Fixation sleeve and assembly comprising such sleeve

Abstract

The invention refers to a fixation sleeve for an implantable lead, wherein the fixation sleeve comprises a substantially tubular body having an internal lumen extending therethrough and extending in a longitudinal direction, the internal lumen being configured to receive a lead body. To securely fixe the fixation sleeve to the lead body using a predefined force, wherein the fixation sleeve has small outer dimensions at the same time, the fixation sleeve is composed of a first component and at least one second component, each of the first component and the at least one second component forming a respective section of the inner surface of the internal lumen, wherein the at least one second component being pivotable relative to the first component between a first position and a second position, wherein in the first position a longitudinal movement of the lead body within the internal lumen is allowed and in the second position a longitudinal movement of the lead body is prevented. The invention further refers to an assembly comprising a medical device and such fixation sleeve as well as to an assembly comprising a suture and such fixation sleeve.

Description

[0001] Fixation Sleeve and Assembly Comprising Such Sleeve

[0002] The invention relates generally to a fixation sleeve for an implantable medical device lead and an assembly comprising the medical device lead and the fixation sleeve.

[0003] Medical devices such as cardiac pacemakers or defibrillators comprise at least one lead emanating from the medical device and terminate at a predefined treatment location on the tissue. The lead applies electrical pulses to the predefined treatment location and / or transmits electrical signals detected at the predefined tissue location to the medical device. A fixation sleeve is used to secure the implanted lead near the treatment location at a predefined fixation location. Such fixation sleeve is generally configured as tubular member, the cavity or lumen of which is adapted to sheathe the electrically conductive lead body of the implantable medical device. A fixation sleeve usually also includes circumferential grooves adapted to receive a thread, e.g. a suture. The grooves facilitate wrapping the fixation sleeve with a thread to secure the sleeve to the body of a lead and to a patient's body tissue. Fixation sleeves are typically formed of soft, implantable elastomer material such as silicone.

[0004] During implantation the lead body is sheathed within the fixation sleeve. Once the lead is properly positioned at the predefined treatment location at the patient's body, the fixation sleeve is slid down the lead body to a point where it is supposed to be fixed at the patient's body - the fixation location. There it is wrapped with a thread in the circumferential groove. The thread is pulled tight and tied by the health care practitioner (HCP, e.g. clinician, nurse, ...) to secure the fixation sleeve to the lead body so that the lead body does not move in longitudinal direction with regard to the fixation sleeve. Additionally, the fixation sleeve is secured by the thread to the body tissue at the fixation location. Securing the fixation sleeve in this manner is important to provide permanent hemostasis and lead stabilization at the treatment location.

[0005] However, because a fixation sleeve is constructed of soft, pliable material, problems may occur during the above-described procedure or afterwards. On the one hand, if the HCP pulls the thread too tight when securing the sleeve to the lead body, the thread may cut through the soft material of the fixation sleeve thereby damaging the lead body. When this happens, the lead must be replaced. Unfortunately, damage to the lead is often not detected until after the implantation is complete. Accordingly, an additional surgery is required to fix the problem thereby ultimately increasing the total cost of the implantation procedure. On the other hand, there may be problems if the fixation sleeve is not securely fixed to the lead body and the lead body moves relative to the fixation sleeve within the patient’s body.

[0006] Document US 2005 / 0055062 Al discloses a screwless system for connecting a probe to an active implantable medical device comprising an axial female housing able to receive a probe connector and a reversible mechanical retention system to secure the probe connector in the housing, for example, a rotary bolt equipped with a side cam surface. Since both, the probe and the retention system are located within the housing, the housing has large outer dimensions which is frequently not desired. The same applies to an apparatus for fixing an electrode known from EP 1 709 990 A2 having a sleeve, wherein the sleeve contains an elastic tube and two parts surrounding the tube, wherein the tube forms the inner longitudinal cavity for accommodating the electrode, wherein the two parts can be pulled apart in the axial direction counter to the restoring force of the elastic tube that holds them together, to an extent such that the two parts can be rotated by twisting or wringing the elastic tube and resecured in the new rotational position in contact with one another against rotary movements. Additionally, the force for fixing the electrode of such system cannot precisely be controlled.

