Abstract:
A vascular introducer is disclosed which includes an elongated primary sheath defining an interior lumen and having opposed proximal and distal end portions, and at least an elongated secondary sheath disposed within the interior lumen of the primary sheath and adapted for movement from a collapsed condition to an open condition in response to insertion of a dilator through an interior lumen thereof.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The subject invention relates to a vascular introducer, and more particularly, to an introducer having multiple sheaths to facilitate sequential placement of multiple diagnostic or therapeutic surgical devices into a blood vessel. 
     2. Background of the Related Art 
     Devices for assisting the percutaneous introduction of diagnostic or therapeutic devices into the body are well known in the art. A particularly useful prior art vascular introducer is disclosed in U.S. Pat. No. 4,687,469 to Osypka. This device, which is designed to facilitate the percutaneous introduction of pacemaker electrodes and cardiovascular catheters, includes a thin-walled sheath configured to be slit open with a cutting blade for easy withdrawal. 
     During a surgical procedure, such as the implantation of a pacemaker electrode or defibrillation lead, it is often necessary to introduce more than one diagnostic or therapeutic device into the body. For example, it is may be necessary to introduce two or more pacemaker electrodes and a cardiovascular catheter during the same procedure. In such an instance, when using either of the prior art vascular introducers described hereinabove, after the introducer sheath has been pealed-away or slit open and withdrawn from the puncture site, a second introducer must be percutaneously advanced into the desired area to facilitate the introduction of a second medial device. This can cause undue trauma to the blood vessel. 
     It would be beneficial therefore, to provide a vascular introducer configured to facilitate the placement of more than one diagnostic or therapeutic device into the body during a surgical procedure. 
     SUMMARY OF THE INVENTION 
     The subject invention is directed to a vascular introducer that is adapted and configured to facilitate percutaneous placement of several diagnostic or therapeutic surgical devices into a blood vessel during a surgical procedure, including, for example, a pacemaker lead and a cardiovascular catheter, or two or more pacemaker leads. The introducer includes an elongated primary sheath defining an interior lumen and having opposed proximal and distal end portions, and at least an elongated secondary sheath disposed within the interior lumen of the primary sheath. The secondary sheath is adapted for movement from a collapsed condition, wherein the sheath assumes a generally arcuate or concave configuration, to an open condition in response to insertion of a dilator through an interior lumen thereof. 
     The introducer may further comprise an elongated tertiary sheath that can be disposed within the interior lumen of the primary sheath or within the interior lumen of the secondary sheath. Those skilled in the art will readily appreciate that the introducer of the subject invention can be provided with more than three sheaths, as the wall thickness of each sheath is relatively thin. It is envisioned that the interior lumen of each sheath can have a different (i.e., smaller and larger) or similar diameter so as to accommodate different or similar surgical devices. 
     In a preferred embodiment of the subject invention, the vascular introducer includes an elongated primary sheath defining an interior lumen and having opposed proximal and distal end portions, at least an elongated secondary sheath disposed within the interior lumen of the primary sheath and adapted for movement from a collapsed condition to an open condition, and an elongated dilator configured for reception within the interior lumen of the primary sheath and adapted for insertion through the interior lumen of the secondary sheath to effectuate movement of the secondary sheath from the collapsed condition to the open condition. 
     Preferably, the dilator has an elongated lumen extending therethrough for receiving an elongated guidewire and a luer-lock adapter may be provided at a proximal end of the dialator. Preferably, a T-shaped griping structure is operatively associated with the proximal end portion of the primary sheath, and the primary sheath includes diametrically opposed elongated score lines, or a similar frangible structure associated therewith, to facilitate separation of the primary sheath from the secondary sheath, and withdrawal of the primary sheath from the surgical site. 
     The subject invention is also directed to a method of implanting surgical devices through the surface of the skin. The method includes the initial step of providing a vascular introducer including an elongated primary sheath defining an interior lumen, an elongated secondary sheath disposed within the interior lumen of the primary sheath in a collapsed condition, and an elongated dilator disposed within the interior lumen of the primary sheath, where the lumen of the secondary sheath can have, in an expanded condition, a larger diameter than the lumen of the primary sheath. The method further includes the step of advancing the vascular introducer through the surface of, the skin to a desired position within a blood vessel, removing the dilator from the interior lumen of the primary sheath and introducing a first surgical device to the desired position within the blood vessel through the interior lumen of the primary sheath. The method further includes the step of separating the primary sheath from the secondary sheath, advancing the dilator through the interior lumen of the secondary sheath to move the secondary sheath into an open condition, and introducing a second surgical device to the desired position within the blood vessel through the interior lumen of the secondary sheath. 
