US20080262523A1 - Devices and methods for treatment of obesity - Google Patents

Abstract

Methods, devices, tools, instruments and systems for treating a patient to induce weight loss. In one method embodiment, a device, including an expandable member in a collapsed configuration, is passed through an opening in the skin of the patient, and into the abdominal cavity of the patient. At least a portion of the expandable member is anchored relative to at least one structure in the abdominal cavity, without piercing the stomach. The expandable member is expanded to an expanded configuration in a space in the abdominal cavity to perform at least one of: prevention of expansion of the stomach of the patient into the space; and compression of a portion of the stomach.

Description

CROSS-REFERENCE
• This application is a continuation-in-part application of co-pending application Ser. No. 11/407,701, filed Apr. 19, 2006, which is incorporated herein by reference thereto, in its entirety, and to which application we claim priority under 35 USC §120.
• This application claims the benefit of U.S. Provisional Application No. 60/833,284, filed Jul. 24, 2006, and U.S. Provisional Application No. 60/877,595, filed Dec. 28, 2006, both of which applications are hereby incorporated herein, in their entireties, by reference thereto.
• This application also hereby incorporates herein by reference thereto, in its entirety, co-pending application Ser. No. (application Ser. No. not yet assigned, Attorney's Docket No. EXPL-001CIP3) filed on even date herewith, and titled “Devices and Methods for Treatment of Obesity”.
FIELD OF THE INVENTION
• The present invention relates to treatment of obesity, more particularly to implantable devices and methods of implanting the devices in the abdominal cavity to treat an obese patient.
BACKGROUND OF THE INVENTION
• Obesity has become a major health concern, both nationally and internationally. The National Center for Health Statistics (NCHS) estimates that over 120 million Americans are overweight, including about 56% of the adult population. Of these, about 52 million are considered obese, as measured by a body mass index (BMI) of 30% or greater. In Europe, an estimated 77 million people are obese, as measured by the same standard. This problem is not limited to western nations, as many developing countries are reported to have obesity rates over 75% of the adult population.
• Co-morbidities that are associated with obesity include, but are not limited to type II Diabetes, high blood pressure, sleep apnea, stroke and arthritis, the symptoms of which often tend to be lessened or alleviated upon loss of weight by a person so affected.
• In the U.S., options for treatment of obesity are currently quite limited. Current treatment methodologies typically rely upon surgically introducing a “malabsorptive” environment in the gastro-intestinal tract, a restrictive environment, or a combination of these. One available treatment method is gastric bypass surgery and another is referred to as gastric banding (one of these techniques is referred to as the LAPBAND™ procedure). These procedures are limited to only those patients with a BMI over 40 (or over 35, with co-morbidities present).
• Gastric bypass procedures incur a great deal of morbidity and create a malabsorptive state in the patient by bypassing a large portion of the intestines. Serious side effects, such as liver failure have been associated with this procedure, as well as chronic diarrhea. Another surgical procedure that has a high degree of morbidity associated with it is known as the “Gastric Bypass Roux-en-Y” procedure. This procedure reduces the capacity of the stomach by creating a smaller stomach pouch. The small space holds only about one ounce of fluid. A tiny stomach outlet is also surgically created to slow the speed at which food leaves the stomach. Staples are used to create a small (15 to 20 cc) stomach pouch, with the rest of the stomach being stapled completely shut and divided from the stomach pouch. The small intestine is divided just beyond the duodenum, brought up, and connected to the newly formed stomach pouch. In addition to the considerable morbidity associated with this procedure, other disadvantages include “dumping syndrome”, where stomach contents are literally “dumped” rapidly into the small intestine which may lead to nausea, weakness, sweating, faintness, and diarrhea; hernias resulting from the surgery; gallstones; leakage of the connection between the pouch and the intestine; stretching of the pouch that was formed; nutritional deficiencies; and possible dehiscence of the staples.
• The LAPBAND™ is a band that, when placed, encircles the fundus-cardia junction and is inflatable to constrict the same. It does not reduce the volume of the stomach, but rather restricts passage of food into the stomach, the theory being that the patient will feel satiety with a much smaller volume of food than previously. Although the LAPBAND™ procedure is less invasive than a gastric bypass procedure, it also typically achieves less weight loss. Further, it is not a simple procedure and requires a substantial amount of training by a surgeon to become proficient in performing the procedure. Also, a substantial amount of dissecting and suturing is required because the pathway by which the band is introduced is not an existing pathway, and must be established by dissection. Great care is required to avoid blood vessels and nerves that may be in the intended pathway to be created by the dissection. After placing the band around the fundus-cardia junction, the ends of the band must be connected together and then it must be cinched down into place. Additionally, complications such as erosion at the fundus-cardia junction, slippage of the band from its intended location, nausea/vomiting, gastroesophageal reflux, dysphagia and lack of effectiveness in causing weight loss have been reported.
• Intragastric balloons have also been placed, in an attempt to fill a portion of the volume in the stomach, with the theory being that it will then require less food than previously, to give the patient a sensation of fullness or satiety. This procedure involves delivery of a balloon (typically, transorally) to the interior of the stomach and inflation of the balloon to take up a portion of the volume inside the stomach. However, intragastric balloons may also lead to complications such as obstruction, vomiting and/or mucosal erosion of the inner lining of the stomach. The balloon can break down over extended exposure to the stomach's acids, and in some cases, after breaking down, the balloon translated through the intestines and caused a bowel obstruction.
• Gastrointestinal sleeves have been implanted to line the stomach and/or a portion of the small intestines to reduce the absorptive capabilities of the small intestine and/or to reduce the volume in the stomach, by reducing the available volume to the tubular structure of the graft running therethrough. Although weight loss may be effective while these types of devices are properly functioning, there are complications with anchoring the device within the stomach/GI tract, as the stomach and GI tract function to break down things that enter into them and to move/transport them through. Accordingly, the integrity of the anchoring of the device, as well as the device itself may be compromised over time by the acids and actions of the stomach and GI tract.
• A sleeve gastrectomy is an operation in which the left side of the stomach is surgically removed. This results in a much reduced stomach which is substantially tubular and may take on the shape of a banana. This procedure is associated with a high degree of morbidity, as a large portion of the stomach is surgically removed. Additionally, there are risks of complications such as dehiscence of the staple line where the staples are installed to close the surgical incisions where the portion of the stomach was removed. Further, the procedure is not reversible.
• In the laparoscopic duodenal switch, the size of the stomach is reduced in similar manner to that performed in a sleeve gastrectomy. Additionally, approximately half of the small intestine is bypassed and the stomach is reconnected to the shortened small intestine. This procedure suffers from the same complications as the sleeve gastrectomy, and even greater morbidity is associated with this procedure due to the additional intestinal bypass that needs to be performed. Still further, complications associated with malabsorption may also present themselves.
• An inflatable gastric device is disclosed in U.S. Pat. No. 4,246,893, in which a balloon is inserted anteriorly of the stomach and posteriorly of the left lobe of the liver. The balloon is then inflated to compress the stomach so that it fills with less food that would ordinarily be possible. Not only does this device compress the stomach, but it also compresses the liver, as seen inFIG. 5 of the patent, which may cause complications with the liver function. Additionally, the balloon is simply placed into this location, and there is no assurance that it will not migrate and lose its effectiveness in compressing the stomach to the degree intended. Still further, the balloon is of a simple spherical design, and, as such, extends pressure outwardly in all directions, 360 degrees, in all planes. Accordingly, the liver is compressed just as much as the stomach is. Also, the compression forces against the stomach are not ideal, as the spherical balloon conformation does not match the conformation of the expanding stomach. The stomach is not spherical when expanded, or concave with a constant radius of curvature, but expands into a designated space that allows the fundus to expand preferentially more than other parts of the stomach.
• Brazzini et al. in WO2005/18417 discloses at least two or more expandable devices used to treat obesity, in which the devices are inserted through the abdominal wall and anchored against the external surface of the stomach wall by an anchoring mechanism that extends through the stomach wall and fixes to the internal surface of the stomach wall.
• U.S. Patent Publication No. 2005/0261712 to Balbierz et al. describes capturing a device against the outer surface of the stomach wall to form a restriction that appears to function similarly to the restriction imposed by the LAPBAND™. The anchoring of the devices disclosed relies upon placement of features against the internal wall of the stomach to form an interlock with the device which is placed against the external wall of the stomach. U.S. Patent Publication Nos. 2005/0267533 and 2006/0212053 to Gertner disclose devices for treatment of obesity that use one or more anchoring mechanisms that are passed through the wall of the stomach to establish an anchor.
• U.S. Pat. No. 6,981,978 to Gannoe discloses devices for reducing the internal cavity of the stomach to a much smaller volume, which may be used to carry out a bypass procedure. Stapling is employed to isolate the smaller volume in the stomach, and thus the same potential disadvantages are present as with other stapling procedures described herein.
• U.S. Pat. No. 6,186,149 to Pacella et al. describes an occluder device that can be used as a dietary control device (seeFIG. 8C). The occluder device is placed against the wall of the stomach and inflated to press inwardly on the stomach wall. A frame is wrapped around the stomach wall and is inflated to press against the stomach wall. However, there is no disclosure of how the frame might be adjusted to maintain a position relative to the stomach wall as the size of the stomach varies.
• Gastric reduction techniques have been attempted, such as by inserting instruments trans-orally and reducing the volume of the stomach by stapling portions of it together. However, this technique is prone to failure due to the staples pulling through the tissues that they are meant to bind.
• Techniques referred to as gastric pacing endeavor to use electrical stimulation to simulate the normal feedback mechanisms of a patient that signal the brain that the patient is full, or satiated. While these techniques are less invasive than some of the other existing treatments, statistics to date have shown that the amount of weight lost by using such techniques is less than satisfactory.
• Currently marketed drugs for weight loss, such as XENICAL®, MERIDIA® and Phen fen have largely failed, due to unacceptable side effects and complications, and sometimes to an ineffective amount of weight loss. Other drugs that are on the horizon include ACCOMPLIA® and SYMLIN®, but these are, as yet, unproven.
• The risk and invasiveness factors of currently available surgeries are often too great for a patient to accept to undergo surgical treatment for his/her obesity. Accordingly, there is a need for less invasive, yet effective surgical treatment procedures for morbidly obese patients (patients having a BMI of 35 or greater). Also, since the current surgical procedures are currently indicated only for those patients having a BMI of 40 or greater, or 35 or greater when co-morbidities are present, it would be desirable to provide a surgical procedure that would be available for slightly less obese patients, e.g., patients having a BMI of 30 to 35 who are not indicated for the currently available surgical procedures. It would further be desirable to provide a surgical procedure that would be indicated for obese patients having a BMI in the range of 30-35, as well as for more obese patients.
SUMMARY OF THE INVENTION
• The present invention provides methods, devices, tools, instruments and systems for treating a patient to induce weight loss.
• At least one method embodiment comprises the steps of: passing a device, including an expandable member in a collapsed configuration, through an opening in the skin of the patient, and into the abdominal cavity of the patient; anchoring at least a portion of the expandable member, relative to at least one structure in the abdominal cavity, without piercing the stomach; and expanding the expandable member to an expanded configuration in a space in the abdominal cavity to perform at least one of: prevention of expansion of the stomach of the patient into the space; and compression of a portion of the stomach.
• A method of implanting a weight-loss treatment device by connecting the device to an anchoring frame is provided, including the steps of: passing the anchoring frame into the abdominal cavity of the patient; anchoring the anchoring frame to at least one structure in the abdominal cavity, without piercing the stomach; passing the device, including an expandable member in a compressed configuration, into the abdominal cavity of the patient; and passing the device over the anchoring frame to anchor the device to the anchoring frame.
• A method of implanting a weight-loss treatment device by connecting the device to an anchoring frame is provided, including: passing the anchoring frame into the abdominal cavity of the patient; passing the device, including an expandable member in a collapsed configuration, into the abdominal cavity of the patient; and passing the device over the anchoring frame to mechanically lock the device to the anchoring frame and to anchor the anchoring frame to at least one structure in the abdominal cavity, without piercing the stomach.
• An implantable device for inducing weight loss is provided, including: an expandable main body member configured to be positioned adjacent a portion of a stomach of a patient, within the abdominal cavity of the patient; the expandable member being inflatable with pressurized fluid, wherein the expandable body member comprises a wall surrounding an internal chamber, the wall being substantially impervious to the pressurized fluid; wherein the expandable main body member further comprises a safety valve configured to open when a pressure inside the expandable main body exceeds a predetermined maximum pressure; and a reserve chamber in fluid communication with the safety valve to receive at least a portion of the pressurized fluid in the internal chamber of the expandable main body member when the safety valve opens.
• An anchoring frame for anchoring a device to an internal structure in a patient's body is provided, including: an elongated main body having proximal and distal ends; at least one channel running substantially over a length of the main body; a contact surface adapted to contact the internal structure in the patient's body; anchors positioned in the anchoring frame for being driven through the contact surface and into the internal structure; and a deployment driver slidable through at least one of the at least one channels, wherein sliding the deployment driver through the at least one channel drives the anchors through the contact surface.
• A combination of an implantable device engaged with an anchoring frame is provided, wherein the implantable device include an expandable member having at least one key extending therefrom or groove formed therein; the anchoring frame includes an elongated main body having proximal and distal ends, and at least one channel or rail running substantially over a length of the main body; and wherein the rail is receivable in the groove and the at least one key is receivable in the channel to mechanically connect the device with the anchoring frame.
• An anchoring frame for anchoring a device to an internal structure in a patient's body is provided, including: an elongated main body having proximal and distal ends; at least one channel running substantially over a length of the main body; a contact surface adapted to contact the internal structure in the patient's body; anchors positioned in the anchoring frame for being driven through the contact surface and into the internal structure; and a deployment driver slidable through at least one of the at least one channels, wherein sliding the deployment driver in a first direction through the at least one channel contacts the driver with first portions of the anchors and drives the anchors through the contact surface, and wherein subsequently sliding the deployment driver in a second direction through the at least one channel contact the driver with second portion s of the anchors and retracts the anchors from extending through the contact surface.
• An anchoring frame deployment tool configured to deliver an anchoring frame percutaneously to a surgical target area in a patient is provided, the tool including: a handle for manual operation by a user; an elongated shaft extending distally from the handle; and an engagement feature provided on a distal end portion of the shaft, configured to engage a channel or a rail of the anchoring frame.
• An anchoring frame deployment tool is provided, including: an elongated shaft having a proximal portion and a distal portions rotatably linked to the proximal portion; an actuator mechanically linked to the distal portion and operable by a user to rotate the distal portion in first and second opposite directions relative to the proximal portion; and a recess or cavity formed in the distal portion shaped and dimensioned to receive the anchoring frame therein.
• An anchoring frame unlocking tool is provided, including: a handle for manipulation by a user; an elongated shaft extending distally from the handle; and a lock depressor extending radially from a distal end portion of the elongated shaft, the lock depressor configured to be mounted on and to slide over a rail of an anchoring frame, and to depress automatic locking structures as the lock depressor passes over the automatic locking structures.
• An implantable device for treatment of obesity is provided, including: an expandable main body member configured to be positioned adjacent a portion of a stomach of a patient, within the abdominal cavity of the patient; the expandable member being inflatable with pressurized fluid; two sets of looped tabs extending substantially along two lines in a longitudinal direction of the expandable main body member, wherein, in an un-expanded configuration in which the main body member lies substantially flat, the two lines are offset, and wherein the main body member is configured to be rolled up, in the unexpanded configuration, into a compact configuration wherein the two lines align and set two sets of looped tabs align so that a shaft, rod or wire can be inserted through the looped tabs to maintain the expandable main body member in the compact configuration.
• An introducer configured to deliver an implantable device into an abdominal cavity of a patient via a percutaneous, laparoscopic or mini-laparoscopic procedure is provided, including: a proximal shaft portion; a splittable introducer housing forming a distal portion of the introducer, the splittable introducer including a plurality of jaws pivotally mounted to the proximal shaft portion and pivotable between an open configuration and a closed configuration, wherein in the closed configuration, the jaws define an internal space configured and dimensioned for receiving the implantable device therein; and an actuator extending proximally of the jaws and operable by a user to open and close the jaws.
• An introducer configured to deliver an implantable device into an abdominal cavity of a patient via a percutaneous, laparoscopic or mini-laparoscopic procedure, the introducer comprising: an inner sheath, the inner sheath comprising a distal end portion configured to receive the device wrapped there around in a compact configuration; and an outer sheath dimensioned to slide over the inner sheath and the device in the compact configuration, to maintain the device in the compact configuration while delivering the device; wherein the outer sheath is retractable from the distal end portion of the inner sheath and the device, to expose the device to be extracted for implantation at a surgical target site, and wherein the distal end portion of the inner sheath is bendable at an angled to a longitudinal axis of the introducer, when the outer sheath is retracted, to reorient the device to facilitate extraction thereof.
• An access member attachment system is provided, including: a tool having a handle at a proximal end portion thereof; a working end at a distal end portion thereof, the working end including a socket shaped and dimensioned to receive an access member therein and to maintain an orientation of the access member relative to the working end during attachment of the access member to a patient; and an anvil configured to slide over a conduit to which the access member is to be attached.
• A method of attaching an access member to a conduit in fluid connection with an expandable member implanted in an abdominal cavity of a patient is provided, wherein the method includes: sliding an anvil over the conduit at a location external of the abdominal cavity; inserting the anvil through an opening in the abdominal wall while continuing to slide the anvil over the conduit; orienting an anvil surface of the anvil against an inner surface of the abdominal wall; while holding the anvil surface pressed against the inner surface of the abdominal wall, driving the access member against an outer surface of the abdominal wall, thereby driving attachment members of the access member through the abdominal wall and against the anvil surface, whereby the attachment members are deformed against the anvil surface, thereby anchoring the access member to the abdominal wall.
• An access member having undeployed and deployed configurations is provided, including: at least one port adapted to be placed in fluid communication with a conduit, the access member having a first outside diameter at a distal portion thereof, in the undeployed configuration, that is less than a second outside diameter of the access member at a distal portion thereof when in the deployed configuration.
• A quick connect access member for attachment to a patient in fluid communication with a conduit in fluid communication with an expandable member implanted in an abdominal cavity of a patient is provided, wherein the access member includes: a base having a contact surface adapted to abut an inner surface of an abdominal wall of the patient; a tubular spacer having a length adapted to span a thickness of the abdominal wall, a proximal end portion of the spacer being provided with a lip; and an external portion connectable to the tubular spacer with a snap fit and configured to press against an external surface of the abdominal wall.
• A quick connect access member for attachment to a patient in fluid communication with a conduit in fluid communication with an expandable member implanted in an abdominal cavity of a patient is provided, wherein the access member includes: a base having a contact surface adapted to abut an inner surface of an abdominal wall of the patient, the base including a socket portion having one or more sets of spring-loaded bearings or detents and a tubular spacer having a length adapted to span a thickness of the abdominal wall; and an external portion connectable to the base portion, the external portion have a distally extending tubular portion have at least one annular recess circumscribing an external surface thereof, configured to mate with the one or more sets of spring loaded bearings or detents.
• A method of treating a patient is provided, including: passing a device including an expandable member through the skin of the patient, through the abdominal wall of the patient and into the abdominal cavity of the patient; expanding the expandable member in a space in the abdominal cavity to perform at least one of: prevention of expansion of the stomach of the patient into the space; and compression of a portion of the stomach; and anchoring the expanded expandable member against the abdominal wall of the patient.
• A method of treating a patient is provided, including: passing a device including an expandable member through a minimally invasive opening through the skin of the patient and the abdominal wall of the patient, and into the abdominal cavity of the patient; accessing a tether looped through a positioning member on the expandable member from a second minimally invasive opening; and drawing the tether through the second minimally invasive opening and drawing on the position member to reorient the expandable member.
• An implantable device for treatment of obesity is provided, including: an expandable main body member configured to be positioned adjacent a portion of a stomach of a patient, within the abdominal cavity of the patient; the expandable member being inflatable with pressurized fluid; and an attachment tab extending from the expandable main body member.
• In at least one embodiment, the attachment tab comprises at least one structural member therein, the at least one structural member being deformable to facilitate passage through a small opening in a patient, and wherein the at least one structural member returns to an undeformed configuration upon entering the abdominal cavity to orient the attachment tab toward a structure in the abdominal cavity to attach the attachment tab to.
• A method of f treating a patient is provided, with the method including: passing a flexible endoscope through an opening in the skin of the patient, and into the abdominal cavity of the patient; passing a device including an expandable member in a collapsed configuration over the flexible endoscope and into the abdominal cavity of the patient; anchoring at least a portion of the expandable member, relative to at least one structure in the abdominal cavity; and removing the flexible endoscope from the patient.
• A method of treating a patient is provided, including: passing a flexible wire through an opening in the skin of the patient, and into the abdominal cavity of the patient; viewing through a distal end portion of the flexible wire; passing a device including an expandable member in a collapsed configuration over the flexible wire and into the abdominal cavity of the patient; and anchoring at least a portion of the expandable member, relative to at least one structure in the abdominal cavity.
• These and other advantages and features of the invention will become apparent to those persons skilled in the art upon reading the details of the methods, devices, tools, instruments and systems as more fully described below.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates the anatomy of the abdominal cavity and its contents, and surrounding features.
• FIG. 1A is an illustration of a diaphragm in an isolated view, illustrating the conformation of the diaphragm as it exists in the body.
• FIG. 2 illustrates the diaphragm in position relative to the rib cage.
• FIGS. 3A and 3B show views of a main body of a device with a shape and size approximating the shape and size of a full (post-prandial) stomach.
• FIGS. 3C and 3D illustrate two variations of a device, wherein the inferior portion of the expandable member inFIG. 3D is longer and thus extends further inferiorly and medially than the inferior portion of the expandable member shown inFIG. 3C.
• FIG. 4 illustrates (by arrows) potential locations on the stomach wall that can be displaced or compressed by one or more expandable devices as described herein.
• FIG. 5 is a photograph of an expandable member formed by sputtering a layer of titanium over a polyurethane expandable member formed in a shape as described with regard toFIGS. 3A-3B above.
• FIG. 6 illustrates an embodiment of a device that employs two expandable members.
• FIGS. 7A-7C illustrate a “nested chamber” configuration of an expandable member, at various stages of inflation.
• FIG. 8A illustrates safety valves installed in both expandable members.
• FIG. 8B illustrates an alternative embodiment, in which a safety valve is in fluid communication with a reserve expandable member.
• FIGS. 9A-9C illustrate an expandable member that includes excess material for additional expansion capacitance, and operation thereof.
• FIGS. 10A-10F illustrate an expandable member that is formed from a linear string of multiple expandable cells (or, alternatively fixed size hollow balls), that can be inserted into the patient one at a time, thereby minimizing the inside diameter requirement of an introducer used to deliver the expandable cells.
• FIG. 11 illustrates a device having been inserted into the abdominal cavity in a manner as described, expandable member having been inflated and the device having been anchored.
