Shape sensing calibration in medical devices

Abstract

A shape-sensing medical device can include a handle and an elongated member. A proximal portion of the elongated member can be attached to a distal section of the handle. A blister pack can be configured to encase at least a portion of the shape-sensing medical device. The blister pack can include a rigid backing with a handle retention feature formed in the rigid backing and configured to fix an orientation of the handle within the blister pack. A first calibration routing can be formed in the rigid backing and configured to secure a distal portion of the elongated member at a first orientation relative to the handle. The blister pack can also include a flexible film attached to the rigid backing to hold the shape-sensing medical device in the blister pack such that the blister pack enables calibration of the shape-sensing medical device while maintaining sterility thereof.

Description

Docket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1SHAPE SENSING CALIBRATION IN MEDICAL DEVICESPRIORITY CLAIM

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 682,595, filed August 13, 2024, the contents of which are incorporated herein.TECHNICAL FIELD

[0002] Examples described herein generally relate to calibrating medical devices. More specifically, the examples described herein generally relate to shape-sensing calibration in medical devices.BACKGROUND

[0003] Shape sensing technology, particularly in the context of medical devices, has revolutionized the way procedures are conducted by providing real-time, three-dimensional positional data of instruments within the human body. This technology typically utilizes optical fibers, such as those incorporating Fiber Bragg Grating (FBG) sensors, which can detect minute changes in shape and transmit this information back to a computing system. These sensors can help advance medical applications, including minimally invasive surgeries and complex diagnostic tools, where precise navigation and positioning of instruments are important. Historically, the calibration and maintenance of the accuracy of these devices have posed significant challenges, especially in ensuring that the devices remain sterile and functional over time and use.SUMMARY

[0004] In examples, a shape-sensing medical device can include a handle and an elongated member. A proximal portion of the elongated member can be attached to a distal section of the handle. A blister pack for sterile calibration of the shape-sensing medical device can be configured to encase at least a portion of the shape-sensing medical device. The blister pack can include a rigid backing with a handle retention feature formed in the rigid backing and configured to fix an orientation of the handle withinDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 the blister pack. A first calibration routing can be formed in the rigid backing and configured to secure a distal portion of the elongated member at a first orientation relative to the handle. The blister pack can also include a flexible film attached to the rigid backing to hold the shape-sensing medical device in the blister pack such that the blister pack enables calibration of the shape-sensing medical device while maintaining sterility thereof.

[0005] In examples, a system can include a medical device and a blister pack. The medical device can include a handle and an elongated member. The handle can be configured to be held by a medical professional during a surgical procedure. A proximal portion of the elongated member can be attached to a distal section of the handle. The blister pack can encase at least a portion of the medical device. The blister pack can include a rigid backing with a handle retention feature formed in the rigid backing and configured to fix an orientation of the handle within the blister pack. A first calibration routing can be formed in the rigid backing and configured to secure a distal portion of the elongated member at a first orientation relative to the handle. The blister pack can include a flexible film attached to the rigid backing to hold the medical device in the blister pack such that the blister pack enables calibration of the medical device while maintaining sterility.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Various examples are illustrated in the figures of the accompanying drawings. Such examples are demonstrative and not intended to be exhaustive or exclusive examples of the present subject matter.

[0007] FIG. 1 illustrates an example system, including a shapesensing medical device and a blister pack.

[0008] FIG. 2 illustrates an example system including a portion of the shape-sensing medical device and an example rigid sleeve.

[0009] FIG. 3 illustrates an example system, including a portion of the shape-sensing medical device and a flexible sleeve.

[0010] FIG. 4 illustrates an example system, including a shapesensing medical device and a blister pack.Docket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1

[0011] FIG. 5 illustrates an example system, including a shapesensing medical device and an example blister pack.

[0012] FIG. 6 illustrates an example calibration indicator.

[0013] FIG. 7 illustrates an example calibration indicator.

[0014] FIG. 8 illustrates an example calibration indicator.DETAILED DESCRIPTION

[0015] The calibration process of an optical “shape sensing” fiberoptic bundle can establish a specific and known configuration of the device to set a “calibration” position relative to the operating conditions of the shape sensing fiberoptic device and other environmental factors. High- end systems like robotic systems achieve this configuration by selfcalibrating before use. For example, a robotic appendage equipped with this technology might be positioned in a predetermined configuration — such as a flat, straight alignment — which can serve as a reference point for future calibrations.

[0016] However, a different approach to calibration can be used for newer, less complex systems. Calibration can be done by manipulating the shape-sensing medical device in a known orientation, which may then be used as a reference point for future positions of the shape-sensing medical device. For example, a disposable endoscope can include 3D shape sensing and navigation technology.

[0017] A shape-sensing medical device can include a handle and an elongated member. A proximal portion of the elongated member can be attached to a distal section of the handle. A blister pack for sterile calibration of the shape-sensing medical device can be configured to encase at least a portion (or the entirety) of the shape-sensing medical device. The blister pack can include a rigid backing with a handle retention feature formed in the rigid backing and configured to fix an orientation of the handle within the blister pack. A first calibration routing can be formed in the rigid backing and configured to secure a distal portion of the elongated member at a first orientation relative to the handle. The blister pack can also include a flexible film attached to the rigid backing to hold the shape-sensing medicalDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 device in the blister pack such that the blister pack enables calibration of the shape-sensing medical device while maintaining sterility (e.g., prevent contamination) thereof.

