Surgical device with inflatable component and methods for using the same

Abstract

A device according to at least one embodiment of the present disclosure includes: an inflation tube and an injection tube each extending along an axis from a proximal end of the device to a distal end of the device; an inflatable component connected to a distal end of the inflation tube, the inflatable component that inflates in at least a first direction; and an injection port positioned opposite the inflatable component, connected to a distal end of the injection tube, and capable of dispensing a fluid in a second direction different than the first direction, where at least one of the inflatable component and the injection port are rotatable about the axis to change at least one of a direction in which the inflatable component inflates and a direction in which the injection port dispenses the fluid.

Description

SURGICAL DEVICE WITH INFLATABLE COMPONENT AND METHODS FOR USING THESAMEBACKGROUND

[0001] The present disclosure is generally directed to surgical devices, and relates more particularly to surgical devices with inflatable components.

[0002] Surgical devices may be used in the course of a surgery or surgical procedure to provide a range of patient treatments or therapies. Some devices may be used to address or repair spinal fractures.BRIEF SUMMARY

[0003] Balloon kyphoplasty is a minimally invasive procedure that uses inflatable balloons to restore vertebral height and correct angular deformity from vertebral compression fractures. Balloon kyphoplasty may use multiple different surgical devices, leading to a complex and time intensive switching out of surgical devices within a minimally invasive port. In accordance with embodiments of the present disclosure, a surgical device is provided which addresses one or more of the foregoing issues. The surgical device includes an inflation tube positioned within a hypotube or braided shaft that provides rigidity to the distal end of the surgical device, which in turn may facilitate positioning of the surgical device relative to the surgical site. The inflation tube includes an inflatable component configured to inflate to displace surrounding anatomical tissues. The surgical device also includes an injection tube (e.g., a Nitinol tube) with an injection port that can dispense bone cement or other fluid into the surgical site. The injection and inflation tubes may be movable within the surgical site to displace various anatomical tissues and fill cavities with fluid. Injection of the fluid and inflation of the inflatable component may be automatically controlled.

[0004] Example aspects of the present disclosure include:

[0005] A device according to at least one embodiment of the present disclosure comprises: an inflation tube and an injection tube each extending along an axis from a proximal end of the device to a distal end of the device; an inflatable component connected to a distal end of the inflation tube, the inflatable component configured to inflate in at least a first direction; and an injection port positioned opposite the inflatable component, connected to a distal end of the injection tube, and configured to dispense a fluid in a second direction different than the first direction, wherein at least one of the inflatable component and the injection port are rotatable about the axis to change at leastone of a direction in which the inflatable component inflates and a direction in which the injection port dispenses the fluid.

[0006] Any of the aspects herein, further comprising: a housing through which the inflation tube and the injection tube extend; and a junction connectable to a proximal end of the housing, the junction comprising an injection channel through which the injection tube at least partially extends and an inflation channel through which the inflation tube at least partially extends.

[0007] Any of the aspects herein, wherein the injection tube is connectable to a fluid reservoir.

[0008] Any of the aspects herein, wherein the inflation tube is connectable to an inflation pump.

[0009] Any of the aspects herein, wherein the injection port is angled relative to the axis such that an angle between the axis and the injection port is less than 90 degrees.

[0010] Any of the aspects herein, further comprising one or more radiopaque markers.

[0011] Any of the aspects herein, wherein the one or more radiopaque markers are positioned on the distal end of the device.

[0012] A surgical device extending from a proximal end to a distal end and according to at least one embodiment of the present disclosure comprises: a housing; a junction connectable to a proximal end of the housing, the junction comprising an inflation channel and a fluid channel; an inflation tube extending through the inflation channel and the housing to the distal end of the surgical device and comprising an inflatable component; a fluid tube extending through the fluid channel and the housing to the distal end of the surgical device and comprising a port configured to dispense a fluid from the fluid tube; and a cannula connected to the inflation tube and the fluid tube and capable of moving relative to the housing to change at least one of a position of the inflatable component and a position of the port.

[0013] Any of the aspects herein, wherein a distal end of the fluid channel is connectable to a fluid reservoir.

[0014] Any of the aspects herein, wherein the fluid reservoir provides bone cement through the fluid tube to the port.

[0015] Any of the aspects herein, wherein a distal end of the inflation channel is connectable to an inflation pump.

[0016] Any of the aspects herein, further comprising one or more radiopaque markers.

[0017] Any of the aspects herein, wherein the one or more radiopaque markers are positioned on the distal end of the surgical device.

[0018] A method according to the present disclosure comprises: introducing a distal end of a surgical device in a first orientation to a surgical site, the distal end of the surgical device comprisingan inflatable component that inflates in a first direction and a port that ejects a fluid in a second direction different from the first direction when the distal end is in the first orientation; causing the inflatable component to inflate in the first direction; rotating one or more components of the surgical device to change the distal end of the surgical device from the first orientation to a second orientation; and causing, when the distal end of the surgical device is in the second orientation, bone cement to be dispensed in a third direction.

[0019] Any of the aspects herein, further comprising: rotating the one or more components of the surgical device to change the distal end of the surgical device from the second orientation to a third orientation; and causing, when the distal end of the surgical device is in the third orientation, the bone cement to be dispensed in a fourth direction.

[0020] Any of the aspects herein, further comprising: causing the inflatable component to deflate; and withdrawing the distal end of the surgical device from the surgical site.

[0021] Any of the aspects herein, wherein the one or more components comprise a junction positioned on a proximal end of the surgical device.

[0022] Any of the aspects herein, wherein the junction comprises an inflation channel through which the inflatable component is connectable to an inflation pump.

[0023] Any of the aspects herein, wherein the junction comprises a fluid channel through which the port is connectable to a fluid reservoir.

[0024] Any of the aspects herein, wherein the surgical device further comprises one or more radiopaque markers.

[0025] Any aspect in combination with any one or more other aspects.

[0026] Any one or more of the features disclosed herein.

[0027] Any one or more of the features as substantially disclosed herein.

[0028] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0029] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages willbecome apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.

