Not Applicable.
The present invention relates in general to harvesting of living vessels for use in grafting, and, more specifically, to a harvesting device for endoscopically removing a vessel and a surrounding pedicle of fat and connective tissue wherein the device is capable of both blunt dissection and active cutting.
Blood vessels are often dissected from one portion of a living body to be implanted in another portion of the body by a surgical procedure, such as in a coronary artery bypass graft (CABG) or other cardiovascular procedure. An artery or vein is “harvested” (i.e., removed) from its natural location in a patient's body and reconnected to provide blood circulation elsewhere in the body. Among the preferred sources for the vessels to be used as the bypass graft are the saphenous vein in the leg and the radial artery in the arm.
Endoscopic surgical procedures for harvesting a section of a blood vessel (e.g., the saphenous vein) subcutaneously have been developed in order to avoid disadvantages and potential complications of harvesting of the blood vessel by exposing the desired vein section externally through a continuous incision along the leg. The continuous incision for exposing the vein and for introducing the surgical instruments to seal and sever adjoining tissue and side branches of the vessel results in a significant healing process and associated risks.
The known minimally-invasive endoscopic techniques employ a small incision for locating the desired vessel and for introducing one or more endoscopic devices into the small incision. For example, typical commercially available products for performing the endoscopic blood vessel harvesting procedure include a number of separate endoscopic devices that are each inserted into the patient. These endoscopic devices include, for example, an insufflation mechanism having plastic tubing to supply air or CO2 to insufflate the subcutaneous area; an endoscope having a camera and light cables in order to visualize both the dissection and harvesting procedures; a dissector mechanism to dissect or separate the vessel from connective tissues in the body (i.e., blunt dissection); and a cutting mechanism to sever and seal any side branches from the vessel and then remove the vessel from the body (i.e., active cutting). In certain instances, the combination of mechanisms can be bulky and cumbersome for the clinician performing the vessel harvesting. Also, in certain instances, these mechanisms require that a relatively large diameter wound and cavity be formed within the patient in order to accommodate all the separate mechanisms.
Existing harvesting devices have required an intricate and physically demanding procedure to isolate a vessel from surrounding tissue and to cut and coagulate side branches. This required a high level of skill and practice for the person performing the harvesting procedure. Even with good expertise, several potential sources of damage to the harvested vessel remain. Harvesting typically requires multiple passes of one or more separate devices resulting in much contact with the vessel, potentially leading to endothelial damage. To create a sufficient working space and to allow visualization for tissue separation and side branch cutting, significant insufflation is often used. The CO2 insufflation gas can lead to tissue acidosis, CO2 embolism, and other complications. The common use of electrocauterization for cutting and coagulating the side branches can result in thermal spreading to the harvested vessel and sometimes also results in side branch stubs that are too short for obtaining a good, leak-proof seal.
It has been discovered that improved patency can be obtained for a vein graft if some surrounding tissue is left intact around the desired vessel. To address the absence of endoscopic devices capable of maintaining a layer of surrounding tissue (i.e., a pedicle) over the harvested vessel, co-pending U.S. application Ser. No. 14/021,537, filed Sep. 9, 2013, entitled “Single-Pass Endoscopic Vessel Harvesting” discloses a ring-shaped blade mounted to a sheath and disposed in a plane substantially perpendicular to the longitudinal direction and proximal of a dissector tip. The blade forms a lateral loop to encircle the vessel from the flanking tunnel and to make a vasiform cut including a pedicle around the vessel as the sheath advances. The disclosure of application Ser. No. 14/021,537 is incorporated herein by reference.
To reduce some disadvantages that may be associated with electrocauterization or other cutting methods, ferromagnetic heating can be used on a cutting surface to generate a controlled heating, as shown in co-pending U.S. application Ser. No. 14/926,305, filed Oct. 29, 2015, entitled “Single-Pass Endoscopic Vessel Harvesting” which is also incorporated herein by reference. Appropriate ferromagnetic materials and the generation of energizing signals can be as disclosed in U.S. Pat. No. 8,292,879.
The dissection of a vessel and the surrounding pedicle requires the cutting and/or separating of various tissue structures with a variety of physical properties, all done in a small working space. Even when using active cutting to harvest both the target vessel and a surrounding pedicle, there remains a need for blunt dissection (e.g., to create the working space or for exposing a side branch or a portion of the target vessel for active cutting). Thus, a device capable of both blunt dissection and active cutting is desirable.