[0018] A system can include a medical device and a blister pack. The medical device can include a handle and an elongated member. The handle can be configured to be held by a medical professional during a surgical procedure. A proximal portion of the elongated member can be attached to a distal section of the handle. The blister pack can encase at least a portion of the medical device. The blister pack can include a rigid backing with a handle retention feature formed in the rigid backing and configured to fix an orientation of the handle within the blister pack. A first calibration routing can be formed in the rigid backing and configured to secure a distal portion of the elongated member at a first orientation relative to the handle. The blister pack can include a flexible film attached to the rigid backing to hold the medical device in the blister pack such that the blister pack enables calibration of the medical device while maintaining sterility.

[0019] The above discussion is intended to provide an overview of the subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The description below provides further information about the present patent application.

[0020] FIG. 1 illustrates an example system 100, including a shapesensing medical device 108 and an example blister pack 102. The shapesensing medical device 108 can be an endoscope, including shape-sensing technologies. The shape-sensing medical device 108 can include a handle 110, an elongated member 112, and a corded plug 122. The handle 110 can be configured to be held by a user of the shape-sensing medical device 108, so the handle 110 can include an ergonomic design that allows a standard user comfortable control of the shape-sensing medical device 108. The handle 110 can extend between a distal section 118 and a proximal section 120. The elongated member 112 can extend between a proximal portion 114 and a distal portion 116. The proximal portion 114 of the elongated member 112 can be attached to the distal section 118 of the handle 110. The cordedDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 plug 122 can attach to the proximal section 120 of the handle 110, opposite the elongated member 112. The shape-sensing medical device 108 can be packaged in a blister pack 102.

[0021] As discussed herein, the blister pack 102 can be configured to store, maintain sterility, and calibrate the shape-sensing medical device 108. The blister pack 102 can include a rigid backing 104 and a flexible film 106 that together form the secure and sterile packaging of the blister pack 102 to encompass the shape-sensing medical device 108.

[0022] The rigid backing 104 can be rigid to support the blister pack 102 and help protect the shape-sensing medical device 108 stored within the blister pack 102. The rigid backing 104 can include paperboard, cardboard, corrugated fiberboard, kraft paper, composite materials (e.g., a mixture of paper, plastics, metals, and polymers), recycled paper materials, biodegradable boards, pressed fiber, any combination thereof, or the like. The rigid backing 104 can include a handle retention feature 124 and a first calibration routing 126.

[0023] The handle retention feature 124 can extend from the rigid backing 104 to hold the handle 110 of the shape-sensing medical device 108 at a known position and orientation within the blister pack 102. The handle retention feature 124 can include one or more features positioned around the handle 110 and configured to receive and secure the handle 110 to the rigid backing 104. The handle retention feature 124 can include features to hold portions of the elongated member 112 and the corded plug 122 as they attach to the handle 110. The additional handle retention features 124 attached to the elongated member 112 and the corded plug 122 can better secure the handle 110 to the rigid backing 104. The handle retention feature 124 can also be installed on the rigid backing 104 before the flexible film 106 is drawn to the rigid backing 104 to make the blister pack 102. Thus, the handle retention feature 124 can include adhesives, hook and loop, other fastening means, combinations thereof, or the like, to hold the handle retention feature 124 on the rigid backing 104 while the flexible film 106 is installed thereon.Docket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1

[0024] The first calibration routing 126 can receive and hold the elongated member 112 in a position and orientation relative to the handle 110. As the first calibration routing 126 is adjustable, the position of the elongated member 112 relative to the handle 110 can be a known position and orientation. The first calibration routing 126 can be formed in the rigid backing 104 and extend from the rigid backing 104. The first calibration routing 126 can also be attachable to the rigid backing 104 before the flexible film 106 is drawn onto the rigid backing 104 to form the blister pack 102. As such, the first calibration routing 126 can include adhesives, hook and loop, other fastening means, combinations thereof, or the like to hold the first calibration routing 126 on the rigid backing 104 while the flexible film 106 is installed thereon.

[0025] A calibration indicator 128 can be installed at a distal end of the first calibration routing 126. The calibration indicator 128 can provide information to a control system of the shape-sensing medical device 108 to help calibrate the shape-sensing medical device 108. The calibration indicator 128 will be discussed in more detail herein. The calibration indicator 128 can be formed in the rigid backing 104 and extend from the rigid backing 104. The calibration indicator 128 can also be attachable to the rigid backing 104 before the flexible film 106 is drawn onto the rigid backing 104 to form the blister pack 102. As such, the calibration indicator 128 can include adhesives, hook and loop, other fastening means, combinations thereof, or the like to hold the calibration indicator 128 on the rigid backing 104 while the flexible film 106 is installed thereon.