[0030] Fig. 1 A shows a conceptual diagram of aspects of a surgical device according to at least one embodiment of the present disclosure;

[0031] Fig. IB shows a detailed view of a distal end of the surgical device according to at least one embodiment of the present disclosure;

[0032] Fig. 1C shows a detailed view of additional aspects of the distal end of the surgical device according to at least one embodiment of the present disclosure;

[0033] Fig. 2A shows a first detailed view of the distal end of the surgical device according to at least one embodiment of the present disclosure;

[0034] Fig. 2B shows a second detailed view of the distal end of the surgical device in a first orientation according to at least one embodiment of the present disclosure;

[0035] Fig. 2C shows a third detailed view of the distal end of the surgical device in a second orientation according to at least one embodiment of the present disclosure;

[0036] Fig. 2D shows a fourth detailed view of the distal end of the surgical device according to at least one embodiment of the present disclosure;

[0037] Fig. 3 is a block diagram of aspects of a system according to at least one embodiment of the present disclosure; and

[0038] Fig. 4 is a flowchart according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0039] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one or more aspects thereof. Unless explicitly stated otherwise, the use or listing of one or more examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure.

[0040] The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.

[0041] Balloon kyphoplasty is a minimally invasive procedure that uses orthopedic balloons to restore vertebral height and correct angular deformity from vertebral compression fractures. Kyphoplasty procedures may require complex introductions and retractions of multiple devices. For example, a balloon may be inserted into the compressed or damaged vertebra via a cannula and then inflated to create a cavity within the vertebra. The balloon may then be deflated and retracted, and another device may be inserted to fill the cavity with bone cement. The bone cement then hardens, resulting in at least a partial restoration of vertebral height.

[0042] Issues with the above may be addressed by embodiments of the disclosure presented herein. In accordance with at least one embodiment of the present disclosure, a surgical device is provided that includes a balloon or other inflatable device that expands on one side (e.g., along a first direction) with a hypotube or braided shaft positioned around the inflation tube that provides additional stiffness to the surgical device. The surgical device also includes an injection tube made of Nitinol or polyimide with side port nozzle(s) for providing bone cement or other fluid to the surgical site. The inlet of the side port nozzle(s) may be angled relative to the injection tube such that the bone cement or other fluid is ejected from the side port nozzle(s) as distally as possible when the balloon is retracted. The surgical device may comprise a low-pressure connection for balloon inflation, such as with a standard lure fitting, such that the surgical device is compatible with balloon inflation devices. The surgical device may also comprise a higher-pressure console connection that enables a high-pressure injection lumen to be joined to the surgical device to provide bone cement or other fluid that can be delivered, via an injection tube and the nozzle, to the surgical site.

[0043] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) complex introductions and retractions of multiple surgical devices when performing balloon kyphoplasty and (2) ineffective or inefficient vertebral height restoration.

[0044] Turning first to Figs. 1 A-1C, example conceptual diagrams of aspects of a surgical device 100 are shown in accordance with embodiments of the present disclosure. The surgical device 100 may be used to perform a balloon kyphoplasty or other surgeries or surgical procedures. The surgical device 100 is illustrated to extend from a proximal end 104 to a distal end 108 and to comprise a housing 112 in which an outer cannula 114 and an inner cannula 118 are positioned, a junction 116 with an inflation channel 120 and a fluid channel 124 (also referred to herein as an injectionchannel), an injection tube 136 (also referred to herein as a fluid tube), an inflation tube 140, an inflatable component 144, an injection port 148, and one or more radiopaque markers 152. It is to be understood that, in other examples, the surgical device 100 may comprise additional or alternative components than those illustrated in Figs. 1A-1C. For example, the surgical device 100 may comprise a plurality of inflatable devices disposed near the distal end 108 of the surgical device 100 with one or more inflation tubes connected thereto.

[0045] In some cases, reference may be made to the dimensions, angles, directions, relative positions, and / or movements associated with one or more components of the surgical device 100 with respect to a coordinate system 102. The coordinate system 102, as shown in the accompanying figures, includes three dimensions comprising an X-axis, a Y-axis, and a Z-axis. Additionally or alternatively, the coordinate system 102 may be used to define planes (e.g., the XY-plane, the XZ- plane, and the YZ-plane) of the surgical device 100. These planes may be disposed orthogonally, or at 90 degrees, to one another. While the origin of the coordinate system 102 may be placed at any point on or near the surgical device 100, for the purposes of description, the axes of the coordinate system 102 are disposed along the same directions from figure to figure. Additionally or alternatively, the directionality of the X-axis, the Y-axis, and the Z-axis may be flipped, as noted with negative directionality (e.g., the negative Z-axis direction is the opposite direction of the Z-axis direction illustrated by the direction of the associated arrow). In some cases, the coordinate system 102 may be defined based on or using cartesian coordinates, cylindrical coordinates, polar coordinates, combinations thereof, and / or the like.

[0046] The housing 112 may comprise the outer cannula 114 and the inner cannula 118. The outer cannula 114 and / or the inner cannula 118 may be cylindrically shaped components that are positioned at least partially within the housing 112 and extend from a distal end of the housing 112 toward the distal end 108 of the surgical device 100. In some cases, the housing 112, the outer cannula 114, and / or the inner cannula 118 may comprise or be made of Nitinol. The outer cannula 114 and / or the inner cannula 118 may interact with the patient when the surgical device 100 is inserted to reach a surgical site. For instance, the surgical device 100 may be inserted into a minimally invasive surgery (MIS) port in the patient such that the outer cannula 114 and the inner cannula 118 extend through the port and into a surgical site (e.g., into an interior of a compressed vertebra whose height is to be at least partially restored using the surgical device 100). In some examples, the housing 112, the outer cannula 114, and / or the inner cannula 118 may extend partially through the patient (e.g., along the Z-axis direction) when the surgical device 100 is introduced to the patient.

[0047] The outer cannula 114 and / or the inner cannula 118 may carry the injection tube 136 and / or the inflation tube 140 to the distal end 108 of the surgical device 100. The inflation tube 140 may be or comprise tubing capable of carrying air or other fluid to and from the inflatable component 144 to respectively inflate or deflate the inflatable component 144. In some examples, the inflation tube 140 may comprise a hypotube (e.g., a thin, metal, medical-grade tube) and / or a braided shaft (e.g., a shaft or other cylindrically shaped component made of Nitinol) that provides additional rigidity to the injection tube 136. The rigidity of the inflation tube 140 may, for example, help facilitate insertion of the distal end 108 of the surgical device 100 into the surgical site. The hypotube and / or braided shaft may partially or wholly encase an outer diameter of the inflation tube 140 and may extend along with the inflation tube 140 toward the distal end 108 of the surgical device 100. In some cases, the hypotube and / or braided shaft may terminate on or near a proximal end of the inflatable component 144 (e.g., to avoid interference with inflation or deflation of the inflatable component 144).

