WO2003013365A1

WO2003013365A1 - Devices and methods for use in blood vessel harvesting

Info

Publication number: WO2003013365A1
Application number: PCT/US2002/025502
Authority: WO
Inventors: James E. Jervis
Original assignee: General Surgical Innovations Inc.
Priority date: 2001-08-10
Filing date: 2002-08-09
Publication date: 2003-02-20

Abstract

The present disclosure provides for tunneling devices, for use in dissecting and harvesting a blood vessel (50), having an elongate body with an open proximal end, a distal end, and a lumen extending therebetween, wherein the lumen has a longitudinal axis. The distal end of the device includes a double lobed (110,112) opening formed therein. The double lobed opening includes a first lobe lying substantially across the longitudinal axis and a second lobe adjacent to and offset from the first lobe. The first lobe is configured for receiving the main body of a blood vessel (50) and the second lobe is configured for receiving and isolating tributary branches (52) of the blood vessel. Methods for use of the tunneling device are also provided.

Description

Attorney Docket: 2763 (203-3170)

DEVICES AND METHODS FOR USE IN BLOOD VESSEL HARVESTING

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority of U.S. Provisional Patent Application Serial No. 60/311,335 filed August 10, 2001, the entire contents of which are incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to methods and devices for endoscopic surgery, particularly to methods and devices for harvesting blood vessels from the body, and more particularly, to devices and methods for separating a blood vessel from surrounding tissue.

2. Background

Numerous surgical procedures have been developed to replace or bypass arteries that have become blocked by disease. Aortocoronary bypass surgery is perhaps the most important of these surgical procedures. The coronary arteries supply blood to the heart. As a result of aging and disease, coronary arteries may become blocked by plaque deposits, stenosis, or cholesterol. In some instances, these blockages can be treated with artherectomy, angioplasty or stent placement, and coronary bypass surgery is not required. Coronary bypass surgery is required when these other methods of treatment cannot be used or have failed to clear the blocked artery. In coronary bypass surgery, a blood vessel is harvested from elsewhere in the body and grafted into place between the aorta and the coronary artery beyond the point of blockage.

The coronary bypass surgery requires a length of blood vessel or artery for the graft. It is preferred to use a blood vessel taken from the patient undergoing the bypass surgery. The patient is a ready source of suitable blood vessels that will not be rejected by the body after transplantation and grafting onto the aorta and coronary artery. The saphenous vein in the leg is the best substitute for small arteries such as the coronary arteries, and it is the preferred blood vessel for use in coronary bypass surgery. This is because the saphenous vein is typically 3 to 5 mm in diameter, i.e., about the same size as the coronary arteries. Also, the venous system of the legs is sufficiently redundant so that, after removal of the saphenous vein, other blood vessels that remain in the leg are adequate to provide return blood flow. The cephalic vein in the arm is an alternative that is sometimes used.

Previously an operation to harvest the saphenous vein required the surgeon to make an incision into the leg in order to gain access to the saphenous vein and then proceed to cut the vein from the leg. In order to expose the vein, the surgeon made a series of incisions generally from the groin to the knee or the ankle leaving one or more skin bridges along the line of the incisions. It was recommended that handling of the saphenous vein be kept to a minimum while the saphenous vein was removed from the surrounding connective tissue. After exposing the saphenous vein, the surgeon grasped the saphenous vein with his fingers while stripping off the surrounding tissues with dissecting scissors or other scraping instruments. The surgeon would use his fingers and/or blunt dissection tools to pull and lift (or mobilize) the vein from the surrounding tissue. The saphenous vein was mobilized or pulled as far as possible through each incision. To reach under the skin bridges, the surgeon lifted the skin with retractors and dug the saphenous vein free. While stripping the vein, the surgeon would encounter the various tributary blood vessels that feed into the saphenous vein. These tributaries needed to be ligated and divided. To divide and ligate the tributaries that lay under the skin bridges, the surgeon needed to cut one end of the saphenous vein and pull it under the skin bridge to gently pull the saphenous vein out from under the skin bridge until the tributary was sufficiently exposed so that it could be ligated and divided. In certain instances surgeons made one continuous incision from the groin to the knee and/or ankle. The surgeon proceeds to pull and lift the saphenous vein from the surrounding tissue and when the saphenous vein was completely mobilized, the surgeon cut the proximal and distal ends of the saphenous vein and removed it from the leg. After removal, the saphenous vein was prepared for implantation into the graft site, and the long incisions made in the leg are stitched closed.

