# US 10,709,848 B2 · Segmented safety cover for needle delivery

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- Number: US 10,709,848 B2
- Document ID: US10709848B2
- Status: Granted
- Kind: B2
- Application number: 15/432,816
- Filed: 2017-02-14
- Published: 2017-10-05
- Granted: 2020-07-14
- Earliest claimed: 2016-04-01
- Applicants: Henry Wickham
- Inventors: Henry Wickham
- Web page: https://patentgrep.com/patent/US10709848B2

## CPC

- A61M 5/3245: {Constructional features thereof, e.g. to improve manipulation or functioning}
- A61B 5/15003: {for venous or arterial blood}
- A61B 5/150389: {Hollow piercing elements, e.g. canulas, needles, for piercing the skin}
- A61B 5/150519: {Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device}
- A61B 5/150656: {semi-automatically triggered, i.e. in which the triggering of the protective sleeve requires a deliberate action by the user, e.g. manual release of spring-biased extension means}
- A61B 5/150839: {Aesthetic features, e.g. distraction means to prevent fears of child patients}
- A61B 5/153: {Devices} specially adapted for taking samples of venous or arterial blood, e.g. with syringes
- A61B 10/02: Instruments for taking cell samples or for biopsy {(A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48)}
- A61B 10/0233: {Pointed or sharp biopsy instruments}
- A61M 5/3204: {Needle cap removers, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices}
- A61M 5/3216: {Caps placed transversally onto the needle, e.g. pivotally attached to the needle base}
- A61M 5/326: {Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user}
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A segmented safety cover may include a proximal segment combined with a needle hub; a needle cannula that extends from the proximal needle hub to a distal sharpened end; a distal end cap with a hollow bore through which the needle cannula passes; a centrally mounted toggle locking mechanism, separating the proximal needle hub from the distal end cap; the toggle locking mechanism is torsion spring assisted; a proximal cover segment is connected to the hub via a proximal hinge and a distal cover segment is connected to the end cap via a distal hinge; said proximal cover segment and said distal cover segment of said toggle locking mechanism being configured with abutting faces when the segmented safety cover is in a safety mode; and wherein the proximal hinge, abutting faces and distal hinge are in line in the safe mode.

## Claims

### Claim 1

A segmented safety cover comprising: a) a proximal segment combined with a needle hub; b) a needle cannula that extends from the proximal needle hub to a distal sharpened end; c) a distal end cap with a hollow bore through which the needle cannula passes; d) a centrally mounted toggle locking mechanism, separating the proximal needle hub from the distal end cap, hingedly connected to both and maintaining the segmented safety cover in a position where it completely covers a needle tip on a needle; e) wherein the toggle locking mechanism is resistively bias-assisted and comprises a proximal cover segment and a distal cover segment which overlay the needle cannula and is linked together through a central hinge; f) said proximal cover segment and said distal cover segment of said toggle locking mechanism being configured with abutting faces that contact each other above said central hinge when the segmented safety cover is in a safety mode; g) wherein the proximal cover segment is connected to the hub via a proximal hinge and the distal cover segment is connected to the end cap via a distal hinge; and h) wherein the proximal hinge, abutting faces and distal hinge are in line and the central hinge is below the abutting faces in the safety mode so that a force exerted on the distal end cap is translated onto the abutting faces above the central hinge thereby maintaining the device in a secured state wherein the segmented safety cover is in a position where it completely covers the needle tip, while maintaining the distal end cap's position covering the needle tip extending through the needle cannula.

### Claim 2 (depends on 1)

The segmented safety cover of claim 1 wherein the needle is present within the cover, and the segmented safety cover is configured so that the pointed injection end of the needle is completely covered by the distal end cap when the torsion spring is secured in the safety mode, and the pointed injection end of the needle is exposed from the distal end cap when the safety mode is removed and compressive force has been applied by the torsion spring, retracting the distal end cap by rotation of both the proximal cover segment and the distal cover segment about the central hinge.