• FIGS. 12A-12K illustrate steps that may be carried out during a procedure for percutaneously implanting an expandableextra-gastric device10 according to an embodiment of the present invention.
• FIGS. 12L-12N illustrate variations of the method depicted inFIGS. 12A-12K.
• FIGS. 13A-13D illustrate an embodiment of an anchoring frame that can be used for anchoring a device in the abdominal space.
• FIG. 14A illustrates an example of a device provided with keys configured to slide within a channel of an anchoring frame.
• FIG. 14B shows an end view of a key inserted into a channel of an anchoring frame.
• FIG. 14C shows an example of a key inserted into a channel of an anchoring frame, wherein the enlarged portion of the key is spherically shaped.
• FIG. 14D illustrates the device ofFIG. 14A having been mounted on an anchoring frame.
• FIG. 15A illustrates another embodiment of ananchoring frame600 that employs a rail configuration for receiving a device thereover.
• FIG. 15B is an end view of a deployment member configured to slide over arail618 of an anchoring frame.
• FIG. 15C shows an end view of a device having one configuration (T-shaped cross-section) of channel configured to slide over a rail of an anchoring frame.
• FIG. 15D shows the device ofFIG. 15C having been mounted on an anchoring frame.
• FIG. 15E is a schematic, sectional illustration (viewed from the foot of the patient with the patient lying on his back) of a device anchored to the abdominal wall via an anchoring frame.
• FIG. 16A illustrates an embodiment of an anchoring frame that includes an actuation mechanism that can be use to anchor the frame to tissue (deploy) as well as to release the frame from such anchoring.
• FIG. 16B illustrates the sharp (distal) ends of anchors deployed out through openings in the contact surface of the anchoring frame.
• FIG. 16C illustrates a tool configured to engage with the deployment member and anchoring frame shown inFIGS. 16A-16B.
• FIG. 17 illustrates an anchoring frame deployment tool that can be used for percutaneous delivery of an anchoring frame.
• FIG. 18A illustrates another embodiment of an anchoring frame deployment tool.
• FIG. 18B is an enlarged partial illustration of the tool ofFIG. 18ashowing the distal end portion.
• FIG. 19A illustrates locks on an end portion of an anchoring frame.
• FIG. 19B illustrates tabs being inserted to depress the locks ofFIG. 19A.
• FIG. 20A shows an anchoring frame unlocking tool that can be used to unlock an anchoring frame to free a device that has been automatically locked into position along the anchoring frame.
• FIG. 20B illustrates an end view of the distal end of the tool ofFIG. 20A.
• FIG. 20C schematically illustrates use of the tool ofFIG. 20A to unlock a device from an anchoring frame so that the device can be removed from the site.
• FIG. 21A illustrates an embodiment of a device provided with looped tabs.
• FIG. 21B illustrates the looped tabs ofFIG. 21A aligned with each other, with a rod or wire inserted through the loops to maintain the device in a rolled up configuration.
• FIG. 21C illustrates an expandable compaction member that may be formed to roll up when inflated, but can be opened up or spread apart or held open in a relatively flattened out configuration in its non-expanded (deflated) state.
• FIG. 21D shows the compaction member ofFIG. 21C maintaining a device in a compacted or collapsed configuration.
• FIG. 21E illustrates a rigid exoskeleton provided to receive an expandable member and maintain it in a compressed or otherwise non-expanded configuration.
• FIG. 21F shows an alternative configuration for placing an expandable member in a compacted or collapsed configuration.
• FIG. 21G shows an expandable member compressed in a capsule that is formed of a water soluble gel or skin.
• FIG. 21H illustrates an embodiment having a flexible, expandable exoskeleton.
• FIGS. 21I-21J illustrate an expandable member that is formed in an elongated tube configuration.
• FIG. 21K illustrates an alternative to the use of tabs in the embodiment ofFIGS. 21I-21J.
• FIG. 22A illustrates a device maintained in a compact configuration by insertion within a sheath.
• FIG. 22B illustrates an expandable member being deployed via an introducer having a splittable introducer housing at a distal end portion thereof.
• FIG. 22C illustrates the compacted device (including expandable member) having been received in the introducer, with the splittable jaws having been closed around the compacted expandable member to maintain it in a compact configuration.
• FIG. 22D illustrates rotation of the compacted expandable member by manipulation of tethers.
• FIG. 22E illustrates the beginning of extraction of the expandable member.
• FIG. 22F illustrates an introducer having an outer sheath that slides freely over an inner sheath.
• FIG. 22G illustrates an expandable member that has been folded over and then rolled up around a distal end portion of the inner sheath of the introducer ofFIG. 22F.
• FIG. 22H illustrates extraction of the expandable member from the inner sheath ofFIG. 22G.
• FIGS. 22I-22J illustrate tongue-rolling of an expandable member.
• FIG. 22K illustrates a tongue-rolled expandable member having bee inserted into an introducer that comprises a rigid, closed-ended (at the proximal end) sheath or tube.
• FIGS. 22L-22M illustrate another variation of an arrangement for compacting a device and maintaining it the compact configuration for delivery into the abdominal cavity.
• FIG. 22N illustrates an optional use of a sheath with the arrangement previously shown inFIGS. 22L-22M.
• FIG. 22O shows a further alternative arrangement, in which the sheath and device after rolling and compressing according to the techniques described above with regard toFIGS. 22L-22M, is back-loaded on an endoscope.
• FIGS. 22P-22Q illustrate an embodiment of an endoscope provided with an expandable distal tip/lens.
• FIG. 22R shows a variant of the tip/lens ofFIGS. 22P-22Q.
• FIG. 22S illustrates an alternative to use of a flexible, steerable endoscope, wherein a wire, that is viewable therethrough, is used.
• FIG. 23 illustrates a device deployment tool that can be used to deploy a device lover an anchoring frame.
• FIGS. 24A-24C illustrate an access member attachment tool and use of the tool for rapid attachment of an access member to a patient.
• FIG. 25A shows use of hook and loop type fasteners or other interlocking mechanism used for a quick connect mechanism to attach an access member to the abdominal muscle.
• FIG. 25B illustrates a quick-connect access member having a ring provided with one or more magnets having polarity on the surface facing access member that is opposite the polarity of the surfaces of magnets facing the ring.
• FIGS. 25C and 25D illustrate undeployed and deployed configurations, respectively, of an access member having deployable anchors.
• FIGS. 25E and 25F illustrate undeployed and deployed configurations, respectively, of an access member having a spring member that functions to anchor the access member to a patient.
• FIGS. 25G-25H show an embodiment of an access member that is connectable via a snap fit that provides a clamping action between a base and an external portion.
• FIG. 25I illustrates an anchoring frame provided with an interlock on a proximal end portion thereof.
• FIG. 25J illustrates a tool for deploying an engagement member into the interlock ofFIG. 25I.
• FIG. 25K shows an embodiment of access member that is connectable via an automatic engagement mechanism that functions like a chuck for a pneumatic tool.
• FIG. 25L-25M show another variation of an air hose-like type of quick connector.
• FIG. 26A illustrated a device being anchored wherein a conduit is actively employed in the anchoring.
• FIG. 26B illustrates tissue ingrowth-enhancing material provided at an interface between the expandable member and the inner wall of the abdominal muscle.
• FIG. 26C illustrates an example of a device including a loop (similar to a belt loop).
• FIG. 26D illustrates positioning of a device by applying a traction force to the loop shown inFIG. 26C.
• FIG. 26E illustrates a distal end portion of an elongated needle having a hooked slot.
• FIG. 26F illustrates a step of attaching an attachment tab to the abdominal wall, according to one embodiment using a laparoscopic procedure.
• FIG. 26G shows an example of a device having three positioning loops longitudinally spaced along an expandable member.
• FIG. 26H illustrates a segmented positioning member having multiple positioning features or channels within a loop.
• FIG. 26I shows a device having an attachment tab extending from a superior portion of an expandable member and another attachment tab extending from an inferior portion of the expandable member.
• FIG. 27A illustrates an example of a device with multiple attachment tabs.
• FIG. 27B illustrates an example of a device having threeattachment tabs150 extending from the inferior portion of expandable member, where the tabs are interjoined by margin portions at the sides of the main bodies of the tabs.
• FIG. 27C schematically illustrates various features that may be provided for attachment of a device within the abdominal cavity, any of which may be used individually, or in any combination with any of the other features disclosed.
• FIG. 28 illustrates one configuration of attachment tab, wherein the main body portion includes a tissue ingrowth-enhancing material.
• FIG. 29A illustrates a device having attachment tabs provided with multiple structural members.
• FIG. 29B illustrates a device with inflatable attachment tabs.
• FIGS. 29C-29E illustrate another variation of a self-expanding attachment tab.
• FIGS. 29F-29G show a device provided with a self expanding attachment tab.
• FIGS. 29H-29I illustrate another example of a device provided with a self expanding attachment tab.
• FIG. 29J illustrates one example of connectors, whereby one of the connectors includes resiliently deformable tangs, which are received and locked in the other of the connectors upon joining.
• FIG. 30A illustrates the orientation of an expandable member of a device when implanted in a patient according to one embodiment of the present invention.
• FIG. 30B illustrates a more flattened surface conformation of a portion of an expandable member, relative to the curvature of the remainder of the expandable member.
• FIGS. 31A-31D illustrate an expandable member having an inflatable portion that provides a surface for conforming to the abdominal structure to be anchored to, wherein this portion is expandable independently of the expandable member.
• FIG. 32A shows an example of a device having two expandable members wherein a conduit connecting to at least one of the expandable members extends proximally from the expandable members, such as through an opening in an attachment tab.
• FIG. 32B illustrates overlaying banding strips and adhering the ends of the banding strips on opposite sides of a conduit to an attachment tab.
• FIG. 32C illustrates a banding sleeve that extends over a majority of the length of the radius (or distance from where attachment tab connects to expandable member to the free edge perimeter) of the attachment tab.
• FIG. 32D illustrates manipulation of one or more conduits to move and position attachment tab(s) into a desired location against the anterior abdominal wall.
• FIG. 32E illustrates a device having separate attachment tabs.
• FIG. 32F illustrates a device having a segmented attachment tab.
• FIG. 33 illustrates a distal end portion of a flexible endoscope that may be used in a procedure to assist visualization of the placement of a device during an implantation procedure.
• FIG. 34 illustrates anchoring of an expandable member using a feature including ratcheted teeth.
DETAILED DESCRIPTION OF THE INVENTION
• Before the present devices and methods are described, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
• Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
• Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
• It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a tube” includes a plurality of such tubes and reference to “the incision” includes reference to one or more incisions and equivalents thereof known to those skilled in the art, and so forth.
• The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
DEFINITIONS
• A “compliant” material refers to a material that is stretchable or expandable. This expansibility allows the material to increase in dimension substantially more than a noncompliant or semi-compliant material, prior to failure. For example, when formed as a balloon structure, a compliant material comprises an expansibility property of being able to increase its radius, beyond its formed radius, under pressure applied into the balloon, by 100 percent or more, without rupturing.
• A “noncompliant” material refers to a material that, when formed as a balloon structure, can increase its radius beyond its formed radius, under pressure applied into the balloon, only up to about 10 percent or less prior to rupturing.
• A “semi-compliant” material refers to a material that, when formed as a balloon structure, can increase its radius beyond its formed radius, under pressure applied into the balloon, by an amount between about 10 percent and about 100 percent, prior to rupturing.
• The “wall” of the stomach refers to all of the layers that make up the stomach wall, including the mucosa, submucosa, muscular layers and serosa. A “layer”, “layer of the stomach wall” or “stomach wall layer” refers to a mucosal layer, submucosal layer, muscular layer or serosal layer.
• A “proximal” end of an instrument is the end that is nearer the surgeon when the surgeon is using the instrument for its intended surgical application.
• A “distal” end of an instrument is the end that is further from the surgeon when the surgeon is using the instrument for its intended surgical application.
• An “internal body structure” when referred to as a structure to which a device is to be anchored, refers to a structure internal to the skin of a patient, and which can be within the abdominal cavity of the patient, or just outside of it, such as including the outer surface of a wall that partially defines the abdominal cavity. Structures to which a device can be anchored include, but are not limited to: one or more ribs, the intercostal muscles, the abdominal surface of the diaphragm, the stomach (but where the anchor does not pass through the wall of the stomach), the anterior abdominal wall, the posterior abdominal wall and the lateral abdominal wall, the esophagus, the angle of his in the stomach, the gastro-intestinal junction, the gastro-esophageal junction, the columnar ligaments of the diaphragm near the gastro-esophageal junction, the superior aspect of the omentum, peritoneum, liver, connective tissues, ligaments, and blood vessels.
• A “body floss wire” is a wire that enters and exits the body in two locations and passes inside the body between the two locations. This arrangement allows excellent control of the tension on the wire, as forces can be applied at both end portions of the wire that enter and exit the body. Additionally, this arrangement provides good control of devices being passed along the wire.
• The preferred embodiments of the present invention prevent the possible issue of erosion caused by an expandable member, by not requiring anchoring to the stomach, and further, by not requiring a compression force to be applied when the stomach is not full of food. By allowing the stomach to move freely in the constrained spaced provided by the expandable member, the stomach's possible expansion size will be decreased, but there will be less opportunity for the formation of pressure necrosis since no one region will be subjected to concentrated forces. With the device in place, there is substantially no distensibility of the stomach as normal exists with an unconstrained stomach. With distensibility restricted and gastric volume reduced, as the patient ingests food, the intra-gastric pressure will rise to a level sufficient to produce satiety without distension or volume expansion of one or more regions of the stomach. The device occupies so much volume in the abdominal cavity that the stomach does not substantially depart from the shape set by the device even when filled with food. Another physiological benefit of the device is that the stomach's ability to relax in response to ingestion of food is reduced or eliminated, through producing earlier satiety. One additional physiological benefit of the expandable member may further be to substantially reduce the actual volume of the stomach itself, remodeling the organ as the muscle contracts into its new shape over the period of weeks or months (just as the heart remodels when constrained from over-expansion). Remodeling the stomach allows the expandable member to be implanted temporarily. The preferred embodiments also are positioned in a location to completely or mostly fill the space normally occupied by the fundus, thus moving the stomach medially and wedging the stomach between the expandable member and the medial and anterior aspects of the liver, and the spine posteriorly. This position also ensures that the expandable member is almost entirely maintained underneath the diaphragmatic umbrella beneath the ribs on the left side, thus concealing the expandable member, and preventing it from producing an unsatisfactory cosmetic result. Further, the preferred embodiments can have elements for anchoring on one or more locations along the abdominal cavity wall to prevent migration. Further, the preferred embodiments are provided with an outer surface that is very atraumatic. Embodiments described at least one expandable member, preferably an inflatable member, made of a material or material composite that is impermeable to gas, as well as embodiments having at least two expandable members, with one expandable member being inflated with a gas and another expandable member being inflated with a liquid.
• The device embodiments of the present invention can be placed with a number of minimally invasive techniques, such as those often referred to as percutaneous, laparoscopic, mini-laparoscopic, or key-hole. Particularly important in at least one embodiment, the procedure requires no general anesthesia and typically only a single, small opening in a patient is required to deliver an implantable device. In particular, in at least one embodiment the procedure can be performed outside of an operating room setting with local anesthesia or conscious sedation and generally without pressurized insufflation.
Abdominal Cavity Anatomy
• FIG. 1 illustrates the anatomy of the abdominal cavity and its contents, and surrounding features. Theabdominal cavity100 is shown divided among four quadrants, the upperright quadrant102, upperleft quadrant104, lowerleft quadrant106 and lowerright quadrant108, as divided by themedian axis110 andtransverse axis112. The lower edge of the ribcage is illustrated by the dottedline114 and the diaphragm is shown at116. As seen inFIGS. 1A and 1B, thediaphragm116 is shaped like a parachute and sits within the ribs. Theesophagus118 passes through thediaphragm116 and joins with thestomach120. Theleft lobe122 of theliver121 lies anteriorly of theesophagus118 and the fundus-cardia junction119. In one aspect of the invention, an expandable device is implanted in an extra-gastric location (i.e., outside of the stomach) generally indicated at124, and then expanded to occupy a space that the fundus of the stomach would ordinarily expand into when the stomach is filled with food. The expanded device prevents this expansion by the fundus, thereby limiting the volume of the cavity in the stomach to a much smaller volume than if the fundus had been allowed to expand into the space. Alternatively, the device is expanded to apply pressure to the fundus of the stomach in a downward direction (e.g., in a direction toward thetransverse axis112 shown, with some transverse movement toward themedian axis110 shown), and optionally, additionally to the main body of the stomach, to reduce the volume inside the stomach to effect satiety in the patient with relatively less food ingested, relative to what the patient would require for satiety without the implant in place.
Devices
• At least some embodiments of devices described herein can be implanted percutaneously, with a relatively quick and simple procedure that requires no general anesthesia and wherein only a single, small opening in a patient is required to deliver the device, which typically has a single expandable member that is self anchoring or can be easily anchored to maintain the simplicity and minimal invasiveness of the procedure.
• In other embodiments, more complex configurations of expandable members are provided, where a device can contain one or more expandable members and implantation and anchoring can be performed laparoscopically. Any of the devices described herein can, of course, be implanted using open surgical procedures. Devices that can be implanted percutaneously can alternatively be implanted using laparoscopic procedures.
• Devices described herein can be implanted permanently, but are also configured for reversibility, to facilitate relatively simple removal procedures, should it be desired to remove a device. Alternatively, devices according to the present invention can be implanted temporarily, such as over a period of months, and then removed or disabled when further treatment is no longer required, or to allow an alternative treatment to be applied.
Device Body Configurations
• FIGS. 3A and 3B show views of adevice10 having amain body10m,10emwith a shape and size approximating the shape and size of the full (post-prandial) stomach120b. Although main body10mneed not be expandable/collapsible to perform restriction of stomach expansion, main body10mis typically formed from one or moreexpandable members10emas will be described in further detail below, for better performance of intended functions and to allow less invasive procedures for implanting the same.
• Main body10m,10emincludes curved left and right sides101 and10r, respectively (FIG. 3A shows the posterior surface ofmain body10m,10em), wherein the left side101 is convex and the right side10ris concave such that themain body10m,10emtakes on a somewhat kidney-shaped configuration. However, the superior portion10sis substantially larger and more bulbous than the inferior portion10i, since the fundus portion of thestomach120 expands much more than the antrum upon receiving food. Thus, as seen in the right side view ofFIG. 3B, the superior portion10sis very bulbous and almost spherical, with a larger cross section than the inferior portion10i, while the inferior portion is more nearly hemispherical, with the center portion of the main body tapering from the superior portion10sto the inferior portion10i. Configured as such, themain body10m,10em, when implanted properly, will occupy the space that naturally exists from thestomach120 to expand into when expanding from a pre-prandial configuration to a post-prandial configuration. By severely limiting this expansion capability, the patient is thereby able to consume only a significantly smaller volume of food than possible if the implant were not present.
• Device10 sizes will likely vary depending on the size of the skeletal system of the patient into whichdevice10 is to be implanted, particularly the size of the rib cage. Further variations may be made to tweak or adjust the amount of restriction along any desired location of the stomach that interfaces withdevice10. One typical variation is in the length and/or size (diameter or expandability capacitance) of the inferior portion10i.FIGS. 3C and 3D illustrate two variations ofdevice10 in which the inferior portion of theexpandable member10eminFIG. 3D is longer and thus extends further inferiorly and medially than the inferior portion of the expandable member shown inFIG. 3C. In both cases, expandable member is shown in an expanded configuration, and a full,unrestricted stomach120 is illustrated behind theexpandable member10emto illustrate the relative amount of restriction that each expandable member shown would impose on thestomach120.
• At least a portion of main body member10mmay be expandable. The entire main body10mmay be made of anexpandable member10em. When in an expanded configuration,expandable member10emcan optionally only abut or lie adjacent to the pre-prandial stomach wall, without imparting any significant deformation forces thereto. However, when the patient eats and the stomach begins to fill,expandable member10emin this case prevents thestomach120 from expanding into the volume occupied byexpandable member10em. In such a case, thestomach120 becomes “deformed” as it attempts to expand and can only expand in a limited fashion, if at all, around a portion of the perimeter ofexpandable member10em. Thus, upon expanding thedevice10, thedevice10 expands in the space(s) normally occupied by thestomach120 as thestomach120 expands when receiving food. Thusdevice10 exerts pressure on, or at least prevents expansion of the fundus and optionally, the antrum. In embodiments where theexpandable device10 is not attached to the stomach, the stomach is free to perform its normal function of mixing food in the stomach for digesting and pushing food out of the stomach. During all of this movement the stomach may slip behind, beside or on top of the expandable device, but the internal volume of the stomach will be held to its smaller volume as theexpandable device10emis occupying the space into which the stomach would normally expand. Further details of methods for treatment of obesity, including procedures for implanting devices described herein are described below.
• As noted above, anexpandable device10 can be implanted adjacent a surface of the stomach wall, either in contact therewith or at a predetermined distance therefrom, to prevent expansion of thestomach120 into a volume occupied by theexpandable device10. Alternatively, some embodiments of the devices described herein can be configured and placed to exert an external compression on one or more locations of the stomach to deform the stomach wall, thereby decreasing the internal volume of the cavity within the stomach that accepts food and liquid intake.FIG. 4 illustrates (by arrows) potential locations on thestomach120 wall that can be compressed (or restricted from expanding) by one ormore devices10 as described herein.
• In one embodiment,expandable member10emshown inFIGS. 3A-3B is composed of aninflatable member10em. Inflatable members described herein can be inflated with gas or liquid or both. Examples of gases or liquids that can be used to inflate inflatable members/devices10 include, but are not limited to: carbon dioxide, helium, isotonic dextrose solution, iostonic saline solution, air.
• It may be preferable to inflate at least a portion of theexpandable member10emshown inFIGS. 3A-3B with one or more gases, to minimize the weight of the implanteddevice10, as an expandable member of the configuration shown can have an internal volume approaching a liter, when filled, and a heavier, fluid-filled device of this type may be more noticeable to the patient. Alternatively,devices10 can be inflated with a porous gel that is porous or microporous to encapsulate air or other gas bubbles, thereby reducing the weight of the gel while still permitting it to apply volumetric pressure to expand an inflatable member. Such gels may be settable, such as ultra-violet (uv) curable or otherwise chemically curable, or, alternatively, can remain in the gel state, so that they can be readily removed or added to, to increase or decrease the amount of inflation/expansion of the expandable member. Gels can be made from a flowable viscoelastic substance made of a polymer mixture, such as silicone oil, boric acid, hyaluronic acid, polyacrylic acid or combinations thereof, for example. The gel, as delivered into theexpandable member10em(e.g., such as by injection or the like) can be aerated or infused with carbon dioxide or an inert gas to create a deformable or non-deformable cellular structure that encapsulates the gas in cells, and thus has relatively low mass but still has significant resistance to compression or deformation.
• When inflating an inflatable member with a pressurized gas, some materials, especially the compliant materials such as silicone, polyurethane and the like, may have an inherent porosity as it is stretched during the expansion, such that it may not adequately maintain a desired pressure within the membrane or wall of the inflatable member over an extended period of time. This seepage or slow leakage of gas from the inflatable member may require a patient to have the implant checked more frequently then required for other physiological concerns, to ensure that it is maintaining adequate pressure and thus is expanded to the extent desired to perform the desired amount of deformation of the stomach. Materials such as silicone and polyurethane have a good history of long term biocompatibility when used as implants and are two of the preferred materials for use in makingdevices10.
• The inflatable members of the inflatable devices described herein can include compliant, noncompliant or semi-compliant materials, or any combination of these. Examples of compliant materials suitable for use in an inflatable member as described herein include, but are not limited to: silicone, latex rubber, and polyurethane. Examples of useable semi-compliant materials include, but are not limited to: nylon, polyethylene, polyester, polyamide and polyurethane, see for example, U.S. Pat. No. 6,500,148, which is hereby incorporated herein, in its entirety, by reference thereto. Polyurethane, nylon, polyethylene and polyester can be compliant or semi-compliant materials, depending upon the specific formulation and hardness or durometer of the material as produced. Examples of noncompliant materials that can be used in the construction of inflatable members described herein include, but are not limited to: polyethylene terepthalate (PET) and urethane. Urethane can be a compliant, semi-compliant or non-compliant material depending upon its specific formulation and hardness or durometer. Compliant, semi-compliant and noncompliant categories are not solely material limited, but are better defined by their expansion characteristics, as noted above. Some materials are best suited for use in one of these categories (e.g., silicone and latex work well to make compliant structures), but other materials can be formulated and/or constructed to provide compliant, semi-compliant or noncompliant properties.