[0007] Accordingly, there is a need for a fixation sleeve that is securely fixed to the lead body, at best using a predefined force and / or geometry in the clamping area, and has small outer dimensions at the same time.

[0008] The above object is solved by a fixation sleeve with the features of claim 1 and by assemblies comprising a fixation sleeve and a lead or a thread with the features of claims 10 and 12.

[0009] In particular, the object is solved by a fixation sleeve for an implantable lead, wherein the fixation sleeve comprises a substantially tubular body having an internal lumen extending therethrough and extending in a longitudinal direction, the internal lumen being configured to receive a lead body (of the lead), wherein the fixation sleeve being composed of a first component and at least one second component, each of the first component and the at least one second component forming a respective section of the inner surface of the internal lumen, wherein the at least one second component being pivotable relative to the first component between a first position and a second position, wherein in the first position a longitudinal movement of the lead body within the internal lumen is allowed and in the second position a longitudinal movement of the lead body is prevented.

[0010] The fixation sleeve has a substantially tubular body that forms an outer shell surface and an internal lumen or bore extending therethrough for receipt and guidance of the body of the implantable lead. The internal lumen substantially extends in longitudinal direction, wherein the lead can be moved along the internal lumen in longitudinal direction when the at least one second component is in the first position relative to the first component. Accordingly, in this position, the fixation sleeve can be moved along the lead body.

[0011] The material of the fixation sleeve located between the internal lumen and the outer shell surface is referred to as wall. Further, the internal lumen has an inner surface.

[0012] As indicated above, the fixation sleeve is composed of a first component and at least one second component. Accordingly, the fixation sleeve may comprise two components or more than two components. Each of the first component and the at least one second component forms a respective section of the inner surface of the internal lumen. Accordingly, the internal lumen is partially formed by the first component and partially by the at least one second component. As explained in detail below, it depends on the specific shape of the first component and the at least one second component which section of the inner surface is formed by these components. For example, a first longitudinal section of the inner surface may be formed by the first component and the adjacent second longitudinal section of the inner surface may be formed by the adjacent second component. Alternatively or additionally, the same longitudinal section of the inner surface may partly be formed by the first component and partly by the second component.

[0013] The fixation sleeve is further configured such that the at least one second component being pivotable / rotatable relative to the first component between a first position and a second position. In the first position a longitudinal movement of the lead body within the internal lumen is allowed. In the second position, a longitudinal movement of the lead body is prevented. Due to the movement / rotation of the first component relative to the at least one second component, the position of the inner surface sections of the internal lumen of the first and the at least one second component relative to each other and thereby the shape of the internal lumen is changed such that longitudinal movement of the lead body within this lumen is not longer possible. In particular, the shape of the internal lumen is changed such that the smallest diameter of the cross section of the internal lumen is reduced (compared to the smallest diameter of the cross section of the internal lumen in the first position) in order to provide a predefined clamping force to the lead body. For example, in the first position the smallest diameter of the internal lumen of the fixation sleeve is, for example, greater than 103% of the outer diameter of the lead body, whereas, in the second position, the smallest diameter of the internal lumen of the fixation sleeve is, for example, smaller than 1% to more than 100% of wall thickness of outer diameter or coating of this outer diameter of the lead body. Further, the inventive fixation sleeve not only exactly defines the clamping force by the internal lumen’s cross section but also the clamping path by the shape and the extension of the internal lumen in longitudinal direction. Accordingly, a predefined fixation of the lead body with a predefined force and / or predefined geometric deformation within the fixation sleeve is provided. Further, the fixation can be realized by a simple action of the HCP during implantation procedure, namely a pivotal movement / rotation of the at least one second component relative to the second component. Additionally, the simple action only causes a change of the internal lumen so that the fixation sleeve has minimal space requirement.

