Abstract:
A vessel harvesting apparatus including a shaft and a tip formed as a unit with, and positioned at a distal end of, the shaft. A handle is connected to a proximal end of the shaft for allowing an operator to feed and manipulate the tip. The tip defines a vessel receiving aperture extending longitudinally through the tip and being laterally offset from and generally parallel to a longitudinal axis of the shaft. The tip has a smooth, contoured outer surface narrowing toward the distal end thereof wherein the tip may be passed along and surrounding a vessel without substantial disruption of surrounding tissue. Transecting and ligating of the vessel positioned in the aperture and side branch vessels against the outer surface of the tip by dissection and/or cauterization is provided. The tip releases the vessel from surrounding tissue while being moved therealong wherein the transected portion of the vessel is more easily removed from surrounding tissue.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     Not applicable  
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
       [0002]     Not applicable  
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC  
       [0003]     Not applicable  
       BACKGROUND OF THE INVENTION  
       [0004]     1. Field of the Invention  
         [0005]     This invention relates generally to apparatus and methods for harvesting of blood vessels and more particularly to an apparatus for separating and removing the saphenous vessel of the leg for use in bypass surgery with minimal tissue trauma.  
         [0006]     2. Description of Related Art  
         [0007]     Healthy blood vessels are typically harvested to repair damaged vessels in other more critical parts of a human circulatory system. In particular, the saphenous vein is harvested from a patient&#39;s leg and utilized in bypass surgery where damaged and blocked arteries of the heart region of the patient are bypassed with the healthy blood vessel harvested.  
         [0008]     Typically, the surgeon will harvest an appropriate length of the leg vessel requiring that the vessel be safely separated from side branch vessels and leg tissue, followed by an appropriate dissection of the end of the harvested vessel. In early surgery of this type, incisions were made along the length of the saphenous vessel to be harvested which was then dissected from the surrounding tissue. More modern surgical techniques have been developed and are utilizing a broad variety of vessel harvesting instruments and apparatus which greatly reduce the trauma to the patient. The following U.S. Patents appear to represent at least a substantial portion of this more modern vessel harvesting technology.  
         [0009]     U.S. Pat. No. 6,660,016 to Lindsay discloses an endoscopic apparatus for harvesting blood vessels including an endoscopic barrel with a plurality of lumens, a handle disposed at a proximal end of the barrel and at lest one member for dissecting and cauterizing a blood vessel. An invention related to devices and methods for removing veins is taught by Spitz in U.S. Pat. No. 6,352,544.  
         [0010]     David, et al., in U.S. Pat. No. 6,241,740 teaches a system and medical device for endoscopically ligating and cutting a body vessel, the improvements including a hinged jaw, an improved delivery system of a ligating clip and a rotating cutting instrument. A surgical instrument comprising an elongated hollow shaft having a longitudinal axis, a lumen, and an optical penetrating tip having a cylindrical portion attached to the distal end of the hollow shaft is taught by Kolata, et al. in U.S. Pat. No. 6,206,823.  
         [0011]     U.S. Pat. No. 6,193,653 to Evans, et al. discloses methods and devices for harvesting vessels comprising a shaft having a handle mounted on one end and a dissecting tip on the other end. A light source is further optionally included and methods for transilluminating a vessel, dissecting the vessel, transecting the vessel and removing the vessel from the body are disclosed.  
         [0012]     A method and apparatus for the minimally invasive harvesting of veins is taught by Ginn, et al. in U.S. Pat. No. 6,022,313 and devices and methods for minimally invasive harvesting of a vessel are shown in U.S. Pat. No. 5,913,866. U.S. Pat. No. 6,019,771 to Bennett, et al. teaches similar devices and methods as Ginn, et al. and we note that these three patents have been assigned to Cardiothoracic Systems, Inc.  
         [0013]     U.S. Published Application US2005/0070940 to Genovesi, et al. teaches a method and device for harvesting vessels comprising a cannula-like device including means for identification, capture, manipulation, hemostasis and cleavage of branch vessels. That published application is a continuation application of U.S. Pat. No. 6,818,003 directed to a method and device for harvesting vessels. The harvesting cannula is configured as an elongated, hollow tube and comprised of three sections: a harvesting head, a tubular control segment and a sliding operation arm.  
