AU2004205213B2

AU2004205213B2 - Instrument for cranial flap clamp

Info

Publication number: AU2004205213B2
Application number: AU2004205213A
Authority: AU
Inventors: James P Hearn; Sean H Kerr; John H Manthorp
Original assignee: Synthes AG Chur
Current assignee: Synthes GmbH
Priority date: 2000-07-27
Filing date: 2004-08-24
Publication date: 2005-08-11
Anticipated expiration: 2021-06-07
Also published as: AU2004205213A1

Description

AUSTRALIA

Patents Act COMPLETE SPECIFICATION

(ORIGINAL)

Class Int. Class Application Number: Lodged: Complete Specification Lodged: Accepted: Published: Priority Related Art: Name of Applicant: Synthes AG Chur Actual Inventor(s): John H Manthorp, James P Hearn, Sean H Kerr Address for Service and Correspondence: PHILLIPS ORMONDE FITZPATRICK Patent and Trade Mark Attorneys 367 Collins Street Melbourne 3000 AUSTRALIA Invention Title: INSTRUMENT FOR CRANIAL FLAP CLAMP Our Ref: 726567 POF Code: 44501/171481 The following statement is a full description of this invention, including the best method of performing it known to applicant(s): -1- 6006q "om Phillips Ormonde Fitzpatrick Tue 26 Jul 2005 09:.26;22 EST Page 5 of la SInstrument for cranial flap clamp 0 The present application is a divisional application from Australian Patent Application number 2001260010 the entire disclosure of which Is incorporated N 5 herein by reference The present invention is directed to an instrument for a cranial flap clamp for Sattaching a bone flap to a skull.

Craniotomies are surgical procedures performed in the treatment of various brain Sproblems, such as tumors, aneurysms, blood clots, head injuries, abscesses, and the like. During a craniotomy procedure, access to the brain is achieved by the creation of a hole in the bone that defines the skull. The hole or "window" in the skull is usually created by identifying the area of the brain to which access is needed, drilling several holes into the skull near the periphery of this area, inserting a cutting tool into one of the holes, and making cuts from one hole to another. Removing the cut-out area of the skull, generally referred to as a bone flap, allows the desired access to the brain.

If all of the drilled holes are joined by cuts, such that the cuts form a complete outline of the "window", then the bone flap can simply be removed. Alternatively, if the cuts form only a partial outline of the window, the bone flap can be bent out of the way, in a hinge-like manner. Although the size and shape of the bone flap will vary with the desired cranial access area and size, a typical bone flap would be generally rectangular in shape and approximately four by six centimeters.

After the desired medical or surgical procedure on the brain has been performed, the bone flap must be replaced and held in a stable position to allow the skull to heal. There are many methods available for affixing the bone flap to the skull.

One general method, for example, requires drilling pairs of holes in the edges of the skull and bone flap, threading wire through the holes, and twisting or tying the ends of the wire together to secure the edges of the bone flap to the skull.

Disadvantages of this method include the tedious nature and length of time W:\sharon\adria n\Divisionals\AC 2001 260010 Div.doc 28/07 2005 TUE 09:23 [TX/RX NO 6533] 1005 required for the procedure and the possibility of injury from drilling the holes too deep or from the sharp ends of the wires.

Another method of fixation generally involves the use of bone plates which are secured across the gaps between the bone flap and skull by screws. The disadvantages associated with the use of plates and screws relate to the undesirable cosmetic appearance resulting from the protrusion of the plate and screw above the bone surface. As there is minimal intervening soft tissue between the skull and the skin, unappealing external appearance is particularly a problem.

The lack of soft tissue also has the unwanted consequence of permitting the patient to feel the plate and screw simply by pressing on the scalp.

From DE-C 198 32 798 LERCH an instrument for applying a cranial flap clamp is known to the applicant. This tool has the disadvantage that the extension member may not be crimped after the two clamping members of the cranial flap clamp have been positioned.

Therefore no tool is available for the surgeon with which he can easily crimp an extension member of a cranial flap clamp consisting of two clamping members and an extension member.

On this point, the invention intends to provide remedial measures. The invention is based on the objective of providing a securing instrument that firstly allows to move the clamping members of the cranial flap clamp from a first to a second position and secondly allows to crimp the extension member which connects the two clamping members in-situ by means of a grimping assembly being mounted on the same securing instrument.

The above discussion of documents, acts, materials, devices, articles and the like is included in this specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any of these matters formed part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed in Australia before the priority date of each claim of this application.

