Positioning a spacer inside a body

Abstract

A method of placing an inflatable spacer inside a living body includes inserting a portion of a dilator assembly into a tissue space inside a living body. The dilator assembly includes a dilator sheath having an open distal end, a dilator core, and a sensor attached to the dilator core. The sensor is responsive to a condition inside the body and transmits sensor feedback to a receiver during positioning of the dilator assembly inside the living body. The inserting includes inserting the dilator assembly into the tissue space to position, based on the sensor feedback, the tapered distal end of the dilator core at a target location inside the living body. The method also includes removing the dilator core from the dilator sheath, inserting a spacer into the living body through the open distal end of the dilator sheath, and removing the dilator sheath from the living body.

Description

POSITIONING SPACER INSIDE A BODYCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority under 35 U. S. C. §119(e) to U. S. Provisional Patent Application Serial No. 63 / 718,015, filed on November 8, 2024, the entire contents of which are hereby incorporated by reference.TECHNICAL FIELD

[0002] This disclosure relates to tissue separation devices.BACKGROUND

[0003] Inter-tissue and inter-organ spacers are often used for creating and occupying a dissected tissue space in a human subject. Examples of inflatable bladders or spacers can be found in US Patent No. US11918414B2, which is incorporated herewith by reference in its entirety. Typically, such spacers are used to distance a healthy tissue or organ from another tissue or organ that is targeted for a treatment such as, for example, a radiation treatment. Spacers can also be used to separate tissue in other surgical procedures, such as in laparoscopic surgery and endoscopic procedures. In radiation therapy, the tissue dissection process and spacer placement can reduce the exposure of the healthy tissue to the potentially negative effects of the treatment. Accurately positioning the spacer in an optimal position and location can be difficult. Methods and equipment to improve tissue separation and spacer placement procedures are sought.SUMMARY

[0004] Implementations of the present disclosure include a method of placing an inflatable spacer inside a living body. The method includes inserting a portion of a dilator assembly into a tissue space inside a living body. The dilator assembly includes a dilator sheath, a dilator core, and a sensor. The dilator sheath has an open distal end. The dilator core is movable with respect to the dilator sheath and has a tapered distal end that extends through the open distal end of the dilator sheath with the dilator core in an extended position. The sensor is attached to the dilator core. The sensor is communicatively coupled to a receiver and is responsive to a condition within the living body with the dilator core in its extended position. The sensor transmits sensor feedback to the receiver during positioning of the dilator assembly inside the living body. The insertingincludes inserting the dilator assembly into the tissue space to position, based on the sensor feedback, the tapered distal end of the dilator core at a target location inside the living body. The method also includes removing, with the dilator sheath positioned at the target location, the dilator core from the dilator sheath. The method also includes inserting, with the dilator core removed from the dilator sheath, a spacer into the living body through the open distal end of the dilator sheath to place the spacer at an interface between tissue masses inside the living body. The method also includes, while leaving the spacer at the interface, removing the dilator sheath from the living body.

[0005] In some implementations, the dilator core includes two or more electrodes attached to the tapered distal end of the dilator core to detect an impedance of body components as each body component contacts the two or more electrodes, and inserting the portion of the dilator assembly includes moving, based on the impedance of each body component, the dilator core to the target location while avoiding damaging the body components during placement of the dilator core.

[0006] In some implementations, the method further includes imaging, using the sensor, an internal portion of the body to generate a visual representation of the internal portion of the living body, and inserting the portion of the dilator assembly includes positioning, based on the visual representation, the dilator core at the target location.

[0007] In some implementations, the sensor resides at a tip of the distal end and includes at least one of an optical sensor, a temperature sensor, or a pressure sensor. The optical sensor transmits image information to the receiver. The temperature sensor transmits temperature information to the receiver. The pressure sensor transmits pressure information to the receiver. Inserting the portion of the dilator assembly includes moving, based on at least one of the image information, temperature information, or pressure information, the dilator core to the target location.

[0008] In some implementations, the sensor includes a pressure sensor responsive to at least one of axial pressure or radial pressure against the sensor as the dilator core moves inside the living body. Inserting the portion of the dilator assembly includes determining the pressure at the tip during the insertion of the dilator assembly to verify that the pressure is at an expected range at a location of the dilator tip.

[0009] In some implementations, the spacer includes an inflatable spacer including a pressure sensor coupled with the inflatable spacer. The pressure sensor is communicatively coupled with and arranged to transmit second sensor feedback to the receiver. The method also includes, after inserting the inflatable spacer, inflating, based on the second sensor feedback, the inflatable spacer at the interface between the tissue masses inside the living body. In some implementations, the method also includes positioning a second pressure sensor inside an organ adjacent the interface between the tissue masses. The second pressure sensor is communicatively coupled with and arranged to transmit third sensor feedback to the receiver to determine a pressure applied to the organ by the inflatable spacer. The method also includes inflating, based on the second and third sensor feedback, the inflatable spacer. In some implementations, the interface includes an interface between a prostate of the living body and a rectum of the living body, and the second pressure sensor is attached to at least one of (i) a transrectal ultrasound probe disposed inside the rectum or (ii) a catheter disposed inside a urinary tract of the living body adjacent the prostate.

[0010] In some implementations, the spacer includes a transparent or translucent inflatable spacer and the inflatable spacer includes an optical sensor attached to a tube fluidly coupled with the inflatable spacer. The optical sensor is communicatively coupled with and arranged to transmit third sensor feedback to the receiver to generate a visual representation of a portion of the living body around the inflatable spacer. The method further includes positioning, based on the visual representation, the inflatable spacer at the interface.

[0011] In some implementations, inserting the portion of the dilator assembly includes automatically inserting, as a function of the sensor feedback, the portion of the dilator assembly into the living body, and inserting the spacer includes automatically inserting, as a function of the sensor feedback, the spacer, positioning the spacer at the interface between the tissue masses inside the living body.

[0012] In some implementations, the sensor includes an optical sensor attached to the tapered distal end, and the receiver includes an electronic screen configured to display, as a function of the sensor feedback, a visual representation of an in-body anatomy of the living body, and inserting the dilator assembly includes inserting, based on the visual representation, the dilator assembly to position the dilator assembly at the target location.

[0013] In some implementations, the sensor includes an optical sensor including a light source, and the optical sensor is arranged to transmit light to the living body and receive light from the living body, and the receiver includes a processor configured to perform spectroscopy as a function of the sensor feedback, and inserting the dilator assembly includes performing a spectroscopy-guided placement of the dilator assembly to position the dilator assembly at the target location.

