Independent surgical center
Abstract
An independent system for a surgical procedure comprising: a surgical tray (10, 201) for housing a first processing unit (301, 509); and a plurality of instruments (12-22) associated with the surgical procedure, wherein the surgical tray (10, 201) and the plurality of instruments are sterilized and unpacked together, and the first processing unit (10, 201) is configured to control at least one of the prepackaged instruments.
Term
1.6 yearsto projected expiry
Projected expiry 21 April 2028, counted from filing; an application has no term until it is granted.
- Priority
- Filed
- Published
- Today
- Projected expiry
16 claims: 13 independent, 3 dependent
- 1REIVINDICACIONES 1. Un sistema independiente para un procedimiento quirúrgico que comprende:una bandeja quirúrgica (10, 201) para alojar una primera unidad de procesamiento (301, 509);y una pluralidad de instrumentos (12-22) asociados con el procedimiento quirúrgico, en donde la bandeja quirúrgica (10, 201) y la pluralidad de instrumentos se esterilizan y se preempaquetan juntos, y la primera unidad de procesamiento (10, 201) se configura para controlar al menos uno de los instrumentos preempaquetados.
- 2El sistema de la reivindicación 1, en donde el procedimiento quirúrgico es un procedimiento quirúrgico oftálmico.
- 3El sistema de cualquiera de las reivindicaciones 1 a 2, en donde el procedimiento quirúrgico incluye realizar cortes de tejido biológico y aspiración de fluido.
- 4El sistema de cualquiera de las reivindicaciones 1 a 3, en donde al menos uno de la pluralidad de instrumentos incluye una segunda unidad de procesamiento (301), en donde la segunda unidad de procesamiento se configura para establecer comunicación con al menos otra de la pluralidad de instrumentos.
- 5El sistema de la reivindicación 4, en donde la segunda unidad de procesamiento se configura para establecer comunicación con la primera unidad de procesamiento (301, 509).
- 6El sistema de la reivindicación 4, en donde al menos uno de la pluralidad de instrumentos incluye controles de usuario (311) para ajustar los parámetros operativos de al menos otro de la pluralidad de instrumentos.
- 7El sistema de cualquiera de las reivindicaciones 1 a 6, en donde al menos uno de la pluralidad de instrumentos es estéril y que se puede usar dentro de una barrera estéril durante el procedimiento quirúrgico.
- 8El sistema de cualquiera de las reivindicaciones 1 a 7, en donde la pluralidad de instrumentos se preempaquetan juntos en un empaquetado estéril.
- 9El sistema de cualquiera de las reivindicaciones 1 a 8, en donde el procedimiento quirúrgico es un procedimiento quirúrgico oftálmico en donde al menos uno de la pluralidad de instrumentos se asocia con una instrumentación de cirugía oftálmica y la pluralidad de instrumentos conectados a la bandeja quirúrgica (10, 201) incluye un dispositivo de corte (20), un dispositivo de iluminación (18), y un dispositivo de infusión (14).
- 10El sistema de cualquiera de las reivindicaciones 1 a 9, en donde el procedimiento quirúrgico incluye realizar una vitrectomía usando una herramienta de corte de tejido biológico y aspiración de fluido (105).
- 11El sistema de cualquiera de las reivindicaciones 1 a 10, en donde la bandeja quirúrgica además aloja una fuente de energía (315).
- 12El sistema de cualquiera de las reivindicaciones 1 a 11, en donde la bandeja quirúrgica además incluye una pantalla o un altavoz configurados para dar como salida indicadores de estado o configuraciones de la pluralidad de instrumentos.
- 13El sistema de cualquiera de las reivindicaciones 1 a 12, en donde la primera unidad de procesamiento (10, 201) está en comunicación cableada o inalámbrica con uno o más de la pluralidad de instrumentos.
- 14El sistema de cualquiera de las reivindicaciones 1 a 13, en donde la bandeja quirúrgica comprende un LED óptico para generar salidas de estado.
- 15El sistema de cualquiera de las reivindicaciones 1 a 14, en donde la bandeja quirúrgica comprende botones o diales ajustables para recibir solicitudes de usuario para controlar la pluralidad de instrumentos.
- 16El sistema de cualquiera de las reivindicaciones 1 a 15, en donde la bandeja quirúrgica tiene generalmente una configuración plana en forma de U. Dispositivo deiluminación Otrosdispositivos
Independent claims16
120 paragraphs, as filed
p00001Independent surgical center
Field of the Invention
p00002The present invention generally relates to surgical systems, and more particularly to a surgical system that includes operable instrumentation without an external control console.
Background of the invention
p00003Innovations in medical surgery have allowed many to recover from conditions previously believed to be intractable or incurable. For example, several ophthalmic surgical procedures have been developed that repair parts of the human eye, which include internal components of the eye, to relieve different visual ailments. As medical surgery develops and expands in new areas of the human body, often with limited accessibility, a more complex surgical instrumentation develops. In addition, the more complex the surgical instrumentation, the greater the demand is usually for the accuracy of the surgical instrumentation.
p00004To increase the precision and accuracy in surgical procedures, control consoles are often integrated into surgical systems. Control consoles can be used, for example, to monitor the status of surgical instruments, and to perform rapid calculations and provide feedback to doctors and other medical personnel to assist in determining how to proceed with the surgical procedure. Ophthalmic surgical procedures are no different. For example, a vitrectomy, which involves the surgical removal of fluid inside the eye, is usually performed using instrumentation conducted by a computerized system housed in a large control console. The control console is generally fixed or housed in a large rolling unit outside the sterile barrier, and includes device modules that connect directly to the surgical instrumentation. With the control console located outside the sterile barrier, the surgeon or other qualified practitioner operates the instrumentation at the patient's level, while at least other medical personnel operate the controls on the control consoles under the direction of the surgeon.
p00005US 6251113 describes a system for controlling a number of ophthalmic surgical instruments. A computerized unit is located in an instrumentation car and is in communication through a data communications bus with the modules to control ophthalmic surgical instruments.
Summary of the invention
p00006The present invention is directed to an independently operable surgical system for performing surgeries and medical procedures, such as, for example, vitrectomies and other ophthalmic surgical procedures.
p00007An independent system for a surgical procedure as defined in claim 1 is comprised of a surgical tray for housing a first processing unit; and a plurality of instruments associated with the surgical procedure, wherein the surgical tray and the plurality of instruments are sterilized and prepackaged together, and the first processing unit is configured to control at least one of the prepackaged instruments. The instruments can be electrical instruments.
p00008A surgical system, which is not part of the present invention, may be comprised of a portable surgical tray that includes a processing unit; a plurality of instruments operatively coupled to the processing unit; and a user input device that provides a user input to control an operational parameter of one or more of the plurality of instruments, wherein the processing unit is configured to receive the user input and transmit an operational command to one or more more than the plurality of instruments.
p00009A self-powered surgical system for a surgical procedure, which is not part of the present invention, may be comprised of a surgical tray; a plurality of hand instruments; a power source in at least one of the surgical tray and a manual instrument; and a processing unit, where the processing unit is configured to execute program instructions,
p00011the program instructions that include instructions for: detecting energy from at least one energy source; direct the energy towards the plurality of hand instruments from at least one energy source; and establish communication with each of the plurality of manual instruments.
p00012A portable biological cutting and aspiration device, which is not part of the present invention, may include: a cutting tip; a fluid aspiration device; and an integrated control unit coupled to the cutting tip and the fluid aspiration device, wherein the control unit is configured to control the cutting and aspiration of the cutting tip and the fluid aspiration device.
p00013A portable infusion and aspiration device, which is not part of the present invention, may include an aspiration chamber; an aspiration line coupled to the biological tissue aspiration and cutting device, the aspiration line configured to suck matter detached from a surgical site within the aspiration chamber; an infusion chamber that has an infusion solution; an infusion line coupled to the infusion chamber and configured to inject the infusion solution into the surgical site to maintain pressure at the surgical site, where the aspiration chamber and the infusion chamber are included in a single disposable module.
