This invention relates generally to biomedical systems and methods. More specifically, the invention relates to systems and methods for harvesting a vessel section.
Heart disease, specifically coronary artery disease, is a major cause of death, disability, and healthcare expense in the United States and other industrialized countries. A common form of heart disease is atherosclerosis, in which the vessels leading to the heart are damaged or obstructed by plaques containing cholesterol, lipoid material, lipophages, and other materials. When severely damaged or obstructed, one or more of the vessels can be bypassed during a coronary artery bypass graft (CABG) procedure. CABG surgery is performed about 350,000 times annually in the United States, making it one of the most commonly performed major operations.
To prevent rejection, the graft material is preferably a blood vessel harvested from elsewhere within a patient's body. The most frequently used bypass vessel is the saphenous vein from the leg. Because the venous system of the leg is redundant, other veins that remain within the patient's leg are able to provide return blood flow following removal of the saphenous vein.
Various methods have been used to harvest the saphenous vein. Until recently, the typical procedure involved making a single long incision that overlies the entire length of the vein, extending from a patient's groin to at least the knee and often to the ankle. This method results in substantial postoperative pain, with patients frequently complaining more of discomfort at the site of the leg vein harvesting than of pain from their CABG surgery wound. In addition, such an extensive incision site is subject to infection and delayed healing, especially in patients with poor circulation, which not infrequently accompanies coronary artery disease. The disfiguring scar from such a large incision is also of concern to some patients.
Less invasive procedures are preferred, and surgical devices and techniques now exist that allow the saphenous vein to be harvested through one or more small, transverse incisions along the length of the vein, generally using an endoscope. Endoscopic procedures yield reduced wound complications and superior cosmetic results compared with traditional methods of vein harvesting. However, this procedure requires considerable manipulation of the vein, has a high conversion rate when visualization is obscured by bleeding or the procedure is taking too long and often requires stitches to repair the vein following harvest. Further, it is generally tedious, time consuming, and relatively complex, requiring extensive accessory equipment and a substantial learning curve for the surgeon.
Some embodiments of the invention provide a cutting device for use in harvesting a section of a vessel from surrounding tissue. The cutting device can include at least one tubular member adapted to surround the vessel along the section of the vessel to be harvested. The cutting device can include a cutting element coupled to the at least one tubular member. The cutting element can be adapted to be moved along the section of the vessel in order to cut the tissue around the vessel. The cutting device can include a centering member coupled to one of the at least one tubular member and the cutting element. The centering member can be adapted to keep the vessel spaced from the cutting element as the cutting element cuts the tissue around the vessel.
According to one method of the invention, a section of a vessel can be harvested from surrounding tissue by making a first incision at a proximal end of the section of the vessel, and making a second incision at a distal end of the section of the vessel. The method can include introducing a vessel support device into the vessel, and orienting a cutting device coaxially with the vessel support device. The method can also include advancing the cutting device over the vessel to core out the section of the vessel and a portion of the surrounding tissue, and spacing a cutting element of the cutting device from the vessel as the cutting element is advanced over the vessel.
Some embodiments of the invention provide a cutting device including at least one tubular member with a flexible section on a portion of a distal end. The cutting device can include a cutting element coupled adjacent to the flexible section of the at least one tubular member. The cutting element can be adapted to be moved along the section of the vessel in order to cut the tissue around the vessel.
Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless specified or limited otherwise, the terms “mounted,” “connected,” “supported,” and “coupled” and variations thereof are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings.
The following discussion is presented to enable a person skilled in the art to make and use embodiments of the invention. Various modifications to the illustrated embodiments will be readily apparent to those skilled in the art, and the generic principles herein can be applied to other embodiments and applications without departing from embodiments of the invention. Thus, embodiments of the invention are not intended to be limited to embodiments shown, but are to be accorded the widest scope consistent with the principles and features disclosed herein. The following detailed description is to be read with reference to the figures, in which like elements in different figures have like reference numerals. The figures, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of embodiments of the invention. Skilled artisans will recognize the examples provided herein have many useful alternatives and fall within the scope of embodiments of the invention.
As used in this specification and in the appended claims, the terms “distal” and “proximal” are with reference to the operator when the device is in use.
The outer tubular member 110 can be substantially rigid and can be constructed of an appropriate biocompatible material, such as a polymer or stainless steel. In some embodiments, a distal portion of the outer tubular member 110 can be flexible. For example, a section of the outer tubular member 110 proximal to the cutting element 130 can include a bellows-like structure to aid in directing the cutting device 100 over the vessel section to be harvested.
The length of the outer tubular member 110 can be based on the length of the vessel section to be harvested. For example, a length of 30 to 60 centimeters can be appropriate for harvesting a section of a typical saphenous vein. The outer tubular member 110 can be long enough to core out the entire vessel section desired.
The surfaces of the cutting device 100 can be coated with a material to decrease friction between the cutting device 100 and the tissue and between the elements of the cutting device 100. The coating material can be parylene, Teflon, or other slippery, lubricious coatings.
