Patent Application
20050177181
The present invention relates generally to apparatus and methods for treatment of obesity, and particularly morbid obesity. In particular, it relates to apparatus and methods that can be applied using minimally invasive techniques for effectively reducing stomach volume, bypassing a portion of the stomach and/or small intestines and/or reducing nutrient absorption in the stomach and/or small intestines. The present invention also relates to devices and methods for attachment of a gastrointestinal sleeve device within a patient's digestive tract for treatment of obesity.
Gastrointestinal sleeve devices for treatment of obesity have been described in the prior applications listed above, as have various devices and methods for attachment of a gastrointestinal sleeve device within a patient's digestive tract. The present invention is the result of continued investigation into devices and methods for attachment of a gastrointestinal sleeve device within a patient's digestive tract.
One objective of the present invention is to achieve a lasting, durable attachment for devices implanted within the gastrointestinal tract, and preferably an attachment that is reversible for later removal and also preferably enables placement, removal and/or replacement of another implanted device. To achieve this it is important to avoid tissue erosion at the attachment points, particularly as a result of pressure necrosis. Excessive pressure on the gastric or esophageal wall frequently leads to pressure necrosis, which can result in detachment of the implanted device. Excessive pressure can occur at attachment points or at any interface between the tissues and an implanted device. Motion of the gastric or esophageal wall due to expansion and contraction due to stomach contents or muscular peristaltic action can create or exacerbate excessive pressure in the tissues, which may lead to ischemia, pressure necrosis and tissue erosion. Avoiding pressure is key to preventing ischemia, pressure necrosis and tissue erosion at the attachment points and any other interface between the tissues and the implanted device.
One aspect of the present invention is to provide surgical fasteners that afford a secure attachment to the gastrointestinal tissue without causing excessive pressure within the tissue. The surgical fasteners can be used for attachment of an artificial stoma device, a gastrointestinal sleeve device or an attachment cuff, to which another implantable device can be attached. Fastener delivery devices that facilitate deployment and peroral placement of secondary devices, e.g. an attachment cuff, are also provided. Fasteners are provided that are especially adapted for convenient and reliable deployment using endoscopic methods via a peroral approach. Fastener delivery devices that facilitate deployment of the fasteners are also provided.
Another aspect of the present invention is to provide an implantable device and/or attachment means that avoids causing excessive pressure within the tissue by having compliance that is compatible with the gastrointestinal tissues where it is attached. Device compliance can also be important for providing a leak free seal between an implanted device and the tissue at the attachment point. Compliance can be provided in the radial or circumferential direction and/or in the vertical, axial or longitudinal direction. The device may have different compliance in different regions to be compatible with the tissue at the attachment point and at other portions of the gastrointestinal tract through which it runs. The device may have different compliance in different directions to be compatible with the tissue at the attachment point while simultaneously achieving other goals of the device. Compliance can be provided in a number of different ways. One way is by elastic or plastic deformation of the device and/or the attachment means. Another way is by a mechanical decoupling that allows relative movement between the device and the attachment points, and/or between the attachment points themselves, without transmitting excessive force or pressure to the tissue.
In some clinical situations, it will be desirable to match compliance between the device and the tissue to which it is attached. In other situations, based upon the clinical situations, it will be desirable to provide a device with higher or lower compliance than the tissue to achieve certain objectives. For example, maintaining the position of the proximal end of an attached sleeve device will require a device that is relatively noncompliant in at least the axial direction.
Compliance of GI tissue can be a time and/or rate dependant phenomenon. GI tissue will resist abrupt tensile forces but will relax and stretch out if force is applied over a long period of time. Compliance of GI tissue also changes with stimulation of the muscular layers. This can be neural and/or hormonal. GI tissue also has a tendency to return to a resting configuration and/or shrink or contract if not exposed to mechanical stress. The compliance of GI tissue can also change. For example, fibrosis and/or scaring effects that may occur at a plication or attachment point would be expected to reduce tissue compliance.
The tissue at the GEJ or cardia can move upward toward the esophagus (e.g. when swallowing or retching) and downward and outward toward the fundus (e.g. when the stomach is engorged). This will then result in a change in the diameter of the tissue ring at the GEJ/cardia. This will be associated with a proportional change in the circumference of the cuff/ring, which will require the cuff material to fold/collapse (with upward motion) or extend/stretch (with downward motion).
The device or fastener may be configured to have a compliance limit. The material stretches to a point (limit) and then will stretch no more. When GI tissue stretches naturally it is only subjected to the force required to stretch the tissue. For GI tissue attached to a cuff or sleeve, when attached to a relatively less compliant material it can be subjected to the additional forces required to stretch the less compliant material. When attached to a material with relatively greater compliance there should be little additional force on the tissue. This would be true until a compliance limit of the material was reached after which appreciable additional forces could be seen by the tissue.
In the case of isolated attachment points (i.e. individual unconnected hangers) the same principles apply, however, in this case it may not be the cuff that connects the attachment points. In this case it can be the sleeve (when in place) that connects and transmits forces between the attachment points. In this case the compliance of the sleeve at the attachment point defines the compliance limit.
An intermediate or transitional proximal sleeve/cuff can be used to decouple a relatively noncompliant sleeve from the GI tissue without use of isolated attachment points. This can be integrated with or separate from the sleeve. A separate and removable intermediate cuff can be constructed similarly to a primary attachment cuff and similarly remain in place when sleeves are removed and/or replaced. It may be desirable to revise or replace a sleeve device to increase or decrease the therapeutic effect and/or to remove a sleeve after a suitable therapeutic interval. Apparatus are disclosed where relative motion between the fasteners and/or interconnected devices can be allowed as an alternate means to decouple a relatively noncompliant sleeve from the GI tissue.
Methods and apparatus are also provided for allowing tissue healing at attachment points and prestrengthening or thickening the tissue prior to attachment of an implantable device. In addition, sutures and surgical fasteners are provided that can accommodate tissue thickening without causing excessive pressure within the tissue.
Accordingly, the present application, the referenced provisionals and the parent application describe devices, features, means and methods that can be used alone or in combination to achieve a lasting, durable attachment for devices implanted within the gastrointestinal tract. Furthermore, this is preferably an attachment that is reversible for later removal and also preferably enables placement, removal and/or replacement of another implanted device.
FIGS. 21, 22A-22B and 23 show another configuration of a T-tag fastener delivery device.
FIG-27 shows another method of orienting a T member of a fastener after insertion.
The parent application, Ser. No. 10/698,148, describes gastrointestinal sleeve devices that can mimic a Roux-en-Y gastric bypass by effectively reducing stomach volume, bypassing a portion of the stomach and/or small intestines, reducing nutrient absorption in the stomach and/or small intestines and depositing minimally or undigested food farther than normal into the intestines, thereby stimulating intestinal responses. The gastrointesintal sleeve devices described therein are all adaptable for use with the apparatus and methods of the present invention.
In conjunction with the stoma and/or gastric sleeve, the volume of the stomach can be reduced by suturing, stapling using open, transesophageal or laparoscopic techniques. Alternatively or in addition, a gastric balloon or other volume displacement device may be used in conjunction with the gastric sleeve to provide a feeling of satiety. These adjunctive techniques have the effect of further reducing nutrient intake (in the case of a stomach reduction and pouch formation upstream of a stoma) and enhancing the effect of peristaltic motions of the stomach for moving food through the gastric sleeve intake (in the case of a stomach reduction downstream of a stoma where there is a gastric sleeve).
