SURGICAL INSTRUMENTS

Abstract

Surgical knives are disclosed, for initiating percutaneous access to a surgical site. The knife has a body with a rear handle and a front cutter portion. It may have a central cannulation to receive a guide wire, along a front-to-rear operating axis. The cutter portion has first and second blades opposed across the axis, each having an outward cutting edge directed laterally outwardly relative to the operating axis and a flat outward face also directed laterally outwardly relative to the operating axis and transversely to the respective outward cutting edge. The first and second outward faces of the two blades converge forwardly to their tip points, which lie close to the axis, and their cutting edges are oppositely directed. Alternatively a single blade may be used, forwardly convergent with the axis.

Claims

1-23. (canceled)

24. Surgical instrument in the form of a surgical knife for providing percutaneous access to a surgical site, wherein the instrument has a rear end, a front end and an operating axis extending from the rear end to the front end, the instrument comprises a cutter portion (2) at the front end and a body (1) having a handle portion at the rear end, and the cutter portion comprises first and second blade portions (3) opposed across the operating axis at opposite sides thereof, each of the first and second blade portions having a tip portion (310) at the front end, an outward cutting edge (30) directed laterally outwardly relative to the operating axis, and an outward face (36) also directed laterally outwardly relative to the operating axis and transversely to the respective outward cutting edge, the first and second outward faces (36) of the two blade portions converging with one another forwardly towards their tip portions (310) and respective said outward cutting edges (30) of the first and second blade portions (3) being generally oppositely outwardly directed.

25. The surgical instrument of claim 24 wherein the body (1) defines a cannulation (14) along the operating axis, to receive a guide wire (11) for guiding movement of the instrument in use.

26. The surgical instrument of claim 24 wherein the tip portions (310) of the first and second blade portions (3) are the parts thereof that lie closest to the operating axis and closest to one another.

27. The surgical instrument of claim 26 wherein said tip portions are points.

28. The surgical instrument of claim 24 wherein the angle of forward convergence of the outward faces (36) of the first and second blade portions is at least 2°, and not more than 20°.

29. The surgical instrument of claim 24 wherein said outward faces (36) of the first and second blade portions are flat.

30. Surgical instrument of claim 24 in which the outward faces (36) of the first and second blade portions diverge rearwardly such that the width between them across the operating axis at a rear extremity of the cutter portion is at least as wide as the body of the instrument immediately behind that extremity.

31. The surgical instrument of claim 24 wherein the first and second blade portions (3) are respective discrete scalpel blades attached to opposite sides of the body at a blade support portion thereof.

32. The surgical instrument of claim 24 wherein the first and second blade portions are fixed against locating formations of the body including forwardly-convergent locating faces (51) against which the blade elements are held, the locating formations including securing formations (52) by which the blade elements (3) are held in place.

33. The surgical instrument of claim 32 wherein blade elements constituting the respective first and second blade portions have openings, and retaining formations (52) of the body extend through the openings to hold the blade elements.

34. The surgical instrument of claim 24 wherein said outward cutting edge (30) of one or both of the first and second blade portions is convex in form.

35. The surgical instrument of claim 24 wherein said outward cutting edge (30) of one or both of the first and second blade portions extends from the tip portion (310) at least to the position of maximum lateral projection thereof; the blade portion outward edge continues rearwardly beyond the position of maximum lateral projection to a rearward region, and at this rearward region, all or part of the outward edge is not a sharp edge.

36. The surgical instrument of claim 24 wherein the first and second blade portions (3) are arranged with symmetry, such as two-fold rotational symmetry, around the operating axis.

37. The surgical instrument of claim 24 wherein the tip portions (310) of the first and second blade portions are each spaced from the forward projection of the operating axis, or of a cannulation when present, by not more than 0.5 mm, and/or are spaced from one another by not more than 2 mm or by not more than 1 mm.

38. Surgical instrument in the form of a surgical knife for providing percutaneous access to a surgical site, wherein the instrument has a rear end, a front end and an operating axis extending from the rear end to the front end, the instrument comprises a cutter portion at the front end and a body having a handle portion at the rear end, and the cutter portion comprises a single blade portion (3), the blade portion having a tip portion (310) at the front end, an outward cutting edge (30) directed laterally outwardly relative to the operating axis, and an outward face (36) also directed laterally outwardly relative to the operating axis and transversely to the outward cutting edge, and wherein the outward face (36) of the blade portion converges forwardly with the operating axis.

39. The surgical instrument of claim 38 wherein the body defines a cannulation along the operating axis, to receive a guide wire for guiding movement of the instrument in use.

