Patent Application
20060020276
The present invention relates to methods and apparatus for achieving prolonged maintenance of gastrointestinal (“GI”) tissue folds by forming, securing and promoting healing of the folds. More particularly, the present invention provides methods and apparatus for remodeling the tissue folds to facilitate their prolonged maintenance.
Extreme or morbid obesity is a serious medical condition pervasive in the United States and other countries. Its complications include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, multiple orthopaedic problems and pulmonary insufficiency with markedly decreased life expectancy.
Several surgical techniques have been developed to treat morbid obesity, including bypassing an absorptive surface of the small intestine, bypassing a portion of the stomach, and reducing or partitioning the stomach size, e.g., via Vertical Banded Gastroplasty (“VBG”) or Magenstrasse and Mill. These procedures may be difficult to perform in morbidly obese patients and/or may present numerous potentially life-threatening post-operative complications. Thus, less invasive techniques have been pursued.
U.S. Pat. Nos. 4,416,267 and 4,485,805 to Garren et al. and Foster, Jr., respectively, propose insertion of an inflated bag within a patient's stomach to decrease the effective volume of the stomach that is available to store food. Accordingly, the patient is satiated without having to consume a large amount of food. A common problem with these inflated bags is that, since the bags float freely within the patient's stomach, the bags may migrate to, and block, a patient's pyloric opening, the portal leading from the stomach to the duodenum, thereby restricting passage of food to the remainder of the gastro-intestinal tract.
Apparatus and methods also are known in which an adjustable elongated gastric band is laparoscopically disposed around the outside of a patient's stomach near the esophagus to form a collar that, when tightened, squeezes the stomach into an hourglass shape, thereby providing a stoma that limits the amount of food that a patient may consume comfortably. An example of an adjustable gastric band is the LAP-BAND® made by INAMED Health of Santa Barbara, Calif.
Numerous disadvantages are associated with using an adjustable gastric band. First, the band may be dislodged if the patient grossly overeats, thereby requiring additional invasive surgery to either reposition or remove the band. Similarly, overeating may cause the band to injure the stomach wall if the stomach over-expands. Laparoscopic disposal of the gastric band around the stomach requires a complex procedure, requires considerable skill on the part of the clinician, and is not free of dangerous complications.
In view of the drawbacks associated with prior art techniques for treating morbid obesity, Applicant previously has described methods and apparatus for treating obesity by endoscopically forming and approximating tissue folds within a patient's stomach in order to reduce an effective cross-section of the stomach. See, for example, co-pending U.S. patent applications Ser. No. 10/735,030, filed Dec. 12, 2003, and Ser. No. TO BE ASSIGNED [Attorney Docket No. 021496-000800US], filed May 7, 2004, both of which are incorporated herein be reference in their entireties. Those references describe formation of serosa-to-serosa gastric plications from the interior of the stomach, such that mucosal tissue is in contact with opposing mucosal tissue along the interior of each gastric tissue fold.
Mucosal tissue typically will not fuse or heal together with opposing, contacting mucosal tissue. Thus, gastric tissue folds may require securing elements, such as anchors, clips or suture, to maintain the folds for prolonged periods of time. If such securing elements were ever to be removed or to ever fail, the gastric tissue folds or plications might unfold.
U.S. patent Publication Ser. No. 2004/0034371 to Lehman et al., published Feb. 19, 2004 (Ser. No. 10/275,521, PCT filed May 18, 2001), which is incorporated herein by reference in its entirety, describes methods and devices for promoting tissue adhesion. The healing process is utilized to form scar tissue that bonds two tissue surfaces together. A tissue injury is accomplished by destroying the mucosal layer of tissue. After the injury is initiated, the injured tissue surfaces are held in close contact, and, as scar tissue created by the injury forms, the tissue surfaces become bonded together in a permanent union. The Lehman reference does not describe removing at least a portion of the injured tissue prior to tissue bonding, nor does it describe using shape-lockable tools to access and/or manipulate the tissue surfaces.
In view of the foregoing, it would be desirable to provide methods and apparatus for achieving prolonged maintenance of gastrointestinal tissue folds without necessitating prolonged use of securing elements.
It would be desirable to provide methods and apparatus that promote remodeling of the folds to facilitate their prolonged maintenance.
