Pumping cartridge for tissue treatment device
By designing a system that includes disposable cutting of handpieces and boxes, using endoscopic ultrasonic cutting and diaphragm pump to achieve fluid perfusion and suction, the problems of insufficient aspiration and imbalance in the existing equipment are solved, and a more efficient and safe surgical process is achieved.
Patent Information
- Application Number
- CN202380063921.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-07-06
- Filing Date
- 2023-07-05
- Publication Date
- 2025-04-18
AI Technical Summary
There are shortcomings in the existing surgical equipment during aspiration and perfusion, especially inadequate aspiration and imbalance in perfusion and aspiration, which leads to the equipment being undesirable in minimally invasive surgery.
A system including disposable cutting handpieces and boxes is designed, which cuts the anatomical sections ultrasonic through an endoscope and is connected to the disposable box through a reusable console. It uses a diaphragm pump and sensor to realize the infusion and suction of fluids, with induction and flow correction functions.
The system can effectively perform minimally invasive surgery, improves the balance and efficiency of aspiration and perfusion, reduces damage to patient tissue, and provides induction and flow correction functions, improving the safety and accuracy of the surgery.
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Figure CN119855622A_ABST
Abstract
Description
[0001] Incorporation by reference into any priority document
[0002] Any and all applications claiming foreign or domestic priority as mentioned in the Application Data Sheet filed with the present application are incorporated herein by reference pursuant to 37 CFR 1.57. Background Art Technical Field
[0003] The disclosed apparatus relates to surgical instruments for minimally invasive surgery. More particularly, the disclosed devices and methods relate to apparatus and methods that can be used as a disposable ultrasonic cutting instrument that is capable of irrigation and aspiration via an integrated pump.
[0004] The present disclosure relates to methods, devices and systems for endoscopic treatment of chronic tendinitis or fasciitis by ultrasonic ablation, as well as similar surgical procedures on other suitable tissues. Background Art
[0006] Repetitive motion or use of body tissues may lead to injury or painful conditions. For example, tennis elbow, or lateral epicondylitis, is a clinical syndrome where patients experience pain on the lateral elbow. This pain on the lateral side of the elbow may worsen over time, and despite adequate treatment, many patients will experience chronic symptoms and ultimately become candidates for surgical treatment.
[0007] Many surgical procedures have been described for the treatment of chronic tendinitis or fasciitis affecting different segments of the body. Specific open techniques generally require open surgical dissection to the pathological tissue and, therefore, the need to repair surgically damaged normal tissue. Some arthroscopic techniques may be less invasive, but some such procedures are associated with neurological complications and may require the use of high-cost operating rooms and associated personnel. Various percutaneous techniques have been described to release, ablate, or resect the pathological tissue. However, these percutaneous techniques generally require significant skin incisions, some surgical dissection, and the aforementioned use of high-cost operating rooms and supporting instruments and personnel.
[0008] Existing devices known in the art have deficiencies, such as insufficient aspiration and / or an unbalanced ratio of irrigation to aspiration. Therefore, there remains a need for an improved disposable surgical cassette having a pump interfaced with a pump motor and power source to power, aspirate, and irrigate a distal surgical ultrasound delivery handpiece. Such a device should provide sensing capabilities, including pressure, bubble, connection detection and identification, and flow correction capabilities in the event of an occlusion or vacuum. Summary of the invention
[0009] The embodiments disclosed herein all have several aspects for soft tissue and / or hard tissue treatment. Without limiting the scope of the present disclosure, a number of embodiments and / or examples will now be briefly discussed. After considering this discussion, and particularly after reading the section entitled "Detailed Description of the Invention," those skilled in the art will understand how the features of the embodiments described herein provide advantages over existing systems, devices, and methods.
[0010] Disclosed herein are methods, devices, and systems for cutting anatomical segments (e.g., tendons and fascia) by endoscopic ultrasound. The device can be a disposable cutting handpiece and box that are attached to a reusable main console for surgery and then safely separated for disposal and / or analysis. The device can also include the ability to store materials, for example, materials collected from the suction handpiece, for disposal or analysis. The cutting handpiece can use piezoelectric crystals to produce ultrasonic cutting action, and can optionally include a beveled end, a suction catheter, and / or an irrigation catheter. The box can include one or more diaphragm pumps, for example, one pump for irrigation and one pump for suction, which are operated by one or more motors installed in the console. The box can include sensors, for example, for detecting pressure or flow, the presence of bubbles, correct connections, and system or feature identification. The box can include an interface for cooperating with one or more sensors in the console. The box can include an electronic connector that interfaces with the console, which transmits power to the handpiece and optionally identifies characteristics such as probe and / or handpiece type and performance characteristics. The box can also include a flow correction loop to reduce unwanted flow blockage or vacuum.
[0011] In some aspects, the technology described herein relates to a fluid infusion and / or aspiration device, including: a reusable portion having a pump motor and a power source; and a disposable portion, which includes: a handpiece; a power cord connected to the handpiece and capable of connecting to the power source; and a diaphragm. When the reusable portion is connected to the disposable portion at the connector, the power source interfaces with the power cord to deliver power to the handpiece, the pump motor interfaces with the diaphragm to produce a diaphragm pump configured to provide a fluid flow in the disposable portion; and the disposable portion separates the fluid from the reusable portion. In some aspects, the disposable portion also includes handpiece identification electronics and / or a valve.
[0012] In some aspects, the technology herein relates to a device, wherein the fluid is an irrigation fluid, the device further comprises an irrigation fluid source, and wherein the diaphragm pump provides the irrigation fluid to the handpiece. In some aspects, the device further comprises a collector, and the diaphragm pump provides a suction fluid flow from the handpiece to the collector. In some aspects, the device comprises a conduit for conveying the fluid flow. In some aspects, the conduit comprises a filter. In some aspects, the filter is positioned to protect the diaphragm pump from particles in the fluid flow.
[0013] In some aspects, the device connector includes a coupling mechanism that transmits motion from the diaphragm pump to the diaphragm. In some aspects, the connector includes one or more sensing devices for sensing flow, bubbles, and / or pressure. In some aspects, the disposable portion includes one or more sensing devices for sensing flow, bubbles, and / or pressure. In some aspects, the device includes a collector, wherein the flow is suction directed from the handpiece to the collector. In some aspects, the collector is a releasable collection bag.