[0014] In one embodiment, the first component and the second component of the fixation sleeve are positioned adjacent to each other or intermeshed with each other with respect to the longitudinal direction. If the first component and the second component are positioned adjacent to each other with respect to the longitudinal direction, the section of the inner surface of the internal lumen formed by the first component is positioned adjacent to the section of the inner surface of the internal lumen formed by the second component. During rotation, the adjacent inner surface sections rotate / move with respect to each other. If the first and the second component are positioned intermeshed with each other, the inner surface of one longitudinal section is formed by the first and the second component that intermesh. The first and the second component have a positive-locking connection, for example by intermeshing webs and openings / recesses / cutouts. This embodiment allows a better clamping force distribution in the second position when the longitudinal movement of the lead body within the internal lumen is prevented.

[0015] In one embodiment, in the second position the lead body is clamped caused by an eccentric dislocation of inner surface section of the internal lumen formed by the first component relative to the inner surface section of the internal lumen formed by the at least one second component. This is realized, for example, by a pivotal movement of the at least one second component about a second axis forming the axis of its internal lumen at the same time, wherein the second axis is different from the first axis of the internal lumen of the first component. For example, the first axis is parallel to the second axis. Alternatively, the pivotal movement is provided about an axis that is different from the axis of the internal lumen of the first component and from the axis of the internal lumen of the at least one second component. The eccentric dislocation of the inner surface sections is provided such that the shape of the internal lumen is changed in the second position compared to the first position as explained above.

[0016] In one embodiment, in the second position the internal lumen is closed such that the inner surface of the internal lumen at least sectionwise tightly surrounds the lead body and in the first position the internal lumen stands open. In the first position, the internal lumen stands open such that the lead body may fully be removed from the internal lumen. The dimension of the opening is such that it is greater than the diameter of the lead body over the full length of the fixation sleeve. In the second position, this opening is reduced / closed such that the lead body is tightly surrounded (clamped) by the inner surface of the internal lumen at least along one or several predefined sections of the internal lumen, for example over more than 180° of the circumference of the lead body. This embodiment provides the possibility that the lead body is implanted without the fixation sleeve during the first steps. Only when the fixation of the lead to the patient’s body is the next step, the fixation sleeve needs to be provided and can easily be clamped to the lead body.

[0017] In one embodiment, the fixation sleeve is configured such that in the second position of the first component relative to the at least one second component, at least one of the first component and the at least one second component can be fixed when the second position is reached, wherein the fixation is detachably or non-detachably. By fixing at least one of the first and the second component, in one embodiment relative to each other, the second position is fixed. Accordingly, the prevention of the longitudinal movement of the lead body can be maintained in a safe manner. A non-detachable fixation usually is even saver, but a detachable fixation may ease the use of the fixation sleeve during implantation process as its position with respect to the lead body may be changed by reopening the fixation sleeve, shifting it along the lead body parallel to its axis and fixing it again at the desired position along the lead body. For example, in one embodiment, the second position is secured by a snap-fit connection and / or by a pin fixing of a first opening at the first component and an aligned second opening at the respective at least one second component and / or by a connector fixing of a first projection at the first component and of a second projection at the respective at least one second component relative to each other. In one embodiment, the first position of the at least one second component relative to the first component may be detachably fixed, as well, for example by a snap-fit connection.

[0018] In one embodiment, the first component comprises a first stop surface defining the first position and / or a second stop surface defining the second position. Such stop surface(s) increase reliability of fixation using the fixation sleeve as the second position is exactly predefined. In one embodiment, the first stop surface and / or the second stop surface as well as the respective counter-surface are configured such that the user (e.g. HCP during implantation) receives an audible and / or tactile and / or visible feedback when the second position at the respective stop surface is reached. This eases the implantation procedure, as well.