Prolonged maintenance of gastrointestinal (“GI”) tissue folds is achieved by providing methods and apparatus for forming, securing and promoting healing of the folds. Such healing may comprise remodeling the tissue folds along region(s) of opposing tissue contact to facilitate prolonged maintenance of the folds. For example, opposing mucosal tissue in contact along each fold may be ablated, abraded, burnt, charred, cut, chemically irritated, biologically irritated or otherwise injured, and preferably removed, to initiate a wound healing response that remodels the tissue and results in scar tissue formation with concomitant fusion of each fold at region(s) of opposing mucosal tissue contact. Such injury and/or removal of mucosal tissue may, for example, be achieved via electromagnetic, thermal, chemical, biologic or mechanical modalities, or a combination thereof. Additional injury/removal modalities will be apparent to those of skill in the art.
During the period of time necessary for remodeling/scar tissue formation, securing elements may be utilized to maintain, e.g., temporarily maintain, contact of opposing injured tissue along each tissue fold. Such securing elements optionally may be removed or may biodegrade upon formation of scar tissue. Alternatively, the elements may be left in place indefinitely to reinforce the scar tissue and ensure prolonged maintenance of the tissue folds. However, upon formation of the scar tissue, the securing elements may no longer solely maintain the folds.
In one aspect, an injury tool is provided to locally injure mucosal tissue. The injury tool may comprise, for example, an ablation tool, such as a monopolar or bipolar Radio Frequency (“RF”) ablation tool. Alternatively, the injury tool may comprise a mechanical abrasion tool. Additional injury tools will be apparent to those of skill in the art.
In one aspect, the injury tool may comprise suction to facilitate tissue engagement and/or aspiration. In another aspect, the tool comprises fluid injection for tissue cooling or cleansing. In yet another aspect, the tool may comprise a removal element for removing injured tissue. Removed tissue may be captured or allowed to pass through the GI tract. The injury tool also may optionally comprise a depth-limiting element that limits a depth of tissue injury.
The injury tool preferably is used in combination with additional tools, e.g., for forming and securing the gastrointestinal tissue folds. These tools may comprise tools for accessing, visualizing, grasping, maneuvering, piercing, folding, plicating, approximating, securing, characterizing, sampling and/or suturing GI tissue. One or more of the tools optionally may be steerable or shape-lockable/rigidizable. Additional tools will be apparent to those of skill in the art. Such tools may be provided as a kit or system in combination with the injury tool. Furthermore, the injury tool may be integrated into a multi-functional tool.
Methods of using apparatus of the present invention also are provided.
Methods and apparatus for achieving prolonged maintenance of gastrointestinal (“GI”) tissue folds by forming, securing and promoting healing of the folds are described below. The methods and apparatus may be utilized within the GI system of a patient in various ways, e.g., transorally, endoluminally, percutaneously, laparoscopically, etc. More particularly, methods and apparatus for remodeling approximated tissue folds to facilitate their prolonged maintenance are disclosed.
With reference to
Generally, in creating a plication through which a securing element may be disposed within or through, a distal tip of a tissue plication apparatus may engage or grasp the tissue and move the engaged tissue to a proximal position relative to the tip of the device, thereby providing a substantially uniform plication of predetermined size.
Formation of a tissue fold may, for example, be accomplished using at least two tissue contact areas that are separated by a linear or curvilinear distance, wherein the separation distance between the tissue contact points affects the length and/or depth of the fold. In operation, a tissue grabbing assembly engages or grasps the tissue wall in its normal state (i.e., non-folded and substantially flat or non-plicated), thus providing a first tissue contact area. The first tissue contact area then is moved to a position proximal of a second tissue contact area to form the tissue fold. The tissue securing element(s) then may be extended across the tissue fold at the second tissue contact area. Optionally, a third tissue contact point may be established such that, upon formation of the tissue fold, the second and third tissue contact areas are disposed on opposing sides of the tissue fold, thereby providing backside stabilization during extension of the securing element(s) across the tissue fold from the second tissue contact area.