[0014] In some aspects, the technology herein relates to a disposable fluid infusion and aspiration device, comprising: a power cord configured to be connected to a handpiece and capable of being connected to a power source in a reusable console; a handpiece identification electronic component; an infusion diaphragm; an aspiration diaphragm; a valve; and a connection area configured to be connected to the reusable console. When the connection area is connected to the reusable console, the power cord receives power to be delivered to the handpiece, the infusion diaphragm interfaces with the pump motor in the reusable console to provide an infusion flow, the aspiration diaphragm interfaces with the pump motor on the reusable console to provide an aspiration flow, and the infusion flow and the aspiration flow are separated from the reusable console. In some aspects, the device includes a filter. In some aspects, the device includes a handpiece. In some aspects, the handpiece includes an identification electronic component, and the software reads the handpiece identification and loads the performance parameters. In some aspects, the device includes one or more sensing devices for sensing flow, bubbles and / or pressure. In some aspects, the device includes a collector, wherein the aspiration flow guides the fluid from the handpiece to the collector. In some aspects, the collector is a releasable collection bag. BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The above and other features, aspects and advantages of the embodiments of the systems, devices and methods described herein are described in detail below with reference to the accompanying drawings of various embodiments, which are intended to illustrate but not limit the embodiments of the present invention. The accompanying drawings include the following figure, in which:
[0016] Figure 1 is a perspective view of an exemplary embodiment of a system disclosed herein.
[0017] Figure 2 is a schematic diagram of an example of a controller showing a command module, a user interface, and a pipeline box.
[0018] Figure 3A , 3B and 3C is an alternative view of an example box.
[0019] Figure 4 An example of an ultrasound handpiece is shown.
[0020] Figure 5 An example of an ultrasound handpiece with electrical and tubing connections is shown.
[0021] Fig. 6A and 6B An example of an ultrasound handpiece with electrical and tubing connections to a cassette and collection bag is shown.
[0022] Figure 7 Examples of boxes and consoles are shown.
[0023] Figure 8 An embodiment of the electrical and plumbing connections within the box is shown.
[0024] Fig. 9 is an exploded view of an embodiment of the cartridge.
[0025] Fig.10 is a perspective view of an embodiment of a box, showing the front side of the box.
[0026] Fig.11 is a perspective view of an embodiment of a box, showing the back side of the box.
[0027] Fig.12 An embodiment of a box with a sensor and a console is shown.
[0028] Fig.13A An example of a connection area of a console is shown.
[0029] Fig. 13B Shows Fig.13A Example of a connection area where the cartridge is partially inserted.
[0030] Fig. 13C Shows Fig.13A Example of the connection area where the cartridge is fully inserted.
[0031] Fig.14 Shows the view from inside the console Fig.13A Example of a connected region.
[0032] Fig.15 An embodiment of the fluid flow path within the cartridge is shown.
[0033] Fig.16A An embodiment of the fluid flow path within the cartridge is shown when the solenoid valve is closed.
[0034] Fig. 16B Shows when Fig.16A An embodiment of the fluid flow path within the box when the solenoid valve is opened.
[0035] Throughout the drawings, reference numerals may be repeated to indicate a general correspondence between reference elements unless otherwise noted. The drawings are provided to illustrate the exemplary embodiments described herein and are not intended to limit the scope of the present disclosure. DETAILED DESCRIPTION
[0036] Disclosed herein are methods, devices, and systems for cutting anatomical segments (e.g., tendons, diseased bones, foot ulcers, and fascia) by endoscopic ultrasound. The device may be a disposable cutting handpiece and box that are attached to a main console for surgery and then safely separated for disposal and / or analysis. The device may also include the ability to store materials, such as materials collected from a suction handpiece, for disposal or analysis. The cutting handpiece may use a piezoelectric crystal to produce an ultrasonic cutting action, and may optionally include a beveled end, a suction catheter, and / or an irrigation catheter. The box may include one or more diaphragm pumps, such as one pump for irrigation and one pump for suction, which are operated by one or more motors installed in the console. The box may include sensors, such as for detecting pressure or flow, the presence of bubbles, proper connections, and system or feature identification. The box may include an interface for cooperating with one or more sensors in the console. The box may include an electronic connection that docks with the console to deliver power to the handpiece and optionally identifies, for example, the characteristics of the probe and / or handpiece type. The box may also include a flow correction circuit for reducing unwanted flow blockage or vacuum.
[0037] Figure 1 An exemplary system according to one embodiment of the present disclosure is shown, which is configured to percutaneously approach and act on target tissue while helping to reduce collateral trauma. In some exemplary embodiments, the minimally invasive ultrasonic nature of the system 100 improves the accuracy of removing diseased tissue compared to surgical procedures involving surgical dissection of healthy tissue. In some embodiments, the percutaneous, minimally invasive nature of the system 100 facilitates treating patients under local anesthesia in an outpatient setting. Performing treatment in an outpatient setting is advantageous in several ways, including, for example, patient comfort and convenience, and avoiding costs associated with operating room time and general anesthesia.
[0038] In some embodiments, Figure 1 As shown, the system 100 includes a delivery device 102 and a controller 104 that can be operably connected to the delivery device 102. In some embodiments, the delivery device 102 can be operably connected to the controller 104 via a power line 106, a suction or vacuum line 108, and an irrigation line 110. Figure 1 As shown, the power cord 106 can be connected to the controller 104 via a wired connection. In some embodiments, the power cord 106 can be connected to the controller 104 via a power cord connector 214. In some embodiments, the controller 104 can be configured to communicate with the delivery device 102 via wireless communication or a combination of wired and wireless communication.
[0039] In some embodiments, the delivery device 102 can be configured to transmit ultrasonic energy at a selected pre-tuned frequency to a percutaneous musculoskeletal site to debride musculoskeletal tissue. Figure 1 As shown, in some embodiments, the delivery device 102 includes a cover 114. Generally, the various components of the delivery device 102 intended for tissue contact are formed from biocompatible and / or other suitable materials. Figure 1 As shown, the delivery device 102 can be ergonomically designed to be handheld (e.g., as a probe) or otherwise suitable for single-handed manual operation. In some embodiments, the delivery device 102 can be suitable for automatic or semi-automatic manipulation (e.g., as part of a robotic system).
[0040] In certain embodiments, the delivery device 102 can be pre-tuned to a selected ultrasonic energy frequency or frequency range. For example, an ultrasonic energy frequency range of about 25 kHz to about 29 kHz can effectively debride pathological musculoskeletal tissue (e.g., scar tissue associated with tendons) while reducing the potential for trauma to healthy soft tissue.
[0041] like Figure 1 and Figure 2 As shown, in some embodiments, the system 100 may include a reusable controller 104 connected to a disposable cartridge 190 and a disposable collector 192. Figure 2 As shown, the reusable controller 104 may include: (a) a housing 176; (b) a command module 178, which includes: (i) a power supply 182; (ii) a processor 184; and (iii) a signal filter 185; (c) a vacuum source 186; and (d) an irrigation source 188. In some embodiments, the vacuum source 186 and the irrigation source 188 each include a pump motor. In some embodiments, the vacuum source 186 and the irrigation source 188 include a single pump motor. In some embodiments, the command module 178 includes a main unit, which preferably includes one or more processors, and the one or more processors are electrically coupled to one or more memory devices, other computer circuits, and one or more interface circuits via an address / data bus. The processor can be any suitable processor and can include volatile memory and non-volatile memory. In some embodiments, the memory stores one or more software programs that interact with other devices in the system 100. These programs can be executed by the processor in any suitable manner. In an exemplary embodiment, the memory can be part of the "cloud" so that the system 100 can utilize cloud computing. The memory may also store digital data representing documents, files, programs, web pages, etc. that are retrieved from the computing device and / or loaded via an input device.