[0026] The flexible film 106 can include polyvinyl chloride (PVC), polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG), polypropylene (PP), polystyrene (PS), aluminum, high-density polyethylene (HDPE), composite materials, any combination thereof, or the like. The flexible film 106 can be configured to be thermally molded or drawn onto the rigid backing 104 to secure the shape-sensing medical device 108 within the blister pack 102 while maintaining a sterile environment for the shapesensing medical device 108. A thickness of the flexible film 106 can be configured to ensure proper security and sealing to maintain the shape-Docket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 sensing medical device 108 within the blister pack 102 while maintaining sterility.

[0027] The flexible film 106 can include a sterile interface 130 formed therein to provide user access to the corded plug 122 while maintaining the sterility of the rest of the components of the shape-sensing medical device 108. The sterile interface 130 can include a flap, opening, slit, other access point, combinations thereof, or the like to provide user access to the corded plug 122 so the user can plug the corded plug 122 into a control system to communicate with the shape-sensing medical device 108 while maintaining sterility of the other components of the shape-sensing medical device 108. To maintain the sterility of the other components of the shape-sensing medical device 108, the sterile interface 130 can include additional material around the sterile interface 130, adhesive, hook and loop, other fasteners, or combinations thereof to help seal off the rest of the blister pack 102 and the sterile interface 130. In other examples, the rigid backing 104 can include a ridge or sealing member that, in combination with the sterile interface 130, helps maintain the sterility of the shape-sensing medical device 108 while providing the user access to the corded plug 122.

[0028] The sterile interface 130 can provide access for the corded plug 122 to connect to a control system 132 while maintaining the rest of the shape-sensing medical device 108 within the blister pack 102. As the rest of the shape-sensing medical device 108 is within the blister pack 102, the sterility, position, and orientation of the components of the shape-sensing medical device 108 can be communicated to the control system 132. The control system 132 can use the known information provided by the positioning of the shape-sensing medical device 108 within the blister pack 102 to calibrate the shape-sensing medical device 108 before use of the device. The calibration indicator 128 can communicate the position, sterility, and orientation of the shape-sensing medical device 108 within the blister pack 102.

[0029] FIG. 2 illustrates an example system 100, which can include a portion of the shape-sensing medical device 108 and a rigid sleeve 202. The rigid sleeve 202 can be installed between the rigid backing and the flexibleDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 film (e.g., the rigid backing 104 and the flexible film 106, see FIG. 1) and at least partially surround the shape-sensing medical device within the blister pack (e.g., the blister pack 102, see FIG. 1). In one or more examples, the rigid sleeve 202 can be used to better improve the sterility of the shapesensing medical device 108. In examples, the rigid sleeve 202 can be installed on the shape-sensing medical device 108 before the shape-sensing medical device 108 is installed in the blister pack 102. In other examples, the rigid sleeve 202 can be installed on the elongated member 112 as the flexible film 106 is being peeled back and the elongated member 112 is exposed. The rigid sleeve 202 can be installed onto the elongated member 112 toward the proximal portion 114 of the elongated member 112 to help cover and provide rigidity support to the elongated member 112. As shown in FIG. 2, the rigid sleeve 202 can extend almost an entire length of the elongated member 112 toward the proximal portion 114 of the elongated member 112. In another example, the rigid sleeve 202 can cover just a distal portion of the elongated member 112. In yet another example, the rigid sleeve 202 can extend about halfway between the distal end of the elongated member 112 and the proximal portion 114 of the elongated member 112. The support provided by the rigid sleeve 202 can further ensure the position of the elongated member 112 relative to the handle 110 (FIG. 1).

[0030] The rigid sleeve 202 can include the calibration indicator 128. In one example, the calibration indicator 128 can indicate a position, orientation, angle relative to the handle, other information regarding the elongated member 112, or the like. In another example, the calibration indicator 128 can indicate the rigid sleeve 202 is installed, which can alter or change the calibration procedures, techniques, or methods. As shown in FIG. 2, the calibration indicator 128 can be installed on a distal end of the rigid sleeve 202. In another example, the calibration indicator 128 can be installed within the distal end of the rigid sleeve 202.

[0031] FIG. 3 illustrates an example system 100, which can include a portion of the shape-sensing medical device 108 and a flexible sleeve 302. The flexible sleeve 302, like the rigid sleeve 202, can help improve the sterility of the shape-sensing medical device 108. In examples, the flexible sleeve 302 can be installed on the shape-sensing medical device 108 beforeDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 the shape-sensing medical device 108 is installed in the blister pack 102. In other examples, the flexible sleeve 302 can be installed on the elongated member 112 as the flexible film 106 (FIG. 1) is being peeled back and the elongated member 112 is exposed. The flexible sleeve 302 can be installed onto the elongated member 112 toward the proximal portion 114 of the elongated member 112 to help cover and provide rigidity support to the elongated member 112. As shown in FIG. 2, the flexible sleeve 302 can extend almost an entire length of the elongated member 112 toward the proximal portion 114 of the elongated member 112. In another example, the flexible sleeve 302 can cover just a distal portion of the elongated member 112. In yet another example, the flexible sleeve 302 can extend about halfway between the distal end of the elongated member 112 and the proximal portion 114 of the elongated member 112.