In each of these examples, the gastrointestinal sleeve device 200 preferably has a length such that ingested food and liquids bypass most of the stomach and at least a portion of the small intestine. Undigested food and liquids exit the distal end 210 of the sleeve device 200 into the small intestine reducing caloric absorption and eliciting physiological responses within the intestines. The gastrointestinal sleeve device 200 can have a constant diameter throughout its length or the diameter may vary along the length. The gastrointestinal sleeve device 200 can be impermeable along the entire length or some or all of the device may be porous or semipermeable. Preferably, the wall of the gastrointestinal sleeve device 200 is thin and flexible so that peristalsis is coupled to the internal lumen 208 of the device. A gastric sleeve that extends beyond the pylorus 220, with or without an intestinal sleeve, can allow use of the pylorus as a natural stoma by configuring the sleeve to close by the pylorus and then open to allow passage of food when the muscles of the pylorus relax. The section of the sleeve device 200 that passes through the pylorus 220 will preferably have enough wall flexibility or compliance to allow normal opening and closing of the pylorus to release and retain stomach contents and to allow drainage of stomach secretions around the outside of the sleeve. This can optionally be accomplished by the inclusion of pleats, channels or other structures to facilitated the collapse and sealing of the sleeve as well as passage of gastric secretions along the outside of the sleeve as shown in
Structures, features and methods illustrated in
Optionally, the sleeve can include coatings on its interior and/or exterior to enhance the surface properties of the sleeve in clinically relevant manners. Coating examples include: 1) parylene coatings to increase the chemical resistance of a sleeve material, 2) coating with an antimicrobial agent to resist infection and/or 3) coating with an anti-inflammatory agent to reduce tissue inflammatory response, as described herein. Similarly, the interior and exterior of the sleeve can optionally be coated with a low friction material (e.g. a hydrogel) to reduce friction of food passage (interior) and reduce gastric irritation (exterior).
The 10/698,148 application describes the use of biodegradable or bioresorbable materials for construction of a gastrointestinal sleeve device to obviate the need for removal of the sleeve device at the end of the treatment period. The entire gastrointestinal sleeve device or a portion of it may be made of biodegradable material. The gastrointestinal sleeve device may be made of biodegradable materials with different rates of degradation or resorption. The gastrointestinal sleeve device may be configured with a series of segments that biodegrade sequentially. For example, a first portion on the distal end of the sleeve may degrade first, followed some time later by a second intermediate portion and a third proximal portion. Next the attachment would degrade and, finally, the T-tags or other fasteners would degrade. Alternatively, the gastrointestinal sleeve device may be configured with a series of short segments of non-biodegradable material that are attached to one another with biodegradable material. The biodegradable attachment portions may be made of biodegradable materials with different rates of degradation or resorption so that they biodegrade sequentially. In either case, the biodegradable material would allow a gradual change of therapy over time, without having to revise or replace the implant. The patient could get used to the gradual change in therapy more readily than a sudden change and would be better able to avoid a rebound in weight gain. It would also allow for a safe mode of degradation and elimination. The device would degrade into pieces small enough that they could be eliminated without any danger of bowel obstruction.
Alternatively, selected portions of the gastrointestinal sleeve device may be made of biodegradable material. For example, openings in the sleeve can be covered with biodegradable material that will gradually degrade over time, eventually allowing food to mix with digestive secretions. The biodegradable material would allow a gradual change of therapy over time, without having to revise or replace the implant. The gastrointestinal sleeve device with the openings in it could be left in place for long-term maintenance of weight loss or it could eventually be removed.
Biodegradable material suitable for construction of a gastrointestinal sleeve device is sold under the name Plastifilm by OsteoBiologics, Inc., located in San Antonio, Tex. This biodegradable polymeric film material is described in U.S. Pat. 6,514,286, which is hereby incorporated by reference. Additional information from the supplier about this material is available at: http://www.obi.com/.
Another aspect of the present invention involves devices and methods for delivery and deployment of a gastrointestinal sleeve device into a patient's gastrointestinal tract. One method to facilitate delivery of the device into and through the patient's small intestine is to place a guidewire and/or catheter into the intestine to the depth desired and then push the gastrointestinal sleeve device over the guidewire. Successful techniques for placing a guidewire into the small intestines have been described by G. Long, T. Mills and C. P. Swain in an article entitled Techniques for advancing guide wires and devices in the lumen of the gastrointestinal tract. Another technique that could be adapted for placing a device such as a gastrointestinal sleeve device into the small intestine was described by H. Yamamoto and K. Sugano in an article entitled A new method of enteroscopy—the double-balloon method, Can J Gastroenterol. 2003 April;17(4):273-4. These techniques can be used in combination with many of the delivery and deployment methods described herein and in the prior application.
The 10/698,148 application describes gastric and gastrointestinal sleeve devices that include inflatable balloons for structural support of the sleeve and/or for enhancing the patient's feeling of satiety. An enhanced method of using these devices is to inflate the balloons with a fluid containing a nontoxic detectable dye, such as methylene blue. If any of the inflatable balloon members should develop a leak, the methylene blue will be passed in the urine and be detectable by the patient. The patient should then contact a physician to determine whether repair or replacement of the device is indicated.
Another concept described in the 10/698,148 application involves the placement of a mounting ring or other attachment device within the gastrointestinal system and attaching various other devices or components to the attachment device. Enhancements to that concept for treating GERD, MO and other disorders of the gastrointestinal tract could include placing/attaching a nonrestrictive mounting ring at or near the GEJ and attaching/removing/replacing various therapeutic or diagnostic devices to the mounting ring, such as a valve to prevent reflux, a restriction to food intake, a sleeve, a telemetry or imaging capsule, etc.
Methods of insertion and retrieval of a gastrointestinal sleeve device are also described in the parent application. In addition to the methods described therein, a GI sleeve can be inserted and/or retrieved using a flexible endoscope. A skilled GI endoscopist can “drive” a special endoscope (an enteroscope) through the duodenum and deep into the jejunum. With proper interfacing structure on a GI sleeve, the sleeve can piggyback on the endoscope as it is driven into the jejunum and then released with its distal end left in the jejunum when the endoscope is retracted and removed from the body. This can be accomplished perorally either before or after attachment of the proximal end of the sleeve to the GEJ or some other clinically desirable location.
Various means can be used as an interface between the endoscope and the distal end of the GI sleeve device. If the sleeve device has a solid distal end or other graspable portion, such as a tab or loop near the distal end, a standard or custom endoscopic snare or grasper can be extended through the endoscope working channel to grasp the sleeve device. Alternatively, the distal end of the sleeve device can be configured with a socket or pocket to engage a flexible pusher, which may be configured as a rod, tube or guidewire. As another alternative, the sleeve device can be configured with a distal end that can be cut off to release the device. The distal end of the sleeve device is grasped with a snare or the like extended through the endoscope working channel. Once the sleeve device is delivered far enough distally in the GI tract, the distal end of the sleeve device is cut off to release the device.
The method of delivery is different depending upon whether or not the proximal end of the sleeve is attached in the GI tract before sleeve delivery. It is much simpler if distal delivery is performed prior to attaching the proximal end of the sleeve, therefore this method is described. The following method is exemplary and positions the sleeve coaxial (outside) the endoscope. With minor modifications the same method can be applied to a parallel (side by side) delivery.
The distal end of the GI sleeve device can be delivered through the stomach and into the small intestine by the following steps:
One option for release of the GI sleeve device includes the following steps:
Another option for release of the GI sleeve device includes the following steps:
One method for retrieval of a GI sleeve device, proximal end first, includes the following steps:
An alternate method for retrieval of a GI sleeve device, distal end first, includes the following steps:
One of the challenges in treating morbid obesity with implantable devices such as those described herein and in the prior application, and in gastric surgery in general, is avoidance of tissue erosion at the attachment points, particularly as a result of pressure necrosis. Prolonged ischemia due to excessive pressure on the gastric or esophageal wall frequently leads to pressure necrosis, which can result in detachment of the implanted device. Excessive pressure can occur at attachment points or at any interface between the tissues and an implanted device. Motion of the gastric or esophageal wall due to expansion and contraction due to stomach contents or muscular peristaltic action can create or exacerbate excessive pressure in the tissues, which may lead to ischemia, pressure necrosis and tissue erosion. Avoiding ischemia is key to preventing pressure necrosis and tissue erosion at the attachment points and any other interface between the tissues and the implanted device. Tissue, devices and device attachment in many clinical situations are designed to function in concert. For example it can be desirable to have a device which does not change the anatomy at its attachment location, allows the tissue to move with minimal resistance and is attached with an attachment means that elicits minimal foreign body reaction and imposes a minimal increase in tissue pressure. Alternatively, the device and its attachment may be constructed to elicit a controlled or measured tissue response that may increase and improve the tissues ability to retain the device and attachment means.
