GB2520324A

GB2520324A - Pleural powder insufflation device

Info

Publication number: GB2520324A
Application number: GB1320290.8A
Authority: GB
Inventors: Edwin Roe; Richard Varey
Original assignee: Rocket Medical PLC
Current assignee: Rocket Medical PLC
Priority date: 2013-11-18
Filing date: 2013-11-18
Publication date: 2015-05-20
Anticipated expiration: 2033-11-18
Also published as: GB2520324B; WO2015071667A2; GB201320290D0; WO2015071667A3

Abstract

The invention comprises a hand-held powder insufflation device 2 comprising an actuator for providing a succession of bursts of gas, an interface 64 for attaching a powder container to said device; and a conduit for communicating said bursts of gas to said interface, wherein said interface 64 comprises a gas entry aperture 58 through which said bursts of gas enter said powder container and a gas exit aperture 60 through which a mixture of gas and powder exits; said interface 64 being configured to hold said body with its opening located downwards. The actuator comprises handles 8, 10 which move a piston 12 and head 18 along a barrel 22 to force air through into flow assembly 52, through the powder container via gas apertures 58, 60, to outlet 56. Spring 48 biases the handles 8, 10 to return to the starting position, and draw air through valve 54. Interface 64 comprises a resilient deformable curve 68 with a span of 181-210 degrees. In use the powder container is placed within the span of the curve, causing the curve to deform, such that the container is gripped by the curve.

Description

*10 -1-Neural powder Insufflatfon device

Field of the Invention

The invention is a device for the insuiftation of powder into the Lungs. Specifically, the device is a medical device for the insuff(atlon of powder into the lungs of human subjects during pleuraL procedures.

Background and prior art

Insufflation, also known as taLc poudrage, is a widely used method of instilling talc into the pleural space. It Is usuaLly performed during thoracoscopy under local anaesthesia or after video assisted thoracic surgery (VATS).

Clinicians and customers indicate that the current methods and equipment for talc poudrage are clumsy to use, often requiring multiple kits; as such, they can yieLd poor results.

ClinicIans are currently using equipment supplied by the thoracoscopy suite equipment manufacturers, Karl Stortz or Richard Wolf, or equipment supplied by the talc suppLier Novatech.

Typically3 the Stortz and Wolf versions of such equipment might comprise an insufflation device with an elongate end for introducing to the site requiring poudrage, with a tube running from the device to apparatus for fitting to a container (and, in use, the container itself), followed by a further tube terminating in a puffer bulb, which provides air for puffing talc through the apparatus into a patient's lungs. The Novatech apparatus dispenses with any sort of dedicated dispensing device at all, using a plurality of interconnected tubes, for attaching to a puffer bulb and a powder source.

These prior art inventions are unwiekb' and difficult to use -in the case of Stortz and Wolf, they require a two-man team to use. The tubing required to connect the components of powder container, air actuator and powder administration device Is complicated and hard to positio,z the presence of the long tubing means that dosing is imprecise and that powder is wasted.

There is a real need for a more compact, less wasteful means of administering powder to the pleural space.

it is to these problems amongst others which the Invention seeks to provide solutions.

Summary of the Invention

in a first broad, Independent aspect, the invention comprises a hand-held powder insufflatlon device comprising an actuator for providing a succession of bursts of gas, an interface for attaching a powder container to said device; said powder container incorporating a body and an opening and a conduit for communicating said bursts of gas to said Interface, wherein said interface comprises a gas entry aperture through which said bursts of gas enter said powder container and a gas exit aperture through which a mixture of gas and powder exits; said interface being configured to hold said body with Its opening located downwards.

The advantage of inverting the container -holding it upside down relative to the device such that the powder tends to fall to the opening of the container-is that It allows for the dispensation of the whole container of powder to the patient, rather than partial containers of powder as currentLy. This ensures that no powder (which might otherwise get stuck in the container) is wasted, and that it is possible to give a Longer continuous dose from a single powder bottle, without having to change bottles.

