The present invention generally relates to medical systems and apparatus and uses thereof for treating obesity and/or obesity-related diseases, and more specifically, relates to gastric band devices and drive systems for operating gastric band devices.
Adjustable gastric banding apparatus have provided an effective and substantially less invasive alternative to gastric bypass surgery and other conventional surgical weight loss procedures. Despite the positive outcomes of invasive weight loss procedures, such as gastric bypass surgery, it has been recognized that sustained weight loss can be achieved through a laparoscopically-placed gastric band, for example, the LAP-BAND® (Allergan, Inc., Irvine, Calif.) gastric band or the LAP-BAND AP® (Allergan, Inc., Irvine, Calif.) gastric band. Generally, gastric bands are placed about the cardia, or upper portion, of a patient's stomach forming a stoma that restricts the food's passage into a lower portion of the stomach. When the stoma is of an appropriate size that is restricted by a gastric band, food held in the upper portion of the stomach provides a feeling of satiety or fullness that discourages overeating. Unlike gastric bypass procedures, gastric band apparatus are reversible and require no permanent modification to the gastrointestinal tract.
Existing gastric bands periodically require adjustment to maintain an effective constriction about the portion of the patient's stomach to be constricted. Such adjustments are desired to account for changes in the stomach tissue, reduction of fat, or other factors causing movement and/or size change of the portion of the patient's stomach to be constricted. Some attempts have been made to allow for such adjustment of gastric bands. For example, hydraulic gastric bands utilize a fluid such as saline to fill an inflatable portion of the gastric band using a subcutaneous injection port of the gastric band. Adjustments to the amount of inflation may be made by injecting or extracting the fluid through the patient's skin into or out of the injection port, which then directs the fluid into or out of the inflatable portion of the gastric band. These types of adjustments may be undesirable because of the discomfort caused by the injections.
Further, other types of gastric bands include motorized systems designed to alleviate the pain and discomfort associated with the fluid controlled bands. Examples of motorized gastric bands are illustrated and discussed in Forsell, U.S. Pat. No. 6,470,892, and Dargent, et al., U.S. Pat. No. 6,547,801. Such gastric bands may be controlled telemetrically, through control and/or power signals transmitted from outside the patient's body to inside the patient's body. A physician, or the patient, may control the adjustments made to the band. The physician or patient may easily and remotely adjust the band, without having to insert a needle into the patient's body.
However, motorized gastric bands have drawbacks, mostly deriving from the requirement that a small motor be placed within the patient's body for an extended period of time, and be required to operate effectively for an extended period of time. It is preferable the motor be small, to allow the gastric band to easily fit within the patient's body. A small motor also reduces the total displacement of the gastric band within the patient's body. Yet, a small motor may not be durable, and may not be able to exert a great force against the patient's stomach. It is also preferred the motor be powerful, to exert a large constrictive force to the patient's stomach over a series of repeated constrictions. Exotic and expensive motors may be used to provide such a desired effect. However, the gastric band itself may also be structured to assist a motor during operation, to increase the power efficiency and durability of the motor. A well-designed gastric band may not only promote efficiency and durability, but may also generally improve performance and simplicity of the device, while reducing production costs.
Accordingly, it is desirable to develop a gastric band device that increases performance of the gastric band during operation, and allows the gastric band to operate over an extended period of time without failure. It is additionally desirable to develop drive systems and transmission systems that more efficiently deliver a constrictive force to the patient's stomach.
Generally described herein are gastric band devices and drive systems for operating gastric band devices, that seek to improve on gastric band devices and drive systems as known in the art. The gastric band devices and drive systems discussed in this disclosure seek to give effect to a series of desired characteristics that improve upon existing gastric band technology.
Such desired characteristics may include a small size. It is generally desired that the gastric band devices and drive systems be capable of passing through a 15 mm standard trocar device.
Other desired characteristics may include a speed requirement. It is generally desired that the gastric band device be capable of fully constricting a patient's stomach in no more than six minutes, and preferably between two to three minutes or less.
Other desired characteristics may include a reliability requirement. The gastric band device should be able to achieve over 1,000 constrictions, or preferably over 50,000 constrictions without failure.
Other desired characteristics may include a large-scale manufacturing requirement. A large number, on the order of thousands of gastric band devices, should be easily and reliably produced over a year long period.
Other desired characteristics may include a structural rigidity requirement. The gastric band device should be structured to withstand forces caused by the natural movements of the patient's body and digestive tract.
Other desired characteristics may include a biocompatibility and MRI (Magnetic Resonance Imaging) compatibility requirement. The gastric band device should be corrosion resistant, and should be able to resist a sterilization cycle of 132 degrees Celsius during 20 hours. In addition, the gastric band device should be able to be cut with standard surgical cutting instruments. The gastric band device should also preferably be MRI compatible up to 3 Tesla.
Other desired characteristics may include a power requirement. The gastric band device should be able to operate initially at no more than approximately 100 milliwatts to form a diameter change in from approximately 29 millimeters to 15 millimeters. In addition, the motor system should be able to detect blocking of the constriction process, and should be able to retain a degree of constriction when unpowered. Furthermore, the adjustment cycle should be divided into a minimum of 10-20 steps.
These desired characteristics are representative, and do not limit the scope and breadth of the gastric band devices and drive systems discussed throughout this application. However, the gastric band system may be configured to achieve these desired characteristics using certain design principles.
For example, the total friction of the gastric band device should be reduced, to increase total power efficiency and longevity of the device.
In addition, a periodic or pulsing action may constrict the patient's stomach more effectively.
Corrugated materials may enable a large deformation of the material in response to a relatively low applied force.
A variable transmission may promote power efficiency, as a low force should be present during initial constriction, and a high force should be present during the latter parts of constriction. The patient's stomach generally increases resistance to constriction as is it compressed further. A variable transmission may also promote a faster initial constriction and a slower latter constriction.
A gastric band device may be biased to naturally exert a force towards the stomach, or to a middle point of the constrictive cycle, to assist the motor in constriction.
A multi-step, or ratcheting-type process may decrease the total power needed to constrict the stomach. In addition, a periodic or pulsating action may reduce the total power needed to constrict the stomach.
A substantially central, evenly distributed constrictive force reduces the power needed to constrict the patient's stomach. In response to an even force, the stomach is not drawn in one direction, but rather is compressed simultaneously from all radial directions, towards the center of the constricted region.
The gastric band may be designed to have asymmetric activation, where the closing of the gastric band may require a high force and a low speed, and the opening may require a low force and a high speed.
The gastric band may be designed to have a substantially constant outer diameter, preventing disturbance of nearby tissue. Long term implantation of a gastric band device can cause tissue to grow around the device. A constant diameter, and/or a constant cross section may prevent deformation of these surrounding tissues.
The gastric band should be structured to be stabilized against axial forces, such as the force exerted when the patient vomits. A stabilized gastric band prevents damage to the gastric band and movement of the gastric band, in response to such axial forces.
The gastric band should be cushioned, or have a wide structure, to distribute the force from the gastric band evenly to the patient's stomach. A wider and softer gastric band may more evenly compress the patient's stomach, preventing damage to the stomach.
The gastric band should be covered with a membrane, to promote biocompatibility and aesthetic functions.
In light of these design principles, the following gastric band devices and drive systems are disclosed in this application to implement these principles and others and to improve on prior gastric band systems.
In one embodiment, the gastric band device comprises a plurality of force transmission devices, or lever devices, positioned to extend towards a central region of the gastric band, when the gastric band is positioned in a loop around a portion of the patient's stomach. Each lever device has an end extending towards the central region of the gastric band, substantially perpendicular to the inner surface of the gastric band. The lever devices apply a constrictive force to the patient's stomach.
In one embodiment, a drive system is configured to drive a gastric band device. The drive system comprises a motor system and a drive element being driven by the motor system. In various embodiments of the drive system, the motor system may comprise a motor and a series of engaging mechanisms, configured to drive the drive element. In addition, the motor system may be configured to drive a single drive element or multiple drive elements. The drive elements may be driven in opposite directions. Also, the motor system may be configured to rotate or twist a drive element. Further, the drive element may comprise a strap-like band, or a cord. In addition, the drive element may comprise a ring, a screw, or a string-of-pearl device. The motor may be an AC or DC motor, or may have piezoelectric properties. In addition, the motor may be shaped to have a narrow diameter. The motor may be shaped to have a hollow axis. The motor may be positioned external to the body. The drive system may include a position measurement system.
In one embodiment, the gastric band device comprises a cord coupled to a cylindrical transmission device. The cord extends around a portion of the patient's stomach and applies a degree of constriction to the patient's stomach. The cord wraps around the cylindrical transmission device. Rotation of the cylindrical transmission device tensions the cord and constricts the stomach. The cylindrical transmission device may be configured to vary a force output by the cord in response to a constant input force applied to the cylindrical transmission device.