### Claim 3 (depends on 1)

The segmented safety cover of claim 1 wherein the proximal hinge, distal hinge and central hinge are configured to form a triangular configuration when the segmented safety cover is in a delivery mode for the needle within the needle cannula, and the distal cover segment and the distal end cap are configured to slide with respect to the needle cannula within the hollow bore, and wherein the abutting faces rotate away from each other, as the central hinge is elevated with top portions of the abutting faces having rotated with the central hinge farther away from each other than do lower portions of the abutting faces, when a force parallel to a plane formed between the abutting faces is applied upwardly towards the abutting faces.

### Claim 4 (depends on 3)

The segmented safety cap of claim 3 wherein upon forming the triangular configuration, the distal end cap is configured to retract over the needle cannula and towards the needle hub, and relative to the distal cover, appears to rotate away from the distal cover segment and expose the injection end of the needle.

### Claim 5 (depends on 3)

The segmented safety cover of claim 3 wherein the torsion spring comprises a double coil spring with a first extension of the double coil spring extending approximately parallel to the distal segment in the safety mode, and a second extension of the double coil spring extending approximately parallel to the proximal segment in the safety mode.

### Claim 6 (depends on 3)

The segmented safety cover of claim 3 wherein in the safety mode, the distal cover segment and proximal cover segment are in the secured state, resisting movement of the distal cover segment and the proximal cover segment by the torsion spring.

### Claim 7 (depends on 6)

The segmented safety cover of claim 6 wherein two manually operated pressure plates that overlap sides of the distal cover segment and the proximal cover segment are configured to dislocate the secured state when pressure is applied to the two pressure plates to apply a dislocating force vector approximately parallel to the two abutting faces and cause the two abutting faces to rotate away from each other to end the safety mode.

### Claim 8 (depends on 7)

The segmented safety cover of claim 7 where said pressure plates are resiliently biased to disengage from a dislocated mode to return to the secured state and a ready mode when triggered by said distal end cap when the distal end cap pushes against a patient's skin during the injection procedure, where said dislocated pressure plates release the segmented safety cover to return to its secured state as the needle is withdrawn from the patient.

### Claim 9 (depends on 1)

The segmented safety cover of claim 1 wherein the torsion spring comprises a double coil spring with a first extension of the double coil spring extending approximately parallel to the distal segment in the safety mode, and a second extension of the double coil spring extending approximately parallel to the proximal segment in the safety mode.

### Claim 10

A segmented safety cover comprising: a) a proximal segment combined with a needle hub; b) a needle cannula that extends from the proximal needle hub to a distal sharpened end; c) a distal end cap with a hollow bore through which the needle cannula passes; d) a centrally mounted toggle locking mechanism, separating the proximal needle hub from the distal end cap, hingedly connected to both and maintaining the segmented safety cover in a position where it completely covers a needle tip on a needle; e) wherein the toggle locking mechanism is resistively bias-assisted and comprises a proximal cover segment and a distal cover segment which overlay the needle cannula and is linked together through a central hinge; f) said proximal cover segment and said distal cover segment of said toggle locking mechanism being configured with abutting faces that contact each other above said central hinge when the segmented safety cover is in a safety mode; g) wherein the proximal cover segment is connected to the hub via a proximal hinge and the distal cover segment is connected to the end cap via a distal hinge; and h) wherein the proximal hinge, abutting faces and distal hinge are in line and the central hinge is below the abutting faces in the safety mode so that a force exerted on the distal end cap is translated onto the abutting faces above the central hinge thereby maintaining the device in a secured state wherein the segmented safety cover is in a position where it completely covers the needle tip, while maintaining the distal end cap's position covering the needle tip extending through the needle cannula, wherein the torsion spring comprises a double coil spring with a first extension of the double coil spring extending approximately parallel to the distal segment in the safety mode, and a second extension of the double coil spring extending approximately parallel to the proximal segment in the safety mode, wherein a first one coil of the double coil spring is on a first side of the cannula shaft and a second one coil of the double coil spring is on a second and opposite side of the cannula shaft with respect to the first coil.

