WO2012024261A2

WO2012024261A2 - Debris removal system for surgical cutting instrumentation

Info

Publication number: WO2012024261A2
Application number: PCT/US2011/047860
Authority: WO
Inventors: Jeffrey Andrew Sharp
Original assignee: Smith & Nephew, Inc.
Priority date: 2010-08-16
Filing date: 2011-08-16
Publication date: 2012-02-23
Also published as: WO2012024261A3

Abstract

An apparatus for guiding surgical instrumentation relative to tissue includes a body having an outer surface configured to contact the tissue, the body defining an aperture therethrough, the aperture configured for receiving the surgical instrumentation and for guiding the surgical instrumentation relative to the tissue, at least one passageway within the body and in fluid flow communication with the aperture and an opening at the outer surface of the body, the opening in fluid flow communication with the at least one passageway and the aperture and the at least one passageway terminating at the opening.

Description

DEBRIS REMOVAL SYSTEM FOR SURGICAL CUTTING

INSTRUMENTATION

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to and the full benefit of United States Provisional Application Serial Number 61/373,979, filed August 16, 2010, and titled "Debris Removal System for Surgical Cutting Instrumentation," the entire contents of which are incorporated herein by reference.

Technical Field

[0002] This disclosure relates to orthopaedic cutting guides.

Background

[0003] Implant guides or resection aids are used during orthopaedic procedures to accurately insert pins, guide cuts, and place implants. These guides may be generic or designed specifically for one patient. The patient-matched guides are based on data received from an MRI or CT scan of the patient and rely on matching an anatomic feature for correct positioning of the guide during a surgical procedure.

[0004] Typically, templates and guides are made from a plastic or polymer, such as Nylon, to save costs. However, harder stainless steel cutting instruments generally used with cutting blocks (e.g., drills, pins, oscillating saw blades, reciprocating saw blades, etc.) may create significant block material debris when they are used. Debris in and around the surgical site is a concern with cutting blocks.

[0005] Accordingly, there remains a need for a solution that reduces the amount of debris introduced to the surgical site, as well as a method to remove fluid and debris created when a surgical procedure is performed. SUMMARY

[0006] In one general aspect, an apparatus for guiding surgical instrumentation relative to tissue includes a body having an outer surface configured to contact the tissue, the body defining an aperture therethrough, the aperture configured for receiving the surgical instrumentation and for guiding the surgical instrumentation relative to the tissue, at least one passageway within the body and in fluid flow communication with the aperture, and an opening at the outer surface of the body, the opening in fluid flow communication with the at least one passageway and the aperture and the at least one passageway terminating at the opening.

[0007] Implementations include one or more of the following features. For example, the apparatus includes a connector formed at the outer surface of the body and in fluid flow communication with the opening, the connector configured to couple to a tubular member for permitting fluid flow to or from the apparatus. The apparatus includes a tubular member configured to couple to the connector and to permit fluid flow to or from the apparatus. The body defines a second opening at the outer surface of the body, the second opening in fluid flow communication with the at least one passageway and the aperture. The apparatus includes a second connector formed at the outer surface of the body and in fluid flow communication with the second opening, the second connector configured to couple to a tubular member for permitting fluid flow to or from the apparatus. The apparatus includes a second tubular member configured to couple to the second connector and to permit fluid flow to or from the apparatus. A portion of the outer surface of the body substantially conforms to the shape of at least a portion of the tissue to which the body is configured to contact. The body further defines a plurality of openings through the outer tissue contacting surface and in fluid flow communication with the passageways such that when a vacuum is applied to the apparatus, the body is held in place relative to the tissue. A portion of the body defining the aperture includes a surface comprising a plurality of recesses formed in a waffle-like pattern. The at least one passageway is formed into or adjacent the plurality of recesses. The body defines a plurality of passageways extending between the aperture and the opening [0008] In another general aspect, a patient-matched apparatus for guiding surgical

instrumentation relative to tissue includes a body having an outer surface, a portion of the outer surface configured to contact the tissue and substantially conform to a shape of at least a portion of the contacted tissue, the body defining an aperture therethrough, the aperture configured to receive the surgical instrumentation and to guide the surgical instrumentation relative to the tissue, a plurality of passageways within the body and in fluid flow communication with the aperture, and at least one opening at the outer surface of the body, the at least one opening in fluid flow communication with the plurality of passageways and the aperture for permitting fluid flow to or from the apparatus.