The first tissue contact area may be utilized to engage and then stretch or rotate the tissue wall over the second tissue contact area to form the tissue fold. The tissue fold may then be articulated to a position where a portion of the tissue fold overlies the second tissue contact area at an orientation that is substantially normal to the tissue fold. A tissue securing element may then be delivered across the tissue fold at or near the second tissue contact area. An apparatus which is particularly suited to deliver the securing elements described herein may be seen in further detail in co-pending U.S. patent application Ser. No. 10/735,030 filed Dec. 12, 2003 and entitled “Apparatus And Methods For Forming And Securing Gastrointestinal Tissue Folds,” which previously has been incorporated herein by reference.
An illustrative side view of a tissue plication assembly 10 which may be utilized with tissue securing elements described herein is shown in
Tissue manipulation assembly 14 is located at the distal end of tubular body 12 and is generally used to contact and form the tissue plication, as mentioned above.
Upper bail 20 is shown in the figure as an open looped member and lower bail 26 is shown as a solid member; however, this is intended to be merely illustrative and either or both members may be configured as looped or solid members. Tissue acquisition member 28 may be an elongate member, e.g., a wire, hypotube, etc., which terminates at a tissue grasper 30, in this example a helically-shaped member, configured to be reversibly rotatable for advancement into the tissue for the purpose of grasping or acquiring a region of tissue to be formed into a plication. Tissue acquisition member 28 may extend distally from handle 16 through body 12 and distally between upper bail 20 and lower bail 26. Acquisition member 28 may also be translatable and rotatable within body 12 such that tissue grasper 30 is able to translate longitudinally between upper bail 20 and lower bail 26. To support the longitudinal and rotational movement of acquisition member 28, an optional guide or sled 32 may be connected to upper bail 20 or lower bail 26 to freely slide thereon. Guide 32 may also be slidably connected to acquisition member 28 such that guide 32 supports the longitudinal motion of acquisition member 28.
An example of a tissue plication procedure for forming and securing a tissue fold, illustratively with a securing element comprising a tissue anchor, is seen in
Plication assembly 10 illustratively has been advanced through steerable and/or shape-lockable or rigidizable overtube 1 to facilitate positioning of tissue manipulation assembly 14 adjacent the desired region of tissue wall 40. Furthermore, overtube 1 aids force transmission along plication assembly 10 to facilitate tissue folding, securing, approximating, etc. Exemplary steerable and/or shape-lockable overtubes are described in greater detail in Applicant's co-pending U.S. patent application Ser. No. TO BE ASSIGNED [Attorney Docket No. 021496-000130US], filed Mar. 9, 2004, and entitled, “Endoluminal Tool Deployment System,” which is incorporated herein by reference in its entirety. During advancement of plication assembly 10 through overtube 1, launch tube 18 may be configured in a delivery profile such that tube 18 is disposed within or between the arms of upper bail 20 to present a relatively small profile.
Once tissue manipulation assembly 14 has been desirably positioned relative to tissue wall 40, tissue acquisition member 30 may be advanced distally such that tissue acquisition member 30 comes into contact with tissue wall 40 at acquisition location or point 42. As acquisition member 30 is distally advanced relative to body 12, guide 32, if utilized, may slide distally along with member 30 to aid in stabilizing the grasper. If a helically-shaped acquisition member 30 is utilized, as illustrated in
The grasped tissue may then be pulled proximally between upper 20 and lower bails 26 via acquisition member 30 such that the acquired tissue is drawn into a tissue fold 44, as seen in
Once the tissue fold 44 has been formed, launch tube 18 may be advanced from its proximal end at handle 16 such that a portion 46 of launch tube 18, which extends distally from body 12, is forced to rotate at hinge or pivot 22 and reconfigure itself such that portion 46 forms a curved or arcuate shape that positions launch tube opening 24 perpendicularly relative to a longitudinal axis of body 12 and/or bail members 20, 26. Launch tube 18, or at least portion 46 of launch tube 18, is preferably fabricated from a highly flexible material or it may be fabricated, e.g., from Nitinol tubing material which is adapted to flex, e.g., via circumferential slots, to permit bending. Alternatively, assembly 14 may be configured such that launch tube 18 is reconfigured simultaneously with the proximal withdrawal of acquisition member 30 and acquired tissue 44.
