The present invention relates generally to interventional devices and methods, and more particularly to minimally invasive interventional devices and methods for moving, lifting, positioning, retracting or otherwise manipulating tissues within a patient.
It is widely recognized that laparoscopic surgery is less invasive than open surgery. In fact, since the late 1980's, laparoscopic surgery has become the standard of care for a variety of common interventional procedures, such as cholecystectomy, diagnostic peritonoscopy, tubal ligation, appendectomy, and hernia repair, among others. Laparoscopy currently involves the injection of low pressure gas (typically CO2) into the abdominal cavity to effectively inflate said cavity, lifting the abdominal wall away from other internal organs and thereby creating a working space for clinicians to perform the desired diagnostic and therapeutic procedures. Instruments are then inserted through the abdominal wall and into the abdominal cavity at multiple small incision points (typically 3-7) via devices known as trocars that provide instrument access.
Recently, efforts are underway to make laparoscopy even less invasive. Techniques known as single incision laparoscopic surgery (SILS) or single port access (SPA) surgery utilize specially designed trocars through which multiple instruments may be inserted into the patient at a single incision to accomplish the procedure. Endoscopic procedures are also being developed employing devices that enter the body via natural orifices such as the mouth, anus, and vagina, and then pierce through the internal hollow organ walls to access the abdominal cavity to carry out the desired diagnostic and therapeutic procedures. These natural orifice translumenal endoscopic surgery (NOTES) approaches are considered even less invasive, involving no external incisions, less scarring, faster recovery times, etc. The number of minimally invasive laparoscopic, endoscopic and NOTES procedures performed each year is growing rapidly, fueled by the increasing worldwide demand for surgical intervention in general (e.g. for treating epidemics such as obesity and its related co-morbidities) along with patients' desires for better cosmetic results, less pain and scarring, etc.
During surgical intervention, it is often necessary to move, lift, reposition, retract or otherwise manipulate tissues and/or internal organs in order to view and/or treat various areas within the body cavity that would otherwise be difficult to access. Various commercially available devices exist and are well known in the art for manipulating organs. Typically these are simple handheld mechanical instruments such as graspers, retractors, probes, or other blunt instruments capable of moving organs by pushing, pulling, grasping, lifting or otherwise repositioning them. Some organs, such as the liver, stomach, and spleen, can be very challenging to move and lift, as they are voluminous, heavy and difficult to grip, and are easily damaged, or bleed if traumatized. Many of the aforementioned devices (e.g. graspers, blunt probes, and the like) impart high stress concentrations on the tissues/organs and are thus less safe than desired. Other of the aforementioned devices (e.g. retractors) are bulky, cumbersome or otherwise inconvenient for the surgeon to use, and are therefore not suitable for integration into the emerging class of minimally invasive procedures (e.g. SILS, SPA, NOTES procedures) where the tools are smaller, have less structural strength, and they must pass through smaller and sometimes tortuous openings in order to reach the treatment area.
There is therefore a clear need for new interventional methods and devices that are convenient to use, and capable of safely moving, lifting, repositioning or otherwise manipulating heavy, large, or easily damaged body organs. The ability to simply and atraumatically manipulate body organs in minimally invasive laparoscopic, endoscopic and NOTES procedures would be of tremendous benefit to surgeons, patients and health care systems.
The devices and methods of the present invention represent an entirely new interventional approach for lifting and manipulating the position of body organs to provide unencumbered performance of various diagnostic and therapeutic procedures. The devices and methods of the present invention overcome the above stated shortcomings and limitations of the prior art; specifically these methods and devices are less invasive, more convenient to deploy and use, easier to control, and are significantly safer (i.e. less traumatic to tissues and organs).
The present invention may be best described as a system consisting of a vacuum actuated manifold that is inserted into the body, a vacuum source external to the body, and a vacuum communication member connecting the external vacuum source to said manifold. According to the methods of the present invention, the manifold is first inserted into the body and positioned so at least one portion of a surface of the manifold is in direct contact with at least a portion of the surface of the tissue or organ to be manipulated. At least one other portion of a surface of said manifold is positioned in direct contact with at least one moveable structure which can be easily and controllably manipulated by a clinician, and that is provided and used in conjunction with the device, according to the methods disclosed herein.
