Implantable blood conveying device, manipulating device and coupling device

Abstract

An implantable component is described which is connectable to a manipulating device in a self-retaining manner by a coupling device, which provides a first coupling element and a second coupling element. The implantable component can thus be really positioned by the manipulating device which can, for example, already be connected to the implantable component before a therapeutic procedure and can be separated therefrom again after the surgical procedure. This is in particular advantageous with minimally invasive procedures.

Claims

1. At least one manipulating device for handling a component of a system for blood conveying, comprising: an implantable component adapted to be implantable into a patient's body, said component also adapted to convey blood; said at least one manipulating device connected to said implantable component, wherein said at least one manipulating device is adapted to provide manipulation of the implantable component in all spatial directions; wherein said at least one manipulating device comprises a hollow shaft connected to said implantable component, and a rotatable core, wherein said rotatable core has a threaded bolt affixed to one end, and wherein said implantable component has a threaded bore adapted to selectively receive said threaded bolt therein; wherein where said hollow shaft connects with said bore said hollow shaft has a flange that is at least partially received on said implantable component, wherein said flange is adapted to improve controllability of the implantable component.

2. The at least one manipulating device of claim 1, further comprising spigots on the shaft, wherein said spigots are adapted to engage with corresponding bores in the implantable component.

3. The at least one manipulating device of claim 2, wherein said spigots are adapted to manipulate the implantable component.

4. The at least one manipulating device of claim 2, wherein said spigots are located opposite one another and on opposite sides of said bore.

5. The at least one manipulating device of claim 2, wherein said spigots extend transversely from said flange.

6. The at least one manipulating device of claim 2, wherein said bolt extends through an aperture in said flange.

7. The at least one manipulating device of claim 2, wherein said flange extends on either side of said shaft.

8. The at least one manipulating device of claim 1, wherein said at least one manipulating device, said hollow shaft and said threaded bolt are one piece.

9. At least one manipulating device for handling a component of a system for blood conveying, comprising: an implantable component adapted to be implantable into a patient's body, said component also adapted to convey blood; said at least one manipulating device connected to said implantable component, wherein said at least one manipulating device is adapted to provide manipulation of the implantable component in all spatial directions; a plate having a threaded bore therein, said plate connected to said manipulating device, wherein said at least one manipulating device comprises a hollow shaft connected to said implantable component, and a rotatable core, wherein said rotatable core has a threaded bolt affixed to one end, wherein said threaded bore is adapted to selectively receive said threaded bolt therein; wherein where said hollow shaft connects with said bore said hollow shaft has a flange that is at least partially received on said implantable component, wherein said flange is adapted to prevent rotation of the implantable component when the connection to the manipulating device loosens.

10. The at least one manipulating device of claim 9, wherein said manipulating device, said plate and said hollow shaft are one piece.

11. At least one manipulating device for handling a component of a system for blood conveying, comprising: an implantable component adapted to be implantable into a patient's body, said component also adapted to convey blood; said at least one manipulating device connected to said implantable component, wherein said at least one manipulating device is adapted to provide manipulation of the implantable component in all spatial directions; wherein said at least one manipulating device comprises a hollow shaft connected to said implantable component, and a rotatable core, wherein said rotatable core has a threaded bolt affixed to one end, and wherein said implantable component has a threaded bore adapted to selectively receive said threaded bolt therein, wherein spigots are on the shaft, wherein said spigots are adapted to engage with corresponding bores in the implantable component.

12. The at least one manipulating device of claim 11, wherein said spigots are adapted to manipulate the implantable component.

13. The at least one manipulating device of claim 11, wherein said spigots are located opposite one another and on opposite sides of said bore.

14. The at least one manipulating device of claim 11, wherein said spigots extend transversely from a flange on said shaft.

15. The at least one manipulating device of claim 14, wherein said bolt extends through an aperture in said flange.

16. The at least one manipulating device of claim 14, wherein said flange extends on either side of said shaft.

Description

DESCRIPTION OF THE FIGURES

(1) The device will be shown and described in the following with reference to an embodiment in a drawing. There are shown

(2) FIG. 1 a representation of an implantable component and of two manipulating devices in a three-dimensional view;

(3) FIG. 2 schematically in section, a manipulating device, a section of an implantable component and a coupling device;

(4) FIG. 3 a view of a coupling device;

(5) FIG. 4 a coupling device from FIG. 3 in a plan view;

(6) FIG. 5 a further coupling device;

(7) FIG. 6 a coupling device, a section of a component and a manipulating device;

(8) FIG. 7 a section of a component and a coupling device;

(9) FIG. 8 a section of an implantable component;

(10) FIG. 9 a section of an implantable component with a coupling device;

(11) FIG. 10 an alternative coupling device to that shown in FIG. 9;

(12) FIG. 11 a section of a component with a coupling device;

(13) FIG. 12 a part of an implantable component in a section with a coupling device;

(14) FIG. 13 a further alternative of a coupling device with a section of an implantable component; and

(15) FIG. 14 an alternative of a coupling device with an inflatable coupling element.

