Surgical guide carrier with protective barrier

Abstract

To provide a surgical guide production apparatus and accessories to simplify a process of using the production apparatus within a surgical environment.SOLUTION: A cutting attachment is provided for use on a surgical guide production apparatus. The cutting attachment comprises: a cutting element; a connector for connecting the cutting element to a drive mechanism of the surgical guide production apparatus so that the cutting element can be driven by the drive mechanism to modify an impression of a surgical site to produce a surgical guide; and a protective barrier. The protective barrier is configured to be positioned around the cutting element to surround a cutting area to help prevent contaminants from entering or leaving the cutting area during the modification of the impression.SELECTED DRAWING: Figure 1

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 Art

[0002] Surgeons often use surgical guides to ensure that an incision is made in the correct position on a patient. For example, in osteopathy, surgical guides are common to ensure that a surgeon drills a hole along the correct axis in the correct position. Due to the variety of a patient's anatomical structures, surgical guides often have to be customized for each patient for each operation.

[0003] Additional manufacturing can be utilized to create surgical guides based on a patient's scan, but these guides often have poor compatibility with the patient. This is because the guide can be designed to fit the geometry of hard anatomical features such as bone; however, in practice, a surgeon does not remove all of the surrounding soft tissue. Thus, the remaining soft tissue can make the surgical guide less compatible, thereby reducing the accuracy of the surgical procedure.

[0004] To address the above problems, Patent Document 1 (incorporated herein by reference in its entirety) proposes a method of taking an impression of a surgical site during surgery. The impression can then be quickly modified (e.g., by drilling appropriate guide holes or guide features) using a surgical guide production apparatus placed in the operating room so that the surgeon has a surgical guide that exactly fits the current surgical site.

[0005] The above method provides a rapid and effective way to manufacture surgical guides, but there are problems associated with providing the manufacturing apparatus in a sterile environment such as an operating room.

[0006] The manufacturing apparatus often uses a drill bit or other cutting element to create holes in the impression or make incisions. This can create debris that may contaminate the surrounding area, including sterilized instruments.

[0007] In addition, it is often difficult to sterilize large medical devices with several moving parts. The sterilization procedure means that there is a period when the manufacturing apparatus cannot be used after the operation. This means that either the same operation cannot be performed until the manufacturing instruments are sterilized, or the hospital has to purchase additional manufacturing apparatus for use while one is being sterilized.

[0008] Furthermore, nurses and surgeons must maintain the sterile area of the operating room during the operation. Some parts of the manufacturing apparatus can be sterilized, but other parts may not be sterilized in order to save costs and speed up the sterilization process. Therefore, there is a risk that a nurse or doctor using the manufacturing apparatus may accidentally touch the non-sterile area. This can cause the sterile field in the operating room to be contaminated if the nurse or doctor continues to work without resterilizing the exposed parts of the patient's body or clothing. This results in the nurse or doctor having to stop work to change sterilized clothing or wash their hands and arms again to sterilize the contaminated skin.

[0009] Therefore, there is a need for an improved surgical guide manufacturing apparatus and related attachments to help maintain a sterile environment in the operating room.

Prior Art Documents

Patent Documents

[0010]

Patent Document 1

SUMMARY OF THE INVENTION

[0011] According to a first aspect of the present invention, there is provided a cutting attachment for use in a surgical guide manufacturing apparatus, the cutting attachment comprising: 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 be able to manufacture a surgical guide; and a protective barrier configured to be positioned around the cutting element so as to surround the cutting area to help prevent contaminants from entering or exiting the cutting area during the modification of the impression.

[0012] By providing a protective barrier integrated with the cutting attachment, the protective barrier can help shield the cutting attachment and the sterilized parts of the surgical guide manufacturing apparatus and can help avoid contamination of the impression of the surgical site being modified.

[0013] The protective barrier may be rigid or flexible. When the protective barrier is flexible (e.g., a flexible sheet such as a barrier drape), the user can hold the cutting attachment with the protective barrier wrapped around the cutting element to help shield the cutting element when the cutting element 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 so as to surround or enclose the cutting area. The cutting area may include the cutting element, the surgical guide, and the local surrounding space. Thus, the cutting area may be a volume surrounding the space in which the surgical guide can be modified.

[0015] The protective barrier can be connected to the cutting element so as to form a 360° seal around the cutting element. This ensures that debris cannot pass between the protective barrier and the cutting element.

[0016] Advantageously, the cutting attachment may further have a support that is connected to the protective barrier and configured to be moved to position the protective barrier around the cutting area.

[0017] The support can be configured to be coupled to a driven support arm of the surgical manufacturing apparatus such that the surgical manufacturing apparatus can move the protective barrier to a position around 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 a straight wall is provided around the perimeter of the cutting area and also help ensure that sufficient slack is provided in the base of the protective barrier to allow the cutting element to be moved by the surgical guide manufacturing apparatus.

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

[0020] Advantageously, the cutting attachment may further have one or more support frames that are 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 can help prevent the sheet from sagging, billowing, bowing into, or colliding with the cutting area.

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

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

[0023] Advantageously, the cutting attachment may be sterilizable or configured to be sterilized. In this embodiment, the cutting attachment should be manufactured from a sterilization - suitable material before 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 have a coding element configured to indicate the type of the cutting attachment and be read by the surgical guide manufacturing apparatus so that the surgical guide manufacturing apparatus can verify that the correct type of cutting attachment is fitted. This helps to prevent errors when manufacturing the surgical guide.

[0025] The coding element can be a radio frequency identification (RFID) chip, a barcode, a QR code (registered trademark), a memory device (e.g., flash), or any other form of machine-readable medium. For example, the coding element can encode the type of cutting element via its physical shape, which can be read by a manufacturing device, for example, via an optical sensor or button configuration. Different types of cutting attachments can include different types of cutting elements (e.g., drills, bars, 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 device, the surgical guide carrier comprising: a connector for attaching the surgical guide carrier to a mount of the surgical guide manufacturing device; a coupling configured to receive and releasably hold an impression of a surgical site such that the surgical guide manufacturing device can modify the impression to manufacture a surgical guide when the impression is held within the surgical guide carrier and when the surgical guide carrier is attached to the surgical guide manufacturing device; and a protective barrier configured to be positioned around at least a portion of the surgical guide manufacturing device to provide a barrier between the surgical guide and at least a portion of the surgical guide manufacturing device.

[0027] The impression of the surgical site can be taken on a formable material carrier configured to be coupled to the surgical guide carrier via the coupling. By providing the protective barrier, the impression of the surgical site can be protected from sections of the surgical guide manufacturing device that may not be sterilized. This is advantageous as it is difficult to sterilize a device with moving parts and reduces the downtime of the surgical guide manufacturing device in the operating room. Also, the protective barrier helps prevent debris from the modification of the impression from contaminating the surgical guide manufacturing device.

[0028] The protective barrier can be connected to the junction so as to provide a 360° seal between the protective barrier and the junction. This prevents contaminants from passing between the protective barrier and the junction.

[0029] The surgical guide carrier can be configured to be attached to the manufacturing apparatus at a predefined position and orientation and / or can 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 can be sterilized or can be configured to be sterilized, and the protective barrier can provide a sterilization barrier to help prevent contamination of the impression being modified. This ensures that it can be used in a sterile environment such as an operating room.

[0031] Advantageously, the protective barrier can be flexible. This can be a flexible sheet. This allows the junction to move during modification without compromising the sterilization barrier.

[0032] In one embodiment, the surgical guide carrier is configured such that the protective barrier can be fixed 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 hand from possible contamination from the mount when attaching the surgical guide carrier to the surgical guide manufacturing apparatus and when attaching or removing the formable material carrier. Further, the mount can be disposed on or can include a rotation mechanism that enables the impression to be properly positioned for modification. Such a mechanism can be difficult to sterilize. Thus, providing a protective barrier to surround the mount (and perhaps the rotation mechanism as well) avoids the need to sterilize this part 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 that can accommodate a mount of a surgical guide manufacturing device therein and being configured such that the opening can be expanded from a first configuration to a second configuration larger than the first configuration so that the support frame can fit onto a fixed section of the surgical guide manufacturing device, and the support frame being biased towards the first configuration so that when released, the support frame returns to the first configuration to fix the protective barrier onto the fixed section. This provides a simple mechanism for securing the protective barrier to the manufacturing device.