Generally, the spacer 224 should be configured to limit the amount of compression applied to the gastric or esophageal wall upon deployment of the fastener 222. Where some compression is desired, the spacer distance, that is the distance along the stem from the T 226 to the proximal cap 232 after deployment, should be slightly less than the total thickness of the tissue and other structures to be attached. The spacer distance should take into account whether a single-wall transmural attachment or a double-wall plicated attachment is intended, as well as the thickness of any device structures that will be held by the fastener. In cases where it is not necessary to apply compression, the spacer distance may be greater than the total thickness of the tissue and other structures to be attached.
In an alternate embodiment of the T-tag fastener 222 of
The T-tag fastener 222 of
A gastrointestinal sleeve, a mounting ring or other device may be attached directly to the gastric wall using several of the T-tag fasteners as rivets. Alternatively, the stem and/or the proximal cap may be configured with a ring, a hook or the like for attaching another device to. As another alternative, the suture tails may be used for tying a device to the fasteners.
The low profile provided by the tandem configuration of the T member 244 and spacer 242 is desirable to minimize the size of the needle or cannula 248 needed to deliver the fastener 240. This is important not only for minimizing the size of the tissue puncture, but also to reduce the amount of force needed to deliver and deploy the fastener 240 through an endoscope. The delivery needle or cannula 248 will preferably be 17 gauge or smaller, more preferably 19 gauge or smaller.
The T-tag fastener 240 is typically deployed as a blind fastener, for example for transmural attachment through the gastric wall. The delivery cannula 248 is used to pierce through the tissue to be attached; then the T 244 is pushed out of the cannula 248 on the far side of the tissue using a pusher rod or tube that extends through the cannula 248. The needle or cannula 248 is withdrawn and the T 244, which is now approximately perpendicular to the sutures 246, is snugged up to the back surface of the tissue with a little tension on the sutures 246, as shown in
Spacers illustrated in
When placing T-tag fasteners or other fasteners in the region of the GEJ, it is important to avoid other anatomical structures in the vicinity of the stomach and esophagus. One method for this is to create a safe space behind the GEJ for deploying the fasteners. One method to accomplish this is described in the parent application, Ser. No. 10/698,148. Alternatively, one can take advantage of the fact that the proximal stomach generally lies just below the diaphragm when the patient is in a head-up position. Space will be created between the stomach and diaphragm into which transmural fasteners can be safely placed. This safe space can be increased by having the patient inhale deeply while in a head-up position to push the stomach down with the diaphragm, then exhale to lift the diaphragm up off of the stomach. Preferably, the fasteners 250 will be delivered parallel to the diaphragm 252, as shown in
Alternatively or in addition, pneumoperitoneum can be used to create a safe space around the stomach and esophagus. Pneumoperitoneal pressure will tend to collapse the stomach away from other surrounding organs and would be balanced by the pressure used to endoscopically insufflate the stomach for improved visualization and access.
Other tactics to avoid other anatomical structures in the vicinity of the stomach and esophagus include the use of imaging techniques such as fluoroscopy, esophageal ultrasound imaging, external ultrasound imaging and/or Doppler imaging when placing fasteners. Alternatively or in addition an “endoscopic compass” can be used to provide a reference for orienting the endoscope when using fastening devices. A small magnetized needle (i.e. a compass needle) is placed near the distal end of the endoscope where it can be viewed by the operator through the endoscope. A magnet is placed on the patient to provide a reference point for the compass, for example the reference magnet can be placed on the patient's back directly over the spine. The compass needle will point toward the reference magnet on the spine. Using the compass needle as a reference, the operator will be able to avoid inadvertently puncturing the aorta, which lies directly posterior to the esophagus.
The concept of the Veress needle can be adapted for avoiding puncturing other anatomical structures in the vicinity of the stomach and esophagus during endoscopic attachment of devices near the GEJ. A Veress needle is a needle equipped with a spring-loaded obturator that is often used for insufflation of the abdomen in laparoscopic surgery. A long, flexible device with a needle at the distal end and a spring-loaded obturator within the needle would be used to safely puncture the gastric or esophageal wall. Once the needle has passed through the wall, the spring-loaded obturator advances automatically to avoid damage to any surrounding tissues. A delivery cannula can be advanced over the needle and the needle can be exchanged with a fastener delivery device. Alternatively, this concept can be adapted directly into the fastener delivery device. A T-tag fastener or the like would be spring-loaded into the lumen of a delivery cannula so that it would be ejected out of the lumen immediately after the cannula has traversed the gastric or esophageal wall.
Another method for avoiding deploying fasteners into the aorta would involve a small diameter needle with a flow detector (e.g. a Doppler flow sensor) or pressure detector for detecting blood flow or blood pressure. Alternatively, a flow detector or pressure detector can be mounted on a separate guidewire inserted through the needle. The flow detector can be used to detect blood flow before the wall of the aorta is punctured. Alternatively, if backflow of blood or blood pressure is detected, indicating that the needle has punctured the aorta, the needle will be withdrawn and a fastener will not be delivered at that site. The small diameter puncture in the aorta should heal without complications.
Alternatively or in addition, the organs and other anatomical structures in the vicinity of the stomach and esophagus can be protected during endoscopic attachment techniques by using a depth stop on the needle or delivery cannula to prevent it from penetrating farther than necessary to traverse the gastric or esophageal wall. Examples of fastener delivery devices with a depth stop to protect nearby organs and structures are described in U.S. provisional patent application 60/569,442.
One method for placing an implantable device within a patient's body has been described as a “parachuting” technique. In this technique, multiple elongated sutures are sewn through the tissue where the device is to be implanted with the ends of the sutures extending out of the patient's body. The ends of the sutures are passed through a sewing ring or similar structure on the device while the device is still outside of the patient's body, then the device is parachuted or slid into place along the sutures. The device is typically secured in place by knotting the elongated sutures with the help of a knot pusher or similar device and then the sutures are cut off close to the knots. U.S. provisional patent application 60/534,056 describes a variation of this method for implanting a device within a patient's digestive tract using T-tag fasteners. Alternatively, suture locks such as those described in U.S. Pat. No. 4,235,238 or those used in the BARD Endocinch system can be used to secure the suture prior to cutting.
When parachuted into place along the sutures, the device may be folded or compressed to pass through the esophagus or through a delivery tube placed in the esophagus. When using this parachuting technique it is desirable to minimize the friction between the device and the sutures. This can be done by using a low friction material or a low friction coating on the sutures and/or the device. This is also done by dimensioning and/or orienting structures, e.g. holes, to guide the parachuted device to reduce friction.
Alternatively, the device 120 may be partially parachuted into place, meaning that 2-4 parachute sutures are used to slide the device 120 into position with the proper orientation. Then additional fasteners, for example T-tag fasteners, are delivered to complete the attachment of the device 120 to the tissue.
If suture tails are delivered through a closed lumen (e.g. in or attached to an endoscope), the lumen must be removed from around the suture tails before a device can be parachuted over the sutures if the device is too large to pass through the lumen. This can present a challenge related to maintaining the organization of the suture tails and preventing confusion, crossing, winding and/or tangling of the suture tails. If T-tag fasteners and their suture tails are passed externally e.g. through an external lumen with a longitudinal slot or in a non-enclosed rail type system, the suture tails can be managed external to the lumen used to place the T-tag fasteners and external to the scope. This facilitates manipulation of the scope, simplifies scope exchanges and simplifies suture tail management.
Suture tail management external to the scope or an enclosed lumen can be combined with suture holders external to the patient, similar to those used for parachuting replacement heart valves into place. Snugging the sutures as described above is simpler when the suture tails are external to the scope, as is avoidance of crossing, winding and/or tangling of the suture tails. Suture holders, such as slots, clamps or clips, can be combined with a mouth guard for organizing the sutures during a peroral parachuting procedure.
One aspect of suture tail management is that it must happen from one end of the system to the other. Therefore, the method and apparatus must address this issue. For example, after placement of a T-tag fastener, a slight tension on the suture tail can hold the suture against the wall of the lumen or in a straight position where it is less likely to tangle. Apparatus can include means to maintain tension while allowing scope movement and manipulation, e.g. tension from a long soft spring, an elastic band or a spring-loaded reel.
Sometimes, when performing an endoscopic procedure, an overtube is used to line the esophagus and protect it from damage due to insertion and manipulation of the endoscope and related tools and devices. Other practitioners prefer to avoid the use of an overtube. In either case, it may be desirable to secure an implant being parachuted down the esophagus in a collapsed, folded or otherwise reduced configuration. A major issue when parachuting a device into place is friction between the device and the sutures, and collapsing or folding the device may exacerbate the problems with friction.
