CN1748659B - Implantable band with attachment mechanism having dissimilar material properties - Google Patents

Abstract

An implantable band for placement around an anatomical passageway, such as the stomach or other lumen, has a strap made of material having at least one first material property, and has an attachment mechanism having material which has at least one second material property which is different from the first material property. The attachment mechanism may include plastically or elastically deformable material.

Description

The implantable band that has bindiny mechanism with dissimilar material properties

Related application

The application's requirement is on June 27th, 2003 with the applying date, denomination of invention is " adjustable gastric band that has improved bindiny mechanism ", series number is 60/483,353 temporary patent application, with the applying date be JIUYUE in 2003 30 days, denomination of invention is " implantable band that has deformable bindiny mechanism ", series number is 60/507,612 temporary patent application is as priority, and disclosed content also is incorporated herein by reference in the above-mentioned application simultaneously.The application is also with reference to following 30 days the common pendent U.S. Patent application of JIUYUE in 2003 that applies for: denomination of invention is " implantable band that has improved bindiny mechanism ", and series number is 60/507,625 temporary patent application; Denomination of invention is " implantable band that has transverse attachment mechanism ", and series number is 10/677,088 patent application; Denomination of invention is " implantable band that has non-mechanical attachment mechanism ", and series number is that 10/676,368 patent application and denomination of invention are " implantable band that has bindiny mechanism ", and series number is 60/507,916 provisional application.The application is also with reference to following 19 days the common pendent U.S. Patent application of December in 2003 that applies for: denomination of invention is " implantable band that has improved bindiny mechanism ", series number is 10/742,483 application, with denomination of invention be " implantable band that has bindiny mechanism ", series number is 10/741,869 application.

Technical field

The present invention relates generally to a kind of operation implantable band that is used for around anatomical passageway, relates in particular to a kind ofly to be used for adjustable gastric band around stomach for controlling obesity.The present invention especially will be used for the improved bindiny mechanism of adjustable gastric band and describe in conjunction with a kind of.

Background technology

Begin in early days since the eighties, adjustable gastric band provides for stomach bypass and other and has been used for effective selection scheme of the irreversible loss in weight operative treatment of morbid oberity.Described stomach band is around the top of patient's stomach, and with the opening of formation less than the normal interior diameter of stomach, thereby erstricted diet enters the digestion part of bottom from the top of stomach.When opening size is suitable, thus the food that is retained in epigastric cause that a kind of sensation of swelling stops that patient eats too much.

Except being provided with in latched position the diameter of stomach band, the adjustable of stomach band realizes that by the swelling gasbag of inner orientation this is similar to the blood pressure cuff usually, and liquid for example saline is expelled to wherein to obtain required diameter by fluid injection opening.Described air bag is by vacuumizing or only part inflation expressly, with the adjustment of permission health and the treatment at neo-implanted band position when being positioned in the body for the first time.Because adjustable gastric band can keep for a long time in the patient body, described fluid injection opening is installed to subcutaneous to avoid infection especially, for example is positioned at before the breastbone.After implanting first, the surgeon can adjust the elasticity of band according to patient's needs.Be inserted into the silicone septum of injection port by repairing primary (Huber) syringe needle through skin, thereby can adjust the Fluid Volume in the adjustable gastric band.In case this syringe needle is removed, described barrier film seals described hole by the pressure load that barrier film produces.A flexible duct is communicated with described injection port and described adjustable gastric band.

The bindiny mechanism that is used for adjustable gastric band must provide the original dimension of the opening of stomach.A generally well-known connected mode is to sew up the end of adjustable gastric band.Another generally well-known connected mode comprises that an end of the stomach band that ends in the flexible duct with expansion is pulled by the hole in this stomach band second end, is sewn onto endless belt part-with the Weishang that is incorporated into seam then.After being sutured in the appropriate location, injection port is fixed on suitable position.

Although these known method can be effectively fixing stomach band, but still need to do further to improve, to simplify clinical implant procedure, secular stability is provided and conveniently adjusts or move.

Relied on although sew up as the most effective connected mode in the past, also needed a kind of need not sew up fixedly connected, also do not need simultaneously to produce this connection with very big power.In addition, use laparoscopic tool may be difficult to grasp or carry out this connection.Therefore, there is very big demand in the adjustable gastric band that has improved bindiny mechanism.

Summary of the invention

By a kind of usefulness adjustable gastric band device that littler power connects is provided, the present invention is devoted to solve these and other problem that exists in the prior art, thereby convenient use laparoscopic tool is operated, and this connection can keep reliable in very long service time.

A total target of the present invention provides a kind of adjustable gastric band, wherein this stomach band comprises the material with at least one first material behavior and the material of bindiny mechanism, and described bindiny mechanism comprises the material with at least one second material behavior corresponding but inequality with described first material behavior.Described bindiny mechanism can comprise plasticity or elastic deformation material.

Another target of the present invention provides the adjustable gastric band of a kind of reversibility easily operation, and wherein this stomach band can be fixed or unload and do not reduce the retentivity of bindiny mechanism.

Another target of the present invention provides a kind of bindiny mechanism, and this bindiny mechanism needs less power to lock and bigger power is opened described end.

Description of drawings

The accompanying drawing that combines with description and constitute a description part shows embodiments of the invention, with total description of the invention described above, below the specific descriptions of described embodiment be used to explain principle of the present invention.

Fig. 1 shows the sketch map of a kind of adjustable gastric band around the top of stomach.

Fig. 2 is the viewgraph of cross-section of the adjustable gastric band 2-2 along the line of Fig. 1.

Fig. 3 is the top plan view that has the adjustable gastric band of bindiny mechanism, and wherein said bindiny mechanism is made up of different plastic deformation materials.

Fig. 4 is the partial enlarged drawing of the end of band shown in Figure 3.

Fig. 5 is the viewgraph of cross-section of Fig. 4 5-5 along the line.

Fig. 6 is the viewgraph of cross-section of Fig. 4 6-6 along the line.

Fig. 7 is the viewgraph of cross-section of Fig. 6 7-7 along the line.

Fig. 8 is the top plan view of partial cross-section of another embodiment that has the adjustable gastric band of bindiny mechanism, and wherein said bindiny mechanism is made up of different elastic deformation materials.

