WO2025194068A1

WO2025194068A1 - Automated indeflator for medical balloon device with pre-loaded compliance data and/or feedback control

Info

Publication number: WO2025194068A1
Application number: PCT/US2025/019980
Authority: WO
Inventors: Sabrina Hua; James K. DELAHUNTY; Suzon HENRY; Carlos H. LIMA
Original assignee: Medtronic Vascular Inc
Current assignee: Medtronic Vascular Inc
Priority date: 2024-03-15
Filing date: 2025-03-14
Publication date: 2025-09-18
Anticipated expiration: 2026-09-15

Abstract

An automated indeflator (12) for a medical balloon device (14) (e.g., medical balloon and/or stent received on the balloon) includes pre-loaded compliance data related to a specific medical balloon product. The compliance data relates balloon diameter to inflation pressure. Operational parameters of the indeflator are based, at least in part, on the compliance data of the selected medical balloon product. A closed-loop feedback system controls an operation of the indeflator by monitoring apposition of the balloon device against a wall of a body lumen.

Description

AUTOMATED INDEFLATOR FOR MEDICAL BALLOON DEVICE WITH PRE-LOADED COMPLIANCE DATA AND/OR FEEDBACK CONTROL FIELD

[0001] The present technology is generally related to an automated indeflator for a medical balloon device with pre-loaded compliance data for operating the indeflator and/or a closed-loop feedback control system with apposition monitoring.

BACKGROUND

[0002] An indeflator is a device that controls the inflation and deflation of medical balloons used in procedures such as angioplasty, stent placement, or balloon dilation. These balloons and stents are commonly used to open up narrowed or blocked blood vessels, for example.

[0003] With respect to angioplasty procedures, an indeflator is connected to a balloon catheter, which is positioned at the site of a lesion or narrowing in the blood vessel. The clinician operates the indeflator to deliver a controlled amount of inflation fluid (such as saline or contrast dye) into the balloon. This inflation expands the balloon, which compresses the plaque or blockage against the vessel wall and opens the vessel lumen. The indeflator often includes pressure monitoring capabilities, allowing the clinician to monitor the pressure within the balloon during inflation. This helps ensure that the balloon is inflated to the appropriate pressure level, avoiding over-inflation, which could lead to vessel injury or rupture, and under-inflation, which could lead to ineffective treatment. [0004] Typically, a stent is also placed at the lesion during the angioplasty procedure. In such cases, a stent is received over the deflated balloon and delivered to the lesion site, whereupon the clinician inflates the balloon to expand and deploy the stent. The balloon is inflated to a selected pressure to ensure that the balloon expands sufficiently to achieve suitable or optimal apposition against the vessel wall. Poor apposition, where the stent does not fully expand or does not make proper contact with the vessel wall, can lead to several complications, such as residual stenosis, stent thrombosis, restenosis, and/or tears in the vessel wall at the edges of the stent. The balloon pressure chosen by the clinician may be determined based on factors such as the size and ty pe of the stent, the diameter of the target vessel, and the presence of calcified lesions or other challenging anatomical features. SUMMARY

[0005] The techniques of this disclosure generally relate to automated operation of inflating a medical balloon device using an indeflator that is pre-loaded with compliance data for the balloon and/or uses a closed-loop feedback control system with apposition monitoring.

[0006] In one aspect, the present disclosure provides an indeflator for a medical device having an inflatable balloon device for treating a body lumen. The indeflator comprises a fluid mover configured to deliver pressurized inflation fluid to the balloon device. A control system is configured to operate the fluid mover. The control system includes a processor and memory- including operating instructions accessible by the processor for operating the indeflator to treat the body lumen using the balloon device. The memory' further includes a compliance database accessible by the processor. The compliance database stores compliance data for each of a plurality of medical device products that include a balloon device. The compliance data for each medical device product relates inflation pressure to balloon device diameter. The operating instructions include querying instructions which when executed by the processor cause the processor to query the compliance database and retrieve, for a selected one of the plurality of medical device products, an inflation pressure based on an inputted inflated balloon device diameter. The operating instructions include actuating instructions which when executed by the processor cause the processor to operate the indeflator using the retrieved inflation pressure as an operating parameter.