     The method further comprises the steps of percutaneously inserting a cannulated needle into the desired area within the blood vessel, verifying the position of the needle under fluoroscopy and by observing fluid return, inserting a guidewire through the needle and into a desired area within the blood vessel and withdrawing the needle from the desired area. The method also includes the steps of threading the dilator over the guidewire to advance the vascular introducer to the desired area within the blood vessel, and then separating or displacing the primary sheath from the secondary sheath. 
     These and other unique features of the vascular introducer of the subject invention and the method of utilizing the same will become more readily apparent from the following description of the drawings taken in conjunction with the detailed of the preferred embodiments. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     So that those having ordinary skill in the art to which the subject invention appertains will more readily understand how to construct and use the vascular introducer of the subject invention, reference may be had to the drawings wherein: 
     FIG. 1 is a perspective view of a multi-sheath vascular introducer constructed in accordance with a preferred embodiment of the subject invention; 
     FIG. 2 is a cross-sectional view taken along line  2 — 2  of FIG. 1 illustrating the inner sheath of the introducer in a collapsed condition within the outer sheath of the introducer wherein the inner sheath assumes a generally arcuate configuration; 
     FIG. 3 is a perspective view of the vascular introducer of FIG. 1 with the outer sheath partially peeled away to reveal the inner sheath in a collapsed condition; 
     FIG. 4 is a perspective view of the proximal portion of the inner sheath in a collapsed arcuate condition; 
     FIG. 5 is a perspective view of the proximal portion of the inner sheath illustrating the manner by which the inner sheath of the vascular introducer is moved to an open tubular condition from a collapsed arcuate configuration by introducing a dilator into the lumen thereof; 
     FIG. 6 is a perspective view of the dilator extending through the lumen of the inner sheath of the vascular introducer of FIG. 1; 
     FIG. 7 is a cross-sectional view taken along line  7 — 7  of FIG. 6 illustrating the diametrically opposed score lines of the inner sheath for facilitating the separation of the sheath; 
     FIG. 8 is a perspective view of the proximal end portion of another multi-lumen vascular introducer constructed in accordance with a preferred embodiment of the subject invention which includes first and second nested inner sheaths of different diameter disposed within an outer sheath; 
     FIG. 9 is an enlarged perspective view of a portion of the proximal end of the vascular introducer of FIG. 8 illustrating the nested inner sheaths thereof in a collapsed condition; 
     FIG. 10 is a cross-sectional view taken along line  10 — 10  of FIG. 8 illustrating the relationship of the nested inner sheaths within the outer sheath; 
     FIG. 11 is a perspective view of the proximal end portion of another multi-sheath vascular introducer constructed in accordance with a preferred embodiment of the subject invention which includes first and second overlaid inner sheaths of different diameter disposed within an outer sheath; 
     FIG. 12 is a cross-sectional view taken along line  12 — 12  of FIG. 11 illustrating the relationship of the overlaid inner sheaths within the outer sheath; 
     FIG. 13 is a perspective view of the proximal end portion of another multi-sheath vascular introducer constructed in accordance with a preferred embodiment of the subject invention which includes first and second inner sheaths of similar diameter in diametrically opposed orientation within an outer sheath; 
     FIG. 14 is a cross-sectional view taken along line  14 - 14  of FIG. 13 illustrating the relationship of the diametrically opposed inner sheaths within the outer sheath; 
     FIG. 15 is an end view of another multi-sheath introducer constructed in accordance with a preferred embodiment of the subject invention which includes a frangible layer of material connecting adjacent edges of the outer sheath; and 
     FIG. 16 is an end view of another multi-sheath introducer constructed in accordance with a preferred embodiment of the subject invention wherein adjacent edges of the outer sheath are secured to one another by a frangible weldment. 
    
    
     These and other features of the introducer assembly of the subject invention will become more readily apparent to those having ordinary skill in the art form the following detailed description of the preferred embodiments. 
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     In the description which follows the term “proximal” refers to the end of the vascular introducer which is farthest from the surgical site, while the term “Idistal” refers to the end of the device which is nearest to the surgical site. In addition, the phrase “outer sheath” is used interchangeably with the term “primary sheath,” the phrases “secondary sheath” and “tertiary sheath” are used interchangeably with the terms “first inner sheath” and “second inner sheath,” respectively. 
