AU2011292143A1

AU2011292143A1 - Patient-matched tissue guide for placing a surgical device

Info

Publication number: AU2011292143A1
Application number: AU2011292143A
Authority: AU
Inventors: Luke Gibson
Original assignee: Smith and Nephew Inc
Current assignee: Smith and Nephew Inc
Priority date: 2010-08-16
Filing date: 2011-08-16
Publication date: 2013-03-14
Also published as: BR112013003628A2; CN103476354A; WO2012024281A2; MX2013001950A; RU2013111483A; WO2012024281A3; KR20130137157A

Abstract

An apparatus for guiding surgical instrumentation during surgery including a body having a first surface and a second surface, the second surface shaped to substantially match an outer surface of a patient's anatomy and at least one aperture extending between the first surface and the second surface of the body and configured to receive the surgical instrumentation and guide the surgical instrumentation relative to the patient's anatomy.

Description

WO 2012/024281 PCT/US2011/047897 PATIENT-MATCHED TISSUE GUIDE FOR PLACING A SURGICAL DEVICE CROSS REFERENCE TO RELATED APPLICATION 5 [0001] This application claims priority to and the full benefit of United States Provisional Application Serial Number 61/373,958, filed August 16, 2010, and titled "Patient-Matched Skin Guide for Placing a Surgical Device," the entire contents of which are incorporated herein by reference. Technical Field 10 [0002] This disclosure relates to patient-matched orthopaedic guides. Background [0003] Patient-matched or patient-specific implant guides are used during orthopaedic procedures to accurately insert pins, guide cuts, and place implants. The patient-matched guides are generally based on data received from an MRI or CT scan of the patient and rely on matching 15 an anatomic feature for correct positioning of the guide during a surgical procedure. [0004] Typically, templates and guides are designed to interface with a subcutaneous surface, such as bone or cartilage. For example, once a surgeon has exposed the portion of bone that the guide is designed for, the body of the orthopaedic guide can be placed on the bone or cartilage and aligned to guide the placement of a pin or screw, or the use of another surgical instrument. 20 [0005] There remains a need for a less invasive solution that reduces the size and amount of incisions needed to use a surgical instrument guide while maintaining the ease of use and speed associated with patient-matched guides. SUMMARY [0006] In one general aspect, an apparatus for guiding surgical instrumentation during surgery 25 includes a body having a first surface and a second surface, the second surface shaped to substantially match an outer surface of a patient's anatomy, and at least one aperture extending -1- WO 2012/024281 PCT/US2011/047897 between the first surface and the second surface of the body and configured to receive the surgical instrumentation and guide the surgical instrumentation relative to the patient's anatomy. [0007] Implementations may include one or more of the following features. For example, the apparatus further includes a guide extending from the body and defining a channel that is 5 substantially aligned with the aperture and configured to receive and guide the surgical instrumentation relative to the patient's anatomy. The outer surface of the patient's anatomy comprises the skin of the patient. The guide is coupled to the body or is integral with the body. The second surface defines a patient-specific three-dimensional shape. The body comprises a marker that is recognizable to an imaging apparatus. The orientation and position of the guide 10 relative to the body is patient-specific. [0008] In another general aspect, a patient-matched surgical instrument guiding apparatus includes a body having a first surface and a second surface, the second surface configured for positioning over a patient's skin and shaped to substantially match a contour of an area of the patient's skin adjacent a surgical site, and a guide extending from the body, the guide defining at 15 least one longitudinal passage configured to receive the surgical instrument and guide the surgical instrument relative to the body. [0009] Implementations may include one or more of the following features. For example, the position and orientation of the longitudinal passage of the guide is patient-specific. The guide is removably coupled to the body. The second surface defines a patient-specific three-dimensional 20 shape. The body or the guide comprises a marker that is recognizable to an imaging apparatus. The longitudinal passage is an internal bore passing through the guide. The longitudinal passage is defined along an outer surface of the guide. [0010] In another general aspect, a method of aligning a surgical instrument relative to a patient's anatomy during a surgical procedure includes positioning a body of an instrument 25 alignment guide against an area of a patient's skin adjacent a surgical site, the body having a first surface and a second surface, the second surface shaped to substantially match a contour of the area of the patient's skin adjacent the surgical site, and inserting the surgical instrument along a -2- WO 2012/024281 PCT/US2011/047897 guiding passage relative to the body of the instrument alignment guide such that the surgical instrument follows a patient-specifically defined axis relative to the surgical site. [0011] Implementations may include one or more of the following features. For example, inserting the surgical instrument comprises inserting the surgical instrument through a guide 5 coupled to the body of the instrument alignment guide. The method further includes performing an imaging scan of the surgical site prior to inserting the surgical instrument along the guiding passage. [0012] In another general aspect, a method includes positioning a body of an instrument alignment guide against an area of a patient's skin, the body having a first surface and a second 10 surface, the second surface shaped to substantially match a contour of the area of the patient's skin, performing an imaging scan, and determining an orientation and location of the body relative to the patient's anatomy. [0013] Implementations may include one or more of the following features. For example, the method further includes inserting a surgical instrument along a guiding passage relative to the 15 body of the instrument alignment guide such that the surgical instrument follows a patient specifically defined axis relative to a surgical site. [0014] In another general aspect, a patient-matched orthopaedic