DETAILED DESCRIPTION OF THE DEVICE

(16) FIG. 1 shows schematically and in a stylized fashion an implantable component 1, which, for example, represents a pump for conveying blood as a part of a cardiac assist system, having a cylindrical outer wall 2 of a pump housing and a axial rotor, which is not shown in detail, supported in the hollow cylinder.

(17) A coupling element 4 of a manipulating device 5 is fastened to the end face 3 of the component 1 and is connected to a coupling element which is not shown in any more detail and which is integrated in the component 1.

(18) The coupling element 4 is connected to a shaft 6 of the manipulating device 5 which is connected at its proximal end to a handle 7. A knob 8 is moreover provided at the handle 7 and can, for example, be connected to a core 9 which extends in a hollow space of the shaft 6 up to the coupling element 4.

(19) The knob 8 can be moved with respect to the handle 7, for example displaced and/or rotated, to move the core 9 with respect to the shaft 6 in order thus to actuate the coupling element 4 and, for example to release the manipulating device 5 from the component 1.

(20) A further manipulating device 5′ is connected to the component 1 at another point via a further coupling element 4′. The further manipulating device 5′ likewise has a handle 7′ and a knob 8′. The component 1 cannot only be displaced, but also rotated by both manipulating devices 5, 5′ together which are fastened at the component 1 to points spaced apart from one another.

(21) The second manipulating device 5′ can also have a core 9′, which is movable by means of the knob 8′, within a hollow shaft 6′.

(22) FIG. 2 shows an exemplary implementation of a coupling device 10 at the component 1 having a blind hole which has an internal thread into which a threaded bolt 11 is screwed. The threaded bolt 11 is connected as a coupling element of the manipulating device to a core 9 which extends through a hollow shaft 6 and can be rotated therein to screw the threaded bolt 11 into or out of the threaded bore 10. The shaft 6 can thus be fastened to the component 1, which is only shown sectionally in FIG. 2, and released from it again.

(23) Generally, a coupling element can be formed by a cut-out, in particular a bore or a groove, having an undercut or without an undercut.

(24) It is prevented by additional spigots 50 at the shaft, which engage into corresponding bores of the implant, that the implant also rotates on the release of the screw connection. This moreover ensures that the implant can also be rotatingly manipulated.

(25) A flange 72 can also be provided in the shaft 6 and can be screwed to the component 1 by means of the threaded bolt 11 and a head 73 of the threaded bolt by screwing into the threaded bore 10.

(26) FIG. 3 schematically shows a coupling element 12 of a manipulating device in the form of a flat, plate-shaped thermoplastic end part at which a shaft 13 is engaged which forms a part of a manipulating device. The plate-shaped part 12 is connected to the wall piece 14, for example made in a planar fashion and forming a coupling element at the component side, for example welded thereto, bonded thereto or manufactured in one piece therewith as an injection molded part. The component 1 can thus be manipulated by means of the shaft 13 until the coupling element 12 is broken off at the component by kinking the plate 12.

(27) For better clarity, this configuration is shown in a plan view in FIG. 4, with the plate 12 and the shaft 13 being recognizable. The plate 12 can be kinked and removed by pivoting in the direction of the arrows 15, 16.

(28) The attachment of the plate-shaped piece 12 in the wall 14 of the component 1 forms the coupling element which is integrated there and to which the kinkable part of the plate 12 is connected as a coupling element of the manipulating device.

(29) In accordance with FIG. 5, a shaft 17 is connected to a bell-shaped coupling element 18 which is connected to the implantable component 1 by means of a short wire 19. The wire 19 provides that the bell 18 is seated on the component 1 and the component 1 can thus be moved by means of the shaft 17.

(30) The wire 19 can be turned off or torn off by a rotation of the shaft 17 at its longitudinal axis or by a tilting of the bell part with a large expenditure of force to remove the manipulating device 17, 18 from the component 1. The coupling elements 18, 19 provide a good handling of the component 1 via the manipulating device as long as the connection exists.