         [0014]     Another published application to Hess, et al., US 2003/0065348 and U.S. Pat. No. 6,656,176, disclose endoscopic vessel harvesting devices and methods. The method comprises locating the vessel, inserting the device through an incision, dissecting the vessel from the surrounding tissue and capturing vessels. The device comprises a headpiece having electrodes for ligation, a shaft having a lumen, and a vessel capturing means.  
         [0015]     Other published applications and issued patents are known to applicant as follows: 
        U.S. Pat. No. 6,527,786 to Davis, et al.     U.S. Pat. No. 6,679,892 to Guido, et al.     U.S. Pat. No. 6,464,708 to Higuma, et al.     U.S. Pat. No. 6,464,685 to Suzuki, et al.     U.S. Pat. No. 5,695,514 to Chin     U.S. Pat. No. 5,569,291 to Pirvitera, et al.     U.S. Pat. No. 6,004,335 to Vaitekunas, et al.     U.S. Pat. No. 6,375,635 to Moutafis, et al.     U.S. Pat. No. 6,214,028 to Yoon, et al.     U.S. Pat. No. 6,149,659 to Ahmed     U.S. Pat. No. 6,143,005 to Yoon, et al.     U.S. Pat. No. 6,099,535 to Lamport, et al.     U.S. Pat. No. 6,074,402 to Peifer, et al.     U.S. Pat. No. 6,007,551 to Peifer, et al.     U.S. Pat. No. 6,730,101 to Peifer, et al.     U.S. Pat. No. 6,565,578 to Peifer, et al.     U.S. Pat. No. 6,685,713 to Ahmed     U.S. Pat. No. 6,610,072 to Christy, et al.     U.S. Pat. No. 6,632,228 to Fortier, et al.     U.S. Pat. No. 6,607,542 to Wild     U.S. Publ. US2004/0122458 to Opie, et al.     U.S. Publ. US2005/0004586 to Suval     U.S. Publ. US2004/0204725 to Bayer     U.S. Pubi. US2005/0096677 to Wellman, et al.        
 
       BRIEF SUMMARY OF THE INVENTION  
       [0040]     This invention is directed to a vessel harvesting apparatus including a shaft and a tip preferably formed as a unit with, and positioned at a distal end of, the shaft. A handle is connected to a proximal end of the shaft for allowing an operator to feed and manipulate the tip. The tip defines a vessel receiving aperture extending longitudinally through the tip and being laterally offset from and generally parallel to a longitudinal axis of the shaft. The tip has a smooth, contoured outer surface narrowing toward the distal end thereof wherein the tip may be passed along and surrounding a vessel without substantial disruption of surrounding tissue. Transecting and ligating of the vessel positioned in the aperture and side branch vessels against the outer surface of the tip by dissection and/or cauterization is provided. The tip releases the vessel from surrounding tissue while being moved therealong wherein the transected portion of the vessel is more easily removed from surrounding tissue.  
         [0041]     It is therefore an object of this invention to provide an improved vessel harvesting apparatus which effectively releases and removes a vessel segment to be harvested from human tissue with minimal trauma to the patient.  
         [0042]     Still another object of this invention is to provide for an array of vessel transecting and ligating structures for the efficient dissection of side branch vessels and for the transecting of the harvested vessel from the remaining vessel and surrounding tissue.  
         [0043]     Yet another object of this invention is to provide an apparatus for harvesting vessels for use in subsequent surgical repair of a patient&#39;s circulatory system which involves a single pass along the harvested vessel and which incorporates all of the necessary functions for vessel removal.  
         [0044]     And still another object of this invention is to provide an apparatus for vessel harvesting which minimizes trauma to adjacent tissue and typically requires only a single pass to prepare the vessel for harvesting.  
         [0045]     In accordance with these and other objects which will become apparent hereinafter, the instant invention will now be described with reference to the accompanying drawings. 
     
    
     BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)  
       [0046]      FIG. 1  is a side elevation view of one embodiment of the invention in relation to a harvested vessel and a side branch vessel in phantom.  
         [0047]      FIG. 2  is an end elevation view showing the tip of  FIG. 1 .  
         [0048]      FIG. 3  is an enlarged side elevation broken view of the tip portion of  FIG. 1 .  
         [0049]      FIG. 4  is a top plan view of  FIG. 3 .  