Brief description of the drawings
p00014Fig. 1 is a block diagram of several instruments inserted in the eye in the course of performing a vitrectomy;
p00015Fig. 2a is a block diagram of a surgical system that includes an independent surgical center 10 according to an embodiment of the invention;
p00016Fig. 2b is a schematic illustration of an independent surgical center implemented as a surgical tray according to an embodiment of the invention;
p00017Fig. 3 is a block diagram of the internal components of an independent surgical center according to an embodiment of the invention;
p00018Fig. 4 is a process diagram of an initialization and communication establishment process for an independent surgical center;
p00019Fig. 5 is a block diagram of an independent surgical center implemented as a surgical tray in communication with a handpiece;
p00020Fig. 6 is a process diagram of a process executed by the independent surgical center processing unit according to an embodiment of the invention;
p00021Fig. 7 is an alternative independent surgical center;
p00022Fig. 8 is a block diagram of an independent surgical center performed as the infusion / aspiration cartridge; and
p00023Fig. 9 is a block diagram of yet another independent surgical center.
Detailed description
p00024Fig. 1 is a block diagram of several instruments inserted in the eye in the course of performing a vitrectomy. The vitreous is a normally clear, jelly-like substance that fills the center of the eye, for example, the eye 101. In some cases, blood, detritus, or tissue from a vitreous scar may accumulate, which partially or totally obstructs vision. In these cases, vitrectomy, or surgical removal of all or part of the vitreous of the eye can be performed.
p00025To perform a vitrectomy, a number of incisions are made in the sclera 103, the white part of the eye. Several instruments access the center of the eye through the incisions. The instruments inserted in Fig. 1 include a manual tool for biological tissue cutting and fluid aspiration ("handpiece") 105, a lighting device 107, and an infusion device 109. The handpiece includes a biological tissue cutter to cut or detach parts of the vitreous from the eye, as well as an aspirator to remove the cut or detached parts. The infusion device is used to replace the fluid and maintain adequate pressure in the eye. The lighting device is used as a light source to see inside the center of the eye during the procedure.
p00026The present invention is directed to an independent surgical system operable without the use of an external surgical console. In some embodiments, for example, a modular surgical system consists of independent surgical instrumentation. Surgical instrumentation may include, for example, a series of interwoven hand instruments, such as the cutting handpiece and the lighting device. In some modalities, individual instruments contain self-sustained operational intelligence and do not depend on commands from a control source, providing a surgeon or other medical professional with full and independent control of each individual instrument within a sterile field.
p00027Although the independent surgical center is described herein primarily in connection with vitrectomy procedures, one skilled in the art should recognize that the center may also be configured for other medical procedures performed on all tissues that include the eye or other parts of the human body. . For example, phacoemulsification involves the removal of a lens from an eye using a similar handpiece that includes an ultrasonic cutter and a vacuum cleaner. For several other applications, the instruments may include, for example, different cutters, vacuum devices, irrigation devices, vision devices, and / or lighting devices, among others. According to one embodiment of the invention, most, if not all, of the instruments of a particular system contain the circuitry and energy to control and operate themselves independently of one another. In some embodiments, the instruments can communicate with each other through a wireless connection, and an instrument can act as a main processing or control unit. Therefore, although the description can often refer to details of the embodiments of the invention configured for a vitrectomy, the description is not intended to represent the only application in which the invention can be used. Although different procedures may involve slightly different modalities, it should be understood that equivalent functions and structures can be performed by the different modalities that are further intended to be encompassed within the scope of the invention.
p00028Fig. 2a is a block diagram of a surgical system that includes an independent surgical center 10 according to an embodiment of the invention. The independent surgical center 10 acts as a control device for the surgical system and is operatively coupled to one or more medical instruments, such as, for example, one or more vision devices 12, infusion devices 14, irrigation devices 16, lighting devices 18, and cutting devices 20, via wired or wireless connections 24f, 24e, 24d, 24c, 24b. The independent surgical center 10 is also operatively coupled to other devices 22 via the wired or wireless connection 24a. Such other devices may include, but are not limited to, pedals, secondary display screens, audio outputs, and the like.
p00029According to one embodiment of the invention, the independent surgical center 10 is also optionally coupled to a personal surgical center through the connection 24g. Preferably, the 24g connection is a wireless connection, although the connection may alternatively take the form of a wired connection. As described in detail in WO 2008/131362, derived from the applicants request of the United States entitled Personal Surgical Center filed on the same date as the United States application from which this request is derived, the personal surgical center 26 is configured to monitor the configurations of the various medical instruments while the actual control of the medical instruments is through the independent surgical center 10 and / or through logic and circuitry included in the medical instruments themselves. In this regard, the independent surgical center 10 and the medical instruments 12-20 are located within the sterile field in which surgery is performed, while the personal surgical center 26 is located outside the sterile field. In this way, the surgeon has direct access and control of the independent surgical center 10 and the instruments during surgery.
p00030The various connections 24a-24g of the independent surgical center 10 can be wired or wireless. A wireless connection can be, without being limited to, a wireless local area connection, such as, for example, an 802.11 connection, a personal area network connection such as, for example, Bluetooth, or any other radio or cellular connection Conventional in art. A wired connection can be, for example, a serial bus, a parallel bus, an Ethernet connection, or the like. For example, the connection 24b between the cutting device 20 and the independent surgical center 10 may be a wired connection. Additionally, the infusion and aspiration lines can connect the infusion device and the irrigation device to the independent surgical center 10 and / or the cutting device 30.
p00031The independent surgical center 10 includes the circuitry, energy, and logic to drive and control one or more of the medical instruments. According to one embodiment of the invention, the independent surgical center 10 is performed as a surgical tray. According to another embodiment of the invention, the independent surgical center is performed as a particular medical instrumentation such as, for example, an infusion / aspiration module. According to this last modality, the particular medical instrumentation not only has the logic and circuitry to control it, but also acts as a control center to control the functionality of some or all other instruments.
p00032Fig. 2b is a schematic illustration of an independent surgical center implemented as a surgical tray according to an embodiment of the invention. In the embodiment illustrated in Fig. 2, surgical tray 201 houses and controls several medical instruments that can be associated with different surgical procedures. In some embodiments, the surgical tray of Fig. two It provides a sterile environment to package the individual instruments before, and in some cases after, a procedure is performed. In some embodiments, the tray, and the instruments held in the tray, are designed to be discarded after a single use.
p00033In the embodiment illustrated in Fig. 2b, the tray houses several manual instruments and removable surgical supplies, including a handpiece 203, an infusion line 205, a lighting device 207, a speculum 209, a syringe 211, cannulas 213, swabs 215, and a supply of artificial tears 217. The tray also houses a cartridge that includes a suction chamber 219, an infusion chamber 221, and a pump or similar device for each respective chamber. In the embodiment illustrated in Fig. 2b, the handpiece is coupled to the suction chamber 219 through the suction line 210, and to the infusion chamber 221 through the infusion line 205.
