LOW PARTICULATE SURGICAL SPEAR

Abstract

There is disclosed a surgical sponge device comprising a sponge portion and a handle portion The sponge portion is formed from an open cell foam material having an external surface. The handle portion comprises a grip at one end thereof that compressively grips mutually opposed external surface regions of the sponge portion an edge of the sponge portion. Substantially all of the external surface of the sponge portion is formed as an uncut external surface, except for at least one predetermined region of the external surface that is located close to the grip, the at least one predetermined region of the external surface being formed as a cut external surface. Because most of the external surface of the sponge portion is uncut, it will be free of unwanted particulate material.

Claims

1. A surgical sponge device comprising: a sponge portion and a handle portion, wherein the sponge portion is formed from an open cell foam material having an external surface, wherein the handle portion comprises a grip at one end thereof that mechanically grips mutually opposed external surface regions of the sponge portion an edge of the sponge portion, and wherein substantially all of the external surface of the sponge portion is formed as an uncut external surface, except for at least one predetermined region of the external surface that is located close to the grip, the at least one predetermined region of the external surface being formed as a cut external surface.

2. The device as claimed in claim 1, wherein the uncut external surface is substantially free of particulate matter.

3. The device as claimed in claim 1, wherein the grip comprises a pair of mutually opposed gripping members.

4. The device as claimed in claim 1, wherein the sponge portion is formed from a polyvinyl alcohol-based (PVA) sponge material.

5. The device as claimed in claim 4, wherein the uncut external surface is less porous than the open cell structure inside the foam material.

6. The device as claimed in claim 1, wherein the sponge portion is formed from a cellulose-based sponge material.

7. The device as claimed in claim 1, wherein the sponge portion is formed from a polyurethane-based sponge material.

8. The device as claimed in claim 1, wherein the sponge portion is formed from a sponge material that is compressible when dry.

9. The device as claimed in claim 1, wherein the sponge portion has a substantially triangular or triangular prism shape, with an apex of the substantially triangular or triangular prism shape being disposed away from the handle portion, and an opposed base of the substantially triangular or triangular prism shape being gripped by the grip.

10. The device as claimed in claim 1, wherein the sponge portion has a substantially coffin-like shape.

11. The device as claimed in claim 1, wherein the sponge portion has a substantially teardrop-like shape.

12. The device as claimed in claim 1, wherein the sponge portion is compressed and relatively rigid prior to use, and wherein the sponge portion expands and softens upon absorption of liquid.

13. The device as claimed in claim 1, wherein only an edge region of the sponge portion that is held by the grip is compressed, the rest of the sponge portion being in an expanded configuration even when dry.

14. A sponge web formed from an open cell foam material, the sponge web comprising: a plurality of individual sponge portions each having a base edge and an opposed tip region, the sponge web having an uncut external surface, and adjacent sponge portions being connected to each other in the web at their base edges.

15. The sponge web as claimed in claim 14, wherein the uncut external surface is substantially free of particulate matter.

16. The sponge web as claimed in claim 14, wherein the plurality of individual sponge portions comprise first and second rows of facing sponge portions arranged such that the respective tip regions of the first and second rows interdigitate but are spaced from each other by a gap.

17. The sponge web as claimed in claim 14, further comprising a plurality of handle portions each having a grip at one end thereof, the grip of each handle portion being attached to the base edge of an individual sponge portion.

18. The sponge web as claimed in claim 14, formed from a polyvinyl alcohol-based (PVA) sponge material.

19. The sponge web as claimed in claim 18, wherein the uncut external surface is less porous than the open cell structure inside the foam material.