[0042] In certain embodiments, the command module 178 can be configured to control flow from the vacuum source 186 and / or from the irrigation source 188. In some embodiments, the command module 178 can be configured to provide power to the delivery device 102. In some embodiments, the command module 178 can be configured to provide instructions to a user and / or enable a user to select instructions, such as via the user interface 180. In some embodiments, the command module 178 includes a signal filter 185 for delivering a conditioned power signal (e.g., a power supply signal at a selected amplitude and frequency) to the delivery device 102.
[0043] like Figure 2 As further shown in FIG. 1 , the command module 178 may include at least one processor 184. In some embodiments, the controller 104 includes a user interface 180. The user interface 180 may include a touch screen system for controlling the system 100. In some embodiments, the controller 104 includes a power supply 182. The power supply 182 may include a battery, a capacitor, a transformer connected to an external power source (e.g., a wall outlet), a combination thereof, or other means for providing power to the system 100. The power supply 182 may also deliver power directly or indirectly to various components of the controller 104 as needed.
[0044] In some embodiments, the controller 104 includes a vacuum source 186. The vacuum source 186 can be a peristaltic pump. In some embodiments, the vacuum source 186 can be a pump motor for operating a diaphragm in a connected disposable cartridge 190.
[0045] The reusable controller 104 can removably receive a connected disposable cartridge 190. In some embodiments, for example Figure 1 In the illustrated system 100, the disposable cartridge 190 may include a dosing line 111 having a spike 113, and the spike 113 may be operably coupled to the dosing line 111. In some embodiments, the cartridge 190 includes a collector 192. The collector 192 may be configured to contain debris, fluid, or other material aspirated by the aspiration flow D. The collector 192 may be a bag or other container. Figure 1 and Figure 2 As shown, the collector 192 can be separate from the cartridge 190. In other embodiments, the collector 192 can be maintained by the cartridge 190, formed as a part of the cartridge 190, or a component within the cartridge 190. In some embodiments, such as those discussed below, Figure 6A-6B As shown in the box, the collector 192 can be configured to be releasably connected to the box 190, such as by a snap connection, a magnetic connection, a screw, a Luer connector, etc. In some embodiments, the collector 192 can be connected to the box 190 using double-sided tape.
[0046] In some embodiments, the controller 104 may include an irrigation source 188. The irrigation source 188 may include a reservoir of an irrigation agent (e.g., saline). In some embodiments, the reservoir may be pressurized by gravity, a plunger (e.g., a syringe), and / or a pump (e.g., a peristaltic pump operated by the controller 104 and optionally disposed in the housing 176) to generate a fluid flow F. In some embodiments, the irrigation source 188 may be separated from the system 100. In some embodiments, the spike 113 may be configured to penetrate a separate irrigation source to supply a fluid flow to the system 100. In some embodiments, the controller 104 includes a valve actuator 194, which may be configured to direct the fluid flow F into a vacuum conduit of the delivery device 102, for example, for flushing purposes. In some embodiments, the irrigation source 188 may be a peristaltic pump. In some embodiments, the irrigation source 188 may be a pump for operating a diaphragm in a connected disposable box 190. In some embodiments, the vacuum source 186 discussed above can be combined with the irrigation source 188 , such as as a single pump motor for operating both diaphragms in a connected disposable cassette 190 .
[0047] In some embodiments, the user interface 180 may include buttons for a flushing phase, an emptying phase, and / or a reset phase. In some embodiments, the user interface 180 enables the delivery device 102 to operate sequentially, starting with an ultrasound level selection, an irrigation level selection, and an aspiration level selection. In some embodiments, the user interface may display an ultrasound image while the handpiece is debriding the diseased area. When operating the system 100, the user may be allowed to sequentially select various levels. In some embodiments, the levels and / or sequence parameters may be sequentially highlighted and / or requested. For example, in some embodiments, the user may not be able to make subsequent selections until the previous one (or more) selections are completed.
[0048] In some embodiments, ultrasonic energy, perfusate flow, and suction flow are delivered and / or controlled independently. In some operational embodiments, these features can be coupled together for delivery. For example, ultrasonic energy and perfusate can be delivered simultaneously, while the suction flow can be delivered intermittently. In some embodiments, ultrasonic energy and perfusate flow can be selectively paused during suction and can be restarted after treatment is restarted. In some embodiments, during suction, the perfusate flow can be stopped while the ultrasonic energy continues, although such operation reduces some of the beneficial effects of using perfusate during ultrasonic treatment (e.g., continuous terminal cooling and tissue emulsification, etc.). In some embodiments, ultrasonic energy, perfusate flow, and suction flow can be coupled and / or decoupled periodically or temporarily throughout the surgical procedure.
[0049] In some embodiments, Figure 2 and Figures 3A-3CAs shown, the box 190 includes: (a) a housing 208; (b) a valve 209; (c) a portion of the vacuum line 108; and (d) a portion of the irrigation line 110 (indicated by the dashed line). In some embodiments, the vacuum line 108 and the irrigation line 110 include multiple segments of interconnected medical tubing, although a unitary construction is also a possible option. The box 190 can connect the vacuum line 108 to the vacuum source 186 in a relatively sterile manner. For example, where the vacuum source 186 includes a peristaltic pump, the tubing box 190 includes a seat structure 210 for engaging the vacuum line 108 with a pump driver 212 of the vacuum source 186 to generate a suction flow in the vacuum line 108.
[0050] Figures 3A-3C An exemplary cartridge 190 is shown. Figure 3A The inside of the box 190 is shown, Figure 3B An exemplary bottom side of frame 190 is shown, and Figure 3C 1 is a schematic diagram of an example cassette 190. In some embodiments, the vacuum line 108 and the irrigation line 110 can be referred to as a line set. In operation of an exemplary embodiment, a pump driver 212 (e.g., a peristaltic pump) of the vacuum source 186 can be housed in the seat structure 210 such that the vacuum line 108 is engaged against the seat structure 210 between the pump driver 212 and the seat structure 210. The valve 209 can be engaged by the valve actuator 194 to press the valve 209 closed so that flow from the irrigation line 110 does not pass through the vacuum line 108 to the delivery device 102 (see Figure 2 ). In some embodiments, valve 209 can be released to allow fluid to flow into vacuum line 108, to the device and through the vacuum conduit, such as to flush vacuum line 108. In some embodiments, the perfusate flowing through perfusion line 110 is optionally gravity pressurized or otherwise forced through system 100.
