Surgical guide carrier with protective barrier - Patents.com

Abstract

To provide a surgical guide carrier for attaching to a surgical guide production apparatus.SOLUTION: The surgical guide carrier comprises: a connector for attaching the surgical guide carrier to a mount on the surgical guide production apparatus; a coupling portion for receiving and releasably retaining an impression of a surgical site so that, when the impression is retained in the surgical guide carrier and when the surgical guide carrier is attached to the surgical guide production apparatus, the surgical guide production apparatus can modify the impression to produce a surgical guide; and a protective barrier configured to be positioned around at least part of the surgical guide production apparatus to provide a barrier between the surgical guide and at least part of the surgical guide production apparatus.SELECTED DRAWING: Figure 25F

Description

[Technical field]

[0001] The present disclosure relates to bone graft production apparatuses, surgical guide production apparatuses, cutting attachments for surgical guide production apparatuses, surgical guide carriers, and mouldable material carriers. [Background technology]

[0002] Surgeons often use surgical guides to ensure that they make incisions in a patient at the correct location. For example, in osteopathy, surgical guides are common to ensure that surgeons drill holes in the correct location and along the correct axis. Because patient anatomy varies, surgical guides often must be customized for each patient for each surgery.

[0003] Additive manufacturing can be used to create surgical guides based on patient scans, but these guides often have poor fit with the patient. This is because the guides can be designed to fit the geometry of hard anatomical features such as bones; however, in practice, surgeons do not remove all of the surrounding soft tissue. Thus, the remaining soft tissue can cause the surgical guide to fit poorly, thereby reducing the precision of the surgical procedure.

[0004] To address the above problems, U.S. Patent No. 6,399,633 (incorporated herein by reference in its entirety) proposes a method to take an impression of a surgical site during surgery. The impression can then be quickly modified (e.g., by drilling appropriate guide holes or features) using a surgical guide manufacturing device located in the operating room so that the surgeon has a surgical guide that precisely fits the current surgical site.

[0005] While the above-described methods provide a fast and effective method of manufacturing surgical guides, there are problems associated with providing the manufacturing equipment within a sterile environment, such as an operating room.

[0006] Manufacturing equipment often uses drill bits or other cutting elements to drill holes or make incisions in the impression, which can create debris that can contaminate the surrounding area, including sterile instruments.

[0007] In addition, it is often difficult to sterilize large medical devices that have several moving parts. Sterilization procedures mean that there is a period of time after a surgery is completed where the manufacturing equipment cannot be used. This means that similar surgeries cannot be performed until the manufacturing equipment is sterilized, or the hospital must purchase additional manufacturing equipment to use when one is sterilized.

[0008] Additionally, nurses and surgeons must maintain a sterile field in the operating room during surgery. Some parts of the manufacturing equipment can be sterilized, while others may not be sterilized to save costs and speed up the sterilization process. Thus, there is a risk that a nurse or doctor using the manufacturing equipment may accidentally touch a non-sterile area. This can cause the sterile field in the operating room to become contaminated if the nurse or doctor continues to work without resterilizing the affected parts of the therapist's body or clothing. This results in the nurse or doctor having to stop working to change sterile clothing or to wash their hands or arms again to sterilize the contaminated skin.

[0009] Therefore, there is a need for improved surgical guide manufacturing apparatus and associated attachments to help maintain a sterile environment within the operating room. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] International Publication No. 2015 / 075423 Summary of the Invention

[0011] According to a first aspect of the present invention, there is provided a cutting attachment for use with a surgical guide manufacturing apparatus, the cutting attachment having: a cutting element; a connector for connecting the cutting element to a drive mechanism of the surgical guide manufacturing apparatus such that the cutting element can be driven by the drive mechanism to modify an impression of a surgical site to manufacture a surgical guide; and a protective barrier configured to be positioned around the cutting element to surround the cutting area to help prevent contaminants from entering or exiting the cutting area during modification of the impression.

[0012] By providing a protective barrier integrated into the cutting attachment, the protective barrier can help shield the sterile portions of the cutting attachment and the surgical guide manufacturing apparatus, helping to avoid contamination of the surgical site impression during revision.

[0013] The protective barrier may be rigid or flexible. If the protective barrier is flexible (e.g., a flexible sheet such as a barrier drape), the user can grasp the cutting attachment with the protective barrier wrapped around the cutting element to help shield the cutting element as it is attached to the surgical guide manufacturing apparatus.

[0014] In use, the protective barrier can be positioned around the cutting area, for example, by lifting the protective barrier to surround or encircle the cutting area. The cutting area can include the cutting element, the surgical guide, and the localized surrounding space. Thus, the cutting area can be the volume that surrounds the space in which the surgical guide can be modified.

[0015] The protective barrier may be connected to the cutting element to form a 360° seal around the cutting element, ensuring that debris cannot pass between the protective barrier and the cutting element.

[0016] Advantageously, the cutting attachment may further comprise a support connected to the protective barrier and configured to be moved to position the protective barrier about the cutting area.

[0017] The support can be configured to be coupled to a driven support arm of a surgical manufacturing apparatus such that the surgical manufacturing apparatus can move the protective barrier into position about the cutting area.

[0018] In addition, the cutting attachment may further have a connector for connecting an intermediate portion of the protective barrier to the base of the surgical guide manufacturing apparatus at the base of the cutting area. If the protective barrier is a flexible sheet such as a barrier drape, this can help ensure that straight walls are provided around the perimeter of the cutting area and can also help ensure that there is sufficient slack in the protective barrier at the base to allow the cutting element to be moved by the surgical guide manufacturing apparatus.

[0019] Advantageously, the protective barrier may comprise a flexible sheet, which allows the cutting element to be moved during modification without compromising the sterile barrier.

[0020] Advantageously, the cutting attachment may further comprise one or more support frames connected to the protective barrier and configured to be positioned around the cutting area to prevent the protective barrier from entering the cutting area. If the protective barrier is a flexible sheet, this may help to prevent the sheet from sagging, billowing, bowing into or crashing into the cutting area.

[0021] The cutting attachment can have a lower support frame configured to weigh down the protective barrier to position at least a portion of the protective barrier against a base of the manufacturing apparatus. Alternatively, or in addition, the lower support frame can be configured to couple to a base of the manufacturing apparatus.

[0022] The cutting element may include a cutting element for a power tool. It may be any power tool cutting element, for example, any tool that may be actuated in a cutting action with a power tool. It may be a drill bit, a saw, a bur, a reamer, a knife, a needle, or any other suitable cutting element. Power tools may generate a large amount of debris. In this case, the protective barrier serves the additional function of preventing contamination of the surrounding area with debris from the cutting.

[0023] Advantageously, the cutting attachment may be sterilized or configured to be sterilized. In this embodiment, the cutting attachment should be manufactured from materials suitable for sterilization, either prior to purchase or by the end user. This ensures that it can be used in a sterile environment, such as an operating room.

[0024] Advantageously, the cutting attachment may further comprise a coding element indicating the type of cutting attachment and configured to be read by the surgical guide manufacturing device so that the surgical guide manufacturing device can verify that the correct type of cutting attachment has been fitted, which helps to prevent errors when manufacturing the surgical guide.

[0025] The coding element may be a radio frequency identification (RFID) chip, a bar code, a QR code, a memory device (e.g., flash), or any other form of machine-readable media. For example, the coding element may encode the type of cutting element via its physical shape, which may be read by the manufacturing equipment, e.g., via an optical sensor or button configuration. Different types of cutting attachments may include different types of cutting elements (e.g., drills, burrs, etc.), cutting elements of different lengths or diameters, cutting elements of different materials, and / or cutting attachments from different manufacturers.

[0026] According to a second aspect of the present invention, there is provided a surgical guide carrier for attachment to a surgical guide manufacturing apparatus having: a connector for attaching the surgical guide carrier to a mount of the surgical guide manufacturing apparatus; a coupling portion for receiving and releasably holding an impression of a surgical site when the impression is held in the surgical guide carrier and when the surgical guide carrier is attached to the surgical guide manufacturing apparatus such that the surgical guide manufacturing apparatus can modify the impression to manufacture a surgical guide; and a protective barrier configured to be positioned around at least a portion of the surgical guide manufacturing apparatus to provide a barrier between the surgical guide and at least a portion of the surgical guide manufacturing apparatus.

[0027] An impression of the surgical site may be taken on a formable material carrier configured to be coupled to the surgical guide carrier via a coupling. By providing a protective barrier, the impression of the surgical site may be protected from sections of the surgical guide manufacturing apparatus that may not be sterile. This is advantageous because it is difficult to sterilize an apparatus with moving parts, reducing downtime of the surgical guide manufacturing apparatus between surgeries. The protective barrier also helps prevent debris from the impression modification from contaminating the surgical guide manufacturing apparatus.

[0028] The protective barrier may be connected to the joint to provide a 360° seal between the protective barrier and the joint, which prevents contaminants from passing between the protective barrier and the joint.

[0029] The surgical guide carrier may be configured to be attached to the manufacturing apparatus in a predefined position and orientation and / or may have reference markers to enable the position and / or orientation of the surgical guide carrier relative to the manufacturing apparatus to be determined.

[0030] Advantageously, the surgical guide carrier may be sterilized or configured to be sterilized, and the protective barrier may provide a sterile barrier to help prevent contamination of the impression during revision, ensuring that it may be used in a sterile environment, such as an operating room.

[0031] Advantageously, the protective barrier may be flexible, it may be a flexible sheet, this allows the joints to move during modification without compromising the sterile barrier.

[0032] In one embodiment, the surgical guide carrier is configured such that a protective barrier can be secured to the surgical guide manufacturing apparatus such that the protective barrier surrounds the mount of the surgical guide manufacturing apparatus. This protects the user's hands from possible contamination from the mount when attaching the surgical guide carrier to the surgical guide manufacturing apparatus and when attaching or removing the moldable material carrier. Additionally, the mount can be located on or include a rotation mechanism that allows the impression to be properly positioned for modification. Such mechanisms can be difficult to sterilize. Thus, providing a protective barrier to surround the mount (and possibly also the rotation mechanism) avoids the need to sterilize this portion of the manufacturing apparatus.

[0033] The surgical guide carrier may further have a support frame connected to the protective barrier, the support frame forming an opening into which a mount of the surgical guide manufacturing apparatus may be received and which may be configured such that the opening may be expandable from a first configuration to a second configuration larger than the first configuration such that the support frame may fit over a fixed section of the surgical guide manufacturing apparatus, the support frame being biased towards the first configuration such that when the support frame is released it returns to the first configuration to secure the protective barrier over the fixed section. This provides a simple mechanism for securing the protective barrier to the manufacturing apparatus.

[0034] The surgical guide carrier may further have one or more levers connected to the support frame and configured to enable the support frame to receive an expansion force to expand the opening from a first configuration to a second configuration. The one or more levers may be incorporated into one or more corresponding handles that protrude away from the opening to help keep a user's hands away from the manufacturing apparatus when securing the protective barrier to the manufacturing apparatus.

[0035] Advantageously, the support frame may have: one or more locking members, each configured to be biased towards a first position in which the locking member protrudes into the opening and configured to be movable from the first position to a second position to expand the opening; or an elastic loop configured to be expandable to expand the opening.

[0036] Advantageously, the surgical guide carrier may further have a handle connected to the support frame and projecting away from the opening, which aids in positioning a user's hands away from the manufacturing apparatus when attaching a protective barrier to the manufacturing apparatus to avoid accidental contamination.

[0037] The surgical guide carrier may further have a rotatable section on which the coupling portion is disposed, the rotatable section configured to receive a rotational force from the surgical guide manufacturing apparatus such that the coupling portion can be rotated into position for manufacturing of the surgical guide.