p00034According to one embodiment of the invention, the tray is in wired or wireless communication with one or more pieces of surgical instrumentation housed in the tray that require power or control from the tray. The tray may also be in wireless communication with other devices not housed in the tray, for example, a pedal, and / or an external monitor. The tray can act as a means of communication between each of the instruments of the surgical system. In modes where the tray communicates with an external monitor, the entire system is generally independently operable, with the monitor typically serving only as a data collection, display and storage capability.
p00035According to one embodiment of the invention, the various medical instruments, which include the tray, are designed to be portable, lightweight, and inexpensive. In some embodiments, the tray includes internal circuitry and various components to control the various medical instruments. Internal components may include, for example, a processing unit, user controls, a power source, and a plurality of different interface devices. The processing unit may be, for example, a microprocessor based unit, an ASIC, or the like. The interface devices may include, for example, a wireless communication interface for communicating with the other instruments of the surgical system. The power source, for example, a battery, allows the tray to be energized independently, and in some modes, provides power to devices connected to the tray, such as the handpiece. In some modes, the tray may also include a screen or speaker, which can output several status indicators or configurations of the connected instruments.
p00036In some embodiments, the tray is designed for single use only, and the instruments in the tray are prepackaged together in sterile packaging. In these modalities, the packaging can be opened, and the tray and components within the tray, activated, within a sterile operating field just before performing the surgical procedure. This gives a medical professional access to and control of all applicable surgical instrumentation within the sterile field, which includes any controls and status indicators of instruments located in the tray. In some modes, after activation, the tray can perform an initial scan or a similar information retrieval process, to determine the available devices or instruments with which it can communicate during the procedure. The tray can establish communication lines, usually wirelessly, with the various different instruments in the tray.
p00037According to one embodiment of the invention, the tray is connected to the handpiece 203 and the infusion line 205. In biological tissue cutting applications, the handpiece can include a biological tissue cutter, and can be connected to the tray through the fluid aspiration line 210. In operation, the cutter cuts or detaches biological tissue, and the aspiration line sucks the detached tissue, where it is collected in the isolated aspiration chamber 219. Infusion line 205 can be used to inject the surgical site with fluid or gas solutions or other materials to replace the aspirated tissue. For example, in vitrectomies, the pressure is maintained within the eye through the infusion of a balanced saline solution to replace the aspirated vitreous. Infusion fluids can be kept in an infusion chamber of the tray, or alternatively in a sealed infusion bag or bag held in the infusion chamber, and infused into a patient through the infusion line at a rate determined by the controls located in the tray. According to one embodiment of the invention, both the suction chamber 219 and the infusion chamber 221 reside in a single disposable module.
p00038In some embodiments, the operating parameters for the different instruments, for example, the cutting speed, the suction pressure, the infusion rate, and the lighting level, can be controlled directly through the individual devices used to perform each function. respective. For example, the handpiece may include controls to control the cutting speed and suction pressure, providing a surgeon with more direct control over the procedure. Alternatively, the input devices coupled to the tray can be used to control the parameters of one or more of the medical instruments. An illustrative input device is a pedal wirelessly connected to the tray. A surgeon can use the pedal to control, for example, cutting speed and suction pressure. The tray receives the changes to the cutting speed and / or the suction pressure, and in turn controls the handpiece based on the input received. Similarly, the level of illumination can be controlled directly in the lighting device, and the infusion rate can be controlled either by controls located in the infusion line or in the tray. One skilled in the art should recognize that other input devices such as levers, switches, and / or buttons can be used for control input in addition to or in place of the pedal.
p00039The tray can also communicate with the various instruments to retrieve status information, for example, instrument configurations, current operating parameters, and fault conditions, from the various instruments. For example, although the lighting device is completely detachable from the tray, and can be operated and controlled independently of the tray, the tray can nevertheless receive information about the current lighting level and communicate that information to the surgeon or practitioner. According to one embodiment of the invention, the tray forwards the monitored information to the personal surgical center 26 through the data communication link 24g. In some modes, the information can be displayed on a built-in screen mounted on the tray. In other embodiments, other user output or feedback means may be incorporated, for example, a series of LEDs that indicate current parameter or status information of the various instruments.
p00040Fig. 3 is a block diagram of the internal components of an independent surgical center 10 according to an embodiment of the invention. According to the embodiment illustrated, the independent surgical center 10 includes a processing unit 301 connected and in communication with a wireless communication interface 303, a status indicator such as a monitor or collection of LED 305, a suction device 307, an infusion device 309, a plurality of user controls or other input devices 311, and other components or circuitry 313. A power source 315 can also be connected to the various components, and provide power to operate the other components. The infusion device can also be connected to a supply of infusion fluid or gas 317, for example, a balanced saline reservoir.
p00041The process unit 301 facilitates the operation of one or more instruments by sending control commands to those instruments, and acts as an information resource by collecting current parameter settings and other status information from the same or other instruments of the surgical system. In some embodiments, status information is collected from all connected instruments and communicated by the tray to a surgeon or other user of the surgical system, as well as optionally to the personal surgical center 26.
p00042The processing unit 301 can control medical instruments based on user requests. In some cases, the requests may come from user controls located in the independent surgical center itself, in the form of, for example, adjustable buttons or dials. In other cases, user controls can be received from connected devices, for example, the handpiece or infusion line as illustrated in Fig. 2b. In still other cases, control or adjustment requests can be received from remote instruments of the surgical system, for example, the lighting device 18, or for example, a pedal, via the wireless communication interface 303.
p00043The processing unit 301 processes the user requests and generates command signals to send to the instruments or devices for which the settings are intended. In some embodiments, the independent surgical center 10 can be configured to direct or control the operation of particular devices in the surgical system. For example, in the tray mode as the independent surgical center, the tray may be limited to controlling devices located in or within the tray itself, such as, for example, the aspiration device 307 and the infusion device 309. In some other embodiments, the processing unit 301 can serve as a central control unit for the various instruments and devices in the surgical system, and can receive all instrument adjustment requests and send associated control commands to the appropriate devices in the system.
p00044In operation, a user request can be received from a first device, for example, the handpiece, and intended to adjust a second device, for example, the aspiration device. The processing unit 301 can directly adjust the control parameters of the suction device, which can be, for example, a centrifugal pump, a venturi pump, a peristaltic pump, or any suitable vacuum-based system, or it can alternatively be an engine that controls a syringe or piston to apply vacuum pressure. Similar adjustments can be made to a connected infusion device, which may be, for example, a general disposable pump, a peristaltic pump, a Harvard apparatus syringe pump, a spring loaded syringe, or an IV pole. In some embodiments, an infusion solution supply is prepackaged with the system, the solution that is appropriate for the particular application for which the system is intended. In vitrectomy procedures, the prepackaged solution may be a sterile balanced saline solution. If a pump is used, it can pressurize the infusion chamber that keeps the saline solution balanced, causing the solution to enter the eye. Alternatively, a separate sealed infusion bag that keeps the saline balanced can be housed in the infusion chamber and connected to the infusion line. The pressure level of the infusion chamber can be increased, compressing the infusion bag, and forcing the balanced saline solution out of the infusion bag into the eye.