In one aspect of the invention, a vessel dissector is provided for harvesting a target vessel from a donor site. A tubular member extends longitudinally between proximal and distal ends. A blunt transparent tip has a terminus for blunt dissection of tissue at the donor site and a base affixed to the distal end of the tubular member with a predetermined outside diameter. An active ring set has first and second ring segments mounted to distal ends of respective manipulator bars mounted in the tubular member for relative movement. The ring segments juxtapose to define a closed loop with an inner diameter larger than the predetermined outside diameter of the tip base. The ring segments are movable between a retracted position nested at the base and respective extended positions distally forward of the terminus. At least one of the ring segments is energizable to cut and cauterize a cylindrical pedicle from the tissue at the donor site including the target vessel. The ring segments independently extend longitudinally to provide a variable gap between the ring segments to capture, cut, and cauterize side branches to the target vessel between the ring segments.
A vessel harvesting system shown in
Dissector apparatus 11 includes a tubular main body portion 16 comprising a hollow longitudinal rod within which endoscope 10 is to be inserted. Endoscope 10 is inserted or removed from longitudinal rod 16 through a handle portion 17. Endoscope 10 may be secured inside dissector 11 by a small nub 18, found opposite light guide port 15 on end adapter 14 of endoscope 10 and held by a conventional mechanism found inside handle portion 17.
The material of longitudinal rod 16 material is selected from fluoropolymers, which are well known materials. Examples of fluoropolymers include polymers such as polytetrafluoroethylene (PTFE commonly referred to as Teflon), perfluoroalkoxy (PFA), fluorinated ethylene propylene (FEP), polyvinylidene fluoride (PVDF), ethylene-tetrafluoroethylene (ETFE), ethylene-chlorotrifluoroethylene (ECTFE), and mixtures of fluoropolymers such as MFA or THV, or mixtures of any of the foregoing. The most preferred material for constituting the outer surface of longitudinal rod 16 is PTFE. The use of a fluoropolymer reduces the friction caused by moving rod 16 through connective tissue, thereby reducing the force required to perform a dissection.
A blunt dissector tip 19 is disposed at the distal end of longitudinal rod 16. Tip 19 has a conical shape and comprises a transparent synthetic resin material to facilitate viewing through tip 19 using endoscope 10. Trocar 12 includes a body 20 to guide dissector apparatus 11 into the incision site. An aperture seal 21 is located on the surface of the proximal end of body 20. Aperture seal 21 allows dissector 11 to be inserted in body 20 of trocar 12 in one fluid forward motion. The outer surface of trocar body 20 includes a projection to engage with living tissue and a holding portion 22 to hold the body 20 onto the living tissue.
To conduct the harvesting of a vessel, an incision may be made in the vicinity of a knee or a wrist immediately above a target blood vessel to be harvested. Body 20 of trocar 12 is inserted in the incision and held by holding portion 22 with respect to the incision. Endoscope 10 is inserted in dissector apparatus 11. Light guide connector 15 of endoscope 10 is inserted in dissector 11. Small nub 18 located on the bottom portion of endoscope 10 engages a mechanism in handle 17 to lock them. The distal end of endoscope 10 is caused to project from the distal end of longitudinal rod 16 into tip 18 for providing a view through tip 18. Endoscope 10 and dissector 11 are then inserted into the body through trocar 12 in one forward movement.
Tip 44 has a base section 49 proximate to the distal end of tubular member 42. Base 49 provides a predetermined outside diameter which is selected to receive ring segments 51 and 52 when they are retracted. Thus, ring segments 51 and 52 may be nested at base 49 to facilitate use of tip 44 and terminus 45 in blunt dissection of tissue that the donor site for the target vessel. The outside diameter of base 49 may be stepped down from the outside diameter of body member 42 by an amount sufficient to accommodate the radial thickness of ring segments 51 and 52 to aid in smooth sliding of body member 42 within the body cavity during blunt dissection.
