CN101108135B - Method of implanting a medical device using a suture tab extender - Google Patents

Method of implanting a medical device using a suture tab extender Download PDF

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Publication number
CN101108135B
CN101108135B CN2007101361806A CN200710136180A CN101108135B CN 101108135 B CN101108135 B CN 101108135B CN 2007101361806 A CN2007101361806 A CN 2007101361806A CN 200710136180 A CN200710136180 A CN 200710136180A CN 101108135 B CN101108135 B CN 101108135B
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China
Prior art keywords
band
stomach
capsule
dilator
latch members
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CN2007101361806A
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CN101108135A (en
Inventor
K·L·詹姆博
J·P·威利
L·S·威纳尔
D·R·詹森
P·J·斯温登
C·W·温登豪斯
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Ethicon Endo Surgery Inc
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Ethicon Endo Surgery Inc
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Priority claimed from US11/489,752 external-priority patent/US7618365B2/en
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Abstract

A removable suture tab extender for a gastric band is shaped and dimensioned for selective attachment to a first end of the gastric band, the gastric band including a latching mechanism composed of a first latching member positioned at the first end of the gastric band and a second latching member positioned at a second end of the gastric band. The gastric band extender includes an elongated body member having a first end and a second end. The first end of the elongated body member is shaped and dimensioned for coupling with the first latching member. The second end of the elongated body member includes a gripping section shaped and dimensioned to facilitate gripping thereof as the gastric band extender is passed through the second latching member.

Description

Use the method for suture tab extender implantable medical device
The application is the U.S. Patent application No.11/182 that is entitled as " LATCHING FOR GASTRICBAND " that submitted on July 15th, 2005, the part continuation application of 072 (being in the checking process), and require the U.S. Provisional Application No.60/699 that is entitled as " GASTRIC BAND " that submitted on July 15th, 2005,369 priority.The application is the U.S. Patent application No.11/364 that is entitled as " GASTRIC BAND " that submitted on March 1st, 2006,362 part continuation application, U.S. Patent application No.11/364,362 is the U.S. Patent application No.11/364 that are entitled as " GASTRIC BAND SUTURE TAB EXTENDER " that submitted on March 1st, 2006,361 part continuation application, U.S. Patent application No.11/364,361 is the U.S. Patent application No.11/364 that are entitled as " Precurved Gastric Band " that submitted on March 1st, 2006,363 part continuation application.
Technical field
The present invention relates to a kind of stomach band and relevant adnexa.
Background technology
Morbid oberity is a kind of serious medical conditions.In fact, morbid oberity has become very general in the U.S. and other countries, and its trend seems just to develop towards passive direction.The complication relevant with morbid oberity comprises hypertension, diabetes, coronary artery disease, apoplexy, congestive heart failure, multiple orthopaedic problem and the pulmonic insufficiency of remarkable reduction life expectancy.Consider these problems, those skilled in the art understand certainly, and fund relevant with morbid oberity and material cost are huge.In fact, according to estimates,, relate to fat cost above 1,000 hundred million dollars only in country of the U.S..
Develop multiple surgical operation and treated obesity.The most normal operation of carrying out at present is R-Y (Roux-en-Y) gastric bypass (RYGB).This operation has the complexity of height, is generally used for treating the patient who presents morbid oberity.The Bariatric operation of other form comprises Fobi bag (Fobi pouch), gallbladder-pancreas shunt and gastroplasty or " stomach is performed the operation at interval ".In addition, erstricted diet also is known through the passage of stomach and the implantable device that influences feeling of repletion.
Consider the invasive character of height of this class of many kinds operation, attempted developing and have less wound and less invasive operation.It is a kind of gastric reduction surgery that stomach is tied up art, and it attempts to come the picked-up of erstricted diet by reducing the stomach size.Compare with RYGB and other gastric reduction surgery, stomach is tied up art does not need to change the anatomical configurations of digestive tract in duodenum or colon.
Early stage from the 1980s, the stomach band has just become gastric bypass and other the effective of irreversible lipposuction treatment who is used for morbid oberity substitutes.Tie up at stomach under the leading of art and carried out multiple operation.Some are tied up technology and adopt the stomach ring, and other adopts band, and some adopt the stomach nail, and also have some other operations to adopt the combination of ring, band and nail.In these operations, what the most generally adopt is the stomach hoop, vertically tie up gastroplasty (VBG), falope gastroplasty (SRG) and scalable silicone rubber stomach ties up art (AGB).
Usually, the stomach band twines around the top of patient's stomach, thereby forms the stoma, and described stoma is littler than the normal internal diameter of stomach.This erstricted diet arrives bottom digestion part from the top of stomach.When stoma's size was suitable, the food that remains on the top of stomach provided the feeling of repletion that prevents surfeit.
More particularly, in practice, the stomach band inserts the rear of stomach, and the end of stomach band is connected, with around this device of stomach locking.But suitable locking is carried out in the end that is difficult to handle the stomach band usually.Like this, need to improve the mechanism of discharging the stomach band around stomach.The invention provides this mechanism of extending apparatus form, be used for using, and can after the stomach band is suitably installed, be removed with existing stomach band.The present invention also provides the improved stomach band structure of being convenient to around the stomach dispensing, and has improved function after the dispensing.
Summary of the invention
According to the present invention, a kind of method of implanting the surgery implantable band is provided, described method comprises the step that band is set, described band comprises elongated body member, described elongated body member comprises first end and the second end, described first end is provided with first latch members, and described the second end is provided with second latch members.Described first latch members has the suture tab extender from its extension.Be connected with suture on the described suture tab extender.Described the second end is provided with retained part, and the shape and size of described retained part are convenient to carry out clamping when stomach band dilator passes described second latch members.Described method also comprises the steps: to locate described band around anatomical structure, described suture tab extender is set and connects described first latch members and second latch members afterwards by passing described second latch members, thereby around the described band of described structure locking.Described method also comprises the step that removes described suture tab extender from described band.
