Adjustable depth limiting drill guide and suture transporting method

A surgical guide system comprises a guide body having a receiver and a reference plate joined by a connecting arm, a portion of the receiver and a portion of the reference plate intersecting a guide axis, the guide body operable for at least one bone to be interposed between the receiver and reference plate. The guide body further comprising a shuttle cable configured on the reference plate for engagement with a surgical tool A method includes positioning the surgical guide system on at least one bone, the bone the having a first side and a second side, guiding a surgical tool through a hole in the at least one bony structure, engaging a portion of the shuttle cable, and retrieving a first end of the shuttle cable through the hole.

FIELD OF THE INVENTION

The present invention relates to devices and methods for orthopedic tissue reconstruction procedures requiring drilling through bone tissue.

BACKGROUND

In the field of orthopedic surgery, several different instruments have been developed for guiding a drill or other surgical instrument along a preferred trajectory though a bone in order to perform a reconstruction of a damaged ligament or reduce a fracture. In some cases, after drilling through tissue, a shuttle cable, commonly a surgical suture or wire, is passed through the drill hole to aid in the transportation of other surgical devices through the hole. One problem encountered with the available adjustable drill guide systems which rely on a solid portion of the drill guide contacting the drill tip to act as the depth limiting feature, is the potential for the cutting portion of the drill tip to be damaged as it contacts the limiting surface, possibly contributing to a foreign material load if it begins to cut into the depth limiting surface.

A limitation of current available drill guides, which include a suture passing capability, is reliance on connecting the shuttle suture to the drill guide through the drill hole, without confirmation of a secure connection, before being removed from the drilling location to transport the shuttle suture. Should the connection system fail or the shuttle suture become disengaged from the drill guide during the retrieval, a repositioning and possible second drilling step would be needed to transport the shuttle suture, costing unnecessary surgical steps, surgical time, and possible harm to the patient.

In many cases the user may acquire a preoperative x-ray image of the pathology but may not have access to intraoperative visualization. Current devices are not enabled to provide the user an intraoperative measurement of the reduction distance, which limits the accuracy of the reconstruction, or requires the user to employ a separate measurement device, adding surgical steps and time to complete the procedure.

A further limitation of the current marketed devices is the complexity of the assemblies contributing to a higher device cost as the number of components in the assembly increases. Another drawback of a complex assembly is the increased opportunity for bacterial contamination in the small crevices between components, making the device difficult to sterilize. Therefore, a clear need exists for a solution to the aforementioned problems.

BRIEF SUMMARY OF THE INVENTION

In one embodiment of the invention a surgical guide system is provided, comprising a guide body having a receiver and a reference plate joined by a connecting arm, a portion of the receiver and a portion of the reference plate intersecting a guide axis, the guide body operable for at least one bone to be interposed between the receiver and reference plate, the receiver comprising a tubular body having a proximal end and a distal end, and an adjustment aperture formed through the receiver from the proximal end to the distal end, and a guide sleeve comprising a tubular body having a proximal end and a distal end, the proximal end operable for coupling with the receiver within the adjustment aperture, wherein a rotation of the guide sleeve with respect to the receiver causes a change in distance between the guide sleeve and the reference plate, and the lumen of the guide sleeve is operable to guide a surgical instrument along the guide axis therethrough, and the guide axis intersects at least one surface of the at least one bone interposed between the receiver and the reference plate during use. Also in one embodiment, the guide sleeve is recessed below the proximal surface of the receiver and may further include a locating member comprising a tubular body having a proximal end and a distal end; and a reference arm extending from the distal end of the tubular body having a portion offset from said guide axis, wherein the locating member is rotatable on the guide sleeve, and a portion of the reference arm is operable to contact a portion of a first surface on the at least one bone interposed between the receiver and the reference plate, the guide axis intersecting a second surface on the at least one bone. Also in one embodiment, the receiver further comprises a scale calibrated to provide a measurement of the distance between the guide sleeve and the reference plate when a designated feature of the of the drill sleeve and the scale are both in view. Also in one embodiment, the connecting arm further comprising a channel operable to contain a portion of a shuttle cable, wherein at least a portion of the shuttle cable is recessed below the outer surface of the connecting arm. Also in one embodiment the reference plate may further comprise at least one orientation aperture operable for containing a shuttle cable for engagement with a surgical device. Also in one embodiment, the guide body further comprises at least one retainer groove, wherein the groove is operable to secure a portion of the shuttle cable. Also in one embodiment, the reference plate further comprises an aperture operable to receive a surgical instrument and may further also include a slot formed from the proximal surface to the distal surface. Also in one embodiment, the surgical guide may include a shuttle cable, wherein a first portion of the shuttle cable is coupled to reference plate and at least a second portion is coupled to the receiver or features extending from the receiver, wherein at least a third portion of the shuttle cable is configured on the reference plate for engagement with a surgical tool. The surgical guide system may also include a driver operable to couple with the guide sleeve, wherein a torque applied to the driver causes the guide sleeve to rotate.