     Referring now to the drawings wherein like reference numerals identify similar structural elements of the subject invention, there is illustrated in FIG. 1 a multi-sheath vascular introducer constructed in accordance with a preferred embodiment of the subject invention and designated generally by reference numeral  10 . 
     Vascular introducer  10  includes an elongated tubular body  12  defining opposed proximal and distal end portions  14  and  16 . A T-shaped handle assembly  18  is operatively associated with the proximal end  14  of body  12  and the distal end  16  of body  12  is tapered to facilitate percutaneous introduction of the device. As best seen in FIG. 2, the body  12  of vascular introducer  10  is includes an outer (primary) tubular sheath  12   a  and an inner (secondary) sheath  12   b.  The inner sheath  12   b  is disposed in a collapsed condition within the outer sheath  12   a.  In the collapsed condition, the inner sheath  12   b  assumes an arcuate or concave configuration. The wall thickness “t” of the outer sheath,  12   a  and the inner sheath  12   b  are substantially similar. 
     In accordance with the subject invention, the outer sheath  12   a  is configured for introduction of a first surgical device into a blood vessel, such as, for example a pacemaker lead, and the second sheath  12   b  is configured for the subsequent introduction of a second surgical instrument into the same blood vessel, such as, for example, a cardiovascular catheter or a second pacemaker lead. 
     Those skilled in the art will readily appreciate that the inner diameter of the lumen of the outer sheath  12   a  may be different than the inner diameter of the lumen of the inner sheath  12   b.  This will accommodate surgical instruments of different outer diameter. Thus, the inner diameter of the lumen of outer sheath  12   a  may be equal to, greater than or less than the inner diameter of the lumen of inner sheath  12   b.  It should be appreciated that when the inner sheath  12   b  is in the collapsed state, it does not interfere with the introduction of the first surgical instrument through the lumen of the outer sheath  12   a.  However, it should also be recognized that the effective inner diameter of the outer sheath  12   a  is limited by the doubled wall thickness of the collapsed inner sheath  12   b  disposed within the lumen of outer sheath  12   a  as shown by radius D e . 
     Referring now to FIG. 3, the outer sheath  12   a  of the vascular introducer  10  is configured to be peeled away and separated from the inner sheath  12   b  in a conventional manner, by providing, for example, diametrically opposed scorelines along the length of the outer sheath. This concepts is well known in the art, as illustrated for example in U.S. Pat. No. 4,512,351 to Pohndorf, and is effectuated by grasping the opposed portions of the T-shaped gripping handle  18  and pulling them apart from one another in the direction indicated by the arrows along the entire length of the body  12 . Alternatively, the outer sheath  12   a  may be cut away from the inner sheath  12   b  using a tool such as that which is described in U.S. Pat. No. 4,687,469. Once the outer (primary) sheath  12   a  has been peeled away, the inner (secondary) sheath  12   b  is revealed in a collapsed position, as illustrated in FIG.  4 . 
     Subsequently, as shown in FIG. 5, a dilator  20  having an outer diameter that is approximately equal to the inner diameter of the interior lumen of the inner sheath  12   b  (see FIG. 7) is inserted into the interior lumen of the inner sheath  12   b.  Then, as illustrated in FIG. 6, the dilator  20  (or a dilator sized to correspond to the lumen of the inner sheath) is extended through the interior lumen of the inner sheath  12   b  to open the lumen. Dilator  20  is then removed from the sheath to permit the introduction of the second surgical instrument therethrough. Dilator  20  is of conventional configuration and generally includes a tapered distal end portion  22  for ease of introduction and a central lumen  24  for receiving a guidewire therethrough, which will be discussed in greater detail hereinbelow. 
     Referring now to FIG. 8, there is disclosed another vascular introducer constructed in accordance with a preferred embodiment of the subject invention and designated generally by reference numeral  100 . Vascular introducer  100  includes an elongated tubular body  112  having opposed proximal and distal end portions, the proximal end portion  114  having a T-shaped handle assembly  118  associated therewith. As best seen in FIGS. 9 and 10, tubular body  112  includes an outer (primary) sheath  112   a,  a first inner (secondary) sheath  112   b  disposed within the outer sheath  112   a  in a collapsed condition, and a second inner (tertiary) sheath  112   c  nested within the interior lumen of the first inner sheath  112   b.  In this embodiment, the effective inner diameter of the outer sheath  112   a  is limited by the combined wall thickness (4t) of the collapsed nested inner sheaths  112   b  and  112   c  as shown by radius D e . 