A further advantage is that ft allows the practitioner to relatively precisely dose a bottle to patient.

This device is singularLy handheld and singularly hand-operated. it provides an advantage therefore over the prior art which comprises a plurality of tubes and sections and requires both hands or even two people to perform insufflatlon.

Preferably, where the powder container comprises a neck and wherein the aperture of the container is situated at the end of the neck distal the container, wherein the interface comprises attachment means comprising a raised retaining portion which partially surrounds the neck of the container.

This feature is particulañy advantageous, in that during the undertang of the quick real F time task of lung insufflation it can be necessary to use more than one container of powder (the powder is dispensed in relatively small bottles) and as such the ability to quickLy and easily change bottles carries a marked advantage over the prior art where 2o powder may be Located within the device itself making it thus very difficult to access Let atone re-flU; or wherein the device utilises the known containers but seeks to lock them In or onto the device firmly such that changing between bottLes is a difficult multi-step process which effectively dispenses with the advantages of the device as a handheld device so that the device may have to be put down and several actions be taken relative to it in order to make the change of the bottles.

The partial surmumiding is a simple means of providing a light touch-fit connection -via slight friction or a cOck-in, click-out fit Into the partial surround -. thereby facilitating a straightforward way of alLowing the quick removal of a first container bottle and Its so replacement with a second.

More preferably, the raised retaining portion tightly grips the container.

More preferably, the container further comprises a lip surrounding the opening and projecting from the neck, and wherein the raised retaining portion further comprises a channel portion and a bracket portion, wherein the bracket portion is so sized and shaped as to match the profile of the neck of an inserted container and wherein the channel portion is so sized and shaped to accept a portion of the lip of the container, such that, in use, the container is held in a grip along two notional axes.

The use of a bracket and channel allows for a continuous connection about the neck of the bottle, and further utilises the lip such that the connection is made in multiple axes, thus to ensuring a firm fIt.

Preferably, the attachment comprises a continuously curved portion.

The continuously curved portion provides a further means of ensuring continuous contact ts with the circular neck of the style of container.

More preferably, the curve has a span of 181-210 degrees.

Advantageously, the slightly more than half-or semi-circular curve provides a fit that uses the minimum of additional material and ensures that the fit is particularly light, such that the powder container can be changed quickly by simply removing the container from contact with the device.

More preferably, the curved portion is of a resiliently deformable plastics material and wherein the curved portion must be deformed in order to locate or remove the container in use and wherein the touch fit comprises a light grip of the container by the curved portion.

The deformabte plastics material, in tandem with the curved portion, provides a simple and so effective means of Lightly holding a container in place such that it is readily removable and replaceable.

Preferably, the device comprises a piston bearing portion and a valve bearing portion and wherein the piston bearing portion comprises a piston and a barrel, wherein the barrel comprises an inner bore and wherein the piston forms a touching fit with the Inner bore of the barrel, the device being so configured that movement of the piston forces air along the conduit and through the gas entry aperture and the gas exit aperture.

This configuration, of a single handheld plunger-based device presents a departure from other handhetd devices wherein propellant or another powder actuation means is employed.

This plunger-based version is simple to create and requires relatively little energy to manufacture.

Preferably, the device further comprises a handle such that when the handle is squeezed, the piston Is forced down the barrel, forcing the air through the conduit.

The squeezabte handle and collocated handle portions advantageously provide a means of one-handed dispensing of the powder.

More preferably, the handle comprises a first portion attached to the barrel and a second portion attached to the piston and wherein, in use, air is pushed through the device by w bringing the first portion and the second portion together -thereby moving the piston down the barrel The palm and fingers configuration provides a particularty preferred movement, because the squeezing of the fingers into the palm is a natural movement which can be done with a degree of control and also quickly.

