专利摘要:
The invention relates to an implantable surgical device for urinary incontinence. It includes a valve (100) that is adapted to be implanted in the urethra. The valve (100) includes an actuator so that the valve can be magnetically changed between a closed position and an open position. According to the invention, the valve (100) includes an annular member (1) which forms an opening (1a) and further includes a disc-shaped member (2). The disc-shaped member (2) is rotatably mounted for angular displacement between a first position in which the disc-shaped member (2) closes the opening (1a) of the annular member (1) and a second angular position in which the disc-shaped member (2) does not close the opening. (Fi9 1)
公开号:SE0950082A1
申请号:SE0950082
申请日:2009-02-16
公开日:2010-08-17
发明作者:Hassan Kansoul
申请人:Hassan Kansoul;
IPC主号:
专利说明:

2025302dysfunction and substandard general compatibility between differentpatient groups. In many cases, diapers can be the ultimate solution.
To avoid the problems described above have implantation of a valvein the urethra has been proposed, which valve is magnetically controlled from the outside of the person inquestion. Examples of this can be found in US 6234956, US 6409556, US 3731670, US5004454, WO 2005077301 and JP 10295713.
US 66234956 describes a urine valve with a rotating magnetic rotor,which by means of a mechanical gear shift displaces the valve housing against actionof a feather. As a result, the valve is complicated and susceptible to disturbances.
US 6409656 describes a valve which is operated perpendicular to the urethrato control and strangle a fate through it. The device has a large numbermoving elements that cooperate.
US 3731670 discloses a solenoid valve housing in the shape of a ball whichby magnetic force can be brought into abutment against either of two seats,whereby abutment against one of them allows urine passage and abutment against itothers prevent passage. The presence of a number of components forthe valve function makes it complicated. Operation requires a movement ofthe actuating magnet from one position to another, which requires a certain precisionand skill when controlled. The design of the valve makes it difficult to usea catheter.
US 5004454 describes a valve with a valve housing attached to a springand which is magnetic. Depending on the construction, the opening is in the openthe situation is relatively small. Furthermore, the spring and the valve prevent the passage of a catheter.
WO 2005077301 describes a valve in which the valve housing itself must be onemagnet. The valve body is movable against the action of a spring. The complicatedthe construction can lead to sensitivity to disturbances. The valve body preventspassage of a catheter.
JP 102 95713 describes fl your various examples of magnetically controlled valvesat different levels of complexity. Common to them all is that the valve preventspassage of a catheter.
The object of the present invention is to provide a device ofthe current type, which is simple, reliable and makes insertion of a catheterthrough the urethra easily.202530Summary of the inventionThe object of the invention is achieved by an arrangement thereofInitially specified strokes include the specific features of the valveincludes an annular member which forms an opening and which further includesa disc-shaped member, the disc-shaped member being rotatably mounted forangular displacement mellan between a first angular end position in which the disc-shaped membercloses the opening of the annular member and a second angular end position in whichthe disc-shaped member does not close the opening of the annular member.
Due to the fact that the operated part of the valve is arrangedto exclusively perform a rotational movement, the valve becomes very simple. Thereforeovercomes many of the disadvantages associated with devices according to the knowntechnology due to their complexity. Thus reducing the rotation displacementsignificantly the risk of malfunction of the valve. The construction does that tooeasy for a catheter to pass through the valve, as the valve body willturn to its open position when a catheter reaches the downstream side of itdisc-shaped body and presses on it.
The invented valve can be easily implanted laparoscopically in about 5 more10 min.
According to a preferred embodiment, the disc-shaped member is rotatably attachedat the annular member.
Thereby, the rotational movement of the disc-shaped member will bedirectly related to the annular organ, resulting in a precise and safecooperation between the two bodies. The use of the annular organas a support for the rotation also eliminates the need to provide a separateelements such as a support.
According to a further preferred embodiment, the axis of rotation is asymmetricalwith respect to the disc-shaped member, so that the axis of rotation divides the disc-shapedthe member in a larger portion and a smaller portion, or alternatively so that the axis of rotation islocated at one lateral side of the disc-shaped member onlyforming a single portion of the disc-shaped member, the larger portionalternatively the solitary portion they fi nier a valve cover.
