Patent Application
20080097491
In response to the foregoing challenges that have been experienced by those of skill in the art, the present invention is directed toward an apparatus for anchoring a first body tissue to a second body tissue and a method for using such an apparatus.
Should such a device be caused to enter a body from an exterior position, traverse two or more body tissue layers, and be situated at a distal end within a suitable body cavity or orifice, the device may be used to pull the two or more tissue layers into contact thereby anchoring one to the other. Such a device would prove useful in the formation of artificial stomas into or within a living body.
According to some embodiments the material selected to form the device 10 may include polyurethane (PU), low-density polyethylene (LDPE), polyvinyl chloride (PVC), polyamid (PA) or polyethylene teraphthalate (PETP), These materials are biocompatible and, when being processed into correspondingly thin walls, are especially suited for forming the ballooning retention element 18. Copolymer admixtures for modifying the characteristics of the material are also possible, for example a low density polyethylene and ethylene-vinylacetate copolymer (LDPE-EVA), or blends of the above mentioned materials (e.g. PU with PVC or PU with PA) would be considered suitable for such a device. Other materials would also be suitable so long as they exhibit properties enabling them to be processed into devices having microthin walls, and do not deform elastically to a degree that an anchoring function of the balloon element can not be secured respectively that the balloon element might slip through the insertion channel in the body wall.
Formation of the ballooning retention element 18 may be achieved by situating the shaft 16 at an appropriate position in a suitable mold (not shown), applying heat and expanding the heated region of the shaft itself controllably, typically by inflating the region within the heated mold itself. This process enables the discrete region to be distended without otherwise damaging the shaft. Due to the controlled distention of the region forming the ballooning retention element, the wall thickness is characteristically reduced in that area. Stretching the region during this process serves to molecularly align the polymeric chains thus making the product otherwise stronger than it would be even at microthin wall thicknesses. Such techniques would be known and understood by those of skill in the art.
Final wall thicknesses for the ballooning retention element 18 are considered to be microthin in nature, and may range from about 25 microns down to about 3 microns whereas the shaft wall thicknesses may range from about 50 microns to about 150 microns. As seen in
During the manufacturing process for the device, the distal end 12 would be blocked, sealed, or otherwise made fluid tight. Although the distended region or ballooning retention element 18 may be situated at the distal end 12, it may alternatively be proximal to the distal end such that the device 10 at the distal end 12 terminates in a nipple or tip 20. This tip 20 may also be made non-collapsible by the filling of the tip 20 with a potting compound such as a polymer, for example, silicone or the like, or another biocompatible material. This would provide a degree of rigidity to the distal end 12 of the device 10 and may be desirable in some embodiments.
Turning now to
During the molding process, additional desirable features may be incorporated into the ballooning retention element which would prove useful in the application of the invention. For example, the ballooning retention element 18 may be preshaped so as to possess sufficiently small shoulder radii at regions 28 and 30 so that a face 32 may be created which is flat in shape. This would create a large resting or bearing surface to seat with the second body tissue layer 24. The surface area of the face 32 working in conjunction with inflation of the ballooning retention element 18 would help minimize the likelihood of the retention element slipping out of the orifice 26.
Other desirable retention element shapes may be created as well depending upon the application. For example, the overall geometry of the ballooning retention element 18 may be bullet-shaped, disc-shaped, spherical, cylindrical, frustoconical or any other suitable shape limited only by the purpose intended and the skill of those in the art at forming preshaped balloons.
Once the device 10 is in place, the ballooning retention element 18 properly situated and inflated, as described below in more detail, in many embodiments the proximal end may simply be tied off. The reason that tying the device at the proximal end would be possible is due to the small size of the device and the low inflation pressures needed to fully inflate the device once it is in place. It is envisioned that the diameter of the shaft 16 in many embodiments may be as small as from about 0.8 mm to about to 1.5 mm, and the device may be considered fully inflated at pressures as low as from about 50 mbar to about 200 mbar.