In one embodiment, the gastric band device comprises a plurality of force transmission devices, or slide supports, positioned to extend towards a central region of the band, when the band is positioned in a loop around a portion of the patient's stomach. Each slide support has an end extending towards the central region of the band, substantially perpendicular to the inner surface of the band. The slide supports apply a constrictive force to the patient's stomach.
In one embodiment, the gastric band device comprises a plurality of force transmission devices, or springs, positioned to extend towards a central region of the gastric band, when the gastric band is positioned in a loop around a portion of the patient's stomach. Each spring has an end extending towards the central region of the gastric band, substantially perpendicular to the inner surface of the gastric band. The springs apply a constrictive force to the patient's stomach.
In one embodiment, the gastric band device comprises a plurality of force transmission devices, or mechanical actuators, positioned to extend towards a central region of the gastric band, when the gastric band is positioned in a loop around a portion of the patient's stomach. Each mechanical actuator has an end extending towards the central region of the gastric band substantially perpendicular to the inner surface of the gastric band. The mechanical actuators apply a constrictive force to the patient's stomach.
In one embodiment, the gastric band device comprises a plurality of force transmission devices, or hydraulic piston actuators, positioned to extend towards a central region of the gastric band, when the gastric band is positioned in a loop around a portion of the patient's stomach. Each hydraulic piston actuator has an end extending towards the central region of the gastric band, substantially perpendicular to the inner surface of the gastric band. The hydraulic piston actuators apply a constrictive force to the patient's stomach.
In one embodiment, the gastric band device comprises a spring extending in a loop around a portion of the patient's stomach. The spring may be biased to form a ring having a rest diameter (a diameter the ring would have in the absence of an applied force) that constricts the patient's stomach. The spring bias assists the motor to increase the degree of constriction applied the patient's stomach.
In one embodiment, the gastric band device comprises a gastric band configured to be positioned in a loop around a portion of the patient's stomach. An axis extends through the center of the loop. The gastric band has a pivotal portion and a rotatable portion positioned at a distance from the pivotal portion along the axis. The rotatable portion rotates to compress the patient's stomach, and vary a radial distance of the rotatable portion from the axis.
In one embodiment, the gastric band device comprises an incompressible body configured to apply a degree of constriction to the patient's stomach. The incompressible body deflects in response to a compression force applied to the incompressible body. The deflection compresses the stomach. The incompressible body may encircle a portion of the patient's stomach.
In one embodiment, the gastric band device comprises a rotatable constriction device configured to be positioned in a loop around a portion of the patient's stomach. The rotatable constriction device has a first end and a second end, the first end being rotatable relative to the second end. The rotation of the first end relative to the second end causes the rotatable constriction device to twist, causing a diameter of the rotatable constriction device to decrease. The decreased diameter increases a degree of constriction applied to the patient's stomach.
In one embodiment, the gastric band device comprises a stretchable constriction device configured to be positioned in a loop around a portion of the patient's stomach. The stretchable constriction device is capable of stretching along an axis, or in a direction radial to the axis. The stretchable constriction device is structured such that a change in the axial length of the stretchable constriction device varies the radial diameter of the stretchable constriction device. A stretching or compression force may be applied to the stretchable constriction device to vary the radial diameter.
In one embodiment, the gastric band device comprises a plurality of force transmission surfaces configured to encircle a portion of the patient's stomach. The force transmission surfaces form an inner region containing, or being complementary with, the portion of the patient's stomach to be constricted. A sliding, or translating motion of the force transmission surfaces relative to the inner region varies the size of the inner region and the degree of constriction applied to the stomach. The force transmission surfaces may be coupled to a gastric band, and configured to slide relative to the gastric band.
In one embodiment, the gastric band device comprises a cord configured to encircle a portion of the patient's stomach. The cord may form loops around the patient's stomach. A tension force may be applied to the cord to increase the degree of constriction applied by the cord to the patient's stomach.
In one embodiment, the gastric band device comprises a collar configured to encircle a portion of the patient's stomach. The collar may have two ends, the two ends being positioned at a distance from each other to define a degree of constriction applied by the collar to the patient's stomach. The two ends may be connected with a connector device, or a cord. The cord may be routed through routing devices to connect the ends of the collar together. The routing devices may comprise leverage devices or mechanical advantage devices.
In one embodiment, the gastric band device comprises an electroactive polymer device configured to apply a force to the patient's stomach. The degree of force varies in response to a voltage applied to the electroactive polymer device. The electroactive polymer device may change in size, dimensions, or shape, to vary the force applied to the patient's stomach. The electroactive polymer device may comprise a gastric band extending in a loop around a portion of the patient's stomach. The gastric band may deform to vary the degree of constriction applied by the gastric band to the patient's stomach.
The present invention relates to gastric band devices configured to apply a degree of constriction to a patient's stomach, and drive systems configured to vary the degree of constriction applied by the gastric band devices to the stomach.
The band 116 (shown in
The purpose of constricting the patient's stomach is to assist the patient in losing weight. A constriction of the patient's stomach forms a stoma that serves to restrict the flow of food through the patient's digestive tract. A restricted flow of food will more quickly produce satiety signals sent to the patient's brain when the patient eats. The patient will feel full more quickly while eating and will eat less. The decreased food intake will cause the patient to lose weight.
It is preferable that the degree of constriction applied to the patient's stomach be variable, so that a high degree of constriction or a low degree of constriction is not always applied to the patient's stomach. A high degree of constriction may be desirable during the time the patient is eating, but may be undesirable during other times, for example, when the patient is sleeping. In addition, the degree of constriction may need to be adjusted according to various changing biological characteristics of the patient, including a varied size of the stomach. Furthermore, the degree of constriction may need to be changed in order to control the rate of the patient's weight loss. A physician may need to monitor the degree of constriction, and vary the degree of constriction frequently over an extended period of time.
The gastric band device 100 is designed to be inserted laparoscopically into a patient's body, meaning that the gastric band device 100 is inserted using laparoscopic tools. Prior to insertion, the gastric band device 100 is configured such that the first end 118 of the band 116 (shown in
The grip flange 104 provides a grip point for the physician, to allow the physician to manipulate the gastric band device 100 with laparoscopic tools. The grip flange 104 extends outward from one end of the clip 102 and is made flexible to aid the physician during implantation of the gastric band device 100. The flexibility of the grip flange 104 also prevents the clip 102 from disengaging if the grip flange 104 is forced or deflected in a direction after the gastric band device 100 is implanted.
The physician may also position the antenna pod 112 within the patient's body after the band 116 (shown in
The antenna pod 112 is preferably positioned within the patient's body, but near the outer surface of the patient's body, for example, near the patient's sternum. The antenna pod 112 is positioned near the outer surface of the patient's body so that it more easily receives control and/or power signals sent telemetrically from an external controller (not shown). The antenna pod 112 may also more easily send signals telemetrically to the external controller if it is positioned near the outer surface of the patient's body.
The control and/or power signals received by the antenna pod 112 are processed within the antenna pod 112 and are transmitted to a motor system 158 (shown in
The motor system 158 (shown in
The mechanism used to vary the degree of constriction includes a band 116 and a plurality of force transmission devices, or lever devices 122 coupled to an interior surface of the band 116.
The band 116 has a first end 118 and a second end 120, and is configured in the shape of a loop around a portion of the patient's stomach, as discussed in relation to
The band 116 has a substantially strap-like, or lengthened rectangular shape. The band 116 is made from a material being strong, yet flexible to allow the band 116 to be formed into a loop using laparoscopic tools. For example, the band 116 may be made from a durable plastic, or the like.
The band 116 may be formed from two bands, an outer band 128 and an inner band 130, or equivalently referred to as a first band 128 and a second band 130. The inner band 130 may be slidably coupled to the outer band 128, and may be positioned against an interior surface of the outer band 128. The inner band 130 is concentric with the outer band 128 and both have a substantially strap-like shape. The inner band 130 is configured to slide along the interior surface of the outer band 128 and slide, or rotate, around a circumference formed by the outer band 128. The inner band 130 is configured to slide along the interior surface of the outer band 128 substantially free of friction.
A plurality of retainer devices 132 comprising clamps, latches, or hooks may be integral with the outer band 128 and extend over a portion of the inner band 130. The retainer devices 132 may slidably couple the inner band 130 to the outer band 128, preventing movement of the inner band 130 in a direction away from the outer band 128, yet allowing sliding movement of the inner band 130 in a direction along the outer band 128.