Fig. 9 is the partial enlarged drawing of the bindiny mechanism of Fig. 8.

Figure 10 is the local enlarged cross-sectional view of the embodiment of another bindiny mechanism similar to Fig. 9, and wherein said bindiny mechanism is made up of different elastic deformation materials.

Figure 11 is the top plan view of partial cross-section of another embodiment of bindiny mechanism, and wherein said bindiny mechanism is made up of different elastic deformation materials.

Figure 11 A is the end-view of accepter shown in Figure 11.

Figure 12 is the local amplification vertical view of the cross section of embodiment shown in Figure 11, and it has shown interconnected bindiny mechanism.

Figure 13 is the local enlarged perspective of another embodiment of bindiny mechanism, and wherein said bindiny mechanism is made up of different elastic deformation materials.

Figure 14 is the local enlarged perspective of embodiment shown in Figure 13, and it has shown interconnected bindiny mechanism.

Figure 15 is the amplification cross section of Figure 14 15-15 along the line.

Figure 16 is the decomposition diagram of amplification of another embodiment of bindiny mechanism, and wherein said bindiny mechanism is made up of different elastic deformation materials.

Figure 17 is the enlarged perspective of the cross section of shell shown in Figure 16.

Figure 18-20 and Figure 17 are similar, wherein are placed with insert in the shell, and Figure 18-20 has shown the diverse location of insert in operating process.

Figure 21-the 23rd, the top view of bindiny mechanism shown in Figure 16-20.

Figure 24 is the local enlarged perspective of another embodiment of bindiny mechanism, and wherein said bindiny mechanism is made up of different elastic deformation materials.

Figure 25 is the local enlarged perspective of embodiment shown in Figure 24, and it has shown interconnective bindiny mechanism.

Figure 26 is the local enlarged perspective of embodiment shown in Figure 24, its shown with the terminal isolating interlude of described adjustable gastric band among syndeton.

Will describe the preferred embodiments of the present invention in detail now, this embodiment as shown in drawings.

The specific embodiment

In the following description, identical reference marker is represented identical or corresponding part in following accompanying drawing.Simultaneously, in the following description, for example be to be understood that before, after, in, outer, or similarly term belongs to and makes things convenient for term, rather than be interpreted into determinate term.Term used in the present invention does not mean that qualification, as long as device described herein or part wherein can be added or use in other location.The present invention will describe in more detail with reference to the accompanying drawings.

With reference to figure 1, wherein shown the top of adjustable gastric band 10 around stomach 12, by its two ends being linked together and by part 14 being sewn onto the part 14 extend through adjustable gastric bands 10 that the Weishang makes stomach 12, thereby stomach band is remained on the appropriate location.With reference to figure 2, described adjustable gastric band 10 comprises inextensible lining band 16, and by the inflatable air bag 18 that medical grade silicone polymer or any other suitable material are made, described air bag 18 is carried by the inner surface 20 of lining band 16.Described air bag 18 can be fixed on the inner surface 20 with any known method, perhaps even with lining band 16 forms overall structure, although lining band 16 can be formed by different materials usually.

The end of flexible duct 22 and inner chamber 24 fluid connections of air bag 18, another inner chamber (not shown) fluid connection terminal and remote injection port 26.Described remote injection port 26 comprises silicone septum 28.When described adjustable gastric band 10 was implanted around the part of stomach, described remote injection port 26 also was implanted to a suitable position, is usually located at rectus layer (rectus sheaths), repaiies the endermic inlet of primary (Huber) syringe needle with formation.

As everyone knows, inner chamber 24, flexible duct 22 and remote injection port 26 preferably are full of physiology compatible liquid, for example saline solution at least in part.Adjust after the operation by air bag 18 girth that surrounds, size with consequent opening, realize that by inner chamber 24 increases or removal liquid the operation of this increase or removal liquid is finished in the silicone septum 28 of skin insertion injection port 18 by repairing primary (Huber) syringe needle from air bag 18.

Known in this area, adjustable gastric band 10 can be had enough the suitable medical material of necessary intensity and made by any, to be used for special laparoscopic surgery or special patient.

As mentioned above, the two ends of adjustable gastric band 10 interconnection together (the concrete mechanism of bindiny mechanism does not at length show in Fig. 1).

The present invention relates to be used for the different embodiment of bindiny mechanism that two ends are linked together, it comprises a kind of material with at least one material behavior, and described material behavior is different with the material behavior of the material that described band is mainly comprised.General structure with adjustable gastric band 10 as indicated above is identical with the embodiment shown in Fig. 3-7 as illustrated in fig. 1 and 2, and the difference between the embodiment is specific bindiny mechanism.It should be noted that enforcement of the present invention can use any band, rather than be limited to use and have above or the adjustable gastric band of described special characteristic hereinafter.

With reference now to Fig. 3,, adjustable gastric band 30 comprises extending is with 32, and it is along stretching referred to herein as axial direction, even when implanted, adjustable gastric band 30 still has bow-shaped structural.Describedly be with 32 to comprise inner surface 34 and outer surface 36, described air bag 38 is near the inside stretching, extension of inner surface 34.Described adjustable gastric band 30 comprises the first end 40 that overlaps on the second end 42.Described first and second ends 40,42 are fixed together by deformable bindiny mechanism.

With reference to figure 4, in described embodiment, first end 40 with 32 has the first of bindiny mechanism, this part with shown in the cylindrical shaft part 44 of extension link to each other, this shaft portion has some fasteners 46, conical butt collar flange 46 as shown in the figure, it tilts away from terminal 44a along the configuration of shaft portion 44 axially spaced-aparts.The described the second end 42 of lining band 32 has the second portion that links to each other with bindiny mechanism, and this part is expressed as in the drawings and extends laterally part 48, and wherein this extension vertically stretches out from outer surface 36 usually.

Described parts 48 are configured to hold first end 40.With reference to figure 6 and 7, extend laterally part 48 and limit a chamber at least in part, also be referred to as passage 50, it is configured to hold first end 40.Described parts 48 comprise two legs of placing at interval 52,54 that stretch out from outer surface 36, and define space 56 between them.Passage 50 is led in space 56.