[0007] In another aspect, the disclosure provides a medical device system comprising a medical device including an inflatable balloon device sized and shaped to be received in a body lumen of a subject. An indeflator includes a fluid mover configured to be in fluid communication with the inflatable balloon. The indeflator is operational to inflate the medical balloon device when the medical balloon device is received in the body lumen such that the inflatable balloon device is in apposition against a wall of the body lumen. A closed-loop feedback system includes at least one apposition sensor configured to monitor, in real-time, apposition of the medical balloon device against the wall of the body lumen, and a feedback processor configured to analyze generated real-time apposition data from the at least apposition sensor and perform a feedback operation, using the indeflator, based on the analyzed real-time apposition data. [0008] In yet another aspect, the disclosure provides a closed-loop feedback system for a medical device system that includes a balloon device configured to be received in a body lumen, and an indeflator operable to inflate the balloon device in the body lumen. The closed-loop feedback system comprises: at least one apposition sensor configured to monitor, in real-time, apposition of the medical balloon device against a wall of the body lumen; and a feedback processor configured to analyze generated real-time apposition data from the at least apposition sensor and perform a feedback operation, using the indeflator, based on the analyzed real-time apposition data.

[0009] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

[0010] FIG. 1 is a perspective of a medical device system including an indeflator and a medical balloon device received in a blood vessel, including views of the balloon device inflated to deploy a stent and removed from the blood vessel with the stent remaining in the blood vessel.

[0011] FIG. 2 is an enlarged elevational view of the medical balloon device inflated in the blood vessel to deploy the stent, as shown in FIG. 1.

[0012] FIG. 3 is an enlarged elevational view of the medical balloon device removed from the blood vessel with the stent remaining in the blood vessel, as shown in FIG. 1. [0013] FIG. 4 is a schematic diagram of the medical device system.

[0014] FIG. 5 is another schematic diagram of the medical device system.

[0015] FIG. 6 is a graph illustrating an exemplary operating protocol of the control system, whereby the indeflator is operated by cycling through periods of pressure for full inflation, dwell time, and full deflation.

[0016] FIG. 7 is a graph illustrating an exemplary operating protocol of the control system, whereby the indeflator is operated by cycling through periods of pressures of partial inflation and dwell time, wherein subsequent periods increase the pressure of partial inflation a pre-determined amount until a period that includes pressure for full inflation. [0017] FIG. 8 is a graph illustrating an exemplary operating protocol of the control system, whereby the indeflator is operated by cycling through periods of pressure of partial inflation, partial deflation, pressure of full inflation, and full deflation.

[0018] FIG. 9 is a schematic diagram of the medical device system including a closed- loop feedback system.

[0019] FIG. 10 is a schematic diagram of the closed-loop feedback system.

[0020] FIG. 11 is a schematic diagram of another embodiment of medical device system.

DETAILED DESCRIPTION

[0021] The present description is generally directed to an automated indeflator for a medical device system including a medical balloon device. The medical balloon device may be a balloon or a balloon in combination with a stent, where the stent is received on the balloon. The disclosed embodiments may be used in combination with one another, as explained in more detail below, or may be separate, independent embodiments.

[0022] In a disclosed embodiment, the automated indeflator may include a preloaded database including balloon compliance data for different products. The automated indeflator is automatically operated using this compliance data and input from a clinician including, for example, one or more of a selected inflated balloon diameter, a selected inflation time, selected dwell time, a selected deflation time, or a selected number of inflation/deflation cycles.

[0023] In another disclosed embodiment, the indeflator may include a closed-loop feedback control that monitors, in real-time, apposition of the balloon and/or a stent of the balloon device against a lumen wall at a treatment site. In one example, one or more sensors at the treatment site monitor one or more parameters that correlate to the apposition of the balloon and/or stent at the treatment site. The closed-loop feedback control system performs a feedback operation based on feedback data from the one or more sensors. The feedback operation may include, for example, adjusting one or more operating parameters of the indeflator for the purpose of enhancing proper apposition of the balloon and/or stent at the treatment site, or communicating a state of apposition of the balloon and/or stent to the clinician. [0024] Referring to FIG. 1, a medical device system is generally indicated at reference numeral 10. The medical device system includes an indeflator, generally indicated at 12, and a medical device, generally indicated at 14, couplable to and in fluid communication with the indeflator. As explained in detail below, the balloon medical device 14 includes an inflatable balloon 16 configured to be delivered to a treatment site in a body lumen BL (e.g., blood vessel, such as an artery), as shown in FIG. 1. As shown in FIG. 2, the balloon 16 is subsequently inflated by the indeflator 12 at the treatment site. As an example, the balloon 16 may be coupled to a distal end portion of catheter body 18 to form a balloon catheter. The catheter body 18 is sized and shaped to track through the body lumen to deliver the balloon 16 to the treatment site (e g., lesion L). An inflation lumen (not shown) extending along the catheter body 18 enables inflation fluid (e.g., saline) from the indeflator 12 to be delivered to and withdrawn from the balloon to inflate and deflate the balloon, respectively.