[0032] As the flexible sleeve 302 is flexible, it maintains the sterility of the shape-sensing medical device 108 while allowing a clinician to reposition or alter an orientation of the elongated member 112 relative to the handle 110 (FIG. 1). Thus, the flexible sleeve 302 can be used when calibration of the shape-sensing medical device 108 implements more than one calibration routing.

[0033] Examples of a blister pack 102, including multiple calibration routings, will be discussed with reference to FIG. 4 and FIG. 5. FIG. 4 illustrates an example system 400, including an example shape-sensing medical device 108 and an example blister pack 102. As shown in FIG. 4, the system 400 can include a rigid backing 402 including a second calibration routing 404. The system 400 can also include a second calibration routing indicator 406 and a flexible film open limit indicator 408.

[0034] The rigid backing 402 can be used for shape-sensing medical devices 108 that implement more than one calibration routing. The second calibration routing 404 can include an arcuate shape (e.g., a curvature) that extends away from the first calibration routing 126 to alter an orientation of the elongated member 112 relative to the handle 110 and change a position of the elongated member 112. The second calibration routing indicator 406 can be installed within the blister pack 102 at the end of the secondDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 calibration routing 404 to indicate to the control system 132 that the elongated member 112 is installed within the second calibration routing 404. As such, the first calibration routing 126 and the calibration indicator 128 can be a first orientation and calibration point, then the second calibration routing 404 and the second calibration routing indicator 406 can be a second orientation and calibration point.

[0035] The elongated member 112 can be moved between the first calibration routing 126 and the second calibration routing 404 in multiple manners. In one example, the blister pack 102 can be designed to be loose between the first calibration routing 126 and the second calibration routing 404 to provide manipulation of the elongated member 112 between the first calibration routing 126 and the second calibration routing 404 while maintaining the position of the flexible film 106. Here, the rigid backing 402 can include one or more formations to encourage air gaps between the rigid backing 402 and the flexible film 106 during the sealing of the blister pack 102. In other examples, such as one that utilizes one or more sleeves (e.g., the rigid sleeve 202, see FIG. 2 or the flexible sleeve 302, see FIG. 3) the flexible film 106 can be drawn back from the rigid backing 402 to provide access to move the elongated member 112 between the first calibration routing 126 and the second calibration routing 404.

[0036] In examples, either the rigid backing 402 or the flexible film 106 can include the flexible film open limit indicator 408 to indicate a maximum amount the flexible film 106 can be removed from the rigid backing 402 while maintaining sterility of the shape-sensing medical device 108. The flexible film open limit indicator 408 can be a visual indication, as shown in FIG. 4, or another signal that the flexible film 106 should not be further withdrawn from the rigid backing 402. For example, the flexible film open limit indicator 408 can include additional security between the rigid backing 402 and the flexible film 106 to make removing the flexible film 106 from the rigid backing 402 more difficult than it is before reaching the flexible film open limit indicator 408. This resistance to further opening of the blister pack 102 can be provided by adhesive, hook and loop, other fasteners, surface finishes on the rigid backing 402, or other techniques that can increase a bond between the rigid backing 402 and the flexible film 106.Docket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1

[0037] In other examples, as shown in FIG. 4, the seal width around a periphery of the blister pack 102 can be increased across the blister pack 102. One or more stop buffers or stop bars 410 (e.g., formations of increased engagement between the flexible film 106 and the rigid backing 402) can be utilized to further increase the force applied to open or limit the further opening of the blister pack 102. As shown in FIG. 4, the stop bars 410 can be formed to increase contact between the flexible film 106 and the rigid backing 402. The increased contact between the flexible film 106 and the rigid backing 402 can collect heat during the blister pack forming process, which can better secure the flexible film 106 to the rigid backing 402 at the stop bars 410. In examples, more than one stop bars 410 can be used to change the force applied to open the blister pack 102 or limit opening of the blister pack 102. Moreover, the shape and size of the stop bars 410 can be adjusted to accommodate different opening forces.

[0038] More than one flexible film open limit indicator 408 can be included in the blister pack 102. For example, another flexible film open limit indicator 408 can be included to indicate an amount the blister pack 102 should be opened to safely install the sleeve (e.g., the rigid sleeve 202, see FIG. 2 or the flexible sleeve 302, see FIG. 3) onto the elongated member 112. Multiple flexible film open limit indicators 408 can be included to indicate an opening limit for the first calibration routing 126 and the second calibration routing 404. In yet another example, any number of the flexible film open limit indicator 408 can be used to communicate open limits for different uses of the blister pack 102.