         [0050]      FIG. 5  is a bottom plan view of  FIG. 3 .  
         [0051]      FIG. 6  is an end view of one embodiment of a segmented openable tip.  
         [0052]      FIG. 7  is a side elevation view of  FIG. 6 .  
         [0053]      FIG. 8  is an end elevation view of another embodiment of a segmented openable tip.  
         [0054]      FIG. 9  is a side elevation view of still another embodiment of the invention.  
         [0055]      FIG. 10  is an end elevation view of the tip of  FIG. 9 .  
         [0056]      FIG. 11  is an enlarged side elevation view of the tip of  FIG. 9 .  
         [0057]      FIG. 12  is an end elevation view of yet another embodiment of the tip showing a vessel transecting loop in the closed position in phantom.  
         [0058]      FIG. 13  is a side elevation view of  FIG. 12 .  
         [0059]      FIG. 14  is an end elevation view of yet another embodiment of the tip.  
         [0060]      FIG. 15  is a side elevation view of  FIG. 14  showing the vessel and the side branch vessel in phantom.  
         [0061]      FIG. 16  is an enlarged side elevation broken view of yet another embodiment of the tip and also showing the harvested vessel and the side branch vessel in phantom.  
         [0062]      FIG. 17  is a side elevation view of still another embodiment of the invention showing the addition of elongated branch vessel support rods, one of which is shown inserted into a vessel shown in phantom. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0063]     Referring now to the drawings, and firstly to FIGS.  1  to  5 , one embodiment of the invention is there shown generally at numeral  10  in  FIG. 1 . This vessel harvesting apparatus  10  includes a vessel harvesting device  12  formed as a unit including an elongated slender shaft  14 , a laterally extending handle  16  connected and molded as a unit to the proximal end of shaft  14  and a generally barrel-shaped or enlarged and smoothly tapering tip  24 .  
         [0064]     The elongated shaft  14  may be solid or hollow in cross section and of sufficient stiffness and rigidity to allow the tip  24  to be manipulated and moved along within the patient&#39;s body tissue in order to harvest a blood vessel for use in other surgery such as bypass surgery.  
         [0065]     The tip  24  may be characterized in shape and configuration as that of a barrel or having of a tapering smooth bullet-shaped outer surface which is enlarged in lateral dimension and over a relatively short length of the shaft  14  as best seen in  FIGS. 3, 4  and  5  with respect to the shaft  14 . A typical transverse size ratio between the tip  24  and the shaft  14  is in the range of about 2-3:1. This enlarged lateral configuration of the tip  24  serves to enhance vessel separation from adjacent tissue as described more fully herebelow. The smooth gradual transition between the larger tip  24  and the shaft  14  also reduces the drag of the narrower shaft  14  and the force necessary to move the tip  24  along and around the harvested vessel C.  
         [0066]     An elongated cylindrical aperture  26  is formed longitudinally through the tip  24  about an axis  28  which is generally parallel to the length of the shaft  14  and laterally offset therefrom as distance Z as best seen in  FIGS. 1 and 3  which is preferably 1-2 times the thickness of the shaft. The aperture  26  is sized so as to be slidably moved over and along the vessel C shown in  FIG. 1  to be harvested. A range of diameters or transverse sizes of the aperture  26  may be provided and made available for the surgeon to select from at the time of surgery depending upon the transverse size of the harvested vessel C. Note the smooth contoured outer surface of the tip  24  broadly blending from the shaft  14  and uniformly terminating at radius  34 .  
         [0067]     In well-known fashion, the vessel harvesting procedure will typically begin with the forming of an incision at the distal aspect of the vessel, including transecting the to-be-harvested vessel. Thereafter, the tip  24  is guided over the to-be-harvested vessel C in  FIG. 1  by manipulation thereof by handle  16 . The vessel harvesting proceeds by generally axial movement of the device  12  in the direction of the arrow with respect to the harvested vessel C. The shape of the tip  24  is ideal for the gentle release of the vessel C from adjacent tissue without excessive trauma to that support tissue.  