The manifold is configured to communicate vacuum (i.e. pressure lower than ambient) to both the tissue/organ to be manipulated and the moveable structure to which it is placed in direct contact. Accordingly, in operation, vacuum is supplied by the external vacuum source and delivered by the vacuum communication member to at least a portion of the manifold, or more typically a space, area or region within the manifold that may be evacuated to a controlled and desired pressure. Communication of the vacuum created within said portion of the manifold to each of the tissue/organ to be manipulated and the moveable structure is typically accomplished by providing one or more ports, openings, holes, passages, and the like, within the surface portions of the manifold in contact with the tissue/organ and the moveable structure. Communication of a controlled vacuum pressure from within the manifold to the tissue/organ and moveable structure generates controllably adjustable holding forces between the surface portions of the manifold in contact with each of the surfaces of the tissue/organ and the moveable structure, respectively, thereby joining or otherwise adhering the manifold to both the organ and the moveable structure surfaces. This effectively attaches the organ and moveable structure together in a temporary and releasable manner (i.e. for as long as the vacuum remains actuated), via the intermediately positioned manifold. Once so joined together, manipulation of the moveable structure by the operator thereby transfers mechanical forces to the target tissue/organ, via the intermediate manifold, allowing the target tissue/organ to be lifted, moved, positioned or otherwise manipulated in the desired manner.
In certain preferred embodiments, the manifold of the present invention is designed to be initially collapsed (e.g. by compressing, folding, rolling, etc.) and is delivered into the body in the collapsed (i.e. pre-deployed) configuration having a reduced profile. Insertion of the collapsed manifold into the body cavity can be accomplished by methods well known in the art, such as via a trocar, tiny laparotomy, or endoscope. Once inside the body cavity, the manifold is expanded (i.e. deployed) and positioned appropriately for subsequent actuation by the user, as described below. Said deployment can be accomplished manually by the operator, or in certain embodiments, the manifold deploys in a self-actuating manner when released from the delivery device, returning to a pre-determined shape as a result of inflation, elastic recovery, the incorporation of mechanical spring elements, shape memory materials, and the like.
In some embodiments the size and geometry of the manifold may be adjusted or selected, either before or during use, according to the size and type of organ/tissue to be manipulated in order to optimize the holding force and ensure safe operation.
The manifold can be rigid, flexible and combinations of the foregoing, and it can be produced from any suitable biocompatible material that may be safely inserted and used within a patient. At least some portions of the manifold, as described below, must be sufficiently air impermeable so as to be capable of withstanding moderate vacuum pressures. Examples of suitable biocompatible materials well known in the art include metals, alloys, thermoplastics, silicones, rubbers, fabrics, and the like, and combinations of the foregoing. The manifold and associated hardware, in whole or in part, may be designed for single patient use, for reposable use, or reusable, and combinations of the foregoing.
In some embodiments, the manifold may be provided as a rigid ring, flexible tube, or expandable balloon, formed into the shape of a loop, doughnut or other similar geometrical shape (though not limited to being circular) so as to provide a central hole or opening that provides the space, area or region within the manifold to be evacuated. In other embodiments, the manifold may be formed in more of a linear, tubular configuration, so as to be configured having one or more central channels or lumens that provide the evacuation space(s). In yet other embodiments, the manifold may be provided in the form of a disk, plate or sheet-like structure produced from a material such as porous matrix, foam, sponge, or the like, and having an air impermeable coating at least partially surrounding the structure so as to be capable of being evacuated internally.
