Patent Application
20120215061
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 banding systems that self-adjust when an obstruction is present in a gastric lumen of a stomach of a patient.
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, the food held in the upper portion of the stomach may provide a feeling of satiety or fullness that discourages overeating. Unlike gastric bypass procedures, gastric band apparatuses are reversible and require no permanent modification to the gastrointestinal tract. An example of a gastric banding system is disclosed in Roslin, et al., U.S. Patent Pub. No. 2006/0235448, the entire disclosure of which is incorporated herein by this specific reference.
Over time, a stoma created by a gastric band may need adjustment in order to maintain an appropriate size, which is neither too restrictive nor too passive. Accordingly, prior art gastric band systems provide a subcutaneous fluid access port connected to an expandable or inflatable portion of the gastric band. By adding fluid to or removing fluid from the inflatable portion by means of a hypodermic needle inserted into the access port, the effective size of the gastric band can be adjusted to provide a tighter or looser constriction.
Birk, et al., U.S. application Ser. No. 12/816,310 discloses a hydraulic mechanical gastric band that includes an external control unit capable of communicating with a sensor to regulate the constriction of the band about the organ or the duct. The sensor sends data to the external control unit to control operations of the gastric band based on the data from the sensor. However, this application includes an external control unit to control operations of the gastric band.
Sometimes, adjustment of a gastric band may be desirable in between adjustments made by a physician. For example, during normal operation of the gastric band, the gastric band applies pressure to an outer surface of the upper stomach. But in some instances, the patient may swallow a bolus, or attempt to pass an obstruction (e.g., a large piece of food), that is too large to pass through the constriction produced by the gastric band. The result can be a painful experience which, if it persists, may require medical intervention to release the blockage.
Some attempts have been made to account for the possibility of a blockage. For example, Coe, et al., U.S. Patent Pub. No. 2009/0216255 discloses a flow control device that moves fluid between a hydraulic restriction system and a fluid source. The additional flow control device controls a rate of fluid flow between the restriction device and the fluid source. In addition, Coe, et al., European Patent Application No. 2 074 970 A1 discloses a separate restriction device and a pressure adjustment device. The pressure adjustment device regulates a constant force applied by the restriction device using, for example, a bellows and a spring.
Further, Lechner, U.S. Patent Pub. No. 2009/0054914 discloses a controllable stomach band that has a chamber for controlling restriction of the stomach band. The chamber is coupled to a separate pressure chamber that receives fluid leaving the chamber in the stomach band. The pressure chamber is separated from the esophageal-gastric junction of the patient's stomach.
Further, Steffen, U.S. Patent Pub. No. 2009/0062826 discloses an adjustable gastric band with a “conveyance device” that is powered by a “power storage device.” The power storage device operates the conveyance device to move fluid between expandable chambers to adjust the gastric band.
Some attempts have been made to account for the possibility of blockage (e.g., by a bolus of food). For example, Snow, et al., U.S. application Ser. No. 12/770,617 discloses a self-adjusting gastric band that temporarily and automatically opens up to allow a bolus through. However, this application does not utilize complicated fluid control mechanisms, flow rate limiting devices, and/or valves to regulate the transfer of fluid within the self-adjusting gastric band.
Accordingly, it is desirable to develop a gastric banding system that is capable of providing needed pressure to the stomach, yet is also capable of adapting and opening up to allow an obstruction to pass through a portion of the stomach being constricted. A reversible self-opening mechanism, or adjustment system, may be utilized to allow an obstruction to pass through a portion of a gastric lumen constricted by a gastric band. The adjustment system may allow the gastric band to open quickly in response to the obstruction passing through the gastric lumen, yet may also allow the gastric band to slowly return to the size the gastric band had before the obstruction was present.
In one embodiment, the present invention comprises a system including a gastric band having an inflatable member configured to contain fluid and apply constriction to a portion of a gastric lumen of the stomach, the inflatable member being moveable from a constricted state to a passage state for allowing an obstruction to pass through a portion of the gastric lumen, the passage state being when less fluid is contained in the inflatable member than in the constricted state. A valve is configured to move from a closed position to an open position when a pressure of the fluid from the inflatable member increases over a threshold in response to the obstruction passing through the gastric lumen, and to allow the fluid from the inflatable member to pass through the valve at a first flow rate. A reservoir is configured to receive the fluid passed through the valve, allowing the inflatable member to move from the constricted state to the passage state, and allowing the obstruction to pass through the portion of the gastric lumen. A flow restriction device is configured to allow the fluid received by the reservoir to pass from the reservoir to the inflatable member at a second flow rate that is less than the first flow rate, allowing the inflatable member to return to the constricted state.
