The present invention relates generally to surgical methods and apparatus and, more specifically, to an implant system and device adapted to create a continent ostomy and prevent herniation.
An ostomy is a surgical procedure that creates an opening in the abdominal wall for waste products to move out of the body. It is performed when a medical condition is so severe that an ostomy offers a better alternative—e.g., when cancer, trauma, malformations, obstructions, Crohn's disease and other conditions or diseases have required removal of all or a substantial amount of the patient's intestines.
Studies have shown that having ostomy surgery and caring for an ostomy can cause problematic quality of life issues and concerns for patients. The physical aspects of wearing the appliance itself, such as the possible fear of leakage and odor, can lead patients to social isolation. Further, patients often do not seek help once they have been released from the hospital. The psychological impact on body image, sexual activity, coping and adjustment is significant. Poor psychosocial adjustment has been linked to increased depression and death in the ostomate population.
One of the most difficult outcomes of an ostomy surgery is the need to move the ostomy site due to initial poor placement or herniation. This involves a second surgery that can be made more difficult due to abdominal adhesions, internal bowel restrictions and blood supply. It has been reported, in 2009 alone, that there were approximately 17,000 related revisions and/or herniation repair procedures.
As such, there is a desire to obtain a continent ostomy to prevent major complications and follow-up revision surgery.
The present invention provides a 3D-structured implant that fits the shape of the interface between the intestine and the abdominal wall. The general configuration can be a funnel-like or device construct where the “funnel neck” can encapsulate and support the intestine and the larger “funnel top” can attach to and reinforce the abdominal wall.
The implant can consist of a structure of flexible members (e.g., patterned strut members or mesh) that can be designed to have specific mechanical properties in different areas of the implant. In one embodiment, the mesh construct can be configured to have an auxetic property of deformation (e.g., negative Poisson's Ratio). As such, the implant can appropriately react or adapt to abdominal pressure that pushes on the implant. The foreshortening of the intestinal portion of the implant causes a diameter reduction as well, in effect squeezing the intestine upon increased pressure. This can have the dual benefit of holding the intestine tighter during high abdominal pressure events to prevent herniation/prolapse, and also providing sphincter-like squeezing force to maintain continence during these stress or pressure events.
In other embodiments, the implant can be configured to provide a gentle squeezing force around the intestine by including specific properties into the implant structure by changing the overall diameter, strut width, strut angles, strut shape, and the like. Additionally, the funnel neck portion of the implant can be designed with a number of undulations to allow for preferential folding or collapsing of the implant diameter to help with the described squeezing action.
In still other embodiments, magnets or like features can be included with the implant. The magnets can be included to facilitate or provide additional force or actuation to close the implant funnel neck and aid in providing a continent ostomy. The magnets can be embedded in specifically designed cells of the implant structure, over-molded into the implant, or otherwise attached or provided with the implant. The distribution and configuration of the magnets with the implant can be designed to be both attractive and repulsive to achieve specific behaviors out of the implant. For example, the magnets can be attractive in a circumferential configuration to provide squeezing on the intestine. Alternatively, the magnets can have an attractive force in the longitudinal direction to rely on the auxetic nature of the implant to provide intestinal squeezing while still having a repulsive force circumferentially to prevent over-constriction of the intestine. A plug can be provided as well with magnets adapted to attract to the magnets of the implant to facilitate securement of the plug relative to the implant, with the intestinal wall provided therebetween.
Additional embodiments of the ostomy implant can include coatings to prevent adhesion or to facilitate healing. For instance, a coating of a methylcellulose compound on the external side of the intestinal portion of the mesh or struts could be included to prevent adhesion and maintain relative movement of the organ against adjacent tissue. Barbed or like anchor devices can be included to a periphery portion of the abdominal wall portion of the implant to speed up implantation and fixation.
Manufacture or formation of the implant can be accomplished by injection molding, direct extrusion rapid-prototyping, or via like processes or techniques.
a-3c are partial views of patterned strut and cell configurations for use with portions of an ostomy implant device, in accordance with embodiments of the present invention.