[0034] The surgical guide carrier may further have 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 one or more levers may be incorporated into one or more corresponding handles that protrude away from the opening to help keep the user's hand away from the manufacturing device when fixing the protective barrier to the manufacturing device.

[0035] Advantageously, the support frame may have one or more locking members, each configured to be biased towards a first position where the locking member protrudes into the opening and being 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 protruding away from the opening. This helps position the user's hand away from the manufacturing device when attaching the protective barrier to the manufacturing device to avoid accidental contamination.

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

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

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

[0040] The opening and the internal cavity serve to distribute the formable material uniformly. The syringe may comprise a 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 the surface of the formable material carrier opposite the first surface. Alternatively, the inlet may be located on the side wall of the formable material carrier. This can facilitate injecting the formable material into the formable material carrier. The openings may be distributed substantially uniformly across the first surface to provide a uniform distribution of the formable material. Alternatively, the formable material carrier may be configured to distribute a greater amount of formable material to the center of the first surface (e.g., through the distribution of the openings in the first surface or the arrangement of the internal cavity).

[0042] The formable material carrier may be made of two or more parts (e.g., made of injection-molded plastic) and combined together (e.g., via snap fittings, screws or other fixing means) or manufactured as a single part (e.g., by additive manufacturing).

[0043] Advantageously, the formable material carrier may further have: a connection for connecting the formable material carrier to the surgical guide manufacturing device at a predetermined position and orientation; and / or a reference marker to enable the position and / or orientation of the formable material carrier on the surgical guide manufacturing device to be determined. This enables various elements to be aligned with each other. The connection to the surgical guide manufacturing device can be made via a surgical guide carrier attached to the surgical guide manufacturing device.

[0044] The formable material carrier may further include one or more protrusions or one or more recesses formed on the outer surface to provide a grip. The grip can be on the side wall or the rear wall of the formable material carrier to form a grip for holding the formable material carrier. Alternatively, or in addition, the grip can be on the first surface grip to assist in fixing the formable material to the front surface. The formable material can cure around the protrusion (or within the recess) to assist in fixing the formable material to the formable material carrier.

[0045] Advantageously, the inlet can be formed by a frustoconical opening for receiving an injector for supplying the formable material. This can be in the form of a countersink. This helps the user to accurately align the injector within the inlet and helps to provide a seal around the injector when it is fully inserted to prevent the formable material from leaking back out of the inlet.

[0046] The internal cavity can be formed from several tunnels connecting the inlet to the opening in the first surface.

[0047] Advantageously, the opening in the first surface can have a set of one or more openings, each set of openings having openings distributed in a star pattern around a corresponding central axis, and the internal tunnels connecting each of the openings centered at a point along the central axis. This helps to distribute the formable material evenly across the first surface. The star pattern can be a certain kind of asterisk.

[0048] Advantageously, the internal cavity can be formed from one or more splitting sections, each splitting section having an entry portion connected to and opening into a split cavity into which the formable material can be pushed through the entry, a barrier disposed over the entry portion so as to at least partially impede the progress of the formable material, and two or more outlet openings disposed around the barrier, such that when the formable material is pushed into the split cavity through the entry portion, the formable material is split and pushed out through the corresponding outlet openings. This serves to split the formable material.

[0049] Advantageously, the barrier can completely cover the cross-section of the entry portion (however, the barrier is spaced from the entry portion). By disposing a barrier that covers the entry portion, the formable material is forced to fill the split cavity before being pushed out of the outlet openings. This serves to provide a uniform distribution of the formable material. A plurality of stages of the splitting section can be provided, and each outlet opening of the previous stage is connected to the entry portion of the corresponding subsequent splitting section.

[0050] The outlet openings can be disposed equidistant from the center of the barrier and can have equal cross-sectional areas such that the formable material is split into substantially equal volumes of formable material. This serves to provide a uniform distribution of the formable material. Alternatively, one or more splitting sections can be arranged to provide a larger volume of formable material at the center of the first surface than around the perimeter 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 comprising: 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 to modify the impression of the surgical site to manufacture the surgical guide when coupled to the coupling element, wherein in use, the drive mechanism is disposed 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 serves to remove debris from the impression / surgical guide.

[0052] The drive mechanism may include a motor for driving the cutting element (e.g., rotating a drill) and a motor for moving the cutting element to a predetermined position and urging the cutting element into the formable material. The surgical guide manufacturing apparatus further includes a rotation mechanism having a mount disposed thereon and configured to rotate the mount about an inclined axis (extending horizontally) and rotate the impression about a yaw axis (extending radially from the inclined axis). This enables 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 an impression mounted on the surgical guide carrier about the yaw axis.

[0053] Advantageously, the surgical guide manufacturing apparatus may further include 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 portion configured to couple to a section of the protective barrier; and a positioning mechanism configured to move the portion from a first position that allows access to the mount and the coupling to a second position where the protective barrier is positioned around a 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.

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

[0055] Advantageously, the surgical guide manufacturing apparatus further has a fixed section configured to releasably secure a second protective barrier around the mount to isolate the surgical guide from the mount. This 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 during loading / removal of 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 one or more of the cutting elements and / or one or more characteristics of the surgical guide carrier for the impression; and a processor configured to: determine one or more characteristics from the code and compare the one or more characteristics with 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 can be configured for use with a manufacturing apparatus for manufacturing bone grafts or implants. This can be added to or can instead be in addition to being configured for use with a surgical guide manufacturing apparatus. Similarly, the manufacturing apparatus itself can be configured for one or both uses. For example, the features described above with reference to the 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 comprising: a cutting element; a connector for connecting the cutting element to a drive mechanism of the manufacturing apparatus so that the cutting element can be driven by the drive mechanism to manufacture a surgical guide, a surgical implant or a surgical bone graft; and a protective barrier configured to be positioned around the cutting element so as to help prevent contaminants from entering or exiting the cutting area during modification of the impression.

[0059] Furthermore, according to a further embodiment, a carrier for attachment to a surgical manufacturing apparatus is provided, the carrier comprising: a connector for attaching the carrier to a mount of the manufacturing apparatus; a coupling for receiving and holding an impression of a surgical site so that the manufacturing apparatus can modify the impression to manufacture a surgical guide or a surgical implant when the impression is held by the carrier and the carrier is attached to the manufacturing apparatus; or a section of bone so that the manufacturing apparatus can modify the section of bone to manufacture a bone graft when the section of bone is held by the carrier and the carrier is attached to the manufacturing apparatus; and a protective barrier configured to be positioned around at least a portion of the manufacturing apparatus so as to provide a barrier between the mount and at least a portion of the manufacturing apparatus.

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

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

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

[0063] The manufacturing device can cut bone in order to shape the bone according to at least a part of the planned bone graft. For example, the bone can be shaped before it is reversed (e.g., attached to its opposite side) so that substantially one side of the bone enables the opposite side to be shaped.

[0064] According to one embodiment, the manufacturing device further has a mount for holding a set of cutting elements, and the manufacturing device is configured to change between cutting elements. This enables different tools to be used when modifying the bone section. For example, a tool rack can be arranged within the manufacturing device and the coupling can be attached to a movable arm. The movable arm can be configured to move the coupling to place a cutting element attached to the coupling in the rack / mount and remove a new cutting element from the rack / mount. The various cutting elements can 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 damage (from the cutting elements) to 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 device further has a processor configured to determine the shape of the planned bone graft based on image data representing the anatomical features of the patient's anatomical structure.

[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 the shape of the surface of the mold in order to generate mold surface data for determining the shape of the planned bone graft based on the mold surface data and the image data representing the anatomical features of the patient's anatomical structure.

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

[0068] By registering the shape of the type of surgical site, the bone graft can be shaped to more precisely conform to the surgical site. For example, the soft tissue may not have been completely removed from the surgical site, which can cause problems in fitting a bone graft prepared based only on image data of the patient's anatomical features (e.g., showing bone and hard tissue). Additionally, by taking a mold of the surgical site, the bone graft can be shaped to conform to features added to the surgical site during the operation. 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 implanted within the surgical site. By taking a mold of the surgical site, the bone graft can be more precisely conformed to these features of the surgical site and thus shaped to improve alignment to the surgical site and reduce movement within the surgical site.

