Patent Application
20210228311
The present disclosure relates to the field of medical procedures, specifically to devices and methods for attaching a medical device to a body of a subject, and more specifically, to an attachment frame for a body mountable medical device.
Many routine treatments employed in modern clinical practice involve percutaneous insertion of medical tools, such as needles and catheters, for biopsy, drug delivery and other diagnostic and therapeutic procedures. The aim of an insertion procedure is to place the tip of an appropriate medical tool safely and accurately in a target region, which could be a lesion, tumor, organ or vessel. Examples of treatments requiring insertion of such medical tools include vaccinations, blood/fluid sampling, regional anesthesia, tissue biopsy, catheter insertion, cryogenic ablation, electrolytic ablation, brachytherapy, neurosurgery, deep brain stimulation and various minimally invasive surgeries.
Guidance and steering of needles in soft tissue is a complicated task that requires good three-dimensional coordination, knowledge of the patient anatomy and a high level of experience. Therefore, image-guided automated (e.g., robotic) systems have been proposed for performing these functions. Among such systems are those described in U.S. Pat. No. 7,008,373 to Stoianovici, for “System and method for robot targeting under fluoroscopy”, and in U.S. Pat. No. 8,348,861 to Glozman et al, for “Controlled Steering of a Flexible Needle”.
In recent years, body mounted automated medical devices and methods for planning their trajectories have been introduced. Some of these devices are guiding devices that assist in choosing the insertion point and/or in aligning the needle with the insertion point and with the target and the physician then inserts the needle manually, and some are devices that also insert the needle towards the target, as disclosed, for example, in U.S. Application Publication No. 2006/0229641 to Gupta et al, for “Guidance and Insertion System”, U.S Application Publication No. 2009/0112119 to Kim, for “Rotating Biopsy Device and Biopsy Robot”, U.S. Pat. No. 9,326,825 to Cleary et al, for “Patient Mounted MRI and CT Compatible Robot for Needle Guidance in Interventional Procedures” and U.S. Patent Application Publication No. 2016/0249990 to Glozman et al, for “Needle Steering by Shaft Manipulation”.
Attaching the medical device to the patient's body is advantageous since it compensates for patient motion during the procedure as the device moves together with the patient. This minimizes tissue damage and patient discomfort which may be caused by relative movement between the device and the patient.
Gupta et al discloses a guidance and insertion device that is attached to the patient's body using tabs that tape the device's support base to the tissue surface or that include slots for receiving straps that secure the support base onto the patient. Kim discloses a portable biopsy robot that is attached to the patient's skin using a strong adhesive located on the bottom of the robot. Cleary et al discloses a patient mountable robot that is attached to the patient's body using a four-adjustable-leg mechanism, each of the legs having an adhesive pad that directly contacts and sticks to the patient's body. Glozman et al discloses a robotic needle manipulator that is attached to the patient's body using belts or adhesives.
Direct attachment to the patient's skin using adhesives prevents a much-desired flexibility in positioning the automated device on the patient's body, and in re-positioning the device if necessary. Further, the use of adhesives does not allow placement of a sterile drape between the device and the patient's body in case the device is reusable and non-sterile, and may cause discomfort and skin irritation to the patient.
Thus, there is a need for improved devices and methods for attaching a medical device to a body of a subject.
The disclosures of each of the publications mentioned in this section and in other sections of the specification, are hereby incorporated by reference, each in its entirety.
The present disclosure describes an apparatus for attaching a medical device (e.g., an insertion device) to the subject's body.
When a medical device is attached to the subject's body using belts or straps, it is important to moderate the strapping force, as it effects the loads on the subject, which may cause displacement of internal soft tissues as well as discomfort to the subject. As there is friction between the straps and the subject's skin, some of the total strapping force is used to overcome the force created by friction. Therefore, the attachment solution should strive to minimize the total strapping loads, by maximizing the mounting area and minimizing the strapping force losses.
Maximizing the mounting area may be achieved by using an intermediary element, such as a mounting base (also referred to as “attachment frame” or “mediator plate”), as disclosed, for example, in co-owned U.S. patent application Ser. No. 16/092,786, to Arnold et al. Thus, an attachment apparatus of the present disclosure may comprise a mounting base configured to be secured to the subject's body, e.g., using straps (also referred to as “belts”), and to receive the medical device thereon. The medical device may be secured to the mounting base using securing elements, such as latches.