         [0068]     Two spaced apart bi-polar cauterizing members or rings  30  and  32  are molded as a unit into the tip  24  having an exposed outer surface thereof in smooth uninterrupted continuity with respect to the outer surface of the tip  24 . Conductive wires  20  and  22  extend through the shaft  14  and handle  16  to connector  18  which exteriorly connects to a suitable electric power source +/− V. This voltage source is sufficient to implement a bi-polar cautery environment between the cautery bands  30  and  32  at  38   a  and  38   b . These cautery rings  30  and  32  extend circumferentially around virtually the entire tip  24  such that, as seen in  FIG. 1 , when a side branch vessel P or R of the vessel to be harvested C is encountered by the tip  24 , the surgeon will then apply an appropriate voltage producing sufficient cauterizing heat in the regions  38   a  and  38   b  to cauterize, transect and ligate the side branch vessels P and R at regions O and S, respectively in one operation.  
         [0069]     Referring briefly to  FIG. 5 , the longitudinal aperture  26  is blended at the proximal end thereof at  26   a  in bullet-shaped fashion to accommodate the tapered proximal surface  24   b  of tip  24 . In similar fashion, the distal end of the aperture  26  is blended to accommodate an inclined distal end  24   a , both features of which decrease the force necessary to separate the harvested vessel from surrounding tissue and thus reduce the overall trauma associated with this portion of a typical vessel harvesting surgical procedure.  
         [0070]     Referring now to  FIGS. 6, 7  and  8 , an alternate embodiment of the tip is there shown at  24   c  at the distal end of shaft  14   a . This tip  24   c  includes openable tip segments  44  and  46  which are hingedly connected along longitudinal hinges  40  and  42  such that the tip segments  44  and  46  are openable in the direction of arrow A to be inserted around the harvested vessel without the initial requirement of dissecting the vessel first. These tip segments  44  and  46  meet at  48  such that the aperture  24   b  remains substantially cylindrical to avoid damaging or excessive rubbing of the vessel to be harvested.  
         [0071]     In  FIG. 8 , the lower tip segment  54  is formed of a single piece pivotally connected along a single longitudinal hinge  52 , the lower tip segment  54  being openable in the direction of arrow B and closeable around the vessel at  56  so as to maintain the interior smoothness and uninterrupted nature of the longitudinal aperture  26   c.    
         [0072]     Referring now to  FIGS. 9, 10  and  11 , another embodiment of the vessel harvesting apparatus is there shown generally at numeral  60  and includes the molded harvesting device  62  formed to include an elongated shaft  64 , a molded handle  66  and a molded tip  80 . In this embodiment  62 , the handle  66  is made rotatably adjustable with respect to the tip  80  by a releasable rotating joint  74  such that, as seen in phantom, the handle  66  may be oriented at any desired different radial angle with respect to the tip  80  as desired during the surgical procedure.  
         [0073]     A variety of lumens or internal passageways  76  and  78  are provided within the shaft  64  which, again may be tubular in nature or molded to have a substantially filled cross section. These lumens  76  and  78  extend beyond the distal end of the shaft  64  and terminate, for example, at  82 ,  84  and  86  strategically located with respect to the configuration of the tip  80  and the longitudinal aperture  88 . The lumens  76  and  78  accommodate and position ancillary surgical accessories such as an endoscope attached at the proximal end of the shaft  64  to a camera  70 , or to camera tips located at  82  and  84  with appropriate wires  76  and  78 , or to a gas source of CO 2  or O 2  insufflations. Thus, as desired, the function of additional lighting, an optical endoscope function, and/or the addition of selected gas at the current exact point of release of the harvested vessel from adjacent tissue may also be provided. These ancillary functions may be supported by a small battery  72  housed within the handle  66  which may be hollowed for that purpose.  
         [0074]     Referring now to  FIGS. 12 and 13 , another embodiment of the shaft  100  and tip  102  is there shown. In this embodiment of the tip  102 , the function of transecting and ligating the harvested vessel is there shown. A looped ligation suture  108  and a metal transecting wire snare  110  are nested in side-by-side relationship within an annular groove  112  formed into the cylindrical surface of the longitudinal aperture  114 . After the tip  102  has been moved along the harvested vessel shown in phantom at C a distance sufficient to produce a desired vessel length to be harvested, the loop of suture  108  is pulled taught by the suture extension  104  which extends outwardly from the handle (not shown). The suture may then be clipped by a heat cutting blade  116  or other suitable suture cutting mechanism. Thereafter, the extension of the metal wire snare  110  is pulled in the direction of arrow E which extends again through the handle (not shown) of this embodiment  100  thus reducing the diameter of the wire snare  110  into an approximate configuration shown in phantom in  FIG. 12  at  110   a  which moves upwardly in the direction of arrow G. At any size in this size range shown in phantom in  FIG. 12 , the metal wire snare  110   a  is sufficiently small to have transected the vessel C and suture  108  leaving the tightened suture knot  108  in place around the transected end of the vessel remaining within the tissue.  