[0038] Advantageously, the surgical guide carrier may further have a coding element that indicates the type of surgical guide carrier and is configured to be read by the surgical guide manufacturing device so that the surgical guide manufacturing device can verify that the correct type of surgical guide carrier has been attached. The coding element may be a radio frequency identification (RFID) chip, a bar code, a QR code, a memory device (e.g., flash), or any other form of machine-readable medium. For example, the coding element may encode the type of surgical guide carrier via its physical shape, which may be read by the manufacturing device, for example, via an optical sensor or button configuration. Different types of surgical guide carriers may include different types of carriers (e.g., different types of impressions / surgical guides), carriers of different sizes or shapes, surgical guide carriers of different materials, and / or surgical guide carriers from different manufacturers.

[0039] According to a third aspect of the present invention there is provided a formable material carrier for use in making an impression of a surgical site, the formable material carrier having a first surface onto which formable material may be dispensed: an inlet is formed in the formable material carrier into which the formable material is urged into and an internal cavity is formed in the formable material carrier, the internal cavity being connected to the inlet; and a plurality of openings are formed in the first surface and connected to the internal cavity such that when the formable material is urged into the inlet the formable material is received in the internal cavity and urged out of the openings so that the formable material is distributed across the first surface.

[0040] The opening and internal cavity aid in uniform distribution of the formable material. A syringe may be provided with the formable material carrier (e.g., a kit of parts) for injecting the formable material into the formable material carrier. The syringe may contain a predefined amount of formable material to ensure that an appropriate amount of material is injected into the formable material carrier.

[0041] The inlet may be centrally located within an opposite surface of the formable material carrier relative to the first surface. Alternatively, the inlet may be located in a sidewall of the formable material carrier. This may facilitate injecting the formable material into the formable material carrier. The openings may be substantially uniformly distributed across the first surface to provide a uniform distribution of the formable material. Alternatively, the formable material carrier may be configured to distribute a larger amount of formable material to the center of the first surface (e.g., through a distribution of openings in the first surface, or an arrangement of internal cavities).

[0042] The moldable material carrier may be made of two or more parts (e.g., made from injection molded plastic) and assembled together (e.g., via snap fittings, screws or other fastening means), or may be manufactured as a single piece (e.g., by additive manufacturing).

[0043] Advantageously, the formable material carrier may further comprise: a connection for connecting the formable material carrier to the surgical guide manufacturing apparatus in a predefined position and orientation; and / or a fiducial marker for enabling the position and / or orientation of the formable material carrier on the surgical guide manufacturing apparatus to be determined. This allows the various elements to be aligned with each other. The connection to the surgical guide manufacturing apparatus can be made via a surgical guide carrier attached to the surgical guide manufacturing apparatus.

[0044] The formable material carrier may further include one or more protrusions or one or more indentations formed on the outer surface to provide a grip. The grips can be on the side or back wall of the formable material carrier to form a grip for holding the formable material carrier. Alternatively, or in addition, the grips can be on the first surface grip to help secure the formable material to the front surface. The formable material may harden around the protrusions (or within the indentations) to help secure the formable material to the formable material carrier.

[0045] Advantageously, the inlet may be formed with a frusto-conical opening for receipt of a syringe for delivering the moldable material, which may be in the form of a countersink, which helps the user to accurately align the syringe within the inlet and provides a seal around the syringe when it is fully inserted to avoid moldable material leaking back out of the inlet.

[0046] The internal cavity may be formed from a number of tunnels connecting the inlet to the opening in the first surface.

[0047] Advantageously, the openings in the first surface may have one or more sets of openings, each set of openings having openings distributed in a star pattern around a corresponding central axis, with an internal tunnel connecting each of the centrally located openings at a point along the central axis. This helps to distribute the moldable material evenly across the first surface. The star pattern may be a type of asterisk.

[0048] Advantageously, the internal cavity may be formed from one or more splitting sections, each splitting section having an entry part connected to the inlet and opening into the split cavity through which the formable material may be forced, a barrier arranged on the entry part so as to at least partially impede the progress of the formable material, and two or more outlet openings arranged around the barrier, such that when the formable material is forced into the split cavity through the entry part, it is split and extruded through corresponding outlet openings, which serves to split the formable material.

[0049] Advantageously, the barrier may completely cover the cross section of the entry part (although the barrier is spaced from the entry part). By locating the barrier over the entry part, the formable material is forced to fill the split cavity before being forced out through the exit opening. This helps to provide an even distribution of the formable material. Multiple stages of split sections may be provided, with each exit opening of a previous stage being connected to the entry part of a corresponding subsequent split section.

[0050] The outlet openings may be positioned equidistant from the center of the barrier and may have equal cross-sectional areas such that the moldable material is divided into substantially equal volumes of moldable material. This helps to provide an even distribution of the moldable material. Alternatively, the one or more dividing sections may be positioned to provide a greater volume of moldable material at the center of the first surface than at the periphery of the first surface.

[0051] According to a further aspect of the present invention, there is provided a surgical guide manufacturing apparatus for modifying an impression of a surgical site to manufacture a surgical guide, the surgical guide manufacturing apparatus having: a mount for releasably receiving an impression of a surgical site; a coupling configured to couple a cutting element to the surgical guide manufacturing apparatus; and a drive mechanism configured to drive the cutting element when coupled to the coupling element to modify the impression of the surgical site to manufacture a surgical guide; wherein in use the drive mechanism is positioned below the mount such that debris from the impression falls away from the impression as it is modified. Positioning the drive mechanism below the mount aids in removing debris from the impression / surgical guide.

[0052] The drive mechanism may have a motor for driving the cutting element (e.g., rotating a drill) and a motor for moving the cutting element into position and urging the cutting element into the moldable material. The surgical guide manufacturing apparatus further has a rotation mechanism on which the mount is disposed and which rotates the mount about a tilt axis (extending horizontally) and rotates the impression about a yaw axis (extending radially from the tilt axis). This allows the surgical guide manufacturing apparatus to properly position the impression for modification. The rotation mechanism may include a yaw axis drive member for rotating a rotatable section of the surgical guide carrier to rotate the impression mounted on the surgical guide carrier about the yaw axis.

[0053] Advantageously, the surgical guide manufacturing apparatus may further have a protective barrier coupling mechanism configured to releasably couple the protective barrier to the surgical guide manufacturing apparatus, the protective barrier coupling mechanism having: a movable part configured to couple to a section of the protective barrier; and a positioning mechanism configured to move the part from a first position allowing access to the mount and coupling to a second position in which the protective barrier is positioned around the cutting area including the cutting element and impression to help prevent contaminants from entering or exiting the cutting area during impression modification.

[0054] By positioning the drive mechanism below the mount and allowing a protective barrier to be positioned around the cutting area, debris from the revision can be effectively contained within the protective barrier and easily discarded after revision.

[0055] Advantageously, the surgical guide manufacturing apparatus further includes a securing section configured to releasably secure a second protective barrier to the surgical guide manufacturing apparatus in a configuration disposed about the mount to isolate the surgical guide from the mount, which helps prevent debris from the surgical guide from contaminating the surgical guide manufacturing apparatus and prevents accidental contamination of the user through accidental contact with the mount when loading / removing the surgical guide.

[0056] The surgical guide manufacturing apparatus may further include: a sensor configured to read a coding element attached to the surgical guide carrier for the impression and / or the cutting element, the coding element storing a code indicative of one or more characteristics of the cutting element and / or one or more characteristics of the surgical guide carrier for the impression; and a processor configured to: determine the one or more characteristics from the code, compare the one or more characteristics to one or more expected characteristics, and in response to determining that the one or more characteristics match the one or more expected characteristics, enable the drive mechanism to be used to modify the mold, or in response to determining that the one or more characteristics do not match the one or more expected characteristics, prevent the drive mechanism from being used to modify the impression. This helps prevent production errors through the use of incorrect attachments.

[0057] Further embodiments may be configured for use with a manufacturing apparatus for manufacturing a bone graft or implant. This may be in addition to, or instead of, being configured for use with a surgical guide manufacturing apparatus. Similarly, the manufacturing apparatus itself may be configured for one or both uses. For example, the features described above with reference to a surgical guide manufacturing apparatus are equally applicable to a manufacturing apparatus for modifying a bone graft to manufacture a bone graft.

[0058] For example, according to an embodiment, a cutting attachment for use with a surgical manufacturing apparatus is provided, the cutting attachment having: a cutting element; a connector for connecting the cutting element to a drive mechanism of the manufacturing apparatus such that the cutting element can be driven by the drive mechanism to manufacture a surgical guide, surgical implant or surgical bone graft; and a protective barrier configured to be positioned around the cutting element to surround the cutting area to help prevent contaminants from entering or exiting the cutting area during modification of the impression.

[0059] Moreover, according to a further embodiment, there is provided a carrier for mounting to a surgical manufacturing apparatus, the carrier having: a connector for mounting the carrier to a mount of the manufacturing apparatus; a coupling for receiving and holding an impression of a surgical site such that when an impression is held in the carrier and the carrier is mounted to the manufacturing apparatus, the manufacturing apparatus can modify the impression to manufacture a surgical guide or a surgical implant; or a section of bone such that when a section of bone is held in the carrier and the carrier is mounted to the manufacturing apparatus, the manufacturing apparatus can modify the section of bone to manufacture a bone graft; and a protective barrier configured to be positioned around at least a portion of the manufacturing apparatus to provide a barrier between the mount and at least a portion of the manufacturing apparatus.

[0060] According to a further aspect of the invention, there is provided a manufacturing apparatus for modifying a section of bone to manufacture a bone graft, the manufacturing apparatus having a mount for receiving the section of bone, a surface shape recorder for recording a shape of a surface of the section of bone received by the mount to generate surface data for registering the section of bone to the manufacturing apparatus and the shape of the planned bone graft, a cutting element or coupling configured to couple the cutting element to the manufacturing apparatus, and a drive mechanism configured to drive the cutting element such that when coupled to the coupling element, the section of bone conforms to at least a portion of the shape of the planned bone graft.

[0061] This allows the bone graft to be more accurately formed based on the planned bone graft shape. The bone section may be a resected or cut portion of bone taken from the patient for use in manufacturing the bone graft. The planned bone graft shape may be determined based on image data (e.g., CT or MRI image data) of the patient's anatomical features and / or a scan of the mould of the surgical site. This ensures better attachment of the bone graft to reduce movement within the surgical site when attached.

[0062] The surface profiler may be a scanner (e.g., an optical scanner) for determining the geometry of the surface of the bone section. The bone surface may be represented by either a surface model or a volume model. The surface data may be utilized to determine an overall geometric model of the bone section. The cutting element may be configured to cut, mill or drill. The mount may be configured to securely receive the bone section. This may be via one or more clips, clamps, screws, or other attachment means.

[0063] The manufacturing device may cut the bone to shape the bone according to at least a portion of the planned bone graft. For example, substantially one side of the bone may be shaped before the bone is inverted (e.g., attached to its opposite side) to allow the opposite side to be shaped.

[0064] According to one embodiment, the manufacturing device further comprises a mount for holding a set of cutting elements, the manufacturing device being configured to change between cutting elements. This allows different tools to be used when modifying a bone section. For example, a rack of tools may be placed in the manufacturing device and a coupling may be attached to a movable arm. The movable arm may be configured to place the cutting elements attached to the coupling in the rack / mount and move the coupling to retrieve new cutting elements from the rack / mount. The different cutting elements may include, for example, cutting elements for cutting, sawing, milling or drilling. This avoids the need for user intervention during bone modification, thus reducing the risk of injury (from the cutting elements) by the user and reducing the risk of contamination of the bone graft, the manufacturing device or the user.

[0065] According to one embodiment, the manufacturing apparatus further comprises a processor configured to determine a shape of the planned bone graft based on image data representative of anatomical features of the patient's anatomy.

[0066] According to a further embodiment, the mount is configured to receive a mold of the surgical site and the surface shape recorder is configured to record a shape of a surface of the mold to generate mold surface data for determining a shape of the planned bone graft based on the mold surface data and image data representative of anatomical features of the patient's anatomy.