20. The sponge web as claimed in claim 14, formed from a cellulose-based sponge material.

21. The sponge web as claimed in claim 14, formed from a polyurethane-based sponge material.

22. The sponge web as claimed in claim 14, formed from a sponge material that is compressible when dry.

23. A method of manufacturing a surgical sponge device comprising a sponge portion and a handle portion, the method including the steps of: i) providing a mould configured to define a plurality of voids that are connected to each other only along at least one edge portion of the mould; ii) filling the mould with reagents selected to generate an open cell foam material within the mould, the open cell foam material taking the form of a plurality of sponge portions having shapes defined by the plurality of voids, the sponge portions connected to each other only at base regions thereof corresponding to the void connections in the mould, the open cell foam material having an uncut external surface where it contacts the mould; iii) removing the open cell foam material from the mould; iv) washing and treating the open cell foam material; v) subsequent to step vi); connecting multiple handle portions to the open cell foam material at the base regions of the sponge portions and cutting the open cell foam material to separate the open cell foam material into a plurality of surgical sponge devices, each device having a handle portion connected to a sponge portion formed of the open cell foam material having the uncut external surface formed substantially all of its external surface except for at least one predetermined region of the external surface that is located close to the point of connection of the handle portion, the at least one predetermined region of the external surface being formed as a cut external surface, and wherein the handle portions each comprise a grip at one end thereof that mechanically grips mutually opposed external surface regions of the sponge portion an edge of the sponge portion.

24. The method according to claim 23, wherein the mould comprises a single mould cavity with a plurality of voids, each void defining a sponge portion.

25. The method according to claim 23, wherein the mould has a saw-tooth configuration, each void comprising a tooth of the saw-tooth configuration.

26. The method according to claim 23, wherein the mould includes a central divider having a zig-zag or wave profile defining two sets of complementary, inter-engaging voids.

27. The method according to claim 23, wherein the open cell foam material is dried and pressed between steps iv) and v).

28. The method according to claim 27, wherein only edge portions of the open cell foam material are pressed between steps iv) and v).

29. The method according to claim 23, wherein inside surfaces of the mould have a smooth texture, thus resulting in an external skin on the open cell foam material that has a smooth texture.

30. The method according to claim 23, wherein inside surfaces of the mould have a roughened texture, thus resulting in an external skin on the open cell foam material that has a roughened texture.

31.-33. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Embodiments of the invention are further described hereinafter with reference to the accompanying drawings, in which:

[0046] FIG. 1 shows a prior art surgical spear in pressed and expanded conditions;

[0047] FIG. 2 shows a surgical spear of an embodiment of the present disclosure in pressed and expanded conditions;

[0048] FIG. 3 shows a sponge web with an uncut external surface;

[0049] FIG. 4 shows an alternative sponge web with an uncut external surface;

[0050] FIG. 5 shows a mould suitable for casting the sponge web of FIG. 4;

[0051] FIG. 6 shows how the sponge web of FIG. 4 can be trimmed;

[0052] FIG. 7 shows the addition of handle portions to the edges of the sponge web of FIG. 4;

[0053] FIG. 8 shows how the sponge web and attached handles portions of FIG. 7 can be cut into surgical spears having different base shapes;

[0054] FIGS. 9 and 10 show examples of shapes for the surgical spears;

[0055] FIGS. 11 to 14 show further alternative sponge webs;

[0056] FIG. 15 shows the sponge web of FIG. 4 subjected to a partial edge press and to a full press;

[0057] FIG. 16 shows the edge pressed sponge web of FIG. 15 provided with handle portions; and

[0058] FIG. 17 is a process flow chart illustrating a manufacturing technique.

DETAILED DESCRIPTION

[0059] FIG. 2 shows a surgical spear 1 according to an embodiment of the present disclosure in both pressed and expanded conditions, and in two orientations. The spear 1 comprises a triangular surgical sponge portion 2 having an apex 3 and a base portion 4. The sponge portion 2 is made from an open cell foam material such as a cast polyvinyl alcohol (PVA), cellulose, polyurethane or other material having an uncut external surface 10. The spear 1 further comprises a handle portion 5, typically made of a plastic or thermoplastic material, the handle portion 5 including a pair of gripping members 6. The gripping members 6 are configured for gripping the base portion 4 of the surgical sponge portion 2. The only cut external surface portions of the sponge portion 2 are the edge portions 11 and, optionally, the base edge portion 12. It can be seen that the cut external surface portions 11, 12 comprise only a very small part of the overall surface area of the sponge portion 2, and are located close to the gripping members 6 and thus remote from the apex 3 of the sponge portion 2, which is the part of the surgical spear 1 that is used for contacting a surgical site. A substantial majority of the overall surface area of the sponge portion 2 comprises the uncut external surface 10, which is free of particulate. Unlike the prior art spear of FIG. 1, there is no internal paddle-shaped member 104, and the shape of the spear 1 is similar or identical to that of traditional surgical spears preferred by many surgeons.