The manifold is generally designed and configured having at least one portion of its surface intended to be positioned in contact with the tissue/organ to be manipulated and at least one portion of its surface designed to be positioned in contact with at least one moveable structure that is provided and used in conjunction with the manifold. Each of said contacting surface portions is further configured having at least one vacuum port, hole, passage or other opening therein that is capable of communicating vacuum between the evacuation space within the manifold and each of the tissue/organ and the moveable structure to which it is placed in contact. Typically, though not necessarily, the contacting surface portions and associated vacuum ports for the tissue/organ to be manipulated and the moveable structure are positioned on opposite-facing sides of the manifold. The size, shape, surface area, etc., of each of the contacting surface portions and associated vacuum ports are optimized to ensure that there is sufficient holding force generated based on the pressure differential established during actuation to securely attach each of said surfaces to the tissue/organ and moveable structure, respectively, while simultaneously distributing these holding forces over a sufficiently large surface area such that stress concentrations that may cause organ trauma or tissue damage are minimized. This method of distributing the mechanical forces needed to hold, lift and manipulate heavy organs or body tissues over a substantially large surface area of contact results in significantly reduced contact stresses compared to prior art devices that necessarily concentrate such stresses, such as graspers, blunt dissectors or metallic mechanical retractor devices. The reduced risk of trauma to tissues and organs during their manipulation is a significant improvement over the prior art.
Accordingly, it is helpful to explain some basic design considerations involved in optimizing the pressure differential and contact surface areas to provide a known, desired lifting force, while distributing these forces over a sufficiently large area such that peak stresses on tissue are kept below a safe threshold. The following simplified calculations provide an example of these design considerations.
Assume the goal is to safely lift a patient's liver that weighs up to 1.0 kg. Further, assume the insufflation pressure (i.e. the positive pressure within the abdominal cavity, relative to atmospheric pressure) is established at 15 mm Hg (2.0 kPa), which is a value typically used in standard laparoscopic procedures. We can calculate the theoretical lifting force as a function of pressure differential (i.e. the difference between the absolute pressure established within the manifold during actuation and the ambient insufflation pressure) for manifolds having different size, i.e. different surface areas of vacuum in contact with the liver.
Other design considerations may also need to be factored in. For example, assume that clinical research has indicated it is most desirable not to exceed a maximum direct contact stress on the liver of about 20 kPa (150 mm Hg) in order to avoid undesirable tissue damage and ensure patient safety. This places a constraint on the vacuum pressure that can be safely employed by the system. In this case, it would be advisable not to reduce the absolute vacuum pressure below about 625 mm Hg during manipulation of the liver. According to
It should be obvious to those skilled in the art that the above theoretical calculations are highly simplified and it is therefore advisable that further detailed modeling and experimentation be performed to optimize safety and performance for the intended mission before finalizing device design. For example, contact surface areas of vacuum are not likely to remain flat and circular, even when a circular geometry for the vacuum ports is employed because both the manifold and tissues are relatively soft and deformable under pressure. There may also be stretching of tissue, shape variations at the seal edges, variable tissue properties, etc., that need to be taken into account.
As described previously, at least a portion of the space existing between each of said contacting surfaces is configured to be evacuated by being in communication with the external vacuum source. Typically the evacuation space is created by, and its size, shape and other characteristics are determined by design of the manifold, e.g. the manifold size, shape, materials of construction, method of deployment, etc. The portions of the manifold that define the evacuation space and those that form the contacting surfaces may be provided as separate structures comprising a manifold assembly, or the manifold may comprise a single unitary structure that serves both the evacuation space and surface contacting functions. In either case, the manifold is designed and configured to ensure that a user controllable vacuum pressure is achievable and maintainable within the evacuation space. The manifold is further designed and configured to ensure that vacuum created within the evacuation space can be transmitted via one or more vacuum ports positioned on each contacting surface, such that sufficient holding forces are generated to temporarily and releasably attach the manifold to both the tissue/organ and moveable structure. It is often desirable to ensure there is sufficient extra holding force provided while vacuum is maintained to safely and effectively move, lift or otherwise manipulate the tissue/organ and/or moveable structure without unintended leakage of vacuum that may lead to separation or release during such use. Accordingly, the rate of evacuation (i.e. the pumping speed) can also be an important design consideration, requiring optimization of both the pumping capacity of the external vacuum source and the size of the lumen within the vacuum communication member.