[0019] To fix the fixation sleeve at the predefined fixation location within the patient’s body, in one embodiment, an outer surface of the tubular body, i.e. the outer surface of the first component and / or the at least one second component comprises at least one groove, e.g. circumferential or helical groove, configured to receive a thread. After fixation, the thread is located within this groove and cannot move relative to the fixation sleeve. Thereby a safe fixation is achieved. In one embodiment, the outer shell surface of the first component and / or of the at least one second component adjacent to the at least one groove is inclined towards the groove. This inclination further eases the accommodation of the thread within the groove as it helps the thread to slide towards the groove during implantation procedure. Accordingly, the HCP work is further expedited.

[0020] In one embodiment, the first component and the at least one second component are fully separate components configured to form a positive locking connection. For example, the first component comprises a projection having an outer surface with a circular cross section and the second component comprises a corresponding recess having an inner surface with a corresponding (in its shape) circular cross section so that the projection is guided within the recess during its pivoting / rotating movement thereby ensuring a correct pivoting movement. By separate manufacturing of the first component and the at least one second component the production costs can be reduced. The separate manufacturing of the elements and the subsequent attachment eases the production process with the tradeoff of increased number of production steps. For example, the at least one first component and the at least one second component is produced by injection molding. In one embodiment, the first component may comprise a circumferentially extending first finger or web (bar, land) and the at least one second segment may comprise a circumferentially extending second finger or web (bar, land), wherein the first finger or web and the second finger or web mesh with one another.

[0021] In one embodiment, the at least one first component and the at least one second component are arranged alternating in longitudinal direction. Accordingly, one first component is located next to one or two second components and vice versa in longitudinal direction. By the alternate arrangement of first and second component, the radial (clamping) forces provided by the components in their second position is equally distributed over the whole extension in longitudinal direction. In one embodiment, the material of the first component and the at least one second component may be one material of the group comprising a thermoplastic material, e.g. Polyether ether ketone (PEEK), Polyurethane (PU), Polyethylen (PE) or Polyoxymethylen (POM). Alternatively, materials from additive manufacturing may be applied, also non-thermoplastic materials. The material of the first component and of the at least one second component may be similar or different. The material hinders the penetration of the thread into the tubular wall. Accordingly, the risk is reduced that the thread accommodated within the at least one groove cuts through the material and damages the lead body accommodated within the internal lumen of the fixation sleeve. In one embodiment, the first component and / or the at least one second component may comprise at least one eyelet at its outer shell surface. The eyelet may be used to easily suture the fixation sleeve to the patient's tissue at the fixation location. The inner hole diameter of such eyelet may be, for example, 0,2 to 1mm.

[0022] The outer dimension of the fixation sleeve (e.g. its outer diameter, i.e. the dimension perpendicular to the longitudinal axis) may be, for example, smaller than 2mm to 8mm The length of the fixation sleeve in the longitudinal direction may be, for example, 18mm to 50mm.

[0023] The object is further solved by an assembly comprising a lead for a medical device (such as a pacemaker, defibrillator, neurostimulator) and a fixation sleeve as described above, wherein the fixation sleeve sheathes a body section of the lead and is movable along a lead body (of the lead) in longitudinal direction as long as the at least one second component is in the first position relative to the first component. The assembly with the fixation sleeve and the lead has the above described advantages and embodiments. Prior implantation and prior fixation of the fixation sleeve to the lead body and the patient's tissue, the fixation sleeve can be moved along the lead body in the longitudinal direction to adapt the position of the fixation sleeve to the personal needs of the patient. During implantation procedure, first, the tip (electrode) of the lead is properly placed at the predefined treatment position. Then, if necessary, after sliding the fixation sleeve along the lead body, the fixation sleeve is attached to the fixation location. In one embodiment of the assembly, the lead comprises an electrically conducting tip at its distal end and a connector for electrical and mechanical connection to the medical device at its proximal end.