guide includes a body comprised of slots, tubes, or bores to guide surgical instrumentation relative to a patient's anatomy with an outer surface configured to at least partially conform to the anatomical 20 geometry of a patient. The conformal surface of the patient-matched orthopaedic guide may be configured to conform to the skin or other soft tissue of a patient, eliminating the need for incisions to uncover the anatomical surface that interfaces with the conformal surface of the guide. [0015] Implementations may include one or more of the following features. For example, a 25 guide may extend from the body of the orthopaedic guide to receive and guide a surgical instrument relative to the patient's anatomy. The guide defines a passageway that may be aligned with a passageway in the body. The guide may also be adjustable. The passageway -3 - WO 2012/024281 PCT/US2011/047897 through the guide is not necessarily enclosed by the guide, but may be set into the outer surface of the guide. [0016] In another general aspect, a system includes a guide comprising a body having a first surface and a second surface, the second surface shaped to substantially match an outer surface 5 of a patient's anatomy and at least one aperture extending between the first surface and the second surface of the body and configured to receive a surgical instrument and guide the surgical instrument relative to the patient's anatomy, and an external fixator configured to cooperate with the guide to locate the surgical instrument relative to the patient's anatomy. The external fixator can be an Ilizarov or Hoffman-type, or other applicable external fixator, which cooperates with 10 the guide to locate a surgical instrument, such as a screw or pin, relative to the patient's anatomy. Multiple apertures may. be incorporated into the patient-matched tissue guide. The apertures may be angled relative to one another and/or the patient's anatomy to allow the best fit for the external fixation. [0017] The disclosed apparatuses and methods include several advancements. For example, 15 the disclosed apparatuses and methods provide features and structures that allow for surgeries to be minimally invasive by providing a way for the orthopaedic guide to be placed on soft tissue such as skin or fatty tissue without the need for an incision. Thus, reducing surgery and healing time, while still maintaining the advantages of other patient-matched techniques. [0018] Other advantages and features will be apparent from the following detailed description 20 when read in conjunction with the attached drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0019] FIG. 1 illustrates a perspective view of an exemplary implementation of the device on a patient's wrist. 25 [0020] FIG. 2 is a side schematic view of an exemplary implementation of the device. [0021] FIG. 3 is a side schematic view of another exemplary implementation of the device. -4- WO 2012/024281 PCT/US2011/047897 [0022] FIG. 4 shows a perspective view of the device in use in conjunction with an external fixation device. [0023] It should be understood that the drawings are not necessarily to scale and that the disclosed implementations are sometimes illustrated diagrammatically and in partial views. In 5 certain instances, details which are not necessary for an understanding of the disclosure or which render other details difficult to perceive may have been omitted. It should be understood, of course, that this disclosure is not limited to the particular implementations illustrated herein. DETAILED DESCRIPTION 10 [0024] Fig. 1 illustrates an exemplary implementation of a patient-specific tissue guide 100 configured to guide surgical instrumentation relative to a patient's anatomy. In this example, the tissue guide 100 is configured to guide surgical instrumentation, such as a drill and/or a screw, relative to a patient's wrist area. The guide 100 includes a body 110, with a patient-matched surface 120 configured to contact and conform to an outer portion of the patient's anatomy, for 15 example the skin. Because the conforming surface 120 is configured to contact and conform to an outer portion of the skin or fatty tissue, the need for one or more incisions is reduced or eliminated in order to properly place the guide 100 relative to the patient's anatomy and to guide surgical instrumentation relative to the targeted site. An additional guide 130 extends from the body 110 and is configured to receive surgical instrumentation and guide the surgical 20 instrumentation relative to the patent's anatomy as will be explained in more detail below. [0025] FIG. 2 shows a side view of an exemplary implementation of a patient-matched tissue guide 200. The patient-specific guide 200 includes a body 210 having an outer surface 220 of which at least a portion 230 is configured to conform to the contours of the outer surface of a patient's anatomy 240, such as the patient's skin. The conformal surface 230 may define a 25 patient-specific three-dimensional shape. At least one aperture 250 runs from the outer surface 220 of the body 210 to the conformal surface 230. The aperture 250 guides surgical instrumentation relative to the patient's anatomy. Additionally, the body 210 may contain a -5- WO 2012/024281 PCT/US2011/047897 marker 270 at a known location relative to the geometry of the body 210 that is recognizable to an imaging device (not shown). [0026] A guide 280 may be removably coupled to the body 210. The guide 280 defines a longitudinal channel 290, which is aligned with the aperture 250. The channel 290 , in 5 conjunction with the aperture 250 defines an axis 297, which is based on patient-specific data received via MRI or CT scans, and is configured to guide a surgical instrument, such as a drill bit, screw, reamer, etc., relative to the patient's anatomy. A marker 270 that is recognizable to an imaging apparatus may be attached to the guide body 210 at a known location relative to the geometry of the guide 200. The placement of the guide 280 relative to the body 210 may be 10 based on patient-specific data and may be adjustable after placement of the guide 200 relative to the patient's anatomy. [0027] In use, a surgical instrument is aligned relative to a patient's anatomy by positioning the body 210 of the instrument alignment guide 200 against an area of a patient's outer tissue 240 adjacent to the surgical site. The conformal surface 230 matching an area of the patient's tissue 15 240 is brought adjacent to the surgical site. A surgical instrument is inserted along the guiding passage