WO2024049475A1

WO2024049475A1 - Automated patient support

Info

Publication number: WO2024049475A1
Application number: PCT/US2022/075779
Authority: WO
Inventors: Daniel R. Burnett; Brian NOWROOZI; Christina Skieller; Omar STAUBLI-GRANT; Daniel Beeler; Mitchell KATONA
Original assignee: Theranova, Llc
Priority date: 2022-08-31
Filing date: 2022-08-31
Publication date: 2024-03-07

Abstract

Automated patient support apparatus and methods are described herein where one variation of an access device may generally comprise a sleeve shaft having an elongate length and a sleeve body coupled to a proximal end of the length, wherein the sleeve body and sleeve shaft collectively define a lumen therethrough. The sleeve shaft is insertable within a working lumen of a first instrument such that a fluid tight seal between the sleeve body and the working lumen is formed, and the lumen is configured maintain a pressure within and through the sleeve body and the sleeve shaft.

Description

AUTOMATED PATIENT SUPPORT

FIELD OF THE INVENTION

[0001] The present invention relates to adjunct peritoneal resuscitation/support for trauma patients, which may include fluid lavage, providing oxygen, and/or nutrients and/or reducing CO2, in the body.

INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each such individual publication or patent application were specifically and individually indicated to be so incorporated by reference.

BACKGROUND

[0003] Severe trauma is a leading cause of death on the battlefield and one of the leading causes of death in the young adult civilian population. Fatal injuries without any treatment option (e.g., cervical spinal injury and aortic rupture) result in immediate death at the scene. For survivors of the trauma event itself, life-threatening complications in the early course are bleeding, shock and/or severe respiratory failure following chest trauma or massive blood transfusion. The early goal in trauma care is to combat shock. Bleeding shock can be treated effectively on scene by controlling the source of bleeding and rapidly initiating fluid resuscitation. In cases of severe trauma, early damage control surgery and extensive blood transfusion are immediately necessary.

[0004] Direct (or adjunct) Peritoneal Resuscitation (DPR) is used as a resuscitation strategy in severely injured trauma patients with hemorrhagic shock and shows a reduction of intraabdominal complications.

DPR consists of suffusing the peritoneal cavity with a hypertonic glucose-based peritoneal dialysis solution. Evidence has demonstrated that DPR can improve microvascular perfusion and reduce tissue injury following hemorrhagic shock. When used in adjunctive treatment to hemorrhagic shock resuscitation DPR has been associated with less tissue edema, decreased abdominal complications,

[0005] Extracorporeal Membrane Oxygenation (ECMO) or Extracorporeal Life Support (ECLS) has been successfully used to treat post-traumatic respiratory failure in patients with blunt chest trauma. Published reports have shown success of ECLS support in post-traumatic ARDS (Acute respiratory distress syndrome) patients and severe trauma patients with resistant cardiopulmonary failure and coexisting bleeding shock. While these cases were in the setting of a fully equipped intensive care unit with no resource constraints, they demonstrate the successful extension of this lifesaving technology to trauma patients.

[0006] Existing ECMO and DPR devices are heavy, bulky and overly cumbersome for field applications. Not only does ECMO require heavy machinery and equipment, it also requires risky cannulation of the large vessels of the body for extracorporeal circulation. Accordingly, developing a small, lightweight, easy to use device for ECMO and/or DPR is critical for effectively treating trauma patients with respiratory failure before they can receive full treatment in the hospital setting

SUMMARY

[0007] The Automated Peritoneal Support (APS) system is a lightweight, compact and easy- to-use treatment for respiratory failure, and/or trauma, on the battlefield, or elsewhere, such as accidents, etc.

[0008] Post-traumatic respiratory failure, also called acute lung injury, is a common injury on the battlefield and results in a deficit in gas exchange across the alveoli. This deficit leads to acute hypoxia and hypercarbia which, if left unchecked, will lead to death. In the advanced ICU post-traumatic respiratory failure has been successfully treated by ECMO. ECMO, though, requires bulky, heavy equipment and is difficult and risky to initiate even in the most controlled of settings. Peritoneal lavage, using the APS, alternatively, is easy to setup and has been shown to combat hypoxia in four animal studies using three different animal models: dogs, pigs and rats. The APS system achieves superior oxygenation through the use of a pressurized oxygenation chamber/source that supersaturates the circulating lavage/perfusate with oxygen. In addition, or alternatively, CO2 may be effectively removed from the perfusate solution and/or the patient to reduce CO2 accumulation in the patient (i.e. reduce the CO2 of the patient, maintain the CO2 level of the patient, or minimize the CO2 level increase of the patient). Other methods of CO2 reduction are also disclosed herein. Taken together, this combination replaces normal lung function by delivering O2 and eliminating CO2 from the patient via the peritoneal cavity. Alternatively, these functions may be performed separately.

[0009] The APS device may comprise several components: 1) The lavage circuit, including pump and vacuum chamber/source, 2) A source of pressurized oxygen, 3) A sterile access device, 4) sterile, lavage fluid, 5) disposable tubing, and 6) one or more lavage catheters and 7) a controller. Other components may also be included.

[0010] The APS device may also, or alternatively, supply DPR capabilities.

[0011] In order to initiate treatment using the APS system, the medic first obtains peritoneal cavity access. This can be done in a relatively bloodless manner with minimal training using a blunt-tipped threaded trocar, which is a simple, safe, timely, and effective approach for gaining peritoneal access. This approach is effective across a wide variety of patients, including the obese and those who had had previous surgery. Furthermore, using a blunt-tipped threaded trocar does not require visual recognition of anatomic layers and may be taught to nonsurgeon physicians, or even non-physicians, who perform peritoneal access.

[0012] The APS device may be used to treat hypoxemia, hypercapnia, trauma and/or other patient conditions.

[0013] In one variation of an access device, the device may generally comprise a sleeve shaft having an elongate length and a sleeve body coupled to a proximal end of the length, wherein the sleeve body and sleeve shaft collectively define a lumen therethrough. The sleeve shaft is insertable within a working lumen of a first instrument such that a fluid tight seal between the sleeve body and the working lumen is formed, and the lumen is configured maintain a pressure within and through the sleeve body and the sleeve shaft.

[0014] In one variation of a method of accessing a body cavity, the method may generally comprise positioning a sleeve shaft having an elongate length within a working lumen of a first instrument, wherein a proximal end of the length is coupled to a sleeve body and where the sleeve body and sleeve shaft collectively define a lumen therethrough, positioning a second instrument through the lumen of the sleeve body and sleeve shaft such that a fluid tight seal between the second instrument and the lumen through the sleeve body and the sleeve shaft is formed, advancing the first instrument into a tissue region while moving the first instrument relative to the sleeve shaft and the second instrument, and monitoring a pressure within the lumen to determine when a distal tip of the sleeve shaft has entered a body cavity.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Fig. 1 is an example of a component of a portable Automated Peritoneal Oxygenator device.

[0016] Fig. 2 is an example of a sterile access device. [0017] Fig. 3 shows the device of Fig. 2 in use to access a body cavity.

[0018] Fig. 4 shows an embodiment of the APS system.

[0019] Fig. 5 shows an embodiment of the APS system which includes continuous, or semi- continuous, CO2 degassing module and O2 aerator module.

[0020] Fig. 6 shows an embodiment of the APS system which is designed to reduce the CO2 accumulation in the patient.

[0021] Fig. 7 shows an embodiment of the APS system which reconditions and recirculates at least a portion of the perfusate.

[0022] Fig. 8 shows an embodiment of the APS system using vacuum and/or a gas chamber/membrane, connected to a CO2 degassing module.

[0023] Fig. 9 shows an embodiment of the APS system using a CO2 scrubber.

[0024] Fig. 10 shows an access device in the prior art.

[0025] Fig. 11 shows an embodiment of the conductive access device where the electrodes are incorporated into the threads of the access device.

[0026] Fig. 12 shows an embodiment of the conductive access device where at least one electrode is incorporated into the shaft of the device.

[0027] Fig. 13 shows an embodiment of the conductive access device where one of the electrodes is located at the distal tip of the access device.

[0028] Fig. 14 shows an embodiment of the conductive access device where at least one electrode is located on the distal edge of the access device.

[0029] Fig. 15 shows an embodiment of the conductive access device where the electrodes are incorporated into different threads of the access device.

[0030] Fig. 16 shows the distal tip of an embodiment of the conductive access device where 2 electrodes are at the blunt tip of the cannula.

[0031] Fig. 17 shows data collected in an in vivo porcine model to obtain conductivity measurements in real-time using an embodiment of the conductive access device.

[0032] Fig. 18A-B show an embodiment of the access device which includes a stylet.

[0033] Fig. 19A-B show an embodiment of the access device which incorporates a spring loaded or hydraulic stylet

[0034] Fig. 20 shows an embodiment of a stylet which is hollow. [0035] Fig. 21 shows an embodiment of the access device with one electrode on the distal end of the stylet and one electrode on the distal end of the cannula component.

[0036] Fig. 22 shows a cross section of the access device with a solid stylet. Stylet

[0037] Fig. 23 shows a cross section of the access device with a hollow stylet.

[0038] Fig. 24 shows a cross section of the access device with and insulated lead within the inner lumen of the cannula component.

[0039] Fig. 25 shows a cross section of the access device with and insulated lead embedded within an insulated coating of the inner lumen of the cannula component.

[0040] Fig. 26 shows a cross section of the access device with two insulated leads within the inner lumen of the cannula component.

[0041] Fig. 27 shows a cross section of the access device with a lead embedded in an insulated coating of the inner lumen of the cannula.

[0042] Fig. 28 shows a cross section of the access device with two insulated leads within the inner lumen of the cannula component.

[0043] Fig. 29 shows the distal tip of an embodiment of the access device.

[0044] Fig. 30 shows the distal tip of an embodiment of the access device.

[0045] Fig. 31 shows the distal tip of an embodiment of the access device.

[0046] Fig. 32 shows the distal tip of an embodiment of the access device.

[0047] Fig. 33 shows the distal tip of an embodiment of the access device.

[0048] Figs. 34A and 34B show an embodiment of the access device which includes a transparent tip.

[0049] Figs. 35A and 35B show another embodiment of the access device with a transparent tip.

[0050] Figs. 36A and 36B show an embodiment of the access device with a relatively short transparent tip.

[0051] Figs. 37A and 37B show an embodiment of the access device with a tapered cannula.

[0052] Fig. 38 shows an embodiment of the access device with an angled/flattened transparent tip.

[0053] Fig. 39 shows an embodiment of the access device where the cannula does not have threads. [0054] Fig. 40 shows an embodiment of the access device where the transparent distal tip has threads.

[0055] Fig. 41 shows an embodiment of the access device where the transparent distal tip is nearly flush with, or inside, the opening of the cannula.

[0056] Figs. 42-45 show embodiments of a transparent tip with both a flat surface and an angled surface.

[0057] Fig. 46 shows the transparent tip of Fig. 42 in place in a cannula.

