Artificial retractable structure
阅读说明:本技术 人造可收缩结构 (Artificial retractable structure ) 是由 克里斯多夫·奥贝特 费比安·卡奇 弗朗索瓦·卡保德 于 2017-11-30 设计创作,主要内容包括:用于医疗设备的人造可收缩结构(1),所述人造可收缩结构(3)包括:-被适配成接触中空人体器官的细长构件(3);-被适配成将人造可收缩结构(1)形成为围绕所述中空人体器官的闭合环的闭合件(9);-被布置成连接至控制单元(28)的张紧系统(11),所述张紧系统(1)被适配成响应于由所述控制单元(28)施加的力来改变所述闭合环的内径。根据本发明,所述细长构件(3)包括弹力芯部(5)和生物相容性外护套(7)。此外,所述张紧系统(11)包括附接到所述细长构件的第一点(3c)上的第一张紧元件(13)以及附接到所述细长构件的第二点(3d)上的第二张紧元件(15),所述张紧元件(15,17)中的每一个穿过位于所述第一点(3c)与所述第二点(3d)之间的适配器(17)。(Artificial contractile structure (1) for medical devices, said artificial contractile structure (3) comprising: -an elongated member (3) adapted to contact a hollow human organ; -a closure (9) adapted to form an artificial collapsible structure (1) as a closed loop around the hollow human organ; -a tensioning system (11) arranged to be connected to a control unit (28), the tensioning system (1) being adapted to change the inner diameter of the closed loop in response to a force applied by the control unit (28). According to the invention, the elongated member (3) comprises a resilient core (5) and a biocompatible outer sheath (7). Furthermore, the tensioning system (11) comprises a first tensioning element (13) attached to a first point (3c) of the elongated member and a second tensioning element (15) attached to a second point (3d) of the elongated member, each of the tensioning elements (15, 17) passing through an adapter (17) located between the first point (3c) and the second point (3 d).)
1. Artificial contractile structure (1) for medical devices, said artificial contractile structure (3) comprising:
-an elongated member (3) adapted to contact a hollow human organ, the elongated member comprising an elongated body extending in a longitudinal direction between a first end and a second end;
-a tensioning system (11) arranged to be connected to a control unit (28), the tensioning system (1) being adapted to bring the first and second ends of the elongated body closer to each other in response to a force exerted by the control unit (28);
characterized in that the elongated member (3) comprises a resilient core (5) and a biocompatible outer sheath (7), and wherein the tensioning system (11) comprises a first tensioning element (13) attached to the first end (3a) of the elongated member and a second tensioning element (15) attached to the second end (3b) of the elongated member, each of the tensioning elements (15, 17) passing through an adapter (17) between the first and second ends.
2. An artificial collapsible structure (1) according to claim 1 wherein the resilient core (5) comprises a mesh structure.
3. An artificial collapsible structure (1) according to claim 1 or 2 wherein the resilient core (5) comprises a shape memory alloy.
4. An artificial collapsible structure (1) according to one of the claims 1 to 3 further comprising a closure (9) adapted to form the artificial collapsible structure (1) as a closed loop around the hollow human organ, the first tensioning element (13) being attached at a first portion of the closure (9) and the second tensioning element (15) being attached at a second portion of the closure (9).
5. An artificial contractile structure (1) according to one of the claims 1 to 3, further comprising an arched self-supporting structure (27) in which the elongated member is mounted, the self-supporting structure being configured for insertion between the patient's circular striated muscle and the vaginal wall.
6. Medical device comprising an artificial collapsible structure (1) according to one of claims 1 to 5, wherein the tensioning system (11) further comprises a flexible transmission (19) pivotably attached to the elongated member (3), the first tensioning element (13) and the second tensioning element (15) passing through the flexible transmission (19).
7. The medical device according to claim 6, wherein the flexible transmission (19) is attached to an adapter (17), the adapter (17) comprising at least one fixed or rotatable pulley (21a, 21b) around which the first tensioning element (13) and the second tensioning element (15) pass in order to enter the flexible transmission (19).
8. Medical device according to one of claims 6 to 7, further comprising a control system (28) comprising an actuator (28b), the first tensioning element (13) and the second tensioning element (15) being attached to the actuator (28b) by means of a connector (29), respectively, the connector (29) being attached to the actuator (28b) by means of a push-fit connection.