[0025] In one example, the medical device may be configured as an angioplasty catheter for plain old balloon angioplasty (POBA). In another example, as illustrated in FIGS. 1-3, the medical device may be configured as a stent delivery catheter in which a stent 20 (e.g., coronary stent) or other expandable structure is received over the balloon 16 and expandable upon inflation of the balloon to deploy the stent at the treatment site (e.g., coronary artery), as shown in FIG. 2. In this embodiment, the balloon device includes both the balloon 16 and the stent 20. The medical device may be configured for other types of medical treatments or therapies involving other types of body lumens.

[0026] The indeflator 12 includes a control system 30 including a processor 32 and memon 34 accessible by the processor. The processor 32 may include multiple processors, a multi -threaded processor, a multi-core processor, and/or a multi -processor architecture. In some examples, the processor 32 may be an application specific integrated circuit (ASIC) or a field programmable integrated circuit (FPGA). In some implementations, the processor 32 may be circuitry arranged to perform particular computations, such as, related to artificial intelligence (Al), graphics and machine learning. The processor 32 can include multiple processors, such as, for example, a central processing unit (CPU) and a graphics processing unit (GPU).

[0027] The memory 34 includes (i.e.. stores) processor-readable instructions to be executed by the processor 32 as well as data elements used in the execution of those instructions. The memory 34 may include both volatile and nonvolatile memory⁷, which are both examples of tangible media configured to store processor readable data and instructions to implement various embodiments of the processes described herein. Other types of tangible media include removable memory (e.g., pluggable USB memory devices, mobile device SIM cards), optical storage media such as CD-ROMS, DVDs, semiconductor memories such as flash memories, non-transitory read-only -memories (ROMS), dynamic random access memory⁷ (DRAM), NAND memory⁷, NOR memory⁷, phase-change memory⁷, battery-backed volatile memories, networked storage devices, and the like. The memory 34 may include a number of memories including a main random access memory (RAM) for storage of instructions and data during program execution and a read only memory⁷ (ROM) in which read-only non-transitory⁷ instructions are stored. The memory 34 may include a file storage subsystem providing persistent (non-volatile) storage for program and data files. The memory 34 may further include removable storage systems, such as removable flash memory.

[0028] The indeflator 12 further includes a fluid mover 38, such as a syringe, pump or other fluid mover, suitable for delivering pressurized inflation fluid to the balloon 16. An actuator 40, such as a stepper motor or other actuator, is operatively coupled to the fluid mover 38 and configured to actuate the fluid mover to inflate/deflate the balloon 16. The control system 30 is in communication with actuator 40 for selective operation thereof. The illustrated indeflator 12 also includes a pressure sensor 44 in communication with the fluid mover 38 for monitoring fluid pressure correlating to fluid pressure within the balloon 16. The control system 30, the fluid mover 38. the actuator 40, and the pressure sensor 44 may be received in or otherw ise coupled to an indeflator housing 46. The indeflator 12 also includes a medical device connector 48 including fluid tubing fluidly connecting the fluid mover 38 to the balloon medical device 14. A user interface (e.g., touchscreen 50 and/or scanner 52) of the indeflator 12 enables a clinician to communicate with the control system 30, which is explained in more detail below. The illustrated embodiment may also include a remote user interface (e.g., smart mobile device 54) that is in wireless communication with the control system 30.

[0029] The control system 30 of the indeflator 12 includes pre-loaded compliance data relating to selected medical device products including a balloon device that can be inflated/deflated by the indeflator 12. In one example, a database 58 is stored in the memory and accessible by the processor. The database 58 may be a relational database relating selected medical device products to inflation pressure and stent/balloon diameter (i.e., compliance data). In one example, each medical device may have its own relational database, relating inflation pressure to stent/balloon diameter. The database may be updated remotely to add additional medical device products or by the user. Via the user interface (e.g., touchscreen 50, scanner 52, and/or remote smart device 54), a clinician may select a medical device product from a plurality' of stored medical device products by selecting the medical device product from a stored list via the user interface, inputting a medical device product name, code or SKU, and/or scanning a code (e.g., bar code. QR code, etc.) associated with the medical device 14. This selected medical device product is saved in the memory 34 and accessible by the processor 32 to select the appropriate compliance database.