[0048] It is to be understood that, while a single inflation tube 140 and single inflatable component 144 is discussed, the surgical device 100 may comprise a plurality of inflation tubes and inflatable components. For example, the surgical device 100 may comprise two inflation tubes and two inflatable components. In this example, the two inflatable components may be or comprise two halfballoons, with each balloon configured to inflate to form a half-sphere shape. The two half-balloons may be positioned on the distal end 108 of the surgical device 100 such that, when both the halfballoons inflated, the two half-balloons occupy the same volume as that of a single, full balloon. The two half-balloons may be independently inflatable (e.g., the two inflation tubes are connected to separate inflation pumps), providing a physician with increased flexibility in performing a ky phoplasty or other surgical procedure.

[0049] The injection tube 136 may be or comprise tubing capable of carrying bone cement or other fluid (e.g., alcohol, saline, etc.) to the injection port 148 for injection into the environment around the surgical device 100. In some cases, the injection port 148 may be or comprise Nitinol and / or Polyimide material the provide additional rigidity to the injection tube 136. The rigidity of the injection tube 136 may, for example, help facilitate insertion of the distal end 108 of the surgical device 100 into the surgical site. It is to be understood that, while a single injection tube 136 and a single injection port 148 are shown, an additional or alternative number of injection tubes and injection ports may be present in the surgical device 100. For example, the surgical device 100 may comprise a plurality of injection ports positioned on the distal end 108 of the surgical device 100. The injection ports may be positioned at different angles relative to the injection tube 136 to facilitate more efficient bone cement injection. For example, a first injection port may be angleddistally while a second injection port is angled proximally. Such positioning of the first and second injection ports may enable more efficient bone cement injection (e.g., the different angles may allow a cavity in the vertebra to be more quickly filled with bone cement). Additionally or alternatively, the surgical device 100 may comprise a plurality of injection tubes each connected to a different injection port. Each injection tube may be connected to a different fluid reservoir and / or fluid pump, such that each injection tube can carry bone cement independent of the other injection tube(s). In some cases, flow of bone cement through the injection tubes may be controlled by a controller 302. The use of multiple injection tubes may improve the efficiency of the surgical device 100 (e.g., by permitting a greater amount of bone cement to be delivered to the surgical site per unit time).

[0050] A proximal end of the housing 112 may include one or more ports, holes, apertures, etc. that enables the junction 116 or other components to be connected to the housing 112, the outer cannula 114, and / or the inner cannula 118. In some examples, the junction 116 may be integrally formed with the outer cannula 114 and / or the inner cannula 118 (e.g., the junction 116 and the outer cannula 114 and / or inner cannula 118 are formed as the same component and positioned within the housing 112) while in other examples the junction 116 may be separable from the outer cannula 114 and / or the inner cannula 118 (e.g., a distal end of the junction 116 is partially inserted into the housing 112 and connected to the outer cannula 114 and / or the inner cannula 118).

[0051] The junction 116 may provide one or more channels that enable components within the housing 112, such as the injection tube 136 and / or the inflation tube 140, to connect to components external to the surgical device 100 such as inflation and injection systems for controlling one or more functions of the surgical device 100. As depicted in Fig. 1A, the junction 116 comprises two channels: the inflation channel 120 and the fluid channel 124. The inflation channel 120 may, for example, enable one or more inflation devices such as an inflation pump 332 of an inflation system 328 to be connected to the inflation tube 140 to inflate and deflate the inflatable component 144. In one example, the inflation channel 120 comprises an inflation connector 132 configured to connect the inflation tube 140 with one or more inflation pumps (e.g., inflation pump 332). The fluid channel 124 may, for example, enable one or more injection systems such as an injection system 316 to be connected to the injection tube 136 to enable bone cement or other fluids (e.g., alcohol, saline, etc.) to be introduced to the surgical site via the injection port 148. In one example, the fluid channel 124 comprises a fluid connector 128 that enables the injection tube 136 to connect to a fluid reservoir 324. connected to the injection tube 136. The fluid connector 128 may provide an injection lumen that transfers bone cement or other fluids from a fluid pump 320 to the injection port 148 via the injection tube 136. It is to be understood that, while two channels are discussed herein, an additionalor alternative number of channels may be present (e.g., a single channel through which both the injection tube 136 and the inflation tube 140 extend, three channels, four channels, etc.).

[0052] The inflatable component 144 may be positioned on the distal end 108 of the surgical device 100. The inflatable component 144 may be connected to the inflation tube 140 to enable the inflation pump 332 to inflate the inflatable component 144, such as by pumping air through the inflation tube 140. In some examples, the inflatable component 144 may be or comprise a balloon (e.g., a balloon capable of inflating to three, four, five, six, seven, eight, or more millimeters (mm) in diameter). In one example, the inflatable component 144 is configured to inflate along a single side of the surgical device 100. For example, the inflatable component 144 may be or comprise a halfballoon configured to inflate such that the inflatable component 144 expands along a single direction but not in one or more other directions. The inflatable component 144 illustrated in Fig. IB for example may be configured to inflate in the Y-axis direction, but not in the negative Y-axis direction. In such examples, the inflatable component 144 may inflate into a half sphere or semisphere shape.

[0053] The injection port 148 may be positioned on the distal end 108 of the surgical device 100. The injection port 148 may be connected to the injection tube 136, which may enable a fluid such as bone cement to flow from the fluid reservoir 324 connected to the injection tube 136 via the fluid connector 128 to the distal end 108 of the surgical device 100. The injection port 148 may then dispense or otherwise eject the bone cement to the surrounding environment (e.g., to the surgical site). When the surgery or surgical procedure is directed to a balloon kyphoplasty, for example, the injection port 148 may eject bone cement into an interior of a compressed vertebra. In some examples, the injection port 148 may be angled, or may otherwise be adjustable to be angled relative to the injection tube 136, to dispense bone cement or other fluid in different directions. In the example shown in Fig. 1C, the injection port 148 may be positioned at an angle relative to the injection tube 136 to dispense bone cement primarily along a direction 150. In other words, an angle 146 between the direction 150 in which the injection port 148 is aligned and a longitudinal axis 156 of the injection tube 136 (e.g., an axis parallel to the Z-axis) may be less than 90 degrees. In some cases, the angle 146 may be adjustable (e.g., the injection port 148 may be pivotable relative to the injection tube 136) such that the direction 150 in which the injection port 148 dispenses fluid can be changed.

