GB2556903A

GB2556903A - Positioning device and method

Info

Publication number: GB2556903A
Application number: GB1619904.4A
Authority: GB
Inventors: Golo Evans Sam; Fitzsimons Duncan
Original assignee: SALAR SURGICAL Ltd
Current assignee: SALAR SURGICAL Ltd
Priority date: 2016-11-24
Filing date: 2016-11-24
Publication date: 2018-06-13
Also published as: GB201619904D0

Abstract

A positioning device for use with a hypodermic needle. The positioning device 10 comprises a connector 42 for connecting to a hypodermic needle 40, a sheath 18 comprising a central region configured to accommodate a shaft of a hypodermic needle along its longitudinal axis and a convex or planar contact surface 20 for positioning on an injection site. A deformable link 16 may connect the sheath to the connector. The deformable link 16 may be a bow spring, compression spring or leaf spring. The contact surface 20 may be frusto-conical or part-spherical, and may be symmetrical about the longitudinal axis; the surface 20 may be planar at an angle to the axis. Also claimed is a method of use wherein the contact surface is placed against the skin and pressing downwards upon the syringe to expose the needle.

Description

(71) Applicant(s):

Salar Surgical ltd

Oldfield Road, Pencoed, Bridgend, Mid Glamorgan, CF35 5LJ, United Kingdom (72) Inventor(s):

Sam Golo Evans Duncan Fitzsimons

(51) INT CL: A61M 5/32 (2006.01)
(56) Documents Cited:
GB 2529390 A	GB 2321014 A
GB 2252046 A	WO 2015/062845	A1
WO 2010/126432 A1	WO 2009/140529	A2
US 5250031 A US 20030149404 A1 (58) Field of Search: INT CLA61M Other: EPODOC & WPI	US 2876770 A

(74) Agent and/or Address for Service:

Greaves Brewster LLP

Copa House, Station Road, CHEDDAR, Somerset, BS27 3AH, United Kingdom (54) Title ofthe Invention: Positioning device and method Abstract Title: Syringe Positioning device and method (57) A positioning device for use with a hypodermic needle. The positioning device 10 comprises a connector 42 for connecting to a hypodermic needle 40, a sheath 18 comprising a central region configured to accommodate a shaft of a hypodermic needle along its longitudinal axis and a convex or planar contact surface 20 for positioning on an injection site. A deformable link 16 may connect the sheath to the connector. The deformable link 16 may be a bow spring, compression spring or leaf spring. The contact surface 20 may be frusto-conical or part-spherical, and may be symmetrical about the longitudinal axis; the surface 20 may be planar at an angle to the axis. Also claimed is a method of use wherein the contact surface is placed against the skin and pressing downwards upon the syringe to expose the needle.

Fig. 2

At least one drawing originally filed was informal and the print reproduced here is taken from a later filed formal copy.

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Positioning device and method

TECHNICAL FIELD

This invention relates to a device and method for positioning a hypodermic needle.

BACKGROUND

Hypodermic needles are used to inject therapeutic agents into or to remove fluids from a body, particularly a human or animal body. In some applications, it is desirable to control both the length of hypodermic needle which is inserted into the body and also the angle of the hypodermic needle with respect to the surface of the body. Examples of where the depth and angle of the hypodermic needle are important include most general and specialist injections - including immunisations & vaccinations, administration of biologic therapies, intralesional drug delivery, administration of insulin and anti-coagulants, botulinim toxin and dental injections. Conventionally practitioner skill is used to control the depth and angle of the hypodermic needle.

WO2015/075430 discloses a positioning system for a hypodermic needle, particularly relating to a guidance system for injecting therapeutic agents into an eye.

SUMMARY OF THE INVENTION

An aspect of the present invention provides a positioning device for a hypodermic needle, comprising:

a sheath comprising a central region configured to accommodate a shaft of a hypodermic needle and a contact surface for positioning on an injection site;

a connection for connecting the sheath for relative movement with the hypodermic needle;

wherein the contact surface comprises at least one planar and/or convex surface.

The connection may comprise comprises a connector for connecting to a hypodermic needle and a deformable link connecting the sheath to the connector.

The at least one planar and/or convex surface may be placed on the injection site to thereby controls the angle of the hypodermic needle relative to the surface of the injection site.