Description of drawings
Fig. 1 is the perspective view that is fixed to the suture tab extender (suture tab extender) on the stomach band.
Fig. 2 is the perspective view of removable suture tab extender.
Fig. 3 is the perspective view around the fixed stomach band of stomach.
Fig. 4,5 is a different perspective view according to stomach band of the present invention with 5a.
Fig. 6,7 and 8 has demonstrated each step that is connected the stomach band with suture tab extender of the present invention.
Fig. 9 is the perspective view according to the suture tab extender of another embodiment.
Figure 10 is the perspective view according to the suture tab extender of an alternate embodiments.
Figure 11,12,13 and 14 is respectively the perspective view of capsule in accordance with another embodiment of the present invention, the perspective view of band, the cutaway view of stomach band and the perspective view of stomach band.
Figure 15 and 16 is respectively the cutaway view of perspective view stomach function regulating band of the stomach band of the alternate embodiments according to the present invention.
Figure 17 is the cutaway view of stomach band according to another embodiment of the invention.
Figure 18,19,20 and 21 is respectively the perspective view of the band of another embodiment according to the present invention, the perspective view of capsule, the cutaway view of stomach band and the perspective view of stomach band.
Figure 22-31 has demonstrated each embodiment that supply pipe is positioned at the capsule formula stomach band of diverse location.
Figure 32-43 has demonstrated each embodiment of suture tab extender with different syndetons.
The specific embodiment
At this specific embodiment of the present invention is described.Yet should be understood that the disclosed embodiments only are to exemplary illustration of the present invention, it can be embodied in the various forms.Therefore, the embodiment of Xiang Ximiaoshuing should not be construed as restrictive here, and as just the basis of claims be used to instruct those skilled in the art how to make and/or use basis of the present invention.
With reference to Fig. 1 and 2, the removable suture tab extender 100 that is used for 10 couplings of stomach band is disclosed.Dilator 100 is designed to increase the purposes of stomach band 10, and the use of auxiliary stomach band blocking mechanism 20.Specifically, dilator 100 provides a kind of mechanism, be used for by first latch members 22 of blocking mechanism 20 being inserted or being pushed second latch members 26 or by nipper being inserted second latch members 26, assist first latch members 22 to pass second latch members 26, grasp the tip 112 of dilator, pass second latch members 26 then and retract, so that lock.
For dilator 100 is fixed on the stomach band 10, the strap 108 of dilator 100 passes the hole 38 at the tip of blocking mechanism 20 and inserts.Then strap 108 is adhered on the bearing in the connection recess of dilator 100.According to an alternate embodiment, with reference to Figure 10, dilator 300 can be provided with recess 311 in the end that connects recess 310, and strap 308 can be adhered in this recess 311.
In case stomach band 10 is correctly located and fix around stomach, dilator 100 removes or cuts off from stomach band 10 easily, thus, as is with when itself being cut, and makes the risk minimization of belt edge of " sharp " of generation.In order to remove dilator 100, the hole 38 in the tip 36 of stomach band 10 and comprise adherent strap 108 and connect cutting strap 108 between the recesses 110.This allows dilator 100 integral body to be removed, and makes stomach band 10 excellent fully, without any the belt edge of " sharp ".
Also can be provided with groove 109 (see figure 2)s on the dilator 100, be used between the tip 36 of stomach band 10 and strap 108, inserting shears, to be convenient to downcut dilator 100 better.Dilator 100 is removed from health fully after stomach band 10 downcuts at dilator 100.Dilator 100 also allows to form interim locking, thereby allows to regulate around stomach before final locking blocking mechanism 20.Although dilator downcuts from stomach band body is whole in a preferred embodiment, but in alternate embodiment, may need to make dilator be positioned at the appropriate position on the stomach band and utilize interim locking piece (promptly below with the retaining member of describing in detail 114,214) as the additional fixedly locked position that is used for various stomach sizes.
In fact, with reference to Fig. 3, suture tab extender 100 of the present invention is being fixed on the first end 14 of stomach band 10 near first latch members 22.Afterwards, the stomach band 10 that is connected with dilator 100 inserts the stomach back.Promote then or first latch members 22 of pulling blocking mechanism 20 and second latch members 26 that dilator 100 passes blocking mechanism 20.Suture tab extender 100 of the present invention also provides longer zone, to grasp and to handle first latch members 22 when it when stomach passes through and pass second latch members 26.
According to a preferred embodiment, as below will be in greater detail, dilator 100 be elongated elastomer members, and it is fixed on the first end 14 of stomach band 10, so that first latch members 22 and second latch members 26 cooperate and locking.Dilator 100 preferably is connected on the pulling-on piece 24 at the first end 14 of stomach band 10, so that dilator 100 is kept in position.Once cut removable dilator 100 by the strap on the dilator 100 108, and dilator 100 is combined with groove or open recess, for example cup-like structure 106, are used for the first end 14 and the dilator 100 of stomach band 10 are closely linked together, thereby do as a whole moving.
More particularly, will be expressly understood more that the pulling-on piece 24 of stomach band 10 is positioned in the groove 106 of dilator 100 by following description, and with strap 108 safety and be connected to securely on the dilator 100.In addition, according to the preferred embodiment, the second end of dilator can comprise suture loop 105, is used for compatible with golden finger shape device 150.Those skilled in the art understand certainly, and golden finger shape device 150 helps to make stomach band 10 to pass tunnel behind the stomach.Perhaps, for the doctor who makes stomach band 10 pass tunnel behind the stomach with other devices, the grip portion of dilator 100 or flat end 112 are compatible through devices with these bands.Usually, golden finger shape device is hinged band process device, is used for carrying out behind stomach before passing the stomach band blunt dissection.This device hinged and be provided at stomach after.There is recess in tip at golden finger shape device, and suture loop is hooked on this recess.In case catch suture, golden finger shape device is drawn out tunnel behind the stomach, and suture loop is with this device pulling band.In addition, for the ease of using through device (band passing-devices) with these other band, one section expander behind the flat end can be (the tubing shape) of circle, makes dilator directed easily.
