METHOD AND SYSTEM FOR REDUCING PATIENT STRESS DURING PROLONGED SUBCUTANEOUS PHARMACEUTICAL INJECTION

A method for reducing patient stress during prolonged subcutaneous pharmaceutical injection wherein a flexible, nonmetallic sleeve is provided for pharmaceutical delivery. A penetration needle, disposed in the sleeve, allows the flexible sleeve to penetrate a patient's skin. Once the flexible, nonmetallic sleeve has penetrated a patient's skin the penetration needle is removed and a delivery needle is introduced to an upper and of the sleeve.

BACKGROUND

Application of pharmaceuticals has come a long way in the past couple of decades. One of the most liberating mechanisms for introducing a pharmaceutical into a human recipient is a concept based on a “wearable injector”. A wearable injector includes a reservoir, which contains a quantity of pharmaceutical agent. A wearable injector also includes a delivery timing mechanism which provides a means for introducing a particular quantity of pharmaceutical agent into a recipient over a particular interval of time.

It can be appreciated that a wearable injector allows a patient to receive sustained application of a pharmaceutical agent over a much longer period of time, especially when compared to a single injection by hypodermic needle. Despite of the advantages provided by a wearable injector, all wearable injectors available today continue to rely upon a rigid needle, which penetrates a patient's skin and stays in place during the entire duration of pharmaceutical agent delivery.

It can be appreciated that the rigid needle is likely to cause skin irritation proximate to the penetration point. Accordingly, severe patient discomfort may result. Patient discomfort is but one potential indication when using a rigid needle to maintain penetration of a patient's skin over an extended duration of time. Irritation may lead to inflammation. In yet other cases, the rigid needle may tear at the skin causing repeated exposure to microbial infection.

Another issue with the use of a wearable injector is the fact that the injector itself may occasionally need to be repositioned. For example, a wearable injector, once its rigid needle has penetrated a patient's skin, is typically affixed to the skin by some form of adhesive. When such adhesive binding to the patient's skin fails, the wearable injector must be removed from the skin and the rigid needle is then exposed to sources of infection. And even though the rigid needle is exposed to sources of infection, it is typically reused to re-penetrate the skin in order to re-affix the wearable injector to the patient.

DETAILED DESCRIPTION

In the interest of clarity, several example alternative methods are described in plain language. Such plain language descriptions of the various steps included in a particular method allow for easier comprehension and a more fluid description of a claimed method and its application. Accordingly, specific method steps are identified by the term “step” followed by a numeric reference to a flow diagram presented in the figures, e.g. (step5). All such method “steps” are intended to be included in an open-ended enumeration of steps included in a particular claimed method. For example, the phrase “according to this example method, the item is processed using A” is to be given the meaning of “the present method includes step A, which is used to process the item”. All variations of such natural language descriptions of method steps are to be afforded this same open-ended enumeration of a step included in a particular claimed method.

FIG. 1Ais a flow diagram that depicts one example method of reducing the stress associated with prolonged pharmaceutical application. According to this example method, stress upon a patient can be reduced during subcutaneous pharmaceutical injection by method that comprises providing a flexible, nonmetallic sleeve (step10), providing a penetration needle within the sleeve (step15), fixing an upper end of the sleeve in a holder (step20), penetrating the skin using the sleeve reinforced with the penetration needle (step25), affixing the holder to a patient's skin (step30), removing the penetration needle from the sleeve (step35) and accepting a delivery needle into the sleeve (step40).

FIGS. 1B through 1Dare pictorial diagrams that depict one example application of the present method. It should be appreciated that, according to one illustrative use case, the flexible sleeve220penetrates a patient's skin275in that it is concentric with the penetration needle225provided therein. The penetration needle225protrudes beyond the flexible, nonmetallic sleeve220. Once the penetration needle225penetrates the patient's skin, the flexible sleeve220follows along.

FIG. 1Cshows that once the flexible sleeve220penetrates the skin275, the penetration needle225is withdrawn from the sleeve220.FIG. 1Dillustrates that a, once a wearable injector255is snapped into a holder, which in this illustrative embodiment includes a first-half205and a second-half210, a delivery needle260included in the wearable injector255is received into the flexible sleeve220.

FIG. 2is a flow diagram that depicts one alternative example method for fixing an upper end of the sleeve in a holder. It should be appreciated that, according to this example method, fixing an upper end of the sleeve and a holder comprises supporting a lower surface of a collar included in the sleeve with a recessed upper surface included in a holder (step45). This alternative method also includes a step for holding the top of the collar substantially flush with an upper surface of the holder (step50). In this manner, the collar, which according to one example embodiment is integral with the upper end of the sleeve, is prevented from slipping downward through the holder.

FIG. 1Bshows one example structure and wherein the flexible sleeve220includes a collar240. As seen in this figure, a recessed feature includes a surface235that is set downward from a top surface236included in the holder. It should likewise be appreciated that the holder, according to one alternative embodiment, includes a first-half205and a second-half210.

FIG. 3is a flow diagram that depicts one alternative example method for providing a penetration needle into the sleeve. According to this alternative example method, providing a penetration needle into the sleeve comprises penetrating a barrier over the upper end of the sleeve (step55) and receiving the penetration needle through the barrier (step60).

