WO2005102409A2 - A system for perfusion management - Google Patents
A system for perfusion management Download PDFInfo
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- WO2005102409A2 WO2005102409A2 PCT/US2005/013347 US2005013347W WO2005102409A2 WO 2005102409 A2 WO2005102409 A2 WO 2005102409A2 US 2005013347 W US2005013347 W US 2005013347W WO 2005102409 A2 WO2005102409 A2 WO 2005102409A2
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- perfusion
- arm
- coupled
- cell
- nucleic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16804—Flow controllers
- A61M5/16827—Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
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- A61B5/0031—Implanted circuitry
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- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
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- A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
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- A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
- A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
Definitions
- TECHNICAL FIELD The present application relates, in general, to detection and or treatment.
- a system includes, but is not limited to at least one arm; a control circuit coupled to said at least one arm; at least one receptacle coupled to said at least one arm; and at least one sensor coupled to said at least one arm, said system configured for implantation in an animal.
- a control circuit coupled to said at least one arm
- at least one receptacle coupled to said at least one arm
- at least one sensor coupled to said at least one arm, said system configured for implantation in an animal.
- a method includes but is not limited to: making a device, by providing a cavity for storing a receivable; and including at least one transmitting channel coupled to said cavity for delivering said receivable from said cavity to a predetermined location in an animal, cooperative with a monitoring system and a detecting system including logic or software operative for delivering said receivable.
- a method includes but is not limited to: placing a device comprising a receiving unit for storing a deliverable and in communication with a pliable duct; directing said pliable duct to a location; and administering said deliverable from said receiving unit to said location cooperative with a guiding system and a detecting system.
- related systems include but are not limited to circuitry and/or programming for effecting the herein-referenced method aspects; the circuitry and/or programming can be virtually any combination of hardware, software, and/or firmware configured to effect the herein- referenced method aspects depending upon the design choices of the system designer.
- Figure 1 is a front-plan view of a device for perfusion management 100.
- Figure 2 is a front-plan view of another aspect of the device for perfusion management 100.
- Figure 3 is an exploded view of an arm 104.
- Figure 4 is a schematic view of the control circuit 110 and devices in communication with the control circuit 110.
- Figure 5 illustrates an example wherein the device for perfusion management 100 is placed in a selected location in a human body 501.
- FIG. 1 shown is a front plan view illustrative of various exemplary perfusion management device(s) and/or process(es). Accordingly, the present application first describes certain specific exemplary structures of Figure 1; thereafter, the present appUcation illustrates certain specific exemplary processes. Those having skill in the art will appreciate that the specific devices and processes described herein are intended as merely illustrative of their more general counterparts.
- the device for perfusion management 100 includes a body portion 102 from which at least one arm 104 projects.
- a receptacle 106 witi- ⁇ ithe body portion 102 contains a fluid, for example, a fluid for treatment.
- a controllable valve 108 provides a path through which the fluid may travel to the at least one arm 104.
- a control circuit 110 provides a control signal that may open or close the control valve 108.
- the control circuit 110 may be connected to a sense line 112 that allows it to monitor the fluid levels within the receptacle 106. Additionally, a sense line 114 connects the control circuit 110 to a sensor 116 at the distal end of the at least one arm 104.
- each of the at least one arm 104 is in fluid
- Each receptacle 106 may be filled with a different fluid for delivery.
- the. one or more receptacles 106 may be coupled to a mixing chamber where the fluid contents of each receptacle 106 are present for mixing and the mixed contents enter the arm for delivery to a selected location.
- the choice of fluid in the receptacle 106 may depend, for example, on the purpose of the device, for example, treatment of colon cancer, treatment of breast cancer, or treatment of an arterial disease.
- the choice of fluid in the receptacle 106 includes, but is not limited to, for example, a chemical, a chemical compound, a protein, a lipoprotein, a glycoprotein, a sugar, a lipid, an antigen, an antibody, a cytokine, a peptide, a neurotransmitter, a hormone, an ion, a messenger a molecule, a nucleic acid, an engineered nucleic acid, a nucleic acid vector, a drag, a cell, a cell fragment, a cell organelle, a liposome, a pharmaceutical agent, a biological material, or a biological fraction.
- the receptacle 106 may also be utilized for storage and disposal of operational fluids.
- fluid-like substances such as gels
- fluidizable substances or non-fluid type substances such as small solid particles
- the nature of the fluid in the receptacle 106 includes, for example, and is not limited to, a liquid, a solution, a mixture, a gel, a colloid, a colloid of a suitable viscosity, a suspension, an emulsion, or any material of low shear-strength for delivery to a site.