[0069] The mold can be releasably received in the same manner as a section of bone is releasably received.

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

[0071] According to a further aspect of the invention, there is provided a kit of parts for manufacturing a surgical guide comprising any combination of the above manufacturing apparatus; the above cutting attachment; the above surgical guide carrier; and the above moldable material carrier. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0073]

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[0074] Embodiments of the present invention aim to solve the problem of how to maintain the sterility of the surgical guide and the surrounding operating room during in - surgery manufacturing.

[0075] Figure 1 shows a manufacturing apparatus according to an embodiment of the present invention. The manufacturing apparatus 100 is configured to modify an impression of a surgical site in order to manufacture a surgical guide. The manufacturing apparatus 100 is intended to be used in an operating room and is arranged next to the operating table. The embodiments described herein ensure that sterilized personnel such as operating room nurses and surgeons can use the manufacturing apparatus and the surgical guide without compromising sterility.

[0076] The manufacturing apparatus 100 has a coupling portion 112 configured to couple to a replaceable cutting attachment 200, and an attachment point 110 on which a surgical guide carrier 300 can be mounted. The surgical guide carrier 300 is a removable attachment point for the surgical guide. The surgical guide carrier 300 is configured to fix an impression of the 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 with a stored medical scan of the patient's anatomical structure. This medical scan can be an MRI scan, a CT scan, or any other scan capable of recording the patient's anatomical structure. The scan of the surface of the impression can be an optical scan or any other scan capable of measuring the geometric shape of the surface of the impression.

[0078] The manufacturing apparatus 100 is configured to align the impression with the patient's anatomical features. This enables the manufacturing apparatus 100 to determine where surgical guide holes need to be drilled into the impression in order to manufacture a surgical guide according to a predetermined surgical plan.

[0079] The alignment (registration) process enables the manufacturing apparatus 100 to calibrate itself with respect to the impression in order to ensure that the guide holes are drilled in the correct positions.

[0080] A general process of scanning and modifying an impression of a surgical site using a manufacturing apparatus is described in more detail in International Publication No. WO 2015 / 075423, which is hereby incorporated by reference in its entirety.

[0081] The overall system according to the embodiments described herein includes a manufacturing apparatus 100 and several single-use sterilization pack accessories for ensuring that a sterilized environment is maintained in the operating room.

[0082] The first accessory consists of a cutting attachment 200 (in this example, a drill attachment) having an integrated sterilization barrier drape (shown in FIGS. 4-8). For clarity, the barrier drape is not shown in FIG. 1. The cutting attachment 200 can be removably attached to the manufacturing apparatus 100 at the coupling portion 112. The coupling portion 112 is connected to a motor for driving the cutting attachment 200.

[0083] The coupling portion 112 is disposed on a movable arm. The manufacturing apparatus is configured to move the movable arm along three orthogonal directions, x, y, and z (shown in FIGS. 1 and 2). This enables 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 a surgical guide hole within the impression at the required position.

[0084] The second accessory consists of a surgical guide carrier 300 having an integrated sterilization 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 attached onto the attachment point 110 of the manufacturing apparatus 100. The attachment point 110 is attached to the gimbal 140 of the manufacturing apparatus 100. The gimbal 140 forms part of a rotation mechanism including a motor configured to rotate the attachment point and the surgical guide carrier 300 about an inclined axis extending parallel to the ground (along a horizontal plane).

[0085] The rotation mechanism further has a yaw axis drive member disposed on the gimbal, and this yaw axis drive member is configured to engage with a yaw axis key groove in the surgical guide carrier 300 and rotate a rotatable section of the surgical guide carrier about the yaw axis extending radially from the tilt axis.

[0086] Accordingly, the rotation mechanism enables the manufacturing apparatus 100 to rotate the surgical guide carrier 300 itself about the tilt axis, rotate the impression of the surgical site about the yaw axis, move the impression to the correct orientation, and form the surgical guide holes along the correct lines.

[0087] The gimbal 140 also enables the manufacturing apparatus 100 to rotate the surgical guide carrier 300 forward to couple and then separate the surgical guide from the manufacturing apparatus 100, and rotate the surgical guide carrier 300 backward to enable 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 coupling portion 112 such that debris from the impression falls downward toward the cutting element away from the impression when the impression is modified.

[0089] The third accessory consists of a formable material carrier (shown in FIGS. 12 - 15). The formable material carrier enables an impression of the surgical site to be taken and forms part of the surgical guide when the impression is modified. The formable material carrier has several channels such that formable material is injected into the formable material carrier and is evenly distributed across the front face of the formable material carrier.

[0090] A further accessory has a formable material dispenser and formable material (shown in FIGS. 14 and 15). This can be used to dispense formable material onto the surgical guide.

[0091] An impression of the surgical site can be taken using a formable material dispensed onto a formable material carrier. Then, when the surgical guide carrier is attached onto the manufacturing apparatus 100, the formable material carrier and the impression can be coupled to the manufacturing apparatus 100 via the surgical guide carrier. The manufacturing apparatus 100 can then scan the impression of the surgical site and modify the impression with the cutting attachment 200.

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

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

[0094] FIG. 2 shows a side view of the manufacturing apparatus. Again, the barrier drapes for the cutting attachment 200 and the surgical guide carrier 300 are not shown. The gimbal 140 is positioned directly above the joint 112 for the cutting attachment 200. This defines a cutting area between the joint 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 point is mounted) is located directly above the junction 112, debris from the drilling falls downward, away from the attachment point, when the impression is being modified by the cutting attachment 200. This helps to remove debris from the surgical guide when the surgical guide is being formed / modified. This also helps to keep the debris within the boundaries of the barrier drape and helps to collect the debris within the barrier drape for the cutting attachment so that the debris can be easily collected and discarded after the surgical guide is completed. This ensures that there is no cross-contamination from one procedure to the next.

[0096] As described above, the cutting attachment 200 includes a barrier drape. This is in the form of an elongated tube that is attached at one end to the 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 storage position (as shown in FIGS. 1 and 2) where the driven support ring 160 is proximal to the junction, to an upper extended position to lift the barrier drape for the cutting attachment 200 so as to seal the cutting area. This prevents debris from the drilling from escaping the cutting area and contaminating the operating room. In the upper position, the driven support ring 160 is close to the gimbal 140.

[0098] The manufacturing apparatus 100 further has an upper housing lip 180. The upper housing lip 180 provides a lip that protrudes outward, and a barrier drape for the surgical guide carrier 300 can be fixed on this lip. This isolates the rotation mechanism from the cutting area, prevents debris from the surgical guide from clogging the rotation mechanism, and prevents contaminants from the rotation mechanism from falling onto the cutting area and contaminating the surgical guide. In addition, this provides a sterilization barrier to avoid accidental contamination of the user through contact with the rotation mechanism when the user attaches or removes the surgical guide.

[0099] Accordingly, when in a predetermined position, the barrier drape isolates the movable parts (which are difficult to sterilize) of the manufacturing apparatus from the sterilized cutting area to avoid contamination of the surgical guide and / or the user.

[0100] Figure 3 shows the internal support mechanism of the manufacturing apparatus. The driven support ring 160 is shown being lifted at the center of the upwardly extending arm 170. A motor 165 is disposed within the housing of the manufacturing apparatus 100 to raise and lower the driven support ring 160. Similarly, a motor 145 is disposed within the upper housing of the manufacturing apparatus 100 supported by the upwardly extending arm 170 to drive the gimbal 140.

[0101] Figure 4 shows a cutting attachment having an integrated barrier drape according to an embodiment. The cutting attachment 200 has a cutting element 210 disposed at the center. In this case, the cutting element is a drill bit. Various types of cutting elements (e.g., drill bits, chisels, and cutting elements of various sizes) can be used. Accordingly, different cutting attachments (including integrated barrier drapes) can be provided for different cutting elements for different applications. The various cutting elements can be made of stainless steel or any other suitable durable material.