[0058] Fig. 47 shows the transparent tip of Fig. 42 flush with, or nearly flush with, a cannula tip.

[0059] Fig. 48 shows an embodiment of an access device which may be used with any of the APS systems disclosed herein.

[0060] Fig. 49 shows the embodiment shown in Fig. 48 fully assembled.

[0061] 50-54 show various views of the sleeve.

[0062] Figs. 55 and 56 show an embodiment of the distal tip of the sleeve.

[0063] Figs. 57A - 57D show some various configurations of the distal ends of the scope and sleeve and trocar.

[0064] Fig. 58 shows potential fluid communication paths through the sleeve body portion.

[0065] Fig. 59 shows an example of a data processing system.

DETAILED DESCRIPTION

[0066] An embodiment of the portable, compact APS system is shown in Fig. 1. This system allows for treatment of post-traumatic respiratory failure by exchanging gases utilizing a continuous (or intermittent) fluid oxygen-rich lavage of the peritoneal cavity. The device is light-weight, portable, and easy to use, allowing for field use where conventional ECMO systems are impractical. The device may be under 30 pounds. Alternatively, the device may be under 25 pounds. Alternatively, the device may be under 20 pounds. Alternatively, the device may be under 15 pounds. Alternatively, the device may be under 10 pounds. Alternatively, the device may be under 5 pounds. Alternatively, the device may be under 3 pounds. Alternatively, the device may be under 2 pounds. Alternatively, the device may be under 1 pound.

[0067] Fig. 1 shows the APS component including outgoing oxygenated lavage fluid port 102, which is in fluid communication with oxygen saturation chamber 104. Incoming fluid port 106 is in fluid communication with CO2 degassing chamber 108. Valve 110 connects the oxygen saturation chamber and the CO2 degassing chamber. Valve may be a one-way valve and may be passive or controlled by the controller. Display 112 is also shown.

[0068] Embodiments of the APS may be used with 2.5L of isotonic perfusate fluid (i.e. saline) where a 2L volume is indwelling in the peritoneal cavity and 500mL is maintained in the device (being degassed (CO2 reduced) then oxygenated) at any one time. The volume of 2L was chosen based on the peritoneal dialysis literature showing that the average person can easily receive 2L of fluid in their abdominal cavity without sequelae, however different volumes may be used. The 500mL volume being processed by the device is then infused into the peritoneal cavity via a catheter, while the indwelling fluid is extracted from the peritoneal cavity via either the same catheter (which may be multi-lumen), or a second catheter. If two catheters are used, they may be placed distant from each other within the peritoneal cavity, to ensure that the oxygenated lavage fluid is not extracted before its oxygen is reduced. This extracted fluid is then degassed and oxygenated and the cycle repeats or continues. Alternatively, the device may maintain a different volume of fluid, including around 2L, or around 1L-2L, or around 0.5L- 1L of fluid. The fluid may be infused via the more proximal part of the catheter which is within the peritoneal cavity, and extracted via the more distal part of the catheter, or the inverse may be configured.

[0069] In animal studies, it was demonstrated that effective peritoneal gas exchange required an increase of the partial pressure of oxygen (pCh) in the lavage fluid to about 500mmHg and a reduction in the partial pressure of carbon dioxide (pCCh) to about lOmmHg.

[0070] Saline may be used as the lavage fluid, or other fluids may be used (or added to saline). For example, fluids with low osmotic activity may be used, such as dextran, polyethylene glycol, albumin, etc. Icodextrin, for example 7.5%, may be added to saline. Fluids which resist absorption within the peritoneal cavity may also be used to increase oxygen transfer.

[0071] In some embodiments a microbubble oxygen formulation may be used as the lavage. In some embodiments, the lavage solution may be supersaturated to a partial pressure of oxygen of around 900mmHg or higher.

[0072] In some embodiments, the APS includes a lavage circuit/controller with the ability to tightly control the incoming and outgoing solution pCh and pCCh. Oxygen and carbon dioxide sensors may be included in line with the in-flow and outflow of the lavage circuit/controller. The lavage fluid entering the device may have a pO2 of about lOOmmHg and pCO2 of about 50mmHg. The fluid may be degassed until a pCO2 of about lOmmHg is achieved. Variables that may be altered to optimize this step may be depth of vacuum, duration of vacuum, geometry of the chamber etc. The lavage fluid may then be transferred to the oxygenation chamber where O2 may be bubbled through the fluid until a pCh of about 500mmHg is achieved. This step may be optimized based on peak oxygen pressure and duration of exposure. [0073] Abdominal access may be obtained using the blunt-tipped access device after which a catheter is inserted into the peritoneal cavity. The catheter may be dual-lumen (one lumen for perfusate inflow and one for perfusate outflow), may have a weighted tip, and/or may include pressure sensing capability or other sensing capability. More than one catheter may also be used, for example, a separate catheter each for inflow of perfusate and outflow of perfusate.

[0074] In some embodiments, the catheter may include a third lumen which is in fluid communication with a balloon at or near the distal tip of the catheter. The balloon may be inflated and pulled against the abdominal wall to secure and stabilize the catheter during lavage. [0075] In some embodiments, the access device may include the ability to measure pressure within the lumen air column. The controller may use changes in pressure measured within the access device to determine when the peritoneal cavity has been reached. For example, a fairly sudden pressure drop may indicate that the tip of the access device is in the peritoneal cavity. The amplitude, slope, or other shape data relating to the pressure vs. time curve may be used by the controller for the analysis. The use of pressure may be used in conjunction with other technologies to determine that the peritoneal cavity, or other cavity, has been accessed. For example, pressure and conductivity/impedance may be used, or pressure and direct visualization may be used. Pressure sensing may be accomplished with a pressure sensor in the access device, or with a pressure sensor further back in the system which is in fluid communication with a column of fluid within the lumen of the access device.

[0076] In some embodiments, air/gas or liquid bubbles may be introduced through the access device to determine when the device has entered the peritoneal cavity.

[0077] In some embodiments, the catheter and/or access device has the ability to measure intraabdominal pressure (IAP). This may be done through a lumen of either device or via a balloon on either device. The IAP may be monitored throughout the procedure, or intermittently, and may be used to control the influx and/or egress of fluid into/out of the peritoneal cavity. In some embodiments, the IAP is controlled to around 13 mmHg. In some embodiments, the IAP is controlled to around 12-14 mmHg. In some embodiments, the IAP is controlled to around 13-15 mmHg. In some embodiments, the IAP is controlled to around 10- 15 mmHg. In some embodiments, the IAP is controlled to around 8-15 mmHg. In some embodiments, the IAP is controlled to around 5-20 mmHg.

[0078] An embodiment of blunt- tipped access device 200 is shown in FIGS. 2 and 3. Embodiments of the access device may also include those disclosed in US Application Serial number 16/027,064 filed on July 3^rd, 2018 and US Application Serial number 15/993,483 filed May 30^th 2018, each of which is hereby incorporated by reference in its entirety. For example, the blunt-tipped access device may have threads along a portion of its length to allow advancement of the access device via rotation of the access device. The access device may include one, two or more sensors or electrodes to sense conductance or other properties of tissue as its tip passes through the tissue. These sensors can help identify the type of tissue through which the access device is passing to more safely access the peritoneal cavity without damaging other tissue. The access device may also include the ability to visualize directly, through a lumen of the access device, with a scope and a connected camera. The access device may include an asymmetric tip. The access device may include a clear tip.

[0079] Additional embodiments of blunt-tipped access devices are disclosed herein.

[0080] Fig. 4 shows an embodiment of the APS in use. Controller 402 controls the system, including the operation of vacuum source/vacuum chamber 404, CO2 degassing module 406, O2 source 408 and the O2 aerator module 410, the flow of fluid through the system, (which may include the operation of one or more pumps 412, and/or one or more valves 414), any sensors within the system including O2, CO2 sensors 416 and 418 of the lavage fluid, and O2 and/or CO2 sensor 420 sensing the oxygen and carbon dioxide levels of the patient, etc. The controller also controls the operation of display 422, interfaces 424, etc.

[0081] This embodiment is shown as a closed loop system. In other words, the lavage fluid is cycled from the patient’s peritoneal cavity, into the CO2 degassing module, into the O2 aerator module, and back into the peritoneal cavity. Sensors may be placed throughout the system to control the O2 and CO2 content of the lavage fluid at various stages. For example, CO2 and/or O2 sensors may sense the O2 and/or CO2 content of the lavage fluid as it exits the patient. This measurement will provide the controller information on how much CO2 needs to be removed from the fluid, and how much O2 needs to be added to the fluid. Open looped systems are also envisioned for all embodiments disclosed herein. See Fig. 6 for an example of an open loop system.

[0082] If the sensors sense that CO2 is higher than desired, then the lavage fluid will be degassed of CO2 in the CO2 degassing module. The amount of time in the chamber, or the speed with which the fluid travels through the chamber, or the amount of CO2 removed is determine by the controller based on the sensed CO2 levels and any desired level of CO2. The desired level of CO2 may be preset by the user, preset by the system, or may depend on other factors. The amount of CO2 removed may alternatively or additionally be determined by a CO2 sensor which senses the CO2 level within the patient’s blood, shown here as a transcutaneous finger sensor, such as a pulse oximeter, and/or other sensor. Blood gas concentrations may be detected via transcutaneous sensors, percutaneous sensors, implanted sensors, etc. Alternatively, or additionally, sensors may sense the gas, such as O2 and CO2, contained in respiration, sweat, urine etc.

[0083] The amount of time that the lavage fluid spends in the CO2 degassing module may be controlled by one or more valves, by a pump, or by some combination. A CO2 sensor may sense the CO2 level of the fluid within the degassing module to determine when the fluid is degassed adequately.

[0084] The CO2 degassing module may be fluidly connected to a vacuum chamber and/or vacuum source. For example, a vacuum source may be a pump creating a vacuum within a vacuum chamber or directly within the CO2 degassing module. The pump may be part of the portable system, or may be separate, and/or may be used to prime the vacuum chamber only occasionally. A valve may be incorporated between the vacuum source/chamber and the CO2 degassing module to control the amount of CO2 degassing.

[0085] Once the fluid is degassed, it flows to the O2 aerator module to be saturated or supersaturated with O2. The amount of added O2 necessary may be determined by an O2 sensor of the fluid coming directly from the peritoneal cavity, and/or an O2 sensor between the CO2 degassing module and the O2 module, and/or an O2 sensor measuring the O2 level of the patient. [0086] An O2 sensor may also be present within the O2 aerator module itself, to monitor progress of oxygenating the fluid. The amount of O2 added to the fluid may be controlled by valves, time in the module, amount of O2 allowed to enter the chamber, the format of the O2, the configuration of the chamber, the concentration of the O2 gas, the flow-through rate, etc. CO2 and/or O2 sensors may also exist between the CO2 degassing module and the O2 aerator module.

