WO2019115656A1

WO2019115656A1 - A non-slip mat for an ultrasound probe, and method of use thereof

Info

Publication number: WO2019115656A1
Application number: PCT/EP2018/084648
Authority: WO
Inventors: Aisling NI ANNAIDH; Tony GEOGHEGAN
Original assignee: Ni Annaidh Aisling; Geoghegan Tony
Priority date: 2017-12-12
Filing date: 2018-12-12
Publication date: 2019-06-20
Also published as: GB201720688D0

Abstract

A non-slip mat (1) for preventing an ultrasound probe (12) slipping from a surgical drape (11) covered surgical table (10) is described. The mat has a planar configuration with an upper surface (4) configured to support an ultrasound probe and an under surface (5) disposed for contact with the surgical drape covered surgical table. The upper surface and under surface of the mat comprise a non-tacky silicone elastomer, and the upper surface comprises a plurality of spaced-apart transverse ridges (6). The non-tacky silicone elastomer is configured for non-stick adherence with a surgical drape covered surface, said non-stick adherence being sufficient to prevent horizontal displacement of the mat (1) on the surgical drape (11) covered surface when an ultrasound probe (12) is rested on the mat, and allow the mat be removed from the surgical drape covered surface without the drape sticking to the mat.

Description

TITLE

A non-slip mat for an ultrasound probe, and method of use thereof

Field of the Invention

The present invention relates to a non-slip mat for an ultrasound probe. Also contemplated are methods of securely placing an ultrasound probe on a non-slip mat during an ultrasound guided surgical or medical procedure that employs an ultrasound probe.

Background to the Invention

The majority of image guided procedures performed by radiologists are carried out under ultrasound guidance. During these procedures, the radiologist will be required to use the ultrasound probe intermittently during the procedure, for example guiding the positioning of a needle in a patient, and during periods of non-use the probe is laid to rest on a supporting surface, for example, a surgical instrument table positioned adjacent the patient, or even on the operating table adjacent the patient. Ultrasound probes have heavy flexes which are prone to pull the probe off the supporting surface with the risk of the probe falling to the ground and being damaged or contaminated. This problem is compounded by the use of fabric surgical drapes which are employed to cover the instrument table in operating theatres. These drapes have smooth non-sick surfaces that do not provide much purchase for an ultrasound probe resting on the drape. In addition, the probes employed during image guided procedures are covered with plastic sheaths, and coated with ultrasound gel, making them slippy.

A solution to this problem is provided by Hays Innovations (www.havsinnovations.org) and comprises a system for tethering the ultrasound probe to the surgical drape covering the patient, comprising two sets of Velcro strips, one attached to the probe head and one attached to the cable of the probe. A number of problems arise with this system: it takes several seconds to remove a backing layer to stick it to the sterile drape and to attach the second Velcro strip to the probe head; once the Velcro is attached to the drape it cannot be moved around again; and, when pulling the probe from the Velcro strip it may rip the drape. At a minimum, the Velcro causes the drape to pull up off the table / patient and requires a second hand to hold down the drape. Therefore, this solution is not ideal. It is an object of the invention to overcome at least one of the above-referenced problems.

Summary of the Invention

The present invention addresses the need for an improved method and system for securing an ultrasound probe to a surgical drape covered surface during an ultrasound guided surgical procedure, which is simple, inexpensive and practical, and which reduces the incidence of ultrasound probe slippage in a clinical setting. The solution consists of a non-slip planar mat that is formed from a material that limits or prevents displacement of the mat on a surgical drape covered instrument table when the ultrasound probe is resting on the mat. The Applicant has also realised that the mat is often required to be moved by a radiologist during a procedure, and that it is essential that when moving the mat that it does not stick to the drape as otherwise it could drag the drape from the table resulting in surgical instruments falling off the table. To meet these objectives, the mat is provided with a lower surface comprising a non-tacky silicone elastomer configured for non-stick adherence with a surgical drape covered surface, in which the non-stick adherence is sufficient to prevent horizontal displacement of the mat on the surgical drape covered surface when an ultrasound probe is rested on the mat, yet allow the mat be removed from the surgical drape covered surface without the drape sticking to the mat. The mat has an upper probe-supporting surface formed from a non-tacky silicone elastomer that provides a greater coefficient of friction than surgical drape material to inhibit slip of the ultrasound probe proximally along the mat under the weight of the probe flex. In addition, a series of spaced apart transverse ridges are typically provided on the probe-supporting surface, which have been found to break up the momentum generated by a slipping probe, and thereby further inhibit or prevent probe slippage.