[0102] The cutting element 210 is attached to the central housing 215 such that the cutting element 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 has a barrier drape 220 shown as a transparent sheet in FIG. 4. The barrier drape 220 is fixed centrally around the entire outside of the central housing 215. The barrier drape 220 extends radially outward from the central housing to a lower ring 230 surrounding the central housing 215. The barrier drape 220 is fixed 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 coupling portion for fixing the upper ring 240 to the driven support ring 160 of the manufacturing apparatus 100. This enables 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 support the barrier drape 220 by pushing down the base of the barrier drape 220 and stretching the barrier drape 220 to avoid the barrier drape 220 sagging or being blown away into the cutting area. For this purpose, 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 support frames and can be of any suitable shape to prevent the barrier drape 220 from entering the cutting area.

[0105] This embodiment relates to a drill attachment including a drill bit, although alternative attachments having alternative cutting elements may be implemented with a similar barrier drape according to embodiments of the present invention. The alternative cutting elements may include a saw for cutting slots, a bar or reamer for cutting larger holes, or other cutting elements.

[0106] FIG. 5 is a cross-sectional view of a cutting attachment having 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. The barrier drape 220 is fixed 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 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 an intermediate support ring 235 such that the support rings 230, 235, 240 hold the barrier drape 220 away from the cutting region.

[0109] A coding element 250 is disposed within the rear housing 219. The coding element 250 includes an indication of the type of cutting element 210 incorporated into the cutting attachment 200. The coding element 250 is readable by a sensor within the manufacturing apparatus 100 such that the manufacturing apparatus can confirm that the correct cutting element 210 is attached.

[0110] Manufacturing apparatus 100 is configured to disable the drive mechanism for the cutting element in response to a determination that an incorrect cutting element 210 is attached. Similarly, manufacturing apparatus 100 is configured to enable the drive mechanism for the cutting element in response to a determination that the correct cutting element 210 is attached.

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

[0112] The coding element can indicate the type of different cutting attachments, including different cutting element types (e.g., drill, bar, etc.), different cutting element lengths or diameters, different cutting element materials, and / or different cutting attachment manufacturers.

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

[0114] When the driven support ring 160 raises the upper ring 240, the barrier drape 220 raises together with the intermediate support ring 235. With the full extension of the barrier drape 220, the intermediate support ring 235 is disposed with a space between the upper support ring 240 and the lower support ring 230.

[0115] The barrier drape 220 has a certain slack between the lower support ring 230 and the central housing 215. This enables the central housing 215 and the cutting element 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 push down the barrier drape 220 so as to ensure that a section of the barrier drape 220 between the lower support ring 230 and the central housing 215 is not lifted when the upper support ring is lifted. This helps to maintain the barrier drape 220 in a stretched state between the lower support ring 230 and the upper support ring 240 to prevent the barrier drape 220 from colliding with the cutting area. This also helps to maintain the slack around the cutting attachment and allows it to be moved. Alternatively, or in addition, the lower support ring 230 may have a coupling section for fixing the lower support ring 230 to the manufacturing apparatus 100 so as to prevent the lower support ring 230 from rising when the upper support ring 240 rises.

[0117] The x-axis and the y-axis are arranged along the horizontal plane. Movement along these axes enables the manufacturing apparatus 100 to position the cutting element 210 along the correct line in order to modify the impression of the surgical site and create the necessary surgical guide holes.

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

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

[0120] The coupling section 212 of the cutting element 210 is configured to fit with a corresponding coupling section of the manufacturing apparatus 100. The coupling section 212 has a drive surface configured to receive a driving force from the manufacturing apparatus in order to drive the cutting element 210.

[0121] A ball bearing 214 is disposed within the central housing 215. The ball bearing holds the cutting element 210 within the central housing 215 while enabling the cutting element 210 to be driven to rotate within the central housing 215.

[0122] The rear housing 219 has a locking mechanism 216 disposed on the outer surface of the rear housing 219. This enables the cutting element 210 to be locked in a predetermined position within the coupling section of the manufacturing apparatus 100 via a corresponding locking mechanism within the manufacturing apparatus 100.

[0123] A coding element 250 is disposed within the rear housing 219, enabling the manufacturing apparatus 100 to identify various characteristics of the cutting element 210 and verify that the appropriate cutting element 210 is attached.

[0124] FIG. 8 shows a detailed perspective view of the drill and connection portion 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 inclined surfaces that help bias the cutting attachment 200 into the correct position within the coupling section of the manufacturing apparatus 100. Accordingly, the static location features 213 are configured to be received within corresponding cavities within the coupling section of the manufacturing apparatus 100. Also, the static location features 213 provide a purchase for the rear housing 219 to prevent the rear housing from rotating when the cutting element 210 is being driven.

[0125] Figure 9 shows a surgical guide carrier having 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 portion 310 has a connection portion for fixing the carrier portion 310 to the manufacturing apparatus 100. In the present embodiment, the connection portion has a pair of grooves 312 for receiving corresponding interlock portions of the manufacturing apparatus 100. The grooves 312 enable the carrier portion 310 to be slid to a position on the manufacturing apparatus 100. This enables the carrier portion 310 to be fixed to the manufacturing apparatus 100 at a predefined position and orientation so that the manufacturing apparatus 100 can align itself with the carrier portion 310.

[0127] The connection portion further has a pair of release levers 314, which are configured to enable the carrier portion 310 to be removed from the manufacturing apparatus 100 when the release levers 314 are biased towards each other. The release levers 314 include teeth for fixing the carrier portion 310 to a position on the manufacturing apparatus 100 when the carrier portion 310 is correctly positioned on the manufacturing apparatus 100 and the release levers 314 are released.

[0128] The carrier portion 310 has a rotatable portion 320. The rotatable portion 320 is a rotatable platform configured to be rotatable within the carrier portion 310 about a yaw axis. The carrier portion 310 is configured to fix a surgical guide to the front of the rotatable portion 320. The rotatable portion 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 so that the manufacturing apparatus 100 can drive the rotatable portion 320 to rotate about the yaw axis (a yaw axis extending perpendicular to the front and rear surfaces).

[0129] The barrier drape 340 is fixed to the carrier portion 310 between the front housing and the rear housing of the carrier portion 310. The barrier drape 340 surrounds the carrier portion 310 and forms a barrier that prevents debris from passing from the front surface of the carrier portion 310 to the rear surface of the carrier portion 310.

[0130] The barrier drape 340 is substantially hemispherical in shape and has a hole located at the center to which the carrier portion 310 is fixed. The upper support ring 370 is connected to the rim of the hemisphere. This enables the barrier drape 340 to be lifted over the gimbal 140 of the manufacturing apparatus 100 and fixed onto the upper housing lip 180 of the manufacturing apparatus 100.

[0131] The upper support ring 370 is expandable so as to be able to pass over the upper housing lip 180 of the manufacturing apparatus 100, but is biased towards a smaller radius in order to fix the barrier drape onto the upper housing lip 180. To achieve this, the upper support ring 370 has a partially overlapping helix of elastic material. This can be formed of plastic. The inner end of the helix is disposed radially inward of the outer end of the helix.

[0132] The inner end and the outer end each have a lever 375 that projects in the corresponding radial direction. The lever 375 at the inner end 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, enabling the upper support ring 370 to pass over the upper housing lip 180 of the manufacturing apparatus 100. The upper support ring 370 is elastic and is thus biased to return to an arrangement having a diameter smaller than the diameter of the upper housing lip 180 in order to fix the upper support ring 370 in place.

[0133] The upper support ring 370 also includes a radially protruding handle 390. This enables the user to lift the upper support ring 370 onto the upper housing lip 180 of the manufacturing apparatus while keeping their hand off the non-sterile portion of the manufacturing apparatus.

[0134] In an alternative embodiment, the lever 375 can function as a handle for the upper support ring 370, has a length sufficient for the user to grip, and is configured to support the weight of the surgical guide carrier 300 so that a separate handle need not be provided.

[0135] The connection portion of the carrier part 310 in the above embodiment provides means for fixing the carrier part to the manufacturing apparatus 100 in a predefined orientation, but this is not essential. In an alternative embodiment, the connection portion can 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 portion allows the carrier part to be connected optionally or at least without requiring a specific orientation. In this embodiment, a reference marker is provided on the carrier part such that the manufacturing apparatus can determine the orientation of the carrier part 310, or at least the orientation of the rotatable part 320, by scanning the reference marker.