Typically, when straps 13 are used to secure the mounting base 12 to the patient's body, the straps 13 surround the patient's body 5 and maintain direct contact with the patient's skin along substantially the entire circumference of the body, as shown in
In some embodiments, the medical device is an insertion device configured to insert a medical tool, such as a needle or an introducer, into the body of the patient, for the purpose of performing, for example, a biopsy or an ablation procedure, or for delivering a substance, such as medication, into the body. In such cases, the required insertion force is typically predetermined, and hence the required vertical force applied to the mounting base is also predetermined, as these forces must be substantially equal to prevent movement of the mounting base and the coupled insertion device (assuming no relative movement therebetween), while executing the insertion procedure. If the mounting base is attached to the subject's body such that only the vertical force is applied to the mounting base, the strapping force losses are minimized, and thus the total strapping force and the load/pressure sensed by the subject, are minimized.
In some embodiments, the attachment apparatus may comprise one or more extending members (also referred to as “cranes”) coupled to the attachment frame at one or both ends of the frame, such that at least one strap is coupled to the attachment frame via a crane. The extending members may be separate units removably coupleable to the attachment frame using dedicated connectors, e.g., latches, or they may be coupled to the attachment frame during assembly. Alternatively, the attachment frame and at least one of the one or more extending members may be integrally formed. In some embodiments, the length of the cranes may be adjustable, to enable coupling of the straps to the attachment frame such that they are substantially orthogonal to the frame, thus maximizing the equivalent force vector applied by the straps on the attachment frame, and, generally, the cranes add a level of flexibility to the task of positioning the attachment frame on the subject.
Further, since the straps are substantially orthogonal to the attachment frame when the cranes are utilized, the contact area between the straps and the subject's skin is minimized, and thus, the friction losses are minimized, resulting in the decrease of the total strapping force needed to achieve the mandatory minimal effective mounting force of the attachment frame.
There is provided herein, in accordance with some embodiments, an attachment apparatus for attaching a medical device to a body of a subject, the apparatus including: an attachment frame configured for positioning on the body of the subject and for receiving the medical device thereon; one or more extending members coupleable to the attachment frame and extendable essentially sideways therefrom; one or more straps; and one or more strap connectors configured to couple the one or more straps to at least one of the attachment frame and the one or more extending members.
According to some embodiments, the one or more extending members may be configured as elongated members.
According to some embodiments, the attachment frame may include at least one channel, and wherein at least one of the one or more extending members is reversibly deployable from within the at least one channel. The attachment frame may include at least one locking member configured to lock the position of the at least one of the one or more extending members within the at least one channel. The at least one locking member may be rotatable.
According to some embodiments, the at least one of the one or more extending members may be configured as a telescopic member.
According to some embodiments, at least one of the one or more strap connectors may be configured to enable pivoting of at least one of the one or more straps coupled thereto relative to the at least one of the attachment frame and the one or more extending members.
According to some embodiments, at least one of the one or more strap connectors may either include or be coupled to a stretching mechanism. According to some embodiments, the at least one of the one or more strap connectors may include a first portion configured to be coupled to the at least one of the attachment frame and the one or more extending members, and a second portion configured to be coupled to at least one of the one or more straps and moveable relative to the first portion along a longitudinal axis of the at least one of the one or more strap connectors, and wherein the stretching mechanism may include at least one elastic member coupled to both of the first and second portions. According to some embodiments, the at least one of the one or more strap connectors may further include an indicator configured to indicate a stretching degree of the stretching mechanism. The indicator may include an indication bar and at least one marking. The indicator may include a rotatable member.
According to some embodiments, at least one of the one or more strap connectors may include a locking mechanism configured to lock the position of at least one of the one or more straps relative to the at least one of the one or more strap connectors. The locking mechanism may include at least one of: a rotating element, a puncturing element and a ratchet mechanism.
According to some embodiments, the at least one of the attachment frame and the one or more extending members may include one or more couplers configured to engage with the one or more strap connectors. The one or more strap connectors may include ball connectors, and the one or more couplers may include socket connectors configured to receive the ball connectors. The attachment frame may include two frame couplers positioned at a first end of the attachment frame and configured to engage with the one or more strap connectors, and wherein two extending members are coupled to the attachment frame at a second end of the attachment frame, each of the two extending members may include an extending member coupler configured to engage with the one or more strap connectors.