[0054] The radiopaque marker 152 may comprise radiopaque material such that the radiopaque marker 152 appears or is otherwise detectable in medical images (e.g., CT scans, MRI images, fluoroscopic images, ultrasound images, etc.). In some cases, the radiopaque marker 152 may enablenavigation of the distal end 108 of the surgical device 100 via monitoring of the pose of the radiopaque marker 152 in medical images (whether manually by a physician viewing a live feed of medical image data or automatically by the controller 302 processing the medical image data). While a single radiopaque marker 152 is depicted in the figures, it is to be understood that an additional number of radiopaque markers may be present. Additionally or alternatively, the radiopaque marker 152 may be positioned at different locations on the distal end 108 of the surgical device 100 or any other portion of the surgical device 100 that has been inserted into the patient.

[0055] The junction 116 may be rotatable or otherwise movable relative to the housing 112, the outer cannula 114, and / or the inner cannula 118. For example, the junction 116 may be rotatable about an axis parallel the Z-axis (e.g., a rotation in the XY-plane) to change the direction in which the inflatable component 144 inflates and / or the direction in which the injection port 148 points relative to the surgical site. With reference Figs. 2A-2D, aspects of a distal end 202 of the surgical device 100 are shown in accordance with embodiments of the present disclosure. The surgical device 100 is illustrated to comprise an inflation tube 204 with an inflatable component 212 and an injection tube 208 with an injection port 216. In some examples, the inflation tube 204 may be similar to or the same as the inflation tube 140, the injection tube 208 may be similar to or the same as the injection tube 136, the inflatable component 212 may be similar to or the same as the inflatable component 144, and the injection port 216 may be similar to or the same as the injection port 148.

[0056] In an example balloon kyphoplasty, the distal end 202 of the surgical device 100 may be inserted into an interior of a compressed vertebra to provide treatment thereto. The distal end 202 of the surgical device 100 may be inserted through an MIS port. After placement of the distal end 202 of the surgical device 100 in the compressed vertebra, a proximal end of the inflation tube 204 may be connected to the inflation pump 332 and a proximal end of the injection tube 208 may be connected to the fluid reservoir 324. The inflation pump 332 may be activated to begin inflation of the inflatable component 212. In some cases, pressure sensors (e.g., pressure sensors 336) may provide pressure measurements (e.g., an inlet pressure) associated with the inflation of the inflatable component 212, and such measurements may be used in a feedback mechanism (e.g., a proportional- derivative (PD) controller, a proportional-integral-derivative (PID) controller, etc.) performed by the controller 302 to ensure that the inflatable component 212 is not overinflated. In the example shown in Fig. 2B, the inflatable component 212 may be or comprise a half balloon that is inflated in the Y- axis direction but not in the negative Y-axis direction, such that the inflatable component 212 forms a half sphere shape once inflated. The inflation of the inflatable component 212 may displace anatomical tissue (e.g., trabecular bone) surrounding the inflatable component 212 within the interiorof the compressed vertebra, forming a cavity when the inflatable component 212 is deflated or moved.

[0057] After the inflatable component 212 has been inflated, the distal end 202 of the surgical device 100 may be rotated (e.g., about an axis parallel to the Z-axis direction) to change the position of the inflatable component 212 and the injection port 216. As shown in Fig. 2C for example, the distal end 202 may be rotated 180 degrees until the injection port 216 points in the Y-axis direction (which corresponds to the direction in which the inflatable component 212 was initially inflated). After the rotation of the distal end 202, the fluid pump 320 may pump bone cement through the injection tube 208 and the bone cement may be dispensed through the injection port 216 and into the cavity formed by the inflation of the inflatable component 212. While the rotation of the distal end 202 shown in Figs. 2B-2C is 180 degrees, it is to be understood that a different degree of rotation may be performed. The injection of the bone cement into the cavity may be controlled by the controller 302 based on, for example, sensors that measure the flow of bone cement from the fluid reservoir 324. When the sensors detect a backflow (e.g., when the cavity is sufficiently filled such that bone cement begins flowing backward through the injection tube 136), the controller 302 may determine that the cavity has been filled, and automatically disable the fluid pump 320. Additionally or alternatively, the dispensing of the bone cement may be monitored using one or more imaging modalities (e.g., ultrasound) to determine when the cavity has been filled. For example, a processor 304 may execute content in a memory 306 that enables the controller 302 to perform image processing of image data generated by ultrasound device(s) (e.g., an ultrasound transceiver) to determine, based on the ultrasound image, whether the cavity has been filled. When the controller 302 determines that the cavity has been filled, the controller 302 may automatically disable the fluid pump 320.

[0058] During the rotation of the distal end 202 of the surgical device 100, the inflatable component 212 may remain inflated and continue to displace surrounding anatomical tissue as the inflatable component 212 moves to the position shown in Fig. 2C. In some cases, the distal end 202 may be rotated based on measurements generated by the pressure sensors 336. For example, forces generated by the surrounding anatomical tissue as the inflatable component 212 rotates may be captured as changes in the internal pressure of the inflatable component 212 and / or the inflation tube 204, and the controller 302 of the inflation pump 332 may adjust operation of the inflation pump 332 to maintain the inflation of the inflatable component 212. In some cases, the distal end 202 may be rotated incrementally, allowing for stabilization of the pressure inside the inflatable component 212before continuing to reduce or mitigate the likelihood of damage to the inflatable component 212 and / or to the surrounding anatomical tissue.

[0059] After bone cement has been ejected in the Y-axis direction, the distal end 202 may again be rotated back to the position shown in Fig. 2B (e.g., with the injection port 216 pointing in the negative Y-axis direction). Since the inflatable component 212 remained inflated during the rotation, the anatomical tissue that initially abutted the injection port 216 when the injection port 216 pointed in the negative Y-axis direction will have been displaced by the inflatable component 212 to form another cavity. The fluid pump 320 may then be controlled to pump additional bone cement from the fluid reservoir 324 through the injection tube 208 such that bone cement is dispensed through the injection port 216 and into the cavity. After the cavities have been filled with bone cement, the inflatable component 212 may be deflated (e.g., the inflation pump 332 may draw a vacuum in the inflation tube 204). In some cases, the inflatable component 212 may be deflated while the injection port 216 is dispensing bone cement. Once the inflatable component 212 has been deflated, the distal end 202 of the surgical device 100 may be withdrawn from the surgical site to allow the bone cement to set or harden.