[0067] According to a further embodiment, the manufacturing apparatus further comprises a processor configured to determine a shape of the planned bone graft based on the mold surface data and image data representative of anatomical features of the patient's anatomy.

[0068] By registering the shape of the mold of the surgical site, the bone graft can be shaped to more accurately fit the surgical site. For example, soft tissue may not be completely removed from the surgical site, which can cause problems fitting a bone graft prepared based solely on image data of the patient's anatomical features (e.g., showing bone and hard tissue). Furthermore, by taking a mold of the surgical site, the bone graft can be shaped to fit features added to the surgical site during surgery. For example, a section can be cut from the bone within the surgical site to which the bone graft can be fitted. Alternatively, one or more prostheses may already be fitted within the surgical site. By taking a mold of the surgical site, the bone graft can be shaped to more accurately fit these features of the surgical site, thus improving alignment to the surgical site and reducing movement within the surgical site.

[0069] The form may be releasably received in the same manner that a section of bone may be releasably received.

[0070] The manufacturing apparatus may be further configured to modify a model of the surgical site to manufacture the surgical guide.

[0071] According to a further aspect of the present invention, there is provided a kit of parts for manufacturing a surgical guide comprising any combination of the above-described manufacturing apparatus; the above-described cutting attachment; the above-described surgical guide carrier; and the above-described moldable material carrier. [Brief description of the drawings]

[0072] Embodiments of the present invention are described herein with reference to the accompanying drawings.

[0073] [Figure 1] 1 illustrates a manufacturing apparatus according to one embodiment. [Diagram 2] FIG. [Diagram 3] 1 shows the internal support features of the manufacturing equipment. [Figure 4] 1 illustrates a cutting attachment with an integrated barrier drape according to one embodiment. [Diagram 5] 1 illustrates a cross-sectional view of a cutting attachment with a barrier drape in a retracted configuration. [Figure 6] 1 illustrates a cross-sectional view of a cutting attachment with a barrier drape in an extended configuration. [Figure 7] 1 shows a detailed cross-sectional view of the drill and connection of the cutting attachment. [Figure 8] FIG. 2 shows a detailed perspective view of the drill and connection part of the cutting attachment. [Figure 9] 1 illustrates a surgical guide carrier with an integrated barrier drape according to one embodiment. [Figure 10] 13 illustrates a surgical guide carrier with an integrated barrier drape according to an alternative embodiment. [Figure 11] 13 shows a detailed view of the front of the carrier portion of the surgical guide carrier. [Figure 12] 1 shows a cross-sectional view of a surgical guide carrier. [Figure 13] 1 shows a formable material carrier according to a first embodiment. [Figure 14] 1 shows a perspective view of an injector for injecting formable material into a formable material carrier. [Figure 15] 3 shows the internal structure of a moldable material carrier. [Figure 16] 1 shows a cross-sectional view of an injector injecting formable material into a formable material carrier. [Figure 17] 2 shows a formable material carrier according to a second embodiment. [Figure 18] 18 shows a cross-sectional view of the formable material carrier of FIG. 17. [Figure 19] 18A and 18B show cross-sectional and perspective views of an injector for injecting formable material into the formable material carrier of FIG. 17. [Figure 20] 18 shows a cross-sectional view of the rear section of the formable material carrier of FIG. 17. [Figure 21] 18 illustrates a first stage splitter of the formable material carrier of FIG. 17. [Figure 22A] 18 illustrates a front perspective view of the second stage splitter of the formable material carrier of FIG. 17. [Figure 22B] FIG. 2 shows a rear perspective view of the second stage splitter. [Figure 22C] FIG. 2 is a plan view of the rear side of the second stage splitter. [Figure 23A] 18 shows the front side of the front section of the formable material carrier of FIG. 17. [Figure 23B] The rear of the front section is shown. [Figure 24] FIG. 2 shows a plan view of the rear side of the front section. [Figure 25A] 1 illustrates a first step in a surgical guide manufacturing procedure according to one embodiment. [Figure 25B] 1 illustrates a second step in a surgical guide manufacturing procedure according to one embodiment. [Figure 25C] 13 illustrates a third step in a manufacturing procedure for a surgical guide according to one embodiment. [Figure 25D] 1 illustrates a fourth step in a manufacturing procedure for a surgical guide according to one embodiment; [Figure 25E] 13 illustrates a fifth step in a manufacturing procedure for a surgical guide according to one embodiment. [Figure 25F] 13 illustrates a sixth step in a manufacturing procedure for a surgical guide according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0074] SUMMARY OF THE PRESENT EMBODIMENTS Embodiments of the present invention aim to solve the problem of how to maintain the sterility of surgical guides and the surrounding operating room during intraoperative manufacturing.

[0075] 1 illustrates a manufacturing apparatus according to one embodiment of the present invention. The manufacturing apparatus 100 is configured to modify an impression of a surgical site to manufacture a surgical guide. The manufacturing apparatus 100 is intended for use in an operating room and is placed next to a surgical table. The embodiments described herein ensure that sterile personnel, such as scrub nurses and surgeons, can use the manufacturing apparatus and surgical guides without compromising sterility.

[0076] The manufacturing apparatus 100 has a coupling portion 112 configured to couple to an interchangeable cutting attachment 200 and an attachment point 110 onto which a surgical guide carrier 300 can be attached. The surgical guide carrier 300 is a removable attachment point for a surgical guide. The surgical guide carrier 300 is configured to secure an impression of a surgical site to the manufacturing apparatus 100 in a predefined position and orientation. The manufacturing apparatus 100 includes a scanner 150 for scanning the surface of the impression.

[0077] The manufacturing apparatus 100 is configured to scan the surface of the impression and compare it to a stored medical scan of the patient's anatomy. The medical scan may be an MRI scan, a CT scan, or other scan capable of recording the patient's anatomy. The scan of the impression's surface may be an optical scan or any other scan capable of measuring the geometry of the impression's surface.

[0078] The manufacturing apparatus 100 is configured to align the impression to the anatomical features of the patient, which allows the manufacturing apparatus 100 to determine where surgical guide holes need to be drilled in the impression in order to manufacture a surgical guide according to a predetermined surgical plan.

[0079] The registration process allows the manufacturing apparatus 100 to calibrate itself to the impression to ensure that the guide holes are drilled in the correct locations.

[0080] The general process of scanning and modifying an impression of a surgical site using a manufacturing device is described in more detail in WO 2015 / 075423, which is incorporated by reference in its entirety.

[0081] The overall system according to the embodiments described herein includes a manufacturing machine 100 and several single-use sterilization pack accessories to ensure that a sterile environment within the operating room is maintained.

[0082] The first accessory consists of a cutting attachment 200 (in this example, a drill attachment) with an integrated sterile barrier drape (shown in Figures 4-8). For clarity, the barrier drape is not shown in Figure 1. The cutting attachment 200 is removably attachable to the manufacturing apparatus 100 at a coupling 112 of the manufacturing apparatus 100. The coupling 112 is connected to a motor for driving the cutting attachment 200.

[0083] The coupling 112 is located on the movable arm. The manufacturing apparatus is configured such that the movable arm can be moved along three orthogonal directions, x, y and z (shown in FIGS. 1 and 2). This allows the manufacturing apparatus 100 to position the cutting attachment 200 in the correct position and drive the cutting attachment 200 into the impression to form surgical guide holes in the impression at the required locations.

[0084] The second accessory consists of a surgical guide carrier 300 with an integrated sterile barrier drape (shown in FIGS. 9-11). For clarity, the barrier drape is not shown in FIGS. 1-3. The surgical guide carrier 300 can be releasably mounted on an attachment point 110 of the manufacturing apparatus 100. The attachment point 110 is attached to a gimbal 140 of the manufacturing apparatus 100. The gimbal 140 forms part of a rotation mechanism that includes the attachment point and a motor configured to rotate the surgical guide carrier 300 about an inclined axis that extends parallel (along a horizontal plane) to the ground.

[0085] The rotation mechanism further includes a yaw axis drive member disposed on the gimbal and configured to mate with a yaw axis keyway in the surgical guide carrier 300 to rotate a rotatable section of the surgical guide carrier about a yaw axis extending radially from the tilt axis.

[0086] The rotation mechanism thus enables the manufacturing apparatus 100 to rotate the surgical guide carrier 300 itself about a tilt axis and rotate the impression of the surgical site about a yaw axis to move the impression in the correct orientation so that the surgical guide holes are formed along the correct line.

[0087] The gimbal 140 also allows the manufacturing apparatus 100 to rotate the surgical guide carrier 300 in a forward direction to allow surgical guides to be coupled and decoupled from the manufacturing apparatus 100, and rotate the surgical guide carrier 300 in a backward direction to allow the manufacturing apparatus 100 to scan the surface of the impression of the surgical site and create a plan to modify the impression.

[0088] The attachment point 110 is located above the bond portion 112 so that when the impression is modified, debris from the impression falls away from the impression and downward toward the cutting element.

[0089] The third accessory consists of a moldable material carrier (shown in Figures 12-15). The moldable material carrier allows an impression of the surgical site to be taken and forms part of the surgical guide when the impression is revised. The moldable material carrier has several channels so that the moldable material is injected into the moldable material carrier and distributed evenly across the front surface of the moldable material carrier.

[0090] Further accessories include a formable material dispenser and a formable material (shown in Figures 14 and 15), which can be used to dispense the formable material onto the surgical guide.

[0091] An impression of the surgical site can be taken using the moldable material dispensed on the moldable material carrier. The moldable material carrier and impression can then be coupled to the manufacturing apparatus 100 via the surgical guide carrier when the surgical guide carrier is mounted on the manufacturing apparatus 100. The manufacturing apparatus 100 can then scan the impression of the surgical site and modify the impression with the cutting attachment 200.

[0092] Preparation of the manufacturing apparatus 100 can be performed by a sterile scrub nurse. The individual accessories can be supplied in either a double wrapped or blister pack configuration. The circulating nurse can then open the outer packaging so that the sterile accessories can be aseptically transferred for use by the scrub nurse.

[0093] The purpose of the sterile pack accessory is to simplify the process of using the manufacturing equipment within the surgical environment. The accessory ensures that a protective sterile barrier is maintained between the non-sterile parts of the manufacturing equipment and the user. In addition, the accessory ensures that any debris generated from the modification of the surgical guide is isolated within the boundaries of the single-use accessory. This means that after surgery, the accessory can be quickly and easily removed from the manufacturing equipment without the risk of biological material being transferred to the manufacturing equipment or other parts of the operating room. This improves preparation time and avoids lengthy and costly reprocessing and its associated risks.

[0094] 2 shows a side view of the manufacturing apparatus. Again, the barrier drape for the cutting attachment 200 and surgical guide carrier 300 is not shown. The gimbal 140 is positioned directly above the coupling 112 for the cutting attachment 200. This defines the cutting area between the coupling 112 and the gimbal 140. When the barrier drape is in place, a sterile zone is located in the area of ​​this cutting area.

[0095] When the gimbal 140 (on which the attachment points are attached) is positioned directly above the joint 112, debris from the drilling falls downward, away from the attachment points, as the impression is being modified by the cutting attachment 200. This helps remove debris from the surgical guide as it is being formed / modified. This also helps keep the debris within the confines of the barrier drape and also helps collect the debris within the barrier drape for the cutting attachment so that it can be easily collected and discarded after the surgical guide is completed. This ensures there is no cross contamination from one procedure to the next.

[0096] As mentioned above, the cutting attachment 200 includes a barrier drape, which is in the form of an elongated tube that is attached at one end to a central housing of the cutting attachment 200. The outer edge of the elongated tube can be secured around the driven support ring 160 of the manufacturing apparatus 100. The driven support ring 160 is connected to an arm 170 that extends above the manufacturing apparatus 100.