[0014] Implementations of the present disclosure include a medical dilator assembly for placement of a spacer within a living body. The medical dilator assembly includes a dilator sheath, a dilator core, and a spacer. The dilator sheath has an open end. The dilator core includes an elongated body with a distal end. The elongated body is disposed at least partially within the dilator sheath with the distal end extending through the open end of the dilator sheath. The dilator core is partially inserted, together with the dilator sheath, into a tissue space inside a living body and can be removed from the living body to leave the dilator sheath. The spacer is inserted, with the dilator core removed from the dilator sheath, into the living body through the open end of the dilator sheath to place the spacer at an interface between tissue masses inside the living body. The dilator core further includes a sensor communicatively coupled to a receiver and responsive to a condition within the living body with the dilator core disposed within the dilator sheath. The sensor transmits sensor feedback to the receiver during positioning of the distal end of the dilator core at a target location inside the living body to facilitate placement of the spacer.

[0015] In some implementations, the dilator core includes two or more electrodes attached to the distal end of the dilator core and communicatively coupled to the receiver or a second receiver. Each of the two or more electrodes are spaced from each other along a width of the dilator core and transmit, with the two or more electrodes in contact with a body component inside the living body, electrical information of the body component to the receiver or second receiver to determine, based on an electrical impedance of the body component, a type of the body component to prevent, based on the type of the body component, damaging the body component during placement of the dilator core at the target location inside the living body.

[0016] In some implementations, the medical dilator assembly further includes a pressure sensor and a tube. The pressure sensor is coupled with the spacer. The spacer is an inflatable spacer. The tube is releasably coupled with the inflatable spacer. The tube directs a fluid into the inflatable spacer to inflate the inflatable spacer at the interface between the tissue masses. Thereceiver or a second receiver receives, from the pressure sensor during inflation or deflation of the inflatable spacer between the tissue masses, second sensor feedback. This allows a pressure inside the inflatable spacer to be adjusted based on the sensor feedback. In some implementations, the spacer includes an inflatable spacer including at least one of a pressure sensor or a strain sensor. The pressure sensor is attached to at least one of i) the tube inside the inflatable spacer or ii) a wall of the inflatable spacer, and the strain sensor is attached to the wall of the inflatable spacer to sense a strain in the wall of the inflatable spacer.

[0017] In some implementations, the sensor includes an optical sensor attached to the distal end of the dilator core, and the receiver includes an electronic screen configured to display, as a function of the sensor feedback, a visual representation of an in-body anatomy of the living body. The dilator core is positioned at the target location based on the visual representation. In some implementations, the distal end includes a tapered distal end and the optical sensor resides at a tip of the tapered distal end. The visual representation includes an image or video of the in-body anatomy located in at least one of (i) a location in front of the tapered distal end, or (ii) a location surrounding the tapered distal end.

[0018] In some implementations, the optical sensor includes a light source, and the optical sensor is arranged to transmit light to an internal portion of the living body and receive light from the internal portion. The receiver includes a processor that performs spectroscopy calculations as a function of the sensor feedback for spectroscopy-guided placement of the dilator core.

[0019] In some implementations, the sensor includes a first position and orientation sensor, and the dilator core includes a second position and orientation sensor attached to the dilator core and residing away from the first position and orientation sensor. The first and second position and orientation sensors transmit feedback to the receiver to allow determining, based on the sensor feedback, at least one of a position or orientation of the dilator core inside the living body. In some implementations, the first and second position and orientation sensors are configured to transmit feedback to the receiver to allow moving, based on the sensor feedback, the dilator core and dilator sheath along a predetermined path to the target location.

[0020] In some implementations, the sensor resides at a tip of the distal end and includes at least one of an optical sensor, a temperature sensor, or a pressure sensor. The dilator core further includes two or more electrodes at the distal end. The two or more electrodes transmit, with the two or more electrodes in contact with a body component inside the living body, electricalinformation of the body component to the receiver or a second receiver to determine, as a function of a determined bioelectrical impedance of the body component, a type of the body component to guide, along with the sensor, the placement of the dilator core at the target location inside the living body.

[0021] In some implementations, the medical dilator assembly further includes imaging, using the sensor, an internal portion of the living body to generate a visual representation of the internal portion of the living body to position, based on the visual representation, the dilator core at the target location.

[0022] In some implementations, the sensor includes a pressure sensor that resides at a tip of the distal end. The pressure sensor is responsive to at least one of axial pressure or radial pressure against the sensor as the dilator core moves inside the living body to prevent, based on the sensor feedback, damaging components inside the living body during placement of the dilator core at the target location.

[0023] In some implementations, the medical dilator assembly also including a pressure sensor positioned inside an organ adjacent the interface between the tissue masses. The pressure sensor is communicatively coupled with and arranged to transmit second sensor feedback to the receiver to allow the determination of a pressure applied to the organ by the spacer to inflate, based on the second sensor feedback, the spacer. In some implementations, the interface includes an interface between a prostate of the living body and a rectum of the living body, and the pressure sensor is attached to at least one of (i) a transrectal ultrasound probe disposed inside the rectum or (ii) a catheter disposed inside a urinary tract of the living body adjacent the prostate.

[0024] In some implementations, the spacer includes a transparent or translucent inflatable spacer and the inflatable spacer includes an optical sensor attached to a tube fluidly coupled with the inflatable spacer. The optical sensor is communicatively coupled with and arranged to transmit second sensor feedback to the receiver to generate a visual representation of a portion of the living body around the inflatable spacer to position, based on the visual representation, the inflatable spacer at the interface.

[0025] Particular implementations of the subject matter described in this specification can be implemented so as to realize one or more of the following advantages. For example, the delivery system of the present disclosure allows precise placement of an in-body spacer while avoiding damaging surrounding tissues. The delivery system of the present disclosure includes adilator assembly with sensors that can provide real-time information of the inner body area or the dilator assembly or both. This can allow accurate navigation inside the body to position the dilator assembly and place the spacer at a target location. The sensors can also be used to perform diagnosis procedures and prevent tissue damage. Moreover, the inflatable spacer can have a sensor that provides information including one or more parameters of the spacer, which can guide the placement and expansion of the spacer.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] FIG. 1 is a side schematic view of an example medical assembly.

[0027] FIG. 2 is a side schematic view of an example medical dilator.

[0028] FIGS. 3-8 are side schematic views of example sequential steps to place an inflatable spacer inside a living body.

[0029] FIG. 9 is a flow chart of an example method of placing an inflatable spacer inside a living body.