The tissue wall of a body lumen, such as the stomach, typically comprises an inner mucosal layer, connective tissue, the muscularis layer and the serosa layer. To obtain a durable purchase, e.g., in performing a stomach reduction procedure, the securing elements, e.g., staples or anchors, used to achieve reduction of the body lumen are preferably engaged at least through or at the muscularis tissue layer, and more preferably, the serosa layer. Advantageously, stretching of tissue fold 44 between bail members 20, 26 permits an anchor to be ejected through both the muscularis and serosa layers, thus enabling durable gastrointestinal tissue approximation.
As shown in
Because needle assembly 48 penetrates the tissue wall twice, it exits within the body lumen, thus reducing the potential for injury to surrounding organs. A detail cross-sectional view is shown in
Once launch tube 18 has been desirably positioned with respect to tissue fold F, needle 54 may be urged or pushed into or through tissue fold F via needle pushrod or member 56 from its proximal end preferably located within handle 16. Needle 54 may define needle lumen 58 within which distal anchor 62 and/or proximal anchor 64 may be situated during deployment and positioning of the assembly. A single suture or flexible element 70 (or multiple suture elements) may connect proximal anchor 64 and distal anchor 62 to one another. For instance, element 70 may comprise various materials such as monofilament, multifilament, or any other conventional suture material, elastic or elastomeric materials, e.g., rubber, etc. Biocompatible metals may also be utilized for suture materials.
Needle 54 may optionally define needle slot 60 along its length to allow suture 70 to pass freely within and out of needle 54 when distal anchor 62 is ejected from needle lumen 58. Alternatively, rather than utilizing needle slot 60, needle 54 may define a solid structure with suture 70 being passed into needle lumen 58 via the distal opening of needle 54.
The proximal end of suture 70 may pass slidingly through proximal anchor 64 to terminate in suture loop 74 via cinching knot 72. Suture loop 74 may be omitted and the proximal end of suture 70 may terminate proximally of the apparatus 10 within control handle 16, proximally of control handle 16, or at some point distally of control handle 16. In this variation, suture loop 74 may be provided to allow for a grasping or hooking tool to temporarily hold suture loop 74 for facilitating the cinching of proximal 64 and distal 62 anchors towards one another for retaining a configuration of tissue fold F, as described in further detail below. Cinching knot 72 may also comprise a slidable knot which may be slid distally along suture 70 to lock or hold against proximal anchor 64 once the tissue fold F and anchors 62, 64 have been desirably positioned and tensioned, as also described below in further detail.
After needle assembly 48 has been pushed distally out through launch tube opening 24 and penetrated into and/or through tissue fold F, as shown in
Referring now to
With reference now to
During the period of time necessary for remodeling and/or scar tissue formation, securing elements, such as those previously described, may be utilized to maintain contact of opposing injured tissue along each tissue fold. The securing elements optionally may be removed or may biodegrade upon formation of scar tissue. Alternatively, the elements may be left in place indefinitely to reinforce the scar tissue and facilitate prolonged maintenance of the tissue folds. However, upon formation of the scar tissue, the securing elements need no longer solely maintain the folds.
In
The method of
Referring now to
The method of
With reference to
Injury tool 100 may be used in combination with apparatus for forming, securing and approximating tissue folds. For example, the tool may be integrated into tissue manipulation assembly 14 of
With reference to
Referring now to
As seen in
Referring now to
Injury tool 100 preferably is used in combination with additional tools, e.g., for forming and securing gastrointestinal tissue folds, such as plication assembly 10 and/or overtube 1. More generally, the additional tools may comprise tools for accessing, visualizing, grasping, maneuvering, piercing, folding, plicating, approximating, securing, characterizing, sampling and/or suturing GI tissue. One or more of the tools optionally may be steerable and/or shape-lockable/rigidizable. Additional tools will be apparent to those of skill in the art. Such tools may be provided as a kit or system in combination with the injury tool. Furthermore, the injury tool may be integrated into multi-functional tools. The tools preferably are configured for endoluminal passage within a patient's GI tract.
Although preferred illustrative embodiments of the present invention are described hereinabove, it will be apparent to those skilled in the art that various changes and modifications may be made thereto without departing from the invention. It is intended in the appended claims to cover all such changes and modifications that fall within the true spirit and scope of the invention.