• One way of eliminating or substantially reducing seepage, such as when an expandable member comprises a compliant material that is stretched to a degree that would normally exhibit such seepage, is to provide a very thin metallic coating over the compliant material using a biocompatible metal to form the coating, as the metal layer is substantially nonporous when the integrity of such layer is maintained.FIG. 5 is a photograph of anexpandable member10emformed by sputtering a layer of titanium over a polyurethane expandable member formed in a shape as described with regard toFIGS. 3A-3B above.FIG. 5 shows theexpandable member10emin an expanded configuration. In order to avoid wrinkles in the metallized layer of theexpandable member10em, the compliant material (e.g., polyurethane in this case) was stretched over a mold configured in an expanded shape of the expandable member and welded in this three dimensional configuration, while inverting the seams, so that the smooth, seamless configuration shown resulted. Other biocompatible metals (e.g., silver, gold, tantalum, palladium, platinum or some other biocompatible metal) may be substituted for titanium, and compliant materials other than polyurethane (e.g., silicone, latex rubber, etc.) can be substituted for the substrate of such anexpandable member10em.
• Another approach to reducing seepage is by co-extrusion, e.g., co-extruding EVOH (ethylene-vinyl alcohol copolymer) and polyurethane to form theexpandable member10em, with or without a metallic coating as described above.
• Further descriptions of methods and materials for making a metallic coated expandable member can be found in provisional application Ser. No. 60/877,595 which was incorporated by reference above.
• FIG. 6 illustrates an embodiment of a device that employs twoexpandable members10em₁and10em₂. The two expandable members in this case are separately and independently expandable, and may be expanded both by the same expansion medium (or by mechanical expansion methods/features described herein), or may be expanded by different expansion media or techniques or mechanical features, to provide what is termed herein as a hybrid device. In the example shown inFIG. 6, bothexpandable members10em₁and10em₂are designed to be inflated by gas, liquid, combination of gas and liquid, foams or any of the other inflation media described above. In one particular hybrid embodiment,expandable member10em₁is inflated by one or more gases andexpandable member10em₂is inflated by a liquid such as isotonic saline or isotonic dextrose solution, for example. Sinceexpandable member10em₁contains a large volume, as noted above, this expandable member is inflated with a gas so as to be less noticeable by the recipient patient when implanted. In use of this hybrid configuration,expandable member10em₁is fully inflated to occupy the space into which the stomach would normally expand when taking in food. Accordingly,expandable member10em₁may be designed as a “fixed volume” expandable member, such that this expandable member will be expanded to a predetermined pressure so as to occupy a known volume.Expandable member10em₂, having a much smaller expanded volume thanexpandable member10em₁(for example, the volume of10em₁can be about 75 to about 80 percent of the total volume of the implant, i.e., about 75 to 80 percent of the combined volumes of10em₁+10em₂) uses a liquid medium for expansion thereof, as noted above.Expandable member10em₂may be designed as a variable volume expandable member, so that expansion thereof can be varied to add to the fixed volume ofexpandable member10em₁in the amount desired. In use, this liquid medium can be used to adjust the degree of expansion ofexpandable10em₂, once the expansion ofexpandable member10em₁has already been established to further compress into thestomach120 or to better interface with the surface of the stomach, as the liquid in a less than fully expandedexpandable member10em₂is able to conform well to the surface shape of the stomach.
• One particular location that many surgeons are interested in restricting and/or compressing is the Angle of His, andexpandable member10em₂is placed to provide further compression capability at this location of thestomach120 whendevice10 is implanted as described. Also, since liquid is relatively incompressible,expandable member10em₂exhibits less give, causing the stomach to be deformed at the interface between the stomach andexpandable member10em₂, rather than compression ofexpandable member10em₂. Further, the liquid-filledchamber10em₂provides a softer surface to interface with the stomach then would the surface of a pressurized, fully expanded gas-filled chamber. Still further, because liquid is relatively incompressible, a user knows how much additional volume theexpandable member10em₂is being expanded by (and thus also the relative degree of additional compression provided) when a specific volume of liquid is inputted throughlumen12₂. Thus, for example, if a physician adds 60 cc of liquid throughlumen12₂, the physician will know that the volume ofexpandable member10em₂has expanded by 60 cc. Further, the use of liquid in the expandable member (such asexpandable member10em₂) may provide relatively more pressure in preventing expansion of the stomach due to the density of the device, relative to one that is filled with gas. Further, the liquid may feel more “organ-like”, since organs are primarily liquid, and therefore be generally better tolerated by the stomach and other organs in the abdominal cavity. Still further,expandable member10em₁can be expanded to a state where the properties of this expandable chamber do not exhibit significant seepage, so that this pressure can be maintained for an extended period of time.Expandable member10em₂on the other hand, can be expanded to a much greater percentage without concern about seepage, since materials used are much less porous to liquid. For example,expandable member10em₁may be made of one or more plies of titanium-coated polyurethane, as described above, andexpandable member10em₂may be formed of silicone. For example, the siliconeexpandable member10em₂can expand up to at least 800 percent of its normal volume.
• In the example shown inFIG. 6,expandable member10em₂is shown partially inflated. When fully deflated, the external surface ofexpandable member10em₂can be compressed to contact and conform to the adjacent wall ofexpandable member10em₁that it overlies. Further infusion of fluid intoexpandable member10em₂causes it to expand outwardly in the directions indicated by the arrows inFIG. 6. Thus, as can be seen,expandable member10em₂in this example has been placed to primarily effect compression of the fundus (or further reduction of the space provided for the fundus to normally expand into). However, the invention is not limited to this design, asexpandable member10em₂could be lengthened to also provide further expandability in the region of the antrum of the stomach, or could be provided to expand only against the antrum. Further, other placements of such a secondaryexpandable member10em₂can be designed to tailor the directionality of additional compression forces (and/or space filling) to be applied.
• InFIG. 6, adual lumen conduit12 is provided for inputting expansion media into the twoexpandable members10em₁and10em₂. Thus lumen12₁leads toexpandable member10em₁andlumen12₂extends intoexpandable member10em₁and leads intoexpandable member10em₂. Alternatively,lumen12₂can extend externally overexpandable member10em₁and then enter intoexpandable member10em₂.
• Further variations and embodiments of devices havingexpandable members10em₁and10em₂are described in provisional application Ser. No. 60/877,595 which was incorporated by reference above.
• The reduction in volume of the “full” stomach that can be achieved by filling the space that the stomach normally expands into and/or compression of the stomach that is achievable by any of the devices described is in the range of about 700 cc to about 1,200 cc. The adjustable range ofdevice10 can be about zero cc to about 650 cc or about 50 to 600 ml, typically about 100 to 500 ml or 100 to 400 ml, wherein variations in these ranges can be achieved by varying the degree of expansion of one or moreexpandable members10em. With a hybrid device described above theexpandable member10em₁is expanded to occlude most, if not all of the space into which the fundus (and optionally antrum) would normally expand when taking in food, with any medial space remaining betweenexpandable member10em₁and the empty stomach being fillable by adjusting the degree of expansion ofexpandable member10em₂. Thus, for example, if the full volume capacity of a stomach120 (with no implant impeding its expansion) is about 1,000 cc, thendevice10 can be configured to initially displace about 400 to 600 cc of volume, so that the stomach's remaining capacitance is about 400 to 600 cc. Over time,device10 can be expanded to occupy 800 to 900 cc of space, so that the stomach's capacity is reduced to about 100 to 200 cc. This adjustment can be done incrementally over time, for example. Ahybrid device10 such as the one described with regard toFIG. 6 can be implanted and the initial volume displacement referred to can be achieved by inflatingexpandable member10em₁with gas, for example. Further subsequent reductions in the stomach's capacity can be achieved by adding fluid toexpandable member10em₂to expand this member as desired.
• As noted above, the expandable members described herein may be expanded by an expansion medium (such as liquid, gas, gas and liquid, foam, etc.) or by mechanical expansion methods and/or features. It should be further noted here that a single expandable member can be expanded (and/or maintained at a desired degree of expansion) by a combination of one or more expansion media and one or more mechanical expansion methods and/or features. We refer to these as complex expandable members and examples of such are described below. Thus, for example, an expandable member that is inflated by gas pressure may be further supported by some other expansion means, such as a mechanical expansion member. This mechanical expansion member can alleviate some of the pressure that would otherwise be required to maintain the expandable member at a predetermined size (volume). Further, if seepage occurs, the secondary (mechanical) expansion member can maintain the expandable member at the desired volume. It is further noted here that a complex expandable member can be used in adevice10 having a single expandable member, such as like that shown inFIG. 5, or may be combined with one or more additional expandable members, e.g., like the example shown inFIG. 6, wherein the one or more additional expandable members may be expandable by expansion medium or expansion method and/or features, or may also be a complex expandable member. In at least one embodiment,device10 is provided with a complex expandable member having the shape ofexpandable member10em₁inFIG. 6 above, and a secondexpandable member10em₂, like that described inFIG. 6 above is provided as a fluid expandable member. Further examples and embodiments of devices employing at least one complex expandable member are provided in provisional application Ser. No. 60/877,595.
• FIGS. 7A-7C illustrate a “nested chamber” configuration of anexpandable member10em, in which chambers10c1-10c4 (although different numbers of chambers can be provided, which number may be two, three, or more than four) can be sequentially expanded, to vary the size of the expandable member and thus the amount of restriction and/or compression of the stomach to be applied bydevice10. Adjacent chambers are separated by a baffle ormembrane36 that may be formed of the same material as the wall ofexpandable member10em, with each baffle ormembrane36 containing at least one one-way valve38 therein.Valves38 are configured to open at progressively greater pressures, so that the chambers can be opened sequentially and only to the extent desired, based on the amount of pressure applied throughconduit12. Reduction in the overall volume ofexpandable member10emcan be achieved by passing a guide wire throughconduit12 and through allvalves38.Valves38 open when the guidewire is extended therethrough, allowing the contents of each chamber to funnel out throughconduit12, thereby deflating the expandable member. After this, the chambers can again be sequentially inflated as described to achieve the desired volume.
• More specifically, in the example shown, thevalve38 in themembrane36 separating chambers10c1 and10c2 opens at a lower pressure than thevalve38 inmembrane36 separating chambers10c2 and10c3. Similarly, thevalve38 in membrane26 separating chambers10c2 and10c3 opens at a lower pressure than thevalve38 inmembrane36 separating chambers10c3 and10c4. The relative locations of the chambers are not limited to those shown, but can be altered to utilize the effects of the pressure-controlled sequential expansion to first occupy primary spaces desired to be filled to block expansion of the stomach, or to apply pressure to the stomach, with subsequently expanding chambers expanding to provide supplemental space filling/pressure in adjacent areas. An operator could choose only to inflate chamber10c1 by inflating to a pressure less than that at which thevalve38 between chambers10c1 and10c2 opens at. InFIG. 7A, expandable member has been inflated to a pressure greater than the pressure at whichvalve38 separating chambers10c1 and10c2 opens at. Therefore, both chambers10c1 and10c2 have been inflated. This may provide sufficient restriction/compression for some patients, or for initial treatment of a patient. In some cases, even inflation of only chamber10c1 may be sufficient for early treatment or for patient's having a relatively small rib cage, for example. After progress in losing weight has been made over time, or for patients with a larger rib cage, for example, the operator may want to increase the size and/or length ofexpandable member10em(in the example shown, both are accomplished). By inputting more gas throughconduit12 to establish a higher pressure to meet or exceed the pressure at which valve38 (positioned between chambers10c2 and10c3) opens,valve38 is force open, thereby inflating chamber10c3, as illustrated inFIG. 7B. Chamber10c4 can be inflated by increasing the pressure still further to open thevalve38 between chambers10c3 and10c4, as illustrated inFIG. 7C.
• Any inflatableexpandable member10emdescribed herein, whether inflatable by gas, liquid or some combination thereof may be provided with a safety valve. Thus, for example,FIG. 8A illustrates each ofexpandable members10em₁and10em₂being provided with asafety valve40.Safety valve40 may be a flapper valve or other type of pressure release valve that opens when a predetermined pressure has been exceeded. Thus,safety valve40 prevents overpressurization/overfilling of the expandable member that it is installed in.Safety valve40 can be particularly valuable if the patient that the expandable member is implanted in is subjected to trauma (e.g., automobile accident, fall or other sudden impact that would spike the pressure in the expandable member and possibly cause catastrophic failure), or, in the case of an expandable member inflated with gas, in situations such as cabin depressurization in an aircraft, etc. When pressure within the expandable member has returned below the predetermined pressure (through escape of gas and or fluid from the safety valve40) safety valve closes again, thereby retaining the remaining gas and/or fluid.
• FIG. 8B illustrates an alternative embodiment, in whichsafety valve40 is in fluid communication with a reserveexpandable member10emr. In this case, if the patient is exposed to any of the conditions described above (which may also include simply moving from a low altitude location, e.g., sea level, to a location high in the mountains, for example) or any condition that would causeexpandable member10emto significantly expand, thereby causing the compliant material that it is made of to become more porous resulting in leakage of gas therethrough, the rise in relative pressure that would ordinarily cause such an expansion instead openssafety valve40 and gas passes therethrough and into reserveexpandable member10emrthat is formed of a noncompliant material. Reserveexpandable member10emris shown in an expanded configuration in phantom lines inFIG. 8B. The noncompliant material of reserveexpandable member10emrprevent gas loss, and the gas in reserveexpandable member10emrcan then be recaptured intoexpandable member10emwhen the patient has returned to the “normal” altitude from where he started, or once the traumatic event has ended.
• FIGS. 9A-9C illustrate anexpandable member10emthat includes excess material for additional expansion capacitance, whether inflated by gas or liquid or some combination thereof.Expandable member10emcan be made from any of the materials and by any of the techniques described previously. In this embodiment,excess material42 is provided, such as in the form of pleats, folds, corrugations, or the like, and this portion of the expandable member does not expand upon initial expansion of the expandable member. That is, at a first pressure P1, at which theexpandable member10emis inflated (seeFIG. 9A), theexcess material42 remains in its compact configuration. At a somewhat higher pressure P2>P1, the excess material begins expanding, seeFIG. 9B. The amount of this expansion can be varied by varying the inflation pressure, so as to control the amount of additional expansion ofexpandable member10emvia expansion ofexcess material42.FIG. 9C showsexpansion member10emfully expanded, such as when a pressure P3>P2 or pressure higher than P3 has been inputted to expandable member to cause a complete expansion of the excess material. The folds of theexcess material42 may be thicker and/or less compliant than the material that makes up the rest of theexpandable member10emin order to provide the additional resistance to expansion. Alternatively, or additionally, the folds of the excess material may be partially and temporarily fixed together, such as by partial thermal bonding or other mechanism of adhesion, for example.
• FIGS. 10A-10F illustrate anexpandable member10emthat is formed from a linear string of multipleexpandable cells46, that can be inserted into the patient one at a time, thereby minimizing the inside diameter requirement of an introducer used to deliver theexpandable cells46.Cells46 may all be inflated together, substantially simultaneously. Alternatively, valves may be provided between the cells so that they can be sequentially, individually inflated. Further alternatively, the valves may allow sequential inflation, all at the same time with a single inflation step, but prevent loss of inflation media once it has entered the cells. Accordingly, if one cell fails and deflates, the remainder of thecells46 remain fully inflated. Accordingly, this embodiment lends itself very well to percutaneous implantation procedures. Of course this embodiment could also be implanted using laparoscopic procedures or open surgical procedures, but it provides a particular advantage for use in percutaneous delivery, as noted. Typically thecells46 are inflated after delivery into the abdominal cavity. However, thecells46 may alternatively be inflated while outside of the patient's body and then inserted into the abdominal cavity.
• Cells46 ofexpandable member10emare connected in fluid communication with one another viaconduits12 that connectadjacent cells46.Conduits12 are flexible, so that the string or chain ofcells46 can be readily deformed and manipulated to assume a variety of shapes. One ormore anchoring tabs48 are provided extending from eachcell46, but not in fluid communication with thecell48, so that thesetabs48 can be sutured through, tacked or stapled without losing pressure from thecell46.
• FIG. 10B illustrates acartridge50 thatexpandable member10emcan be delivered from during a percutaneous implantation, to delivercells46 into a patient's abdominal cavity. Thecells46 and interconnectingconduits12 that form the long string of the expandable member are rolled or bunched up inside ofcartridge50 for subsequent one at a time delivery ofcells46 into the patient's anatomy.FIG. 10C shows anintroducer52 that is configured to receivecartridge50 and advance the string ofcells46 one at a time therefrom for delivery thereof, as described below. After insertion ofcartridge50 intointroducer52, as indicated by the arrow betweenFIGS. 10B and 10C, and formation of a small percutaneous opening into a patient's abdominal cavity (e.g., less than about 7 cm or less than about 6 cm or less than about 5 cm or less than about 4 cm or less than about 3 cm), the distal end ofintroducer50 is inserted into the abdominal cavity and located adjacent a target surgical site where it is desired to fill space to restrict the expansion capacity of the stomach and/or to apply compression to the stomach, as schematically illustrated inFIG. 10D. Note thatexpandable member10emhas been arranged in the introducer so that the distalmost tab48 extends distally of the distal end ofintroducer52.
• Upon positioning the distal end ofintroducer52 at the target location, the distalmost tab48 can then be fixed to anchor the distal most cell in a desired location. Anchoring can be performed by stapling, tacking or suturing, for example, and can be to any structure adjacent thestomach120, but typically not to thestomach120 itself. Typically,cells46 will be stapled viatabs48 to at least one of thediaphragm116 and anteriorabdominal wall127. With this initial fixation, the first (i.e., distal-most)cell46 can be driven out ofintroducer50, such as by actuation of actuator54, for example. Alternatively, actuator54 may be configured to install staples, tacks or sutures throughtabs48, andcells46 may be removed from introducer, by retracting the introducer proximally to draw the fixedcell46 out of the distal end of the introducer, seeFIG. 20E.Cells46 can be inflated individually after stapling or other fixation, or may all be inflated after finishing of the installation of allcells46 to be used, or may be inflated prior to installing. The introducer can then be advanced distally again to the target location to anchor the next inline cell46. This process can be repeated until asmany cells46 have been anchored as necessary to fill the desired volume of space, as illustrated atFIG. 10F. The cartridge ofcells46 does not have to be used entirely, as the surgeon can sever a link betweenadjacent cells46 so as to tailor the number ofcells46 used in a particular procedure. The severed proximal end can then be caped or sewn shut (after any further inflation performed, if necessary), or connected in fluid communication with anaccess port80. When cells are provided with valves, as described above, no further inflation should be necessary after severing.Introducer52 is then removed from the port and the port is closed, leaving a custom designed, custom-shapedexpandable member10emin place, with the shape and volume being determined by the placement of thecells46 and the number ofcells46 placed.
Implantation
• As noted above,device10 can be implanted so that, whenexpandable member10emis expanded to an expanded configuration,expandable member10emcan apply compression to thestomach120 wall, or optionally only abut or lie adjacent to thepre-prandial stomach120 wall, without imparting any significant deformation forces thereto. However, when the patient eats and the stomach begins to fill,expandable member10emin either case prevents thestomach120 from expanding into the volume occupied byexpandable member10em. Thus, either the stomach is initially “deformed” bydevice10, or thestomach120 becomes “deformed” as it attempts to expand and can only expand in a limited fashion, if at all, around a portion of the perimeter ofexpandable member10em. In either case, thestomach120 is prevented from expanding to the extent that was possible prior to implantation ofdevice10.
• Thus, upon expanding the one or more expandable members, thedevice10 expands in the space(s) normally occupied by thestomach120 as thestomach120 expands when receiving food. Thusdevice10 exerts pressure on, or at least prevents expansion of the fundus and optionally, the antrum and/or portions of the stomach intermediate the fundus and antrum.
• As noted above, anexpandable device10 can be implanted adjacent a surface of the stomach wall, either in contact therewith or at a predetermined distance therefrom, to prevent expansion of thestomach120 into a volume occupied by theexpandable device10.Device10 can be inserted, in a contracted or compressed configuration, so as to minimize the cross-sectional area of the device as it passes, through the skin of a patient, through the abdominal wall of the patient and into the abdominal cavity. This delivery may be accomplished percutaneously or laparoscopically, for example. Once in the abdominal cavity,device10 is positioned in a space adjacent thestomach120, so as to fill the space and not compress the pre-prandial stomach, or alternatively to additionally provide some compression of the pre-prandial stomach, when expandable member(s) is/are expanded. As mentioned previously this positioning is to orient the device to generally follow the contours of thestomach120 and surrounding organs, as the shape ofdevice10 is designed for the same.
• Once properly positioned,expandable member10emis expanded, either by inflation or mechanical means, or both, to occupy the desired space in the abdominal cavity.FIGS. 3C and 3D illustrate examples ofdevices10 as properly positioned and in expanded configurations. Thus, expansion of at least one expandable member accomplishes at least one of: prevention of expansion of thestomach120 of the patient into the space occupied by expandeddevice10; and compression of a portion of thestomach120 by expandeddevice10.Device10 may be anchored to one or more structures in the abdominal cavity. For example,FIG. 1130 illustrates adevice10 having been inserted into the abdominal cavity in a manner as described, andexpandable member10emhaving been inflated. Any of thedevices10/expandable members10emdescribed herein may be provided with one ormore anchoring tabs150 attached thereto. In the example shown inFIG. 1130, anchoringtabs150 have been bonded to the surface ofexpandable member10em, such as with a silicone room temperature vulcanizing (RTV) adhesive, for example.Tabs150 may also have material thereon that encourages tissue ingrowth to provide permanent fixation oftabs150 to the anteriorabdominal wall127 or other interior abdominal structure, to fortify the fixation provided by staples, sutures, tacks or the like. Alternatively, asingle tab150 can be placed aroundexpandable member10emto extend from and cover all of the areas covered by the threetabs150 shown inFIG. 11. It would be readily apparent to those of ordinary skill in the art that other combinations of number of and shapes oftabs150 could be substituted.
• Tabs150 are anchored to a structure (other than the stomach) in the abdominal cavity to maintain the desired positioning and orientation ofdevice10 relative to thestomach120. InFIG. 1130,tabs150 have been attached to theabdominal wall127 via sutures, staples, tacks or the like154 to fixtabs150 with respect to theabdominal wall127.Port90 is shown anchored to the opposite (external) side of theabdominal wall127.
• Further, additionally or alternatively, aportion156 of the surface ofexpandable member10emthat does not come into contact withstomach120 can be roughened or provided with some porosity (wherein the porosity does not extend all the way through the wall of theexpandable member10em) to promote adhesion and/or tissue ingrowth for anchoringdevice10.
• FIGS. 12A-12K illustrate steps that may be carried out during a procedure for percutaneously implanting an expandableextra-gastric device10 according to an embodiment of the present invention. Prior to making an incision, the local area (the area of the skin in and surrounding the location where the incision is to be made) may be prepared by disinfecting with alcohol and or betadine. Additionally, the patient may be given a mild sedative or may be on conscious sedation. Though not preferred, the procedure can also be carried out under general anesthesia.
• Next a powerful local anesthetic such as marcaine (bupivicaine) or other powerful anesthetic, optionally mixed with an epinephrine or other vasoconstrictor to reduce any bleeding that might result from mild trauma can be injected into the local area through theskin125 of the patient1 down to the muscular layer and to infiltrate the fat layer and entire local area (the anesthetic portion of the mixture may not be needed if the procedure is performed under general anesthesia). Injection may be performed using asyringe219, as illustrated inFIG. 12A, or other injection tool. After allowing time for the injected anesthesia to take effect, asmall incision223 is made in theskin125 of the patient1, with ascalpel229 or other surgical cutting tool, in the local area over the surgical target area wheredevice10 is to be implanted. Optionally, in the example shown, theincision223 is made slightly inferior to the lower rib line114 (FIG. 12A shows a frontal schematic view of the abdominal portion of the patient1). Alternatively, a needle (e.g., veress needle501) can be inserted, without the need to make theincision223, as illustrated inFIG. 12L. A conventional veress needle does not have a lumen for a guidewire. By adding a small sheath outside the shaft of the veress needle apparatus, a modified veress needle is created such that aguidewire502 can be easily introduced through the sheath.FIG. 12L further illustrate that the location of insertion in well below the xiphoid, to the left of midline, near the palpated edge of the costal cartilages. It is noted that in the alternative method illustrated inFIG. 12A, thatincision223 can also be made in this location.