As shown in Figure 7, the surperficial 50a of passage 50 part 46 that is configured to be connected stops the axial shrinkage of first end 40 from passage 50.Especially, passage 50 comprises some axially spaced, common keepers 58 in the form of a ring, also is referred to as to encircle 58, and its annular is disconnected by space 56.In described embodiment, each keeper 58 comprises the maintenance face 58b that generally includes Frusto-conical surperficial 58a and transversal usually (longitudinally).

The part in described passage 50 and gap 56 is held actuator 60 and surrounds, and shown in figure " U " shape part, also can use other any suitable shape, and it is positioned entirely among the parts 48.Described actuator 60 is by any plastic deformation easily or be curled into required form and the material that do not rupture is made, thereby impels described keeper 58 near axle 44, in axial or side direction the contraction of first end 40 is produced the resistance that increases.Therefore, this material behavior of actuator 60 does not at least promptly have precedence over important elastic deformability's plastic deformation ability, has low relatively yield point, and is different from the corresponding material behavior with 16 remainder manufactured materialss.Energy is delivered to actuator 60 so that its plastic deformation, thereby causes first end 40 and the second end 42 to be fixed together.

More particularly, Texturized described actuator 60 causes it to be squeezed on the axle 44, thereby causes keeper 58 on the direction of arrow 62 link 46 to be moved axially the bigger resistance of generation.Curl and also can cause closing described gap 56.

For first end 40 is connected to the second end 42, axle 44 is pushed by passage 50.According to described embodiment, by axle 44 being advanced to desired location, thereby can be possible with being arranged to surpass a diameter with 30 through passage 50, link 46 runs into the axially movable minimum drag from described fi-ustoconical surface 58a simultaneously.In case be positioned at desired location, described actuator 60 can curl it by grasper or other proper tools and drive described link.In order to separate above-mentioned two ends, the gap 56 of described closure can be separated, for example by using grasper to separate the apparent surface in described gap 56.

Described actuator 60 can be made by any required distortion and suitable material biologically of power of providing when curling, for example the plastically deformable metal.Although described actuator 60 is shown as being positioned over fully among the described the second end 42, for example pass through insert molding, described actuator 60 also can exceed described outer surface, as long as it still remains in the second end 42 to a certain extent, and keeps the complete of the second end 42.The width in gap 56 is selected to the interval that can provide enough placing the axle 44 by wherein, and closes by curling, thereby can excessively not limit the distortion of actuator 60.

With reference now to Fig. 8 and 9,, it shows another embodiment with deformable bindiny mechanism, and wherein said bindiny mechanism is a strain.Described adjustablegastric band 70 comprisesfirst end 72 and thesecond end 74, and as shown in the figure, it interconnects byinner surface 76 inadjacent end 72 and 74.Describedfirst end 72 comprises the first that links to each other with bindiny mechanism, and this part is expressed as in the drawings and extends laterallypart 78, and wherein 72inner surface 76 vertically stretches out this extension from the end usually.Describedparts 78 are configured to engage the second portion of the described bindiny mechanism that links to each other with described the second end 74.Especially, the describedpart 78 that extends laterally defines thepassage 80 that is connected withinner surface 76 atfirst end 72, and it is configured to hold described the second end 74.Describedparts 78 comprise two legs of placing atinterval 82 and 84, and described leg stretches out frominner surface 76 in the opposite edges oflining band 70, andlateral member 86 is extended between them.

The second end of the bindiny mechanism that links to each other with thesecond end 74 is expressed as comprisingkeeper 88, and described keeper extends laterally fromouter surface 90 wherein.Thiskeeper 88 comprisesinclined surface 92, and it can be as shown in the figure arc, or the plane.Thiskeeper 88 also comprises themaintenance face 96 that vertically stretches out fromouter surface 90 usually, and perpendicular to any the relatively moving between first andsecond ends 72 and 74.Describedmaintenance face 96 must stretch out certain distance from the top edge ofpassage 80, breaks away from required power thereby be enough to provide stop.In described embodiment,maintenance face 96 exceeds the top of lateral member 86 a little.

Describedkeeper 88 comprisesparts 98, its preferably by with make with the different material of 100 remainder, or have at least with the different elasticity of 100 remainder.Especially, in this embodiment, the elasticity of the material ofmanufacture component 98 is different with the elasticity made from 100 material, and the material ofmanufacture component 98 has bigger elasticity, with the bias voltage holding member flexibly towards shown in shape.Structure shown in the use, when being inserted intopassage 80, bigger elasticity allows holdingmember 88 more easily to compress.

In disclosed this embodiment, describedparts 98 are depicted as helical spring, and it is placed among thechamber 102 that is formed in the keeper 88.The describedchamber 102 that hasparts 98 can use any suitable method to form, for example by the mold operation of two steps, insert molding or other technique known.If this chamber is identical with material with 100 remainder, when all being silicones especially, the existence inchamber 102 allowskeeper 88 easier deflection on side direction.Describedparts 98 have lateral elasticity, outwards promotekeeper 88, so thatmaintenance face 96 remains on a certain position, thereby need very big axial force to separate described two ends.Because the lateral elasticity and the describedchamber 102 perpendicular to the direction that moves ofparts 98, only need relatively little side force to move to a certain position, thereby can not hinder or reduce the resistance that thesecond end 74 shrinks frompassage 80 withlateral member 86 belows or near themaintenance face 96 of below.

Described different material, the chamber that elastic deformation part and it are positioned over wherein can be any suitable shape.With reference to Figure 10, another embodiment of elastomeric element 104 is positioned in the chamber 106 with illustrating.These parts 104 are V-shaped, and the end openings of broad is towards maintenance face 108.

With reference to Figure 11, it has shown another embodiment of bindiny mechanism, and it represents with 110 that usually it comprises receiving-member 112 and the elastomeric element that is carried byfirst end 114, and this elastomeric element is expressed as twocantilever springs 116 of being carried by the second end 118.Described receivingelement 112 andspring 116 can be by any medical compatible material manufacturings with sufficient intensity.In described embodiment, but receivingelement 112 andspring 116 by the polymer manufacturing of injection molding, this polymer clipped object is molded in first andsecond ends 114 and 116 of adjustable gastric band (not shown in Figure 11), wherein this stomach band is made by silicones.The material behavior of making this material of receivingelement 112 andspring 116 is different from the material behavior of the material of making band.Especially in described this embodiment, this material is harder than the material (for example silicones) of band, rigidity more.