In one embodiment, the valve and the flow restriction device are contained within an access port housing. A reservoir is coupled to the access port housing. The reservoir is configured to receive fluid from the gastric band automatically when an obstruction passes through the gastric lumen. The obstruction creates a force that is large enough to open the valve, which causes fluid to pass from the gastric band to the reservoir at a faster flow rate. Once the obstruction has passed through the constricted portion of the gastric lumen, the pressure of the reservoir is greater than that of the gastric band, and fluid then flows back to the gastric band through the flow restriction device, at a slower flow rate. The flow restriction device allows the gastric band to slowly return to an equilibrium size, or the size the gastric band had before the obstruction was present. The slow return of the gastric band to its equilibrium size prevents wear on the gastric band, and prevents damage to local tissues. The threshold opening pressure of the valve allows the gastric band to substantially maintain its size up to the threshold pressure, enhancing the therapeutic success of the gastric band.
In one embodiment, the present invention comprises a system including a gastric band having an inflatable member configured to contain fluid and apply constriction to a portion of a gastric lumen of the stomach, the inflatable member being moveable from a constricted state to a passage state for allowing an obstruction to pass through a portion of the gastric lumen, the passage state being when less fluid is contained in the inflatable member than in the constricted state. A valve is configured to move from a closed position to an open position when a pressure of the fluid in the inflatable member increases over a threshold in response to the obstruction passing through the gastric lumen, the valve in the open position allowing fluid to pass through the valve at a first flow rate. A reservoir is configured to receive fluid when the valve is in the open position, causing the inflatable member to move from the constricted state to the passage state, and allowing the obstruction to pass through the portion of the gastric lumen. A flow restriction device is configured to pass fluid through the flow restriction device at a second flow rate that is less than the first flow rate, allowing the inflatable member to return to the constricted state from the passage state.
In one embodiment, a shunt valve is incorporated into the gastric banding system. The shunt valve allows a physician to vary an amount of fluid in the gastric banding system without having to pass fluid through the flow restriction device.
In one embodiment, an asymmetric flow regulator, including a valve that is configured to open to allow fluid from the gastric band to pass through the valve, when a pressure of the fluid exceeds a threshold, and a flow restriction device, is utilized. The asymmetric flow regulator is positioned in series with a reservoir and an access port.
In one embodiment, an asymmetric flow regulator, including a valve that is configured to open to allow fluid from the gastric band to pass through the valve, when a pressure of the fluid exceeds a threshold, and a flow restriction device, is utilized. The asymmetric flow regulator is positioned in parallel with a reservoir and an access port.
The present invention generally provides for gastric banding systems, for example, systems for the treatment of obesity and obesity related conditions, as well as systems that allow adjustment of gastric bands in response to an obstruction passing through a gastric lumen.
The present invention provides for an adjustment system that automatically increases the size of a constricted portion of a gastric lumen in response to an obstruction passing through the gastric lumen. The size of the constricted portion of the gastric lumen increases rapidly when the obstruction approaches a gastric band that constricts the lumen. The adjustment system is also configured to slowly return the constricted gastric lumen to an equilibrium size the lumen had, prior to the obstruction passing through the lumen.
The gastric band 12 comprises a strap-like member capable of encircling a portion of a patient's stomach 22 to form a stoma. The gastric band 12 is preferably a hydraulic gastric band, having an inflatable member 24 that is filled with a fluid, such as saline. The inflatable member 24 serves as a cuff or a ring around a portion of the patient's stomach, which constricts the stomach, to a degree, based on the amount of fluid in the inflatable member 24.
The access port 16 comprises an implantable device that is used by a physician to inflate the inflatable member 24 of the gastric band 12. The access port 16 is configured to be fixed subcutaneously within the patient's body. The access port 16 is preferably fixed to the patient's muscle wall. The access port 16 is fixed to the muscle wall through sutures, anchors, tacks, or the like. The access port 16 is capable of receiving a syringe 26 that is inserted by a physician to transfer fluid to and from the inflatable member 24 of the gastric band 12. The fluid passes between the access port 16 and the inflatable member 24 through the tube 15.