The following method is intended to reduce the problems with friction between the device and the sutures when parachuting a device through the esophagus. The method allows the device to be parachuted through the esophagus in a folded configuration, while it also allows the sutures to pass through the device while it is in an unfolded position. In addition, the method allows the sutures to be pulled through the device one at a time, which further reduces the problems with friction. This method can be used, for example, with the t-tag and/or t-tag delivery systems described herein.
In some embodiments, a stopper member 107, or other securing means such as an adhesive, crimp or knot may be used alone or in combination to create a tapered or gradual proximal transition, which may facilitate passage of the secondary T member 106 through other structures as shown in
The fastening gap determines the tension on the suture 104 and hence the pressure on the tissue exerted by the primary T member 102 and the implanted device 120. This would ideally be sufficient to create a seal (optionally in conjunction with ingrowth) while applying minimal force to the tissue. Optionally, this gap can be variable and or changeable as described herein.
Other configurations of fasteners and fastener delivery devices known in the art can be used in conjunction with the present invention. For example, U.S. Pat. No. 4,235,238 describes various fasteners and endoscopic fastener delivery devices for use in the gastrointestinal system. Other attachment and /or parachuting approaches can be used with these dual t-tag fasteners to secure devices, for example, to plications.
The delivery device can include means to apply force to the implanted device 120, which may facilitate and/or cause swiveling or rotation of the secondary T member 106. In some embodiments, this device can also cut the suture 104.
The pusher causes the secondary T member 106 to swivel as it advances distally. The pusher may include a window to allow the first end 108 of the secondary T member 106 to swivel. This window should be preferably open at the distal end. Optionally, the pusher may include another window to allow the second end 110 of the secondary T member 106 and the suture 104 to swivel. Optionally, the window can also be used to cut the suture as shown in
The distal end of delivery device may be used to apply force to the implanted device 120, as shown in
One example of a pusher, as shown in
One method of deploying the secondary T-tag 106 utilizes the following steps:
Delivery cannula devices/systems (hereinafter delivery cannula) can be configured for the delivery of multiple T-tag or other fasteners. In particular these delivery cannulae allow placement of multiple T-tags (or in the case of a dual-headed T-tag fastener, primary T members) through a layer of tissue and/or a device while facilitating the management of multiple fastener suture tails.
A delivery cannula can include some or all of the following components, which will be described in more detail below in relation to specific embodiments of delivery cannulas:
In a basic delivery cannula embodiment, the first components are a single elongated hypodermic tube with a sharpened distal tip as the penetrating cannula and a wire or rod as the pusher. This type of device generally delivers a single fastener before being withdrawn to clear the suture tail from the tube. A more complicated delivery cannula is similar to the above, but incorporating a longitudinally slotted hypotube. This allows the tail/suture of the T-tag fastener to be external to the hypotube and allows a smaller diameter hypotube as well as other suture/tail handling advantages. In this case the above-mentioned penetrating, transit and loading cannulas are embodied in the single cannula.
In all the delivery cannulas, the penetrating cannula must be movable relative to the tissue through which it penetrates for T-tag fastener delivery. In a basic delivery cannula, the penetrating cannula will move in conjunction with the transit cannula and loading cannula. In more complex delivery cannulas, the penetrating cannula will move relative to the transit cannula and/or loading cannula.
The delivery cannula can be configured to be used:
The delivery cannula should include means to keep the penetrating cannula point from inadvertently damaging tissue or the device through which it is delivered. For example, a Varess needle style obturator or other obturator can be used. The obturator must be removed to deliver the T-tag fastener through the lumen of the penetrating cannula. An external needle protector, or garage, may also be used, which has the advantage that it would not have to be removed for T-tag fastener delivery. A slotted garage could have additional advantages for T-tag fastener delivery. A penetrating cannula that is spring loaded within a garage where it only exits the garage under the impetus of a pusher in preparation to penetrating tissue would also have certain advantages.
Retracting the penetrating cannula into the biopsy or instrument channel of the endoscope will protect the tissue from inadvertent damage, but not the lining of the instrument channel. To protect the biopsy channel, the penetrating cannula could be retracted within the transit cannula or into a structure (garage) located at the juncture of the penetrating cannula and the transit cannula.
As an alternative to the slotted hypotube previously mentioned, a magnetic or mechanical rail system can be used in place of or in combination with the transit cannula. In this case, the pusher captures the primary T member 102 for delivery to the penetrating cannula. The pusher is magnetically or mechanically coupled to the transit cannula.
Similarly, a smaller diameter, short length slotted hypotube transit cannula can be used with a monorail T capturing pusher as a means to transfer the T-tag fastener to the penetrating cannula. In this context “monorail” refers to a short distal coupling section such as those used to couple a monorail or rapid exchange catheter to a guidewire. In this case, the monorail transit cannula, such as shown in
Having elongated suture tails extending out of a patient's mouth (or other orifice) with an associated need to pass devices over the suture tails can be cumbersome if standard “exchange length” techniques are applied. A monorail style device could be used through an internal or external endoscope lumen or independent of the endoscope. This type of design allows control of the T member in a short slotted cannula while the majority of the length of the suture tail would be external to an elongated transit cannula. This may also provide an easier path for the long suture tail as when an elongated slotted cannula might not maintain a slot free of obstruction when the endoscope was subjected to flexion.
If the monorail portion of the device extends out of the lumen of the endoscope, the monorail portion can optionally be of sufficient length to partially remain within the endoscope lumen to provide improved support and manipulation capability.
A two-channel endoscope can be used to deploy a series of T-tag fasteners. In one method of using such a 2-channel endoscope the T-tag fasteners are delivered through the first channel of the scope. The distal T members of the fasteners, individually or collectively, are placed outside the distal end of the scope. A delivery device is placed in the second channel and positioned near the distal tip of the scope. A capture/pusher device is passed through the first delivery cannula and a single distal T member is captured and drawn into the delivery cannula. The penetrating cannula of the delivery device is preferably slotted. The delivery device is used to deploy a series of T-tag fasteners into the tissue in the manner described above. The steps of T member capture by the pusher, drawing into the delivery cannula and deployment are repeated for each T fastener. As the endoscope is removed from the patient, the multiple suture tails of the T-tag fasteners are drawn out of the distal end of the first channel of the endoscope. The suture tails should be long enough to extend out of the patient's body, for example out through the patient's mouth. Labeling, color-coding or other means may be used to help organize the suture tails. A device can be threaded onto the proximal ends of the sutures and parachuted into place. Optionally, the ends of the suture tails may have needles attached to facilitate passing the sutures through preformed holes or a sewing ring on the device.
A tubular member that functions as a garage or protective shield 152 for the penetrating cannula 114 may be mounted externally on the endoscope 142, e.g. with one or more interference fit mounting clips 144. The garage 152 has an ID larger than the penetrating cannula OD to allow sliding of the penetrating cannula 114 relative to the garage 152 with clearance and/or a slot 154 for the suture tail. The penetrating cannula 114 may be spring mounted in the garage 152, so that the penetrating cannula 114 retracts into garage 152 automatically or upon withdrawal from tissue.
The distal end of the transit cannula 156 connects to the proximal end of the garage 152. The garage 152 and the transit cannula 156 may be constructed of separate pieces of tubing as shown or, alternatively, they may be constructed of one continuous piece of tubing. The transit cannula 156 has a diameter the same or slightly larger than the penetrating cannula 114, optionally slotted, mounted externally on endoscope 142, e.g. with one or more interference fit mounting clips 144. In conjunction with the pusher 122, it delivers the T-tag fastener 100 to the penetrating cannula 114 while it is positioned in the garage 152. Preferably, it is designed to prevent binding when the endoscope 142 is deflected, including retroflexed, e.g. with a bellows or other flexible structure 158 at major flex points. The transit cannula 156 may be ferrous/magnetic for magnetic coupling between the transit cannula 156 and pusher 122. Alternatively, it could be a mechanical coupling or alternatively could use a monorail configuration.
A loading cannula or other fastener loading mechanism attaches to the scope biopsy port or scope handle. The loading cannula may load the pusher with T-tag fasteners individually or may feed T-tag fasteners from a magazine to pusher for delivery of multiple tags.