9. Medical device according to claim 8, wherein the push-fit connection comprises a helical spring (33) or an O-ring connected with a first annular groove (33 g; 32d) provided in one of the actuator (28b) and the connector (29) and providing a kinematic connection with another annular groove (32 d; 33g) provided in the other of the actuator (28b) and the connector (29).
10. Medical device according to one of claims 8 to 9, wherein the connector (29) comprises a connecting rod (32) longitudinally movable within a coaxial plunger (30), the connecting rod being attached to the tensioning element (13, 15).
11. The medical device of claim 10, wherein the connecting rod (32) comprises a toothed portion (32a) cooperating with a hooking member of the plunger (30) to allow locking of the connecting rod (32) in the plunger.
12. Method of manufacturing an artificial collapsible structure (1) according to any of claims 1-5, the method comprising the steps of:
-forming said resilient core (5);
-applying the biocompatible sheath (7) onto the resilient core (5);
-assembling the closure (9) and the tensioning system (11, 13, 15) onto the elongated member before or after applying the biocompatible sheath (7).
13. A method according to claim 12, wherein the resilient core (5) is formed of a shape memory alloy capable of assuming a first state and a second state, the method comprising the steps of:
-making the resilient core (5) substantially flat in the first state and bending the resilient core in the second state;
-bringing the resilient core (5) into its first state;
-applying the biocompatible sheath (7) onto the resilient core (5) when the resilient core (5) is in the first state;
-after application of the biocompatible sheath (7), bringing the resilient core (5) into its second state in order to exert a curvature on the elongated member (3).
14. The method according to claim 13, wherein the tensioning system (11, 13, 15) is applied at least partially onto the elongated member (3) before the step of applying the biocompatible sheath (7) onto the resilient core (5).
15. Method according to one of claims 12 to 14, wherein the biocompatible sheath (7) is applied by over-moulding onto the resilient core (5).
Technical Field
The present invention relates to the field of artificial sphincters, particularly but not exclusively for the treatment of urinary incontinence.
Background
WO2015/117664 describes a form of mechanical artificial collapsible structure proposed as a replacement for problematic hydraulic Systems such as AUS 800 sold by American Medical Systems (American Medical Systems) inc. The artificial contractile structure disclosed in the above document comprises a flat strip arranged to be closed in a loop around the urethra (or any other hollow body organ) of a patient by means of an occlusive member. Once applied to the hollow body organ, the hollow body organ can be contracted by means of tension applied by the wire passing through the strip structure. A series of lateral stiffening elements are formed on the outer side of the strip, which cause the strip to adopt a substantially U-shaped cross-section when said tension is applied, thus gently applying pressure to the organ.
In acute trials, such artificial contractile structures have shown promise in treating male incontinence, but have certain drawbacks in treating the same conditions in women, since their shape is not sufficient to adapt to the female urethra. Indeed, the collapsible structure disclosed in WO2015/117664 is designed to extend on both sides of the locking system as it is wrapped around the male urethra. When strength is applied to the cable, the portion extending beyond the locking system exhibits a lower resistance to shrinkage and will shrink first, thereby reducing the efficiency of the ferrule so designed. Although methods exist to reinforce this portion (the so-called "dead space") so that the contractible portion surrounding the urethra preferentially contracts, these methods require additional equipment and complicate the procedure. The present invention aims to solve such a situation.
Since the female urethra is larger than the male urethra and their anatomical conditions are very different, the pull distance required to contract the structure may exceed the actual length of the structure disclosed in WO2015/117664, and thus the desired pull distance required to cause the patient to again moderate may not be achieved in the long term.
In addition, the sphincter responsible for closing or opening the female urethra has a substantially U-shaped (viewed in anatomical mid-plane) shape, which only partially surrounds the female urethra. Thus, in the case of male patients, providing contractile force over the entire circumference of the female urethra, particularly under the urethra where the vaginal wall is located, is prohibited, as this may cause friction and erosion.