According to some embodiments, the attachment apparatus may further include a harness configured for positioning between the body of the subject and a surface configured for the subject to lie thereon. The attachment apparatus may further include one or more harness connectors configured to couple the one or more straps to the harness. The one or more harness connectors may include an inner space adapted to receive therein an edge of the harness. The one or more harness connectors may include a gripper configured to hold the edge of the harness within the inner space.
According to some embodiments, the attachment frame may include one or more alignment elements configured to engage with corresponding alignment members of the medical device upon positioning the medical device on the attachment frame, to facilitate proper alignment between the medical device and the attachment frame. The one or more alignment elements of the attachment frame may include one or more grooves, and the one or more alignment members of the medical device may include protrusions receivable within the one or more grooves.
According to some embodiments, the attachment frame may include a first portion of a coupling mechanism configured to couple the medical device to the attachment frame. The first portion of the coupling mechanism may be configured to engage with a second portion of the coupling mechanism, the second portion of the coupling mechanism being part of the medical device. According to some embodiments, at least one of the first and second portions of the coupling mechanism may include one or more indicators configured to indicate at least proper engagement of the first and second portions of the coupling mechanism. The first portion of the coupling mechanism may include one or more notches, and the second portion of the coupling mechanism may include one or more latches. According to some embodiments, at least one of the first and second portions of the coupling mechanism may include a safety mechanism configured to prevent engagement between the first and second portions of the coupling mechanism if the medical device in not properly positioned on the attachment frame. The safety mechanism may include a stopper configured to be disabled upon engagement of one or more alignment elements of the attachment frame with one or more corresponding alignment members of the medical device.
According to some embodiments, the attachment frame may include at least one sensor configured to detect movement of the attachment frame relative to the body of the subject and to generate an alert if the relative movement exceeds a predefined threshold. According to some embodiments, the at least one sensor may include one or more of: a distance sensor, a proximity sensor and an accelerometer.
According to some embodiments, the attachment apparatus may further include a lifting member configured to controllably lift the medical device from the attachment frame in one or more of a parallel manner and an angular manner. The lifting member may include at least one rail and at least one fixator configured to fixate the position of the medical device along the at least one rail. The lifting member may be removably coupleable to the attachment frame. The lifting member may rigidly be coupled to, or an integral part of, the attachment frame.
According to some embodiments, the attachment apparatus may further include at least one pad coupleable to at least a portion of the bottom surface of the attachment frame.
According to some embodiments, the medical device may be an insertion device, which includes a medical tool configured for insertion into the body of the subject, and wherein the attachment apparatus may further include an aiming apparatus removably coupleable to the attachment frame, the aiming apparatus being configured to facilitate proper positioning of the attachment frame relative to an entry point for entry of the medical tool into the body of the subject. According to some embodiments, the aiming apparatus may include a base having an opening configured for positioning above the entry point. The aiming apparatus may further include at least one coupling member configured to couple the aiming apparatus to the attachment frame. According to some embodiments, the at least one coupling member may include at least one latch configured to engage with at least one notch of the attachment frame. The aiming apparatus may further include an orienting mechanism configured to facilitate proper orienting of the attachment frame to enable insertion of the medical tool into the body of the subject, at the entry point, at a predetermined entry angle. The orienting mechanism may include a rotating arm, an upper arch, and an orienting member configured to be coupled to the rotating arm at its lower portion and to the upper arch at its top portion. The orienting mechanism may include a first locking element configured to prevent rotation of the rotating arm about its axis. The orienting mechanism may include a second locking element configured to prevent pivoting of the orienting member about an axis of a hinge coupling the orienting member to the rotating arm.
There is further provided herein, according to some embodiments, a method for attaching a medical device to a body of a subject, the method includes: providing an attachment apparatus essentially as described herein (each option is a separate embodiment); positioning the attachment frame on the body of the subject; using the one or more strap connectors, coupling the one or more straps to the at least one of the attachment frame and the one or more extending members; and coupling the medical device to the attachment frame.
According to some embodiments, the method may further include a step of deploying at least one of the one or more extending members from within at least one channel of the attachment frame.
According to some embodiments, the method may further include a step of locking the position of the at least one of the one or more extending members within the at least one channel, using at least one locking member of the attachment frame.
According to some embodiments, the method may further include a step of coupling the one or more straps to a harness configured for positioning between the body of the subject and a surface configured for the subject to lie thereon, using one or more harness connectors.