- one or more fluids are delivered to one or more of selected locations by the device for perfusion management 100.
- the selected location may be, for example, in proximity to or within a tumor, a circulatory system, an aorta, a vena cava, a site of therapy, or a site of investigation in an animal.
- a pump 218 provides fluid at a controlled flow rate for delivery to a site from the receptacle 106.
- the type of pump is not critical to the invention and may include, for example, a mechanical pump, a piezoelectric pump, an osmotic pump, a source of
- a System for Perfusion Management pressure or a device for ma taining a positive flow of fluid through the device.
- fluid flow may be further modulated with micro valves and self- pressurizing fluidic reservoirs.
- the fluid may be delivered without a pump.
- fluid delivery may be controlled using a pressurized bladder, controlled dissolution or dilution of a material, a drip or gravity type of approach, or any other suitable approach to deliver an appropriate amount or an appropriate delivery-rate of the fluid.
- the sensor 116 is an array of sensors, deployed from one or more portholes, at the distal end of each of the extended parts 304.
- the portholes are sized and shaped to provide access through which the sensors 116 may be deployed.
- the portholes may include seals, stress reHef or other features appropriate for proper mechanical deployment. I-n one approach, one or more of the portholes can be controllably opened or closed to provide communication exterior to the arm or main body. The sensor 116 may be retracted within the porthole and deployed through the porthole.
- the array of sensors may include, but is not limited to, for example, sensors for detecting pressure, temperature, chemical, gas, electrolyte, flow, volume, composition, or concentration.
- microelectrodes such as, for example, solid-state microlectrodes, are sensitized with an agent for detecting a relevant interacter. Examples of the agent include, but are not limited to, for example, agonists of angiogenesis.
- the choice of sensor 116 depends on the physiological variable being monitored, treated, or controlled.
- physiological variable refers to any and all measurements relating to the functioning of a living organism in normal, sub-normal, or abnormal states.
- an operative tool 324 is coupled to the distal most extended part 304, or deployed from the porthole, or carried by the arm 104, further including a carrying line 334 in communication with the
- the operative tool 324 includes, but is not limited to, for example, one or more of a combination of, a tool positioner, an ablation device, a laser, a vacuum, a siphon 326, an evacuation device, a fluid dispenser 328, a cauterizer 330, a stent 332, a tissue-liquefying device, or a source of an electric charge or electromagnetic radiation 422.
- the vacuum or the siphon 326 is employed for removing a cell, a mass of cells, a tissue, a fluid, a gel, a sample, a debris, a contaminant, or other material for which removal is desired or appropriate.
- the ablation device operates for perturbing or reducing the structural integrity or viability of a cell, a mass of cells, an assembly of biological materials exhibiting shear strength, or a tissue.
- the assembly of biological materials includes, for example, blood clots, cartilage, or bone.
- the source of an electric charge or electromagnetic radiation 422 includes, but is not limited to, for example, steady state electric currents, time-varying electric currents, alternating electric currents, radio waves, microwaves, ultraviolet rays, infra-red rays, optical rays, terahertz beams, and the like.
- the operative tool 324 may include a set of devices having general or "multipurpose" utility.
- the operative tool 324 may include, but is not limited to, for example, a combination of the fluid dispenser 328, the siphon 326, and the ablation device.
- the operative tool combination for example, delivers the fluid or gel, ablates cells, and removes debris.
- the plurality of extended parts 304 may themselves be hollow forming a conduit for delivery of the fluid to a site, or for housing a circuitry coupling the control circuit 110 to the operative tool 324, or for housing a mechanism that guides the arm 104 or the plurality of extended parts 304.
- the device for perfusion management 100 shows a data transmitter 410, and a data receiver 408 coupled to the control circuit 110.
- An antenna 412 may be used for transmitting data to the
- the antenna 412 is shown diagrammatically, but may be a structure, such as a strip antenna, that may be integrated in a manner that does not impair or significantly perturb system performance.
- the control circuit 110 is depicted as having a processor 402 coupled to a memory 404 that provides data storage and retrieval capability, and a power source 406. Feedback circuitry or logic circuitry provides communi cation between the control circuit 110 and devices in communication with it. In some applications, a software program providing instructions may be stored in the memory 404 to control operation of the control circuitry or to store data gathered under control of the control circuitry. Additionally, the control circuit 110 may have components for system integrated digital data gathering, processing, storage, compression and transmission.