[0039] FIG. 5 illustrates an example system 500 including an example shape-sensing medical device 108 and an example blister pack 102. As shown in FIG. 5, the system 500 can include a third calibration routing 504 and a third calibration routing indicator 506. The system 500 can be used for shape-sensing medical devices 108 that implement more than two calibration routings. The third calibration routing 504 can include an arcuate shape that extends away from the first calibration routing 126 in a direction opposite the second calibration routing 404 to alter an orientation of the elongated member 112 relative to the handle 110 and change a position of the elongated member 112 from the orientation or position of the elongatedDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 member 112 in the first calibration routing 126 or the second calibration routing 404.

[0040] The third calibration routing indicator 506 can be installed within the blister pack 102 at the end of the third calibration routing 504 to indicate to the control system 132 that the elongated member 112 is installed within the third calibration routing 504. As such, the first calibration routing 126 and the calibration indicator 128 can be a first orientation and calibration point, the second calibration routing 404 and the second calibration routing indicator 406 can be a second orientation and calibration point, and the third calibration routing 504 and the third calibration routing indicator 506 can be a third orientation and calibration point.

[0041] The elongated member 112 can be moved between the first calibration routing 126, the second calibration routing 404, and the third calibration routing 504 in multiple manners. In one example, the blister pack 102 can be designed to be loose between the first calibration routing 126, the second calibration routing 404, and the third calibration routing 504 to provide manipulation of the elongated member 112 between the first calibration routing 126, the second calibration routing 404, or the third calibration routing 504 without opening or pulling back the flexible film 106. Here, the rigid backing 502 can include one or more formations to encourage air gaps between the rigid backing 502 and the flexible film 106 during the sealing of the blister pack 102. In other examples, such as one that utilizes one or more sleeves (e.g., the rigid sleeve 202, see FIG. 2 or the flexible sleeve 302, see FIG. 3) the flexible film 106 can be drawn back from the rigid backing 502 to provide access to move the elongated member 112 between the first calibration routing 126, the second calibration routing 404, and the third calibration routing 504.

[0042] FIG. 6 illustrates an example calibration indicator 600 (e.g., the calibration indicator 128, see FIG. 1; the second calibration routing indicator 406, see FIG. 4; the third calibration routing indicator 506, see FIG. 5; or the like). The calibration indicator 600 can be used to calibrate one or more parameters of the shape-sensing medical device (e.g., the shapesensing medical device 108, see FIG. 1). As shown in FIG. 6, the calibrationDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 indicator 600 can be a two-by-two grid including a first quadrant 602, a second quadrant 604, a third quadrant 606, and a fourth quadrant 608. Each quadrant of the first quadrant 602, the second quadrant 604, the third quadrant 606, and the fourth quadrant 608 can include different patterns used to calibrate one or more parameters of the shape-sensing medical device. For example, the patterns in the first quadrant 602, the second quadrant 604, the third quadrant 606, and the fourth quadrant 608 can be used to calibrate the brightness, contrast, sharpness, other video quality, or the like of the shapesensing medical device. The different patterns in the first quadrant 602, the second quadrant 604, the third quadrant 606, and the fourth quadrant 608 can help the control system 132 (FIG. 1) identify a calibration routing that the elongated member is positioned within to help calibrate the position and orientation of the shape-sensing medical device relative to the handle (e.g., the handle 110, see. FIG. 1).

[0043] FIG. 7 illustrates an example calibration indicator 700 (e.g., the calibration indicator 128, see FIG. 1; the second calibration routing indicator 406, see FIG. 4; the third calibration routing indicator 506, see FIG. 5; or the like). The calibration indicator 700 can be used to calibrate one or more parameters of the shape-sensing medical device (e.g., the shapesensing medical device 108, see FIG. 1). As shown in FIG. 7, the calibration indicator 700 can be a two-by-two grid including a first quadrant 702, a second quadrant 704, a third quadrant 706, and a fourth quadrant 708. Each quadrant of the first quadrant 702, the second quadrant 704, the third quadrant 706, and the fourth quadrant 708 can include a different shape used to calibrate one or more parameters of the shape-sensing medical device. For example, the shapes within each of the quadrants can be used to calibrate the brightness, sharpness, contrast, or other video parameters of the shapesensing medical device, or detecting shapes of specified forms. For example, the first quadrant 702 can include a circle, the second quadrant 704 can include a triangle, the third quadrant 706 can include a pentagon, and the fourth quadrant 708 can include a star. In other examples, any shape can be used in any quadrant of the first quadrant 702, the second quadrant 704, the third quadrant 706, or the fourth quadrant 708. The different shapes, or the combination of shapes in each of the first quadrant 702, the second quadrantDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1704, the third quadrant 706, and the fourth quadrant 708 can indicate to the control system 132 (FIG. 1) that the elongated member is positioned within one of the calibration routings (e.g., the first calibration routing 126, see FIG. 1, the second calibration routing 404, see FIG. 4, the third calibration routing 504, see FIG. 5, or the like).