According to some embodiments, the method may further include a step of coupling an aiming apparatus to the attachment frame.
According to some embodiments, the method may further include a step of adjusting at least one of the height and the angle of the medical device relative to the attachment frame, using a lifting member.
There is further provided herein, according to some embodiments, an attachment apparatus for attaching a medical device to a body of a subject, the apparatus includes: a back base configured for positioning between the body of the subject and a surface configured for the subject to lie thereon; an attachment frame configured for positioning on the body of the subject and for receiving the medical device thereon, the attachment frame includes at least one channel; one or more extending members, at least one of the one or more extending members being configured for reversible deployment from within the at least one channel; one or more straps configured to be connected to the back base and to at least one of the attachment frame and the one or more extending members; one or more first connectors configured to connect a first end of the one or more straps to the at least one of the attachment frame and the one or more extending members; and one or more second connectors configured to connect a second end of the one or more straps to the back base.
According to some embodiments, the attachment frame may include at least one locking member configured to lock the position of the at least one of the one or more extending members within the at least one channel.
According to some embodiments, at least one of the one or more first connectors is configured to enable pivoting of at least one of the one or more straps coupled thereto relative to the at least one of the attachment frame and the one or more extending members.
According to some embodiments, the at least one of the attachment frame and the one or more extending members may include one or more couplers configured to engage with the one or more first connectors. The one or more first connectors may include ball connectors, and the one or more couplers may include socket connectors configured to receive the ball connectors. The attachment frame may include two frame couplers positioned at a first end of the attachment frame and configured to engage with the one or more first connectors, and wherein two extending members are coupled to the attachment frame at a second end of the attachment frame, each of the two extending members may include an extending member coupler configured to engage with the one or more first connectors.
According to some embodiments, at least one of the one or more first connectors either includes or is coupled to a stretching mechanism.
According to some embodiments, at least one of the one or more second connectors either includes or is coupled to a stretching mechanism.
According to some embodiments, the attachment frame may include one or more alignment elements configured to engage with corresponding alignment members of the medical device upon positioning the medical device on the attachment frame, to facilitate proper alignment between the medical device and the attachment frame.
According to some embodiments, the attachment frame may include a first portion of a coupling mechanism configured to couple the medical device to the attachment frame by engaging with a second portion of the coupling mechanism, the second portion of the coupling mechanism being part of the medical device. The first portion of the coupling mechanism may include one or more notches, and the second portion of the coupling mechanism may include one or more latches. According to some embodiments, at least one of the first and second portions of the coupling mechanism may include one or more indicators configured to indicate at least proper engagement of the first and second portions of the coupling mechanism.
According to some embodiments, the attachment frame and the one or more extending members may be integrally formed.
According to some embodiments, the one or more extending members may be configured to be coupled to the attachment frame.
It is to be understood that although some examples used throughout this disclosure relate to attachment of insertion devices to the body of a subject, the disclosed attachment apparatus is not limited for use with insertion devices alone and may be used with any medical device that is intended for attachment to the subject's body. Further, it can be appreciated that “attachment” of the medical device to the subject's body is to be interpreted as including direct attachment to the body, as well as attachment to the body via an intermediary element, such as a mounting base and/or cushion, etc.
Also, it is to be understood that although some examples used throughout this disclosure relate to insertion of a needle into a subject's body, this is done for simplicity reasons alone, and the scope of this disclosure is not limited to attachment of devices for insertion of a needle alone to the patient's body, but may include attachment of devices for insertion of any tool intended to be inserted into a subject's body for diagnostic and/or therapeutic purposes, including a needle, port, introducer, catheter (e.g., ablation catheter), cannula, surgical tool, fluid delivery tool, or any other such insertable tool.
In addition, it is to be understood that the term “strap” used throughout this disclosure to describe means for securing a medical device to the patient's body, may include any element suitable to be wrapped around at least part of the patient's body, such as strings, wires, cables, etc.
Finally, the terms “user”, “physician” and “clinician” are used interchangeably throughout this disclosure and they may refer to any person taking part in the performed medical procedure.
Some embodiments of the disclosure are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the disclosure. For the sake of clarity, some objects depicted in the figures are not to scale.
In the figures:
The principles, uses, and implementations of the teachings herein may be better understood with reference to the accompanying description and figures. Upon perusal of the description and figures present herein, one skilled in the art will be able to implement the teachings herein without undue effort or experimentation. In the figures, same reference numerals refer to same parts throughout.