The angle between the at least one planar and/or convex surface of the contact surface and the longitudinal axis may be in the region of 0° to 90°, or 30° to 80°, 30° to 70°, or 30° to 60°, or 30° to 50°, or 30° to 40°, or 80° to 90°, or 40° to 70°, or 50° to 70°, or 60° to 70°. The angle between the at least one planar and/or convex surface of the contact surface and the longitudinal axis may be in the region of 3° to 15°, or 5° to 15°, or 3° to 10°,

The contact surface may be symmetrical about the longitudinal axis.

In one embodiment, the contact surface has a frusto-conical shape. The angle between the side of the frusto-conical surface and the longitudinal axis is in the region of 5° to 65°, or 10° to 65°, or 20° to 65°, or 30° to 65°, or 40° to 65°, or 50° to 65°, or 3° to 10°, or 5° to 10°, or 10° to 50°, or 10° to 40°, or 10° to 30°, or 10° to 20°.

The contact surface may comprise a convex shape, which may be symmetrical about the longitudinal axis. The contact surface may comprise a continuous convex shape. For example, the contact surface may have a part-spherical shape.

The contact surface may have a substantially planar surface. A substantially planar surface is includes a surface with a slight curve but which in use acts as a planar surface by lying flat on a surface. The angle between the planar surface and the longitudinal axis may be in the range of 30° to 90°. In one embodiment, the angle between the planar surface and the longitudinal axis is substantially 90°, for example 85° to 95°. In another embodiment, the angle between the planar surface and the longitudinal axis is in the range of 30° to 80°, for example 30° to 70°, or 30° to 60°, or 30° to 50°, or 30° to 40°, or 40° to 80°, 50° to 80°, or 60° to 80°, or 70° to 80°.

The width of the planar surface of the contact surface may be between 7-22mm, for example 10-22mm. The planar surface may have a circular cross section although other shapes may be used. Alternative cross sections include oval, hexagonal, square etc.

In one embodiment the height of the contact surface along the longitudinal axis is in the range of 10-15mm. This height of the contact surface ensures that the deformable link is spaced from the injection site to avoid any obstruction. For example, this is particularly suitable for dental applications.

The contact surface may have a smooth or textured surface finish. A textured surface finish may, for example, comprise one or more protrusions or dimples on the surface. A textured surface finish may improve comfort for the patient and/or improve grip.

The contact surface may comprise an integral part of the sheath or may be a separate component attached to the sheath. For example, the contact surface may be part of a tip component which is connected to the sheath, for example by a friction fit or adhesive.

The contact surface may comprise a relatively hard or soft surface, selected to best suit the medical application. For example a relatively soft surface can be achieved using a thermoplastic elastomer (TPE), such as Mediprene™, and a relatively hard surface can be achieved using an engineering thermoplastic, such as polyoxymethylene (POM), for example Hostaform™.

The sheath may be moveable between a first position in which, in use, the sheath covers the tip of the hypodermic needle and a second position in which, in use, a defined length of hypodermic needle is exposed. The first position may comprise the passive state of the positioning device, i.e. when no force is applied to the deformable link.

The device can be tailored to different length hypodermic needles by selecting the length of sheath and or deformable link to match the length of hypodermic needle.

The deformable link may be elastically deformable, for example it may comprise a spring. In one embodiment the deformable link comprises a bow spring. The bow spring may comprise a medically approved TPE, such as Mediprene™. Alternative deformable links may be used, for example a compression spring, a leaf spring or a coil spring.

The connector may comprise a connecting hub. The connecting hub may have the size and shape to, in use, fit over a hub of a hypodermic needle. The connecting hub may be conical or frustoconical. The connecting hub may attach to the hub of the hypodermic needle by a friction fit. In one embodiment, the connecting hub is clipped to the hub of the hypodermic needle. In another embodiment, the connecting hub may have grooves to allow the secure fitting of ridges commonly found on hypodermic needles. In another embodiment the connecting hub may be bonded to the hypodermic needle hub. In another embodiment, the hub of the device is manufactured to be an integral part of the hub of the needle. The connecting hub may have a central aperture through which, in use, the needle shaft of the hypodermic needle passes. The connecting hub may be made from plastics material. The term hub of a hypodermic needle means the part of a hypodermic needle for connecting to a syringe, for example a Luer connector or push connection. Alternatively, the connector may comprise an integral part of the hypodermic needle.