C:\DOCUME-\sdear\LOCALS-I\Temp\AC 2001 260010 Div.doc According to a first aspect, the present invention provides a securing instrument for a cranial flap clamp including: a) first and second pivotally connected handles each of said handles having proximal and distal portions; b) a gripping arm operatively connected with the first handle and having proximal and distal portions; c) a tensioning arm operatively connected with the second handle and having proximal and distal portions, the gripping and tensioning arms movable in response to movement of the first and second handles; d) a slot extending through the distal portions of the gripping and tensioning arms for receiving the extension member of a cranial flap clamp; e) a clamping element operatively associated with the slot and having active and inactive configurations, the inactive configuration allowing sliding of an extension member of a cranial flap clamp through the slot and the active configuration clamping a portion of an extension member against a wall of the slot to inhibit sliding of an extension member through the slot; and f) a crimping assembly operatively associated with at least one of the gripping and tensioning arms for crimping an extension member, g) wherein pivoting of the first and second handles causes the gripping and tensioning arms to separate with the tensioning arm engaging the outer surface of a second clamping member of a cranial flap clamp and the clamping element in the active position thereby moving the first and second clamping members of a cranial flap clamp from the first position to the second position.

The present invention relates to a securing instrument for use with a cranial flap clamp. The securing instrument has first and second pivotally connected handles, a gripping arm operatively connected with the first handle, and a tensioning arm operatively connected with the second handle. The gripping and tensioning arms are movable in response to movement of the first and second handles and a slot extends through the distal portions of the gripping and tensioning arms for receiving the extension member of the cranial flap clamp. The securing instrument also includes a clamping element operatively associated with the slot. The clamping element has an inactive configuration, allowing sliding of the extension member through the slot, and an active configuration, clamping a portion of the C:\DOCUME-1l\sdear\LOCALS-1\Temp\AC 2001 260010 Div.doc extension member against a wall of the slot to inhibit sliding of the extension member through the slot. A crimping assembly is operatively associated with the arms for crimping the extension member.

In use, pivoting of the first and second handles causes the gripping and tensioning arms to separate with the tensioning arm engaging the outer surface of the second clamping member and the clamping element in the active position, thereby moving the first and second clamping members from the first position to the second position.

The clamping element can be a clamp rotatably coupled to the gripping arm so that rotation of the clamp within the slot upon separation of the gripping and tensioning arms moves the clamping element from the inactive configuration to the active configuration. Furthermore, a resilient member, such as a spring, can bias the clamping element in the active configuration when the gripping and tensioning arms are separated. The tensioning arm can include a foot with a ramped surface maintaining the clamping element in the inactive configuration when the gripping and tensioning arms are in contact.

In an exemplary embodiment, the crimping assembly comprises a slider having a crimping edge for crimping the extension member and sides configured and dimensioned for sliding in a grooved end of the tensioning arm, and a link operatively associated with the tensioning arm for sliding movement with respect thereto. The link has a distal end coupled to the slider and a proximal end with teeth. A lever is rotatably coupled to the tensioning arm and has a distal end with teeth engaging the teeth of the distal end of the link. The crimping assembly can also include a cutting stop that cooperates with the crimping edge of the slider to crimp and cut the extension member.

In order to isolate the distal end of the securing instrument so that only the distal end is in contact with the cranium, both the gripping and tensioning arms can have a curved or angled intermediate portion so that the distal portion of the gripping arm extends from the intermediate portion substantially parallel to the proximal portion.

C:\DOCUME-1\sdear\LOCALS-1\Temp\AC 2001 260010 Div.doc A resilient element can be placed between the first and second handles, thereby biasing the first and second handles away from each other. In order to maintain the first and second handles at a given position, the securing instrument can include a locking bar having a first end pivotably coupled to the first handle and a curved body portion with a plurality of teeth and a locking clip pivotably coupled to the second handle and having a through channel. The locking clip is movable between a free position in which the locking bar is moveable in and out of the channel and a ratchet position in which the teeth of the locking bar engage an edge of the channel to prohibit the locking bar from moving out of the channel.

FIG. 1 is side view of a securing instrument for use with a cranial flap clamp; FIG. 2 is a cross sectional view of the distal portion of the securing instrument of FIG. 1; FIG. 3 is a cross sectional view of the proximal portion of the gripping arm of the securing instrument of FIG. 1; and FIG. 4 a side view of a cranial flap clamp for use with the securing instrument of FIGs. 1 to 3.

The present invention relates to an instrument for use with a cranial flap clamp (Fig. 4) for fixing a bone flap to a skull. Typically, such clamps include a first clamping member 12, an extension member 16, and a second clamping member 14. Preferably, at least a portion of the inner surface 18 of the first clamping member 12 is positionable against inferior surfaces of the bone flap and skull and at least a portion of the inner surface 28 of the second clamping member 14 is positionable against superior surfaces of the bone flap and skull. The extension member 16 extends from the first clamping member 12 and is configured and dimensioned to fit between the bone flap and the skull. The second clamping member 14 has an opening through its inner and outer surfaces 28;30 for slidably receiving the extension member 16.