p00045Some surgical procedures may involve gas exchange, or a combination of fluid and gas exchange. In some embodiments of the invention, infusion device 309 can provide multiple sources of infusion, and maintain various types of liquids and gases for infusion. In these embodiments, the independent surgical center 10 may also include a control that determines the source of infusion that is applied in the surgical procedure. For example, for a surgical system that includes an infusion source with a liquid solution and an infusion source with an air fluid or gaseous matter, the independent surgical center 10 may provide a control for selecting between the exchange of liquid solution or the air fluid exchange.
p00046According to one embodiment of the invention, the independent surgical center also provides feedback to users in the form of configuration monitors and status indicators. The processing unit 301 receives status information from the plurality of connected instruments, typically performed through the data communication lines for the connected instruments, or through the wireless communication interface for the remote instruments. The processing unit compiles the information and communicates the information to the surgeon or another user. According to one embodiment of the invention, the independent surgical center may include a small monitor or screen to display information about the surgical procedure or instrumentation. Additionally, or instead of, a monitor, optical LEDs and / or audio speakers can be provided to generate status outputs or alerts for various system events.
p00047Fig. 4 is a process diagram of an initialization and communication establishment process for an independent surgical center. The process can be implemented as computer program instructions stored in memory (not shown) and invoked by the processing unit 301. The process of Fig. 4 can be performed when the system is initialized. In block 411, the process activates or begins to supply power to the processing unit 301. The independent surgical center 10 that houses the processing unit can also house the power source 315 to supply power to the processing unit. The system can be connected to an external power source, for example, an electrical outlet. However, an internal power source, for example, a battery, generally provides better maneuverability. Where the power source is housed in the system tray, the power source can also energize the aspiration and infusion devices 307, 309, and can also provide power to a connected handpiece. Where the independent surgical center 10 is performed as the surgical tray, the energy to the independent surgical center 10 is activated once the tray is opened or removed from its packaging, through an automatic activation switch or a similar mechanism. The processing unit detects energy from the power source and activates the system. An additional user-controlled switch or control device can be provided to manually activate the power supply.
p00048In block 413, the process detects one or more devices or instruments that can be used during a procedure in which the independent surgical center is used. In this regard, the process invokes the wireless communication interface 303, such as, for example, a radio frequency identification (RFID) reader, and automatically interrogates one or more identification tags, such as, for example, an RFID , label attached to one or more devices or instruments or to the packaging that holds one of the devices or instruments individually or multiplely. The RFID tag transmits identification information (for example the device ID or model number) as well as specific information on the individual instruments, for example, instrument types, configuration parameters, and available power settings. Some instruments may be included in surgical packages that include specific surgical instrumentation associated with a particular procedure. The packages may include RFID systems that identify the instruments in the package, or alternatively, each of the available instruments may include a separate RFID tag, so that communication can be more easily established with each of the individual devices. In some modalities, for example, the modalities described with respect to Fig. 2a, the surgical tray may include instruments that can be used for several different procedures. In these embodiments, the system can be configured to provide the selection of a desired procedure, and the tray can identify each available instrument to determine if each instrument is to be used for the desired procedure.
p00049In block 415, the process establishes communication with the only or more identified devices. The communication can then be used to control the operation of the identified devices and / or to receive status information from the identified devices, it may not be necessary to establish wireless communication with all the identified devices. For example, the process can be configured to select the instruments to be used in a particular procedure in response to a user command, and establish wireless links with those instruments, rather than with all available instruments. The processing unit first directs a power source to supply power to a selected instrument before communication between the processing unit and the selected instrument can be established.
p00050In block 417, the process sends the initial configuration settings to the devices with which communication has been established. The wireless data received from the various connected instruments can be used to, for example, extract and configure the appropriate configuration or monitoring screens in the independent surgical center itself, an external status monitor coupled to the independent surgical center, and / or in the personal surgical center The wireless connection can also be used to transmit initial surgical configurations and instrument failure parameters to one or more of the individual instruments. Each independent surgical center can be preconfigured to perform a specific procedure, and the processing unit 301 can send initial configuration settings to one or more instruments based on the preconfigurations for a particular procedure. The personal surgical center may invoke the reading of user controls 311 or enter user preferences or patient data or statistics. The initial configuration settings may instead be based on more specific user or patient information provided through the user controls.
p00051Fig. 5 is a block diagram of an independent surgical center implemented as a surgical tray 505 in communication with a handpiece 503 the handpiece is a biological tissue cutting system and fluid aspiration. A suction line or tube 501 connects the handpiece 503 to the tray 505 to suction unwanted materials from a surgery site. In this regard, the tray includes a suction chamber and a suction device 507, for example, a pump or vacuum. The suction device provides suction or vacuum to the handpiece through the suction line 501, and a similar reservoir or chamber is provided for the collection of the aspirated materials through the line or tube. The aspiration chamber may be similar to the aspiration chamber 219 of Fig. 2b.
p00052The handpiece vacuum can be configured with an internal pump and a collection chamber. The suction line 501 would no longer be necessary, and the connection between the handpiece and the tray would be completely wireless.
p00053In Fig. 5, in addition to the aspiration device 507, the tray includes a processing unit 509, a power source 511, an infusion device 513, a wireless transceiver 515, and status indicators 517. The processing unit 509, the power source 511, the infusion device 513, the wireless transceiver 515, and the status indicators 517 may be similar to the processing unit 301, the power source 315, the infusion device 309 , wireless communication interface 303, and monitor / LED 305 described with respect to Fig. 3. Handpiece 503 includes a biological tissue cutter 519 and a set of user controls 521. The components in the tray and the handpiece can be arranged differently. There may also be different combinations of components, including several components not included in Fig. 5, which may be included in other embodiments of the invention, depending on the application of each respective system.
p00054The user controls 521 included in the handpiece can, for example, control the cutting speed of the cutter in the handpiece, or for example, the aspiration level of the aspiration device, located in the tray, or both. Generally, user controls associated with a particular instrument or component of the system are located in that particular instrument or component, providing intuitive device-control associations and easier access to system users. User controls on the handpiece can be connected to and operated according to the processing unit
p00055509 The handpiece may also receive additional instructions or operating parameters, for example, a maximum allowable cutting speed from the processing unit. The cutter 519 can communicate with the processing unit also, for example, to transmit status information about the current cutting speed. In addition, the power source 311 of Fig. 5 is housed in the tray, providing power to the components of the tray. An electric line 523 can be attached from the tray to the handpiece, to facilitate communication between the handpiece and the tray, as well as supplying power to the handpiece components.
p00056The suction device 507 housed in the tray can be one of several different vacuum instruments, for example, a centrifugal pump, or a suitable vacuum-based alternative system. Controls for the suction device can be provided on the handpiece, or on the tray. Controls for the aspiration device can be provided on another instrument, for example, a pedal, in wireless (or wired) communication with the tray. The processing unit 509 retrieves the requests for adjustment of the aspiration from one of the various controls, and applies the adjustments to the aspiration device 507. The adjustments may cause the aspiration speed of the aspiration line, and consequently the speed of handpiece aspiration, fluctuate.
p00057The infusion device 513 housed in the tray is typically connected to an outgoing infusion line (not shown). The infusion device may be one of several different infusion instruments, for example, a Harvard apparatus syringe pump, or for example, a spring loaded syringe. The infusion device supplies different fluids or gases to a surgical site through the infusion line, the particular fluid or gas depending on the particular surgical procedure performed. In vitrectomies, for example, a sterile balanced saline solution is provided to the eye by the infusion device. The infusion rate of the infusion device can be controlled by the processing unit 509 of the tray based on, for example, the aspiration rate. In some applications, the infusion rate can be synchronized with the aspiration rate, to maintain a constant pressure or a constant volume at the surgical site. The tray can provide an independent set of user controls for the infusion rate, so that the infusion rate can be adjusted independently of the aspiration rate.
