CA2134735C

CA2134735C - Introducer system having kink resistant splittable sheath

Info

Publication number: CA2134735C
Application number: CA002134735A
Authority: CA
Inventors: Raymond H. Schaerf
Original assignee: Medtronic Inc
Current assignee: Medtronic Inc
Priority date: 1993-11-04
Filing date: 1994-10-31
Publication date: 1999-02-02
Anticipated expiration: 2014-10-31
Also published as: US5409469A; JP2687098B2; JPH07178183A; EP0655257A2; CA2134735A1; AU7579694A; AU668321B2; EP0655257A3

Abstract

This invention relates to a flexible kink resistant introducer system for introducing an elongated object into the venous system and especially for introducing a cardiac pacemaker lead. The introducer system features a sheath having a kink resistant section allowing the sheath to be bent in that region and still allow a lead to be introduced therethrough. The kink resistant section comprises a series of bellows or pleats. The bellows or pleats may further be arranged to form a screw about a portion of the sheath to thereby permit the sheath to be screwed into body tissue.
The sheath preferably is constructed to readily tear in a longitudinal direction and thus permits the system to be removed from the venous system without having to withdraw the sheath over an end of the pacemaker lead.

Description

_ I-2203 213~73~

HAVING ~INR RE8I~TANT 8PLITTAB~E 8~EATH

FI~Tn OF THE INVENTION
This invention relates generally to an introducer system having a kink resistant sheath for the insertion of catheters and other instruments into the body and more particularly to an introducer system having a kink resistant splittable sheath used to introduce pacemaker leads into the venous system.

BACKGROUND OF THE lNV~'l'lON
Generally speaking, pacing systems include an implantable pulse generator, commonly known as a pacemaker, electrically connected to the heart by at least one transvenous endocardial lead. More specifically an endocardial lead provides an electrical pathway between the pacemaker, connected to the proximal end of the lead, and endocardial tissue, in contact with the distal end of the lead. Endocardial tissue refers to a specific layer of tissue in the interior of the heart's chambers. In such a manner electrical pulses emitted by the pacemaker travel through the endocardial lead and stimulate the heart.
Endocardial leads are often placed in contact with the endocardial tissue by passage through a venous access, such as the subclavian vein or one of its tributaries. In such a manner transvenous endocardial leads offer as an advantage that they may be placed into contact with the heart without requiring major thoracic surgery. Rather, transvenous endocardial leads may be introduced into a vein and maneuvered therefrom into contact with the heart.
A multi-step procedure is often used to introduce such leads within the venous system. Generally this procedure consists of inserting a hollow needle into a blood vessel, such as the subclavian vein. A wire guide is then passed through the needle into the interior portion of the vessel. The needle is then withdrawn and an introducer sheath and dilator assembly is then inserted over the wire guide into the vessel. The assembly is advanced into a 213~735 ~ 2203 -suitable position within the vessel, i.e. so that the distal end is well within the vessel but the proximal end is outside the patient. Next the dilator and wire guide are removed.
The introducer sheath is left in position and therefore offers direct access from outside the patient to the interior of the blood vessel. In such a fashion a lead can be passed into the vessel through the introducer sheath and ultimately be positioned within the heart. Finally the introducer ~heath is removed from the body. With respect to pacemaker leads, however, which typically have a relatively bulky connector pin assembly at the proximal end, the introducer sheath is removed from the body by being split apart. In such a manner the introducer sheath does not have to be removed over the relatively bulky connector pin assembly at the proximal end of the lead.
An introducer sheath therefore, through its hollow lumen, provides access to the interior of a vessel. A lead introduced into the blood vessel may then moved along the blood vessel until properly positioned within the heart.
To provide such access an introducer sheath must be flexible. Specifically, flexibility permits the introducer sheath to bend and form to a curve compatible with the blood vessel. In such a manner the introducer sheath end is substantially parallel to the blood vessel and a lead which is introduced therethrough is properly oriented along the vessel interior. If the sheath did not conform to the vessel shape, a lead introduced would abut against the vessel wall, possibly injuring the patient and damaging the lead. One problem which may occur, however, due to the flexibility required of the introducer sheath is that the mid-portion of the ~heath may form a kink.
Kinking within the introducer sheath may cause serious problems, especially with respect to pacemaker leads.
Generally a kink within an introducer sheath is not detected until a lead is attempted to be introduced therethrough. At that time the lead, and in particular the sensitive electrode at the distal end of the lead, strikes the kinked section and is blocked. Continual pushing on the lead may cause damage to the electrode as well as damage to the helical coil and ~ ~ 3~7~