[0051] In some embodiments, the delivery device 102 is a disposable delivery device, such as Figure 4The disposable delivery device 400 shown. The delivery device 400 may include a suction or vacuum conduit 402 and an irrigation conduit 404. In some embodiments, such as the delivery device 400, the vacuum conduit 402 may be an inner conduit and the irrigation conduit 404 may be an outer conduit. In some embodiments, the vacuum conduit 402 may be an outer conduit and the irrigation conduit 404 may be an inner conduit. In certain embodiments, the vacuum conduit 402 and the irrigation conduit 404 are arranged longitudinally, such as side by side or one above the other. In some embodiments, the vacuum conduit 402 and the irrigation conduit 404 are a single conduit, such as a conduit that controls the suction and irrigation functions through valves, or a conduit having multiple chambers for each function. Those skilled in the art will appreciate that other potential arrangements may be suitable.
[0052] like Figure 5 As shown, the disposable delivery device 500 may include multiple proximal connectors. For example, in some embodiments, the disposable delivery device 500 may include a power connector 502, a suction connector 510, and an irrigation connector 520. In some embodiments, the suction connector 510 may be connected to the delivery device 500 via a suction line 512. In some embodiments, the irrigation connector 520 may be connected to the delivery device 500 via an irrigation line 522. In some embodiments, the power connector 502 may be connected to the delivery device 500 via a cable 504 for transmitting ultrasound or other signals. Some or all of the pipelines 512 and 522 and / or cables 504 may be combined in a single pipeline and / or connector. In some embodiments, some or all of the pipelines 512, pipelines 522, and cables 504 may be bundled together. In some examples, some or all of the connectors 502, 510, 520 may be combined in a single connector and / or connector harness.
[0053] like Figure 6A-6BAs shown, the disposable delivery device 500 can be releasably connected to the box 540. For example, as shown, the power connector 502 of the disposable delivery device 500 can be connected to the power cord 506. The suction connector 510 can be connected to the suction line 514, for example to provide the suction flow F2 from the handpiece 500. The irrigation connector 520 can be connected to the irrigation line 524, for example to provide the irrigation flow F1. The additional pipeline 534 with an optional connector can be used to connect the box 540 to the irrigation source, for example to provide the irrigation agent flow F4 such as saline. In some embodiments, the fluid and power connection are made with any suitable connector. For example, the power connection can be made with one or more cables and / or switches, and the fluid connection can be made with one or more pipes and / or valves, such as Luer valves, reflux valves and / or controllable valves. In some embodiments, some or all of the pipelines 514, 524 and 534 and / or the power cord 506 can be combined in a single pipeline and / or connector. In some embodiments, some or all of tubing 514, tubing 524, tubing 534, and power cord 506 may be bundled together.
[0054] In some embodiments, the cartridge 540 includes the ability to store material, e.g., collected material from the suction handpiece 500, for disposal and / or analysis. In some embodiments, the material is collected in a collector 542, e.g., Figure 6A-6B The collection bag or other flexible storage means shown. In some embodiments, the collector 542 can be attached to or connected to the box 540 to accommodate the suction material flow F3 from the box 540. In some embodiments, the collector 542 can be a canister, a reservoir, or other rigid storage means. In some embodiments, the collector 542 can be releasably connected to the box 540, as discussed in further detail below. In some embodiments, the reservoir 542 can be integrated with the interior or exterior of the box 540 (e.g., as described above with respect to Figure 1 Collector 192 discussed).
[0055] In certain embodiments, a plurality of disposable delivery devices (e.g., delivery device 500) are provided with corresponding disposable boxes, such as boxes 190, 540 for each delivery device. Prior to delivery to the user, the device is individually pre-tuned to the appropriate ultrasonic energy frequency (as described above) to eliminate the need to test and adjust the power signal parameters or delivery device configuration before or during each operation. In some embodiments, a disposable box / delivery device set is set or configured before delivery to the end user. The kit can be used for the treatment operation and optionally discarded at the end of the operation, thereby reducing the operation time, the skill level required to "tune" the system 100, and / or the additional components or systems for tuning the delivery device 500. In addition, the combination of box 190 and delivery device 102, delivery device 500 and box 540, etc. eliminates the need to sterilize the instrument before surgery because all parts that come into contact with body fluids are pre-sterilized and discarded at the end of the operation.
[0056] In some embodiments, after tissue treatment is completed, the cartridge 540 can be removed from the controller 104, discarded and replaced with a second sterile cartridge, which can be pre-connected or subsequently connected to a second sterile delivery device (not shown) to sterilize the system 100 for a new procedure.
[0057] In some embodiments, the disposable portion including the handpiece 500, the cartridge 540, and the collector 542 can be as discussed above and Figure 6A-6B Make the connections as shown. Fig. 6A As shown, the disposable part can provide one or more fluid flow paths. In some embodiments, an irrigation agent (e.g., saline or an IV bag) can be connected to an irrigation line 534 to provide a flow F4 of the irrigation agent. The irrigation agent flow F4 enters the box 540, where it can be pumped as described below. The irrigation agent flow F1 leaves the box 540 through the irrigation line 524 and the connector 520, and arrives at the irrigation line 522 of the handpiece 500, where it can be used to irrigate the handpiece 500 and / or the treated tissue. Similarly, the suction flow F2 can be provided from the handpiece 500, through the suction line 512 of the handpiece 500, arrives at the connector 510 and the suction line 514, and enters the box 540, where it can be pumped as described below. The box 540 can pump the material to be aspirated to provide a suction material flow F3 from the box 540 to the collector 542.
[0058] Figure 7-1 6 shows various features of an alternative embodiment of the cartridge 540. Figure 7As shown, the disposable cassette 11 can be docked with a console 12. In some examples, the interface can include a pump connector 13 leading to at least one fluid pump in the console 12. The pump connector 13 can include a mechanism to transmit motion from a pump component in the console 12 to a mating pump component in the cassette 11. For example, the pump connector 13 can connect a pump diaphragm in the disposable cassette 11 to a diaphragm pump motor housed in the console 12. Figure 8 The internal arrangement of the disposable cartridge 11 is shown. In some embodiments, two pumping interfaces, e.g. Figure 8 The irrigation pump region 810 and the aspiration pump region 820 shown each use a pump connector 13 to cooperate with a corresponding pump motor contained in the console 12. In some embodiments, the pump connector 13 is a single connector. As shown, the first pump, such as the irrigation pump region 810, uses a pump connector 13 to cooperate with a diaphragm pump motor in the console 12. This arrangement allows the body-contacting components and fluids to be contained in the disposable portion including the box 11, the collector, the handpiece 500 and the tubing, as discussed below, while keeping the reusable portion including the console 12 free of any body-contacting materials and / or fluids.