With reference to figure 11A, described receivingelement 112 comprises two pairs of sidewalls of placing at interval 120,122,124 and 126, and described sidewall defines a chamber 120, also is referred to as recess, and it is configured to hold two legs of placing atinterval 130 and 132 of described spring 116.Describedsidewall 122 and 124 comprises twoholes 134 and 136, and it is configured to hold theend 138 and 140 ofleg 122 and 124.Eachterminal 138 and 140step 142 and 144 that comprise separately, described step is configured to certain size, thereby engage respectively separatelyhole 134 and 136side 146 and 148, shrink to stop fromrecess 128, as mentioned below.

Describedspring 116 comprises from separatelyleg 138 and 140 outwardly directedsteps 150 and 152.Described thesecond end 118 is molded as a part that remains there aroundspring 116, andleg 138 and 140 stretches out from terminal 154.Also haveconcave surface 156 and 158, it can comprise as shown in the figure surperficial burr and projection, aligns withstep 150 and 152 usually, so that the position of catching thesecond end 118 to be provided, is used for these twoends 114 and 118 are clipped together.

With reference to Figure 12, forbindiny mechanism 110 is linked together,leg 130 and 132 is inserted in the recess 128.Terminal 138 and 140 comprise inclined-plane 160 and 162, and these inclined-planes engage turning 164 and 166 when inserting, and when leg advances inrecess 128leg 130 and 132 are pushed toward each other.The structure of described material andspring 116 provides elasticity for twolegs 138 and 140.Terminal 138 and 140 all the way move forward to them inrecess 128 can outwards move to be embedded inhole 134 and 136 and with described twoends 114 and 118 and combine, and thismoment terminal 154 is usually near ends 168.

As shown in the figure,hole 134 and 136 passes completely through the receivingelement 112 corresponding sidewalls of placing atinterval 122 and 124 respectively, and step 142 and 144 does not reach the outside in described hole.The silicone material that describedhole 134 and 136 is shown as byend 114 covers.In case connect as shown in figure, described receivingelement 112 andspring 116 are not exposed, but in the band cover of packing into, thereby can not produce corrosion to surrounding tissue.

For describedfirst end 114 is separated from described thesecond end 118, describedconcave surface 156 and 158 inwardly pushes, thereby causeleg 130 and 132 to move inward up toterminal 138 and 140 134 and 136 withdrawals from the hole, describedspring 116 can be withdrawn from receivingelement 112 simultaneously.Describedconcave surface 156 and 158 can push by using grasper.

With reference to figure 13-15, it has shown another embodiment of bindiny mechanism, and by 170 expressions, this bindiny mechanism comprisesfirst end 172 and thesecond end 174 usually, and it is by making with the remainder identical materials of described band, for example silicones.Describedfirst end 172 comprisestaper keeper 176, especially is conical butt as shown in the figure, its be placed on theannular recess 178 that separates firstcylindrical part 180 andkeeper 176 bottoms near.Secondcircumferential section 184 extends between first circumferential section and keeper 176.What stretch out fromkeeper 176 opposite ends is anothercylindrical part 186.

Described thesecond end 174 defines and is generally columniforminner chamber 188, usually also be referred to as the hole, it is by complementally shaped or configured for holding describedfirst end 172, the interior diameter that has the overall diameter that is a bit larger tham described firstcylindrical part 180 as shown in the figure, its amount that has more enough allow describedfirst end 172 to use following method to be inserted in the chamber 188.Thesecond end 174 comprises two transverse grooves of placing atinterval 190 and 192 that communicate with describedinner chamber 188, and it is positioned over the relative both sides of described thesecond end 174.

Elastic component 196, the illustrated alligator clamp that is generally U-shaped, have two from the bottom 202 legs that stretch out 198 and 200, be in free state usually parallel to each other.Described alligator clamp 196 can provide the elasticity of necessity and the suitable medical compatible material manufacturing of intensity by any.The one or more material behavior that forms the material of alligator clamp 196 is different from the one or more material behavior of the correspondence of the material of making described band.In described embodiment, described alligator clamp 196 is harder than described band, have more elasticity.

Described alligator clamp 196 is carried by described thesecond end 174, and two leg 198 and 200 partly is placed inhole 190 and 192 respectively.The end 198a and the 200a of described leg stretch outhole 190 and 192, and terminate in sweep.Described bottom 202 is molded into described thesecond end 174, and leg 198 and 200 is freely outwards stretched, and passes through between leg 198 and 200 to allowkeeper 176.

Under free state, the distance between the leg 198 and 200 enough allows the leading end 176a ofkeeper 176 from passing through between them.Preferably, the diameter of terminal 176a is less than the distance of leg 198 and 200 leg correspondences.Forbindiny mechanism 170 is linked together, describedfirst end 172 is inserted in the described chamber 188.When describedfirst end 172 advances inchamber 188, the tilted shape of describedkeeper 176 is separated leg 198 and 200,190 and 192 align withgroove 178 up to the hole, leg 198 and 200 moves in thegroove 178 there, preferably flexibly bear against as shown in figure 15 on describedcylindrical part 184, but move to a position at least enough describedfirst end 172 is remained in thechamber 188 near thebottom 182 ofkeeper 176.

For describedfirst end 172 is separated from the second end, leg 198 and 200 is drawn back enough far away, to allow bottom 182 from passing through between them.This can realize by using grasper.

Main reference Figure 16-23, especially Figure 16 and Figure 21-23, and it has shown another embodiment of the bindiny mechanism of adjustablegastric band 254, and by 204 expressions, it comprises first end 206 and the second end 208 usually in described bindiny mechanism.Figure 16 has shown the decomposition diagram of thisbindiny mechanism 204 that does not comprise band.Described first end 206 carries plug-inpackage 210, and the second end 208 carries casing assembly 212.Described plug-inpackage 210 andcasing assembly 212 can be connected on first and second ends 206 and 208 with any suitable method.In described embodiment, plug-inpackage 210 andcasing assembly 212 are molded into respectively in end 206 and 208, and are with 254 to axially align with described.Should be noted in the discussion above that described plug-inpackage 210 andcasing assembly 212 can be selectively with respect to being with 254 side direction or transversal orientation.