[0060] FIG. 3 shows a web 7 of surgical sponge material after it has been cast and cured in a mould of complementary shape, but prior to pressing. The web 7 has a saw-tooth configuration, with individual triangular surgical sponge portions 2 joined together at their base portions 4. Each surgical sponge portion 2 has a pointed apex 3. In the specific embodiment shown in the Figure, the web 7 has a thickness of about 8 mm, and the base portion 4 of each triangular surgical sponge portion 2 is about 8 mm wide. The base portions 4 have a height of about 5 mm for ease of handling during processing. The surface portions of the web 7 that have been in contact with the mould comprise uncut external surface portions 10 which are substantially free of undesirable particulate. The embodiment shown has 16 triangular surgical sponge portions 2 joined together in the web 7, but it will be appreciated that other numbers of sponge portions 2 may be formed in a web 7 as required.

[0061] FIG. 4 shows an alternative web 7 of surgical sponge material after is has been cast, cured and removed from a mould. The web 7 is similar to the web 7 of FIG. 3, except that it has been formed in a double-sided mould (see FIG. 5). This allows the simultaneous casting of two sets of inter-engaging triangular surgical sponge portions 2, each set being held together by a respective base portion 4. After pressing and drying, the thickness of the web 7 is around 1.4 mm.

[0062] FIG. 5 shows a cut open or cross section of a mould 15 suitable for casting the sponge web 7. The mould 15 includes a central divider 16 that serves to define the saw-tooth configuration of the sponge portions 2. It will be understood that the central divider 16 may take shapes other than a zig-zag shape, depending on the desired shape of the finished surgical spear sponge portions 2. For example, the apexes may be flattened or rounded rather than sharply pointed, or the central divider may have a sinusoidal other configuration as required. A pathway 17 extends around the central divider 16 and inside inner walls 18 of the mould 15 so as to allow the liquid sponge forming components easily to fill the mould 15, and to define the connecting base portions 4 of the sponge web 7. When casting the sponge web 7, surface areas of the sponge web that cure against surfaces of the mould 15, such as the base 19 and a matching top portion (not shown), the inner walls 18 and the central divider 16, will form the uncut external surfaces 10 of the sponge web 7.

[0063] FIG. 6 shows how the sponge web 7 may optionally be trimmed along lines 20 after curing and pressing so as to adjust the width of the base portions 4. Although this will expose an additional cut surface 12, this cut surface will be held in the grip 6 of the handle portion 5 and hence will not come into contact with the surgical site. Accordingly, the risk of particulate contamination remains very low.

[0064] FIG. 7 shows the pressed sponge web 7 with handle portions 5 injection moulded and attached along both opposed edges 12 of the web 7.

[0065] FIG. 8 shows how the pressed sponge web 7 with attached handle portions 5 may be cut into individual surgical spears 1 with sponge portions 2 of different shapes, as shown in FIGS. 9 and 10. Cut lines 21 are substantially perpendicular to a longitudinal axis of the sponge web 7 and result in surgical spears 1a with sponge portions 2a having parallel cut surfaces 11a. Cut lines 22 are straight but angled relative to the longitudinal axis of the sponge web 7, resulting in surgical spears 1b with coffin-shaped sponge portions 2b having convergent cut surfaces 11b. Cut lines 23 are curved, resulting in surgical spears 1 c with teardrop-shaped sponge portions 2c having curved cut surfaces 11c. It can be seen that the sponge portions 2a, 2b and 2c shown in FIG. 10 all have flattened apexes 3, in contrast to the pointed apexes 3 of the sponge portions 2a, 2b, 2c of FIG. 9. This is simply to illustrate that different shapes may be obtained by appropriate configuration of the mould 15 and central divider 16.