With the asymmetrical arrangement of the rotary shaft comes the openingthrough the annular member to be divided into a large opening section and asmall opening section or only a single large opening. With a large2025304opening section, the flow through the valve becomes less restricted than ifthe rotary arrangement would divide the opening into two substantially equal openings.
Furthermore, the asymmetrical arrangement also makes the passage of a catheter easiersince the rotary arrangement is not centrally located.
According to a further preferred embodiment, the extent ofthe valve cover perpendicular to the axis of rotation in the range 70 to 100% of the extent ofthe disc-shaped member in the same direction.
The larger the asymmetry is, ie the larger part of the disc-shaped organ thatconstitutes the valve cover, the more obvious are the advantages mentioned above. Ifthe valve cover represents at least 70% of the disc-shaped memberthe asymmetry is normally sufficient. Preferably it represents at least 80%hence. When only fl conditions of fate are considered, the best is of course aboutthe valve cover includes the entire disc-shaped member, i.e. 100% thereof. However, canthe arrangement of the rotary shaft becomes more complicated the more laterally it is located,which may be the case if the axis of rotation divides the disc-shaped member so that more than 90%hence the valve cover.
According to a further preferred embodiment, the valve cover abuts thereinthe first angular end position towards the annular member on the upstream sideand projecting in the second angular end position forward in the upstream direction.
This means that the valve cover in the closed position is exposed to the pressure fromthe urine in the bladder on the upstream side so that the pressure presses onvalve cover to maintain a closed position. This reduces the risk ofurine leakage in the closed position. This use of a natural function inthe person's body provides a simple, safe and unadulterated way toprovide the closing force.
According to a further preferred embodiment, the second angular end position is inthe range 70 ° to 110 ° from the first angular end position.
By arranging the valve so that the valve cover is in the open positionsubstantially perpendicular to the opening, the restriction from the valve cover comes onby fl the area of fate to be minimized in the open position, thus allowing a goodfl condition of fate. The passage of a catheter is also easiest when the valve cover isperpendicular to the opening. Although it is optimal that the valve cover is perpendicular to itopen mode, a satisfactory function will be achieved even ifthe valve cover is inclined i20 ° from such a position.2025305According to a further preferred embodiment, the axis of rotation is located in oneplane parallel to the lateral extent of the annular member.
The parallel arrangement of the rotary shaft contributes to a precise, simple andreliable operation of the valve compared to if the axis of rotation would beskewed with respect to said plane.
According to a further preferred embodiment, the plane of the axis of rotation is locatedbetween the upstream end face and the downstream end face ofthe elongated organ.
This arrangement further contributes to an optimal function of the valve.
Since the axis of rotation is thus not axially displaced from the annular member isinteraction between the disc-shaped member and the ring-shaped memberuncomplicated. The best precision is achieved if the axis of rotation is located in the median planebetween the end faces.
According to a further preferred embodiment, the annular member isand the disc-shaped member is substantially circular in an axial direction.
Although it is within the general scope of the present invention thateither or both of these components may be elliptical, polygonal or offany other shape, the circular shape has certain advantages. Because the urethranormally is substantially circular is a circular shape of the annular elementparticularly suitable for implantation of the valve therein. A circular shape on itthe disc-shaped body provides the best condition for a homogeneous andundisturbed fl fate through the valve and also makes it easy to obtain a goodcircumferential seal when the valve is closed.
According to a further preferred embodiment, the annular member isattached to a tubular member, which at one of its ends has an outwardly directed ns end.
The tubular member provides an elongate contact betweenthe valve and the inner wall of the urethra and thus avoidedstress concentrations on the urethra. With the fl end at the end of the tubularthe means, the valve may be located so that the provided end extendsinto the bladder and with the tubular member extending into the urethra.
Thereby, the valve can be kept in place by this and the need for specificsfasteners for attaching the valve to the walls of the urethra can be eliminated.102025306According to a further preferred embodiment, the annular member isprovided with fasteners adapted to secure the device to the interiorthe wall of the urethra.
This fastener can be a complement to the valve to secure the valve inthe urethra. Furthermore, such an adhesive may be an alternative to such an fl even in caseswhere a fl end in the bladder for one reason or another is not appropriate.
According to a further preferred embodiment, the fastener includes onefl ertal needles.