[0060] In some examples, the amount of bone cement injected into the surgical site may be monitored and controlled by the controller 302 based on an estimated size of the surgical site (e.g., based on the volume of the cavity formed in the vertebra). For example, the controller 302 may receive one or more images of the vertebra (e.g., ultrasound images generated by an imaging device) after the inflatable component 212 has been used to form the cavity in the vertebra. The controller 302 may process the images (e.g., using one or more image processing algorithms) to generate an estimated size of the cavity (e.g., a volume of the cavity, 3D dimensions of the cavity, etc.). Additionally or alternatively, the controller 302 may estimate the size of the cavity based on pressure measurements generated by the pressure sensors 336. For example, the controller 302 may use the pressure measurements and the known balloon size to determine a volume associated with the inflatable component 212 when the inflatable component 212 is inflated. In other words, the volume of the inflatable component 212 when inflated may correspond to the volume of the cavity formed when the inflatable component 212 is then deflated.

[0061] Based on the estimated size of the cavity, the controller 302 may control the amount of bone cement injected. For example, the controller 302 may cause the injection of bone cement when the distal end 202 of the surgical device 100 is positioned in a first orientation. The controller 302 may then determine, based on the estimated size of the cavity and the amount of bone cement injected (which may be based on, for example, a volume change of the bone cement in the fluidreservoir 324, a flow rate of bone cement determined based on flow rate sensor measurements, combinations thereof, etc.), a remaining amount of bone cement to be injected when the distal end 202 of the surgical device 100 is moved to a second, different orientation. After the distal end 202 of the surgical device 100 has been moved to the second, different orientation, the controller 302 may control the fluid pump 320 to cause the remaining amount of bone cement to be injected into the cavity. In such examples, the estimated size of the cavity, the amount of bone cement injected, and / or the remaining amount of bone cement required to fill the cavity may be rendered to a display 312. In some cases, the distal end 202 may be moved to a plurality of different orientations (such as when the physician iteratively rotates the distal end 202 relative to the patient to dispense bone cement in a variety of different directions) and the controller 302 may iteratively determine the amount of remaining bone cement needed to fill the cavity and control the fluid pump 320 accordingly.

[0062] In some cases, the injection of the bone cement may occur incrementally after the inflatable component 212 has been inflated. For example and with reference to Fig. 2B, the inflatable component 212 may be inflated in the Y-axis direction, and then the inflation tube 204 and the inflatable component 212 may be moved along the negative Z-axis direction. In such examples, the inflation tube 204 and the inflatable component 212 may be movable relative to the injection tube 208 and the injection port 216. After the inflation tube 204 and the inflatable component 212 have been moved, the injection port 216 may eject bone cement into the cavity formed by the inflatable component 212. As another example, the inflatable component 212 may comprise a full balloon that is inflated to displace surrounding anatomical tissue, then deflated to form a cavity. After deflation of the inflatable component 212, the injection port 216 may then be used to dispense bone cement into the cavity. After the bone cement has been dispensed, the surgical device 100 may be extracted from the surgical site.

[0063] The system 300 illustrated in Fig. 3 may be used to control one or more functions of the surgical device 100. The system 300 is illustrated to include the surgical device 100, the controller 302, a display 312, the injection system 316, the inflation system 328, a database 340, and a cloud network 344.

[0064] The controller 302 comprises the processor 304, the memory 306, a communication interface 308, and a user interface 310. In some cases, the controller 302 may comprise more or fewer components than those depicted in Fig. 3. The controller 302 can control one or more components of the system 300 and / or the surgical device 100 based on processing the content of the memory 306 by the processor 304.

[0065] Instructions may be executed by one or more processors, such as the processor 304 of the controller 302. The processor 304 may be or comprise one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple Al l, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors), graphics processing units (e.g., Nvidia GeForce RTX 2000-series processors, Nvidia GeForce RTX 3000- series processors, AMD Radeon RX 5000-series processors, AMD Radeon RX 6000-series processors, or any other graphics processing units), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements. The processor 304 may be configured to execute instructions stored in the memory 306, which instructions may cause the processor 304 to carry out one or more computing steps utilizing or based on data received from the surgical device 100, one or more components of the controller 302, the display 312, the injection system 316, the inflation system 328, the database 340, and / or the cloud network 344.

[0066] The memory 306 may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory for storing computer- readable data and / or instructions. The memory 306 may store information or data useful for completing, for example, one or more steps of the method 400 described herein, or any other methods. In some cases the memory 306 may store instructions that support one or more functions of the surgical device 100 or components thereof, one or more components of the injection system 316, one or more components of the inflation system 328, combinations thereof, and / or the like. For instance, the memory 306 may store content (e.g., instructions) that, when executed by the processor 304, cause or enable inflation of the inflatable component 144 of the surgical device 100, injection of fluid (e.g., bone cement) into a target surgical site, combinations thereof, and / or the like. Such content, if provided as an instruction, may in some cases be organized into one or more applications, modules, packages, layers, or engines. Additionally or alternatively, the memory 306 may store other types of content or data that can be processed by the processor 304 to carry out steps of the various methods and features described herein. Thus, although various contents of the memory 306 may be described as instructions, it should be appreciated that functionality described herein can be achieved through use of instructions, algorithms, data, and / or the like. Such instructions, algorithms, data, etc.may cause or enable the processor 304 to manipulate data stored in the memory 306 and / or received from or via the surgical device 100, one or more components of the controller 302, one or more components of the injection system 316, one or more components of the inflation system 328, the database 340, and / or the cloud network 344.

[0067] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, functions may be implemented using machine learning models, neural networks, artificial neural networks, or combinations thereof (alone or in combination with instructions). Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0068] The communication interface 308 may be used for receiving data or other information from an external source (such as from the surgical device 100, the display 312, the injection system 316, the inflation system 328, the database 340, the cloud network 344, and / or any other system or component not part of the system 300) and / or for transmitting instructions, data, or other information to an external system or device (such as to the surgical device 100, the display 312, the injection system 316, the inflation system 328, the database 340, the cloud network 344, and / or any other system or component not part of the system 300). The communication interface 308 may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and / or one or more wireless transceivers or interfaces (configured, for example, to transmit and / or receive information via one or more wireless communication protocols such as 802.1 la / b / g / n, Bluetooth, NFC, ZigBee, and so forth). In some cases, the communication interface 308 may be useful for enabling the controller 302 to communicate with one or more other processors or computing devices, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.

[0069] The user interface 310 may be or comprise a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and / or any other device for receiving information from a user and / or for providing information to a user. The user interface 310 may be used, for example, to receive a user selection or other user input regarding one or more steps of the method 400 or any other method described herein. Notwithstanding the foregoing, any required input for any step of the method 400 or any method described herein may be generated automatically by the system 300 (e.g., by thecontroller 302 or another component of the system 300) or received by the system 300 from a source external to the system 300. In some examples, the user interface 310 may be useful to allow a surgeon or other user to modify instructions to be executed by the processor 304 according to one or more embodiments of the present disclosure, and / or to modify or adjust a setting of other information displayed on the user interface 310 or corresponding thereto.