In one embodiment, the manifold may be provided in the shape of a ring or other similar geometrical structure having a hole or opening through its central region that forms the evacuation space. In this case, the top- and bottom-most portions of the structure form the contacting surface portions, and the open areas defined within the plane of each contacting surface portion serve as opposite-facing vacuum ports that are essentially contiguous with the central evacuation space. The central hole or opening defining the evacuation space is in vacuum communication with the vacuum communication member, and hence the vacuum source, via at least one vacuum passage incorporated into the manifold structure. Said at least one vacuum passage can be selected from the group consisting of openings, holes, slots, perforations, channels, pores, and combinations of the foregoing. In some cases there may be a single such vacuum passage through the walls of the manifold, while in other cases there may be a plurality of such vacuum passages distributed across a surface. The number, size, shape, orientation and position of the one or more vacuum passages may be optimized in order to control, e.g. the rate of evacuation, the uniformity of holding forces, etc.
In another embodiment, the manifold may be provided in the form of a disk, plate or sheet-like structure, wherein the inside and at least a portion of the upper and lower surfaces are at least partially porous and permeable, capable of transmitting vacuum within its interior, while at least a portion of the external surrounding surfaces are solid or dense, forming an impermeable seal around its perimeter. In this case, the internal portion of the structure itself comprises both the evacuation space and vacuum passages, and the top and bottom portions of the structure form the contacting surfaces having one or more vacuum ports therein.
The vacuum communication member, typically a flexible hose, tube, or the like, is operatively connected between the manifold and external vacuum source (usually positioned outside the body for convenience), passing through the body wall via either the same access site that was used to deliver the manifold into the body cavity or any other convenient access opening.
Once introduced into the body, the manifold is positioned appropriately between the target tissue/organ and the moveable structure. Positioning may be effected using any number of conventional tools, such as a grasper, forceps, probe, or the like. Alternatively, in some embodiments, the devices may optionally incorporate additional components or structures that provide operable mechanisms for assisting with the movement or positioning of the device prior to and during deployment. Examples of such mechanisms include guidewires, articulating joints, remotely steerable motors, permanent magnets, and the like, that may be manipulated either inside or outside the body. In one such embodiment, a permanent magnet incorporated within the manifold may communicate with another permanent magnet located outside the body such that movement of the external magnet by the clinician allows non-contacting movement and positioning of the manifold inside the patient.
The moveable structure used in conjunction with the present invention may be another mechanical system component or instrument provided for such use, and it may be used either internal or external to the patient's body. Alternatively, the moveable structure may actually be part of the patient's body that can be easily moved or otherwise manipulated by the operator during the course of the interventional procedure.
In the case of a mechanical system component, the moveable structure may be introduced into the body cavity along with, and initially attached to the manifold. Alternatively, it may be inserted into the body cavity after the manifold is initially deployed, then brought into contact with and operably attached to the manifold during use. For example, a longitudinal arm, shaft, tube, rod, etc., may be introduced into the body cavity via any convenient access port. The distal end of said device may optionally be configured having a portion that is designed with customized size, shape, surface area, etc. (e.g. a flat surface, curved surface, etc.,) that is intended to readily promote attachment to the manifold when vacuum is actuated.
Alternatively, a device used outside the body, such as a permanent magnet, may be in magnetic field communication with a permanent magnet or other magnetically active component optionally incorporated in, or previously placed in contact with, the manifold. In this manner, movement of the permanent magnet outside the body will produce a non-contacting coupled movement in the manifold, which can aid in positioning the device within the body prior to actuation, and also allow manipulation of the tissue/organ to which the manifold is temporarily attached after vacuum actuation.
In certain other embodiments, the moveable structure of the present invention, to which the manifold is temporarily joined, is another tissue or part of the patient's body that may be manipulated by the surgeon, thereby causing the desired movement of the target tissue/organ to which the manifold is also temporarily joined, as described previously. For example, the manifold may be positioned with one surface in contact with the tissue/organ to be manipulated (e.g. the patient's liver) and another surface in contact with the patient's abdominal wall. Upon actuation of the manifold by supplying vacuum from the vacuum source via the vacuum communication member, the manifold becomes temporarily and releasably joined between the liver and the abdominal wall. Movement of the patient's abdominal wall, e.g. by lifting, will therefore cause the liver to also be simultaneously lifted, providing the surgeon with the desired clinically advantageous positioning and visibility for carrying out the intended diagnostic or therapeutic interventional procedures.
