EP1248657A1

EP1248657A1 - Pen needle assembly and adapter

Info

Publication number: EP1248657A1
Application number: EP01904918A
Authority: EP
Inventors: Joel Douglas; John Ramirez
Original assignee: Sterling Medivations Inc
Current assignee: Sterling Medivations Inc
Priority date: 2000-01-18
Filing date: 2001-01-17
Publication date: 2002-10-16
Also published as: WO2001052925A1; IL150412A0; JP2003531646A; AU2001232853A1

Abstract

A pen needle assembly (30) for connecting onto a medication delivery device (10) to deliver medicine to a patient directly through the pen needle or through a catheter (70). The pen needle being attached to the medication delivery device by a cap (40), such that, the needle of the pen needle does not twist while being inserted into the cartridge of the medication delivery device. An adapter (50) can be attached to the pen needle so that a catheter connector (62) can be connected to the adapter without being damaged by the pen needle.

Description

PEN NEEDLE ASSEMBLY AND ADAPTER

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to a pen needle assembly. More particularly, the present invention pertains to a pen needle assembly that can be used either to deliver medication subcutaneously or be connected to a subcutaneous catheter.

Brief Description of the Related Art

There are many medical conditions that require the administration of liquid medicaments transcutaneously (through the skin) for prolonged periods. Diabetes, for example, may be controlled by daily, or more frequent, injections of insulin. The ability to administer numerous small dosages of insulin has been proven to be the best way to insure tight glucose control for a patient. The National Institutes of Health (NIH) conducted a long-term study of people with diabetes known as the Diabetes Complications and Control Trial (DCCT) where it was determined that the proper management of diabetes requires 4 or more injections of insulin per day. However, current devices either are not convenient or easy to use by patients. Syringes and insulin pens all require the patients to inject themselves and do not provide a convenient or discreet mechanism to accomplish medication delivery.

Medication to be injected with known hypodermic syringes are often stored in a vial having a pierceable elastomeric seal. The medicine is accessed by piercing the elastomeric seal with a needle cannula. A selected dose of the medication is drawn into the chamber of the syringe barrel by moving a plunger a selected distance in a proximal direction. The needle cannula is then withdrawn from the vial and the medication is injected into the patient by moving the plunger in a distal direction. Some medication, such .is, insulin is self-administered. The typical diabetes patient will require injections 0/ insulin several times during the course of the day. The required dose of insulin will vary from patient to patient, and for each patient may vary during the course of the day and from day to day. The dosage taken typically includes some combination of a slow or medium acting insulin and a faster acting insulin. The self-administering of the medication may periodically be required when the patient is in a public location, such as places of employment or in restaurants. The required manipulation of the known hypodermic syringe and vial can be inconvenient and embarrassing in these public environments.

Medication delivery pens and insulin pumps have been developed to facilitate the self-administration of medication. One known medication delivery pen includes a cartridge holder into which a cartridge of insulin or other medication may be received. The cartridge holder is an elongate generally tubular structure with proximal and distal ends. The distal end of the known cartridge holder includes means for mounting a driver and dose setting apparatus as explained further below. A disposable cartridge for use with the known cartridge holder includes a distal end having a pierceable elastomeric seal that can be pierced by one end of a double-ended needle cannula. The proximal end of this known cartridge includes a plunger that is slidably disposed in fluid tight engagement with the cylindrical wall of the cartridge. This known medication delivery pen is used by inserting the cartridge of medication into the cartridge holder. A known pen body apparatus can designate a dose of medication to be delivered by the pen and includes a driving apparatus for urging the plunger of the cartridge distally for a distance corresponding to the selected dose.