Removable dilator 100 is designed to use with various stomach bands.For example, dilator is designed to be called with the name of submitting on July 15th, 2005 that disclosed stomach band uses among the total U.S. Patent application No.11/182072 of " LATCHINGDEVIDE FOR GASTRIC BAND ", and this paper is incorporated in this patent application by reference into.
Generally speaking, with reference to Fig. 4,5,5a, stomach band 10 comprises the band main body 12 with first end 14 and opposite second end 16.Band main body 12 and blocking mechanism 20 are preferably made by silicones (silicone).Although as below will describing in detail, the stomach band is a capsule formula stomach band, and under the situation that does not deviate from spirit of the present invention, blocking mechanism of the present invention can use with various band structures.
Briefly mention as top, the shape and size of stomach band 10 are suitable in the precalculated position around stomach to reduce the size of stomach.Stomach band 10 adopts flexible blocking mechanism 20, its can do not destroy breech-block enough 20 or obviously reduce to lock again after the situation of hold facility under the locking and unlocking.According to the direction of motion with will to lock still be that blocking mechanism 20, the first and second ends 14,16 of release stomach band 10 are used separately as sun (male) member and the moon (female) member.
First end 14 comprises housing member or is called first latch members 22, it is made of the hollow semilune housing with pulling-on piece 24 basically, this pulling-on piece is used to pass collar member (perhaps being called second latch members 26) and grasps and spur, and this collar member is made of the semi-circular hole on the second end 16 30.The semilune housing of first latch members 22 can be collapsed when being passed collar member 26 pullings by nipper or promoting.Collar member 26 comprises tongue 28, makes that housing member 22 passes semi-circular hole 30 in tongue 28 slid underneath when locking.In case housing member 22 is through tongue 28, effect has just changed.First end 14 is as female element when housing member 22 is flexibly got back to its original-shape and be allowed to slide back the second end 16 (being male element now) and be positioned at tongue 28 tops.Like this, serve as male element and female element at blocking mechanism 20 operating period housing member 22, collar member 26 20 operating periods of blocking mechanism also as male element and female element.That is to say that housing member 22 as male element, is used as female element at tongue 28 peace seats afterwards during passing collar member 26 insertions in wherein the time.
By adopting nipper that first end 14 is pulled away from the second end 16 forward, make tongue move apart housing member 22, realize release.The shape of the M shape of housing member 22 allows it to collapse and pass collar member 26 and move below tongue 28.
More particularly, the housing member 22 at first end 14 places of stomach band 10 is essentially semilune, has the wide end 32 of opening, and end 32 is tapered towards near the narrow end 34 the tip 36 of first end 14.Housing member 22 is hollow basically, and is formed by the material of for example silicones, allows its compression and expansion.
With reference to Fig. 5 a, housing member 22 is formed with the outer surface 23a that is essentially M shape when its wide end 32 is seen.That is to say that the outer surface of housing member 22 has the profile that is essentially M shape, and near the inner surface 23b the wide end 32 of housing member 22 has slick basically semicircle profile.Have been found that single face M shape profile can improve flexible and control force when housing member 22 passes collar member 26.In addition, the shape of the M shape of the wide end 32 of housing member 22 is convenient to release, because this shape makes easier and can control compression to housing member 22 better.
As mentioned above, housing member 22 passes collar member 26 slips.Afterwards, its original-shape is got back at the center 54 of the wide end 32 of M shape, and it is matched on tongue 28.When stomach band 10 was released, housing member 22 was drawn forward from collar member 26, and the wide end 32 of M shape allows it to pass collar member 26 for 28 times at tongue to move.The prefabricated shape of housing member 22 is not only at the guide frame that slides on housing member 22 as tongue 28 during the release, but also the hole 30 that allows housing member 22 more easily to pass collar member 26 is slided back.
Hole 38 is formed near the narrow end 34 of the tip 36 of first end 14 and housing member 22 the pulling-on piece 24.The shape and size in hole 38 are suitable for being accommodated in normally used suture or nipper when the stomach band is installed.In addition, pulling-on piece 24 is formed with projection 39, and it helps to grasp pulling-on piece 24 in the locking and unlocking process.
The clamping components 51 that stretches out backward also is formed on the first end 14, but on a side relative with hole 38 of housing member 22, is positioned near the wide end 32 of housing member 22.The shape and size of clamping components 51 allow two-way contact, with the locking and unlocking blocking mechanism 20.More particularly, clamping components 51 comprises projection 56 along its end face and bottom surface 53,55.These projections are convenient to along the first direction clamping.Clamping components 51 also is formed with the reinforcement middle body 57 of " hourglass " shape.Strengthening middle body 57 allows along the second direction clamping.
Get back to first edge 46 of the wide end 32 butt collar member 26 of its original-shape and housing member 22 by housing member 22 after guaranteeing when housing member 22 passes collar member 26 compression, realize the firm fastening of housing member 22 and collar member 26.
Stretch tongue 28 by being provided with for collar member 26, further improve locking from the tip 50 of the second end 16 from collar member 26.After housing member 22 has passed collar member 26 and the tensioning of stomach band, when first and second ends 14 and 16 are spurred toward each other, and housing member 22 attempts to pass towards the position of unclamping collar member 26 when retracting, and the shape and size of tongue 28 are suitable for pacifying seat in the wide end 32 of housing member 22.Like this, tongue 28 can be directed downwards, makes itself and housing member 22 slide in the reliable mode of facility.Can make the color difference of tongue 28, so that the indication that whether is suitably locked about blocking mechanism 20 to be provided.