[0009] Implementations include one or more of the following features. For example, the apparatus further includes a connector formed at the outer surface of the body and in fluid flow communication with the at least one opening, the connector configured to couple to a tubular member for permitting fluid flow to or from the apparatus. The apparatus further includes a tubular member coupled to the connector to permit fluid flow to or from the apparatus. The apparatus includes a second connector formed at the outer surface of the body and in fluid flow communication with the at least one opening, the second connector configured to couple to a tubular member for permitting fluid flow to or from the apparatus. The apparatus includes a second tubular member coupled to the second connector to permit fluid flow to or from the apparatus. The body further defines a plurality of openings through the portion of the outer tissue contacting surface, the plurality of openings in fluid flow communication with the plurality of passageways such that when a vacuum is applied to the apparatus, the body is held in place relative to the tissue.

[0010] In another general aspect, a method of manufacturing an apparatus for guiding surgical instrumentation relative to tissue includes forming a body having an outer surface, a portion of the outer surface configured to contact the tissue and substantially conform to a shape of at least a portion of the contacted tissue, forming an aperture through the body so that the aperture is shaped and configured to receive the surgical instrumentation and to guide the surgical instrumentation relative to the tissue, forming a plurality of passageways within the body such that the plurality of passageways are in fluid flow communication with the aperture, and forming at least one opening at the outer surface of the body, the at least one opening in fluid flow communication with the plurality of passageways and the aperture for permitting fluid flow to or from the apparatus.

[0011] Implementations include one or more of the following features. For example, the method further includes forming a connector at the outer surface of the body and in fluid flow communication with the at least one opening, the connector configured to couple to a tubular member for permitting fluid flow to or from the apparatus. The method further includes forming a second connector at the outer surface of the body and in fluid flow communication with the at least one opening, the second connector configured to couple to a tubular member for permitting fluid flow to or from the apparatus. The method includes forming a plurality of openings through the portion of the outer tissue contacting surface such that the plurality of openings are in fluid flow communication with the plurality of passageways. Forming the plurality of passageways is carried out using one of selective laser sintering (SLS) and electron beam manufacturing.

[0012] In another general aspect, a method of removing excess material from a surgical site during a surgical procedure includes positioning a surgical instrument guide against a tissue surface, guiding a surgical instrument through an aperture formed in the guide relative to the tissue, providing a negative pressure through at least one opening formed at an outer surface of the surgical instrument guide and one or more passageways formed within the surgical instrument guide and the aperture, and removing via the at least one opening the excess material formed during the surgical procedure.

[0013] Implementations include one or more of the following features. For example, the method further includes providing a fluid to the surgical instrument guide through the at least one opening, the one or more passageways, and the aperture. The method further includes providing a fluid to the surgical instrument guide through a second opening formed at an outer surface of the surgical instrument guide and in fluid flow communication with the one or more passageways and the aperture. The fluid and the negative pressure are provided substantially simultaneously to the surgical instrument guide. Positioning a surgical instrument guide against a tissue surface includes providing a negative pressure through the one or more passageways and one or more apertures formed on a tissue-conforming outer surface of the guide.

[0014] In another general aspect, a cutting block includes a body containing at least one opening or aperture configured to receive a cutting tool (e.g., drill, saw, etc.) as well as channels allowing for fluid contact between the aperture and an outlet or inlet port to allow for removal of debris and fluid or introduction of cutting and/or lavage fluid.

[0015] Implementations include one or more of the following features. For example, the cutting block may include a vacuum system built into the cutting blocks. This may involve placing one or more outlets onto the block. One or more mini ports, chambers, ducts, pipes, tubes, or drains may be placed onto, adjacent to, or within the surfaces of the blocks designed to guide a surgical tool. As a cutting tool is used, any bone chips, cartilage chips, biofluids, or wear debris from the block itself created by the surgical tool is removed from the block and surrounding areas of the surgical site, through a network of ducts and ultimately to one or more outlets. The one or more outlets may be provided as one or more cannulated nipples, bosses, or protrusions which are sized to allow egress of the debris and other biofluids. A vacuum tube is secured to the block easily.