When implanting the valve, the needle may be arranged to partially penetratethrough the wall of the urethra, thus easily providing onevery secure mount. Preferably, the needles are arcuate so that they functionsuch as hooks.
According to a further preferred embodiment, the device includesload means arranged to provide a force on the disc-shapedthe body in the direction of its first angular position.
Thereby, the closing of the valve will be safer than byrely solely on the pressure upstream of the urine and gravity to holdvalve closed. The risk that the disc-shaped organ will move up anddown when the person is physically active, such as jumping or running, will be reducedthrough this arrangement. The load means may be a spring, for example onetorsion springs that provide a torsional force around the axis of rotation, or canthe load is exerted by a permanent magnet. With this embodiment mustthe actuator outweighs the loading force to open itdisc-shaped body.
According to a further preferred embodiment includesthe actuator a component which is of magnetic material.
Thereby, the valve can be operated magnetically, which is a simple andreliable way of maneuvering. It is preferred that the magnetic device bedisc-shaped organ or part thereof, which leads to a very direct way ofaffect the valve.
According to a further preferred embodiment, the component is ofmagnetic material a magnet.
Thereby, the operation of an external magnet can be better controlled,either so that the valve opens by applying a repellent magnet102025307force on the component, eg the disc-shaped member or so that it is executed byan attractive magnetic force.
According to a further preferred embodiment, the device includesfurther a magnetic connecting device which includes a first magneticunit of magnetic material that is adapted to be positioned right next to itthe valve, a second unit of magnetic material adapted to bepositioned just under the skin of a person and bandages ofmagnetic material connecting the first and second devices.
This magnetic connection serves as a magnetic amplifierfl fate generated by a magnet outside the body. By keeping it externalthe magnet just next to the outside of the skin in the area where the other magneticthe unit is located, the magnetic force will be transmitted to the valve.
Through this reinforcement, the part of the disc-shaped member that is offmagnetic material is made smaller than otherwise. This helps to make itcomplete the valve smaller and lighter, leading to lower requirements for the fastener andminor inconvenience to the person wearing the implant. The embodiment with thisMagnetic amplifying arrangements are particularly suitable when relativelya lot of body tissues between the valve and the skin, for example when it comes to the issueabout a fat person.
According to a further preferred embodiment includesthe actuator a temperature sensitive bistable unit.
Thereby, operation of the valve can be effected by actingthe temperature in the bistable unit. This is a useful alternative to itmagnetic operation and is correspondingly safe and simple.
Preferably, the bistable unit is a bistable torsion unit, wherebythe change in the state of the bistable unit can directly effect onerotational movement. It is not excluded that the temperature-sensitive operation iscombined with a magnetic maneuver.
According to a further preferred embodiment relating theretoThe temperature sensitive actuator includes the device an electriccoil with a magnetic core and a lead wire connecting the coil tothe actuator, the electrical coil being adapted to bepositioned just under the skin of a person.2025308The temperature of the actuator can thus be affected externallya very convenient way by inducing a current in the coil by means of aexternal magnet.
According to a further preferred embodiment, a system forurinary incontinence a device according to the present invention and a separate onemagnet adapted to affect the disc-shaped member when itThe separate magnet is positioned just next to the outside of the skin of a personhas the device implanted.
This provides a complete system for bladder control.
The invention will be further explained by the following detailsdescription of examples of the invented device and with reference toaccompanying drawings.
Brief description of the sealsFig. 1 is a perspective view of a valve according to the invention.
Fig. 2 is an end view of a second example of a valve according to the invention withthe valve in a closed position.
Fig. 3 is a view similar to that of fi g 2 with the valve in a closed position.
Fig. 4Fig. 5Fig. 6Figures 7 and 8 are cross-sections similar to that in Figure 6 but illustrating alternative examples.
Fig. 9Fig. 10 schematically illustrates a further example of the invention.is a side view of the valve according to fl g 2 and 3 in a closed position.is a view similar to that of Fig. 3 with the valve in an open position.is a cross-section along the line Vl-Vl of the valve in fi g 2.is a cross-sectional view through a detail of a valve according to the invention.
Fig. 11 is a perspective view of a valve according to yet another example ofrecovery.