C:\DOCUME-I\sdear\LOCALS-I\Temp\AC 2001 260010 Div.doc Securing instrument 210 includes first and second handles 212, 214. First and second handles 212, 214 are pivotably connected such that upon squeezing, the distal ends of first and second handles 212,214 spread apart from each other. A resilient element 216, such as a leaf spring, is located between first and second handles 212, 214 and biases their proximal ends away from each other so that upon releasing of the squeezing pressure, the distal ends of first and second handles 212, 214 pivot back toward each other until contact.

A locking mechanism can be provided to resist the biasing force of resilient element 216. For example, a locking clip 218 is located on second handle 214 and is movable between a free position in which a locking bar 220 is free to move through a channel in locking clip 218 and a ratchet position in which locking bar 220 can only move through locking clip 218 in one direction. This ratchet mechanism allows first and second handles 212, 214 to maintain their relative positions after squeezing and release of the squeezing pressure. In order to create the ratchet effect, a portion of locking bar 220 can be provided with teeth 222 that engage an edge of the channel when locking clip 218 is in the ratchet position.

A gripping arm 224 is operatively connected with first handle 212 and a tensioning arm 226 is operatively connected with second handle 214. Gripping and tensioning arms 224, 226 are movable in response to movement of the first and second handles. Thus, as first and second handles 212, 214 are squeezed, gripping and tensioning arms 224, 226 separate or spread apart from each other.

A slot 228 extends through the distal portions of gripping and tensioning arms 224, 226 for receiving the extension member 16 of the cranial flap clamp 10. Gripping and tensioning arms 224, 226 can be made as straight extensions from the distal ends of their respective handle. In an exemplary embodiment, however, each of gripping and tensioning arms 224, 226 has a curved body portion with the distal end of securing instrument 210 isolated from the rest of the instrument, so that in use, only the distal end of securing instrument 210 is in contact with the cranium.

C:\DOCUME-I\sdear\LOCALS-1\Temp\AC 2001 260010 Div.doc 7 A clamping element 230 is operatively associated with slot 228. Clamping element 230 has an inactive configuration in which extension member 16 can freely slide through slot 228 and an active configuration in which a portion of extension member 16 is clamped against a wall of slot 228 to inhibit sliding of the extension member 16 through slot 228. Clamping element 230 includes a clamp 232 rotatably coupled to gripping arm 224. Rotation of clamp 232 within slot 228 upon separation of gripping and tensioning arms 224, 226 moves clamping element 230 from the inactive configuration to the active configuration. A resilient member 234 biases clamping element 230 in the active configuration when gripping and tensioning arms 224, 226 are separated. Tensioning arm 226 includes a foot 236 with a ramped surface maintaining clamping element 230 in the inactive configuration when gripping and tensioning arms 224, 226 are in contact.

In order to crimp the extension member 16 after proper positioning, a crimping assembly 238 is operatively associated with tensioning arm 226. Alternatively, crimping assembly 238 can be associated with gripping arm 224. In an exemplary embodiment, a slider 240 has a crimping edge 242 for crimping the extension member 16 and sides 244 configured and dimensioned for sliding in a grooved end of tensioning arm 226. A link 246 is operatively associated with tensioning arm 226 so that link 246 can slide with respect to tensioning arm 226. Link 246 has a distal end coupled to slider 240 and a proximal end with teeth 248. A lever 250 has a distal end rotatably coupled to tensioning arm 226. The distal end of lever 250 is provided with teeth 252 that engage teeth 248 of the distal end of link 246. As lever 250 is pivoted, the engagement of teeth 248, 252 causes the pivoting to be translated to sliding motion of link 246 and slider 240. A leaf spring or other similar mechanism can be used to cause lever 250 to pivot back.

Crimping assembly 238 can also include a cutting stop 254 cooperating with crimping edge 242 of slider 240 to crimp and cut the extension member 16.

In use, extension member 16 is inserted into slot 228 and securing instrument 210 is moved down toward the cranium with the cranial flap clamp 10 in the position shown in FIG. 4. First and second handles 212, 214 are pivoted to cause gripping and tensioning arms 224, 226 to move away from each other. This movement causes tensioning arm 226 to push against the outer surface 30 of the second C:\DOCUME-l\sdear\LOCALS-1\TempAC 2001 260010 Div.doc 8 clamping member 14 and clamping element 230 to be in the active position, thereby holding the extension member 16 and drawing the first clamping member 12 toward the second clamping member 14. With the first and second clamping members 12;14 in the second position, crimping assembly 238 can be used to crimp and cut the extension member 16.