[0097] The manufacturing apparatus 100 is configured to lift the driven support ring 160 from a lower, stored position (as shown in FIGS. 1 and 2 ), where the driven support ring 160 is proximal to the joint, to an upper, extended position to lift the barrier drape for the cutting attachment 200 to seal the cutting area. This prevents drilling debris from escaping the cutting area and contaminating the operating room. In the upper position, the driven support ring 160 is proximate to the gimbal 140.

[0098] The manufacturing apparatus 100 further includes an upper housing lip 180. The upper housing lip 180 provides an outwardly protruding lip over which a barrier drape for the surgical guide carrier 300 may be secured. This isolates the rotating mechanism from the cutting area, prevents debris from the surgical guide from clogging the rotating mechanism, and prevents contaminants from the rotating mechanism from falling into the cutting area and contaminating the surgical guide. Additionally, it provides a sterile barrier to avoid accidental contamination of the user through contact with the rotating mechanism when the user is installing or removing the surgical guide.

[0099] Thus, when in place, the barrier drape isolates the (difficult to sterilize) moving parts of the manufacturing equipment from the sterile cutting area to avoid contamination of the surgical guide and / or the user.

[0100] 3 shows the internal support features of the manufacturing apparatus. Driven support ring 160 is shown elevated centrally on upwardly extending arm 170. Motor 165 is disposed within the housing of manufacturing apparatus 100 for raising and lowering driven support ring 160. Similarly, motor 145 is disposed within the upper housing of manufacturing apparatus 100 supported by upwardly extending arm 170 for driving gimbal 140.

[0101] 4 illustrates a cutting attachment with an integrated barrier drape, according to one embodiment. The cutting attachment 200 has a centrally located cutting element 210. In this case, the cutting element is a drill bit. Various types of cutting elements (e.g., drill bits, saw blades, and cutting elements of various sizes) may be used. Thus, different cutting attachments (including integrated barrier drapes) may be provided with different cutting elements for different applications. The various cutting elements may be made of stainless steel or any other suitable durable material.

[0102] The cutting elements 210 are mounted in a central housing 215 such that the cutting elements 210 can be driven to rotate by the manufacturing apparatus 100. The central housing 215 is configured to couple to a coupling portion of the manufacturing apparatus 100.

[0103] The cutting attachment 200 further includes a barrier drape 220, shown as a transparent sheet in Figure 4. The barrier drape 220 is centrally secured around the entire exterior of the central housing 215. The barrier drape 220 extends radially outward from the central housing to a lower ring 230 that surrounds the central housing 215. The barrier drape 220 is secured to the lower ring 230.

[0104] The upper ring 240 is disposed above the lower ring 230. The outer end of the barrier drape 220 is attached to the upper ring 240. The upper ring 240 has a connection for fixing the upper ring 240 to the driven support ring 160 of the manufacturing apparatus 100. This allows the barrier drape 220 to be lifted around the cutting area of ​​the manufacturing apparatus 100 by the driven support ring 160. The lower ring 230 is configured to hold down the base of the barrier drape 220 and support the barrier drape 220 to keep it taut to avoid the barrier drape 220 sagging or blowing away into the cutting area. To this end, an intermediate support ring 235 is connected to the barrier drape 220 between the upper ring 240 and the lower ring 230. The upper ring 240, the lower ring 230, and the intermediate support ring 235 are generally a support frame and may be of any suitable shape to prevent the barrier drape 220 from encroaching on the cutting area.

[0105] Although this embodiment is directed to a drill attachment that includes a drill bit, alternative attachments having alternative cutting elements may be implemented with similar barrier drapes according to embodiments of the present invention. Alternative cutting elements may include saws for cutting slots, burrs or reamers for cutting larger holes, or other cutting elements.

[0106] 5 is a cross-sectional view of a cutting attachment with a barrier drape in a retracted configuration. The central housing 215 has a front housing 217 and a rear housing 219. The front housing 217 and the rear housing 219 may be formed from injection molded plastic. A barrier drape 220 is secured to an inner edge 222 between the front housing 217 and the rear housing 219.

[0107] A coupling section 212 is connected to the cutting element 210 and is configured to mate with a corresponding coupling portion of the manufacturing apparatus 100 such that the manufacturing apparatus 100 can drive the cutting element 210 .

[0108] The barrier drape 220 passes through an upper support ring 240, a lower support ring 230, and a middle support ring 235 such that the support rings 230, 235, 240 hold the barrier drape 220 away from the cutting area.

[0109] A coding element 250 is disposed within rear housing 219. Coding element 250 includes an indication of the type of cutting element 210 that is incorporated into cutting attachment 200. Coding element 250 is readable by a sensor within manufacturing equipment 100 so that the manufacturing equipment can verify that the correct cutting element 210 is installed.

[0110] The manufacturing machine 100 is configured to disable the drive mechanism for the cutting element in response to determining that an incorrect cutting element 210 has been installed. Similarly, the manufacturing machine 100 is configured to enable the drive mechanism for the cutting element in response to determining that a correct cutting element 210 has been installed.

[0111] The coding element 250 may be a radio frequency identification (RFID) chip, a bar code, a QR code, a memory device (e.g., flash), or any other form of machine-readable medium. For example, the coding element may encode the type of cutting element via its physical shape that can be read by manufacturing equipment, for example, via an optical sensor or button configuration.

[0112] The coding elements can indicate different cutting attachment types, including different cutting element types (e.g., drills, burrs, etc.), different cutting element lengths or diameters, different cutting element materials, and / or different cutting attachment manufacturers.

[0113] 6 is a cross-sectional view of the cutting attachment with the barrier drape in an expanded configuration. The upper ring 240 has a lip such that it can be secured onto the driven support ring 160 of the manufacturing apparatus 100.

[0114] As the driven support ring 160 raises the upper ring 240, the barrier drape 220 rises along with the middle support ring 235. At full expansion of the barrier drape 220, the middle support ring 235 is spaced between the upper support ring 240 and the lower support ring 230.

[0115] The barrier drape 220 has some slack between the lower support ring 230 and the central housing 215. This allows the central housing 215 and cutting elements 210 to be moved by the manufacturing apparatus 100 along three orthogonal axes x, y and z.

[0116] The lower support ring 230 is configured to press down on the barrier drape 220 to ensure that the section of the barrier drape 220 between the lower support ring 230 and the central housing 215 does not lift when the upper support ring is lifted. This helps to maintain the barrier drape 220 taut between the lower support ring 230 and the upper support ring 240 to prevent the barrier drape 220 from impacting the cutting area. This also helps to maintain slack around the cutting attachment and allow it to be moved. Alternatively, or in addition, the lower support ring 230 may have a coupling section to secure the lower support ring 230 to the manufacturing apparatus 100 to prevent the lower support ring 230 from lifting when the upper support ring 240 is lifted.

[0117] The x and y axes are disposed along a horizontal plane. Movement along these axes allows the manufacturing apparatus 100 to position the cutting elements 210 along the correct lines to modify the surgical site impression and manufacture the necessary surgical guide holes.

[0118] The z-axis is oriented perpendicular to the horizontal plane. Movement along the z-axis allows the manufacturing apparatus 100 to urge the cutting element 210 against the impression to modify the impression. Thus, the sterile drape 220 is sufficiently baggy between the lower support ring 230 and the central housing 215 to allow the cutting element 210 to be lifted up to the impression at the surgical site.

[0119] 7 shows a detailed cross section of the drill and connection portion of the cutting attachment. The cutting element 210, in this case a drill bit, has a cutting section at its distal end and a coupling section 212 at its proximal end.

[0120] The mating section 212 of the cutting element 210 is configured to mate with a corresponding mating section of the manufacturing equipment 100. The mating section 212 has a drive surface configured to receive a drive force from the manufacturing equipment to drive the cutting element 210.

[0121] Ball bearings 214 are disposed within the central housing 215. The ball bearings retain the cutting elements 210 within the central housing 215 while allowing the cutting elements 210 to be driven to rotate within the central housing 215.

[0122] The rear housing 219 has a locking mechanism 216 disposed on an exterior surface of the rear housing 219 that allows the cutting element 210 to be locked into place within the mating section of the manufacturing apparatus 100 via a corresponding locking mechanism in the manufacturing apparatus 100.

[0123] A coding element 250 is disposed within rear housing 219 and allows manufacturing machine 100 to identify various characteristics of cutting element 210 and verify that the proper cutting element 210 is installed.

[0124] 8 shows a detailed perspective view of the drill and connection of the cutting attachment. The rear housing 219 includes static location features 213 at the proximal end of the cutting attachment 200. The static location features 213 have pointed protrusions with angled surfaces that help bias the cutting attachment 200 into the correct position in the mating section of the manufacturing apparatus 100. The static location features 213 are thus configured to be received within corresponding cavities in the mating section of the manufacturing apparatus 100. The static location features 213 also provide a purchase for the rear housing 219 to prevent the rear housing from rotating when the cutting element 210 is being driven.

[0125] 9 shows a surgical guide carrier with an integrated barrier drape, according to one embodiment. The surgical guide carrier 300 includes a carrier portion 310, a barrier drape 340 connected to the carrier portion 310, and an upper support ring 370 connected to the barrier drape 340.

[0126] The carrier part 310 has connecting portions for fixing the carrier part 310 to the manufacturing apparatus 100. In this embodiment, the connecting portions have a pair of grooves 312 for receiving corresponding interlocking portions of the manufacturing apparatus 100. The grooves 312 allow the carrier part 310 to slide into position on the manufacturing apparatus 100. This allows the carrier part 310 to be fixed to the manufacturing apparatus 100 in a predefined position and orientation such that the manufacturing apparatus 100 can align itself with the carrier part 310.

[0127] The connection portion further includes a pair of release levers 314 that are configured to allow the carrier portion 310 to be removed from the manufacturing apparatus 100 when the release levers 314 are biased toward one another. The release levers 314 include teeth that secure the carrier portion 310 in position on the manufacturing apparatus 100 when the carrier portion 310 is properly positioned on the manufacturing apparatus 100 and the release levers 314 are released.

[0128] The carrier part 310 has a rotatable part 320. The rotatable part 320 is a rotatable platform configured to rotate within the carrier part 310 about a yaw axis. The carrier part 310 is configured to secure a surgical guide to a front part of the rotatable part 320. The rotatable part 320 has a yaw axis keyway 322 on a rear surface (opposite the front surface) configured to mate with a yaw axis drive member of the manufacturing apparatus 100 such that the manufacturing apparatus 100 can drive the rotatable part 320 to rotate about the yaw axis (the yaw axis extending perpendicularly to the front and rear surfaces).

[0129] The barrier drape 340 is secured to the carrier part 310 between the front and rear housings of the carrier part 310. The barrier drape 340 surrounds the carrier part 310 and forms a barrier that prevents debris from passing from the front of the carrier part 310 to the rear of the carrier part 310.

[0130] The barrier drape 340 is substantially in the shape of a hollow hemisphere with a centrally located hole through which the carrier portion 310 is secured. An upper support ring 370 is connected to the rim of the hemisphere. This allows the barrier drape 340 to be lifted over the gimbal 140 of the manufacturing apparatus 100 and secured onto the upper housing lip 180 of the manufacturing apparatus 100.

[0131] The upper support ring 370 is expandable so that it can pass over the upper housing lip 180 of the manufacturing apparatus 100, but is biased toward a smaller radius to secure the barrier drape onto the upper housing lip 180. To accomplish this, the upper support ring 370 has overlapping spirals of resilient material, which may be formed of plastic. The inner end of the spiral is disposed radially inward of the outer end of the spiral.

[0132] The inner and outer ends each have a corresponding radially projecting lever 375. The inner end lever 375 has a passage through which the outer end passes. When the two levers are biased towards each other, the diameter of the upper support ring 370 increases, allowing the upper support ring 370 to pass over the upper housing lip 180 of the manufacturing apparatus 100. The upper support ring 370 is resilient and therefore biased back into an arrangement having a diameter smaller than the diameter of the upper housing lip 180 to secure the upper support ring 370 in place.