lnsulatlve sheath of the lead body. Because such damage may not be readily apparent, implantatlon of a damaged lead may result, ln turn, creatlng the posslblllty of serious harm to the patlent.
A further problem exists ln pacemaker patlents who have had multlple leads implanted over tlme. Scar tlssue at the slte of lmplantation has been found to create difflcultles wlth past lead introductlon systems. Speclflcally the relatively tough scar tlssue hlnders the introductlon of a dilator and lntroducer sheath assembly. Many tlmes, only through use of larger lnclslons than are otherwlse deslrable ls such an assembly able to be lnserted.
SUMMARY OF THE INVENTION
It ls an ob~ect of the present lnventlon to provlde an lntroducer system havlng a sheath whlch ls reslstant to the formatlon of klnks.
It ls a further ob~ect of the lnventlon to provlde an lntroducer system havlng a klnk reslstant sheath for lntroduclng an elongated ob~ect lnto the venous system and especlally for lntroduclng a cardlac pacemaker lead.
It ls a further ob~ect of the lnventlon to provlde an lntroducer system havlng a klnk reslstant sheath whlch provldes lmproved lnsertion through scar tlssue.
These ob~ects are met by the present lnvention whlch provides an lntroducer system featuring a sheath having a klnk reslstant sectlon allowlng the sheath to be bent ln that reglon and stlll allow a lead to be lntroduced therethrough.

~ 4 7 ~ ~
3a The kink resistant section may comprise a series of bellows or pleats. The bellows or pleats may be further arranged to form a screw about a portion of the sheath to thereby permlt the sheath to be screwed into body tissue. The sheath preferably is constructed to readily spllt in a longltudinal direction and thus permlts the system to be removed from the venous system wlthout havlng to withdraw the sheath over an end of the pacemaker lead.
Accordlng to a broad aspect of the lnventlon there is provlded an lntroducer system for a catheter or lead, the lntroducer system comprlslng: a sheath havlng a flrst end and a second end, the sheath belng compatlble for lnsertlon wlthln a body, the flrst end conflgured to lnsert the sheath wlthln the body wlth the second end extendlng out of the body, the sheath havlng a central lumen conflgured to permlt lntroduc-tlon of at least one lead or catheter therethrough; a flexlble klnk reslstant sectlon located along the sheath; means for permlttlng removal of the sheath from the lead or catheter dlsposed therethrough wlthout requlrlng the sheath to be removed from an end of the lead or catheter dlsposed there-through; and a dllator dlsposed through the central lumen of the sheath, the dllator havlng a flrst end and a second end, the first end of the dllator being tapered.

.~ ~ 66742-491 _ I-2203 213~ 735 _ 4 BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing and other aspects of the present invention will be best appreciated with reference to the detailed description of the invention in conjunction with the accompanying drawings, wherein:
FIG. 1 depicts the venous positioning and placement of transvenous endocardial leads in a patient.
FIG. 2 depicts an appropriate entry site for implantation of a transvenous endocardial lead.
FIGS. 3 - 14 depict successive stages of introducing a transvenous endocardial lead into a vein.
FIG. 15 depicts an introducer sheath used in a body and having a kink.
FIG. 16 depicts a lead introducer system in accordance with one embodiment of the present invention.
FIG. 17 depicts an introducer sheath of the present invention used in a body and not having a kink.
FIG. 18 depicts an alternate embodiment of a lead introducer system of the present invention.
FIG. 19 is a detailed sectional view of a kink resistant section used in an introducer system of the present invention.
FIG. 20 is a detailed sectional view of an alternate embodiment of a kink resistant section used in an introducer system of the present invention.
FIG. 21 is a detailed sectional view of an alternate embodiment of a kink resistant section used in an introducer system of the present invention.
FIG. 22 is a detailed sectional view of an alternate embodiment of a kink resistant section used in an introducer system of the present invention.
FIG. 23 is a detailed sectional view of an alternate embodiment of a kink resistant section used in an introducer system of the present invention.
FIGS. 24 and 25 depict a detailed view of the distal end of an alternate embodiment of a lead introducer system featuring a sliding cap which may be incorporated with the present invention.

