# US 2013/0158475 A1 · Devices for Delivering a Medicament and Connector for Same

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- Number: US 2013/0158475 A1
- Document ID: US20130158475A1
- Status: Published application
- Kind: A1
- Application number: 13/709,872
- Filed: 2012-12-10
- Published: 2013-06-20
- Earliest claimed: 2008-08-01
- Assignees: Tian Xia
- Inventors: Tian Xia; Aaron L. Hirschmann
- Web page: https://patentgrep.com/patent/US20130158475A1

## CPC

- A61M 39/1011: {Locking means for securing connection; Additional tamper safeties (A61M39/16 takes precedence)}
- A61M 5/178: Syringes
- A61M 11/06: of the injector type
- A61M 15/08: Inhaling devices inserted into the nose
- A61M 15/085: {Fixing means therefor}
- A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008})
- A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)}
- A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 2202/0468: non-physiological
- A61M 2202/048: Anaesthetics
- A61M 2202/064: Powder
- A61M 2209/06: Packaging for specific medical equipment
- A61M 2210/0618: Nose
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A method and device for delivering medicament such as for ameliorating pain in a patient from an injector superiorly and/or laterally and/or anteriorly towards the sphenopalatine ganglion (SPG). A device for delivering a medicament to a patient in need thereof includes (a) an injector containing a first end configured to remain outside a nasal passage of the patient and a second end configured for entry into the nasal passage of the patient; and (b) an introducer configured for engagement with a nostril of the patient and containing a passageway configured for slidably receiving the injector. The injector is moveable between a storage position preceding the engagement and an engaging position pursuant to the engagement. The device may further include a locking connection assembly that is useful in other devices.

## Claims

### Claim 1

A connector interface comprising:
a first luer-lock element including a notch;
a second luer-lock element including a tooth that engages the notch and, when engaged, prevents disengagement of the second luer-lock element from the first luer-lock element.

### Claim 2 (depends on 1)

The connector interface of claim 1 where the notch includes a first face at an acute angle relative to a plane defined by the first end and a second face at substantially a perpendicular angle relative to said plane.

### Claim 3 (depends on 1)

The connector interface of claim 1, where the first luer-lock element and the second luer-lock element cannot be disengaged without damaging the first luer-lock element, the second luer-lock element, or both.

### Claim 4

A connector interface configured for substantially permanent use or single use, the interface comprising:
an inner connection configured as a two-element luer-lock including a tabbed hub of a female fitting element that rotatingly engages into threads within a sleeve of a male fitting element;
where the sleeve includes a notched cylinder end, including at least two notches;
where a base portion of the female fitting element includes at least two teeth that rotate engage lockingly into the at least two notches when the tabbed hub is fully engaged with the threads;
where the notches include a first face at an acute angle relative to a plane defined by the cylinder end and a second face at substantially a perpendicular angle relative to said plane; and
where counter-rotation brings the teeth into locking contact with the second face of the notches that effectively stops counter-rotation.

### Claim 5 (depends on 4)

The connector interface of claim 4, where counter-rotation force sufficient to overcome the locking contact deforms, breaks, or otherwise damages at least one of the teeth, the notches, or both.

### Claim 6 (depends on 4)

A medical device comprising a syringe and an injector coupled lockingly together by the connector interface of claim 4.

### Claim 7

A connector interface comprising:
a first connector element and a second connector element;
wherein the first connector element includes
a first cylindrical female portion disposed coaxially around
a first cylindrical male engaging portion, and
a first engaging end defined by corresponding termini of the first cylindrical male portion and the first cylindrical female portion;
wherein the second connector element includes
a second cylindrical female portion that engagingly receives therein the first male portion,
the second cylindrical female portion circumferentially defined by a second cylindrical male portion that engages into the first female portion, and
a second engaging end defined by a co-terminus of the second cylindrical male portion and the second cylindrical female portion;
wherein the first male portion is circumferentially coaxially encompassed by the first female portion;
wherein the first female portion includes at least one inward-facing helically threaded surface that is complementary to and that engagingly receives at least one tab radially protruding externally from the second male portion; and
wherein an external surface of the second male portion includes a first plurality of generally longitudinal teeth opposite the second engaging end, and the first engaging end includes a second plurality of notches complementary to and that lockingly receive an end portion of the first plurality of longitudinal teeth when the at least one tab is fully engaged with the at least one inward-facing helically threaded surface;
wherein the at least one tab, the at least one inward-facing helically threaded surface, the first engaging end, the second engaging end, and the longitudinal teeth are dimensioned and longitudinally spaced relative to each other such that substantially complete engagement between the first connector element and second connector element forms an effective fluid-patent seal and forms a locked relationship between the at least one plurality of notches and the notches.

### Claim 8 (depends on 7)

The connector interface of claim 7, wherein at least one of the first connector element and the second connector element comprises polymer construction configured such that, after a complete locking engagement of the teeth with the notches by rotational engagement of the at least one inward-facing threaded surface with the at least one tab, counter-rotational disengagement of the teeth from the notches damages at least one of the teeth and/or notches in a manner effectively compromising any future locking engagement thereof.

### Claim 9 (depends on 8)

The connector interface of claim 8, wherein the polymer construction comprises a polycarbonate.

### Claim 10 (depends on 7)

The connector interface of claim 7, wherein the first connector element is comprised by a syringe and the second connector element is comprised by an injector associated with a first end region of an introducer, where the introducer first end region is configured to remain outside a patient's nasal passage, a second end region of the introducer is configured to engage a short distance into the nasal passage, and an extendible injector portion is configured to extend actuatably through and beyond the introducer second end region to access the patient's sphenopalatine ganglion region.

