The present invention relates to a oat _t more

particularly to a mat for temporarily retaining the

insertion tube of an endoscope during endoscopic procedurea .

Phen laser::,lag an endoscope into a patient, it nary be necessary for the oper ting doctor to reloa.se bis grip on an oninserted length of insertion, tube momentarily in order to free hia bands for a manual task, such as operating a tool in the endoscope. Hcnever , tem or ily relinquishing grip on the insert ion tube can result in the endoscope becoming dislodged or rotated out of position as tension aitPin the insertion tube is released. This is particularly

problematic w ere the endoscope is inserted into a

convoluted passage, such as during colonoscopy , where a fair amount of tad sting and bending of the insertion tabs may have been required to correctly position the endoscope.

In some cases, the operating doctor may a tempt to maintain the position of the endoscope insertion tube when performing a manual task by clamping tne insertion tubs between their leg and the bed to temporarily cold the scope in position, before releasing their hands from the insertion tabs . alternatively, the doctor may attempt to manipulate the patient's body to bold the scope in position against an anchor point, such as the bed<

However, such methods of retaining the insertion cubs require the doctor to contort either themselves or the patient into a clamping position and do not provide a consistent or reliable level of control, further,, both. net: node car; res lt l dam ge to the scope if it la n arneb be caeca the rn;a unrelated feody part a d a solid anchor point _<

According to :.: he present inv ioo, there ia provided a ;nat 5 for empora ily retaining i: a insertion be of an endoscope _: · tire mat comprising a base sslacs, and an array of raeit :i arc: fingers at leaec 1 en long extending coward ^' ; y f .ton tiro base surface and arranged to receive, grip and retain the insertion tube between ad acen Singers- nhan it ba boon pressed bcravear aly towards theQ base surface and to release oho insertion cube ohca it la coved upwardly relation: to una bane carfare _: aho.ra.ln at least sooe of ten fiagers cooaortss a plurality of aoduXsa on an cater soriace for retaining the insertio tuba , 5 T'hia enables the operating doctor to temporarily bold the lengt h of nninsert od t ube in a cons l atent unamer and nithout resorting to coatarti.ng either taeroacraes or the patient. The array al loans the cat: to bold the insertion cube in saury different aonf garations , The proeoat invention also redoces the risk c 0 scope deoege caused by erusbi:eg ^: as the foroe on. the ; a car;: hoc

tube is; spread.

The insertion tufas c be rata Lac a between the f iruyers of the vert s - ;.y by the grip provided by ahj a cent fingers ahan theya are deformed by the insertion tube. Advantageous i go at leant

care of tbo fingers have an enlarged head at their carta I end for retaining the insert too tnbe. This tec re a.;; a a: the force required to .secure the iaaertion. tnbe trot- the onto redocinc the rick; of inalhtonc-ionn.! resioval,

0

The enlarged head, may be of amy suitable con iguration, so.cn an a circular, conical, or frustoc ni ai ca , or a mushroom-shaped head. Preferably,, the enlarged head is sabstauttally spherical. Such a sha provides for easy insertion and remov l of the i s r s on tube from the fingera of the o t while still providing suf icient resistance to unintentional release of the tube f om the mac. the enlarged hea may oin the stem of the finger with a sharp corner. Advantageously, a. fillet is provided at tire unction, between the enlarged head and the finger to

increase the grip on the insertion tube.. This improves the ease with which the suet is manufactured and reduces stress concentrations., as well, as reducing the effort required to enerect th insertion tube from the fingers. advantageously, the fingers have a rubberised and/or teuturisad surface. This provides greate friction between the insertion tube and the fingers to reduce the risk of unintentional removal of the insertion tube from the isai

The ma ma he a passive device, i.e. one in which the fingers deform, in response to an external force, such as that of the insertion tube being pressed between the fingers and rewards she base of the mat by the operating doctor, hlternat ivelyt the mat may include an activation device and at least some of the fingers may be actively deformable upon corneand frost the activation device to increase the grip on the insertion tube..