~_ 5 DET~TT~n DESCRIPTION OF THE PREFERRED EMBODIMEN~
It is to be understood, that the present invention is not limited to use only in introducing atrial or ventricular pacing leads, and may be employed in introducing many of various types of therapeutic or diagnostic device~
including transvenous leads in~n~e~ to be disposed at various places within patient 10, including, for example, leads int~n~e~ to be disposed within the patient's coronary sinus, as well as various other types of electrical leads, including nerve, muscle or defibrillation leads. It is to be further understood, moreover, the present invention may be employed in introducing many of various types of therapeùtic or diagnostic catheters and is not limited only to the introduction of electrical leads. For purposes of illustration only, however, the present invention is below described in the context of the introduction of endocardial pacing leads.
FIG. 1 depicts a typical arrangement of a pacing system implanted in a patient 10, the pacing system comprising a subcutaneously disposed pacemaker 12 and transvenous pacing leads 14 and 16. In FIG. 1, the distal end of pacing lead 14 is shown disposed generally in the atrial region of the patient's heart 18, while the distal end of pacing lead 16 is disposed generally in the ventricular region of heart 18.
The preferred prior art method of lead introduction compatible with an introducer system in accordance with the present invention will be described with reference to FIGS.

2 through 14.
Referring to FIG. 2, and in accordance with common practice in the medical arts, the entry site for a subclavian vein puncture is commonly chosen to be just below and slightly medial to the junction of the middle and inner third of the clavicle 20, at an area designated generally as 22 in FIG. 2. In FIG. 2, the patient's subclavian vein 24 and heart 18 are shown in phantom.
Turning to FIG. 3, the subclavian vein puncture is accomplished by the physician using a disposable syringe 26 having a thin-wall needle 28 detachably connected thereto.

~ I-2203 2134 735 ~_ 6 Aspiration is performed as the needle is advanced into the subclavian vein, to verify proper needle placement within vessel 24. Next, aspirating syringe 26 is disconnected from needle 28, which remains in vessel 24 as shown in FIG. 4.
Typically, the physician will place his or her finger over the needle to avoid air aspiration and excessive blee~ng.
The next step in the lead implantation proce~llre involves insertion of a conventional J-type guide wire 30 through needle 28, as illustrated in FIG. 5. Typically, guide wire 30 is equipped with a tip deflector 32 for facilitating insertion of wire 30 into the lumen of needle 28. As shown in FIG. 6, as wire 30 is fed through needle 28 in the direction of arrow 34, the distal end of wire 30 exits the tip of needle 28, and wire 30 regains its "J" shape within vessel 24. Once wire 30 has entered vessel 24, needle 28 is withdrawn in the direction of arrow 36 in FIG. 7, leaving wire 30 in place. Wire 30 is advanced along vessel 24 until its distal end is disposed generally in the area of the patient's superior vena cava, leaving approximately 15 to 20-cm of the proximal end of wire 30 exposed.
A small skin incision 38 is made at the guide wire entry site, parallel to clavicle 20, as shown in FIG. 8. In the next stage of the implantation procedure, an introducer sheath 40 with tapered vessel dilator 42, as an assembly, are threaded onto the proximal end of wire 30. Sheath 40 and dilator 42 are advanced in the direction of arrow 44, through the subclavian fascia and into subclavian vein 24, until a short length (e.g., 2 to 8-cm) of sheath 40 and vessel dilator 42 remain exposed, as shown in FIG. 9.
Next, as shown in FIGS. 10 and 11, vessel dilator 42 is withdrawn in the direction of arrow 46 and sheath 40 is introduced further within subclavian vein 24, leaving introducer sheath 40 and guide wire 30 in place with its distal end disposed within subclavian vein 24. Guide wire 30 may be removed at this point as well, although it may be left in place in case the lead needs to be repositioned or reinserted. As shown in FIG. 11, introducer sheath 40 must bend to conform to the shape of subclavian vein 24 to provide an unobstructed conduit for lead 14 to be introduced.

7 ~ S

Through such curvature, moreover, lead 14 may be lntroduced so as to be parallel to veln 24 and not abut and damage wall 25 of subclavlan veln 24.
In the flnal stages of the lead lmplantatlon procedure, lllustrated ln FIGS. 12 through 14, paclng lead 14 ls lnserted into the proxlmal end of lntroducer sheath 40 ln the dlrectlon of arrow 48, and advanced lnto the deslred posltlon wlthln patlent 10 through vessel 24. Lastly, lntroducer sheath 40 ls removed. Removal of lntroducer sheath 40 may be accompllshed in one of several known ways, dependlng upon the partlcular type of lntroducer sheath 40. For example, as dlsclosed ln U. S. Patent No. 4,306,562, sheath 40 may be longltudlnally spllt by pulllng tabs 50 and 52. Other sheaths are known whlch are severable by means of a speclal slltter devlce or the llke.
As shown in FIG. 1, pacemaker 12 may operate ln con~unctlon wlth two paclng leads. In that case, as wlth slngle-lead lmplants, lt may be necessary to keep gulde wlre 30 in place untll after the flrst lead has been lmplanted.
Thus, as prevlously noted with reference to FIGS. 10 and 11, guide wlre 30 may be left ln place when dllator 42 ls wlthdrawn. The flrst lead, lf lt ls sufflclently small, may be lntroduced lnto subclavlan veln 24 alongslde gulde wlre 30, and then the flrst lntroducer sheath ls removed leavlng gulde wlre 30 ln place. Then, a second lntroducer sheath and vessel dllator can be gulded along gulde wlre 30 ln the same manner as the flrst, before gulde wlre 30 ls flnally removed.