[0059] Reference Figure 8 , 15 , 16A and 16B, in some embodiments, the cassette 11 can include a perfusion circuit to move fluid (e.g., a perfusion fluid such as saline) from an external connector (not shown) to the handpiece. In some embodiments, the perfusion fluid is pumped into the internal perfusion line 812 through the perfusion line 534 and the perfusion pump area 810. In some embodiments, the perfusion line 812 exits the housing of the cassette 11 at the opening 804 to create an exposed segment 812a, as discussed below. The perfusion line 812 then enters the connector 808 to connect to the perfusion line 524, which exits the cassette 11 at the opening 41 (see Fig.10 ) for connection to a handpiece, such as Figure 6A-6B shown.
[0060] Still refer to Figure 8 , 15 , 16A and 16B, in some embodiments, the cartridge 11 may include a suction circuit to move fluid from the handpiece to the collector. For example, in some embodiments, fluid from the handpiece (see Figure 6A-6B ) enters the box 11 at the opening 41 (see Fig.10 ). The suction line 514 is connected to the internal suction line 822 via the connector 808. In some embodiments, the suction line 822 exits the housing of the cassette 11 at the opening 806 to create an exposed section 822a, as discussed below. The suction line 822 is then connected to the outlet 42 (see Fig.10In some embodiments, the outlet 42 can be connected to an internal collector, as discussed above. In some embodiments, the outlet 42 can be releasably connected to the collector, for example Figure 6A-6B Bag collector 542 is shown. An aspiration circuit may be used to allow cassette 11 to move fluid (eg, excess perfusate, waste, and / or debris) from the handpiece to a collector.
[0061] In some embodiments, the aspiration circuit and / or the perfusion circuit can include one or more filters. The filter can be located within the flow circuit to prevent debris, particles, or other contaminants from reaching the protected location. For example, in some embodiments, a filter or a series of filters can be used to prevent contaminants from reaching the sensor, as discussed below. In some embodiments, a filter or a series of filters can be used to prevent aspirated debris from reaching the aspiration pump area. Similarly, a filter or a series of filters can be used to prevent external contaminants in the perfusate line (e.g., particles accidentally introduced during connection to a saline source) from reaching the perfusion pump area and / or the handpiece 500. In some embodiments, the filter can be accessible for cleaning and / or replacement.
[0062] Still refer to Figure 8 , 15 , 16A and 16B, in some embodiments, the cartridge 11 may include a flow corrector. Fig.15 As shown, the flow correction circuit may include a secondary flow path 1510. The secondary flow path 1510 may include a flow path that may be passed through an opening 51 (see Fig.11 ) is close to the exposed section 1510a. The exposed section 1510a cooperates with the electromagnetic pinch valve 1450, such as Fig.14 The pinch valve 1450 may be normally closed, as shown. Fig.16A 42 and holds the secondary flow path 1510 closed. This arrangement allows only aspirated material to flow into the cartridge 11 and out through the outlet 42 to the collector 542. Occasionally, the handpiece 400 may become clogged, usually due to tissue buildup or bulk material blocking the needle opening. If the handpiece 400 becomes clogged, vacuum will build up and the obstruction cannot be relieved. At this point, a sensor (e.g., an aspiration pressure sensor as discussed below) can detect an increase in pressure and the pinch valve 1450 releases to open the secondary path 1510, as shown. Fig. 16BAs shown. The secondary path 1510 recirculates between the outlet 42 and the collector 542 to temporarily prevent flow in the suction line 822. The outlet 42 then also becomes an inlet. By maintaining the inlet / outlet 42 into the collector 542 above the location where the fluid is collected, fluid can be prevented from recirculating from the collector 542 back into the suction pumping circuit. The collector 542 can be provided with an opening for air that allows air to flow into the cartridge 11 and break the vacuum pressure. Once the vacuum is broken, the obstruction will be released from the end of the handpiece, the pinch valve 1450 will close again, and flow will resume through the normal suction path, as shown in FIG. Fig.15 and 16A shown.
[0063] like Figure 8 As further shown, in some embodiments, the box 11 can include a circuit board 832 connected to the power cord 506. The power cord 506 can be connected to the power connector 502 to operate the handpiece 500. The power cord 506 can be used to transmit control signals and / or power to operate the ultrasonic cutting of the handpiece 500. In some embodiments, the power cord 506 can also enable two-way communication with the handpiece 500 for feedback. In some embodiments, the power cord 506 can be connected to the circuit board 832 in the box 11. In some embodiments, when the box 11 is connected, the circuit board 832 is connected to the console 12. In some embodiments, the circuit board 832 can be connected to the console 12 separately through a wired and / or wireless connection.
[0064] Fig. 9An exploded view of an embodiment of the box 11 is shown, wherein various fluids and wires are omitted for clarity. As shown, the box can include a front housing 21 that cooperates with a rear housing 22 to enclose some or all of the various components discussed above. As shown, the box 11 can combine the irrigation pump area 810 and the suction pump area 820 into a valve and diaphragm block 23. When the front housing 21 and the rear housing 22 engage and the box 11 is inserted into the console 12, the valve and diaphragm block 23 can compress the valve and diaphragm to produce a fluid-tight seal. The valve gasket 24 can surround the valve and diaphragm block 23 to improve the seal. The valve block 25 can compress the valve at the outlet 42 to produce a seal and connect the handpiece 400 fluid to a collector, such as a collector 542, through a surgical line loop. The diaphragm 27 in the pump area (e.g., irrigation pump area 810 and / or suction pump area 820) cooperates with one or more diaphragm pumps or pump motors in the console 12 through a diaphragm connector 26. In some embodiments, each of the irrigation pump area 810 and the aspiration pump area 820 connections uses a corresponding diaphragm 27 and diaphragm connector 26. In some embodiments, the pump areas 810, 820 (including pump motors, diaphragms 27, connectors 26 or other components) can be balanced to provide approximately equal aspiration and irrigation flows. In some embodiments, the pump areas 810, 820 can be dynamically adjusted, such as by dynamically controlling the operating rate of the pump motor within the console 12.