In the case of well established laparoscopic procedures, insufflation is routinely used to inflate the body cavity and lift the abdominal wall, thereby creating operative working space for the surgeon. Therefore, referring to the example above where the surgeon desires to retract the liver by lifting it out of the way, it is possible to first insert the manifold into the patient's body while the body cavity is inflated by insufflation. After deploying the manifold, the operator may then position it by laying it on top of the liver so its bottom surface is in contact with the liver. The surgeon may then decrease the insufflation pressure (i.e. reduce the absolute pressure within the abdominal cavity), partially deflating the body cavity. This lowers the abdominal wall, bringing it into contact with the top surface of the manifold. Upon actuation of the manifold by supplying vacuum thereto, the manifold becomes temporarily and releasably joined to the liver below and the abdominal wall above. Subsequently, the surgeon may again increase the insufflation pressure, re-inflating the body cavity to lift the abdominal wall, simultaneously lifting the manifold and liver joined thereto. In this manner, the liver is safely and completely retracted out of the way, providing the surgeon a clear and unobstructed operative working space.
In the present invention, in many cases only a very small, flexible tube may need to pass through the abdominal wall to serve as the vacuum communication member needed to actuate the device. This tube may be routed in any number of ways that don't necessarily require a dedicated trocar, which advantageously frees up a trocar for use with other instruments. For example, the tube may be routed through a small auxiliary channel that may designed and provided in the trocar. It may also be routed along the outside wall of the trocar, through a separate laparotomy without use of a trocar, etc. Alternatively, in some cases, the vacuum actuated manifold may be sealed off using an optional valve configured as part of the manifold assembly such that after vacuum is actuatingly established inside the patient, the tube may be disconnected and removed while the device remains actuated. Compared to prior art mechanical devices, the present invention may therefore eliminate the need for a separate trocar. It also takes up less space within the operative field and minimizes the possibility of causing inadvertent damage to the liver or surrounding tissues and organs.
Substantially similar methods to those described above for using other tissue or another portion of the patient's body (e.g. the abdominal wall) to serve as the moveable structure of the present invention can also be used when other (non-insufflation) methods for lifting the abdominal wall are employed to create the operative working space.
Beyond using the abdominal wall as the moveable structure, it is also possible to use certain other conveniently manipulated tissues or organs within the body as moveable structures in order to manipulate other tissues/organs that may be in close proximity and temporarily joinable to each other using the vacuum actuated manifold, as described herein.
It should be obvious that a wide variety of target tissues, organs and other body structures may be manipulated using the methods and devices of the present invention. Similarly, an equally wide variety of options exist for providing the necessary moveable structure to be used in conjunction with these devices. Accordingly, there are many potential uses and applications of the present invention in a wide variety of interventional procedures. For example, there are many situations where it may be desirable or simply convenient for a clinician to temporarily and releasably attached one body tissue to either another tissue or an inserted device, in the simplest and safest manner possible. Such other uses and applications are all considered within the scope of the present invention.
While the present invention will be described more fully hereinafter with reference to the accompanying drawings, in which particular embodiments are shown and explained, persons skilled in the art may modify the embodiments herein described while achieving the same methods, functions and results. Accordingly, the descriptions that follow are to be understood as illustrative and exemplary of specific structures, aspects and features within the broad scope of the present invention and not as limiting of such broad scope.