By being provided with, promptly, further improve the clamping of the second end 16 towards the clamping components at the tip 50 of the second end 16 towards preceding clamping components 58.Shape and size towards preceding clamping components 58 allow two-way contact, with the locking and unlocking blocking mechanism 20.More particularly, clamping components 58 has projection 59 along its end face and bottom surface 62,64.These projections 59 are convenient to along the first direction clamping.Clamping components 58 also is formed with the reinforcement middle body 60 of " hourglass " shape.Strengthening middle body 60 allows along the second direction clamping.
The shape and size of clamping components 58 are suitable for receiving housing member 22 and make housing member 22 be positioned at the center when housing member 22 passing collar member 26.Clamping components 58 also helps compression shell member 22 when housing member 22 passes collar member 26.
According to a preferred embodiment of the present invention, the stomach band is the capsule formula stomach band shown in Figure 11-16.Like this, stomach band 410 is made of reinforcing band 412 basically, and elongate connector 414 is fixed in the reinforcing band 412.Be with 412 to comprise that first end 416 and the second end 418, the first and second latch members 422,426 are respectively fixed on first and second ends 416,418.Be with 412 also to comprise inner surface 428 and outer surface 430.Outer surface 430 is smooth basically and when stomach band 410 major part around patient's the stomach outer surface 431 of formation stomach band 410 fixedly the time.The shape and size of the inner surface 428 with 412 are suitable for being connected on the outer surface 438 of capsule 414.
For capsule 414, it also comprises first end 432, the second end 434, inner surface 436 and outer surface 438.Inner surface 436 is slick basically, and its shape and size are suitable for engaging patient's stomach when the stomach band is fixed to the upper.The shape and size of the outer surface 438 of capsule 414 are suitable for being connected with inner surface 428 with 12.
With reference to Figure 11-16, can be respectively by Overmolded or molded separately bonding subsequently come connecting band 412 and capsule 414 (identical Reference numeral is used for different embodiment).Which kind of manufacturing technology no matter, the outer surface 438 of capsule 414 is formed with groove 439, and the shape and size of groove 439 are suitable for taking in is with 412.With reference to Figure 15 and 16, wherein be with 412 to bond on the capsule 414, groove 439 is formed with glue crack 439a, and the shape and size of glue crack 439a are suitable for taking in a spot of glue, can influence with 412 positions in groove 439 sharply.
According to an alternate embodiment, with reference to Figure 17, it is contemplated that can by capsule 414 ' and be with 412 ' between add one deck unvulcanized material 413 ' (constituent class is similar to miscellaneous part) and then they sulfided, connect capsule 414 ' and be with 412 '.In addition, one deck strengthen structure 415 ' (net, foreign material or more the silicone material of high rigidity) be included in unvulcanized material 413 ' layer in.Strengthen structure 415 ' be encapsulated in this device in assembling and when sulfuration, and provide additional structure and different mechanical performances for product.
In addition, with reference to Figure 18-21, imagined another stomach band 410 according to the present invention " structure." fixing, capsule 414 " outer surface 428 " forms stomach band 410 outer surface 430 of exposure " " according to this embodiment, with the inner surface 417 of 412 " along capsules 414 ".Embodiment is the same as described above, and inner surface 417 " is formed with groove 439 ", and its shape and size are suitable for taking in is with 412 ".By " glue crack 439a being set " along groove 439 and will being with in 412 " stationary positioned is at grooves 439 " along groove 439 " length be provided with keep buckle 439b " realization.Glue crack 439a " is substantially similar to the glue crack of adopting with reference among Figure 16 and 17 embodiment that describe.
As for keeping button 439b in "; groove 439 " is configured with the projection 439c in the relative sensing "; its shape and size are suitable for splicing tpae 412 " and will be with 412 " and remain on groove 439 " temporarily, and the glue that is used for connecting band 412 " and capsule 414 " vulcanized in gluing operating period.More particularly, the projection 439c in pointing to " shape and size be suitable for will be with 412 " remains on groove 439c " in mode around being with 412 " and twines.
According to a preferred embodiment, be with in 412 " being positioned at capsule 414 as follows ".One of capsule opening 433 on two ends 432 of " by capsule 414 " with 412 ", 434 " ", 435 " inserts.Capsule 414 " groove 439 on maintenance buckle 439b, specifically for projection 439c " at parts by along at capsule 414 " with 412 " between the pin of insertion temporarily parts are kept together when gluing.Perhaps, it is contemplated that capsule can be Overmolded to being with.
According to preferred embodiment, as top concise and to the point description, capsule and band can by bonding, common mode, Overmolded or so that the mode that the different parts of stomach band link together fixedly the mechanical connection (for example joint sleeve) of capsule and band be fixed together.At band and capsule when Overmolded, stopper 415 is used for closure and is used for the central outlet of Overmolded capsule, and stopper 415 can with stomach belt structure formation one (referring to Figure 14 and 15).Those skilled in the art understand certainly, and common mode is substantially the same with Overmolded process, but the material of different performance is injected in the mould simultaneously.With Overmolded the same, common mode needs the central outlet in the closed capsule of stopper.
No matter product is molded or fits together, and band and capsule parts can be by identical materials or different materials (material hardness meter, for example BaSO 4, TiO 2The filler of coloring agent etc.) constitutes.In addition, the element in the same parts (being locking member or end cap) can change on composition.These elements can be with on bonding agent, mechanical fasteners (being snap fit), welding, common mode or the Overmolded bearing of receiving product.Although described band is fixed on the outer surface of capsule, under the situation that does not deviate from spirit of the present invention, it is contemplated that band can be positioned at the inside or the outside on capsule surface, perhaps is integral with scrotiform.
For the assemble method (promptly bonding, mechanical connection, Overmolded) that allows to connect different parts, unique band can make up so that different structures to be provided with the capsule parts.For example, the band with variable locking mechanism can exchange with the capsule of different length, with the probability of multiple combination that product is provided.