In described embodiment, described plug-inpackage 210 comprisesinsert 214,lid 216 and retainer 218.Describedinsert 214 is pivotally connected to byretainer 218 and covers 216.As shown in the figure, describedinsert 214 compriseshole 220, and this hole is configured to holdingportion retainer 218, although can use any suitable retainer or chocking construction, described retainer is expressed as bolt in the drawings.Described lid also compriseshole 222, and by this hole, thescrew portion 218a ofretainer 218 extends and engages with the female thread in hole 220.Describedlid 216 can comprise bore hole or other recess (not shown) near theupper end 214a placement ofinsert 214 on its surface.This recess can form and the complementary shape of the adjacent part ofinsert 214, thereby holds the part ofinsert 214, still allowsinsert 214 to rotate fully simultaneously.The structure that any permission insert is carried suitably by first end 206 and freely rotates can be used.

Describedinsert 214 comprises threelegs 224, and each leg comprises and extends radially outpart 224a and axial extension 224b.Although shown theleg 224 at three intervals, also can be with one or more leg at interval.In described embodiment,leg 224 is equidistant placement on circumference, angle between them is 120 °, althoughaxially extension 224b be successive and with extend radially outpart 224a and align, discontinuous and align and also can realize the function of describedleg 224.

In described embodiment, describedcasing assembly 212 comprisesshell 226, andblock piece 228 is shown as helicalspring biasing member 230 of strain andend cap 232 in the drawings.With reference to Figure 17, describedshell 226 defines inner chamber, also is referred to asbore hole 234 equally.Start from the 234a of first of the upper end 226a ofshell 226, also be referred to as the intake section ofbore hole 234, have the complementary nominal diameter of specified overall diameter (not comprising leg 224) with insert 214.Someaxial grooves 236 form and stretch out from the inner surface 234b of intake section 234a.Describedgroove 236 is constructed to be permeable to holdleg 224, and the quantity of describedgroove 236 and interval are complementary with the quantity and the interval of leg 224.The size of the width of described groove 236 (circumference) and the degree of depth (surpass inner surface 234b) is set toleg 224 provides the gap, thereby is not needing or having only under the situation of very little axial force that leg is slided therein.To be noted that becauseinsert 214 rotates inshell 226 to connect and to disconnect (start or close) describedbindiny mechanism 204, sobest leg 224 and groove 236 are along circumference/equidistant angularly even placement.

Described borehole 234 comprises second portion 234c.Described second portion 234c has the diameter that the diameter clearance is provided forleg 224, thereby in case describedleg 224 passes (clear) describedgroove 236, describedinsert 214 can freely rotate inshell 226, and it will hereinafter be described.In described embodiment, the diameter of the described second portion 234c degree of depth withgroove 236 basically is identical, and its inner surface 234d is consistent continuously with the bottom 236a ofgroove 236.

Describedintake section 234 defines someactuate slopes 238 and 240, and described inclined-plane is with respect to the protruding segment distance of described inner surface 234b, thereby provides the diameter clearance for leg 224.Described inclined-plane 238 extends between the upper end of lower end that extends axially side 236b and axially extended stop surface 242.Described inclined-plane 240 is in the lower end of stop surface 242 and extend axially between the lower end of side 236c and extend.In described embodiment, described inner surface 234d extends to inclined-plane 238 and 240.

Some axial grooves 244 stretch out from the lower end formation of second portion 234c and from inner surface 234d.Described groove 244 is configured to hold theleg 228a ofblock piece 228, thereby forleg 228a provides enough gaps, not needing or have only under the situation of very little axial force that leg is slided therein, up to being blocked by terminal 244a.The quantity of groove 244 and interval are complementary with the quantity and the interval of leg 228.In described embodiment, described groove 244 andleg 228 are along circumference/equidistant angularly even placement, although can also use any quantity and location, as long as it can provide required function.

With reference to Figure 18, described inner surface 234d forms the complementary shape of outer surface 228b withblock piece 228 equally, and wherein said block piece is positioned in the bore hole 234.In described embodiment, described surperficial 228b is columniform, and has the little diameter than described inner surface 234d, and its degree that reduces enough allowsblock piece 228 to slide therein and do not need or only need very little axial force.Forblock piece 228 is remained in theshell 226, describedend cap 232 is fixed on the 226b of lower end, and biasingmember 230 is placed on the lower end ofblock piece 228 and covers between 232 the upper end, thereby blockpiece 228 is born against to arrival end 234a.Describedlid 232 and lower end 226b can link together with any suitable method, for example are threaded.

Describedblock piece 228 comprises someinclined ramp 246 and sagging inclined-plane 248 (being clockwise direction) when the top is seen, it intersects at thesummit 250 and theminimum point 252 of radial direction.Described inclined-plane 246 and 248 and extendaxially part 224b and be configured to common cooperation, the startup of describedbindiny mechanism 204 and down periods wheninsert 214 is born against onblock piece 228, thereby biasvoltage insert 214 rotationally.In described embodiment, each extends axiallypart 224b and comprises the lower surface 224c that ends atradial edges 224d, and wherein said radial edges is configured to engage the inclined-plane 246 and 248 of block piece 228.Be noted that described inclined-plane 246 and 248, extendaxially part 224b, the littler circumferential distance place that is configured near the center ofinsert 214 ends of surperficial 224c andleg 224d must be complimentary to one another, conflict avoiding.Also can use other the identical structure of function that is reached with these features.For example, extending axiallypart 224b can only extend vertically, and aligns with the remainder ofleg 224, rather than radial inward exceeds the circumference ofinsert 214.

Figure 18-20 shows the diverse location at the startup ofbindiny mechanism 204 and down periods insert 214.It should be noted that in Figure 18-20 curvature on inclined-plane 238 ' is opposite with the curvature shown in Figure 17.The shape of described inclined-plane and leg can be any suitable shape, and these shapes cooperate jointly, thereby obtains to realize like that as will be described below that mobile one and quantitative calibration of insert rotate (indexed rotation).