[0133] The upper support ring 370 also includes a radially protruding handle 390 that allows a user to lift the upper support ring 370 over the upper housing lip 180 of the manufacturing apparatus while keeping their hands off the non-sterile portions of the manufacturing apparatus 100.

[0134] In an alternative embodiment, the lever 375 can function as a handle for the upper support ring 370 and is long enough for a user to grasp and configured to support the weight of the surgical guide carrier 300 so as to avoid the need for a separate handle.

[0135] Although the connection of the carrier part 310 in the above embodiment provides a means to fix the carrier part to the manufacturing apparatus 100 in a predefined orientation, this is not required. In an alternative embodiment, the connection may simply connect the carrier part 310 to the manufacturing apparatus such that the rotatable part 320 can be rotated about the yaw axis. The connection allows the carrier part to be connected arbitrarily, or at least without requiring a specific orientation. In this embodiment, fiducial markers are provided on the carrier part to allow the manufacturing apparatus to determine the orientation of the carrier part 310, or at least the orientation of the rotatable part 320, by scanning the fiducial markers.

[0136] Figure 10 shows a surgical guide carrier with an integrated barrier drape according to an alternative embodiment. The surgical guide carrier in this embodiment has a barrier drape 340 and a carrier portion 310 similar to those of the embodiment of Figure 9. As mentioned above, the embodiment of Figure 10 has an upper support ring 380 with a different configuration.

[0137] In this embodiment, the upper support ring 380 has a frame with an opening of a fixed diameter larger than the diameter of the upper housing lip 180 to allow it to pass through the upper housing lip 180. To secure the upper support ring 380 over the upper housing lip 180, the upper support ring 380 further has a pair of opposing locking members 382 that project radially into the opening in the frame. The locking members 382 are disposed on either side of the frame and project toward each other.

[0138] The locking members 382 are movably mounted on the frame such that they may be moved at least partially out of the opening and away from each other. This reduces the extent to which the locking members 382 protrude into the opening to allow the upper support ring 380 to pass around and over the upper housing lip 180. Each locking member 382 is biased towards the center of the opening such that, when released, the locking member 382 moves back into the opening and secures the upper support ring 380 onto the upper housing lip 180. The biasing force may be provided by a spring, or any other form of resilient member.

[0139] Each locking member 382 is attached to a handle 385 that projects outwardly from the frame. The handles 385 allow a user to lift the upper support ring 380 over the upper housing lip 180 while keeping their hands free from the manufacturing apparatus 100. Each handle 385 has a grip section that allows the user to retract the locking member 382 from the opening, as described above.

[0140] 11 shows a detailed view of the front of the carrier portion of the surgical guide carrier. The carrier portion 310 has a coupling portion 330 disposed on the front of the rotatable portion 320. The coupling portion 330 is configured to receive and releasably couple the moldable material carrier.

[0141] The coupling part 330 has a U-shaped housing with two side walls connected via a rear wall. The side walls and rear wall protrude from the front surface of the carrier part 310. The side walls extend parallel to each other. Each side wall includes an upper lip protruding towards the opposite side wall. The side walls and upper lip thus form opposing channels into which corresponding sections of the formable material carrier can be inserted. The upper lips are received within corresponding channels in the formable material carrier and prevent the formable material carrier from falling out of the coupling part 330 without passing along the channel of the coupling part 330.

[0142] The coupling portion 330 has a locking mechanism for fixing the formable material carrier in place within the channel. The locking mechanism has a pair of locking members 332 that each protrude into a corresponding channel of the coupling portion 330. The two locking members 332 are connected to a release button 334. The locking mechanism is configured to bias the locking members 332 toward an upward position extending into the channel, toward the upper lip. The locking members 332 can be at least partially pushed out of the channel via depression of the release button 334. This reduces the extent to which the locking members 332 protrude into the channel, thereby allowing the formable material carrier to be inserted or removed from the coupling portion 330.

[0143] Each locking member 332 has an inclined surface at the entrance of the channel facing the entrance of the coupling. The inclined surface causes the locking members 332 to be depressed when the formable material carrier is urged along the channel into the coupling to allow the formable material carrier to be fully inserted into position. When the formable material carrier is fully inserted into the coupling 330, the locking members 332 are received within corresponding cavities in the formable material carrier to secure the formable material carrier in position.

[0144] The carrier portion 310 has a coding element 350. Similar to the coding element of the cutting attachment 200, this coding element 350 includes an indication of one or more characteristics of the carrier attachment 300. This indicates the type of carrier attachment 300 to allow the manufacturing apparatus 100 to determine if the correct carrier attachment 300 has been attached. Different types of carrier attachments 300 may include different sizes or shapes of coupling portions 330 for different sizes or shapes of surgical guides.

[0145] Similar to the coding element of cutting attachment 200, the coding element of carrier attachment 300 may be a radio frequency identification (RFID) chip, a bar code, a QR code, a memory device (e.g., flash), or any other form of machine-readable medium. For example, the coding element may encode the type of cutting element via its physical shape that can be read by manufacturing equipment, e.g., via an optical sensor or button configuration.

[0146] The manufacturing equipment 100 may be configured to start or stop based on whether the correct type of carrier attachment 300 is loaded into the manufacturing equipment 100 .

[0147] 12 shows a cross-sectional view of a surgical guide carrier. A barrier drape 340 is secured between a front housing 316 and a rear housing 318 of a carrier part 310. A rotatable portion 320 passes through the carrier part 310 from a yaw axis keyway 322 to a coupling part 330. The carrier part 310 allows the rotatable portion 320 to rotate about the yaw axis within the carrier part 310 via a rotational force incident on the yaw axis keyway 322 such that the coupling part 330 rotates.

[0148] 13 shows a formable material carrier according to a first embodiment. The formable material carrier 400 is configured to receive formable material in a manner such that the formable material is evenly distributed across a front surface 412 of the formable material carrier 400.

[0149] The moldable material carrier 400 and the moldable material can be used to form an impression of a surgical site. Once the moldable material hardens, the moldable material carrier is attached to a surgical guide carrier 300, which is attached to a manufacturing apparatus 100. The manufacturing apparatus 100 can then scan the impression and modify the impression according to a surgical plan to manufacture a surgical guide.

[0150] The moldable material carrier 400 is formed from a front portion 410 and a rear portion 420 that may be formed separately and then joined together. The front and rear portions may be formed of injection molded plastic. The moldable material carrier 400 has an inlet formed in a rear face of the rear portion 420 of the moldable material carrier 400. The rear face is opposite to the front face 412 of the moldable material carrier 400. The inlet is connected to an outlet hole 416 in the front face 412 via an internal passage. This means that the moldable material carrier 400 is configured such that when the moldable material is injected into the inlet, the moldable material is forced through the moldable material carrier 400 and out of the outlet hole 416. The outlet holes 416 are equally spaced across the front face 412 of the moldable material carrier 400. This helps to distribute the moldable material evenly across the front face 412.

[0151] The front surface 412 has a number of small protrusions 414 evenly distributed across the extent of the front surface 412. These protrusions 414 provide a purchase for the formable material by allowing the formable material to wrap around the protrusions and then harden. This means that the formable material is more firmly secured to the formable material carrier 400.

[0152] The rear portion 420 has a coupling portion for coupling the moldable material carrier 400 to the surgical guide carrier 300. The coupling portion has two channels 430 through the side of the rear portion 420. The two channels 430 are formed to receive the top lips of the coupling portion 330 of the surgical guide carrier 300. This allows the moldable material carrier 400 to be slid into the channels of the surgical guide carrier 300. Two recesses 432 are formed in the rear surface of the moldable material carrier 400 to receive the locking members 332 of the coupling portion 330 of the surgical guide carrier 300. This allows the moldable material carrier 400 to be locked into place within the coupling portion 330 of the surgical guide carrier 300.

[0153] A flat surface 436 is disposed on the leading side of the formable material carrier 400. The flat surface 436 extends perpendicular to the channel 430. The flat surface 436 allows the formable material carrier 400 to sit square within the surgical guide carrier 300. This provides a secure fit to avoid movement of the formable material carrier 400 within the surgical guide carrier 300.

[0154] FIG. 14 shows a perspective view of a syringe for injecting formable material into the formable material carrier. As mentioned above, an inlet 424 is formed in the rear surface 422 of the formable material carrier 400. The inlet 424 is substantially conical and has tapered walls such that its diameter decreases as it passes deeper into the formable material carrier. The tapered walls allow the conical tip of the syringe to fit securely into the inlet 424. This provides an interference fit around the syringe to prevent the formable material from leaking out of the inlet 424 as it is being forced into the formable material carrier 424. The tapered walls also help the user to properly position the syringe to ensure effective transfer of the formable material into the formable material carrier 400.

[0155] 15 shows the internal structure of the formable material carrier. The formable material carrier 400 has a front portion 410 and a rear portion 420. The front portion 410 has a front side 412 and a rear side 418 opposite the front side 412. The rear side 420 has a rear side 422 and a front side 428 opposite the rear side 422. When the formable material carrier 400 is assembled, the rear side 418 of the front portion 410 is secured to the front side 428 of the rear portion 420.

[0156] An interconnecting channel 429 is formed in a front surface 428 of the rear portion 420. An inlet 424 in a rear surface 422 of the rear portion 420 passes through the rear portion 420 and opens into the channel 429.

[0157] A corresponding set of channels 419 are formed in the rear face 418 of the front portion 410. The channels 419 in the front portion 410 feed into exit holes 416 in the front face 412 of the front portion 410.

[0158] Channels 419 and 429 are mirror images of each other. Channels 419 and 429 are in the form of one 7-point asterisk or star and one 6-point asterisk or star. Each asterisk is linked to the other via one of its points / legs.

[0159] When the front portion 410 and the rear portion 420 are combined, the two sets of channels 419, 429 combine to form tunnels in the formable element carrier 400. Thus, formable material can be injected into the inlets 424, forced through the tunnels, and out the exit holes 416.

[0160] The inlets 424 and the outlet holes 416 are positioned to ensure an even distribution of the formable material across the front face 412. Thus, the inlet 424 is centrally positioned on the rear face 422. This results in a longitudinally extending tunnel connecting the inlet to two central outlet holes 416 that sit on either side of the inlet 424. These two central outlet holes 416 and the inlet 424 all lie along the central axis of the formable material carrier 400. One of the central outlet holes 416 is surrounded by six outer outlet holes 416, each linked to a corresponding central outlet hole 416. The others of these central outlet holes 416 are surrounded by five outer outlet holes 416, each linked to a corresponding central outlet hole 416. The star-shaped formation of the tunnels helps to ensure an even distribution of the formable material across the front face 412.

[0161] It should be noted that the exact number of channels and holes may vary between embodiments depending on the size of the formable material carrier.

[0162] 16 shows a cross-sectional view of a syringe injecting formable material into the formable material carrier. The syringe fits into a tapered channel that forms part of the inlet. The tapered walls prevent the tip of the syringe from being inserted into the longitudinally extending tunnel that connects the inlet to the central exit hole 416. The tapered walls also provide a seal around the syringe to prevent the formable material from leaking out of the inlet 424 as it is injected into the formable material carrier 400.

[0163] When formable material is injected into the inlet 424, it passes through the interior tunnel and is forced out of the exit holes 416 to be distributed across the front surface 412 of the formable material carrier.

[0164] The formable material carrier described with reference to Figures 13-16 is just one embodiment. There are many different configurations that allow the formable material to be distributed evenly across the surface of the formable material holder. For example, a second embodiment is described with reference to Figures 17-24.

[0165] 17 shows a formable material carrier according to a second embodiment. The formable material carrier 500 of the second embodiment is similar to that of the first embodiment, but includes several dividing stages to evenly divide the formable material so as to distribute it across the front surface.

[0166] The formable material carrier 500 has a front section 510 and a rear section 520. The front section 510 fits into a cavity in the rear section 520. Several openings 512 extend through the front section 510 and act as extra holes for the formable material. In this embodiment, the openings 512 are triangular.