The procedure described above can be used to harvest blood vessels for a femoral popliteal bypass, in which an occluded femoral artery is bypassed from above the occlusion to the popliteal artery above or below the knee. The procedure can also be used to harvest blood vessels for the revascularization of the superior mesenteric artery that supplies blood to the abdominal cavity and intestines. In this case, the harvested blood vessel is inserted between the distal end of the aorta and patent (unblocked) section of the mesenteric artery. For bypass grafts of the lower popliteal branches in the calf, the procedure can be used to harvest the umbilical blood vessel. The harvested blood vessel can also be used for a blood vessel loop in the arm (for dialysis) between the cephalic vein and brachial artery. The procedures may be used also to harvest blood vessels for femoral-tibial, femora-peroneal, aorto-femoral, and iliac-femoral bypass operations and any other bypass operation.

As can be seen from the description of the harvesting operation, the harvesting operation is very traumatic in its own right and the long incisions created in the leg can be slow to heal and very painful.

Endoscopic surgical techniques for operations such as gall bladder removal and hernia repair have become common. In an endoscopic surgical technique the surgeon performing such a technique makes a few small incisions in the patient and inserts long tools, including forceps, scissors, and staplers through the incision deep into the body. Viewing the tools through an endoscopic laparoscope, or a video display from the endoscope, the surgeon can perform all the cutting and suturing operations necessary for a wide variety of operations. The procedures are also referred to as laparoscopic surgery, minimally invasive surgery, or video-assisted surgery. References to endoscopic surgery and endoscopes below are intended to encompass all these fields, and all operations described below with reference to endoscopes, can also be accomplished with laparoscopes, gastroscopes, and any other imaging devices which may be conveniently used.

Minimally invasive procedures for blood vessel removal have been proposed in U.S. Pat. No. 5,373,840 to Knighton. Knighton discloses a method of cutting the saphenous vein at one end, grasping the one end of the blood vessel with graspers or forceps and sliding a ring over the saphenous vein while holding it. Knighton uses a dissecting tool with an annular cutting ring, and requires that the saphenous vein be overrun or progressively surrounded with the dissecting tool and the endoscope, so that after the endoscope has been inserted as far as it will go, the entire dissected portion of the saphenous vein has been pulled in the lumen of the endoscope. As shown in FIGS. 1 and 10 of Knighton, the method requires deployment of the forceps inside the annular dissection loop, and it requires deployment of the loop and graspers inside the endoscope lumen. The saphenous vein must be cut and grasped by the forceps before it can be dissected by the dissecting ring. Consequently, this method also results in a high degree of trauma to the patient.

Thus, it is an object of the present disclosure to provide methods and devices for harvesting blood vessels with a less traumatic operation than the operations presently used to harvest blood vessels.

SUMMARY

The present disclosure is directed to devices for dissecting and harvesting blood vessels from the body. The present disclosure is also directed to methods of using the devices of the present disclosure to perform the blood vessel dissection and harvesting. In accordance with one aspect of the present disclosure, a tunneling device for separating blood vessels from a patient's body includes an elongate body having an open proximal end, a distal end, and a lumen extending therebetween, wherein the lumen defines a longitudinal axis. The device further includes a double lobed opening formed in the distal end of the elongate body and communicating with the lumen. The double lobed opening formed in the distal end can include a first lobe and a second lobe interconnected by an intermediate portion. The first lobe is preferably centered substantially on the longitudinal axis of the elongate body, while the center of the second lobe is radially offset from the center of the first lobe. The intermediate portion is defined by a pair of opposing tabs. The device can be provided with a distal end which is substantially conical in shape. The conical distal end can have a sloping side surface tapering distally toward the longitudinal axis and can terminate in a substantially blunt distal surface. Preferably, the first lobe is at least partly formed in the blunt distal surface while the second lobe is formed in the sloping surface of the distal end or in the sloping side surface and in the elongate body. The first lobe is configured to receive a main body of the blood vessel while the second lobe is configured to receive a branch tributary of the blood vessel. In one embodiment, the elongate body is cylindrical in cross-section, however, the elongate body may have a cross-section of any shape that is suitable for advancement along a blood vessel and for creating a space within the patient's body around the blood vessel. Further, the first and second lobes can be elliptical or rectangular.