p00058In Fig. 5, the tray also communicates wirelessly with the other instruments in the surgical system through the wireless transceiver 515. The tray can act as a control device and can be used to control the functionality of some or all other instruments. . For example, for a vitrectomy procedure, possible wirelessly connected devices may include, a lighting device, a pedal, and an external monitor. In some cases, connected devices can be used to control certain aspects of the system. For example, the pedal may provide an alternative mechanism to control the cutting speed and the level of aspiration of the system. In these cases, the pedal can wirelessly send adjustment commands to the tray, where the processing unit routes the adjustment commands to the appropriate destination.
p00059In other cases, one or more of the instruments used to perform the surgical procedure are independently controlled and operated, and user controls for each respective instrument can be provided directly on the instrument. For example, the lighting device may be a manual, portable, self-powered LED lighting instrument or a comparable lighting device. Similar to the cutter controls that are provided on the handpiece, the lighting controls can be provided directly on the lighting device to control the operating parameters, such as the light intensity of the lighting provided. In these cases, wirelessly connected instruments can still transmit useful statistics, current settings, or status information in the surgical procedure to tray 505. The tray may also include a screen, speakers, or other status indicators 517, to communicate the information to a user of the system. An external monitor can also be wirelessly connected to the tray, and used to store compiled information in the surgical procedure. The various instruments can also communicate wirelessly with the tray, as well as with each other, to optimize the operating parameters.
p00060Fig. 6 is a process diagram of a process executed by the processing unit 509, 301 of the independent surgical center according to an embodiment of the invention. The process of Fig. 6 may represent the process that is performed by the processing unit housed in the tray in Fig. 5. In some embodiments of the invention, the process may be performed on another instrument or system component, based on where the processing unit is located in the system. In some embodiments, the system may include multiple processing units, and the process of Fig. 6 may be performed by one
p00061or more of the multiple processing units.
p00062In block 611, the process receives a signal from an instrument in communication with the independent surgical center. In the mode illustrated in Fig. 5, the tray 505 can receive the signals from an instrument through a wired connection, for example, the handpiece 503 as illustrated in Fig. 5, or it can receive the signals from an instrument through a wireless connection, for example, from the lighting device.
p00063In block 613, the process determines whether the received signal is a status update signal or an adjustment request signal. In some embodiments, the processing unit 509, 301 can be used to adjust the operating parameters of the selected instruments, and can also be used to process and communicate to a user the status of the same or other instruments. If the processing unit determines that the signal is an adjustment request signal, the process proceeds to block 615. If the processing unit determines that the signal is a status update signal, the process instead proceeds to block 619.
p00064In block 615, the process determines the device for which the adjustment signal is directed. In some embodiments, the adjustment signal can be received by a user control directly connected to the processing unit. For example, in the mode of Fig. 5, the adjustment signal may originate from a user control that controls the infusion device located next to the processing unit in the tray. In other embodiments, the adjustment signal can be received wirelessly from a user control located on a remote instrument, for example, a pedal associated with the tray. Some of the adjustment requests can be destined for the device or component from which the signal originated, while some of the adjustment requests can be destined for a different device, either a device in the tray or a completely separate instrument in the surgical system Regardless of the source of the adjustment signal, the processing unit determines the desired target device or instrument.
p00065In block 617, the process sends an adjustment command to the target device or instrument. Depending on the system configuration, the adjustment command may be an unaltered adjustment signal, where the processing unit acts as a switch or routing device for the system,
p00066or the adjustment command may be a completely new command signal generated by the processing unit based on an adjustment request signal received, for example, a signal received as described above with respect to block 611. In most of the system modes, after an adjustment command is sent to a respective device or instrument, the device's operating parameters or settings are adjusted according to the adjustment command.
p00067If the signal is a status update signal, the process, in block 619, determines the source of the status update signal. In most modes, the status update signals include status update information of the device from which the status update signal originated. The status update information may include various information about a source device, for example, current settings, operating parameters, remaining energy levels, instrument failure conditions, and other information. The status information for each specific instrument in the system is different depending on the functionality of the instrument. For example, a handpiece can provide the status of the cutting speed of a cutter or suction levels, while a lighting device can provide the status of lighting level.
p00068In block 621, the process updates the status of a device or instrument. If the originally received signal was an adjustment signal or a status update signal, the system processing unit can update the status information concerning the received signal. In cases where the signal was an adjustment signal, the processing unit can update the status information of the destination device to which the adjustment request was sent. In cases where the signal was a status update signal, the processor can directly update the status information of the device from which the status update signal originated, based on the content of the status update signal. The processing unit can display status updates, for example, on a monitor located in the instrument housing of the processing unit. Alternatively, status updates can be expressed visually through changes, for example, in LED indicators, or auditory through, for example, audio alerts issued through available speakers. In some embodiments, visual or auditory status indicators may be available in several other system instruments in addition to, or instead of, the instrument case of the processing unit. In these modalities, the processing unit can send the status update information to an instrument suitable for user exit or feedback purposes. According to one embodiment of the invention, the update information is transmitted to the personal surgical center to register in a registration file generated by the surgical procedure. After the status updates have been applied or registered by the system, the process returns.
p00069The center illustrated in Fig. 7 is operable independently of an external console, and operates similarly to the system described with respect to Fig. 2b. However, the system of Fig. 7 does not include a tray that acts as a central control unit. Instead, in Fig. 7, the system includes a separate suction / infusion cartridge 701, which includes isolated suction chambers 703 and infusion 705, and a separate device for each chamber, for example, a suction pump or similar device 707 and an infusion pump or similar device 709. The cartridge is connected to a handpiece 711 and an infusion line 713.
p00070The cartridge 701 as a central control unit instead of the tray as in Fig. 2b. The cartridge is in communication with other surgical instrumentations of the surgical system. Communication is generally established through wireless connections. In this regard, the cartridge is in wireless communication 715 with a lighting device 717 and other devices 719, for example, a pedal, an external console, and / or various status indicators associated with the system. The handpiece and the infusion line can also be integrated into a device separate from the cartridge 701, and be in communication with the cartridge through a wireless connection. The cartridge can serve as a means of wireless communication between the devices, including the handpiece and the infusion line. Where the cartridge communicates with an external console, the cartridge generally remains operable independently, with the monitor typically serving as a data collection and storage device. The external monitor may be able to serve the system in a larger capacity, for example, by controlling selected instruments from the system. However, in most of these applications the system remains functional independently without the external console.
p00071In Fig. 7, the cartridge is designed to be an independent instrument. In some embodiments, the cartridge includes a protrusion 721 on the back that allows the cartridge to hang to other equipment within the sterile field, for example, a surgical tray or a Mayo tray. The cartridge includes several components and devices for controlling the system, for example, a processing unit, user controls, a power source 723, and a plurality of different interface devices that may be similar to the processing unit 301, 509 , user controls 311, 521, and power source 315, 511 of Figs. 3 or 5 Interface devices may include, for example, the aspiration chamber and a port for a handpiece, the infusion chamber and a port for an infusion line, and a wireless communication interface for communicating with the other instruments of the system . The power source provides power to the cartridge and allows the cartridge to operate and feed independently of other devices, and can provide power to the connected devices, such as the handpiece. The cartridge can also include a screen and / or speaker, which can output several status indicators or configurations of the connected instruments.