[0030] In one embodiment, in addition to selecting/inputting the medical device for treatment, additional operating parameters may be selected by the clinician. For example, using the user interface (e.g., touchscreen 50 and/or smart device 54), the clinician may input a selected inflated diameter of the balloon device (e.g., balloon 16 or balloon in combination with stent 20) during the procedure. The selected inflated diameter may be based on angiography obtained before, during, and/or after the procedure, or on other information or knowledge. In one example, the processor 32 may use structured query language (SQL) to query' the selected compliance database 58 and select the related inflation pressure that relates to the inputted selected diameter.

[0031] After selection of the inflation pressure using the compliance database 58. the processor 32 operates the indeflator 12 (e.g., controls the actuator 40) according to preprogrammed instructions stored in the memory'. The pre-programmed instructions are operation protocols that use real-time pressure data from the pressure sensor 44 to "ramp up" to the selected final inflation pressure. In one example, the operation protocol may be automatically selected by the processor 32 based on the medical device product and/or the inputted inflated balloon diameter. Alternatively, or in addition, the clinician may use the user interface to select an operation protocol from a set of the pre-programmed protocols. For the selected operation protocol, the clinician may input one or more of a selected inflation time, selected inflation dwell time, a selected deflation time, or a selected number of inflation/deflation cycles. One or more of these operating parameters may be automatically selected by the processor 32 based on one or more of the selected medical device product, the inputted inflated balloon diameter, or the operation protocol. Suitable, non-limiting operation protocols that are pre-programmed and executable by the processor 32 are shown in FIGS. 6-8. Other operation protocols may be used, including bespoke operation protocols that may be programmed by the clinician using the user interface. [0032] Referring to FIG. 6, in this exemplary operating protocol the control system 30 operates the indeflator 12 by cycling through periods of pressure for full inflation, dwell time, and full deflation. Referring to FIG. 7, in this exemplary operating protocol the control system 30 operates the indeflator 12 by cycling through periods of pressures of partial inflation and dwell time, wherein subsequent periods increase the pressure of partial inflation a pre-determined amount until a period that includes pressure for full inflation. Referring to FIG. 8. this exemplary operating protocol the control system 30 operates the indeflator 12 by cycling through periods of pressure of partial inflation, partial deflation, pressure of full inflation, and full deflation. The purpose of each operating protocol is to induce or enhance plastic deformation of the lesion L (e.g., plaque) and/or stent 20. It is believed that after a single cycle of inflation and deflating a balloon and/or stent, the lesion and/or stent tends inherently collapse to a smaller diameter due to the expanded internal energy. In order to condition the lesion and/or the stent, multiple inflation cycles can lead to preferred '‘plastic deformation” and conditioning of the vessel to obtain a strain or displacement that minimizes recoil and enhances apposition against the lumen wall.

[0033] Referring to FIG. 9. in one embodiment the medical device system 10 includes a closed-loop feedback system 64 configured to monitor the apposition of the balloon 1 and/or stent 20 with the lumen wall (e.g., lesion site) during inflation of the balloon and/or deployment of the stent, respectively, and actuate a feedback operation of the indeflator 12 based on the real-time apposition. As an example, during treatment using the balloon 16, the apposition of the balloon and/or stent 20 against the lumen wall at the treatment site is monitored using apposition sensors 68 to provide a real-time apposition signal indicative of apposition. Referring to FIGS. 9 and 10, the real-time apposition signal is processed by a processor 70 of the closed-loop feedback system 64 to provide apposition data for analysis. The processor 70 is programmed to analyze the apposition data according to processor-readable apposition-analysis instructions stored in memory 72 of the feedback control system. Based on the analysis of the apposition data, the processor 70 performs one or more feedback operations according to operation instructions. As examples, the feedback operation includes one or more of adjustment of one or more operating parameters of the indeflator 12 to enhance apposition of the balloon device (e.g., balloon 16 and/or stent 20) with the lumen wall, or communication that the apposition is suitable or not suitable (e.g., apposition is within or not within an acceptable range).