• FIG. 12B shows an access sheath orcannula535 being inserted to guide delivery and placement ofdevice10 and anchoring during later steps of the procedure described below. A trocar536 (shown in phantom lines inFIG. 12B) may optionally be inserted along with insertion of sheath/cannula535 in order to facilitate formation of a pathway into which sheath/cannula535 is inserted, and then removed from the sheath prior to insertion of any other objects such asdevice10, instruments, etc. Insertion of the sheath/cannula535 can be performed without any additional visualization provided (i.e., just by eyesight), or may be guided by use of an endoscope537 (shown in phantom lines) and/or with fluoroscopic visualization. Ifendoscope537 is used,trocar536 is removed after partial insertion of sheath/cannula535 and then endoscope is inserted through sheath/cannula535 to guide the remaining insertion to be performed, and particularly, the final placement of sheath/cannula535.
• Once sheath/cannula535 has been properly placed to the satisfaction of the surgeon (e.g., in one example, sheath/cannula535 is inserted into a region about three to four inches below the level of the inferior border of theliver121 at or immediately to the right of midline) the same anesthetic or mixture of anesthetics used to numb the incision site prior to making theinitial incision223 can be injected into the abdomen through cannula/sheath535 to numb the site interiorly of the abdominal wall.
• Next, as shown inFIG. 12C, aguidewire502 is inserted through cannula/sheath535.Guidewire502 may be inserted under fluoroscopic visualization, 3-D RF or electromagnetic visualization (e.g., using preexisting or real-time data sets from MRI, cat scan, three-dimensional ultrasound, or other three-dimensional data set, etc.) or blindly to pass around thestomach120 so that it rides against thediaphragm116 and is thereby guided along thediaphragm116 until reaching or closely approaching thespleen128. Alternatively, a rod may be inserted instead ofguidewire502, wherein the rod is stiffer thanguidewire502 and/or have variable regions of stiffness or flexibility greater than those ofguidewire502. Additionally, the rod may have a lager cross-sectional area thanguidewire502 and optionally may have one or more lumens therethrough for delivery of suction, irrigation, injection of other fluids, injection of medicaments, etc. The rod may be inserted in similar manner to guidewire502 by may be less likely to kink. The rod may be pre-shaped to more rigidly define a course of travel ofdevice10 that it guides, relative to use of theguidewire502, which is typically flexible. Optionally, a flexible endoscope can be inserted through cannula/sheath535 to visualize guidewire orrod502 and confirm that it has been properly placed.
• Once properly placed, ananchoring frame600 and an anchoringframe delivery tool630 on whichanchoring frame600 is mounted (in a manner as described in greater detail below) are advanced overguidewire502 and into sheath/cannula535 (seeFIG. 12D) after which anchoringframe delivery tool630 is operated to deliver anchoringframe600 into the target position along the abdominal wall, where it is anchored there. Prior to anchoring, the surgeon will check to ensure that no bowel, omentum or other tissue is located between the anchoringframe600/tool630 and theabdominal wall127. After anchoring theanchoring frame600 to theabdominal wall127, anchoring frame delivery tool is then removed from sheath/cannula535 and offguidewire502.FIG. 12E illustrates a sectional view of the patient1 (viewed from the feet of the patient) that shows the anchoring of anchoringframe600 to theabdominal wall127, with the anchoringframe delivery tool630 having been removed.FIG. 12F is a schematic illustration from a frontal view perspective, like those ofFIGS. 12A-12D, showing theanchoring frame600 anchored in place against theabdominal wall127, as also shown in the sectional view ofFIG. 12E.
• Once anchoring frame has been anchored to the target location, as illustrated inFIGS. 12E and 12F, a device deployment tool660 having already been preloaded with adevice10 in a collapsed or compressed configuration, is next advanced over theguidewire502 and over anchoringframe600 in a manner described in greater detail below. Positioning of thedevice10 can be monitored during this delivery using fluoroscopy, X-ray, CT or MRI visualization guidance, for example, or simply via direct visualization with an endoscope, such as a flexible endoscope inserted through sheath/cannula535, for example. Alternatively an endoscope may be inserted into device deployment tool660 or other tool to perform such viewing, or an endoscope can be inserted through an additional opening through the patient accessing the abdominal cavity.Device10 is advanced to the end of anchoring frame where it automatically locks into position there.FIG. 12G shows a sectional illustration ofdevice10 having been locked into position on anchoringframe600, with device delivery tool660 having been removed.
• At this stage, when the surgeon is satisfied thatdevice10 has been properly positioned and locked to anchoringframe600, cannula/sheath535 and guidewire502 are both removed. Fordevices10 that include one or more inflatableexpandable members10em, at least oneconduit12 will remain extending fromdevice10, proximally out through theincision223 having been made in the patient. The one ormore conduits12 can then be used to inflate the one or more expandable members. For devices that do not include an inflatableexpandable member10em, aconduit12 is not necessarily required, although there may be one present, depending upon the type of mechanically expandable member(s) that is/are used. For example, a conduit may be provided to insert a wire therethrough to mechanically expand theexpandable member10em. Otherwise, if aconduit12 is not included, then the one or more expandable members are expanded in a manner as has already been described.
• Getting back todevices10 having at least one inflatable expandable member, one or moreexpandable members10emmay be inflated at this stage to test the amount of displacement and positioning of the device when in an expanded configuration, which may help to determine whetherdevice10 will perform as intended. One method of testing in this manner is with the use of an intra-gastric sizing device310 (e.g. an intra-gastric balloon catheter) in a manner as described in application Ser. No. 11/407,701. Additionally, or alternatively, testing may be performed by visually observing the effects of expansion, such as by inputting radiopaque fluid into thestomach120, and/or by observing the expansion of the device when it is provided with one or more radiopaque indicators, as has already been described previously. Visualization, in such instances may be performed fluoroscopically or with other X-ray visualization, for example.
• FIG. 12H illustrates expansion of a firstexpandable member10em₁using pressurized gas, for example. At this time, an intra-gastric sizing device may optionally be already in position, and typically is placed and inflated to the desired size prior to expandingexpandable member10em₁. For devices having only oneexpandable member10em, expansion of this expandable member would then be performed to accomplish the desired amount of space restriction as indicated by feedback from intra-gastric sizing device130, for example. In the example shown, where two expandable members are provided,expandable member10em₁is typically inflated to a predetermined pressure where it has been determined that the expandable member has not expanded or stretched to a degree where the leakage rate of gas through the member is unacceptable. Typically, a maximum pressure will have been predetermined where the leakage rate is not excessive, andexpandable member10em₁will not be expanded by a pressure that is greater than this maximum pressure. If the resulting degree of expansion ofexpandable member10em₁does not provide sufficient displacement, then the second expandable member is expanded, such as by inputting pressurized liquid intoexpandable member10em₂, to expand it until sufficient displacement has been achieved, such as confirmed by visualization and/or feedback from intra-gastric sizing device, for example, seeFIG. 12I.
• At this time,conduits12₁,12₂can be either clamped off to maintain the pressures withinexpandable members10em₁,10em₂, or the pressures can be released, thereby allowingexpandable members10em₁,10em₂. It is easier procedurally to release the pressures and so this is typically done. However, the surgeon may choose to clamp off the conduits to maintain at least partial pressures in the expandable members to ensure that they maintain the observed positions. In any case, conduit(s)12 are next trimmed to an appropriate length for connection with anadjustment member80, as illustrated inFIG. 12J.
• Conduit(s)12 are then connected to a mating connector onadjustment member80 or to adeployment tool370 configured to mateconduit12 withadjustment member80, and, after connection ofconduit12 toadjustment member80, adjustmentmember deployment tool370 is then used to anchoradjustment member80 to the patient. By advancingdeployment tool370 into the patient, the portion of conduit that had extended from the patient1 is pushed back into the patient, until the adjustment member is positioned in the target location where it is intended to be anchored. This positioning can be verified using any of the previously described visualization techniques, or can be performed blindly, with feedback from palpitation, for example. In the example shown inFIG. 12K,adjustment member80 is anchored subcutaneously, to the external surface of theabdominal wall127. As has been disclosed previously,adjustment member80 can alternatively be anchored subcutaneously, to an inner layer of the skin for example, or otherwise in thefat layer131 without being anchored directly to theabdominal wall127. Onceadjustment member80 has been anchored in the desired location,deployment tool370 is withdrawn and the one or more expandable members are reinflated, if they had been previously deflated, or topped off, if theconduits12 were clamped to maintain some pressure, to return the one or more expandable members to their desired sizes. In this way, the patient can begin to experience beneficial weight loss from the effects ofdevice10 on thestomach120 beginning immediately after completion of the procedure, unlike current procedures, which typically require around six weeks before a return visit to “complete” the procedure to make it effective in helping weight loss. The same type or types of monitoring can be used here, as described above with regard toFIGS. 12H-12I, to provide feedback as to when the one or more expandable members have been expanded by the desired amount. Alternatively, one or more of the one or more expandable members may be left in an unexpanded configuration, with the patient being allowed to heal and then return to have the expandable members(s) inflated. Further alternatively,device10 may be implanted in combination with a constricting band, such as the LapBand™ or similar implant to improve results from such constricting band, or to make weight loss efficacious where prior implantation of such a constricting band has not been efficacious. For example, a constricting band generally useful for restricting the amount of solid food ingested by the patient1. However, a patient1 may “cheat” the effectiveness of a constricting band approach by drinking high caloric liquids, for example. For example, a patient could drink a thirty-two ounce milkshake and this would pass right through the constriction established by the constricting band. However, withdevice10 implanted and expanded as described, the stomach is preventing from expanding, even by high caloric liquids.
• Once the surgeon is satisfied that the expandable member(s) have been expanded by the desired amount, or if the expandable members(s) are to be left in a contracted (unexpanded or partially expanded) state, the patient is closed, including, suturing theskin125 at the site of theincision223.
• FIGS. 12L-12N illustrate variations in the percutaneous procedure described above that can be alternatively performed. As already noted above,FIG. 12L schematically illustrates percutaneous insertion of a guidewire through aneedle501, wherein the incision and sheath insertion steps ofFIG. 12A-12B need not be carried out.FIG. 12M illustrates the insertion ofguidewire502 to follow the contour of the caudal surface of the diaphragm as it is pushed up and around thestomach120, as far as the spleen, like described inFIG. 12C above. The distal end ofguidewire502 may be provided in a “J” shape or other bent shape to make it more atraumatic.
• Once theguidewire502 has been placed as desired,needle501 is pulled off ofguidewire502 and removed. A port535 (similar to a laparoscopic port or other access sheath orcannula535 is then inserted through the opening made byneedle501, as illustrated inFIG. 12N. Installation of anchoringframe600,device10 andaccess member80 may then be performed as described above with regard toFIGS. 12D-12K. In another variation regarding expandingexpandable members10em, for adevice10 having two expandable members,expandable member10em₁may be expanded with gas after theaccess member80 is installed/anchored, andexpandable member10em₂may be expanded with fluid, after completion of the procedure and some passage of time (e.g., during a follow-up visit).
• Any of the variations of the procedure described above may be executed under fluoroscopic visualization, 3-dimensional navigation or other CT/MRI guidance. Further alternatively, any of these procedures may be performed as mini laparoscopic procedures (e.g., where the entire abdominal space is not insufflated, but only a small portion is and general anesthesia is not used; or where at least one of the steps involving insertion into the abdominal cavity is performed without direct visualization provided by an endoscope, for example. Anchoring of anchoringframe600 may be performed as a separate step of the procedure, as shown and described above, or, alternatively, may be combined with thedevice10 insertion and positioning part of the procedure, wherein the act of sliding thedevice10 over the anchoring frame drives the anchoring of theanchoring frame600 at the same time thatdevice10 is positioned (slid) thereon. All tools referenced in the above procedure may include lumens to permit insertion of other tools and/or devices therethrough, including, but not limited to: endoscopes, wires, etc. and/or to allow delivery of suction, irrigation, and/or other substances. Alternatively to mounting theadjustment member80 toconduit12 in any of the manners described above, adjustment member may be pre-attached or integral withconduit12. As already noted previously,device10 may include one or more chambers (expandable members) and may also contain fluids, gases, structural members, foams and/or other space occupying materials.
• Referring toFIGS. 13A-13D, an embodiment of ananchoring frame600 is illustrated that can be used for anchoring adevice10 in the abdominal space, such as, but not limited to the manner described above with regard toFIGS. 12A-12K, for example.FIG. 13A illustrates a perspective view of anchoring frame in an undeployed configuration, i.e., when anchors102 have not been deployed to anchor the anchoring frame. In the undeployed configuration, anchoringframe600 has acontact surface604 that is configured, shaped and dimensioned to conform to a tissue surface in the abdominal cavity to which theanchoring frame600 is to be anchored.Openings606 are provided that extend from an inner surface of anchoring frame, through the wall on which thecontact surface604 is formed, and through thecontact surface604.Openings606 are arranged for delivery of anchors602 therethrough and are thus aligned with anchors602 as will be described in greater detail below. Although shown as substantially straight, anchoring frame andcontact surface604 may have a curvature that is formed to follow the general contour of the structure in the abdominal cavity that it is to be anchored to. Thus, for example, for anchoring to theabdominal wall127 in the procedure describe above, anchoringframe600 andcontact surface604 are curved to conform to the contour of theabdominal wall127 just below thediaphragm116. Thus, the curvature (or straightness) of theanchoring frame600 andcontact surface604 is dictated by the contour of the tissue surface that it is intended to be anchored to. Thus, anchoringframe600 can be substantially rigid and shaped with a predefined curvature (or shape) ofcontact surface604 to match that of the tissue surface that it is to be anchored to. Alternatively, and preferably, anchoring frame may be flexible, so that when compressive forces are applied to it, by applying a force distally to the proximal end of anchoringframe600, such as with anchoringframe deployment tool630, for example, while the distal end of anchoring frame is fixed, such as by being abutted up against a ball end of a guidewire, for example, the compressive force causes theframe600 andcontact surface604 to bend and thereby abut against the surface of the tissue to be anchored to.Frame600 andsurface604 may be structurally biased so as to be predisposed to bending in one direction away from the longitudinal axis of theframe600, as opposed to bending in the opposite direction, to ensure that the contact surface bows out in the direction where it will contact the tissue structure to which it is to be anchored.
• Within thechannel608 are positioned a series ofanchors610 such as staples, tacks, spikes or other sharpened mechanical member configured to be driven into the tissue and to maintain anchoring within the tissue after piercing it. The staples of other sharpened mechanical members are positioned inframe600 in small channels and are completely retracted so as not to extend throughsurface604 asframe600 is being delivered into the abdominal cavity. Adeployment member612 is provided within anchoringframe600 that is configured for deploying the anchors.Deployment member612 includes anenlarged driver613 located distally ofanchors10, and a cable orwire614 that extends proximally fromdrive613 and out the proximal end of anchoringframe600. Cable/wire614 has sufficient length so that when anchoring frame is placed in position on the target area in the abdominal cavity to which it is to be anchored, the proximal end portion of cable/wire614 still extends out of the patient1 (such as out of theincision223 in the procedure described above, for example).
• Whenframe600 is positioned in the abdominal cavity at the target location where it is to be anchored, e.g., against the abdominal wall,frame600 is held motionless against the target area while deployment member is retracted proximally. Ifframe600 is a flexible frame, constant pressure is exerted in a distal direction against the frame to ensure that it remains buckled/bent against the target area, so that it conforms to and contacts the target surface (e.g., abdominal wall). By pulling on cable/wire614 while holdingframe600 substantially motionless,deployment driver613 is retracted proximally throughchannel608, as illustrated inFIG. 13C. As it is retracted,driver613 contacts anchors610 driving them out throughopenings606 and into the tissue, thereby anchoringframe600 to the tissue as desired. Upon completely withdrawingdeployment member614/driver613, andopen channel608 is then provided for guiding one or more keys provided on adevice10 that are slidable in channel and are configured to be prevented from pulling through the slot at the bottom of thechannel608.
• To further enhance anchoring offrame600, all of a portion ofsurface604 may be covered with aningrowth layer616, such as a fabric layer (e.g., polyethylene terepthalate or other porous, biocompatible fabric) or other porous layer configured to encourage tissue ingrowth.
• FIG. 14A illustrates an example of adevice10 provided withkeys618 configured to slide withinchannel608 while being prevented from sliding out throughslot608s. Thus,keys608 are generally matching to the cross-sectional configuration ofchannel608, while each having aneck portion618nof narrower dimension that is configured to slide withinslot608s.FIG. 14B shows an end view ofkey618 inserted intochannel608 offrame600. Alternatively, key618 need not have a cross sectional shape that matches the cross-sectional shape ofchannel608, as long as the enlarged portion ofkey618 is too large to pass through slot618s, yet small enough to slide withinchannel608, andneck618nis of small enough dimension to slight throughslot608s.FIG. 14C shows an example of a key618 wherein the enlarged portion is spherically shaped.Keys618 are not limited to the shapes described but can take on virtually any cross-sectional shape, as long as the requirements in size described above are met, relative to cooperating withchannel608 and slot608s. Of course, some cross-sectional shapes are more advantageous than others with regard to functionality, such as minimizing resistance/friction between thekeys618 andchannel608 asdevice10 is deployed overframe600.
• The number ofkeys618 attached todevice10 is also variable and may vary from one up to several dozen. Lengths of the keys (relative to the longitudinal axis of frame600) can also be a variety of sizes, up to and including, a continuous key that extends over the full length ofchannel608.FIG. 14D illustrates thedevice10 ofFIG. 14A having been mounted on anchoringframe600 ofFIGS. 13A-13D. Of course, during the insertion ofdevice10 into the abdominal cavity target area,device10 will typically be in a compact, collapsed configuration to minimize its size during the delivery and as it is mounted on anchoringframe600. An exception may be in a situation wheredevice10 is implanted using an open procedure.
• FIG. 15A illustrates another embodiment of ananchoring frame600 that employs a rail configuration for receiving a device thereover. Anchoringframe600 is constructed similarly to any of the variations described above with regard toframe600 inFIGS. 13A-13D, including thecontact surface604,optional ingrowth layer616, anchors610, andopenings606.Frame600 is installable over a removable wire, such asguidewire502, for example, with the wire being removable after completion of the procedure. In this arrangement, however, rather than having achannel608 to slidably receive one ormore keys618, rail orbeam618 functions as a key with respect to a channel or groove608 formed indevice10 that slides over rail orbeam618. As with thekeys618 ondevice10, the rail orbeam618 need not be T-shaped in cross-section, as shown inFIG. 15A, as long as the enlarged portion ofrail618 is too large to pass throughslot608sin thechannel608 ofdevice10, yet small enough to slide withinchannel608, andneck618nis of small enough dimension to slide throughslot608s. Likewise channel608 need not be T-shaped in cross section, but may have some other cross-section shape that forms an enlarged portion to slide withinchannel608 and is impassable throughslot608s, and aneck portion618nthat is slidable withinslot608s.
• In order to deployanchors610 into the tissue to anchor theanchoring frame600 ofFIG. 15A,deployment member612 in this case is provided to slide overrail618 as illustrated in the end view ofFIG. 15B (anchors610 are not shown, for simplicity of illustration, since the mechanism for driving theanchors610 bydriver613 is the same as that described with regard toFIG. 13B above).Deployment member612 includes anenlarged driver613 that is located in the channels formed on both sides of neck616nthat is located distally ofanchors610, prior to deployment, and a cable orwire614 that extends proximally fromdriver613 and out the proximal end of anchoringframe600. Cable/wire614 has sufficient length so that when anchoring frame is placed in position on the target area in the abdominal cavity to which it is to be anchored, the proximal end portion of cable/wire614 still extends out of the patient1 (such as out of theincision223 in the procedure described above, for example).
• Whenframe600 is positioned in the abdominal cavity at the target location where it is to be anchored, e.g., against the abdominal wall,frame600 is held motionless against the target area while deployment member is retracted proximally. Ifframe600 is a flexible frame, constant pressure is exerted in a distal direction against the frame to ensure that it remains buckled/bent against the target area, so that it conforms to and contacts the target surface (e.g., abdominal wall). By pulling on cable/wire614 while holdingframe600 substantially motionless,deployment driver613 is retracted proximally to slide alongrail618. As it is retracted,driver613 contacts anchors610 on both sides ofneck618n, thereby driving them out throughopenings606 and into the tissue, thereby anchoringframe600 to the tissue as desired. Upon completely withdrawingdeployment member614/driver613, rail is then unobscured bydriver613, so that thechannel608 ofdevice10 can be slid thereover.
• FIG. 15C shows an end view ofdevice10 having one configuration (T-shaped cross-section) ofchannel608 configured to slide overrail618 to securedevice10 to anchoringframe600.FIG. 15D showsdevice10 ofFIG. 15C having been mounted on anchoringframe600 ofFIGS. 15A-15B. Note thatchannel608 can extend over a length ofdevice10 that is much greater than the length offrame600, to provide guidance of delivery of the distal end of the device, even though the distal end ofdevice10 is not engaged withframe600 whendevice10 has been installed in the intended position as shown inFIG. 15D.
• FIG. 15E is a schematic, sectional illustration (viewed from the foot of the patient with the patient lying on his back) ofdevice10 anchored to theabdominal wall127 via anchoringframe600, withdevice10 shown in an expanded configuration.
• FIG. 16A illustrates an embodiment of ananchoring frame600 that includes an actuation mechanism that can be use to anchor theframe600 to tissue (deploy) as well as to release theframe600 from such anchoring. In this case,deployment member612 is provided in achannel608 above arail618 that is configured to receivedevice10 thereover, anddeployment member612 is configured to not only anchor theframe600 to a tissue surface, but is also operable to reverse this anchoring, so as to allow removal or repositioning and re-anchoring offrame600. Thus, the enlarged members ordrivers613 ofdeployment member612 include deployment driver surfaces613aand retraction driver surfaces613bas illustrated inFIG. 16A. Upon slidingdeployment member612 relative to frame600 in a direction to contact deployment driver surfaces613awith anchors610 (i.e., to the left, as shown inFIG. 16A) and continuing to slidedeployment member612 in that direction, deployment driver surfaces613adrive anchors to rotate so as to extend the sharp (distal) ends of anchors out ofopenings606, as illustrated inFIG. 16B. Deployment driver surfaces613aare abrupt or steep and may even be formed as substantially perpendicular to the longitudinal axis offrame600. Retraction driver surfaces613bare ramped or cammed so as to allow the rotation of the opposite (proximal) ends down intochannel608 without contactingdeployment member612 during deployment of the distal ends.
• Thus,FIG. 16B illustratesanchors610 in the deployed configuration, wherein, whencontact surface604 is contacted to a tissue surface and anchors610 are deployed in this manner, this anchorsframe600 to the tissue. Should the operator wish to remove anchoringframe600, or reposition it,deployment member612 is slid in the opposite direction relative to frame600 (i.e., to the right inFIG. 16B). This causes retraction driver surfaces to contact the proximal ends610pofanchors610, and continued movement ofdeployment member612 causes drivers613pto reverse rotateanchors610 to the positions shown inFIG. 16A. These deployment and retraction functions are repeatable. That is, after retracting theanchors610 as described, anchoring frame can be repositioned on a tissue surface, anddeployment member612 can be actuated again to deployanchors610 and thereby anchor theframe600 to the new location.
• FIG. 16C illustrates atool625 configured to engage withdeployment member612 and anchoringframe600 and, when engaged, can be used to move, orient and position anchoring frame, as well as operatedeployment member612 to deployanchors610 and/or retractanchors610.Tool625 includes anelongated shaft627 having sufficient length so that whentool625 is engaged withanchoring frame600 anddeployment member612 in a manner as described hereafter, a proximal end portion oftool625, including actuators to be manipulated by a surgeon or other user, extend out of the body of the patient1, even whenframe600 has been inserted into the abdominal cavity as far as it needs to be advanced to anchor it at a desired location. The distal end oftool625 includes aquick release mechanism628 configured to engage with engagement features615 on a proximal end portion of anchoringframe600. For example,quick release mechanism628 may include a plurality of hooks orteeth628hthat engage with engagement features615 provided as mating or interengaging hooks to teeth. The hooks orteeth628hcan be drawn toward one another, radially inwardly, such as by rotation ofquick release actuator629, for example, so that they no longer engage withengagement members615, but can be slid therepast, quickly releasingtool625 from anchoringframe600.
• Acam driver629 is formed at a distal end of a cam driver shaft629dthat is axially drivable with respect toshaft627 by pivotingcam driver actuator631 relative toshaft627. Aslidable safety lock633 may be provided onshaft627 that is slidable in a first direction to prevent pivoting ofactuator631 relative toshaft627, thereby preventing inadvertent deployment or retraction ofanchors610 whencam driver629 oftool625 is engaged withdeployment member612, such as by engagement with camdriver engagement member612c, for example. By slidingsafety lock633 in the opposite direction, this unlocksactuator631 and the operator can then eitherpivot actuator631 towardshaft627 to drivedeployment member612 to deployanchors610, orpivot actuator631 away fromshaft627 to retract anchors into anchoringframe600. Upon quick release oftool625 fromframe600 as described,cam driver629 can be released from camdrive engagement member612cby simply rotatingtool625 about its longitudinal axis so thatcam driver629 andengagement member612cbecome misaligned.
