Device and method for a self-attaching suture sleeve

[0001] The present device relates generally to a suture sleeve for an implantable medical device lead and particularly, but not by way of limitation, to such a suture sleeve that is adapted to attach to the lead body of an implantable medical device without the use of sutures.

[0002] Heart disease is a major health risk in the United States and elsewhere. One well-known treatment approach utilizes an implantable medical device, like a cardiac pacing device (i.e., a pacemaker) or a defibrillator, to manage a patient's heart rate or correct cardiac arrhythmias. An arrhythmia is generally defined as an abnormal cardiac rhythm.

[0003] A pacemaker delivers a relatively mild, periodic electrical impulse to epicardial or endocardial tissue as necessary to maintain normal sinus rhythm. In comparison to a pacemaker, an implanted defibrillator applies a much stronger electrical stimulus to the heart to “shock” it into a normal rhythm. The electrical charges for both implanted pacemakers and defibrillators are applied through electrically conductive leads that emanate from the medical device and terminate at an appropriate location on the tissue.

[0004] Suture sleeves are used to secure the implanted lead at the implant site. Suture sleeves are generally configured as tubular members, the cavity or lumen of which is adapted to sheathe the electrically conductive lead body of an implantable medical device. A suture sleeve also includes circumferential grooves adapted to receive a suture. The circumferential grooves facilitate wrapping the suture sleeve with a suture to secure the sleeve to the body of a lead and to a patient's body tissue, usually the fascia tissue of the heart. Suture leads are typically formed of soft, implantable elastomer material, such as silicone.

[0005] Suture sleeves come in several configurations. Some come from the implantable medical device manufacturer or other distributor with the lead already sheathed by the suture sleeve, thereby eliminating the need to thread or feed the lead through the sleeve during surgery. Other suture sleeves are separate from the lead, and the lead must be fed through the sleeve. Still other suture sleeves include a slit along the longitudinal axis of the sleeve to allow the sleeve to sheathe a lead body by passing the lead through the slit into the cavity or inner lumen of the suture sleeve.

[0006] Once the lead body is sheathed within the suture sleeve and properly positioned at the implant site, the suture sleeve is slid down the lead body to a point near the implant site and wrapped with a suture in the circumferential groove. The suture is pulled tight and tied to longitudinally secure the suture sleeve to the lead. The suture sleeve is then sutured to body tissue. Securing a suture sleeve in this manner is important to provide permanent hemostasis and lead stabilization at the implant site.

[0007] However, because suture sleeves must be moved along the longitudinal axis of the lead body during the implantation procedure and are constructed of soft, pliable material, problems may occur. For example, because the inner lumen of a typical suture sleeve is generally cylindrical, friction due to contact between the inside of the suture sleeve and the body of the lead may cause the sleeve to stick to the lead and make it difficult or impossible to slide the sleeve along the longitudinal axis of the lead body. On other occasions, if the clinician pulls the suture too tight when securing the sleeve to the lead, the suture can cut through the soft material of the suture sleeve and the insulation surrounding the lead, thereby damaging the lead. When this happens, the lead must be replaced. Unfortunately, damage to the lead is often not detected until after the surgery is complete, thereby requiring additional surgery to correct the problem and ultimately increasing the total cost of the implantation procedure.

[0008] Thus, for these and other reasons, there is a need for a suture sleeve that eliminates the risk of cutting through the sleeve when initially securing the sleeve to a lead body.

[0009] According to one aspect of the invention, there is provided a suture sleeve that is adapted to attach to the lead body of an implantable medical device without the use of a suture. The sleeve comprises an elastic, tubular body including first and second ends. The tubular body of the suture sleeve defines an inner lumen. As used herein, the word lumen refers to the canal, duct or cavity defined by the tubular body of the suture sleeve. Also, as used herein, a “clinician” can be a physician, physician assistant (PA), nurse, medical technologist, or any other patient health care provider.

[0010] The first end is relatively rigid in comparison to the second end and further comprises at least one circumferential groove adapted to receive a suture. The circumference of the inner lumen at the first end is generally larger than a typical circumference of a lead body. This reduces contact friction between the inner lumen and the lead to allow a clinician to easily slide the sleeve along the longitudinal axis of the lead body. In one embodiment, the first end further comprises three circumferential grooves, each groove adapted to receive a suture.