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

[0137] In this embodiment, the upper support ring 380 has a frame with an opening of a fixed diameter that is larger than the diameter of the upper housing lip 180 so as to enable it to pass through the upper housing lip 180. To fix the upper support ring 380 above the upper housing lip 180, the upper support ring 380 further has a pair of opposing lock members 382 that project radially into the opening of the frame. The lock members 382 are arranged on both sides of the frame opposite to each other and project towards each other.

[0138] The lock members 382 are movably mounted on the frame so that they can be moved away from each other at least partially out of the opening. This reduces the extent to which the lock members 382 project into the opening so as to enable the upper support ring 380 to pass around and above the upper housing lip 180. When released, each lock member 382 is biased towards the center of the opening so that the lock member 382 returns into the opening and fixes the upper support ring 380 above the upper housing lip 180. The biasing force can be provided by a spring or any other form of elastic member.

[0139] Each lock member 382 is attached to a handle 385 that projects outward from the frame. The handle 385 enables the user to lift the upper support ring 380 above the upper housing lip 180 while holding it away from and releasing it from the manufacturing apparatus 100. Each handle 385 has a grip section that enables the user to retract the lock member 382 from the opening as described above.

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

[0141] The coupling part 330 has a U-shaped housing having two side walls connected via a rear wall. The side walls and the rear wall project from the front surface of the carrier part 310. The side walls extend parallel to each other. Each side wall has an upper lip projecting towards the opposite side wall. Thus, the side walls and the upper lips form opposing channels into which corresponding sections of the formable material carrier can be inserted. The upper lip is received within a corresponding channel within the formable material carrier and prevents the formable material carrier from dropping from the coupling part 330 without passing along the channel of the coupling part 330.

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

[0143] Each locking member 332 has an inclined surface facing the entrance of the coupling part at the entrance of the channel. The inclined surface causes the locking member 332 to be pushed down so that when the formable material carrier is biased along the channel into the coupling part, the formable material carrier can be fully inserted into a predetermined position. When the formable material carrier is fully inserted into the coupling part 330, the locking member 332 is received within a corresponding cavity within the formable material carrier so as to fix the formable material carrier in a predetermined position.

[0144] The carrier part 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 the carrier attachment 300 so that the manufacturing apparatus 100 can determine whether the correct carrier attachment 300 is attached. Different types of carrier attachments 300 may include different sizes or shapes of the coupling part 330 for different sizes or shapes of the surgical guide.

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

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

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

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

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

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

[0151] The front surface 412 has a plurality of small protrusions 414 that are evenly distributed over the extent of the front surface 412. These protrusions 414 provide purchase for the formable material by allowing the formable material to stay around the protrusions and then cure. This means that the formable material is more firmly fixed by the formable material carrier 400.

[0152] The rear portion 420 has a coupling portion for coupling the formable material carrier 400 to the surgical guide carrier 300. The coupling portion has two channels 430 passing through the side surface of the rear portion 420. The two channels 430 are formed to receive the upper lip of the coupling portion 330 of the surgical guide carrier 300. This enables the formable material carrier 400 to be slid into the channel of the surgical guide carrier 300. Two recesses 432 are formed on the rear surface of the formable material carrier 400 to receive the locking members 332 of the coupling portion 330 of the surgical guide carrier 300. This enables the formable material carrier 400 to be locked in a predetermined position within the coupling portion 330 of the surgical guide carrier 300.

[0153] A plane 436 is disposed on the leading side of the formable material carrier 400. The plane 436 extends perpendicular to the channels 430. The plane 436 enables the formable material carrier 400 to sit square within the surgical guide carrier. 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 an injector for injecting a formable material into a formable material carrier. As described above, the inlet 424 is formed on the rear surface 422 of the formable material carrier 400. The inlet 424 is substantially conical and has a tapered wall such that its diameter decreases as it passes deeper into the formable material carrier. The tapered wall enables the conical tip of the injector to fit snugly within the inlet 424. This provides an interference fit around the injector to prevent the formable material from leaking out of the inlet 424 when the formable material is being pushed into the formable material carrier 424. Also, the tapered wall helps the user to correctly position the injector to ensure effective transfer of the formable material into the formable material carrier 400.

[0155] Figure 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 surface 412 and a rear surface 418 opposite the front surface 412. The rear portion 420 includes a rear surface 422 and a front surface 428 opposite the rear surface 422. When the formable material carrier 400 is assembled, the rear surface 418 of the front portion 410 is fixed to the front surface 428 of the rear portion 420.

[0156] An interconnect channel 429 is formed in the front surface 428 of the rear portion 420. An inlet 424 in the 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 is formed in the rear surface 418 of the front portion 410. The channels 419 of the front portion 410 enter an exit hole 416 in the front surface 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 seven-point asterisk or star and one six-point asterisk or star. Each asterisk is linked to the other through one of the points / legs.

[0159] When the front portion 410 and the rear portion 420 are combined, two sets of channels 419, 429 combine to form a tunnel within the formable element carrier 400. Thus, the formable material can be injected into the inlet 424 and extruded from the exit hole 416 through the tunnel.

[0160] The inlet 424 and the outlet holes 416 are arranged to ensure a uniform distribution of the formable material across the front face 412. Accordingly, the inlet 424 is centrally located on the rear face 422. This results in a longitudinally extending tunnel that connects the inlet to two central outlet holes 416 that sit on either side of the inlet 424. All of these two central outlet holes 416 and the inlet 424 are 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 being linked to the corresponding central outlet hole 416. The other of these central outlet holes 416 is surrounded by five outer outlet holes 416, each being linked to the corresponding central outlet hole 416. The star formation of the tunnel helps to ensure a uniform distribution of the formable material across the front face 412.

[0161] Note that the exact number of channels and holes can vary between embodiments depending on the size of the formable material carrier.

[0162] FIG. 16 shows a cross-sectional view of an injector for injecting formable material into the formable material carrier. The injector fits into a tapered channel that forms part of the inlet. The tapered wall prevents the tip of the injector from being inserted into the longitudinally extending tunnel that connects the inlet to the central outlet holes 416. Also, the tapered wall provides a seal around the injector to prevent the formable material from leaking out of the inlet 424 when the formable material is injected into the formable material carrier 400.

[0163] When the formable material is injected into the inlet 424, the formable material passes through the internal tunnel and is pushed out from the outlet holes 416 so as to be distributed across the front face 412 of the formable material carrier.

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

[0165] Figure 17 shows a formable material carrier according to the second embodiment. The formable material carrier 500 of the second embodiment is similar to that of the first embodiment, but includes several splitting stages for evenly dividing 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 within the rear section 520. Several openings 512 penetrate the front section 510 and act as extra holes for the formable material. In this embodiment, the openings 512 are triangular.

[0167] The rear section 520 forms the outer housing of the formable material carrier 500. The rear section 520 is substantially cup-shaped, forms an internal cavity, and the first and second splitters, as well as the front section 510, can be received therein. The rear section 520 has several protrusions 522 distributed around the outer surface of the side walls of the rear section 520 to provide an additional grip to the user when holding the formable material carrier 500.

[0168] An inlet 524 is formed in the side wall at one end of the formable material carrier 500. This inlet 524 is an opening that performs a similar function to the inlets shown in FIGS. 13 - 16. 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 pushed out through the openings 512 of the front section 510 to evenly distribute the formable material across the front surface of the front section 510, and is connected to the internal cavity.

[0169] By arranging the inlet 524 on the side wall rather than at the rear of the formable material carrier 500, the formable material can be more easily injected through the inlet when the user is holding the formable material carrier 500.

[0170] The coupling mechanism is disposed at the rear of the formable material carrier 500. These coupling mechanisms are similar to those provided in the embodiments of FIGS. 13 - 16. Two coupling channels 526 are formed in the side walls. The coupling channels 526 are disposed 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 enables the formable material carrier 500 to be slid into the coupling portion 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 portion 330 of the surgical guide carrier 300. This enables the formable material carrier 400 to be locked in a predetermined position within the coupling portion 330 of the surgical guide carrier 300.