The user of the pen mounts a known double-ended needle cannula to the distal end of the cartridge holder such that the proximal point of the needle cannula pierces the elastomeric seal on the cartridge. The patient then selects a dose and operates the pen to urge the plunger distally to deliver the selected dose. The patient then removes and discards the needle cannula, and keeps the known medication delivery pen in a convenient location for the next required medication administration. The medication in the cartridge will become exhausted after several such administrations of medication. The patient then separates the cartridge holder from the pen body. The empty cartridge may then be removed and discarded. A new cartridge can be inserted into the cartridge holder, and the cartridge holder and pen body can be reassembled and used as explained above.

In general, whenever a medication is to be delivered subcutaneously to a patient from an external source, a passageway such as a hollow needle or other type of cannula catheter device must first be inserted through the skin of the patient in order to provide a passageway or channel through which the fluid may pass from its source external to the patient to the desired subcutaneous location under the skin of the patient. Once this passageway has been installed, any suitable infusion device or system may be used in conjunction with an appropriate catheter connecting the external source of fluid with the passageway leading to the subcutaneous delivery point to deliver the fluid to the patient at an appropriate delivery rate.

However, several problems associated with infusing fluids into the patient as described above are usually encountered. Most systems require the patient to use a syringe that is fitted with a thread or luer loc fitting. The patient must fill the syringe and attach the catheter to it. However, in doing so the medication can become contaminated and is therefore no longer sterile. Non-sterile solutions can lead to infection. In addition, the inconvenience of having to fill the syringe in the first place, and then attach and prime the catheter is difficult for many patients. In the early 1990's prefilled cartridges were developed which included septums to allow the medication to remain sterile. The cartridges are also difficult to use in the current pump infusion systems because of the design and construction of the fluid delivery system. To permit the use of a prefilled cartridge, the catheter must have a needle located on each end of the catheter. However, most catheters do not provide a means for puncturing the septum of an insulin cartridge and are configured with either a luer loc or threaded adapter. To provide a needle fixtured in the cartridge attachment end of the catheter is needed to permit the patient to use these cartridges with current infusion systems.

The recent popularity of insulin infusion systems as an alternative to multiple daily injections for insulin-dependent diabetics requires the use of such an injection set to deliver insulin from a small, portable insulin infusion pump to the subcutaneous injection location. However, these devices require the patient to fill a syringe that defeats the sterility of the mixture.

Another significant problem that occurs whenever a needle or equivalent device is used to pierce the septum of the medication cartridge, and the needle is attached to the cartridge or cartridge holder with threads, is that the needle has to rotate in the septum as the needle is attached. This necessitates the lubrication of the needle that means that an additional contaminant is introduced to the medication. Also by not requiring the needle to rotate while being attached then when the needle is used with a catheter the catheter is not twisted making it more comfortable and convenient for the patient.

SUMMARY OF THE INVENTION

According to an embodiment of the present invention, a pen needle assembly is provided for attachment to a medication delivery pen. The medication delivery pen includes a body, a cartridge retainer, and a cartridge. The pen needle assembly includes a pen needle having a hub and a cannula, with the cannula having a proximal end and a distal end. The cannula is mounted within the hub and extends therethrough, such that the proximal and distal ends are located on opposite sides of the hub. A cap for securing the pen needle to the cartridge retainer, in which the proximal end of the pen needle is inserted into the cartridge without twisting the cannula, when the cap secures the pen needle to the cartridge retainer. According to a second exemplary embodiment, a pen needle assembly for attachment to a medication delivery pen is provided. The medication delivery pen includes a body, a cartridge retainer, and a cartridge. The pen needle assembly includes a pen needle which has a shroud and a cannula. The cannula has a proximal end and a distal end and is mounted within the shroud and extends therethrough, such that the proximal and distal ends are located on opposite sides of the shroud. The shroud is connectable to the cartridge retainer, in which the proximal end of the pen needle is inserted into the cartridge when the cap secures the pen needle to the cartridge retainer. An adapter for connecting the pen needle to a catheter is provided over the cannula of the pen needle.