The lumen of the elongate body preferably has a diameter that is sized to accommodate at least one blood vessel therein. The lumen may also be sized and adapted as with sub lumen to accommodate instruments, such as, e.g., an endoscope, in addition to the blood vessel therein. The device is preferably manufactured from a plastic, rubber or other pliant material that is capable of conforming to the contours of the blood vessel.

The present disclosure also provides a method of harvesting a section of a blood vessel from a body using a tunneling device as disclosed herein. The tunneling device preferably including an elongate body having an open proximal end, a substantially conical distal end, a lumen extending therebetween, and a double lobed opening formed in the distal end. The double lobed opening can have a first lobe lying substantially across the longitudinal axis of the elongate body and a second lobe offset from the first lobe. The distal end of the device is inserted into the patient's body through a first incision. The device is then manipulated in order to position the blood vessel within the first lobe of the double lobed opening of the device such that the blood vessel is disposed along the longitudinal axis of the device. The tunneling device is advanced within the body toward a second incision. While it is advanced, the device is progressed substantially along the blood vessel such that the distal end of the device creates a space in the body tissue while also dissecting the blood vessel away from the body tissue.

Tributary branches of the blood vessel can be isolated within the second lobe of the double lobed opening «f the device. The branch can then be ligated and divided away from the blood vessel. Advancement of the device along the blood vessel and toward the second incision can be continued until the desired section of the blood vessel, which may be the entire length of the blood vessel, is completely separated and dissected away from the body tissue. Once the desired section of the blood vessel is dissected, the section is removed from the body. For example, a blood vessel harvesting tool may be provided and inserted into the space created by the advancement of the tunneling device within the body. The blood vessel harvesting tool can be used to facilitate ligating and cutting of the desired section of the blood vessel, after which the cut section of the blood vessel is removed from the body. Preferably, the distal and proximal ends of the section are cut and the section is removed by pulling through one of the incisions. The method also provides for inserting an endoscope into the lumen of the tunneling device and then viewing the advancement of the device via the endoscope. Other objects and features of the present disclosure will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with the general description given above, and the detailed description of the embodiments given below, serve to explain the principles of the present disclosure.

FIG. 1 is a side elevational view, with portions broken away, of an embodiment of a blood vessel harvesting device in accordance with the present disclosure; FIG. 2 is a distal end view of the device of FIG. 1;

FIG. 3 is a side elevational view of a portion of the device of FIG. 1 illustrating the use of the device to separate the saphenous vein and to isolate tributary branches from the saphenous vein; FIG. 4 is a side elevational view of the device of FIG. 1 illustrating the introduction of the device into the body to separate the saphenous vein;

FIG. 5 is a side elevational view of an additional embodiment of a blood vessel harvesting device in accordance with the present disclosure;

FIG. 6A is a partial side elevational view of a distal end of a blood vessel harvesting device having substantially elliptical openings formed therein; and

FIG. 6B is a partial side elevational view of a distal end of a blood vessel harvesting device having substantially rectangular openings. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed blood vessel harvesting device will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. In the drawings and in the description which follows, the term "proximal", as is traditional will refer to the end of the surgical device or instrument of the present disclosure which is closest to the operator, while the term "distal" will refer to the end of the device which is furthest from the operator.

The methods and devices presented herein take advantage of laparoscopic procedures to lessen the trauma of blood vessel harvesting operations. Instead of making an incision along or over the entire length, or essentially the entire length of the blood vessel to be harvested, the method according to the present disclosure may be conducted with only a few small incisions. All that is needed is a working space large enough to allow the surgeon to use the device of the present disclosure and view the operation through an appropriate viewing scope.

Referring now to FIGS. 1-4, a blood vessel harvesting device, in accordance with the principles of the present disclosure, is shown generally as reference numeral 100. Although device 100 offers significant advantages to blood vessel harvesting procedures from the leg of a patient, it will be understood that the device is applicable for use in any blood vessel harvesting procedure. Device 100 includes a body 101 having a proximal end 102, a distal end 104 and defines a lumen 106 having a central longitudinal axis therethrough. Device 100 is preferably elongate and tubular in shape and, more preferably cylindrical in cross-section. Alternatively, the cross-section of device 100 may be any shape that is suitable for advancement over a blood vessel and for creating a space around the blood vessel.