According to a first aspect of the present invention, there is provided a non-slip mat for preventing an ultrasound probe slipping from a surgical drape covered surgical table, the mat having a planar configuration with an upper surface configured to support an ultrasound probe and an under surface disposed for contact with the surgical drape covered surgical table. Typically, the under surface of the mat comprise a material configured for non-stick adherence with a surgical drape covered surface (for example a silicone material, preferably a non-tacky silicone elastomer). Suitably, the non-stick adherence is sufficient to prevent horizontal displacement of the mat on the surgical drape covered surface when an ultrasound probe is rested on the mat, and allow the mat be removed from the surgical drape covered surface without the drape sticking to the mat. The mat typically has an upper probe-supporting surface formed from a material that provides a greater coefficient of friction than surgical drape material to inhibit slip of the ultrasound probe proximally along the mat under the weight of the probe flex Suitably, the upper surface comprises a plurality of spaced-apart transverse ridges.

In one embodiment, the material is a non-tacky silicone elastomer. In one embodiment, the mat is composed of the non-tacky silicone elastomer.

In one embodiment, the mat is formed from a non-tacky silicone elastomer.

In one embodiment, the non-tacky silicone elastomer has a Shore hardness of 00-30. Exemplary silicone materials include ECOFLEX® 00-30 silicone.

In one embodiment, the coefficient of friction between the mat and a dry covered ultrasound probe is at least 0.8, 0.9 or preferably at least 1.0, as determined using the method described below.

In one embodiment, the coefficient of friction between the mat and a wet covered ultrasound probe is at least 0.4, 0.5, or preferably at least 0.6, as determined using the method described below

In one embodiment, the mat has a longitudinal aspect and a transverse aspect, where a length of the mat in the longitudinal aspect is greater than the width of the mat in the transverse aspect.

In one embodiment, the mat has a maximum length of 130-170mm, and a maximum width of 80-120 mm.

In one embodiment, the mat has a maximum length of 140-160mm, and a maximum width of 90-110 mm.

In one embodiment, the mat has a height of 4-6mm, preferably about 5 mm. In one embodiment, the transverse ridges have a height of 1-3 mm, preferably about 2 mm.

In one embodiment, the transverse ridges are spaced apart by a distance of 10-20 mm, 13- 17 mm, or preferably about 15 mm. This spacing is suitable for receiving a distal end of the probe between the ridges.

In one embodiment, the under surface of the mat has a suffuse planar surface.

In another embodiment, the under surface of the mat has a plurality of transverse ridges.

In one embodiment, the mat has a weight of 50-1 OOg, preferably 70-90g, and ideally about 80g.

The invention also relates to a stick-on silicone patch configured to adhere to an underside of an ultrasound probe and prevent the probe slipping off a surgical drape covered instrument table.

Also contemplated is a kit comprising a non-slip mat according to the invention, in combination with a sheath cover for an ultrasound probe and/or an ultrasound gel.

Also contemplated is a method of securely placing an ultrasound probe on a surgical drape covered support surface comprising the steps of:

placing a non-slip mat according to the invention on the surgical drape covered support surface; and

placing the ultrasound probe on the non-slip mat.

In one embodiment, the support surface is a surgical instrument table.

In one embodiment, the method is performed prior to or during an ultrasound guided surgical or medical procedure that employs an ultrasound probe.