It is understood that embodiments of the present invention may include a band 116 having various shapes equivalent to the shape shown in
A plurality of force transmission devices, or lever devices 122 as shown in
The second end 142 of the lever device 122 defines the boundaries of the inner region 101. Each lever device 122 is configured to exert a force against the inner region 101, or against the portion of the patient's stomach being complementary with the inner region 101. In other words, the second end 142 of each lever device 122 presses against the portion to the patient's stomach, to apply a degree of constriction against the patient's stomach. The degree of constriction is related to the size of the inner region 101 defined by the second ends 142 of the lever devices 122.
In the embodiment shown in
In the embodiment shown in
A pivot device 131 is positioned at the first end 148 of the first lever arm 124. The pivot device 131 may comprise a cylindrical-shaped device that rotates within a cylindrical-shaped housing. It is understood the pivot device 131 may be equivalently replaced with any device allowing the first lever arm 124 to pivot relative to the band 116.
In the embodiment shown in
The second lever arm 126 has a substantially columnar or mast-like shape, with the first end 144 of the second lever arm 126 having a forked shape. The forked shape forms two attachment points connecting the second lever arm 126 to the band 116. In the embodiment shown in
Both the first lever arm 124 and the second lever arm 126 are made of rigid material, such as a hard plastic or metal. The generally rigid material allows the arms 124, 126 to be sturdy and not deform when a force is transmitted to the patient's stomach.
The connection between the first lever arm 124 and the second lever arm 126 forms an interior region 136 having a generally triangular shape. This interior region 136 is bounded on three sides by the first lever arm 124, the second lever arm 126, and the band 116.
The connection between the first lever arm 124 and the second lever arm 126 also produces an extended portion 125 (shown in
The connection between the first lever arm 124 and the second lever arm 126 also produces an angle 168, illustrated in
The first end 148 of the first lever arm 124 may pivotally be coupled to the inner band 130 via a pivot device 131. In addition, the first end 144 of the second lever arm 126 may pivotally be coupled to the outer band 128 via a pivot device 133. As the inner band 130 may be slidable relative to the outer band 128, the position of the first lever arm 124 may vary relative to the position of the second lever arm 126, based on the relative movement of the inner band 130 and the outer band 128.
In the embodiment shown in
The motor system 158 may comprise any standard mechanical motor system capable of driving a drive element (or element to be driven) in a particular direction. In the embodiment shown in
Additional elements shown in the embodiment of
The gastric band device 100 may also include a membrane 106, which provides biocompatibility between the gastric band device 100 and the patient's stomach. The membrane 106 may be made from a flexible material, such as silicone, which allows the membrane 106 to stretch to conform to the motion of the lever device 122. In addition, the membrane 106 also serves to prevent body tissue from entering and interacting with the moving portions of the gastric band device 100, or cavities of the gastric band device 100 changing in size, for example, the interior region 136.
In one embodiment, the membrane 106 may have a corrugated surface comprising a series of alternating ridges and grooves. The corrugated surface may reduce the force required to deform the membrane 106, and may allow the membrane 106 to be expanded, or stretched, over a longer distance.
In the embodiment shown in
In addition, the second lever arm 126 couples to a midpoint of the first lever arm 124, between the first end 148 and the second end 150 of the first lever arm 124. The connection between the first lever arm 124 and the second lever arm 126 forms an angle 168 being a pivot region. In addition, an angle 180 is formed between the first lever arm 124 and the band 116. The second end 150 of the first lever arm 124, and equivalently, the second end 142 of the lever device 122, is positioned at a distance 166 from the band 116. The angle 180 may have a value of about 20 degrees as shown in
Of particular note in
The variable output force mechanism illustrated in
Additional benefits of the variable output force mechanism illustrated in
Further benefits of the mechanism illustrated in
In
In
In
In the embodiment shown in
In
In
In
In the embodiment shown in
The gastric banding devices shown in
The lever devices 122, 122l, 122m, 122n may not form an empty interior region 136, 136l, 136m, 136n, as the interior region 136, 136l, 136m, 136n may be filled with a compressible substance. The lever arms 124, 124l, 124m, 124n, 126, 126l, 126m, 126n may be connected as a single bent piece of material, for example, a single bar bent to form an angle.
The gastric banding device 100 illustrated in the various embodiments throughout
In addition, each lever device 122, 122l, 122m, 122n extends from the band 116 towards the inner region 101 formed when the band 116 is positioned in the loop. The lever devices 122, 122l, 122m, 122n thus form a skeletal structure that strengthens the device 100 against longitudinal forces exerted by the patient's stomach (e.g., during convulsive movements of the stomach, or during eating activities). In addition, the skeletal structure reduces the strength of a membrane 106 necessary to maintain stability of the band. The skeletal structure, rather than the membrane 106, provides stability for the device 100. A weaker membrane, for example a weak rubber membrane, may be used, reducing the total force required to stretch the membrane, and increasing the efficiency of the device 100.
In addition, as discussed in relation to
In addition, each lever device 122, 122l, 122m, 122n is preferably positioned equidistant along the band 116, which produces a substantially even radial force directed towards the center portion of the patient's stomach to be constricted.
The drive system 200a shown in
In the embodiment shown in
The motor system housing 257 may include openings that allow the band 254 to extend therethrough. A stop bumper 204 may be positioned along the motor system housing 257 to prevent the band 254 from disengaging from the motor system housing 257.
The band 254 may include grip devices 256 that allow the engagement gear 210 to firmly engage the drive element 201. In the embodiment shown in
In operation, the motor 259 shown in
In the embodiment shown in
The benefit of a string-of-pearl device 212, rather than a strap-like device, or band 254 represented in
The pitch of the threading along the threaded screw device 222 may also be varied along the length of the threaded screw device 222, to allow for different movement rates of the slide nuts 224. The pitch of the threading of each slide nut 224 may also be varied to produce nuts 224 moving at various rates along the threaded screw device 222.
The cylindrically shaped motor 226 may comprise a stepper motor that operates as known in the art. In this embodiment, the motor coils 232 produce an electromotive force, capable of rotating the screw gear system 230 and accordingly driving the threaded screw device 222. The size of the motor coils 232 defines the total force that may be output to the threaded screw device 222. Thus, it may be desirable to provide large sized motor coils 232, to output a large amount of force to the patient's stomach. However, a drawback to larger sized motor coils 232 is that the larger size increases the total diameter 229 of the cylindrically shaped motor 226. This result may be undesirable, as a larger size 229 of the cylindrically shaped motor 226 may increase the total size of a gastric band device placed within a patient's body, which may produce a greater disturbance within the patient's body. Also, a gastric band device having a large size may be more difficult to insert laparoscopically into a patient's body (e.g., through a trocar).
The cylindrical coil 242 is configured to rotate around the magnetic core 240. The rotary element 244 coupled to the cylindrical coil 242 rotates with the cylindrical coil 242 and rotates the drive shaft 248. The drive shaft 248 consequently rotates the nut actuator 220, which causes the threaded screw device 222 to be driven in a direction along the axis of the hollow center motor 238.
The configuration of motor system 258i as shown in
The piezoelectric motor 282 may provide benefits over motors requiring magnets and/or coils, as shown, for example in
The electrical contacts 264 may be positioned to be responsive to a magnetic force produced by the magnetic indicator device 262. For example, the magnetic indicator device 262 may comprise a magnet having a magnetic field. Because the magnet is coupled to the threaded screw device 222, the magnet moves during operation of the motor 259. If the electrical contacts 264 are positioned along the path of the magnet 262, the strength of the magnetic field detected by the electrical contacts 264 increases as the magnet passes nearby. The electrical contacts 264 may be configured to be magnetically responsive, and contact when the magnet is close nearby. The connection between the electrical contacts 264 may provide an electrical signal to the motor 259. Thus, the electrical contacts 264 serve as a position detector to provide information to the motor 259 about the relative location of the threaded screw element 222 (e.g., a signal is produced when the magnet is nearby).
It is understood that the above example is exemplary in nature, and the operation of the magnetic position sensor system 260 may vary from the above-discussed model. For example, a plurality of electrical contacts 264, or a plurality of magnetic indicator devices 262 may be used to provide a variety of information about the position of the drive element 201. Each electrical contact 264 may be positioned in line along the path of the magnetic indicator device 262, and may provide an electrical signal to the motor 259 indicating the magnetic indicator device 262 is nearby. Similarly, the plurality of magnetic indicator devices 262 may be positioned in line along the drive element 201, each configured to exert a different magnetic force to the electrical contact 264. A combination of these methods may be used. In addition, the magnetic indicator device 262 may comprise a mechanism to actuate an electromagnet that indicates the position of the drive element 201. Furthermore, each electrical contact 264 may not be directly responsive to the magnetic indicator device 262, but rather may be actuated by another mechanism relying on an electromagnetic field to sense position. In addition, the magnetic position sensor system may include a variety of other configurations and mechanisms capable of detecting position via a magnetic field, or an electromagnetic field.