40. The surgical instrument of claim 38 wherein the front end of the body has an outward separation face (151) axially overlapping with at least part of the blade portion (3) and directed outwardly in the opposite direction to the outward face of the blade portion, the body's separation face converging forwardly with the outward face (36) of the blade portion.

41. The surgical instrument of claim 38 wherein the tip portion of the blade portion is the part thereof that lies closest to the operating axis.

42. The surgical instrument of claim 38 wherein said tip portion is a point.

43. The surgical instrument of claim 38 wherein the blade portion (3) is double-edged.

44. The surgical instrument of claim 38 wherein the angle of forward convergence of the outward face of the blade portion and the operating axis is at least 1°, and not more than 10°.

45. The surgical instrument of claim 38 wherein said outward face (36) of the single blade portion is flat.

46. The surgical instrument of claim 24 further comprising a conduit (19) for feeding a fluid to the front end thereof during use.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Embodiments of the invention are now described by way of example, with reference to the accompanying drawings in which:

[0039] FIG. 1 is a side view of a surgical instrument which is a first embodiment of the invention, in the nature of a scalpel or plunge knife, showing also a guide wire;

[0040] FIG. 2 is a further side view of the first embodiment taken at 90° to the FIG. 1 view;

[0041] FIG. 3 is an end view from the rear end;

[0042] FIG. 4 is an end view from the front end;

[0043] FIG. 5 is an enlarged side view of the front end of the body with the blades removed, showing a blade mounting portion from the same direction as in FIG. 1;

[0044] FIG. 6 is a view of the blade mounting portion from the same direction as in FIG. 2;

[0045] FIG. 7 is a view of the body with the blades removed from the front end;

[0046] FIG. 8 is an enlarged oblique view of the front end of the instrument on a guide wire;

[0047] FIG. 9 is a section through the body at A-A of FIG. 1;

[0048] FIG. 10 is a side view of the body from the same direction as FIG. 2, with the guide wire and blades absent;

[0049] FIG. 11 is a side view of the body of a second embodiment of surgical instrument of the same general type as the first embodiment;

[0050] FIG. 12 is a longitudinal cross-sectional view of the body of the second embodiment;

[0051] FIG. 13 is an oblique view of the surgical instrument body of the second embodiment;

[0052] FIG. 14 is a fragmentary side view of the front end of a third embodiment of the invention, being a single-bladed scalpel or plunge knife, showing also a guide wire;

[0053] FIG. 15 is a further side view of the third embodiment taken at 90° to the FIG. 14 view;

[0054] FIG. 16 is a fragmentary side view of the front end of a fourth embodiment of the invention, being a single-bladed scalpel or plunge knife, again showing also a guide wire, and

[0055] FIG. 17 is a further side view of the fourth embodiment taken at 90° to the FIG. 16 view.

DETAILED DESCRIPTION

[0056] Referring firstly to FIG. 1, a surgical instrument embodying our proposals is shown in the form of a scalpel or plunge knife 100. It consists essentially of a straight elongate body 1 with a handle or grip portion 12 at its rear end, a central shaft portion 13 and a cutter portion 2 at its front end. The cutter portion consists of a blade mounting portion 5 of the body 1 and a pair of blades 3. In this embodiment the body is formed of injection-moulded plastics material and the blades are steel scalpel blades.

[0057] The body is penetrated by a longitudinal central cannulation 14, being a straight cylindrical passage extending through the instrument and providing for it to be mounted on a metal guide wire 11 (only a short segment of the guide wire being shown) so that the instrument can be slid along the guide wire 11 in use. As is well known, guide wires are used to guide the direction, position and orientation of a surgical instrument in relation to a selected surgical site.

[0058] At the cutter portion 2, a pair of identical steel scalpel blades 3—constituting the blade portions of the concept described above—are mounted opposed across the axis defined by the central cannulation 14 and guide wire 11. Each blade 3 has a cutting edge 3 directed generally laterally outwardly relative to the axis and leading forward to a point 310 adjacent the axis, lying closely against the guide wire 11 in use (see FIG. 2).

[0059] The following terminology is used to refer to the orientation of the various components. A forward direction (F) and a rearward direction (R) are defined longitudinally as indicated in FIG. 2. Then, with reference to the front end view of FIG. 4, it can be seen that laterally the outward faces 36 of the respective blades 3 are directed oppositely away from each other, and these outward lateral directions are designated the separation direction (S). The curved cutting edges 30 of the blades are directed in respective lateral directions opposite and approximately parallel to one another and also perpendicular to the separation direction S, and these directions are designated the cut direction C. Immediately behind the points, tangents to the cutting edges initially diverge from one another (in the cut direction) at about 110°.