[0065] Fig.11 The back or console-facing side of an embodiment of the cassette 11 is shown. The diaphragm connector 56 can be similar in some or all respects to the diaphragm connector 26 discussed above. As shown, in some embodiments, the diaphragm connector 56 is exposed on the back of the cassette 11 to interface with a motor in the console 12. The console motor can be activated to actuate a diaphragm in the cassette 11, such as diaphragm 27, to create a diaphragm pump for the irrigation pump area 810 and the aspiration pump area 820, as discussed above. Fig.11 Also shown are tracks 52, which in some embodiments can be used to engage the cassette 11 with the console 12. For example, the tracks 52 can help insert the cassette 11 into the mating connection area of the console 12 and can help prevent bending and / or inverted placement. Fig.11As shown, the cassette 11 may include a track 52 at the center. Some embodiments of the cassette 11 may additionally or alternatively include a track 52 at the edge of the back of the cassette 11, the front of the cassette 11, and / or any side of the cassette 11. In some embodiments, the side of the cassette 11 may include an engagement member, such as a catch 53 for locking a latch. In some embodiments, the docking member may include a release member, such as a button, a lever, a slider, etc., to releasably secure the cassette 11 in the console 12. In some embodiments, the docking member may be a breakable clip that must be broken or otherwise disabled to remove the cassette 11 from the console 12. This feature can prevent the cassette 11 from being reused after removal, effectively making the cassette 11 a disposable cassette 11 for single use.
[0066] Fig.12 A box 31 is shown which may be similar to the box 11 in some or all aspects. As shown, the box 31 is docked with a console 32, which includes various sensors. For example, in some embodiments, the console 32 may include a pressure sensor 33 for aspiration, a box placement sensor 34, a pressure sensor 35 for perfusion, a bubble detection sensor 36, and / or a box identification sensor 37. In some embodiments, the sensor may be used to generate an alarm and / or warning of an incorrect or undesirable situation. In some embodiments, the sensor may be used to automatically stop or prevent system operation, or automatically enable and / or control system operation. In some embodiments, the sensor may use a sensor threshold to establish a safe operating parameter. In some embodiments, some or all sensors may be combined, such as a combined pressure sensor for detecting pressure in the aspiration and perfusion circuits, a combined pressure and bubble sensor, or other appropriate combination. In some embodiments, the perfusion and / or aspiration circuit may include a flow sensor. In some embodiments, some or all of the pressure sensors 33 for aspiration, the box placement sensor 34, the pressure sensor 35 for perfusion, the bubble detection sensor 36, the box identification sensor 37, or other sensors may be included in the box 31 and docked with the console 32 via an appropriate connector.
[0067] The pressure sensor 33 for aspiration and the pressure sensor 35 for irrigation can be similar in some or all aspects. The pressure sensors 33, 35 can be used to measure the fluid pressure in the corresponding aspiration line and irrigation line. In some embodiments, for example Figure 8In the box 11 shown, the suction line 822 and the irrigation line 812 in the box 11 include corresponding exposed sections 822a and 812a. When the box 11 (or 31) is placed in the console 12 (or 32), these sections 822a, 812a cooperate with the pressure sensors 33, 35. In some embodiments, the suction line 822 includes a pipe for suctioning materials, as discussed above. The exposed section 822a can be compressed onto the pressure sensor 33 for suction. As the vacuum of the suction pump increases, the diameter of the suction pipeline section 822a will shrink and reduce the pressure on the sensor 33. The pressure change can be used to detect the obstruction at the end of the handpiece, which will cause the vacuum to increase until the obstruction is eliminated. Similarly, in some embodiments, the irrigation line 812 includes a pipe for irrigation fluid, as discussed above. The exposed section 812a can be compressed onto the pressure sensor 35 for irrigation. As the fluid pressure increases, the diameter of the perfusion tubing segment 812a expands and increases the pressure on the sensor 35. The pressure change can be used to detect whether there is flow through the perfusion tubing 812, which indicates whether the perfusion fluid source (e.g., IV bag) is empty or full. In some embodiments, some or all of the tubing in the box that interfaces with the pressure sensor can be protected with a filter. For example, a filter can be included in the fluid flow path at or before the exposed segment 822a and / or 812. In some embodiments, such as when the sensor is located in the box 11, a filter can be included in the fluid flow path before the pressure sensor.
[0068] In some embodiments, the box placement sensor 34 can detect the correct placement of the box 11, 31 in the console 12, 32. In some embodiments, the box placement sensor 34 can be a switch activated by a spring-loaded pin. When the box 31 is correctly placed in the console 32, it presses the spring-loaded pin, which pushes the lever on the switch. When the switch is activated, it indicates that the dark box 31 is correctly in place. In some embodiments, the box placement sensor 34 includes a plurality of spring-loaded pins, each of which has a respective switch. This arrangement can advantageously detect the correct alignment of the inserted box 31. In some embodiments, the box placement sensor 34 can include an electrical switch that must be engaged before using the system, such as automatically locking the system until the box 31 is correctly inserted. In some embodiments, if the box 31 is not correctly inserted, the box placement sensor 34 can trigger an alarm or other warning.
[0069] In some embodiments, the bubble detection sensor 36 can be used to detect the presence of bubbles. In some embodiments, the perfusion fluid source may contain bubbles, for example, there may be a balloon in an IV bag used as a saline perfusion fluid source. The perfusion pressure sensor 35 discussed above can be used to measure the perfusion fluid flow rate and can detect pressure changes, but cannot identify the cause of the detected pressure. Therefore, there may be a situation where the perfusion path 812 pumps air or other gases instead of the intended perfusion fluid. The bubble detection sensor 36 is able to distinguish between gas (air) and liquid (saline) through the perfusion pipeline 812, so that the user can be reminded that they are not properly perfused. In some embodiments, some or all of the tubing in the box that interfaces with the bubble sensor can be protected by a filter. For example, the filter can be included in the fluid flow path at or before the exposed section 822a and / or 812. In some embodiments, for example, when the sensor is located in the box 11, the filter can be included in the fluid flow path before the bubble sensor.
[0070] In some embodiments, the box identification sensor 37 can be used to identify various system attributes. In some embodiments, the PCB (e.g., the circuit board 832 in the box 11) interacts with the elastic pin in the console 32. When the pin contacts the pad on the PCB, the console 32 will be able to detect the information of the box 31. For example, the box identification sensor 37 can be used to identify the box type, box manufacturer, perfusion fluid type, sterilization state, number of uses, expiration date, handpiece type and / or size and / or clinical operator. This information can be encoded in the pin discussed above or by other hardware encoding. In some embodiments, information can be encoded by software read by the box identification sensor 37 and / or the console 32. In some embodiments, the box identification sensor 37 can be included on a circuit board, which is also used to dock with the box circuit board (e.g., the circuit board 832 discussed above) to deliver power to the handpiece when the box 31 and the handpiece 400 are connected. In some embodiments, the identification sensor can be included in the handpiece and / or the handpiece connector. For example, a handpiece may include handpiece type, handpiece manufacturer, irrigation fluid type, sterilization status, number of uses, expiration date, handpiece type and / or size, and / or clinical operator, as well as other characteristics described above.