In one embodiment, the method includes a step of removing the ultrasound probe from the non-slip mat to use the probe, and optionally replacing the probe on the non-slip mat after use of the probe. Also contemplated is a method of performing an ultrasound procedure during an ultrasound guided surgical procedure that employs an ultrasound probe and a non-slip mat according to the invention, the method comprising the steps of:

placing the non-slip mat on a surgical drape covered support surface;

placing the covered ultrasound probe on the non-slip mat,

using the ultrasound probe to perform an ultrasound imaging step; and

replacing the ultrasound probe on the non-slip mat when the ultrasound imaging step is completed, whereby the non-slip mat helps prevent the ultrasound probe slipping off the surgical drape covered support surface during periods of non-use.

Typically, the method involves placing the probe on the mat such that a longitudinal aspect of the probe is parallel to a longitudinal aspect of the mat, with a distal end of the probe preferably nestled between two ridges on the upper surface of the mat.

In one embodiment, the support surface is a surgical instrument table.

Other aspects and preferred embodiments of the invention are defined and described in the other claims set out below.

Brief Description of the Figures

Figure 1 is a perspective view of a non-slip mat for an ultrasound probe according to a first embodiment of the invention;

Figure 2 is a top plan view of the non-slip mat for an ultrasound probe of Fig. 1 ;

Figure 3 is a underneath plan view of the non-slip mat for an ultrasound probe of Fig. 1 ;

Figure 4 is a side elevational view of the non-slip mat for an ultrasound probe of Fig. 1 ;

Figure 5 is an elevational view of the non-slip mat of Figure 1 on a drape-covered surgical instrument table, with a ultrasound probe securely resting on the mat;

Figure 6 is an illustration of the coefficient of friction (COF) measurement system; and Figure 7 is a graph plotting horizontal force applied to the probe on the mat Vs

displacement of the probe on the mat as measured using the measurement system of Figure 6.

Detailed Description of the Invention

All publications, patents, patent applications and other references mentioned herein are hereby incorporated by reference in their entireties for all purposes as if each individual publication, patent or patent application were specifically and individually indicated to be incorporated by reference and the content thereof recited in full.

Definitions and general preferences

Where used herein and unless specifically indicated otherwise, the following terms are intended to have the following meanings in addition to any broader (or narrower) meanings the terms might enjoy in the art:

Unless otherwise required by context, the use herein of the singular is to be read to include the plural and vice versa. The term "a" or "an" used in relation to an entity is to be read to refer to one or more of that entity. As such, the terms "a" (or "an"), "one or more," and "at least one" are used interchangeably herein.

As used herein, the term "comprise," or variations thereof such as "comprises" or

"comprising," are to be read to indicate the inclusion of any recited integer (e.g. a feature, element, characteristic, property, method/process step or limitation) or group of integers (e.g. features, element, characteristics, properties, method/process steps or limitations) but not the exclusion of any other integer or group of integers. Thus, as used herein the term "comprising" is inclusive or open-ended and does not exclude additional, unrecited integers or method/process steps.

As used herein, the term“preventing an ultrasound probe slipping from a surgical drape covered surgical table” should be understood as completely or partially preventing slipping of the probe. The mat of the invention is configured to lessen the incidence of probe slippage during the procedure, and maintain the probe in the same position during periods of non-use.

As used herein, the term“non-tacky elastomer” as applied to a non-slip mat of the invention means an elastomer which can be placed on a surgical drape and removed from the surgical drape without the drape sticking to the elastomer. Typically, the elastomer is one upon which an ultrasound probe can be placed without horizontal displacement under the weight of the probe flex, but will not stick to the probe when the probe is lifted away from the elastomer.Examples include elastomers, typically silicone elastomers, having a shore hardness of A or 00, typically 00-20 or 00-30, for example silicone elastomers such as ECOFLEX® 0030, SYLGARD-184

As used herein, the term“ultrasound probe” refers to a sensor employed in ultrasound imaging (or sonography) of mammals during medical or surgical procedures. Various different types of ultrasound probes are available including linear transducers, convex transducers, phased array transducers, endocavity transducers and pencil transducers, for example SONOSITE transducers, SIEMENS ultrasound transducers, ACUSON ultrasound transducers, PHILIPS ultrasound transducer probes, ATL ultrasound transducer probes,

GE ultrasound probes, and HP ultrasound transducer probes. In one embodiment, the anti- slip mat of the invention is dimensioned to accommodate linear transducers, convex transducers, phased array transducers, endocavity transducers and pencil transducers. The term“covered ultrasound probe” refers to a probe covered with a sterile sheath cover.