[0016] Implementations include a cutting block having an aperture configured to receive a drill or guide rod. The block may have one or more ports located at one or more portions along its length. These port(s) are located internally to the block and exit at an outlet which may include a nipple or pneumatic barb. A vacuum tube is connected to the outlet and provides a convenient way for egress of biofluids, bone and cartilage debris, and (polymeric) wear debris caused by friction between the drill and the cutting block.

[0017] In another implementation, a cutting block may have a captured, partially captured, or non-captured slot surface configured to receive a saw blade such as an oscillating saw blade or a reciprocating saw blade. The slot may have one or more ports located at one or more portions along its length. These port(s) are located internally to the block and exit at an outlet which may be a nipple or pneumatic barb. A vacuum tube is connected to the outlet and provides a convenient way for egress of biofluids, bone and cartilage debris, and (polymeric) wear debris caused by friction between the drill and the cutting block.

[0018] The vacuum system used may also contain suction ports provided on tissue- conforming surfaces of the cutting block. The vacuum provides a negative pressure and therefore, may also serve to maintain the block in position with respect to the tissue, such as bone, cartilage, or other tissue surface to which it is attached. The amount of vacuum may be increased to secure the block to the tissue or surgical site or decreased to release the block from the tissue or surgical site. The amount of vacuum can be set to a desired amount so that placement pins are not necessary to hold the block to the tissue during use of the surgical tools and instruments. This means for securing the block to the surgical site using vacuum may be provided alone or in combination with the aforementioned means for removing debris.

[0019] The system provided may also be used to inject a pressurized lubricating fluid to decrease temperature and wear during cutting block use. The lubricating fluid coats the surgical cutting tool (e.g., drill, saw blade, etc.) and creates a fluid bearing surface between the guide surface of the block and the tool. In this sense, less wear debris from the block material is created.

[0020] Pressurized fluid may also be used as a lavage or reservoir to catch bone chips, cartilage chips, and wear debris from the block, to make it easier to remove such debris when compared with conventional systems. The fluid may be viscous such as liquid (e.g., water), or non-viscous such as a gas (air).

[0021] More than one tube hook up port may be provided. For instance, a single block may have a first input pressurized port for the insertion of a lubricating fluid and lavage, and second output port for sucking out biodebris, biofluid, and cutting block wear debris.

[0022] A waffle-pattern may be employed as the cutting guide surface which makes contact with the surgical tool. The recesses generally act as a basin or reservoir to hold the debris. The one or more ports, chambers, ducts, pipes, tubes, or drains may be placed onto, adjacent to, or within these recessed surfaces. The waffle pattern may doubly serve as a reservoir for lubricating fluid if used, and additionally reduces the amount of contact area and therefore reduces the amount of friction between the cutting block and the cutting tool.

[0023] The duct geometries and positions can be designed, for example, with computer modeling techniques, and then can easily be manufactured by, for example, using layer-by-layer 3D printing manufacturing techniques such as selective laser sintering (SLS), electron beam manufacturing (EMB), or other stereolithography methods.

[0024] While the implementations are useful for patient-matched cutting blocks, they can be employed in any surgical apparatus, such as standard conventional cutting blocks, shafts of acetabular shell inserters, shafts of acetabular reamers, and intramedullary reamers (e.g., cannulated reamers) .

[0025] The disclosed apparatuses and methods include several advancements. For example, the disclosed apparatuses and methods create less debris (bone, blood, body fluid, cutting block material, saw blade material) in the surgical site than current practices. Moreover, the disclosed apparatuses and methods reduce the amount of debris (bone, blood, body fluid, cutting block material, saw blade material) outside of the surgical site. In addition, the disclosed apparatuses and methods allow for easy hook up and use of equipment to remove debris and introduce fluid to the surgical site, as well as the ability to attach a cutting block to the surgical site without the use of nails or pins, reducing healing time and preserving more natural bone than other methods using pins and nails.