[0034] The feedback processor 70 may be the processor 32 of the control system 30 or a different processor, such as a dedicated processor, to provide apposition data for analysis. Likewise, the processor 70 of the closed-loop feedback system 64 that analyzes the data may be the processor 32 of the control system 30 or a different processor, such as a dedicated processor. For purposes of this disclosure, the closed-loop feedback system 64 of the medical device system 10 includes any control system, processor, memory, etc. that performs or is involved in the performance of operations for the closed-loop feedback system. For ease of discussion, reference is made to the "feedback sensor," the "feedback processor 70," and the "feedback memory 72" when discussing the closed-loop feedback system 64.

[0035] In one embodiment, during treatment the apposition of the balloon device (e.g., balloon 16 and/or stent 20) against the lumen wall at the treatment site is monitored using one or more suitable feedback sensors 72 (i.e., imaging sensors) to provide signals indicative of real-time image data for use by the feedback processor 70 of the closed-loop feedback system 64. The sensors 72 may be disposed inside the lumen during imaging and treatment or outside the lumen (and body). The sensors 68 may be coupled to the medical device 14, such as on the balloon 16 and/or the stent 20, or the sensors may be separate from the medical device.

[0036] As shown in FIGS. 2 and 3, the imaging feedback sensors 68 may be electrical impedance tomography (EIT) sensors coupled to the balloon device (balloon 16 and/or the stent 20). In particular, the EIT sensors 68 may be electrodes coupled to the surface of the balloon 16 and/or stent 20 that will be in apposition with the body lumen wall. During monitoring of apposition, current is supplied to the electrodes 68, and the resulting voltages at other electrodes are analyzed by the feedback processor 70 to recreate tomographic image data of the apposition of the balloon 16 and/or stent 20 with the body lumen wall. The processor 70 performs suitable image analysis according to processor- readable image analysis instructions. Based on the analysis of this tomographic data, the processor 70 performs an operation, such as adjustment of one or more operating parameters of the indeflator 12 to enhance apposition of the balloon 16 and/or stent 20 with the body lumen wall and/or communication to the clinician that the apposition is or is not suitable (e.g., apposition is or is not within an acceptable range).

[0037] In other examples, the imaging sensors 68 for monitoring apposition from inside the lumen (e.g., blood vessel) may be intravascular ultrasound (IVUS) imaging sensors, optical coherence tomography (OCT) imaging sensor, or other types of imaging sensors suitable for monitoring apposition from inside the lumen. The sensors may be coupled directly to the medical device (e.g., catheter) or may be coupled to a separate medical device (e.g., catheter). The signals generated by the sensors 68 may be communicated to the processor 70 by wired or wireless communication.

[0038] Referring to FIG. 11, in yet other examples, the apposition of the balloon 16 and/or stent 20 may be monitored using imaging sensors 68 disposed outside the body lumen. As examples, these sensors 68 may be part of a fluoroscopy system (e.g., angiography), ultrasound system (e.g., intravascular ultrasound (IVUS)), or an optical coherence tomography (OCT) system, a real-time magnetic resonance imaging (MRI) system, or a positron emission tomography (PET) scan system.

[0039] In another embodiment, the apposition sensor(s) 68 may be or include other ty pes of sensors other than imaging sensors for use in providing information regarding apposition of the balloon 16 and/or stent 20 with the body lumen wall. As an example, the apposition sensor 68 may include force sensors (e.g.. load cells, piezoelectric transducers, capacitive force sensors, or optical force sensors) on the surface of the balloon 1 and/or stent 20 configured to sense force applied against the body lumen wall during inflation of the balloon. The sensors 68 may be spaced along and around the balloon and/or stent to provide the processor 70 with force measurements for analysis.

[0040] In one example, the feedback processor 70 executes processor-readable apposition-analysis instructions, which may be stored in the memory 72, to analyze the real-time apposition data (e g. imaging data or apposition force data). Such appositionanalysis instructions are configured to enable the feedback processor 70 to extract meaningful information from the image data. Suitable image analysis techniques include feature detection and tracking; and object detection and recognition, such as by using machine learning or patern recognition techniques. As an example, machine leaming/patem recognition algorithm may be used to detect the catheter or balloon on the imaging output (i.e., feature detection) and then other sequential processing steps may be taken to identify key characteristics, such as balloon width at various points along its length, to provide feedback on balloon expansion. Other analysis techniques and software for performing such analyses are within the scope of this disclosure. In one example, the feedback processor is configured to perform frame-by-frame processing of the image data to derive a serious of measurement in real-time throughout balloon expansion.