[0087] After the lavage fluid has been adequately CO2 degassed and oxygenated, it flows back into the peritoneal cavity via a catheter, such as catheter 426, or other device. Sensors, such as O2 and CO2 sensors may measure the oxygenated perfusate also. [0088] Valves, controlled by the controller, or passive valves, may be present throughout the system, including those shown in Figs. 4 and 5 and also elsewhere. One pump is shown here on the output side of the O2 aerator module, but zero, one or more pumps may be present in the system, including on the input side, between modules, etc. Fig. 4 shows the CO2 degassing occurring before the oxygenation, however, one of these modules may be absent, or the CO2 degassing may occur after the oxygenation of the fluid, or the two (oxygenation and degassing) may occur simultaneously or semi-simultaneously. The process may also be alternating or continuous.

[0089] One or more pumps may be used to move the fluid through the various stages. The moving of the fluid may be continuous or staged or paused. For example, fluid may be paused while in the degassing chamber and/or oxygen saturation chamber, to allow for equilibrium. One or both chambers may alternatively be elongated so that the fluid moves through continuously and may therefore not be paused, or paused less. The controller may pause or speed the transport of fluid through the various sections/chambers based on readings from the O2 and/or CO2 sensors.

[0090] The adding of fluid and removing of fluid from the peritoneal cavity may be continuous, or may be intermittent. For example, 2L of oxygenated fluid may be perfused into the peritoneal cavity. The fluid may be left there for a set period of time, then the process may be repeated (removing 2L and adding 2L of fluid), or the process may be continuous. The cavity may be kept full, with fluid cycling in and out in approximately equal volumes, or the peritoneal cavity may be intermittently filled and emptied, like a lung. A combination of both methods may also be utilized.

[0091] The controller may also include a display, either integrated into the APS device or remote (wired or wireless). The display may display the status of the fluid gas levels, the status of the patient blood or respiratory gas levels, IAP, other patient vital signs, system capacity remaining, including battery charge remaining, O2 and vacuum capacity remaining, interface status, etc. The controller of the APS may interface, either via wires or wirelessly, with other systems including mobile phones, tablets, computers, laptops, electronic health/medical records, etc. The controller may also incorporate an alert system including audio, visual, remote, tactile alerts, for any status, including system or patient statuses.

[0092] The display may display any of the various parameters in real time, including IAP, duration of the resuscitation procedure, current dwell time, etc. [0093] Trends of the various parameters over time may be displayed, including risk and progression levels. For example, the display may display and alert for developing and/or progressing hypoxemia and/or hypercapnia.

[0094] Fig. 5 shows an embodiment of the APS system which includes continuous, or semi- continuous, CO2 degassing module and O2 aerator module. In this embodiment, lavage fluid flows through the modules in a controlled manner, so that the exposure of the fluid to the vacuum and/or gas is better controlled. The surface area of a flow tube within the chamber is increased via a coil or other configuration, similar to that of a radiator. All or a portion of the walls of the coiled tube may be made from a membrane which is permeable to gas, such as O2 and CO2, but impermeable to liquid, such as saline or water. The walls of the coiled flow tube may be made from a semi-permeable material, which allows gasses to permeate the tubing, but not water. Some examples include PTFE membranes, silicone membranes etc. This allows the control of adding O2 into, and removing CO2 from, the lavage to be controlled by controlling the flow of the fluid through the modules. The rate of fluid flow can be controlled by one or more pumps, and one or more valves. For example, depending on the CO2 degassing needs of the fluid from the peritoneal cavity, the controller may pass all, or only a portion of the fluid through the CO2 degassing module. The flow rate of the fluid passing through the module may additionally or alternatively be controlled by a pump. Valves and bypass tube(s) 502 can control the volume or portion of fluid that passes through the module and the volume or portion of fluid that bypasses the module. The same can be done on the O2 aerator module.

[0095] Lavage fluid within the system may be ventilated anywhere within the system, for example via a filter, for example, a PTFE or silicone filter.

[0096] The APS system may be powered by an electrical outlet, by a battery, or both. If a battery is present, it may be recharged via solar power.

[0097] Generally, the controller will seek to stabilize the patient as quickly as possible, given the constraints of the system. For example, if battery power, vacuum supply, or O2 supply is low, the patient may not be stabilized as quickly as he/she would if the system were adequately supplied. The controller may automatically take into consideration the system constraints, as well as timing requirements (how long the patient needs to be stabilized, or how many patients need to be stabilized), to optimize the stabilization process.

[0098] Several physiological targets may be input into the controller (either manually, or preset, or set by algorithm). These include blood CO2, O2 levels, blood gas ratios, respiratory O2, CO2 levels, respiratory gas ratios, respiratory rate, heart rate, temperature, hematocrit, other blood and respiratory gas levels, oxygenation rate, CO2 degassing rate, lavage oxygenation level, lavage CO2 level, peritoneal pressure, etc.

[0099] Arterial blood gases and hematocrit may be measured by the system during the procedure.

[00100] Some embodiments include the ability to perform dialysis on the patient in addition to reducing the patient’s CO2 and/or increasing the patient’s O2 via the APS system to help prevent acute kidney injury or other issues.

[00101] In some embodiments, the APS system reduces the CO2 levels of the patient without substantially increasing the O2 levels of the patient. In some embodiments the APS system both reduces CO2 and increases O2. In some embodiments, the APS system increases O2 without substantially decreasing CO2.

[00102] Reduction of CO2

[00103] It has been demonstrated that patients with reduced lung function may benefit from CO2 reduction alone, without substantial O2 increase. For example, see “Low-frequency positive-pressure ventilation with extracorporeal CO2 removal in severe acute respiratory failure” (Gattinoni L, Pesenti A, Mascheroni D, Marcolin R, Fumagalli R, Rossi F, lapichino G, Romagnoli G, Uziel L, Agostoni A, et al.) which is incorporated herein by reference in its entirety.

[00104] In embodiments which reduce CO2, the CO2 reduction may be achieved in any one or more of the following ways:

• Increasing the pH of the perfusate fluid.

• Exposure of the perfusate fluid to a gas such as O2 or air.

• Exposing the perfusate fluid to a vacuum.

• CO2 “scrubbing” of the perfusate fluid.

• Other methods may also be used.

[00105] Increasing the pH of the perfusate fluid.

[00106] Carbon dioxide (CO2) is a by-product of cellular respiration and is dissolved in the blood where it is converted to carbonic acid by carbonic anhydrase. The carbonic acid then dissociates into bicarbonate and hydrogen ions. This process is represented by the following formula:

[00107] Using a higher pH perfusate solution in the peritoneal cavity reduces the CO2 available to the body and therefor effectively removes CO2 from the patient via the peritoneal cavity. For example, a dialysate fluid with reduced, or zero, concentration of bicarbonate may be used as the perfusate solution. An example of a zero bicarbonte dialysate solution is included in “Extracorporeal CO2 removal by hemodialysis: in vitro model and feasibility” (May AG, Sen A, Cove ME, Kellum JA, Federspiel WJ) and is reproduced below:

[00108] It is understood that this is only an example of a high pH perfusate solution. Other formulations may be used. The pH of the perfusate solution using this technique may range from about 8 to about 9. Alternatively, the pH of the perfusate solution using this technique may range from about 9 to about 10. Alternatively, the pH of the perfusate solution using this technique may range from about 10 to about 11. Alternatively, the pH of the perfusate solution using this technique may range from about 11 to about 12. Alternatively, the pH of the perfusate solution using this technique may range from about 12 to about 13. Alternatively, the pH of the perfusate solution using this technique may range from about 13 to about 14. Alternatively, the pH of the perfusate solution using this technique may range from about 8 to about 10. Alternatively, the pH of the perfusate solution using this technique may range from about 9 to about 11. Alternatively, the pH of the perfusate solution using this technique may range from about 10 to about 12.

[00109] Because the perfusion/lavage is occurring within the peritoneal cavity, and not in the blood stream, higher pH solutions may be used than those used for blood dialysis. [00110] In embodiments where CO2 reduction is the primary goal (as opposed to O2 increase), lower perfusate flow and smaller catheter(s) may be used. The peritoneal perfusion may be continuous or intermittent. For example, a volume of fluid may be introduced into the cavity, allowed to equilibrate with the tissues, effectively removing CO2 from the subject (or increasing O2, in embodiments that include this feature), and then removed after a period of time, or after sensors within the system or monitoring the patient indicate that the fluid should be removed. A sensor or sensors on the access catheter may also be used to monitor the various concentrations of the perfusate over time to determine when the perfusate needs to be replaced or cycled more quickly or slowly. Sensor on the catheter may also monitor pressure, or other parameters.

[00111] Alternatively, the perfusate may flow into and out of the peritoneal cavity of the patient continually at a set rate. The rate of the inflow may or may not be essentially the same as the rate of outflow. Where the fluid is perfused continuously, the perfusion may be for a set period of time at some frequency, for example, for one hour 3 times/week), or the perfusion may be ongoing, for example, with a portable, battery operated device, or in the case of injury. The same pump may be used for both fluid inflow and outflow or separate pumps may be used, or a pump in only one direction may be used (input only or output only).

[00112] The perfusate may be recycled within the system or fresh perfusate may be used and waste perfusate discarded, as in an open loop system. Perfusate recycling may be done by increasing the pH of the perfusate after removal of the perfusate from the peritoneal space and before reintroducing the perfusate fluid back into the patient. The pH of the perfusate may be increased via the addition of a base, such as NaOH, or other methods.

[00113] Fig. 6 shows an embodiment of the APS system which is designed to reduce the CO2 accumulation in the patient via an open loop system. In an open loop system the perfusate source and waste perfusate are separate. In other words, the perfusate is not recycled or recirculated. It should be noted that because the APS system uses perfusate which is not native to the body (i.e., not blood), the perfusate may be discarded rather than recycled. This is one of the advantages of using the peritoneal cavity to support the lung, or other, function of the patient, instead of using circulating blood, as is used with ECMO systems. An open loop system, or a closed loop system, may be used with any of the embodiments disclosed herein.

[00114] This embodiment may not appreciably increase the O2 level of the patient. Shown are high pH perfusate source 602, perfusate waste reservoir 604, pump or pumps 606 which pump perfusate into and/or out of peritoneal cavity 608 via catheter or catheters 610. Source 602 and reservoir 604 may or may not be incorporated into controller 612, or connected to the controller. Display 614 may be incorporated into, or connected to, controller 612. Interfaces connector 616 may be incorporated into, or connected to, controller 612.

[00115] Sensors 618 may sense the chemical and/or pH makeup of the perfusate before entering and after exiting the body. These sensors may be incorporated into the controller or may be separate. In addition, patient sensor 620 may be used to sense the O2, CO2, or other parameter of the patient. The feedback from any of the sensors may be used to control the volume, rate, pressure, flow of the patient perfusion inflow and/or outflow. For example, a high patient CO2 concentration may trigger the controller to automatically increase the flow rate of the perfusate into the patient and/or out of the patient. Alternatively, the controller may increase the dwell time of the perfusate within the patient. Alternatively, the controller may increase the pH concentration of the perfusate going into the patient. This may be done using optional perfusate mixer 622 which mixes very high pH perfusate with a more neutral perfusate 624 in a controlled manner. The perfusate reservoirs may be incorporated into the controller or be separate from, and connected to, the controller. Alternatively, the controller may increase the volume of perfusate in the peritoneal cavity.