### Claim 11 (depends on 7)

The connector interface of claim 7, wherein at least one of the plurality of notches includes a surface that is angled relative to a central longitudinal axis of the connector interface, wherein a contact of the angled surface with a corresponding tooth, during rotation in an engagement direction, biases the first connector element away from the second connector element in a manner biasing the threaded surface with the at least one tab.

### Claim 12 (depends on 7)

The connector interface of claim 7, wherein the first male engaging portion comprises a tapered configuration including a smaller outer diameter near the engaging end and a larger outer diameter longitudinally spaced from the engaging end.

### Claim 13 (depends on 12)

The connector interface of claim 12, where the larger outer diameter engages an inner diameter of the second female portion to form at least part of the effective fluid-patent seal.

### Claim 14 (depends on 7)

The connector interface of claim 7, where the first connector element is comprised by one of an injector and a syringe, and the second connector element is comprised by the other of the injector and the syringe.

### Claim 15 (depends on 7)

The connector interface of claim 7, where the second cylindrical female portion comprises a conically tapered inner diameter surface that is largest at or near the second engaging end.

### Claim 16 (depends on 7)

The connector interface of claim 7, where engagement of the teeth and notches provides tactile and/or audio feedback to confirm complete engagement therebetween.

### Claim 17 (depends on 7)

The connector interface of claim 7, wherein the first connector element and the second connector element are configured as luer lock components complying with ISO standards 594-1 and 594-2.

### Claim 18

A device configured for fluid delivery via a patient nostril, the device comprising:
an introducer and an injector;
the injector including:
an elongate injector tube defining a central longitudinal axis and including a channel-engaging lateral projection near a first injector end, and
at least one injector tube aperture near a second injector end, the second injector end disposed longitudinally opposite the first injector end;
the introducer including:
a first introducer end;
a second introducer end longitudinally opposite the first introducer end;
a generally cylindrical elongate body wall defining a longitudinal, generally cylindrical, lumen that extends between the first introducer end and the second introducer end;
wherein the lumen includes at least two longitudinal channels parallel to each other, the channels forming a depressed track along a lumen-facing body wall surface;
where the longitudinal channels merge to form a single channel near the first end such that the complete channel forms a generally goalpost-shaped, U-shaped or Y-shaped configuration; and
where the injector tube aperture is disposed at a first radial angle relative to the longitudinal axis when the channel-engaging projection is in one of the at least two longitudinal channels, and is disposed at a second radial angle relative to the longitudinal axis when the channel-engaging projection is in another of the at least two longitudinal channels, where the first and second radial angles correspond the angle required for a spray path access to a patient's sphenopalatine ganglion region from, respectively, that patient's right and left nostrils, and where the injector tube, projection, and channels are longitudinally dimensioned to extend and orient the aperture toward that region.

### Claim 19 (depends on 18)

The device of claim 18, where the channel-engaging lateral projection includes a structural region configured to bend or break under a predetermined force, such that application of said force diminishes a channel-engaging effectiveness of the projection.

### Claim 20 (depends on 18)

The device of claim 18, where the first injector end comprises:
mating luer lock components complying with ISO standards 594-1 and 594-2; and
a tooth-and-notch locking structure comprised by complementary circumferential end surfaces of the luer lock components;
where the first predetermined force corresponds to an unlocking force required to rotationally disengage the additional tooth-and-notch locking structure when fully engaged.

### Claim 21 (depends on 18)

The device of claim 18, comprising at least one means for limiting the device to a single effective use.

### Claim 22 (depends on 18)

The device of claim 18, where the second injector end is closed and the aperture is coplanar with, and oriented at a non-perpendicular angle relative to, the central longitudinal axis.

### Claim 23 (depends on 22)

The device of claim 22, where the aperture has a diameter of about 0.01 inches (about 0.25 mm) and the non-perpendicular angle is between about 30° and about 60°.

### Claim 24 (depends on 18)

The device of claim 18, further comprising a syringe engaged to the first injector end.

### Claim 25 (depends on 24)

The device of claim 24, where the syringe includes a barrel and a locking plunger, said plunger including flexible side detents that locking engage an inner surface of the barrel when the plunger is advanced within the barrel.

### Claim 26

A device for delivering a medicament to a patient in need thereof, the device having:
an injector comprising a first end configured to remain outside a patient's nasal passage and a second end configured for entry into the patient's nasal passage; and an introducer configured for engagement into a nostril of the patient and comprising a passageway configured for receiving the injector;
wherein the injector is moveable—relative to the introducer—between a storage position preceding the engagement and an engaging position pursuant to the engagement, where said engagement position is different from the storage position as the injector is extended outward from the introducer; and
wherein the engaging position is configured such that the second end of the injector is situated medial and/or posterior and/or inferior to a sphenopalatine ganglion of a patient;
wherein the second end of the injector comprises one or a plurality of apertures configured for dispersing a medicament superiorly and/or laterally and/or anteriorly towards the sphenopalatine ganglion; and
wherein the injector comprises a channel that extends from the first end to the one or a plurality of apertures at the second end and that is configured to receive a medicament and to communicate the medicament to the one or a plurality of apertures; and
wherein the improvement comprises:
the introducer passageway further including at least two longitudinal channels that are generally parallel to each other, the channels forming a depressed track along a passageway-facing body wall surface, where the longitudinal channels merge to form a single channel near the first end such that the complete channel forms a generally goalpost-shaped, U-shaped or Y-shaped configuration;
the injector further comprising a channel-engaging lateral projection near a first injector end, said projection engaged selectably into the channels such that orientation of the projection into a second end of either of the longitudinal channels, opposite the first end, corresponds to the engaging position.
