WO2009031144A1

WO2009031144A1 - Envelope containing sterile needle

Info

Publication number: WO2009031144A1
Application number: PCT/IL2008/001192
Authority: WO
Inventors: Zeev Bronfeld
Original assignee: Sindolor Medical Ltd
Priority date: 2007-09-05
Filing date: 2008-09-04
Publication date: 2009-03-12
Also published as: IL185741A0

Abstract

A sterile needle envelope (SNE) (140) enclosing a sharp ended needle (130) is disclosed. The aforementioned needle is adapted and disposed to pierce the envelope whilst the needle is penetrating the body of the patient.

Description

ENVELOPE CONTAINING STERILE NEEDLE

FIELD OF THE INVENTION

[001] The present invention relates to the field of syringe needles and devices. More specifically, the present invention relates to packaging of syringe needles for home, field and high patient throughput use. BACKGROUND OF THE INVENTION

Many chronic sufferers of disease such as diabetes are medically obliged to self inject therapeutic preparations.-The traditional hypodermic syringe is difficult to use by non medical operators. Devices and methods have been developed to 'de-skill" the operation of self injection by means of auto injectors. Most auto injectors are spring-loaded syringes. By design, autoinjectors are intended for self-administration by patients. The site of injection depends on the drug loaded, but it typically is administered into the thigh or the buttocks. The injectors were initially designed to overcome the hesitation associated with self-administration of needle-based drugs. Examples include EpiPens, or the recently introduced Twinject, which is often prescribed to people who are at risk for anaphylaxis. Rebiject and Rebiject II autoinjectors for Rebif, the drug for interferon beta- Ia used to treat Multiple Sclerosis. Other autoinjectors exist for diabetics. With the population aging, and more and more relatively infirm people needing to self - inject drugs, a long felt need exists for making these operations easy and safe. A long felt need exists for an easily fitted sterile needle suitably packaged for an autoinjector which, when presented to the body of the patient for injection, pierces the patient whilst maintaining it's sterility up to the moment of penetration. SUMMARY OF THE INVENTION

A surprising object of the invention is to provide a sterile needle envelope (SNE) enclosing a sharp ended needle wherein the røedle is adapted' and disposed to pierce the envelope whilst the needle is penetrating the body of the patient.

Moreover, another object of the invention is to disclose an SNE as defined above, further

^'wherein the SNE further comprises means for- connecting the needle to an external liquid reservoir (ELR).

Another object of the invention is to provide an SNE as defined above, wherein the envelope is made at least in part from an essentially flexible material. The material is selected from the group consisting of rubber, latex, plastic, synthetic material, metal, glass, glass-like material, plexiglass, rubber, rubber-like material and any composition thereof.

Another object of the invention is to provide an SNE as defined above, wherein the SNE further comprises means for connecting the needle to an external needle urging means

(NUM).

Another object of the invention is to provide an SNE as defined above, wherein the SNE further comprises means for directly connecting said needle to external reciprocating needle injecting means.

Another object of the invention is to provide an SNE as defined above, wherein the SNE further comprises means for indirectly connecting said needle to external reciprocating needle injecting means.

Another object of the invention is to provide an SNE as defined above, wherein the needle has a bore of about 0.1mm. to about 0.3 mm. Another object of the invention is to provide an SNE as defined above, wherein the needle has a bore of aboutlO microns to about 500 microns

Another object^* of the invention is to provide an SNE as defined above, wherein at least a section of a distal portion of the SNE is at least one of the following: frangible, perforatable, and pierceable.

Another object of the invention is to provide an SNE as defined above, wherein the section is frangible, perforatable and pierceable in a predetermined manner.

Another objective of the invention is to provide an SNE as defined above, wherein a distal end of the needle is adapted so as to prevent blocking by envelope fragments and debris during piercing of the SNE by the needle.

A yet further object of the invention is to provide an SNE as defined above, wherein said

NUM is part of an autoinjector.

A still further object of the invention is to provide an SNE as defined above wherein said

NUM is part of a needle cartridge.

A still further object of the invention is to provide an SNE as defined above wherein the

NUM is part of a syrette.

Lastly, a further object of the invention is to provide an SNE as defined above wherein the NUM is part of a standard hypodermic syringe.