[00116] Fig. 7 shows an embodiment of the APS system which reconditions and recirculates at least a portion of the perfusate. The perfusate is reconditioned by alkalizing module 702 which increases the pH of the perfusate fluid before circulating the fluid back into the peritoneal cavity of the patient. The perfusate may be reconditioned by adding of a base, or by other methods.

[00117] The controller may also control the temperature of the perfusate, so that it is body temperature, higher than body temperature or lower than body temperature. This may be done via a heating element or other ways (not shown).

[00118] The flow rate of perfusate entering the patient may be around 200 mL/min to around 2000 mL/min. Alternatively, the flow rate of the perfusate may be around 200 mL/min to around 400 mL/min. Alternatively, the flow rate of the perfusate may be around 200 mL/min to around 600 mL/min. Alternatively, the flow rate of the perfusate may be around 200 mL/min to around 1000 mL/min.

[00119] The volume of perfusate fluid residing in the peritoneal space of the patient during the procedure may be around 1.5 - 2.5 Liters.

[00120] The duration of the procedure may be minutes, hours or days and may last until lung function is returned. [00121] The access catheter(s) used in the procedure may be around 3-6 mm in diameter. Alternatively, the access catheter(s) used in the procedure may be around 3-4 mm in diameter. Alternatively, the access catheter(s) used in the procedure may be around 4-6 mm in diameter. [00122] The pump controlling the inflow of perfusate to the patient may begin before the pump controlling the outflow of used perfusate from the patient to allow for a volume of perfusate to reside in the peritoneal cavity during the procedure. At the end of the procedure, the pump controlling the outflow of perfusate may operate after the pump controlling the inflow of perfusate is no longer pumping so that the peritoneal cavity may be completely empties of perfusate fluid.

[00123] Some embodiments of the APS system may be portable. Some embodiments may be designed to be worn and used by the patient for long periods of time, or even most or all of the time. Some embodiments may operate via a rechargeable battery. Some embodiments may strap onto the patient via a belt, sling, or garment (such as shorts or underwear). Some embodiments may be small enough to clip onto a belt or pants.

[00124] Exposure of the perfusate fluid to a gas such as O2 or air.

[00125] In some embodiments the CO2 concentration within the perfusate is reduced by exposing the perfusate to another gas such as O2 or air. This can be done via an oxygenator type membrane (such as those used in extracorporeal membrane oxygenation) or bubbling or other methods.

[00126] Exposing the perfusate fluid to a vacuum.

[00127] In some embodiments of the APS system, CO2 is reduced in the liquid perfusate by applying a vacuum to the liquid.

[00128] Fig. 8 shows an embodiment of the APS system using vacuum and/or a gas chamber/membrane, connected to CO2 degassing module 802. The vacuum and/or gas source and/or membrane 804 may be incorporated into the controller, or outside of the controller and connected to the controller.

[00129] CO2 “scrubbing” of the perfusate fluid.

[00130] In some embodiments of the APS system, CO2 is reduced in the perfusate liquid by “scrubbing” the perfusate. CO2 scrubbing may be done using a catalyst, amine scrubbing, quicklime, serpentinite, magnesium silicate hydroxide, olivine, molecular sieves, activated carbon, algae, carbonic anhydrase inhibitor, O2, or other methods. [00131] Fig. 9 shows an embodiment of the APS system using CO2 scrubber 902 to reduce the CO2 concentration of the perfusate before recirculating the perfusate back into the patient. [00132] In some embodiments, the controller monitors and controls the pressure within the peritoneal cavity and maintains the pressure at a set pressure. This pressure may be high enough to effectively prevent internal bleeding, for example, by creating a pressure which is higher than the venous pressure or even the arterial pressure. Peritoneal pressure may be maintained at around 1-8 mmHg. In some embodiments, the peritoneal pressure is prevented from going above 8 mmHg.

[00133] Any combination of technologies disclosed herein may be used. For example, a high pH perfusate may be used to reduce the patient’s CO2 level in combination with increasing the O2 level of the patient. Other combinations are also envisioned.

[00134] Any of the APS embodiments disclosed herein which are focused on controlling O2 and/or CO2 levels, may also be applied to other APS systems, including those focused on peritoneal resuscitation and/or peritoneal lavage, with or without O2 and/or CO2 level management. In other words, Any of the APS systems can be used with simple dialysate lavage or other fluid lavage or any fluid perfusate.

[00135] Some embodiments of the APS system may include support for organs other than the lungs. For example, support for the liver and/or kidneys may be incorporated into the system. Kidney dialysis via the peritoneal cavity may be included. Toxin removal or nutrient supplementation of any kind is envisioned via the perfusing of the peritoneal cavity. The lavage fluid may include nutrients which may include glucose, lactate or other nutrients. The lavage fluid makeup may be customized based on body sensors, fluid sensors, fluid flow or other factors.

[00136] In some embodiments of the APS system, the catheter or catheters that supply and remove perfusate from the peritoneal cavity may incorporate a mechanism that prevents the opening(s) of the catheter(s) from butting up against tissue, preventing proper function. For example, a catheter which is used for removing perfusate (which may be the same catheter which supplies the perfusate, or may be a separate catheter or a separate opening of the same catheter) may incorporate a mechanism to prevent its being obstructed by tissue. Examples of mechanisms may include a wire, polymer, or other material cage which allows fluid flow through its openings, but holds the openings of the catheter away from body tissue. Another example of a mechanism may be a catheter with multiple arms and/or multiple openings so that if some of the openings are obstructed, other openings will not be obstructed. [00137] Some embodiments of the APS system incorporate an agitation mechanism to agitate, or message, the peritoneal cavity to promote free fluid flow within the cavity. For example, the system may include an external massager or agitator which massages or agitates the abdomen of the patient. Or, for example, the agitation may be internal, incorporated into a perfusate catheter or a separate device. The agitation may include pressurized fluid, mechanical agitation, bubbles of gas or fluid, pulsating fluid delivery and/or removal etc.

[00138] Other embodiments of the access device

[00139] The access devices and methods disclosed herein may include conductive areas which can determine the conductivity and/or impedance of tissue as the device is moved through the tissue and placed. Certain changes in conductivity/impedance may indicate when the access device is placed in its desired location. The conductive/impedance properties of the body tissues may be inherent, or may be altered by the device, or otherwise. For example, a blunt access device may blanch tissue as the tissue is spread by the device, creating changes in tissue conductivity/impedance. Another example is an access device which includes cautery or ablation capabilities. The cauterization or ablation of the tissue may change the conductivity/impedance of the tissue.

[00140] Access to body cavities or body tissue is often gained using a trocar, cannula, needle, catheter etc. These devices may be solid or hollow, sharp or blunt. For example, Fig. 10 shows a blunt hollow cannula, similar to that described in U.S. Patent 5,478,329, which is hereby incorporated by reference in its entirety. The cannula shown in Fig. 10 includes shaft 1002, head 1004, threads 1006, inner lumen 1008, blunt tip 1010, and optional concave cutting edge 1012. This device is currently used to access body cavities/tissue by first making a small incision, then rotating the device into the body tissue. The threads help force the blunt tip through tissue as the cannula is rotated. The blunt tip helps to separate tissue, rather than cut tissue, which helps avoid severing blood vessels and causing major damage to tissue.

[00141] Fig. 11 shows an embodiment of a new conductive access device. The conductive access device may include a cannula with an inner lumen, threads and a blunt tip, or the conductive access device may be sharp, solid and/or non-threaded. Fig. 20 includes cannula 1101, first electrode, or conductive surface, 1102 and second electrode, or conductive surface, 1104. The conductive access device may also include electrode leads 1106 and 1108, or one or more than one lead may be incorporated into the conductive access device shaft and/or head. For example, the leads may run down the inner wall of the device, as shown here, or one or more leads may be incorporated into the threads, the shaft wall etc. The leads may be insulated by a non-conductive coating, for example a polymer coating. An electrode may be simply an extension of a lead where the lead is insulated and the electrode is not insulated, for example, a wire, stylet, ribbon, cannula which is partially coated with an insulating material (the lead portion) and partially non-insulated (the electrode portion). An inner tube or coating, for example an extruded polymer tube may be added to the inner lumen of the device to protect the leads from damage from any tools that may be used through the cannula. The coating may alternatively/additionally for the lead portion of an electrode where the cannula comprises the lead and the electrode. The outer shaft of the conductive access device may include non- conductive coating 1110 on all or part of its surface, as shown by the grey areas here. The conductive surfaces are shown as darker here, near the non-head, or distal, end of the device. In this embodiment, the shaft of the conductive access device may be made from a conductive material, such as metal. Most of the shaft of the conductive access device may be coated with a non-conductive coating such as a polymer. The coating may be shrink wrapped, sprayed on, dipped etc. Electrodes 1102 and 1104 are either masked, or left uncoated by the nonconductive coating. The coating may be on the outside of the shaft, the inside of the shaft, or both.

[00142] Alternatively, the conductive access device may be made from a non-conductive material, such as a hard polymer, and the electrodes may be made of a conductive material, such as metal. The conductive access device may be disposable or reusable. If it is made primarily from a polymer, it may be disposable, while a controller component may be reusable. If the conductive access device is made primarily from a metal, it may be reusable.

[00143] Leads 1106 and 1108 may pass through the head of the conductive access device, or may exit the device at any point. The leads are connected, either via wires, or wirelessly, to a controller which collects and may store the conductivity/ impedance data from the electrodes, analyzes the data, and displays, or otherwise reports to the user the location of the conductive access device based on the conductivity/impedance data and/or changes in the conductivity /impedance data as the access device is advanced or moved through tissue. In some embodiments, one or more electrodes are placed at or near the distal tip of the conductive access device so that the location information informs the user of the location of the distal tip of the conductive access device.

[00144] In some embodiments, the controller may control the automatic application of force to the access device in either or both the advancing (into the body) direction and a rotational direction. [00145] In some embodiments, the controller may have the capability to receive and analyze information from other sensors on the device or in the system. For example, the access device may incorporate pressure or force sensors, to avoid excessive force or to sense when force necessary for advancement is diminished, possibly indicating a body cavity has likely been accessed.

[00146] In use, some embodiments of the conductive access device are used as follows. As the device is advanced through body tissue toward the desired location, conductivity and/or impedance (hereafter referred to as “conductivity”) data between 2 or more electrodes is measured, effectively measuring the conductivity of the body tissue at or near the distal tip of the conductive access device. Because the conductivity of tissue is different for different tissue in different locations in the body, information relating to the location of the distal tip of the conductive access device can be obtained, and used to monitor access progress.