l 66742-491 7 ~ ~
7a As depicted ln FIG. 15 one problem assoclated wlth lead introductlon systems and partlcularly wlth the sheath used ln previous lead lntroductlon systems ls the formation of a klnk 54. As seen a klnk 54 ln sheath 56 prevents lead 14 from belng introduced therethrough. As mentioned such klnks may be undetected so that a lead inserted lnto the sheath is blocked, posslbly resultlng ln damage to the lead.
Turnlng now to FIG. 16, an lntroducer system 60 ln accordance wlth one embodlment of the present lnventlon ls lllustrated. Introducer system 60 comprlses an lntroducer sheath 61 ln whlch a vessel dllator 66 ls lnserted. A tapered end 68 of vessel dllator 66 facllltates the ~A 6 213~ 735 _ -introduction of sheath 60 into the subclavian vessel 24.
Thereafter, guide wire 30 and vessel dilator 66 are withdrawn from the patient and central lumen 65 within sheath 61 provides access to the vessel 24.
In the embodiment of Figure 16, sheath 61 includes means for permitting removal of sheath 61 from a lead disposed therethrough without requiring sheath 61 to be removed from an end of the lead. Specifically sheath 61 may be removed from a pacing lead by being longitudinally split apart along line 63. In particular, introducer sheath 61 is split apart by grasping tabs 62 and 64 as it is being withdrawn from the lead introduction site. In the preferred embodiment line 63 comprises a scoring within wall of sheath 63 as is well known in the art. Various other equivalent means may also be used to accomplish splitting sheath 61 along line 63, these include by providing a line of weakened wall, as shown in Vegoe et al United States Patent No.
5,180,372, as well as providing a sheath slitter or the like, as is commonly known in the art. In addition, the weakened section may consist of material having the physical property of molecular orientation whereby a tear in the material runs readily only in a longitudinal direction along the length of sheath 61, as is well known in the art.
As seen in Figure 16 kink resistant section 70 has a series of pleats 72. Pleats 72 permit kink resistant section 70 to bend more readily within a body 10 without the formation of kinks, as best seen in Figure 17. Sheath 61 is preferably made from a biocompatible plastic, such as polytetrafluoroethylene.
As seen sheath 60 has a proximal end having tabs 62, 64 213473~
~,. ..

-8a 66742-491 and a distal end, through which introducer 68 extends. Sheath 60 further has proximal span 35, intermediate span 36 (having kink resistant section 70) and distal span 37. Moreover, as seen proximal span 35 and distal span 37 have approximately equal lengths.
Figure 18 depicts an alternate embodiment of a lead introducer system of the present invention. As seen the introducer system 60 is substantially similar to that previously described with the exception that the kink ~ 2203 213~735 '~,.

resistant section 70 has a helical pleat 74. Helical pleat 74 forms a screw on the outer surface of sheath 61, thereby permitting sheath 61 to be screwed into tissue. As previously mentioned, on patients who have had multiple leads implanted scar tissue often covers the site of lead introduction and hampers implantation. Helical pleat 74 is believed to facilitate implantation by permitting sheath 61 to be screwed through scar tissue.
FIG. 19 is a detailed sectional view of kink resistant section 70 used in an introducer system of the present invention. As seen, pleats 72 extend throughout wall 73 of sheath 61.
An alternate embodiment of kink resistant section 70 used in an introducer system of the present invention is lS seen in FIG. 20. In this embodiment pleats 72 do not extend throughout wall 73 of sheath 61. As such the interior surface of sheath 61 is smooth along the kink resistant section 70. Such an embodiment is believed to facilitate passage of a lead therethrough.
FIG. 21 is a detailed sectional view of a still further alternate embodiment of a kink resistant section used in an introducer system of the present invention. This embodiment likewise features pleats 72 which do not extend throughout wall 73 of sheath 61. Pleats 72, however, are located within the inner wall of sheath 61. As such outer surface of sheath 61 is smooth along kink resistant section 70.
FIG. 22 is a detailed sectional view of an alternate embodiment of a kink resistant section used in an introducer system of the present invention in which pleats 72 are recessed within outer surface of sheath 61.
FIG. 23 is a detailed sectional view of an alternate embodiment of a kink resistant section used in an introducer system of the present invention in which kink resistant section 70 has a series of grooves 76. Further alternate embodiments may feature other ways of accomplishing a kink resistant section as are well known in the art, such as a series of bellows or a corrugated surface, for example.