The gastric band 12 is inserted into the patient's body laparoscopically. During laparoscopic insertion of the gastric band 12, the gastric band 12 is wrapped around the portion of the patient's body to be constricted, and is then secured in position. The inflatable member 24 contacts the portion of the patient's stomach to be constricted. The gastric band 12 preferably encircles the cardia, or esophageal junction, of the patient's stomach. After the gastric band 12 has been fixed around a portion of the patient's stomach, the access port 16 is fixed to the patient's muscle wall. The tube 15 is then connected from the inflatable member 24 of the gastric band 12 to the access port 16. A physician will then inject the access port 16 with an amount of fluid, as desired, to inflate the inflatable member 24 to an appropriate degree or size, depending on the physical characteristics of the patient, and the desired treatment plan for the patient. For example, if the patient is severely obese, then a greater degree of restriction and a greater amount of fluid may be necessary to constrict the portion of the patient's stomach. If the patient is mildly obese, then a lesser degree of restriction, and less fluid may be passed to the inflatable member 24, than if the patient is severely obese.
The patient's stomach is constricted in order to treat obesity. The constriction causes the food to pass from the patient's esophagus 28 to the lower portions of the patient's stomach 22, at a rate that is slower than would normally occur without the restriction. The decreased rate of food flow increases a feeling of fullness for the patient, and enhances satiety signals that are sent to the patient's brain. The enhanced feeling of fullness causes the patient to reduce food consumption, which desirably causes the patient to lose weight.
In a standard gastric banding system, the size of the constriction of the patient's stomach, and the size of the gastric lumen 33, is fixed. In other words, in a standard gastric banding system, after the gastric band and the access port have been implanted into a patient's body, the size of the lumen 33 is set by the physician, via the access port. In one embodiment, the size of the lumen 33 may only be adjusted if the physician inserts a syringe into the access port and adds or removes fluid from the gastric band lumen 33. However, a lumen 33 with a fixed size may be undesirable if an obstruction, or a large bolus of food, attempts to pass through the lumen 33. The obstruction may become stuck in the lumen 33 as it may not be able to pass through the construction formed by the gastric band. This result is undesirable because it could cause pain for the patient. The patient may need to visit a physician to loosen the band in order to allow the obstruction to pass through the constriction. The obstruction may comprise a large bolus of food traveling through the esophagus to the patient's stomach. The obstruction may also comprise the patient's vomit, attempting to travel from the patient's stomach up through the patient's esophagus.
It is thus desirable if an adjustment system 14 is incorporated into the gastric banding system 10, to allow a size of a portion of the gastric lumen 33 constricted by a gastric band to vary in response to an obstruction passing through the gastric lumen 33.
The components and operation of the adjustment system 14 will now be discussed in relation to
The access port 16 includes a housing 34, a septum 32 and a fluid chamber 36 (visible in
The reservoir 18 comprises a structure configured to receive fluid from the gastric band 12. The reservoir 18 may comprise a flexible, or elastic, structure having a volume capable of automatically varying to accommodate an amount of fluid entering the reservoir 18. In the embodiment shown in
The physical properties of the reservoir 18 may be selected as desired to effect various performance attributes of the adjustment system 14. For example, a relatively large reservoir 18 may allow the reservoir 18 to more quickly receive fluid from the gastric band 12. A larger reservoir 18 will allow a large quantity of fluid to pass from the gastric band 12 to the reservoir 18. In addition, a more flexible reservoir 18 may allow fluid to more quickly pass to the reservoir 18 from the gastric band 12. Further, a smaller reservoir 18 may reduce the total size of the adjustment system 14. Moreover, a less flexible reservoir 18 may reduce the disruption caused by the reservoir 18 towards local tissues, when the reservoir 18 inflates with fluid. The reservoir 18 may be made of an elastic resilient material, such as silicone, or may be made of a rubber or appropriate plastic. The materials selected to form the reservoir 18 may be varied as desired, and the size of the reservoir 18 may be varied as desired. In one embodiment, the reservoir 18 may be sized such that the gastric banding system 10 contains approximately 56 mL (fifty-six milliliters) of fluid. This volume is exemplary and may be varied as desired.
The reservoir 18 is coupled to the housing 34 through a coupling device, namely, through a tube coupler or a connecting nipple structure. Other appropriate coupling devices may be utilized as desired. The reservoir 18 may be securely or detachably fixed to the housing 34. In an embodiment in which the reservoir 18 is detachably fixed to the housing 34, a detachable locking mechanism may be used to couple the reservoir 18 to the housing 34.
