The presently disclosed embodiments relate to endoscopic cannulas and methods of their use.
Vessel harvesting is a surgical technique that is commonly used in conjunction with coronary artery bypass surgery. During a bypass surgery, blood is rerouted to bypass blocked arteries to restore and improve blood flow and oxygen to the heart. The blood may be rerouted using a bypass graft, where one end of the by-pass graft is attached to a blood source upstream of the blocked area and the other end is attached downstream of the blocked area, creating a “conduit” channel or new blood flow connection bypassing the blocked area. Commonly, a surgeon will remove or “harvest” healthy blood vessels from another part of the body to create the bypass graft. The success of coronary artery bypass graft surgery may be influenced by the quality of the conduit and how it is handled or treated during the vessel harvest and preparation steps prior to grafting.
Vessel harvesting methods involve selecting a vessel, traditionally, the great saphenous vein in the leg or the radial artery in the arm to be used as a bypass conduit sealing off and cutting smaller blood vessels that branch off the main vessel conduit and harvesting the main conduit from the body. This practice does not harm the remaining blood vessel network, which heals and maintains sufficient blood flow to the extremities, allowing the patient to return to normal function without noticeable effects.
Minimally invasive technique for vessel harvesting is known as endoscopic vessel harvesting, a procedure that requires only small incisions. While the endoscopic vessel harvesting procedure is an improvement over a traditional “open” procedure that required a single, long incision from groin to ankle, the endoscopic procedure is still cumbersome and difficult. In particular, current endoscopic harvesting systems require multiple tools, which increases the potential for injury to the bypass conduit as well as increases the duration of the procedure. Accordingly, improvements in systems and methods for endoscopic vessel harvesting are still needed.
Unitary endoscopic vessel harvesting devices are disclosed. In some aspects, there is disclosed a surgical device for harvesting a blood vessel that may include an elongated body extending between a proximal end and a distal end, and having one or more lumens extending through the elongated body and a tip disposed at the distal end of the elongated body. The harvesting device may further include a gripping unit disposed about the dissection tip, the gripping unit including a proximal member and a distal member configured to capture a blood vessel therebetween. The blood vessel grasped between first gripping member and the second gripping member may be sealed a plurality of individually controlled cauterizing elements disposed on the gripping unit.
In some aspects, there is disclosed a device for harvesting a blood vessel that may include an elongated body an elongated body extending between a proximal end and a distal end, and having one or more lumens extending through the elongated body. A tip may be disposed at the distal end of the elongated body. The vessel harvesting device may further include a gripping unit having a first gripping element disposed about the dissection tip and a second gripping element disposed about the dissection tip distally of the first gripping member, the second gripping member being moveable with respect to the first gripping member between an open position away from the first gripping member and a closed position toward the first gripping member for gripping a blood vessel between the first gripping member and the second gripping member. The vessel harvesting device may also include a first cauterizing element disposed along a first length of the gripping unit and a second cauterizing element disposed along a second length of the gripping unit, which can be controlled independently of one another such that the blood vessel, when gripped between the first gripping member and the second gripping member, is sealed by the first cauterizing element or the second cauterizing element.
In some aspects, there is disclosed a method for harvesting a blood vessel. The First, a cannula having a dissection tip disposed at a distal tip of an elongated body and a gripping unit disposed over the dissection tip along a main vessel to dissect the main vessel and its branch vessels from the surrounding tissue. Upon encountering a branch vessel, a gripping unit may be activated to capture the branch vessel between a proximal member and a distal member of the gripping unit. Next, the cauterizing unit may be activated to seal and sever the captured branch vessel. This process may be repeated until a section of the main vessel of a desired length has been dissected and the branch vessels along this section have been severed. The main vessel may then be captured between the proximal member and the distal member and pressed against the cauterizing element supported by the gripping unit. The cauterizing element may again be energized to first seal and then sever the blood vessel. In some embodiments, the design of the harvesting device of the present disclosure enables performing the harvesting procedure without insufflation.
The presently disclosed embodiments will be further explained with reference to the attached drawings, wherein like structures are referred to by like numerals throughout the several views. The drawings shown are not necessarily to scale, with emphasis instead generally being placed upon illustrating the principles of the presently disclosed embodiments.