The actively deformable fingers may be formed, from a. smart material and/or may be at least partly inflatable , The actively daformable fingers which are at least partly inflatable may he entirely inflatabl , or inflatable at any point along their length in order to grip the insertion tore upon cotmaarid from the activation device. n a preferred eohodiment, each actively deforoahle finger has an inflatable bladder at its hiatal end. With his- arrangement, the .insertion tube can he gripped and retained in the oat without exerting the excessive ressure on the tube or che fingers themselves which may otherwise result from inflating the fingers at -a point coincident with the carina- diameter of the ince t.ion tube.

Th activation device may he con igured for operation by hand, or a om tical ly euch as hy the use of censo a .

Preferably, the activation device has a foot pum or foot switch. This allows .hands - iree operation of the activation device without the need for censors and further control aearun for example by opening a relief valve to release air from inflated lungers to allow the insertion she to be released from the mat.

The fingers may be from 1 cm to 1.5 cm long.

Preferably, tire fingers are at ieaet l.S cm loony In a preferred embodiment, the fingers are between 20 and 2S m long <

The array of fingers may he arranged in clusters of one or more pairs and/or with a different density in different parts of the mat to allow the mat to provide different levels of grip as desired. he array may he arranged with a different density of fingers. Preferabl _s the array is a uniform grid, with fingers arranged in aligned rows and columns. This enable secure and eonslatent gripping o ls insertion tube regardless Of the orientation of the mat.

The minimum ciearunce between the enlarged head of adjacent fingers may vary depending on the diaoetar of the insertion tube with which the oat will be used. This can be achieved either by using different oats for different diameter tubes, or by having areas on one o t with differing minimum clearances . The latter arrangement allows one mat type to be used for several different diameter tubes-.

Preferably , the fingers are arranged in the array with a minimum clearance of at least S mm between, the enlarged head of adj acesit fingers„

The base surface may be carved to allow the mat to be fitted over a rounded surface whan in use. Pre erably, the base surface is planar, thus allowing the met to be stable when placed on the bed.

The base surface ay be any suitable shape when viewed from above, such as rectamgulaxc or circular* In a preferred embodiment, the base surface has an outer edge which is shaped to fit around a patient. This allows the mat to be placed close to the patient axed point of insertion, reducing the length of unasserted tube betreen the oat and the patient and thus reducing the mo ement of the endoscope tin relative to the mat ,

The fingers say be arranged over the entire base surface of the mat. or over substantially the entire base stirface with a margin around the edge. Preferably, the base surface has a portion which, is substantially tree of fingers nd arranged such, that the portion can tit codec and bo gripped by a pa ient ^! e body . i h this air¾sge¾en , the weight of the patient's body may be used to hold tha pat in place

The mat may he arrang d tor uee with any type of eohoccope , for exa le gaatroscopasp huodenoecopec _;

entetoocopse or; hronctoucopee , Iboefsrablyc the endoscope is a coioncecone ,

The ma teay have a rubber iseh non-chip surface on its oederride to hold it in poc.t ion doring nse.

In a preferred embodiment , at least SCM of the fingers comprise a reinforcing material arranged to incre s finger stiffness .

The fingers may he fined co the bane corface . In cue embodiment, at least some of the fingers are removable from the base so isen , This aliens greater flexibility mi id- regards to the arrangement of the fingers.

Preferably, the removable fingera are each slidehie mithin a hole in the base surface such that they may he removed. Thin provides a. straight- forward and secure connection of the fingers co the base surface . e mat m y be simply placed on the bod next to the patient. In a preferred embodiment ., the oat farther comprises a belt attached to the base surface for securing the mat to a patient aaa/ ^' or a bed on aidoh the patient is S disposed.

The present invention will now be described, by way of xample only _. , with reference to the accompanying drawings in which ;

Figure 1 la a plan view of a mat according to a first oohod inent of the p esort:, invention;

Figure 2 is a partial section, perspecti e view taken through the line XI ~ IT of Figure I;

S Figare ;> is a plan view of the oat of Figare i . showing the mat being used to retain the insertion tube of an endoscop ;

Figure 4 is an enlarged, partial porepeotive aide view of the mat of Figure 1 _r showing the mat being used to retain0 the insertion tube of an endoscope;

Figure 5 is a plan perspective view of a mat according oo a second embodiment of the present invention;

Figure e is a side view of the tips of the inge s of the mat of Figure 5 ;

t Figure ? is a bottom, perspective view of part of the mac of Figure S, showing a finge partially removed, from the base surface