[0026] Other advantages and features will be apparent from the following detailed description when read in conjunction with the attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] FIG. 1 illustrates a set of patient-matched blocks in position on a tibia and femur.

[0028] FIGS. 2A and 2B are cross-section cutaway schematics of an exemplary

implementation of a cutting block. [0029] FIG. 3 is a cross-section cutaway schematic of a second exemplary implementation of a patient-matched block.

[0030] FIG. 3A is an example of a pattern on the face of the aperture of the patient-matched block of FIG. 3.

[0031] FIG. 4 is a cross-section cutaway schematic of a third exemplary implementation of a patient-matched block.

[0032] 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 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

[0033] FIG. 1 illustrates two patient-specific cutting guides, specifically, femoral cutting block 100 and tibial cutting block 101. The cutting blocks 100, 101 may be used in preparing resection of a joint before an implant is attached, during, for example, knee reconstructive surgery. The femoral cutting block 100 is connected to the femur 112 and the tibial cutting block 101 is connected to tibia 102 using, for example, positioning pins (not shown) passed through guide holes 105 formed in each of the femoral cutting block 100 and the tibial cutting block 101 to hold the respective cutting block in place. Each cutting block 100, 101 also includes slots 103, 113, respectively, that allow for access for a bone saw to, for example, resection the joint

[0034] FIGS. 2A and 2B illustrate cross-sectional cutaway views of an exemplary

implementation of a cutting block 200 that is configured to allow for removal of debris and/or fluid from a surgical site (FIG. 2A) or to permit introduction of cutting and/or lavage fluid to a surgical site (FIG. 2B). The cutting block 200 includes a body 205 having at least one or more apertures or openings 210 defined through the body 205. The apertures or openings 210 are configured to receive surgical instrumentation, such as a cutting tool (e.g., a drill, saw, reamer, etc.), and to guide the surgical instrumentation relative to a tissue, such as, for example, the tibia 102 or femur 112. The body 205 also includes one or more passageways 215 defined within the body 205. The one or more passageways 215 are connected with the apertures or openings 210 to allow for fluid flow communication between the apertures or openings 210 and an additional opening 220 defined at an outer surface 225 of the cutting block 200. The opening 220 is in fluid-flow communication with the one or more passageways 215 and the aperture 210. In the implementations shown in FIGS. 2A and 2B, the passageways 215 are constructed at 90 degrees to the cutting slot or aperture 210 but could be disposed at any angle depending on desired fluid- flow properties. A connector, such as a nipple, luer connector, etc. 230 may be removably attached to the cutting block 200 via threads, clips, etc. and is in fluid flow communication with the opening 220. The connector 230 may be coupled to a tubular member 240 to provide a convenient way for egress of biofluids, bone and cartilage debris, and wear debris caused by friction between, for example, a cutting instrument and the cutting block 200, as depicted by the arrow A in FIG. 2 A. The connector 230 may also be coupled to the tubular member 240 to provide lavage and/or lubricating fluid to the cutting slot or aperture 210 as depicted by the arrow B in FIG. 2B. The fluid may be viscous (e.g., water) or non-viscous such as gas (air). A portion of the outer surface 225 of the cutting block 200 is configured to contact tissue.