p00072In some embodiments, the independent surgical center 10 and the individual instruments in the surgical system, which include the cartridge, are prepackaged together in sterile packaging. In these modalities, the packaging can be opened, and the independent surgical center 10 and the individual instruments activated, within the sterile operative field, giving the medical professional full access to the instruments and user controls of the independent surgical center 10 within the sterile field In some modalities, after activation, the cartridge can perform an initial scan to determine the available devices or instruments with which it can establish wireless communication for the surgical procedure.
p00073The handpiece 711 coupled to the cartridge 701 may include a biological tissue cutter 725, and can be connected to the cartridge through a fluid aspiration line 727. The aspiration line ends at a tip of the handpiece, with the cutter located near the tip. User controls located on the cartridge, handpiece, and / or infusion line may be available to adjust the aspiration and infusion levels of the system. The operating parameters for other instruments, for example, the level of illumination, can be controlled directly through the individual devices used to perform each respective function, or they can alternatively be controlled in the cartridge if the user controls for the other instruments are provided to the users in the cartridge.
p00074The cartridge can also act as a feedback or user exit system. The cartridge can communicate with the various instruments to retrieve status information and transmit the information to a user of the system. The information can be displayed on a built-in screen mounted on the cartridge. Other means of output or user feedback can be incorporated, for example, LED indicators representing current parameter or status information of the various instruments, or audio alerts when, for example, fault levels are triggered.
p00075Fig. 8 is a block diagram of an independent surgical center made as the infusion / aspiration cartridge 701 of Fig. 7. In many respects, the structure and functionality of the independent surgical center of Fig. 8 are similar to the structure and functionality of the center as discussed in Fig. 5, with a separate suction / infusion cartridge replaced in the center instead of the tray. The center includes handpiece 711 coupled to cartridge 701. In the embodiment of Fig. 8, the cartridge includes a processing unit and user controls 805, a power source 807, a suction device 809, an infusion device 811, and a wireless transceiver 813, while the piece of hand includes an 815 biological tissue cutter, as well as its own 817 wireless transceiver and its own power source
p00076819.
p00077Having different combinations of components housed in each instrument allows operational variations between different modalities. In Fig. 8, for example, the power source in the handpiece provides power to the rest of the components in the handpiece, allowing the handpiece to be energized independently of the cartridge. A dedicated power source therefore avoids the need for a power line that runs between the cartridge and the handpiece. In addition, the wireless transceiver housed in the handpiece allows the handpiece to communicate wirelessly 821 with the cartridge, also avoids the need for an electrical cable or communication line, such as the power line described with respect to Fig. 5. Therefore, in Fig. 8, the only remaining connection between the handpiece and the cartridge is the suction line 727, which transfers the aspirated materials from the return handpiece to an aspiration chamber in the cartridge. The handpiece can be operable completely independent of the cartridge, if an additional pump and suction chamber, for example, are located directly, or fixed next, to the handpiece. Similarly, with other instruments in the system, each independently operable instrument includes a dedicated power source, and may also include some means of wireless communication if communication with the processor 805 that acts as the main source of control is desired.
p00078In Fig. 8, the cartridge does not include a monitor or other status indicators. There may not be any status indicator provided by the independent surgical center to communicate status information and other useful system information to a user. The different types of status indicators can be located on one or more remote instruments from the independent surgical center. The status indicators located in each individual instrument can correspond, or in any other way relate to, the function that the instrument provides in the context of the surgical system.
p00079Fig. 9 is a block diagram of yet another independent surgical center. Fig. 9 may represent a possible arrangement of alternative components for the center of Fig. 7. As noted and as similarly described in Fig. 8, the system illustrated in Fig. 9 includes a handpiece 901 interconnected with a cartridge 903. However, in Fig. 9, the handpiece serves as a system processing center instead of the cartridge.
p00080In Fig. 9, the handpiece includes a processing unit and user controls 905, a power source 907, a wireless transceiver 909, and a biological tissue cutter 911. The cartridge includes a power source 913, a suction device 915, and an infusion device 917. The handpiece processing unit can serve as the system processing center, and establish communication with the various system instruments, as well as the processing units as described with respect to the tray of Fig. 5 and the cartridge of Fig. 8. Alternatively, a remote instrument of the system, for example, a lighting device, can instead house the main processing unit of the system. In Fig. 9, a wireless transceiver located in the handpiece is provided for the processing unit to communicate wirelessly with the remote instruments of the system. An energy source is also provided to energize the handpiece. The wireless transceiver and the power source can alternatively be housed in the cartridge, to reduce the size of the handpiece and make it easier for users to manipulate.
p00081In Fig. 9, the cartridge acts as a support instrument for the handpiece. The user controls for the aspiration device and the infusion device are located in the processing unit in the handpiece, but can alternatively be located in the cartridge where the user controls are located in the handpiece, the requests for Adjustment can be processed by the processing unit in the handpiece, and adjustment commands generated by the processing unit can be sent to the appropriate device in the cartridge. The handpiece processing unit can also control operating parameters of some remote devices with which the handpiece is connected wirelessly. The handpiece processing unit can also serve as a status updater, where status update signals are received by the processing unit from various system devices, are processed by the processing unit, and communicated to the user. of the system, through any of the various means of feedback or output as described above.
p00082Other embodiments of the invention may include several combinations of different components and differences in functionality. For example, the handpiece may include flow sensors to monitor aspiration levels at the surgical site, or aspiration sensors or detectors may instead be located at or near the aspiration chamber. In addition, in some embodiments, a suction adjuster or similar device can also be located in the handpiece, for example, a throttle valve or a similar variable orifice. The suction level can be monitored and adjusted by controlling the throttle valve or the hole diameter. In these modes, the pressure in the suction chamber can be maintained at a constant level. Several other features can also be incorporated in different instruments of the system. For example, the tray or cartridge may include a port for emptying the aspiration chamber and / or a port for filling or refilling the infusion fluid or gas in the infusion chamber. Many other possible features can be incorporated into the individual instrumentation in each respective system.
p00083The different instruments in the independent surgical system as described are easily portable, require low capital investment, are configured and disassembled efficiently, allow the presence of less personnel in the operating room, are adaptable for use in existing surgery centers , and are easily expandable. Each instrument is easily movable within operating rooms, surgery centers, and offices. A doctor's office is a potential new place where several different procedures can be performed. In a doctor's office, space is limited, and using large surgical instrumentation may not always be a realistic option. The highly portable instruments of the invention make the establishment of several procedures faster and more convenient, and may allow certain procedures to be performed even in a doctor's office. Portable surgical systems can also be used by visiting surgeons, and can potentially be taken to and used in remote locations, such as, for example, economically disadvantaged nations. In that same sense, the instruments described are also low cost. The instruments used in the systems discussed above are generally all manufactured as disposable units designed for single use.
p00084Additionally, the configuration times for the system are greatly reduced. In most of the embodiments of the invention, the initialization of the system and the establishment of communication between the different instruments are automatic, and most of the instruments are configured to be immediately ready for use. Connections, for example, a suction line that runs between a handpiece and a tray or cartridge, can be made before packaging, and infusion supplies can be prepackaged for each system. In addition, there is generally no need to connect additional cables, and there is no center console to which each individual instrument needs to be connected manually. Once a procedure has been completed, the instruments can be discarded. In some embodiments, some instruments, for example, pumps or suction or infusion devices, can be sent back to a manufacturer for recycling or reuse.
p00085A portable biological tissue cutter and an infusion / aspiration module that can operate separately from the independent surgical center are described below.