In another aspect of the invention, a method of transporting a shuttle cable through bone tissue is provided comprising the steps: (a) positioning the surgical guide system of any of the previous claims on at least one bone, the bone the having a first side and a second side, wherein the bone is interposed between the receiver and the reference plate, the receiver being on the first side of the bone and the reference plate being on the second side, wherein the guide axis intersects a hole formed in the bone, wherein the surgical guide system has a portion of a shuttle cable coupled to the reference plate configured for engaging a surgical tool, the shuttle cable having a first end and a second end, (b) guiding a surgical tool through the hole in the at least one bony structure from the first side to the second side, (c) engaging the surgical tool with a portion of the shuttle cable, (d) retrieving a first end of the shuttle cable through the hole from the second side of the bone to the first side, and (e) moving the guide body away from the bone, wherein one end of the shuttle cable is available for manipulation on the first side of the hole, and a second end of the flexible member is available for manipulation on the second side of the hole, and a portion of the flexible member passes through the hole. Also in one embodiment, the method further comprises the step of forming a hole in at least one bone from a first side to a second side, wherein the hole is collinear with the guide axis.

While the invention is amenable to various modifications, permutations, and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the embodiments described. The invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION

The inventor provides a unique adjustable and depth-limiting drill guide system for safely forming apertures in bone tissue during surgical reconstruction procedures. The drill guide system may also provide capability to allow the user to retrieve a shuttle suture or wire through a formed aperture thereby connecting the formed aperture to an auxiliary surgical portal for the transfer of other surgical devices. The present invention is described in enabling detail in the following examples, which may represent more than one embodiment of the present invention. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment.

Referring now toFIG. 1, one embodiment of an adjustable, depth-limiting guide system100is shown in an exploded view. In this example, guide system100is comprised of a guide body101, a guide sleeve102adjustable within guide body101, and a driver103. The components of guide system100may be manufactured using standard machining techniques, moulding processes, casting processes, additive manufacturing or other methods using bio-compatible materials suitable for surgical instrumentation. These materials include, but are not limited to alloys of stainless steel, alloys of titanium, thermoplastics such as polyphenyl sulfone (PPSU), polyoxymethylene (acetal), polyether-etherketone (PEEK), or fiber-reinforced composites using thermoset or thermoplastic resins.

FIGS. 2A-2Dare side, front, top, and perspective views, respectively, of guide body101which is comprised of a receiver200formed at the proximal end, a reference plate201formed at the distal end, and a connecting arm202. Receiver200is an elongate, tubular body having an adjustment aperture206formed collinear with a guide axis210which intersects reference plate201, and a thread form209functional along the inner diameter of adjustment aperture206for adjusting the axial position of guide sleeve102in receiver200. A depth limiting surface203forms one end of guide body101having a known distance from reference plate201. Incorporated into receiver200is a slot207functioning to allow passage of elements of guide sleeve102which exceed the inner diameter of adjustment aperture206, and to allow visualization of the position of guide sleeve102relative to depth limiting surface203. A scale204may be incorporated on the outer surface of receiver200in proximity to slot207providing the user a distance measurement between reference plate201and the distal end of guide sleeve102. A handle208may extend radially from the sides receiver200enabling manipulation of guide body101during positioning.