The reservoir 18 is preferably positioned exterior to the housing 34 to accommodate size changes of the reservoir 18. In an embodiment in which the reservoir 18 comprises a bladder or balloon configured to vary in size, the externally placed reservoir 18 may allow the reservoir 18 to expand without being confined by the size of the housing 34. In one embodiment, the reservoir 18 may be positioned external to the housing 34, yet placed within a shell that is configured to house the reservoir 18. The shell may be sized to allow the reservoir 18 to increase or decrease in size without interference from the interior surfaces of the shell (e.g., restrained by the interior surfaces of the shell).
Further, the reservoir 18 is preferably positioned exterior to the housing 34, to allow the reservoir 18 to be removed from the housing 34 and replaced as necessary. As discussed above, the physical properties of the reservoir 18 may be varied as desired. A physician may determine a larger reservoir 18 is necessary for use in the adjustment system 14. An external reservoir may more easily allow a physician to access the reservoir 18 and replace the reservoir 18, without having to remove the gastric band 12 or the access port 16 from the patient's body.
The tube 15 connects the gastric band 12 to the access port housing 34. A fluid conduit 44 connects the tube 15 to the asymmetric flow regulator 20. A coupler 42 connects the reservoir 18 to the access port housing 34. A fluid conduit 46 connects the asymmetric flow regulator 20 to the coupler 42. A fluid conduit 48 connects the shunt valve 38 to the conduit 46 leading to the coupler 42. A fluid conduit 50 connects the shunt valve 38 to the conduit 44 leading to the tube 15.
The asymmetric flow regulator 20 comprises a mechanism including a valve that is configured to open to allow fluid from the gastric band 12 to pass through the valve, when a pressure of incident fluid exceeds a threshold. The asymmetric flow regulator 20 further comprises a flow restriction device that is configured to allow fluid from the reservoir 18 to pass to the gastric band 12. In the embodiment shown in
In the embodiment shown in
The threshold value of the one-way valve 52 can be adjusted by varying the compressive force of the spring against the ball, as desired. The compressive force may be varied either mechanically, or hydraulically, as is known in the art. For example, a twisting mechanism may vary the spring constant of the spring, and consequently increase the compressive force of the spring. In addition, a hydraulic pressure may press against the spring to vary the compressive force of the spring. The threshold value of the one-way valve 52 may be adjusted either prior to implantation of the housing 34 or after the housing 34 has been implanted into the patient's body. In one embodiment, the physician may insert a syringe into the housing 34, after the housing 34 has been implanted, to hydraulically vary the threshold value of the one-way valve 52. The threshold value is defined by a structural configuration of the one-way valve 52, or, in other words, a physical property of the one-way valve 52 (e.g., the tension of the spring) defines the value of the threshold force required to open the valve 52.
In one embodiment, the one-way valve 52 may be configured as a valve such as an adjustable diaphragm valve, or adjustable duckbill valve. In one embodiment, the one-way valve 52 may be adjusted through telemetric means, in which a physician wirelessly communicates with a controller that controls the opening and closing of the one-way valve 52, and the threshold opening pressure of the one-way valve 52. In one embodiment, the one-way valve 52 may be configured to comprise any equivalent mechanism capable of only allowing fluid flow in one direction. In one embodiment, the valve of the asymmetric flow regulator 20, shown in
In the embodiment shown in
The asymmetric flow regulator 20 preferably includes a flow restriction device, shown in
In one embodiment, the flow control valve 54 may comprise a variable flow control valve 54, capable of varying the flow rate passing through the flow control valve 54. For example, the flow control valve 54 may comprise a tube having inflatable walls that surround a fluid passageway. The rate of fluid passage through the walls depends on the degree to which the walls are inflated. The flow rate may therefore be varied by varying the amount of fluid contained within the walls of the valve 54, and therefore varying the size of the walls. The amount of fluid in the walls may be varied prior to, or after implantation of the housing 34. A physician may insert a syringe into the access port housing 34 to add or remove fluid from the walls of the valve 54.
In one embodiment, the flow restriction device may comprise a narrow fluid conduit, being sized more narrowly than other fluid conduits utilized in the adjustment system 14, for example, conduits 44, 46, 48, 50, or fluid conduits 56, 58, 60, 62. For example, in this embodiment, the flow restriction device may comprise a narrow tubing. This tubing may allow fluid to pass from the reservoir 18 to the gastric band 12 at a rate that is less than a rate at which fluid passes through the one-way valve 52.