The invention described and claimed herein is not to be limited in scope by the specific embodiments herein disclosed, since these embodiments are intended solely as illustrations of several aspects of the invention. Any equivalent embodiments are intended to be within the scope of this invention. Indeed, various modifications of the invention in addition to those shown and described herein will become apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the appended claims.

C:\DOCUME-l\sdear\LOCALS-1\Temp\AC 2001 260010 Div.doc

Claims

1. A securing instrument for a cranial flap clamp including: a) irst and second pivotally connected handles each of said handles having proximal and distal portions; b) gripping arm operatively connected with the first handle and having proximal and distal portions; c) tensioning arm operatively connected with the second handle and having proximal and distal portions, the gripping and tensioning arms movable in response to movement of the first and second handles; d) slot extending through the distal portions of the gripping and tensioning arms for receiving the extension member of a cranial flap clamp; e) clamping element operatively associated with the slot and having active and inactive configurations, the inactive configuration allowing sliding of an extension member of a cranial flap clamp through the slot and the active configuration clamping a portion of an extension member against a wall of the slot to inhibit sliding of an extension member through the slot and f) crimping assembly operatively associated with at least one of the gripping and tensioning arms for crimping an extension member, g) herein pivoting of the first and second handles causes the gripping and tensioning arms to separate with the tensioning arm engaging the outer surface of a second clamping member of a cranial flap clamp and the clamping element in the active position thereby moving the first and second clamping members of a cranial flap clamp from the first position to the second position.

2. The securing instrument of claim 1 wherein the clamping element includes a clamp rotatably coupled to the gripping arm and wherein rotation of the clamp within the slot upon separation of the gripping and tensioning arms moves the clamping element from the inactive configuration to the active configuration.

3. The securing instrument of claim 2 further including a resilient member biasing the clamping element in the active configuration when the gripping and tensioning arms are separated. C:\DOCUME-l\sdear\LOCALS-1\Temp\AC 2001 260010 Div.doc

4. The securing instrument of claim 3 wherein the tensioning arm includes a foot maintaining the clamping element in the inactive configuration when the gripping and tensioning arms are in contact.

5. The securing instrument of claim 4 wherein the foot includes a ramped surface.

6. The securing instrument of any one of claims 1 to 5 wherein the distal portion of the tensioning arm includes a grooved end and the crimping assembly includes: A) slider having a crimping edge for crimping the extension member of a cranial flap clamp and sides configured and dimensioned for sliding in the, grooved end of the tensioning arm B) link operatively associated with the tensioning arm for sliding movement with respect thereto, the link having a distal end coupled to the slider and a proximal end with teeth and C) lever having a distal end rotatably coupled to the proximal portion of the tensioning arm, the distal end having teeth engaging the teeth of the distal end of the link.

7. The securing instrument of claim 6 wherein the crimping assembly includes a cutting stop, the cutting stop cooperating with the crimping edge of the slider to crimp and cut the extension member of a cranial flap clamp.

8. he securing instrument of any one of claims 1 to 7 wherein: a) he gripping arm further includes an intermediate portion located between the gripping arm proximal and distal portions with the gripping arm proximal portion extending from the distal portion of the first handle the distal portion of the gripping arm extending from the intermediate portion substantially parallel to the proximal portion, and the intermediate portion angling from the gripping arm proximal portion and; b) he tensioning arm further includes an intermediate portion located between the tensioning arm proximal and distal portions with the tensioning arm proximal portion extending from the distal portion of the second handle the distal C:\DOCUME-I\sdear\LOCALS-1\Temp\AC 2001 260010 Div.doc portion of the tensioning arm extending from the intermediate portion substantially parallel to the proximal portion, and the intermediate portion angling from the tensioning arm proximal portion.

9. The securing instrument of any one of claims 1 to 8 further including a resilient element located between the first and second handles biasing the first and second handles away from each other.

The securing instrument of claim 9 further including: A) a locking bar having a first end pivotably coupled to the first handle and a curved body portion with a plurality of teeth and B) a locking clip pivotably coupled to the second handle and having a through channel, C) wherein the locking clip is movable between a free position in which the locking bar is moveable in and out of the channel and a ratchet position in which the teeth of the locking bar engage an edge of the channel to prohibit the locking bar from moving out of the channel.

11. A securing instrument substantially as hereinbefore described with reference to the embodiment illustrated in the accompanying drawings. Dated: 24 August 2004 PHILLIPS ORMONDE FITZPATRICK Attorneys for: o SYNTHES AG CHUR C:\DOCUME~1\sdear\LOCALS-1\Temp\AC 2001 260010 Div.doc