[0024] The object is further solved by an assembly comprising a thread and a fixation sleeve as described above, wherein the suture and the fixation sleeve are configured such that during implantation procedure the thread is used to fix the fixation sleeve at a predefined fixation location within the patient’s body. The assembly with the fixation sleeve and the thread has the above described advantages and embodiments (with regard to the fixation sleeve). The suture may comprise or consist of at least one material of the group comprising Polypropylen (PP) or Polytetrafluorethylen (PTFE). The diameter of the thread may be, for example, 1 Ph. Eur. to 8 Ph. Eur (1 Ph. Eur. = 0,1mm). The fixation sleeve may comprise a groove at the outer surface of the tubular body to guide the thread during / after implantation and to prevent slipping of the fixation sleeve relative to the patient’s body.

[0025] The present invention will now be described in further detail with reference to the accompanying schematic drawings, wherein

[0026] Fig. 1 shows a patient with an example medical device, lead and fixation sleeve in a front view,

[0027] Fig. 2 depicts a first embodiment of a fixation sleeve in an exploded and perspective side view,

[0028] Fig. 3 shows the embodiment of Fig. 2 in an exploded and perspective top view,

[0029] Fig. 4 depicts the embodiment of Fig. 2 in a perspective top view in a first position,

[0030] Fig. 5 shows the embodiment of Fig. 2 in a perspective top view in a second position,

[0031] Fig. 6 shows a second embodiment of a fixation sleeve in an exploded and perspective side view,

[0032] Fig. 7 depicts the embodiment of Fig. 6 in a longitudinal section with a lead body,

[0033] Fig. 8 shows the embodiment of Fig. 6 in a perspective top view in a first position,

[0034] Fig. 9 shows the embodiment of Fig. 6 in a perspective top view in a second position,

[0035] Fig. 10 depicts a third embodiment of a fixation sleeve in a perspective top view in a first position,

[0036] Fig. 11 shows a first component of the embodiment of Fig. 10 in a perspective top view, Fig. 12 shows a second component of the embodiment of Fig. 10 in a perspective top view,

[0037] Fig. 13 depicts the embodiment of Fig. 10 in a perspective top view during pivoting movement between the first position and a second position,

[0038] Fig. 14 shows the embodiment of Fig. 10 in a perspective top view in the second position,

[0039] Fig. 15-17 depicts three different cross sections of the embodiment of Fig. 10 in a perspective top view,

[0040] Fig. 18 depicts a fourth embodiment of a fixation sleeve in a perspective side view in a first position,

[0041] Fig. 19 shows a first component of the embodiment of Fig. 18 in a perspective side view,

[0042] Fig. 20 shows a second component of the embodiment of Fig. 18 in a perspective side view, and

[0043] Fig. 21 shows the embodiment of Fig. 18 in a perspective side view in the second position.

[0044] Referring to the drawings, Fig. 1 shows a pacemaker system including a pacemaker 10 of a patient 1, and an electrode lead 20 electrically and mechanically connected to the pacemaker 10 by a connector 22. A distal tip of the lead 20 with an electrode 24 is positioned within a heart 30 of the patient 1 at a predefined treatment position. The lead 20 passes through a fixation sleeve 40 which in turn is sutured into surrounding tissue of the patient 1 at a predefined fixation position using a thread (e.g. a suture) to help position and stabilize the location of lead 20 and electrode 24.