Referring generally to
The implants 10, and portions thereof, could take on a myriad of different sizes, shapes and configurations depending on the particular treatment application, or deployment and support needs. The various implants 10, structures, features and methods detailed herein are envisioned for use with many known implant and repair devices (e.g., for male and female), features, tools and methods, including those disclosed in U.S. Pat. Nos. 7,500,945, 7,407,480, 7,351,197, 7,347,812, 7,303,525, 7,025,063, 6,691,711, 6,648,921, and 6,612,977, International Patent Publication Nos. WO 2008/057261 and WO 2007/097994, and U.S. Patent Publication Nos. 2011/0124956, 2011/0144417, 2010/0261955, 2002/151762 and 2002/147382. Accordingly, the above-identified disclosures are fully incorporated herein by reference in their entirety.
As shown in
For instance, portions of the implant 10, such as portions 12, 14 can be formed or patterned by way of a polymer molding process to create a unitary homogeneous non-woven, or non-knitted, device or construct. Other embodiments can be formed from an already unitary homogeneous sheet or film via laser cutting, die cutting, stamping and like procedures. Still other embodiments can be constructed of woven or knitted mesh filaments where a non-homogenous mesh material is desired.
As a result of the manufacturing process, such as molding or cutting for homogenous or non-woven implants 10, repeating cells 20 form a lattice structure for at least the portions 12, 14 of the implant 10, as shown in
In certain embodiments, the patterned struts 20a define a general pinwheel configuration to further define cellular voids 21 for the cells 20 (e.g.,
The cross section of non-woven strut members 20a can be generally circular, oval or otherwise formed to have rounded portions with exemplary embodiments of the present invention. This can be an advantage over the bunched woven or knitted filament mesh strands of conventional implants. The rounded portions of the struts 20a of the present invention provide an improved implantation feel and a consistent surface adapted to retain its shape and to reduce or eliminate snagging or resistance during deployment and positioning. In addition, it provides a desirable tactile feel and surface for the physician to grasp and manipulate during implantation.
The implant 10, as generally shown in FIGS. 6 and 8-9, includes an interior receiving region or lumen 15 adapted to surround a portion of the intestine I. The implant 10 can be provided to the physician as a continuous circumference construct adapted to traverse along a portion of the intestine I to secure the intestine within the region 15. In certain embodiments, the implant 10 can be shaped to encompass or surround the intestine I by joining free ends or longitudinal edges of the implant 10. The implant 10 can be wrapped around the intestine I with the free ends attached or joined together (suture, clips, hooks, etc.) to secure the implant 10 around the intestine I. Further, the top portion 14 can be attached to the interior abdominal wall via suturing, stapling, adhesives, tissue anchoring and like surgical attachment devices and techniques.
As shown in
In certain embodiment, as demonstrated in
In still other embodiments, as shown in
The magnets 22 on the implant 10 can be configured to interface with an external device that can be inserted into the ostomy or on the outside of the ostomy, such as a plug 26 (
In certain embodiments, the magnets 22 are fixed or otherwise provided with the implant 10. In other embodiments, there can be some relative motion between the magnet 22 and the implant 10, e.g., within or along cells 20 or struts 20a. Further, the magnets 24 of the plug 26 can be selectively movable or actuated to move a distance away from the magnets 22 of the implant 10 to assist in moving the plug 26, releasing the plug 26, or adjusting the plug 26 relative to the implant magnets 22.
Additional embodiments of the ostomy implant 10 can include coatings to prevent adhesion or to facilitate healing. For instance, a coating of a methylcellulose compound on the external side of the intestinal portion 12 of the implant 10 can be included to prevent adhesion and maintain relative movement of the organ against adjacent tissue. Barbed or like anchor features can be included to a peripheral portion of the abdominal wall portion 14 of the implant to speed up implantation and fixation.
Manufacturing or formation of the implant 10 can be accomplished by injection molding, extrusion, rapid-prototyping, laser etching, or via like processes or techniques.
The implant systems 10, their various components, structures, features, tools, materials and methods may have a number of suitable configurations as shown and described in the previously-incorporated references. Various methods and tools for introducing, deploying, anchoring and manipulating implants to treat incontinence and prolapse as disclosed in the previously-incorporated references are envisioned for use with the present invention as well. Further, the system and its components or structures can be constructed of known and compatible materials know to those skilled in the art, including metals, polymers, and the like.
All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated, and include those references incorporated within the identified patents, patent applications and publications.
Obviously, numerous modifications and variations of the present invention are possible in light of the teachings herein. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced other than as specifically described herein.