[0167] Rear section 520 forms the outer housing of formable material carrier 500. Rear section 520 is substantially cup-shaped and forms an interior cavity within which first and second splitters, as well as front section 510, may be received. Rear section 520 has a number of protrusions 522 distributed about an outer surface of a sidewall of rear section 520 to provide a user with additional grip when holding formable material carrier 500.

[0168] An inlet 524 is formed in a sidewall at one end of the formable material carrier 500. This inlet 524 is an opening that functions similarly to the inlets shown in Figures 13-16. The inlet 524 is connected to the internal cavity such that when the formable material is inserted into the inlet 524, the formable material enters the internal cavity, is split by the first and second splitters, and is forced out of the openings 512 in the front section 510 to evenly distribute the formable material across the front surface of the front section 510.

[0169] By locating the inlet 524 on a sidewall rather than the rear of the moldable material carrier 500 , the moldable material can be more easily injected through the inlet while the user is holding the moldable material carrier 500 .

[0170] Coupling mechanisms are arranged at the rear of the formable material carrier 500. These coupling mechanisms are similar to those provided in the embodiment of Figs. 13-16. Two coupling channels 526 are formed in the side walls. The coupling channels 526 are arranged on opposite sides of the formable material carrier 500 relative to each other. The coupling channels 526 run longitudinally along the side walls parallel to the front and rear faces. This allows the formable material carrier 500 to be slid into the coupling part of the surgical guide carrier 300. A recess 528 is formed at the rear of the rear section to receive the locking member 332 of the coupling part 330 of the surgical guide carrier 300. This allows the formable material carrier 400 to be locked in place in the coupling part 330 of the surgical guide carrier 300.

[0171] Figure 18 shows a cross-sectional view of the formable material carrier of Figure 17. A rear section 520 has a base and a peripheral sidewall that projects from the base and surrounds a cavity. An inlet 524 is formed in the side of the rear section 520 and passes through the base. The inlet 524 is substantially conical in shape and narrows as it enters the base. The inlet 524 enters the center of the base and is connected to an internal tunnel 530 that opens at a central opening in the cavity.

[0172] A first splitter 540 is placed in the cavity above the central opening. It serves to split the moldable material exiting the central opening into two. A second splitter 550 is placed in the cavity above the first splitter 540. It serves to further split the moldable material. A front section 510 is placed in the cavity above the second splitter 550. The front section 510 is secured in the cavity by an interference fit with the mating section of the rear section. When the front section 510 is secured in the cavity, the first splitter 540 and the second splitter 550 are also held in the cavity.

[0173] Figure 19 shows cross-sectional and perspective views of an injector injecting formable material into the formable material carrier of Figure 17. Similar to the formable material carrier of Figure 14, the formable material may be injected into the carrier via an injector 600.

[0174] A controlled amount of moldable material is provided in the syringe (the syringe is pre-filled with the correct amount of material for the type of surgical guide), which ensures that the proper amount of material is dispensed throughout the moldable material carrier 500.

[0175] As the formable material is forced into the inlet 524, it is forced into the cavity and divided evenly through the first and second splitters 540 and 550 and the openings 512 in the forward section 510. The formable material is forced out of the openings 512 to provide an even distribution of the formable material across the front of the formable material carrier 500.

[0176] Figure 20 shows a cross-sectional view of the rear section of the formable material carrier of Figure 17. As mentioned above, the side inlet 524 of the rear section 520 is connected to an internal tunnel 530 which is connected to a central opening that opens into the cavity.

[0177] A central recess 532 is disposed at the base of the cavity for receiving a portion of the first splitter 540 .

[0178] A groove 521 is formed in the inner surface of the side wall and extends around the periphery of the side wall parallel to the base of the cavity, providing a joint into which the front section 510 can be secured, for example by a snap fit.

[0179] Figure 21 shows a first stage splitter of the formable material carrier of Figure 17. The first stage splitter 540 divides the formable material exiting the central opening into two portions.

[0180] A first opening 542 and a second opening 544 are formed in the first stage splitter 540 and lead from the rear side to the front side of the first stage splitter 540. The two openings 542, 544 are disposed along a central axis of the formable material carrier but are separated from one another along the central axis. The two openings 542, 544 are substantially evenly spaced along the length of the formable material carrier.

[0181] The front side of the first stage splitter 540 is substantially flat. The rear side of the first stage splitter 540 has a splitter protruding from the base of the first stage splitter 540. The splitter fits into the central cavity 532. The splitter has a first cavity located at the center of the splitter 540 and opening to the rear of the splitter 540. The first cavity forms a channel between a first opening 542 and a second opening 544. The two openings 542, 544 open into the channel.

[0182] When the first stage splitter 540 is positioned within the cavity of the rear section 520, the channel is positioned above a central opening of the rear section 520. The first opening 542 and the second opening 544 are offset from and do not overlap with the central opening. This means that as the formable material is extruded from the central opening, it is extruded to the base of the first stage splitter 540 and is thus forced through the channel towards the first opening 542 and the second opening 544.

[0183] The first opening 542 and the second opening 544 are equidistant from the central opening and have equal cross-sections, meaning that the moldable material is divided evenly between the first opening 542 and the second opening 544.

[0184] Figure 22A shows a front perspective view of the second stage splitter of the formable material carrier of Figure 17. Second stage splitter 550 splits each of the two portions of formable material from first stage splitter 540 into six corresponding portions. Thus, second stage splitter 550 splits the formable material into a total of twelve portions.

[0185] The second stage splitter 550 is substantially planar and has twelve openings 556 that lead from a front surface of the second stage splitter 550 to a rear surface of the second stage splitter 550. The twelve openings 556 are arranged across the front surface of the second stage splitter 550 in the form of two circles that intersect at a center point of the second stage splitter 550. Each of the twelve openings 556 has substantially the same cross section as the other openings 556.

[0186] When the second stage splitter 550 is placed over the first stage splitter 550 , the two circles are centered over the first opening 542 and the second opening 544 of the first stage splitter 540 .

[0187] 22B is a perspective view of the rear of the second stage splitter. The second stage splitter 540 is divided into a first split section 552 and a second split section 554. Each of the split sections 552, 554 has six channels connected to six of the twelve openings 556. All six channels meet at the center of the split section. The two split sections 552, 554 are not connected to each other.

[0188] 22C is a plan view of the rear face of the second stage splitter. The first split section 552 is a six-point star shape. The second split section 554 is an eight-point star shape with two adjacent points removed. The first split fits partially into the gap of the second split where two adjacent points are missing.

[0189] Each divided section 552, 554 has a center point from which its respective channels emanate. For each divided section 552, each opening 556 is located an equal distance away from its respective center point. In other words, each divided section 552, 554 includes channels of equal length. This ensures that the moldable material within each divided section is evenly divided.

[0190] When the second stage splitter 550 is positioned above the first stage splitter 540 , the center point is located above the first opening 542 and the second opening 544 of the first stage splitter 540 .

[0191] As the formable material is extruded through first opening 542 and second opening 544, it is forced against the rear face of second stage splitter 550. The formable material is thus forced along each of the channels and out of the corresponding opening 556, thereby dividing the formable material into twelve portions.

[0192] The formable material is divided substantially evenly among the twelve openings 556 because the openings have the same cross-section and are located the same distance from the center point for each divided section.

[0193] Figure 23A shows a front view of the front portion of the formable material carrier of Figure 17. The front portion 510 of the formable material carrier is configured to split each of the portions of formable material received from the second stage splitter 550 into three equal portions. Thus, the front portion 510 forms a third stage splitter for splitting the formable material into a total of 36 portions.

[0194] A lip 514 is disposed on an outer edge of the front portion 510. The lip 514 is configured to be received within a channel 521 in a sidewall of the rear section 520 of the formable material carrier 500 to secure the front portion 510 within the rear section 520.

[0195] 23B shows the rear face of the front section. Twelve triangular cavities 516 are formed in the rear face, one for each opening in the second stage splitter 550. The triangular cavities 516, as well as the openings 556 on the second stage splitter 550, are arranged in a star pattern.

[0196] The rear face of the front section 510 is effectively subdivided by a number of spokes 517. Two sets of spokes radiate from two corresponding central points. This divides the rear face into twelve openings 516 of equal cross-section. When the front section 510 is positioned over the second stage splitter 550, the triangular cavities 516 are centered over corresponding openings 556 in the second stage splitter 550.

[0197] 24 shows a plan view of the rear face of the front section. Each triangular cavity 516 is triangular in cross section and opens into the rear face of the front section 510. Each triangular cavity 516 is connected to three corresponding triangular openings 512 in the front side (front face) of the front section 510. Each of the three triangular openings 512 opens into a respective corner of the corresponding triangular cavity 516.

[0198] The three triangular openings 512 are centered over the cavity 516 and are separated by a dividing wall 518 that forms an upper roof of the cavity 516. In this case, the dividing wall 518 is triangular. When the front section 510 is positioned above the second stage splitter 550, the dividing wall 518 passes entirely over the corresponding openings 556 in the second stage splitter 550. This prevents the formable material from exiting the openings 556 without some deflection. As the formable material is extruded from the openings 556, it is forced against the dividing wall 518 and deflected into one of the three triangular openings 512. This ensures that the triangular cavities 516 are filled with the formable material before it is extruded from the triangular openings 512. This therefore provides an even distribution of the formable material.

[0199] Each of the triangular openings 512 has a cross-section of the same area and is located the same distance away from the center point of the corresponding triangular cavity 516. In addition, the triangular openings 512 are substantially evenly distributed across the front surface of the front section 510. Thus, the front section 510 divides the formable material evenly to provide an even distribution of the formable material across the front surface of the front section 510.

[0200] While the above embodiments describe particular arrangements in which the formable material may be divided into a particular number of portions (13 portions in the first embodiment and 36 portions in the second embodiment), it will be understood that the number of portions may vary depending on the size of the formable material carrier and the function it performs. Additional or fewer division stages may be performed depending on the number of portions that need to be provided.

[0201] Similarly, although the above embodiments describe triangular openings and triangular cavities, the shapes of the openings and cavities may be adapted to the particular geometry of the formable material carrier.

[0202] Additionally, while the above-described embodiments are directed to evenly distributing the formable material, it will be appreciated that alternative embodiments may place splitters or openings on the front surface of the formable material carrier to provide more volume of formable material in the center of the front surface than at the periphery, which may be useful in situations where the mold is expected to fit within a socket and thus be substantially dome-shaped.

[0203] Additionally, although the moldable material carrier has been described as being formed from multiple pieces that may be connected to one another, the moldable material carrier may be manufactured by a variety of methods, including additive manufacturing, and thus may be formed as a single piece or separate pieces.

[0204] Several parts of an overall system are described herein. These parts combine to provide an overall system for creating a surgical guide. These parts may be provided separately or together. The process of manufacturing a surgical guide from an impression of a surgical site is described below.

[0205] 25A illustrates the first step in a surgical guide manufacturing procedure, according to one embodiment. The driven support ring 160 is lowered to its retracted position. The attachment point 110 for the surgical guide carrier 300 is tilted forward via the gimbal 140 to allow the user to access the attachment point 110.

[0206] 25B illustrates a second step in the surgical guide manufacturing procedure, according to one embodiment. The carrier portion 310 of the surgical guide carrier 300 is secured to the mount point 110 by placing the carrier portion 310 in the mount. This is done with the user's hands inserted into the barrier drape 340 of the surgical guide carrier 300 to provide a sterile barrier against contamination from non-sterile portions of the manufacturing apparatus 100 (e.g., the gimbal 140). If the manufacturing apparatus records that an incorrect surgical guide carrier 300 has been used, the manufacturing apparatus may warn the user and / or disable.