[0171] FIG. 18 shows a cross - sectional view of the formable material carrier of FIG. 17. The rear section 520 has a base and peripheral side walls that project from the base and surround the 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 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 within the cavity.

[0172] A first splitter 540 is disposed within the cavity above the central opening. This serves to divide the formable material emerging from the central opening into two parts. A second splitter 550 is disposed within the cavity above the first splitter 540. This serves to further divide the formable material. The front section 510 is disposed within the cavity above the second splitter 550. The front section 510 is fixed within the cavity by an interference fit with the coupling section of the rear section. When the front section 510 is fixed within the cavity, the first splitter 540 and the second splitter 550 are also retained within the cavity.

[0173] FIG. 19 shows a cross-sectional view and a perspective view of an injector for injecting a formable material into the formable material carrier of FIG. 17. Similar to the formable material carrier of FIG. 14, the formable material can be injected into the carrier via injector 600.

[0174] A controlled amount of formable material is provided in the injector (the injector is pre-filled with the correct amount of material for a surgical guide type). This ensures that the appropriate amount of material is distributed across the formable material carrier 500.

[0175] When the formable material is pushed into inlet 524, the formable material is pushed into the cavity and evenly divided through the openings 512 of the first splitter 540, the second splitter 550, and the front section 510. The formable material is extruded from the openings 512 to provide a uniform distribution of the formable material across the front face of the formable material carrier 500.

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

[0177] The central depression 532 is disposed at the base of the cavity to receive a portion of the first splitter 540.

[0178] A groove 521 is formed on the inner surface of the sidewall and extends around the sidewall parallel to the base of the cavity. This provides a joint by which the front section 510 can be fixed, for example, by snap fitting.

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

[0180] The first opening 542 and the second opening 544 are formed in the first stage splitter 540 and communicate from the rear side to the front side of the first stage splitter 540. The two openings 542, 544 are arranged along the central axis of the formable material carrier, but are separated from each other along the central axis. The two openings 542, 544 are substantially evenly spaced over 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 dividing portion that protrudes from the base of the first stage splitter 540. This dividing portion fits into the central cavity 532. The dividing portion is located at the center of the dividing portion 540 and has a first cavity that opens to the rear of the dividing portion 540. The first cavity forms a channel between the first opening 542 and the second opening 544. The two openings 542, 544 open into the channel.

[0182] When the first stage splitter 540 is positioned in the cavity of the rear section 520, the channel is positioned above the central opening of the rear section 520. The first opening 542 and the second opening 544 are offset from the central opening and do not overlap the central opening. This means that when the formable material is extruded from the central opening, it is pushed to the base of the first stage splitter 540 and thus is passed 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 the same cross-section. This means that the formable material is evenly divided between the first opening 542 and the second opening 544.

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

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

[0186] When the second stage splitter 550 is placed on 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] FIG. 22B is a perspective view of the rear face of the second stage splitter. The second stage splitter 540 is divided into a first dividing section 552 and a second dividing section 554. Each of the dividing sections 552, 554 has six channels connected to each of the six of the twelve openings 556. The six channels all converge at the center of the dividing section. The two dividing sections 552, 554 are not connected to each other.

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

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

[0190] When the second stage splitter 550 is disposed above the first stage splitter 540, the center points are disposed above the first opening 542 and the second opening 544 of the first stage splitter 540.

[0191] When the formable material is extruded from the first opening 542 and the second opening 544, the formable material is extruded against the rear surface of the second stage splitter 550. Accordingly, the formable material is pushed along each of the channels and extruded from the corresponding openings 556, thereby dividing the formable material into twelve parts.

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

[0193] FIG. 23A shows the front face of the front portion of the formable material carrier of FIG. 17. The front portion 510 of the formable material carrier is configured to divide each of the portions of the formable material received from the second stage splitter 550 into three equal parts. Accordingly, the front portion 510 forms a third stage splitter for dividing the formable material into a total of thirty-six parts.

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

[0195] Figure 23B shows the rear surface of the front portion. Twelve triangular cavities 516 are formed on the rear surface, one in each opening of the second-stage splitter 550. Similar to the openings 556 on the second-stage splitter 550, the triangular cavities 516 are arranged in a star pattern.

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

[0197] Figure 24 shows a plan view of the rear surface of the front section. Each triangular cavity 516 has a triangular cross-section and opens onto the rear surface of the front section 510. Each triangular cavity 516 is connected to three corresponding triangular openings 512 on the front side (front surface) of the front section 510. Each of the three triangular openings 512 opens at 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 the 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 over the entire corresponding opening 556 within the second-stage splitter 550. This prevents the formable material from exiting the opening 556 without any deflection. When the formable material is extruded from the opening 556, it is pushed against the dividing wall 518 and deflected into one of the three triangular openings 512. This ensures that the triangular cavity 516 is filled with formable material before the formable material is extruded from the triangular opening 512. Thus, this provides a uniform distribution of the formable material.

[0199] Each of the triangular openings 512 has a cross-section of the same area and is arranged at the same distance from the center point of the corresponding triangular cavity 516. Additionally, the triangular openings 512 are substantially evenly distributed across the front face of the front section 510. Thus, the front section 510 divides the formable material uniformly, providing a uniform distribution of the formable material across the front face of the front section 510.

[0200] The above-described embodiments describe a specific arrangement in which the formable material can be divided into a specific number of parts (13 parts in the first embodiment, 36 parts in the second embodiment), but it will be understood that the number of parts can be changed according to the size of the formable material carrier and the function it performs. Depending on the number of parts that need to be provided, additional splitting stages or fewer splitting stages can be implemented.

[0201] Similarly, the above-described embodiments describe triangular openings and triangular cavities, but the shape of the openings and cavities can be adapted to the specific geometry of the formable material carrier.

[0202] In addition, while the above-described embodiments are aimed at evenly distributing the formable material, it will be understood that alternative embodiments can place splitters or openings on the front face of the formable material carrier to provide more of the formable material volume at the center of the front face than at the periphery. This can be useful in situations where the mold is expected to be fitted into a socket and thus be substantially dome-shaped.

[0203] Furthermore, the formable material carrier is described as being formed from a plurality of parts that can be connected to each other, but the formable material carrier can be manufactured by various methods including additive manufacturing and can thus be formed as a single part or as separate parts.

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

[0205] Figure 25A shows a 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] Figure 25B shows a second step in a surgical guide manufacturing procedure according to one embodiment. The carrier portion 310 of the surgical guide carrier 300 is fixed to the mount point 110 by placing the carrier portion 310 into the mount. This is done by inserting the user's hand into the barrier drape 340 of the surgical guide carrier 300 to provide a sterilization barrier against contamination from the non-sterile part of the manufacturing device 100 (e.g., the gimbal 140). If the manufacturing device records that an incorrect surgical guide carrier 300 has been used, the manufacturing device may issue a warning to the user and / or render itself inoperative.

[0207] The upper support ring 370 is expanded to be able to fit onto the upper housing lip 180 of the manufacturing device 100. The upper support ring 370 is then lifted onto the upper housing lip 180 and allowed to contract, thereby fixing the barrier drape 340 onto the upper housing lip 180 so as to enclose the gimbal 140.

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

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

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

[0211] Figure 25E shows the fifth step in the manufacturing procedure of a surgical guide according to an embodiment. The gimbal 140 is tilted rearward towards the scanner 150. The scanner 150 scans the surface of the impression.

[0212] Next, the manufacturing apparatus 100 aligns the surface of the impression to the patient's anatomical features shown in the patient's medical scan. Next, the manufacturing apparatus 100 determines the appropriate actions to modify the impression in order to create a surgical guide according to a pre-defined surgical plan.

[0213] Figure 25F shows the sixth step in the manufacturing procedure of a surgical guide according to an embodiment. The driven support ring 160 is lifted to lift the barrier drape 220 of the cutting attachment 200 around the cutting area to seal the cutting area from the surrounding area.

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

[0215] Since 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 modified falls away from the impression and is collected within the barrier drape 220 of the cutting attachment 200. When the operation is complete, since the cutting attachment 200 is removed from the manufacturing apparatus 100, this debris can be easily collected by the user within the barrier drape 220.