While the above-identified drawings set forth presently disclosed embodiments, other embodiments are also contemplated, as noted in the discussion. This disclosure presents illustrative embodiments by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the presently disclosed embodiments.
The present disclosure provides a unitary device for endoscopic vessel harvesting. Present systems for endoscopic vessel harvesting contain multiple components. Typically, an endoscopic dissection device is used to isolate the main vessel from the surrounding connective tissue by dissecting the main vessel from surrounding connective tissue. An endoscopic cannula is then used to introduce an endoscopic tributary sealing instrument to seal side branches. Once the side branches are sealed, yet another device is used to harvest a section of the main vessel to be used as a bypass graft. The unitary devices of the present disclosure combine the dissection function, the tributary sealing and severing function, and, optionally, main vessel sealing and severing function, which can result in decreased vessel manipulation and improvement in ease of the procedure. The devices of the present disclosure may also be used to extract the sealed and severed main vessel from the patient.
Decreased vessel manipulation may decrease the potential for injury to the graft. Repeated vessel contact with multiple passes of harvesting instrumentation increases potential vessel injury. A unitary device such as the device of the present disclosure may dissect, i.e., separate the main vessel, from surrounding tissue, cauterize and transect the tributaries and the main vessel as the device is advanced, and the vessel may be harvested with a single passage of the device, rather than multiple device insertions and retractions. Such a device with a decreased diameter may be used for dissection as well as tributary ligation; graft trauma should be decreased. The relative smaller diameter of the present device can also facilitate harvesting of more tortuous vessels; for example, the internal mammary artery.
Referring to
Referring to
The endoscopic cannula 100 may be a multi-lumen cannula with lumena that accommodate advancing instruments or materials therethrough. The endoscopic cannula 100 may include an endoscopic lumen 103 into which an endoscope 116 may be inserted for visualizing procedures performed using the cannula 100. The endoscopic cannula 100 may include an adapter 114 at the proximal end 104 for advancing the endoscope 116 into the endoscopic cannula 100. Additional lumens of the cannula 100 are described below.
In some embodiments, the endoscopic cannula 100 may include a dissection tip 120 disposed at or about the distal end 106 of the endoscopic cannula 100. The dissection tip 120 may include an inner cavity in fluid communication with the endoscopic lumen 103 to enable the endoscope 116 to be advanced into the dissection tip 120. The tip 120 may be transparent to allow for endoscopic viewing through the tip 120 of the procedures performed using the cannula 100. The dissection tip 120 may be provided with any shape as long as it facilitates endoscopic viewing therethrough, and allows for necessary control during tissue dissecting, i.e. separation. In some embodiments, the dissection tip may be generally conical. In some embodiments, the dissection tip 120 may include a generally flat shoulder 122 (best seen in
To further reduce likelihood of trauma during the dissection process, in some embodiments, the dissection tip 120 may be radially pliable, flexible or deformable so that the dissection tip may deflect slightly under exertion of force applied to the dissection tip 120, such as when a side branch is encountered during the dissection. In some embodiments, the dissection tip 120 is radially compressible so that the walls of the dissection tip 120 can deform under exertion of force normal to the tip surface. To that end, the dissection tip 120 may be formed from thin wall plastic material, such as polycarbonate or polyethylene terephthalate glycol-modified (PETG), to enable the dissection tip to flex under load. At the same time, the dissection tip 120 may be provided with sufficient column strength in axial or longitudinal direction to allow dissection of the vessel from the surrounding connective tissue.
In reference to
On the other hand, as is illustrated in
Referring back to
In reference to
To permit translation of the gripping unit 130 relative to the dissection tip 120, in some embodiments, the gripping unit 130 may be mounted on one or more actuating rods 132 for advancing and retracting the gripping unit 130 relative to the dissection tip 120. The actuating rods 132 may be passed from the gripping unit 130 proximally through a one or more lumens of the elongated body 102 of the cannula 100 to allow the user to control the translation of the gripping unit 130 from the proximal end 104 of the cannula 100. It should, of course, be understood that other mechanisms for translating the gripping unit 130 relative to the dissection tip 120 may be employed.