In one embodiment, the flow restriction device may comprise any mechanism capable of reducing the flow rate of fluid passing therethrough. In one embodiment, the restricted flow rate through a flow restriction device may be defined as a rate, being less than the rate at which fluid is capable of flowing through the one-way valve 52, when the one-way valve 52 is open. In one embodiment, the restricted flow rate through a flow restriction device may be defined as a rate that causes the inflatable member 24 of the gastric band 12 to fill at a rate, which is less than the rate at which fluid exits the gastric band 12, when it passes through the one-way valve 52.
The various conduits 44, 46, 48, 50, 56, 58, 60, 62 shown schematically in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
The shunt valve 38, to be discussed further in relation to
Referring back to
The adjustment system 14 is also configured to slowly return the size of the constricted gastric lumen 33 to the size it had prior to the obstruction passing through the lumen 33, or the size when no obstruction is passing through.
The equilibrium pressure of the inflatable member 24 and the reservoir 18 is preferably set by a physician, to optimally reduce food intake for the patient, depending on the unique physical characteristics and size of the patient. For example, if the physician desires that a greater degree of constriction be applied to the gastric lumen 33, then a greater amount of fluid may be passed into the gastric banding system 10, which increases the equilibrium pressure. A physician may adjust the equilibrium pressure by varying the amount of fluid in the gastric banding system 10 through use of the shunt valve 38, in a process discussed more fully in relation to
Forces may be exerted against the gastric band 12 that cause the equilibrium state to be disturbed. If the equilibrium state is disrupted by forces, to the extent that the one-way valve 52 does not open, then fluid will slowly pass through the flow control valve 54 between the reservoir 18 and the inflatable member 24, to maintain the equilibrium state, between the pressures of the inflatable member 24 and the reservoir 18. For example, the one-way valve's 52 threshold pressure may be set at a differential of 10 mmHg between the inflatable member 24 and the reservoir 18. Further, the pressure of the inflatable member 24 in an equilibrium state may be 11 mmHg, and the pressure of the reservoir 18 may be 11 mmHg. If forces are exerted against the gastric band 12 to raise the pressure of the inflatable member 24 to 15 mmHg, then the 10 mmHg differential has not been met. Fluid will then only flow through the flow control valve 54 at a slow flow rate, until the pressures of the inflatable member 24 and the reservoir 18 equalize at 15 mmHg. The size of the gastric lumen 33 and the size of the gastric band's 12 diameter 30 increase in response to the fluid being transferred from the inflatable member 24 to the reservoir 18.
The slow flow of fluid through the flow control device 54 beneficially maintains equilibrium across the inflatable member 24 and the reservoir 18, and adjusts a size of the gastric lumen 33 in response to prolonged forces exerted against the gastric band 12. The flow through the flow control device 54, and the adjusted size of the gastric lumen 33 occur until an equilibrium pressure is reached between the pressures of the inflatable member 24 and the reservoir 18.
The slow flow of fluid through the flow control valve 54, however, may not be sufficient to adjust a size of the gastric band 12 quickly, in response to an obstruction passing through the gastric lumen 33. An alternate mechanism, namely, the one-way valve 52, is utilized to allow fluid to pass at a large, or fast, flow rate from the inflatable member 24 to the reservoir 18, to quickly increase the size of the gastric lumen 33, and accordingly quickly increase the diameter 30 of the gastric band 12. The fast flow rate may be defined as a rate being faster than fluid may pass through the flow restriction device, represented in
A large force exerted against the gastric band 12 will overcome the threshold pressure of the one-way valve 52. The one-way valve 52 will open in response to pressure of the fluid in the inflatable member 24 increasing over a threshold. The large force exerted against the gastric band 12 may be caused by an obstruction passing through the gastric lumen 33. Fluid will pass from the inflatable member 24 to the reservoir 18 at a fast flow rate through the one-way valve 52. Fluid will pass through the one-way valve 52 until the threshold pressure differential is met, at which time the one-way valve 52 will close. The remaining pressure differential may be equalized through fluid flow through the flow control valve 54.