• FIG. 17 illustrates an anchoringframe deployment tool630 that can be used for percutaneous delivery of anchoringframe600.Tool630 includes ahandle632 for manual operation by a user (e.g., surgeon) and an elongated,rigid shaft634 extending distally therefrom. Anengagement feature636 is provided onshaft636 for engaging with anchoring frame and securing it during the delivery thereof. For example, engagement feature may be a rail, e.g., a t-shaped rail or other cross sectional configuration that slides within a channel inframe600, somewhat like a tongue-and-groove fitting, or may include a channel that slides over a rail portion offrame600, etc. Anactuator638 is provided onhandle632 that is actuatable to trigger staples or othermechanical members610 to be driven through the openings inframe600 to extend through thesurface604 and into the target internal abdominal structure (e.g., abdominal wall) toanchor frame600 thereto. One or more lumens may be provided throughshaft634 for delivery of irrigating fluids (or other substances) and for application of suction to the distal end ofshaft634, viaports640 and642, respectively.
• FIG. 18A illustrates another embodiment of an anchoringframe deployment tool630 that is configured to receive anendoscope537 therein to facilitate viewing of the placement of anchoringframe600. A video camera538 may be provided onendoscope537 so as to monitor the visualization on a screen, or, optionally, viewing may be performed directly through an ocular.
• Shaft634 articulates, via one or more articulatingjoints644. Anarticulation actuator646 is provided on ornear handle630 for operation by a user to control the articulation of adistal portion634dofshaft634 with respect to aproximal portion634pofshaft634. In the example shown,articulation actuator646 is a rotatable wheel that is rotatable in a first direction to articulatedistal portion634din a first angular direction about joint644, while rotation ofactuator646 in the opposite direction articulatesdistal portion634din the opposite direction.Articulation actuator646 and/or articulation joint644 provide frictional resistance, so that whenactuator646 is not being rotated,distal portion634dis maintained in its orientation relative toproximal portion634p.
• A window oropening648 is provided proximally of articulating joint644 to enable viewing through the distal end ofendoscope537 that is positioned inshaft634 at the location of opening/window648 whenendoscope537 is inserted intotool630. Window/opening648 may be an opening (e.g., cutout), or may be a window, e.g., a cutout that is sealed over with a transparent material.
• Distal portion634dincludes a recess orcavity650 configured to receive anchoringframe600 therein. Thus, recess orcavity650 is shaped and dimensioned to receive anchoringframe600 therein and to confine anchoringframe600 from movements axially with respect to the longitudinal axis ofdistal portion634d.Frame600 may be received in recess, cavity or slot650 by friction fit and/or a releasable clamping mechanism (not shown, see co-pending application Ser. No. (application Ser. No. not yet assigned, Attorney's Docket No. EXPL-001CIP3,FIGS. 36A-36D and description thereof)) may be optionally provided on opposite sides of slot, recess orcavity650 for releasably clampingframe600 wherein it is received therein, with clamping and releasing motions being controlled by a clamp actuator (not shown, see co-pending application Ser. No. (application Ser. No. not yet assigned, Attorney's Docket No. EXPL-001CIP3,FIGS. 36A-36D and description thereof)). Application Ser. No. (application Ser. No. not yet assigned, Attorney's Docket No. EXPL-001CIP3) is hereby incorporated herein, in its entirety, by reference thereto.FIG. 18B shows an enlarged partial view ofshaft634 with anchoringframe600 mounted withindistal end portion634d, and showing the distal end ofendoscope537 withinproximal end portion634p.
• In use, after insertion and placement ofguidewire502, such as in a percutaneous procedure as described above,deployment tool630 is passed overguidewire502, with the proximal end of guidewire first being inserted into the distal end ofshaft634, throughshaft634 and handle632 and proximally out ofhandle632, as illustrated inFIG. 18A. By insertion oftool630 into the abdominal cavity, the abdominal wall (e.g., the anterior abdominal wall can be directly visualized byendoscope537/camera538 viewing through opening/window648. This visualization is performed to ensure that that is no tissue located between the anchoring site (e.g., anterior abdominal wall127) and anchoringframe600 prior to anchoring theframe600 to the anchoring site. Once it has been visually confirmed that there is no tissue intervening betweenframe600 and the anchoring site,actuator646 is manipulated to rotatedistal portion634dup against the anchoring site, thereby contactingsurface604 to the anchoring site.Anchors610 are then deployed into the anchoring site, such as by a mechanism described above for example. In an alternative embodiment, needles and sutures may be substituted foranchors610, such as described in application Ser. No. (application Ser. No. not yet assigned, Attorney's Docket No. EXPL-001CIP3,FIG. 36C and description thereof). Adeployment actuator652, such as a trigger, lever or other equivalent mechanical actuator can be provided onhandle632 for operation by the user. Thus when actuator652 (FIG. 18A) is actuated, this retractsenlarged member613 to driveanchors610 into the tissue, thereby anchoring theframe600. Deployment actuator may be provided with a safety mechanism or lock654 that can be locked up until the time that the operator is ready to deploy theanchors610, to prevent inadvertent deployment ofanchors610 before theframe600 has been properly positioned and is ready to be anchored.
• Whendevice10 has been fully inserted into its intended position relative to anchoringframe600, device is locked into this position byautomatic lock620.FIGS. 19A-19B show one embodiment of anautomatic lock620 that may be provided on the proximal end offrame600 on the underside of the top portion oftrack618.FIGS. 19A and 19B show partial views of anchoringframe600 withanchors610 not being shown for simplicity of illustration. InFIG. 19A, locks620 are shown deployed. Locks220 may be spring steel or some other biased members that are biased toward the deployed configuration shown inFIG. 19A, while being deformable so as to lie substantially parallel or flush with the underside. Thus, when thechannel608 rides over theenlarged portion618 at the bottom of the rail, in this case in a tongue and groove type of interfit, the top surfaces on opposite sides ofslot608 contact theundersurface618uof the top portion of theframe600 and are guide therealong. As the top surfaces ride overautomatic locks620, they depress them towards the undersurface so that the device is able to slide along the rail. Once theentire channel608 ofdevice10 has passed locks620 (distally thereof), locks resiliently spring back into the conformation shown inFIG. 19A, thereby preventingdevice10 from being retracted proximally back off offrame600. Detents and/or other stopping structure (not shown) are provided at the distal end portion of theframe600 to preventchannel608 from being slid too far distally with respect to anchoringframe600/enlarged portion618.
• Prior to anchoring theframe600 to the desired target tissue, automatic locks are held recessed (in an unlocked configuration) against theundersurface618. This is necessary to allow the retraction of theenlarged member613 ofdeployment member612 during deployment ofanchors610. For example,lock prevention tabs622 may be inserted inslots624 to maintain a biasing force onlocks620 to keep them in the unlocked configuration.Tabs622 may be integrated, such as to form a U-shaped member like shown inFIG. 19B and a wire orsuture626 extends proximally therefrom and has a length sufficient to extend out of the patient1, even whenframe600 is located in its intended anchoring position. Afterenlarged member613 has been retracted throughframe600 to driveanchors610 into the target tissue, in a manner as already described above, anddeployment member612/enlarged member613 has been removed from anchoringframe600, the operator pulls on wire/suture626, thereby slidingtabs622 out of their respective positions and removingtabs622form anchoring frame600. Upon this removal, locks620 resiliently spring back into the locked configuration shown inFIG. 19A.
• FIG. 20A shows an anchoringframe unlocking tool670, that can be used to unlock the anchoring frame tofree device10 that has been automatically locked into position along anchoringframe600. For example, it may be difficult to removeframe600 if tissue has ingrown into tissue ingrowth surfaces provided onsurface604, so this removal mechanism makes it much easier to remove the expandable member(s)10emfor replacement, or withdrawal if no longer indicated.Tool670 includes a handle672, andelongated shaft674 and alock depressor676 at the distal end ofshaft674.Lock depressor676 is configured to be mounted and slide overrail618 and includesdepressor portions676dthat extend above the portion that fits overrail618 and that press againstautomatic locks620 to depress them to the unlocked configuration asdepressor676 is slid over therail618.FIG. 20B shows an end view oftool670 that illustrates a configuration of alock depressor676 according to one embodiment. Optionally, an actuator678 may be provided to actuate the depressor portions form a retracted configuration to the extended configuration shown inFIG. 20B.
• FIG. 20C schematically illustrates use oftool670 to unlockdevice10 from anchoringframe600 so thatdevice10 can be removed from the site.Tool670 is inserted (e.g., throughincision233 in the percutaneous procedures described above, or along any other approach provided by other procedures, such as mini-laparoscopic, laparoscopic, open, etc.) andlock depressor676 is mounted overrail618.Tool670 is then distally advanced overrail618. Aslock depressor676 advances distally, it depresses theautomatic locks620, as shown. Upon full depression oflocks620, or simply by distally advancingtool670 untillock depressor676 contacts the proximal end ofchannel608 of thedevice10,device10 is now ready to be removed off offrame600. By applying retraction force toconduit12,channel608 slides proximally overchannel618, thereby withdrawingdevice10 andtool670 together.Tool670 may be operated to maintain contact with the proximal end ofchannel608 to ensure thatlocks620 remain unlocked aschannel608 is withdrawn thereover. In an alternate method, locks620 may be formed with thin enough material so that an impulsive tug onconduit12 is sufficient to bendlocks620 over backwards to allow channel608 (and thus device10) to be withdrawn off offrame600.
• As noted above,device10 is provided in a compact (non-expanded) configuration during delivery, at least when delivering by a percutaneous, mini-laparoscopic or laparoscopic procedure.FIG. 21A illustrates an embodiment ofdevice10 provided with loopedtabs682, with one set682aextending lengthwise (e.g. relatively aligned along channel608) on one side ofexpandable member10em, and an alternating set608bon the opposite side of theexpandable member10em. With expandable member in a deflated configuration, expandable member can be rolled in the direction indicated by arrows inFIG. 21A about its longitudinal axis, so that theexpandable member10emis rolled up on itself to form a compact structure resembling a cylinder. Once rolled up into this configuration, loopedtabs682aand682balign with each other and a rod orwire684 can be inserted through the loops of loopedtabs682a,682bto maintaindevice10 in the rolled up configuration, as shown inFIG. 21B. It is noted thatchannel608 is still exposed on an external surface of the device even when in the rolled up condition, so that it can be mounted and slid overrail618 during the delivery ofdevice10. Oncedevice10 has been positioned overframe600/rail618 in the desired location,wire684, which has sufficient length to extend out of the patient even whendevice10 is mounted in the intended position onframe600, can be withdrawn by an operator, thereby freeing the expandable member. Upon inputting of gas and/or liquid toexpandable member10em, it unfurls and assumes its expanded configuration. Although devices that are attached by ananchoring frame600 typically will not require further anchoring, it is noted that such procedures are not limited to anchoring using only the anchoring frame, as any of the other attachment or anchoring techniques and features may optionally be used in addition to anchoring with ananchoring frame600. In this regard, it is noted that loopedtabs682 may be used as attachment areas, e.g., through which sutures, staples or tacks, etc. may be driven to further attachdevice10 to the patient. Still further, whether or not used to attachdevice10, looped tabs also provide convenient and safe areas for manipulation by the use of tools, such as graspers, etc. It is further noted that this type of compaction feature can be provided for devices that are not attached to ananchoring frame600, but are attached by other means described herein, or are attached only by attachingtabs682 to tissues within the patient.
• Alternatively, anexpandable compaction member686 may be provided to surround and compactexpandable member10emfor delivery thereof as illustrated inFIGS. 21C-21D. For example,expandable compaction member686 may be a thermoformed balloon that is formed to roll up when inflated, but can be opened up or spread apart or held open in a relatively flattened out configuration in its non-expanded (deflated) state as illustrated inFIG. 21C. This open configuration allows a rolled up or otherwise compressed expandable member to be placed onexpandable compaction member686.Expandable compaction member686 is then inflated/expanded viaconduit686i, whereupon it assumes it rolled-up configuration, thereby substantially surrounding the compactedexpandable member10emas illustrated in the end view ofFIG. 21D. In this configuration, theexpandable member10emandcompaction member686 are deliverable into the abdominal cavity for location at the intended surgical target site.
• Once in the intended surgical target site, i.e., in the location where it is desired to expand theexpandable member10em,compaction member686 may then be deflated and then withdrawn from its encapsulation ofexpandable member10emand from the abdominal cavity. Optionally, expandable member may first be attached to a rail or to some other fixation point to prevent it from being withdrawn ascompaction member686 is withdrawn. After removal ofcompaction member686,expandable member10emcan be expanded in the course of a procedure as described with regard to any of the embodiments described herein or in any of the disclosures for which priority has been relied upon.
• FIG. 21E illustrates another embodiment in which arigid exoskeleton688 is provided to receiveexpandable member10emand maintain it in a compressed or otherwise non-expanded configuration for delivery into the surgical target area. For example, exoskeleton may be in the form of a rigid canister as illustrated inFIG. 21E, that functions similar to a film canister for 35 mm film. That is,expandable member10emcan be rolled up or otherwise inserted intocanister688 to be retained therein in a non-expanded state. Typically, at least an edge of theexpandable member10emwill be left slightly protruding from the opening or slot688sprovided inexoskeleton688. In the example shown inFIG. 21E, the edge ofexpandable member10emprotruding from opening688sincludestabs682, loopedtabs682aor other features for engaging with a rail or other anchored structure in theabdominal cavity682. In the case of loopedtabs682, of other feature for engaging a rail or other fixed structure, these features can be looped over or otherwise engage with the fixed structure in the abdominal cavity when the exoskeleton containing the compressed or otherwise non-expanded expandable member is inserted into the surgical target location in the abdominal cavity. Upon fixing the loopedtabs682aor other feature to the rail or other fixed structure,expandable member10emcan then be extracted fromexoskeleton688 by rotatingexoskeleton688 in a rotational direction opposite to the direction of the arrows shown inFIG. 21E. This causes extraction of theexpandable member10emout of theexoskeleton688 as illustrated by the directional arrows shown inFIG. 21E. Rotation can be effected by a rod orwire689 that is fixed to a proximal end portion ofexoskeleton688 and which may be rigid or flexible, but is torsionally rigid in either case. Alternatively,rigid exoskeleton688 can be retracted in a linear direction opposite the directional arrows shown inFIG. 21E. This motion, applied against the force provided by the fixation ofexpandable member10emrelative to at least one fixed structure in the abdominal cavity, cause extraction ofexpandable member10emout ofrigid exoskeleton688 asrigid exoskeleton688 moves away from the fixed/anchored portion ofexpandable member10em.
• Iftabs682 are provided on the edge ofexpandable member10em, one or more oftabs682 may be temporarily or permanently anchored to a structure in the abdominal cavity, e.g., by suturing, stapling, tacking and/or adhesives or other alternative fixing members or substances, and then an unrolling motion like that described above can be carried out to extract theexpandable member10em. Alternatively, or if no additional features are present on the edge of theexpandable member10em, one ormore tabs682 or the edge of theexpandable member10emcan be grasped, by graspers, or other long slender tool and then exoskeleton688 can be rotated as described. In any of the procedures described above, onceexpandable member10emhas been completely extracted fromexoskeleton688,exoskeleton688 is withdrawn out of the patient to provide working space for continuing procedures to implantdevice10.
• FIG. 21F shows still another alternative configuration for placingexpandable member10emin a compacted or collapsed configuration for delivery into the abdominal cavity to the surgical target area. In this example, expandable member is folded into an accordion-fold configuration so that the expandable member is folded over on itself along folds687, similar to the way that a bicycle tube is packaged for sale. In this folded configuration,expandable member10emcan be received in anexoskeleton688 such as described above, or can be delivered via a sheath, for example. Additionally or alternatively,expandable member10emcan be temporarily retained in the folded configuration by attaching the adjacent pleats or folds together using weak adhesive bonds that are broken whenexpandable member10emis expanded, by the force of the inflation fluid pressure, for example.
• In another embodiment,expandable member10emmay be compressed in acapsule692 that is formed of a water soluble gel orskin692sas illustrated inFIG. 21G. In this case, the compressedexpandable member10emis inserted into the abdominal cavity and to the surgical target area location whilesoluble skin692smaintainsexpandable member10emcompacted. Ascapsule692 enters the aqueous environment of the abdominal cavity,skin692sbegins to dissolve. After a predetermined amount of time in the aqueous environment of the abdominal cavity,skin692 has dissolved by a sufficient amount such that the input of expansion media intoexpandable member10emcausesexpandable member10emto expand with sufficient force to rupturecapsule692 if is has not dissolved to the extent where it has ruptured simply by dissolution. In either case,capsule692 can be retracted out of the patient, using graspers, for example, but need not be, as it will completely dissolve with the passage of additional time.
• FIG. 21H illustrates an embodiment having a flexible,expandable exoskeleton694. In this example,expandable member10emis surrounded byexpandable exoskeleton694, which may be a pleated silicone capsule (or balloon), for example, or partially slitted silicone capsule or balloon, or may have either of these structures and be formed from polyurethane or other biocompatible elastomer, for example.Exoskeleton694 is formed so that it maintains the compacted configuration shown inFIG. 21H as long asexpandable member10emdoes not contain an expansion medium or fluid. After placement of theexoskeleton694 containingexpandable member10emat the desired surgical target site,exoskeleton694 is inflated by inputting expansion medium (e.g., gas or liquid) through a lumen inconduit12, and expansion medium is inputted through another lumen inconduit12 causing expansion ofexpandable member10em. Alternatively, expansion medium inputted throughconduit12 toexpandable member10emcan expand bothexpandable member10emandexoskeleton694 simultaneously, with the pleats or slits assisting the expansion.Exoskeleton694 may be provided with one ormore tabs682 that can be used to anchor theexoskeleton694 in the expanded configuration, and this may also help to maintainexpandable member10emin the desired expanded volume, asexoskeleton694 supports some of the load applied todevice10 caused by expansion of the device against the structures in the abdominal cavity.
• FIGS. 21I-21J illustrate anexpandable member10emthat is formed in an elongated tube configuration. This tube formation allowsexpandable member10emto be linearly deployed through a small opening in a patient (or alternatively, may be used in an open surgical procedure).Tabs682 are provided at spaced locations along the elongated tube, and act as fixation or anchoring points along theexpandable member10em. Thus, portions of theexpandable member10emcan be anchored as they are inserted into and arrive at the surgical target area, such as by stapling, suturing, tacking, etc.,tabs682 to fixed structures within the abdominal cavity. In this way, elongated member can be laid out and fixed at the surgical target array in an almost infinite number of different configurations that are customizable according to the way that the user bends and fixes the portions of the expandable member. In the example shown inFIG. 21J, expandable member has been fixed in a serpentine configuration, but this embodiment in is in no way limited to this configuration, as a coiled configuration could be provided, or groups or bunches of portions could be configured, or many other customizable configuration can be fixed, including a more or less random distribution of the portions fixed to structures in the abdominal cavity.
• FIG. 21K illustrates an alternative to the use oftabs682 in the embodiment ofFIGS. 21I-21J. In this case, aflange682F is provided along one or more continuous lengths ofexpandable member10em, up to the full length of theexpandable member10em, to increase the flexibility of the choice of fixation points, since stapling, tacking or suturing can be performed anywhere along the one ormore flanges682F. It is noted that this alternative feature is not limited to the elongated tubular form of an expandable member, as one ormore flanges682 may be provided along any of theexpandable members10emdescribed herein.
• In another embodiment,device10 is compacted and maintained in a compact configuration by insertion within asheath690 as illustrated inFIG. 22A.Sheath690 does not completely encircleexpandable member10em, but includes a slit through which a rail or channel connected toexpandable member10em, and which is to be connected to frame600, is exposed.Device10 can be compacted into a compressed form using any of a variety of techniques, including, but not limited to: rolling (like described above, but wherein loopedtabs682 are not required), accordion folding (like a bicycle inner tube when it is first purchased), tongue rolled (described in further detail below), randomly compressed by drawing and maintaining a vacuum on expandable member(s)10em, or other folding and compressing.
• FIG. 22B illustrates anexpandable member10emofdevice10 being deployed via anintroducer696 having a splittable introducer housing at a distal end portion thereof. In the example shown, the distal end portion of introducer is split into two portions orjaws696J that are pivotably mounted for rotation with respect to the remainder of theintroducer696, for example, via pivot joint696P. However, it is noted that the distal end portion may be splittable into three or more component jaws696P, as this embodiment is not limited to splitting using only two jaws696P. It is further noted thatjaws696J do not have to form equal portions of the distal end ofintroducer696 as shown.FIG. 22B showsexpandable member10emin a substantially flattened, non-expanded configuration, prior to further compacting it by rolling, accordion-folding, or otherwise further compacting theexpandable member10em/device10 to be received in thesplittable jaws696J ofintroducer696, that form a housing for the compactedexpandable member10emfor delivery into the abdominal cavity. A structure referred to as a “doghouse” surrounds theconduit12 where it connects toexpandable member10emand may form a socket into whichconduit12 is received. In any case, the doghouse strengthens the joint betweenconduit12 andexpandable member10em, to minimize risk of failure at the joint. The doghouse may be made from the same material asconduit12 and/orexpandable member10em.Conduit12 extends trough the tube of theintroducer696 and out of a proximal end portion thereof whendevice10 is loaded in theintroducer696.
• FIG. 22C illustrates the compacted device10 (includingexpandable member10em) having been received in theintroducer696, with thesplittable jaws696J having been closed around the compactedexpandable member10emto maintain it in a compact configuration as it is delivered throughopening223 and through an opening formed in theabdominal muscle127 for a percutaneous implantation procedure.
• Oncejaws696J have completely passed through the opening in theabdominal muscle127 and have been placed in the abdominal cavity in the vicinity of the desired location for placement ofexpandable member10em,jaws696J are opened by manipulation oftethers696T extending throughintroducer696 and out of a proximal end thereof for manipulation by a user.Tethers696T, although provided as a pair of tethers at the proximal end of theintroducer696 and connected at the distal ends to a rod orroller697 around whichexpandable member10emhas been rolled up in this example. Alternatively, tethers696T can be formed as onecontinuous tether696T having two proximal ends extending out of the proximal end portion ofintroducer696 and around whichexpandable member10emis rolled or folded at a distal end portion thereof. Upon applying tension totethers696T when the operator/user pulls on the proximal end portions oftethers696T extending proximally fromintroducer696 while maintaining theintroducer696 in a fixed position relative to theabdominal muscle696, this rotates the compactedexpandable member10em(androller697, when present) as illustrated inFIG. 22D, thereby also openingjaws696J. Alternatively,jaws696J may operate like laparoscopic graspers to open and close and are therefore opened first before applying tension ontethers696T to extractdevice10 in a manner described above.
• Whendevice10 has been properly oriented with respect tointroducer696, as illustrated inFIG. 22E, one ormore tabs682 may be fixed to a structure in the abdominal cavity, andexpandable member10emcan then be extracted from its compact configuration, such as by unrolling (in the embodiment shown) unfolding, or otherwise extracting the expandable member from the compact state it assumed to be received in theintroducer696, by withdrawing theintroducer696 as the distal end of expandable member is retained by the fixation. Alternatively, graspers or other instrument may be used to grasp a distal most tab or a distal portion ofexpandable member10emto hold it relatively motionless asintroducer696 is retracted and thus drawn away fromdevice10, thereby extractingexpandable member10em, as the proximal ends ofjaws696 are retracted back into the opening through the abdominal muscle, this closes the jaws, allowing them to be completely removed from the abdominal cavity, takingtethers696T (andoptionally roller697, if present) along with it. It should be noted that althoughdevice10 is shown positioned substantially perpendicular to the longitudinal axis ofintroducer696 as the desired orientation of thedevice10 for extractingexpandable member10em, that this embodiment is not limited to this orientation. For example, a rolled up expandable member, as shown, may be oriented at an acute angle (in either direction) to the perpendicular to the longitudinal axis ofintroducer696, depending upon various factors, such as the available working space, desired final orientation of theexpandable member10em, etc. Also,tabs682,flange682F or other attachment features can be anchored to structures within the abdominal cavity in an incremental fashion, asexpandable member10emcan be incrementally extracted, a portion at a time, with anchoring being performed between incremental extraction steps.
• FIGS. 22F-22H illustrate operation of another delivery tool for use in delivering and facilitation of anchoring ofdevice10 in the abdominal cavity. This tool also advantageously provides the ability to deliverdevice10 by a percutaneous procedure or laparoscopic procedure. Of course, this tool can also be used in open procedures. The tool includes an inner sheath/delivery shaft696iabout whichexpandable member10emcan be rolled. In the example illustrated inFIG. 22G,expandable member10emhas been folded over and then rolled up around the distal end portion of inner sheath/delivery shaft696i. A portion of delivery shaft/inner sheath696iproximal of the portion about whichexpandable member10emis rolled, may be formed in abend696bas shown inFIG. 22G. Inner sheath/delivery shaft696imay be formed to have thebend696bas shown inFIG. 22G, when in an unbiased configuration, but is flexible so that inner sheath/delivery shaft696ican be biased into a substantially straight configuration. Alternatively, bend696bmay be formed as a pivoted or hinged joint, which can be operated upon retraction of outer sheath696otherefrom.