As shown in
Moreover, as shown in
In reference to
By way of a non-limiting example, the actuating system 160 may comprise two controlling members 162, 164 disposed on the actuating rods 132 and biased away to one another with the spring 166. One controlling member is connected to the proximal member 150 via an actuating rod and the second controlling member is connected to the distal member 170 via an actuating rod, such that the movement of controlling members 162, 164 translates the proximal member 150 and the distal member 170. Accordingly, the position of the proximal member 150 and the distal member 170 with respect to the dissection tip 120 and one another may be controlled by the user by adjusting the position of the controlling member 162, 164.
In some embodiments, the proximal member 150 and the distal member 170 may be toroidal or circular in shape. The circular configuration of the gripping unit 130 may facilitate capture of a vessel regardless of the position and orientation of the cannula 100 relative to the vessel. In some embodiments, the diameter of the circular proximal member 150 and the distal member 170 may be selected depending on the size of the vessel that will need to be captured between the proximal member 150 and the distal member 170, thus providing flexibility to the cannula to be used to sever and seal branch vessels as well as the main trunk. The shape of the dissection tip 120, how far distally the gripping unit 130 may be translated, or both may also be adjusted to allow the gripping unit 130 to accommodate vessels of varying size. In general, the larger the clearance from the surface of the dissection tip 120 to the top of the gripping unit 130, the larger the vessel that can be accommodated between the proximal member 150 and the distal member 170 without causing the vessel to slip out from the gripping unit 130. In some embodiments, by allowing the gripping unit 130 to translate past the distal tip of the dissection tip 120, larger vessels may be accommodated in the gripping unit 130. In some embodiments, the ring-shaped proximal member 150 and the distal member 170 may be concentrically positioned about the dissection tip 120. It should be noted that the proximal member 150 and the distal member 170 may be provided with a different shape as long as the gripping unit 130 is capable of sealing and severing a blood vessel. In some embodiments, the proximal member 150 and the distal member 170 may be oval, polygonal or irregularly shaped.
Referring to
In some embodiments, the cauterizing element 172 may be made of a wire that can be connected to an electricity source by an electrode extending proximally from the cauterizing element 172 through a lumen of the cannula 100. In some embodiments, the one or more supporting rods may act to conduct electricity from the electricity source to the wire 172. The wire can be heated to a desired temperature by conducting electrical current supplied by an electricity source to permit the cauterizing element to seal and sever the vessel compressed against it by the cooperating proximal member 150 and distal member 170.
In reference to
In some embodiments, the cauterizing element 172 may be connected to a battery for supplying electrical current to the cauterizing element 172 for resistive heating of the cauterizing element 172. Manually controllable switch or a timer for controlling the heating of the cauterizing element 172 may be provided on the endoscopic cannula 100 at a location that is conveniently operable by the user's thumb or finger. Of course, electrical current can also be supplied from an external source through, for example, a foot-operated controller to selectively heat the cauterizing element 172. In other embodiments, instead of electrical current, a relatively high level of radiant energy may be supplied along a fiber optical channel, for example, from an external laser to an absorptive load that is thereby heated to cut and seal the vessel. In yet other embodiments, an ultrasonic crystal resonator or other vibrator may be utilized to ultrasonically heat the vessel compressed inside the gripping unit 130 in response to ultrasonic signal applied to the vessel. Radiofrequency energy may also be transmitted through wires 178 and 180. Monopolar radiofrequency current may be transmitted through each wire separately. Conversely, bipolar electrocautery current may be applied between wires 78 and 180 to cauterize tissue incorporated between the outer wire 180 and the inner wire 178. Finally, the cauterizing element 172 may be energized with ultrasound energy.
In reference to
As shown in
In operation, an initial incision may be made in conventional manner to expose the target vessel (e.g., the saphenous vein). The cannula 100 may be inserted into the incision and guided to the target vessel. The cannula 100 may then be advanced substantially along the target vessel to dissect the target vessel from the surrounding tissue. In some embodiments, the cannula 100 may be introduced through a sealable port used to seal the incision to allow insufflation of the space created by the dissection of the target vessel from surrounding tissues.