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

[0217] Including barrier drapes integrally formed with the cutting attachment and the surgical guide carrier respectively allows these attachments to be loaded into a manufacturing apparatus having a barrier drape that covers the user's hand. This means that the manufacturing apparatus itself does not need to be sterilized, thereby reducing the cost of operating the manufacturing apparatus and shortening the post-operative turnaround time.

[0218] By providing an elongated tubular barrier drape as part of the cutting attachment, this 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 leaking out of the manufacturing device and contaminating the surroundings. Since the cutting attachment is loaded into the manufacturing device below the surgical guide carrier, debris falls away from the surgical guide during modification and is collected within the barrier drape of the cutting attachment. This helps to 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 device.

[0219] By providing an integrated barrier drape with a surgical guide carrier, the rotating mechanism to which the surgical guide carrier is attached is protected from debris from the modification of the surgical guide. Further, a sterilization barrier is formed between the rotating mechanism and the cutting area to prevent contaminants from falling onto the sterilized cutting area. Additionally, the barrier drape reduces the risk of contaminating the user's hands when loading or removing the formable material carrier and / or the surgical guide carrier.

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

[0221] The above embodiments refer to a drill attachment having a drill bit, but alternative cutting or modifying means may be implemented in the cutting attachment. Suitable alternative cutting tools include bars, knives, bores, reamers, saw blades, needles, or other tools having suitable cutting edges. Alternatively, a blunt tool may be utilized if the impression remains malleable. Nevertheless, the same concept applies. That is, the cutting / modifying attachment is disposed centrally within the cutting / modifying attachment and includes a barrier drape that can be lifted around the cutting / modifying area to provide a sterilization barrier against contaminants.

[0222] The above embodiments describe the upper, lower, and intermediate support rings of the barrier drape of the drill attachment, but these need not be circular and can be of any shape forming a loop such as square, rectangular, or otherwise.

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

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

[0225] The above description relates to a surgical guide manufacturing apparatus and an accessory for a surgical guide manufacturing apparatus. As described above, further embodiments are not limited to this application and are configured to be used to shape bone to create bone grafts for use in surgery. This can be added to or instead of being configured to create a surgical guide.

[0226] Bone grafts can be utilized when additional bone needs to be added to the surgical site. For example, in the case of performing a total shoulder arthroplasty, a prosthesis is implanted into the glenoid fossa of the scapula. If the patient has significant glenoid wear, it can become difficult to position the prosthesis and ensure that it is firmly located. In these cases, a bone graft can be added to fill the surgical site, as a result of which the prosthesis can be more reliably implanted in the desired anatomical position, and at the same time, the bone at the surgical site can be preserved.

[0227] Bone grafts are often supplied from bone harvested from the patient. This is particularly the case in total shoulder arthroplasty where the bone (such as the humeral head) that is cut out and replaced by the prosthesis can be easily removed from a part of the humerus. The removed bone (which would otherwise be discarded) can be formed into a bone graft for the surgical site.

[0228] The manufacturing apparatus described herein can be utilized to form bone into bone grafts. During the preoperative stage, the shape of the required bone graft can be determined from a scan of the patient (such as a CT scan). This shape can include guide holes (or other forms of alignment parts) for accurately aligning the bone graft within the surgical site. This can use guide elements (such as pins) provided via a surgical guide manufactured by the manufacturing apparatus.

[0229] To manufacture a bone graft, a donor bone can be attached within a manufacturing apparatus. In one embodiment, the bone is attached onto an attachment point. This can be achieved by a carrier configured to hold the bone and attach to the attachment point. The bone can be fixed to the attachment point / carrier via a vice, screw, etc. Alternatively, the bone can be attached to a surgical guide (or a 3D printed sterile guide) described herein, which is then attached to a surgical guide carrier.

[0230] Once attached to the attachment point, the manufacturing apparatus is configured to scan the surface of the bone to register the shape of the bone and determine where the bone should be cut. To cut the bone, a cutting element such as a bar or a mill is provided. The manufacturing apparatus is configured to shape the bone into a bone graft using the cutting element. This effectively forms a 5-axis milling machine (including the X, Y, Z, tilt, and yaw axes 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 manufacturing apparatus, reversed, and reattached so that modification of both sides of the bone enables the formation of the entire bone graft. Alternatively, only one side can be shaped by the manufacturing apparatus and the other side can be shaped by the surgeon when the bone graft is implanted.

[0232] The manufacturing apparatus can include a plurality of different cutting elements for use in modifying the bone. For example, a mill, bar, drill, and / or saw can be used to shape the bone. The various cutting elements can be attached within the manufacturing apparatus and the manufacturing apparatus can be configured to exchange between the cutting elements as needed. For example, a coupling section for the cutting element can place the cutting element initially fixed within the coupling section into the mount and obtain a new cutting element for use in cutting the bone. Naturally, this mechanism can also be used when modifying a mold to make a surgical guide.

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

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

[0235] In light of the above, a manufacturing device according to embodiments described herein can be configured to modify bone to produce a bone graft. These embodiments may or may not use the attachments described herein that include an integrated barrier drape. If the integrated barrier drape attachments are used, these attachments can be modified for use in producing a bone graft. For example, a surgical guide carrier can be a bone carrier for attaching a donor bone to the manufacturing device. Similarly, a cutting attachment can be modified to include alternative cutting elements (e.g., a mill or bar) or to include replaceable cutting elements.