As shown in
A long arrow 68 indicates a fluid flow at a fast flow rate passing to the one-way valve 52. A long arrow 70 indicates fluid flow at a fast flow rate passing through the one-way valve 52. A long arrow 72 indicates a fluid flow at a fast flow rate passing to the reservoir 18. A short arrow 74 indicates a fluid flow at a slow flow rate through the flow control valve 54. The fast flow rate is greater than the slow flow rate.
The adjustment system 14 beneficially rapidly increases the size of the portion of the gastric lumen 33 that is constricted in response to an obstruction 64 passing through the gastric lumen 33. The adjustment system 14 does so automatically, or without user intervention, in response to luminal 33 pressure increasing or rising above a threshold level. The rapid increase of the size of the portion of the gastric lumen 33 beneficially allows the obstruction 64 to quickly pass through the constriction of the gastric lumen 33. It is desired that the diameter 30 of the inflatable member 24 is able to increase to the passage state, or passage size, which allows the obstruction 64 to pass through the gastric lumen 33.
The flow of fluid from the inflatable member 24 to the reservoir 18 occurs until the pressure of the reservoir 18 equals or is approximately equal to the pressure of the inflatable member 24.
The force exerted by the obstruction 64 against the gastric band 12 will be reduced once the obstruction 64 passes through the constriction of the gastric lumen 33. The fluid pressure in the reservoir 18 will then exceed the pressure in the inflatable member 24 of the gastric band 12. The pressure differential will cause fluid to flow back from the reservoir 18 to the inflatable member 24 of the gastric band 12, until the pressure between the inflatable member 24 and the reservoir 18 is again equalized. The fluid returning from the reservoir 18 to the inflatable member 24 can not pass through the one-way valve 52. Instead, the fluid will return to the inflatable member 24 through the flow control valve 54, at a slow flow rate.
In one embodiment, the reservoir 18 may be configured to exert a compressive, or elastic, force against the fluid contained within the reservoir 18. The force may further contribute to the pressure of the reservoir 18.
The slow flow rate of fluid from the flow control valve 54 to the inflatable member 24 beneficially constricts the gastric lumen 33 slowly after the obstruction 64 has passed. The slow return reduces the possibility of damage to the patient's stomach that could be caused by a relatively quick return of fluid to the inflatable member 24. The slow return of fluid allows the patient's stomach to be slowly compressed, which reduces the possibility of local tissues rupturing or becoming damaged. In addition, wear on the gastric banding system 10 is reduced. Furthermore, the slow return maintains the diameter 30 of the gastric band 12 at an increased size, or the passage state, for a prolonged period of time. It is beneficial to maintain the diameter 30 of the gastric band 12 in the passage state, because it is expected that if one obstruction 64 has passed through the constriction of the gastric lumen 33, then it is likely that another obstruction 64 may be forthcoming. For example, if the patient is eating many large pieces of steak, then it is likely that after one large piece of steak is consumed, then another will be subsequently consumed. The slow return of fluid may keep the gastric band 12 open for a duration that allows for a successive obstruction 64 to more easily pass through the constriction, before the construction closes again. The gastric band 12 will not have to open and close quickly for each successive obstruction 64 passing through the patient's gastric lumen 33.
In one embodiment, the time for the gastric band 12 to open and return to the equilibrium state may be approximately 15 minutes. In one embodiment, the time for the gastric band 12 to open and return to the equilibrium state may be in a range of between approximately 1 minute and 15 minutes. These durations are exemplary in nature and may be varied as desired.
In the embodiment shown in
As discussed in relation to
In one embodiment, the shunt valve 38 may comprise a valve capable of being opened by a fluid pressure exerted against the valve 38, by fluid exiting or entering the syringe 26. In one embodiment, the shunt valve 38 may comprise any valve capable of producing equivalent operation, capable of opening and closing to allow fluid to flow to the reservoir 18 and the inflatable member 24, without having to pass through the asymmetric flow regulator 20.