The device may further comprise a locking device, which locks the sheath over the hypodermic needle after use. In an embodiment, the locking mechanism comprises a recess in the sheath, wherein in an unlocked position the needle passes through a channel in the sheath and in a locked position, the needle rests in the recess. In the unlocked position the needle tip is covered by the sheath, but may be exposed by depressing the contact surface of the sheath against the surface to be injected, moving the sheath relative to the needle by displacement of the deformable link. The sheath may comprise a channel, an inner wall and an outer wall and wherein the locking device comprises a recess defined between the inner wall and outer wall. The device may be put into the locking position by manipulating the deformable link to increase the distance between the connector and sheath. Manipulating the deformable link in this way will disengage the hypodermic needle from the channel. The needle tip will then be disengaged from the opening of the channel. When the deformable link is then released, the needle tip will be trapped in the recess. The link will remain visibly deformed to demonstrate the locked needle. The outer surface of the inner wall may taper outwards from its upper surface. This shape will encourage the hypodermic needle to enter the recess.

An aspect ofthe present invention provides a hypodermic needle comprising a hub, a needle shaft and a positioning device according to aspects of this invention.

A further aspect of the present invention provides a method of positioning a syringe with hypodermic needle for delivery of the contents of the syringe to a body or the removal of samples from a body using the positioning device according aspects of this invention, the method comprising the steps of:

placing the contact surface of the sheath onto the surface of the body, so that the planar or convex surface is positioned on the surface of the body;

pushing the syringe downwards so that the sheath is displaced against the deformable link to thereby expose the tip of the hypodermic needle which penetrates the body.

A further aspect of the invention comprises a positioning device for use with a hypodermic needle, the positioning device comprising:

a connector for connecting to a hypodermic needle;

a sheath comprising a central region configured to accommodate a shaft of a hypodermic needle along its longitudinal axis and a contact surface for positioning on an injection site;

a deformable link connecting the sheath to the connector;

wherein the contact surface has at least one planar and/or convex surface.

A further aspect of the invention provides a positioning device for a hypodermic needle, comprising:

a sheath comprising a central region configured to accommodate a shaft of a hypodermic needle along its longitudinal axis and a contact surface for positioning on an injection site.

Throughout the description and claims of this specification, the words “comprise” and “contain” and variations of the words, for example “comprising” and “comprises”, mean “including but not limited to”, and do not exclude other components, integers or steps. Moreover the singular encompasses the plural unless the context otherwise requires: in particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.

Preferred features of each aspect of the invention may be as described in connection with any of the other aspects. Within the scope of this application it is expressly intended that the various aspects, embodiments, examples and alternatives set out in the preceding paragraphs, in the claims and/or in the following description and drawings, and in particular the individual features thereof, may be taken independently or in any combination. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination, unless such features are incompatible.

BRIEF DESCRIPTION OF THE DRAWINGS

One or more embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

Figures 1A to 1D shows front, side top and bottom views of a positioning device according to a first embodiment;

Figure 1E shows a cross sectional view of the positioning device of Fig 1B along line B-B. Figure 1F shows a front view of the positioning device of Fig 1A in a retracted position;

Figure 2 shows the positioning device of Figures 1A-1F mounted on a syringe and hypodermic needle;

Figures 3A to 3D show embodiments of the positioning device having a conical sheath, mushroom sheath, ball sheath and disc sheath respectively;

Figures 4A and 4B show front and side view of an embodiment of the positioning device having a large disc sheath;

Figures 5A and 5B show front and side views of an embodiment of the positioning device having a sheath angled at 45°;

Figure 6A is a front view of an embodiment of the positioning device with a long sheath; Figure 6B is a cross sectional view ofthe positioning device of Figure 6A along lines C-C; Figure 6C is a front view of the sheath of the positioning device of Figure 6A; and Figures 7A to 7C are front views showing three different embodiments of a sheath of a positioning device illustrating a smooth finish, protrusions on the surface and dimples on the surface respectively.

DETAILED DESCRIPTION

Figures 1A-1F illustrate different views of a first embodiment of the positioning device. The positioning device 10 is mounted on the hub of a hypodermic needle (shown in Figure 2).