Fig. 12 is an end view similar to that of Fig. 2 but illustrating yet anotherexamples of the invention.
Fig. 13 schematically illustrates yet another example of the invention.
Detailed description of examplesFig. 1 in a perspective view illustrates a first example of an incontinence valveaccording to the invention. The main components are an annular member 1 and onedisc-shaped organ 2. Both organs are made of a biocompatible material such as102025309titanium or a suitable polymer such as polyethylene. The annular member 1 shallattached to the inside of a person's urethra. For this purpose, it is externalthe edge of the annular member 1 provided with hook-shaped needles 3. A dei 4 ofthe disc-shaped member is of magnetic material, either it is a magnet itselfor is a material that is affected by magnetic force.
The disc-shaped member 2 is rotatably arranged about an axis of rotation A. In onefirst angular position, the disc-shaped member 2 is substantially parallel to itannular 1 member and substantially flush therewith so that the opening thereofthe annular member 1 is closed by the disc-shaped member 2 and in which positionurine passage through the valve is prevented.
In a second angular position of the disc-shaped member 2, the latter forms onesubstantially right angle with the disc-shaped member 1, which position is illustrated Ifi guren. In this position, the opening in the annular member 1 is not blocked by itdisc-shaped organ and urine can pass through it.
Figures 2 and 3 In an alternative example, the valve in an open illustratesrespectively closed mode. In this example, the axis of rotation A of the disc-shaped member is 2displaced laterally from the diameter of the opening in the annular member, whichdivides the disc-shaped member into a larger portion 5 and a smaller portion 6.
The extent of the larger portion 5 perpendicular to the axis of rotation A is about 75% ofthe total extent of the disc-shaped member in the same direction. Thethe annular member 1 in this example has a circular opening and an elliptical oneexternal shape.
Figs. 4 and 5 are side views of the valve according to fi g 2 and 3 in the closedrespectively open mode. The flow direction of urine is indicated by the arrow B.
As shown in fi g 4, the disc-shaped member has a side extensionwhich is larger than the opening 1a of the annular member 1. Thereby it restsouter periphery of the larger section 5 on the upstream side thereofthe disc-shaped member 1, and the outer periphery of the smaller section 6 rests onthe downstream side of the disc-shaped member 1. Each ofsections 5, 6 have an axial extent that increases with increasing distance torotary shaft. The larger portion 5 has a convex surface on the upstream sideand a concave surface on the downstream side, thus forming acrescent-shaped cross-section. Alternatively, the disc-shaped member may be flat.20253010The valve is normally in the closed position as illustrated in fi g 2 and 4.
The valve is held in this position by the pressure from the urine in the bladder acting inarrow B direction. Since the larger portion 5 has a larger surface facingthis pressure dominates the closing force on the larger portion 5 over the force onthe smaller portion 6 acting in the opposite direction.
If the person carrying the valve needs to empty the bladder fl the valve is flattenedto an open position by placing a magnet in a suitable place on the outside of the skinbut next to the valve. The layer net attracts the magnetic material 4 to the larger onethe portion 5 of the disc-shaped member so that it will be lifted from the position inthe rotary shaft A to the position illustrated in fi g 5.
If the valve should fail, the valve can be opened with a catheter insertedthrough the urethra from below in fl g 4. When the catheter is against the lower side ofthe larger portion 5 will further push the catheter upwards to push it upwardsthe larger portion 5 upwards so that the disc-shaped member 2 rotates to its open position,as illustrated in Fig. 5.
The rotational arrangement of the disc-shaped member can be obtained in different waysway. An alternative illustrated in 6 g 6 is to have a bore 7 through itdisc-shaped member 2, where the bore is coaxial with the axis of rotation A. A pin 8extends through the bore and is attached with its two ends to itthe disc-shaped member 1. The disc-shaped member 2 is thus rotatably mounted ontap 8.
Fig. 7 illustrates an alternative example of the Twisting arrangement, where itthe disc-shaped member at two opposite sides has a short pin 10, both of which arecoaxial with the axis of rotation A. The annular member 1 has a bore 9 as onthe corresponding way is located on opposite sides. The pins 10 extend intoand bore 9 and thus establishes a rotary bearing.