In the above embodiments as well as others, a retainer 34 may be provided so as to retain the device 10 in position. The retainer 34 is envisioned to have numerous possible configurations some of which will be discussed at greater length in this specification. In a first embodiment, depicted in
A retainer of this construction would have a very low profile and could easily be concealed by the application of a bandage over the skin of the patient. This would enable the device 10 to be in place, performing its function, yet not be noticeable to the public. This may provide a beneficial effect to the health and mental well-being of the patient as well as enable the patient to be more active in that little of the device would protrude from the patient's body. Moreover, tis would assist in maintaining sterility of the site, and may minimize the potential for inadvertent traumatic injury to the area.
In a second embodiment depicted in
A third embodiment, may be similar to that depicted in U.S. patent application Ser. No. 11/139,927 filed on May 27, 2005 entitled “Clamp for Flexible Tube” which is copending and commonly assigned, the disclosure of which is herein incorporated by reference in its entirety.
To inflate the device, a connector 48, depicted later in
In some embodiments, the connector 48 may comprise a releasable one-way valve disposed at the proximal end of the device 10. Appropriate valves capable of serving in this function are known and their incorporation into the device 10 would prevent inadvertent deflation once the inflation source was removed from the connector. Such devices are well known in the medical field and would be understood by those having skill in the art. These valves are suitable for actuation by means of the syringe. It would be understood that such a valve would serve as a means to control the injection of fluids into or the removal of the same from the device 10. As would be apparent, control of the inflation of the device 10 enables the user or a physician, etc., to selectively control inflation and deflation of the ballooning retention element 18.
A number of techniques and adaptations to the basic device may be utilized to initially situate the device 10 within the body orifice 26. They should be considered as adding optional structure to the basic device described above. Each of these new structures may be substituted in whole or in part in any combination for any other to create additional embodiments. For example, one optional structure may be a rod 50. One such example is depicted in
In some embodiments, such as that shown in
The rod 50 would terminate at a point within the potting compound and be bedded therein as described above. Though the potting compound would be situated within an internal portion of the device and thus would not normally be accessible to the body, in most instances it likely would comprise a biocompatible material such as the silicone plug as described earlier. Whatever material is selected for use, it should be capable of capturing one end of the rod. In forming this linkage or connection, it would be understood that any force applied to the one end of the rod is transferred to the other end without buckling. The clinician by manipulating the rod could effect the position of the tip within the orifice. In those embodiments having a rod 50, the rod may be removable or sufficiently flexible to enable the shaft 16 to be tied off as described above. If the rod 50 were wire-like, in some cases it may remain in place and not interfere with the tying process and may even prove useful in assisting with the tying of the shaft so as to be fluid tight, however, this certainly should not be considered to constitute a requirement.
Though the embodiment depicted and described places the rod 50 within the device 10 and shaft 16, this is not a requirement for any of the embodiments. In fact, the rod may run along an exterior surface of the device or be placed within a wall of the device itself. In any event, it should not be lost sight of that the purpose of the rod is to enable placement of the device itself into the patient and allow manipulation of the tip 20, which is located at the distal end 12 of the device. By articulating or otherwise moving the rod 50 at or near the proximal end 14 of the device, which would be external to the patient once the device is in place, the articulation is transferred through the device 10 from the proximal end 14 to the distal end 12.
The above described embodiments may be further adapted by additional elements to create further embodiments. Additional embodiments contemplate the use of more refined introducers for placing the device 10 within a patient. For example,
The sheath 52 may be provided with a trocar tip 58 capable of creating the initial penetration through the tissue layers. The device 10 should be capable of deployment and inflation without risk of puncture or damage. This is especially of concern in those embodiments having the trocar tip 58. The rod 50 as depicted in
As stated, in the
An alternative to the fully splittable sheath 52 of
In either described embodiment, it may be seen that the sheath 52 or 62 may serve as the rigid or semi-rigid implement for insertion of the device 10 within the body. Of course, the rod 50 may still prove useful in certain embodiments such as those described above in which it is desirable to deploy the device from the bore of either sheath. Another feature that may be incorporated into any of the embodiments is to provide the device 10 with a lengthening feature. This may prove additionally useful in those embodiments which are deployed via a rigid or semi-rigid sheath yet not require the need for the rod 50 to deploy the device 10. In such an embodiment, as the ballooning retention element 18 is inflated, inflation is first caused to extend the device longitudinally prior to any radial expansion of the ballooning retention element 18. Such a feature would enable the inflation process itself to deploy the ballooning retention element from the sheath.