Capsule 414 is configured to when being applied to the Weishang to improve and the contacting of coat of the stomach.Like this, as below will be in greater detail, capsule 414 be configured to the large volume capsule of the low-pressure of prebuckling.When being configured on being applied to gastric tissue, capsule 414 keeps soft and flexible surface (low-pressure).Capsule 414 also is configured to provide the covering of 360 degree, discontinuous to prevent tissue contracts or stomach shape, like this, can adopt the denomination of invention of submitting on July 15th, 2005 to be disclosed capsule structure among the total U.S. Patent application No.11/182070 of " GASTRIC BAND WITH MATING END PROFILES ", this paper is incorporated in this patent application by reference into.Capsule 414 also be constructed such that its arrive complete expansion and around structure, have minimal " folding ".In addition, capsule 414 is configured to not folding, perhaps folds (mono-axial, be not biaxial) when wherein extracting out when all fluids.
Like this, the application's the capsule that preferred embodiment adopted 414 is made of elastomeric material.Because the design of this capsule, it can be not cause in the capsule mode of high-tension to expand when capsule is full of or to expand at stomach band conditioning period.Capsule 414 is suitable for taking in the fluid of large volume under relatively low pressure power.Like this, capsule 414 is taken in fluid during discharging, and tensile traditional approach expands or expansion but can not form with the wall along capsule 414.In other words, when capsule 414 is filled into when realizing volume that maximum stomach restriction recommended, capsule material does not expand.But capsule 414 is filled out the certain percentage of its premier's opinion volume (being maximum packing volume).Because capsule 414 is not filled into its maximum packing volume, it keeps low-pressure, allow capsule 414 and stomach to adapt, rather than stomach contacts with inflexible capsule.
According to a preferred embodiment of the present invention, capsule 414 is designed to heap(ed) capacity between about 10cc and about 18cc, is preferably 18cc, though in order to realize that minimum stomach size (approximately 9cc arrives about 12cc, preferably 9cc) capsule can be full of fully.By providing, so just improved the pliability and the adaptability of capsule when suitably being filled when realizing its function and the capsule 414 of its heap(ed) capacity of no show.Although disclose specific volume in accordance with a preferred embodiment of the present invention, it will be appreciated by those skilled in the art that under the situation that does not deviate from spirit of the present invention to change packing volume.
In addition, capsule 414 is manufactured into and makes it have crooked structure when not stressing.Although within the scope of the invention various curvature can be arranged, curved configuration is designed to provide about 0.5 inch to arrive about 1.5 inches radius of curvature.In addition, it is contemplated that capsule is at the radius that can have variation when its length is extended.Generally speaking, the curvature of capsule is designed near when capsule 414 is subjected to bias voltage and presents relaxed configuration first and second latch members 422,426 not being furthered or making the required curvature of they contacts.Have the capsule 414 of intrinsic curvature by manufacturing, what formed when obviously having reduced the dispensing fluid is folding.Like this, band is folded and first and second latch members 422,426 that further to reduce by prebuckling equally.
Those skilled in the art understand certainly, and it is roughly the same to be configured to the curvature of its curvature and capsule 414 with 412, make reduced with 412 and capsule 414 between undesirable tension force.In addition, consider prebuckling character, with the 412 easy outer surfaces that adapt to harmonization of the stomach band 412 with 412.
By the capsule 414 that has recessed cross section along the inner surface 436 of capsule is provided, further improved and the contacting of gastric tissue.This kind cross-sectional configuration be convenient to find time capsule and make it become straight.
By implementing the said structure standard, capsule 414 shrinks, and does not have fold or projection to form on the inner surface 436 of capsule 414, realize the capsule 414 of low-pressure and prebuckling, and capsule 414 changes shape when its filling (zipper pouch fills up).For change of shape, capsule 414 is constructed such that it had wideer and more flat cross section relatively before filling perpendicular to the cross section of the longitudinal axis of capsule 414.When being filled between capsule 414 is being applied to patient's gastric phase subsequently, the shape of cross section of capsule 414 changes over round capsule, has narrower cross section, has bigger distance between surface 436 and the outer surface 430 within it.Like this, can further imagine, the capsule cross section can be molded as round rectangle, and wherein " angle " provides support, and disperses change of shape and reduces folding.Fill preceding wide and flat capsule by being provided at, reduced the inner surface of capsule and the distance between the band.This has reduced the final profile of stomach band, and has improved the stomach band and be easy to carry with unfolded ability.
Those skilled in the art understand certainly, and supply pipe is used for the inner chamber of the capsule of stomach band is connected with source of pressurised fluid.The use of this pipe and long-range fluid source allows capsule to carry out manual expansion and contraction in a predetermined manner.The definite position of pipe is important because the doctor do not wish other of locking or stomach band operating period tubing become visual disorder.In addition, finish in case the stomach band is placed, this pipe should not form tissue on every side and stimulate (directly stabbing liver or spleen).The doctor does not also wish whether be compromised because the doctor can not easily see organizing by pulling pipe in tunnel behind the stomach.Pipe should be with acting on the safe grasp position that the stomach band is handled, and fluid flow cannot be twisted together and prevent in the junction of Guan Zaiyu stomach band, and the position of pipe should be convenient to by little intubate.
Like this, according to a preferred embodiment of the invention,, shown different pipe layouts with reference to Figure 22-31.Shown among these different embodiment each, pipe is positioned at an end of stomach band.By pipe being positioned at an end of stomach band, the power of finding to have reduced the power on pipe, the stomach band and finally having reduced the Weishang.The ability of pipe stomach function regulating band deflection has also been improved in this location, so that insert and expand into when launching its original-shape.
With reference to Figure 22, pipe 540 is oriented from stomach band outer surface and leaves stomach band 510.According to a preferred embodiment of this design, pipe 540 is positioned such that it leaves outer surface 531 under the center line 542 of the longitudinal extension of stomach band 510.Pipe 540 is positioned such that it leaves blocking mechanism 20 and places, and is in the tilted angle at (according to the general 34 ° of angles of preferred embodiment) with respect to the longitudinal axis of stomach band 510, easily inserts by intubate allowing.