According to a third exemplary embodiment, a pen needle assembly is provided, which includes a pen needle having a shroud and a connecting means located above the shroud. An adapter having a first portion is connectable onto the connecting means and a second portion is connectable to a catheter connector. An inner shield covers the adapter and an outer shield, having an open bottom portion, is coverable by a seal. The outer shield houses the pen needle, adapter and inner shield.

Yet another exemplary embodiment of the present invention relates to a method for connecting a pen needle assembly to a medication delivery device for delivery of medication to a patient. In the method, a pen needle assembly having a pen needle, an adapter, and an inner shield, all of which are housed within an outer shield in which an opening thereof is closed by a removable seal, is provided. The seal and the pen needle assembly are removed from the outer shield. The pen needle assembly is attached onto the medication delivery device and the inner shield is removed from the assembly.

Still other objects, features, and attendant advantages of the present invention will become apparent to those skilled in the art from a reading of the following detailed description of embodiments constructed in accordance therewith, taken in conjunction with the accompanying drawings. BRIEF DE CRIPTION OF THE DRAWINGS

The invention of the present application will now be described in more detail with reference to preferred embodiments of the apparatus and method, given only by way of example, and with reference to the accompanying drawings, in which: Fig. 1 illustrates an exploded perspective view of a first exemplary embodiment of a device according to the present invention;

Fig. 2 shows an enlarged view of a section of Fig. 1;

Fig. 3 illustrates an exploded side view of another embodiment in accordance with the present invention; Fig. 4 illustrates an exploded perspective view of another embodiment in accordance with the present invention;

Fig. 5 illustrates a perspective view of yet another embodiment in accordance with the present invention;

Fig. 6 illustrates a cross-sectional side view of yet another embodiment in accordance with the present invention;

Fig. 6 A illustrates a view along line 6A-6A in Fig. 6;

Fig. 6B illustrates a view along line 6B-6B in Fig. 6;

Fig. 7 illustrates a side view of yet another embodiment in accordance with the present invention; Fig. 8 illustrates an exploded view of the embodiment shown in Fig. 7;

Fig. 9 illustrates the steps involved in a method of attaching a pen needle assembly to a medicine delivery device and a catheter; and

Fig. 10 illustrates the steps involved in a method of attaching a pen needle assembly to a medicine delivery device.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

One advantage in having the capability of alternately using a catheter or a pen needle is unique to the invention because of the compact size, non-twisting attachment design, and positive adjustment capability. When the patient uses a catheter, the occurrence of infection and irritation is reduced because the medication, e.g., insulin, does not continuously enter the subcutaneous site. The patient can also use the device in a manner similar to currently available injection pens to delivery insulin when they do not want to use a catheter, thereby increasing the convenience of the device. By combining catheter aided delivery, pen tip delivery, sanitary cartridge utilization, a reduction of injection site irritation, compact size, and the ability to select the method of delivery on a day-to-day basis, the patient is given many advantages by devices and methods of the present invention.

In general, a medication injection or delivery system is provided for injecting fluids such as insulin within body tissue. The mechanics of the device 10 are described in greater detail in Attorney Docket No. 032994-012, filed September 29, 2000, entitled "Reusable Medication Delivery Device", Joel Douglas et al., which is incorporated by reference herein.

While it is contemplated that the present invention will utilize a standard insulin cartridge, holding 100-200 insulin units in a 1.5-3.0 milliliter volume, the present invention is not so limited, and can be resized and reconfigured to be used with medication cartridges or ampules of any size.

The ability to provide a small, discreet injection device that is capable of being used with both a catheter and an injection needle provides a significant advantage for the patient who must inject themselves on a regular basis, such as a person with diabetes. The patient can configure the device with a catheter on those occasions where discreet injection is needed, such as at work or other public situations. The catheter is then inserted subcutaneously and the medication is injected by setting the dosage mechanism and releasing or manually injecting the dosage. The catheter can be left in the patient for up to three days and thereby eliminates the need to insert a needle into themselves again over the three day period. Devices of the present invention can have a small size and compact shape, which can allow the patient to wear it or hide it in their clothes so that it is not obvious to the people around them. The alternate configuration of being used with a conventional pen tip provides a means for the patient to use the same device to inject themselves when they do not want to use a catheter. The ability to use the device with two injection methods is unique and made possible by the removable adaptors of the present invention.