More preferably, the device is so sized and shaped to fit into the user's hand, Is use, with the fIrst portion being contacted, in use, by the user's fingers and the second portion being contacted, In use, by the user's palm, and wherein the device is operated by bringing the palm and fingers together.

More preferably, the first and second portions are biased apart by a spring.

The biasing sphng allows for the movement of the two handle portions back irU.o the first position allowing for a quick series of pulls of oowder to be dispensed, Preferably, the relative movement of the first and second portions is governed fry a pAuralfty of elongate guides.

The guide portions advantageously ensure that the two handle portions are correctly collocated at all times.

to More preferably, the guides comprise a plurality of Eateraliy cu.Rocated fringes, said fringes being in a lateraUv sliding collection with one another, The use of channels allows for the continuously correct collocation of the two handle portions to be achieved, Pctf'erabiy, the second pardon comorkes a first end, proximal the plunger, and a second end, distal the plunger and wherein the second portion widens towards the distal end.

The flared second portion comprises a sympathetic shape that fits and follows the line of o the palm of the hand thus providing a second portion which is easier to hold, Preferably, the interface is detachable from the rest of the device.

The detachable interlace advantageously allows for the cleaning of the interface hut also for the handhetd device to be used with other interfaces and for other tasks.

The invention also comprises a device, substantially as described herein, with reference to and as illustrated by any approoriate combination of the text and/or drawings.

n a second broad, independent aspect, the invention comprises a valve comprising an interface for attaching a powder container to said device principal conduit, a conduit in communication with said interface an air inlet in fluid' communication with the principal conduit, wherein the interface comprises a gas entry aperture and' a gas exit aperture; said interface being configured to hold the body of a powder container with its opening located downwards, and wherein the interface comprises a connection for connecting the container to the device, said connection comprising a curve with a span of 181-210 degrees, wherein the curve is of a resiliently deformable plastics material and wherein in use the container is placed within the span of the curve, causing the curve to deform, such that the container is gripped by the curve.

The valve advantageously comprises the same advantages afforded by to the features when mentioned in the context of the device above.

The invention also comprises a valve, substantially as described herein, with reference to any appropriate combination of the text and/or drawings.

Brief descdptlon of the figures The invention wilt now be described by way or example only with reference to the figures of which: Figure us a diagrammatic perspective view of the invention: Figure 2 a further diagrammatic perspective view of the Invention; and FIgure 3 is an exploded diagrammatic perspective view of the invention.

Detailed desciiption of the preferred embodiments At figure 1 there is shown a single handheld lung insufrlation device indicated generally at 2. The device 2 comprises a piston bearing portion 4 and a barrel bearing portion 6. Each of the piston bearing portion 4 and the barrel bearing portion 6 comprise a handle; a first handle section 8 and a second handle section 10 respectively. At figure 3, piston 12, which resides Inside cylindrical piston housing 14 is shown. Piston 12 comprises shaft 16 and head 18 wIth head 18 comprIsing at [east a resiliently deformable surface of natural or synthetic rubber or the like, being so sized and shaped that it forms a moveabLe seal inside and against the inner bore 20 of barrel 22 of barrel bearing portion 6. The various portions are constructed so that the present a single piece to the user and can be held operated by one hand of one person in a pistol-like fashion.

Figure it first handle portion $ comprises a proximal end 24 adjacent piston bearing 1: portion 4 and a second, distaL end 26. The first handle portion 8 Is narrower at proximal end 24 than distal end 26; the first handle portion 8 flares towards distal portion 26. The first handle portion 8 has a back edge 28 which is rounded. The first handle portion 8 further comprises a bevelLed corner 30. The edge 30 and corner 32 are examples of features of the device 2 which make it tactile and easier to handLe it does not present sharp edges to the user, at least not related to the portions which the user must touch.