[0030] FIG. 10 is a schematic illustration of an example control system or controller for a delivery system according to the present disclosure.DETAILED DESCRIPTION OF THE DISCLOSURE

[0031] Apparatuses and methods for separation or dissection of one tissue from another are disclosed. The delivery system or medical assembly of the present disclosure includes a dilator assembly and a tissue separation assembly. The dilator assembly includes a dilator and a dilatorsheath mounted concentrically around the dilator. The dilator assembly is inserted into the body and, once positioned at the target location, the dilator can be removed from the sheath to allow the inflatable spacer to be inserted through the distal open end of the sheath to place the inflatable spacer. The sensors can be attached to the dilator assembly or the spacer or both to position the dilator at the right location, as well as to position the inflatable spacer in the optimal location.

[0032] The tissue separation or dissection assembly accomplishes the separation using a spacer (e.g., inflatable balloon or bladder). The separation can be accomplished by delivering the spacer between tissues until the spacer biodegrades and / or is removed. Such inflatable spacers are known to be useful in cases where physical separation between adjacent tissues, such as organs or organ tissues, is desirable. For example, an inflated spacer can help protect one tissue from effects of a treatment to the second tissue - for example, a radiation treatment. In some aspects, anapparatus for use in the separation procedures includes a tissue separation assembly with sensors to facilitate positioning the spacer at a desired or optimal location. A tissue separation assembly can be inserted into a subject’s body, for example, through an incision in the subject’s perineum or abdominal wall, depending on which tissues or organs are involved.

[0033] The tissue separation assembly can be inserted between tissue masses inside a living body by placing, with a tube attached to the spacer, the spacer into the interface between the tissue masses. The delivery system has sensors or electrodes that allow sensor-guided, image-guided, or impedance-guided placement of the dilator and inflatable spacer. The orientation of the inserted tissue separation assembly can be adjusted based on the sensor feedback to position the inflatable spacer at a desired position and location. Once the inflatable spacer is in the correct position, the spacer is inflated to separate the tissue masses. The tube can be withdrawn from the living body after sealing the spacer, leaving the inflatable spacer in place.

[0034] The sensors of the delivery system can help prevent the tip of the dilator assembly from getting too close to undesired anatomical location or organs. In some embodiment, such verification is done by comparing the detected location of the tip to the patient anatomy, which can be measured before and during the delivery procedure.

[0035] In some aspects, the sensors measure parameters at the tip of the dilator assembly. Such parameters include tip pressure, tip impedance, tip temperature, or tip movement. Such parameters can be used to avoid damaging tissue, redirect the trajectory of the dilator assembly, or verifying that the tissue in contact with the tip is not infected or is necrotic. In some aspects, sensing of internal body parameters is used for a specific patient population, such as patients that undergo full or partial removal of internal organs (e.g., prostate and bowls) or patients that suffer from urinary tract disfunction. In some aspects, the delivery system minimizes or prevents adverse events like organ penetration / perforation, blood vessels penetration, and nerve damage. The sensing information can also be used for verifying that the introduction trajectory is according to the planned trajectory.

[0036] The terms ‘distal’ and ‘proximal’ as used throughout this disclosure and in the claims appended thereto are to be understood according to their accepted usage, wherein the ‘distal’ direction is the direction further into a patient’s body and away from a user, e.g., a medical practitioner using the device, while the proximal direction indicates the opposite direction. Distaland proximal directions are shown for clarity in FIG. 1, with distal being to the left of the page, and proximal being to right of the page.

[0037] FIG. 1 shows a medical assembly 10 (e.g., a medical dilator assembly or delivery system) for placement of an inflatable spacer 104 within a living body. The medical assembly 10 includes a dilator assembly 12 and a tissue separation assembly 100. The dilator assembly 12 includes a dilator sheath 122 and a dilator 102 (e.g., a dilator core 102). The dilator sheath 122 has an open end 123. The dilator core 102 has an elongated body 105 with a distal side 118 (e.g., distal end 118) and a proximal side 120 (e.g., proximal end 120). The dilator core 102 has a tapered end 103 at its distal end and a handle 107 at its proximal end 120.

[0038] Referring also to FIG. 2, when the dilator core 102 is assembled with the dilator sheath 122, the elongated body 105 is at least partially inside the dilator sheath 122 with the distal end 118 of the dilator core 102 extending through the open end 123 of the dilator sheath 122. The elongated body 105 can be cylindrical in shape to fit tightly within the tubular lumen 124 of the dilator sheath 122. As further described in detail below with respect to FIGS. 3-4, the dilator core 102 can be partially inserted, together with the dilator sheath 122, into a tissue space inside a living body to facilitate the placement of the inflatable spacer 104 inside the body. For example, the core 102 can be removed from the sheath 122 to leave the sheath 122 inside the living body, allowing the inflatable spacer 104 to be introduced through the lumen 124 and the open end 123 of the sheath 122 into the living body.

[0039] The tissue separation assembly 100 includes a tube 116 (e.g., an introducer tube 116 or inflation lumen 116) and the inflatable spacer 104 (e.g., an inflatable balloon or bladder). The tube 116 is releasably attached and fluidly coupled with the inflatable spacer 104. The inflatable spacer 104 is designed to be inserted, with the dilator core 102 removed from the dilator sheath 122, into the living body through the open end 123 of the dilator sheath 122 to place the inflatable spacer 104 at an interface between tissue masses inside the living body. Once the inflatable spacer 104 is placed at the right location, the tube 116 directs fluid into the spacer 104 to inflate the spacer 104, and is then detached from the spacer 104, leaving the inflated spacer 104 inside the body.

[0040] As shown in FIG. 1, the dilator core 102 also has a sensor 109 communicatively coupled to a receiver 125 (or to a receiver of a group of receivers 125). The sensor 109 allows the dilator core 102 to be responsive to a condition inside the living body to allow sensor-guidedplacement of the dilator assembly 12 inside the body. The sensor 109 is responsive to the condition within the living body as the dilator core 102 resides within the dilator sheath 122 in its extended position (e.g., when the tapered end 103 is extending through the open end 123 of the sheath 122). The sensor 109 transmits sensor feedback to the receiver 125 during positioning of the distal end 118 of the dilator core 102 at a target location inside the living body to then facilitate placement of the inflatable spacer 104.

[0041] The tissue separation assembly 100 also includes a pressure sensor 106 coupled with the inflatable spacer 104. For example, the pressure sensor 106 is attached to a wall 108 of the inflatable spacer 104 or to a section of the tube 116 that resides inside the inflatable spacer 104. The receiver 125 (or another receiver) receives, from the pressure sensor 106 and during inflation or deflation of the inflatable spacer 104, sensor feedback. The sensor feedback allows a pressure inside the inflatable spacer 104 to be monitored and adjusted based on the sensor feedback. For example, once the pressure inside the spacer 104 meets a pressure threshold, the inflating of the spacer 104 is stopped. In some aspects, the pressure sensor 106 can be retrieved upon demand. For example, if the sensor is attached to the tube 116, once the tube is detached and retrieved from the spacer 104, the sensor 106 is also retrieved from the spacer 104.