Device 100 is preferably of an adequate length to enable a surgeon to introduce device 100 into the body and advance it completely over the blood vessel, while having enough length left proximally outside the body to allow the surgeon to further manipulate device 100 and to introduce surgical instruments and the like into lumen 106 of device 100, if desired. Lumen 106 is of an adequate diameter to at least accommodate the blood vessel that is being dissected from the body. It is envisioned that lumen 106 can have a diameter and can include one or more other or sub-lumen sufficient to simultaneously accommodate both the blood vessel and the surgical instruments, such as, e.g., endoscopes, retractors, blood vessel harvestors, surgical clips, and the like, that may be required to dissect and cut the blood vessel from the body. The distal end 104 of the device 100 is preferably substantially conical in shape and terminates in a substantially blunt distal surface.

Distal end 104 includes a distal tip 114 defined by a sloping face 118 that tapers distally toward the central longitudinal axis of device 100. It is contemplated that the blunt, conical shape of distal end 104 facilitates the dissection of the blood vessel away from the body as a surgeon advances device 100 within the body. For example, distal tip 114, which, as previously discussed, is tapered distally toward the longitudinal axis of device 100, initially dissects the blood vessel away from the surrounding tissue. As device 100 is advanced, sloping face 118 of conical distal end 104 continues the separation of the surrounding tissue from the blood vessel.

As best seen in FIGS. 1-3, distal end 104 includes a double lobe-shaped opening 108 in communication with lumen 106 of device 100. In a preferred embodiment, opening 108 is elongate and includes a first lobe 110, a second lobe 112, and in a more preferred embodiment opening 108 includes an intermediate portion 116 interconnecting first and second lobes 110, 112, respectively. First lobe 110, second lobe 112, and preferably intermediate portion 116 together define the double lobe- shaped opening 108. Opening 108 is preferably a continuous opening with no sharp corners dividing first and second lobes 110, 112 or intermediate portion 116. Intermediate portion 116 preferably is defined by a pair of opposing tabs 115a and 115b. Preferably, intermediate portion 116 tapers or narrows down from, and is narrower than both of first and second lobes 110, 112. Consequently, double lobe- shaped opening 108 preferably resembles a figure eight having an open mid-section. First lobe 110 is configured and dimensioned to accept or encompass the main branch or vessel. Tabs 115a and 115b are configured and dimensioned and preferably extend convexly relative to the interior of opening 108, to guide a tributary branch of the blood vessel toward and generally isolate it in second lobe 112 as device 100 is distally advanced along the blood vessel. Second lobe 112 preferably is configured and dimensioned to accept, encompass or generally isolate the tributary branch(es) of the blood vessel. First lobe 110 preferably is centered substantially on or along and lies across the longitudinal axis of device 100 while second lobe 112 preferably is offset, preferably radially outwardly, from first lobe 110. In one preferred embodiment, first lobe 110 is a distally facing opening that is normal to the longitudinal axis of device 100. Further, in comparison to first lobe 110, second lobe 112 preferably lies relatively parallel to the longitudinal axis of device 100 and generally faces radially of the longitudinal axis and preferably also generally distally of the instrument. Second lobe 112 is at least partly, more preferably substantially, formed in sloping face 118 of the distal end 104, while first lobe 110 preferably is disposed in distal tip 114. Although second lobe 112 preferably is formed primarily in sloping face 118, it can also extend proximally into or be located entirely in aportion of elongate side wall 120 of device 100.

As seen in FIG. 5, in an alternative embodiment, double lobed opening 108a of device 100a has a second lobe 112a that lies substantially parallel to the longitudinal axis of device 100a, generally faces distally and radially or sideways and is generally disposed at an angle to first lobe 110. For example, second lobe 112a may lie at an angle of about 0° to about 90°, preferably about 45°, from first lobe 110.

Turning back to Figure 2, second lobe 112 is offset preferably radially, from first lobe 110 and, as a result, is configured to engage and isolate one or more tributary branches of the main body of the blood vessel while the main body of the blood vessel is still retained in first lobe 110. By isolating the branches, second lobe 112 facilitates the ligation and dividing of the branches away from the blood vessel, as is described in further detail herein.