[0207] The upper support ring 370 is expanded to allow it to fit over the upper housing lip 180 of the manufacturing apparatus 100. The upper support ring 370 is then raised over the upper housing lip 180 and allowed to contract, thereby securing the barrier drape 340 over the upper housing lip 180 to encase the gimbal 140.

[0208] 25C illustrates a third step in the surgical guide manufacturing procedure, according to one embodiment. The gimbal 140 is then tilted to a rearward position to move the attachment point 110 and surgical guide carrier 300 out of the way of the user so that the cutting attachment 200 can be mated to the manufacturing apparatus 100.

[0209] The cutting element 210 is coupled to the coupling section 112 of the manufacturing equipment 100, and the upper support ring 240 of the cutting attachment 200 is secured above the driven support ring 160. If the manufacturing equipment records that the incorrect cutting attachment 200 has been used, the manufacturing equipment may disable and / or issue a warning to the user.

[0210] 25D illustrates a fourth step in the manufacturing procedure for the surgical guide, according to one embodiment. The gimbal 140 is tilted forward to allow a user to access the surgical guide carrier 300. After an impression of the surgical site is obtained using the moldable material deposited on the moldable material carrier 400, the moldable material carrier 400 is mounted on the surgical guide carrier 300.

[0211] 25E illustrates a fifth step in the manufacturing procedure for the surgical guide, according to one embodiment. The gimbal 140 is tilted back towards the scanner 150. The scanner 150 scans the surface of the impression.

[0212] The manufacturing machine 100 then aligns the surfaces of the impression to the patient's anatomical features shown in the patient's medical scan. The manufacturing machine 100 then determines the appropriate actions to modify the impression to create a surgical guide according to a predefined surgical plan.

[0213] 25F illustrates a sixth step in the manufacturing procedure for the surgical guide, according to one embodiment. The driven support ring 160 is raised to raise the barrier drape 220 of the cutting attachment 200 around the cutting area to seal the cutting area from the surrounding areas.

[0214] The impression is then rotated, via the rotation mechanism, to the correct tilt and yaw angles and the cutting attachment 210 is moved to the correct location in the x, y and z axes for the first surgical guide hole to be fabricated. The cutting attachment 210 (in this case a drill) is driven into the impression at the surgical site to create the guide hole. This process is repeated until a surgical guide with the required number of guide holes has been created. The driven support ring 160 is then lowered so that the surgical guide can be removed from the surgical guide carrier 300.

[0215] Because the coupling portion 112 of the cutting attachment 210 is located below the attachment point 110 of the carrier portion 310, debris from the impression being corrected falls away from the impression and collects in the barrier drape 220 of the cutting attachment 200. Once the operation is complete, the cutting attachment 200 is removed from the manufacturing apparatus 100 so that this debris can be easily collected in the barrier drape 220 by the user.

[0216] The embodiments described herein include a surgical guide manufacturing apparatus and various attachments for the surgical guide manufacturing apparatus that help enable the manufacturing apparatus to be utilized in a sterile environment, such as an operating room, without compromising the sterile environment.

[0217] The inclusion of an integrated barrier drape on each cutting attachment and surgical guide carrier allows these attachments to be loaded onto a manufacturing machine that has the barrier drape covering the user's hands, which means that the manufacturing machine itself does not need to be sterilized, thereby reducing the cost of operating the manufacturing machine and reducing turnaround time after surgery.

[0218] By providing an elongated tubular barrier drape as part of the cutting attachment, the barrier drape can be positioned around the cutting area to seal the cutting area from the outside. This prevents debris from the cutting process from escaping the manufacturing apparatus and contaminating the surroundings. Because the cutting attachment is loaded onto the manufacturing apparatus below the surgical guide carrier, debris falls off the surgical guide during revision and is collected within the barrier drape of the cutting attachment. This helps contain the debris within the barrier drape and allows the user to easily dispose of this debris when the cutting attachment is separated from the manufacturing apparatus.

[0219] By providing an integral barrier drape with the surgical guide carrier, the rotation mechanism to which the surgical guide carrier is attached is protected from debris from modification of the surgical guide. Furthermore, a sterile barrier is formed between the rotation mechanism and the cutting area to prevent contaminants from falling into the sterile cutting area. Additionally, the barrier drape reduces the risk of contamination of the user's hands when loading or unloading the moldable material carrier and / or the surgical guide carrier.

[0220] Respective coding elements may be provided within each of the attachments. These coding elements indicate various characteristics or types of each attachment. The manufacturing machine can be configured to read these coding elements and determine whether the correct attachments are installed to manufacture the required surgical guide. If it is determined that the correct attachments are not installed, the manufacturing machine can disable itself, for example, by disabling the drive mechanism of the cutting attachment.

[0221] Although the above-described embodiments refer to a drill attachment having a drill bit, alternative cutting or modification means may be implemented in the cutting attachment. Suitable alternative cutting tools include burrs, knives, bores, reamers, saw blades, needles, or other tools having suitable cutting edges. Alternatively, if the impression is still malleable, a blunt tool may be utilized. Nevertheless, the same concepts apply; that is, the cutting / modification attachment is placed in the center of the cutting / modification attachment including a barrier drape that may be lifted around the cutting / modification area to provide a sterile barrier against contaminants.

[0222] Although the above embodiments describe upper, lower, and middle support rings of the barrier drape of the drill attachment, these do not have to be circular, but can be any shape that forms a loop, such as square, rectangular, or other.

[0223] While the above embodiments describe a formable material carrier having front and rear portions that are fixed together, alternative embodiments may have additional parts that are joined together. Alternatively, the formable material carrier may be formed as a single unit, for example, by additive manufacturing.

[0224] Although the above embodiments describe how the manufacturing device may align the impression scan of the surgical site to the patient's anatomical features and determine how to modify the impression to create the surgical guide, this may instead be performed by an external computer. Thus, a controller may be connected to the manufacturing device to perform the steps. The manufacturing device may be configured to transfer the impression scan to the controller and receive instructions to modify the impression from the controller. Similarly, the controller may be integrated within the manufacturing device.

[0225] The above description relates to surgical guide manufacturing devices and accessories for surgical guide manufacturing devices. As noted above, further embodiments are not limited to this application and are configured for use in preparing bone to create bone grafts for use in surgery. This may be in addition to, or instead of, being configured to create surgical guides.

[0226] Bone grafts can be utilized when additional bone needs to be added to a surgical site. For example, when performing a total shoulder replacement, a prosthesis is placed into the glenoid cavity of the scapula. If the patient has significant glenoid wear, it can be difficult to position the prosthesis and ensure that it is securely seated. In these cases, bone grafts can be added to fill the surgical site, so that the prosthesis can be more securely placed in the desired anatomical location while simultaneously preserving bone at the surgical site.

[0227] Bone grafts are often sourced from bone harvested from the patient. This is particularly the case in total shoulder arthroplasty, where bone can simply be taken from the portion of the humerus (e.g., the humeral head) that is to be cut and replaced with the prosthesis. The removed bone (which would otherwise be discarded) can be formed into a bone graft at the surgical site.

[0228] The manufacturing apparatus described herein can be utilized to form bone into a bone graft. During the pre-operative phase, the shape of the required bone graft can be determined from a patient scan (e.g., CT scan). This shape can include guide holes (or other forms of alignment features) for precise alignment of the bone graft within the surgical site. This can use guide elements (e.g., pins) provided via a surgical guide produced by the manufacturing apparatus.

[0229] To manufacture the bone graft, a donor bone can be mounted in the manufacturing device. In one embodiment, the bone is mounted on the attachment points. This can be accomplished by a carrier configured to hold the bone and be attached to the attachment points. The bone can be secured to the attachment points / carrier via vices, screws, etc. Alternatively, the bone can be attached to a surgical guide (or a 3D printed sterile guide) as described herein, which is then attached to a surgical guide carrier.

[0230] Once attached to the attachment points, the manufacturing device is configured to scan the surface of the bone to register the shape of the bone and determine where the bone should be cut. A cutting element, such as a bur or mill, is provided to cut the bone. The manufacturing device is configured to use the cutting element to shape the bone into a bone graft. This effectively forms a 5-axis milling machine (including X, Y, Z, tilt and yaw axes as described with reference to FIG. 1).

[0231] Since only one side of the bone can be modified at a time, the bone can be removed from the fabrication device, inverted, and reattached to allow modification of both sides of the bone to form the entire bone graft. Alternatively, only one side can be shaped by the fabrication device and the other side can be shaped by the surgeon as the bone graft is attached.

[0232] The manufacturing device may include a number of different cutting elements for use in modifying bone. For example, mills, burrs, drills and / or saws may be used to shape the bone. A variety of cutting elements may be mounted within the manufacturing device, and the manufacturing device may be configured to swap between cutting elements as needed. For example, a coupling section for the cutting elements may place a cutting element originally secured within the coupling section into a mount to retrieve a new cutting element for use in cutting bone. Of course, this mechanism may also be used when modifying a mold to create a surgical guide.

[0233] The bone graft may be shaped to fit within the surgical site. To accomplish this more accurately, an impression of the surgical site may be taken and used to determine the correct shape of the bone graft. The impression may be scanned by the manufacturing device to determine the shape of the surgical site. If a surgical guide is also being formed, the same impression may be used for both purposes (i.e., to manufacture the surgical guide and to determine the required shape of the bone graft).

[0234] The bone graft may be shaped to fit over a guide element, such as a guide pin / rod, that is secured within the surgical site. Alternatively, or in addition, the bone graft may be shaped to fit within a corresponding recess formed within the surgical site. For example, a recess may be cut (using the mold described above) into the bone within the surgical site into which the bone graft may be fitted. By fitting the bone graft within the recess, movement of the bone graft within the surgical site may be reduced.

[0235] In light of the above, the manufacturing apparatus according to the embodiments described herein may be configured to modify bone to manufacture bone grafts. These embodiments may or may not use the attachments described herein, including integrated barrier drapes. If integrated barrier drape attachments are used, these attachments may be modified for use to create bone grafts. For example, the surgical guide carrier can be a bone carrier for attaching donor bone to the manufacturing apparatus. Similarly, the cutting attachments may be modified to include alternative cutting elements (e.g., mills or burrs) or to include interchangeable cutting elements.

[0236] While specific configurations are described, they are presented by way of example only and are not intended to limit the scope of the invention. Indeed, the novel methods and apparatus described herein may be embodied in a variety of other forms, and various omissions, substitutions and changes may be made in the form of the methods and systems described herein.