In some embodiments, the cutting element 130 includes one or more blades positioned adjacent to the distal end of the outer tubular member 110. The cutting element 130 can be mounted either inside or outside of the outer tubular member 110. In some embodiments, the diameter of the outer tubular member 110 combined with the positioning of the cutting element 130 determines the diameter of the cored-out vessel and adjoining tissue section that is harvested. In one embodiment, the diameter of the core is adequate to avoid slicing the edges of the vessel being harvested as well as to transect branch vessels, such that the portions of the branch vessels that remain attached to the vessel section are long enough to tie off or otherwise seal to yield a vessel section appropriate for use as a graft, for example in a CABG procedure.
In one embodiment, the inner tubular member 120 can be received within a lumen 112 of the outer tubular member 110. The inner tubular member 120 can be somewhat longer than the outer tubular member 110 to allow the two members to be manipulated independently. The lumen 112 of the outer tubular member 110 can provide a close-sliding fit for the inner tubular member 120, allowing the inner tubular member 120 to slide both longitudinally and rotationally within the outer tubular member 110.
In one embodiment, the inner tubular member 120 can be substantially rigid and can be constructed of an appropriate biocompatible material, such as a polymer or stainless steel. In one embodiment, a distal portion of the inner tubular member 120 can include one or more flexible materials. The flexible section of the inner tubular member 120 can be, for example, a soft polymer, a wire-reinforced polymer, a perforated section, a bellows section, or a jointed section.
The lumen 122 of inner tubular member 120 is sized to accommodate the vessel section being harvested and can taper inwardly from the distal end, the inner diameter of a distal portion thus being larger than the inner diameter of a proximal portion. An inward taper can lightly compress the vessel section to provide better centering of the inner tubular member 120 on the vessel section.
The cutting device 100 can include a component to aid in positioning the device relative to the vessel to provide better centering of the vessel within the device.
In one embodiment, the centering elements 242 can include one or more protrusions that extend into the lumen 112, 122 of the inner or outer tubular member 110, 120. For example, a single ring-like structure, as shown in
In another embodiment, the centering member can be a system including at least one sensor for tracking the location of the cutting device 100 relative to a rod, a dilator, a catheter, or a guidewire, for example, positioned within the vessel to be harvested. In this system, at least one Hall-effect sensor, for example, can detect the presence of a metal, for example, in the rod, dilator, catheter, or guidewire, placed within the vessel. Software associated with the sensor(s) can display concentric circles (or other geometrical shapes) representing the positions of the cutting device 100 and the rod, dilator, catheter, or guidewire. In one embodiment, an operator can center the cutting device 100 over the vessel by maintaining the circle representing the rod, dilator, catheter, or guidewire centered within the circle representing the cutting device 100. Alternatively, software associated with the sensor(s) can provide an audible indication of the relative locations of the cutting device 100 and rod, dilator, catheter, or guidewire. For example, the volume or pitch can change if the cutting device 100 deviates off center with respect to the rod, dilator, catheter, or guidewire.
In another embodiment, the centering member includes two magnetic or electromagnetic fields that repel each other. One intravascular field can be located within a catheter or guidewire inside the vessel and the opposing field can be located on the cutting element 130 and/or the outer tubular member 110. The forces can repel each other keeping the cutting element 130 and the outer tubular member 110 away from the inside of the vessel allowing a tissue core to be cut around the vessel without compromising the vessel.
In some embodiments, the outer and inner tubular members 110, 120 can be advanced over a vessel section to core out the vessel section along with tissue adjoining the vessel section. The inner and outer tubular members 110, 120 can be advanced independently. For example, the inner tubular member 120 can be advanced first to hold the vessel and the surrounding tissue while the outer tubular member 110 is advanced second to cut the tissue being held by the inner tubular member 120. Alternately, the outer tubular member 110 can be advanced first to cut the tissue and the inner tubular member 120 can be advanced second to center and hold the tissue. The process of incrementally advancing the tubular members 110, 120 can be repeated until the entire section of vessel has been excised. In one embodiment, advancing the inner tubular member 120 ahead of the outer tubular member 110 can protect the walls of the vessel from the cutting element 130 positioned on the outer tubular member 110. The outer and inner tubular members 110, 120 can also be advanced together with the outer tubular member 110 rotating and the inner tubular member 120 not rotating. Alternative methods of advancing the tubular members 110, 120 include pushing and/or pulling, rotating, and twisting first in one direction and then in the other direction. In one embodiment, the outer tubular member 110 and the inner tubular member 120 can be twisted in opposite directions to provide a scissoring action.
Another embodiment of a cutting device 100 is similar to that described above and illustrated in
A catheter can be introduced into the vessel section over the previously placed guidewire (Block 420). A proximal portion of the vessel section can be secured to the catheter (Block 425), for example by suturing the vessel onto a barb positioned adjacent to the proximal end of the catheter. Alternatively, the catheter can be introduced into the vessel without a guidewire being previously placed.