In the description and claims of the application the expression “at least one of A and B”, (e.g. wherein A and B are elements, method steps, claim limitations, etc.) is equivalent to “only A, only B, or both A and B”. In particular, the expressions “at least one of A and B”, “at least one of A or B”, “one or more of A and B”, and “one or more of A or B” are interchangeable.
In the description and claims of the application, the words “include” and “have”, and forms thereof, are not limited to members in a list with which the words may be associated.
The attachment apparatus 20 may further include cranes 204, to which straps (not shown in
In some embodiments, the cranes 204 may be separate units removably coupleable to the mediator plate 202, using dedicated connectors 2025, e.g., latches. The cranes 204 may be coupled to one end of the mediator plate 202, or to both ends of the plate 202, as shown in
In some embodiments, in order to accommodate different body types having different circumferences, as well as different locations on the subject's body having different circumferences, the attachment apparatus 20 may include a plurality of cranes 204 having varying lengths, or more then one set of cranes 204 having varying lengths, if cranes 204 are coupled to both ends of the mediator plate 202. In the example shown in
In some embodiments, the distal end of the crane 404, i.e., the end which is farthest from the frame 402 when the crane is deployed, may comprise a crane connector 4045 to which a strap can be coupled, to secure the attachment frame 402 to the subject's body. In case only one end of the frame 402 is provided with cranes 404, as shown, for example, in
The attachment frame 402 may further include one or more grooves 4027, which are sized and shaped to receive corresponding protrusions (not shown in
The attachment frame 402 may further include one or more notches 4028 for receiving and engaging with corresponding one or more latches (not shown in
In some embodiments, additional elements (e.g., stoppers) may be used to ensure proper positioning of the medical device on the attachment frame, as well as to prevent movement of the medical device relative to the attachment frame after it has been positioned on the frame and before is has been secured thereto.
In some embodiments, one or more registration elements (e.g., fiducial markers) may be positioned on the attachment frame, for determining the medical device's position in the image space during image-guided procedures.
In some embodiments, the attachment apparatus is reusable, such that the same apparatus can be used repeatedly in several medical procedures, performed on different patients. In other embodiments, the attachment apparatus, or at least one or more of its components, such as the attachment frame, is disposable, such that a new apparatus (or frame) is used in each medical procedure, and the apparatus (or frame) is disposed of after the procedure has been completed.
In some embodiments, the bottom surface of the attachment frame 402 may be covered entirely or partially with a substantially soft pad (not shown), such as a pad made of foam, to provide padding and minimize any discomfort or pain to the patient due to attachment of the attachment frame and the medical device to his/her body.
In some embodiments, the medical device 300 is reusable, at least in part. In such embodiments, the medical device 300 may be positioned on the attachment frame 502 only after the medical device 300 has been covered with a sterile drape.
In some embodiments, the latches 308 may include a spring which maintains them in their open position when they are not grasped by the notches 6028. Further, in some embodiments, the latches and/or the attachment frame may comprise a mechanical mechanism that prevents the user from locking the latches if the medical device in not properly positioned on the attachment frame 602, e.g., if the protrusions are not properly positioned within the grooves. For example, the latches may include a stopper (not shown) which prevents moving them downwards, and which is released only when the protrusions are inserted into the grooves, or, the notches may be initially blocked by a designated barrier, such that the barrier is removed and they can be accessed only when the protrusions are inserted into the grooves.
In some embodiments, the medical device 300 (e.g., its latches 308) and/or the attachment apparatus (e.g., the attachment frame 602) may include at least one visual or auditory indicator (not shown), to indicate to the user that the medical device 300 is properly positioned on and/or properly secured to the attachment frame 602. The indicator may be mechanically and/or electronically activated.
In some embodiments, the orienting mechanism 850 may be configured such that the rotation angles of the rotating arm 856 and of the orienting member 852 relative to the rotating arm 856, are limited to the maximal angles which can be reached by the insertion device, e.g., by the end effector of the insertion device. Thus, in case an attempt to align the attachment frame, using the aiming apparatus 800, according to the desired insertion angle, fails, the user can adjust the position and/or the angle of the attachment frame relative to the patient's body, e.g., using cushion/s or a lifting member, as disclosed hereinbelow.