[0041] The closed-loop feedback system 64 performs one or more feedback operations based on the apposition analysis performed by the feedback processor 70. In one or more embodiments, the feedback processor 70 adjusts one or more operating parameters of the indeflator 12 to enhance apposition of the balloon 16 and/or stent 20 against the lumen wall. For example, the feedback processor 70 may adjust the full inflation pressure, such as increasing full inflation pressure to enhance apposition. The feedback processor 70 may adjust parameters of an operating protocol, such as by adjusting dwell time, adjusting timing between active inflation, adjusting pressure differential between each cycle, among other possible adjustments. The feedback processor 70 may continue to adjust one or more operating parameters based on the real-time apposition data according to processor- readable instructions until the processor determines that real-time apposition is within a suitable, predetermined range.

[0042] In one or more embodiments, upon determination that the real-time apposition is within a suitable, predetermined range and/or the operating protocol is suitably progressing or cycling through periods, the closed-loop feedback system 64 may communicate such to the clinician and/or automatically cease further automated operation of the indeflator 12. The processor of the closed-loop feedback may communicate via the user interface, such as by using sound, haptic feedback, and/or visual indications. A clinician may be asked to confirm suitable apposition of the balloon and/or stent, and input such confirmation. The clinician may then complete the procedure, such as by withdrawing the deflated balloon 16 from the patient.

[0043] In one embodiment the closed-loop feedback system 64 is used in combination with the selected pre-programmed operation protocol, which may be selected based on the pre-loaded compliance data and the inputed desired diameter of the balloon/stent, as described above. In one example, the indeflator 12 is operated in two stages: a first stage in which the indeflator is operated according to the selected pre-programmed protocol and is run independent of the closed-loop feedback system 64; and a second stage in which the indeflator is operated by the closed-loop feedback system. In another embodiment, the indeflator 12 is operated in one stage, with the closed-loop feedback system 64 being the primary operation control.

[0044] The invention may be further described by reference to the following numbered paragraphs:

1. An indeflator for a medical device having an inflatable balloon device for treating a body lumen, the indeflator comprising: a fluid mover configured to deliver pressurized inflation fluid to the balloon device; a control system configured to operate the fluid mover, the control system including a processor and memory including operating instructions accessible by the processor for operating the indeflator to treat the body lumen using the balloon device, wherein the memory further includes a compliance database accessible by the processor, the compliance database storing compliance data for each of a plurality of medical device products that include a balloon device, wherein the compliance data for each medical device product relates inflation pressure to balloon device diameter, wherein the operating instructions include querying instructions which when executed by the processor cause the processor to query the compliance database and retrieve, for a selected one of the plurality of medical device products, an inflation pressure based on an inputted inflated balloon device diameter, wherein the operating instructions include actuating instructions which when executed by the processor cause the processor to operate the indeflator using the retrieved inflation pressure as an operating parameter.

2. The indeflator set forth in paragraph 1, wherein the actuating instructions when executed by the processor cause the processor to use the retrieved inflation pressure as a final inflation pressure of the balloon device.

3. The indeflator set forth in any of paragraphs 1 or 2. wherein the actuating instructions when executed by the processor cause the processor to operate the indeflator according to a pre-programmed protocol, the pre-programmed protocol including one or more periods of inflating, inflated dwelling, and deflating the balloon device.

4. The indeflator set forth in paragraph 3, wherein the pre-programmed protocol includes cycling through a plurality of the periods of inflating, inflated dwelling, and deflating the balloon device.

5. The indeflator set forth in paragraph 3, wherein the actuating instructions when executed by the processor cause the processor to select the pre-programmed protocol from a plurality of pre-programmed protocols based on one or both of the selected one of the plurality of medical device products and the inputted inflated balloon device diameter.

6. The indeflator set forth in paragraph 1 , further comprising a pressure sensor configured to monitor inflation pressure of the balloon device during operation of the indeflator, wherein the control system is in communication with the pressure sensor and configured to use the monitored pressure as feedback when operating the indeflator.

7. The indeflator set forth in any of paragraphs 1 to 6, in combination with a closed-loop feedback system including at least one apposition sensor configured to monitor, in real-time, apposition of the balloon device against a wall of the body lumen, and a feedback processor configured to analyze generated real-time apposition data from the at least apposition sensor and perform a feedback operation, using the indeflator, based on the analyzed real-time apposition data.