[0042] If the sensor 106 is attached to the wall 108 of the inflatable spacer 104, the sensor 106 can be a strain sensor that measures the strain in the wall 108 of the inflatable spacer 104, which can then be used to determine the fluid pressure inside the inflatable spacer 104. In some aspects, the inflatable spacer 104 is transparent or translucent and the inflatable spacer has a sensor 142 used for body imaging. For example, the sensor 142 is an optical sensor (e.g., a camera) or an illumination source attached to the tube 116. The sensor 142 transmits sensor feedback to the receiver 125 to generate a visual representation 139 of a portion of the living body around the inflatable spacer 104. Thus, the positioning of the spacer 104 can be performed based on fluid pressure measurements as well as a visual representation of the interior of the body.

[0043] In some aspects, the receiver 125 is part of a computer system 126. The computer system 126 includes one or more processors and one or more computer-readable mediums storing instructions executable by the one or more processors to perform the operations described herein. The computer system 126 can include a monitor with an electronic screen 128. As further described in detail below with respect to FIG. 3, the computer system 126 can be implemented as a controller used to control a robot in or near real-time to perform the steps described herein. The controllertransmits signals to the robot to place the components of the medical assembly 10 inside the living body.

[0044] As used herein, the term “real-time” refers to transmitting or processing data without intentional delay given the processing limitations of a system, the time required to accurately obtain data, and the rate of change of the data. Although there may be some actual delays, the delays are generally imperceptible to a user.

[0045] Referring now to FIGS. 2 and 3, the sensors of the dilator assembly 12 allow the dilator assembly 102 to be placed inside a living body 114 based on sensor feedback. The sensor feedback is used to place the distal end 103 of the dilator core 102 at a target location 150 inside the living body 114. With the distal end 103 at the target location 150, the dilator core 102 is removed to allow the inflatable spacer (shown in FIG. 1) to be placed at an interface 141 between tissue masses.

[0046] In FIG. 3, the interface 141 is defined between a first tissue mass 110 and a second tissue mass 112. For example, the first tissue mass 110 is the soft tissue of a rectum 111 (e.g., rectal wall 111) and the second tissue mass 112 is the soft tissue of a prostate 113. The tissue masses 110, 112 reside in an anatomic target location 150 inside the body 114. As described in detail below with respect to FIGS. 6-7, the inflatable spacer 104 stays in the anatomic target location 150 in an inflated state, between the prostate 113 and the rectum 111. The dilator assembly 12 is inserted into the body 114 through a perineum 154 of the body 114. The exemplary use case illustrates features that are applicable to other examples of tissues and organs as discussed herein and are not limited to the prostate-rectum case.

[0047] The dilator core 102 has one or more sensors that are responsive to different conditions inside the living body 114. The sensors allow the distal end 103 of the dilator assembly 12 to be accurately placed at the target location 150 inside the living body 114. Referring briefly FIG. 2, the dilator core 102 can have one or more of the following sensors: a pressure sensor 127, a temperature sensor 129, an optical sensor 131, a light or illumination source 133, a pair of position / orientation sensors 119, 121, or a group of electrodes 115, 117. Each of the sensors 115, 117, 119, 121, 127, 129, 131, 133 can be attached to the same or different part of the dilator assembly 12. For example, each of the sensors can be attached to either the elongated body 105 of the dilator core 102, the tapered end 103 of the dilator core 102, the handle 107 of the dilator core 102, or to the dilator sheath 122. Moreover, each sensor can be connected (with a wire orwirelessly) to the same or a different receiver / computer to process the sensor feedback received from such sensor.

[0048] In some aspects, all of the sensors are attached to the tapered distal end 103 of the dilator core 102. One or more of the sensors resides at the tip 140 of the tapered end 103 of the dilator core 102. For example, the sensor 109 at the tip 140 can be an optical sensor, a pressure sensor, an illumination source, a pair of electrodes, or a combination of these. When the dilator core 102 is in its extended position (e.g., with its tapered end 103 extending though the open distal end of the sheath 122), the sensors in the tapered end 103 are responsive to a condition within the living body 114.

[0049] As shown in FIGS. 1 and 3, the dilator assembly 12 and tissue separation assembly 100 can be manually or automatically operated and inserted into the body based on the sensor feedback. For example, the computer system 126 can display in the electronic screen 128 the sensor feedback or information derived from the sensor feedback, and the medical practitioner operating the dilator assembly 12 and / or the tissue separation assembly 100 can change an orientation or position of the dilator assembly 12 and / or tissue separation assembly 100 based on what is displayed on the electronic screen 128. For example, if the pressure displayed is higher than a certain threshold, the medical practitioner can change the trajectory or orientation of the dilator assembly 12. Additionally, once the computer system 126 determines that the sensor feedback (e.g., pressure sensor feedback, temperature sensor feedback, optical sensor feedback, or electrode signals) satisfies a respective threshold, the computer can notify (e.g., provide alerts if the pressure values are out of an expected range) the medical practitioner so that the medical practitioner can know when to change the position or orientation of the dilator assembly 12 or the separation assembly 100.

[0050] As shown in FIG. 2, the dilator core 102 has a pressure sensor 127 and two electrodes 115, 117 at the tip 140. Alternatively, as shown in dashed lines, the two electrodes 115, 117 can reside away from the tip 140, farther from the tip 140 than the pressure sensor 127. The two electrodes 115, 117 are spaced from each other along a width “w” of the dilator core 102. For example, the electrodes 115, 117 reside along a common radial plane (e.g., a plan normal with respect to a longitudinal axis of the dilator core 102) but are separated from each other along the circumference of the tapered end 103.

[0051] In some aspects, the dilator assembly 12 has a first position and / or orientation sensor 121 and a second position and / or orientation sensor 119 that allow the processor to determine the position and / or orientation of the dilator assembly 12 within the living body. The first position and orientation sensor 121 can reside at the distal side 118 of the dilator assembly 12 and the second position and orientation sensor 119 can reside at the proximal side 120 of the dilator assembly 12. For example, the sensors 119, 121 can be attached to the dilator core 102, with the first position and orientation sensor 121 attached to the tapered end 103 and the second position and orientation sensor 119 attached to the handle 107. The two sensors 119, 121 transmit feedback to the receiver of the computer system which determines, based on the sensor feedback, a position and / or orientation of the dilator core 102 inside the living body. Thus, the dilator assembly 12 can be inserted along a predetermined path inside the living body based on the feedback from sensors 119, 121 to reach the target location without damaging an internal part of the body. For example, once the sensor feedback from sensors 119, 121 satisfy a threshold, the orientation of the dilator assembly 12 can be changed.