In some embodiments, the anchoring base 854 may be provided with notches 8545, and the proximal end of the rotating arm 856 may be provided with an indicator 8565, which is positioned adjacent the notches 8545, to indicate to the user, and assist him/her in controlling, the degree of rotation of the rotating arm 856. In some embodiments, the arch 857 may be provided with notches 8575 disposed along at least a portion of the arch 857, to indicate to the user, and assist him/her in controlling, the degree of pivoting of the orienting member 852 relative to the rotating arm 856.
In some embodiments, once the desired orientation of the orienting member 852 has been reached, the user can lock the orienting member 852 at the desired orientation, using one or more locking mechanisms. In some embodiments, the rotating arm 856 may comprise a knob 8568, which can be rotated, for example clockwise, to lock the orientation of the rotating arm 856 via friction with the anchoring base 854, and prevent further rotation of the rotating arm 856 about its axis. Similarly, in some embodiments, the orienting member 852 may comprise a knob 8528, which can be rotated, for example clockwise, to lock the orientation of the orienting member 852 relative to the rotating arm 856, i.e., by locking the position of the protrusion 8525 within the elongated groove 8572, via friction with the arch 857, and prevent further movement of the orienting member 852 along the arch 857.
In some embodiments, after the attachment frame has been secured to the patient's body in alignment with the entry point and at the desired entry angle, and while the aiming apparatus 800 is still coupled to the attachment frame, imaging of the region of interest, which includes both the entry point and the target point, may be initiated, to verify, prior to removal of the aiming apparatus 800 from the attachment frame and coupling of the insertion device to the attachment frame, that the set entry angle matches the desired entry angle according to the preplanned trajectory between the entry point and the target.
In some embodiments, the orienting member 852 may include one or more registration elements, e.g., fiducial markers, such that the position of the orienting member 852 relative to the image space can be determined. In some embodiments, the determined position of the orienting member 852 relative to the image space can then be used, for example by the insertion device's software, in order to position the medical tool, or the insertion device's end effector to which the medical tool is coupled, in the desired position and orientation for the commencement of the medical procedure.
In some embodiments, the attachment frame may include a plurality of visible markings, e.g., notches, grid lines, to assist the user if repositioning of the attachment frame is required. The markings may be configured such that they can be detected also by the imaging system, e.g., in a CT image.
It can be appreciated, that alternative orienting mechanisms may be used with the attachment frame. For example, in some embodiments, a ball and socket mechanism (not shown) may be utilized, e.g., a ball having a hollow channel formed therethrough (a bead-like configuration) may be coupled to the opening 812 of the aiming apparatus' plate 810, such that it can be rotated therein and locked at the desired orientation.
It can be appreciated that other connection mechanisms, which provide similar, or substantially similar, rotation/pivoting capabilities for the straps, may be equally advantageous.
As the patient inhales, his/her lungs inflate, causing the chest/abdomen to expand radially. As the patient exhales, his/her lungs deflate, causing the chest/abdomen to shrink radially. Thus, if the straps which secure the medical device or the attachment frame to the patient's body have no flexibility, there is a risk that they might become too tight during inhalation, which might cause significant discomfort to the patient, and/or that they become too loose during exhalation, which might enable relative movement between the medical device and the patient's body. Such relative movement might cause not only significant discomfort to the patient, but also physical harm to the patient, such as tearing of tissues due to uncontrolled sudden movements of the medical tool while it is positioned inside the patient's body. Further, in some insertion devices, steering of the medical tool is based on the assumption that there is no relative movement between the device and the patient's body, thus, relative movement between the device and the patient's body might impair the accuracy of the device and compromise the success of the medical procedure.
In order to accommodate body movements associated, for example, with breathing, and to ensure that the straps do not become too tight during inhalation and/or too loose during exhalation, in some embodiments, the buckles coupling the straps to the attachment frame/medical device may include, or be coupled to, a stretching mechanism, e.g., having an elastic member, which can stretch during inhalation and return to its relaxed state during exhalation. In other embodiments, the buckle itself may be formed having elastic capabilities, as described below.
In some embodiments, the user may wish to verify, during strapping of the attachment frame to the patient's body, that the attachment enables both stretching and relaxing of the elastic member, which are required to accommodate the movements of the patient's body during the breathing cycle, as well as coughing, etc.