A third example of the rotation arrangement is illustrated in i g 8. Itthe disc-shaped member 2 and the annular member 1 are connected by two pins11 which are located coaxially with the axis of rotation A on opposite sides. Every tap isattached to both the annular member 1 and the disc-shaped member 2. The pins aremade of relatively fl visible material and has a cross-section and a length that allows itto be easily twisted at least 90 °. To facilitate twisting, the pins canpreferably be band-shaped. The pins act as torsion springs such asdrives the disc-shaped member to its closed position.1020253011Fig. 9 illustrates a detail of an example of the valve in the closed position,wherein the annular member has an inner end 12 for providing a seat therefordisc-shaped member 2 to obtain a good seal. To improve the sealfurthermore, the disc-shaped member 2 can have a silicone coating right next to its owncircumferential edge. In addition or alternatively, the adjacent part of it canannular member 1 be coated with silicone.
In some cases it may be necessary to amplify the magnetic effect.
Fig. 10 illustrates an example thereof. Adjacent the valve 100 is a first unit 102 ofmagnetic material implanted and next to the skin of the person is a second device103 of magnetic material implanted. The two units 102, 103 are connectedwith a magnetic metal wire 104 or the like. When the valve 100 is to be opened,a magnet 101 is placed next to the skin in the area where the second unit 103 isimplanted. The magnetic force from the magnet 101 will thustransferred to the valve 100 to open it as described in connection with fi g 4and 5.
Fig. 11 illustrates a second example where the device includes onetubular member 13 and an fl end 14. The flange is intended to be implanted so that itabuts the bladder neck with the tubular member 13 extending intothe urethra. The flange 13 thus holds the valve in position. In the example shown isfl end 14 in one piece with the annular member 1. The valve will thusbe located where the urethra ends in the bladder. Alternatively, fl änsen 14 may constitutea separate element, and the annular member is arranged in the tube thereondownstream side of the island.Yet another example is illustrated in fi g 12. In this case, the axis of rotation is Alocated at one lateral edge of the disc-shaped member 2. Itthe disc-shaped member thus has only a single portion covering the entire opening1a of the annular member 1 and forms a valve cover 15. The disc-shapedthe member 2 may be attached to the annular member by a pivot mechanism.
Fig. 13 illustrates a further example of a device according torecovery. The device is controlled by an external device such as a magnet 101which generates an induction magnetic field acting on a receiving part 105 which islocated directly under the skin (C). The receiving part 105 is constituted, for exampleof a coil with a magnetic core. This arrangement serves to induce onecontrol current transmitted by lead wire connection 108 to2012the implantation site at the junction between the bladder (A) and the urethra (B).
The lead wire connection 106 connected to the implant is inserted into the bladder(A) at the site of implant insertion and the tissue seal 107 is realizedby conventional techniques such as biocompatible polymeric printing plates.
The operating current in the lead wire connection 106 induces atemperature change in a bistable torsion actuator 108, therebyinducing a structural change in a shape memory alloy component ofthe implant. The actuator changes the position of the disc-shaped member ofthe implant between angular end positions. Structural change maneuvers the opening atthe valve to control bladder emptying. When the control current is raisedby removing external activation, the bistable returnstorsion actuator 108 to a "closed" configuration becausecooling of the shape memory alloy component is provided by ambient liquid.
The bistable torsional actuator may be located above orunder the disc-shaped member to exert its actuating force on the smaller portionof the disc-shaped member, alternatively as part of the axis of rotation.
The bistable actuator 108 is preferably encapsulated thereinbiocompatible polymeric material.
When the device is to be implanted, the surgeon can access the urethra fromthe bladder by laparoscopic surgery of a type well known to surgeons.
From the inside of the bladder, the surgeon can place the device in the urethra.
权利要求:
Claims (21)
[1]
An implantable surgical device for urinary incontinence, including a valve (100) adapted to be implanted in the urethra, the valve (100) including an actuator (4, 108) arranged to change the valve (100) between a closed and an open position, characterized in that the valve (100) includes an annular member (1) forming an opening (1a) and a disc-shaped member (2), the disc-shaped member (2) being rotatably mounted for angular displacement between a first angular end position in which the disc-shaped member (2) closes the opening (1a) of the annular member (1) and a second angular end position in which the disc-shaped member (2) does not close the opening (1a) of the annular member (1).