[0045] A first embodiment of a fixation sleeve is shown in Fig. 2 to 5. The fixation sleeve 40 comprises a first component 41 and a second component 42, both components having substantially tubular shape. A first cylindrical bore 51 of the first component 41 and a second cylindrical bore 52 of the second component form the internal lumen for accommodation of a lead body (of the lead 20). Accordingly, when viewed in longitudinal direction (see arrow 45 in Fig. 2), the internal lumen consists of the first bore 51 and the second bore 52, wherein the first bore 51 and the second bore 52 are directly adjacently located. The first bore 51 is eccentrically relative to a shell surface 53 of a projection 54 provided at one end of the first component 41 in longitudinal direction. The second component 42 comprises a recess / cutout 55 corresponding in its shape (i.e. the shape of its inner surface) to the shell surface 53, wherein the recess 55 is eccentrical relative to the second bore 52. The second component 42 is pivotally assembled with regard to the first component 41, wherein the rotational movement is provided by cooperation of the outer shell surface 53 of the projection 54 of the first component and the corresponding inner surface of recess 55. The second component 42 may be pivoted relative to the first component 41 between a first position shown in Fig. 4 and a second position shown in Fig. 5. In the first position, the first bore 51 is aligned with the second bore 52 in longitudinal direction such that the resulting internal lumen (consisting of the first bore 51 and the second bore 52) allows to move a lead body accommodated within this lumen. In the second position, due to the eccentricity of the rotational movement and the bores 51, 52, the cross section of the internal lumen is reduced as depicted in Fig. 5 thereby clamping the lead body accommodated within the lumen.

[0046] At the outer surface, the first and the second components 41, 42 comprise several grooves 57 for accommodation of the thread during implantation. Further, the components 41, 42 comprise a snap-fit connection with a first element 58 and a second element 59 configured such that the snap-fit connection is closed as soon as the second component 42 is in the second position relative to the first component 41. For that, the first element 58 of the snap-fit connection extends over the projection 54 in longitudinal direction. Further, each of the first element 58 and the second element 59 of the snap-fit connection form a stop surface that provides a predefined position and an audible signal as soon as the snap-fit connection is closed.

[0047] The second embodiment of a fixation sleeve 140 (see Fig. 6 to 9) comprises four first components 141 and three second components 142 that are positioned alternating next to each other along the longitudinal direction (see arrow 145). Each component 141, 142 has a tubular shape, wherein the respective through-going bore 151, 152 is provided eccentric to the rotational axis of the pivoting movement of the second component 142 relative to the first component 141. In the first position shown in Fig. 8, the bores 151, 152 are aligned such that the lead body can be moved in longitudinal direction when accommodated within the internal lumen composed of the bores 151, 152. In the second position, depicted in Fig. 9, the internal lumen is reduced due to the eccentricity of the lumen sections 152 when the second component 142 is pivoted relative to the first component 141. The components 141, 142 are correctly positioned in the first and in the second position by a pin 156 that is pushed through another bore 153 of the first component 141 and a circumferential slit 155 of the second component 142, the bore 153 and the slit 155 extending in longitudinal direction. The slit 155 allows rotation of the second component 142 relative to the first component 141. Each component 142 comprises a pin 158 extending in radial direction from the outer surface of the second component 142, wherein the respective pin 158 can be gripped by the HCP to rotate the second components 142 relative to the first components 141 until the second position is taken. As shown in Fig. 8 and 9, the pins 158 may be connected using a bar 159 extending parallel to the longitudinal direction. The bar 159 allows common rotation of the second components 142. The interlocking and spatial cohesion does not necessarily take place within the components shown here. The illustration is only intended to show an exemplary cascading of several identical interlocks. The illustration of the common connection of positions 158 through 159 is only exemplary and can also be realized differently, e.g. by a circumferential ring. Preferably, positions 141 should also be led outwards (not shown) to hold them in place. A detent may then be realized between the outer rings. Grooves for thread attachment may be arranged on the outer rings (not shown).

[0048] The internal lumen 141, 142 is reduced in the second position shown in Fig. 9 such that the lead body accommodated within the internal lumen 151, 152 is clamped. Fig. 7 shows the lead body depicted by a dot-dashed line clamped with a predefined force by eccentric bores 151, 152. In the first position, the lead body is allowed to longitudinally move as the dimension of the internal lumen 151, 152, in particular the diameter at the narrowest cross section, is greater.