Currently, standard incontinence treatment for female patients is by means of so-called slings, which are passive devices that are attached to exert pressure on the urethra, replacing a certain amount of muscle function, thereby restoring continence. However, in long-term use, the sling often fails because the constant pressure of the sling on soft tissue causes the sling to erode or migrate through the urethra, thereby reducing the pressure applied to the urethra and requiring the placement of another sling. Indeed, some patients may be placed multiple lifting ropes over time.
Due to the deficiencies of the sling and the limitations of the hydraulic system, there is a long felt need for an improved system to better treat female incontinence.
Disclosure of Invention
It is an object of the present invention to overcome the above-mentioned disadvantages of the prior art and thereby provide an artificial collapsible structure which is particularly suitable for treating female incontinence. Although the artificial contractile structure of the present invention is mainly used for treating female incontinence, it can also be used for men, and can be used for contracting other hollow body organs, such as blood vessels, ducts (such as bile ducts), intestines, etc.
This object is achieved by an artificial contractile structure for medical devices as defined in claim 1. The artificial collapsible structure (also referred to as a "cuff") comprises an elongated member, i.e. a long, relatively thin member, which may be a strip having a flat cross-section or may have a more complex cross-section such as a V-shape or a U-shape or a corrugated shape, comprising an elongated body extending in a longitudinal direction between a first end and a second end. The elongate member is adapted to contact a hollow body organ, such as the urethra, around at least a portion of its circumference.
There is also provided a tensioning system arranged to be connected to a control unit, the tensioning system being adapted to bring the first and second ends of the elongate body closer to each other in response to a force applied by the control unit so as to constrict the hollow human organ to form the artificial sphincter.
According to the invention, the elongate member comprises a resilient core and a biocompatible outer sheath, and the tensioning system comprises a first tensioning element (such as a wire, cord, filament or ribbon or the like) attached to said first end of said elongate member and a second tensioning element (again such as a wire, cord, filament or ribbon or the like) attached to a second point of said elongate member. Each of the tensioning elements passes through an adapter located between the first point and the second point on the elongate member.
This configuration allows for uniform selective pressure to be applied to the hollow body organ and for positioning and adjustment around the hollow body organ solely by laparoscopic surgery.
Advantageously, the resilient core comprises a mesh structure. This construction allows the resilience and dimensions of the resilient core to be optimised.
Advantageously, the resilient core comprises a shape memory alloy. These alloys generally have excellent elasticity and allow for the particularly advantageous manufacturing methods disclosed below.
Advantageously, said first tensioning element is attached at said first end of said body of the elongated member and said second tensioning element is attached at said second end of said body of the elongated member. Thus, the ferrule does not exhibit any so-called "dead space" or dead space.
Alternatively, the first tensioning element may be attached at the first end of the elongate member at a first anchor member arranged within the elongate member and the second tensioning element may be attached at the second end of the body of the elongate member at a second anchor member arranged within the elongate member.
In an embodiment, the first and second anchoring members comprise pivoting means about which the first and second tensioning elements can slide in response to a force applied by the control unit in order to contract the hollow human organ and thus form the artificial sphincter.
In an embodiment, the first and second anchor members may be integrally formed in the resilient core of the artificial collapsible structure.
In an embodiment, the artificial collapsible structure may further comprise an occlusive member adapted to form the artificial structure into an occlusive ring around the hollow organ. Preferably, the closure then forms a connection between the first and second ends of the elongate member.
In an embodiment, the artificial contractile structure may further comprise an arcuate self-supporting structure in which the elongated member is mounted, the self-supporting structure being configured for insertion on top of the circular striated muscle, thereby preventing dissection of the vaginal wall of the patient. Such a configuration may be very advantageous for implantation in female patients.
Advantageously, the closure may be integral with the elongate member, i.e. integral with the elongate member, thereby forming a simple construction with a minimum number of components.
Advantageously, the tensioning system further comprises a flexible transmission pivotably attached to the elongate member, the first and second tensioning elements passing through the flexible transmission. Thus, the flexible drive means may pivot relative to the elongate member without kinking, which is useful not only in use, but also when inserted into a patient via a trocar, as the flexible drive means may be easily folded together with the cuff. The cuff and the flexible drive means together form a medical device.
Advantageously, the flexible drive is attached to an adapter, the adapter comprising at least one pulley around which the first and second tensioning elements pass in order to enter the flexible drive. One or more pulleys may be rotating or stationary and serve to minimize friction with the tensioning element as the one or more pulleys transition from the cuff to the flexible drive.