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

[0237] The following appendix is noted. (Appendix 1) A cutting attachment for use in a surgical guide manufacturing apparatus, comprising: a cutting element; a connector for connecting the cutting element to a drive mechanism of the surgical guide manufacturing apparatus so 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 around the cutting element to help prevent contaminants from entering or exiting the cutting area during the modification of the impression; having a cutting attachment. (Appendix 2) The cutting attachment according to Appendix 1, further comprising a support connected to the protective barrier and configured to be moved to position the protective barrier around the cutting area. The cutting attachment according to Appendix 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 to a position around the cutting area. The cutting attachment according to Appendix 2. (Appendix 4) The protective barrier includes a flexible sheet. The cutting attachment according to any one of Appendices 1 to 3. (Appendix 5) The cutting attachment according to Appendix 4, 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. The cutting attachment according to Appendix 4. (Appendix 6) The cutting element includes a cutting element for a power tool. The cutting attachment according to any one of Appendices 1 to 5. (Appendix 7) The cutting attachment is sterilized or configured to be sterilized, The cutting attachment according to any one of appended claims 1 to 6. (Appended claim 8) The surgical guide manufacturing apparatus further has a coding element configured to indicate the type of the cutting attachment and to be read by the surgical guide manufacturing apparatus so that it can be verified that the correct type of the cutting attachment is fitted. The cutting attachment according to any one of appended claims 1 to 7. (Appended claim 9) A surgical guide carrier for attachment to a surgical guide manufacturing apparatus, the surgical guide carrier comprising: A connector for attaching the surgical guide carrier to a mount of the surgical guide manufacturing apparatus; A coupling portion that receives and releasably holds an impression of a surgical site so that when the impression is held within the surgical guide carrier and when the surgical guide carrier is attached to the surgical guide manufacturing apparatus, 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. (Appended claim 10) The surgical guide carrier is sterilized or configured to be sterilized, The protective barrier provides a sterilization barrier to help prevent contamination of the impression being modified. The surgical guide carrier according to appended claim 9. (Appended claim 11) The protective barrier is flexible. The surgical guide carrier according to appended claim 9 or 10. (Appended claim 12) The protective barrier may be configured to be fixed to the surgical guide manufacturing apparatus such that the protective barrier surrounds the mount of the surgical guide manufacturing apparatus. The surgical guide carrier according to any one of appendices 9 to 11. (Appendix 13) The surgical guide carrier further includes a support frame connected to the protective barrier. The support frame forms an opening that can be expanded from a first configuration to a second configuration larger than the first configuration such that the mount of the surgical guide manufacturing apparatus can be received within the opening and the support frame can be fitted over a fixed section of the surgical guide manufacturing apparatus. The support frame is biased toward the first configuration such that when released, the support frame returns to the first configuration to fix the protective barrier over the fixed section. The surgical guide carrier according to appendix 12 that cites appendix 11. (Appendix 14) The support frame further includes 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 the first configuration to the second configuration. The surgical guide carrier according to appendix 13. (Appendix 15) The support frame: One or more locking members, each configured to be biased toward a first position in which the locking member protrudes into the opening and 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; has The surgical guide carrier according to appendix 13 or 14. (Appendix 16) Further having a handle connected to the support frame and protruding away from the opening The surgical guide carrier according to any one of appendices 13 to 15. (Appendix 17) Further having a rotatable section on which the connecting portion is disposed, and the rotatable section is configured to receive a rotational force from the surgical guide manufacturing apparatus so that the connecting portion can be rotated to a position for manufacturing the surgical guide. The surgical guide carrier according to any one of appendices 9 to 16. (Appendix 18) Indicating the type of the surgical guide carrier, and further having a coding element configured to be read by the surgical guide manufacturing apparatus so that the surgical guide manufacturing apparatus can verify that a surgical guide carrier of the correct type is attached. The surgical guide carrier according to any one of appendices 9 to 17. (Appendix 19) A formable material carrier for use in manufacturing an impression of a surgical site, the formable material carrier having a first surface on which a formable material can be dispensed: An inlet is formed in the formable material carrier, and a formable material is pushed into the inlet. An internal cavity is formed in the formable material carrier, and the internal cavity is connected to the inlet; A plurality of openings are formed in the first surface, and when the formable material is pushed into the inlet, the formable material is received into the internal cavity and extruded from the openings so that the formable material is distributed over the first surface, and the openings are connected to the internal cavity. Formable material carrier. (Appendix 20) A connection portion for connecting the formable material carrier to a surgical guide manufacturing apparatus at a predetermined position and orientation; and / or A reference marker for enabling the position and / or orientation of the formable material carrier on the surgical guide manufacturing apparatus to be determined; further comprising the formable material carrier according to appended claim 19. (Appended claim 21) further comprising one or more protrusions or one or more recesses formed on the outer surface for providing a grip, the formable material carrier according to appended claim 19 or 20. (Appended claim 22) The inlet is formed by a frustoconical opening for receiving an injector for supplying the formable material, the formable material carrier according to any one of appended claims 19 to 21. (Appended claim 23) The internal cavity is formed from several tunnels connecting the inlet to the opening in the first surface, the formable material carrier according to any one of appended claims 19 to 22. (Appended claim 24) The opening in the first surface has a set of one or more openings, each set of openings having openings distributed in a star pattern around a corresponding central axis, and the internal tunnels connect each of the openings centered at a point along the central axis, the formable material carrier according to appended claim 23. (Appended claim 25) The internal cavity is formed from one or more divided sections, each divided section comprising: an entry portion connected to the inlet and opening into a divided cavity through which the formable material is pushed; a barrier disposed above the entry portion so as to at least partially impede the progress of the formable material; two or more outlet openings disposed around the barrier; and having When the formable material is pushed into the divided cavity through the entry portion, the formable material is divided and extruded through the corresponding exit opening. The formable material carrier according to any one of Appendices 19 to 24. (Appendix 26) The exit opening is arranged at an equal distance from the center of the barrier and has an equal cross-sectional area so that the formable material is divided into the formable material of substantially equal volume. The formable material carrier according to Appendix 25. (Appendix 27) A surgical guide manufacturing apparatus for modifying an impression of a surgical site for manufacturing 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 to drive the cutting element to modify the impression of the surgical site for manufacturing the surgical guide when coupled to the coupling element; Having In use, the drive mechanism is disposed under the mount such that debris from the impression falls away from the impression when being modified. Surgical guide manufacturing apparatus. (Appendix 28) The surgical guide manufacturing apparatus further comprises 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 part from a first position that allows access to the mount and the coupling portion to a second position where the protective barrier is positioned around the cutting region including the cutting element and the impression to help prevent contaminants from entering or exiting the cutting region during modification of the impression. Having The surgical guide manufacturing apparatus according to Appendix 27. (Appendix 29) The surgical guide manufacturing apparatus further has a fixing section configured to releasably fix a second protective barrier around the mount so as to isolate the surgical guide from the mount. The surgical guide manufacturing apparatus according to Appendix 27 or 28. (Appendix 30) A sensor configured to read a coding element attached to the cutting element and / or the surgical guide carrier for the impression, the coding element storing a code indicating one or more characteristics of one of the cutting elements and / or one or more characteristics of the surgical guide carrier for the impression; A processor: Determine the one or more characteristics from the code and compare the one or more characteristics with one or more expected characteristics; 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; A processor configured as such; Further having The surgical guide manufacturing apparatus according to any one of Appendices 27 to 29. (Appendix 31) A manufacturing apparatus for modifying a section of bone to produce a bone graft, the manufacturing apparatus comprising: A mount for receiving the section of bone; A surface shape recorder for recording the shape of the surface of the section of bone received by the mount to generate surface data for aligning the section of bone with the manufacturing apparatus and the shape of the planned bone graft; A cutting element or a coupling configured to couple the cutting element to the manufacturing apparatus; A drive mechanism configured to drive the cutting element so that when coupled to the coupling element, the section of the bone conforms to at least a portion of the shape of the planned bone graft; having a manufacturing apparatus. (Appendix 32) The manufacturing apparatus further has a mount for holding the set of cutting elements, and the manufacturing apparatus is configured to replace the cutting elements The manufacturing apparatus according to Appendix 31. (Appendix 33) The manufacturing apparatus according to Appendix 31 or 32, further having a processor configured to determine the shape of the planned bone graft based on image data representing anatomical features of the patient's anatomical structure. The manufacturing apparatus according to Appendix 31 or 32. (Appendix 34) The mount is configured to receive the shape of the surgical site; The surface shape recorder is configured to record the shape of the surface of the mold in order to generate mold surface data for determining the shape of the planned bone graft based on the mold surface data and the image data representing the anatomical features of the patient's anatomical structure. The manufacturing apparatus according to any one of Appendices 31 to 33. (Appendix 35) The manufacturing apparatus according to Appendix 34, further having a processor configured to determine the shape of the planned bone graft based on the mold surface data and the image data representing the anatomical features of the patient's anatomical structure. The manufacturing apparatus according to Appendix 34. (Appendix 36) The manufacturing apparatus according to any one of Appendices 31 to 33, further configured according to the surgical guide manufacturing apparatus according to any one of Appendices 27 to 30. (Appendix 37) The manufacturing apparatus according to any one of Appendices 27 to 30; The cutting attachment according to any one of Appendices 1 to 8; The surgical guide carrier according to any one of Appendices 9 to 18; and A moldable material carrier according to any one of supplementary notes 19 to 26; A kit of parts for manufacturing a surgical guide having any combination thereof.

Claims

1. A surgical guide manufacturing apparatus for modifying an impression of a surgical site for manufacturing a surgical guide, the surgical guide manufacturing apparatus comprising: a mount for releasably receiving the impression of the surgical site; a coupling configured to couple a cutting element to the surgical guide manufacturing apparatus; a drive mechanism configured to drive the cutting element to modify the impression of the surgical site for manufacturing the surgical guide when coupled to the coupling element; having, in use, the drive mechanism is disposed below the mount such that debris from the impression falls away from the impression when being modified; A surgical guide manufacturing apparatus.

2. further comprising 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 part from a first position that enables access to the mount and the coupling to a second position where the protective barrier is positioned around the cutting region including the cutting element and the impression to assist in preventing contaminants from entering or exiting the cutting region during modification of the impression; having, The surgical guide manufacturing apparatus according to claim 1.

3. further comprising a fixing section configured to releasably fix a second protective barrier around the mount to isolate the surgical guide from the mount, The surgical guide manufacturing apparatus according to claim 1 or 2.

4. A sensor configured to read a coding element attached to a surgical guide carrier for the cutting element and / or the impression, the coding element storing a code indicating 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 with 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 Preventing the drive mechanism from being used to modify the impression in response to determining that the one or more characteristics do not match the one or more desired characteristics; A processor configured to; Further comprising The surgical guide manufacturing apparatus according to any one of claims 1 to 3.

Images