Handpiece of biological tissue cutting and aspiration
p00086The biological tissue and aspiration handpiece (for example, vitrectomy handpiece or other similar handpieces) is portable, lightweight and can be powered by battery to energize the cutter and / or aspiration. It can be used in the field, offices, surgery centers and operating rooms. The handpiece of biological tissue cutting and aspiration can be used as an independent instrument or together with the independent surgical center discussed above. The handpiece can be disposable and is connected to the suction / infusion module, which provides a suction pressure to the cutter. Fig. 7 illustrates an illustrative aspiration / infusion module 701 with the infusion line 713 that appears on the right and the biological tissue and aspiration handpiece that appears on the left. The left side of the module works to provide suction pressure to the handpiece of biological tissue cutting and aspiration, while the right side provides infusion.
p00087For example, the biological tissue and aspiration handpiece is a disposable handpiece such as that described in the applicants' US patent application entitled disposable vitrectomy handpiece, filed on December 21, 2007 and published as US 2008/0208233, which is addressed to experts. Additionally, the biological tissue and aspiration handpiece can incorporate battery power and a flow controller / throttle valve. The handpiece can communicate wirelessly (for example Bluetooth) with other surgical instruments, a monitor
p00088or internal or external speaker, or a control center in the suction / infusion module. Alternatively, the handpiece can communicate wirelessly with a personal surgical center, as described for example in the United States patent application entitled Personal Surgical Center, filed on the same date as this. The surgical parameters (for example the cutting speed, the suction pressure / flow rate) can be controlled directly on the handpiece, or through a pedal wirelessly connected to the handpiece. Such parameters can control a cutting tip, a suction pump, and the like. The controller circuitry can be incorporated directly into the handpiece, the surgical tray, or the aspiration / infusion module depending on how the handpiece is energized (ie by battery or through the aspiration / infusion module).
p00089As noted above, the biological tissue aspiration handpiece is an independent instrument, not used with an external control center. The handpiece is used in conjunction with other independent instrumentation, such as a lighting device. The controls for the handpiece are located in the handpiece itself, eliminating the need for a surgical console. The handpiece itself or the surgical tray may have a screen or speaker to inform the surgeon of current surgical settings and instrument failures. According to one embodiment, the handpiece includes a control unit that can be, for example, a microprocessor-based unit, an ASIC, or the like, and another circuitry described with respect to Fig. 9.
p00090As noted above, the biological tissue and aspiration handpiece can be used in conjunction with an aspiration / infusion module that includes a control center or together with a control center in an external, portable computer. Although it may be possible to connect the system to an outlet, battery power allows for better maneuverability of the handpiece. The battery can be placed inside the handpiece, the surgical tray or in the suction / infusion module itself. When the battery is placed inside the handpiece, it adds weight and size to the unit, reducing maneuverability and ergonomics. The suction / infusion module can be larger and heavier because the ergonomics in this instrument are not so critical. However, when the battery is placed in the aspiration / infusion module or the surgical tray, an electrical line would need to be attached to the handpiece along with the aspiration line.
p00091The wireless control (for example Bluetooth) can be mounted on the handpiece, the suction / infusion module, the surgical tray or all of the above. This will depend on how the device is configured. If the handpiece uses battery power and does not include a link to the aspiration module or the surgical tray, wireless communication will need to be mounted on all units. However, if there is a direct wired link between the two, wireless communications can then be mounted on any unit. In one application, wireless communication will be mounted on the suction / infusion module or the surgical tray to reduce the weight of the handpiece. Fig. 5 It illustrates a system in which battery power for the handpiece of biological tissue cutting and aspiration, wireless communication and aspiration all originate from the surgical tray.
p00092As noted above, the handpiece may include a screen or speaker to transmit information regarding the status, failure, cutting speed etc. of the instrument. For example, the handpiece may include an LED or speaker in the handpiece itself. Alternatively, the instrument and operation information may be indicated on a screen or speaker in the surgical tray or may be displayed in a center on a laptop.
p00093When used together with a center on a laptop, the biological tissue cutting and aspiration handpiece can communicate with the laptop directly or indirectly through the surgical tray. The center on a laptop can indicate the instrument and operation information, such as the current cutting speed, battery life (if applicable), and any failures. Additional information may also be received, such as the maximum allowable cutting speed and other surgical parameters. After the start, the handpiece of biological tissue cutting and aspiration can be identified in the center on a laptop and indicate if it has been used before.
p00094If flow detection or flow control is used, the sensors and actuators can be placed near or directly on the handpiece of biological tissue cutting and aspiration.
Suction / infusion module
p00095The suction / infusion module is portable, lightweight, and attached to a hand piece of biological tissue aspiration and an infusion line. The suction / infusion module can be made integrated with the surgical tray, but according to one modality, the module is separated from the tray. The module includes a control unit that can be, for example, a microprocessor-based unit, an ASIC, or the like, and another circuitry described with respect to Fig. 8 which allows the module to be the control center with respect to the module and / or the biological tissue cutting device.
p00096The module can be used in the field, offices, surgery centers and operating rooms. The module can be used as a stand-alone instrument or together with a surgical center, such as the one discussed above. Alternatively, the module can be used in conjunction with a personal surgical center, such as that described in WO 2008/131362 as discussed above.
p00097The aspiration / infusion module includes an infusion fluid (such as BSS) and an aspiration line. The aspiration is applied to a portable surgical handpiece, such as the biological tissue cutting and aspiration handpiece described above. The infusion joins an infusion line. The suction / infusion module may include a module for a gas-liquid exchange system. In addition, there may be ports to allow filling the BSS container (if required) or emptying the suction module. In addition, from the filling port, a surgeon can inject glucose or other medication (for example, dyes for visualization) for certain cases into the infusion module.
p00098When the aspiration / infusion module is used together with a personal surgical center, it is fed separately from the center. Although it may be possible to connect the system to a power outlet, battery power allows better maneuverability. The battery can be placed in the module itself or in the surgical tray, and energize any vacuum or infusion pumps as well as the handpiece of biological tissue cutting and aspiration. The power to the module can be turned on once the module or surgical tray is removed from the packaging (for example by turning on a switch, a button, etc.). This will initiate communication with the personal surgical center, if present.
p00099The suction / infusion module can be an independent instrument. The vacuum source can be mounted directly on the module itself. This may be a vacuum based system, similar to the venturi system, or a flow based system (peristaltic pump). Any suitable vacuum-based system can be used, for example, the vacuum source may consist of a small, battery-powered vacuum pump that provides vacuum pressure to the handpiece. Alternatively, the vacuum source may be an engine that controls a syringe / piston or a pump to apply vacuum pressure. The vacuum source can provide a constant vacuum level, which is loaded only when needed, or it can allow variable vacuum configurations. For flow-based vacuum, a small electric pump is added to the module instead of the peristaltic pump.
p00100The aspiration / infusion module communicates with the personal surgical center (when present) through a wireless link. When the center is not used, the module can communicate wirelessly with other instrumentation, such as the biological tissue cutting handpiece or lighting.
p00101The module may also include a pre-packaged vacuum source, which could be sent as an evacuated container. For use, the seal is broken, and the vacuum is applied to the handpiece. However, if the vacuum is lost, the module cannot be recharged.