BRIEF DESCRIPTION OF THE FIGURES

[002] The subject matter regarded as the invention will become more clearly understood in light of the ensuing description of embodiments thereof, given by way of example only, with reference to the accompanying figures (FIGs), wherein [003] FIG. 1 is a schematic block diagram illustration of an syringe device comprising a needle that is sealingly enclosed by a sterile needle envelope, according to some embodiments of the invention; ^{■ • < ■}

[004] FIG. 2A is a schematic block diagram illustration of the syringe device, wherein a distal needle edge thereof engages with a distal end of the sterile needle envelope, according to some embodiments of the invention;

[005] FIG. 2B is another schematic block diagram illustration of the syringe device, wherein the distal end of the sterile needle envelope is being perforated by the distal needle edge, according to some embodiments of the invention;

[006] FIG. 3 is a -schematic block diagram illustration of administration of substance to an syringe site via the needle, according to some embodiments of the invention; and

[007] The figures taken with description make apparent to those skilled in the art how the invention may be embodied in practice.

[008] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.

DETAILED DESCRIPTION OF THE INVENTION

The invention discloses a sterile needle envelope (SNE) enclosing a sharp ended needle.

The needle is adapted and disposed to pierce the envelope whilst the needle is penetrating the body of the patient. Reference is made to a further disclosure such that the SNE comprises means for connecting the needle to an external liquid reservoir (ELR).

A further disclosure is made of an SNE as defined above, wherein the envelope is made at least in part from an essentially flexible material. The material is selected from the group consisting of rubber, latex, plastic, synthetic material, metal, glass, glass-like material, plexiglass, rubber, rubber-like material and any composition thereof.

A further disclosure is made of an SNE as defined above, wherein the SNE further comprises means for connecting the needle to an external needle urging means (NUM).

Reference is now made to an SNE as defined above, wherein the SNE further comprises means for connecting the needle to an.external reciprocating needle injecting means.

Reference is now made to an SNE as defined above, wherein the needle has a bore of about 0.1mm. to about 0.3 mm.

Reference is further made to an SNE as defined above, wherein the needle has a bore of about 10 microns to about 500 microns.

Reference is again made to an SNE as defined above, wherein at least a section of a distal portion of the SNE is characterized by at least one of the following: frangible, perforatable, and pierceable.

Reference is now made to an SNE as defined above, wherein at least a section of a distal portion of the SNE is frangible, perforatable and pierceable in a predetermined manner.

Reference is now made to an SNE as defined above, wherein a distal end of the needle is adapted so as to prevent blocking by envelope fragments and debris during the piercing of the SNE by the needle. Moreover reference is further made to the SNE as defined above, wherein the NUM is part of an autoinjector.

Yet further reference is made to the SNE as defined above, wherein the NUM is part of a needle cartridge.

Reference is yet further made to the SNE as defined above, wherein the NUM is part of a syrette.

Lastly, reference is made to the SNE as defined above, wherein the NUM is part of a standard hypodermic syringe.

The term "autoinjector" herein refers to a device designed to deliver a single dose of a particular drug, often by self administration.

The present invention discloses a sterile needle envelope (SNE). The SNE encloses a hypodermic needle, in order to minimize the risk of contamination of the needle prior to its engagement with the patient's skin.

[Q09] In some embodiments of the invention, the SNE is configured to be . fitted to an injection device such as an autoinjector, syrette or hypodermic syringe. The envelope may be frangible and/or perforatable by the needle.

[0010] Instantaneously after the perforation of the SNE, the needle may be suitably engaged with the patient's skin and the needle may be urged into the body.

[0011] Reference is now made to FIG. 1. According to some embodiments of the invention, a syringe device 100 may include- an external liquid reservoir (ELR) 110 having an opening

111, whereby ELR 110 is configured to securely contain therein substances such as, for example, and insulin. ELR 110 may further include means and/or may be configured to enable varying the volumetric capacity -of ELR llO.Før example, ELR 110,,may be .embodied by a receptacle wherein means that enable varying the receptacle's volumetric capacity may include a plunger (e.g., plunger 120) that is slidably coupled within the receptacle, whereby the plunger may be configured such to abut against the inner wall of the receptacle. Thusly, plunger 120 provides a substantially sealed seal. It should be noted that the term "substantially sealed seal" includes "sealed"seal".