[0011] The second end is movable between furled and unfurled positions. In the furled position, the circumference of the lumen at the second end adjacent the first end is about equal the first end lumen circumference. Therefore, the suture sleeve with the second end in the furled position does not impede the sliding of the sleeve along the longitudinal axis of a lead body. The circumference of the inner lumen at the second end distal the first end is generally smaller than a typical circumference of a lead body and comprises an elastic, tubular structure that when unfurled onto the lead body, secures the suture sleeve to the lead. Therefore, after the clinician properly positions the suture sleeve along the longitudinal axis of a lead body with the second end in the furled position, the second end is unfurled and the smaller circumference of the elastic second end grips the lead body to secure the suture sleeve at the appropriate location along the body of the lead. In this way, the suture sleeve self-attaches to the lead body without the use of a suture, which is the typical way of securing a suture sleeve to a lead.

[0012] In a further embodiment, first and second ends include a slit traversing the longitudinal axis of the sleeve, said slit adapted to receive a lead body passed there through and into the lumen. In a preferred embodiment, the first end comprises three circumferential grooves and a lumen circumference greater than the typical circumference of a lead body, and a second end lumen circumference less than the typical circumference of a lead body.

[0013] The various embodiments described above are provided by way of illustration only and should not be construed to limit the invention. Those skilled in the art will readily recognize various modifications and changes that may be made to the present invention without following the example embodiments and applications illustrated and described herein, and without departing from the true spirit and scope of the present invention, which is set forth in the following claims.

[0017] In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which are shown by way of illustration specific embodiments or examples. These embodiments may be combined, other embodiments may be utilized, and structural and logical changes may be made without departing from the spirit and scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents.

[0018] The present device is described with respect to a suture sleeve adapted to be initially secured to a lead of an implantable medical device without the use of sutures.

[0019] FIG. 1 is an orthogonal view, illustrating generally, among other things, one embodiment of a self-attaching suture sleeve 100 comprising an elastic, tubular body including first and second ends. In comparison to the second end 102, the first end 101 of the suture sleeve 100 comprises a relatively rigid tubular structure.

[0020] The first end 101 also comprises a least one circumferential groove 103 adapted to receive a suture. However, the primary purpose of the circumferential groove 103 in this embodiment is not to initially secure the sleeve 100 to the lead. It may be used, however, to secure the sleeve 100 to body tissue and, if necessary, assist in securing the sleeve 100 to the lead.

[0021] The circumference of the lumen 104 of the first end 101 is adapted to be larger than the circumference of the lumen of the second end 105 and further adapted to be greater than a circumference of a lead body. As further shown in FIG. 1, the circumference of the lumen 104 of the first end 101 is adapted to sheathe a lead in such a way that the sleeve 100 can be longitudinally slid over the lead body with reduced contact, and hence friction, with the lead body. The reduced contact area of the lumen 104 of the first end 101 prevents the sleeve 100 from sticking to the lead body and allows a clinician to easily position the sleeve 100 at the implant site by sliding the sleeve to the desired location.

[0022] The second end 102 is movable between furled 102a and unfurled 102b positions. In the furled position 102a, the circumference of the lumen 104a at the termination 110a of the first end 101 is about equal the circumference of the lumen 104 of the first end 101. In the furled position, the second end 102 does not hamper the sleeve's 100 ability to slide easily over the lead body. In the unfurled position 102b, the circumference of the lumen 105 of the second end 102 is generally less than a circumference of a lead body. Because the second end 102 comprises elastic material, it snugly grips a lead body and initially secures the suture sleeve 100 to the lead body when unfurled 102b. Thereafter, a clinician may secure the sleeve 100 to body tissue using circumferential groove 103 or other means.

[0023] FIG. 2 is an orthogonal view, illustrating generally, among other things, another embodiment of a self-attaching suture sleeve 100 comprising a slit 200 (exaggerated for illustrative purposes only) traversing a longitudinal axis of the sleeve 100, said slit adapted to receive a lead body passed there through and into first and second end lumens 104, 105. The elastic nature of the suture sleeve 100 biases the slit 200 to a closed position to sheathe and retain a lead body passed through the slit 200. With the slit 200 in the biased, closed position, the tubular body 100 along the slit line is essentially contiguous.

[0024] It is to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-described embodiments may be used in combination with each other. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including,” “includes” and “in which” are used as the plain-English equivalents of the respective terms “comprising,” “comprises” and “wherein.”