Anatomical model

[0001] This patent application:

[0002] (i) is a continuation-in-part of prior U.S. patent application Ser. No. 11/804,873, filed May 21, 2007 now U.S. Pat. No. 7,854,612 by James J. Frassica et al. for ANATOMICAL MODEL, which in turn claims benefit of prior U.S. Provisional Patent Application Ser. No. 60/801,719, filed May 19, 2006 by James Frassica et al. for ANATOMICAL MODEL PROV); and

[0003] (ii) claims benefit of prior U.S. Provisional Patent Application Ser. No. 61/000,539, filed Oct. 26, 2007 by James J. Frassica et al. for ANATOMICAL MODEL.

[0004] The three above-identified patent applications are hereby incorporated herein by reference.

[0005] This invention relates to anatomical models in general, and more particularly to anatomical models of a mammalian tract for use in teaching endoscopic insertion techniques and therapeutic procedures to physicians and other medical personnel.

[0006] In most mammals, mucous membranes line the passages by which internal organs communicate with the exterior environment. By way of example but not limitation, the two primary mammalian tracts (i.e., the gastrointestinal and genitourinary tracts) are lined with mucous membranes. These mucous membranes are generally soft and velvety, and very vascular, and their surfaces are coated over by their mucous secretion, which is typically of a viscous consistency. The mucous serves to protect tissue from foreign substances which may be introduced into the body.

[0007] In order to provide a training tool for physicians and other medical personnel who are learning endoscopic insertion techniques and therapeutic procedures, it has been found desirable to provide a clinically realistic anatomical model of the mucous membranes which line the two primary mammalian tracts, i.e., the gastrointestinal and genitourinary tracts.

[0008] Many, if not most, of the prior art anatomical models of the gastrointestinal and genitourinary tracts are single-walled tubular models which are positioned on a base plate. These single-walled tubular models generally utilize elastomeric materials such as silicone or a thermoplastic elastomer (TPE) to simulate the pliable, compliant nature of a gastrointestinal and/or genitourinary tract organ, e.g., the bowel, etc.

[0009] However, there are many deficiencies associated with these prior art anatomical models.

[0010] For example, elastomeric materials tend to have a high coefficient of friction, which is the opposite of the slippery mucous-lined anatomy of the gastrointestinal and genitourinary tracts. Thus, forming the anatomical model out of an elastomer makes it difficult to pass the instrumentation (e.g., an endoscope) through the anatomical model in a realistic manner. One solution to this problem is to add a lubricant to the anatomical model and/or the instrumentation. However, this approach is not completely satisfactory, since the lubricant can dry out, even in a relatively short time period, which can then make it even more difficult to pass instrumentation through the model.

[0011] Another significant deficiency of prior art anatomical models is that these models fail to realistically incorporate the external compression (e.g., abdominal pressure from adjacent organs) which acts on the gastrointestinal and/or genitourinary tract. For example, the bowel and the urethra are both tubular organs which typically lay in a flat condition when these organs are not distended. Prior art anatomical models are generally constructed with self-supporting walls which do not simulate the lay-flat anatomy which is being compressed by abdominal pressure from adjacent organs.

[0012] In addition to the foregoing, the gastrointestinal and/or genitourinary tracts are typically supported by the adjacent anatomy via movable connections. By way of example but not limitation, the small bowel is typically movably supported by the mesentery. Prior art anatomical models are generally constructed with fixed supports which do not properly simulate the movable connections which can be characteristic of the gastrointestinal and/or genitourinary tracts.

[0013] For these reasons, and others, there is presently a need for a more realistic and accurate anatomical model which can be used as a training tool for physicians and other medical personnel to learn endoscopic insertion techniques and therapeutic procedures.

[0014] It is, therefore, an object of the present invention to provide an accurate and realistic anatomical model which can be used by physicians and other medical personnel to learn endoscopic insertion techniques and therapeutic procedures.

[0015] This and other objects are addressed by the provision and use of the present invention which, in one form of the invention, generally comprises an anatomical model comprising an inner lumen and an outer lumen, wherein the inner lumen is disposed inside of the outer lumen so as to create a space therebetween, and further wherein a fluid is disposed within the space, interior to the outer lumen and exterior to the inner lumen, whereby the inner lumen can accurately simulate the mucous membrane lining a mammalian tract (e.g., the gastrointestinal or genitourinary tract).