As used herein, the term“sheath cover” or“sterile sheath cover” refers to the sterile cover employed to cover ultrasound probes during use. In the tests described below, the ultrasound probe was covered with the sheath cover. Typically, the sheath cover is formed from a polyurethane or polyethylene film.

As used herein, the terms“coefficient of friction between the mat and a dry ultrasound probe” and“coefficient of friction between the mat and a wet ultrasound probe” refer to the coefficient of friction determined using a modification of the standard test ASTM D-1894-14 as described in the experimental section below. In the wet test, the ultrasound probe is wet with an ultrasound gel. In all tests the ultrasound probe is covered with a sterile ultrasound sheath cover. Exemplification

The invention will now be described with reference to specific Examples. These are merely exemplary and for illustrative purposes only: they are not intended to be limiting in any way to the scope of the monopoly claimed or to the invention described. These examples constitute the best mode currently contemplated for practicing the invention.

Referring to the drawings, and initially to Figs 1 to 4, there is illustrated a non-slip mat 1 according to the invention and indicated generally by the reference numeral 1. The non-slip mat 1 is useful for supporting an ultrasound probe in an operating theatre and helping prevent the probe slip off a surgical instrument table. The non-slip mat 1 has a planar configuration and a generally rectangular footprint with a curved distal end 2, a proximal end 3, a length of 150 mm, width of 100 mm, and a height of 5 mm. These dimensions have been found to be suitable for supporting most ultrasound probes commonly used in surgery. The mat 1 has an upper surface 4, an under surface 5, and a series of transverse ridges 6 that extend across the upper surface 4 of the mat 1. In the embodiment shown, the transverse ridges have a height of 2 mm at their mid-point, and have a slightly curved configuration (curving proximally towards their extremities). The transverse ridges are spaced apart longitudinally along the mat by a distance of 15 mm. A proximal ridge 7 is provided towards the proximal end 3 of the mat 1 , having a height of 3mm.

The mat is formed from an elastomeric polymer, specifically ECOFLEX® 0030, having a shore hardness of 00-30. This material has been found to be ideal for adhering to a surgical drape covered metal instrument table with minimum horizontal displacement when supporting an ultrasound probe, while allowing the mat to be removed from the drape/table without the drape sticking to the mat. This is an important consideration, as often during a procedure a radiologist will need to re-position the mat with one hand which is difficult if the mat sticks to the drape.

In use, and referring to Figure 5, the non-slip mat 1 is placed on a surgical instrument table 10 covered in a surgical drape 1 1 , and an ultrasound probe 12 having a flex 13 and covered in a sterile cover (not shown) is placed on the mat 1 as shown in Fig. 5 with a longitudinal aspect of the probe 12 parallel to a longitudinal aspect of the mat 1 , and the probe flex 13 disposed towards the proximal end 3 of the mat 1. When required during the procedure, the radiologist can easily remove the probe from the mat for use on the patient, and replace the probe on the mat when it is not required, where the non-slip mat holds the probe securely in position due to the coefficient of friction between silicone elastomer surface of the mat the probe. In addition, the under surface of the mat adheres securely to the drape surface preventing horizontal displacement of the mat with respect to the drape.

Experimental

A surgical drape was attached to a polyethylene base plate with duct tape. The mat of the invention was then placed on top of the drape. The Ultrasonic (US) probe head was covered with a sterile probe cover and was then pulled across the matd at a rate of 50 mm/min. The horizontal force required to cause the probe to slip over the mat was measured via a 1 kN load cell attached to a universal tensile testing unit. The test set up is illustrated in Fig. 6.