The T-tag fastener delivery device could use any long tail T-tag fastener, including the dual headed T-tag fastener described herein and in the prior application.
Other aspects of T-tag fastener delivery devices 150 include:
If used through an endoscope lumen or external to the endoscope, the delivery cannula or its components would be flexible to accommodate the flexing and articulations of the endoscope. Some examples of flexible constructions for the delivery cannula are shown in
Longitudinally slotted cannulas have advantages related to cannula sizing and also for delivering multiple T-tag fasteners. The suture tails of each T-tag fastener can exit the cannula through the slot after the fastener is deployed so that they will not damage or interfere with subsequently deployed fasteners. A parachute T-tag fastener or a snap T-tag fastener, described below, can have particular advantages in this regard. Any of the illustrated structures in
One aspect in common between the parachute T-tag fastener 100 and the snap T-tag fastener 130 is the presence of a relatively large element (i.e. the proximal T member 106 or the snap 132) on the suture tail 104 in proximity to the distal T member 102. With appropriate dimensioning, the proximal T member 106 of a parachute T-tag fastener 100 or the snap 132 of a snap T-tag fastener 130 remains outside the slotted penetrating cannula 114 and facilitates positioning the suture 104 outside of the cannula 114, as shown in
As a flexible endoscope bends in use, a precision longitudinal slot over the bending portion of the scope could be technically challenging. The fastener delivery apparatus 170 shown in
When the pusher assembly 182 is advanced distally on the keyed wire 174, the socket 188 engages and then pushes the loading cannula 180 distally until it engages the slotted socket 176 and the penetrating cannula 114. The pusher rod 184 first advances the snap T-tag fastener 130 from the loading cannula 180 into the penetrating cannula 114. As the pusher rod 184 moves farther distally, the penetrating cannula 114 advances distally out of the garage 172 to pierce the tissue. Once the penetrating cannula 114 is fully extended, the pusher rod 184 deploys the T-tag fastener 130 by pushing it distally out of the penetrating cannula 114. Furthermore, the relative spring rates of the penetrating cannula spring 178 and pusher assembly spring 187 are such that the penetrating cannula 114 is fully deployed before the pusher assembly spring 187 begins to collapse. Use of a spring in this manner prevents inadvertent or premature T-tag fastener deployment. Pusher assembly spring travel is of sufficient length to fully expel the T member from the penetrating cannula 114. For example, if approximately 250 gm of penetration force is desired to be transmitted to the penetrating cannula, the penetrating cannula spring may be fully collapsed at 250 gm and the pusher assembly spring will begin to collapse at 250 gm and may be fully collapsed at 275 to 300 gm.
The interface between the proximal end of the keyed wire 174, the T-tag fastener cartridge magazine and the pusher assembly 182 can all be combined in a deployment handle assembly similar to the one shown in
In this embodiment, once the loading cannula and cartridge are mated, further advance of the mated cartridge and pusher rod would result in:
Retraction of the pusher rod would:
When placing T-tag fasteners it can be beneficial to orient the T members in a specific direction relative to the anatomy. Two approaches are discussed:
If a non-slotted penetrating cannula is used, then an oriented pusher or keyed cannula or keyed pusher and keyed T member can be used to control the orientation of the T member as it exits the delivery cannula.
Use of a slotted delivery cannula with the suture tail of the T-tag fastener positioned through the slot can maintain orientation of the T member as it passes through the delivery cannula. This may be sufficient to orient the T member, but the suture tail will generally exit the slot before the T member is fully deployed. Keying the proximal portion of the T member to the slot can improved control of orientation during deployment.
As shown in
Another aspect of the T-tag fastener delivery device shown in
The T-tag fastener delivery device may have a fixed orientation with respect to the endoscope. Preferably, a visual indication of the delivery device orientation is provided for the endoscope operator. Alternatively, the delivery device may be rotatable with respect to the endoscope. This will require a mechanism for controlled rotation of the delivery device, e.g. a rotating shaft with gears to transmit the rotation to the delivery cannula, and a visual indication that changes to indicate the rotational orientation of the delivery cannula. With a video endoscope, this can be done electronically and indicated on the viewing monitor.
It is also possible to orient a T member 102 of a fastener after insertion. As shown in
Similarly, the T member can be oriented directly by a rotational drive tool 330 that is passed over the suture tails and through the tissue, where it engages the side of the T member 102 to transmit rotation to the deployed T member 102 as shown in
Rollers, a low friction coating or other material or structure on the T member of the fastener would allow the fastener to slide on the serosa and thereby direct itself to a desired orientation. A roller or low friction material on the T member would also facilitate reorienting the T member to a desired orientation using a rotational drive tool as described above.
One other aspect of T-tag fastener delivery is the potential for a T member to pass proximally through the track formed by the penetrating cannula rather than rotating to be parallel to the tissue surface as desired. In many cases the connection of the T member and the stem, for example as shown in
One of the challenges when performing endoscopic suturing, stapling or other types of attachment, e.g. with T-tag fasteners, is that the tissue tends to move away from the attachment device. A separate grasper can be inserted through an instrument lumen in the endoscope for holding the tissue, but this approach has its drawbacks because it is very difficult to achieve a good cooperation between the two instruments. To facilitate endoscopic attachment methods, a better cooperation can be achieved when an attachment device is combined with or otherwise mechanically linked to a grasper.
In one embodiment shown in
In another embodiment shown in
In another embodiment shown in
The combined instrument 400 is introduced endoscopically and the distal end is maneuvered into contact with the tissue to be attached. The grasper 416 is actuated to hold the tissue and the attachment device 408 is passed through the lumen to deliver a suture needle or fastener into or through the tissue. Because the grasper 416 and the attachment device 408 are so closely linked, the tissue cannot move out of the way of the attachment device 408, allowing the suture or fastener to be delivered through the tissue reliably and efficiently.
Alternatively or in addition, a vacuum coupling cuff on the distal tip of the endoscope can be used to allow vacuum holding of the tissue during attachment.
In some applications of the T-tag fastener, it will be advantageous to provide different configurations for the T member(s).
Expandable or swellable T members also have advantages for greater anchoring force and/or reduced pressure on the tissues where they are attached. A T member could be configured of a material that is initially small and/or soft for insertion of the T members. After insertion, the T member would expand or swell and then harden in the expanded configuration. This could result from a chemical reaction that is initiated by absorption of water or another reactant. A reagent in the material of the T member or added to it after insertion could initiate or catalyze the reaction of a hardenable material, e.g. a cyanoacrylate adhesive. Various materials and configurations for this function are described in the parent application, Ser. No. 10/698,148.
Other enhancements can be applied to the T-tag fasteners described herein and those described in the parent application, Ser. No. 10/698,148 and provisional 60/613,917. For example, the T member of the T-tag fastener can be configured to minimize pressure concentrations on the tissue. When applied by direct insertion, the T member of the T-tag fastener can be configured to distribute forces over a larger surface area. For example, the T member can be configured as a disk, square, rectangle or other shape with a large surface area. For blind insertion, the T member of the T-tag fastener can be configured to expand after insertion through the tissue to distribute forces over a larger area. For example, the T member can expand to form a disk, square, rectangle, I, X, Y or other configuration with a large surface area, as described herein (e.g.
All or a portion of the fastener can be coated and/or made with a material that will encourage tissue ingrowth to create a seal and to promote a strong and durable attachment. All or a portion of the fastener can be coated and/or made with a swellable material to create a seal and/or to spread out the force of attachment over a greater surface area, thereby reducing the pressure on the tissue. All or a portion of the fastener can be coated and/or made with a material that is biodegradable or bioresorbable. Examples of such coatings materials are described in the parent application, Ser. No. 10/698,148.
In some of the examples herein and in the prior application, the T-tag fasteners are placed transmurally or through a full thickness plication. In an alternate method, an intramural T-tag can be placed submucosally, preferably in the muscularis, where the T member would anchor the suture. The T would have a structure that is all or partly biodegradable. In this way, after the initial weakening of the tissue that occurs soon after the initial suturing, all or part of the T would degrade leaving the suture (with or without some supporting structure) securely anchored in the tissue by fibrotic tissue that would form around the degrading T.