[0052] The pressure sensor 127 can reside at the tip 140 of the tapered end 103 and be responsive to axial pressure or radial pressure (or both) applied to the sensor 127. For example, the pressure sensor 127 can detect axial pressure when the sensor 127 is pushed against an organ. The sensor 127 can also sense radial pressure when the sensor 127 is sandwiched between two organs or otherwise bearing radially against a body component. The sensor 127 transmits sensor feedback (e.g., pressure information) to the computer system, which determines the pressure on the sensor. A practitioner can move, based on the sensor feedback, the dilator assembly 12 inside the living body to prevent damaging components inside the living body during placement of the dilator assembly 12. For example, to prevent damaging tissue, when the pressure is outside an expected range, the system provides an alert to notify the practitioner.

[0053] In some aspects, the pressure sensor is used to verify that the pressure is at an expected range at the location of the dilator tip. In some aspects, the pressure value generated by the pressure sensor can be used to identify the type of living body tissue that the dilator is entering into. For example, the pressure at the tip can be associated with a pressure experienced at the surface of a type of tissue to allow the system to determine the type of tissue.

[0054] As shown in FIGS. 3 and 4, the electrodes 115, 117 are arranged such that, when the tapered end 103 of the dilator core 102 is inside the living body 114, the two electrodes 115,117 contact tissue 152 (or another internal body component 152) at the same time. This allows the measurement of impedance (e.g., bioelectrical impedance) of the tissue 152 (or another component 152) in contact with the electrodes 115, 117. The two electrodes 115, 117 can be used to detect the impedance of any component inside the living body such as tissue (e.g., muscle, organs, nerves, etc.), fluids, fat, bone, blood vessels, etc. Alternatively, the delivery system can detect air, water, blood, or any injected material. With the impedance measurements, the type of body component can be determined to help guide the placement of the dilator assembly 12.

[0055] The electrodes 115, 117 and other sensor can be used in conjunction with other guiding techniques to place the dissector and spacer. For example, the dilator assembly 12 and / or spacer 104 are introduced using minimally invasive techniques (e.g., using a “key hole” introduction technique) through the perineum 154 using sensor feedback as well as transrectal ultrasound (TRUS) guidance. As shown in FIG. 4, the TRUS guidance can be accomplished using a transrectal ultrasound probe 156 to generate a visual representation such as an axial ultrasound view. In some aspects, the prostate 113 and surrounding tissues, as well as the space between rectum 111 and prostate 113, is visualized using other modalities such as X-ray imaging, magnetic resonance imaging (MRI), or computed tomography (CT).

[0056] The electrodes 115, 117 are communicatively coupled to the receiver 125 (shown in FIG. 1 ). The electrodes 115, 117 transmit, with the electrodes 115, 117 in contact with a body component 152, electrical information (e.g., a voltage) of the body component 152 to the receiver 125. The computer system then determines, based on the electrical information, an electrical impedance of the body component. The computer system (or the medical practitioner) then determines, based on the electrical impedance, a type of body component. For example, the computer system determines if the body component that is touching the electrodes 115, 117 is the prostate 113, the rectum 111, a fluid, etc. In some aspects, the computer can determine based on the electrical information that the tapered end of the dilator core 102 is touching two components or organs at the same time.

[0057] Thus, the dilator assembly 12 can serve as an “impedance probe.” The dilator core 102 applies a small AC current between the two electrodes. The receiver 125 then receives information (e.g., a current and / or voltage from the dilator core 102) generated from touching the body component 152 which is then transmitted to the computer system 126. The computer system 126 then derives the impedance from the measured voltage (e.g., voltage drop across the tissuebeing tested) and applied current. Then, since different components 152 have different impedances, the computer system 126 associates the impedance with the type of body component to determine what component 152 is in contact with the electrodes 115, 117.

[0058] Determining the type of body component can help prevent, based on the type of the body component, damaging the body component during placement of the dilator core 102 at the target location 150 of the living body 114. For example, a user (e.g., a medical practitioner) introducing the dilator assembly 12 into a living body is able to determine what type of tissue the tapered end 103 of the dilator core 102 is touching, which allows the user to know where the dilator core 102 is located and whether the dilator core 102 needs to be moved or redirected to avoid damaging tissue or organs. For example, as shown in FIG. 4, if the tapered end 103 of the dilator core 102 touches the rectal wall 111 or prostate 113, the user can change the direction of the dilator core 102 to avoid damaging the rectal wall 111 or prostate 113.

[0059] The optical sensor 131 can be attached to the tapered distal end 103 such as the tip 140 of the tapered distal end 103. The receiver 125 receives image information from the sensor 131 and the electronic screen 128 displays, as a function of the image information, a visual representation 139 (see FIG. 1) of an in-body anatomy 153 of the living body 114. The visual representation can be an image or video of the in-body anatomy 153 located in front of the tapered distal end 103, surrounding the tapered distal end 103, or both. The dilator core 102 can be positioned at the target location 150 based on the visual representation.

[0060] In some aspects, the dilator core 102 has light or illumination source 133 that transmits and receives light to and from an internal portion of the living body 114. The light source 133 sends information to the receiver from which the computer system perform spectroscopy as a function of the sensor feedback for spectroscopy-guided placement of the dilator core 102. For example, the dilator core 102 can have a light source 133 that shines into the body. The light interacts with different tissues and cells, which absorb or scatter it in unique ways. Each type of tissue can have a “signature” that helps identify it. The light source 133 also includes or serves as a detector (e.g., a camera) that picks up the light that comes back after interacting with the tissues. This could be light that has been changed in color or intensity. The computer system then analyses the light and light’s properties, which allows the computer system or the medical practitioner to determine what type of tissue is in front of or around the dilator assembly. The sensor feedback can also be used to determine the health of tissues, detect diseases, or even identify types of cells.

[0061] As shown in FIG. 3, the dilator assembly 12 can be introduced by a robot 130 (e.g., an autonomic delivery system). For example, a robot 130 can be connected to a controller 137 that receives instruction from the computer system 126 to move, when the sensor feedback satisfies a threshold, the dilator assembly 12 with respect to the living body 114. For example, inserting the portion of the dilator assembly 12 can be done automatically as a function of the sensor feedback, and inserting the inflatable spacer can be done automatically as a function of the sensor feedback. Such controller 137 can be implemented as processing circuitry, firmware, software, or combinations of them. The controller 137 can also be part of the computer system 126.

[0062] Thus, the system allows remote or autonomic guidance of the dilator assembly 12 and spacer 104 into the body cavity. For example, the sensor information can provide information to a remote operator or the autonomic delivery system about the location and orientation of the delivery system. In some aspects, such guided delivery system uses a preset trajectory path that is prepared before the delivery operation. In some aspects, the guided delivery system follows the preset trajectory or provides alerts if the delivery system trajectory deviates from the preset trajectory.