FIG. 1Bshows that, according to one example embodiment, the flexible sleeve220includes a collar integrated there with at the flexible sleeve's220upper end. It should be appreciated that, according to yet another alternative example embodiment, the collar240includes a barrier at the upper end of the collar240. According to one illustrative use case, this example alternative method provides for penetrating such a barrier when the penetration needle225is inserted into the sleeve220. It should likewise be appreciated that the barrier, according to yet another alternative example embodiment, provides for substantially preventing ingress of unwanted matter from an outside environment into the flexible nonmetallic sleeve220.

FIG. 4is a flow diagram that depicts one alternative example method for accepting a delivery needle into the sleeve. According to this alternative example method, accepting a delivery needle into the sleeve comprises accepting a portion of the delivery needle into the sleeve (step65) and preventing the received portion of the delivery needle from protruding into a patient (step70).

FIG. 1Balso shows that, according to yet another alternative example embodiment, the thickness of the holder is sized in order to prevent the delivery needle from protruding into the sleeve220to such extent as to extend into a patient's skin.

FIG. 5is a flow diagram that depicts one alternative example method for accepting a delivery needle into the sleeve substantially contemporaneous with receiving a delivery reservoir into a holder. As depicted in the figure, one alternative example method for accepting a delivery needle comprises receiving a portion of the delivery needle into the sleeve (step75) and receiving a delivery reservoir into a holder (step80). It should be appreciated that, according to this alternative example method, the delivery reservoir is received into the holder substantially contemporaneous with receiving a portion of the delivery needle into the sleeve.

It should be appreciated that, according to one illustrative use case, as a delivery reservoir, which is typically included in a wearable injector, is positioned into a holder, the delivery needle260begins to penetrate a barrier included over the top end of the collar240that is integral to the flexible sleeve220. As the wearable injector is further positioned into the holder, which in this alternative example embodiment includes a first-half205and a second-half210, the delivery needle260is further situated into the flexible, nonmetallic sleeve220.

FIG. 6is a flow diagram that depicts one alternative example method for affixing the holder to a patient's skin. According to this alternative example method, affixing the holder to a patient's skin comprises providing an adhesive on a bottom surface of the holder (step85) and then pressing the adhesive to the skin (step90). It should be appreciated that, according to one illustrative use case, the holder must be held on a patient's skin for a duration of time. Accordingly, this alternative example method provides for a means for maintaining the holder in position on a patient. As a result, a wearable injector positioned and retained in the holder can be worn by a patient for such duration as required to administer a pharmaceutical over a particular interval of time.

FIG. 7is a flow diagram that depicts one alternative example method wherein a seal is maintained between a delivery needle and the upper end of the sleeve. It should be appreciated that, according to this example method, an additional step is included for substantially sealing between the delivery needle and the upper end of the sleeve (step95). It should be appreciated that once a delivery needle is disposed in the upper end of the sleeve, it is important to maintain a sterile environment so that infection cannot be introduced into a patient. It should be appreciated that, according to one illustrative use case, maintaining a seal between the delivery needle and the upper end of the sleeve is accomplished by a barrier that is integral to the top end of the sleeve and which exhibits elasticity sufficient to conform in a substantially hermetic way around the perimeter of the delivery needle.

FIG. 8is a flow diagram that depicts one alternative example method wherein an upper end of the sleeve is sealed when the penetration needle is removed. One alternative example method further comprises a step for sealing the upper end of the sleeve (step105) when the penetration needle is removed (step100). It should be appreciated that, when the penetration needle is removed from the sleeve, is important to maintain a sterile environment within the sleeve so that infection cannot be introduced into a patient. As such, one illustrative application of the present method is accomplished where a barrier is made integral to the top of a sleeve and wherein said barrier exhibit sufficient elasticity to conform to the penetration needle and also exhibit sufficient elasticity to substantially seal itself when the penetration needle is removed. In this sense, the barrier is “self-healing”.

FIG. 9is a flow diagram that depicts yet another example method wherein a delivery reservoir is restrained in a delivery holder. It should be appreciated that, according to one alternative example method, a delivery reservoir (e.g. a wearable injector) is introduced into a holder (step110). According to this alternative example method, the delivery reservoir is then restrained in the holder (step115).

FIG. 10is a flow diagram that depicts one alternative example method wherein a holder can be changed while maintaining penetration of a delivery needle in the sleeve and the sleeve in a patient. It should be appreciated that, according to this alternative example method, one included step provides for maintaining the delivery needle in a substantially similar position in the sleeve (step120). It should be appreciated that, according to various illustrative use cases, a user may need to change the holder for various reasons. One such reason is that any adhesive that is included on an underside of the holder has ceased to be effective. Again, this is only one illustrative use case and it is not intended to limit the scope of the claims appended hereto.

According to this alternative example method, the holder is then detached from the sleeve in a further included step (step125). In yet an additional step, a new holder is then attached to the sleeve (step130). It should be noted that, according to various illustrative use cases, detaching the holder from the sleeve, as in step125, and then attaching a new holder to the same sleeve is accomplished while the sleeve is maintained in its inserted position and the delivery needle is also maintained in position in the sleeve. Once the new holder is attached to the sleeve, it is affixed to the skin in an additional included step (step135).