### Claim 11 (depends on 3)

A method for enabling injection of fluids using the segmented safety cover with a needle present within the cover of claim 3 comprising applying force to both the proximal cover segment and the distal cover segment from the torsion spring to elevate the central hinge and retract the distal end cap to slide over the needle cannula to expose the needle tip; wherein the proximal hinge, distal hinge and central hinge are arranged in the form of an inverted triangle formed by a line connecting said proximal and said distal hinges that lies parallel to the needle cannula and said central hinge defining a vertex of the inverted triangle below said proximal and distal hinges, and an exposure position for the needle tip is created only when the central hinge is elevated above the line connecting said proximal and said distal hinges from the position of the central hinge as the vertex of the inverted triangle.

### Claim 12

A segmented safety cover comprising: a) a proximal segment fixed with a needle hub, said proximal segment also being integrated with a blood collecting needle; b) a distal end cap with a hollow bore that covers a needle tip on the blood collecting needle through which said needle cannula may pass; c) a rigidly interlocked, torsion spring assisted centrally hinged toggle locking mechanism that covers the needle cannula, where said center segment comprises a hollow proximal cover segment and distal hollow cover segment linked through a central hinge; d) wherein said proximal cover segment and distal cover segment are configured with two vertical, contacting and abutting faces above said central hinge; e) wherein a proximal cover segment of said central toggle locking mechanism is hingedly connected to said proximal segment by a proximal hinge and said distal cover segment of said central toggle locking mechanism is hingedly connected to said distal end cap by a distal hinge; f) wherein the proximal hinge, distal hinge and central hinge are arranged in the form of an inverted triangle formed by a line connecting said proximal and said distal hinges that lies parallel to the cannula shaft and said central hinge defining a vertex of the inverted triangle below said proximal and distal hinges; and g) wherein an exposure position for a needle from within the cannula shaft is created only when the central hinge is elevated above the line connecting said proximal and said distal hinges from the position of the central hinge as the vertex of the inverted triangle; wherein, when the two vertical abutting faces are in a safety mode abutting each other, a vector force passing through the central hinge towards the abutting faces, the vector forces causes the central hinge to elevate and rotate and the abutting faces to rotate away from each other.

### Claim 13 (depends on 12)

The segmented safety cover according to claim 12 wherein said central toggle locking mechanism includes a resiliently biased wedge mechanism which is configured to be pressure activated to arrest said toggle locking mechanism in a temporary dislocated position to enable exposure of said cannula tip prior to the invasive procedure.

### Claim 14 (depends on 13)

The segmented safety cover according to claim 13 wherein said wedge mechanism comprises a resiliently biased wedge extension mounted on the distal cover segment or proximal cover segment, and the spring-loaded wedge is located above the center hinge.

### Claim 15 (depends on 14)

The segmented safety cap of claim 14 wherein said wedge is configured to be clamped into a wedged-in position by spring force generated by the torsion spring, and wherein the wedge is configured to be resiliently biased to disengage from a wedged-in position when pressure applied by the torsion spring is reduced when said distal end cap pushes against a patient's skin.

### Claim 16 (depends on 15)

The segmented safety cover of claim 15 where said torsion spring is centred to and fitted on an inside of said centre hinge and comprises single or double coil loops on one or either side of the needle that allows the center hinge to be lowered past said needle cannula without interference by said needle cannula.

### Claim 17 (depends on 15)

The segmented safety cap of claim 15 wherein said resiliently biased wedge is integrated into a latch disk with single or multiple recess features on an inside face of the latch disk and a locking face on the wedge that allows it to wedge into or against a locking face on the proximal cover segment or distal cover segment when the wedge is pressure activated.