[0070] Although the user interface 310 is shown as part of the controller 302, in some embodiments, the controller 302 may utilize a user interface 310 that is housed separately from one or more remaining components of the controller 302. In some cases, the user interface 310 may be located proximate one or more other components of the controller 302, while in other cases, the user interface 310 may be located remotely from one or more other components of the controller 302.

[0071] The display 312 may be or comprise a screen or touchscreen that renders information about the surgical plan, operation or functionality of the surgical device 100, and / or the like for the user of the system 300 (e.g., a surgeon) to view. In some cases, the user may be able to control one or more components of the system 300 through the display 312 (e.g., the display 312 may comprise the user interface 310). In one example, the display 312 may display information about the inflation of the inflatable component 144 and / or information about the injection of bone cement via the injection port 148. The type of information rendered to the display 312 is in no way limited, and examples of information related to the surgery or surgical procedure may include pressure sensor measurements, flow rate sensor measurements, a current step in the surgery or surgical procedure, information about the operation of the surgical device 100, combinations thereof, and / or the like.

[0072] The injection system 316 may regulate the flow of bone cement or other fluids into the surgical device 100. The injection system 316 is illustrated to comprise the fluid pump 320 and the fluid reservoir 324, although the injection system 316 may comprise additional or alternative components. The fluid pump 320 may be configured to pump fluid (e.g., bone cement, alcohol, saline, etc.) from the fluid reservoir 324 to the surgical device 100 via the injection tube 136. For example, a fluid conduit may extend from the fluid reservoir 324 to the fluid connector 128 of the surgical device 100, and the fluid connector 128 may connect the fluid conduit to the injection tube 136 via a lumen to enable fluid delivery to the injection port 148. In some cases, the fluid pump 320 may be controlled by the controller 302 based on sensor measurements from one or more flow sensors (not shown). The flow sensors may measure a flow rate of the fluid from the fluid reservoir 324 to the surgical device 100. When the flow sensor measurement indicates a backflow, the controller 302 may disable the fluid pump 320. The backflow may occur when, for example, a cavity at a surgical site receiving treatment has been filled with the fluid (e.g., bone cement), such that thefluid flows back down the injection tube 136 toward the fluid reservoir 324. Additionally or alternatively, the flow sensor measurements may be used in a feedback mechanism performed by the controller 302 to control the flow of fluid from the fluid reservoir 324 to the surgical device 100. The feedback mechanism may be or comprise, for example, a PD controller, a PID controller, and / or the like.

[0073] The inflation system 328 may regulate the inflation or deflation of one or more inflatable components (e.g., inflatable component 144, inflatable component 212, etc.) of the surgical device 100. The inflation system 328 is illustrated to comprise the inflation pump 332 and the pressure sensors 336, but the inflation system 328 may comprise additional or alternative components. The inflation pump 332 may be a device configured to provide air to the one or more inflatable components via an inflation tube (e.g., inflation tube 140, inflation tube 204, etc.). For example, the inflatable components may be connected to the inflation tube, which extends from the distal end 108 to the proximal end 104 of the surgical device 100 and connects to the inflation pump 332 (e.g., via the inflation connector 132). In some cases, the inflation pump 332 may be controlled by the controller 302 based on measurements generated by the pressure sensors 336. The pressure sensors 336 may generate readings (e.g., inlet pressure readings) corresponding to the inflation pump 332 when the inflation pump 332 is inflating or deflating the inflatable component(s). When the readings meet or exceed a threshold value, the controller 302 may disable the inflation pump 332. The threshold value may reflect a pressure value associated with the inflatable component being fully inflated, such that the controller 302 disables the inflation pump 332 to ensure that the inflatable component is not overinflated.

[0074] The database 340 may store information useful for performing one or more surgeries or surgical procedures, such as a balloon kyphoplasty. For example, the database 340 may store one or more surgical plans (e.g., information related to the type of surgical device to be used in the surgery or surgical procedure, information about the anatomical element(s) to receive treatment during the surgery or surgical procedure, etc.); information related to the surgical device 100 (e.g., a model type, recommended inflation settings for the inflatable component 144 of the surgical device 100, etc.); information about the components of the injection system 316 and / or the inflation system 328 (e.g., type of fluid to be delivered to the surgical device 100 by the fluid pump 320, operating parameters of the inflation pump 332, measurements captured by the pressure sensors 336, etc.); threshold values (e.g., a maximum pressure of an inflatable component); and / or any other useful information. The database 340 may be configured to provide such information to the controller 302 or to any other device of the system 300 (e.g., to the display 312, to the injection system 316, and / orto the inflation system 328) or external to the system 300, whether directly or via the cloud network 344. In some examples, the database 340 may be or comprise part of a hospital data storage system, such as a health information system (HIS) and / or another system for collecting, storing, managing, and / or transmitting electronic medical records or other medical information.

[0075] The cloud network 344 may be or represent the Internet, cloud network, or any other wide area network. One or more components of the system 300, such as the controller 302, may be connected to the cloud network 344 via the communication interface 308, using a wired connection, a wireless connection, or both. In some examples, the cloud network 344 may be used by the components of the system 300 to communicate with one another and / or with device(s) external to the system 300.

[0076] The system 300 or similar systems may be used, for example, to carry out one or more aspects of the method 400 and / or any of the methods described herein. The system 300 or similar systems may also be used for other purposes.

[0077] Fig. 4 depicts a method 400 that may be used, for example, to deliver bone cement or other fluid to a surgical site using a surgical device. It is to be understood that, while the method 400 below specifies seven different steps, embodiments of the method 400 may comprise more or fewer steps than those described below, and / or one or more steps that are different than the steps described below.

[0078] One or more steps of the method 400 may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor 304 of the controller 302 described above. Additionally or alternatively, the at least one processor may be part of another component of the system 300, such as part of the injection system 316 or the inflation system 328. A processor other than any processor described herein may also be used to execute the method 400. The at least one processor may perform the method 400 by executing elements stored in a memory such as the memory 306. The elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 400. One or more portions of a method 400 may be performed by the processor executing any of the contents of memory 306.

[0079] The method 400 comprises introducing a distal end of a surgical device in a first orientation to a surgical site (step 404). The surgical device (e.g., surgical device 100) may be inserted into the surgical site (e.g., an interior of a compressed vertebra) to provide a therapy (e.g., vertebral height restoration). In some cases, a distal end of the surgical device may be inserted into the surgical site via an MIS port. When the distal end of the surgical device is in the first orientation, an inflatablecomponent of the surgical device may be configured to inflate in a first direction, and an injection port of the surgical device may be configured to eject bone cement or other fluid (e.g., alcohol, saline, etc.) in a second direction different than the first direction.