In Figure 18,insert 214 is placed in thebore hole 234 ofshell 216 at least in part, and eachleg 224 is positioned in separately the groove 236.Whenleg 224 like this during the location, extend axially eachedge 224d ofpart 224b and engage placement with separately sagging inclined-plane 248.When insert 214 axially advances in bore hole, the sagging surface on described inclined-plane 248 isbias voltage edge 224d rotationally, but this rotation is stoped by baffle plate 236b at first, it is enough far away to advance inbore hole 234 up to insert 214, so thattop edge 224e passes the lower end onlower end 238a '/inclined-plane 238 ' of (clear) side 236b.Describedblock piece 228 axially moves inbore hole 134 when insert 214 advances, but does not rotate.

In case describedtop edge 224e passes describedlower end 238a ', can rotate with describedinsert 214, the sagging surface on described inclined-plane 248 causes insert to rotate, arriveminimum point 252 up tolower limb 224d, wherein said minimum point is sagging surperficial 248 terminal point, promptly saggingsurperficial 248 parts that stop operating.In this position, describedtop edge 224e rotates throughlower end 238a ', and is positioned under the inclined-plane 238 '.

When the axial force on acting oninsert 214 discharged subsequently, upwards theblock piece 228 of bias voltage upwards promotedinsert 214, passes the contact site ofedge 224d andinclined ramp 246, promotedtop edge 224e and engaged with inclined-plane 238 '.It should be noted thattop edge 224e can only beradially extension 224a and the surface a 238 ' part that contacts, as shown in figure 28, perhaps except engaging byedge 224e, surface 224f can be configured to engagement ramp 238 ', shown in Figure 19 or 20, perhaps replacetop edge 224e engagement ramp 238 '.

Figure 19 shows engaging oftop edge 224e and surperficial 224f and inclined-plane 238 ', and wherein said inclined-plane applies forward the rotation bias voltage of (being clockwise direction in the drawings) on insert 214.Because the upwards bias voltage that blockpiece 228 produces,inclined ramp 246 stops insert 214 to rotate forward.Yet, the bias voltage that rotates forward that is produced by inclined-plane 238 ' enough overcomes the obstruction rotation bias voltage that is produced byinclined ramp 246, describedinsert 214 advances rotationally, stoped by stop surface 242 up to rotating, as shown in figure 20, described insert remains in thebore hole 234, and describedbindiny mechanism 204 is activated, thereby described band is fixed together.

As shown in figure 20,lower limb 224d advances to and exceeds summit 250.In order to separate the end of described band,bindiny mechanism 204 closes by pressing down insert, that is to say, promotes insert inbore hole 234, andlower limb 224d is born against on sagging inclined-plane 248.Along with this start-up operation, sagging inclined-plane 248 isbias voltage edge 224 rotationally, is stoped by stop surface 242 at first but rotate in this case, and it is enough far away to advance inbore hole 234 up to insert 214, so thatupper end 224e passes thelower end 242a of stop surface 242.

In casetop edge 224e passeslower end 242a and describedinsert 214 can rotate, the sagging surface on inclined-plane 248 causes insert to rotate, and arrivesminimum point 252 up to lower limb 24d.In this position,top edge 224e rotates throughlower end 242a, and is positioned under the inclined-plane 240 '.

When the axial force on acting oninsert 214 discharged subsequently, upwards theblock piece 228 of bias voltage upwards promotedinsert 214, passes the contact site ofedge 224d andinclined ramp 246, promotedtop edge 224e and engaged with inclined-plane 240 '.Above mentioned about surface 238 ',top edge 224e can only beradially extension 224a and the surface a 240 ' part that contacts, perhaps except engaging byedge 224e, surface 224f can be configured to engagement ramp 240 ', perhaps replacestop edge 224e engagement ramp 238 '.

Being bonded on to apply on theinsert 214 of describedtop edge 224e and surperficial 224f and described inclined-plane 240 ' rotated bias voltage forward, and describedinclined ramp 246 stops the described ofinserts 214 to be rotated forward.The bias voltage that rotates forward that is produced by inclined-plane 240 ' enough overcomes the obstruction rotation bias voltage that is produced byinclined ramp 246, and insert advances ingroove 236 rotationally, thereby allowsinsert 214 to be withdrawn.

With reference to figure 21-23, wherein show the startup of bindiny mechanism.Figure 21 has shown first and second ends 206 and 206 before starting, and these two ends are in alignment with each other usually and are close.In thesefigure arrow 206a and 208a be presented atcover 216 and shell 226 on, rotation withinsert 214 between the explanation starting period, and described arrow can but optionally be included in the actual device, to allow can see between the starting period rotation of relative bearing andinsert.Leg 224 and groove 236 alignment, thus insert 214 can be inserted in the bore hole 234.Figure 22 shows theinsert 214 that enters intobore hole 236, inblock piece 228 axially movable positions.It rotates when describedinsert 214 insertions are enough far away, and when axial force discharged, it remained in theshell 226 as shown in figure 23,arrow 206a and 208a alignment this moment.Advance insert to realize closing by axial rotation ground, then from it is recalled frombore hole 234.

The parts ofbindiny mechanism 204 can be by any medical compatible material manufacture, such as, but be not limited to metal, plastics or their combination.In described embodiment,bindiny mechanism 204 by with described with different material manufacture.The material behavior of making the material of plug-inpackage 210 andcasing assembly 212 is different from the material behavior of the material of making described band.The common harder and rigidity of these parts.Described biasingmember 230 has bigger elasticity.

With reference to figure 24-26, it has shown another embodiment of the bindiny mechanism of adjustablegastric band 258, usually by 256 expressions, it comprises the first of the bindiny mechanism that links to each other withfirst end 260, with the second portion of the bindiny mechanism that links to each other with thesecond end 262 in described bindiny mechanism.First end 260 also is referred to as the ligule part, can be by forming with described 258 identical materials of being with, and be shown as and have usually with described with 258 identical width and thickness.