As shown in Figure 2, first and second lobes 110, 112 are arcuate, preferably substantially circular in shape. As illustrated in FIG. 6A, in an alternative embodiment of the blood vessel harvesting device, here generally referred to as 100b, first and second lobes 110a, 112b of device 100b may be substantially elliptical in shape. Device 100b includes an elliptical double lobe-shaped opening 108b having an elliptical first lobe 110b, an elliptical second lobe 112b, and a narrowed intermediate portion 116b therebetween. Intermediate portion 116b is defined by a pair of opposing convex tabs 115a, 115b.

In other embodiments, the first and second lobes may be substantially square or rectangular in shape. Figure 6B illustrates a device 100c having a double lobe-shaped opening 108c having a rectangular first lobe 110c, a rectangular second lobe 112c and an intermediate portion 116c therebetween. Intermediate section 116b is defined by triangular tabs 115a, 115b. In addition to these embodiments, any other shaped double lobed opening 108 may be employed that is suitable for passing a main portion of a blood vessel through first lobe 110 while isolating a tributary branch of that vessel away from first lobe 110 using second lobe 112, as the device is progressed within the body.

The present disclosure also provides methods for using device 100 to dissect and harvest a blood vessel from the body. In a preferred method, the surgeon creates a working space under the skin and over the blood vessel that is desired to be harvested, such as, e.g., a saphenous vein 50, using known laparoscopic techniques. Referring additionally now to FIG. 4, using saphenous vein 50 as an example, the surgeon makes several small incisions, e.g., 60, 62, in a body "T" (i.e., a leg) to expose saphenous vein 50. These incisions are generally referred to as cut-downs. A distal incision, near the knee, and a proximal incision, near the groin, are preferred, although any suitable incision(s) may be made that will allow the device 100 to be introduced into body "T". For example, if the entire length of saphenous vein 50 is to be harvested, an additional incision can be made close to the ankle. When incisions are made at both the knee and close to the ankle, device 100 may be used to dissect saphenous vein 50 first in the thigh, and then in the calf, or vice versa. Saphenous vein 50 can be seen through the cut-downs. The use of three or four incisions to harvest the entire saphenous vein 50 is merely a matter of convenience. Those particularly skilled in laparoscopic procedures may require fewer incisions, and also more small incisions may be required.

As illustrated in Figure 4, after making the desired incisions, the surgeon inserts device 100 into body "T" at a first incision and advances device 100 over and along saphenous vein 50 towards a second incision. Preferably, the proximal end of saphenous vein 50 is cut and ligated in order to allow device 100 to initially advance over and along saphenous vein 50 toward the second incision, with saphenous vein 50 being disposed within lumen 106 of device 100 during the advancement. In the example shown in Figure 4, device 100 is inserted into a proximal incision 60 at the groin and is advanced along saphenous vein 50 towards a distal incision 62 at the knee. As the surgeon advances device 100, distal end 104 dissects saphenous vein 50 away from surrounding tissue 40, while also creating a channel or tunnel 30 running along saphenous vein 50. Specifically, distal tip 114, which as previously described is relatively blunt and tapered toward the longitudinal axis of device 100, initially dissects saphenous vein 50 from surrounding tissue 40. Then, as device 100 is continually advanced, sloping face 118 of conical distal end 104 further separates the surrounding tissue 40 from saphenous vein 50. As a result, tunnel 30 is created as device 100 is advanced distally within the body "T".

In one embodiment, tunnel 30 is injected or infused with carbon dioxide (CO₂) or other gas (or liquid) in a procedure known as insufflation, which pressurizes the tumiel 30 and keeps it open and expanded. As a result, insufflation facilitates viewing inside the tunnel 30 as well as the insertion and manipulation of an endoscope and other instruments into the tunnel 30. Insufflation is accomplished with techniques generally known to endoscopic and laparoscopic surgeons. One suitable technique is described in U.S. Patent No. 6,068,639 to Fogarty et al., the disclosure of which is fully incorporated herein by reference .