or aperture 250 relative to the instrument alignment guide 200 such that the surgical instrument follows a patient-specific axis 297 relative to the surgical site. If a guide 280 is coupled to the body 210 of the instrument 200, the surgical instrument is also inserted through the channel 290 in the guide as well. 20 [0028] An imaging scan can be performed before and/or after the instrument alignment guide 200 is placed on the patient's skin. Image scans are one method that may be employed to determine the proper orientation and location of the body relative to the patient's anatomy. An image scan of the surgical site may be performed prior to inserting the surgical instrument along the passage 250 of the body or the channel 290 of the guide 200. This may allow the surgeon to 25 check the positioning of the guide with respect to the anatomy of the patient before beginning surgery. [0029] Fig. 3 shows a side view of an alternative implementation of a patient-matched tissue guide 300. The body 310 of the patient-specific guide 300 has an outer surface 320 of which at -6- WO 2012/024281 PCT/US2011/047897 least a portion 330 is configured to conform to the contours of the tissue to which it contacts, such as the outer surface of a patient's skin. At least one aperture or channel 340 runs from the outer surface 320 of the body 310 to the conformal surface 330. Additionally, the body 310 may include one or more markers 360 that is distinguishable from the surrounding material by 5 imaging methods, and that may be used for positioning of the guide 300 or locating other instrumentation during a surgical procedure. [0030] An instrument guide 370 may be connected to the body 310. The guide 370 cooperates with the channel or aperture 340 to define an axis 380 that is further defined by patient-specific data received via MRI or CT scan. The axis 380 represents the patient-specific path along which 10 the surgical instrument is guided by the channel or aperture 340 and/or a longitudinal bore 390 defined by the guide 370. For example, the axis 380 is configured to guide a drill bit or screw along a specific path and across a fracture in a patient's wrist. In this implementation, the guide 370 has a longitudinal bore 390 along the patient-specific axis 380, which is defined along an outer surface 315 of the guide 370. One or more markers 360 may be attached or coupled to the 15 guide 370 and used in conjunction with imaging technology for positioning the guide 370 or locating other instrumentation relative to the surgical site. [0031] Fig. 4 illustrates a system 400 that includes patient-matched tissue guides 405, 406 and an external fixator 450, such as an Ilizarov fixation device. In the depicted implementation, there is a proximal guide 405 and a distal guide 406. In some implementations, guides 405, 406 may 20 be monolithic or they may be integral. Further, guides 405, 406 may be separate components but held together in a fixed relationship by a bracket (not shown) or some other device. The guides 405, 406 include a body 410 and a pilot 470 defining one or more channels or apertures (not shown) that define an axis based on patient-specific data derived from a MRI or CT scan. The axis represents a patient-specific path along which a surgical instrument, such as a pin 420, is 25 guided through the body 410 and/or the pilot 470. For example, the axis may be configured to guide a screw, kirschner wire, or pin along a patient-specific path into and through a patient's tibia in order to avoid arteries, veins, or other critical anatomical features. In some implementations, the body 410 includes multiple pilots 470 that are substantially on the same -7- WO 2012/024281 PCT/US2011/047897 plane. For example, the body 410 may include four pilots on the same plane but angled away from one another to allow for the implantation of two kirschner wires. The patient specific data can be used to accurately place the pilots 470 and allow for the correct angulation between pilots. Further, the patient specific data can be used to correlate pilot placement on the proximal guide 5 405 and the distal guide 406. In order to properly match polar opposite pilots 470, each guide 405, 406 may be pliant or two-piece, snap together such that they substantially encircle a body portion. Multiple pilots 470 of different sizes may be provided on each body 410 to allow for placement of multiple instruments (e.g., multiple screws, kirschner wires, or pins) to cooperate with an external fixation device 450. These pilots 470 may be offset and/or angled relative to 10 one another to allow for proper alignment upon implantation or after rotation/distraction of the joint(s). [0032] In use, a surgeon may view a proposed tissue-guide 405, 406 and communicate with a designer or manufacturer via a website to accept or revise a patient-specific surgical plan. A patient-matched guide 405, 406 can be then be made that conforms to the patient's anatomy and 15 will direct surgical instruments relative to the patient's anatomy. The surgical instrument is aligned relative to a patient's anatomy by positioning the body 410 of the instrument alignment guide 405, 406 against an area of a patient's outer tissue 440 adjacent to the surgical site. A conformal surface of the guide 405 (not shown) matching an area of the patient's tissue 440 is brought adjacent to the surgical site. A surgical instrument, for example a screw, kirschner wire, 20 or pin, is inserted through pilot 470 and relative to the body 410 such that the surgical instrument follows a patient-specific path relative to the surgical site. The external fixator 450 cooperates with the screws, kirschner wires, and/or pins to locate the surgical instrument relative to the patient's anatomy. Additionally, the external fixator 450 and the tissue guide 405, 406 may be provided in a kit. 25 [0033] While only certain implementations have been set forth, alternatives and modifications will be apparent from the above description to those skilled in the art. For example, although the channel or passageways described herein are shown to have a circular cross-sectional shape, other shapes are also within the scope of this disclosure. Furthermore, the shape of the -8- WO 2012/024281 PCT/US2011/047897 passageway in the body of apparatus need not be the same as that of the passageway in the guide. The guide may be integral with the body or may be coupled in some other manner. These and other alternatives are considered equivalents and within the spirit and scope of this disclosure and the appended claims. 5 -9-