[0080] The method 400 also comprises inflating an inflatable component of the surgical device in a first direction (step 408). Once inserted into the surgical site, an inflatable component (e.g., inflatable component 144, inflatable component 212, etc.) may be inflated. The inflatable component may be positioned on the distal end of the surgical device and may be connected to an inflation tube (e.g., inflation tube 140, inflation tube 204, etc.) that extends between the distal end and the proximal end of the surgical device. The inflation tube may be connected to an inflation pump (e.g., inflation pump 332) that pumps gas or other fluid through the inflation tube to inflate the inflatable component. The inflatable component may comprise a half-balloon that inflates in the first direction to displace anatomical tissue (e.g., trabecular bone) proximate the half-balloon. In some cases, the half-balloon may inflate into a half sphere shape and create a half sphere shaped cavity in the surgical site.

[0081] The method 400 also comprises rotating one or more components of the surgical device to change the distal end of the surgical device from the first orientation to a second orientation (step 412). After the inflatable component has been inflated, the one or more components (e.g., junction 116) of the surgical device may be rotated to change the distal end of the surgical device from the first orientation to the second orientation. When in the second orientation, the inflatable component may be oriented in a direction other than the first direction, and the injection port may be oriented in a direction other than the second direction. For example, the distal end of the surgical device may be moved to the second orientation when the distal end of the surgical device is rotated 1 degree, 2 degrees, 5 degrees, 10 degrees, 30 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 105 degrees, 120 degrees, 135 degrees, 150 degrees, 175 degrees, 180 degrees, etc. in a clockwise or counterclockwise fashion about a longitudinal axis of the surgical device (e.g., an axis that is parallel to the Z-axis direction).

[0082] The method 400 also comprises causing bone cement to be dispensed in a third direction (step 416). While in the second orientation, a fluid pump (e.g., fluid pump 320) may be activated to provide bone cement to one or more injection ports (e.g., injection port 148, injection port 216, etc.) that then dispense the bone cement. In some examples, the second orientation may correspond to a 180 rotation of the distal end of the surgical device, such that the one or more injection ports are aligned along or approximately along the first direction. In other words, the third direction may be the same as or in approximately the same direction as the first direction (e.g., within severaldegrees). In such examples, the one or more injection ports may dispense the bone cement in the first direction to fill the cavity formed by inflation of the inflatable component in the step 408. In some cases, the bone cement may be dispensed until flow sensors detect a backflow and the fluid pump is automatically disabled by the controller (e.g., controller 302).

[0083] The method 400 also comprises rotating the one or more components of the surgical device to change the distal end of the surgical device from the second orientation to a third orientation (step 420). Once the cavity formed by the inflatable component has been filled, the surgical device may be further moved from the second orientation to the third orientation. In one example, the third orientation is the same as the first orientation. In other words, the distal end of the surgical device may have rotated 360 degrees. Given the first rotation of the one or more components, the inflatable component may have further displaced anatomical tissues (e.g., trabecular bone) along the second direction to form a second cavity. The change in the distal end of the surgical device from the second orientation to the third orientation may move the one or more injection ports to be aligned with the second direction, such that the second cavity can be filled by bone cement.

[0084] The method 400 also comprises causing bone cement to be dispensed in a fourth direction (step 424). The bone cement may be dispensed from the one or more injection ports that are aligned with the fourth direction (which in some cases may be similar to or approximately the same as the second direction). In some examples, the dispensing of the bone cement may be similar to the dispensing of the bone cement discussed above in the step 416.

[0085] The method 400 also comprises deflating the inflatable component and withdrawing the surgical device from the surgical site (step 428). Once one or more cavities in the surgical site have been filled with bone cement, the inflatable component may be deflated. In some cases, the deflation may occur by causing the inflation pump to depressurize the inflation tube and / or the inflatable component. The distal end of the surgical device may then be withdrawn from the surgical site and the bone cement may be allowed to harden.

[0086] A set of example statements is provided below:

[0087] Statement 1 : A device, comprising: an inflation tube (140) and an injection tube (136) each extending along an axis from a proximal end (104) of the device to a distal end (108, 202) of the device; an inflatable component (144, 212) connected to a distal end of the inflation tube (140), the inflatable component (144, 212) configured to inflate in at least a first direction; and an injection port (148, 216) positioned opposite the inflatable component (144, 212), connected to a distal end of the injection tube (136), and configured to dispense a fluid in a second direction different than the first direction, wherein at least one of the inflatable component (144, 212) and the injection port(148, 216) are rotatable about the axis to change at least one of a direction in which the inflatable component (144, 212) inflates and a direction in which the injection port (148, 216) dispenses the fluid.

[0088] Statement 2: The device of Statement 1, further comprising: a housing (112) through which the inflation tube (140) and the injection tube (136) extend; and a junction (116) connectable to a proximal end of the housing (112), the junction (116) comprising an injection channel (124) through which the injection tube (136) at least partially extends and an inflation channel (120) through which the inflation tube (140) at least partially extends.

[0089] Statement 3: The device of any of Statements 1-2, wherein the injection tube (136) is connectable to a fluid reservoir (324).

[0090] Statement 4: The device of any of Statements 1-3, wherein the inflation tube (140) is connectable to an inflation pump (332).

[0091] Statement 5: The device of any of Statements 1-4, wherein the injection port (148, 216) is angled relative to the axis such that an angle between the axis and the injection port (148, 216) is less than 90 degrees.

[0092] Statement 6: The device of any of Statements 1-5, further comprising one or more radiopaque markers (152).

[0093] Statement 7: The device of Statement 6, wherein the one or more radiopaque markers (152) are positioned on the distal end (108, 202) of the device.

[0094] Statement 8: A surgical device extending from a proximal end (104) to a distal end (108, 202), the surgical device comprising: a housing (112); a junction (116) connectable to a proximal end of the housing (112), the junction (116) comprising an inflation channel (120) and a fluid channel (124); an inflation tube (140) extending through the inflation channel (120) and the housing (112) to the distal end (108, 202) of the surgical device and comprising an inflatable component (144, 212); a fluid tube (136) extending through the fluid channel (124) and the housing (112) to the distal end (108, 202) of the surgical device and comprising a port (148, 216) configured to dispense a fluid from the fluid tube (136); and a cannula (114, 118) connected to the inflation tube (140) and the fluid tube (136) and capable of moving relative to the housing (112) to change at least one of a position of the inflatable component (144, 212) and a position of the port (148, 216).