For this purpose, the buckle 100 may include an indicator, which may be associated with the elastic member 1060, and indicates to the user if the attachment frame is attached such that it enables both stretching and relaxing of the elastic member. For example, the upper part 1020 of the buckle may include an indication bar provided with a dial, which moves along the indication bar as the elastic member 1060 stretches and relaxes. The indication bar may comprise a color scale. For example, it may include a middle green section located between two red sections, such that the dial being on (or pointing to) the green section indicates that the degree of stretching of the elastic member is in the range which allows stretching and relaxing of the elastic member 960 during the breathing cycle.
In some embodiments, the upper part of the buckle may be provided with a scale (not shown), such as a numeric scale, or a color scale, to which the arrow may point, to assist the user in identifying the degree of stretching of the elastic member. For example, the upper part of the buckle may include a strip having a green section in between two red sections, such that the arrow pointing to the green section indicates that the degree of stretching of the elastic member is in the required range.
It can be appreciated that the stretching mechanisms and stretchable buckles disclosed hereinabove are not limited to implementation in buckles having a ball connector, and they may be implemented in buckles having any other type of suitable connector for coupling them to the crane and/or attachment frame and/or medical device.
It can be appreciated that other locking mechanisms may be implemented in the buckles. For example,
Further, it can be appreciated that the locking mechanisms disclosed hereinabove are not limited to implementation in buckles having ball connectors, and they may be implemented in buckles having any other type of suitable connector for coupling them to the crane and/or attachment frame and/or medical device.
It can be appreciated that all of the buckles disclosed hereinabove may be used for securing either an attachment frame to the patient's body or a medical device directly to the patient's body, when an attachment frame is not employed. In the latter case, the buckles may be coupled to connectors, such as socket connectors, provided on the medical device itself, e.g., on the base or the housing/cover of the medical device.
In some embodiments, the attachment apparatus may include a harness (also referred to as “back base”), which is positioned between the patient's body and the patient bed. The harness may be either reusable, i.e., used in multiple procedures, or disposable, i.e., disposed of after a single use.
In some embodiments, the straps of the attachment apparatus may be rigidly connected to the harness such that their loose ends comprising the connectors, e.g., ball buckles, are removably coupleable to the attachment frame or directly to the medical device. In other embodiments, the straps may be rigidly connected to the attachment frame or to the medical device such that their loose ends comprising the connectors are removably coupleable to the harness. In further embodiments, the straps may be stand-alone components, initially unattached to either of the harness or the medical device/attachment frame, such that the user connects the straps to both the harness and the attachment frame/medical device during preparation for the medical procedure.
In some embodiments, removal of the strap from the harness is achieved by lifting the lever 172, so as to release the tooth's grip on the harness.
In some embodiments, the buckle which secures the strap to the harness may be rigidly coupled to the harness, i.e., an integral component of the harness, separate from the strap, such that securing the strap to the harness is achieved by coupling the strap to the harness' buckle.
In some embodiments, the buckles used for coupling the straps to the harness may include, or be coupled to, a stretching mechanism similar to the any one of the stretching mechanisms described hereinabove with regard to the buckles used for coupling the straps to the attachment frame or to the medical device, or any other suitable stretching mechanism.
In some embodiments, once the attachment frame is secured to the patient's body, the user may wish to check the attachment force to verify that it is equal to or larger than the insertion force, such that inserting the medical tool into the patient's body will not cause movement of the attachment frame with the medical device coupled thereto relative to the patient's body. The attachment force may be measured using standard force measurement instruments or using a dedicated force measurement jig, having a mechanical or electronic indicator to indicate to the user once the required force (e.g., 1 Kg, 1.5 Kg, etc.) is reached. The attachment force may be measured relative to the attachment frame or relative to the alignment jig when coupled to the attachment frame.
In some embodiments, the attachment apparatus is provided with, or is adapted to have coupled thereto, a respiration sensor. The respiration sensor may be a pressure sensor or a sensor which senses the chest or abdominal expansion/contraction, and provides the physician with data regarding the breathing cycle of the subject, such as the respiration waveform.
In some embodiments, as shown in
The data from the respiration sensor 180 may be transferred to the system controller (not shown) and may be used for synchronizing the activation of the medical device (e.g., the insertion and/or steering of a needle) and/or the initiation of a scan (e.g., a CT scan) in image-guided procedures, with a specific point or points in the breathing cycle. The initiation of the scan may be automatic, or the user may be prompted to manually initiate a scan. Respiration sensors which may be utilized are, for example, Respiration Sensor-SA9311M manufactured by Thought Technology Ltd. of Montreal West, Quebec, Canada, or the Piezoelectric Respiration (PZT) Sensor manufactured by Plux of Lisbon, Portugal.