[0060] With reference to the use of the instrument, it will be understood that the instrument is advanced forwardly into the skin and underlying tissue along the guide wire 11, entering at the points 310 of the two blades 3 and thereafter enlarging a cut simultaneously in opposite directions in the cut direction C, while opening up or spreading the sides or walls of the cut away from each other in the separation direction S. This separation is achieved by the advancing of the instrument in combination with the rearward divergence of the outward surfaces 36 of the blades 3, continuing with a correspondingly divergent region 135 of the body shaft 13 behind the blades. The divergent outward surfaces progressively separate and open the sides of the incision.

[0061] While the separation and cut directions are proposed as orthogonal directions radial of the axis defined by the central cannulation 14 (the operating axis in this embodiment), references to components or motions being directed in the separation direction, cut direction or axial direction are not necessarily intended to require exact alignment with those directions, but general alignment with those directions for functional purposes. They are terms for ease of explanation and description.

[0062] The grip portion 12 has a set of radial grip projections 15—here in the form of lobes but they could take a variety of forms—so that the user can easily control the direction and rotational alignment of the instrument. The central cannulation 14 is open laterally through a series of windows 145 opening alternately to opposite sides of the body 1. These are not functional in the instrument, but are to facilitate moulding of a component having the desired cannulation. The method uses plural radially-inserted mould elements, at a series of respective adjacent longitudinal regions which are axially adjoining but circumferentially spaced. It enables formation of a long central bore, effectively of uniform diameter (since the narrow side openings do not allow escape of a stiff wire), without the need for a removable longitudinal mandrel (which would require a draft angle and give non-uniform diameter), or a separate boring or drilling step. This method may be an independent aspect of our proposals.

[0063] At the front end of the body 1 the blade mounting portion 5 (see also FIGS. 5-7) has a generally spatulate form with a pair of opposed flat blade support surfaces 51 which are angled towards each other at a convergence angle of 8°, and are angled symmetrically to either side of the operating axis. That is to say, the (minimum) angle α—see FIG. 6—between each support surface 51 and the operating axis is 4°. The front opening 141 of the central cannulation 14 is at their front ends. A shaped stake projection 52 in the form of an elongate rib projects up from each blade support surface 51 and fits a correspondingly-shaped mounting slot 38 of the blade 3 so as to assure its exact longitudinal orientation. The blade 3 can be fixed in place by conventional “staking” i.e. heat-deforming the stake elements 52 so that they spread down over the outer surfaces of the blades; this is a well-known technique.

[0064] In the fitted position—see also FIG. 8—the tip regions 31 of the blades project forwardly of the front end of the body so that the extreme points 310 of the blades touch the guide wire 11 emerging between them. In this embodiment the blades are mounted so that when the guide wire is absent their points nearly touch, and are therefore positively urged against the guide wire surface with a slight bias owing to resilient flexion of the blades as the guide wire is inserted. This helps to avoid cut tissue catching between or behind the blade tips. The blades in this embodiment are single-edged, with a relatively straight non-cutting and non-functional rear edge 38 which extends down to the point 310, and a convex cutting edge 30 extending from the tip 310 around the convex belly 33 of the blade reaching the maximum lateral projection from the axis, and then a trailing or rearward region 34 descending back towards the non-sharpened shank 35 at the rear end of the blade, which is functional only for location and handling. The blades are flat, and identical to one another. Such scalpel blades are readily commercially available: the ones shown are of the No. 22 pattern and a variety of similar forms are available, such as numbers 10, 13, 18, 19, 20-24 and 36. However it is desirable that the blade presents a substantial planar and plain outward face, for which purpose blade types 22, 22a and 24 are especially suitable. However depending on the application, blades of substantially different forms may be used. They need not necessarily have convex cutting edges. Equally they need not be single-edged, they might be double edged with cutting edges directed in both directions relative to the axis although this may be redundant if the two blade portions co-operate to form a single incision which is the preferred action. Also it is possible that the outward face of one or both of the blade portions is not planar but convex, e.g. convexly curved, in a section plane transverse to the operating axis.

[0065] FIGS. 11 to 13 show the body of a second embodiment having the same general features as the first embodiment, so that the corresponding reference numerals are used. A first difference is that the body 1 is of stainless steel rather than injection-moulded plastics. As a result the cannulation 14 can be a simple drilled bore and the shaft portion 13 is rather more slender especially in the separation direction. This embodiment has a local lateral enlargement or shoulder 138 of the body just behind the rear ends of the blades (blades not shown) to maintain separation of the sides of the incision in front of the narrower shaft portion. The mounting ribs 52 are formed with overhangs to trap the blades in position. The convergent angle of the blade support surfaces 51 and the types of blades to be used may be the same as for the first embodiment.