The DCCT determined that the proper management of diabetes requires 4 or more injections of insulin per day. Currently, however, insulin-dependent diabetics rarely observe this critical treatment therapy because of the difficult and indiscreet nature of the current insulin delivery methods. All the available devices require the patient to carry the device and insulin, and inject in public. Those patients that use insulin pumps are afforded a more discreet means of infusion, but because of the basal rate therapy, require that they test their glucose levels 7 to 10 times a day. The present invention does not change the method of treatment but facilitates the delivery of insulin by providing a dual methodology to delivery the insulin that is selectable by the patient. They can either use a catheter or a pen-tip to deliver the required dosage of insulin. By creating a dual mode medication delivery device for the administration of a medicament, such as insulin, to a patient in small, controlled doses over an extended period the patients therapy is improved while maintaining a continuity with their existing means of treatment.

Referring to the drawing figures, like reference numerals designate identical or corresponding elements throughout the several figures.

Figure 1 illustrates an exploded perspective view of a first exemplary embodiment of a device according to the present invention. Figure 1 shows a medicine delivery device 10 having a device body 12 and a plunger 14 provided on the distal end of the body. A cartridge retainer 16 is connected to the delivery device 10 and is preferably fastened thereto with threads 22 located on a proximal end of the cartridge retainer. A cartridge 24 containing medicine and having a stopper 26 provided on a proximal end thereof is inserted within the cartridge retainer 16. The distal end of the cartridge 24 includes an elastomeric septum 28. A pen needle assembly 30, which includes a hub 38, a needle cannula 32 is also provided. The needle cannula 32 includes a proximal end 34 and a distal end 36. A cap 40 is provided to be placed over the pen needle assembly 30 to thereby support the pen needle assembly on the cartridge 24. By supporting the pen needle assembly 30 on the cartridge 24 in this manner, the proximal end 34 of the needle cannula 32 can be inserted into the septum 28 and thereby into the cartridge without causing the needle cannula to be twisted.

Thus, the medicine in the cartridge 24 can be injected by subcutaneously inserting the distal end 26 of the pen needle assembly 30 and actuating the medicine delivery device 10. Alternatively, if the patient wishes to inject the medicine through a catheter 70, the patient need only attach an adapter 50 onto the cap 40.

As seen in Figure 2, the cap 40 includes a threaded portion 42 on a distal end thereof. The adapter 50 includes a threaded distal end 52 and a threaded proximal end 54. The proximal end 54 is threadably connected to the threaded distal end 42 of the cap 40. The adapter 50 also includes an axially extending portion 56 having a length slightly longer than the length of the distal end 36 of the pen needle assembly 30. Thus, once the adapter 50 is coupled to the cap 40, the axially extending portion 56 covers and protects the pen needle assembly 30. In addition, the axially extending portion 56 also provides a threaded distal end 52 for threadably connecting to a catheter connector tube 62 of a catheter 70. Thus, the adaptor 50 also prevents the distal end 36 of the pen needle assembly 30 from damaging the catheter 70 during the connection of the pen needle assembly to the catheter connector tube 62 and also during injection of the medicine.