• As shown inFIG. 22F, an outer sheath696ois provided that slides freely overinner sheath696i. After compactingexpandable member10em, such as by rolling it around the distal end portion ofinner sheath696i, the distal end portion ofinner sheath696iis biased to substantially straighteninner sheath696i, and outer sheath696ois slid distally over inner sheath6961 to cover theexpandable member10emand maintain it in a compact or compressed configuration as shown inFIG. 22F. The tool anddevice10 as shown inFIG. 22F are then ready for use. The distalend containing device10/expandable member10emis inserted into the abdominal cavity, such as by delivery though a percutaneous or laparoscopic opening, for example. One in the vicinity of the intended implantation site (surgical target location), outer sheath696ocan be retracted relative toinner sheath696i. As outer sheath696ois retracted to the extent that bend696bis no longer covered,inner sheath696ireturns to its unbiased, bent configuration, as illustrated inFIG. 22G. At this time, the distal end portion ofexpandable member10em, and typically at least one attachment tab682 (orattachment flange682F, as shown inFIG. 22G) are presented and the distal end portion ofexpandable member10emcan be sutured, stapled, tacked, etc. to an internal structure in the abdominal cavity. By incrementally retractinginner sheath696i, incremental portions ofexpandable member10emcan be extracted (e.g., unrolled and/or unfolded) with fixation of these portions being accomplished between the incremental extraction steps. Alternatively,expandable member10emcan be nearly fully extracted or fully extracted after just the first fixation of the distal end portion has been accomplished, or even without any anchoring oftabs682/682F if the surgeon desired to just grasp the distal end portion ofexpandable member10emwith graspers or other temporary fixation tool asinner sheath696iis retracted.FIG. 22H illustrates the expandable member when is has been almost completely extracted.
• FIGS. 22I-22K illustrate operation of another delivery tool for use in delivering and facilitation of anchoring ofdevice10 in the abdominal cavity. This tool also advantageously provides the ability to deliverdevice10 by a percutaneous procedure or laparoscopic procedure. Of course, this tool can also be used in open procedures. The tool in this embodiment includes an introducer that comprises a rigid, closed-ended (at the proximal end) sheath ortube696 that houses theexpandable member10emduring delivery thereof, as illustrated inFIG. 22K. Anattachment tab682 or other distal portion ofexpandable member10emmay be left extending distally fromsheath696 afterexpandable member10emis loaded intosheath696 for delivery thereof, as shown inFIG. 22K. This facilitates grasping of the distal portion and/or anchoring thereof to a structure in the abdominal cavity, as described below.
• Expandable member10em, in a non-expanded or deflated state is substantially flattened and then rolled from both side edges (FIG. 22I) toward a central axis, to form what is referred to as a “tongue-roll” configuration, as illustrated inFIG. 22J. By rolling upexpandable member10emfrom both side edges, this avoid twisting oflumen12 which is located substantially in alignment with the central axis ofexpandable member10emin this case. The tongue-rolledexpandable member10emis then inserted into the open distal end ofintroducer696 and slid into thesheath696 of the introducer until configured as shown inFIG. 22K. In the example shown,lumen12 is short and does not extend much (if at all) past the edge ofexpandable member10em. In cases wherelumen12 is longer,lumen12 can extend alongside the tongue-rolledexpandable member10emto extend out of the distal end opening ofsheath696 and then bend back to run along the length ofintroducer sheath696 so that a proximal end oflumen12 extends out of the body with the proximal end ofsheath696 as expandable member is placed in the abdominal cavity.
• Since the introducer comprises arigid sheath696, it can be used to perform blunt dissection while deliveringexpandable member10emto the intended surgical target location in the abdominal cavity. Once the distal end portion of the introducer/sheath696 that containsexpandable member10emhas been located in the vicinity of the surgical target location, the attachment tab682 (orflange682F) that extends distally of the distal end ofsheath696 can be sutured, stapled, tacked, etc. to an internal structure in the abdominal cavity. By incrementally retractingsheath696, incremental portions ofexpandable member10emcan be extracted (e.g., and unrolled) with fixation of these portions being accomplished between the incremental extraction steps. Alternatively,expandable member10emcan be nearly fully extracted or fully extracted after just the first fixation of the distal end portion has been accomplished, or even without any anchoring oftabs682/682F if the surgeon desires to just grasp the distal end portion ofexpandable member10emwith graspers or other temporary fixation tool assheath696 is retracted.
• FIGS. 22L-22M illustrate another variation of an arrangement for compactingdevice10 and maintaining it the compact configuration for delivery into the abdominal cavity. In another embodiment,device10 is compacted and maintained in a compact configuration by insertion within asheath690 as illustrated inFIG. 22A.Sheath690 does not completely encircleexpandable member10em, but includes a slit through which a rail or channel connected toexpandable member10em, and which is to be connected to frame600, is exposed.Device10 can be compacted into the compressed configuration by rolling it inflexible sheath690. In this case,sheath690 can completely surrounddevice10 when the device is to be anchored usingtabs150. Once rolled up, such as by tongue-rolling or other rolling technique, thesheath690 anddevice10 assembly can be further compacted/compressed by drawing it through afunnel compactor691 as illustrated inFIG. 22M, by pushing and/or pullingassembly690,10 to the left inFIG. 22M and/or pushing or pullingcompactor funnel691 to the right inFIG. 22M. The small opening of thefunnel compactor691 can be made to have an inside diameter of a maximum, predetermined size acceptable for delivery of the assembly through a small opening and into the abdominal cavity.
• Further optionally, an additional sheath orinserter696 can be mounted over the small end ofcompactor funnel691, as illustrated inFIG. 22N, so that the furthercompressed assembly690,10 is loaded into this additional sheath orinserter696. The introducer orsheath696 can then be inserted through a small opening in the skin of the patient and into the abdominal cavity, whereassembly690,10 can be extracted according to any of the techniques described above. Further alternatively,sheath696 may be open ended at both ends, and a pusher rod can be pushed through the proximal end opening of sheath orintroducer696 to drive theassembly690,10 out of the distal end opening. In any of these arrangements, once theassembly690,10 has been extracted, it can be unrolled, anddevice10 can be positioned and anchored according to any of the techniques described herein.Sheath690 is removed from the abdominal cavity and from the patient.
• FIG. 22O shows a further alternative arrangement, in whichsheath690 anddevice10 after rolling and compressing according to the techniques described above with regard toFIGS. 22L-22M, is back-loaded on a steerable,flexible endoscope356. Alternatively,sheath690 anddevice10 can be wrapped and compressed around steerable,flexible endoscope356 to backload theassembly690,10 thereon, without the use ofcompactor funnel691. According to either of these techniques, after making asmall incision223 in the patient, theendoscope356 is advanced through the opening and into the abdominal cavity. Theendoscope356 can be steered during this process to advance thedistal tip790 thereof to a desired location in the abdominal cavity where it is desired to placedevice10. Also, full insufflation of the abdominal cavity is not needed in order to deliverdevice10 by this technique. Once thedistal tip796 ofendoscope356 has been steered and advanced to a desired location in the abdominal cavity,assembly690,10 can then be delivered over the shaft ofendoscope356 and ejected off of the distal end of endoscope.Device10 may be delivered over ananchoring frame600 using this technique, and/or ejected into the abdominal cavity for subsequent positioning and anchoring bytabs150.
• Optionally, as theendoscope356 assembly is being advanced, impulse puffs of pressurized gas can be intermittently applied through the distal end of endoscope356 (or with an additional conduit that delivers these impulses to the location of (or just distal to) the distal end ofendoscope356 to help open a pathway along which it is desired to steer theendoscope356. Further alternatively,device10 can be compacted and back-loaded aroundendoscope356 withoutsheath690.
• Further alternatively and optionally,endoscope356 may be provided with an expandable distal tip/lens790ethat is expandable distally away from and around thedistal end790 of endoscope through which viewing is performed, as illustrated inFIGS. 22P-22Q. Thisexpandable tip790 can be expanded to displace tissue away from viewingend790 to provide a clear view so the that operator can more easily steer the distal end to a desired location. This arrangement does not require the use of “puffs” or impulses of pressurized insufflation gas, or any insufflation whatsoever.FIG. 22Q illustrates expandable tip/lens as an inflatable balloon which is shown in an inflated/expanded configuration.FIG. 22R shows a variant of the tip/lens790ein an expanded configuration, in whichballoon790 is further reinforced bydeployable wires791 that can be extended distally (as shown) and retracted proximally of thedistal end790 when it is desired to have thetip790 in a non-expanded (undeployed) configuration.Wires791 can be biased toward the expanded configuration shown, so that they expand theballoon790ewithout the need to inflation gas or liquid into theballoon790e. Alternatively, balloon70ecan be expanded by both gas or liquid (typically liquid) and the mechanical forces applied by expandingwires791.
• FIG. 22S illustrates an alternative to use of a flexible,steerable endoscope356 inserted and used as a guide rail for delivery of device10 (as well as, optionally, other devices or instruments) thereover and into the abdominal cavity, as described above with regard toFIG. 22O. InFIG. 22S, aflexible wire502ethat is similar in construction to guidewire502, only slightly larger in cross-sectional diameter, includes one or more optical fibers extending the length thereof to facilitate viewing through thedistal end portion502deofwire502e. Accordingly,wire502ecan be inserted in the same manner asguidewire502 and used for the same purposes. However, visualization can be performed as theflexible wire502eis being inserted and advanced, for visual verification that the distal end portion is being delivered to an intended location in the abdominal cavity.
• Optionally,wire502emay include an expandable tip, such as an inflatable balloon, like70edescribe above with regard toFIG. 22Q. This balloon can be expanded to provided an enlarged visual field. By foregoing the steering mechanism of asteerable endoscope356 and guiding thewire502e, assisted by visualization, into the abdominal cavity in a manner as described with regard to insertion ofguidewire502, this allows502eto have a significantly smaller cross sectional area than asteerable endoscope356.
• FIG. 23 illustrates adevice deployment tool700 that can be used to deploydevice10 over anchoringframe600.Tool700 includes ahandle702 for manual operation by a user (e.g., surgeon) and anelongated shaft704 extending distally therefrom.Shaft704 in included a groove or rail that substantially matches a groove or rail offrame600 over whichdevice10 is to be mounted. Accordingly,device10 slides over the groove or rail oftool700 and can be delivered over guidewire orrod502 into alignment with the groove or rail offrame600 wheredevice10 can then be pushed off of shaft (rail or groove)704 and over the rail or groove offrame600 to anchor theexpandable member10emof thedevice10 to frame600. One or more lumens may be provided throughshaft704 for delivery of irrigating fluids (or other substances) and for application of suction to the distal end ofshaft704, viaports640 and642, respectively.
• FIGS. 24A-24C illustrate an accessmember attachment tool730 and use oftool730 for rapid attachment ofaccess member80 to the patient1. Accessmember attachment tool730 includes ahandle732 for handling and control by a user, and a workingend736 at a distal end portion thereof. According to this approach, ananvil738 is slid over conduit(s)12 prior to connectingaccess member80 to the distal end(s) of conduit(s)12. Workingend736 is configured to receivedaccess member80 therein, e.g., working end may include a socket shaped and dimensioned to receiveaccess member80 therein and to maintain the orientation of access member so as to control it during attachment to the patient.
• Anvil738 is first delivered by manipulating (e.g., twisting and pushing) it throughopening223 and through the opening in theabdominal muscle127, as illustrated inFIG. 24B.Distal end736 oftool730 may be inserted into thefat layer131 either before or after manipulatinganvil738 into the desired orientation for use. Once anvil has been inserted through the opening in the abdominal muscle and manipulated to orient theanvil surface738sin contact with theabdominal muscle wall127,tool730 is used to driveaccess member80 againstanvil surface738sas illustrated inFIG. 24C. An inner shaft oftool730 clamps or otherwise engagestubing12 and/oranvil738 and draws them towardportion736 whenactuator744 is actuated.Access member80 includes penetratingmembers740 that extend distally from the contact surface of access member that contacts theabdominal muscle127 as access member is driven againstanvil738. Asaccess member80 is driven againstanvil surface738s, penetratingmembers740 are driven against theanvil surface738sand thereby bent over, as illustrated inFIG. 24C, thereby anchoring access member to the abdominal muscle wall. Driving ofaccess member80 againstanvil738 may be performed by simply pushing withhandle732. Additionally, or alternatively, and further optionally,actuator744 may be operably configured to deploy penetrating members distally from the contact surface ofaccess member80 upon actuation of the actuator.
• Alternative mechanisms may be used for attachment ofaccess member80 to the patient1. For example,FIG. 25A shows use of hook andloop type fasteners746a,746bor other interlocking mechanism used for a quick connect mechanism to attachaccess member80 to theabdominal muscle127 of the patient1. In the example shown, aring747 that contains or is made of one of either hook or loop material (746aor746b, respectively) is stapled or sutured to theabdominal muscle layer127 to surround the opening in the abdominal muscle and conduit(s)12. The contact surface of access member is provided with the other of either the hook or loop material, respectively, such that when access member is pushed againstring747, the interlocking mechanism746 (in this example, hook and loop materials) interlock, thereby attachingaccess member80 to the patient.
• InFIG. 25B,ring747 is provided with one ormore magnets748bhaving polarity on the surface facingaccess member80 that is opposite the polarity of the surfaces ofmagnets748afacingring747.Ring747 may be provided with anchors749 and/or may be sutured, or adhered toabdominal muscle layer127. By pressingaccess member80 against the anchoredring747,connection mechanism748 connectsaccess member80 to the patient1 via the attraction forces ofmagnets748a,748b.
• FIGS. 25C and 25D illustrate undeployed and deployed configurations, respectively, of an access member having deployable anchors750.Anchors750 are extendable, for example, by collapsing external tubing using compression force. By retracting the inner tubing or shaft that is axially positioned insideanchors750 with a distal end connected thereto, this drives anchors750 into the extended configuration shown inFIG. 25D. That is, the functionality is like a moly-bolt.Anchors750 include arms that are hingedly connected and which bend to expand outwardly, as they are compressed by retracting the internal tube.
• FIGS. 25E and 25F illustrate undeployed and deployed configurations, respectively, of an access member having aspring member752 that functions to anchoraccess member80 to the patient1. In the undeployed configuration ofFIG. 25E,spring member752 is wound to as to assume a relatively small outside diameter. This wound configuration can be maintained by asafety lock754 provided in access member that is actuatable between a locked and an unlocked position. After insertingaccess member80 into position with respect to theabdominal muscle wall127, so thatspring member752 passes through the opening in the abdominal muscle and is located inside theabdominal muscle wall127 as illustrated inFIG. 25E,safety lock754 is released, so thatspring member752 unwinds to its deployed configuration, where it has a much larger outside diameter that is too large to pass back through the opening in theabdominal muscle127, seeFIG. 25F.
• FIGS. 25G-25H show an embodiment of access member that is connectable via a snap fit that provides a clamping action betweenbase80bandexternal portion80e.Base80bis provided with a spacer756 having a length about the same as the thickness of theabdominal muscle127. The top portion of tubular spacer is provided with a lip756athat has a outside diameter slightly greater than the inside diameter or the opening758ato socket758.Base80binserted through the opening in the abdominal muscle and oriented so thatcontact surface80sbaligns with the inner wall ofabdominal muscle127 and spacer756 extends out through the opening in theabdominal wall127.External portion80eis then pressed againstbase80bwith tubular spacer756 aligned with socket758, so that lip756asnaps through opening758aand is retained within socket758, thereby connectingaccess member80 to theabdominal wall127.
• Anchoringframe600 may be provided with aninterlock760 on a proximal end portion thereof, as shown inFIG. 25I. In this case, anchoringframe600 is provided with sufficient length to extend to the location against theabdominal wall127 where it is desired to attachaccess member80. Interlock760 may be provided with resilientlydeflectable teeth762 that deform as engagement members764 (FIG. 25J) located onaccess member80 are inserted therethrough. Engagement members may have threading or be otherwise formed to have alternating large and small diameter portions, so that the large diameter portions deflectteeth762, while the small diameter portions allowteeth762 to rebound thereagainst to form a lock relative to the adjacent large diameter portions.
• FIG. 25K shows an embodiment ofaccess member80 that is connectable via anautomatic engagement mechanism763 that functions like a chuck for a pneumatic tool. That is, the base portion that is inserted intra-abdominally includes a socket portion having one or more sets of spring-loaded bearings ordetents765, and the external portion includes a tubular shaft to be inserted into the socket portion and which has one or moreannular recesses767 configured to mate withdetents765. Thus, when the tubular shaft of the external portion is inserted into the socket portion, the outer wall of the tubular shaft depressesdetents765 allowing the tubular shaft to be further inserted. When aligned withannular recesses767, detents resiliently return to their orientations shown inFIG. 25K and are received in recess(es)767, thereby locking the two components ofaccess member80 together on opposite sides of theabdominal muscle127.
• FIGS. 25L-25M show another variation of an air hose type of quick connector. In either this embodiment or the embodiment ofFIG. 25K, the male and female connector parts can be reversed relative to the positions shown. In this embodiment,connector769 may be provided either as a part ofaccess member80, or simply as a connector for anchoringdevice10 to theabdominal wall127 and/or to provide a connection toconduit12 that extends externally of the abdominal wall.Balls765 and groove767 function in the same way as described above with regard toFIG. 25K. However, in this instance,connector769 includes a lockingsleeve771 that slides overballs765 to maintain them in the locked configuration (FIG. 25L). Lockingsleeve771 is retractable, as shown inFIG. 25M to allowballs765 to deflect radially outwardly to allow insertion of the male portion of theconnector769 into the female portion and then slidesleeve771 back overballs765 to lock them in position ingroove767.Sleeve771 may be spring biased toward the closed/locked position, wherein it can be manually retracted to the unlocked position.
• As already noted,device10 may be implanted by a variety of different methods, including percutaneous methods (examples of which have been described in detail above and which typically do not require pressurized insufflation of the entire abdominal cavity, or generalized anesthesia, and one or more steps may be performed without direct visualization), laparoscopic methods (which typically include pressurized insufflation of the entire abdominal cavity and the patient1 under general anesthesia), min-laparoscopic methods and open methods. In addition to anchoringdevice10 via anchoringframe600, or alternative thereto, other anchoring features and/or techniques may be employed. Any of the various features and/or techniques described herein may be used together, or separately, unless it use of one feature or technique would clearly preclude use of another specifically disclosed feature and technique and they would therefore not be useable together.
• One such method of anchoring involves anchoringdevice10 to theabdominal wall127 via tubing extending fromdevice10 and through the abdominal wall. For example,conduit12 may be used to accomplish such anchoring, as illustrated inFIG. 26A. In examples wheredevice10 is implanted an expanded in the space along thediaphragm116 as described above, it has been experienced, that, once expanded,expandable member10emmaintains its position quite well in superior-inferior directions with tendency to move being more likely laterally. By anchoring device10eto the abdominalwall using tubing12, this securesexpandable member10emfrom such lateral movements. Becausedevice10 is less likely to move superiorly or inferiorly, this type of anchoring may be sufficient in itself for implantation ofdevice10. An advantage of anchoring only by this technique is that no suturing or stapling inside the abdominal cavity is required. InFIG. 26A, alock nut766 is threaded overtubing12 to secureexpandable member10emin contact with the innerabdominal wall127.Lock nut766 may include a contact surface covered with tissue ingrowth material such as Dacron, polyester, or other porous material designed to encourage tissue ingrowth or may be formed entirely of a tissue ingrowth material. Further optionally,access member80 may be configured to function as an anchor to replace the lock nut, whereinaccess member80 can be fixed by any of the features described herein. This method of anchoring assists inpositioning device10 and stabilizing it in its intended position.
• In addition or alternative to providing tissue ingrowth enhancing material on the external side of theabdominal muscle wall127, tissueingrowth enhancing material768 may be provided at the interface betweenexpandable member10emand the inner wall of theabdominal muscle127, as illustrated inFIG. 26B. For example, a disk of tissueingrowth enhancing material768 may be slid overconduit12. Alternatively, one or more attachment tabs including tissueingrowth enhancing material768 may be fixed todevice10, such asexpandable member10em, as described in more detail below. Examples of tissue ingrowth-enhancing materials include, but are not limited to, expanded polytetrafluoroethylene (having an internodal distance typical of those materials used for vascular grafts); mesh materials made of polyester, polypropylene, or the like, typically with pores in the range of about 0.7 mm to about 1.5 mm or about 0.5 mm to about 1.2 mm; polyester having a maximum water permeability of about 1800 to about 4000 ml/cm²/min; or felts made of expanded polytetrafluoroethylene or polyester having a maximum water permeability in the range of about 550 to about 3050 ml/cm²/min.
• In addition or alternative to anchoringdevice10 against an intra-abdominal structure (e.g., abdominal muscle wall or other structure) usingconduit12,device10 may be provided with apositioning member770 that can be used to further position or relocatedevice10 and assist in anchoringdevice10 in such position or location.FIG. 26C illustrates an example of adevice10 including a loop (similar to a belt loop, and which may be made of Dacron-reinforced tubing, for example) shaped positioning member270. When used in a laparoscopic procedure or other procedure using multiple ports through the patient's skin and into the abdominal cavity,device10 can be inserted through a first port. A suture ortether59 can be looped throughpositioning member770 and tied off to form a looped suture ortether59. Then a surgeon or assistant can access the suture ortether59 via an incision adjacent the port through which thedevice10 was inserted, to hook, grasp or otherwise capture suture ortether59 and pull it out through the incision where access was made (FIG. 26D). For example, graspers, an elongated instrument having a hook at a distal end thereof, or other endoscopic instrument may be used to capture suture ortether59 and pull it out of the opening though the patient's skin. This tension exerted on suture ortether59 and pulling of the suture ortether59 out of the patient drawsdevice10 toward the opening through which suture or tether is drawn, thereby drawing an inferior surface ofexpandable member10em1 up against theabdominal wall127 in this example. Alternatively, tension may be applied to the suture ortether59 as it extends from the opening through which thedevice10 was inserted, to draw attachment tab(s)150 up against the abdominal wall for attaching tab(s)150 thereto. For a percutaneous procedure where only a single port is provided for delivery and implantation ofdevice10 an additional puncture can be performed through the patient's skin and into the abdominal cavity, at a location where it is desired to draw suture ortether59 through and to drawdevice10 against an intra-abdominal structure. For example, an elongated needle772 (FIG. 26E) having a hookedslot774 may be used to pierce the patient's skin, access the abdominal cavity, and capture suture ortether59 in hookedslot774.Needle772 can then be retracted out of the patient1 to draw suture ortether59 out of the patient to drawdevice10 against a structure in the abdominal cavity to anchor it there.
• FIG. 26F illustrates a step of attachingattachment tab150 to theabdominal wall127, according to one embodiment using a laparoscopic procedure. In this case, tension is applied to tether/suture59 as it extends through theopening223/port390athat was used to insertdevice10 into the abdominal cavity. As tension is appliedgraspers784 having been inserted throughport390dare used to manipulateattachment tab150 to approximate it to theabdominal wall150 for attachment thereto. Thus, tension may also be applied via thegraspers784. Alaparoscopic stapler786, inserted throughport390bis used to staple attachment tab(s) to theabdominal wall127. Visualization of all operations can be provided viaendoscope356 inserted throughport390c. It is noted that invention is not limited to the locations and number of ports shown, as the locations and numbers may vary. For example, an additional opening may be provided to insert a liver retractor for retraction of the liver during the procedure, such as was described in application Ser. No. 11/407,701 with regard toFIG. 67. Also, the arrangement of the instruments shown may vary depending on need for the steps being performed. As one non-limiting example,stapler786 may be inserted throughport390cwhileendoscope356 is inserted throughport390b. Further alternatively, suture/tether may be drawn through another port, as already noted above. This attachment process can be carried out in addition to fixingdevice10 to ananchoring frame600 according to any of the techniques described above, or alternative to it, where aframe600 is not used.
• Further optionally,device10 may be provided with a plurality ofpositioning members770 such as positioning loops, for example, spaced longitudinally alongdevice10. Two, three, four or moresuch members770 may be provided alongexpandable member10em, for example.FIG. 26G shows an example ofdevice10 having three positioningloops770 longitudinally spaced alongexpandable member10em₁. By providingmultiple positioning members770 that are longitudinally spaced, the same device can be used for patients having different anatomies that may have different positioning requirements for the expandeddevice10 and or may have different volume requirements of a spaced to be filled bydevice10. Depending upon theloop770 selected by the surgeon to be used to position andanchor device10,device10 can be anchored, for example to theabdominal wall127, with more or less of the surface ofexpandable member10em₁drawn up against theabdominal wall127. This in turn varies the angulation and positioning ofdevice10 in the abdominal cavity. Typically, the surgeon will have an idea of which positioningmember770 is to be used for the particular patient thatdevice10 is being implanted in, for example, after studying the anatomy of the patient's abdominal cavity and structures therein, as provided by prior MRI or CT scanning for example. In such case, only onepositioning member770 will have a suture ortether59 looped there around to be used as described above. Alternatively, more than one, up to all of thepositioning members770 may have a suture ortether59 looped there around so that the surgeon can try alternative positioning with more that one positioning member, using one at a time successively and observing (such as by fluoroscopy, for example) the relative positions ofdevice10 resulting from each use of adifferent positing member770. The “best fit” can then be selected and used to complete the anchoring of the device. Prior to that however, the tethers orsutures59 that are not chosen for final use in positioning are cut and removed through the opening that will be used to draw the selected tether or suture therethrough for positioning. Thus, these cut, non-selected tethers orsutures59 are removed from the surgical site prior to use of the selected suture ortether59 to perform attachment/anchoring ofdevice10.