As device 100 is advanced within body "T", device 100 will typically come into contact with tributary branches 52 of saphenous vein 50. Saphenous vein 50 has a number of tributary blood vessels, referred to herein as branches 52, that carry venous blood into the saphenous vein 50. Branches 52 must be tied off and separated from saphenous vein 50 before saphenous vein 50 can be removed. In medical terms, branches 52 must be ligated and divided. Branches 52 are initially identified by the surgeon because the surgeon will feel the resistance of a branch 52 while advancing device 100 and will generally not be able to continue advancing device 100 along saphenous vein 50 until branch 52 is ligated and divided. When a branch 52 is encountered, the surgeon can use standard endoscopic and laparoscopic tools to close branch 52 and cut it from saphenous vein 50. Double lobed opening 108 of device 100 is particularly suited for the cutting of branches 52 away from saphenous vein 50. When device 100 comes into contact with a branch 52, device 100 is maneuvered so that the main portion of saphenous vein 50 remains within first lobe 110 that preferably lies on the longitudinal axis of device 100. The positioning of first lobe 110 on distal tip 114 and normal to the longitudinal axis of device 100, enables the surgeon to retain the main portion of saphenous vein 50 within first lobe 110. Device 100 is then manipulated so that branch 52 is isolated by, and retained in, the offset second lobe 112. This may be accomplished, for example, by rotating and otherwise manipulating device 100 until branch 52 is within offset second lobe 112. The position of the second lobe 112, i.e., preferably on sloping face 118 of distal end 104 and generally parallel to the longitudinal axis relative to first lobe 110, allows the surgeon to isolate and retain branch 52 in second lobe 112.

Since branch 52 is retained within second lobe 112, the surgeon is able to clearly visualize branch 52 in order to ligate and divide branch 52 without causing trauma to the main body of saphenous vein 50. Preferably, the surgeon ligates and divides each branch 52 that is brought within second lobe 112 along a length thereof. The surgeon may also ligate and divide branch 52 after it abuts the proximal wall of second lobe 112. In one embodiment, the surgeon passes a suitable surgical mstrument outside of device 100, but within tunnel 30 created by the advancement of device 100, and places the instrument into contact with branch 52. As previously discussed, branch 52 has been isolated away from saphenous vein 50 by offset second lobe 112 of device 100 and is therefore easily identified and reached by the surgeon.

With branch 52 isolated, prior to cutting branch 52, the surgeon will place a pair of surgical clips 54 on a portion of branch 52 near saphenous vein 52 in order to ligate branch 52. Then, using the surgical instrument, between the pair of clips 54, the surgeon will transect branch 52 from saphenous vein 50. Suitable surgical instruments to cut or divide branch 52 include dissectors, retractors, or other sharp instruments capable of cutting tissue and capable of being advanced within tunnel 30 created by device 100. Once a branch 52 is divided from saphenous vein 50, the surgeon may continue advancing device 100 along saphenous vein 50 until the next branch 52 is isolated and the procedure is repeated.

It is contemplated that a vessel cutting and ligating device, as described in commonly assigned International Patent Application No. PCT/US02/20450, filed June 26, 2002, entitled "Conduit Harvesting Instrument and Method" to Bayer, et al., claiming priority of U.S. Provisional Patent Application No. 60/301,059 filed June 26, 2001, the entire contents of which are hereby incorporated by reference, can be used in conjunction with any of the vessel harvesting devices disclosed herein. As disclosed therein, the cutting and ligating device may utilize electrosurgical energy to cut/ligate various branches from the main blood vessel.

Once the surgeon has dissected away the desired length of saphenous vein 50 by advancing device 100, the surgeon removes saphenous vein 50 from the surrounding connective tissue by placing a suitable instrument, such as, e.g., a blood vessel harvesting tool, into tunnel 30 created by device 100. The surgeon then advances the harvesting tool into contact with saphenous vein 50 and uses the tool to separate saphenous vein 50 from the surrounding tissue. Suitable blood vessel harvesting tools, and related methods of use, are disclosed in previously mentioned U.S. Patent No. 6,068,639 to Fogarty et al.

After the desired length, which in some cases may be the entire length, of saphenous vein 50 has been dissected, the surgeon ligates and cuts the distal end of the desired length or section using a suitable instrument. The surgeon then grasps the cut section of saphenous vein 50 with laparoscopic grippers. The surgeon then pulls the separated section of saphenous vein 50 from the leg through a suitable incision, such as, e.g., groin incision 60, knee incision 62, or the ankle incision (not shown).

In the method described above, device 100 is used for dissection or tunneling in a visually obstructed field. When used in the leg, the advancement of device 100 can be observed by watching the skin rise as device 100 tunnels and advances under the skin. Because the location of saphenous vein 50 is well known and its exact course through the leg can be readily determined, the surgeon can be sure that device 100 is following the intended path along saphenous vein 50. In some cases, however, the surgeon may wish to observe the advancement of device 100 endoscopically or the surgeon may wish to observe various structures as device 100 passes those structures. In these instances, device 100 is constructed with a sufficient diameter to allow passage of an endoscope or other viewing instrument through lumen 106 thereof.