         [0075]     In  FIGS. 14 and 15 , one method of disconnecting side branch vessels at L from the harvested vessel K shown in phantom is provided. This branch vessel truncation is accomplished by the exposure in the direction of arrow J of a circular or ring-shaped knife  124  which, when stored, is positioned within a continuous groove  128  formed into the distal end of the longitudinal aperture  125 . When the knife ring  124  is extended longitudinally as shown in phantom in the direction of arrow J by pushing on a control wire H, the proximal end of which is extended from the handle (not shown), the cutting edge  126  is exposed. By slight rotational movement of the knife edge  126  by handle movement, transection of the side branch vessel L is accomplished at cut line M.  
         [0076]     Referring now to  FIG. 16 , alternate embodiments for (a) the cauterizer of the harvested vessel K, (b) cutting transection and (c) heat cauterization of the side branch vessel L are there shown. The tip  122   a  includes the previously described knife ring  124   a  which is slightly enlarged in diameter and snugly fits within the mating circular-spiral cavity  128   a  such that the cutting edge  126   a  is fully within the distal end surface of the tip  122   a  when not in use. When a side branch vessel L is encountered, the knife ring  124   a  is extended such that the cutting edge  126   a  is pressed against and will transect the side branch vessel A at cut line M′. Note that the diameter of the knife ring  124   a  is enlarged so that a larger vessel stump remains attached to the harvested vessel K to facilitate suture closure thereof after the vessel K is removed.  
         [0077]     Cauterization, which accomplishes both transection and ligation in one operation, is provided in this tip embodiment  122   a  with respect to both the harvested vessel K and any side branch vessel shown typically at L. There are two pairs of cauterization rings, the outer cauterizing rings  31  and  33  and the inner cauterization rings  30  and  32   a . The outer cauterizing rings  31  and  33  are spaced apart a distance at  132  which is uniform around the entire circumference or periphery of the tip  122   a  so that the heat factor for cauterization is thereby uniform in all directions and positions on the outer surface of the tip  122   a . Thus, when the side branch vessel L lays across and between the outer cauterizing rings  131  and  133 , cauterization, transection and ligation in the region  132  are accomplished. To cauterize and transect the vessel K, the inner cauterizing rings  130  and  132   a  may be selectively energized by electric power (not shown) so that cauterization of the vessel K occurs at  133  around the entire circumference of the vessel K.  
         [0078]     Lastly in  FIG. 17 , an alternate embodiment of the entire device is shown at  12   a  and includes a molded handle  16   a  which is rotatably positionable with respect to the tip  24   a  on shaft portion  12   a . An elongated tubular splicing member  138  is tightly but forcibly movably positioned within the tubular portions of each of the shaft sections  14   a  and  14   b  such that the shaft sections  14   a  and  14   b  are also extendable in the direction of the arrows. A very thin sheath  142  covers the exposed portion of the splicing member  138  and the gap between the ends of the shaft  14   a  and  14   b  so as to minimize any tissue disruption as the shaft, led by the tip  24   a , passes through the tissue and along and around the periphery and side walls of the vessel to be harvested.  
         [0079]     To support harvested vessels which may be weakened or lack sufficient side wall integrity to undergo harvesting as above described, support rods  134 ,  138  and  140  are provided in different diameters and are selected depending upon the size of the vessel C to be harvested. The array of vessel support members shown at  136  would be available at the time of surgery and the particular diameter or transverse size of the vessel support member  134 ,  138  or  140  would be selected. It is anticipated that these diameters would be in the range of 2 mm to 10 mm in diameter.  
         [0080]     While the instant invention has been shown and described herein in what are conceived to be the most practical and preferred embodiments, it is recognized that departures may be made therefrom within the scope of the invention, which is therefore not to be limited to the details disclosed herein, but is to be afforded the full scope of the claims so as to embrace any and all equivalent apparatus and articles.