• Still further, positioningmembers770 may be segmented777 to provide multiple positioning features or channels778 within a loop770 (as illustrated inFIG. 26H) ormultiple positioning members770 may be spaced in a direction perpendicular to the longitudinal spacing (as indicated in phantom lines inFIG. 26G) to provide further positioning control choices for orientingdevice10 angularly about a longitudinal axis, as indicated by the direction oforientation adjustment776 inFIG. 26G. The choice of positioningmember770 among the longitudinally spacedmembers770 varies the positioning about a transverse axis of device10 (i.e., axis passing into the page and through the middle ofexpandable member10em₁.
• To facilitate anchoring ofdevice10 after positioning by positioning members,device10 may be provided with one ormore attachment tabs150.FIG. 26F illustrates a singlecontinuous attachment tab150 that extends fromexpandable member10em₁about a circumferentially extending portion of the surface of the inferior portion ofexpandable member10em₁.Attachment tab150 may be bonded to the surface of expandable10em₁, such as with silicone dip layer, for example, or using room temperature vulcanizing silicone adhesive. Alternatively, unvulcanized silicone sheeting can be placed betweentab150 andexpandable member10emand these layers can be vulcanized together using a heated press. Further alternatively, if the materials are made of polyurethane, a solvent bond can be made using a slurry mixture of polyurethane to bond apolyurethane tab150 to a polyurethaneexpandable member10em.
• Alternatively,multiple attachment tabs150 can be placed at locations aroundexpandable member10emto extend from and substantially cover areas covered by a largersingle attachment tab150.FIG. 27A illustrates one such example of adevice10 withmultiple attachment tabs150, in this case, having threeattachment tabs150. By providing multiple attachment tabs, the tabs are more easily able to conform to the structure that they are being attached to, particularly if there is some curvature or other surface shape other than planar in the structure. That is,tabs150 can be overlapped to reduce the overall coverage of the structure to be attached to and this increases the convexity of the attachment surfaces formed bytabs150 to better conform to a concave shape of an internal surface of the structure to be attached to (e.g., abdominal wall), or otherwise change to a surface shape to be conformed to, or spread apart to increase the convexity of the attachment surfaces formed bytabs150, or otherwise change to a surface shape to be conformed to. The overlapping prevents folds or wrinkles that would otherwise occur with asingle tab150 such as like that inFIG. 26F, and the spreading would just not be possible with a single tab like that shown inFIG. 26F. The use of attachment tab(s)150 also gives the surgeon the option to not useaccess member80 and/orconduit12 to perform an anchoring function. This allowsaccess member80 to be placed further away from the ribs, potentially offering the patient less discomfort, and also allowsconduit12 to be placed so that it is not under tension to perform an anchoring function, thereby lessening the mechanical requirements forconduit12.
• Attachment tabs150, although typically located to extend from the inferior portion ofexpandable member10em, need not be so located, but can be placed to extend from any locations ondevice10 orexpandable member10em. As one example,FIG. 26I shows adevice10 having anattachment tab150 extending from a superior portion ofexpandable member10emand anotherattachment tab150 extending from an inferior portion ofexpandable member10em.Tab150 will typically be provided with a tissue ingrowth material, such as any of the examples described above. In at least one embodiment, polyester-reinforced silicone sheeting forms the base structure oftab150 and this is the material that is bonded onto a siliconeexpandable member10em. The tissue ingrowth-enhancing members orpatches152 are then separately bonded onto the base structure. In at least one alternative embodiment, the base structure is made of polyester-reinforced polyurethane sheet, while the tissue ingrowth-enhancing member s orpatches152 can be made of any of the same materials already described above.Tabs150 can withstand a tensile force of at least about three to five pounds, on a suture looped therethrough, without tearing of the base structure or the suture ripping out of the base structure.
• Tabs can be attached to an intra-abdominal structure by stapling, tacking, suturing or the like.FIG. 28 illustrates one configuration ofattachment tab150, wherein themain body portion150aincludes a tissue ingrowth-enhancing material. However, amargin portion150bis provided that connects toexpandable member10emthat is not tissue ingrowth promoting. Accordingly, after anchoringdevice10 viaattachment tab150 to a tissue structure within the abdominal cavity, the anchoring may be further fortified after a healing period by the ingrowth of tissue intomain body150a. However, since no tissue ingrowth occurs atmargin150b,device10 can be more easily removed, if necessary, by cutting through themargin material150b, thereby releasingdevice10 from the anchoredmain body portion150a. Further advantageously,margin portion150bcan be made of clear material so as to also function as a “window” so that the surgeon can view through it while performing the attachment ofmain body150ato ensure that no bowel or other tissue not meant to be anchored to, exists betweenattachment tab150 and the tissue intended to be anchored to, at the time of anchoring. For example,margin portion150bmay be made of silicone or other transparent material that is biocompatible and has sufficient mechanical strength to maintain the attachment/anchoring function.
• FIG. 27B illustrates an example of a device having threeattachment tabs150 extending from the inferior portion ofexpandable member10em, but where thetabs150 are interjoined by margin portions at the side of themain bodies150. The margin portions are separate to allowtabs150 to be overlapped. Additionally,margins150bcompletely surround themain body portions150ain this embodiment. Potential suturing (or stapling, tacking, or the like) locations are indicated by thecircles150sshown on each of themain body portions150a. The circular structure shown centrally located between thetabs150 is another tab that may include tissue ingrowth enhancing material and/or the base structure material oftabs150. A positioning loop may be attached to the center of the circle or pass therethrough and be bonded beneath the circle, and used in a manner as described in application Ser. No. (application Ser. No. not yet assigned, Attorney's Docket No. EXPL-001CIP3, e.g., seeFIGS. 22 and 23 and descriptions thereof). Alternatively or additionally, this circular structure may be a grasping feature for the surgeon to manipulate theexpandable member10emduring the implantation process. In this case, the circular patch is bonded to the expandable member only over a central portion thereof, with a free edge or border that is not bonded, so that it can be grasped by graspers or other instrumentation. Backingstructure10dsmay be made, for example, of a reinforced silicone sheet to help distribute the forces generated on attachment tabs anchored to the intra-abdominal structure, over a large area of theexpandable member10em. Thebacking structure10dsmay be made of multiple layers of reinforced silicone with non-reinforced silicone sheeting at the margins to provide an interface withexpandable member10emthat substantially avoids generation of stress concentrations. Thebacking structure10dsalso provides structural support toexpandable member10em(e.g., to help prevent kinking) and helps define and maintain the expanded shape ofexpandable member10emin the expanded configuration. The substantially oval-shaped patch above the circular one is also a grasping feature.
• FIG. 27C schematically illustrates various features that may be provided for attachment ofdevice10 within the abdominal cavity, any of which may be used individually, or in any combination with any of the other features disclosed. Any individual use or combination of these features may also be used in addition to anchoring with anchoringframe600. “Active attachment” features or methods includes those that involve mechanical or chemical attachment of a portion of the device to the patient, including, but not limited to, sutures, tacks, staples, adhesives, etc. “Passive attachment” features or method refer to configuring a surface to enhance tissue ingrowth therein or to encourage encapsulation, for example. Thus, all or a portion ofexpandable member10em(and/or other component of device10) may be provided with a roughened or “bumpy”surface788, as such surfaces have been shown to encourage encapsulation of an implant. Also,porous surfaces782 may be provided on any portion ofdevice10 that is desired to be anchored, to encourage tissue ingrowth. Thus, for example,attachment tab150 can be used solely as a passive attachment feature when it is not actively stapled, tacked or sutured to the abdominal wall, but is merely placed in apposition thereto, and includes aporous portion782 that allows tissue to grow into it. Alternatively, attachment tab could be completely nonporous, such as made of silicone, and attached only actively, such as by stapling. Further alternatively,attachment tab150 may function for both active and passive attachment when it is stapled, tacked, sutured or adhered to an intra-abdominal structure and also includes a porous portion that encourages tissue ingrowth. Further, any of the other components may include a tissue ingrowth surface on a part or all of such component to provide passive attachment. For passive attachment, a period of about three to about six weeks is generally sufficient to anchor a tissue ingrowth surface of the type described herein, with ingrown tissue. In one experiment a one square inch surface of such material, after three weeks implanted in a dog was found to hold eight pounds of force. The omentum may also be actively attached todevice10 as serve as a buffer betweendevice10 and other organs in the abdomen to reduce irritation.
• Optionally, in order to assist the surgeon in properly orienting attachment tab(s)150 for attachment to the intended intra-abdominal structure, attachment tab(s) may be provided with one or more structural members152 (FIG. 29A) that are deformable, so thatattachment tabs150 can be compacted to a compact configuration for delivery of device percutaneously or laparoscopically, but which resiliently return to their non-compacted shapes when a compacting force is no longer applied toattachment tabs150. For example,structural member152 may be a rib or sheet of shape memory material, such as nickel-titanium alloy or shape memory plastic, or may be made of spring steel (e.g., stainless steel). Alternatively,attachment tabs150 may be inflatable, so that they can be expanded to a preshaped and predetermined orientation to facilitate the surgeon's placement of the attachment tabs against the tissue to be anchored to, and anchoring thetabs150 to the tissue.Inflatable tabs150 can have attachment features such as flanges at the borders thereof that are not inflatable so that sutures, staples, tacks, etc, can be passed therethrough to anchor thetabs150 without deflating them. Theseinflatable tabs150 may also include tissue ingrowth enhancing materials on portions thereof to encourage long term, permanent attachment of the tabs when tissue grows into this material. Ifmultiple attachment tabs150 are provided, as inFIG. 29B, asingle conduit153 may be provided to inflate/expand theattachment tabs150, or multiple conduits may be provided. For example, aconduit153 may be provided for the inferiorly locatedtabs150, another conduit may feed the intermediately locatedtabs153 and a third conduit may connect to the superiorly placedtab150. Further alternatively, eachattachment tab150 may be provided with adedicated conduit153 in fluid communication therewith.
• FIGS. 29C-29E illustrate another variation of a self-expandingattachment tab150. In this case,structural member152 is a self-expanding wire frame configured to conform the attachment tab(s) to the intra-abdominal structure that attachment tab(s)150 is/are intended to be anchored to.FIG. 29C illustratesattachment tab150 in the self-expanded configuration, wherein wire-frame152 is biased toward this configuration.Wire frame152 may be made of spring steel (e.g., stainless steel), nickel-titanium alloy, or shape-memory polymer, for example. The self-expandingwire frame152 may be sandwiched between layers of, or embedded in the material of the attachment tab(s), for example Dacron-reinforced silicone.
• FIG. 29D illustratesattachment tab150 in a compressed configuration in preparation for loading into a sheath and/or insertion of device through a small opening in the patient1.Wire frame152 collapses into the shape shown under compressive forces applied radially inwardly ontab150.FIG. 29E illustratesdevice10 having been inserted into the abdominal cavity, whereuponattachment tab150 expands via the self expansion ofwire frame152 thereby orientingattachment tab150 in approximation with theabdominal wall127 and to conform to the curvature thereof for attachment thereto.Expandable member10emis illustrated in an expanded configuration.
• FIGS. 29F-29G show another example ofdevice10 provided with a self expandingattachment tab150. In this case, self-expandingmember152 includes bands of resilient, self-expanding material such as any of those discussed above with regard towire frame152. Self-expanding member may be sandwiched, or embedded intab150 in a manner as also described previously.FIG. 29F showstab150 fully expanded andexpandable member10emalso in an expanded configuration.FIG. 31G illustrates expandable member in a contracted or deflated configuration.Self expanding member152 in this embodiment is compressed by folding over the bands of the member towardexpandable member10emas shown. Conduit12 (not shown) may pass through a central opening152oofself expanding member152 andtab150.
• FIGS. 29H-29I illustrate another example ofdevice10 provided with a self expandingattachment tab150. In this case, self-expandingmember152 includes folded bands or bows of resilient, self-expanding material, such as any of the previously mentioned materials. Bows are biased toward the folded-over configuration shown inFIG. 29H, where they provide an enlarged radius that preventstab150 from passing back through the opening through which device was delivered into the patient and expandattachment tab150 to conform to theabdominal wall127 for attachment thereto.FIG. 29I showsexpandable member10emin a compressed configuration and self-expanding member also in a compressed configuration, in preparation for delivery ofdevice10 through a small opening in a patient and into the abdominal cavity. In this embodiment,self expanding member152 is compressed by applying tension to the proximal end thereof while holding the distal end relatively motionless, whereby it is pulled in the proximal direction to lengthen the self-expanding member, while straightening the bows and thus greatly reducing the radius ofself expanding member152/attachment tab150. Self-expanding member may be sandwiched, or embedded intab150 in a manner as also described previously.
• Further alternatively, the embodiment shown inFIGS. 29H-29I may be made from straight bands of spring steel or other material described previously and thus be biased toward the smaller radius, collapsed configuration illustrated inFIG. 29I. In this case, the proximal and distal end rings ofstructural member152 are provided with mating interlocking connectors152L1 and152L2, respectively. Thus, after insertion ofdevice10 in the collapsed configuration shown inFIG. 29I, the proximal end connector152L1 is pushed toward the distal end connector152L2 while applying a pulling or tension force to the distal end connector152L2 (for example, by applying tension to conduit12). When connectors152L1,152L2 meet, they interlock, thereby maintaining structural member in the expanded configuration shown inFIG. 29H.FIG. 29J illustrates one example of connectors152L1,152L2, whereby one of the connectors includes resiliently deformable tangs, which are received and locked in the other of the connectors upon joining. Connectors152L1,152L2 are not limited to the type shown inFIG. 29J, but could be alternative types of mechanical connectors, such as arrangements designed to produce a snap fit, as would be readily apparent to those of ordinary skill in the art.
• A portion ofexpandable member10emmay be customized to provide a surface shape that is tailored to better conform to an intra-abdominal structure to be anchored to. For example, for attachment to the inner surface of the anteriorabdominal muscle wall127, theportion10emaof theexpandable member10emthat contacts theabdominal wall127 is provided to have a more flattened surface shape, relative to the contour of the remainder ofexpandable member10em.FIG. 30A illustrates the orientation ofexpandable member10emofdevice10 when implanted in a patient according to one embodiment of the present invention, wherein the hatchedportion10emaofexpandable member10emindicates the portion that contacts theabdominal wall127.Expandable member10emis placed anteriorly of the stomach and is oriented from an inferior and anterior portion against the anteriorabdominal wall127 towards the spine in a posterior direction, and towards the head in the superior direction.FIG. 30B illustrates the more flattened surface conformation ofportion10emarelative to the curvature of the remainder ofexpandable member10em. Locations of optional attachment tab(s)150 are indicated in phantom lines.Portion10emais provided with a matching contour to the contour of theabdominal wall127 in the location where it contacts theabdominal wall127. This matching contour not only facilitates attachment of attachment tab(s)150, but also facilitates proper orientation ofexpandable member10em, even when attachment tab(s) are not used to anchor at this location.
• Alternatively, theportion10emathat provides the surface for conforming to the abdominal structure to be anchored to (e.g., abdominal wall) may be provided on aninflatable member10em₃that is expandable independently ofexpandable member10em(or10em₁or10em₂) as illustrated inFIGS. 31A-31D.FIG. 31A showsinflatable member10em₃in an expanded (inflated) configuration whileexpandable member10emis in a non-expanded or compressed configuration.FIG. 31B showsinflatable member10em₃in an expanded (inflated) configuration andexpandable member10emin an expanded configuration.Separate access members80 may be provided for inputting compressed liquid throughconduits12 and12₃toexpandable members10emand10em₃, respectively, as shown inFIG. 31A. Alternatively,conduits12 and12₃may both be connected to amulti-channel access member80. With bothexpandable members10emand10em₃deflated, the members can be substantially flattened as illustrated inFIG. 31C.Expandable members10emand10em₃can then be tightly rolled about the longitudinal axis ofdevice10, in the direction of the arrow shown inFIG. 31C or direction opposite thereto, to form a compact, rolled device ready for delivery into a patient, seeFIG. 31D.Device10 can be inserted in the arrangement shown, or, optionally, may be encased in a sheath (not shown) for delivery thereof.
• After insertion ofdevice10 though an opening in the patient and into the abdominal cavity,expandable member10em₃can be expanded as shown inFIG. 31A (either before or after securement of the one ormore access members80 to the patient) whereupon surface10emaclosely approximates the inner anteriorabdominal wall127.Surface10emacan then be attached to the abdominal wall by suturing, stapling, tacking, etc. one ormore attachment tabs150 to the abdominal wall.Expandable member10emcan next be expanded to fill the space for restricting expansion of the stomach (and optionally, compressing the stomach), or the patient1 can be closed up and allowed a healing period prior to returning for expansion ofexpandable member10em.
• To assist in orienting attachment tab(s) anddevice10 into an intended location and orientation to be implanted in,conduit12 may be integrated with, or attached toattachment tab150 to extend radially outward along the attachment tab. Sinceconduit12 extends out of the body even afterdevice10 has been inserted into the abdominal cavity, manipulation and positioning ofattachment tab150 can be performed by pulling and/or pushing onconduit12 from a location outside the body.FIG. 32A shows an example of adevice10 having twoexpandable members10em₁,10em₂, wherein a conduit12 (12₁or12₂,12₂in the example shown) for one of theexpandable members10em₁,10em₂, respectively) extends proximally fromexpandable members10em₁,10em₂, such as through an opening inattachment tab150, and a conduit fluidly connected to the other of theexpandable members10em₁,10em₂extends radially outward from the expandable member that it connects with, alongattachment tab150.
• Conduit12 may be sandwiched between layers ofattachment member150 or may be fixed to the surface ofattachment member150 for example, by overlaying banding strips780 and adhering the ends of the banding strips on opposite sides ofconduit12 toattachment tab150, as illustrated inFIG. 32B. For example, banding strips780 may be made of silicone or reinforced silicone (e.g., Dacron reinforced silicone) and may be adhered toattachment tab150 using RTV (room temperature vulcanizing) silicone adhesive. As an alternative to the use of bandingstrips780, abanding sleeve782 may be provided that extends over a majority of the length of the radius (or distance from where attachment tab connects toexpandable member10emto the free edge perimeter) ofattachment tab150, as illustrated inFIG. 32C.Banding sleeve782 may be made of any of the same materials as bandingstrips780 and may be adhered in the same way.
• In use,device10 may be inserted through a smallpercutaneous opening223, as described above, or through a port in a laparoscopic procedure, with bothconduits121,122 extending out of the insertion opening. In the case of a laparoscopic procedure, a tool, such as a grasper or other tool designed for laparoscopic use can be inserted through a second opening orport390 to capture one of the conduits (e.g.,conduit12₁as shown inFIG. 32D) and draw it out of thesecond opening390.Conduits12₂and12₁can then be manipulated to move and position attachment tab(s)150 into a desired location against the anteriorabdominal wall127. In the case of a percutaneous procedure, a small puncture can be made at390, using atool772 such as described with regard toFIG. 26E, for example, or other tool or combination of tool configured to perform a puncture and to capture aconduit12, and the conduit can then be capture and withdrawn through theopening390.Laparoscopic ports390 may have a diameter of about ten to about twelve millimeters, up to about eighteen millimeters and as small as about five millimeters, although the typical size is about eight to twelve millimeters.Percutaneous opening223 may be formed by an incision less than about seven cm, typically less than about five cm.
• Alternatively,conduits12₁and12₂may pass throughseparate attachment tabs150, as shown inFIG. 34E. By providing separate or segmented attachment features150, this allows more flexibility in placement of theattachment tabs150 as to anchoring location, and also may help in conforming to the tissues to be anchored to, but still provides the control of positioning and orientation of the inferior portion ofdevice10 andattachment tab150 that was described with regard toFIG. 32D above.Attachment tabs150 may be separate, as shown inFIG. 32E, or this flexibility may also be provided by asegmented attachment tab150 as illustrated inFIG. 32F, where12_2oshows an opening through whichconduit12₂passes and12_1oshows a tunnel or lumen through whichconduit12₁passes. If the outermost layer ofexpandable member10emis made of silicone, RTV silicone adhesive can be used to adhere attachment tab(s)150 to the expandable member. One or more of theattachment tabs150 may extend alongexpandable member10em, or may join withbacking support10dsto provide a larger surface area for force distribution. These extensions and/orbacking support10dsmay optionally also be provided with one or more patches of tissue ingrowth-enhancing material. Further, the a portion or all of a side of expandable member, such as the anterior facing surface, as illustrated inFIG. 27B may be coated with a layer or otherwise structurally reinforced so as not to expand, or at least not expand as much as the remainder ofexpandable member10em, to prevent or at least reduce expansion of expandable member in the anterior direction, and thereby reduce any visible bulging on the external abdomen of the patient (i.e., skin appearance/shape outside the abdominal cavity), whileexpandable member10emis allowed to preferentially expand posteriorly and medially to effect filling of the space intended to be filled.
• In an alternative attachment procedure,tube12₁and12₂can be routed through different openings in a patient, similar to any of the ways described above with regard toFIG. 32D. However, in this alternative approach,attachment tabs150 are not attached (at least not stapled, tacked or sutured to the abdominal wall, but they may be maintained to encourage tissue ingrowth, or a more conforming tissue ingrowth layer can be provided over an inferior portion ofexpandable member10em, or neither) to the abdominal wall. Rather,tubes12₁and12₂are used to position and orientdevice10 as desired anddevice10 is anchored viatube12₁and12₂, using nuts, sutures, access members, or any of the other features/techniques described previously. Thus, no suturing or stapling to the abdominal wall (at least to the abdominal wall inside the abdominal cavity) is required.
• In any of the procedures described herein, it may be advantageous to orient the patient on his back, with the table angled from about fifteen to about forty-five degrees, typically about thirty degrees, to elevate the head of the patient1. This causes the organs in the abdominal cavity to shift in and inferior direction thereby providing more space in the superior portion of the abdominal cavity and adjacent thediaphragm116 to facilitate the insertion procedures.
• FIG. 33 illustrates a distal end portion of a flexible,endoscope356 that may be used in a mini-laparoscopic or laparoscopic procedure to assist visualization of the placement ofdevice10 during an implantation procedure.Endoscope356 may be used with our without additional fluoroscopic visualization. For example, in an office setting, use ofendoscope356 without any fluoroscopic visualization may be sufficient for a minimally invasive procedure such as described herein.Endoscope356 includes anatraumatic lens790 at a distal end portion thereof, with a camera or other visualization means792 (e.g., optical fibers extending up to thelens790 or a CCD camera placed just proximally of lens790) to provide an image that is delivered to the proximal end ofendoscope356 outside of the body of the patient. Theshaft794 ofendoscope356 is flexible, may be constructed according to existing flexible catheter technology and typically has an outside diameter of five mm or less, preferably about four mm or less, more preferably about three mm or less. The diameter ofendoscope shaft794/lens790 is in the range of about two to about ten mm, typically about five mm. The distal end portion ofendoscope356 is steerable, as illustrated by the phantom lines inFIG. 33, andendoscope356 may be maneuvered or steered into a surgical site to provide a desired view, as well as steered, once in a desired site, to provide panning of a location in the abdomen. Steering may be controlled by wires that run along the length of viewing fibers withinshaft794 up to thetip790. The wires that the proximal end portion are connected to a steering mechanism that tensions the wires and causes deflections at the tip of thescope356. For a more detailed description, see Breedveld et al., “A New, Easily Miniaturized Steerable Endoscope”, IEEE Engineering in Medicine and Biology, November/December 2005, pp. 40-47, which is hereby incorporated herein, in its entirety, by reference thereto. Alternatively,endoscope356 may be inserted through a guide catheter for delivery of the distal end portion to a desired location.
• Once the distal end ofendoscope356 has been maneuvered into a desired viewing location, aballoon796, that is mounted annularly aroundshaft794 just proximal oflens790, can be inflated to lift adjacent tissues to improve the visualization throughlens790.
• Another feature for anchoringexpandable member10emofdevice10 is illustrated inFIG. 34. This feature includes ratcheted teeth (e.g., spacedteeth800 and acollar802. Theteeth800 are spaced alongconduit12 and annularly surround the conduit wall to radially extend outward therefrom.Teeth800 have an outside diameter at a distal portion thereof that is larger than the inside diameter ofcollar802, and the proximal end portions ofteeth800 have an outside diameter that is less than the inside diameter ofcollar802. Further,teeth800 are deformable, and tapered to allow them to be pulled throughcollar802. As atooth800 passes throughcollar800 it deforms to allow the passage, and then re-expands to its original configuration. Since the distal ends ofteeth800 are not tapered or beveled,teeth800 are prevented from passing back throughcollar802 in the distal direction. Thus, upon insertion, initial placement and expansion ofexpandable member10em, the surgeon can next place collar892 up against the external surface of theabdominal wall127, as shown inFIG. 34, and pullconduit12 proximally therethrough to pull one or more ofteeth800 throughcollar802, thereby anchoringexpandable member10emto the abdominal wall. The surgeon can adjust the positioning ofexpandable member10em, according to the number ofteeth800 that are pulled throughcollar802, wherein theteeth800 andcollar802 function like a ratchet. Theconduit12 extending proximally ofcollar802 is connected to accessmember80 which can also be attached to the abdominal wall at another location. This arrangement also relieves stress fromaccess member80 and the connection ofconduit12 withaccess member80.
• While the present invention has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.