S The second handle portIon 10 presents a straight member 32. The member 32 has incut 5 34 whIch like member 32 is elongate, running along the length of the member 32. The second handle portion 10 JoIns with barrel bearing portIon 6 via a toric reinforcement F portion 36 which runs around the outer sectional perimeter of the barrel bearing portion 6 and is of a single piece with said barrel bearing portion 6.

The first handle portion Sand second handle portion 10 are slideably attached to one another via a plurality of interlocking shelves 38 with the shelves 38 projecting from second handle portion 10 comprising a plurality of flanges or fringes projecting from a centrally disposed pLate 42. The shelves 38 of the first handle portion 8 are disposed as projections 44 within the cavity of cavity 46 of first handle portion 8. ProJections 44 and shelves 38 mate to form a sliding fit between first and second handle portions 8, 10. The movement between first and second handle portions 8, 10 is between a an extended position wherein the first handle portion 8 and the second handle portion 10 are extended apart from each other to a second position, wherein they are brought together thereby forcing the piston 12 along the inner bore 20 of the barrel 22. The respective handle portions 8, 10 can be moved from the first position to the second position and vice versa.

A biasing sprIng 48 biases the first handLe portion 8 and the second handle portion 10 apart. The movement can be characterized as a linear, reciprocating movement n The barrel 22 has a tapered end 50 and tapers to meet flow assembly 52. Flow assembly 52 comprises an inLet 54 and an outlet 56 the latter of which may be attached to rubber tubing such as a catheter. Between inlet 54 and outlet 56 there is gas entry aperture 58 F and gas exit aperture 60. At inlet 54 gas entry aperture 58, gas exit aperture 60 and outlet 56 form a flow path -however, it is necessary for a container (not shown) to be placed F over gas entry aperture 58 and gas exit aperture 60 in order for the flow path to be completed. In the present embodiment, the gas used is air drawn from the atmosphere through inlet 54. Other propellant gases may be utilised,

I

The gas entry aperture 58 and the gas exit aperture 60 are surrounded by 0 ring 62 and part surrounded by interface 64. interface 64 serves to retain a container, in an In use upside down position i.e. with aperture and where applicable neck and Lip of container held within interface 64 and sealed to the flow path by 0 ring 62. interface 64 is mounted on discoid base 66 and comprises a curve 68. Curve 68 comprises an 1810 span, although a range of 1810 to 210C is useful for the purposes of gripping or clamping a container such that the container is readily removable and replaceable. Curve 68 iS made of deformable material such as plastics material The curve 68 comprises a bracket 70 and a channel 72 with the bracket 70 providing a uniform rim and the channel 72 likewise providing a iv uniform channel around the span of said curve 68. A container with a neck and a lip, I.e.

standard talc dispensing bottle configuration wilt be held In place along two axes; in other words it will be gripped from the side by the curve 68 and will be held in place longitudinally by the bracket 70 and channel 72.

is At Figure 3 It can be seen that Inlet 54 comprises a one-way valve 74 and that the valve assembly 52 further comprises a narrowing portion 76 for concentrating the airflow in use. F in use, when the device 2 is in a first position and the first and second handle portions 8,10 are apart, gas is drawn through inlet 52 and into the barrel 22. The user who holds the device 2 wIth the first handle portion 8 in the palm of his or her hand and the second handle portion 10 held by his fingers, squeezes first and second handle portions 8,10 together, thereby pushing piston 12 along barrel 22 and forcing air through narrow portion 5 76. The air then flows through gas entiy aperture 58 and swirls around the container and exits through gas exit aperture 60 and subsequently through outlet 56. When the air is in the container it entrains the powder such that powder is evacuated from the container through gas exit aperture 60 with the gas/air, and is subsequently channelled along and through outlet 56. The biasing spring 48 serves to move the first handle portion 8 and second handle portion 10 back into the first position, when the grip of the user is relaxed.