Figure 8 is a plan view of the baee surfsee of the mat of Figure 5 with a first arrangement of holes;

) Figure is a bottom perspective view of. the mat of

Figure S with an alternative arrangement of holes; Figure 10 ta a. bot om; pars eccav view of part of the m t of Figure 5; and

Figure 11. la a aide perapeeti ae view o the oat of Figure S attached to a bad d ad cen to a patient, a.a illuafrated i.a Figures 1 aral 2.. mat 10 aoaipriaes a plaxraa baae surface 12 fros¾ ehtab a. plurality of fleaible tlagera 14 upwardly exceed la a direct.ear- gaaarrally

perpendicular to the pla.ee of the base seriate 12, The flayers 14 are arranged on the base surface 12 in a a.ax eea grid to fore an array 16 covering the read ori y of the baae surface 12, The aeeaaeder of the base surface 12 is left free of iieaex a to fore a margin 1» around the edgea of he: baae surface 12. haaa finger 14 la agproaieately 20 to 25 oo long and. includes a tapered atee 20 catena ing from the baae aarfaae 12 and an enlarged, spherical head 22 connected at aha dlatal end of the stee 20 by a fillet 24, Bach atea 20 tapera teearae its distal and and eaah spherical head 22 baa a di seetar of approximately 12 ran . Fa;tending into the core o each ateai 20 ia a stiffening atruetare 20 for-aaa froa a tape.tad rod 28 er.tendi.ng upwardly froo a support plate 30 disposed nithla the baae sarfa.ee 12 and beneath the finger 1 ,

The array 10 is areaaand. on the baae surface 1.2 such that adjacent fingera 14 in each row/eelxaaa of the grid are epaeed at ana.fore; intervala baaed upon she diameter of the tube with which., the oat 10 will be used, a!oag with th stirfneae of the fingera 14. idea lie , the grid should he arranged so that the distance between the centralinea of adjacent: ring rs 14 is not loss than too diameter of the insertion tub® oiob h ch it ill be used and the distance bet een the enlarged heads 22 at their closest part, i.e. "the min mum clearance*! is at least 5 mm lecc than the diameter of the .insertion tube.. In this example, the ma 3.0 is intended for use with an insertion tube for a

colonoscopy _: tha insertion tube having a diameter of 12 to 13.2 re . ons, the fingers 14 are spaced at 1? em

intervale, i.e. from centreline to centreline, ¾ith a 5 mm clearance between adjacent enlarged heads 22,

The met 10 may foe formed from: any suitable oaterial and by any suitable me hod, For eramp! e , the outer surface of the mat 10 is formed from an autoela-/able material .. saeh as silicone rubber using an injection moulding tool (not shown) with a series of slides to form the enlarged heads 2 ... The stiffening structures 26 are formed from a material which is denser than that of the rest of the at 10, for example polypropylene, polycarbonate _. , or polybutylene terepnthsclate, and are positioned within the tool prior to the injection of the outer material, wnich is then orereouided to fir. the stiffening structures 26 in place..

Referring to Figures 3 and 4, in nee, the mat 10 is positioned at the foot of the bed (not shown) close to the patient and the point of .insertion, with the fingers 14 pointing upwardly. During an endoscopic procedure, when the operating doctor is required to free up one of his hands, no may press the snie.sereed lennth of insertion tube 40

downwardly against the sphe ical heads 22 of two or more finger 14 and towards the base surface 12, This movement causes the fingers 14 to flex away from the insertion tube 40 fco allow the insert ion tube 40 to nass between adjacent heads 22 and be bedded in the array it . The fingers 14 then return to an upright position to grip the tuba 40 and hold it in plane between adjacent stems 20, as shown in Figures 3 and .. allowing the operating doctor to perform rmanaa.! tasks without the need to bold the insertion tube 40..

To remove the insertion tube 40 fro the -ret 10, the tune 40 is simply pulled upward against the enlarged heads 22 to flea the fingers 14 away from the tube 40 and acre the heads 22 apart. The tube 40 can then pass between, the heads 22 and be removed from the mat 10, Is. addition to itmproviua ease of manufacture and reducing stress concentrations, the fillets 24 also act to reduce the effort required to entrant the tube 40 from the fingers 14 by smoothing the transition from the stem 20 to the enlarged head 22 of each finger 14. hhen the -rat 10 is no longer required; for example once a particular endoscopic procedure is com lete; it may then he clinically disposed of or sterilised and re- used .