It is also understood that the magnetic position sensor system 260 may provide a signal directly to a control device separate from the motor 259, for example, an antenna pod 112 as shown in
In operation, the motor 259 drives the drive element, which is illustrated as a threaded screw device 222 in
It is understood that the configuration of the mechanical position sensor system 268 shown in
The drive systems, position systems, and external motor configurations shown in
The drive systems, position systems, and external motor configurations shown in
An elongated member 328 is positioned within a region bounded by the band 316, to apply a degree of constriction to a portion of the patient's stomach. The elongated member 328 forms a loop defining an inner region 301, which is complementary with, or configured to constrict the patient's stomach. A flexible membrane 306 may be coupled to the band 316, or extend around the band 316, similar to the membrane 106 shown in
A spring 330 may be positioned within the elongated member 328. The spring 330 may have a first end coupled to the cord 322, and a second end coupled to the band 316. The spring 330 is configured to stretch and provide a degree of constriction to the patient's stomach. The spring 330 may comprise a helical spring made stiff enough to provide a degree of constriction to the stomach, yet also flexible enough to extend around the stomach in a loop.
The cord 322 has a first end 324 coupled to the cylindrical transmission device 332, and a second end 326 coupled to the spring 330. The cord 322 is made from a strong yet flexible material, capable of withstanding the force applied to the cord 322 by the cylindrical transmission device 332, yet also being able to wrap around the inner region 301 to constrict the patient's stomach. The second end 326 of the cord 322 may extend into the elongated member 328, and may directly apply a constrictive force to the patient's stomach. The cord 322 may also wrap around the inner region 301 entirely, applying a degree of constriction to the patient's stomach.
The cylindrical transmission device 332, as shown in
In operation, to increase the degree of constriction to the stomach, the motor 359 rotates the cylindrical transmission device 332, which pulls on the cord 322. The tensioned cord 322 presses against the patient's stomach, constricting the stomach. The spring 330 provides tension to the second end 326 of the cord 322. To decrease the degree of constriction, the motor 359 operates to release the cord 322. It is understood that the embodiment shown in
The spool 334 rotates about a transmission shaft 336, which may be coupled to the motor housing 308. A spool grip surface 313 is positioned at the first end 344 of the spool 334. The spool grip surface 313 may comprise a friction surface or a gear surface. The spool grip surface 313 engages with an actuator grip surface 311, which similarly comprises a friction surface or gear surface, positioned on the rotary actuator 335.
In operation, the motor 359 rotates the rotary actuator 335, which rotates the cylindrical transmission device 332 via the contacting grip surfaces 311, 313. The spool 334 pulls or releases on the first end 324 of the cord 322, which correspondingly increases or decreases the degree of constriction applied to the stomach.
The spool 334 is configured to have ends 344, 346 with different sized diameters, and a tapered portion 348 connecting the ends 344, 346. The cord 322 wraps around the spool 334 such that successive wraps of the cord 322 over the tapered portion loop over a smaller diameter of the spool 334. In other words, each loop of the cord 322 around the spool 334 is positioned at a different distance from the shaft 336. The tapering of the spool 334 allows the spool 334 to serve as a variable transmission, applying a varying force to the first end 324 of the cord 322 in response to a constant force applied by the motor 359 to the spool 334.
The force applied to the first end 324 of the cord 322 is relatively low during an initial constriction of the patient's stomach, as the first end 344 of the spool 334 has a relatively large diameter. In addition, the speed the cord 322 is driven at this point is relatively large. As the spool 334 rotates to retract the cord 322, and wrap the cord 322 over the spool 334, the cord 322 loops over a successively smaller diameter of the spool 334, which increases the force applied to the cord 322, yet decreases the speed at which the cord 322 is drawn. As discussed in regard to the variable output transmission described in
The double nautilus spool 360 has a first end 344i, a second end 346i, and tapered portion 348i positioned between the two ends 344i, 346i. A surface groove 342i runs along the outer surface of the spool 360.
The embodiments of the cylindrical transmission devices 332, 332c-332l shown in
The cylindrical transmission device 332, 332c-332l provides the benefit of producing a force transmission mechanism capable of varying an output force in response to a constant input. In addition, the cord 322 comprises a flexible force applicator, that may be easily cut with surgical or laparoscopic tools.
The first end 418 of the band 416 and the second end 420 of the band 416 are coupled together to define the loop. The loop has a generally circular shape, to allow the band 416 to symmetrically fit around and encircle the portion of the patient's stomach. The motor housing 408 may be positioned between the first end 418 of the band 416 and the second end 420 of the band 416, to couple the ends 418, 420 together.
The loop shape of the band 416 defines an inner region 401 that is bounded by the band 416 and by the slide supports 422. The patient's stomach may be complementary with, or contained within, the inner region 401 formed by the loop. A flexible membrane 406 may be coupled to the band 416, or extend around the band 416, similar to the membrane 106 shown in
A plurality of slide supports 422 are coupled to the band 416 and extend in a direction towards the inner region 401 formed by the loop. Each slide support 422 has a first end 440 coupled to the band 416 and a second end 442 extending in a direction away from the band 416, towards the inner region 401. Each slide support 422 extends in a direction perpendicular to the portion of the band 416, towards the inner region 401, to apply a force substantially centripetal to the inner region 401. The slide supports 422 are configured to evenly apply a force radially towards the inner region 401.
Each slide support 422 is generally comprised from two force transmission supports, referred to as a first force transmission support, or a pivot lever 424, and a second force transmission support, or a lever support 426. The pivot lever 424 has a first end 448 coupled to the band 416 and a second end 450 extending in a direction away from the band 416, towards the inner region 401. The pivot lever 424 may comprise a rigid arm device, biased to deflect towards the lever support 426, or may comprise a spring with a spring force biased in the direction away from the inner region 401, and towards the lever support 426. The pivot lever 424 may be configured as a bar spring, or a non-helical spring being flexibly coupled to the band 416. The flexible coupling between the pivot lever 424 and the band 416 may produce a deflection of the pivot lever 424 in a direction away from the inner region 401 of the band 416, and towards the lever support 426.
The lever support 426 has a first end 444 coupled to the band 416 and a second end 446 extending in a direction away from the band 416, towards the inner region 401. The lever support 426 may comprise a rigid structure with a second end 446 that slidably contacts the pivot lever 424 and directs the pivot lever 424 in a direction towards the inner region 401 of the band 416. The lever support 426 may also be configured to direct the pivot lever 424 in a direction against the spring bias of the pivot lever 424, if the pivot lever 424 is configured as a spring.
The lever support 426 may have a wedge shape, including a sloped leading edge 470 (shown in
A pad 438 may be positioned at the second end 442 of the slide support 422. Similar to the pad 138 shown in
The band 416, similar to the band 116 shown in
The first end 448 of the pivot lever 424 may be coupled to the outer band 428 and the first end 444 of the lever support 426 may be coupled to the inner band 430. Thus, when the inner band 430 is slid relative to the outer band 428, the lever support 426 may move towards or away from the pivot lever 424. The movement of the lever support 426 varies the distance between the pivot lever 424 and the lever support 426, and accordingly varies a distance of the second end 442 of the slide support 422 from the band 416.
The pivot lever 424 and the lever support 426 slidably contact each other at an angle 468. A change in the distance between the pivot lever 424 and the lever support 426 will vary a size of the angle 468. In addition, a change in the angle 468 will vary the distance of the slide support 422 from the band 416, which will correspondingly vary a degree of constriction applied towards the inner region 401, and will accordingly vary a degree of constriction applied to the patient's stomach.
Each slide support 422 may be spaced an equidistant from another slide support 422. The number of slide supports 422 may vary from one slide support 422 to as many slide supports 422 as may feasibly fit within the band 416 to produce an equivalent operation of the gastric band device 400. A single slide support 422 may be positioned within the band 416 to constrict the patient's stomach.
The pivot lever 424, as discussed in relation to
The embodiments of the gastric band device 400 shown in
The gastric band device 400 and the slide supports 422, 422e, 422f discussed in relation to
The first end 518 of the band 516 and the second end 520 of the band 516 are coupled together to define the loop. The loop has a generally circular shape, to allow the band 516 to symmetrically fit around and encircle a portion of the patient's stomach. The motor housing 508 may be positioned between the first end 518 of the band 516 and the second end 520 of the band 516, to couple the ends 518, 520 together.