p00102The flow control for aspiration can be controlled from the surgical handpiece. The flow control can be on the handpiece or on a pedal that can be connected wirelessly. The infusion control can be on the surgical handpiece, on a pedal, controlled by the height of an IV pole, or by a switch on the suction / infusion module itself.
p00103The vacuum in the module can be constant or variable. With a variable vacuum level control, the vacuum level is modified based on surgical settings. The vacuum joins directly to the vitrectomy aspiration line, and the flow is based on the vacuum level.
p00104If the vacuum is kept constant in the module, a variable throttle / orifice valve can be used to modulate the flow. In this scenario, all the vacuum would be maintained in the module and applied for almost all the time to the back of the suction line. The throttle valve would be used to modulate the flow level. A pressure sensor could be mounted upstream (as close to the handpiece of biological tissue cutting and aspiration) from the throttle valve. This would monitor the actual pressure and allow precise throttle valve configurations continuously. A flow sensor can be used to measure the flow rate instead of the pressure sensor. The flow can be modulated by adjusting the throttle valve. In any scenario, the overhead would be reduced by monitoring the flow near the handpiece. For a flow-based system, the surgeon would control the speed at which the vacuum pump removes tissue from the eye. The flow can be monitored by a sensor in the module or in the surgical instrument handpiece. This could be used for feedback of flow conditions.
p00105The infusion can be applied from a small disposable pump, a Harvard-type device mechanism, a spring loaded syringe, a small fluid pump, or by mounting the unit on an IV pole. A prepackaged amount of a sterile balanced saline solution (BSS) is provided for the procedure. The volume of BSS is the same or smaller than the volume of the suction module.
p00106If a disposable pump is used in the module, it can pressurize the module causing the BSS to enter the eye. A filter may be required to keep the inside of the infusion module free of airborne particles. Alternatively, a small sealed infusion bag can be mounted to the infusion line. The chamber around the infusion line is pressurized, causing the infusion fluid to enter the eye and not come into direct contact with the pressurized air. A peristaltic pump can also be used to infuse the eye. Alternatively, a Harvard-type device or spring-compressed syringe can be used to infuse the BSS.
p00107If an IV pole is used, the module could hang from many different designs of IV posts. In addition, a specific IV pole can be designed to work with the module. In this scenario, there would be a place for the module to adjust and the IV pole can provide power to the suction pump. An infusion pump would not be required to maintain pressure in the eye.
p00108As noted above, the aspiration / infusion module can communicate with a personal surgical center if such a center is used. It will send status information regarding the status of the instruments, and will receive information that can change the operable parameters. Once the suction / infusion module is turned on, the personal surgical center will be contacted to indicate the serial number, if it has been used before, and the type of instrumentation that is in use (25 vs. 23 gauge instrumentation) , which vitrectomy tube is in use, etc. The module can also communicate the battery status and any instrument failures that may occur.
p00109A wireless control can be mounted on the biological tissue and aspiration handpiece, the aspiration / infusion module, the illuminator, the surgical tray, or all of the above. This will depend on how the device is configured. If the biological tissue and aspiration handpiece uses battery power and is not directly linked to the aspiration module, wireless communication is mounted on both units. If there is a direct wired link between the two, wireless communication can be mounted on any unit, but it does not need to be mounted on both units. Wireless communication can be mounted on the module to reduce the weight of the handpiece.
p00110The aspiration / infusion module may include a chamber for the exchange of gas-liquid in the eye. This could be a syringe filled with the appropriate gas or mixture of gases. A Harvard type apparatus, a spring mechanism, or a pump could also be used to administer the gas-liquid exchange. The gas line would connect to the infusion line. A remote switch could be used to initiate gas exchange. The button for this can be on the lighting device, the surgical tray, the handpiece of biological tissue cutting and aspiration, or any other suitable place. The specific gases used depend on the specific procedures performed.
p00111The instrument settings, operating parameters, and status can be displayed in the suction / infusion module itself. Alternatively, this information can be directed and displayed in the independent surgical center, the module, or the personal surgical center connected (either directly or wirelessly) to the module. The information can be displayed on an external monitor or through a speaker connected (either directly or wirelessly) to the module. The information displayed may include infusion bottle pressure, cutting speed for the vitrectomy probe, fault conditions, battery conditions, and other operating parameters.
p001125 The module may include a protrusion on the back of the module that allows the module to hang from the surgical tray. Alternatively, the module is incorporated in the tray. The aspiration and infusion pump (s) and the battery can be separated from the aspiration / infusion modules, allowing the surgeon to completely separate the aspiration and infusion modules after the procedure and discard them. The pump or battery component can be renewed and then redeployed.
p0011310 Although the invention has been described with respect to certain specific modalities, those skilled in the art will have no difficulty in conceiving variations to the described modalities that in no way depart from the scope of the present invention. In addition, for those skilled in various subjects, the invention herein may suggest solutions to other tasks and adaptations for other applications. It is the intention of
p00114fifteen Applicants cover all such uses of the invention, and those changes and modifications that could be made to the modalities of the present invention chosen for the purpose of description without departing from the scope of the invention. Thus, the present embodiments of the invention should be considered in all aspects as illustrative and not restrictive.
91 members in 13 offices
Priority claims3
| Document | Office | Kind | Date |
|---|---|---|---|
| 925546P | United States of America | – | |
| 92554607 | United States of America | P | |
| 2008061058 | United States of America | W |
Members91
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| WO2008131350A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2008131357A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2008131362A2 | World Intellectual Property Organization (WIPO) | A2 | |
| US2008272023A1 | United States of America | A1 | |
| US2008281254A1 | United States of America | A1 | |
| US2008281301A1 | United States of America | A1 | |
| WO2008131362A3 | World Intellectual Property Organization (WIPO) | A3 | |
| US2009143734A1 | United States of America | A1 | |
| EP2136746A1 | European Patent Office (EPO) | A1 | |
| EP2139423A1 | European Patent Office (EPO) | A1 | |
| MX2009011163A | Mexico | A | |
| CN101765414A | China | A | |
| US2010174415A1 | United States of America | A1 | |
| JP2010524593A | Japan | A | |
| EP2136746A4 | European Patent Office (EPO) | A4 | |
| CA2786024A1 | Canada | A1 | |
| WO2011085127A1 | World Intellectual Property Organization (WIPO) | A1 | |
| US2011190690A1 | United States of America | A1 | |
| US2011276340A1 | United States of America | A1 | |
| US8177064B2 | United States of America | B2 | |
| US8177776B2 | United States of America | B2 | |
| AU2011204369A1 | Australia | A1 | |
| MX2012007900A | Mexico | A | |
| WO2012151062A1 | World Intellectual Property Organization (WIPO) | A1 | |
| CN102781361A | China | A | |
| EP2521509A1 | European Patent Office (EPO) | A1 | |
| US8323271B2 | United States of America | B2 | |
| EP2136746B1 | European Patent Office (EPO) | B1 | |
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Numbers
- Publication
- 2400538
- Application
- 8746468
Titles2
- Spanish
- Centro quirúrgico independiente
- English
- Independent surgical center
Classification
- CPC, 14
- A61F9/00736
- A61B2017/00199
- A61B2017/00221
- A61B2017/00225
- A61B2017/0023
- A61B2017/00544
- A61B2017/00734
- A61F9/00745
- A61B90/30
- A61B50/33
- A61B2050/3008
- A61B90/98
- A61B18/1206
- A61B2018/00601
- IPC, 4
- A61F9 007
- A61B17 00
- A61B19 00
- A61B19 02