Connecting arm202is an elongate body which extends from the outer surface of receiver200distally providing a rigid connection to reference plate201and shaped to allow for a bone or a plurality of bones tissue to be interposed between receiver200and reference plate201. It should be noted that the curvature of connecting arm202should not limited to the example illustrated but may be shaped advantageously to enable various orientations, positions to encompass a variety of bony shapes. In this example, reference plate201is a generally flat oval body having a proximal surface and a distal surface and is shaped advantageously to conform to the tissue surface it is designed to oppose. A probe205may extend from the distal end of reference plate201to provide the user with tactile feedback of tissue shape during the positioning of guide body101.

FIGS. 3A-3Dillustrate perspective, front, side, and top views, respectively, of guide sleeve102, according to one embodiment of the present invention. Guide sleeve102comprises a guide sleeve body300, a locating member301, and a retaining pin302. Locating member301is designed to provide a mechanical reference from the edge of a bone surface to guide axis210and is operable to freely rotate on the distal end of guide sleeve body300.

FIGS. 4A-4Care front, top, and perspective views, respectively, of guide sleeve body300, in accordance with the disclosure. In this example, guide sleeve body300is a tubular body, designed for adjustable engagement with guide body101, having a reference surface403at its proximal end with the distal end designed for engagement with a bone surface. A drill aperture405is formed in guide sleeve body300and may be dimensioned to accept and guide a drill or other instrument therethrough. A thread form401is incorporated in the proximal end to engage and allow adjustment within receiver200(not shown). A female hex drive404is formed in proximal end of guide sleeve body300. A retaining groove402is formed at the distal end designed to accept retaining pin302(not shown).

FIGS. 5A-5Dare front, side, top, and perspective views, respectively, of locating member301, according to one embodiment of the present invention. Locating member301is comprised of a tubular barrel500having a proximal end and a bone contacting end, and an reference arm501. Barrel500has an inner diameter dimensioned to accept the distal end of guide sleeve body300with a sliding fit. A plurality of traction spikes503are formed on the bone-contacting face of barrel500to improve grip on the bone surface, minimizing the translation of guide sleeve102(not shown) from the desired position on the bone surface. Reference arm501may extend radially and distally from the outer diameter of barrel500at the bone-contacting end. When in operation, reference arm501is opposed to a bone surface, enabling guide sleeve102(not shown) to be positioned at a pre-set distance from the edge of the bone. Additionally, a pin retaining hole504is formed at the proximal end of barrel500.

FIG. 6is an exploded view of guide sleeve102, according to one embodiment of the present invention. In this illustration, guide sleeve body300, locating member301, and retaining pin302are shown aligned for assembly.

FIGS. 7A-7Dare front, top, and perspective views, respectively, of driver103, according to one embodiment of the present invention. In this example, driver103is comprised of a tubular driver body700with an operating knob701formed at the proximal end and a male hex drive702at the distal end. Male hex drive702is designed to couple with and enable the user to rotate guide sleeve body300(not shown) when adjustment is required. A central aperture704and a slot705formed from the proximal end to the distal end operable to allow passage for flexible wires or shuttle sutures to the interior of central aperture704. A calibrated scale703may be marked on the outer surface of driver body700providing the user a second indication of the between reference plate201(not shown) and the distal end of guide sleeve102(not shown). A plurality of traction grooves706may be formed in operating knob701for improved grip for the user during operation.

FIGS. 8A-8Billustrate the depth-limiting function of guide system100, according to an embodiment of the present invention.FIG. 8Aillustrates a drill800having a mechanical depth stop801formed at a distance from the cutting end of drill800calibrated to the distance between depth limiting surface203and reference plate201. Drill guide102is coupled with guide body101and adjusted such that reference surface403is recessed below depth limiting surface203. As shown inFIG. 8B, when drill800is advanced through guide sleeve102, depth stop801will contact depth limiting surface203and prevent further advancement of drill800into reference plate201.