The loop shape of the band 516 defines an inner region 501 that is bounded by the band 516 and by the springs 522. The patient's stomach may be complementary with the inner region 501 formed by the loop. A flexible membrane 506 may be coupled to the band 516, or extend around the band 516, similar to the membrane 106 shown in
Each spring 522 has two ends, a first end 540 and a second end 542. The first end 540 of the spring 522 couples to the band 516 and the second end 542 of the spring 522 extends from the band 516 in a direction towards the inner region 501 formed by the loop. The spring 522 extends towards the inner region 501 in a direction substantially perpendicular to the portion of the band 516 to which the spring 522 is connected. The springs 522 produce a substantially central force directed towards the inner region 501, forcing the inner region 501 in a centripetal direction.
The spring 522 may be a coil spring, or a helical spring, that is biased to direct a force towards the inner region 501 of the band, and accordingly apply a degree of constriction to the inner region 501, and the patient's stomach. The spring 522 may have any other equivalent shape that produces a force directed towards the inner region 501 of the band 516.
Referring to
Referring back to
Referring to
The cord 528 has a first end and a second end, the first end engages with the motor system 558 located in the motor housing 508. The second end may also be coupled to the motor system 558, or may be fixedly attached to a portion of the band 516.
In operation, the motor system 558 may retract both ends, or one end of the cord 528 to increase the size of the inner region 501 and decrease the degree of constriction applied by the springs 522 to the patient's stomach. The shortened length of the cord 528 compresses the springs 522, causing a distance 588 of the second end 542 of the springs 522 from the band 516 to be decreased, consequently increasing the size of the inner region 501. To decrease the size of the inner region 501, the motor system 558 extends the length of cord 528. The springs 522 then apply a force in a direction towards the inner region 501 of the band, causing the stomach to compress. The outer diameter of the band 516 does not vary during operation of the motor.
The motor system 558 may comprise any of the motor systems shown in
The embodiment shown in
The number of springs 522 may vary from one spring 522 to as many springs 522 as may feasibly fit within the band 516 to produce an equivalent operation of the gastric band device 500. A single spring 522 may be positioned within the band 516 to constrict the patient's stomach.
The gastric band device 500 discussed in relation to
The gastric band device 600 includes a band 616 having a first end 618 and a second end 620 and a motor housing 608 coupled to the band 616. The band 616 is positioned in a loop around the portion of the patient's stomach, in a manner similar to the gastric band device 100 described in relation to
The first end 618 of the band 616 and the second end 620 of the band 616 are coupled together to define the loop. The loop has a generally circular shape, to allow the band 616 to symmetrically fit around and encircle the portion of the patient's stomach. The motor housing 608 may be positioned between the first end 618 of the band 616 and the second end 620 of the band 616, to couple the ends 618, 620 together.
The loop shape of the band 616 defines an inner region 601 that is bounded by the band 616 and by the mechanical actuators 622. The patient's stomach may be complementary with the inner region 601 formed by the loop. A flexible membrane 606 may be coupled to the band 616, or extend around the band 616, similar to the membrane 106 shown in
Each mechanical actuator 622 has a first end 640 coupled to the band 616 and a second end 642 extending from the band 616 in a direction towards the inner region 601. The second end 642 applies a degree of constriction to the inner region 601, and accordingly to the patient's stomach. The mechanical actuators 622 may be spaced equidistant from each other along the band 616. The mechanical actuators 622 extend in a direction substantially perpendicular to the surface of the band 616 to which the mechanical actuator 622 is connected. This configuration allows each mechanical actuator 622 to exert a force substantially centripetal to the inner region 601.
Each mechanical actuator 622 comprises a columnar riser device 604 slidably coupled to a base 602. The base 602 couples to the band 616, and the columnar riser device 604 is directed to apply a degree of constriction to the inner region 601. The columnar riser device 604 slides relative to the base 602 to vary the degree of constriction applied by the columnar riser device 604 to the inner region 601. A columnar riser cap 654 may be positioned at the second end of the mechanical actuator 622.
The mechanical actuator control system 610 may comprise a motor system contained within the motor housing 608 and comprising any of the motor systems shown in
The band 616 may comprise three bands, including an outer band 631, a middle band 628, and an inner band 630. The inner band 630 may be equivalently referred to as the first band 630, the middle band 628 may be equivalently referred to as the second band 628, and the outer band 631 may be equivalently referred to as the third band 631. The outer band 631 may extend around the patient's stomach. The inner band 630 may be positioned concentric with the outer band 631, and within an interior region of the outer band 631. The middle band 628 may be positioned between the outer band 631 and the inner band 630. The ends of the outer band 631 may be fixedly attached to the motor housing 608. However, the ends of the inner band 630 and the middle band 628 may not be directly coupled to the motor housing 608. Rather, one end of the inner band 630 and one end of the middle band 628 may be coupled to the motor system contained within the motor housing 608. The motor system may be configured similarly to the motor system 258b, shown in
Referring to
The first flexible member 614 comprises a flexible strap-like structure having two surfaces, one surface being smooth and a second surface including the combining device, or teeth 612. The teeth 612 may comprise ridges forming a half-zipper structure. The teeth 612 may be spaced equally apart along the length of the first flexible member 614. The teeth 612 may be structured to engage with similar teeth 612 located on one side of the second flexible member 624.
The second flexible member 624 similarly comprises a flexible strap-like structure having two surfaces, one surface being smooth and a second surface including the combining device or teeth 612. The teeth 612 are structured to interlock together when the two flexible members 614, 624 are combined.
A first end 648 of the first flexible member 614 couples to the middle band 628. A second end 652 of the first flexible member 614 extends in a direction towards the inner region 601. Similarly, a first end 644 of the second flexible member 624 couples to the inner band 630. A second end 646 of the second flexible member 624 extends in a direction towards the inner region 601. The second ends 652, 646 of the flexible members 614, 624 comprise the second end 642 of the mechanical actuator 622 and a second end of the columnar riser device 604. In addition, the first ends 648, 644 of the flexible members 614, 624 particularly the portions of the flexible members 614, 624 extending through a central cavity 634 in the base 602, define a first end of the columnar riser device 604. The first end of the columnar riser device 604 is thus slidably coupled to the base 602. The columnar riser cap 654 may be positioned at the second end of the columnar riser device 604, and may connect the flexible members 614, 624.
The base 602 has a generally columnar shape. One end of the base 602 connects to the outer band 631 and a second end of the base 602 extends in a direction towards the inner region 601 of the band 616 (shown in
A distance 688 of the second end 642 of the mechanical actuator 622 from the band 616 is defined by the length of the flexible members 614 that have passed through the base 602. The distance 688 of the second end 642 of the mechanical actuator 622 increases if a greater length of the flexible members 614624 has passed through the base 602 in a direction towards the inner region 601.
Because the second end 652 of the first flexible member 614 and the second end 646 of the second flexible member 624 are connected to the respective middle band 628 and inner band 630, the mechanical actuator control system 610 may independently drive the bands 628, 630 in opposite directions to vary a distance 688 of the mechanical actuator 622 from the band 616. If the flexible members 614, 624 are drawn together, the distance 688 increases, and the degree of constriction to the patient's stomach correspondingly increases. If the flexible members 614, 624 are drawn apart, the distance 688 decreases. It is noted the distance 688 of the mechanical actuator 622 from the band 616 corresponds to the distance of the second end of the columnar riser device 604 from the band 616.
The columnar riser device 604 formed by the two flexible members 614, 624 has a rigid structure caused by the engagement of the members 614, 624. The teeth 612 form a rigid interior section of the columnar riser device 604 that prevents the columnar riser device 604 from flexing in a direction perpendicular to the portion of the band 616 to which the base 602 is fixed.
The embodiments shown in
The number of mechanical actuators 622, 622c may vary from one mechanical actuator 622, 622c to as many mechanical actuators 622, 622c as may feasibly fit within the band 616 to produce an equivalent operation of the gastric band device 600. A single mechanical actuator 622, 622c may be positioned within the band 616 to constrict the patient's stomach.
The gastric band device 600, discussed in relation to
The first end 718 of the band 716 and the second end 720 of the band 716 are coupled together to define the loop. The loop has a generally circular shape, to allow the band 716 to symmetrically fit around and encircle a portion of the patient's stomach. The pump housing 708 may be positioned between the first end 718 of the band 716 and the second end 720 of the band 716, to couple the ends 718, 720 together.
The loop shape of the band 716 defines an inner region 701 that is bounded by the band 716 and by the hydraulic piston actuators 722. The patient's stomach may be complementary with the inner region 701 formed by the loop. A flexible membrane 706 may be coupled to the band 716, or extend around the band 716, similar to the membrane 106 shown in
The hydraulic piston actuators 722 comprise hydraulically-controlled cylinders having a first end 742 and a second end 740. The first end 742 of the hydraulic piston actuator 722 is coupled to the band 716 and the second end 740 of the hydraulic piston actuator 722 extends in a direction towards the inner region 701. The hydraulic piston actuators 722 extend in a direction substantially perpendicular to the surface of the band 716 to which the hydraulic piston actuator 722 is connected. This configuration allows each hydraulic piston actuator 722 to exert a force substantially centripetal to the inner region 701.