[0044] FIG. 8 illustrates an example calibration indicator 800 (e.g., the calibration indicator 128, see FIG. 1; the second calibration routing indicator 406, see FIG. 4; the third calibration routing indicator 506, see FIG. 5; or the like). The calibration indicator 800 can be used to calibrate one or more parameters of the shape-sensing medical device (e.g., the shapesensing medical device 108, see FIG. 1). As shown in FIG. 8, the calibration indicator 800 can be a two-by-two grid including a first quadrant 802, a second quadrant 804, a third quadrant 806, and a fourth quadrant 808. Each quadrant of the first quadrant 802, the second quadrant 804, the third quadrant 806, and the fourth quadrant 808 can include a different color, shade of color, or the like, used to calibrate one or more parameters of the shape-sensing medical device. The different colors or shadings in each of the quadrants can also indicate to the control system 132 (FIG. 1) that the elongated member is positioned within one of the calibration routings (e.g., the first calibration routing 126, see FIG. 1, the second calibration routing 404, see FIG. 4, the third calibration routing 504, see FIG. 5, or the like).

[0045] The example calibration indicators, as shown in FIG. 6-FIG. 8, are just examples of calibration indicators. The inventors of the present disclosure recognize that other forms of calibration markings, patterns, colors, shadings, or the like can be used to help calibrate the shape-sensing medical device within the calibration routines.

[0046] The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.

[0047] Example l is a blister pack for sterile calibration of a shapesensing medical device, the shape-sensing medical device including a handle and an elongated member, a proximal portion of the elongated member is attached to a distal section of the handle, the blister pack configured toDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 encase at least a portion of the shape-sensing medical device, the blister pack comprising: a rigid backing including: a handle retention feature formed in the rigid backing and configured to fix an orientation of the handle within the blister pack; and a first calibration routing formed in the rigid backing and configured to secure a distal portion of the elongated member at a first orientation relative to the handle; and a flexible film attached to the rigid backing to hold the shape-sensing medical device in the blister pack such that the blister pack enables calibration of the shape-sensing medical device while maintaining sterility thereof.

[0048] In Example 2, the subject matter of Example 1 optionally includes wherein the blister pack comprises: a sterile interface removably attached to the flexible film and configured to provide access to a corded plug of the shape-sensing medical device while maintaining a sterility of the shape-sensing medical device.

[0049] In Example 3, the subject matter of any one or more of Examples 1-2 optionally include a rigid sleeve configured to be installed between the rigid backing and the flexible film, the rigid sleeve configured to receive the elongated member such as to encompass the elongated member to maintain a sterility of the elongated member after the blister pack is opened.

[0050] In Example 4, the subject matter of Example 3 optionally includes wherein the rigid sleeve is configured to receive the elongated member such that the rigid sleeve extends from the distal portion of the elongated member and onto the distal section of the handle.

[0051] In Example 5, the subject matter of Example 4 optionally includes wherein the rigid sleeve comprises: a calibration indicator detectable by the shape-sensing medical device to calibrate the shapesensing medical device based on a position of the elongated member relative to the handle as confirmed by the rigid sleeve.

[0052] In Example 6, the subject matter of any one or more of Examples 3-5 optionally include wherein the rigid sleeve is configured to be installed on the elongated member and the distal section of the handle before the shape-sensing medical device is packaged in the blister pack.Docket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1

[0053] In Example 7, the subject matter of any one or more of Examples 1-6 optionally include wherein the rigid backing comprises: a first calibration routing indicator detectable by the shape-sensing medical device to indicate the elongated member is positioned within the first calibration routing.

[0054] In Example 8, the subject matter of Example 7 optionally includes wherein the rigid backing comprises: a second calibration routing formed in the rigid backing and configured to secure the distal portion of the elongated member at a second orientation relative to the handle; and a second calibration routing indicator detectable by the shape-sensing medical device to indicate the elongated member is positioned within the second calibration routing.

[0055] In Example 9, the subject matter of Example 8 optionally includes wherein the rigid backing comprises: a third calibration routing formed in the rigid backing and configured to secure the distal portion of the elongated member at a third orientation relative to the handle; and a third calibration routing indicator detectable by the shape-sensing medical device to indicate the elongated member is positioned within the third calibration routing.

[0056] In Example 10, the subject matter of Example 9 optionally includes wherein at least one of the first calibration routing indicator, the second calibration routing indicator, or the third calibration routing indicator includes a two-by-two grid, each quadrant of the two-by-two grid is colored differently than other quadrants of the two-by-two grid such that the two-by- two grid is configured for color calibration of the shape-sensing medical device.

[0057] In Example 11, the subject matter of Example 10 optionally includes wherein each quadrant of the two-by-two grid includes a different shape such that the two-by-two grid is configured for shape calibration of the shape-sensing medical device.

[0058] In Example 12, the subject matter of any one or more of Examples 9-11 optionally include wherein at least one of the first calibration routing indicator, the second calibration routing indicator, or the thirdDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 calibration routing indicator includes a two-by-two grid, each quadrant of the two-by-two grid is a different shade of gray than other quadrants of the two-by-two grid such that the two-by-two grid is configured for brightness calibration of the shape-sensing medical device.

[0059] In Example 13, the subject matter of any one or more of Examples 9-12 optionally include wherein the first orientation is substantially straight relative to the handle, wherein the second orientation includes a curvature away from the first orientation in a first direction, and wherein the third orientation includes a curvature away from the first orientation in a second direction opposite the first direction.