FIGS. 9A-9Billustrate the exemplary use of scale204, according to an embodiment of the present invention.FIG. 9Ais a pre-operative x-ray image of the superior human torso illustrating an acromioclavicular separation of the right shoulder with the left shoulder the unaffected side. A measurement can be made from the inferior aspect of the coracoid process to the superior aspect of the clavicle as shown. The normal, anatomical measurement, DA, taken on the unaffected side, can be compared to the affected side, measures as DA+S, where S represents the separation distance added to the normal anatomical distance of the unaffected side. For this example, the ideal bone aperture for reconstruction should be made when the affected side has been reduced from the displaced distance, DA+S, to the anatomical distance, DA.FIG. 9Bshows guide body101with guide sleeve102adjusted such that reference surface403is recessed below depth limiting surface203. A distance measurement reading can be made when reference surface403is viewed through slot207and compared to the calibrated markings on scale204. The indicated distance will correspond with the distance, D, between the bone-contacting side of locating member301and the proximal surface of reference plate201.

FIGS. 10A-10Fillustrate exemplary steps for placing and drilling through bone tissue using guide system100, according to an embodiment of the present invention. In this example, guide system100is used to reduce an acromioclavicular separation and form an aperture through a clavicle1000and a coracoid1001interposed between receiver200and reference plate201, while the clavicle is maintained in its reduced position by guide system100.

FIG. 10Ashows guide body101placed such that reference plate201is located opposing the inferior aspect of coracoid1001by extending connecting arm202through a first surgical portal1002anterior to clavicle1000and medial to the acromioclavicular joint. Also illustrated is guide sleeve102coupled with driver103and aligned for coupling with receiver200. Reference arm501is aligned with slot207enabling guide sleeve102to be introduced into receiver200along guide axis210.FIGS. 10B-10Cillustrate guide system100placed in the desired surgical location with the bone-contacting end of guide sleeve102approximated to the superior aspect of clavicle1000with reference arm501approximated to the posterior aspect of clavicle1000accomplished by advancing the distal end of guide sleeve102through receiver200and a second surgical portal1003by a rotation of driver103. In this position, the injured joint is ready for reduction and a joint separation measurement can be made using scale703, if viewed from the anterior, or scale204if viewed from the posterior, to confirm the separation distance, DA+S, previously identified on the patient's pre-operative x-ray. The measurement from scale703is acquired by referencing the indicated mark which is aligned to depth limiting depth limiting surface203when driver103is mated to guide sleeve102as shown inFIG. 10C.FIG. 10Dillustrates guide system100in its adjusted position viewed from the posterior. The acromioclavicular joint is reduced by turning driver103and advancing guide sleeve102through receiver200until scale703indicates the desired distance, DA, which may be confirmed with an intra-operative x-ray if needed. In this configuration the tissue has been realigned to its anatomical position and the aperture in the bone can then be formed.FIG. 10Eillustrates guide body101and guide sleeve102positioned for drilling with driver103(not shown) removed from the assembly and reference surface403recessed below depth limiting surface203.FIG. 10Fillustrates the depth-limited drilling step. Drill800is introduced into guide sleeve102and advanced until depth stop801contacts depth limiting surface203, thereby forming an aperture through both clavicle1000and coracoid1001.

FIG. 11Ashows top and perspective views, respectively, of a guide body1100, according to an embodiment of the present invention. In this example, an guide aperture1101has been formed in reference plate201collinear with guide axis210and having a diameter to provide a slip fit with drill800(not shown).FIG. 11Bfurther illustrates the depth-limiting capability of guide body1100. The user may need to verify the completed drilling of the bone tissue and may choose to visualize the cutting end of drill800. Depth stop801may be positioned on drill800such that when depth stop801is advanced to approximate depth limiting surface203, a portion of the cutting end of drill800exits the distal side of reference plate201through guide aperture1101and can be visualized providing the user with a confirmation of complete drilling and enable other instruments to be passed through clavicle1000to arrive on the distal side of coracoid1001and available for manipulation by the user.