An exemplary system of the present invention is shown schematically in
In the example shown, manifold 110 consists of a rigid ring produced from a commercially available biocompatible thermoplastic material that may be manufactured by methods well known in the art, such as injection molding, machining, and the like. Manifold 110 may be produced having a wide variety of sizes and shapes, depending on and optimized for the specific intended use. However, in general, it is desirable to minimize the overall size of the device, consistent with providing sufficient holding forces for the intended use, while minimizing the potential for tissue damage and organ trauma by maximizing the available tissue surface contact areas. Accordingly, the outer diameter of manifold 110 is preferably between 0.1 cm and 30 cm, more preferably between 0.5 cm and 20 cm, and most preferably between 1 cm and 10 cm. Based on the outer diameter, the inner diameter of manifold 110 may be designed accordingly to provide the desired volume of evacuation space 160 and the desired size (i.e. surface area) of the vacuum ports, which controls the vacuum contact area and hence the holding forces produced during actuation (as described in
Vacuum communication member 130 is typically provided as a flexible hose or conduit produced from a commercially available biocompatible thermoplastic material capable of vacuum use, along with associated fittings, connections, switches, sensors, control valves, etc. well known to those skilled in the art of vacuum systems. The outer and inner diameters of vacuum communication member 130 may vary considerably depending on the size of manifold 110 and evacuation space 160, as well as the desired rate of evacuation, desired maximum achievable vacuum pressure, desire to overcome small vacuum leakage in actual practice, etc. In general, the outer diameter of vacuum communication member 130 is preferably between 0.01 cm and 2 cm, more preferably between 0.05 cm and 1 cm, and most preferably between 0.1 cm and 0.5 cm.
As shown in
The range of vacuum pressures needed during actuation, which determines the required capabilities and ratings for external vacuum source 120, the materials of construction and dimensions of the various system components, etc., depends on the dimensions of manifold 110, the contacting surface areas of vacuum provided by the vacuum ports on lower surface 150 and upper surface 155, as well as the design requirement for the interventional mission (e.g. the weight of the organ to be lifted, desired safety factor, etc.), as explained previously with reference to
As shown in
In another embodiment, illustrated in
A top, cross sectional view of manifold 305 is shown in
Another embodiment of the present invention is illustrated in
Also shown in
Balloon 405 may then be inflated by actuating the remote pressure delivery source, as previously described. At this point, the surgeon would reduce the CO2 insufflation pressure within abdominal cavity 505, thereby lowering abdominal wall 515 down onto the top surface of balloon 405. Deployment and actuation of the device may then proceed as described previously with respect to
Additional features and mechanisms may be incorporated into devices of the present invention to aid in easy deployment, simplify grasping, positioning and actuation of the device, etc. For example, considering the embodiment described in
Another embodiment of the present invention is illustrated in
Perimeter 716 is preferably made from a thin, vacuum impermeable coating, fabric or the like, that completely surrounds and covers all external surfaces of central portion 710 that are not intended to either contact tissue or the moveable structure during device operation. Alternatively, perimeter 716 may be formed by selectively heat sealing or partially melting the outer surface of the porous material comprising central portion 710. During use, after insertion into the patient's body and self-actuating inflated expansion of central portion 710, as described above, the external vacuum source (not shown) is actuated. Reduced pressure is thereby delivered to central portion 710 via vacuum tube 704 and vacuum passages 706. Because perimeter 716 is vacuum impermeable, the internal vacuum generated inside central portion 710 produces a suction effect at each of tissue contacting surface 712 and moveable structure contacting surface 714. This suction creates forces that act to draw toward and temporarily attach assembly 702 to each of the tissue/organ to be manipulated and the moveable structure, respectively. Optional seals 718, which may be produced from soft, flexible impermeable material such as rubber, fabric, or the like, may be provided and configured at the top and bottom surfaces of assembly 702 in order to assist with the initial contact and suction effects needed to achieve temporary attachment to each contacting surface during device actuation. Some advantages of this embodiment are that the device is compressible to a very small profile in the pre-deployed configuration for insertion into the patient's body, the structure is self-inflating on initial deployment, and the surface areas provided for contacting each of the tissue/organ to be manipulated and the moveable structure may be designed to be significantly larger than in the case of an inflatable balloon. This further reduces stress concentrations on tissues during vacuum actuation, thereby providing a safer, more atraumatic and easily releasable temporary attachment that allows for improved organ manipulation.
There are a variety of minor modifications to the devices and operational methods that can be employed to allow the present invention to be used without requiring any separate incisions or trocars. For example, in one such alternative (not shown), it is possible to use the device of the present invention with a trocar that will used for other purposes, such as trocar 545. In this case, the device is first inserted through abdominal wall 515 and into the patient's abdominal cavity through an incision made in abdominal wall 515, but prior to placing trocar 545 into the incision. Trocar 545 may then be placed through the abdominal wall with tube 408 routed, e.g. adjacent the outside surface of the trocar, therefore not requiring use of the working channel of the trocar. Because tube 408 is very small and flexible, it is able to conform to the interface between trocar 545 and abdominal wall 515 and therefore the rate of leakage of insufflation pressure using this configuration, if any, is relatively low.