With reference to Figure 23, pipe 640 is molded on the second end 634 of capsule 614.Specifically, pipe 640 is molded in the end of capsule 614 and forms one with the shape of capsule.As the previous embodiment, pipe 640 is directed obliquely with respect to the longitudinal axis of stomach band 610, and is positioned at the center line below of the longitudinal extension of stomach band 610 equally.This skew allows 632,634 contacts of capsule end, is not subjected to the interference from pipe 640.
With reference to Figure 24, demonstrated another embodiment, wherein manage 740 cross side 744 that when capsule 714 is positioned among the patient, leaves capsule 714, the i.e. positive bottom surfaces of capsule 714.The inlet point of pipe 740 is aimed at second latch members 726 basically with respect to the longitudinal axis of stomach band 710.As the previous embodiment, pipe 740 longitudinal axis inclined orientation with respect to stomach band 710.
Shown in Figure 25 and 26, pipe 840 is integrally connected on the side of latch members.According to the embodiment of the disclosure, pipe 840 is formed in second latch members 826, although it is contemplated that, under the situation that does not deviate from spirit of the present invention, pipe 840 can form one with first latch members 822.Pipe 840 enters second latch members 826 and passes the main body that second latch members 826 extends into capsule 814.In case manage 840 main bodys that are arranged in capsule 814, pipe 840 turns to the centrage (perhaps center line 842) of capsule 814, even is used to fill saline.Pipe 840 is also with respect to the longitudinal axis inclined orientation of stomach band 810, and is positioned at the below of center line 842 of the longitudinal extension of stomach band 810 equally.This skew allows 832,834 contacts of capsule end, is not subjected to the interference from pipe 840.
With reference to Figure 27 and 28, show other embodiment respectively.According to embodiment shown in Figure 27, pipe 940 is molded in the stopper 946, and stopper 946 is used for covering the core of capsule 914.According to embodiment shown in Figure 28, pipe 1040 is molded as the part of the one of second latch members 1026.Therefore, the fluid passage extends through pipe 1040, enters the path 10 48 that is formed in second latch members 1026, and finally enters capsule 1014.More particularly, enter the bridger of an end second latch members 1026 (promptly second latch members 1026 limits empty place) in case manage 1040, pipe 1040 is divided into bifurcated pipe 1052, and its two walls 1054 by the hole 1030 of second latch members 1026 enter capsule 1014.
Figure 29 and 30 has demonstrated another embodiment, wherein manages 1140 and is integrally formed in blocking mechanism 1120, is preferably placed at a side of second blocking mechanism 1126.Pipe 1140 extends from second latch members, 1126 back by gusset piece 1156 then, to allow to enter the low angle that enters of capsule 1114.
With reference to Figure 31, pipe 1240 inlets are formed on to be with on 1212 (more specifically the saying to be second latch members 1226), to allow independent molded strip 1212 and capsule 1214.Pipe 1240 can be used in a single day being compressed to the position that fibrous tissue just finds blocking mechanism 1220 in implant by being connected on second latch members 1226.As the previous embodiment, manage 1240 longitudinal axis inclined orientation, and be positioned at center line 1242 belows of the longitudinal extension of stomach band 1210 equally with respect to stomach band 1210.This skew allows the end 1234 of capsule to contact not managed 1240 interference.
In addition, any tubular structure of describing with reference to Figure 22-31 can be in conjunction with some strain relief member, to lessen fatigue during deflection back and forth in health when tubing.Can realize this strain relief (for example, show similarly among Figure 31, but for making a mark) by one section thicker material being positioned at the tubing entrance of leading in the capsule referring to the gusset piece 1156 of Figure 29.This section thick material allows tubing crooked to a greater degree when the joint bending of leaving between pipe and the capsule.In other words, the material of this section thickening has increased this regional rigidity of tubing, so that the tubing deflection can not twist together, and makes bending point further move apart the point of the fragility between band, capsule, the tubing.Strain relief member is preferably made by silicones, but also can adopt other materials on (plastics, metal etc.).In addition, in all these embodiment, tubing can be by multiple manufacture method for example Overmolded or assembling or gluing in any being connected on band or the capsule.
Although described the present invention and the coupling of stomach band it will be appreciated by those skilled in the art that foregoing invention is equally applicable to the implantable band of other types.For example, the band that is used for the treatment of fecal incontinence.At United States Patent (USP) 6,461, a kind of such band has been described in 292.Also this band can be used for the treatment of urinary incontinence.A kind of such band has been described in U.S. Patent application 2003/0105385.This band can also be used for the treatment of heartburn and/or the anti-stream of acid.At United States Patent (USP) 6,470, a kind of such band has been described in 892.This band also can be used for the treatment of sexual impotence.A kind of such band has been described in U.S. Patent application 2003/0114729.
With reference to Fig. 1 and 2, dilator 100 comprises the elongated body member with first end 102 and the second end 104.First end 102 comprises open recess 106, and its shape and size are suitable for taking in the pulling-on piece 24 of first latch members 22 at first end 14 places of stomach band 10.The first end 102 of dilator 100 further is provided with strap 108.The shape and size of strap 108 are suitable for passing the hole that is formed in the pulling-on piece 24 38 and finally are connected in the connection recess 110 in the outer surface of the first end 102 that is formed at dilator 100.Like this, the strap 108 that extends from dilator 100 passes pulling-on piece 24 and forms circle, easily with the first end 102 and first latch members 22 of dilator 100, optionally to connect or dismounting.
The second end 104 of dilator 100 comprises retained part 112, and its shape and size are convenient to clamping when dilator 100 passes collar member 26 and stomach band 10 around patient's stomach dispensing.In addition, also have suture loop 105, it is compatible with above-described golden finger shape device 150, and the retained part of dilator 100 blunt end part 112 is compatible through devices with other bands in other words.Between the first end 102 of dilator 100 and the second end 104, be formed with the retaining member 114 of horizontal expansion.Retaining member 114 is when be semicircle when the plane cross section is seen.Retaining member 114 is tapered, broadens towards the first end 102 of dilator 100, forms a surface, can slide on this surface in idle interval collar member 26, dilator 100 is connected on the collar member 26 temporarily.This taper has formed composition surface 118, and when the first end 102 of dilator 100 temporarily was latched on the collar member 26, this surface 118 remained on collar member 26 between the first end 102 and retaining member 114 of expansion of dilator 100.