8. A method of operating the indeflator set forth in paragraph 1, the method comprising: receiving, by the control system, the selected one of the plurality of medical device products; receiving, by the control system, the inputted inflated balloon diameter; querying, by the processor, the compliance database to retrieve inflation pressure based on the selected one of the plurality of medical device products and the inputted inflated balloon diameter; and operating, by the processor, the indeflator using the retrieved inflation pressure as an operating parameter.

9. A medical device system comprising: a medical device including an inflatable balloon device sized and shaped to be received in a body lumen of a subject; an indeflator including a fluid mover configured to be in fluid communication with the inflatable balloon, wherein the indeflator is operational to inflate the medical balloon device when the medical balloon device is received in the body lumen such that the inflatable balloon device is in apposition against a wall of the body lumen; and a closed-loop feedback system including at least one apposition sensor configured to monitor, in real-time, apposition of the medical balloon device against the wall of the body lumen, and a feedback processor configured to analyze generated real-time apposition data from the at least apposition sensor and perform a feedback operation, using the indeflator, based on the analyzed real-time apposition data.

10. The medical device system set forth in paragraph 9, wherein the feedback operation includes one or more of: i) adjustment of one or more operating parameters of the indeflator to enhance apposition of the balloon device with the wall of the body lumen, ii) communication that the apposition is suitable, iii) communication that the apposition is not suitable.

11. The medical device system set forth in any of paragraphs 9 and 10. wherein the feedback operation includes adjustment of one or more operating parameters of the indeflator to enhance apposition of the balloon device with the wall of the body lumen.

12. The medical device system set forth in any of paragraphs 9 to 11, wherein the at least one apposition sensor includes at least one imaging sensor configured to monitor apposition of the balloon device against the wall of the body lumen.

13. The medical device system set forth in paragraph 12. wherein the at least one imaging sensor is coupled to the balloon device and configured to monitor apposition of the balloon device against the wall of the body lumen from inside the body lumen.

14. The medical device system set forth in paragraph 13, wherein the imaging sensor includes a plurality of electrical impedance tomography (EIT) sensors.

15. The medical device system set forth in paragraph 9, wherein the imaging sensor is configured to monitor apposition of the balloon device against the wall of the body lumen from inside the body lumen.

16. The medical device system set forth in any of paragraphs 9 to 15, wherein the balloon device includes a balloon and a stent received on the balloon, wherein the at least one apposition sensor includes a plurality of electrical impedance tomography (EIT) sensors coupled to the stent.

17. A method of operating the medical device system of paragraph 9, the method comprising: analyzing, by the processor, the generated real-time apposition data from at least one apposition sensor; and performing, by the processor, a feedback operation of the indeflator based on the analyzed real-time apposition data.

18. The method set forth in paragraph 17. wherein said performing, by the processor, a feedback operation includes adjusting one or more operating parameters of the indeflator to enhance apposition of the balloon device with the wall of the body lumen.

19. A closed-loop feedback system for a medical device system that includes a balloon device configured to be received in a body lumen, and an indeflator operable to inflate the balloon device in the body lumen, the closed-loop feedback system comprising: at least one apposition sensor configured to monitor, in real-time, apposition of the medical balloon device against a wall of the body lumen; and a feedback processor configured to analyze generated real-time apposition data from the at least apposition sensor and perform a feedback operation, using the indeflator, based on the analyzed real-time apposition data.

20. The closed-loop feedback system set forth in paragraph 19, wherein the feedback operation includes adjusting one or more operating parameters of the indeflator to enhance apposition of the balloon device with the wall of the body lumen

[0045] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device. [0046] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0047] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

Claims

WHAT IS CLAIMED IS:

1. An indeflator for a medical device having an inflatable balloon device for treating a body lumen, the indeflator comprising: a fluid mover configured to deliver pressurized inflation fluid to the balloon device; a control system configured to operate the fluid mover, the control system including a processor and memory including operating instructions accessible by the processor for operating the indeflator to treat the body lumen using the balloon device, wherein the memory further includes a compliance database accessible by the processor, the compliance database storing compliance data for each of a plurality of medical device products that include a balloon device, wherein the compliance data for each medical device product relates inflation pressure to balloon device diameter. wherein the operating instructions include querying instructions which when executed by the processor cause the processor to query the compliance database and retrieve, for a selected one of the plurality of medical device products, an inflation pressure based on an inputted inflated balloon device diameter, wherein the operating instructions include actuating instructions which when executed by the processor cause the processor to operate the indeflator using the retrieved inflation pressure as an operating parameter.