According to another embodiment of the present invention, as illustrated in Figure 3, the pen needle 100 includes a shroud 106, a needle cannula 102, and a needle mounting portion 104. The needle cannula 102 extends through the shroud 106 and is insertable into the elastomeric septum 28 of the cartridge 24. The shroud 106 is attached to the distal end 20 of the cartridge retainer 16. As the pen needle 100 is connected to the cartridge retainer 16, the needle cannula 102 extends into the elastomeric septum 28. With this configuration, the patient can directly insert the needle cannula 102 into their skin. Pen needles usable in the present invention are currently commercially available, for example a Novofine^® 30 1/3 inch (8 mm) pen needle (Novo Nordisk, Princeton, NJ). A more detailed description of the pen needle and the manner in which it operates may be found in Attorney Docket No. 032994-012, filed September 29, 2000, entitled "Reusable Medication Delivery Device", Joel Douglas et al., which is incorporated by reference herein.

Alternatively, the patient may also supply an adaptor 110 over the needle cannula 102 to inject medicine through a catheter connector (not shown). In this regard, since there are no means for fastening the adapter 110 to the pen needle 100, an adapter holder 120 is provided. The adapter holder 120 is placed over the adapter 110 and the pen needle 100 and is connected to the cartridge retainer 16. The adapter holder 120 can be fastened to the cartridge retainer 16 by any suitable means, for example, by mating threads or tongue and groove connection. Once the adapter holder 120 is fastened to the cartridge retainer 16, the connector 110 is substantially held in place over the needle cannula 102. Thus, the adapter 110 protects the needle cannula 102 from becoming damaged and also allows for the connection thereof with a catheter tube while protecting the catheter tube from being damaged by the needle cannula.

Figure 4 illustrates yet another embodiment of the present invention, in which the adapter 50' is fastened directly to the pen needle 100' . In this embodiment, the pen needle 100' is provided with a threaded portion 104' . The adapter 50' is also provided with a threaded portion (not shown) which is sized to matingly engage the threaded portion 104' . Thus, in this embodiment, the patient can directly inject medicine into his or her skin or can attach an adapter 50' directly onto the pen needle 100' to attach a catheter connector tube thereto. Figure 5 illustrates another embodiment of the present invention, in which the pen needle assembly 130 is formed integrally with an adapter for connecting the pen needle assembly to a catheter connector tube. In this embodiment, the pen needle assembly 130 includes a luer connector 132 attached to a distal end thereof. Figure 6 illustrates a cross- sectional side view of the pen needle assembly 130 without the luer connector 132.

Figures 6A and 6B show the respective bottom and top views of the pen needle assembly 130.

Figures 7 and 8 illustrate yet another embodiment of the present invention. As seen in Figure 8, a pen needle adapter assembly 80 includes an outer shield 82, which houses an inner shield 84, a luer adapter 86, and a pen needle 100, all of which are housed within the outer shield 82 prior to use. The above-cited elements are placed inside the outer shield 82 through an opening provided at a bottom end thereof and is closed off by a removable seal 88. In Figure 8, the luer adapter 86 is removably connectable to the pen needle 100.

Figure 9 illustrates the process, going from the left side of the page to the right side of the page, in which the pen needle adapter assembly 80 is connected to an insulin pen 90 and a catheter luer connector 92. As seen in Figure 9, the seal 88 is first removed from the outer shield 82. The pen needle 100, luer adapter 86, and inner shield 84 are then removed from the outer shield 82 and attached to the insulin pen 90. Once this is complete, the inner shield 84 is detached from the pen needle 100. As can be realized by the present invention, the inner shield 84 protects the pen needle 100 from contamination during its installation onto the insulin pen 90. After the inner shield 84 has been removed, the catheter luer connector 92 is connected to the luer adapter 86.

Figure 10 illustrates an alternative process, going from the left side of the page to the right side of the page, in which the pen needle adapter assembly 80 is connected to an insulin pen 90. As seen in Figure 10, the process is substantially the same as that described above with respect to Figure 9, except that Figure 10 shows that the luer adapter 86 is also detached from the pen needle 100 after the pen needle has been connected to the insulin pen 90. Once the luer adapter 86 has been removed, the needle cannula 32 is no longer covered and can thus be inserted into the patient's skin.