[00147] For example, the table below lists the electrical conductivity of various tissues up to 1MHz. Other frequencies may be used by various embodiments of the conductive access device disclosed herein. The difference in conductivity can be used to identify the location of the conductive access device as it advances through tissue, and into different types of tissue.

From the IT ’IS Foundation

[00148] In some embodiments, the conductive access device may be rotated/advanced automatically via a motor connected to the controller. The motor may automatically start, stop, slow or reverse based on signals from the controller based on data received from the device.

For example, the motor may stop when the conductivity across the electrodes of the device indicate that the distal tip of the device is in the abdominal cavity, if this is the desired final location of the device. Alternatively, the motor may slow or stop if the amount of force required to advance the device is too high. [00149] Fig. 12 shows an embodiment of the conductive access device where at least one of the electrodes is incorporated into the shaft surface of the cannula. In this figure, electrode 1102 is incorporated into a thread while electrode 1104 is incorporated into a surface of the shaft. This may be done by leaving part of the shaft uncoated with insulating material, similar to the examples mentioned in association with Fig. 11. The leads to the electrodes may run down the inner lumen of the device, under the insulating coating, within the insulating coating, within a spiraling thread or elsewhere. [00150] Fig. 13 shows an embodiment of the conductive access device where at least one electrode is at the most distal tip of the cannula. This Figure shows an example where the most distal electrode is at the most distal blunt tip of the cannula.

[00151] Fig. 14 shows an embodiment of the conductive access device where at least one electrode is on the distal edge and/or inside of the lumen of the cannula. At least one electrode may also be completely inside the lumen of the cannula. This placement may reduce the chances of damage to the electrode as the device is being used/advanced. An inner protective sheath may be used to protect all or a portion of the leads and/or electrodes. Alternatively or additionally, channels or guides may be used within the cannula shaft and/or lumen to protect and/or guide the leads.

[00152] Fig. 15 shows an embodiment of the conductive access device where 2 electrodes are incorporated into separate thread lines. In this embodiment, 2 or more separate sets of threads are used on the outside of the shaft. In this embodiment, the leads for the electrodes may be incorporated into the threads so that each lead has its own set of threads and the 2 sets of threads are not in contact with each other. In this (and other) embodiment, leads 1106 and 1108 may be embedded into the threads themselves. The leads may even be the threads, if they are properly insulated for most of the length of the shaft, revealing the electrodes at the distal end where there is no insulation. Alternatively, or additionally, the cannula, itself, may serve as a lead, by insulating at least a portion of the cannula.

[00153] Fig. 16 shows the distal tip of an embodiment of the conductive access device where 2 electrodes are at the blunt tip of the cannula. As with any of the embodiments disclosed herein, more electrodes may be present, for example, 4 electrodes. As with any of the embodiments disclosed herein, the access device may have a blunt tip, or may have a sharp tip. [00154] Fig. 17 shows data collected in an in vivo porcine model to obtain conductivity measurements in real-time using an embodiment of the conductive access device. A midline incision was made at the level of the umbilicus to allow for visual confirmation of anatomical placement of the device. Measurements were taken at the level of the skin, the subcutaneous fat, fascia, muscle, and peritoneal cavity. The cannula was inserted to each tissue layer ten times, and placement was confirmed visually and with fluoroscopy. A separate conductivity measurement was taken upon each insertion resulting in a total of 50 measurements total (10 per tissue type). Data were analyzed using a repeated measures ANOVA to determine differences in conductivity measurements between tissue types, the results of which are shown in Fig. 17. The results of the post-hoc Tukey multiple comparisons reveal a significant difference between the layers of the abdominal wall including the skin and the subcutaneous fat (p=0.0083), the skin and the muscle (p<0.0001), the skin and fascia (p=0.0027), and the subcutaneous fat and the muscle (p=0.01251). In addition, the results reveal a significantly higher conductivity (p<0.0001) for the peritoneal cavity by an order of magnitude when compared to each of the layers of the abdominal wall. These data show that electrical conductivity can be used to determine positioning of the conductive access device in real time as it passes through the layers of the abdominal wall and into the peritoneal cavity.

[00155] Fig. 18A-B show an embodiment of the access device which includes a stylet. Stylet 1802 is configured to fit through the lumen of cannula component 1803. Stylet 1802 includes electrode portion 1102 and may be made out of polymer, metal, or other suitable material. If the stylet is made out of metal, insulating coating 1110 may be incorporated to insulate the bulk of the stylet. The stylet is electrically connected to the controller via wires or other means. Stylet 1802 may be solid or hollow, with a lumen down its length. Stylet may be blunt tipped, sharp tipped, flat tipped, or shaped in any way at the tip.

[00156] Fig. 18B shows the stylet inside the lumen of the cannula component. In this figure, the stylet is solid, without an inner lumen. The distal tip of the stylet serves as one electrode 1102 and the distal tip of the cannula component serves as the other electrode 1104. In this embodiment, both the stylet and the cannula component electrodes are electrically connected to the controller via leads 1106 and 1108. In this embodiment, the distal tip of stylet 1802 is configured to be fixed distance 1804 from the distal end of the cannula component. The fixed distance may be positive, so that the stylet protrudes from the cannula component, negative, so the stylet is recessed into the cannula component, or zero, where the stylet is flush with the cannula component. In this embodiment, the inside lumen of the cannula may not need to be insulated.

[00157] To maintain distance 1804 during use of the device, locking mechanism 1806 may be incorporated into the cannula component to lock the position of the stylet with respect to the cannula component. Locking mechanism 1806 may be loosened and relocked in the same or different positions as appropriate. Stylet 1802 may be removable from the cannula by unlocking locking mechanism 1806.

[00158] In embodiments where a solid stylet is used, fluid (gas or liquid, for example CO2) may be infused or removed via port 1808 in the cannula component. In these embodiments, the stylet may be removed before the inner lumen of the cannula component is used for fluid/instruments, or, fluid may be infused/removed via the annular space between the inner lumen of the cannula component and the outer surface of the stylet. Alternatively, another lumen may be incorporated into the cannula component.

[00159] Fig. 19A-B show an embodiment of the access device which incorporates a spring loaded or hydraulic stylet. In this embodiment, spring (or other force capacitor) 1902 is incorporated into the assembly so that the spring is in compression when the tip of the access device is in solid tissue, and the spring extends when the tip of the access device is in open anatomy or a hollow organ, such as in the peritoneal cavity. The force exerted by the spring keeps the distal end of the stylet protruding beyond the distal end of the distal tip of the access device. This helps prevent inadvertent damage to internal organs, for example where the access device bumps up against more mobile tissue areas such as bowel, bladder etc. This operation is similar to that of a Veress needle. These embodiments may or may not include a locking mechanism. These embodiments, like all embodiments disclosed herein, may include a blunt or a sharp distal tip.

[00160] Fig. 20 shows an embodiment of a stylet which is hollow. The stylet has a lumen running down the length of it, from port 2004 to opening 2002. Fluid may be infused and/or removed through the stylet lumen while the stylet is in the access device.

[00161] Fig. 21 shows an embodiment of the access device with one electrode, electrode 1102, on the distal end of the stylet, and one electrode, electrode 1104, on the distal end of the cannula component. The electrodes are not visible in this figure because electrode 1102 is on the distal surface of the stylet. In other words, it is insulated so that electrode 1102 does not contact the inner surface of the cannula component. Electrode 1104 is on the inner surface of the inner lumen of the cannula component. This is also shown in Fig. 29. This configuration helps prevent the two electrodes from ever contacting each other accidentally.

[00162] Fig. 22 shows a cross section of the access device with a solid stylet. Stylet 1802 is shown with insulation on the majority of its length. Cannula component 1803 is also shown with an insulating coating on the majority of its length. Metal core 2204 of stylet serves as a portion of the lead for one of the electrodes at the distal tip of the device. Metal core 2206 of the cannula component serves as a portion of the lead for another electrode at the distal tip of the device. In this embodiment, lumen 2202 (here shown as an annular lumen) may be used for infusion and/or removal of fluid. Alternatively, stylet 1802 may be removed from cannula component 1803 to access the inner lumen of the cannula.

[00163] Fig. 23 shows a cross section of the access device with a hollow stylet. In this embodiment, stylet inner lumen 2302 may be used for infusion and/or removal of fluids. Alternatively, or additionally, the annular lumen between the stylet and the cannula may be used, or the stylet may be removed from the cannula component.

[00164] Fig. 24 shows a cross section of the access device with and insulated lead within the inner lumen of the cannula component. Insulated lead 2402 serves as a portion of the lead for one of the electrodes at the distal tip of the device. Lumen 2202 may be used for infusion and/or removal of fluids or for instrument access.

[00165] Fig. 25 shows a cross section of the access device with and insulated lead embedded within an insulated coating of the inner lumen of the cannula component.

[00166] Fig. 26 shows a cross section of the access device with two insulated leads within the inner lumen of the cannula component. Insulated lead 2402 serves as a portion of the lead for one of the electrodes at the distal tip of the device. Insulated lead 2602 serves as a portion of the lead for another of the electrodes at the distal tip of the device. Lumen 2202 may be used for infusion and/or removal of fluids or for instrument access. Note that the cannula portion of this embodiment need not be coated with an insulated material. Coated leads 2402 and 2602 may be free-floating within lumen 2202, or may be attached to the wall of the cannula lumen along all or part of each of their lengths.

[00167] Fig. 27 shows a cross section of the access device with a lead embedded in an insulated coating of the inner lumen of the cannula. Lead 2402 may be flattened, i.e. a ribbon which is wider than it is thick, or any other appropriate shape.

[00168] Fig. 28 shows a cross section of the access device with two insulated leads within the inner lumen of the cannula component. In this embodiment, one or more coated leads is attached to the cannula inner surface via grooves or notches.

[00169] Fig. 29 shows the distal tip of an embodiment of the access device. In this embodiment, one electrode, electrode 1102, is incorporated into the inner surface of the cannula, and one electrode is incorporated into the distal surface of the distal end of the stylet. An insulating coating covers most of the inner surface of the cannula, leaving the distal end serving as an electrode. Alternatively, the ID of the cannula may be uncoated, where the area between the OD of the stylet and the ID of the cannula is small enough, so that tissue may not enter between the two. The insulating coating of the stylet prevents electrode 1104 from coming in contact with electrode 1102 accidentally.

[00170] Fig. 30 shows the distal tip of an embodiment of the access device. In this embodiment, one electrode is incorporated into the distal end of the stylet, and the other is incorporated into the most distal tip of the cannula. [00171] Fig. 31 shows the distal tip of an embodiment of the access device. In this embodiment, one electrode is incorporated into the distal end of the stylet, and the other is incorporated into a thread near the distal tip of the cannula.