(31) In FIG. 6, a coupling device is shown having a coupling element 20 which comprises an elastomer and which is connected to a handle 22 of a manipulating device by means of a shaft 21. The element 20 is fixed in a force-locking manner in a bore 23 as a coupling element of an implementable component 1. For example, the element 20 can be heated and pressed into the bore 23 to establish a connection of the coupling device 20, 23. The manipulating device 20, 21, 22 can subsequently be removed from the component 1 by pulling at the shaft 21. It is also conceivable previously to heat the coupling element 20 or to cool it considerably to allow it to shrink.

(32) In FIG. 7, a coupling device is shown having a first component 1 onto which a coupling element in the form of a plate 24 is set, for example welded, soldered or bonded. The plate 24 can also be designed as an integrated part of the component 1.

(33) A suction cup 25 is placed on the smooth surface of the coupling element 24 and can, for example, comprise an elastomer, but also a hard highly polished plate, for example of steel. The two plates 24, 25 adhere as coupling elements to one another in a sucking manner with a sufficient surface quality. This is in particular the case when one of the components is formed as an elastomer suction cup.

(34) A ventilating passage 26 can be provided within the second coupling element 25; it extends through the shaft 27 and can be aerated or evacuated from the proximal end of the manipulating device 25, 26, 27 to couple or release the coupling device 24, 25.

(35) In FIG. 8, a section of an implantable component 51 is shown schematically having a dovetail groove 28 or a bore having undercuts.

(36) If it is a radially symmetrical bore having undercuts, in accordance with FIG. 9, a tulip-like coupling element 29 having outwardly facing latching noses can thus be inserted therein which elastically latch into the undercuts of the bore 28. The coupling element 29 is connected to a shaft 30 of a manipulating device and can also only be pulled out of the bore 28 by sufficient pulling at this shaft 30 when a blocking element 51 in the form of a cylinder is spaced apart axially from the latching noses 29 within a cut-out 52 in the manipulation apparatus by means of movement of the core 53 and thus releases an inward movement of the latching noses. The shaft 30 is hollow to receive the core 53.

(37) Another constellation of a coupling element 31 is shown in FIG. 10 which is equally arranged in a bore of the implantable component 1 having undercuts and which is substantially cylindrical with outwardly facing latching noses of elastically bendable end regions of end fingers of the coupling element. The coupling element 31 is also fixedly seated in the bore 28, but can be pulled out thereof by expenditure of force or by pulling in the latching noses of the coupling element 31.

(38) FIG. 11 shows a coupling apparatus having a first coupling element 32 and a second coupling element 33 which are each formed in plate-shape. The first coupling element 32 is fastened to a section of an implantable component 1 by bonding, welding or other joining technique and has a planar, smooth surface on the side remote from the component 1. The second coupling element 33 is laid onto the surface and is fastened there, for example, by means of an adhesive, e.g. an epoxy resin or another curable resin.

(39) The coupling elements are thereby connected to one another and the shaft 34 of a manipulating device is connected in a fixed and self-retaining manner to the component 1 via this coupling apparatus.

(40) The connection can be permanently established, for example, before introduction of the component 1 into a patient's body.

(41) To release the coupling connection, the epoxy resin between the coupling elements 32, 33 can be rehardened so much, for example by means of a UV radiation source 35, that it becomes brittle so that the coupling elements 32, 33 can easily be separated from one another.

(42) Provision can, however, also be made that the coupling elements 32, 33 are connected to one another by a thermoplastic adhesive which can be liquefied by irradiation, for example by a heat source, so that the coupling can be dissolved in this manner and the manipulating device can be removed by separation of the second coupling element 33 from the first coupling element 32. Ultrasonic pulses or laser beams can also be used to dissolve the coupling.

(43) A constellation is shown in FIG. 12 in which a hollow cylindrical component 1 as a coupling element has, for example, a spherical fitting surface 54 and two conical fitting surfaces 55, 56. The complementary cone 57 can run into the fitting surface 56 parallel to the longitudinal axis of the cylindrical component 1; the complementary bodies 58, 59 can move radially into the other fitting surfaces. The bodies 57, 58, 59 each represent coupling elements of a manipulating device and can be formed as ferromagnetic bodies, optionally as magnets, and also as switchable electromagnets.

(44) The fitting surfaces 54, 55, 56 can each be surrounded by ferromagnetic and/or magnetized material of the component 1, as shown for the example of the fitting surface 56 by hatching of the magnetic region 60.