[0049] The third embodiment of a fixation sleeve 240 shown in Fig. 10 to 17 comprises a first component 241 and a second component 242 that intermesh with each other. Additionally, in a first position of the second component 242 relative to the first component 241 shown in Fig. 10, the internal lumen consisting of the first sections 251 of the first component 241 and the second section 252 of the second component 242 is open. This means that a lead body located within the sections 251, 252 can be moved in radial direction from the fixation sleeve 240. An HCP may grip the second component 242 at the projecting grip section 254 extending in longitudinal direction relative to the second component 242 and rotate the second component 242 as shown in Fig. 13 and 14, wherein Fig. 13 depicts an intermediate position between the first position of Fig. 10 and the second position drawn in Fig. 14. In the second position a stop surface 257a at a slit end of a recess / cutout extending in circumferential direction abuts to a stop surface 257 at the first component 241. In the second position the internal lumen is fully surrounded by sections 251, 252 of the components 241, 242. Further, the first and second components comprise elements 258, 259 of snap-fit connections which precisely define the first position (see Fig. 10) and the second position (see Fig. 14 and 17). For example, the second component 242 comprises two respective recesses 259 and the first component 241 a respective projection (nose) 258 that is configured to slit into and to accommodate within the recess 259. The clamping forces are distributed over the full length of the fixation sleeve 240 as the first component 241 comprises several webs 255 and the second component 242 respective recesses / cutouts 256 that intermesh with each other.

[0050] The fourth embodiment of a fixation sleeve 340 shown in Fig. 18 to 21 comprises intermeshing webs and cutouts, as well. The fixation sleeve 340 comprises a first component 341 and a second component 342, wherein each component 341, 342 substantially has a tubular shape with a bore 351, 352 running eccentrically with regard to the rotation of the second component 342 relative to the first component 341 around an axis that is parallel to the longitudinal direction (see arrow 345 in Fig. 18) similar to the first to third embodiments. The first component 341 comprises three ring-like or tubular segments 356 which are connected by two bar-like segments 356a running parallel to the longitudinal direction. Analogously, the second component 342 comprises three ring-like or tubular sections 358 that are connected by two bar-like segments 358a. The rotational movement of the second component 342 relative to the first component 341 is guided by projections 353 at the first component 341 similar to the first embodiment. Further, the first component 341 comprises first stop surfaces 357, 357a and the second component 342 comprises a second stop surfaces 359, 359a wherein the first stop surface 357 and the second stop surface 359 abut when the second position is reached (see Fig. 21) and the first stop surface 357a and the second stop surface 359a abut when the first position is reached (see Fig. 18) thereby, in each case, providing an audible and tactile feedback to the HCP. The first position is shown in Fig. 18, whereas the second position is depicted in Fig. 21. Each component further comprises another bore 354, 355 running inclined to the longitudinal direction, wherein in the second position the bores 354 and 355 are aligned to receive a thread (e.g. a suture) or a pin to fix the second position.

[0051] The above explained four embodiments of a fixation sleeve 40, 140, 240, 340 provide simple measures for the HCP to fix the fixation sleeve at the lead body and at the patient’s body that provide a defined clamping force to the lead body as the second position of the pivoting / rotational movement is precisely defined by a snap-fit connection and / or abutting stop surfaces.