[0012] Syringe device 100 further includes a sharp ended needle (hereinafter referred to as "needle") 130, e.g., as known in the art, comprising a bore (not shown). The bore may have a diameter of, for example, about 0.1mm to about 0.3 mm Other embodiments of the invention may have needle bores of about 10 microns to about 500 microns. Needle 130 is mechanically coupled to ELR 110 such that a proximate opening 132 of the bore of needle 130 is positioned relative to outlet 111 of ELR 110. The mechanical coupling may be substantially sealed or sealed. Correspondingly, ELR 110 in association with needle 130 and the corresponding mechanical coupling constitute a sealed cavity having one opening, which is the distal opening 131 of the bore of needle 130. Thusly configured, an increase in the volumetric capacity of ELR 110 generates a vacuum at distal opening 131, thereby enabling suction of a substance into ELR 110. Conversely, a decrease in the volumetric capacity of ELR 110 causes the ejection of the substance from ELR 110 through distal opening 131. [0013] It should be noted that in some embodiments of the invention, the mechanical coupling of needle 130 to ELR 110 may be embodied, for example, by integrally forming needle 130 with ELR 110. In some additional or alternative embodiments of the invention, SNE 140 comprises means, e.g., as known in the art, for connecting needle 130 to ELR 110. For example, needle 130 may be mechanically coupled to ELR 110 by means of a Luer Lock. [0014] Needle 130 may be embodied, for example, by an anti-coring needle (e.g., a Tuohy needle); hypodermic needles and other needles, e.g., as known in the art. Further, needle 130 may have a distal needle edge 133, which may have various shapes. Distal needle edge 133 may be, for example, a sharp pointed tip embodied, for example, by a standard bevel, by a short bevel or by a true short bevel, e.g., as known in the art. Further, needle 130 may be configured to enable intermuscular injection, subcutaneous injection or other injection types. [0015] According to some embodiments of the invention, syringe device 100 may include a sterile needle envelope (SNE) 140, which sealingly encloses at least the portion of needle 130 that may be engaged with' substance transfer site 160. However; in some embodiments Of "the invention, SNE 140 may sealingly enclose all of needle 130, and in some embodiments of the invention, SNE 140 may sealingly enclose needle 130 as well as other elements of syringe device 100 such as, for example, ELR 110. For exemplary and simplifying purposes only, the above-mentioned embodiments are hereinafter referred to by the term "sealingly enclosing" and by grammatical variations thereof.

[001^"6] SNE 140 may have distal SNE end 141 that is positioned in front of distal opening 131, whereby SNE 140 may be made of any suitable packaging material, e.g., as known in the art, such as, _, for example, synthetic material (e.g., plastic, latex), metal, glass or glass-like material (e.g., plexiglass), rubber or rubber-like material or any composition thereof. [0017] Needle 130 as well as at least the inner side of SNE 140 that sealingly encloses needle 130, may be sterile or substantially sterile.

[0018] It should be noted that the sterile needle envelope and grammatical variations thereof as used herein may refer to any type of covering, layer, coating, envelop, wrapping, enclosure, sleeve, shell or membrane adapted to protect needle 130 from contamination or substantial contamination. [0019] In some embodiments of the invention, distal opening 131 of needle 130 is adapted so as to prevent blocking by envelope fragments and debris during piercing and/or perforation and/or fraction Of SNE 140 by needle 130:-

[0020] Reference is now made to FIG. 2A and to FIG. 2B. In some embodiments of the invention, syringe device 100 is adapted or includes a needle urging means (NUM) causing a relative longitudinal displacement of distal -needle edge 133 against distal SNE end 141, -when operation of syringe 100 is initiated by, e.g., a user of syringe device 100. As a result, of said longitudinal displacement, distal edge 131 may perforate or fracture distal SNE end 141. Correspondingly, SNE 140 may is adapted to be connected to reciprocating needle injecting means For .example, in .some embodiments of the invention, needle 130 may be operatively coupled to plunger 120 in a manner such that longitudinal displacement of plunger 120 (which is schematically illustrated with arrow Q) results in a longitudinal displacement of distal needle edge 133 towards distal SNE end 141. Longitudinal displacement of distal needle edge 133 towards distal SNE end 141 may be accomplished, for example, by telescopically lengthening needle 130; by longitudinally displacing needle 130 towards distal SNE end 141 or by other suitable NUM. The longitudinal displacement causes the engagement of distal needle edge 133 with distal SNE end 141, whereby distal needle edge 133 and/or distal SNE end 141 may be configured such that said engagement results in a perforation of distal SNE end 141. For example, in some embodiments of the invention, the perforation may be a result of pressure applied by distal needle edge 133 against distal SNE end 141, whereby the pressure causes tearing of distal SNE end 141. Additionally or alternatively, the perforation may be a result of an incision operation performed by distal needle edge 133 during its engagement with distal SNE end 141. For example, distal needle edge 133 may have a beveled tip that extends towards cutting edges terminating in the wall of needle 130. During engagement of distal needle edge 133 with distal SNE end 141, the beveled tip punches a hole in distal SNE end 141, whereby ongoing longitudinal displacement causes the¹ cutting edges to cut out and/or perform an incision in distal SNE end 141. As a result, traversing of at least some portion of needle 130 towards fluid transfer site 160 is enabled, as is schematically illustrated in FIG. 2B.

