same as drug delivery pen 10 described above. The means for attaching the container retainer 240 to the pen syringe body 270 includes the pen syringe body 27
0 of inner surface 2 of outer sleeve 272 close to the end 271
76 includes a set of ratchet teeth 273. The number of straight half-dented teeth is 279. Container retainer 240
The proximal end 24 of the container retainer 240 is maintained until sufficient force is exerted against the proximal end 32 of the container 30 by the distal end 277 of the inner sleeve 273 of the pen syringe body 270.
2 is inserted into the distal end 271 of the pen injector body 270 and is attached to the pen injector body 270 where the linear ratchet teeth 273 are accurately engaged with the linear split ratchet teeth 279. As a result, the container retainer 240 is firmly attached to the pen injector body 270.

Although the present invention has been described in terms of a number of preferred embodiments, it will be apparent that various modifications can be made without departing from the scope of the invention as defined by the appended claims. .

[Brief description of the drawings]

FIG. 1 is an exploded perspective view of a drug delivery pen of the present invention.

FIG. 2 is a partial cross-sectional view of the pen injector main body of the drug delivery pen shown in FIG. 1, taken along line AA.

FIG. 3 is a perspective view showing that a container is loaded in a container retainer of the drug delivery pen shown in FIG. 1;

FIG. 4 is a perspective view showing that a container is loaded in a container retainer of the drug delivery pen shown in FIG. 1;

FIG. 5 is a perspective view of the drug delivery pen shown in FIG. 1 assembled in a loading position with the container fully loaded in the container retainer.

6 is a cross-sectional view of the drug delivery pen shown in FIG. 5 taken along line AA.

7 is a cross-sectional view of the drug delivery pen shown in FIG. 5, taken along line BB.

8 is a perspective view showing the drug delivery pen shown in FIG. 5 in a state where the container retainer has been rotated to a use preparation position.

9 is a cross-sectional view of the drug delivery pen shown in FIG. 8 taken along line AA.

FIG. 10 is a cross-sectional view of another drug delivery pen having a release mechanism.

11 is a cross-sectional view of the drug delivery pen shown in FIG. 10 taken along line AA.

FIG. 12 is an exploded perspective view of another drug delivery pen for using a threaded container.

FIG. 13 is an exploded perspective view of yet another drug delivery pen with a linear ratchet interface between the container retainer and the pen injector body.

14 is a cross-sectional view of the drug delivery pen shown in FIG. 13 taken along line AA.

[Explanation of symbols]

 10 Drug Delivery Pen 30 Container 33 Piston 34 Cap 40 Container Retainer 45 Cam Track 52 Loading Pocket 53 Ratchet Figur 55 Observation Window 56 Side Opening 57 Snap Wing 70 Pen Syringe Body 75 Cam Follower 90 Release Plunger 90, 91 Spring 92 Collet 99 Release finger 100 Container retainer 240 Container retainer 270 Pen syringe body

 ──────────────────────────────────────────────────続 き Continuation of front page (71) Applicant 595117091 1 BECTION DRIVE, FRA NKLIN LAKES, NEW JE RSEY 07417-1880, UNITED STATES OF AMERICA (72) Inventor Christopher B. King United States of America Greenwood Lake Sterling Road, New York 24 (72) Inventor James Best United States of America Weihaken Bonn Place 55, New Jersey 55 (72) Inventor Daniel A. Walters Rockaway Township, New Jersey USA Township Slope Drive 12F Term (Reference) 4C066 BB01 CC01 DD08 EE06 FF05 GG10 HH04 LL16

Claims (10)

[Claims] 1. A pen syringe body having a distal end, a container retainer having a distal end and a proximal end for containing and supporting a container, and a container loaded / loaded state with respect to the pen syringe body. Means for joining in a ready-to-use state, wherein the container can be loaded into the container retainer when the joining means is in a loading / loading state, A drug delivery pen wherein the container retainer and the pen injector body are ready for performing an injection when the means is in a ready to use condition. 2. The drug delivery pen according to claim 1, wherein said container retainer further comprises means for joining a pen needle to said distal end. 3. The joining means comprises: a plurality of cam followers in the pen syringe body; and a plurality of cam tracks on the container retainer, wherein the cam track comprises the container retainer and the pen syringe body. The drug delivery pen according to claim 1, wherein the pen has a pre-defined changing ramp that functions to provide a pre-defined axial force between the pen. 4. The drug delivery pen according to claim 1, wherein said joining means further comprises means for preventing movement from a ready-to-use state to a loading / loading state. 5. The penetrating device according to claim 5, wherein said preventing means comprises: a plurality of ratchet fingers on said container retainer; and a pen injector body forming a half of said ratchet fingers for preventing said cam followers from moving backward on said respective cam tracks. 5. A drug delivery pen according to claim 4, comprising a ratchet. 6. Each of said cam tracks comprises an axial portion and a radial portion, said radial portion having a varying slope and radial projections, said axial portion having an axial projection, 6. The drug delivery pen according to claim 5, wherein a loading pocket is formed between the axial projection and the radial projection of the truck. 7. The drug according to claim 4, further comprising a release mechanism for releasing said prevention means in order to release said joining means and return from the ready-to-use state to the loading / loading state. Delivery pen. 8. The pen injection device, wherein the prevention means comprises: a plurality of ratchet fingers on the container retainer; and a pen injector body which is half of the ratchet fingers for preventing the cam followers from moving backward on the respective cam tracks. The drug delivery pen according to claim 7, further comprising a ratchet. 9. The release mechanism includes a finger that interacts with a ratchet finger on the container retainer to release the ratchet finger from the ratchet of the pen injector body, and wherein the joining means returns to the loaded / loaded state. To allow the container to be removed from the container retainer when
9. A drug delivery pen according to claim 8, wherein each cam follower is capable of retracting its respective cam track. 10. The release means further comprises a release plunger having an extension housed in a collapsible collet, wherein when the release plunger is pushed in a distal direction, the collet expands, thereby causing the collet to expand. The drug delivery pen according to claim 9, wherein the finger is pushed into an engagement portion of the container retainer with the ratchet finger.