The operation of the shunt valve 38 is schematically represented in
The shunt valve 38 is integrated with the fluid chamber 36. The shunt valve 38 includes a plate 88 and a spring 90 that biases the plate 88 in a direction towards the septum 32. The plate 88 is biased to block passage of fluid from the fluid conduit 50 leading to the inflatable member 24 (shown in
After the syringe 26 needle is removed, the shunt valve 38 closes, and the access port 16 returns to the state shown in
The shunt valve 38 beneficially allows a physician to adjust the fluid level in the reservoir 18 and inflatable member 24, without fluid having to pass through the asymmetric flow regulator 20. For the embodiment of the asymmetric flow regulator 20 shown in
For example, if fluid was entered into the system on the side of the one-way valve 52 that is coupled to the reservoir 18, then the fluid could not pass to the inflatable member 24 through the one-way valve 52. Fluid may only flow through the one-way valve 52 in a direction of: from the gastric band 12 to the reservoir 18. The fluid could only pass slowly through the flow control valve 54. In addition, if fluid was entered into the system on the side of the one-way valve 52 that is coupled to the inflatable member 24, then it could only pass through the one-way valve 52 if the fluid pressure exceeded the threshold pressure of the one-way valve 52. The fluid could otherwise only pass at a slow rate through the flow control valve 54. Thus, without the shunt valve 38, there would be a delayed response between the insertion or removal of fluid through the syringe 26, and the insertion or removal of fluid from the reservoir 18 and/or the inflatable member 24, caused by fluid passing slowly through the flow control valve 54.
The shunt valve 38 also beneficially allows the physician to quickly ascertain the fluid pressures of the reservoir 18 and the inflatable member 24. If the physician uses a syringe 26 having an integrated pressure meter, then the physician may receive more current readings of the fluid pressure in the system 12, than if fluid had to pass through the flow control valve 54 at a slow rate. The shunt valve 38 may lead to more accurate and rapid adjustments of the fluid volumes and pressures in the gastric banding system 10.
The shunt valve 38 also beneficially allows the gastric band 12 to be emptied rapidly without delay. If the gastric band 12 must be quickly removed from the patient's body, the shunt valve 38 may allow the fluid in the gastric band 12 to quickly be extracted if necessary.
The cross sectional view of the access port 16 shown in
In one embodiment, the asymmetric flow regulator 20 may be equivalently replaced by a single valve device. In this embodiment, the single valve device would operate to provide the functions of both the one-way valve 52 and the flow control valve 54, as discussed in relation to
In one embodiment, the flow restriction device may be configured as a device that only allows flow in one direction of: from the reservoir 18 to the inflatable member 24. In this embodiment, the flow restriction device may not allow fluid to pass from the inflatable member 24 to the reservoir 18. The flow restriction device in this embodiment may serve as a return valve, to only allow fluid flow to slowly pass from the reservoir 18 to the inflatable member 24, to return the inflatable member 24 to a constricted state.
The reservoir 106 is configured similarly as the reservoir 18 shown, for example, in
The asymmetric flow regulator 104 is configured similarly as the asymmetric flow regulator 20 shown, for example, in
A coupler 110 links the asymmetric flow regulator 104 to the reservoir 106. A coupler 112 links the reservoir 106 to a fluid chamber 108 of the access port 100. The couplers 110, 112, may be configured to allow components of the gastric banding system 96 to detach from each other. For example, the reservoir 106 may be detachably coupled to the access port 100, and detachably coupled to the asymmetric flow regulator 104. Further, the asymmetric flow regulator 104 may be detachably coupled to the tube 15.
The gastric banding system 96 shown in
The system 96 shown in
A drawback to the embodiment shown in
In one embodiment, the reservoir 106 and the access port 100 may be combined as a single unit. The access port 100 may not be necessary for operation of the system 96, if the reservoir 106 is configured to receive a syringe capable of transferring fluid to and from the reservoir 106. In this embodiment, the reservoir 106 may be appropriately fixed to a portion of the patient's body, in a position that is accessible by a syringe.
The reservoir 118 is configured similarly as the reservoir 18 shown, for example, in
The asymmetric flow regulator 104 is configured similarly as the asymmetric flow regulator 104 shown, for example, in
The t-connector 120 couples the asymmetric flow regulator 104 and the access port 100 to the reservoir 118. The t-connector 120 may be configured to allow the asymmetric flow regulator 104 and the access port 100 and the reservoir 118 to detach from each other.
The gastric banding system 114 shown in
The embodiments of gastric banding systems, and adjustment systems shown throughout this application are not limited to gastric systems, or systems for the treatment of obesity. The gastric banding systems and adjustment systems may be integrated into any medical device wherein an inflatable cuff is desired to quickly open in response to an obstruction or large impulse force being applied to the cuff.
Unless otherwise indicated, all numbers expressing quantities of ingredients, volumes of fluids, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
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.
Furthermore, certain references have been made to patents and printed publications throughout this specification. Each of the above-cited references and printed publications are individually incorporated herein by reference in their entirety.
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.