The hydraulic piston actuators 722 may comprise a base cylinder 704 and a cylinder cap 712, as shown in
The motor system 758 may be coupled to the plunger 734, which presses against fluid contained in the fluid reservoir 732. The pressure exerted by the plunger 734 is conveyed to the hydraulic piston actuators 722 via a fluid conduit 730 extending around the periphery of the band 716. In operation, the plunger 734 slides within the fluid reservoir 732 to either pressurize or depressurize the fluid contained within the hydraulic piston actuators 722. The pressure of the fluid defines the distance of the hydraulic piston actuators 722 from the band 716, and accordingly defines the degree of constriction applied to the patient's stomach.
The base cylinder 704 includes a cylindrically shaped vessel having a central fluid chamber 710 for receiving fluid from the hydraulic control system 702, shown in
The cylinder cap 712 may be slidably engaged with the base cylinder 704, to slide along the length of the outer surface of the base cylinder 704. The cylinder cap 712 slides in accordance with the amount of fluid contained within the central fluid chamber 710 and the interior fluid chamber 714. If more fluid is contained within the chambers 710, 714, the cylinder cap 712 will slide to a greater distance from the band 716. The seal lip 726 prevents the cylinder cap 712 from sliding off the end of the base cylinder 704.
The cylinder cap 712 may define the second end 740 of the hydraulic piston actuator 722, and the relative position of the cylinder cap 712 along the base cylinder 704 may define the distance 788 of the second end 740 of the hydraulic piston actuator 722 from the band 716, and accordingly the degree of constriction applied by the hydraulic piston actuator 722 to the patient's stomach.
The respective chambers 714, 710 of the cylinder cap 712 and the base cylinder 704 are coupled to the fluid conduit 730 extending along the circumference of the band 716. The fluid conduit 730 may be housed within the band 716 and may connect to all hydraulic piston actuators 722 positioned within the interior of the band 716. An aperture 728 may couple the chambers 714, 710 to the fluid conduit 730.
In operation, the hydraulic control system 702, shown in
A hydraulic control system 702c varies the relative amount of fluid contained in the upper fluid chamber 744 and the lower fluid chamber 746. The hydraulic control system 702c comprises a pump 752, a fluid reservoir 733 and a control device 750. The pump 752 may comprise a standard pump as is known in the art. The fluid reservoir 733 is configured to retain an amount of fluid. The pump 752 couples to the fluid reservoir 733 and pressurizes the fluid contained within the fluid reservoir 733. The control device 750 is coupled to the fluid reservoir 733 and the pump 752, and may comprise a valve as is known in the art. The control device 750 couples to the fluid conduits 730c, 703d, and directs the pressurized fluid from the pump 752 to either the upper fluid chamber 744 or the lower fluid chamber 746, to vary the relative amount of fluid located in the chambers 744, 746.
The embodiments shown in
Furthermore, the hydraulic control system 702, 702c may comprise a single pump and/or a motor, or a series of pumps and/or motors, each controlling an individual hydraulic actuator, or a combination of hydraulic actuators.
The number of hydraulic piston actuators 722, 722c may vary from one hydraulic piston actuator 722, 722c to as many hydraulic piston actuators 722, 722c as may feasibly fit within the band 716 to produce an equivalent operation of the gastric band device 700. A single hydraulic piston actuator 722, 722c may be positioned within the band 716 to constrict the patient's stomach.
The gastric band device 700, discussed in relation to
The first end 818 of the band 816 and the second end 820 of the band 816 are coupled together to define the loop. The loop has a generally circular shape, to allow the band 816 to symmetrically fit around and encircle the portion of the patient's stomach. The motor housing 808 may be positioned between the first end 818 of the band 816 and the second end 820 of the band 816, to couple the ends 818, 820 together.
The loop shape of the band 816 defines an inner region 801 that is bounded by the band 816 and by the spring 802. The patient's stomach may be complementary with the inner region 801 formed by the loop. A flexible membrane 806 may be coupled to the band 816, or extend around the band 816, similar to the membrane 106 shown in
The spring 802 may comprise the band 816, as the spring 802 is configured in a loop shape, which will encircle the stomach and provide a degree of constriction to the patient's stomach. However, the spring 802 may also be contained within a separate band 816 structure, as discussed above. If the spring 802 is contained within a separate band 816 structure, the band 816 may include a rigid dorsal periphery 819 and a flexible ventral periphery 821, to prevent movement of an outer diameter of the band 816 during operation of a motor system contained within the motor housing 808. The rigid dorsal periphery 819 and the flexible ventral periphery 821 may operate similarly as with the band 316 discussed in relation to
The spring 802 comprises a wire spring, or a bar spring, or a non-helical spring, curved in a circular shape to form a loop. The spring 802 may represent a single loop of a spring designed to ultimately form a torsion spring.
The spring has two ends, a first end 812 and a second end 824, shown in
The spring 802 is formed to be pre-stressed to have a rest diameter sized to apply a degree of constriction to a patient's stomach. In other words, the spring 802 is shaped and sized to constrict to a rest diameter being smaller than the natural diameter of the portion of the patient's stomach to be constricted. For example, if the patient's esophageal junction is sized at a diameter of about 25 millimeters, then the spring 802, will be biased to constrict to a size of less than about 25 millimeters. The rest diameter represents the diameter of the spring 802 without any external forces applied to the spring 802.
In addition, the spring 802 may be biased to constrict, at rest, to a size smaller than the minimum diameter, and smaller than the maximum diameter, that the gastric band device 800 will constrict the patient's stomach. The spring 802 may be configured to always be biased to exert a constrictive force to the patient's stomach. In this manner, the spring's 802 bias will aid the spring control system 810 to increase the degree of constriction applied to the patient's stomach. The rest diameter of the spring 802 may be set during manufacture, or may be set by a physician after determining the size of the patient's stomach to be constricted.
A spring control system 810 is coupled to the band 816, or, directly to the spring 802 if the spring 802 comprises the band 816. The spring control system 810 comprises a motor system contained within the motor housing 808, and a worm drive 832 (shown in
The spring control system 810 drives the ends 812, 824 of the spring 802 in directions opposite to each other to vary the diameter 804 of the spring 802 when configured in a loop shape.
The embodiment shown in
The gastric band device 800, discussed in relation to
The loop has a generally circular shape, to allow the band 916 to symmetrically fit around and encircle the portion of the patient's stomach. A motor system 958 may be positioned within an interior portion of the band 916, near a suitable mechanism that binds the two ends of the band 916 into a loop.
The loop shape of the band 916 defines an inner region 901 (shown in
The band 916 includes a rotatable portion 906, and a pivotal portion 904. The rotatable portion 906 is configured to rotate around the pivotal portion 904. A body portion 918 may connect the rotatable portion 906 to the pivotal portion 904.
In the embodiment shown in
In the embodiment shown in
The motor system 958 may be positioned within the body portion 918 of the band 916 and may comprise any of the motor systems shown in
The rotatable portion 906 defines a diameter 912, extending perpendicular to the axis 902. A half-value of this diameter 912 represents a radial distance of the rotatable portion 906 from the axis 902. Similarly, the pivotal portion defines a diameter 910, extending perpendicular to the axis 902. A half-value of this diameter 910 represents a radial distance of the pivotal portion 904 from the axis 902.
Referring back to
In operation, the motor system 958 rotates the rotatable portion 906 about the pivotal portion 904 to vary the degree of constriction applied to the portion of the patient's stomach. In the embodiment shown in
The embodiments shown in
The gastric band devices discussed in relation to
The loop has a generally circular shape, to allow the band 1016 to symmetrically fit around and encircle the portion of the patient's stomach. A motor system 1058 may be positioned within an interior portion of the band 1016, near a suitable mechanism that binds the two ends of the band 1016 into a loop.
The loop shape of the band 1016 defines an inner region 1001 (shown in
The incompressible body 1028 may comprise the band 1016, as the incompressible body 1028 may be configured to encircle the stomach in a loop and provide a degree of constriction to the patient's stomach. However, the incompressible body may also be contained within a separate band 1016 structure, including a housing 1040, as shown in
The band 1016 is configured to include an incompressible body 1028 having a free end 1046 that deflects in response to a compressive force. The incompressible body 1028 increases a degree of constriction applied to the patient's stomach in response to the compressive force. The compressive force is applied by an incompressible body compression system 1042, which may comprise a motor system 1058, and a clamp actuator 1036.