[0071] Fig.13A -C shows an embodiment of a console 1300 having a cartridge interface 1310. Fig. 13B As shown, the cartridge 1320 slides into the interface 1310 until it is fully seated, as shown in FIG. Fig. 13C In some embodiments, Fig.13A -C, the box 1320 slides horizontally. In some embodiments, the box 1320 slides vertically, as discussed above Figure 7 and Fig.12 In some embodiments, the cartridge 1320 engages the interface 1310 by twisting or rotating, snapping or pushing into the console 1300, and / or a combination of movements (eg, pushing and twisting, or sliding and then rotating) to lock into place.
[0072] Fig.14 An embodiment of a console 1400 is shown, including an aspiration motor 1410 having a diaphragm pump connector 1412, an irrigation motor 1420 having a diaphragm pump connector 1422, and an electromagnetic pinch valve 1450. As discussed above, in some embodiments, the diaphragm pump connectors 1412 and 1422 interface with the diaphragm connector 56 on the back of the cassette 11, respectively, to allow the motors 1410 and 1420 to actuate the diaphragm 27 in the cassette 11 to allow fluid to flow. The electromagnetic pinch valve 1450 operates a flow correction circuit, as discussed above.
[0073] In some embodiments, the system 100 can be used for any of a variety of surgeries. In some embodiments, the system 100 can be used to perform an ultrasound-guided percutaneous tenotomy. In some embodiments, a handpiece (e.g., handpiece 500) delivers ultrasonic energy at a preselected frequency to debride musculoskeletal tissue when the distal end of the handpiece is percutaneously inserted into or near a target musculoskeletal tissue site. In some embodiments, the system 100 enables a user to fully identify the target tissue site 300 at the time of surgery without having to cut the patient's skin. In some embodiments, the delivery device 102, 500 can be pre-tuned to deliver ultrasonic energy at a frequency that reduces the likelihood of trauma to healthy soft tissue while promoting debridement of diseased tissue. The percutaneous, minimally invasive nature of this procedure facilitates access and treatment of such body tissue under local anesthesia as part of an outpatient-based procedure.
[0074] Any values of threshold values, limits, durations, etc. provided herein are not intended to be absolute, and thus can be approximate. In addition, any threshold values, limits, durations, etc. provided herein can be determined or changed either automatically or by a user. In addition, as used herein, relative terms such as exceeding, being greater than, being less than, etc. relative to a reference value are intended to also encompass equal to a reference value. For example, exceeding a reference value that is a positive value can encompass equal to or greater than a reference value. In addition, as used herein, relative terms such as exceeding, being greater than, being less than, etc. relative to a reference value are intended to also encompass the inverse condition of the disclosed relationship, such as being lower than, being less than, being greater than, etc. relative to a reference value. In addition, although the boxes of various processes can be described with respect to determining whether a value meets or does not meet a specific threshold, these boxes can be similarly understood, for example, with respect to whether a value (i) is lower than or higher than a threshold, or (ii) meets or does not meet a threshold.
[0075] Features, materials, characteristics or groups described in conjunction with a particular aspect, embodiment or example will be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All features disclosed in this specification (including any accompanying claims, abstract and drawings), or all steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features or steps are mutually exclusive. Protection is not limited to the details of any foregoing embodiments. Protection extends to any novel one or any novel combination of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one or any novel combination of the steps of any method or process so disclosed.
[0076] Although certain embodiments have been described, these embodiments are presented only by way of example and are not intended to limit the scope of protection. In fact, the novel methods and systems described herein can be implemented in a variety of other forms. In addition, various omissions, substitutions and changes in the form of the methods and systems described herein can be made. It will be appreciated by those skilled in the art that, in some embodiments, the actual steps taken in the illustrated or disclosed process may be different from those steps shown in the accompanying drawings. Depending on the embodiment, some of the above steps may be removed and other steps may be added. For example, the actual steps or order of steps taken in the disclosed process may be different from those shown in the accompanying drawings. Depending on the embodiment, some of the above steps may be removed and other steps may be added. For example, the various components illustrated in the accompanying drawings may be implemented as software or firmware on a processor, controller, ASIC, FPGA or dedicated hardware. For example, hardware components such as processors, ASICs, FPGAs, etc. can include logic circuits. In addition, the features and attributes of the specific embodiments disclosed above can be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure.
[0077] The user interface screens illustrated and described herein can include additional or alternative components. These components can include menus, lists, buttons, text boxes, labels, radio buttons, scroll bars, sliders, check boxes, combo boxes, status bars, dialog boxes, windows, etc. The user interface screens can include additional or alternative information. The components can be arranged, grouped, displayed in any suitable order.
[0078] Although the present disclosure includes certain embodiments, examples, and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments or uses and obvious modifications and equivalents thereof, including embodiments that do not provide all of the features and advantages set forth herein. Therefore, the scope of the present disclosure is not intended to be limited by the specific disclosure of the preferred embodiments herein, and may be defined by the claims as presented herein or as presented in the future.
[0079] Conditional language, such as "can", "may", "possibly" or "may", unless otherwise explicitly stated or otherwise understood in the context of use, is generally intended to express that certain embodiments include, while other embodiments do not include, certain features, elements or steps. Therefore, such conditional language is generally not intended to imply that features, elements or steps are necessary for one or more embodiments in any way, or that one or more embodiments necessarily include logic for determining whether these features, elements or steps are included in any specific embodiment or will be executed in any specific embodiment with or without user input or prompting. The terms "include", "comprise", "have", etc. are synonyms and are used inclusively in an open manner, and do not exclude additional elements, features, actions, operations, etc. Moreover, the term "or" is used in its inclusive sense (and not in its exclusive sense), so that when used, for example, to connect a list of elements, the term "or" means one, some or all of the elements in the list. In addition, as used herein, in addition to having its ordinary meaning, the term "each" can also mean any subset of a set of elements to which the term "each" is applied.
[0080] Unless expressly stated otherwise, linking language such as the phrase "at least one of X, Y, and Z" is understood along with the context to be generally used to convey that an item, term, etc. can be any of X, Y, or Z. Thus, such linking language is generally not intended to imply that certain embodiments require the presence of at least one X, at least one Y, and at least one Z.
[0081] Language of degree as used herein, such as the terms "approximately," "about," "substantially," and "approximately" as used herein, refers to a value, amount, or characteristic that is close to a stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "substantially," and "substantially" may refer to an amount that is within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of a stated amount. As another example, in certain embodiments, the terms "substantially parallel" and "substantially parallel" refer to a value, amount, or characteristic that deviates from exact parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees.
[0082] The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere in this specification, and may be limited by the claims presented in this section or elsewhere in this specification or presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims, and not limited to the examples described in this specification or during the prosecution of the application, which examples should be interpreted as non-exclusive.