In some embodiments, the attachment frame and/or the medical device may comprise a sensor to indicate if, after the attachment frame has been properly secured to the patient's body and/or after the medical device has been properly coupled to the secured attachment frame, there is movement of the attachment frame and/or the coupled medical device relative to the patient's body, above a predetermined threshold. The sensor may be, for example, a distance sensor, a proximity sensor, an accelerometer (the signals of which may be compared to those of an accelerometer positioned on the patient's body), etc. The relative movement indication provided by the sensor may be visual or auditory.
In some embodiments, due to the natural curves of the patient's body, the attachment frame may require a slight lifting and/or angling, in order to stabilize the medical device when it is attached to the body. The attachment apparatus may include, in such embodiments, one or more cushions (not shown), which can be placed underneath the medical device and/or the attachment frame and/or the straps, to ensure stable positioning of the medical device, using the attachment frame, on a curved surface of the patient's body. The cushions may further be used for adjusting the positioning angle of the attachment frame relative to the patient's body, to ensure that the medical device, e.g., and insertion device, can be positioned relative to the body such that a desired insertion angle for the medical tool can be reached. The cushions may further provide padding and minimize any discomfort or pain to the patient due to attachment of the attachment frame and the medical device to his/her body. In some embodiments, the cushions may be inflatable. In some embodiments, the cushion may be filled, at least in part, with granules, either natural or artificial, such that when vacuum is applied to the cushion, the granules are pressed against each other and the cushion stiffens, providing stability to the medical device, and ensuring that there is substantially no relative movement between the medical device and the patient's body. In some embodiments, the cushion may include therein (or thereon) one or more registration elements (e.g., fiducial markers), for determining the medical device's position in the image space during image-guided procedures, in case the medical device itself is positioned outside the scanned volume, as disclosed, for example, in co-owned U.S. Patent Application Publication No. 2018/368,922, to Roth et al.
In some embodiments, the attachment frame may be configured such that its shape, more specifically, the shape of its bottom surface, i.e., the surface which contacts the patient's body, can adjust according to the natural curves of the patient's body. Alternatively, the user may be provided with a plurality of attachments frames, having a variety of shapes and/or dimensions, which the user can choose from, such that the attachment frame used would be the most suitable for the contour of the patient's body in the location to which the attachment frame is to be secured.
In some embodiments, as shown in
The parallel lifting member 200 may be rigidly coupled to, or an integral part of, the attachment frame 202 or the base/housing of the medical device. Alternatively, the parallel lifting member 200 may be a separate unit which is removably coupleable to both the attachment frame 202 and the medical device 300, such that the user can decide, while securing the attachment frame 202 to the patient's body, if the lifting member 200 is required or not.
In some embodiments, as shown in
The angular lifting member 210 may be rigidly coupled to, or an integral part of, the attachment frame 212 or the base/housing of the medical device. Alternatively, the angular lifting member 210 may be a separate unit which is removably coupleable to both the attachment frame 212 and the medical device 300, such that the user can decide, while securing the attachment frame 212 to the patient's body, if the angular lifting member 210 is required or not.
In procedures involving insertion of a medical tool into the patient's body, in which use of an angular lifting member is required, an angular aiming apparatus may be used in order to facilitate proper positioning of the attachment frame which will ensure alignment of the medical tool tip with the marked entry point. The angular aiming apparatus may be coupled to the attachment frame and once proper positioning is achieved, the user can remove the angular aiming apparatus and couple the insertion device to the attachment frame. In some embodiments, the angular aiming apparatus may be provided with an orienting mechanism, for example similar to the orienting mechanism described with regard to
Although particular implementations have been disclosed herein in detail, this has been done by way of example for purposes of illustration only, and is not intended to be limiting with respect to the scope of the appended claims, which follow. In particular, it is contemplated that various substitutions, alterations, and modifications may be made without departing from the spirit and scope of the disclosure as defined by the claims. Other aspects, advantages, and modifications are considered to be within the scope of the following claims. The claims presented are representative of the implementations and features disclosed herein. Other unclaimed implementations and features are also contemplated. Accordingly, other implementations are within the scope of the following claims.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IL2019/050651 | 6/6/2019 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62763226 | Jun 2018 | US |