     The inner diameter of the lumen of each of the sheaths  112   a,    112   b  and  112   c  may be equal to one another, or they may vary from one to the other depending upon the intended use of the introducer. For example, the inner diameter of the lumen of the first interior sheath  112   b  may be greater than the inner diameter of the lumen of the outer sheath  112   a,  while the inner diameter of the second inner sheath  112   c  may be less than the inner diameter of the lumen of the first inner sheath  112   b.  It is envisioned that the order in which the sheaths are disposed relative to one another can be set in accordance with the order in which surgical instrumentation is introduced into a blood vessel during a particular surgical procedure. Thus, in accordance with the subject invention, there would be an introducer with a particular sheath arrangement which would correspond to, a given surgical procedure. For example, in pediatric surgical procedures where the blood vessels of the patient are relatively small, it would be beneficial to begin the procedure with an introducer having an outer sheath that is relatively small in diameter, and then sequentially increase the size of the subsequent sheaths so as to prevent undue trauma to the blood vessel. 
     In operation, as in the case of vascular introducer  10 , after the outer sheath  112   a  has been used for the introduction of a first surgical device, it may be peeled away and separated from the two inner sheaths  112   b  and  112   c  in a manner similar to that shown in FIG. 3, by pulling apart the opposed portions of the T-shaped handle  118  so that the outer sheath  112   a  separates along its length into two parts. Then, the first inner sheath  112   b  may be opened by extending a dilator therethrough, which would be subsequently removed to facilitate the introduction of a second surgical device therethrough. When the first inner sheath  112   b  is no longer needed, it may be displaced from the second inner sheath  112   c  by peeling it into two parts along weakened score lines, or by slitting it along its length using a cutting tool such as that which is disclosed in U.S. Pat. No. 4,687,469 to Osypka, the disclosure of which is herein incorporated by reference in its entirety. 
     Referring now to FIG. 11, there is disclosed another vascular introducer constructed in accordance with a preferred embodiment of the subject invention and designated generally by reference numeral  200 . Vascular introducer  200  includes an elongated body  212  having opposed proximal and distal end portions, the proximal end portion  214  having a T-shaped handle assembly  218  associated therewith. As best seen in FIG. 12, tubular body  212  includes an outer (primary) sheath  212   a,  a first inner (secondary) sheath  212   b  disposed within the outer sheath  212   a  in a collapsed condition, and a second inner (tertiary) sheath  212   c  overlaying the first inner sheath  212   b  in a collapsed condition. In this embodiment, the effective inner diameter of the outer sheath  212   a  is limited by the combined wall thickness (4t) of the collapsed overlying inner sheaths  212   b  and  212   c  disposed within the lumen of outer sheath  212   a  as shown by radius D e . As in the previous embodiment, the inner diameter of the lumen of each of the sheaths  212   a,    212   b  and  212   c  may be equal to one another, or they may vary from one to the other depending upon the intended use of the introducer. 
     In use, as in the previous embodiments, after an instrument has been introduced through the outer sheath  212   a  of vascular introducer  200 , the outer sheath may be peeled away and separated from the two overlaid inner sheaths  212   b  and  212   c  by pulling apart the opposed portions of the T-shaped handle  218  so that the outer sheath  212   a  separates along its length into two parts. Then, the first inner sheath  212   b  may be opened by extending a dilator therethrough, which would be subsequently removed to facilitate the introduction of a second surgical instrument therethrough. When the first inner sheath  212   b  is no longer needed, it may be removed by peeling it into two parts along weakened score lines, or by slitting it along its length using a cutting tool. Thereafter, the second inner sheath  212   c  may be opened by extending a dilator therethrough, which would be subsequently removed to facilitate the introduction of a third surgical instrument therethrough. 
     Although the embodiments of the multi-lumen vascular introducer illustrated in FIGS. 8 and 11 include only two collapsed inner sheaths, it is envisioned and well within the scope of the subject disclosure that the vascular introducer could include more than two overlayed or nested inner sheaths. The more inner sheaths there are however, the greater will be the combined wall thickness of the inner sheaths and thus, the smaller will be the effective inner diameter of the lumen of the outer sheath. 