As the piston 12 is pulled back along the barrel 22, air Is drawn from air Inlet 52 As such, it is possible to dispense a series of puffs or bursts of powder entrained air into pleural cavity. F. in some embodiments the biasing spring 48 need not take the form of a metal or alloy F spring and may be made of plastics and can be of a configuration other than the coil design presented here. The device 2 is here shown made of plastics materials but other 1.0 cornbhiatons of metaLs, aLLoys and natural fibres are envisaged. Other forms of gas actuaton, such as a puffer bulb or a compressed gas cankter, may be utilised in order to provkle the entrainment gas.

Claims

ICLAIMS1. A hand-heW powder insufflation device comprising an actuator for providing a succession of bursts of gas; an Interface for attaching a powder container to said device; said powder container incorporating a body and an opening and a conduit for communicating said bursts of gas to said interface; wherein said interface comprises a gas entry aperture through which said bursts of gas enter said powder container and a gas exit aperture through which a mixture of gas and powder exits; said interface being configured to hold said body with Its opening located downwards.
2. A device according to claim 1, wherein the powder container comprises a neck and wherein the aperture of the container is situated at the end of the neck distal the I: container, wherein the interface comprises attachment means comprising a raised retaining portion which partially surrounds the neck of the container.
3. A device according to claim 2, wherein the raised retaining portion tightly grips the container.
4. A device according to either claim 3, wherein the container further comprises a Up surrounding the opening and projecting from the neck, and wherein the raised retaining portion further comprises a channel portion and a bracket portion, wherein the bracket portion is so sized and shaped as to match the profile of the neck of an inserted container and wherein the channel portion is so sized and shaped to accept a portion of the lip of the container, such that in use, the container is held in a grip along two notional axes.
5. A device according to any of the preceding claims, wherein the attachment comprises a continuously curved portion.
6. A device according to claim 5, wherein the curve has a span of 181-210 degrees.
7. A device according to claim 5 or claim 6, wherein the curved portion is of a resiliently deformabte plastics material and wherein the curved portion must be deformed in order to Locate or remove the container in use and wherein the touch fit comprises a tight grip of the container by the curved portion,
8. A device according to any of the preceding claims, wherein the device comprises a a piston bearing portion and a valve bearing portion and wherein the piston bearing portion comprises a piston and a barrel wherein the barrel comprises an inner bore and wherein the piston forms a touching fit with the inner bore of the barrel the device being so configured that movement of the piston forces air along the conduit and through the gas entiy aperture and the gas exit aperture.