Claims (12)

1-112. (canceled)

113. An anchoring frame for anchoring a device to an internal structure in a patient's body, said frame comprising:

an elongated main body having proximal and distal ends;

at least one channel running substantially over a length of said main body;

a contact surface adapted to contact the internal structure in the patient's body;

anchors positioned in said anchoring frame for being driven through said contact surface and into the internal structure; and

a deployment driver slidable through at least one of said at least one channels, wherein sliding said deployment driver through said at least one channel drives said anchors through said contact surface.

114. The anchoring frame ofclaim 113, further comprising a lumen passing through at least a portion of said elongated body to configure said anchoring frame to be passed over a guidewire.

115. The anchoring frame ofclaim 113, wherein said elongated body is flexible.

116. The anchoring frame ofclaim 113, further comprising a cable or wire extending proximally from said deployment driver and proximally of the proximal end of said elongated main body.

117. The anchoring frame ofclaim 113, further comprising an interlock on a proximal end portion of said elongated main body, said interlock comprising resiliently deflectable teeth configured to lock with an engagement member receivable in said interlock.

118. In combination, an implantable device engaged with an anchoring frame;

said implantable device comprising an expandable member having at least one key extending therefrom or groove formed therein;

said anchoring frame comprising an elongated main body having proximal and distal ends,

and at least one channel or rail running substantially over a length of said main body;

wherein said rail is receivable in said groove and said at least one key is receivable in said channel to mechanically connect said device with said anchoring frame.

119. The combination ofclaim 118, wherein each of said device and said anchoring frame are configured to be individually implanted in a patient.

120. The combination ofclaim 119, wherein each of said device and said anchoring frame are configured to be delivered individually over a guidewire.

121. The combination ofclaim 118, wherein said anchoring frame further comprises a contact surface adapted to contact an internal structure in a patient's body;

anchors positioned in said anchoring frame for being driven through said contact surface and into the internal structure; and

a deployment driver slidable under the anchors to drive said anchors through said contact surface, thereby anchoring the anchoring frame to the internal structure.

122. An anchoring frame for anchoring a device to an internal structure in a patient's body, said frame comprising:

an elongated main body having proximal and distal ends;

at least one channel running substantially over a length of said main body;

a contact surface adapted to contact the internal structure in the patient's body;

anchors positioned in said anchoring frame for being driven through said contact surface and into the internal structure; and

a deployment driver slidable through at least one of said at least one channels, wherein sliding said deployment driver in a first direction through said at least one channel contacts said driver with first portions of said anchors and drives said anchors through said contact surface, and wherein subsequently sliding said deployment driver in a second direction through said at least one channel contact said driver with second portion s of said anchors and retracts said anchors from extending through said contact surface.

123-184. (canceled)

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