Devices 100, 100a are preferably manufactured from plastic, rubber, or other material that is sufficiently pliant to enable a surgeon to thread device 100 around, and pull device 100 along, a blood vessel without injuring or causing trauma to the vessel. Devices 100-100c of the present invention are suitable for use in other procedures besides dissection for blood vessel harvesting, although its description in that environment is intended to be illustrative of the device. For example, device 100 can be used in any procedure for dissection, separating or retracting body tissue. Device 100 is also capable of being used to dissect nerves from connective tissue in substantially the same manner as previously described with respect to the dissection of a blood vessel. Devices 100- 100c may be made in varying sizes and lengths, so that they can be used to create passageways for laparoscopic surgery. After the passage is created, whether by devices 100- 100c or other means, devices 100- 100c may be used to hold passageways open to allow laparoscopic instruments to be used in front of distal end 104 of device 100. These instruments may be inserted through lumen 106 of device 100 or through one or more separate sub-lumen of lumen 106, or they may be inserted through other access ports, so that device 100 is only used to hold body tissue out of the way of these instruments as the instruments are used. Additionally, device 100 may be used to hold an endoscope or laparoscope in a fixed and stable position within the body, so that the video display that the surgeon watches remains stable. Device 100-100c and methods described above have been developed in the field of blood vessel harvesting and vascular surgery. It is, however, readily apparent that the devices 100- 100c and methods may be used for dissecting and mobilizing other elongate vessels or organs of the body. Various arteries, veins, and blood vessels must be dissected and mobilized for other operations, such as popliteal bypass, or a dialysis vein loop. In these operations, a blood vessel must be harvested, and the sites at which the blood vessel will be attached or anastomosed to must also be uncovered.

The methods described herein may be applied to harvesting blood vessels, veins, or arteries other than saphenous veins, and may be employed for harvesting blood vessels for transplant into any area of the body. Where appropriate, devices 100- 100c and methods may be used during open surgery to facilitate the removal of blood vessels, veins, or arteries, in which case the working space is provided by the normal open surgery techniques.

While the preferred embodiments of the devices and methods have been described herein, they are merely illustrative of the principles of the invention. Other embodiments and configurations may be devised without departing from the spirit of the inventions and the scope of the appended claims.

Claims

WHAT IS CLAIMED:

1. A tunneling device for separating blood vessels from a patient's body, comprising: an elongate body having an open proximal end, a distal end and a lumen extending therebetween, the lumen having a longitudinal axis; and a double lobed opening formed in the distal end of the elongate body and communicating with the lumen.

2. The device of claim 1, wherein the distal end is substantially conical in shape.

3. The device of claim 1, wherein the double lobed opening comprises a first lobe and a second lobe.

4. The device of claim 3, wherein the double lobed opening also comprises an intermediate portion between the first lobe and the second lobe.

5. The device of claim 3, wherein the first lobe is centered substantially on the longitudinal axis of the elongate body.

6. The device of claim 3, wherein a center of the second lobe is offset from the center of the first lobe.

7. The device of claim 3, wherein a center of the second lobe is radially outwardly offset from the center of the first lobe.

8. The device of claim 4, wherein the intermediate portion is defined by a pair of opposing tabs.

9. The device of claim 1, wherein the double lobed opening comprises a first lobe that is centered substantially on and is orthogonal to the longitudinal axis of the elongate body, a second lobe having a center which is offset from the longitudinal axis of the elongate body and an interconnecting intermediate portion defined by a pair of opposing tabs.

10. The device of claim 9, wherein the distal end is conical, has a sloping side surface tapering distally toward the longitudinal axis and terminates in a substantially blunt distal surface.

11. The device of claim 10, wherein the first lobe is at least partly formed in the blunt distal surface.

12. The device of claim 11, wherein the second lobe is formed in the sloping surface of the distal end.

13. The device of claim 11 , wherein the second lobe is formed in the sloping surface and in the elongate body.

14. The device of claim 1, wherein the lumen has a diameter sized to accommodate at least a blood vessel therein.

15. The device of claim 14, wherein the elongate body also has a lumen that has a diameter sized to accommodate an endoscope therein.

16. The device of claim 1 , wherein the elongate body is manufactured from a material chosen from the group consisting of plastic and rubber.