[0066] A further feature shown here is the provision of a supplementary channel 16 running alongside the cannulation 14 and acting as a locating holder for a conduit such as a flexible medication tube 19 (shown in broken lines in FIG. 12) for feeding liquid medication such as a local anaesthetic and/or a vasoconstrictor such as adrenaline to the cutting site. The front end of the channel 16 angles in through the body at a front feed inlet portion 161 to intersect the cannulation 14 so that liquid medication can be fed out through the front opening 141 thereof at the time of making the incision.

[0067] FIGS. 14 and 15 show the front end of a third embodiment, with a single blade. The body and its handle may be as in previous embodiments. Reference numerals refer to the same parts as above.

[0068] The cutter portion consists of a single steel scalpel blade 3 which is flat, and has an inward surface lying against an outward support face of the body's blade support portion defining a predetermined angle with the operating axis as in the embodiments above. In this case the angle (α.sup.2 in FIG. 15) is 3.5°. Blade 3 is double-edged and symmetrical in its plane about its longitudinal centre line. It has a central tip 310 positioned so as to be closely in contact with the guide wire 11 in use as shown in FIG. 15 (optionally with some slight interference). The cutting edge 30 continues up divergently to either side of the tip 310 as a pair of convex laterally-directed cutting edges each directed in a respective sense of the cut direction C. Reaching a maximum lateral dimension, the convex cutting edges then converge back upwardly and inwardly to a neck where they meet a shank portion 35 for anchoring of the blade 3 to the support surface of the body shank 13. The shank portion does not have cutting edges. As in the second embodiment above, the body surface makes a shallow step 131 immediately behind the rear edge of the blade 3. The rear edge is recessed in front of the step so as not to catch on withdrawal of the instrument.

[0069] On the side opposite from the single blade the body's blade support portion has a plain smooth surface 151 acting as a separation surface, in the sense that it is smoothly convergent in the forward direction towards the operating axis. As the scalpel or plunge knife is inserted into an incision made by the blade 3, it acts in concert with the opposed outward face 36 of the blade 3 to open up the incision. In this embodiment the body's separation face 151 includes a flat surface which makes a convergence angle (al in FIG. 15) the same as that of the blade surface i.e. 3.5°, but of course in practice it might not be the same.

[0070] In this embodiment the opposed separation surface 151 of the body terminates about half-way along the blade 3 (the blade length considered as a whole, since its entire outward surface including the shank can act for guiding the opening of an incision). In alternative embodiments the opposed body portion might continue forwardly of this, and may be shaped to approach more closely to the blade tip around the cannulation opening (assuming that a cannulation is provided). This single-blade embodiment has the advantage of simplicity and economy since only one blade is required.

[0071] The illustrated blade in the third embodiment is not a standard scalpel blade. FIGS. 16 and 17 show a fourth embodiment, in the same views as for the third embodiment, illustrating as an alternative the use of a standard single-edged scalpel blade—here a No. 22 blade as in the first and second embodiments—with the same body form and angling of the blade surface as in the third embodiment. A difference here is that the blade is slightly tilted across the axis so that, viewed in the separation direction as in FIG. 16, the operating axis falls about half-way (laterally) across its cutting edge. For the illustrated No. 22 blade this is an inclination 13 to the axis (FIG. 16) of about 4° for the standard mounting slot (as projected onto a plane containing the operating axis that makes the smallest angle with the blade plane). This disposes the cutting edge 30 so that the incision will be formed to either side of the cannulation line to a similar lateral extent.

[0072] The closest approach of the blade edge 30 to the guide wire 11 is desirably a contacting approach. Since the tip point 310 of this blade form extends axially in front of that contact point, and also represents the furthest lateral extent on that side, the tip point 310 projects slightly inwardly—as viewed in the cut direction C, FIG. 17—to overlap the locus of the guide wire in use.

[0073] Operation in practice is the same as for the previous embodiments. The tip point 310 can initiate an incision effectively although it does not lie closest to the operating axis.

[0074] Notes

[0075] In respect of numerical ranges disclosed in the present description it will of course be understood that in the normal way the technical criterion for the upper limit is different from the technical criterion for the lower limit, i.e. the upper and lower limits are intrinsically distinct proposals.

[0076] For the avoidance of doubt it is confirmed that in the general description above, in the usual way the proposal of general preferences and options in respect of different features of the surgical instrument constitutes the proposal of general combinations of those general preferences and options for the different features, insofar as they are combinable and compatible and are put forward in the same context.