The coefficient of friction, m, was determined by the following formula:

Fn

m = g

Where F_h is the horizontal (pulling) force required to initiate movement of the probe and F_w is the force caused by the weight of the probe head.

Three surfaces were tested:

1 ) Drape - covered probe (no non-slip mat

2) Drape - non-slip mat of the invention formed from SYLGARD-184. - covered

probe

3) Drape - non-slip mat of the invention formed from ECOFLEX® 00-30 silicone - covered probe

Three scenarios were tested for each surface: a dry environment, a wet environment and a soiled (with US gel) environment. Each test was repeated three times. The results are provided in Table 1 below, and in Figure 7 in which the solid line represents the horizontal force applied to the probe versus the displacement when the invention is present and the dotted line represents the horizontal force applied to the probe versus the displacement when the invention is not present. The arrows indicate the moment at which the probe starts to move in both situations. At a horizontal force of up to 4.5N , the non-slip mat of the invention prevents any movement of the probe on the mat. It is also noticeable from Figure 7 (solid line) that the ridges cause an increase in friction between the mat and the probe.

Table 1

Hardness values are Shore Hardness.

The COF increases 8-fold using the mat of the invention, even in soiled/wet conditions, the mat of the invention increases the COF 4-fold.

Equivalents

The foregoing description details presently preferred embodiments of the present invention. Numerous modifications and variations in practice thereof are expected to occur to those skilled in the art upon consideration of these descriptions. Those modifications and variations are intended to be encompassed within the claims appended hereto.

Claims

CLAIMS:

1. A kit comprising a non-slip mat (1) for preventing an ultrasound probe (12) slipping from a surgical drape (11 ) covered surgical table (10), a sheath cover for an ultrasound probe, and optionally an ultrasound gel, the non-slip mat having a planar configuration with an upper surface (4) configured to support an ultrasound probe and an under surface (5) disposed for contact with the surgical drape covered surgical table, wherein the under surface of the mat comprises a non-tacky silicone elastomer configured for non-stick adherence with a surgical drape covered surface, in which the non-stick adherence is sufficient to prevent horizontal displacement of the mat on the surgical drape covered surface when an ultrasound probe is rested on the mat, and allow removal of the mat from the surgical drape covered surface without the drape sticking to the mat, wherein the upper surface comprises a non-tacky silicone elastomer and a plurality of spaced-apart transverse ridges (6).

2. A kit according to Claim 1 , in which the non-tacky silicone elastomer has a Shore hardness of 00-30.

3. A kit according to Claim 1 or 2, in which the non-slip mat is formed from a non-tacky silicone elastomer.

4. A kit according to any of Claims 1 to 3, including a plurality of sheath covers.

5. A kit according to any preceding Claim, in which the non-slip mat is configured to provide a coefficient of friction between the non-slip mat and a dry covered ultrasound probe of at least 0.8.

6. A kit according to any preceding Claim, in which the non-slip mat is configured to provide a coefficient of friction between the mat and a wet covered ultrasound probe of at least 0.4.

7. A kit according to any preceding Claim, in which the non-slip mat has a length of 130- 170mm, and a width of 80-120 mm.

8. A kit according to any preceding Claim, in which the non-slip mat has a length of 140- 160mm, and a width of 90-110 mm.

9. A kit according to any preceding Claim, in which the non-slip mat has a height of 4-6mm.

10. A kit according to any preceding Claim, in which the transverse ridges (6) have a height of 1-3 mm.

11. A kit according to any preceding Claim, in which the transverse ridges (6) have a height of about 2 mm.

12. A kit according to any preceding Claim, in which the transverse ridges (6) are spaced apart by a distance of 10-20 mm.

13. A kit according to any preceding Claim, in which the transverse ridges (6) are spaced apart by a distance of 13-17 mm.