17. A method of dissecting a section of a blood vessel from a patient's body using a tunneling device, the method comprising the steps of: providing a tunneling device having an elongate body having an open proximal end, a substantially conical distal end and a lumen extending therebetween, the lumen having a longitudinal axis, and a double lobed opening formed in the distal end, the double lobed opening having a first lobe that lies substantially across the longitudinal axis and a second lobe that is offset from the first lobe; inserting the distal end of the device into a first incision in the body; positioning the blood vessel within the first lobe of the double lobed opening such that the blood vessel is disposed along the longitudinal axis; advancing the tunneling device within the patient's body, along the blood vessel, toward a second incision such that the distal end creates a space in body tissue around the blood vessel and simultaneously dissects the blood vessel from the body tissue as the tunneling device is advanced; isolating a branch of the blood vessel within the second lobe; ligating the branch; dividing the branch from the blood vessel; and repeating the advancing, isolating, ligating and dividing steps until the section of the blood vessel is completely dissected from the body tissue.

18. The method of claim 17, further comprising the step of: removing the dissected section of the blood vessel from the body.

19. The method of claim 17, further comprising the steps of: providing a blood vessel harvesting tool; inserting the blood vessel harvesting tool into the space surrounding the blood vessel created by the advancement of the tunneling device; ligating a section of the blood vessel; cutting the ligated section of the blood vessel; and removing the dissected section of the blood vessel from the body.

20. The method of claim 17, further comprising the steps of: inserting an endoscope into the lumen of the tunneling device; and viewing the advancement of the device via the endoscope.

21. A tunneling device for separating blood vessels from a patient's body, comprising: an elongate body having an open proximal end, a conical distal end, and a lumen extending therebetween, wherein the conical distal end includes a blunt distal tip, and a double lobed opening formed in the distal end and communicating with the lumen, the double lobed opening having a first lobe formed in the blunt distal tip of the distal end and a second lobe adjacent and offset from the first lobe.

22. The device of claim 21 , wherein the second lobe is proximally and radially offset from the first lobe.

23. The device of claim 21 , wherein the first lobe is configured and dimensioned to receive a main body of a blood vessel and the second lobe is configured and dimensioned to receive a branch tributary of the blood vessel.

24. The device of claim 21, wherein the elongate body is cylindrical in cross-section.

25. A tunneling device for separating blood vessels from a patient's body, comprising: an elongate body having an open proximal end, a distal end, and a lumen therebetween, the lumen defining a longitudinal axis; a conical tip formed at the distal end of the elongate body; and a double lobed opening formed in the distal end and communicating with the lumen, the double lobed opening having a first arcuate lobe lying substantially across the longitudinal axis, a second arcuate lobe adjacent and offset from the first lobe, and an intermediate portion interconnecting the first and second lobes.

26. The device of claim 25 , wherein the intermediate portion is narrower than the first lobe.

27. The device of claim 25, wherein the intermediate portion is narrower than each of the first and second lobes.

28. The device of claim 22, wherein the conical tip comprises a sloping face tapering distally toward the longitudinal axis and terminating in a blunt end, wherein the first lobe is formed in the blunt end and is normal to the longitudinal axis, and wherein the second lobe is substantially formed in the sloping face.

29. The device of claim 28, wherein the second lobe lies substantially parallel to the longitudinal axis and orthogonal to the first lobe.

30. The device of claim 25, wherein at least one of the first and second lobes is arcuate.

31. The device of claim 25 , wherein the first and second lobes are elliptical.

32. The device of claim 25, wherein the first and second lobes are rectangular.

33. A tunneling device for separating blood vessels from a patient's body, comprising: an elongate body having an open proximal end, a distal end and a lumen extending therebetween, the lumen having a longitudinal axis; a conical distal tip formed on the distal end, the conical distal tip having a sloping face tapering distally toward the longitudinal axis and terminating in a blunt distal surface; and a double lobed opening formed in the distal tip, the double lobed opening having a first elliptical lobe that lies substantially across the longitudinal axis, a second elliptical lobe adjacent and offset from the first lobe and formed in the sloping face, and an intermediate portion interconnecting the first and second lobes, wherein the open portion of the intermediate portion is narrower than each of the first and second lobes, a center of the first lobe lies on and is substantially orthogonal to the longitudinal axis, and the second lobe is formed in the sloping face.