FIG. 11is a pictorial diagram that illustrates one example embodiment of a system for reducing patient stress during prolonged subcutaneous pharmaceutical injection. According to this example embodiment, such a system200comprises a holder203, and an adhesive surface (see285,290inFIG. 15) disposed on a portion of the bottom surface of the holder. It should be appreciated that, according to this example embodiment, the holder includes a top surface211and a bottom surface (see219inFIG. 15) and also includes an opening209for holding a flexible sleeve.

FIG. 12is a pictorial diagram that illustrates assembly of one alternative example embodiment of a system for reducing patient stress during prolonged transdermal pharmaceutical injection. One alternative example embodiment of the system200further includes a flexible sleeve220that runs through the top and bottom surfaces of the holder203. It should be appreciated that, according to this alternative example embodiment, the flexible sleeve220is disposed in the opening included in the holder203for said purpose. According to this alternative example embodiment, the flexible sleeve220includes an upper end which itself includes a collar240. The collar240is sized in order to fit in a depression included in the top surface of the holder203.

According to one alternative example embodiment, the flexible sleeve220further includes a seal-membrane230disposed across the upper end of the collar240. It should be appreciated that the seal-membrane comprises a pliable material to allow penetration by a penetration needle225. The pliable material, according this alternative embodiment, provides for a self-healing mechanism so that the seal-membrane230will substantially reseal when the penetration needle225is withdrawn from the flexible, nonmetallic sleeve220. As such, the internal volume of the flexible sleeve220is substantially sealed against unwanted foreign matter.

According to one alternative example embodiment, the holder203comprises a first portion210and a second portion205. In this alternative example embodiment, the first portion210and the second portion205include an interlock structure which is used to substantially maintain the position of the first portion210relative to the second portion205when said first and second portions are coupled together.

According to yet another alternative example embodiment, the interlock structure comprises a tongue and groove mechanism. In this alternative example embodiment, a first portion210of the holder203includes a tongue295and the second portion of the holder205includes a corresponding groove298. It should likewise be appreciated that, in order to maintain the position of the first portion210relative to the second portion205when the two portions are coupled together, this alternative example embodiment includes a rough surface296included on a side of the tongue295. It should likewise be appreciated that the width of the groove298is sized so as to make a friction fit with the rough surface296included in the tongue295.

According to yet another alternative example embodiment, the opening245included in the holder203is shrouded by a depressed region235. The depressed region235provides for a depth so as the collar240included at the top end of the sleeve220is supported at the depressed region235. According to one alternative embodiment, the depth of the depressed region corresponds to the thickness of the collar240included at the top end of the flexible-nonmetallic sleeve220. Thus, according to this alternative embodiment, the top surface of the collar, which comprises the seal-membrane230, sits substantially flush with a top surface217of the holder203.

FIGS. 13 and 14are pictorial diagrams that illustrate insertion of a pharmaceutical injection device into the holder. It should be appreciated that a pharmaceutical injection device, which is also referred to as a wearable injector255, is brought into the holder203with a delivery needle260oriented toward the seal-membrane230. It should be appreciated that, once the penetration needle225is removed from the flexible sleeve220, the seal-membrane230substantially reseals itself to reduce the potential for contamination within the volume of the flexible, nonmetallic sleeve220.

According to one alternative example embodiment of a holder, the holder203further includes a retention-clip215. The retention clip215, according to this alternative embodiment, snaps in place over the wearable injector255in order to restrain such pharmaceutical injection device in a desired position.

FIG. 15is a pictorial diagram that depicts an underside of one example embodiment of a holder. According to this example embodiment of a holder203, the holder includes a bottom surface219. Also included and disposed on the bottom surface219is an adhesive surface285. In those alternative embodiments where in the holder comprises two portions, for example a first portion210and a second portion205, the adhesive surface includes a first adhesive surface285disposed on the bottom surface of the first portion210of the holder and a second adhesive surface290disposed on the bottom surface219of the second portion205of the holder.

FIG. 16is a pictorial diagram that illustrates how a flexible sleeve is released from a holder when the holder needs to be replaced. According to yet another alternative example embodiment, the holder also comprises a first portion210and a second portion205and also comprises the coupling structure as heretofore described. In this alternative example embodiment, the holder203provides that the flexible sleeve220is loosed from the holder203when the first and second portions of the holder are disengaged from each other. It should likewise be appreciated that, according to this alternative example embodiment, as the first portion210and second portion205of the holder are disengaged from each other, they are pulled apart in substantially opposite directions in order to leave the flexible sleeve220engaged with a delivery needle included in a pharmaceutical injection device255.

While the present method and apparatus has been described in terms of several alternative and exemplary embodiments, it is contemplated that alternatives, modifications, permutations, and equivalents thereof will become apparent to those skilled in the art upon a reading of the specification and study of the drawings. It is therefore intended that the true spirit and scope of the claims appended hereto include all such alternatives, modifications, permutations, and equivalents.