- the transmission components may communicate through the antenna 412 to a person, system, computer, or device exterior to the body.
- This communication can allow data gathered by the sensors to be displayed, stored or otherwise processed in the external environment. Additionally, this communication may allow for the processed data or a plurality of new data to be received from the exterior by the device for perfusion management 100.
- Data compression can allow the control circuitry to store data representing larger amounts of data to be stored in the memory 404 or to be transmitted to the exterior environment in a more efficient manner.
- one or more of the operative tools 324 are mounted on an actuator 414 which allows for the independent movement of each tool.
- one or more operative tools 324 may be mounted as a unit on one actuator 414 and moved as a group, for example, forming an aspirating-dispensing unit.
- the fluid dispenser 328 and the siphon 326 may be mounted together as a group.
- the actuator 414 may be a motor, a piezo electrically driven actuator, a micromechanical or electrical effector, or the like.
- the arm 104 may include an imaging device deployed from the porthole or from the distal end of the arm 104 or carried by a carrying line 334.
- imaging device being used herein to designate in general those
- control circuit 110 is coupled to the imaging device that includes a laser 418, or a source of light or scene-illuminating radiation, coupled to an optical feed line 420 to iUuminate an area.
- a charge coupled device is positioned to capture data from the illuminated area and provides an electronic signal indicative of the area imaged.
- Conventional circuitry then produces a digital representation that may be displayed, stored in the memory 404, or otherwise processed. The displayed image may serve, for example, for guiding the arm 104 to the selected location or for determining the efficacy of a treatment or a procedure.
- imaging device described herein is exemplary of imaging devices and that other imaging devices, including for example, raster and lme-scanning imagers, nonvisible spectral imagers, and fluorescence imagers, may be included.
- the device for perfusion management 100 is depicted implanted in an aorta 502 with the arm 104 traveling a blood vessel in a human body 501. Additionally, the device for perfusion management 100 is configured for full or partial placement in the human body 501. The configuration may incorporate a combination of the following criteria, including but not limited to, dimensions, composition, shape, power dissipation level, or texture.
- the body portion 102 is sized for implantation in proximity to the aorta 502 or the vena cava and the arm 104 is sized for traveling a blood vessel in an animal, for example, the human body 501.
- each of the extending parts 304 has about a two-fold decrease in diameter.
- the length of the arm 104 depends upon the distance between the selected location and the location of the body portion 102, and the route traveled by the arm 104 to arrive at the selected location. It will be appreciated by those having skill in the art that the arm 104 including the one or more of the operative tools 324 is of a size, dimension or shape operable for traveling one or more blood vessel of decreasing or increasing luminal diameter.
- the arm 104 and the one or more operative tool 324 may pass through the wall of a lumen, or trans-luminally, to the surrounding tissue for detecting, delivery of a treatment, or for sampling. It will also be appreciated by those having skill in the art that the arm 104 and the one or more operative tool 324 may pass through the wall of a lumen, or trans-luminally, to the surrounding tissue for detecting, delivery of a treatment, or for sampling. It will also be appreciated by those
- the device for perfusion management 100 and its components has a size, dimension, shape, material, and properties of flexion, retraction, and extension to allow for the steering, guiding, or positioning of the components of the device for perfusion management 100.
- the arm 104 may need to be steered around an occlusion or a fork in the vasculature.
- the arm 104 may need to retracted, repositioned and then extended in a new direction.
- Extending, retracting or repositioning of the arm 104 may be accomplished by techniques known in the art, for example, by using a guide wire or a by employing a shape polymer.
- the arm may be retracted and then "punched through" an occlusion to dislodge, penetrate, or grapple it.
- a laser beam, a shearing tool, a cutting tool, or a drug, for example, a lytic drug may be employed to degrade or reduce the occlusion.
- the siphon 326 or an evacuation device is employed to evacuate any debris, before the arm 104 continues traveling the circulatory system.
- the device for perfusion management 100 is not restricted to traveling the circulatory system but may be implanted in any tissue, such as, for example, nerve, epithelial, dermal, sub-dermal, connective, or muscle tissue. Additionally, the device for perfusion management 100 may be implanted in inter-tissue spaces, or inter-organ spaces, for example, those found within a body cavity.
- the device for perfusion management 100 includes an array of sensors 116 positioned across the plurality of extended parts 304 for monitoring, tracking, or mapping a gradient of temperature, pressure, flow, or material concentration in one or more locations.