[0095] Statement 9: The surgical device of Statement 8, wherein a distal end of the fluid channel (124) is connectable to a fluid reservoir (324).

[0096] Statement 10: The surgical device of Statement 9, wherein the fluid reservoir (324) provides bone cement through the fluid tube (136) to the port (148, 216).

[0097] Statement 11 : The surgical device of any of Statements 8-10, wherein a distal end of the inflation channel (120) is connectable to an inflation pump (332).

[0098] Statement 12: The surgical device of any of Statements 8-11, further comprising one or more radiopaque markers (152).

[0099] Statement 13: The surgical device of Statement 12, wherein the one or more radiopaque markers (152) are positioned on the distal end (108, 202) of the surgical device.

[0100] Statement 14: A method, comprising: introducing a distal end (108, 202) of a surgical device in a first orientation to a surgical site, the distal end (108, 202) of the surgical device comprising an inflatable component (144, 212) that inflates in a first direction and a port (148, 216) that ejects a fluid in a second direction different from the first direction when the distal end (108, 202) is in the first orientation; causing the inflatable component (144, 212) to inflate in the first direction; rotating one or more components of the surgical device to change the distal end (108, 202) of the surgical device from the first orientation to a second orientation; and causing, when the distal end (108, 202) of the surgical device is in the second orientation, bone cement to be dispensed in a third direction.

[0101] Statement 15: The method of Statement 14, further comprising: rotating the one or more components of the surgical device to change the distal end (108, 202) of the surgical device from the second orientation to a third orientation; and causing, when the distal end (108, 202) of the surgical device is in the third orientation, the bone cement to be dispensed in a fourth direction.

[0102] Statement 16: The method of any of Statements 14-15, further comprising: causing the inflatable component (144, 212) to deflate; and withdrawing the distal end (108, 202) of the surgical device from the surgical site.

[0103] Statement 17: The method of any of Statements 14-16, wherein the one or more components comprise a junction (116) positioned on a proximal end (104) of the surgical device.

[0104] Statement 18: The method of Statement 17, wherein the junction (116) comprises an inflation channel (120) through which the inflatable component (144, 212) is connectable to an inflation pump (332).

[0105] Statement 19: The method of Statement 17, wherein the junction (116) comprises a fluid channel (124) through which the port is connectable to a fluid reservoir (324).

[0106] Statement 20: The method of any of Statements 14-19, wherein the surgical device further comprises one or more radiopaque markers (152).

Claims

Claims1. A device, comprising: an inflation tube (140) and an injection tube (136) each extending along an axis from a proximal end (104) of the device to a distal end (108, 202) of the device; an inflatable component (144, 212) connected to a distal end of the inflation tube (140), the inflatable component (144, 212) configured to inflate in at least a first direction; and an injection port (148, 216) positioned opposite the inflatable component (144, 212), connected to a distal end of the injection tube (136), and configured to dispense a fluid in a second direction different than the first direction, wherein at least one of the inflatable component (144, 212) and the injection port (148, 216) are rotatable about the axis to change at least one of a direction in which the inflatable component (144, 212) inflates and a direction in which the injection port (148, 216) dispenses the fluid.

2. The device of claim 1, further comprising: a housing (112) through which the inflation tube (140) and the injection tube (136) extend; and a junction (116) connectable to a proximal end of the housing (112), the junction (116) comprising an injection channel (124) through which the injection tube (136) at least partially extends and an inflation channel (120) through which the inflation tube (140) at least partially extends.

3. The device of any of claims 1-2, wherein the injection tube (136) is connectable to a fluid reservoir (324).

4. The device of any of claims 1-3, wherein the inflation tube (140) is connectable to an inflation pump (332).

5. The device of any of claims 1-4, wherein the injection port (148, 216) is angled relative to the axis such that an angle between the axis and the injection port (148, 216) is less than 90 degrees.

6. The device of any of claims 1-5, further comprising one or more radiopaque markers (152).

7. The device of claim 6, wherein the one or more radiopaque markers (152) are positioned on the distal end (108, 202) of the device.

8. A surgical device extending from a proximal end (104) to a distal end (108, 202), the surgical device comprising: a housing (112); a junction (116) connectable to a proximal end of the housing (112), the junction (116) comprising an inflation channel (120) and a fluid channel (124); an inflation tube (140) extending through the inflation channel (120) and the housing (112) to the distal end (108, 202) of the surgical device and comprising an inflatable component (144, 212); a fluid tube (136) extending through the fluid channel (124) and the housing (112) to the distal end (108, 202) of the surgical device and comprising a port (148, 216) configured to dispense a fluid from the fluid tube (136); and a cannula (114, 118) connected to the inflation tube (140) and the fluid tube (136) and capable of moving relative to the housing (112) to change at least one of a position of the inflatable component (144, 212) and a position of the port (148, 216).

9. The surgical device of claim 8, wherein a distal end of the fluid channel (124) is connectable to a fluid reservoir (324).

10. The surgical device of claim 9, wherein the fluid reservoir (324) provides bone cement through the fluid tube (136) to the port (148, 216).

11. The surgical device of any of claims 8-10, wherein a distal end of the inflation channel (120) is connectable to an inflation pump (332).

12. The surgical device of any of claims 8-11, further comprising one or more radiopaque markers (152).

13. The surgical device of claim 12, wherein the one or more radiopaque markers (152) are positioned on the distal end (108, 202) of the surgical device.

14. A method, comprising: introducing a distal end (108, 202) of a surgical device in a first orientation to a surgical site, the distal end (108, 202) of the surgical device comprising an inflatable component (144, 212) that inflates in a first direction and a port (148, 216) that ejects a fluid in a second direction different from the first direction when the distal end (108, 202) is in the first orientation; causing the inflatable component (144, 212) to inflate in the first direction; rotating one or more components of the surgical device to change the distal end (108, 202) of the surgical device from the first orientation to a second orientation; and causing, when the distal end (108, 202) of the surgical device is in the second orientation, bone cement to be dispensed in a third direction.

15. The method of claim 14, further comprising: rotating the one or more components of the surgical device to change the distal end (108, 202) of the surgical device from the second orientation to a third orientation; causing, when the distal end (108, 202) of the surgical device is in the third orientation, the bone cement to be dispensed in a fourth direction; causing the inflatable component (144, 212) to deflate; and withdrawing the distal end (108, 202) of the surgical device from the surgical site.

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