FIG. 12Aillustrates a perspective view of a guide body1200, according to another embodiment of the present invention. In this example, a slot1201has been formed in reference plate201of guide body1100. Slot1201allows wires, shuttle sutures, or other surgical instrumentation passed through the bone aperture to be dissociated from reference plate201and transferred to a different surgical portal than used by connecting arm202.FIGS. 12B-12Cillustrate exemplary use steps of drill guide body1200. After forming the bone aperture, a portion of a shuttle cable1202may be passed through guide sleeve102, clavicle1000, coracoid1001, and extend distally from reference plate201. Shuttle cable1202is shown as a flexible member having a first end1203and a second end1204and may consist of a surgical suture, braid, wire, tape, or other device operable to connect to surgical instruments or implants and for transport through tissue. End1203is passed through to the distal side of coracoid1001assembly while end1204is retained on the proximal side of guide body101. End1203is separated from reference plate201via slot1201and may then be transferred to exit an auxiliary surgical portal1205enabling guide body1200to be removed from surgical portal1003independently.

FIGS. 13A-13Dillustrate perspective and close-up views, respectively, of a guide body1300, according to another embodiment of the present invention. In this example, several features are formed in guide body1200to enable the connection of shuttle cable1202enabling the transfer of its ends to surgical portals by using guide body1300as the transport mechanism.

FIG. 13Ashows guide body1300having a orientation aperture1303formed in reference plate201such that slot1201is interposed between orientation aperture1303and a orientation aperture1304(shown inFIG. 13C-13D). Orientation aperture1303may have a diameter ranging approximating 0.15 mm to 1 mm and is designed for a suture shuttle to be passable therethrough. A retaining groove1302is formed in handle208having a width operable to provide an interference fit between a shuttle suture and retaining groove1302for providing the necessary friction for retaining a portion of shuttle cable1202and may vary in width proportional to the chosen cable diameter. A retaining channel1301is formed on the perimeter of connecting arm202having a depth and width operable to contain a portion of shuttle cable1202below the surface of connecting arm202to prevent entanglement with tissue during instrument placement.FIG. 13Bis a detail view of the proximal section of guide body1300where retaining groove1302and retaining channel1301can be appreciated.FIGS. 13C-13Dare perspective views of reference plate201and connecting arm202illustrating orientation aperture1304which, in this example, originates at the joint of connecting arm202and reference plate201and extends through arm202to intersect the origination of retaining channel1301.

FIGS. 14A-14Cillustrate exemplary steps for integrating shuttle cable1202onto guide body1300to form a shuttle assembly1403, according to an embodiment of the present invention. As shown inFIG. 14A, a stopper knot1401is tied in end1203of shuttle cable1202having a diameter sufficiently large such that it will not be passable through orientation aperture1303. End1204is passed through orientation aperture1303from the proximal side to the distal side of reference plate201. End1204is then oriented to span slot1201and introduced into the origin of orientation aperture1304at the distal end of reference plate201to exit orientation aperture1304at its intersection with retaining groove1302as shown inFIG. 14B.FIG. 14Cshows the middle portion of in shuttle cable1202contained in retainer channel1301and end1204secured to handle208. In this example, end1204is pulled by the user into retaining groove1302and wrapped around the circumference of the inner diameter of retaining groove1302at least one time. A capture portion1402of shuttle cable1202spans aperture1101, and is available for retrieval by instruments passed through guide aperture1101along guide axis210.

FIG. 15illustrates a perspective view of shuttle assembly1403during the drilling step of an acromioclavicular joint repair, in accordance with the disclosure. In this view, capture portion1402is provided on the distal side of reference plate201. This design allows for depth-limited drilling through guide sleeve102as previously described, and prevents the cutting tip of drill800from contacting and possibly damaging the shuttle suture.