[00172] Fig. 32 shows the distal tip of an embodiment of the access device. In this embodiment, one electrode is incorporated into the distal end of the cannula, and the other is incorporated into a thread near the distal tip of the cannula. In this embodiment, similar to that shown in Fig. 15, leads for the two electrodes may be incorporated into separate threads. Alternatively, the leads may run down the length of the cannula via any of the methods disclosed herein.

[00173] Fig. 33 shows the distal tip of an embodiment of the access device. In this embodiment, both electrodes are incorporated into the distal end of the stylet. In this embodiment, the cannula portion may be uncoated metal. The stylet may be an extrusion of polymer with one, two, or more electrodes and electrode leads embedded in the insulating polymer.

[00174] In any of the embodiments disclosed herein, the electrode leads may be molded into the access device, for example, in a polymer access device, and exposed at or near the distal tip, or connected to electrodes at or near the distal tip of the access device.

[00175] Some embodiments of the access device may include a transparent component at or near the distal tip. A transparent tip allows direct visualization of the tissue via a camera, scope, fiber optics, etc. The tip may be sharp and/or tapered enough to allow access to a body cavity, such as the peritoneal cavity, via a very small incision followed by blunt dissection by applying axial and/or rotational pressure to the access device. Threads may be used to help advancement via rotational pressure/force. The transparent tip may include grooves and/or threads to aide in the blunt dissection of tissue. The transparent tip may be made out of a hard polymer, and is transparent enough to see tissue through the thickness of the tip. The transparent tip may include one or more openings to allow fluid (liquid and/or gas) to escape the device, for example, for irrigation, suction and/or insufflation.

[00176] Figs. 34A and 34B show an embodiment of the access device which includes transparent tip 3402 to allow direct visualization of the tissue via a camera, scope, fiber optics, etc. In this embodiment, electrodes 1102 and 1104 are on the distal end of the threaded cannula, and transparent tip 3402 protrudes from the distal end of the cannula. The transparent tip has a cavity within which is in fluid communication with the inner lumen of the cannula. A scope or camera may be passed through the inner lumen of the cannula and into the cavity of the transparent tip. As the access device advances through tissue, the tissue can be visualized directly as it comes in contact with the outside surface of the transparent tip. Fig. 34B shows another angle of the access device shown in Fig. 34A.

[00177] Figs. 35A and 35B show another embodiment of the access device with a transparent tip. This embodiment includes electrodes 1102 and 1104 which are incorporated into the transparent tip. This placement helps minimize the distance between the electrodes and the distal tip of the device. Also included here is opening 3502. Any of the embodiments disclosed herein may include no openings, or one or more openings. The opening(s), if present, may be distal to, or proximal to, one or more electrodes 1102 and 1104.

[00178] Figs. 36A and 36B show an embodiment of the access device with a relatively short transparent tip. In this embodiment, the transparent tip may be short, as in 2mm-5mm in length, so that the distance between the tip and electrodes 1104 and 1102 is minimal.

[00179] Figs. 37A and 37B show an embodiment of the access device with a tapered cannula. In this embodiment, the cannula, with the threads, is tapered at the distal tip, to more closely hug a transparent tip. Note that embodiments which do not include a transparent tip may also have a tapered distal end.

[00180] Fig. 38 shows an embodiment of the access device with an angled/flattened transparent tip.

[00181] Fig. 39 shows an embodiment of the access device where the cannula does not have threads.

[00182] Fig. 40 shows an embodiment of the access device where the transparent distal tip has threads.

[00183] Fig. 41 shows an embodiment of the access device where the transparent distal tip is nearly flush with, or inside, the opening of the cannula.

[00184] Figs. 42-45 show embodiments of a transparent tip with both a flat surface and an angled surface. Transparent tip 3402 is shown here with flat surface 4202 and angled surface 4204. The angle 4206 of the angled surface may be around 55 degrees. Alternatively, the angled surface may be around 45-65 degrees. Opening 3502 may be on angled surface 4204, as shown in Figs. 43 and 44, or may be on flat surface 4202, as shown in Fig. 45. More than one opening may be present. [00185] Fig. 46 shows the transparent tip of Fig. 42 in place in cannula 1803. Fig. 46 shows the transparent tip protruding past the tip of the cannula, where Fig. 47 shows the transparent tip flush with, or nearly flush with, the cannula tip.

[00186] Embodiments of the access device may have a tip which is tapered, flat, angled, conical, etc.

[00187] Some embodiments of the access device utilize a rotating, possibly blunt tipped, trocar, and also have connections, leads, tubing and/or wires on the proximal (non-tip) end of the device. Rotation of the connections is not preferred when the trocar is rotated to gain access to the cavity or organ. For example, the trocar may need to be rotated one, more or several full rotations to access the cavity. If the connections were to also rotate, they would become entangled, which may adversely affect the use of the device. It is desirable that the connections remain rotationally stationary while the trocar is rotated.

[00188] To avoid entanglement of the connections, some embodiments incorporate a sleeve, insert, or other mechanism to allow the trocar to rotate, without rotating the connections. For example, a sleeve may be placed inside the trocar so that the trocar can rotate around the sleeve, but the sleeve can remain in place (not rotated or minimally rotated) while the trocar is rotated. The various connections, such as tubings, wires, or other connections, may connect to the sleeve so that the connections do not rotate when the trocar is rotated. In some embodiments, one or more lumens in the sleeve may house a scope, and/or other devices/connections/sensors etc. The sleeve may be rotationally connected to the trocar, and in some embodiments, the sleeve may be rotationally connected to a scope, via an o-ring or o-rings and/or tight fit or other ways. The camera connections that connect to the scope may also be prevented from rotating, when the trocar is rotated, when the scope is inside the inner lumen of the sleeve.

[00189] Fig. 48 shows an embodiment of an access device which may be used with any of the APS systems disclosed herein. Shown here are cannula or trocar 4802, sleeve 4804, scope 4806 and camera 4808. This embodiment uses pressure and/or direct visualization to identify when the access device is in the peritoneal cavity or other cavity or location.

[00190] Also shown here are threads 4810, which are used to rotationally advance trocar 4802 into tissue and into the peritoneal cavity. The trocar shown here also has a relatively blunt tip. Sleeve 4804 includes sleeve shaft portion 4812 and sleeve body portion 4814 as well as sleeve port 4816. Scope 4806 includes scope shaft portion 4818 as well as light port 4820 and eyepiece 4822. Sleeve o-ring 4824 has an ID which is approximately the same diameter as the OD of sleeve shaft 4812, and has an OD which seals within the head of trocar 4802. This allows sleeve shaft 4812 to rotate and/or translate freely within trocar 4802 while maintaining an essentially fluid tight seal between the two components. A lubricant may be used on the o-ring to help with rotation and/or translation of the sleeve shaft with respect to the trocar.

[00191] Scope o-ring 4826 has an ID which is approximately the same size as the OD of scope shaft 4818, and has an OD which seals within sleeve body portion 4814. This allows scope shaft 4818 to rotate and/or translate freely within sleeve 4804 while maintaining an essentially fluid tight seal between the two components. A lubricant may be used on the o-ring to help with rotation and/or translation of the scope shaft with respect to the sleeve.

[00192] Also shown here is light source 4830, which connects to light port 4820 and pressure line 4828 which connects to sleeve port 4816. In some embodiments, other connectors and/or ports may exist on the sleeve for electrical connections, fluid connections, etc., for sensors or other components. In some embodiments, the rotational connector, here shown as o-ring 4824, may include one or more electrical connections, to connect the trocar and the sleeve electrically.

[00193] The arrows in Fig. 48 shown how the various components of the system fit together. The camera fits onto the eyepiece of the scope. The scope slides into the lumen of the sleeve, fluidly sealed with the sleeve via the scope o-ring, so that the scope can rotate and/or translate within the sleeve while maintaining a fluid seal with the sleeve. The sleeve slides into the lumen of the trocar, fluidly sealed with the trocar via the sleeve o-ring so that the sleeve can rotate and/or translate within the trocar while maintaining a fluid seal with the trocar.

[00194] Fig. 49 shows the embodiment shown in Fig. 48 fully assembled. When assembled, the trocar may be rotated, while the sleeve, along with its connections, is not rotated. Similarly, the scope may remain un-rotated while the trocar rotates. The sleeve may also be rotated and/or translated along the length of the trocar for optimal positioning. Similarly, the scope may be translated and/or rotated with respect to the sleeve for optimal positioning. The tip of the scope may be placed at or near the distal tip of the sleeve, which may be located at or near the distal tip of the trocar, so that the tissue at or around the distal tip of the trocar may be visualized while the trocar is advanced through the tissue, aiding in identifying the location of the trocar tip within tissue.

[00195] Also shown here are pressure pump 4902 and pressure sensor 4904, connected via pressure line 4828 to the inner lumen of sleeve 4804. Pressure may be used to assess when the tip of trocar 4802 has entered the peritoneal cavity. A positive pressure may be applied, via the pump and the pressure line, to sleeve port 4816, which is fluidly connected to the inner lumen of the sleeve and/or the inner lumen of the trocar. This positive pressure is measured by the pressure sensor, and maintained during advancement of the trocar through tissue. When the tip of the trocar breaks into the peritoneal cavity, the pressure measured by the pressure sensor will drop suddenly, indicating entry into the peritoneal cavity. This entry may be confirmed by direct visualization via the eyepiece of the scope or the camera connected to the eyepiece. Entry into the peritoneal cavity may be determined by this pressure drop, by direct visualization, or by both. Other sensors may also be used, such as conductivity sensors as disclosed elsewhere herein. In some embodiments, a pressure sensor may be located at or near the tip of the trocar or sleeve.

[00196] Once the distal tip of the access device has entered the cavity, the sleeve and scope are removed, and the trocar may remain to facilitate the introduction of a catheter or catheters, for example a lavage catheter.

[00197] Pump 4902 may use ambient atmospheric air and may filter it, for example with a small pore filter. For example, the filter may have a pore size of around 0.2 microns.

[00198] The pressure sensor and pressure pump may be in communication with controller 4906, which may indicate to the user, via sound, visual, a display, vibration or other means when the device has accessed the desired location. The controller may also control the pressure pump. The controller may be in communication with a mobile phone, tablet or a computer, or the controller may be incorporated into a mobile phone, tablet or a computer.

[00199] In some embodiments, the controller determines and communicates device guidance, based on direct visualization, pressure, conductivity /impedance, or other sensors, and may communicate to the user where in the body the device is located.

[00200] In some embodiments, pump 4902 and/or pressure sensor 4904 and/or controller 4906 may be incorporated into sleeve 4804.

[00201] In some embodiments, camera 4808 may not include a cable, as shown here, and may communicate the imaging via wireless technology, such as Bluetooth technology, WiFi technology or other technology. The image may be communicated to a display, to a controller, to a table, to a mobile phone, to a computer or to another device.