Figures 5 to 11 show a mat 11 according to a farther embodiment of the present isvent .loo. Mat 110 is similar to mat 10 but, rather than having enlarged heads .. fingers 11 instead have a plurality of nodules or spikes 122 _f as shown in Figure t _f to temporarily retain the insertion tube (not shown) between adjacent fingers 114. Fingers 114 are inserted in. holes 113 through the base surface 112 and are slidable relative to the base surface 112, as shown in

Figure ? , so that the may be removed from the base surface and/or rearranged, bach finger 114 has an enlarged base lit. which is wider than the diameter of its respective hole 113. _t to prevent the finger 114 from assing completely through the hole 113. he holes 113 may be positioned in one or more areas of the mat i 1o aact as in one corner us shown i Figure 3.. or in a grid, at sho in Figure 3 _: the latter arrangement allowing greater flexibility with regards to the arrangement of the fin ers 11 , so the fingers 114 are removable, different length fingers 11 can be provided with the mat 110 to allow the mat lit to be adapted depending on the needs of the patient. For exam le _; fingers 114 with a length of 1 cm or more could be used for larger patients with whose the point of entry into the patient is generally further from th® bed. With longer fingers 114. the insertion tube la held by the fingers 114 further from the base surface 112 and close to the point of entry, thus reducing the length, of insertion tube between the seat 110 and the point of entry. Further, the fingers 114 can. be pushed through the holes 113 of the; base surface 112 in either direction _f as shoes in Figure 10, such that tne mat 110 is reversib e .

Mat 110 also includes a belt 112 passin through belt holes 114 in diagonally opposed corners of the bass surface lit to allow the mat 110 to be secured to the bed 116 by passing the belt 132 around the underside of the bed lit _: as shown in Figure 11. or by strapping tne belt 132 around the patient's leg or legs lis. The belt holes 134 are provided in each corner of the base surfare 112 to allow the

orien ation of the mat 110 to be altered by passing the belt 132 through a. different combination of holes 134, In use, mat 110 is sed in a similar manear to mat 2.0, During an dosc ic procedure, ha the operating doctor is required o free u one oh hia hands , he may prase the eaiinserted lengt of insertion tribe dossawardly against the tips of two or more finger 11 and towards t e bass surface 112. This mo ement eacsee the fingere 114 to flex away from the insertion tube to allow the insertion tune 40 to aen between adjacent fingere 114. The finge a 114 then return to an upright position to grip the insertion t else with the nodules 122 and hold it in place, allowing the operating doctor to perform manual taste without the need to hold the ineertion tube.

To remove the insertion tube iron the mat 110, the tube is e imply pulled upward againet the nodules 121 to flea the fingers 114 away from the tube and allow the tube to he removed from, the mat 10.

Although the invention has been described above with reference to one or sore preferred embodiments , it will be appreciated that various changes or modifications may be made witnout departing from the scope of the invention, a defined in the eupended claims , For example, although the mat 10 is describe us being injection one land ae a. unitary structure, it ootid be formed from one or more separate components assembled together, For example , the base su face 12 and fingers 14 could he eonidea separately and the fingers 14 pressed through, holes in the base surface 12 to fo e the mat 10- Alternativel < the base surface 12 could be injection moulded with integral finger status 20, with the enlarged beads 22 being mo lded separately and subsequently attached to the sterna 20 In order to sirvpiify the tooling required to form the mat .

Also, rather than, moulding the stiffening structures 26 withi the mat 10, the fingers 1 could be hoilot? and the stiffening st uctures 26 pressed through, the base surface 12 and into the fingers 14 from underneath .

Furt er, although mat 110 haa been described aa

in.eludi.ng a belt 132 passing through holes 134 protided in the corners of the base surface 112, the holes 134 may be positioned in any suitable ooa ies on. the base surface 112 _s or may he dispensed with entirel along eith the belt 132, Equally _< mat 10 is usable nd.th or without a belt or halt holes .

Like mat 100 _f mat it could also be treeidea nitb.

nodxu.es/spihes 122 to retain the insertion tube either in addition to or instead of enlarged heads 22.