[0060] In Example 14, the subject matter of any one or more of Examples 9-13 optionally include a flexible sleeve configured to be installed between the rigid backing and the flexible film, the flexible sleeve configured to receive the elongated member such as to encompass the elongated member and maintain a sterility of the elongated member after the blister pack is opened.

[0061] In Example 15, the subject matter of Example 14 optionally includes wherein the flexible sleeve is configured to receive the elongated member such that the flexible sleeve extends from the distal portion of the elongated member and onto the distal section of the handle.

[0062] In Example 16, the subject matter of any one or more of Examples 14-15 optionally include a flexible film open limit indicator configured to indicate a position on the blister pack where an end user can remove the flexible film from the rigid backing to expose the elongated member enough to move between the first calibration routing, the second calibration routing, and the third calibration routing while maintaining the sterility of the handle within the blister pack.

[0063] Example 17 is a system comprising: a medical device including: a handle configured to be held by a medical professional during a surgical procedure; and an elongated member, a proximal portion of the elongated member is attached to a distal section of the handle; and a blister pack configured to encase at least a portion of the medical device, the blister pack comprising: a rigid backing including: a handle retention featureDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 formed in the rigid backing and configured to fix an orientation of the handle within the blister pack; and a first calibration routing formed in the rigid backing and configured to secure a distal portion of the elongated member at a first orientation relative to the handle; and a flexible film attached to the rigid backing to hold the medical device in the blister pack such that the blister pack enables calibration of the medical device while maintaining sterility thereof.

[0064] In Example 18, the subject matter of Example 17 optionally includes wherein the rigid backing comprises: a first calibration routing indicator detectable by the medical device to indicate the elongated member is positioned within the first calibration routing; a second calibration routing formed in the rigid backing and configured to secure the distal portion of the elongated member at a second orientation relative to the handle; a second calibration routing indicator detectable by the shape-sensing medical device to indicate the elongated member is positioned within the second calibration routing; a third calibration routing formed in the rigid backing and configured to secure the distal portion of the elongated member at a third orientation relative to the handle; and a third calibration routing indicator detectable by the shape-sensing medical device to indicate the elongated member is positioned within the third calibration routing.

[0065] In Example 19, the subject matter of Example 18 optionally includes wherein at least one of the first calibration routing indicator, the second calibration routing indicator, or the third calibration routing indicator includes a two-by-two grid, each quadrant of the two-by-two grid is colored differently than other quadrants of the two-by-two grid such that the two-by- two grid is configured for color calibration of the medical device.

[0066] In Example 20, the subject matter of Example 19 optionally includes wherein each quadrant of the two-by-two grid includes a different shape such that the two-by-two grid is configured for shape calibration of the shape-sensing medical device.

[0067] Example 21 is a device, apparatus, method, or system including any element of any of Examples 1-20.Docket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1

[0068] The above-detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific examples that may be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0069] All publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.

[0070] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.Docket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1

[0071] The term “about,” as used herein, means approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 10%. In one aspect, the term “about” means plus or minus 10% of the numerical value of the number with which it is being used. Therefore, about 50% means in the range of 45%-55%. Numerical ranges recited herein by endpoints include all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, numerical ranges recited herein by endpoints include subranges subsumed within that range (e.g., 1 to 5 includes 1-1.5, 1.5-2, 2-2.75, 2.75-3, 3-3.90, 3.90-4, 4-4.24, 4.24-5, 2-5, 3-5, 1-4, and 2-4). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about.”

[0072] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other examples may be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is to allow the reader to quickly ascertain the nature of the technical disclosure and is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the examples should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

[0073] The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at leastDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 one use. Reconditioning can include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device can utilize a variety of different techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0074] Preferably, the invention described herein will be processed before surgery. First a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or higher energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility. The device may also be sterilized using any other technique known in the art, including but limited to beta or gamma radiation, ethylene oxide, or steam.

Claims

Docket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1CLAIMSWhat is claimed is:

1. A blister pack for sterile calibration of a shape-sensing medical device, the shape-sensing medical device including a handle and an elongated member, a proximal portion of the elongated member is attached to a distal section of the handle, the blister pack configured to encase at least a portion of the shapesensing medical device, the blister pack comprising: a rigid backing including: a handle retention feature formed in the rigid backing and configured to fix an orientation of the handle within the blister pack; and a first calibration routing formed in the rigid backing and configured to secure a distal portion of the elongated member at a first orientation relative to the handle; and a flexible film attached to the rigid backing to hold the shape-sensing medical device in the blister pack such that the blister pack enables calibration of the shape-sensing medical device while maintaining sterility thereof.

2. The blister pack of claim 1, wherein the blister pack comprises: a sterile interface removably attached to the flexible film and configured to provide access to a corded plug of the shape-sensing medical device while maintaining a sterility of the shape-sensing medical device.