Although described the dilator with groove and retaining member according to a preferred embodiment above, under the situation that does not deviate from spirit of the present invention, dilator can be taked other forms.For example, another preferred embodiment shown in Figure 9 according to reference, extended element 200 comprises the elongated body member with first end 202 and the second end 204.First end 202 comprises the groove of sealing, more particularly is recess 206, and its shape and size are suitable for taking in fully the pulling-on piece 24 of first latch members 22 at first end 14 places of stomach band 10.The first end 202 of extended element 200 also is provided with strap 208.The shape and size of strap 208 are suitable for passing the hole that is formed in the pulling-on piece 24 38 and finally are connected in the connection recess 210 in the outer surface of the first end 202 that is formed at extended element 200.Like this, the first end 202 of extended element 200 can be easily and selectively is fixed on first latch members 22 or from 22 dismountings of first latch members.
The second end 204 of extended element 200 comprises a plurality of projections 212, and its shape and size are convenient to clamping when extended element 200 passes collar member 26 and stomach band 10 around patient's stomach dispensing.In addition, the second end 204 also comprises the suture loop 105 from its extension.Between the first end 202 of extended element 200 and the second end 204, be formed with the retaining member 214 of horizontal expansion.Retaining member 214 comprises first and second engagement members 216,218.Engagement member 216,218 is tapered, first end 202 towards extended element 200 broadens, form a surface, can on this surface, slide in idle interval collar member 26, with before blocking mechanism 20 lockings of finishing stomach band 10 (extended element 200 is from stomach band 10 dismounting after this) extended element 200 is connected on the collar member 26 temporarily.This taper has formed relative composition surface 220,222, when the first end 202 of extended element 200 temporarily was latched on the collar member 26, this surface 220,222 remained on collar member 26 between the first end 202 and engagement member 216,218 of expansion of extended element 200.
Which kind of structure the expander no matter the stomach band uses is, importantly, contacts dilator easily so that remove, and it is minimum wrong probability to occur.Two key issues when removing dilator be the doctor differentiate dilator especially dilator in order to remove the ability of the part of need handling, and according to the ability that mechanism continues to remove dilator that removes that is adopted.Various be used to guarantee clear view and the embodiments of being convenient to cut like this, have been developed.Any embodiment that describes below can be combined with visual detector, color (on the whole dilator or on the strap or) for example only in the zone that will cut, perhaps visual suture thinks that the doctor indicates this to be and the stomach band divided portion that should remove.In addition, these embodiments also provide various means, and wherein dilator can be connected to stomach band (strap, suture etc.).
More particularly, with reference to Figure 32,33,35,36, near first end 1302 straps 1508,1608 or dilator 1500,1600 of dilator 1300 are provided with one or more projections or slope 1330,1530,1630 in the position near opening connection recess or recess 1310, the strap 1308,1508,1608 of dilator 1300,1500,1600 will be positioned in this recess 1310.By (on the first end at dilator or on strap) is provided with projection or slope 1330,1530,1630 in this position, strap 1308,1508,1608 is maintained at first end 1302 tops, and the doctor can easily observe the position of strap 1308,1508,1608.Projection or slope 1330,1530,1630 are positioned near such position, to be cut removing dilator 1300,1500,1600 at described position strap 1308,1508,1608, so projection or slope 1330,1530,1630 provide vision indication about cutting position for the doctor.The embodiment shown in Figure 35 according to reference, two projection 1530a, 1530b center on strap 1508 fully and define a zone, cut strap 1508 this zone doctor.
Except the visuality of having improved strap, in each embodiment, projection or slope are raised to stomach band top a little with strap, increased the distance between the strap stomach function regulating band, the improved passage that is used to locate shears is provided thus, and described shears is used to cut strap and finally removes dilator.By the visuality that gap or recess 1332,1432,1532 have improved the cutting position of this embodiment is set along strap 1308,1408,1508 (seeing Figure 32,33,34,35).Specifically, with reference to Figure 32,33,43, the suture loop at the second end place of dilator 1300,2200 runs through the main body of dilator, and suture 1334,2234 extends through strap 1308,2208 and is used as stiffener.But, part suture 1334,2234 exposes in the precalculated position along strap 1308,2208, make and to pass the hole 38 of stomach band pulling-on piece 24 and to twine stomach band 10 so that two parts are fixed together when strap 1308,2208 that gap 1332,2232 is positioned in the desired position and is used for cutting.
Equally, shown in Figure 34 and 35, the regional area of strap 1408,1508 can be littler than other zones of strap 1408,1508, thereby allow with a step cutting.More particularly, the recess 1432,1532 that preferably forms of this regional area along strap 1408,1508.In addition, owing to distinguish gap or recess 1432,1532 from other parts of strap 1408,1508 according to the barment tag of gap or recess 1432,1532 easily, so the doctor can easily distinguish the position that needs cutting.It is contemplated that the design in this recess or gap can be used with reference to Figure 32,33,36,42,43 described projections with top, adopt though these designs certainly design under the situation of not using projection in the consideration at some.
With reference to Figure 37,39 and 40, other embodiment are disclosed.These embodiment adopt stiffener, and for example suture 1734,1934, with the auxiliary tip that dilator 1700,1900 is connected to the stomach band.In an application (seeing Figure 37), suture 1734 holds down strap 1708 on the main body of strap 1708.Like this, be not own, but cutting anchor suture 1734 discharge strap 1708, thus to remove dilator 1700 as the cutting strap of describing with reference to top each embodiment 1708.Perhaps, suture can be used to hitch strap, and thus strap is fixed on the dilator, need not the auxiliary of bonding agent.Although as stiffener, in spirit of the present invention, also can use other stiffeners, for example net according to a disclosed suture of preferred embodiment.