[0063] The transrectal ultrasound probe 156 can be deployed for guiding the procedure along with the multiple sensors. The probe 156 can be inserted into the rectum 111 of the body 114 before the tissue separation assembly is inserted into the body 114. In FIG. 4, the dilator assembly 12 has been inserted through an incision in the subject’s perineum 154 until the distal tip of the dilator core 102 reaches or is nearby the interface between the rectal wall and the prostate 113. The transrectal ultrasound probe 156 can help verify that the sensor feedback is accurate or vise-versa.

[0064] As shown in FIGS. 4 and 5, once the tapered end 103 is at the distal end of the target location 150, the dilator core 102 is removed from the dilator sheath 122. As sown, during removal, the dilator core 102 moves (is pulled out) with respect to the sheath 122 while the sheath 122 remains in place. In the example shown in FIG. 4, the target location 150 is at the distal end of the interface 141 (or past the interface) between the rectum 111 (e.g., rectal wall 111) and the prostate 113. In some aspects, the target location is near the interface 141, such as past the prostate 113 or before the prostate 113.

[0065] As shown in FIG. 6, with the dilator core 102 removed, the spacer 104 is introduced through the open distal end of the dilator sheath 122 to place the inflatable spacer 104 at theinterface between tissue masses inside the living body. In some aspects, the dilator core has a lumen and the inflatable spacer 104 can be inserted through the lumen of the dilator core without removing the dilator core from the dilator sheath 122. In some aspects, the inflatable spacer 104 can be collapsed to a miniature size, and then deployed by expanding or spreading the device in a highly controllable fashion in specific sizes and directions, thereby avoiding harm to adjacent organs and tissues, while performing the dissection or separation of tissue. Moreover, the inflatable spacer 104 can be inserted into the body 114 in a deflated or partially deflated state. For example, the inflatable spacer 104 can be rolled up, folded, bended, or otherwise deflated before the inflatable spacer 104 is deployed into the body 114. In some aspects, the spacer 104 can be deployed in an inflated state.

[0066] As shown in FIGS. 7 and 8, once the inflatable spacer 104 is at a desired location (e.g., at the interface), the dilator sheath 122 is pulled back to leave the inflatable spacer 104 between the tissue masses. For example, the dilator sheath 122 is withdrawn (pulled back) while maintaining the inflatable spacer 104 and tube 116 in place so that the inflatable spacer 104 is maintained between the prostate 113 and the rectum wall 111. Alternatively, the tube 116 is advanced (e.g., distally advanced) out of the dilator sheath 122 and the sheath 122 is withdrawn.

[0067] As shown in FIG. 8, with the spacer 104 outside the dilator sheath 122, fluid is flowed into the inflatable spacer 104 to inflate the spacer 104. The fluid can be, for example, a saline solution or carbon dioxide gas. The fluid can be flowed directly through the tube 116 (e.g., inflation lumen 116) or a syringe (e.g., a saline syringe) introduced through the interior of the tube 116 to inject fluid into the inflatable spacer 104. The inflatable spacer 104 can be made of a biodegradable material, such as biodegradable polymers. In some aspects, the inflatable spacer 104 is designed to remain inflated on site for weeks or months and fade away or dissolve within a number of weeks or months.

[0068] The inflatable spacer 104 protects the tissues from radiation, mechanical stress, or other potential harms. In some aspects, the inflatable spacer 104 protects the normal tissues by increasing the gap between a radiation source and critical structures. The radiation can fade away while passing through the inflated spacer 104, creating a barrier that protects tissue from harmful radiation. Biodegradable inflatable balloons can also be used to isolate tissue for other purposes, such as to protect tissue from mechanical, thermal, chemical, or electrical stresses.

[0069] In some aspects, to orient the inflatable spacer 104, the inflatable spacer 104 can be deflated (or partially deflated) inside the human body during the placement procedure. For example, as shown in FIG. 8, if the practitioner placing the inflatable spacer 104 can determine, based on the sensor feedback, that the inflated spacer 104 is in an incorrect position. Upon such determination, the practitioner can partially or full deflate the inflatable spacer 104 to allow repositioning of the inflatable spacer 104.

[0070] As shown in FIG. 8, the delivery system can also include one or more pressure sensors disposed inside an adjacent organ to control the pressure of the spacer 104 based on a pressure applied to such an organ. For example, the transrectal ultrasound probe 156 can include a pressure sensor 160 that senses the pressure applied to the rectum 111 during inflation of the spacer 104. Additionally, a catheter 164 inserted through a urinary tract 170 of the living body can have a pressure sensor 166 that senses the pressure applied to the urinary tract 170 during inflation of the spacer 104.

[0071] The pressure sensors 160, 166 are connected to the receiver to allow the computer system to determine the pressure applied to the respective organs by the spacer 104. In some aspects, the ultrasound sensor 160 is attached to and / or disposed inside an inflatable balloon 162 such as an inflatable ring disposed around the transrectal ultrasound probe 156. The ultrasound sensor 160 senses the pressure inside the inflatable balloon 162. Similarly, the catheter sensor 166 can be attached to and / or disposed inside an inflatable balloon 168 attached to the catheter 164. The catheter sensor 166 senses the pressure inside the inflatable balloon 168.

[0072] Thus, the ultrasound pressure sensor 160 can help measure the pressure inside a specific region of the rectum during spacer inflation. In some aspects, the ultrasound sensor is used to view the delivery system and the sensor deployment. The catheter sensor 166 is located near the prostate 113 to sense the pressure applied to the prostate 113. In some aspects, the use of a urinary tract sensor 166 is used in selected patients that suffer from poor urinary flow, for narrowing of the urinary tract 170, or for patients that undergo prostate treatment / resection. Moreover, the pressure sensor in the spacer 104 as well as the pressure sensors 160, 166 in the organs can be used together to help guide the inflation and placement of the spacer 104.

[0073] FIG. 9 shows a flow chart of an example method 900 of placing an inflatable spacer inside a living body. The method 900 include inserting a portion of a dilator assembly into a tissue space inside a living body (905). The dilator assembly includes a dilator sheath having an opendistal end, a dilator core, and a sensor attached to the dilator core. The inserting includes inserting the dilator assembly into the tissue space to position, based on the sensor feedback, the tapered distal end of the dilator core at a target location inside the living body. The method also includes removing, with the dilator sheath positioned at the target location, the dilator core from the dilator sheath (910). The method also includes inserting, with the dilator core removed from the dilator sheath, an inflatable spacer into the living body through the open distal end of the dilator sheath, thereby placing the inflatable spacer at an interface between tissue masses inside the living body (915). The method also includes, while leaving the inflatable spacer at the interface, removing the dilator sheath from the living body (920).