(45) Provision can also be made that the magnetic effect of magnetically effective parts 61 in the interior of the component 1, for example of parts of a pump drive or of a magnetic valve, are used for the coupling.

(46) To facilitate a coupling of the manipulating device to the component by means of imaging processes, a marker body 70 integrated in the wall of the component or a surface coat 71 of a fitting surface 54 comprising a material of high density, in particular metal, preferably a precious metal, chromium or surgical steel, can be provided.

(47) To release such a magnetic coupling, either a corresponding electromagnet can be switched off or the manipulation apparatus can be moved in a jerky manner. A demagnetization of the magnets by means of an alternating field can also take place. A different alignment of the magnetic poles with respect to one another can however, also be achieved by rotating the one magnet with respect to the other so that a simplified release is made possible by the magnetic repelling forces which arise.

(48) In FIG. 13, a coupling apparatus is shown having a plate 32′ which is jointed to an implantable component 1 and which has a blind bore 44 having an internal thread. The plate 32′ having the blind bore 44 in this respect represents a first coupling element of the component 1. A second coupling element can be connected to this first coupling element and has a threaded bolt 45 which is connected to a core 46. The core 46 extends in the hollow space of a shaft 47 which represents a part of a manipulating device and is proximally connected to a handle not shown in FIG. 13. The shaft 47 and the core 46 are connected to the coupling element 32′ of the implantable component 1 by means of the threaded bolt 44.

(49) If the core 46 is rotated with respect to the shaft 47 via a knob at the handle of the manipulating device, the threaded bolt 45 can hereby be screwed into the plate 32′ or out of it or of the threaded bore 44 in order to establish or separate the coupling depending on the situation.

(50) In the state of an established coupling, the coupling apparatus is self-retaining, i.e. the first component 1 can easily be displaced and positioned or rotated as desired at the handle, not shown, of the manipulating device.

(51) The threaded bolt 47 can selectively also be replaced with a nut having an internal thread connected to the core 46 and the threaded bore 44 with a corresponding threaded bolt.

(52) As a further embodiment, the implantable component can also have a wrench flat, for example a hexagonal flat, as a coupling element to which a complementary wrench can engage as a second coupling element. If this combination is designed in a press fit, the connection is self-retaining.

(53) Provision is advantageously made in the described coupling devices to form them at the implant at the surface not conducting blood. Any contamination or damage to the passage conducting blood can thereby be prevented. In addition, any cut-outs, bores or the like provided are not provided at the blood conducting passage so that dead flow regions are avoided.

(54) As shown in FIG. 14, a combination of an inflatable hollow body, in particular of cushion, on the one hand, and of a gripping surface, on the other hand, can also be provided as a coupling device, for example at the component side.

(55) For example, a cushion inflatable via the shaft of a manipulating device can be introduced into a hollow space of a component and inflated there. For this purpose, the corresponding hollow space can have an undercut. The inflatable hollow body can also be made as a torus 63, 64 and be pushed over the component 1 or a part 62 of the component and inflated there.

(56) As soon as the implant has been positioned and aligned, the pressure in the hollow body can be reduced and the coupling apparatus thus separated.

(57) The hollow body can be coated with an elastomer for better adhesion to the component and to save the component surfaces.

(58) A fluid passage 66 is in each case provided in the shaft 65 of the manipulating device for inflating and pressure reducing of the hollow body. Beads 67, 68 can be provided at the component 1 for holding the hollow body which thus form corresponding fitting surfaces as a coupling element at the component side.

(59) The component can be simply positioned and aligned by a surgeon by the different variants shown of a self-retaining coupling apparatus between an implantable component and a manipulating device without the hand of the surgeon having to be directly guided into the operating field. A comparatively small access to the operating field is thereby made possible. The connection between the instrument or the manipulating device, on the one hand, and the component, on the other hand, can already be established before the actual surgical procedure and can be dissolved after the implantation.

(60) The manipulating device, the coupling device and the implantable component can be characterized generally by the following principles of action as special aspects of the invention: 1st aspect: the provision of fixed wrench flats at the component which cooperate with a complementary form of a coupling element; 2nd aspect: the coupling via a force locking (clamping) by an inflatable body or by a body of a coupling element spreadable in an opening; 3rd aspect: the coupling simultaneously at two points spaced apart from one another at the component, whereby the rotatability and tiltability is improved as a consequence of the separate manipulation possibilities of the coupling points; 4th aspect: the magnetic coupling of a coupling element of the manipulating device to a magnetically active part of the implantable component, in particular a drive unit, further particularly a pump unit.