The guidewire (if present) is withdrawn (Block 430), and a rod can be inserted into the catheter to stiffen the vessel section (Block 435). Both the catheter and the rod can be attached to a removable handle (Block 440). The handle can carry the cutting device 100, or the cutting device 100 can be introduced over the handle after the handle has been attached to the catheter and rod. An inner lumen of the cutting device 100 can provide a close-sliding fit for the handle. The cutting device 100 can thus be oriented coaxial with the rod and with the vessel section to be harvested (Block 445).
The cutting device 100 is then advanced over the vessel section to core out the vessel section and tissue adjoining the vessel section (Block 450). The cutting device 100 can be advanced by either pushing or pulling the device over the vessel section. If the cutting device 100 includes two tubular members 110, 120, one positioned within the other as shown in
The cored out vessel section and adjoining tissue are removed from the body of the patient (Block 455). Either before or after removing the vessel section and adjoining tissue, a hemostatic control method for branch vessels severed as a result of coring out the vessel section can be introduced through either the first or the second incision. The hemostatic control method can be, for example, a biological sealant, e.g., platelet gel that can be prepared from the patient's blood and injected or otherwise introduced along the track of the cutting device. The hemostatic control method can also be a thrombogenic substance such as fibrinogen, fibrin and/or thrombin placed in the track left by the cutting device 100. Alternatively, or in combination with a biological sealant, a biocompatible or biodegradable tube can be enclosed within the cutting device 100 to be delivered as the cutting device 100 is advanced over the vessel or after the cutting device 100 has completed coring out the vessel and adjoining tissue. The tube exerts pressure on the cut branch vessels and can be either removed or, in the case of a biodegradable tube, left to dissolve or degrade over a period of a few days, for example. The space left after the removal of the vessel can also be filled with gauze to provide internal pressure to limit bleeding and absorb blood. The gauze can be removed periodically to check for absorbed blood. Limited blood collected on the gauze indicates the wound bleeding has diminished.
Hemostatic control methods are not required for embodiments of the invention as the tubular cutting device 100 itself can exert pressure on the cut branch vessels while it remains within the patient's body. A drain can be inserted at the end of the harvesting procedure to deal with any bleeding that does occur. The site of the vessel harvesting procedure, e.g., the leg of a patient, can also be wrapped with a compression bandage to limit bleeding.
The cutting device 100 is oriented coaxially with the cannula, the balloon and the vessel section to be harvested (Block 446). The cutting device 100 is then advanced over the vessel section to core out the vessel section and tissue adjoining the vessel section (Block 450). The cutting device 100, for example, can be twisted first in one direction and then in the other direction, or it can be rotated over the vessel. The cored out vessel section and adjoining tissue are removed from the body of the patient (Block 455). Either before or after removing the vessel section and adjoining tissue, a hemostatic control method for treating branch vessels severed as a result of coring out the vessel section can be introduced through either the first or the second incision. The hemostatic control method can include, for example, a biological sealant, e.g., platelet gel that can be prepared from the patient's blood and injected or otherwise introduced along the track of the cutting device 100. The hemostatic control method can also be a thrombogenic substance such as fibrinogen, fibrin and/or thrombin placed in the track left by the cutting device 100. Alternatively, or in combination with a biological sealant, a biocompatible or biodegradable tube can be enclosed within the cutting device 100 to be delivered as the cutting device 100 is advanced over the vessel or after the cutting device 100 has completed coring out the vessel and adjoining tissue. The tube exerts pressure on the cut branch vessels and can be either removed or, in the case of a biodegradable tube, left to dissolve or degrade over a period of a few days, for example. The space left after the removal of the vessel can also be filled with gauze to provide internal pressure to limit bleeding and absorb blood. The gauze can be removed periodically to check for absorbed blood. Limited blood collected on the gauze indicates the wound bleeding has diminished.
Regardless of the device being used to stabilize or support the vessel, the routing ridge 506 can contact the tissue being cut and meets resistance against the stabilizing or support device inside the vessel. The contact and resistance exerted against the routing ridge 506 pushes on the cutting device 502 to center the cutting device 502 around the vessel. Thus, as the tubular member 510 is advanced over the vessel, if the vessel is curved in any way, the routing ridge 506 will contact the vessel first before the cutting element 504, thereby centering the cutting element 504 over the vessel prior to the cutting element 504 coming into contact with the vessel and thus avoiding any damage to the vessel.
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It will be appreciated by those skilled in the art that while the invention has been described above in connection with particular embodiments and examples, the invention is not necessarily so limited, and that numerous other embodiments, examples, uses, modifications and departures from the embodiments, examples and uses are intended to be encompassed by the claims attached hereto. The entire disclosure of each patent and publication cited herein is incorporated by reference, as if each such patent or publication were individually incorporated by reference herein.
Various features and advantages of the invention are set forth in the following claims.
This application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application Ser. No. 60/852,020, filed on Oct. 16, 2006, the entire contents of which is hereby incorporated by reference.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US07/22033 | 10/16/2007 | WO | 00 | 2/28/2011 |
Number | Date | Country | |
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60852020 | Oct 2006 | US |