- the one or more locations may be, for example, a tissue, an artery, or a vein.
- the device for perfusion management 100 has an auto-correct feature for correcting a sub-normal or abnormal gradient of temperature, pressure, flow,
- the device for perfusion management 100 has an auto-correct feature for detecting and correcting a sub-normal or abnormal gradient of temperature, pressure, flow, or material concentration.
- the device for perfusion management 100 may be composed of materials known in the art, for example, a metal, a ceramic, a glass, a plastic, a polymer, a biologically compatible material, or a combination.
- the device for perfusion management 100 may be made of helically-coiled stainless steel wire and coated with a polymer, such as, TeflonTM.
- the device for perfusion management 100 may be made of helically-coiled stainless steel wire and coated with a polymer and impregnated with one or more of a biological material, for example, including but not limited to, anti coagulants, or inhibitors.
- the device for perfusion management 100 may be present ex vivo.
- the device for perfusion management 100 is placed in proximity to the location on the animal, for example, the human body 501, and the at least one arm 104 directed to the selected location and an effective agent delivered in proximity to the selected location.
- the arm 104 may be retracted after such a delivery, leaving the device for perfusion management 100 in place at the location, until time for a future delivery of the effective agent or another procedure or operation.
- the maj ority of the device for perfusion management 100 is ex vivo while the arm 104 alternates between ex vivo and in vivo states.
- the device for perfusion management 100 is placed in proximity to the location within the animal, for example, the human body 501, and the arm 104 directed to a selected location and an effective
- the arm 104 may be retracted after such a delivery, leaving the device for perfusion management 100 in place at the location, until time for a future delivery or another operation.
- the majority of the device for perfusion management 100 is in vivo while the arm 104 alternates between retracted, partially retracted or unretracted states.
- the device for perfusion management 100 is operable by a person.
- the person monitors, guides, positions, and performs other actions/operations or manages a response consistent with the device for perfusion management 100 being managed by the person.
- a separate display device can present imagery to aid the person.
- the imagery may be captured as described above with reference to Figure 4, may be computer generated or may be captured by a separate imaging device internal to or external to the animal, for example, the human body 501. Actions may be performed under control of the person who may be on site or may be linked from a remote location, or the device for perfusion management 100 may be programmed to perform some or all functions automatically.
- the device for perfusion management 100 may be programmed to perform functions, such as, lumen clearance, lumen maintenance, monitoring of concentrations, sending of alerts, delivery of one or more of the effective agent at timed intervals or locations, self-check, or self- diagnosis. It will be appreciated by those of skill in the art that the device for perfusion management 100 maybe programmed for complete automatic operation of one or more functions.
- the device for perfusion management 100 need not be limited to managing perfusion.
- the device provides a mechanism for exploring one or more regions and/or reaching a location within an animal, obtaining information,
- a System for Perfusion Management communicating this information, performing operations, performing procedures, or providing treatment.
- the treatment includes but is not limited to, for example, treatment of a subnormal, abnormal or pathological condition.
- the device for perfusion management 100 may find utility in the management of physiological functions, the detection or elimination of pathological functions or conditions, and/or treatment of a disease or a pathological state of non-human animals.
- Other modifications of the subject matter herein will be appreciated by one of skill in the art in light of the teachings herein.
- any two components herein combined to achieve a particular functionality can be seen as “associated with” each other such that the desired functionality is achieved, irrespective of architectures or intermedial components.
- any two components so associated can also be viewed as being “operably connected”, or “operably coupled”, to each other to achieve the desired functionality.
Abstract
Description
Claims
Applications Claiming Priority (8)
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US10/827,578 US20050234440A1 (en) | 2004-04-19 | 2004-04-19 | System with a sensor for perfusion management |
US10/827,390 US8361013B2 (en) | 2004-04-19 | 2004-04-19 | Telescoping perfusion management system |
US10/827,572 US7850676B2 (en) | 2004-04-19 | 2004-04-19 | System with a reservoir for perfusion management |
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US7879023B2 (en) | 2011-02-01 |
US20050234399A1 (en) | 2005-10-20 |
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WO2005102411A2 (en) | 2005-11-03 |
US20110208120A1 (en) | 2011-08-25 |
US8361056B2 (en) | 2013-01-29 |
WO2005102409A3 (en) | 2007-05-03 |
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US8337482B2 (en) | 2012-12-25 |
US20080058713A1 (en) | 2008-03-06 |
WO2005102411A3 (en) | 2009-04-02 |
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