[0074] FIG. 10 is a schematic illustration of an example control system or controller for a delivery system according to the present disclosure. For example, the controller 1000 may include or be part of the controller 137 shown in FIG. 3 or may include or be part of the computer system 126 shown in FIG. 1. The controller 1000 is intended to include various forms of digital computers, such as printed circuit boards (PCB), processors, digital circuitry, or otherwise. Additionally, the system can include portable storage media, such as, Universal Serial Bus (USB) flash drives. For example, the USB flash drives may store operating systems and other applications. The USB flash drives can include input / output components, such as a wireless transmitter or USB connector that may be inserted into a USB port of another computing device.

[0075] The controller 1000 includes a processor 1010, a memory 1020, a storage device 1030, and an input / output device 1040. Each of the components 1010, 1020, 1030, and 1040 are interconnected using a system bus 1050. The processor 1010 is capable of processing instructions for execution within the controller 1000. The processor may be designed using any of a number of architectures. For example, the processor 1010 may be a CISC (Complex Instruction Set Computers) processor, a RISC (Reduced Instruction Set Computer) processor, or a MISC (Minimal Instruction Set Computer) processor.

[0076] In one implementation, the processor 1010 is a single-threaded processor. In another implementation, the processor 1010 is a multi-threaded processor. The processor 1010 is capable of processing instructions stored in the memory 1020 or on the storage device 1030 to display graphical information for a user interface on the input / output device 1040.

[0077] The memory 1020 stores information within the controller 1000. In one implementation, the memory 1020 is a computer-readable medium. In one implementation, thememory 1020 is a volatile memory unit. In another implementation, the memory 1020 is a nonvolatile memory unit.

[0078] The storage device 1030 is capable of providing mass storage for the controller 1000. In one implementation, the storage device 1030 is a computer-readable medium. In various different implementations, the storage device 1030 may be a floppy disk device, a hard disk device, an optical disk device, or a tape device.

[0079] The input / output device 1040 provides input / output operations for the controller 1000. In one implementation, the input / output device 1040 includes a keyboard and / or pointing device. In another implementation, the input / output device 1040 includes a display unit for displaying graphical user interfaces.

[0080] While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any inventions or of what may be claimed, but rather as descriptions of features specific to particular implementations of particular inventions. Certain features that are described in this specification in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

[0081] Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous.

[0082] A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the disclosure. For example, example operations, methods, or processes described herein may include more steps or fewer steps than those described. Further, the steps in such example operations, methods, or processes may be performed in different successions than that describedor illustrated in the figures. Accordingly, other implementations are within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. A method of placing an inflatable spacer inside a living body, the method comprising: inserting a portion of a dilator assembly into a tissue space inside a living body, the dilator assembly comprising:a dilator sheath having an open distal end,a dilator core movable with respect to the dilator sheath and having a tapered distal end extending through the open distal end of the dilator sheath with the dilator core in an extended position, anda sensor attached to the dilator core, the sensor communicatively coupled to a receiver and responsive to a condition within the living body with the dilator core in its extended position, the sensor configured to transmit sensor feedback to the receiver during positioning of the dilator assembly inside the living body, wherein the inserting comprises inserting the dilator assembly into the tissue space to position, based on the sensor feedback, the tapered distal end of the dilator core at a target location inside the living body;removing, with the dilator sheath positioned at the target location, the dilator core from the dilator sheath;inserting, with the dilator core removed from the dilator sheath, a spacer into the living body through the open distal end of the dilator sheath, thereby placing the spacer at an interface between tissue masses inside the living body; and thenwhile leaving the spacer at the interface, removing the dilator sheath from the living body.

2. The method of claim 1, wherein the dilator core comprises two or more electrodes attached to the tapered distal end of the dilator core to detect an impedance of body components as each body component contacts the two or more electrodes, and inserting the portion of the dilator assembly comprises moving, based on the impedance of each body component, the dilator core to the target location while avoiding damaging the body components during placement of the dilator core.

3. The method of claim 1, further comprising imaging, using the sensor, an internal portion of the body to generate a visual representation of the internal portion of the living body, and inserting the portion of the dilator assembly comprises positioning, based on the visual representation, the dilator core at the target location.

4. The method of claim 1, wherein the sensor resides at a tip of the distal end and comprises at least one of an optical sensor, a temperature sensor, or a pressure sensor, the optical sensor configured to transmit image information to the receiver, the temperature sensor configured to transmit temperature information to the receiver, and the pressure sensor configured to transmit pressure information to the receiver, and inserting the portion of the dilator assembly comprises moving, based on at least one of the image information, temperature information, or pressure information, the dilator core to the target location.

5. The method of claim 4, wherein the sensor comprises a pressure sensor, the pressure sensor responsive to at least one of axial pressure or radial pressure against the sensor as the dilator core moves inside the living body, and inserting the portion of the dilator assembly comprises determining the pressure at the tip during the insertion of the dilator assembly to verify that the pressure is at an expected range at a location of the dilator tip.

6. The method of claim 1, wherein the spacer comprises an inflatable spacer comprising a pressure sensor coupled with the inflatable spacer, the pressure sensor communicatively coupled with and arranged to transmit second sensor feedback to the receiver, the method further comprising, after inserting the inflatable spacer, inflating, based on the second sensor feedback, the inflatable spacer at the interface between the tissue masses inside the living body.

7. The method of claim 6, further comprising:positioning a second pressure sensor inside an organ adjacent the interface between the tissue masses, the second pressure sensor communicatively coupled with and arranged to transmit third sensor feedback to the receiver to determine a pressure applied to the organ by the inflatable spacer; andinflating, based on the second and third sensor feedback, the inflatable spacer.

8. The method of claim 7, wherein the interface comprises an interface between a prostate of the living body and a rectum of the living body, and the second pressure sensor is attached to at least one of (i) a transrectal ultrasound probe disposed inside the rectum or (ii) a catheter disposed inside a urinary tract of the living body adjacent the prostate.

9. The method of claim 1, wherein the spacer comprises a transparent or translucent inflatable spacer and the inflatable spacer comprises an optical sensor attached to a tube fluidly coupled with the inflatable spacer, the optical sensor communicatively coupled with and arranged to transmit third sensor feedback to the receiver to generate a visual representation of a portion of the living body around the inflatable spacer, the method further comprising positioning, based on the visual representation, the inflatable spacer at the interface.

10. The method of claim 1, wherein inserting the portion of the dilator assembly comprises automatically inserting, as a function of the sensor feedback, the portion of the dilator assembly into the living body, and inserting the spacer comprises automatically inserting, as a function of the sensor feedback, the spacer, positioning the spacer at the interface between the tissue masses inside the living body.