[0035] Referring to FIG. 2A, in use, the cutting block 200 is positioned against a tissue surface, such as the tibia 102 or femur 112 (FIG. 1). A surgical instrument, such as a drill, saw, reamer, etc., is guided through one of the apertures 210 formed in the cutting block 200 relative to the tissue. A negative pressure is applied or provided through the opening 220 in the outer surface 225 of the cutting block 200 and through the one or more passageways 215 formed within the cutting block 200 to remove any excess material formed during the surgical procedure (e.g., bone chips, cartilage chips, and wear material). Referring to FIG. 2B, in use, in addition to, or in lieu of a negative pressure or vacuum, a fluid may be provided through the opening 220 and the one or more passageways 215 to help decrease temperature and wear during a surgical procedures. The fluid may also act as a reservoir to catch bone chips, cartilage chips, and wear debris from the block 200, making these contaminants easier to remove with, for example, conventional removal systems, such as a suctioning device or syringe. [0036] Fig. 3 illustrates a second exemplary implementation of a patient-matched block 300 with a double nipple 340, 345 configuration. The block 300 includes a body 305 including one or more cutting slots or drill apertures 310 that is used to guide a cutting instrument relative to a tissue, such as the tibia 102 or the femur 112. The body 305 includes one or more passageways 315 that connect the aperture 310 to a first opening 320 formed through an outer surface 330 of the block 300 to allow for fluid flow between the first opening 320 and the aperture 310. A connector, such as a nipple 340 is removably attached to the block 300 at the first opening 320 and is configured to receive a tubular member 350. The one or more passageways 315 also connect the aperture 310 to a second opening 360 formed through the outer surface 330 of the block 300 to allow for fluid flow between the second opening 360 and the aperture 310. A connector, such as a nipple 345 is removably attached to the block 300 at the second opening 360 and is configured to receive a tubular member 370. A portion of the outer surface 330 of the block 300 is shaped or configured to conform to the shape of at least a portion of the tissue to which the block is configured to contact. For example, MRI or CRT scans of the patient's anatomy may be used to construct and/or shape the portion of the outer surface 330 of the block 300 that is to contact the outer surface of, for example, the tibia or femur of the patient. In this manner, patient- specific data may be used to form the conforming outer surface 330 of the block 300.

[0037] The cutting slot or drill aperture 310 may be formed with a pattern on the cutting guide surface 380 (FIG. 3) which makes contact with the surgical tool when the surgical tool or instrument is within the aperture 310. For example, referring to FIG. 3 A, the cutting guide surface 380 may be provided with a waffie-like pattern that includes one or more recesses 385. The recesses 385 formed by this pattern may act as a basin or reservoir to hold debris and lubricating fluid and/or reduce the amount of friction between the cutting block 300 and the cutting tool by reducing the amount of contact area. Additionally, the passageways 315 may be placed onto, adjacent to, or within these recessed surfaces of the waffle-like pattern.

[0038] Referring to FIG. 3, in use, the cutting block 300, and specifically the confirming surface 330, is positioned against a tissue surface, such as the tibia 102 or femur 112 (FIG. 1). A surgical instrument, such as a cutting tool, drill, reamer, etc., is guided through the aperture 310 formed in the cutting block 300 relative to the tissue. A lavage and lubricating fluid may be provided through the second opening 360 and passageways 315 (as depicted by arrow A in FIG. 3). The lavage and lubricating fluid decreases temperature and wear during block use and also acts as a reservoir to catch bone chips, cartilage chips, and wear debris from the block. A negative pressure may also be applied through the opening 320 and one or more passageways 315 formed within the cutting block 300 to remove the excess material formed during the surgical procedure (e.g., bone chips, cartilage chips, and wear material) and the lavage and lubricating fluid. Fluid may be provided and vacuum applied simultaneously to create a fluid loop. Alternatively, fluid and vacuum may be provided at different times depending on the particular application.

[0039] Fig. 4 shows a modified implementation of the patient-matched block 300 of FIG. 3 with a double nipple configuration. In addition to the features described above with respect to FIG. 3, the block 300 includes a plurality of openings 325 formed through the outer tissue contacting surface 330 of the block and in fluid communication or contact with the one or more passageways 315. In use, when a vacuum is applied to the cutting block 300, the vacuum permits the block 300 to be held in place against the conforming tissue with the use of suction rather than a bone spike, nail, or pin. This helps to shorten the length of surgery, save the natural bone material, and reduce healing time. The vacuum can be increased to secure the block 300 to the surgical site without the use of pins or nails and can be reduced to release the block following completion of the surgical procedure.