ID
9, A device according to any of the preceding claims, wherein the device further comprises a handle such that when the handle is squeezed, the piston is forced down the barrel, forcing the air through the conduit.
10. A device according to claim 9, wherein the handle comprises a first portion attached to the barrel and a second portion attached to the piston and wherein, in use, air F is pushed through the device by bringing the first portion and the second portion together -thereby moving the piston down the barrel 11. A device according to either of claims 9 or 10, wherein the device is so sized and shaped to fit into the user's hand, is use, with the first portion being contacted, in use, by the user's fingers and the second portion being contacted, in use, by the user's palm, and wherein the device is operated by bringing the palm and fingers together.12. A device according to claim 9, wherein the first and second portions are biased apart byaspririg.13. A device according to any of claims 9 to 12, wherein the relative movement of the first and second portions is governed by a plurality of elongate guides.14. A device according to cLaim 13, wherein the guides comprise a plurality of laterally F coltocated fringes, said fringes being in a laterally sliding collection with one another.I15. A device according to any of claims, wherein the second portion comprises a first end, proximal the plunger, and a second end, distal the plunger and wherein the second portion widens towards the distal end.16. A device according to any oF claims, wherein the interface is detachable from the rest of the device.17. A device, substantially as described herein, with reference to and as illustrated by any appropriate combination of the text and/or drawings.18. A valve comprising an interface for attaching a powder container to said device principal conduit, a conduit in communication with said Interface an air inlet in fluid communication with the principal conduit, wherein the interface comprises a gas entry aperture and a gas exit aperture; said Interface being configured to hold the body of a is powder container with its opening located downwards, and wherein the interface comprises a connection for connecting the container to the device, said connection comprising a curve with a span of 181-210 degrees, wherein the curve Is of a resiliently deformable plastics material, and wherein in use the container is placed within the span of the curve, causing the curve to deform, such that the container is gripped by the curve.19. A valve, substantially as described herein, with reference to any appropriate combination of the text and/or drawings. *Amended claims have been flIed as follows:-CLAIMS1. A hand-heLd powder insuffLation device comprising an actuator for providing a succession of bursts of gas; an interface adapted for attaching a known, separate powder container to said device; the powder container incorporating a body and an opening; and a conduit for communicating said bursts of gas to said interface; wherein said interface comprises a gas entry aperture through which said bursts of gas enter said powder container and a gas exit aperture through which a mixture of gas and powder exits; said interface being configured to hold the body of the powder container such that its opening is Located downwards; and wherein said interface comprises attachment means; said attachment means comprising a continuously curved portion; wherein the curved portion is of a resiliently deformabLe pLastics materiaL and wherein the C"J curved portion must be deformed in order to Locate or remove the container in use and wherein the touch fit comprises a grip of the container by the curved portion. a)r 15 2. A device according to cLaim 1, wherein the powder container comprises a neck and wherein the aperture of the container is situated at the end of the neck distaL the container, wherein the interface comprises attachment means comprising a raised retaining portion which partiaLLy surrounds the neck of the container.3. A device according to cLaim 2, wherein the raised retaining portion grips the container.4. A device according to either cLaim 3, wherein the container further comprises a Lip surrounding the opening, and projecting from the neck, and wherein the raised retaining portion further comprises a channeL portion and a bracket portion, wherein the bracket portion is so sized and shaped as to match the profiLe of the neck of an inserted container and wherein the channeL portion is so sized and shaped to accept a portion of the Lip of the container, such that, in use, the container is heLd in a grip aLong two notionaL axes.5. A device according to any of the preceding cLaims, wherein the curve has a span of 181-2 10 degrees.6. A device according to any of the preceding cLaims, wherein the device comprises a piston bearing portion and a vaLve bearing portion and wherein the piston bearing portion comprises a piston and a barreL, wherein the barreL comprises an inner bore and wherein the piston forms a touching fit with the inner bore of the barreL, the device being so configured that movement of the piston forces air aLong the conduit and through the gas entry aperture and the gas exit aperture.7. A device according to cLaim 6, wherein the device further comprises a handLe such that when the handLe is squeezed, the piston is forced down the barreL, forcing the air through the conduit 8. A device according to cLaim 7, wherein the handLe comprises a first portion attached to the barreL and a second portion attached to the piston and wherein, in use, air is pushed through the device by bringing the first portion and the second portion together -thereby moving the piston down the barrel. a)9. A device according to either of cLaims 7 orB, wherein the device is so sized and shaped to fit into the user's hand, is use, with the first portion being contacted) in use) by the user's fingers and the second portion being contacted, in use, by the user's paLm, and wherein the device is operated by bringing the paLm and fingers together.10. A device according to cLaim 8, wherein the first and second portions are biased apart by a spring.
11. A device according to any of cLaims 7 to 10, wherein the reLative movement of the first and second portions is governed by a pLurality of elongate guides.
12. A device according to cLaim 11, wherein the guides comprise a pLuraLity of LateraLLy coLLocated fringes, said fringes being in a Laterally sliding colLection with one another.
13. A device according to any of cLaims 8 to 12, wherein the second portion comprises a first end) proximaL the pLunger, and a second end, distaL the pLunger and wherein the second portion widens towards the distaL end.
14. A device according to any of the preceding cLaims, wherein the interface is detachabLe from the rest of the device.
15. A device, substantiaLly as described herein, with reference to and as illustrated by any appropriate combination of the text and/or drawings. (4 r a) r