[00202] The pressure created in the inner lumen of the sleeve by the pressure pump may be around 10 mmHg. Alternatively, the pressure created in the inner lumen of the sleeve by the pressure pump may be around 5- 10 mmHg. Alternatively, the pressure created in the inner lumen of the sleeve by the pressure pump may be around 1- 10 mmHg. Alternatively, the pressure created in the inner lumen of the sleeve by the pressure pump may be around 5- 15 mmHg. Alternatively, the pressure created in the inner lumen of the sleeve by the pressure pump may be around 10- 20 mmHg. Alternatively, the pressure created in the inner lumen of the sleeve by the pressure pump may be less than around 10 mmHg. Alternatively, the pressure created in the inner lumen of the sleeve by the pressure pump may be less than around 15 mmHg. Alternatively, the pressure created in the inner lumen of the sleeve by the pressure pump may be less than around 20 mmHg. Alternatively, the pressure created in the inner lumen of the sleeve by the pressure pump may be less than around 30 mmHg. Alternatively, the pressure created in the inner lumen of the sleeve by the pressure pump may be less than around 40 mmHg.

[00203] A display may show the image from the camera and/or an indication of the pressure within the system, including an indication of a pressure drop when the tip of the access device enters the peritoneal cavity. This display may be on a tablet, phone, or other device. The connection to this display may be wired or wireless. Certain components of the device may be powered by the display device. For example, a tablet or phone may power pump 4902, light source 4830 and/or other components. In some embodiments, pump 4902 may be powered by a USB connection to a small mobile device such as a phone or tablet. Light source 4830 may also be powered the same way.

[00204] Some or all of the components of the system may be disposable. For example, the trocar and sleeve may be disposable. Pump 4902 and pressure sensor 4904, as well as the pressure line may be disposable. In some embodiments, the scope may be disposable. Trocar 4802 and/or sleeve 4804 may be made from a high durometer polymer, or other suitable material. For example, the trocar and/or sleeve may be made from a polymer with a Shore A hardness over 80. Or, for example, the trocar and/or sleeve may be made from a polymer with a Shore A hardness over 90. Or, for example, the trocar and/or sleeve may be made from a polymer with a Shore A hardness over 100. Or, for example, the trocar and/or sleeve may be made from a polymer with a Shore D hardness over 70. Or, for example, the trocar and/or sleeve may be made from a polymer with a Shore D hardness over 90.

[00205] The ID of the trocar may be around 5mm. Alternatively, the ID of the trocar may be around 4-6 mm. Alternatively, the ID of the trocar may be around 5-10 mm.

[00206] Figs. 50-54 show various views of sleeve 4804. Fig. 50 shows sleeve 4804, including sleeve shaft 4812, sleeve port 4816, sleeve body portion 4814, sleeve shaft tip 5002 and sleeve inner struts 5004. [00207] Fig. 51 shows a bottom view of the sleeve, including sleeve port 4816 and sleeve inner struts 5004. Note that the struts allow air to pass between them. This area is in fluid communication with sleeve port 4816 and allows pressure to be measured at the tip of the sleeve. This will be shown in more detail below.

[00208] Fig. 52 shows a cross sectional view of the sleeve. Shown here are sleeve port 4816, o-ring receptacle 5202, which receives scope o-ring 4826, sleeve reservoir 5204 and sleeve holes 5206. The sleeve holes may or may not be present, and may allow for fluid communication between the inner lumen of the sleeve and the inner lumen of the trocar.

[00209] O-rings mentioned herein may include rubber, polymer, metal, silicone, or other material rings. Ring shape may include circles, cylinders, etc. The cross-sectional shape of the o-ring may be a circle, ellipse, square or rectangle or any other shape. The o-ring may or may not be lubricated. O-rings may be a separate component from the sleeve or may be integrated with the sleeve.

[00210] Fig. 53 is similar to the view in Fig. 52, except that it is from an angle does not show the sleeve port.

[00211] Fig. 54 is an angled view of the sleeve.

[00212] Figs. 55 and 56 show an embodiment of distal tip 5002 of sleeve 4804. Shown here is distal opening 5502 as well as distal lip 5504. Distal end 5602 of the scope fits within the inner lumen of the sleeve, allowing for annular lumen 5604 between the scope and the sleeve. The annular lumen is in fluid communication with the inner lumen of the sleeve as well as sleeve port 4816. The device may be configured to maintain space 5606 between the distal tip of the scope and the distal tip of the sleeve, to allow for opening 5502 to be in fluid communication with the inner lumen of the sleeve. The relative size of opening 5502 and scope 5602, as well as the location of scope 5602 with respect to the distal end of the sleeve, may impact the accumulation of fat deposits on or near the distal end of the scope. Different configurations may be used to reduce the likelihood of fat deposits, since the deposits may impede visualization.

[00213] In some embodiments, there is no opening in the distal end of the sleeve, and the distal end of the sleeve may be optically clear. In embodiments where an opening exists, the opening may be any shape and/or size. In some embodiments, opening 5502 is a circle of around 3mm diameter. In some embodiments, opening 5502 is a circle of around 2-4 mm diameter. In some embodiments, opening 5502 is a circle of around 2-5 mm diameter. [00214] Figs. 57 A - 57D show some various configurations of the distal ends of the scope and sleeve and trocar. Fig. 57A shows the distal end of scope 5602 flush with the distal end of sleeve 5002. Distal end of trocar 5702 is also shown and may be essentially flush with the distal ends of the sleeve and the scope. Also shown here is sleeve inner lumen 5604 and trocar inner lumen 5704. Sleeve inner lumen 5604 is an annular lumen when the scope is in place. Trocar inner lumen 5704 is an annular lumen when the sleeve is in place.

[00215] Fig. 57B shows scope 5602 protruding slightly beyond the distal end of sleeve 5002. The scope may protrude around 1mm. Alternatively, the scope may protrude around 0.5-1.0 mm. Alternatively, the scope may protrude around 0.5-2.0 mm. Alternatively, the scope may protrude around 1.0-2.0 mm. Alternatively, the scope may protrude around 1 mm or less. Alternatively, the scope may protrude around 2 mm or less. Alternatively, the scope may protrude around 3 mm or less.

[00216] Fig. 57C shows the distal end of sleeve 5002 protruding slightly beyond the distal end of scope 5602. The sleeve may protrude around 1mm. Alternatively, the sleeve may protrude around 0.5-1.0 mm. Alternatively, the sleeve may protrude around 0.5-2.0 mm. Alternatively, the sleeve may protrude around 1.0-2.0 mm. Alternatively, the sleeve may protrude around 1 mm or less. Alternatively, the sleeve may protrude around 2 mm or less. Alternatively, the sleeve may protrude around 3 mm or less.

[00217] Fig. 57D shows the same configuration of the scope and sleeve as shown in Fig. 56, which includes lip 5504. In this embodiment, the distal end of the sleeve may protrude around 1mm beyond the distal end of the scope. Alternatively, the sleeve may protrude around 0.5- 1.0 mm. Alternatively, the sleeve may protrude around 0.5-2.0 mm. Alternatively, the sleeve may protrude around 1.0-2.0 mm. Alternatively, the sleeve may protrude around 1 mm or less. Alternatively, the sleeve may protrude around 2 mm or less. Alternatively, the sleeve may protrude around 3 mm or less.

[00218] To measure pressure changes within the inner lumen of the sleeve and/or trocar when the distal tip of the device enters the peritoneal cavity, sleeve port 4816 requires fluid communication with the inner lumen of the sleeve and/or the inner lumen of the trocar at the distal tip of the device.

[00219] Fig. 58 shows potential fluid communication paths through sleeve body portion 4814 which allow fluid communication between sleeve port 4816 and sleeve inner lumen 5604 and/or trocar inner lumen 5704. The fluid column transfers changes in pressure from the distal tip of the device to the pressure sensor connected to sleeve port 4816. The fluid column may communicate changes in pressure via sleeve inner lumen 5604 and/or trocar inner lumen 5704. Fluid path 5802 shown here shows the fluid communication via both sleeve inner lumen 5604 and trocar inner lumen 5704. Other fluid paths may also work. Some fluid paths may allow fluid communication between sleeve port 4816 and sleeve inner lumen 5604 only. Some fluid paths may allow fluid communication between sleeve port 4816 and trocar inner lumen 5704 only.

[00220] Any of the sleeve embodiments disclosed herein may be used with any trocar for any procedure and to access any body organ or cavity. The sleeve may be used with or without a scope. The sleeve may be used with or without pressure sensing.

[00221] Some examples of other procedures where the conductive access device may be useful include, laparoscopy, endoscopy, tissue sampling, biopsy, tracheotomy, vascular access, natural body lumen access (i.e. bowel, bladder, stomach, lung access), central nervous system access, lung access, amniotic access, tumor access, etc.

[00222] Some embodiments of the conductive access device may include a force sensor, pressure sensor, or other type of sensor at or near the distal tip of the device, or elsewhere. Some embodiments of the conductive access device controller may include a force detection component which monitors the amount of force necessary to automatically advance the access device, in either or both the rotational direction and the direction toward the inside of the patient’s body.

[00223] Some embodiments of the access device may use automatic insertion of the device, controlled by the controller. Some embodiments of the access device may be manual, where the device is inserted manually into the patient’s body.

[00224] Some embodiments may use only one electrode. Some embodiments may use 2 electrodes, 3 electrodes, 4 electrodes or more electrodes. Embodiments which use 1 electrode, may include a reference electrode patch or other type of electrode configured to be placed on the outside of the patient’s body, or elsewhere on or in the patient’s body.

[00225] Some embodiments may incorporate ablation and/or cauterizing ability into the access device. For example, the same electrodes used for measuring conductance/impedance may be used to cauterize or ablate tissue. The sensing and treatment functions may alternate. For example, conductance/impedance measurements may be used to determine the extent of cauterization and/or ablation of tissue. As tissue is cauterized and/or ablated, the hydration of the tissue decreases which in turn reduces the conductivity of the tissue. This conductivity can be monitored to determine the extent of cauterization/ablation. Alternatively, separate electrodes may be used for cauterization/ablation functions and location functions.

[00226] The inner diameter of the cannula portion of the access device may be around 1.6 mm. Alternatively, the inner diameter of the cannula portion of the access device may be around 1.2-2 mm. Alternatively, the inner diameter of the cannula portion of the access device may be around 2-5 mm. Alternatively, the inner diameter of the cannula portion of the access device may be around 5-10 mm.

[00227] The outer diameter of the stylet may be around 1.6 mm. Alternatively, the outer diameter of the stylet may be around 1.2-2 mm. Alternatively, the outer diameter of the stylet may be around 2-5 mm. Alternatively, the outer diameter of the stylet may be around 5-10 mm. [00228] The outer diameter of the cannula portion of the access device may be around 2 mm. Alternatively, the outer diameter of the cannula portion of the access device may be around 1.5-2.5 mm. Alternatively, the outer diameter of the cannula portion of the access device may be around 2.5-5 mm. Alternatively, the outer diameter of the cannula portion of the access device may be around 5-10 mm.

