1. Field of the Invention
The invention relates to a suture sleeve for one or more implantable leads, the suture sleeve being adapted to be inserted into a vein to secure and protect the one or more leads from damage when a suture thread is positioned and tied around the vein in the region over the suture sleeve to secure the suture sleeve and prevent bleeding from the vein, of the type having two or more lead receiving through holes, into each of which a medical implantable lead may be inserted.
The invention also relates to a method for implanting one or more electrical leads into a vein.
2. Description of the Prior Art
It is sometimes desirable to implant an electrical lead into a vein in an animal or human body, such that the lead extends out from the vein. This is the case e.g. when implanting a pacemaker into a body for monitoring and controlling the heart function. The pacemaker itself is implanted just under the skin in a pacemaker pocket at a suitable position, whereas one or more leads are inserted through an opening in the wall of a vein and pushed in until a distal end enters the heart where it can be attached to the heart wall.
However, the vein must be closed after lead insertion to avoid bleeding and the lead must be fixated in relation to the vein to eliminate the risk that the lead accidentally can be drawn out from its position. Avoiding bleeding is very important to prevent local hematoma since hematoma is considered as a major positive predictor for infection in the pacemaker pocket. This is accomplished by means of a suture thread, which is positioned around the vein and the lead in the area of the cut opening in the wall of the vein and which is tied around the vein and the lead. However, when closing the vein by tying the suture around the vein and the lead, there is a risk that the lead might get damaged by squeezing of the suture thread around the lead if the suture is made too tight. The suture stress will be concentrated to a small area and may cause intensive abrasion load to the lead body. On the other hand, if the suture is not tight enough, bleeding may occur and cause hematoma. If the suture is not combined with fixation of the lead elsewhere, there is also a risk for longitudinal lead movement and lead dislodgment if the suture is not sufficient tight.
To eliminate these risks it is known to use a so called suture sleeve, which is positioned around the lead in the area of the lead-through in the wall of the vein. In this way the suture sleeve will protect the lead from damage by the suture thread and the suture sleeve will fix the lead in a sufficient degree.
However, sometimes it is desirable to connect the pacemaker with the heart by means of two separate leads. In such a case it is common practice to tying the suture around the vein directly onto unprotected leads to prevent from bleeding. The leads are then fix separately some distance from the vein entrance by using the suture sleeves to prevent from longitudinal lead movement and lead dislodgement. This has the effect that the leads in the venous entrance, where they are unprotected from the suture thread, may become damaged.
U.S. Pat. No. 5,107,856 discloses a suture sleeve for two leads and another for three leads. The suture sleeve is formed as a flexible strip having two or three spaced apart lead receiving channels. During use, one lead is positioned in each of the lead receiving channels and then the flexible strip is wrapped around the leads. Finally, the suture sleeve is positioned in the cut opening in the vein and tied around by a suture thread.
However, there are several disadvantages with such a suture sleeve. For example, it is not possible to position and fixate only one or two leads in a suture sleeve, which is adapted for three leads, since then blood will leak out through the channel which has no lead positioned therein. I.e. when inserting two leads into a vein it is necessary to use a suture sleeve being adapted for exactly two leads, and when inserting three leads into the vein it is necessary to use a suture sleeve being adapted for exactly three leads. Accordingly, it is necessary to keep in stock several types of suture sleeves to be prepared for different applications. Moreover, the leads in question are very small having a cross sectional dimension of only about 2 mm, which has to effect that also the suture sleeve will be very small. This will have to result that it is very difficult to wrap around the leads properly with the suture sleeve, insert it through the opening in the vein and fixate the assembly by means of a suture thread in a correct position without losing the suture sleeve during the handling. With a suture sleeve of this kind it is also impossible to completely eliminate bleeding since, as is evident from the drawings in that patent, there will always remain some gaps between the leads and the suture sleeve in an assembled state.
It is an object of the invention to overcome the disadvantages with prior art suture sleeves. More specifically it is an object to provide a suture sleeve for one or more electrical leads which is easy to handle and by means of which it is possible to effectively eliminate any bleeding independently of whether there are leads positioned in every through hole or not.
The invention also relates to a method for implanting one or more electrical leads into a vein of a human or animal body, having essentially the same object as above.
The basis of the invention is the insight that the above object may be achieved by means of a suture sleeve having two or more lead receiving through holes. At least all the holes except one are provided with sealing means, which are easy to break or remove when it is desirable to insert a lead into a specific hole. Accordingly, as long as no lead is inserted into a hole and the sealing means is intact, the sealing means prevents any blood leakage through that hole.
Within this general idea, the invention can be modified in many different ways. In a hereinafter described and in the drawings illustrated embodiment of the invention, the sealing means is in form of a thin membrane, of e.g. silicone, which easily can be broken. However, the sealing means also could be in any other suitable form, e.g. as a removable plug or the like in the hole. Normally, this is not a preferred embodiment, since small removable items in connection with an open cut in a body, could constitute a risk that the item is lost in the cut. The membrane and the plug or the like, could be manufactured as a separate detail and attached in the hole of the suture sleeve by means of for example an adhesive. However, it is preferred to make the sealing means in the same production step as the suture sleeve itself, e.g. by injection molding.
The through holes in the suture sleeve can be made as complete and unbroken holes, in which case the leads are inserted by displacing the leads in the axial direction of each hole. In such a case a sealing means in form of a membrane can be broken by means of the lead when it is inserted into the hole. A prerequisite for forming the suture sleeve in this way is that the lead is substantial isodiametric along its entire length.
However, in many cases the leads have a thickened portion, e.g. in their tip portions. For this reason, according to a hereinafter described embodiment, at least all of the holes except one are formed with a slot along the entire length of the hole and the suture sleeve is formed of an elastic material. In this way a lead can be inserted into a through hole by deflecting the material around the hole, for widening the slot, and inserting the lead sideways through the widened slot. It is, in such a case, favorable if the slot formed through holes, are each provided with a sealing means in form of a membrane, which will brake when deflecting the material around the hole and widening the slot. However, one of the through holes can, as in the described and illustrated embodiment, be unbroken and adapted to be pre-assembled onto a lead. In this way there is no risk of losing the suture sleeve during an implantation.
Moreover, the suture sleeve could be manufactured with an arbitrary number of holes, however at least two. Normally it is sufficient to manufacture the suture sleeve with three holes since this will cover most application ranges for pacemakers. Then it is possible to attach one, two or three electrical leads, as desired, in a secured and bleeding preventing way.
Reference is first made to
The suture sleeve comprises three through holes 2, 2′ and 2″ in its longitudinal direction. As evident from
Each of the through holes 2′, 2″ is formed with a slot 3, and is provided with a sealing means in form of a thin membrane 5, which blocks the through hole. When mounting a lead into one of these through holes, the membrane will break as the slot is widened by deflecting the material around the slot, as is illustrated in
Although modifications and changes may be suggested by those skilled in the art, it is the intention of the inventors to embody within the patent warranted heron all changes and modifications as reasonably and properly come within the scope of their contribution to the art.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/SE07/00294 | 3/26/2007 | WO | 00 | 9/17/2009 |