Ring segments 51 and 52 form overlapping partial rings. When the overlapping rings are juxtaposed with each other they define a closed loop with an inner diameter larger than the predetermined outside diameter of base 49. Offset openings in segments 51 and 52 provide an opening for inserting the vessel/pedicle into the ring for dissection. At least one of ring segments 51 and 52 has an active cutting surface, and preferably both segments 51 and 52 have active cutting surfaces so that together they provide a continuous cutting (vasiform) loop for dissecting the desired pedicle during active dissection.
By extending bars 53 and 54 using ring rod actuators 55 and 56, ring segments 51 and 52 are placed in longitudinally extended positions distally forward of terminus 45. Ring segments 51 and 52 may be independently positioned to provide a variable gap between ring segments 51 and 52. When ring segments 51 and 52 are touching or close together, they may be advanced through tissue in order to make the vasiform cut to dissect a pedicle around target vessel 47 by energizing an active cutting surface such as a ferromagnetic heating surface or an ultrasonic surface. The active cutting surface may be energized by a signal generator or energizer 57 which is turned on and off by a manual push button switch 58, for example. In a preferred embodiment, ferromagnetic heating is used in ring segments 51 and 52 by providing a ferromagnetic coating at strategic locations over a signal conductor that passes through each manipulator bar 53 and 54 and follows a loop around ring segments 51 and 52.
Base section 49 of tip 44 provides a landing region between a slope section 61 and a mounting collar 60 which is bonded to an inner surface of tubular body member 42.
This application claims priority to U.S. provisional application 62/201,345, filed on Aug. 5, 2015, entitled “Vessel Dissector and Harvester,” and to U.S. provisional application 62/201,338, filed on Aug. 5, 2015, entitled “Vessel Cauterizing Ring,” both of which are hereby incorporated by reference in their entirety.
Number | Name | Date | Kind |
---|---|---|---|
5013312 | Parins et al. | May 1991 | A |
5980549 | Chin | Nov 1999 | A |
6129661 | Iafrati et al. | Oct 2000 | A |
6309400 | Beaupre | Oct 2001 | B2 |
6527771 | Weadock | Mar 2003 | B1 |
7077803 | Kasahara et al. | Jul 2006 | B2 |
7331971 | Kasahara et al. | Feb 2008 | B2 |
7510562 | Lindsay | Mar 2009 | B2 |
7556633 | Lindsay | Jul 2009 | B2 |
7909762 | Usher et al. | Mar 2011 | B2 |
7942891 | Genovesi et al. | May 2011 | B2 |
7981133 | Chin | Jul 2011 | B2 |
8097010 | Kasahara et al. | Jan 2012 | B2 |
8292879 | Manwaring | Oct 2012 | B2 |
8372066 | Manwaring et al. | Feb 2013 | B2 |
8372096 | Kadykowski et al. | Feb 2013 | B2 |
8377052 | Manwaring et al. | Feb 2013 | B2 |
8414569 | Manwaring et al. | Apr 2013 | B2 |
8419724 | Manwaring et al. | Apr 2013 | B2 |
8425503 | Manwaring et al. | Apr 2013 | B2 |
8430870 | Manwaring et al. | Apr 2013 | B2 |
8430898 | Wiener et al. | Apr 2013 | B2 |
8491578 | Manwaring et al. | Jul 2013 | B2 |
8523850 | Manwaring et al. | Sep 2013 | B2 |
8523851 | Manwaring et al. | Sep 2013 | B2 |
8523852 | Manwaring et al. | Sep 2013 | B2 |
8617151 | Denis et al. | Dec 2013 | B2 |
8858544 | McNally et al. | Oct 2014 | B2 |
8915909 | Manwaring et al. | Dec 2014 | B2 |
8932279 | Stringham et al. | Jan 2015 | B2 |
9078655 | Manwaringt et al. | Jul 2015 | B2 |
20080208192 | Kadykowski et al. | Aug 2008 | A1 |
20080255407 | Blakeney et al. | Oct 2008 | A1 |
20100292533 | Kasahara et al. | Nov 2010 | A1 |
20130165746 | Chin | Jun 2013 | A1 |
20150073207 | Langford | Mar 2015 | A1 |
Number | Date | Country | |
---|---|---|---|
20170035487 A1 | Feb 2017 | US |
Number | Date | Country | |
---|---|---|---|
62201345 | Aug 2015 | US | |
62201338 | Aug 2015 | US |