Following are descriptions of attachment devices and other means for securing an implantable device within the gastrointestinal system. The implantable devices and/or attachment means can be configured to avoid causing excessive pressure within the tissue by having compliance that is compatible with the gastrointestinal tissues where it is attached. Device compliance can also be important for providing a leak free seal between an implanted device and the tissue at the attachment point. Compliance can be provided in the radial or circumferential direction and/or in the vertical, axial or longitudinal direction. The device may have different compliance in different regions to be compatible with the tissue at the attachment point and at other portions of the gastrointestinal tract through which it runs. The device may have different compliance in different directions to be compatible with the tissue at the attachment point while simultaneously achieving other goals of the device. Compliance can be provided in a number of different ways. One way is by elastic or plastic deformation of the device and/or the attachment means. Another way is by a mechanical decoupling that allows relative movement between the device and the attachment points, and/or between the attachment points themselves, without transmitting excessive force or pressure to the tissue.
In some clinical situations, it will be desirable to match compliance between the device and the tissue to which it is attached. In other situations, based upon the clinical situations, it will be desirable to provide a device with higher or lower compliance than the tissue to achieve certain objectives. For example, maintaining the position of the proximal end of an attached sleeve device will require a device that is relatively noncompliant in at least the axial direction.
The implantable devices and/or attachment means described herein can utilize one or more of the following features to modify the compliance:
Other features may be incorporated in such structures such as:
Certain methods for the use of such structures include:
Another strategy for avoiding excessive pressure on the gastric and esophageal walls and the complications of ischemia and pressure necrosis is to spread out (over a substantial surface area) and/or otherwise reduce the attachment force.
Preferably, the attachment ring 260 is compliant in the radial direction so that expansion and contraction of the stomach and esophagus due to contents and/or muscular action will not place additional, or actually reduce, stress on the attachment points. An elastomeric material, such as silicone or polyurethane that provides approximately 150% or more stretch in the radial direction is preferred. At the same time, the attachment ring can have enough lateral rigidity to act as a mounting platform for the gastrointestinal sleeve device and to resist downward movement due to the weight of the gastrointestinal sleeve device and its contents and peristaltic traction on the sleeve. The lateral rigidity of the attachment ring can be enhanced with radially oriented bending reinforcements, such as ribs or embedded reinforcement members 272. Alternatively, the attachment ring can be flexible and compliant and other means such as hooks, sutures staples, etc., can be used for sleeve attachment.
Another strategy for avoiding excessive pressure on the gastric wall at the attachment points is to reduce the weight that the device attachment must support. This can be accomplished with spiral or longitudinal reinforcement members and/or inflatable balloons for structural support, particularly in the gastric portion of the gastrointestinal sleeve device, as described in the prior application. These features will help to transfer some of the weight to other structures of the stomach such as the antrum or the pylorus and will reduce the tension on the attachment at the GEJ. Likewise, additional attachments points at other points in the stomach will help to reduce the tension on the attachment at the GEJ. Attachment at the pylorus or other points in the stomach will also provide an added measure of safety. If the primary attachment at the proximal end of a sleeve device ever came unfastened, these additional attachment points would prevent the sleeve device from passing through the pylorus and becoming lodged in the intestine.
Another strategy for avoiding excessive pressure on the gastric wall at the attachment points is to provide an axially “floating” attachment for the gastrointestinal sleeve device so that stress transferred to the esophageal or gastric walls can be minimized or controlled. For example,
An alternate means of implementing an axial floating attachment uses vertically mounted isolated sliding attachment members can be used as an attachment structure for an implanted device.
Once the attachment members 340 have been fastened to the stomach wall, the implantable device 120 is connected to them using a like number of sliding connectors 341 attached to the implantable device 120. The sliding connectors 341 are configured allow vertical movement of the implantable device 120 with respect to the attachment members 340 and the stomach wall. Stops or detents may be included to limit the vertical movement of the implantable device 120. In the example shown, the sliding connectors 341 are configured as channels that are slidably connected to rail-shaped attachment members 340. Other configurations of attachment members 340 and sliding connectors 341 are also possible.
The use of isolated attachments to attach a sleeve within the GI tract has been previously disclosed herein and in parent application, Ser. No. 10/698,148. Isolated attachment allows a maximum of relative motion between attachments with a minimum of force resisting that motion. As has been discussed, the attachments can be left in place for a time to heal and become secure prior to the attachment of a sleeve. This concept can be extended to the use of a cuff, which interfaces a replaceable sleeve with GI tissue. Isolated attachments can be placed in the GI tissue, a period of time can allow healing of these attachment points and then the reusable cuff can be fastened to the GI tissue using the previously placed isolated attachments.
The flexible attachment device 430 can be configured as a ring with an L-shaped cross section, with the upper leg of the L forming a cylindrical upper wall 432 and the lower leg of the L forming an annulus or inward-facing lower flange 434. The upper wall 432 is constructed to control, resist and/or recover from collapse due to forces in the stomach wall. In this embodiment the device can be constructed, all or in part, of an ingrowth encouraging material such as Dacron or Teflon (e.g. ePTFE). The material can be woven, knit, felted, expanded or otherwise prepared by means known in the vascular graft and surgical implant art. The material is optionally coated as described herein for encouraging ingrowth and/or resisting the attack of gastric secretions. The inner edge of the flange 434 is shaped to form a sleeve retention ring 436, which is preferably reinforced with a resilient wire 438 of e.g. stainless steel or NiTi. The flange 434 can be constructed of the same materials as the cylinder upper wall 432 or could be constructed from other materials including other biocompatible polymers such as silicone or polyurethane. The outer edge of the flange 434 where it meets the cylindrical upper wall is shaped to form a suture ring 440, also optionally reinforced with a resilient wire. Optionally, the reinforced suture area 440 can be displaced from this meeting point upward along the cylinder wall. In some embodiments, displacement of the suture attachment point can provide space for the sleeve interface. In these embodiments the tissue forming the attachment can provide a resilient sleeve retention, which may be particularly advantageous in preventing upward displacement of the sleeve interface.
Optionally, the upper edge of the cylindrical upper wall 432 is shaped to form a ring 442, optionally reinforced with a resilient wire 444 to help maintain the geometry of the attachment device and to help form a seal against the gastric wall. The inward-facing surfaces 446 of the cylindrical upper wall 432 and the flange 434 are configured for contacting a plication 448 formed in the gastric wall. Optionally, the cylindrical upper wall may have slits or cutouts to increase the flexibility or compliance of the attachment device. Optionally, all or a portion of the tissue contacting surfaces 446 may be made from or covered with a material that encourages tissue ingrowth. Optionally the tissue contacting surfaces 446 may include holes, cavities or opening that encourage tissue ingrowth. These holes, cavities and/or openings may optionally extend completely through the wall of the device.
Preferably, the entire structure of the attachment device 430 is collapsible and expandable so that it can be easily passed through the esophagus in a folded, compressed or collapsed state and re-expanded once it is in the patient's stomach. The attachment device 430 is attached to a plication 448 formed in the gastric wall using endoscopic methods with T-tag fasteners 130, sutures or other fastening means. The sutures or suture tails of the T-tag fasteners 130 may be tied around the suture ring 440, or fastened with snap cap or other suture lock.
In an alternate embodiment, the L-shaped cross section of the attachment device can be reversed so that the lower leg of the L forms an outward-facing lower flange with the sleeve retention ring located at the outer edge of the flange. This alternate geometry of the attachment device will be particularly useful for situations where the implanted device has a larger diameter than the attachment point, as discussed above. Other sleeve interface methods as described herein, the referenced provisionals, and the parent application can also be used as alternatives to an L-shaped flange.
Alternatively, the attachment device may include a means for capturing the upper flange of the sleeve device to reduce or eliminate relative motion between the sleeve device and the attachment device.
The attachment devices of
In other variations of these embodiments, the cylindrical walls can taper inward for attaching an implant device with a smaller diameter than the attachment device or they can taper outward for attaching an implant device with a larger diameter than the attachment device.
The cylindrical attachment device 480 of
The flexible cylindrical attachment device 480 of
Similar results may be accomplished by using a symmetric geometry and an asymmetric flexibility where a more flexible lesser curve side could maintain a similar pressure with 180 degree deflection as seen on the greater curve side with 90 degree deflection.