[0021] In some embodiments of the invention, distal SNE end 141 may be configured to facilitate its perforation by, e.g., distal needle edge 133. For example, distal SNE end 141 may have a pierced boundary; or may have a weakened boundary.

[0022] It should be noted that in some embodiments of the invention, distal needle edge 133 and/or distal SNE end 141 may be configured to avoid insertion and/or clogging of the bore of needle 130 by material of SNE 140.

[0023] Reference is now made to FIG. 3. Syringe device 100 is configured and/or adapted such suitable operation thereof causes longitudinal displacement of distal needle edge 133 towards injection site 160, as well as insertion of needle 130 into injection site 160. Correspondingly, instantaneously after the perforation of distal SNE end 141, needle 130 may engage with the substance transfer site by, e.g., hypodermically introducing the needle into the body. After suitable engagement of the needle with the substance transfer site, operation of the syringe device may be initiated for, e.g., withdrawing a substance from the body, into the syringe device and/or, e.g., for transferring substance from the syringe into the body. [0024] It should be noted that the user of syringe device 100 may be embodied by, for example, a patient, healthcare personnel (e.g., a nurse, a physician) and the like. [0025] It should be noted that the syringe device may be embodied by mechanisms as known in the art and/or by syringe devices that are not yet known in the art.

[0026] According to some embodiments of the invention, SNE 140 enclosing needle 130 is adapted and/or disposed alone to pierce the SNE when needle 130 is penetrating a body via, e.g., liquid transfer site 160.

[0027] In some embodiments of the invention, NUM may be a part of an automjector and/or a needle cartridge.

[0028] While the invention has been described with respect to a limited number of embodiments, these should not be construed as limitations on the scope of the invention, but ^■ rather as exemplifications of some of the embodiments. Those skilled in the art will envision other possible variations, modifications, and programs that are also within the scope of the invention. Accordingly, the scope of the invention should not be limited by what has thus far been described, but by the appended claims and their legal equivalents. Therefore, it is to be understood that alternatives, modifications, and variations of the present invention are to be construed as being within the scope and spirit of the appended claims.

Claims

CLAIMSWhat is claimed is:

1. A sterile¹ needle envelope (SNE) enclosing a sharp ended needle wherein said needle is adapted and disposed to pierce said envelope whilst said needle is penetrating the body of the patient.

2. The SNE according to claim 1, further wherein said SNE further comprises means for directly connecting said needle to an external liquid reservoir (ELR).

3. The SNE according to claim 1, further wherein said SNE further comprises means for indirectly connecting said needle to an external liquid reservoir (ELR).

4. The SNE according to claim 1 wherein said envelope is made at least in part from an essentially flexible material, said material selected from the group consisting of rubber, latex, plastic, synthetic material, metal, glass, glass-like material, plexiglass, rubber, rubber-like material and any composition thereof.

5. The SNE according to claim 1, wherein said SNE further comprises means for directly connecting said needle to external needle urging means (NUM).

6. The SNE according to claim 1, wherein said SNE further comprises means for directly connecting said needle to external needle urging means (NUM).

7. The SNE according to claim 1, wherein said SNE further comprises means for connecting said needle to external reciprocating needle injecting means.

8. The SNE according to' "claim" I; wherein said needle has a bore¹ of about 0.1mm. to about 0.3 mm.

9. The SNE according to claim 1, wherein said needle has a bore of about 10 microns to about 500 microns

10. The SNE according to claim 1, wherein at least a section of a distal portion of said SNE is at least one of the following: frangible, perforatable, and pierceable.

11. The SNE according to claim - 10, wherein, said section is frangible, perforatable and pierceable in a predetermined manner.

12. . The SNE according to claim 1, wherein a distal end of said needle is adapted so as to prevent blocking by envelope fragments and debris during said piercing of said SNE by said needle.

13. . The SNE of claim5, wherein said NUM is part of an autoinjector.

14. The SNE of claim 5, wherein said NUM is part of a needle cartridge.

15. The SNE of claim 5, wherein said NUM is part of a standard hypodermic syringe.

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