In described embodiment, describedsecond portion 262 comprises theproximal part 264 that is adjacent to 258,mid portion 266 and distal portions 268.Theedge 270 ofproximal part 264 is roughened or has burr, and to be used to stoping bindiny mechanism's 256 undesigned separation, it will be described below.Describededge 270 is depicted as along comprising on the length direction ofproximal part 264 that plurality of side is toridge.Edge 270 can coarse injustice or have burr along its whole length, and as shown in the figure, but this is optional.Proximal part 264inner surfacies 272 are depicted as has burr, when it can selectively not have burr yet.

Mid portion 266 comprises thesurface 274 with burr, and this surface is configured to stop whenbindiny mechanism 256 is activated, preferably avoid, and moving axially betweenfirst end 260 and thesecond end 262, it will be described below.A pair of outwardlyopen recess 276 also is referred to as release groove, can form nearproximal part 264 places in mid portion 266.Recess 276 is placed to select closemid portion 266 andproximal part 264, places between mid portion and proximal part, places nearmid portion 266 inproximal part 264, perhaps is positioned over proximal part and midportion simultaneously.Recess 276 is relevant with the operation ofbindiny mechanism 256 with respect to the position of latch (describing hereinafter), rather than above-mentioned feature.

Distal portions 268 can rotate byhinge 278 with respect to mid portion 266.Depend on material, describedhinge 278 can be elastomeric hinge or mouldable active hinge.

The far-end 280 ofdistal portions 268 comprises two latch of placing atinterval 282, and described latch extends laterally from far-end 280.As shown in the figure, latch 282 defines the vertical part with inward-facingsurface 282a separately, and the distance that wherein said inward-facing surface is placed at interval is preferably less than the distance between the edge 270.Far-end 280 can be tapered, and the width of far-end 280 reduces along its length, or has the width littler than the width between theedge 270 along its length, thusinner surface 282a trip edge 270.The width of thefirst end 260 ofclose latch 282 whenbindiny mechanism 256 connects, the width between width between theedge 270 and thesurperficial 282a is configured to allowsurperficial282a trip edge 270.

Latch 282 defines innerextensional surface 282b, theinner surface 284 of this surface coverage far-end 280.Lateral separation between theinner surface 282c of the axial width oflatch 282 and latch 282 allowslatch 282 to passrecess 276 and do not have tangible resistance, and is as mentioned below.

With reference to Figure 25, theinner surface 260a offirst end 260 places nearproximal part 264 andmid portion 266, and far-end 260b is near hinge 278.Distal portions 268 is that fulcrum pivots withhinge 278, thus thefirst end 260 between controldistal portions 268 and near-end andmid portion 264 and 266.268 pairs of first ends of distal portions apply clamping force, so that bear against on the surface withburr 274 betweenfirst end 260 and thesecond end 262 near theinner surface 260a of far-end 260b, this causes owing to the size ofhinge 278 to small part.Theinclined ramp 282d oflatch 282 is used to launchlatch 282, to allowlatch 282 to promote downwards throughfirst end 260 andproximal part 264,pass edge 270 up toinner surface 282c, thereby allow inward-facingsurface 282atrip edge 270, with allow innerextensional surface 282b stop position in abutting connection with or at least in the face of outerlateral section 264a, as shown in figure 25.

Figure 26 shows the intermediateness that bindiny mechanism connects.In order to close or to separatebindiny mechanism 256, described far-end moves axially with respect toproximal part 264 andmid portion 266, align withrecess 276 up to latch 282, thereby allow the far-end oflatch 282 to be moved laterally in therecess 276, to allow near-end andmid portion 264 and 266 to rotate, reduce clamping force thus tofirst end 260 with respect todistal portions 268 pivots.In case this clamping force reduces, first end can separate from thesecond end 262.

Described outer surface with 258 comprises drawinghead 286 and 288, and it can use grasper or other tool holding that is fit to, to influence moving of far-end 280.

As indicated above,first end 260 can it typically is silicones by being with 258 identical materials manufacturings with described.Far-end 280 can be by any material manufacture, as long as described material has the material behavior of enough consistency and elasticitys, thereby forlatch 282 provides necessary restoring force and the chucking power that produces necessary maintenancefirst end 260, the manufactured materials of for example duroplasts, thereby far-end is different with described material with 258 remainder.Whole thesecond end 262 can but optionally by the hard material manufacturing.Selectively, any part that is positioned on the far-end 280, or even be positioned at part on thelatch 282 possibly, can by with described with 258 remainder identical materials or the close material manufacture of performance.For example, alldistal portions 268 can be by the hard material manufacturing.Describedhinge 278 can be elastomeric hinge or mouldable active hinge.It is by the hard material manufacturing that the another kind ofmid portion 266 may be selected.

The parts that should be noted in the discussion above that above-mentioned bindiny mechanism can or have one or more in order to carry out the material manufacture of the necessary material behavior of this component function by any suitable material.If this functions of components requires to allow, these parts can be by make (can certainly by diverse material manufacture) with the band portion identical materials of described band.For example, can make the silicones syndeton parts of the higher Shore hardness of making than silicones of band.In this embodiment, the Shore hardness of silicones band can be 50 ± 5, and the Shore hardness of the parts of the bindiny mechanism at least approximately Shore hardness than band is big by 10.

Those skilled in the art can understand easily that above-mentioned invention can be applied to the implantable band of other type equivalently.For example, band can be used for fecal incontinence.Such band is at United States Patent (USP) 6,461, existing explanation in 292, and the document also is incorporated herein by reference.Band also can be used for the treatment of urinary incontinence.Such band is existing explanation in U.S. Patent application 2003/0105385, and the document also is incorporated herein by reference.Band also can be used for treating epigastric pain and/or acid solution refluence (acid reflux).Such band is at United States Patent (USP) 6,470, existing explanation in 892, and the document also is incorporated herein by reference.Band also can be used for treating sexual impotence.Such band is existing explanation in U.S. Patent application 2003/0114729, and the document also is incorporated herein by reference.

Therefore, in the time of in being used in this description and claim, implantable band is a kind of band, and it can be implanted to a certain position for example to block food and body fluid by anatomical passageway, for example stomach or inner chamber.