FIGS. 16A-16Eillustrate exemplary use steps for transferring one end of shuttle cable1202from surgical portal1002, through the apertures created in clavicle1000and coracoid1001, to then exit surgical portal1003, according to an embodiment of the present invention.FIGS. 16A-16Bshow a retrieval device1600positioned and advanced through guide sleeve102and the apertures drilled in clavicle1000and coracoid1001engaging capture portion1402. End1204is then disengaged from retaining groove1302allowing free movement of shuttle cable1202through containment aperture1304during portal transfer as shown inFIG. 16C. Retrieval device1600is then withdrawn from guide sleeve102transferring end1204from surgical portal1002to surgical portal1003through the drilled apertures as shown inFIG. 16D. It should be noted that the coupling of retrieval device1600to shuttle cable1202should allow for shuttle cable1202to slide axially through the capture mechanism of retrieval device1600during the transfer.FIG. 16Eshows guide body1300removed from surgical portal1002. The connection of end1203to reference plate201causes end1203to be retained on the distal side of coracoid1001and exit surgical portal1002enabling a mechanical link between surgical portal1002and surgical portal1003through the apertures drilled in clavicle1000and coracoid1001.

FIGS. 17A-17Billustrate side and perspective views, respectively, of a guide body1700, according to embodiment of the present invention. In this example, guide body1700includes the features as described as guide body1100further comprising an aperture1701formed between the proximal and distal surfaces of reference plate201and intersecting guide aperture1101, and is designed to retain shuttle cable1202(not shown) in a position to span guide aperture1101and available for engagement with a suture retrieval device introduced into guide aperture1101.

FIGS. 17C-17Dshow a perspective and detail views, respectively, of a shuttle assembly1702, according to an embodiment of the present invention, comprising shuttle cable1202integrated onto guide body1700. Stopper knot1401is tied in end1203in similar fashion as described inFIG. 14such that its diameter is sufficiently large to prevent passage through aperture1701. End1204is then passed through aperture1701from one side of reference plate201exiting the opposite side such that capture portion1402spans guide aperture1101enabling engagement with a suture retrieving device introduced into guide aperture1101. End1204is then passed into containment orientation aperture1304, placed in retaining channel1301, and secured in retaining groove1302.

FIGS. 18A-18Cillustrate exemplary steps for integrating shuttle cable1202onto guide body1700to form a shuttle assembly1800, according to an embodiment of the present invention. As shown inFIG. 18A, end1204is passed through aperture1701from one side of reference plate201exiting the opposite side. End1203and end1204are then passed through orientation aperture1304from the bottom side of reference plate201as shown inFIG. 18B. The limbs of shuttle cable1202may then be placed in retaining channel1301with subsequently secured each in a separate retaining groove1302, as shown inFIG. 18C.

FIGS. 19A-19Dillustrate exemplary steps for using shuttle assembly1800to transfer a limb of shuttle cable1202from a first side of a formed apertures in a plurality of bones to the second side, according to an embodiment of the present invention. In this example, shuttle assembly1800is placed interposing clavicle1000and coracoid1001and coupling guide sleeve102as previously described. After forming an aperture through both bones, retrieval device1600is then introduced into guide sleeve102and passed through the bone apertures to engage with capture portion1402as described inFIG. 16C.FIG. 19Ashows end1204disengaged from retaining groove1302.FIG. 19Bshows retrieval device1600withdrawn from guide sleeve102, thereby transferring end1204from the distal side of coracoid1001to the proximal side of clavicle1000through the drilled apertures. With end1204transferred and exiting surgical portal1003, the user may remove guide sleeve102and dissociate end1203from handle208as illustrated inFIG. 19C. As shown inFIG. 19D, guide body1700is then removed from surgical portal1002with end1204retained on the proximal side of clavicle1000and exiting surgical portal1003. It should be noted that shuttle cable1202now links surgical portal1002to surgical portal1003through the drilled bone apertures.

FIG. 20Ashows a perspective view of the distal portion of a guide body2000, according to another embodiment of the present invention. In this example, retaining groove1302is formed in probe205.FIGS. 20B-20Cillustrates shuttle cable1202integrated onto guide body2000to form a shuttle assembly2002. In this example, end1203is removably secured to reference plate201by the engagement of end1203into retaining groove1302on probe205. Shuttle cable1202may then be placed in retaining channel1301with end1204secured into retaining groove1302on handle208as previously described, with capture portion1402spanning guide aperture1101as shown.