The positioning device 10 comprises a connector 14 which is mountable onto a hypodermic needle hub, a deformable link 16 comprising a pair of bow springs, a sheath 18 and tip 20. The deformable link 16 connects the connector 14 to the sheath 18. Both the sheath 18 and tip 20 have a central opening configured to allow the needle shaft 22 of a hypodermic needle to pass through. The tip 20 has a contact surface 24 which, in use, contacts the body into which the hypodermic needle will penetrate.

Figures 1B and 1F show the positioning device in its passive and retracted positions respectively. As shown in Fig 1B, in the passive position, the bow springs 16 hold the sheath 18 and tip 20 in a position which covers the tip of the hypodermic needle 22, thereby providing sharps protection before the injection takes place. During an injection, the tip 20 is placed on the injection site and the syringe onto which the hypodermic needle and positioning device are mounted is pushed downwards. This downward force causes the bow springs 16 to deflect, so that the sheath 18 and tip 20 are pushed towards the connector 14, thereby allowing the needle shaft 2 to extend out of the tip 20 and penetrate the injection site; this position ofthe device is illustrated in Fig 1D. When the sheath 18 abuts the connector 14, the needle shaft 22 has penetrated the injection site to its full extent and the injection can take place.

The contact surface 24 of the tip 20 has a frusto-conical shape, with an opening angle of approximately 45°. The diameter of the widest section of the tip is approximately 7.8mm.

The conical shape of the sides of the contact surface enables the positioning device to be used to determine the angle of the injection. In use, the angled side of the contact surface 24 is placed on the injection, thereby determining the angle that the hypodermic needle penetrates the surface.

The positioning device thus allows both the angle of injection and the penetration depth to be controlled.

In addition to the sheath 18 covering the hypodermic needle during use, the positioning device has a further safety feature which locks the sheath over the tip of the hypodermic needle after use. The safety features is shown in more detail in the cross-sectional view of Fig 1C. The sheath 18 comprises a channel 26 formed by a central aperture, an outer wall 30, an inner wall 32 around the channel and a recess 34 defined between the inner and outer walls. The outer surface of the inner wall 30 is conical, with its smallest diameter at the top ofthe channel and tapering outwards. The outer wall 34 is cylindrical, thereby forming a circular recess being them.

The safety feature is activated by pressing on the bow springs 16 to push the sheath 18 away from connector 14, thereby disengaging the needle shaft 22 from channel 26. A slight transverse motion of the bow springs 16 pushes the needle shaft 22 into the recess 32. The tolerance between the channel and needle shaft is small and inner wall 30 forms a ridge between the recess 32 and the channel 26 making it difficult for the needle shaft to be accidently pushed back into the channel.

Figure 2 illustrates the positioning device 10 mounted on a hypodermic needle 42 and syringe 40.

Figures 3A-3D illustrate alternative embodiments of the invention, in which the frusto-conical tip is replaced with a tip of alternative shape.

Figure 3A shows a tip having a frusto-conical contact surface, as also illustrated in Figures 1A-1D. In this embodiment, the contact surface ofthe tip has a frusto-conical shape, with an opening angle of 45° and the diameter of the widest point of contact surface 7.8mm. In use, the angled surface tip is placed on the injection site, thereby setting the angle of the hypodermic needle relative to the surface of the injection site as 22.5°. This embodiment controls both the depth and angle of injection and is particularly useful in applications such as Botox injections. Although this embodiment gives an injection angle of 22.5°, injection angles up to +/-60° are possible by selecting tips of different dimensions.

Figure 3B shows a tip having a ‘mushroom’ shaped contact surface. The contact surface has a generally convex shape, with an opening angle of 77° and the diameter at the widest point of the contact surface of 11mm. This shape provides a wider surface contact between the tip and the patient’s skin, resulting in reduced pressure, a range of angles of injection which may be controlled by the user and improved performance on softer tissue (such as skin). The continuously convex shape enables a large range of injection angles to be selected using a single tip, up to a limit of approximately +/- 30°.