Once the ballooning retention element 18 had fully deployed from the sheath 52 or 62 and the likelihood of damage to the device 10 is minimized, the sheath may be withdrawn from the body in any of the fashions described above and the ballooning retention element may continue to be inflated sufficiently so as to secure the device. This controlled expansion may be accomplished by molding the ballooning retention element in a manner that will specifically cause it to deploy from the sheath, or by preloading the device within the sheath so that it will do the same. One possible technique which may be used is to preload the sheath with the device, but to twist the device torsionally during the loading process and bunch up a portion of the device within the sheath. The twist would occlude the passage of the inflation fluid but would cause the device to move until such time as the twist were to clear the sheath. At that time, the device would untwist allowing the ballooning retention element to expand. Obviously folding the device without twisting may be made to accomplish the same effect.
Throughout the specification, the device has been described as being inflated with air from a syringe, however it should be understood that the device may be inflated and deflated upon application or removal of a fluid source such as water or saline, in addition to air. Other fluids, both gaseous and liquid, may also be used and would be understood by those of skill in the art.
Due to the controllable collapsibility of the device 10 it would be more amenable to atraumatic removal from the stoma than are prior art devices. This is because the present invention does not require the significant trans-abdominal exertion typically associated with those prior art devices containing a rigid shaft for carrying the balloon component. In the prior art devices, the mechanics of the balloon member are typically altered negatively over time, for example, balloon members associated with the prior art are known to stiffen and lose their ability to retract fully into the shaft completely. This results in the creation of traumatizing folds that may exacerbate healing of the stoma site upon removal or subsequent manipulation of the catheter. Proper selection of materials will prevent the present invention from exhibiting such features.
The device 10 may be positioned in the living body using techniques and procedures known and understood by those of skill in the art. For example, were the device to be used to anchor an anterior wall of a patient's stomach to the patient's abdominal wall prior to the placement of an enteral feeding device, the patient would be made to lie in a supine position. The patient's gastric lumen would be insufflated via a previously positioned nasogastric tube until it was sufficiently distended. Local anesthesia would be applied to the patient's abdomen and a puncture needle would be plunged through the patient's abdominal wall and into the gastric lumen. Aspiration of air from the needle or puncture site would signify proper needle placement.
In those embodiments that do not require the use of a sheath, the device may be inserted directly through the puncture site by manipulation of the rod as earlier described. In those embodiments with a sheath, the situation would be similar, i.e., the sheath would be inserted through the puncture site and the device deployed through it. Of course those sheaths having a trocar tip would also serve as the puncture needle. In any event, once the device 10 was in place, the ballooning retention element 18 would be inflated. The clinician would exert a gentle tractive force on the protruding shaft until the anterior wall of the stomach contacts the anterior abdominal wall. At that point the retainer would be slid over the shaft and the shaft would be tied in place or would otherwise be engaged with the retainer. In those embodiments where a multipart retainer was used, the shaft would be engaged with the base plate. The cap, if available, would be placed over the base plate.
In many procedures, a plurality of devices are used in close proximity to one another. For example, in a gastropexy procedure, often three or four devices are used in conjunction with one another. Once the stomach wall and the abdominal wall are secured to one another, a gastrostomy tube is often placed into the stomach lumen by making an additional incision at a location interior to the perimeter of the plurality of gastropexy devices. In any event, an individual retainer may be made to have the capability of securing more than one device 10 therein. That is, a single retainer may be used to secure two or more of the devices described above, so long as the devices were sufficiently closely spaced to one another.
As used herein and in the claims, the term “comprising” is inclusive or open-ended and does not exclude additional unrecited elements, compositional components, or method steps.
While various patents have been incorporated herein by reference, to the extent there is any inconsistency between incorporated material and that of the written specification, the written specification shall control. In addition, while the invention has been described in detail with respect to specific embodiments thereof, it will be apparent to those skilled in the art that various alterations, modifications and other changes may be made to the invention without departing from the spirit and scope of the present invention. It is therefore intended that the claims cover all such modifications, alterations and other changes encompassed by the appended claims.