[2]
Device according to claim 1, characterized in that the disc-shaped member (2) is rotatably attached to the annular member.
[3]
Device according to claim 2, characterized in that the axis of rotation (A) is asymmetrical with respect to the disc-shaped member (2), so that the axis of rotation (A) divides the disc-shaped member into a larger portion (5) and a smaller portion (6). ), or alternatively so that the axis of rotation (A) is located at one lateral side of the disc-shaped member (2), which only forms a single portion of the disc-shaped member (2), the larger portion (5) alternatively the single portion they fi nier a valve cover.
[4]
Device according to claim 3, characterized in that the extent of the valve cover (5, 15) perpendicular to the axis of rotation (A) is in the range 70 to 100% of the extent of the disc-shaped member in the same direction, preferably in the range 80-90%.
[5]
Device according to claim 3, characterized in that the valve cover (5, 15) in the first angular end portion abuts against the annular member (1) on the upstream side and projects in the second angular end portion forward in the upstream direction. 20 25 30 14
[6]
Device according to claim 5, characterized in that the second angular end position is in the range 70 ° to 110 ° from the first angular end position.
[7]
Device according to claim 2, characterized in that the axis of rotation (A) is located in a plane which is parallel to the lateral extension of the annular member (2).
[8]
Device according to claim 7, characterized in that said plane is located between the upstream end surface and the downstream end surface of the disc-shaped member (2), preferably in a median plane between said end surfaces.
[9]
Device according to one of Claims 1 to 8, characterized in that the annular member (1) and the disc-shaped member (2) are substantially circular.
[10]
10. (1) is attached to a tubular member (13) having at one of its ends an outwardly directed fl end (14). Device according to claim 1, characterized in that the annular member
[11]
(1) is provided with fastening means (3) which is adapted to fasten the device to the device according to claim 1, characterized in that the annular member is the inner wall of a urethra.
[12]
Device according to claim 11, characterized in that the fastening means (3) includes a number of needles (3).
[13]
Device according to one of Claims 1 to 14, characterized by loading means (11) which are arranged to provide a force on the disc-shaped member (2) in the direction of its first angular position.
[14]
Device according to any one of claims 1-13, characterized in that the actuating means (4) includes a component (4) which is of magnetic material, preferably said component is the disc-shaped member (1) or a part (4) of the disc-shaped member (1). 20 25 30 15
[15]
15. a magnet (4). Device according to claim 14, characterized in that said component is
[16]
The device of any of claims 1-12, further including a magnetic connection arrangement comprising a first unit (102) of magnetic material adapted to be positioned adjacent the valve (100), a second unit (103) of magnetic material comprising is adapted to be positioned just below the skin of a person and connecting means (104) of magnetic material connecting the first and second units.
[17]
Device according to one of Claims 1 to 13, characterized in that the actuator includes a temperature-sensitive bistable unit (108), preferably a bistable torsion unit.
[18]
Device according to claim 17, characterized in that the device includes an electrical coil (105) with a magnetic core and a lead wire (106) connecting the coil (105) to the actuator (108), the electrical coil (105) being adapted to be positioned just under the skin of a person.
[19]
A urinary incontinence system including a device according to any one of claims 1-18 and a separate magnet (101) adapted to actuate the disc-shaped member (2) when the separate magnet (101) is positioned just adjacent to the outside of the skin on a person who has the device implanted.
[20]
A method of providing a bladder evacuation control to a person by implanting a valve in the urethra, the valve including an annular member forming an opening and a disc-shaped member, the disc-shaped member being rotatably mounted for angular displacement between a first angular end position in which it the disc-shaped member closes the opening of the annular member and a second angular end position in which the disc-shaped member does not close the opening of the annular member and by providing the valve with an actuator arranged to change the valve between a closed and an open position. 16
[21]
Method according to Claim 20, characterized in that the method is carried out with a device according to one of Claims 1 to 18.
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同族专利:
公开号 | 公开日
SE534414C2|2011-08-16|
引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题

法律状态:
优先权:
申请号 | 申请日 | 专利标题
SE0950082A|SE534414C2|2009-02-16|2009-02-16|Implantable surgical device|SE0950082A| SE534414C2|2009-02-16|2009-02-16|Implantable surgical device|
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