The flexible cylindrical attachment device 480 can be constructed from a number of materials and methods. By way of example,
In some clinical circumstances, it may be desirable to implant a treatment device that is larger than the attachment means.
Alternatively, the attachment device can provide only a mechanical attachment and the gastrointestinal sleeve device can provide a seal against the gastric wall or a separate sealing device may be provided. In this case, instead of an impermeable skirt, the attachment device may have a suspension frame that provides a mechanical attachment between the attachment ring and the gastrointestinal sleeve device. The suspension frame may be made, for example, from wires or mesh or filaments that provide the necessary mechanical strength, but do not provide a seal. The skirt portion of the attachment device may also be constructed with an impermeable membrane over a suspension frame of this type. Optionally, the suspension frame may include adjustable length tethers for adjusting the distance between the attachment ring and the gastrointestinal sleeve device.
Preferably, the entire structure of the attachment device 420 is collapsible and expandable so that it can be easily passed through the esophagus in a folded, compressed or collapsed state and re-expanded once it is in the patient's stomach. Optionally, the final expanded diameter may be adjustable. Optionally the device 420 may be highly compliant and stretchable where it is attached to the gastric wall.
Although this example shows the implanted device mounted downstream or below the attachment device, in some clinical situations it may be desirable to mount an implant device upstream or above the attachment device. For example, an attachment device in the vicinity of the pylorus may be used to anchor an implant device in the stomach.
With (1) a device system where a primary attachment such as a cuff is placed in a tubular duct, e.g. at the GEJ, and a secondary device such as a gastrointestinal sleeve is removably attached to the primary attachment device and (2) placement of the system with a coaxial procedure, e.g. an endoscope passed down the esophagus, placement of the secondary device within the lumen of the primary device can be a simpler approach. However, certain advantages could be obtained if the secondary device were mounted on the exterior of the primary device. Various sleeve geometries with the sleeve portion of the interface being smaller diameter and internally coaxial to the cuff have been previously described.
All of the configurations can be inverted such that the sleeve is of larger diameter and external to the cuff. Similarly, other interface designs such as hooks and eyes disclosed herein can be configured with the sleeve of a larger diameter than the primary mounting cuff.
If the proximal portion of the sleeve 552 were less compliant than the distal portion of the cuff 550, internal pressure would press the wall of the cuff 550 into sealing contact with the sleeve 552. In this situation, the seal will be maintained so long as the sleeve 552 stretches less than the cuff 550 as internal pressure increases. Also the distance the cuff 550 and the sleeve 552 overlap can be adjusted to improve interface performance related to leak resistance and/or retention strength. This system can also allow holes or perforations in either the cuff or sleeve in the region of overlap of an unperforated surface without allowing leaks. These holes or perforations may be used to attach the components.
The functions of attachment and sealing can be separated, for example highly compliant attachment can be placed at the GEJ and a sealing connection can be placed upstream in the esophagus. The compliant attachment can be accomplished with gathered or pleated stretchable material. The sealing connection can be configured similar to a covered expandable or self-expanding stent. These separate structures can be improved by structure (e.g. one or more vertical bellows-like pleats) that would allow relative vertical displacement of the sealing and attachment zones.
Similarly, the restrictive component of a morbid obesity treatment system has usually been depicted as being at or distal to the attachment point of the device. Since restrictions are most effective when coupled with a constant or restricted volume proximal to the restriction this suggests that little or no compliance would be preferred at the attachment. Alternatively, the compliance of the attachment can be factored into the definition of the restricted volume. In some clinical situations where high compliance is desirable it could be preferable for the restricted outlet of the restricted volume be placed proximal to a compliant attachment e.g. attachment 562 in
Compliant attachment means can be used at or near the GEJ or cardia of the stomach. These attachments can be connected to a restrictive component, which is maintained in a sealing connection with the walls of the GI tract proximal to the attachment. The means used to connect the restrictive component (a device that has a restrictive opening and seals with the walls of the GI tract) do not need to be impervious to masticated food. Sealing means can be passive (for example, an oversized device in a relatively smaller tubular duct) or active (for example, suture, anchor, staple, etc.) However, this sealing is not the primary attachment. It is merely to maintain a seal while the primary compliant attachment resists other forces.
Compliance can be problematic if applied to a restrictive GI sleeve system if the volume of the system proximal to a restriction is desired to be limited to a clinically relevant volume. To this end it can be desirable that increases in volume of this compliant attachment area are minimized.
Another structure that can combine compliance with limits in volume increase is a woven mesh.
Another strategy for avoiding excessive pressure on the gastric or esophageal walls and the complications of ischemia and pressure necrosis is to create an extragastric structure for fastening a gastrointestinal sleeve device, mounting ring or other device to. The extragastric structure supports the device and spreads out the force of attachment without any pressure pinching on the tissue to cause ischemia.
The segments 652 may be free floating, which has the advantage of allowing for expansion and contraction of the stomach and esophagus. Alternatively, a means may be provided for linking the segments 652 end-to-end to form a more solid ring, which has the advantage of distributing the forces on the tissues more effectively. One way to do this is by making the segments 652 with interlocking ends so that the segments can be joined together into a ring after they are inserted through the wall in the region of the GEJ.
In an alternate method, the segments can be inserted laparoscopically and assembled into a ring around the exterior of the GEJ. Once the extragastric structure is in place, sutures or other fasteners can be put through the gastric or esophageal wall to capture the ring and attach a gastrointestinal sleeve device, mounting ring or other device to it.
In an example of a method using an extragastric structure, a 4 cm diameter extragastric support ring 650 can be joined to a 3 cm diameter inner attachment ring 200 with 0.5 cm spacers 662 between the inner and outer rings. The gastric and/or esophageal wall, which is typically about 3-5 mm thick at the GEJ, will be captured between the inner 200 and outer 650 rings with very little pressure at the attachment. Furthermore, any force or tension transferred to the rings from a gastrointestinal sleeve or other device attached to them will be distributed around the periphery of the organ by the inner and outer rings, reducing the tension and attachment pressure on the tissue.
Other methods may be used for forming and/or placing extragastric structures via a peroral route. In one example, a guidewire with a preset curve is inserted through a needle puncture in the wall in the region of the GEJ. The guidewire can be configured as a small diameter wire, constructed for example of SSt or NiTi, with a ball or knob on the distal end to avoid inadvertently piercing the tissues with the wire. Optionally, the guidewire may be coated with a low friction coating. The guidewire is curved so that it will curl around the outside of the GEJ to form a 360 degree loop. Optionally, a wire snare or other tool inserted through the same needle puncture or an adjacent needle puncture may be used to capture the distal end of the guidewire as it comes around full circle. A tubular extragastric member is then inserted over the guidewire so that it makes a complete circle around the GEJ. Optionally, the leading and trailing ends of the extragastric member may be joined together to form a continuous loop. Sutures, T-tags or other fasteners can be inserted through the wall at selected points around the inside of the GEJ to attach to the extragastric member. Once the extragastric member is securely in place, the guidewire can be withdrawn. Alternatively, the extragastric member itself may be made with a present curve so that it will curl around the outside of the GEJ to form a 360 degree loop without the aid of a guidewire.
In an alternative method, suture loops or other fasteners with loops on them could be inserted through the wall of the GEJ prior to insertion of the guidewire and/or extragastric member. The guidewire and/or extragastric member will be passed through the loops on the exterior surface of the GEJ; then the loops can be tightened to fasten the extragastric member in place. The sutures or fasteners could be used to directly or indirectly fasten another device to the extragastric structure as described above.
In a variation on this method, inflatable balloons surrounded by suture loops or the like can be inserted through the wall at the GEJ and inflated on the extragastric surface. The balloons would serve to move any adjacent tissues out of the way and to facilitate passage of the guidewire through the suture loops. In one embodiment, the wire would puncture through the balloons as it passes through the loops. In another embodiment, the balloons could be deflated, leaving the loops open for the wire to pass through. In yet another embodiment, the balloons could be configured so that they would hold the loops open for the wire to pass through without occluding the loops. For example, small toroidal balloons or U-shaped balloons could be used to hold the loops open. Likewise, a toroidal or U-shaped mechanical support can be used in place of the balloons.