In a word, the advantage that many employings principle of the present invention is produced has been described.The proposition of previously described one or more embodiment of the present invention only is for example and explanation.And do not mean that exhaustive list or limit the invention to definite open form.Carry out conspicuous improvement according to above-mentioned instruction or variation is possible.Selecting and describing above-mentioned one or more embodiment is in order to explain principle of the present invention better, thus it allow those of ordinary skill in the art to carry out with the specific use that cooperates expection in various embodiments in actual applications various improvement in utilize the present invention better.Scope of the present invention means by additional claim and limits.

Claims (23)

1. implantation belt that is used for therapeutic treatment, described band comprises:

(a) be configured to lining band around anatomical passageway, described lining band defines circumferencial direction in its vicinity, and described lining band has inner surface and outer surface, and described lining band comprises the material with at least one first material behavior;

(b) be positioned at first and second ends at described lining band two ends, described first and second ends comprise inner surface and outer surface separately, and wherein said surfaces externally and internally is corresponding with the surfaces externally and internally of described lining band; With

(c) whole bindiny mechanism, it is configured to described first end is connected with the second end, to fix described lining band near described anatomical passageway, described syndeton comprises the material with at least one second material behavior, and described at least one second material behavior is different from described at least one first material behavior;

Wherein said bindiny mechanism comprises and described first end (40,72,114,172,206) first of Xiang Lianing and with described the second end (42,74,118,174,208) second portion of Xiang Lianing, described second portion comprises elastomeric element (60,102,104,116,196,230) be placed in one, thereby described first and second ends are fixed together by elastomeric element.

2. implantation belt as claimed in claim 1 is characterized in that: described second portion comprises the chamber, and elastomeric element places described chamber at least in part or places near described chamber.

3. implantation belt as claimed in claim 1 or 2, it is characterized in that: described second portion comprises second parts that extend laterally from described the second end, described second parts define passage (50), this channels configuration becomes described first end and described first parts are passed wherein, described first parts become to work in coordination with described second unit architecture, withdraw from described passage to stop described first parts and described first end.

4. implantation belt as claimed in claim 1 or 2 is characterized in that: described elastomeric element comprises described second material.

5. implantation belt as claimed in claim 1 or 2, it is characterized in that: described first comprises first parts that extend laterally from described first end, described first parts define passage (80), this channels configuration becomes described the second end and described second parts are passed wherein, described first parts become to work in coordination with described second unit architecture, withdraw from described passage to stop described second parts and described the second end.

6. implantation belt as claimed in claim 5 is characterized in that: described passage comprises the keeper (58) at some intervals.

7. implantation belt as claimed in claim 6 is characterized in that: described keeper comprises endless loop.

8. implantation belt as claimed in claim 6 is characterized in that: described first comprises cylindrical part (44).

9. implantation belt as claimed in claim 8 is characterized in that: described cylindrical part comprises at least one joint elements (46), and this unit architecture becomes to cooperate with described passage, withdraws from described passage to stop described second portion.

10. implantation belt as claimed in claim 5 is characterized in that: described second parts comprise the leg (52,54) at two intervals.

11. implantation belt as claimed in claim 2, it is characterized in that: described chamber (188) also are configured to hold described first, described first comprises at least one groove (184), when described first is positioned in the described chamber at the primary importance place at least in part, described elastomeric element is located with respect to described chamber, to engage described at least one groove.

12. implantation belt as claimed in claim 11, it is characterized in that: described second portion comprises the hole (190 at two intervals that are communicated with described chamber, 192), and described elastomeric element comprises the spring (196) that is roughly U-shaped, wherein said spring has the leg (198 at two intervals that stretch out (202) from the bottom, 200), described bottom is positioned in the described second portion, and the leg at each described interval is positioned in separately the hole at least in part.

13. implantation belt as claimed in claim 12 is characterized in that: described first end comprises and comprises an inclined-plane (176) at least, and this inclined-plane is configured to when described first end moves to described primary importance with described leg separately.

14. implantation belt as claimed in claim 1, it is characterized in that: described first parts are the sidewall that extends axially and comprise at least two intervals, described sidewall limits an inner chamber (128) at least, be configured to be positioned at least in part in the described chamber with the elastomeric element (116) of described second parts, and engage in the described sidewall one at least, withdraw from described chamber to stop described second parts.

15. implantation belt as claimed in claim 14 is characterized in that: described elastomeric element comprises the leg (130,132) at first and second intervals.

16. implantation belt as claimed in claim 15, it is characterized in that: each described leg comprises outwardly directed separately step (142,144), and described each sidewall at interval comprises hole (134 separately, 136), described hole is configured to engage one of them of described step, withdraws from described chamber to stop described first parts.

17. as claim 14,15 or 16 described implantation belts, it is characterized in that: described first parts and described second parts are injection molded into described first end and the second end respectively.

18. implantation belt as claimed in claim 2, it is characterized in that: the part in described at least chamber (234) is limited by described second parts, described chamber comprises the inner surface that is substantially an axis of columniform qualification, the groove at some intervals and some inclined-planes, wherein said first comprises can be with respect to the cylindrical parts (214) of described first end rotation, described cylindrical parts comprises some outwardly directed legs (224), and described cylindrical parts is configured to insert in described chamber and rotate.

19. implantation belt as claimed in claim 18, it is characterized in that: described cylindrical parts comprises being positioned over and moves axially parts (214) in the described chamber, the described component axial that moves axially is elastically biased toward, thereby towards the described cylindrical parts of outside direction bias voltage (226) in described chamber.

20. implantation belt as claimed in claim 18 is characterized in that: the described parts that move axially comprise some inclinations and sagging inclined-plane, and described inclined-plane is configured to engage described cylindrical parts and the described cylindrical parts of bias voltage rotationally.

21. implantation belt as claimed in claim 18, it is characterized in that: two inclined-planes in described at least some inclined-planes are positioned over along circumference between two adjacent grooves of some described grooves at least, and described chamber comprises that at least one is positioned over the groove between in described some at least inclined-planes two.

22. as any one described implantation belt in the claim 18 to 21, it is characterized in that: one in described at least axis and the described cylindrical parts is extended vertically.

23. implantation belt as claimed in claim 1 is characterized in that: also comprise the inflatable air bag (18) that the inner surface by lining band carries.

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