Advantageously, there is provided a control system comprising an actuator, the first and second tensioning elements being attached to the actuator by means of a connector, the connector being attached to the actuator by means of a push-fit connection. The connection of the tensioning element and the flexible transmission to the actuator is therefore simple and does not require any rotation.
Advantageously, the push-fit connection comprises one or more helical springs and one or more O-rings connected with a first annular groove provided in one of the actuator and the connector and providing a kinematic connection with another annular groove provided in the other of the actuator and the connector. A particularly simple push-fit is therefore proposed.
Advantageously, the connector comprises a connecting rod longitudinally movable within the coaxial plunger, said connecting rod being attached to said tensioning element. Preferably, the connecting rod comprises a toothed portion cooperating with a releasable hooking member of said plunger to allow locking of the connecting rod in said plunger, while the connector is designed to automatically disconnect when a given force is reached, preventing injuries to the patient, the toothed portion also allowing disconnection from the tensioning element at any position of the rod without applying force to the tensioning element (this in order to protect the urethra from uncontrolled pulling forces).
The object of the invention is also achieved by a method of manufacturing an artificial collapsible structure as defined above, comprising the steps of:
the resilient core is formed thanks to a memory alloy that can be made flat to simplify subsequent operations (bending, overmoulding, shearing, sleeving, etc. of the guides for the tensioning elements);
-applying the biocompatible sheath onto the resilient core, for example by over-moulding or over-moulding a pre-prepared sheath;
-assembling the closure and the tensioning system onto the elongate member before or after applying the biocompatible sheath.
This method results in an artificial collapsible structure having the advantages described above.
Advantageously, the resilient core is formed of a shape memory alloy capable of adopting a first state and a second state and thus exhibiting at least a one-way memory effect, the method comprising the steps of:
-making the resilient core substantially flat in the first state and bending the resilient core in the second state, for example following a circular or elliptical arc or following a horseshoe shape;
-causing the resilient core to adopt the first state, such as by bending the resilient core from its second state into the first state;
-applying the biocompatible sheath onto the resilient core when the resilient core is in the first state;
-after application of the biocompatible sheath, bringing the resilient core into the second state in order to impart a curvature on the elongated member, e.g. by heating the resilient core above a transition temperature of the material of the resilient core.
As a result, the artificial collapsible structure can be assembled and the outer sheath of the artificial collapsible structure can be applied in a flat state, which simplifies handling, and then a curved state can be adopted that facilitates implantation into the patient without applying external forces that could damage the flexible elongate member.
Advantageously, a tensioning system is applied at least partially to the elongated member before the step of applying the biocompatible sheath to the resilient core. The tensioning system may then pass through or under the outer sheath.
Advantageously, the outer sheath is applied to said resilient core by overmoulding, forming a unitary construction without joints.
Drawings
The invention will be described in conjunction with the appended drawings, which show:
FIG. 1: a schematic perspective view of an artificial contractile structure according to the invention in a first embodiment;
-figure 2A: a schematic perspective view of a detail of a first embodiment of an adapter forming part of the artificial collapsible structure of fig. 1;
-figure 2B: a schematic perspective view of a detail of a second embodiment of an adapter forming part of the artificial collapsible structure of fig. 1;
-figure 3A: a schematic perspective view of an artificial contractile structure according to the invention in a first embodiment;
-figure 3B: a schematic cross-sectional view of an artificial collapsible structure according to the invention in a second embodiment;
fig. 4A to 4C: a schematic cross-sectional view of the artificial contractile structure of figure 3 in different constrictions around the female urethra;
-figure 5: a schematic cross-sectional view of a connector for an artificial collapsible structure to a control system according to the invention;
-figure 6: a schematic cross-sectional view of the connector of figure 5 connected to a control system for an artificial collapsible structure according to the invention; and
-figure 7: a schematic flow chart of a particularly advantageous method of manufacturing an artificial collapsible structure according to the invention.
Detailed Description
Fig. 1 shows an artificial collapsible structure 1 according to the invention. Such artificial shrinkable structures are commonly referred to as "cuffs" and in the following description the term will be used interchangeably with "artificial shrinkable structures" for ease of reading.