Claims

1. An apparatus for guiding surgical instrumentation during surgery comprising: a body having a first surface and a second surface, the second surface shaped to substantially match an outer surface of a patient's anatomy; and 5 at least one aperture extending between the first surface and the second surface of the body and configured to receive the surgical instrumentation and guide the surgical instrumentation relative to the patient's anatomy.

2. The apparatus of claim 1, further comprising a guide extending from the body and 10 defining a channel that is substantially aligned with the aperture and configured to receive and guide the surgical instrumentation relative to the patient's anatomy.

3. The apparatus of any one of the preceding claims, wherein the outer surface of the patient's anatomy comprises the skin of the patient and the second surface is shaped to 15 substantially match a contour of an area of the patient's skin adjacent a surgical site.

4. The apparatus of claim 2, wherein the guide is coupled to the body.

5. The apparatus of claim 2, wherein the guide is integral with the body. 20

6. The apparatus of any one of the preceding claims, wherein the second surface defines a patient-specific three-dimensional shape.

7. The apparatus of claim 1, wherein the body comprises a marker that is recognizable to an 25 imaging apparatus.

8. The apparatus of claim 2, wherein the orientation and position of the guide relative to the body is patient-specific. - 10- WO 2012/024281 PCT/US2011/047897

9. The apparatus of claim 2, wherein the channel is defined along an outer surface of the guide. 5

10. A method of aligning a surgical instrument relative to a patient's anatomy during a surgical procedure comprising: positioning a body of an instrument alignment guide against an area of a patient's skin adjacent a surgical site, the body having a first surface and a second surface, the second surface shaped to substantially match a contour of the area of the patient's skin adjacent the surgical site; 10 and inserting the surgical instrument along a guiding passage relative to the body of the instrument alignment guide such that the surgical instrument follows a patient-specifically defined axis relative to the surgical site. 15

11. The method of claim 10, wherein inserting the surgical instrument comprises inserting the surgical instrument through a guide coupled to the body of the instrument alignment guide.

12. The method of claims 10 or 11, further comprising performing an imaging scan of the surgical site prior to inserting the surgical instrument along the guiding passage. 20

13. A method comprising: positioning a body of an instrument alignment guide against an area of a patient's skin, the body having a first surface and a second surface, the second surface shaped to substantially match a contour of the area of the patient's skin; 25 performing an imaging scan; and determining an orientation and location of the body relative to the patient's anatomy. -11 - WO 2012/024281 PCT/US20111/047897

14. The method of claim 13, further comprising inserting a surgical instrument along a guiding passage relative to the body of the instrument alignment guide such that the surgical instrument follows a patient-specifically defined axis relative to a surgical site. 5 15. A system comprising: a guide comprising a body having a first surface and a second surface, the second surface shaped to substantially match an outer surface of a patient's anatomy and at least one aperture extending between the first surface and the second surface of the body and configured to receive a surgical instrument and guide the surgical instrument relative to the patient's anatomy; and 10 an external fixator configured to cooperate with the guide to locate the surgical instrument relative to the patient's anatomy.

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