As the cannula 100 is being advanced, the proximal member 150 and the distal member 170 of the gripping unit 130 may be kept in the proximal position to reduce the profile of the cannula 100 and to provide a substantially unobstructed view of the dissection procedure. As a branch vessel is encountered along the target vessel, connective tissue around the branch vessel may be dissected away from and around the branch vessel. Once the branch vessel has been dissected from the surrounding tissue, the gripping unit 130 may be activated to capture the branch vessel between the proximal member 150 and the distal member 170 of the gripping unit 130 and the cauterizing element 172 may be activated to seal and sever the branch vessel. The distance from the target vessel at which the branch vessel is severed may be controlled by lateral displacement of the gripping unit 130 relative to the dissection tip 120.
After the branch vessel has been hemostatically severed, the gripping unit 130 may be returned to the proximal position and the cannula 100 may be advanced forward until the next branch vessel is encountered, at which point the branch vessel may sealed and severed using the gripping unit 130. Once all branch vessels along a desired length of the target vessel have been sealed and severed, the cannula 100 may be used to seal and cut the target vessel according to procedure similar to the procedure used to cut and seal the branch vessel, except that the gripping unit 130 may have to be advanced further along the dissection tip 120, or even past the dissection tip 120, to be able to accommodate the larger target tissue between the proximal member 150 and the distal member 170. The target vessel may then be extracted through the incision for use as a by-pass graft.
In some embodiments, the cannula 100 of the present disclosure may allow vessel sealing and cutting to be performed in a small cavity. Accordingly, when using the cannula 100 of the present disclosure there may not be a need to maintain the perivascular cavity in an expanded state and thus the procedure may be performed without gas insufflation of the perivascular cavity. The proximal member 150 and the distal member 170 of the gripping unit 130 extend distally from the cannula 100. Because the members 150, 170 are oriented axial to the dissection tip during extension forward the members 150, 170 may remain directly in front of the visual field of an endoscope advanced into the dissection tip, and may stay within visual control. Furthermore, because the members 150, 170 are configured to move substantially along the longitudinal axis of the cannula, with no deviations, the vessel manipulation and sealing can occur in a limited space. These two features allow vessel cautery and transection to be performed in a small cavity, and there may thus be no need for the procedure to be performed under gas insufflation. The members 150, 170 can be visible in a narrow field of view, directly in front of the endoscope, and the members 150, 170 may be positioned to grasp a vessel with the harvest tunnel in a collapsed state.
In operation, the transparent dissection tip 120 can deflect a vessel to one side, so that the members 150, 170 can capture the vessel, while maintaining visualization of all components in a collapsed tissue tunnel, as shown in
The devices, systems and methods of the present disclosure are described in the following Example 1, which is set forth to aid in the understanding of the disclosure, and should not be construed to limit in any way the scope of the disclosure as defined in the claims which follow thereafter. The following example is put forth so as to provide those of ordinary skill in the art with a complete disclosure and description of how to make and use the embodiments of the present disclosure, and are not intended to limit the scope of what the inventors regard as their invention nor are they intended to represent that the experiments below are all or the only experiments performed. Efforts have been made to ensure accuracy with respect to numbers used (e.g. amounts, temperature, etc.) but some experimental errors and deviations should be accounted for. A single dissection tip was manufactured from Polyethylene Terephtalate Glycol (PETG) material having a thickness of 0.006 inches. The deflection of the dissection tip was measured on Instron Model 3345 using a 20 lbf Load Cell. To perform the test and record the results, Instron's Bluehill 2 Software was set as following: Test mode: Compression; Stop Limit: Load, 1 lb; Load Ramp Rate: 10 lb/min; Data Acquisition rate: 10 ms and Output Measurement: Maximum Extension.
All patents, patent applications, and published references cited herein are hereby incorporated by reference in their entirety. It should be emphasized that the above-described embodiments of the present disclosure are merely possible examples of implementations, merely set forth for a clear understanding of the principles of the disclosure. Many variations and modifications may be made to the above-described embodiment(s) without departing substantially from the spirit and principles of the disclosure. It will be appreciated that several of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. All such modifications and variations are intended to be included herein within the scope of this disclosure, as fall within the scope of the appended claims
This application is a continuation in part of U.S. application Ser. No. 13/723,676, filed on Dec. 21, 2012, which application claims priority to and benefit of U.S. Provisional Application No. 61/580,107, filed Dec. 23, 2011, both of these applications are hereby incorporated herein by reference in their entireties.
Number | Date | Country | |
---|---|---|---|
61580107 | Dec 2011 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 13723676 | Dec 2012 | US |
Child | 13795335 | US |