The cuff 1 comprises an elongated member 3, i.e. a long, relatively thin member, which may be a strip with a substantially flat cross-section or may have a V-shaped, U-shaped or corrugated cross-section (or similar), comprising a
In the shown embodiment the
The biocompatible
Alternatively, as shown in fig. 1 and 2, the artificial collapsible structure 1 may comprise a closure strap or closure harness 9. In some cases, such a closure tether 9 may assist in forming cuff 1 as a loop around a hollow body organ (such as the urethra, blood vessels, bowel, etc.). In the embodiment shown, the closure strap 9 is formed as a substantially loose strap or ribbon that is permanently attached at one end 9a to the
In order to secure the loose end 9b of the closure member 9 at a desired point, a plurality of corrugations 9c are provided at intervals of, for example, 2.5mm to 4mm, in order to lock the closure member 9 at the desired point, such that the cuff 1 has a desired circumference to conform to the hollow body organ of the patient around which it is secured. Other forms of closure are also suitable. To assist in passing the end 9b of the closure strap 9 into the opening 3c disposed at the
In order to allow cuff 1 to contract the hollow body organ, a tensioning system 11 is provided. As also shown in fig. 2, the tensioning system 11 comprises a first tensioning element 13, which first tensioning element 13 is fixed at a first point at or near the
The tensioning elements 13, 15 may be wires, cords, filaments, belts or the like. In practice, wovenThe filament effect of (ultra-high molecular weight polyethylene), aramid fiber and the like is good. These filaments may pass through one or more tubes and/or longitudinal channels provided in the structure of the
At a third point 3d between said ends 3a, 3b of the elongated member, an
Fig. 2 shows the
The
The support element 25 may be rigidly fixed to or integral with the resilient core, for example by laser brazing, or may be fixed so as to be movable about at least one further axis so as to form a cardan type joint. For example, the support element may be arranged to pivot according to an axis parallel to the longitudinal axis of the elongated member 3 and/or according to an axis perpendicular to the plane of the tangent of the elongated member 3 that meets the
In a simpler embodiment, the tensioning elements 13, 15 may simply pass through appropriately placed channels or around appropriately placed surfaces, which may be provided with low friction surfaces, such as highly polished biocompatible metals, PTFE, etc. However, the use of pulleys 21a, 21b ensures that friction is kept to a minimum and that the maximum force applied by a control unit (not shown) is applied to the ferrule 1.
A second embodiment of a
In this embodiment,
The self-supporting
The inner wall of the arch of the self-supporting
The
Fig. 3B shows an alternative embodiment of the
Fig. 5 and 6 show a push-
The illustrated
In order to simplify the assembly of the entire system in situ, i.e. within the body cavity of the patient, the attachment of the
As shown in fig. 5 and 6, the tensioning elements 13, 15 are formed from a single filament, the
Advantageously, the connecting
The head 30bc of the
In order to support the
To minimize the ingress of fluid between the
The artificial collapsible structure 1 of the present invention can be manufactured by any convenient conventional manufacturing method wherein the
This manufacturing method is applicable when the
An overview of the main steps of the method is shown in fig. 6.
In step 101, the
In this step, the
As is generally known, since SMA can exhibit one-way and/or two-way memory effects, two shapes can be defined for the
A simple way to exploit this effect is to bend the
Once the
If the tensioning elements 13, 15 do not pass under the
Once the ferrule 1 is so assembled, the
Cuff 1 is then ready for sterilization, packaging and use.
Since cuff 1 is already provided with the appropriate curvature, it is easier for the surgeon to place the cuff around a hollow body organ. A flat cuff is more difficult for the surgeon to operate laparoscopically, as it requires the surgeon to apply the desired curvature before he can close the closure member 9.
One particular advantage of this method is that the curvature of the elongate member 3 need not be formed prior to application of the
In use, cuff 1 is inserted into a patient through a trocar, an incision is made as necessary (depending on the hollow body organ around which cuff 1 is applied) to enable elongated member 3 to pass around the hollow body organ, and closure member 9 is closed and tightened to give cuff 1 the desired diameter. Subsequently, the
Although the present invention has been described in terms of particular embodiments, variations may be made thereto without departing from the scope of the invention as defined by the appended claims.