11. The method of claim 1, wherein the sensor comprises an optical sensor attached to the tapered distal end, and the receiver comprises an electronic screen configured to display, as a function of the sensor feedback, a visual representation of an in-body anatomy of the living body, and inserting the dilator assembly comprises inserting, based on the visual representation, the dilator assembly to position the dilator assembly at the target location.

12. The method of claim 1, wherein the sensor comprises an optical sensor comprising a light source, and the optical sensor is arranged to transmit light to the living body and receive light from the living body, and the receiver comprises a processor configured to perform spectroscopy as a function of the sensor feedback, and inserting the dilator assembly comprises performing a spectroscopy-guided placement of the dilator assembly to position the dilator assembly at the target location.

13. A medical dilator assembly for placement of a spacer within a living body, the medical dilator assembly comprising:a dilator sheath having an open end;a dilator core comprising an elongated body with a distal end, the elongated body disposed at least partially within the dilator sheath with the distal end extending through the open end of the dilator sheath, the dilator core arranged to be partially inserted, together with the dilator sheath, into a tissue space inside a living body and then removed from the living body leaving the dilator sheath; anda spacer arranged to be inserted, with the dilator core removed from the dilator sheath, into the living body through the open end of the dilator sheath to place the spacer at an interface between tissue masses inside the living body;wherein the dilator core further comprises a sensor communicatively coupled to a receiver and responsive to a condition within the living body with the dilator core disposed within the dilator sheath, the sensor configured to transmit sensor feedback to the receiver during positioning of the distal end of the dilator core at a target location inside the living body to facilitate placement of the spacer.

14. The medical dilator assembly of claim 13, wherein the dilator core comprises two or more electrodes attached to the distal end of the dilator core and communicatively coupled to the receiver or a second receiver, each of the two or more electrodes spaced from each other along a width of the dilator core and configured to transmit, with the two or more electrodes in contact with a body component inside the living body, electrical information of the body component to the receiver or second receiver to determine, based on an electrical impedance of the body component, a type of the body component to prevent, based on the type of the body component, damaging the body component during placement of the dilator core at the target location inside the living body.

15. The medical dilator assembly of claim 13, further comprising:a pressure sensor coupled with the spacer, the spacer comprising an inflatable spacer; anda tube releasably coupled with the inflatable spacer, the tube arranged to direct a fluid into the inflatable spacer to inflate the inflatable spacer at the interface between the tissue masses,wherein the receiver or a second receiver is arranged to receive, from the pressure sensor during inflation or deflation of the inflatable spacer between the tissue masses, second sensor feedback, allowing a pressure inside the inflatable spacer to be adjusted based on the sensor feedback.

16. The medical dilator assembly of claim 15, wherein spacer comprises an inflatable spacer comprising at least one of a pressure sensor or a strain sensor, the pressure sensor attached to at least one of i) the tube inside the inflatable spacer or ii) a wall of the inflatable spacer, and the strain sensor is attached to the wall of the inflatable spacer to sense a strain in the wall of the inflatable spacer.

17. The medical dilator assembly of claim 13, wherein the sensor comprises an optical sensor attached to the distal end of the dilator core, and the receiver comprises an electronic screen configured to display, as a function of the sensor feedback, a visual representation of an in-body anatomy of the living body, the dilator core arranged to be positioned at the target location based on the visual representation.

18. The medical dilator assembly of claim 17, wherein the distal end comprises a tapered distal end and the optical sensor resides at a tip of the tapered distal end, and the visual representation comprises an image or video of the in-body anatomy located in at least one of (i) a location in front of the tapered distal end, or (ii) a location surrounding the tapered distal end.

19. The medical dilator assembly of claim 17, wherein the optical sensor comprises a light source, and the optical sensor is arranged to transmit light to an internal portion of the living body and receive light from the internal portion, and the receiver comprises a processor configured to perform spectroscopy as a function of the sensor feedback for spectroscopy-guided placement of the dilator core.

20. The medical dilator assembly of claim 13, wherein the sensor comprises a first position and orientation sensor, and the dilator core comprises a second position and orientation sensor attached to the dilator core and residing away from the first position and orientation sensor, the first and second position and orientation sensors configured to transmit feedback to the receiver to allow determining, based on the sensor feedback, at least one of a position or orientation of the dilator core inside the living body.

21. The medical dilator assembly of claim 20, wherein the first and second position and orientation sensors are configured to transmit feedback to the receiver to allow moving, based on the sensor feedback, the dilator core and dilator sheath along a predetermined path to the target location.

22. The medical dilator assembly of claim 13, wherein the sensor resides at a tip of the distal end and comprises at least one of an optical sensor, a temperature sensor, or a pressure sensor, the dilator core further comprising two or more electrodes at the distal end, the two or more electrodes arranged to transmit, with the two or more electrodes in contact with a body component inside the living body, electrical information of the body component to the receiver or a second receiver to determine, as a function of a determined bioelectrical impedance of the body component, a type of the body component to guide, along with the sensor, the placement of the dilator core at the target location inside the living body.

23. The medical dilator assembly of claim 13, further comprising imaging, using the sensor, an internal portion of the living body to generate a visual representation of the internal portion of the living body to position, based on the visual representation, the dilator core at the target location.

24. The medical dilator assembly of claim 13, wherein the sensor comprises a pressure sensor residing at a tip of the distal end, the pressure sensor responsive to at least one of axial pressure or radial pressure against the sensor as the dilator core moves inside the living body to prevent, based on the sensor feedback, damaging components inside the living body during placement of the dilator core at the target location.

25. The medical dilator assembly of claim 13, further comprising a pressure sensor positioned inside an organ adjacent the interface between the tissue masses, the pressure sensor communicatively coupled with and arranged to transmit second sensor feedback to the receiver to determine a pressure applied to the organ by the spacer to inflate, based on the second sensor feedback, the spacer,26. The medical dilator assembly of claim 25, wherein the interface comprises an interface between a prostate of the living body and a rectum of the living body, and the pressure sensor is attached to at least one of (i) a transrectal ultrasound probe disposed inside the rectum or ( ii ) a catheter disposed inside a urinary tract of the living body adjacent the prostate.

27. The medical dilator assembly of claim 13, wherein the spacer comprises a transparent or translucent inflatable spacer and the inflatable spacer comprises an optical sensor attached to a tube fluidly coupled with the inflatable spacer, the optical sensor communicatively coupled with and arranged to transmit second sensor feedback to the receiver to generate a visual representation of a portion of the living body around the inflatable spacer to position, based on the visual representation, the inflatable spacer at the interface.

Images