[0083] It should also be understood that, unless otherwise specifically stated or otherwise understood in the context of use, conditional language used herein, such as "can", "may", "possibly", or "may", unless otherwise explicitly stated or otherwise understood in the context of use, is generally intended to express that certain embodiments include, while other embodiments do not include, certain features, elements, and / or steps. Therefore, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way necessary for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether these features, elements, or steps are included in any specific embodiment or will be executed in any specific embodiment with or without author input or prompting. The terms "include", "comprise", "have", etc. are synonymous and are used inclusively in an open manner, and do not exclude additional elements, features, actions, operations, etc. In addition, the term "or" is used in its inclusive sense (and not in its exclusive sense), so that when used, for example, to connect a list of elements, the term "or" means one, some, or all of the elements in the list. In addition, unless otherwise specified, the articles "one", "an" and "the" used in the present application and the appended claims should be interpreted as "one or more" or "at least one". Similarly, although operations can be depicted in the drawings in a particular order, it should be recognized that these operations do not need to be performed in the particular order shown or in a sequential order, or all the operations shown must be performed to achieve the desired results. In addition, the drawings can schematically depict one or more exemplary processes in the form of a flow chart. However, other operations not shown can be incorporated into the exemplary methods and processes schematically illustrated. For example, one or more additional operations can be performed before, after, at the same time, or between any of the operations shown. Additionally, in other embodiments, the operations can be rearranged or reordered. In some cases, multitasking and parallel processing may be advantageous. In addition, the separation of various system components in the above-mentioned embodiments should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products. Additionally, other embodiments are within the scope of the following claims. In some cases, the actions listed in the claims can be performed in different orders and still achieve the desired results.
[0084] In addition, although the methods and devices described herein may allow for various modifications and alternative forms, specific examples thereof have been shown in the accompanying drawings and described in detail herein. However, it should be understood that the present invention is not limited to the specific forms or methods disclosed, but on the contrary, the present invention is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the various embodiments as described and the appended claims. In addition, the disclosure of any specific features, aspects, methods, performances, characteristics, qualities, attributes, elements, or the like associated with an embodiment or example herein may be used in all other embodiments or examples set forth herein. Any method disclosed herein does not have to be performed in the order in which it is recorded. The methods disclosed herein may include certain actions taken by practitioners; however, these methods may also include any third-party instructions that express or imply these actions. The scope disclosed herein also includes any and all overlaps, sub-ranges and combinations thereof. For example, "at most", "at least", "greater than", "less than", "between..." and other languages include the numbers listed. Numbers preceded by terms such as "about" or "approximately" include the recited number and should be interpreted based on the circumstances (e.g., as precise as reasonably possible under the circumstances, e.g., ±5%, ±10%, ±15%, etc.). For example, "about 3.5 mm" includes "3.5 mm". Phrases preceded by terms such as "substantially" include the recited phrase and should be interpreted based on the circumstances (e.g., as precise as reasonably possible under the circumstances). For example, "substantially constant" includes "constant". Unless otherwise noted, all measurements are made under standard conditions, including temperature and pressure.
[0085] As used herein, a phrase referring to "at least one" of a series of items refers to any combination of those items, including single members. As an example, "at least one of A, B, or C" is intended to cover: A, B, C, A and B, A and C, B and C, and A, B and C. Connective language such as the phrase "at least one of X, Y, and Z" is understood according to the context of common use to express that an item, term, etc. can be at least one of X, Y, and Z, unless otherwise specifically stated. Therefore, such connective language is generally not intended to imply that certain embodiments require at least one of X, at least one of Y, and at least one of Z to exist. The headings provided herein, if any, are for convenience only and do not necessarily affect the scope or meaning of the apparatus and methods disclosed herein.
[0086] Thus, the claims are not intended to be limited to the examples or implementations shown herein, but are to be accorded the widest scope consistent with this disclosure, the principles and novel features disclosed herein.
Claims
1. A fluid infusion and / or suction device, comprising: Reusable parts include: Pump motor, and Power supply; and Disposable parts, including: Handpiece; a power cord connected to the handpiece and connectable to the power source; and Diaphragm, Wherein, when the reusable part is connected to the disposable part at the connection piece: The power source interfaces with the power cord to deliver power to the handpiece, the pump motor interfaces with the diaphragm to produce a diaphragm pump configured to provide fluid flow in the disposable portion; and The disposable portion separates the fluid from the reusable portion.
2. The device according to claim 1, wherein: The fluid is a irrigation fluid, the device further comprises a irrigation fluid source, and wherein the diaphragm pump provides irrigation fluid to the handpiece.
3. The device according to any one of claims 1-2, further comprising a collector, and wherein: The diaphragm pump provides aspiration fluid flow from the handpiece to the collector.
4. The device according to any one of claims 1 to 3, wherein: The disposable part also includes a conduit for carrying the fluid flow.
5. The apparatus of claim 4, further comprising a filter in the conduit.
6. The device according to claim 5, wherein: The filter is positioned to protect the diaphragm pump from particles in the fluid flow.
7. The device according to any one of claims 1 to 6, wherein: The connection includes a coupling mechanism that transmits motion from the diaphragm pump to the diaphragm.
8. The device according to any one of claims 1 to 7, wherein: The connection includes one or more sensing devices for sensing flow, bubbles and / or pressure.
9. The device according to any one of claims 1-8, wherein the disposable part includes one or more sensing devices for sensing flow, bubbles and / or pressure.
10. The device according to any one of claims 1 to 9, further comprising a collector, wherein: The flow is a suction directed from the handpiece to the collector.
11. The device according to claim 10, wherein: The collector is a removable collection bag.
12. The device according to any one of claims 1-11, further comprising a valve.
13. The device according to any one of claims 1 to 12, wherein: The handpiece also includes identification electronics.
14. A disposable fluid infusion and aspiration device, comprising: a power cord configured to connect to the handpiece and capable of connecting to a power source in the reusable console; Fill the diaphragm; Suction diaphragm; as well as a connection area configured to connect to the reusable console, Wherein, when the connection area is connected to the reusable console: The power cord receives power to deliver power to the handpiece, The irrigation diaphragm interfaces with a pump motor in the reusable console to provide irrigation flow, The suction diaphragm interfaces with a pump motor in the reusable console to provide a suction flow; and The irrigation flow and the aspiration flow are decoupled from the reusable console.
15. The device of claim 12, further comprising a filter.
16. The device of any one of claims 12-13, further comprising the handpiece.
17. The apparatus of any one of claims 12-14, further comprising one or more sensing devices for sensing flow, bubbles and / or pressure.
18. The device according to any one of claims 12 to 15, further comprising a collector, wherein: The suction flow directs fluid from the handpiece to the collector.
19. The device according to claim 16, wherein: The collector is a removable collection bag.