[0016] In another form of the present invention, there is provided an anatomical model which generally comprises a lumen structure supported on a frame using movable connections.

[0017] In one preferred form of the invention, there is provided an anatomical model comprising:

[0018] a lumen structure;

[0019] a frame; and

[0020] movable connections selectively supporting the lumen structure to the frame.

[0025] The present invention generally comprises an anatomical model comprising an inner lumen and an outer lumen, wherein the inner lumen is disposed inside of the outer lumen so as to create a space therebetween, and further wherein a fluid is disposed within the space, interior to the outer lumen and exterior to the inner lumen, whereby the inner lumen can accurately simulate the mucous membrane lining a mammalian tract (e.g., the gastrointestinal or genitourinary tract).

[0026] More particularly, and looking now at FIG. 1, there is shown an anatomical model 5 which comprises two lumens, an inner lumen 10 and an outer lumen 15, wherein inner lumen 10 is disposed inside of outer lumen 15. Inner lumen 10 generally comprises an interior surface 20 and an exterior surface 25. Outer lumen 15 generally comprises an interior surface 30 and an exterior surface 35. On account of the foregoing construction, a space 40 is formed in between exterior surface 25 of inner lumen 10 and interior surface 30 of outer lumen 15. Inner and outer lumens 10, 15 are sized so as to approximate different anatomical locations or pathology.

[0027] In order to simulate the actual force on a mammalian tract (e.g., the gastrointestinal or genitourinary tract), space 40 is filled with a fluid. This fluid creates a radially compressive force on exterior surface 25 of inner lumen 10 which simulates the forces acting on the mammalian tract within the body (e.g., the gastrointestinal or genitourinary tract within the abdomen). In this respect, it should be noted that inner lumen 10 and outer lumen 15 are sealed so as to prevent fluid communication between the inner and outer lumens.

[0028] Inner lumen 10 and outer lumen 15 are formed out of one or more materials which have physical characteristics which, when combined with the effect of a fluid filled space 40, provide properties simulating those of natural tissue. These materials may have inherently low surface friction so as to approximate the coefficient of friction of natural mucosal tissue, or the materials may incorporate a lubricant so as to simulate the low friction of natural mucosal tissue. By way of example but not limitation, the material of inner lumen 10 may comprise polyethylene, and the material of outer lumen 15 may also comprise polyethylene.

[0029] In one preferred embodiment of the present invention, inner lumen 10 and/or outer lumen 15 may be constructed from a clear material so as to provide for external visualization.

[0030] As noted above, space 40 is filled with a fluid in order to simulate the actual force on a mammalian tract (e.g., the gastrointestinal or genitourinary tract). More particularly, this fluid is selected, and pressurized, so as to provide the desired compressive force on exterior surface 25 of inner lumen 10. By way of example but not limitation, this fluid may be a gas pressurized to a desired level. By way of further example but not limitation, the fluid may be a liquid chosen from a wide range of weights or viscosities so as to affect (i.e., determine) the feel of the simulator. By way of further example but not limitation, where space 40 is filled with a gas, that gas may be nitrogen pressurized to a level of 50 mm Hg, and where space 40 is filled with a liquid, the liquid may be water.

[0031] In one preferred embodiment of the present invention, outer lumen 15 may comprise a vessel which holds inner lumen 10.

[0032] And in another preferred embodiment of the present invention, mechanical support may be used to create a 2-dimensional or 3-dimensional shape so as to simulate human or animal anatomy.

[0033] And in another preferred embodiment of the present invention, inner lumen 10 and outer lumen 15 may comprise “lay-flat” tubing so that anatomical model 5 comprises a long “poly-bag”.

[0034] In use, the structure shown in FIG. 1 is provided with the fluid positioned in space 40 so as to provide the desired anatomical characteristics for anatomical model 5. Then instrumentation (e.g., an endoscope) is inserted into inner lumen 10. As this occurs, inner and outer lumens 10, 15, with the fluid-filled space 40 therebetween, model the natural tissue in a more realistic manner than the prior art.

[0035] In one preferred embodiment, a lubricant may be added to aid in the insertion of the instrumentation into inner lumen 10. By way of example but not limitation, the lubricant may comprise a mixture of water and liquid detergent.