In the related embodiment shown in Figure 39,43, the suture material of suture loop 1905 is extended along the length of expander 1900, makes suture material 1934 stretch out (strap that has replaced front embodiment basically) from the first end 1902 of expander 1900.This allows expander 1900 that suture 1934 is twined by the hole in the tip of stomach band 10 38, and engages the projection 1936 of extending from the first end 1902 of expander 1900.This embodiment is except so that reliably mode is fixedly the stomach band easily, and other benefits that also provide are that suture 1934 has ring at the first end 1902 and the second end 1904 places of expander 1900.This has increased the intensity of expander 1900, because suture can not pulled out from dilator because of the expander material damage.
With reference to Figure 38, another embodiment is disclosed.According to this embodiment, in the groove 1806 of tip 1812 peace seats in being formed on dilator 1800 of stomach band 1810.But the tip 1812 of groove 1806 stomach function regulating bands 1810 comprises the hasp element, and the locking mechanism of half machinery is provided between stomach band 1810 and dilator 1800.This embodiment provides dilator 1800 to guide in phase and the ability at the tip 1812 of the stomach band 1810 that leads, and can not reverse or turn down.The locking mechanism of this half machinery can provide the strap fixed and arranged that dilator is repeated to be fixed to the device on the stomach band to use with other conduct.It is also conceivable that this embodiment can have around the suture 1811 and the dilator 1800 at the tip 1812 of stomach band 1810 and has groove 1806, to compress a zone, is matched with in the groove 1806 of dilator 1800 at this snap fit tip, zone 1812.When doctor cutting and remove around suture 1811 time, they can make flexible silicones dilator 1800 expand on the snap fit tip 1812 of pulling-on piece front then, with dilator 1800 integral body from 1810 separation of stomach band.
In addition, with reference to Figure 41, similar employing suture 2034 is fixed to dilator 2000 on the stomach band.But dilator 2000 is fixed on the projection 2036, and this projection 2036 can be peeled off.Like this, when hope removes dilator 2000, only need to peel off projection 2036 and discharge dilator 2000, need not cutting thus.
With reference to Figure 42, another embodiment is disclosed.According to this embodiment, the strap 2108 of dilator 2100 is lengthened out, and is displaced to forward position at open recess 2106 places of dilator 2100 to allow gluing position 2138.This allows the strap 2108 online 2140 places cuttings of dilator 2100, to remove dilator 2100.More particularly, open recess 2106 comprises end 2106a forward, and it is towards the interfix of dilator 2100, and open recess 2106 also comprises position 2106b backward, and it is positioned near the first end 2102 of dilator 2100.Gluing position 2138 is positioned at forward end 2106a.This also is that a kind of integral body removes, and has just changed the length of the position that is used to cut.This embodiment allows strap 2108 bendings, to contact shears or other instruments better when the upward of the front of dilator, because the only gluing 2106a at one end of strap place.
According to another embodiment, with reference to Figure 43, flange or block 2242 are positioned at along the preset points of the length of strap 2208.This makes it possible to respect to the gap 2232 in the location positioning strap 2208 of the suture 2234 needs cuttings of dilator 2200, and avoids making in the process of drawstring suture to contact with stomach band hole.Block 2242 is oriented to engage the pulling-on piece around the hole, to limit the degree that strap 2208 passes.Near the parts that are positioned at the block 2242 of strap 2208 are tapered, and the cross section of part in hole that is positioned at the stomach band is bigger, to provide and the closely cooperating of the hole of stomach band.As the previous embodiment, strap comprises and is used to gap or the notch part distinguishing and cut.In addition, suture loop is extended by dilator fully, and can be by suture loop is broken into knot, and this knot is molded in the part of expansion of block, to improve the intensity of dilator strap.
For a person skilled in the art, it is apparent that foregoing invention can be applied to the implantable band of other types with being equal to.For example, band is used to treat anal incontinence.A kind of such band is described in United States Patent (USP) 6,461, in 292, by reference it is included in here.Band can also be used for the treatment of urinary incontinence.A kind of such band is described in U.S. Patent application 2003/0105385, by reference it is included in here.Band can also be used for the treatment of stomachache and/or acid reflux.A kind of such band is described in United States Patent (USP) 6,470, in 892, by reference it is included in here.Band can also be used for the treatment of sexual impotence.A kind of such band is described in the U.S. Patent application 2003/0114729, by reference it is included in here.
Although shown and described the preferred embodiments of the present invention, should be understood that the described description of not coming round limits the present invention here, but want to cover all modification and the optional structure that falls in the spirit and scope of the present invention.

Claims (4)

1. one kind centers on the localized surgery implantable band of anatomical structure, comprising:
A. elongated body member, it comprises first end and the second end, and described first end is provided with first latch members, and described the second end is provided with second latch members;
B. suture tab extender, it extends and can be removed from described elongated body member from described first latch members, be connected with suture on the described suture tab extender, described the second end is provided with retained part, and the shape and size of described retained part are convenient to carry out clamping when described suture tab extender passes described second latch members and connects described first latch members and second latch members afterwards.
2. surgery implantable band according to claim 1, wherein, described suture tab extender is as single parts.
3. surgery implantable band according to claim 1, wherein, described suture tab extender can be pulled through described second latch members.
4. surgery implantable band according to claim 1, wherein, described suture tab extender can be pushed through described second latch members.
CN2007101361806A 2006-07-20 2007-07-20 Method of implanting a medical device using a suture tab extender Expired - Fee Related CN101108135B (en)

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US11/489,752 2006-07-20
US11/489,752 US7618365B2 (en) 2005-07-15 2006-07-20 Method of implating a medical device using a suture tab extender

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CN101108135B true CN101108135B (en) 2011-03-23

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