2. The indeflator set forth in claim 1, wherein the actuating instructions when executed by the processor cause the processor to use the retrieved inflation pressure as a final inflation pressure of the balloon device.

3. The indeflator set forth in any of claims 1 or 2, wherein the actuating instructions when executed by the processor cause the processor to operate the indeflator according to a pre-programmed protocol, the pre-programmed protocol including one or more periods of inflating, inflated dwelling, and deflating the balloon device.

4. The indeflator set forth in claim 3, wherein the actuating instructions when executed by the processor cause the processor to select the pre-programmed protocol from a plurality of pre-programmed protocols based on one or both of the selected one of the plurality⁷ of medical device products and the inputted inflated balloon device diameter.

5. The indeflator set forth in any of claims 1 to 4, in combination with a closed- loop feedback system including at least one apposition sensor configured to monitor, in real-time, apposition of the balloon device against a wall of the body lumen, and a feedback processor configured to analyze generated real-time apposition data from the at least apposition sensor and perform a feedback operation, using the indeflator, based on the analyzed real-time apposition data.

6. A method of operating the indeflator set forth in claim 1 , the method comprising: receiving, by the control system, the selected one of the plurality of medical device products; receiving, by the control system, the inputted inflated balloon diameter; query ing, by the processor, the compliance database to retrieve inflation pressure based on the selected one of the plurality of medical device products and the inputted inflated balloon diameter; and operating, by the processor, the indeflator using the retrieved inflation pressure as an operating parameter.

7. A medical device system comprising: a medical device including an inflatable balloon device sized and shaped to be received in a body lumen of a subject; an indeflator including a fluid mover configured to be in fluid communication with the inflatable balloon, wherein the indeflator is operational to inflate the medical balloon device when the medical balloon device is received in the body lumen such that the inflatable balloon device is in apposition against a wall of the body lumen; and a closed-loop feedback system including at least one apposition sensor configured to monitor, in real-time, apposition of the medical balloon device against the wall of the body lumen, and a feedback processor configured to analyze generated real-time apposition data from the at least apposition sensor and perform a feedback operation, using the indeflator, based on the analyzed real-time apposition data.

8. The medical device system set forth in claim 7, wherein the feedback operation includes one or more of: i) adjustment of one or more operating parameters of the indeflator to enhance apposition of the balloon device with the wall of the body lumen, ii) communication that the apposition is suitable, iii) communication that the apposition is not suitable.

9. The medical device system set forth in any of claims 7 and 8, wherein the feedback operation includes adjustment of one or more operating parameters of the indeflator to enhance apposition of the balloon device with the wall of the body lumen.

10. The medical device system set forth in any of claims 7 to 9, wherein the at least one apposition sensor includes at least one imaging sensor configured to monitor apposition of the balloon device against the wall of the body lumen.

11. The medical device system set forth in claim 10, wherein the imaging sensor includes a plurality of electrical impedance tomography (EIT) sensors.

12. The medical device system set forth in any of claims 7 to 11. wherein the balloon device includes a stent received on the balloon, wherein the at least one apposition sensor includes a plurality of electrical impedance tomography (EIT) sensors coupled to the stent.

13. A method of operating the medical device system of claim 7, the method comprising: analyzing, by the processor, the generated real-time apposition data from at least one apposition sensor; and performing, by the processor, a feedback operation of the indeflator based on the analyzed real-time apposition data.

14. The method set forth in claim 11, wherein said performing, by the processor, a feedback operation includes adjusting one or more operating parameters of the indeflator to enhance apposition of the balloon device with the wall of the body lumen.

15. A closed-loop feedback system for a medical device system that includes a balloon device configured to be received in a body lumen, and an indeflator operable to inflate the balloon device in the body lumen, the closed-loop feedback system comprising: at least one apposition sensor configured to monitor, in real-time, apposition of the medical balloon device against a wall of the body lumen; and a feedback processor configured to analyze generated real-time apposition data from the at least apposition sensor and perform a feedback operation, using the indeflator, based on the analyzed real-time apposition data.