In another variation on this method, a wire or filament with a magnet or magnetic material at the tip can be inserted through a needle puncture at the GEJ. A magnetic or electromagnetic manipulator inside the esophagus can be used to guide the magnetic tip around the exterior of the GEJ to form a loop. The wire or filament may have a preset curve as in the previous examples to facilitate this step. Once the extragastic structure is in place, the magnetic tip of the wire can be withdrawn in small increments and used to guide the placement of sutures or other fasteners into or around the extragastric structure using a magnetic detector.
In some clinical situations the gastroesophageal junction, or GEJ, is a preferred attachment point for a gastroesophageal sleeve device or attachment device. Attachment at the GEJ excludes all gastric secretions from the interior of the gastrointestinal sleeve device to separate ingested food and liquids in the sleeve device from all digestive secretions. The gastroesophageal junction is one of the preferred attachment sites because the tissue wall is relatively thick at this location and it is relatively easy to access via a per oral route. More specifically, the non-glandular tissue at the squamo-columnar junction (a zone of tissue that is considered to be at the transition of the esophagus to the stomach that is near the GEJ) is the strongest tissue in this region and is currently thought to be the best place to attach a device, for example using T-tags, sutures or other fasteners.
In some clinical situations it may be beneficial to prestrengthen the tissue prior to implantation of a device such as a gastrointestinal sleeve device. For example, energy can be delivered to by RF, ultrasound or other known method to induce an inflammatory, coagulative or necrotic tissue strengthening reaction. Alternatively, placement of material in the muscularis of the stomach wall could generate a foreign body reaction that would progress from inflammation, to granulation of tissue and then to fibrosis. The tissue may initially weaken due to the inflammatory response, but the resulting fibrotic growth will strengthen the tissue. This effect could be enhanced by the choice of material an/or coatings, e.g. an acidic material or coating. The materials could be delivered endoscopically with a needle device through the biopsy channel of an endoscope. The needle delivery device could optionally also deliver an ink, dye or other marking means to facilitate location of the prestrengthened areas. Tissue reaction could take place in days, with 7-14 days being an approximate delay between prestrengthening and attachment procedures.
Material injectable to prestrengthen tissue could be:
All of the prestrengthening strategies described could be used also be applied at the time of the attachment procedure to enhance strength of the attachment.
The methods and apparatus described for tissue strengthening would be expected to result in some degree of tissue thickening as new collagen and fibrotic material will be deposited and/or generated at the location of the foreign body reaction. This tissue thickening would be expected to continue as long as viable tissue receives additional stimulus. This can be controlled by use of timed release chemical stimulants and stimulants with known and potentially controllable half lives. Tissue thickening and tissue strength may be related and may facilitate durable attachment, however tissue thickening may be an inherently desirable result in some clinical situations.
Currently, tissue bulking agents are injected at or near the GEJ to treat GERD. Injection of non-bulking materials that initiate tissue thickening could accomplish the same end result. If the thickened tissue was, by itself or in conjunction with a supporting structure, to form a restrictive stoma, there could be specific advantages relative to a mechanical stoma.
In the case of a flexible ring mounting cuff, for example those shown in
Tissue prestrengthening and/or thickening can be accomplished by inserting a fibrosis inducing agent with a suture tail attached to it. The fibrosis inducing agent will preferably also act as a scaffold for strength. The tail will allow easy identification of the location that has been strengthened for retrieval or guidance of follow on attachment procedures. Once tissue has strengthened, cuff and sleeve can be placed in a single combined procedure as the prestrengthened tissue will not require additional healing time to hold.
Other approaches to induce tissue prestrengthening and/or thickening include:
Circumferential ablation (RF, microwave, ultrasound, etc)
Over-dilation
Circumferential abrasion
Circumferential exposure to agent
An advantage of a circumferential area of tissue strengthening is that it only needs to be located along a vertical axis for subsequent attachment procedures.
Alternately or in addition to the above pre-strengthening of tissue, tissue can be treated to reduce its ability to move or stretch. This can be advantageous in that tissue that has limited stretch or motion may have less impediments to attachment. Tissue that has limited stretch or motion may impose fewer forces on an attached device and therefore impose less pressure that may lead to attachment failure. Furthermore, tissue that has limited stretch or motion may allow attachment of less compliant devices which can provide for advantages foe example simplified sealing.
Means described above to strengthen tissue can also help to limited GI tissue stretch and motion. Other methods that could be applied to reducing stretch and motion, and also for pre-strengthening, include the application of energy for example, by RF, ultrasound or laser. Means that include time release elements as well known in the art of drug eluting vascular stents and birth control devices can be used to provide and/or maintain a long lasting effect (reducing motion and stretch). Such time release means can optionally be combined with fasteners, permanent or replaceable attachment cuffs or proximal sleeve interfaces. Such time release means can optionally be combined with permanently implanted pre-strengthening materials where the material might be incorporated into the tissue to provide increased strength.
In some clinical situations when using a transmural attachment, the wall of tissue may thicken after placement of the attaching device.
In some clinical situations it can be advantageous to maintain the attachment on the surface of the tissue to take advantage of the added strength of the thickened wall.
One configuration of material that could have advantageous performance would:
This performance would be based upon a clinical situation where tissue proliferation (wall thickening) occurs between days 2 and 14.
Alternatively, the material could:
A portion of the suture 522 is folded 3× as shown in
Lengthening could also be accomplished with a coaxial system.
The principle of shortening/lengthening of a braided mesh can be applied to an automatically lengthening suture.
An optimized yielding suture system for GI attachment could have differing responses to short impulse and long continuous loads. Viscoelastic polymer systems such as Tempurfoam resist short term impulse loads and yield to slow steady long term loads. Resistance to short term loads and yielding to long term loads could be advantageous in clinical situations where there can be temporary short term loading due to overeating while yielding to long term loads could relieve overpressurization of tissue to enable tissue perfusion to avoid tissue necrosis due to pressure and/or ischemia.
In other clinical situations yielding to short term transient loads may facilitate secure attachment when coughing, retching, swallowing etc. occur. Resistance and/or recovery—in the face of lower and slower forces can return the suture to a normal length, facilitating leak free securing of an attachment.
Yield points and/or recovery points should be selected so attachment forces do not exceed the acute pull out force of a suture and/or T-tag. Acute pull out forces can be in the range of 3-9 pounds depending on the suture/T-tag configuration. This is of particular concern for short term impulse loads. Loads applied over longer periods should be selected to avoid ischemia and/or pressure necrosis. These forces can be very low and can be less than 1 pound.
In an ideal situation, a suture system will recover to a set length which results in no force applied to the tissue over extended periods of time. Attachment can resist forces between necrosis force/pressure if they are transient and allow tissue time for healing and/or recovery. A system whereby recovery after yielding occurs in a non-continuous manner thereby allowing tissue healing and/or recovery could be desirable in many clinical situations. This may be accomplished by materials that respond to outside stimulus (e.g. electrical, chemical, magnetic, etc.) that can be applied intermittently.
While the present invention has been described herein with respect to the exemplary embodiments and the best mode for practicing the invention, it will be apparent to one of ordinary skill in the art that many modifications, improvements and subcombinations of the various embodiments, adaptations and variations can be made to the invention without departing from the spirit and scope thereof.
This patent application claims the benefit of U.S. provisional patent application 60/534,056, filed on Dec. 31, 2003, by Kagan et al. for Devices and Methods for Treating Morbid Obesity, U.S. provisional patent application 60/569,442, filed on May 7, 2004, by Kagan et al. for Devices and Methods for Treating Morbid Obesity and U.S. provisional patent application 60/613,917, filed on Sep. 27, 2004, by Kagan et al. for Devices and Methods for Attachment of a Gastrointestinal Sleeve. This patent application is also a continuation-in-part of U.S. utility patent application 10/698,148, filed on Oct. 31, 2003 by Kagan et al. for Apparatus and Methods for Treatment of Morbid Obesity. The devices and methods described herein can be combined with and/or used in conjunction with the apparatus and methods described in these prior applications. These and all patents and patent applications referred to herein are hereby incorporated by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 60534056 | Dec 2003 | US | |
| 60569442 | May 2004 | US | |
| 60613917 | Sep 2004 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10698148 | Oct 2003 | US |
| Child | 11025364 | Dec 2004 | US |