The clamp actuator 1036 may serve as a housing 1040 that encircles and contains the incompressible body 1028. The clamp actuator 1036 may be configured similarly as two of the gastric band devices 900 shown and discussed in relation to
The motor system 1058 may be positioned within the body portion 1018 of the clamp actuator 1036 and may comprise any of the motor systems shown in
Referring to
The incompressible body 1028 may comprise a pouch of incompressible fluids or a body made from a flexible material such as silicone. The pouch of fluids may include a physiological solution, silicone oil, or the like. The incompressible body 1028 may be fixed, or adhered to the clamp actuator 1036, or may be held in position by the clamp actuator 1036. In operation, the clamp actuator 1036 applies a compressive force to the incompressible body 1028 in a direction substantially parallel with the axis 1002 shown in
The embodiments shown in
The gastric band devices 1000, 1000e discussed in relation to
The loop has a generally circular shape, to allow the band 1116 to symmetrically fit around and encircle the portion of the patient's stomach. A motor system 1158 may be positioned within the band 1116, contained within an outer housing 1136 of the band 1116.
The loop shape of the band 1116 defines an inner region 1101 (shown in
The rotatable constriction device 1104 itself may comprise the band 1116, as the rotatable constriction device 1104 similarly encircles the patient's stomach and the axis 1102, and applies a degree of constriction to the patient's stomach. However, the rotatable constriction device 1104 may also be contained within a separate band 1116 structure, including an outer housing 1136, as shown in
The rotatable constriction device 1104 comprises a cylindrical sheath, or cylindrical membrane having a first end 1106 and a second end 1108. The rotatable constriction device 1104 may be deformable. An interior of the sheath comprises the inner region 1101. The ends 1106, 1108 are positioned along the axis 1102, at a distance 1110 from each other (as shown in
The motor system 1158 may comprise any of the motor systems shown in
The first end 1106 of the rotatable constriction device 1104 is coupled to the first rotatable band 1128 and the second end 1108 is coupled to the second rotatable band 1130. The rotation actuator system 1118 is configured to rotate rotatable bands 1128, 1130, causing the rotatable constriction device 1104 to twist. The rotatable bands 1128, 1130 are rotated in a direction opposite from each other.
The rotatable constriction device 1104 is made from a material flexible enough to accommodate the twisting motion caused by the actuator system 1118, yet stiff enough to apply a force to the patient's stomach. A durable polymer material, or a fibrous material may be preferable. In addition, the rotatable constriction device 1104 may also comprise a series of rod-like structures extending along the axis 1102, and covered with a membrane, the rod-like structures being configured to produce an equivalent result.
The embodiment shown in
The gastric band device 1100 discussed in relation to
The loop has a generally circular shape, to allow the band 1216 to symmetrically fit around and encircle the portion of the patient's stomach. A motor system 1258 may be positioned within the band 1216, contained within an outer housing 1236 of the band 1216.
The loop shape of the band 1216 defines an inner region that is bounded by the band 1216 and the stretchable constriction device 1204. The patient's stomach may be complementary with the inner region formed by the loop. The band 1216 is configured to loop around an axis 1202 extending centrally through the inner region.
The stretchable constriction device 1204 itself may comprise the band 1216, as the rotatable constriction device 1204 similarly encircles the patient's stomach and the axis 1202, and applies a degree of constriction to the patient's stomach. However, the rotatable constriction device 1204 may also be contained within a separate band 1216 structure, including an outer housing 1236, as shown in
The stretchable constriction device 1204 comprises a cylindrical sheath, or cylindrical membrane having a first end 1206 and a second end 1208. An interior of the sheath comprises an inner region being complementary with the stomach of the patient. The ends 1206, 1208 are positioned along the axis 1202, at an axial distance 1210 from each other. The stretchable constriction device 1204 has a diameter 1220 when the constriction device 1204 is configured in the shape of a loop.
The stretchable constriction device 1204 is coupled to a constriction device actuator system 1218, comprising a motor system 1258, a first telescoping band 1228, and a second telescoping band 1230. The constriction device actuator system 1218 may be contained within an outer housing 1236, that comprises an outer surface of the gastric band device 1200.
The motor system 1258 may comprise any of the motor systems shown in
The first end 1206 of the stretchable constriction device 1204 is coupled to the first telescoping band 1228 and the second end 1208 is coupled to the second telescoping band 1230. The constriction device actuator system 1218 is configured to draw the telescoping bands 1228, 1230 towards each other, or away from each other. If the telescoping bands 1228, 1230 are drawn away from each other, a stretching force is applied to the stretchable constriction device 1204. If the bands 1228, 1230 are drawn towards each other, a compressive force is applied to the stretchable constriction device 1204. The telescoping bands 1228, 1230 are configured to have a variable length, to accommodate the diameter change of the constriction device 1204 (e.g., the telescoping bands 1228, 1230 have a telescoping structure). The motor system 1258 couples to the bands 1228, 1230, through control arms 1238.
The stretchable constriction device 1204 may comprise a structure capable of expanding or decreasing a diameter 1220 in response to a varied axial distance 1210 between the ends 1206, 1208 of the stretchable constriction device 1204. The stretchable constriction device 1204 may therefore be stretchable in either an axial distance 1210 or along the radial diameter 1220. The stretchable constriction device 1204 may comprise a web-like structure, including a plurality of connecting supports 1232 defining a bounded region 1234. The connecting supports 1232 are oriented to allow the size of the bounded region 1234 to vary in response to a varied orientation of the connecting supports 1232. The connecting supports 1232 may be flexibly coupled, or pivotally coupled, to each other to allow the connecting supports 1232 to pivot with respect to each other. The pivotal action varies the size of the bounded region 1234, and transforms a varied axial distance 1210 into a varied diameter 1220. The stretchable constriction device 1204 operates similarly to a stent device commonly used in cardiovascular surgery.
In operation, the constriction device actuator system 1218, either compresses or stretches the stretchable constriction device 1204. The telescoping bands 1228, 1230 transmit the corresponding force to the stretchable constriction device 1204, which causes the diameter 1220 to vary, and the degree of constriction applied by the stretchable constriction device 1204 to the patient's stomach to also vary.
The embodiment shown in
The gastric band device discussed in relation to
The loop has a generally circular shape, or encircling shape, to allow the band 1316 to symmetrically fit around and encircle the portion of the patient's stomach. A motor system 1358 may be coupled to an outer surface of band 1316.
The loop shape of the band 1316 defines an inner region 1302 that is bounded by the band 1316 and the force transmission surfaces 1304. The patient's stomach may be complementary with the inner region 1302 formed by the loop.
Each force transmission surface 1304 comprises a flattened contact surface that applies a degree of constriction to the portion of the patient's stomach to be constricted. The force transmission surface 1304 is oriented to define the inner region 1302, which in
The force transmission structure 1308 is a structure coupling the force transmission surface 1304 to the band 1316. In the embodiment shown in
The band 1316 is shaped to have a substantially polygonal, or hexagonal shape. The force transmission structures 1308 are shaped to fit within the shape defined by the band 1316. A force transmission surface control system 1318 is coupled to the band 1316 and comprises a motor system 1358 and a plurality of linking members 1310. The motor system 1358 may comprise any of the motor systems shown in
The linking members 1310 may comprise cords extending around routing mechanisms, or pulley wheels 1312 positioned along the exterior of the band 1316. Each linking member 1310 may couple to a force transmission structure 1308 through a slide coupler device 1306. The slide coupler devices 1306 additionally couple the force transmission structures 1308 to the band 1316, and allow the force transmission structures 1308 to slide relative to the band 1316. The force transmission structures 1308 slide, or translate in a circular manner around the inner region 1302. The slide coupler device 1306 guides the force transmission structure 1308, and correspondingly the force transmission surface 1304 in a direction 1309 substantially towards the inner region 1302.
The configuration of the gastric band device 1300 shown in
The configuration shown in
The embodiments shown in
The gastric band devices 1300, 1300d discussed in relation to
The loop has a generally circular shape, to allow the band 1416 to symmetrically fit around and encircle the portion of the patient's stomach. A motor system 1458 may be coupled to a portion of the band 1416.
The loop shape of the band 1416 defines an inner region 1401 (shown in
The cord 1404 itself may comprise the band 1416, as the cord 1404 similarly encircles the patient's stomach and applies a degree of constriction to the patient's stomach. However, the cord 1404 may also be contained within a separate band 1416 structure, as shown in
The cord 1404 has a first end 1406 and a second end 1408, and has a portion that loops multiple times around the inner region 1401. The first end 1406 and the second end 1408 of the cord 1404 are coupled to a cord control system 1418, which is coupled to the band 1416 and comprises a motor system 1458. The motor system 1458 may comprise any of the motor systems shown in
The first end 1406 of the cord 1404 extends out from the motor system 1458, and loops around the inner region 1401. The initial loop is referred to as the first portion 1422 of the cord 1404. The first portion 1422 of the cord 1404 continues to loop around the inner region 1401, and becomes the second portion 1424 of the cord 1404 forming a second loop around the inner region 1401. The second portion 1424 of the cord 1404 then loops around the inner region 1401 until it becomes the fifth portion 1430 of the cord 1404.