[0040] 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, passageways are shown at 90 degrees to aperture but can be formed at any angle depending on desired performance. Also, nipples or pneumatic barbs are mentioned specifically, but anything could be used as long as it maintains a seal and provides for a way to connect the blocks to one or more sets of tubing for providing vacuum or lavage/fluid away from and to the blocks, respectively. These nipples or pneumatic barbs are said to be removably attached to the block via threads or clips but could be attached by any suitable means. Alternatively, the nipples or barbs may be integrally formed with the block. Although the application of the cutting block described herein is a knee arthroscopy, the device is not limited to this use. It can be used for other surgeries such as hip blocks (acetabular drill guides, femoral head drill guides, and/or cutting blocks). It can also be used as a guide for drilling holes for screw placement in the acetabulum, and can be used as a bone plate drill guide. Nor is it limited to use with bone, this device could be used in surgeries involving, for example, tooth or soft tissue. These and other alternatives are considered equivalents and within the spirit and scope of this disclosure and the appended claims.

Claims

CLAIMS:

1. An apparatus for guiding surgical instrumentation relative to tissue comprising:

a body having an outer surface configured to contact the tissue, the body defining:

an aperture therethrough, the aperture configured for receiving the surgical instrumentation and for guiding the surgical instrumentation relative to the tissue;

at least one passageway within the body and in fluid flow communication with the aperture; and

an opening at the outer surface of the body, the opening in fluid flow communication with the at least one passageway and the aperture and the at least one

passageway terminating at the opening.

2. The apparatus of claim 1, further comprising a connector formed at the outer surface of the body and in fluid flow communication with the opening, the connector configured to couple to a tubular member for permitting fluid flow to or from the apparatus.

3. The apparatus of claim 1, further comprising a tubular member configured to couple to the connector and to permit fluid flow to or from the apparatus.

4. The apparatus of any one of the preceding claims, wherein the body defines a second opening at the outer surface of the body, the second opening in fluid flow communication with the at least one passageway and the aperture.

5. The apparatus of claim 4, further comprising a second connector formed at the outer surface of the body and in fluid flow communication with the second opening, the second connector configured to couple to a tubular member for permitting fluid flow to or from the apparatus.

6. The apparatus of claim 5, further comprising a second tubular member configured to couple to the second connector and to permit fluid flow to or from the apparatus.

7. The apparatus of claim 1, wherein a portion of the outer surface of the body substantially conforms to the shape of at least a portion of the tissue to which the body is configured to contact.

8. The apparatus of claim 1, wherein the body further defines a plurality of openings through the outer tissue contacting surface and in fluid flow communication with the

passageways such that when a vacuum is applied to the apparatus, the body is held in place relative to the tissue.

9. The apparatus of claim 1, wherein a portion of the body defining the aperture comprises a surface comprising a plurality of recesses formed in a waffle-like pattern.

10. A method of manufacturing an apparatus for guiding surgical instrumentation relative to tissue comprising:

forming a body having an outer surface, a portion of the outer surface configured to contact the tissue and substantially conform to a shape of at least a portion of the contacted tissue;

forming an aperture through the body so that the aperture is shaped and configured to receive the surgical instrumentation and to guide the surgical instrumentation relative to the tissue;

forming a plurality of passageways within the body such that the plurality of

passageways are in fluid flow communication with the aperture; and forming at least one opening at the outer surface of the body, the at least one opening in fluid flow communication with the plurality of passageways and the aperture for permitting fluid flow to or from the apparatus.

11. The method of claim 10, further comprising forming a connector at the outer surface of the body and in fluid flow communication with the at least one opening, the connector configured to couple to a tubular member for permitting fluid flow to or from the apparatus.

12. The method of any one of claims 10 or 11, wherein forming the plurality of passageways is carried out using one of selective laser sintering (SLS) and electron beam manufacturing.

13. A method of removing excess material from a surgical site during a surgical procedure comprising:

positioning a surgical instrument guide against a tissue surface;

guiding a surgical instrument through an aperture formed in the guide relative to the tissue;

providing a negative pressure through at least one opening formed at an outer surface of the surgical instrument guide and one or more passageways formed within the surgical instrument guide and the aperture; and

removing via the at least one opening the excess material formed during the surgical procedure.

14. The method of claim 13, further comprising providing a fluid to the surgical instrument guide through the at least one opening, the one or more passageways, and the aperture.

15. The method of any one of claims 13 or 14, further comprising providing a fluid to the surgical instrument guide through a second opening formed at an outer surface of the surgical instrument guide and in fluid flow communication with the one or more passageways and the aperture.