An advantage of the present invention is that, when used with an administration set which includes a length of tubing, such as the tubing in a catheter 70, between a piercing element (e.g., proximal end 34 of the needle cannula 32) and the needle (e.g., the end of the catheter 70) which is inserted into the user, the tubing can effectively act as a strain relief for the junction of the piercing element and the septum 38, the junction of the needle 32 and the user's skin, or both. Thus, the septum 38 is less prone to be distorted by the piercing element, and thus can increase the accuracy of the dosage administered and assist in maintaining the sterility of the contents of the cartridge 24. Similarly, the user's skin is less prone to be pulled during injection, which can improve the user's comfort levels.

While the invention has been described in detail with reference to preferred embodiments thereof, it will be apparent to one skilled in the art that various changes can be made, and equivalents employed, without departing from the scope of the invention. Each of the foregoing references and documents are incorporated by reference herein in each of their entireties.

Claims

WHAT IS CLAIMED IS:

1. A pen needle assembly for attachment to a medication delivery pen, said medication delivery pen including a body, a cartridge retainer, and a cartridge, said pen needle assembly comprising: a pen needle having a hub and a cannula, said cannula having a proximal end and a distal end; said cannula being mounted within said hub and extending therethrough, such that said proximal and distal ends are located on opposite sides of said hub; and a cap for securing said pen needle to said cartridge retainer, wherein said proximal end of said pen needle is inserted into said cartridge without twisting said cannula when said cap secures said pen needle to said cartridge retainer.

2. A pen needle assembly according to Claim 1, further comprising an adapter having first and second ends, said first end being engageable with said cap and said second end being engageable with a catheter.

3. A pen needle assembly for attachment to a medication delivery pen, said medication delivery pen including a body, a cartridge retainer, and a cartridge, said pen needle assembly comprising: a pen needle having a shroud and a cannula, said cannula having a proximal end and a distal end; said cannula being mounted within said shroud and extending therethrough, such that said proximal and distal ends are located on opposite sides of said shroud; said shroud being connectable to said cartridge retainer, wherein said proximal end of said pen needle is inserted into said cartridge when said cap secures said pen needle to said cartridge retainer; and an adapter for connecting said pen needle to a catheter being provided over said cannula of said pen needle.

4. The pen needle assembly according to Claim 3, wherein said adapter is held on said pen needle by an adapter holder, said adapter holder being placed over said adapter and being connectable to said cartridge retainer.

5. The pen needle assembly according to Claim 3, wherein said pen needle includes a threaded portion provided in a position above said shroud, said adapter also includes a threaded portion, and wherein the threaded portions are matingly engageable with one another.

6. The pen needle assembly according to Claim 3, wherein said pen needle and said adapter are integrally formed.

7. A pen needle assembly comprising: a pen needle having a shroud and a connecting means located above said shroud; an adapter having a first portion connectable onto said connecting means and a second portion connectable to a catheter connector; an inner shield for covering said adapter; an outer shield having an open bottom portion, said open bottom portion being coverable by a seal; and said outer shield housing said pen needle, adapter and inner shield.

8. A method for connecting a pen needle assembly to a medication delivery device for delivery of medication to a patient, said method comprising the steps of: providing a pen needle assembly having a pen needle, an adapter, and an inner shield, all of which are housed within an outer shield in which an opening thereof is closed by a removable seal; removing said seal from said outer shield; removing said pen needle assembly from said outer shield; attaching said pen needle assembly onto said medication delivery device; and removing said inner shield from said assembly.

9. The method as claimed in Claim 8, further comprising: connecting a catheter connector to said adapter and delivering medication from said medication delivery device to said patient through said catheter.

10. The method as claimed in Claim 8, further comprising: removing said adapter to thereby expose a needle of said pen needle; injecting said needle into a patient; and delivering medication from said medication delivery device to said patient.