3. The blister pack of any of claims 1-2, comprising: a rigid sleeve configured to be installed between the rigid backing and the flexible film, the rigid sleeve configured to receive the elongated member such as to encompass the elongated member to maintain a sterility of the elongated member after the blister pack is opened.Docket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO14. The blister pack of claim 3, wherein the rigid sleeve is configured to receive the elongated member such that the rigid sleeve extends from the distal portion of the elongated member and onto the distal section of the handle.

5. The blister pack of claim 4, wherein the rigid sleeve comprises: a calibration indicator detectable by the shape-sensing medical device to calibrate the shape-sensing medical device based on a position of the elongated member relative to the handle as confirmed by the rigid sleeve.

6. The blister pack of any of claims 3-5, wherein the rigid sleeve is configured to be installed on the elongated member and the distal section of the handle before the shape-sensing medical device is packaged in the blister pack.

7. The blister pack of any of claims 1-6, wherein the rigid backing comprises: a first calibration routing indicator detectable by the shape-sensing medical device to indicate the elongated member is positioned within the first calibration routing.

8. The blister pack of claim 7, wherein the rigid backing comprises: a second calibration routing formed in the rigid backing and configured to secure the distal portion of the elongated member at a second orientation relative to the handle; and a second calibration routing indicator detectable by the shape-sensing medical device to indicate the elongated member is positioned within the second calibration routing.

9. The blister pack of claim 8, wherein the rigid backing comprises: a third calibration routing formed in the rigid backing and configured to secure the distal portion of the elongated member at a third orientation relative to the handle; andDocket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 a third calibration routing indicator detectable by the shape-sensing medical device to indicate the elongated member is positioned within the third calibration routing.

10. The blister pack of claim 9, wherein at least one of the first calibration routing indicator, the second calibration routing indicator, or the third calibration routing indicator includes a two-by-two grid, each quadrant of the two-by-two grid is colored differently than other quadrants of the two-by-two grid such that the two-by-two grid is configured for color calibration of the shape-sensing medical device.

11. The blister pack of claim 10, wherein each quadrant of the two-by-two grid includes a different shape such that the two-by-two grid is configured for shape calibration of the shape-sensing medical device.

12. The blister pack of any of claims 9-11, wherein at least one of the first calibration routing indicator, the second calibration routing indicator, or the third calibration routing indicator includes a two-by-two grid, each quadrant of the two-by-two grid is a different shade of gray than other quadrants of the two-by- two grid such that the two-by-two grid is configured for brightness calibration of the shape-sensing medical device.

13. The blister pack of any of claims 8-12, wherein the first orientation is substantially straight relative to the handle, wherein the second orientation includes a curvature away from the first orientation in a first direction.

14. The blister pack of any of claims 8-13, comprising: a flexible sleeve configured to be installed between the rigid backing and the flexible film, the flexible sleeve configured to receive the elongated member such as to encompass the elongated member and maintain a sterility of the elongated member after the blister pack is opened.Docket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO115. The blister pack of claim 14, wherein the flexible sleeve is configured to receive the elongated member such that the flexible sleeve extends from the distal portion of the elongated member and onto the distal section of the handle.

16. The blister pack of any of claims 14-15, comprising: a flexible film open limit indicator configured to indicate a position on the blister pack to mark where the flexible film can be removed from the rigid backing to expose the elongated member enough to move between the first calibration routing and the second calibration routing while maintaining the sterility of the handle within the blister pack.

17. A system comprising: a medical device including: a handle; and an elongated member, a proximal portion of the elongated member is attached to a distal section of the handle; and a blister pack configured to encase at least a portion of the medical device, the blister pack comprising: a rigid backing including: a handle retention feature formed in the rigid backing and configured to fix an orientation of the handle within the blister pack; and a first calibration routing formed in the rigid backing and configured to secure a distal portion of the elongated member at a first orientation relative to the handle; and a flexible film attached to the rigid backing to hold the medical device in the blister pack such that the blister pack enables calibration of the medical device while maintaining sterility thereof.

18. The system of claim 17, wherein the rigid backing comprises:Docket No. CLIENT FILE NO: GAP24072-SUMS-WO1 / / SLW FILE NO: 5409.935WO1 a first calibration routing indicator detectable by the medical device to indicate the elongated member is positioned within the first calibration routing; a second calibration routing formed in the rigid backing and configured to secure the distal portion of the elongated member at a second orientation relative to the handle; a second calibration routing indicator detectable by the medical device to indicate the elongated member is positioned within the second calibration routing; a third calibration routing formed in the rigid backing and configured to secure the distal portion of the elongated member at a third orientation relative to the handle; and a third calibration routing indicator detectable by the medical device to indicate the elongated member is positioned within the third calibration routing.

19. The system of claim 18, wherein at least one of the first calibration routing indicator, the second calibration routing indicator, or the third calibration routing indicator includes a two-by-two grid, each quadrant of the two-by-two grid is colored differently than other quadrants of the two-by-two grid such that the two-by-two grid is configured for color calibration of the medical device.

20. The system of claim 19, wherein each quadrant of the two-by-two grid includes a different shape such that the two-by-two grid is configured for shape calibration of the medical device.

Images