     Referring now to FIG. 13, there is disclosed another vascular introducer constructed in accordance with a preferred embodiment of the subject invention and designated generally by reference numeral  300 . Vascular introducer  300  includes an elongated body  312  having opposed proximal and distal end portions, the proximal end portion  314  having a T-shaped handle assembly  318  associated therewith. As best seen in FIG. 14, tubular body  312  includes an outer sheath  312   a,  a first inner sheath  312   b  disposed within the outer sheath  312   a  in a collapsed condition, and a second inner sheath  312   c  diametrically opposed to the first inner sheath  312   b  in a collapsed condition. 
     In this embodiment although there are two collapsed inner sheaths  312   b  and  312   c  within outer sheath  312   a,  the effective inner diameter of the outer sheath  312   a  is greater than the effective inner diameter of the outer sheaths of the embodiments of FIGS. 8 and 11, as shown by the radius D e  in each embodiment. This is because the wall thickness (2t) of the two collapsed inner sheaths  312   b  and  312   c  provide an individual effect on the interior lumen of the outer sheath rather than a combined effect, as they are neither overlaid or nested as in the previous embodiments. It is envisioned that more than two interior sheaths may be arranged in the manner illustrated in FIG.  14 . For example, there may be two overlaid inner sheaths on either side of the horizontal axis of the outer sheath. Thus, the vascular introducer could provide access to as many as five different devices during a surgical procedure. As in the previous embodiments of the invention, the inner diameter of the lumen of each of the sheaths of the vascular introducer can differ from one another to accommodate different types of devices. 
     Referring now to FIGS. 15 and 16, there are illustrated, in cross-section, the body portions of two other embodiments of the vascular introducer of the subject invention, designated respectively by reference numerals  412  and  512 . Body portion  412  includes an outer sheath  412   a  and an inner sheath  412   b  disposed in a collapsed state. The outer sheath  412   a  of body portion  412  is slit along its length and includes a thin film of frangible material  415 , such as Teflon® which connects the opposed edges of the outer sheath  412   a.  In use, to displace the outer sheath  412   a  from the inner sheath  412   b,  the thin film of frangible material  415  is severed, either manually or with a cutting tool, and the outer sheath  412   a  is removed to reveal the inner sheath  412   b.  Similarly, the body portion  512  includes an outer sheath  512   a  and an inner sheath  512   b  disposed in a collapsed condition. The outer sheath  512   a  of body portion  512  is also slit along its length and the edges are attached to one another by a weldment  515  which may be severed with little effort to displace the outer sheath  512   a  from the inner sheath  512   b  during a surgical procedure. 
     The subject invention is also directed to a method of implanting surgical devices through the surface of the skin. The method includes the initial step of providing a vascular introducer, such as for example, the vascular introducer  10  of FIG. 1, which includes a tubular body  12  having an elongated primary (outer) sheath  12   a  defining an interior lumen, an elongated secondary (inner) sheath  12   b  disposed within the interior lumen of the primary outer sheath in a collapsed condition, and an elongated dilator  20  disposed within the interior lumen of the primary sheath  12   a.  The method further includes the step of advancing the vascular introducer  10  through the surface of the skin to a desired position within a blood vessel, removing the dilator  20  from the interior lumen of the primary sheath  12   a  and introducing a first surgical device (not shown) to the desired position within the blood vessel through the interior lumen of the primary sheath  12   a.    
     The method further includes the step of separating the primary sheath  12   a  from the secondary sheath  12   b,  as shown for example in FIG. 3, advancing the dilator  20  through the interior lumen of the secondary sheath  12   b  to move the secondary sheath  12   b  into an open condition, as shown for example in FIGS. 5 and 6, and introducing a second surgical device (not shown) to the desired position within the blood vessel, through the interior lumen of the secondary sheath  12   b  after the dilator has been removed therefrom. 
     The method also includes the steps of percutaneously inserting a cannulated needle into the desired area within the blood vessel, verifying the position of the needle under fluoroscopy and by observing fluid return, inserting a guidewire through the bore of the needle and into the desired area within the blood vessel, and then withdrawing the needle from the desired area. The method further includes the step of threading the dilator  20  over the guidewire by passing it through the central bore  24  to advance the vascular introducer  10  to the desired area within the blood vessel. 
     Although the disclosed apparatus has been described with respect to preferred embodiments, it is apparent that modifications and changes can be made thereto without departing from the spirit and scope of the invention as defined by the appended claims.