[0036] Thus, the present invention provides an anatomical model comprising an inner lumen and an outer lumen, wherein the inner lumen is disposed inside of the outer lumen so as to create a space therebetween, and further wherein a fluid is disposed within the space, interior to the outer lumen and exterior to the inner lumen, whereby the inner lumen can accurately simulate the mucous membrane lining a mammalian tract (e.g., the gastrointestinal or genitourinary tract).

[0037] In many circumstances, the anatomy of interest may comprise a lumen structure and, furthermore, the lumen structure may be supported on adjacent anatomy via movable connections. By way of example but not limitation, the small bowel comprises a lumen structure which is movably supported by the mesentery along its length. Accordingly, an anatomical model intended to simulate such a small bowel structure should be capable of reproducing not only the lumen passageway of the small bowel, but also the nature and character of the movable connections which attach the lumen passageway to the mesentery.

[0038] Other anatomical lumen structures are also movably supported to adjacent structures at various locations along their length.

[0039] To this end, and looking now at FIG. 2, there is shown an anatomical model 100 which generally comprises a lumen structure 105, a supporting frame 110 and a plurality of movable connections 115 selectively securing lumen structure 105 to supporting frame 110.

[0040] Lumen structure 105 preferably comprises an excised specimen of the organ which is to be simulated. By way of example but not limitation, where the anatomical model is to simulate the small bowel, lumen structure 105 preferably comprises an excised small bowel. However, it should also be appreciated that lumen structure 105 need not necessarily comprise an excised organ—thus, lumen structure 105 may also comprise an artificial structure which simulates the organ in geometric form (e.g., shape and size), mechanical structure (e.g., pliability and resiliency), surface characteristics (e.g., texture and coefficient of friction), etc.

[0041] Frame 110 preferably comprises an elongated structure capable of supporting a length of lumen structure 105. By way of example but not limitation, frame 110 may comprise a base 120, one or more vertical risers 125 extending upward from base 120, and a rod 130 supported above base 120 by the one or more vertical risers 125. Rod 130 is preferably configured so that it extends in a manner which is generally representative of the disposition of the organ which is to be simulated (e.g., where the small bowel is to be simulated, rod 130 preferably extends along a curving pathway as shown in FIG. 2.

[0042] Movable connections 115 serve to selectively secure lumen structure 105 to supporting frame 110. Preferably, movable connections 115 are configured so as to secure lumen structure 105 to supporting frame 110 in a manner which is generally representative of the manner in which the natural organ is secured to its own supporting structure. Thus, for example, and looking now at FIG. 2, where the organ comprises the small bowel which is anatomically connected to the mesentery, movable connections 115 may comprise an organ end 135 comprising an alligator clip 140 for engaging the organ, and a frame end 145 comprising a rod hanger 150 for slidably mounting on rod 130. Alternatively, movable connections 115 may comprise various other clamps, hooks, springs and/or combined elements so as to attach lumen structure 105 to frame 110 in an anatomically realistic manner. Preferably, movable connections 115 are adjustable in location, pathway and function so as to permit accurate simulation of the manner in which the natural organ is secured to its natural supporting structure.

[0043] In order to facilitate ease of use, as well as to simulate natural structure, anatomical model 100 may include an entry port 155 so as to provide access to the internal structure of the lumen structure 105.

[0044] Furthermore, the lumen structure 105 may be supported within an enclosure which can incorporate appropriate liquids and/or temperature control so as to simulate in vivo conditions.

[0045] Additionally, anatomical model 100 may be used with external support elements to create a 2-dimensional path or a 3-dimensional path.

[0046] In one preferred form of the invention, anatomical model 100 comprises a lumen structure 105 in the form of a porcine stomach and small bowel, a frame 110 in the form of a rod following a curved pathway, and movable connections 115 in the form of alligator clips 140/rod hangers 150. See FIG. 2. This construction permits the porcine bowel to be pleated during endoscopic examination on the simulated mesentery.

[0047] FIGS. 3-6 show an endoscope 200 being advanced through the aforementioned anatomical model.

[0048] Thus, the present invention provides an anatomical model which generally comprises a lumen structure supported on a frame using movable connections, in order to simulate both (i) a natural lumen passageway, and (ii) the nature and character of movable connections which attach the lumen passageway to adjacent anatomy.

[0049] While the present invention has been described in terms of certain exemplary preferred embodiments, it will be readily understood and appreciated by those skilled in the art that it is not so limited, and that many additions, deletions and modifications may be made to the preferred embodiments discussed herein without departing from the scope of the invention.