[00229] Some embodiments may incorporate imaging capabilities, such as fiber optics through, or in conjunction with, the access device. The controller may process the images, or images may be viewed directly by the user or both. The controller may collect image processing data, such as the presence of adhesions, tumors, abnormalities etc., and this data may be used to correlate the presence or absence of certain features with conductance/impedance of tissue, force necessary for advancement through tissue, etc. This correlation may then be used to help guide the access device.

[00230] Example of Data Processing System

[00231] Fig. 59 is a block diagram of a data processing system, which may be used with any embodiment of the invention. For example, the system 5900 may be used as part of the controller. Note that while Fig. 59 illustrates various components of a computer system, it is not intended to represent any particular architecture or manner of interconnecting the components; as such details are not germane to the present invention. It will also be appreciated that network computers, handheld computers, mobile devices, tablets, cell phones and other data processing systems which have fewer components or perhaps more components may also be used with the present invention.

[00232] As shown in Fig. 59, the computer system 5900, which is a form of a data processing system, includes a bus or interconnect 5902 which is coupled to one or more microprocessors 5903 and a ROM 5907, a volatile RAM 5905, and a non-volatile memory 5906. The microprocessor 5903 is coupled to cache memory 5904. The bus 5902 interconnects these various components together and also interconnects these components 5903, 5907, 5905, and 5906 to a display controller and display device 5908, as well as to input/output (I/O) devices 5910, which may be mice, keyboards, modems, network interfaces, printers, and other devices which are well-known in the art.

[00233] Typically, the input/output devices 5910 are coupled to the system through input/output controllers 5909. The volatile RAM 5905 is typically implemented as dynamic RAM (DRAM) which requires power continuously in order to refresh or maintain the data in the memory. The non-volatile memory 5906 is typically a magnetic hard drive, a magnetic optical drive, an optical drive, or a DVD RAM or other type of memory system which maintains data even after power is removed from the system. Typically, the non-volatile memory will also be a random access memory, although this is not required.

[00234] While Fig. 59 shows that the non-volatile memory is a local device coupled directly to the rest of the components in the data processing system, the present invention may utilize a non-volatile memory which is remote from the system; such as, a network storage device which is coupled to the data processing system through a network interface such as a modem or Ethernet interface. The bus 5902 may include one or more buses connected to each other through various bridges, controllers, and/or adapters, as is well-known in the art. In one embodiment, the RO controller 5909 includes a USB (Universal Serial Bus) adapter for controlling USB peripherals. Alternatively, I/O controller 5909 may include IEEE-594 adapter, also known as FireWire adapter, for controlling FireWire devices, SPI (serial peripheral interface), I2C (inter-integrated circuit) or UART (universal asynchronous receiver/transmitter), or any other suitable technology. Wireless communication protocols may include Wi-Fi, Bluetooth, ZigBee, near-field, cellular and other protocols.

[00235] Some portions of the preceding detailed descriptions have been presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. These algorithmic descriptions and representations are the ways used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. An algorithm is here, and generally, conceived to be a self-consistent sequence of operations leading to a desired result. The operations are those requiring physical manipulations of physical quantities. [00236] It should be borne in mind, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless specifically stated otherwise as apparent from the above discussion, it is appreciated that throughout the description, discussions utilizing terms such as those set forth in the claims below, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.

[00237] The techniques shown in the figures can be implemented using code and data stored and executed on one or more electronic devices. Such electronic devices store and communicate (internally and/or with other electronic devices over a network) code and data using computer-readable media, such as non-transitory computer-readable storage media (e.g., magnetic disks; optical disks; random access memory; read only memory; flash memory devices; phase-change memory) and transitory computer-readable transmission media (e.g., electrical, optical, acoustical or other form of propagated signals — such as carrier waves, infrared signals, digital signals).

[00238] The processes or methods depicted in the preceding figures may be performed by processing logic that comprises hardware (e.g. circuitry, dedicated logic, etc.), firmware, software (e.g., embodied on a non-transitory computer readable medium), or a combination of both. Although the processes or methods are described above in terms of some sequential operations, it should be appreciated that some of the operations described may be performed in a different order. Moreover, some operations may be performed in parallel rather than sequentially.

[00239] From the foregoing, it will be appreciated that specific embodiments of the invention have been described herein for purposes of illustration, but that various modifications may be made without deviating from the spirit and scope of the various embodiments of the invention. For example, several embodiments may include various suitable combinations of components, devices and/or systems from any of the embodiments described herein. Further, while various advantages associated with certain embodiments of the invention have been described above in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the invention. [00240] The foregoing description of various embodiments of the invention has been presented for purposes of illustration and description. It is not intended to limit the invention to the precise forms disclosed. Many modifications, variations and refinements will be apparent to practitioners skilled in the art. For example, embodiments of the apparatus and related methods can be configured for performing hypothermic treatments at a number of access points in the body including the abdominal, thoracic, spinal and cerebral regions. Embodiments of the apparatus can also be sized or otherwise adapted for pediatric and neonatal applications.

[00241] Elements, characteristics, or acts from one embodiment can be readily recombined or substituted with one or more elements, characteristics or acts from other embodiments to form numerous additional embodiments within the scope of the invention. Moreover, elements that are shown or described as being combined with other elements, can, in various embodiments, exist as standalone elements. Hence, the scope of the present invention is not limited to the specifics of the described embodiments, but is instead limited solely by the appended claims.

Claims

CLAIMS What is claimed is:

1. An access device, comprising: a sleeve shaft having an elongate length; a sleeve body coupled to a proximal end of the length, wherein the sleeve body and sleeve shaft collectively define a lumen therethrough; wherein the sleeve shaft is insertable within a working lumen of a first instrument such that a fluid tight seal between the sleeve body and the working lumen is formed, and wherein the lumen is configured maintain a pressure within and through the sleeve body and the sleeve shaft.

2. The device of claim 1 further comprising a sleeve port positioned along the sleeve body such that the sleeve port is in fluid communication with the lumen of the sleeve shaft.

3. The device of claim 2 wherein sleeve port is in fluid communication with the lumen through one or more sleeve openings defined within the sleeve body and in communication with the lumen of the sleeve shaft.

4. The device of claim 1 further comprising a seal positionable for maintaining the fluid tight seal between the sleeve body and the working lumen.

5. The device of claim 4 wherein the seal comprises an o-ring.

6. The device of claim 1 wherein the first instrument comprises a trocar which defines the working lumen therethrough.

7. The device of claim 1 wherein the sleeve body is rotatable independently of the first instrument while maintaining the fluid tight seal.

8. The device of claim 7 wherein the sleeve body is translatable independently of the first instrument while maintaining the fluid tight seal.

9. The device of claim 1 further comprising a reservoir within the sleeve body and in fluid communication with the lumen.

10. The device of claim 1 further comprising a second instrument which is insertable through the lumen while maintaining the pressure within the lumen and through the sleeve body and the sleeve shaft.

11. The device of claim 10 wherein the second instrument comprises a visualization scope.

12. The device of claim 10 wherein the sleeve body is rotatable independently of the second instrument while maintaining the pressure within the lumen and through the sleeve body and the sleeve shaft.

13. The device of claim 10 wherein the sleeve body is translatable independently of the first instrument while maintaining the pressure within the lumen and through the sleeve body and the sleeve shaft.

14. The device of claim 1 further comprising a pressure sensor which is in fluid communication with a distal tip of the sleeve shaft.

15. The device of claim 14 wherein the pressure sensor is in fluid communication through the sleeve port.

16. The device of claim 14 further comprising a controller in communication with the pressure sensor, wherein the controller is configured to determine when the distal tip is positioned within a body cavity based upon a drop in the pressure within the lumen.

17. The device of claim 16 wherein the controller is configured to determine when the distal tip is positioned within a peritoneal cavity of a patient based upon a drop in the pressure within the lumen.

18. The device of claim 1 further comprising a pump in fluid communication with the lumen via the sleeve port.

19. A method of accessing a body cavity, comprising: positioning a sleeve shaft having an elongate length within a working lumen of a first instrument, wherein a proximal end of the length is coupled to a sleeve body and where the sleeve body and sleeve shaft collectively define a lumen therethrough; positioning a second instrument through the lumen of the sleeve body and sleeve shaft such that a fluid tight seal between the second instrument and the lumen through the sleeve body and the sleeve shaft is formed; advancing the first instrument into a tissue region while moving the first instrument relative to the sleeve shaft and the second instrument; and monitoring a pressure within the lumen to determine when a distal tip of the sleeve shaft has entered a body cavity.

20. The method of claim 19 wherein positioning the sleeve shaft having an elongate length comprises inserting the sleeve shaft within the working lumen so that a fluid tight seal between the sleeve body and the working lumen is formed.

21. The method of claim 19 wherein positioning the sleeve shaft having an elongate length comprises inserting the sleeve shaft within the working lumen of a trocar.

22. The method of claim 19 wherein positioning the sleeve shaft having an elongate length comprises positioning the sleeve shaft such that the sleeve body is rotatable independently of the first instrument while maintaining a fluid tight seal.

23. The method of claim 19 wherein positioning the sleeve shaft having an elongate length comprises positioning the sleeve shaft such that the sleeve body is translatable independently of the first instrument while maintaining a fluid tight seal.

24. The method of claim 19 wherein positioning the sleeve shaft having an elongate length further comprises positioning a seal about an outer surface of the length for maintaining a fluid tight seal between the sleeve body and the working lumen.

25. The method of claim 19 wherein positioning the sleeve shaft having an elongate length further comprises maintaining fluid communication between the working lumen and the lumen of the sleeve shaft through one or more sleeve openings defined within the sleeve body.

26. The method of claim 19 wherein positioning the second instrument comprises maintaining the pressure within the lumen and through the sleeve body and the sleeve shaft.

27. The method of claim 19 wherein positioning the second instrument comprises positioning a visualization scope through the lumen of the sleeve body.

28. The method of claim 19 wherein positioning the second instrument comprises rotating the sleeve body independently of the second instrument while maintaining the pressure within the lumen and through the sleeve body and the sleeve shaft.

29. The method of claim 19 wherein a sleeve port is positioned along the sleeve body such that the sleeve port is in fluid communication through the lumen of the sleeve shaft.

30. The method of claim 19 wherein advancing the first instrument into a tissue region comprises rotating the sleeve body independently of the first instrument while preventing decrease in the pressure within the lumen and through the sleeve body and the sleeve shaft.

31. The method of claim 19 wherein monitoring a pressure within the lumen comprises monitoring the pressure via a pressure sensor which is in fluid communication with a distal tip of the sleeve shaft.

32. The method of claim 31 further comprising determining when the distal tip is positioned within a body cavity based upon a drop in the pressure within the lumen via a controller in communication with the pressure sensor.

33. The method of claim 32 wherein determining when the distal tip is positioned within the body cavity comprises determining when the distal tip is positioned within a peritoneal cavity of a patient based upon the drop in the pressure within the lumen.

34. The method of claim 19 further comprising increasing the pressure within the lumen via a pump in fluid communication with the lumen via a sleeve port.