[0066] The surgical spear 1d of FIGS. 9 and 10 has a rounded sponge portion 2d with a rounded cut surface 11d. The rounded sponge portion 2d may be generally disc-shaped when pressed, and may expand into a ball-shaped sponge when subsequently wetted. The surgical spear 1d of FIGS. 9 and 10 may be made from a sponge web 7 as shown in FIG. 14.

[0067] Each of the sponge portions 2a, 2b, 2c and 2d has an uncut external surface 10 extending over substantially all of the external surface other than areas close to the grips 6 of the handle portions 5.

[0068] FIG. 11 shows an alternative sponge web 7 with sponge portions 2 having a conical shape, and connected to each other at base portions 4.

[0069] FIG. 12 shows an alternative sponge web 7 with sponge portions 2 having a pyramidal shape, and connected to each other at base portions 4.

[0070] FIG. 13 shows an alternative sponge web 7 with sponge portions 2 having a triangular prism shape, and connected to each other by thin bridging portions 24. It will be appreciated that in this embodiment, the exposed base surface 25 of each sponge portion can be formed as an uncut external surface, with only very small cut surface portions being exposed when cutting away the bridging portions 24 after attaching the handle portions 5.

[0071] FIG. 14 shows an alternative sponge web 7 with sponge portions 2 having a ball or spherical shape, and connected to each other at base portions 4. This sponge web 7 may be used for manufacturing the surgical spears 1d of FIG. 10.

[0072] In each of FIGS. 11 to 14, the sponge web 7 is shown in an expanded condition, for example before pressing. It is a property of certain open cell foam materials, in particular PVA sponge and cellulose sponge materials, that they may be cast in a mould, optionally washed or treated with chemical solutions, and then dried and pressed so as to occupy a much smaller volume. The dried and pressed material will be relatively hard and stiff. When the dried and pressed open cell foam material is wetted again, it will absorb liquid and expand to its original volume. In addition, the wetted, expanded open cell foam material may be significantly softer and more pliable than when in the dried and pressed form. Moreover, the soft, pliable, wetted and expanded open cell foam material, if allowed to dry will remain in the expanded state, although it will revert back to a relatively hard and stiff state.

[0073] Pressing the sponge web 7 also facilitates the attachment of the gripping members 6 of the handle portion 5 to the sponge portion 2.

[0074] FIG. 15 shows an alternative, partially pressed sponge web 7 next to a fully pressed sponge web 7. The partially pressed sponge web 7 is pressed only along the base edge portions 4, leaving a central portion 35 of the sponge web 7 and the sponge portions 2 in an expanded state. This may be preferred for certain applications.

[0075] As shown in FIG. 16, the partially pressed sponge web 7 may have handle portions 5 attached to the pressed base edge portions 4 while leaving a central portion 35 of the sponge web 7 and the sponge portions 2 in an expanded state. The sponge web 7 can then be cut between the points of attachment of the handle portions 5 so as to form individual surgical spears 1.

[0076] FIG. 17 is a process flow chart showing the manufacturing steps according to one embodiment. Firstly, an appropriate open cell foam forming composition in liquid form (e.g. PVA or cellulose-based) is prepared and then cast into a mould. The foam forming composition is allowed to react and cure in the mould, and the sponge web thus formed is then removed from the mould, washed, and chemically processed so as to remove any harsh chemicals or materials that were used to form and/or cure the foam material of the sponge web. An optional step of treating the sponge material to enhance its performance may be applied, an exemplary treatment formula being a mixture of surfactant and glycol. The web is then dried, pressed flat and the handle portions are moulded on a separate production line. The web is then separated by cutting into individual surgical spears, depending on the final shape required, with attached handles. Finally, the surgical spears are inspected, packaged and sterilised.

[0077] Throughout the description and claims of this specification, the words comprise and contain and variations of them mean including but not limited to, and they are not intended to (and do not) exclude other moieties, additives, components, integers or steps. Throughout the description and claims of this specification, 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.

[0078] Features, integers, characteristics, compounds, chemical moieties or groups described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The invention is not restricted to the details of any foregoing embodiments. The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0079] The reader's attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.