[0237] The following additional note is added: (Appendix 1) 1. A cutting attachment for use in a surgical guide manufacturing apparatus, comprising: cutting elements; a connector for connecting the cutting element to a drive mechanism of the surgical guide manufacturing apparatus such that the cutting element can be driven by the drive mechanism to modify an impression of a surgical site to manufacture a surgical guide; a protective barrier configured to be positioned about the cutting element to surround the cutting area to help prevent contaminants from entering or exiting the cutting area during modification of the impression; having Cutting attachment. (Appendix 2) a support connected to the protective barrier and configured to be moved to position the protective barrier about the cutting area. 2. A cutting attachment as described in claim 1. (Appendix 3) the support is configured to be coupled to a driven support arm of the surgical guide manufacturing apparatus such that the surgical guide manufacturing apparatus can move the protective barrier into position about the cutting area. 2. A cutting attachment as described in claim 2. (Appendix 4) the protective barrier comprises a flexible sheet; 4. A cutting attachment according to any one of claims 1 to 3. (Appendix 5) and further comprising one or more support frames connected to the protective barrier and configured to be positioned around the cutting area to prevent the protective barrier from entering the cutting area. 5. A cutting attachment as described in claim 4. (Appendix 6) The cutting element comprises a cutting element for a power tool. 6. A cutting attachment according to any one of claims 1 to 5. (Appendix 7) The cutting attachment is sterilized or configured to be sterilized. 7. A cutting attachment according to any one of claims 1 to 6. (Appendix 8) a coding element configured to indicate the type of the cutting attachment and to be read by the surgical guide manufacturing device so that the surgical guide manufacturing device can verify that the correct type of cutting attachment has been fitted; 8. A cutting attachment according to any one of claims 1 to 7. (Appendix 9) 1. A surgical guide carrier for attachment to a surgical guide manufacturing apparatus, said surgical guide carrier comprising: a connector for attaching the surgical guide carrier to a mount of the surgical guide manufacturing apparatus; a coupling that receives and releasably holds an impression of a surgical site when the impression is held within the surgical guide carrier and when the surgical guide carrier is attached to the surgical guide manufacturing apparatus such that the surgical guide manufacturing apparatus can modify the impression to manufacture a surgical guide; a protective barrier configured to be positioned around at least a portion of the surgical guide manufacturing apparatus to provide a barrier between the surgical guide and at least a portion of the surgical guide manufacturing apparatus; having Surgical guide carrier. (Appendix 10) the surgical guide carrier is sterilized or configured to be sterilized; The protective barrier provides a sterility barrier to help prevent contamination of the impression during modification. 10. The surgical guide carrier of claim 9. (Appendix 11) the protective barrier is flexible; 11. The surgical guide carrier of claim 9 or 10. (Appendix 12) a protective barrier configured to be secured to the surgical guide manufacturing apparatus such that the protective barrier surrounds the mount of the surgical guide manufacturing apparatus; 12. A surgical guide carrier according to any one of claims 9 to 11. (Appendix 13) the surgical guide carrier further comprises a support frame connected to the protective barrier; the support frame defines an opening, the opening being configured such that the mount of the surgical guide manufacturing apparatus can be received within the opening and the opening can be expanded from a first configuration to a second configuration larger than the first configuration such that the support frame can fit over a stationary section of the surgical guide manufacturing apparatus; when the support frame is released, the support frame is biased towards the first configuration such that the support frame returns to the first configuration to secure the protective barrier onto the securing section. 13. The surgical guide carrier of claim 12, which references claim 11. (Appendix 14) and further comprising one or more levers connected to the support frame and configured to allow the support frame to receive an expansion force to expand the opening from the first configuration to the second configuration. 14. The surgical guide carrier of claim 13. (Appendix 15) The support frame comprises: one or more locking members, each configured to be biased toward a first position in which the locking member projects into the opening and configured to be movable from the first position to a second position to enlarge the opening; or an elastic loop configured to be expandable to expand the opening; having 15. The surgical guide carrier of claim 13 or 14. (Appendix 16) a handle connected to the support frame and projecting away from the opening. 16. A surgical guide carrier according to any one of claims 13 to 15. (Appendix 17) and a rotatable section on which the coupling portion is disposed, the rotatable section configured to receive a rotational force from the surgical guide manufacturing apparatus such that the coupling portion can be rotated into position for manufacturing the surgical guide. 17. A surgical guide carrier according to any one of claims 9 to 16. (Appendix 18) and a coding element configured to indicate a type of the surgical guide carrier and to be read by the surgical guide manufacturing device so that the surgical guide manufacturing device can verify that the correct type of surgical guide carrier has been attached. 18. A surgical guide carrier according to any one of claims 9 to 17. (Appendix 19) 1. A formable material carrier for use in making an impression of a surgical site, the formable material carrier having a first surface onto which a formable material can be dispensed: An inlet is formed in the formable material carrier and formable material is forced into the inlet; an internal cavity is formed within the formable material carrier, the internal cavity being connected to the inlet; a plurality of openings are formed in the first surface and connected to the internal cavity such that when the formable material is forced into the inlet, the formable material is received in the internal cavity and forced out of the openings to be distributed across the first surface; Formable material carrier. (Appendix 20) a connection for connecting said moldable material carrier to a surgical guide manufacturing device in a predetermined position and orientation; and / or a reference marker for enabling a position and / or orientation of the moldable material carrier on the surgical guide manufacturing apparatus to be determined; Further comprising 20. The formable material carrier of claim 19. (Appendix 21) further having one or more protrusions or one or more indentations formed on the outer surface to provide a grip; 21. The moldable material carrier of claim 19 or 20. (Appendix 22) the inlet is formed with a frusto-conical opening for receipt of a syringe for supplying the moldable material; 22. The moldable material carrier of any one of claims 19 to 21. (Appendix 23) the internal cavity being formed from a number of tunnels connecting the inlet to the opening in the first surface. 23. The moldable material carrier of any one of claims 19 to 22. (Appendix 24) the openings in the first surface include one or more sets of openings, each set of openings having openings distributed in a star pattern around a corresponding central axis, and the interior tunnel connects each of the openings centrally located at a point along the central axis. 24. The formable material carrier of claim 23. (Appendix 25) The internal cavity is formed from one or more divided sections, each of the divided sections comprising: an entry portion connected to the inlet and opening into a split cavity through which the moldable material is forced; a barrier disposed over the entry portion to at least partially impede advancement of the formable material; two or more exit openings disposed around the periphery of the barrier; having when the moldable material is forced into the split cavity through the entry portion, the moldable material is split and forced out through the corresponding exit opening. 25. The moldable material carrier of any one of claims 19 to 24. (Appendix 26) the outlet openings are spaced equidistant from a center of the barrier and have equal cross-sectional areas such that the formable material is divided into substantially equal volumes of the formable material. 26. The formable material carrier of claim 25. (Appendix 27) 1. A surgical guide manufacturing apparatus for modifying an impression of a surgical site to manufacture a surgical guide, the surgical guide manufacturing apparatus comprising: a mount for releasably receiving the impression of the surgical site; a coupling portion configured to couple a cutting element to the surgical guide manufacturing apparatus; a drive mechanism configured, when coupled to the coupling element, to drive the cutting element to modify the impression of the surgical site to produce the surgical guide; having In use, the drive mechanism is positioned beneath the mount such that debris from the impression falls away from the impression as it is corrected. Surgical guide manufacturing equipment. (Appendix 28) and a protective barrier coupling mechanism configured to releasably couple a protective barrier to the surgical guide manufacturing apparatus, the protective barrier coupling mechanism comprising: a movable part configured to couple to a section of the protective barrier; a positioning mechanism configured to move the portion from a first position allowing access to the mount and the coupling to a second position in which the protective barrier is positioned around the cutting area including the cutting element and the impression to help prevent contaminants from entering or exiting the cutting area during modification of the impression; having 28. A surgical guide manufacturing apparatus as described in claim 27. (Appendix 29) and a fastening section configured to releasably secure a second protective barrier to the surgical guide manufacturing apparatus in a configuration disposed about the mount to isolate the surgical guide from the mount. 29. A surgical guide manufacturing apparatus as described in appendix 27 or 28. (Appendix 30) a sensor configured to read a coding element attached to the cutting element and / or to a surgical guide carrier for the impression, the coding element storing a code indicative of one or more characteristics of the cutting element and / or one or more characteristics of the surgical guide carrier for the impression; A processor comprising: determining the one or more characteristics from the code and comparing the one or more characteristics to one or more expected characteristics; enabling the drive mechanism to be used to modify the mold in response to determining that the one or more characteristics match the one or more expected characteristics; or in response to determining that the one or more characteristics do not match the one or more expected characteristics, preventing the drive mechanism from being used to modify the impression; a processor configured to: Further comprising 30. A surgical guide manufacturing apparatus according to any one of claims 27 to 29. (Appendix 31) 1. A manufacturing apparatus for modifying a section of bone to produce a bone graft, the manufacturing apparatus comprising: a mount for receiving said bone section; a surface shape recorder for recording the shape of a surface of the section of bone received by the mount to generate surface data for aligning that section of bone to the manufacturing device and the shape of the planned bone graft; a cutting element or coupling configured to couple a cutting element to the manufacturing apparatus; a drive mechanism configured to drive the cutting element when coupled to the coupling element to cause the section of bone to conform to at least a portion of the shape of the planned bone graft; having Manufacturing equipment. (Appendix 32) a mount for holding the set of cutting elements, the manufacturing device being configured to replace the cutting elements. 32. The manufacturing apparatus of claim 31. (Appendix 33) and a processor configured to determine a shape of the planned bone graft based on image data representative of anatomical features of a patient's anatomy. 33. The manufacturing apparatus according to claim 31 or 32. (Appendix 34) The mount is configured to receive an impression of a surgical site; the surface shape recorder is configured to record a shape of a surface of the mold to generate mold surface data for determining a shape of the planned bone graft based on mold surface data and the image data representative of the anatomical features of the patient's anatomy. 34. The manufacturing apparatus according to any one of claims 31 to 33. (Appendix 35) and a processor configured to determine a shape of the planned bone graft based on the mold surface data and the image data representative of the anatomical features of the patient's anatomy. 35. The manufacturing apparatus of claim 34. (Appendix 36) 34. The surgical guide manufacturing apparatus of any one of claims 31 to 33, further configured in accordance with the surgical guide manufacturing apparatus of any one of claims 27 to 30. (Appendix 37) The manufacturing apparatus according to any one of claims 27 to 30; 9. A cutting attachment according to any one of claims 1 to 8; A surgical guide carrier according to any one of claims 9 to 18; and 27. The formable material carrier according to any one of claims 19 to 26; A kit of parts for manufacturing a surgical guide having any combination of:

Claims

1. 1. A surgical guide carrier for attachment to a surgical guide manufacturing apparatus, said surgical guide carrier comprising: a connector for attaching the surgical guide carrier to a mount of the surgical guide manufacturing apparatus; a coupling that receives and releasably holds an impression of a surgical site when the impression is held within the surgical guide carrier and when the surgical guide carrier is attached to the surgical guide manufacturing apparatus such that the surgical guide manufacturing apparatus can modify the impression to manufacture a surgical guide; a protective barrier configured to be positioned around at least a portion of the surgical guide manufacturing apparatus to provide a barrier between the surgical guide and at least a portion of the surgical guide manufacturing apparatus; having Surgical guide carrier.

2. the surgical guide carrier is sterilized or configured to be sterilized; The protective barrier provides a sterility barrier to help prevent contamination of the impression during modification. The surgical guide carrier of claim 1 .

3. the protective barrier is flexible; A surgical guide carrier according to claim 1 or 2.

4. a protective barrier configured to be secured to the surgical guide manufacturing apparatus such that the protective barrier surrounds the mount of the surgical guide manufacturing apparatus; A surgical guide carrier according to any one of claims 1 to 3.

5. the surgical guide carrier further comprises a support frame connected to the protective barrier; the support frame defines an opening, the opening being configured such that the mount of the surgical guide manufacturing apparatus may be received within the opening and the opening may be configured such that the opening may be expanded from a first configuration to a second configuration larger than the first configuration such that the support frame may fit over a stationary section of the surgical guide manufacturing apparatus; when the support frame is released, the support frame is biased towards the first configuration to return to the first configuration to secure the protective barrier on the securing section. A surgical guide carrier according to claim 4 which recites claim 3.

6. and further comprising one or more levers connected to the support frame and configured to allow the support frame to receive an expansion force to expand the opening from the first configuration to the second configuration. The surgical guide carrier of claim 5.

7. The support frame comprises: one or more locking members, each configured to be biased toward a first position in which the locking member protrudes into the opening and configured to be movable from the first position to a second position to enlarge the opening; or an elastic loop configured to be expandable to enlarge the opening; having A surgical guide carrier according to claim 5 or 6.

8. a handle connected to the support frame and projecting away from the opening. A surgical guide carrier according to any one of claims 5 to 7.

9. and a rotatable section, the coupling portion disposed on the rotatable section, the rotatable section configured to receive a rotational force from the surgical guide manufacturing apparatus such that the coupling portion can be rotated into position for manufacturing of the surgical guide. A surgical guide carrier according to any preceding claim.

10. a coding element indicating a type of the surgical guide carrier and configured to be read by the surgical guide manufacturing device so that the surgical guide manufacturing device can verify that the correct type of surgical guide carrier has been attached; A surgical guide carrier according to any preceding claim.

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