Figure 3C shows a tip having a part-spherical shaped contact surface. In this embodiment, the diameter at the widest part of the contact surface is 7mm.This provides a slightly larger contact surface than the conical tip of Figure 3A but a slightly reduced range of injection angles, for example +/- 45°. As with the embodiment of Figure 3B, the continuous convex surface allows a range of injection angles to be selected with a single tip.

Figure 3D shows a tip having a disc shaped contact surface. The disc has a diameter of 9.6mm and has either a planar or very slightly convex contact surface. The shape of the contact surface limits the injection angle to 90° to the surface of the skin. This is particularly useful for self-administered injections, for example into the stomach or leg.

Figures 4A and 4B illustrate an embodiment which is similar to Figure 3D but with a much larger disc diameter, in this case 16.5mm. The large tip gives very good control to ensure the needle penetrates at 90° to the skin/tissue surface.

Figures 5A and 5B illustrate an embodiment in which a tip has a disc shaped contact surface, which is angled at 45° to the hypodermic needle and the diameter of the contact surface is 20mm. This tip gives very good control over injections at 45°. The contact surface is provided with a textured surface to prevent slipping.

Figures 6A to 6C illustrate an embodiment which is particularly suitable for injections sites with difficult access, such as dental injections. The tip has a frusto-conical surface with the height of the contact surface (measured between highest and lowest points, along the longitudinal axis) of 14.2mm. This increased height of the tip prevents any obstruction between the bow springs and the injection site (e.g. teeth for dental applications).

Figures 7A to 7C illustrate different surface finishes of the contact surface of the tip. Features may be added to the contact surface to improve patient comfort, improve ease of location of the tip, prevent slipping or undesired movement and/or accommodate a specific injection site requirement. For example, Figure 7A shows a smooth finish, Figure 7B shows the contact surface being provided with protrusions for improved grip and Figure 7C illustrates the contact surface being provided with dimples for improved grip.

Claims

1. A positioning device for a hypodermic needle, comprising:

a sheath comprising a central region configured to accommodate a shaft of a hypodermic needle and a contact surface for positioning on an injection site; and a connection for connecting the sheath for relative movement with the hypodermic needle;

2. A positioning device according to claim 1, wherein the connection comprises: a connector for connecting to a hypodermic needle; and a deformable link connecting the sheath to the connector.

3. A positioning device according to any preceding claim, wherein the angle between the at least one planar and/or convex surface of the contact surface and the longitudinal axis of the sheath is in the region of 30° to 90°.

4. A positioning device according to any preceding claim, wherein the contact surface is symmetrical about the longitudinal axis.

5. A positioning device according to any preceding claim wherein the contact surface has a frusto-conical shape.

6. A positioning device according to claim 5, wherein the angle between the side of the frusto-conical surface and the longitudinal axis is in the region of 3° to 65°.

7. A positioning device according to any of claims 1 to 4, wherein the contact surface has a convex shape, which is symmetrical about the longitudinal axis.

8. A positioning device according to any of claims 1-5 and 7, wherein the contact surface has a part-spherical shape.

9. A positioning device according to any of claim 1 to 4, wherein the contact surface has a substantially planar surface and wherein the angle between the planar surface and longitudinal axis is in the range of 30° and 90°.

10. A positioning device according to claim 9, wherein the angle between the planar surface and the longitudinal axis is substantially 90°.

11. A positioning device according to claim 9, wherein the angle between the planar surface and the longitudinal axis is in the range of 30° to 80°.

12. A positioning device according to any of claims 9 to 11 wherein the width of the contact surface of the sheath is the range of 7 to 22mm.

13. A positioning device according to claim 12 the width of the contact surface of the sheath is in the range of 10 to 22mm.

14. A positioning device according to any preceding claim, wherein the distance of the height ofthe sheath along the longitudinal axis is in the range of 10-15mm.

15. A positioning device according to any preceding claim, wherein the contact surface has a smooth surface finish.

16. A positioning device according to any of claims 1 to 14 wherein the contact surface is provided with a textured surface.

17. A hypodermic needle comprising a hub, a needle shaft and a positioning device according to any of claims 1 to 16.

18. A method of positioning a syringe with hypodermic needle for delivery of the contents of the syringe to a body or the removal of samples from a body using the positioning device according to any of claims 1 to 16, the method comprising the steps of:

Intellectual

Property

Office

Application No: GB1619904.4 Examiner: Mr Robert Hunt