In yet another alternative embodiment (not shown), it is also possible to incorporate one or more small, inline shutoff valves (ideally there are separate shutoff valves for each of the pressure and vacuum lines), along the length of tube 408 at or near the location where tube 408 attaches to balloon 405. Tube 408 may then be detachably connected to said shutoff valve(s). In this manner, after insertion of the device into the patient's body and subsequent pressurized deployment, followed by vacuum actuation to temporarily attach balloon 405 to both liver 510 and abdominal wall 515, said shutoff valve(s) can be closed. This will maintain balloon 405 in the deployed (inflated) and vacuum actuated configuration, even after tube 408 is detached from the shutoff valve(s) and removed from the body. In this manner, it is possible to lift and retract the liver or other organs without requiring a continuously active connection between the device and pressure source 530 and vacuum source 540. If desired or necessary to reposition or adjust the device, it is possible at any time to re-insert tube 508 into the patient via any previously placed trocar and re-connect to the shutoff valve(s).
An alternative method of using the systems of the present invention within a patient 902 is illustrated in
In practice, it is possible but not considered necessary for the device of the present invention to be deployed through the working channel of flexible endoscope 904. As shown in
Various additional features and mechanisms may be optionally incorporated into the devices and systems of the present invention to provide greater design flexibility, enhanced functionality, ease-of-use, improved safety, etc. For example, another embodiment of the present invention is illustrated in
Alternatively, as illustrated by another embodiment shown in
Note that in the embodiment illustrated in
To illustrate the useful benefit of incorporating optional independent actuation, for example, in some situations it may desirable to initially attach the manifold to a first tissue to form a subassembly at a first position, then move the subassembly (i.e. the manifold with the first tissue attached thereto) to another second position at which point it may then be attached to another tissue to produce a completed, joined assembly (i.e. the manifold temporarily and releasably attached at two or more contacting surfaces to tissues, organs, moveable structures, etc.) within the body. Similarly, the second tissue to be attached to the initially formed subassembly at the first position may itself be independently moved by the clinician toward the previously formed subassembly, and then attached thereto to form a completed, joined assembly located at the first position. In either case, the subsequent lifting, positioning, retracting or otherwise manipulating of either attached tissue may be accomplished by manipulating either the other attached tissue or the manifold itself.
The present invention has been successfully reduced to practice via a number of different embodiments, as described above. In one example, described here, a manifold according the embodiment shown in
To demonstrate the operational methods and functional capabilities of the present invention, the organ to be manipulated and the moveable structure of the present invention were both simulated using water filled balloons. In this experiment, each balloon was filled with approximately 1 liter of water and then sealed, weighing approximately 1 kg.
The manifold was first placed atop one of the balloons (the bottom balloon, representing the patient's liver), thereby simulating deployment of the device within a patient's insufflated abdominal cavity and positioning of the device on top of the liver, as illustrated in
To simulate lifting of the abdominal wall by re-insufflation of the abdominal cavity, as illustrated in
According to the methods of the present invention, this example clearly illustrates successful operation of one embodiment of the devices and systems of the present invention, demonstrating the ability to deploy, control, actuate and successfully utilize a vacuum actuated manifold of the present invention in the intended manner. Furthermore, given this experiment was carried out within a performance range designed to be useful for a wide variety of interventional procedures, this example further demonstrates the present invention is capable of providing sufficient holding force and lifting capacity to manipulate heavy organs and tissues within the body, such as the liver, and wherein the maximum pressure exerted on the target organ/tissue is limited by design to prevent trauma or unintended damage.
This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application Ser. No. 61/028,571, filed Feb. 14, 2008, and to U.S. Provisional Patent Application Ser. No. 61/105,332, filed Oct. 14, 2008. These patent applications are incorporated herein by reference in their entireties.
Number | Date | Country | |
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61028571 | Feb 2008 | US | |
61105332 | Oct 2008 | US |