14. A non-slip mat (1) for preventing an ultrasound probe (12) slipping from a surgical drape (1 1) covered surgical table (10), the non-slip mat having a planar configuration with an upper surface (4) configured to support an ultrasound probe and an under surface (5) disposed for contact with the surgical drape covered surgical table, wherein the under surface of the mat comprises a non-tacky silicone elastomer configured for non-stick adherence with a surgical drape covered surface, in which the non-stick adherence is sufficient to prevent horizontal displacement of the mat on the surgical drape covered surface when an ultrasound probe is rested on the mat, and allow the mat be removed from the surgical drape covered surface without the drape sticking to the mat, and wherein the upper surface comprises a non-tacky silicone elastomer and a plurality of spaced-apart transverse ridges (6).

15. A non-slip mat according to Claim 14, wherein the upper surface of the mat comprises a non-tacky silicone elastomer configured to prevent horizontal displacement of the probe on the mat under the weight of the probe flex.

16. A non-slip mat according to Claim 14 or 15, in which the mat (1 ) is formed from a non- tacky silicone elastomer.

17. A non-slip mat according to any of Claims 14 to 16, in which the non-tacky silicone elastomer has a Shore hardness of 00-30.

18. A non-slip mat according to any of Claims 14 to 17, in which the coefficient of friction between the mat and a dry covered ultrasound probe is at least 0.8.

19. A non-slip mat according to any of Claims 14 to 18, in which the coefficient of friction between the mat and a wet covered ultrasound probe is at least 0.4.

20.A non-slip mat according to any of Claims 14 to 19, in which the mat has a longitudinal aspect and a transverse aspect, where a length of the mat in the longitudinal aspect is greater than the width of the mat in the transverse aspect.

21 .A non-slip mat according to any of Claims 14 to 20, in which the mat has a length of 130- 170mm, and a width of 80-120 mm.

22. A non-slip mat according to any of Claims 14 to 21 , in which the mat has a length of 140- 160mm, and a width of 90-1 10 mm.

23. A non-slip mat according to any of Claims 14 to 22, in which the mat has a height of 4- 6mm.

24. A non-slip mat according to any of Claims 14 to 23, in which the transverse ridges (6) have a height of 1 -3 mm.

25. A non-slip mat according to Claim 24, in which the transverse ridges (6) have a height of about 2 mm.

26. A non-slip mat according to any of Claims 14 to 25, in which the transverse ridges (6) are spaced apart by a distance of 10-20 mm.

27. A non-slip mat according to Claim 26, in which the transverse ridges (6) are spaced apart by a distance of 13-17 mm.

28. A non-slip mat according to any of Claims 15 to 27, in which the under surface (5) of the mat has a suffuse planar surface.

29. A non-slip mat according to any of Claims 15 to 28, having a weight of 70-90g.

30. A method of securely placing an ultrasound probe on a surgical drape covered support surface comprising the steps of:

placing a non-slip mat according to any of Claims 14 to 30 on the surgical drape covered support surface; and placing the ultrasound probe on the non-slip mat.

31. A method according to Claim 30, in which the support surface is a surgical instrument table.

32. A method according to Claim 30 or 31 , in which the method is performed prior to or during an ultrasound guided surgical or medical procedure that employs an ultrasound probe.

33. A method according to any of Claims 30 to 32, in which the method includes a step of removing the ultrasound probe from the non-slip mat to use the probe, and optionally replacing the probe on the non-slip mat after use of the probe.

34. A method of performing an ultrasound imaging procedure that employs a covered ultrasound probe and a non-slip mat according to any of Claims 14 to 29, comprising the steps of:

placing the non-slip mat on a surgical drape covered support surface;

placing the covered ultrasound probe on the non-slip mat;

removing the covered probe from the non-slip mat and using the covered ultrasound probe to perform an ultrasound imaging procedure; and

replacing the covered ultrasound probe on the non-slip mat when the ultrasound imaging procedure is completed, whereby the non-slip mat helps prevent the covered ultrasound probe slipping off the surgical drape covered support surface during periods of non-use.

35. A method according to Claim 34 in which the support surface is a surgical instrument table.