Claims

Claims1. A fixation sleeve (40, 140, 240, 340) for an implantable lead, wherein the fixation sleeve (40, 140, 240, 340) comprises a substantially tubular body having an internal lumen (51, 52; 151, 152; 251, 252; 351, 352) extending therethrough and extending in a longitudinal direction, the internal lumen (51, 52; 151, 152; 251, 252; 351, 352) being configured to receive a lead body, wherein the fixation sleeve (40, 140, 240, 340) being composed of a first component (41, 141, 241, 341) and at least one second component (42, 142, 242, 342), each of the first component (41, 141, 241, 341) and the at least one second component (42, 142, 242, 342) forming a respective section of the inner surface of the internal lumen (51, 52; 151, 152; 251, 252; 351, 352), wherein the at least one second component (42, 142, 242, 342) being pivotable relative to the first component (41, 141, 241, 341) between a first position and a second position, wherein in the first position a longitudinal movement of the lead body within the internal lumen (51, 52; 151, 152; 251, 252; 351, 352) is allowed and in the second position a longitudinal movement of the lead body is prevented.

2. The fixation sleeve (40, 140, 240, 340) of claim 1, wherein the first component (41, 141, 241, 341) and the second component (42, 142, 242, 342) are positioned adjacent to each other or intermeshed with each other with respect to the longitudinal direction.

3. The fixation sleeve (40, 140, 240, 340) of any one of the previous claims, wherein in the second position the lead body is clamped caused by an eccentric dislocation of inner surface section of the internal lumen (51, 151, 251, 351) formed by the first component (41, 141, 241, 341) relative to the inner surface section of the internal lumen (52, 152, 252, 352) formed by the at least one second component (42, 142, 242, 342).

4. The fixation sleeve (240) of any one of the previous claims, wherein in the second position the internal lumen (251, 252) is closed such that the inner surface of the internal lumen (251, 252) at least sectionwise tightly surrounds the lead body (20) and in the first position the internal lumen (251, 252) stands open.

5. The fixation sleeve (40, 140, 240, 340) of any one of the previous claims, wherein the fixation sleeve is configured such that in the second position of the first component (41, 141, 241, 341) relative to the at least one second component (42, 142, 242, 342), at least one of the first component (41, 141, 241, 341) and the at least one second component (42,142, 242, 342) can be fixed when the second position is reached, wherein the fixation is detachably or non-detachably.

6. The fixation sleeve (40, 140, 240, 340) of any one of the previous claims, wherein the second position is secured by a snap-fit connection (58, 59; 258, 259) and / or by a pin (156) fixing of a first opening (153, 354) at the first component (41, 141, 241, 341) and an aligned second opening (155, 355) at the respective at least one second component (42, 142, 242, 342) and / or by a connector (159) fixing of a first projection at the first component (41, 141, 241, 341) and of a second projection at the respective at least one second component (42, 142, 242, 342) relative to each other.

7. The fixation sleeve (40, 140, 240, 340) of any one of the previous claims, wherein the first component (41, 141, 241, 341) comprises a first stop surface (357a) defining the first position and / or a second stop surface (257) defining the second position.

8. The fixation sleeve of any one of the previous claims, wherein an outer surface of the tubular body comprises at least one groove (57) configured to receive a thread.

9. The fixation sleeve (40, 140, 240, 340) of any one of the previous claims, wherein the first component (41, 141, 241, 341) and the at least one second component (42, 142, 242, 342) are fully separate components configured to form a positive locking connection.

10. An assembly comprising a lead (20) for a medical device and a fixation sleeve (40, 140, 240, 340) according to any one of the claims 1 to 9, wherein the fixation sleeve (40, 140, 240, 340) sheathes a body section of the lead (20) and is movable along the lead body in longitudinal direction as long as the at least one second component (42, 142, 242, 342) is in the first position relative to the first component (41, 141, 241, 341).

11. The assembly of claim 10, wherein the lead (20) comprises an electrically conducting tip (24) at its distal end and a connector (22) for electrical and mechanical connection to the medical device (10) at its proximal end.

12. An assembly comprising a thread and a fixation sleeve (40, 140, 240, 340) according to any one of the claims 1 to 9, wherein the suture and the fixation sleeve (40, 140, 240, 340) are configured such that during implantation procedure the thread is used to fix the fixation sleeve (40, 140, 240, 340) at a predefined fixation location within the patient’s (1) body.

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