213473~

_ In the preferred embodiment, the introducer system of the present invention is sterilized using ethylene oxide and packaged as a kit with a sterilized percutaneous needle 28, a guide wire 30, and a dilator 42 in a hermetically sealed plastic bag (not shown).
Figures 24 and 25 depict a still further alternate embodiment of the present invention. Specifically this embodiment features a device to inhibit blood flow through the sheath when a lead is not positioned within the lumen. As seen cap 78 is positioned within recess 80 so as to slide across the proximal end of sheath 61, and specifically between tabs 62 and 64, and cover the lumen within sheath 61 present when dilator 66 is withdrawn.
Further details concerning the construction of such a device may be seen in the Canadian application of Pohndorf entitled "Lead Introducer with Mechanical Opening Valve", serial No. 2,102,617.
Although the invention has been described in detail with particular reference to a preferred embodiment and alternate embodiments thereof, it will be understood variations and modifications can be effected within the scope of the following claims. Such modifications may include substituting elements or components which perform substantially the same function in substantially the same way to achieve substantially the same result for those described herein.

Claims

1. An introducer system for a catheter or lead, the introducer system comprising:
a sheath having a first end and a second end, the sheath being compatible for insertion within a body, the first end configured to insert the sheath within the body with the second end extending out of the body, the sheath having a central lumen configured to permit introduction of at least one lead or catheter therethrough;
a flexible kink resistant section located along the sheath;
means for permitting removal of the sheath from the lead or catheter disposed therethrough without requiring the sheath to be removed from an end of the lead or catheter disposed therethrough; and a dilator disposed through the central lumen of the sheath, the dilator having a first end and a second end, the first end of the dilator being tapered.

2. The introducer system of claim 1 wherein the means for permitting removal of the sheath comprises means for splitting the sheath away from the lead or catheter disposed therethrough.

3. The introducer system of claim 2 wherein the means for splitting the sheath comprises a first tab on a first side of the second end of the sheath, and a second tab on a second side of the second end of the sheath whereby, when the tabs are pulled apart, the sheath tears longitudinally separating the sheath from the lead or catheter disposed therethrough.

4. The introducer system of claim 2 wherein the means for splitting the sheath comprises a weakened section extending longitudinally from the first end to the second end of the sheath.

5. The introducer system of claim 4 wherein the weakened section comprises a score line.

6. The introducer system of claim 4 wherein the weakened section comprises a section of material having the physical property of molecular orientation whereby a tear in the material runs readily only in a longitudinal direction along the length of the sheath.

7. The introducer system of claim 1 wherein the flexible kink resistant section is smooth on its outer surface permitting the sheath to be slid through tissue of the body.

8. The introducer system of claim 1 wherein the flexible kink resistant section comprises a helical pleat on the outer surface of the sheath, the helical pleat permitting a portion of the sheath to be screwed through tissue of the body.

9. The introducer system of claim 1 further comprising the flexible kink resistant section being continuously smooth on its inner surface.

10. The introducer system of claim 1 further comprising the flexible kink resistant section comprising at least two pleats on the inner surface to increase the flexibility of the section.

11. The introducer system of claim 1 further comprising the flexible kink resistant section comprising at least two pleats on the outer surface to increase the flexibility of the section.

12. The introducer system of claim 1 further comprising the flexible kink resistant section comprising at least two pleats on the outer surface and further comprising at least two pleats on the inner surface.

13. The introducer system of claim 1 wherein the flexible kink resistant section comprises a series of bellows.

14. The introducer system of claim 1 in which the sheath is made from a biocompatible plastic material.

15. The introducer system of claim 14 in which the biocompatible plastic material is polytetrafluoroethylene.

16. The introducer system of claim 1 in which the first end of the sheath is tapered so as to define a tapered end portion, the sheath having an inner surface and an outer surface and having a substantially uniform thickness from the inner surface to the outer surface except at the tapered end portion and the flexible kink resistant section.