The second end 1408 of the cord 1404 extends out from the motor system 1458, and loops around the inner region 1401. The initial loop is referred to as the third portion 1426 of the cord 1404. The third portion 1426 of the cord 1404 continues to loop around the inner region 1401, and becomes the fourth portion 1428 of the cord 1404 forming a second loop around the inner region 1401. The fourth portion 1428 of the cord 1404 then loops around the inner region 1401 until it becomes the fifth portion 1430 of the cord 1404.
The fifth portion 1430 of the cord 1404 extends over a part of the second portion 1424, the first portion 1422, the third portion 1426, and a part of the fourth portion 1428 of the cord 1404. The fifth portion 1430 presses against the overlapped portions 1424, 1422, 1426, 1428 of the cord 1404 to securely tension the cord 1404 when the cord control system 1418 retracts the cord 1404. The routing of the cord 1404 substantially resembles a prusik knot shape, as is known in the art of mountain climbing.
In operation, the cord control system 1418 tensions the ends 1406, 1408 of the cord 1404 to increase the degree of constriction applied to the patient's stomach. A resilient membrane 1432 may be positioned to have the cord 1404 encircle the resilient membrane 1432, the resilient membrane 1432 resisting the tensioning force. The tensioning of the cord 1404 decreases a diameter 1420 formed by the loops of the cord 1404, as shown in
The embodiment shown in
The gastric band device discussed in relation to
The loop has a generally circular shape, to allow the band 1516 to symmetrically fit around and encircle the portion of the patient's stomach. A motor system 1558 may be coupled to a portion of the band 1516.
The loop shape of the band 1516 defines an inner region 1501 (shown in
The collar 1502 itself may comprise the band 1516, as the collar 1502 similarly encircles the patient's stomach and applies a degree of constriction to the patient's stomach. However, the collar 1502 may also be contained within a separate band 1516 structure, as shown in
The collar 1502 has a first end 1506 and a second end 1508, and loops around the inner region 1501, as shown in
A first cord routing device 1510 is coupled to the first end 1506 of the collar 1502. The first cord routing device 1510 includes a plurality of apertures 1526 sized to have a cord 1504 threaded therethrough. A second cord routing device 1512 is coupled to the second end 1508 of the collar 1502, and includes a plurality of apertures 1528 sized to have a cord 1504 threaded therethrough. The cord routing devices 1510, 1512 may comprise equivalent structures capable of routing a cord 1504, including a series of hooks, threaders, pulleys, latches, or the like.
The cord 1504 has a first end 1530 and a second end 1534, the first end 1530 connecting to the first cord routing device 1510 and the second end 1534 connecting to the motor system 1558. The cord 1504 is routed through the plurality of apertures 1528, 1526 in an alternating manner, to link the first end 1506 of the collar 1502 to the second end 1508 of the collar 1502. The passes of the cord 1504 may resemble a lace structure. The number of passes of the cord 1504 through the routing devices 1510, 1512 is shown to be five in
A length 1514 of the cord 1504 extending between the first end 1506 and second end 1508 of the collar 1502 defines the distance between the ends 1506, 1508 of the collar 1502, and the degree of constriction applied by the collar 1502 to the patient's stomach. A smaller length 1514 indicates a greater degree of constriction applied to the stomach.
A cord length control system 1518 is coupled to the band 1516 and to the second end 1534 of the cord 1504. The cord length control system 1518 comprises a motor system 1558 that may comprise any of the motor systems shown in
In operation, the cord length control system 1518 tensions the cord 1504 to decrease the length 1514 of cord 1504 extending between the ends 1506, 1508 of the collar 1502, and correspondingly increase the degree of constriction applied to the patient's stomach. A resilient membrane 1532 may be positioned to have the collar 1502 encircle the resilient membrane 1532, the resilient membrane 1532 resisting the constrictive force applied by the collar 1502. To reduce the degree of constriction, the cord length control system 1518 releases the cord 1504, and the resilient membrane 1532 expands the diameter 1520 formed by the collar 1502. The size of the inner region 1501, shown in
The gastric band device 1500 discussed in relation to
The loop shape of the band 1616a defines an inner region 1601a that is bounded by the band 1616a and by deflectable electroactive polymer devices 1622. The patient's stomach may be complementary with the inner region 1601a formed by the loop. A flexible membrane 1606a may be coupled to the band 1616a, or extend around the band 1616a, similar to the membrane 106 shown in
Each deflectable electroactive polymer device 1622 is positioned within an interior region of the band 1616a, and connects to the band 1616a through a mounting 1610. The deflectable electroactive polymer devices 1622 are positioned substantially equidistant from each other along the interior of the band 1616a.
The deflectable electroactive polymer device 1622 shown in
Each deflectable electroactive polymer device 1622 may have a deflection portion 1618 and a stationary portion 1620. The deflection portion 1618 may be configured to deflect relative to the stationary portion 1620 in response to a voltage applied to the deflectable electroactive polymer device 1622. The deflection portion 1618 may also be positioned to deflect in a direction to apply an increased degree of constriction to the inner region 1601a.
A voltage source, or a power supply 1604 couples to the band 1616a through a electrical line 1608. The band 1616a may be suitably configured to transfer a voltage supplied by the power supply 1604 to the electroactive polymer device 1622.
Each expandable electroactive polymer device 1630 is positioned within an interior region of the band 1616c, and connects to the band 1616c through a mounting 1624. The expandable electroactive polymer devices 1630 are positioned substantially equidistant from each other along the interior of the band 1616c. Each expandable electroactive polymer device 1630 is configured to have dimensions that vary in response to a voltage applied to the expandable electroactive polymer device 1630. For example, a length 1612 of the expandable electroactive polymer device 1630 may vary in response to a voltage applied to the expandable electroactive polymer device 1630. The expandable electroactive polymer device 1630 may be configured to have an expanded length extend towards the inner region 1601c. The expandable electroactive polymer device 1630 shown in
The encircling electroactive polymer device 1652 is configured to expand in a direction towards the inner region 1601e, or extend in a direction towards the inner region 1601e in response to a voltage applied to the encircling electroactive polymer device 1652 by the power supply 1604. The expansion or extension reduces the inner diameter 1626 of the encircling electroactive polymer device 1652 and increases a degree of constriction applied by the encircling electroactive polymer device 1652 to the patient's stomach.
The encircling electroactive polymer device 1652 may comprise a piezoelectric polymer, a gel polymer, an ionic polymer-metal composite, a conductive polymer, a dielectric polymer, an electrostrictive polymer, or combinations thereof.
The embodiments shown in
The gastric band devices 1600a, 1600c, 1600e discussed in relation to
An additional approach to constricting a patient's stomach includes a chicane mechanism, wherein the stomach is bent to increase the food flow resistance. A series of strong bends of the stomach can reduce food flow.
Another approach to constricting a patient's stomach includes a twisted stomach mechanism, wherein the stomach is twisted to increase the food flow resistance.
Another approach to constricting a patient's stomach includes placing a gastric band device inside the patient's stomach. In addition, a control mechanism that could be placed in the patient's stomach, to control actuation of a banding device positioned internal or external to the stomach.
Another approach to constricting a patient's stomach includes storing unused constriction energy in a mechanical device. The mechanical device may store the energy for future use.
The banding devices, referred to as gastric band devices throughout this application, may be equivalently applied to constrict other bodily organs, human or otherwise. In addition, the transmission systems, and drive systems discussed throughout this application may be applied and used to constrict body organs different than the stomach. For example, any of the devices or systems discussed in this application may be applied to control urinary tracts, cardiovascular tracts, and other portions of the digestive system, including intestines, rectums, and various parts of the stomach, without deviating from the scope of this invention. The devices or systems may be applied to control various ailments other than obesity, including urinary or anal incontinence.
In addition, any element discussed with regard to one gastric band device, transmission device, or drive system may be equivalently introduced and/or interchanged with an element in another gastric band device, transmission device, or drive system. For example, the cylindrical transmission systems may be equivalently applied to other gastric band devices or drive systems where appropriate. In addition, the corrugated membrane discussed in relation to
The terms “a,” “an,” “the” and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.
Certain embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
Specific embodiments disclosed herein may be further limited in the claims using consisting of or and consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of” excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the invention so claimed are inherently or expressly described and enabled herein.
In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.
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Number | Date | Country | |
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20120123196 A1 | May 2012 | US |