Minimally invasive no touch (MINT) technique and system for implementing same

Abstract

A method of implementing a minimally invasive no touch (MINT) procedure for atraumatically harvesting a blood vessel for implantation to bypass a blocked artery in a patient. The method includes making an incision in the patient near the a vessel for harvesting to create an opening, extending a distal end of an endoscopic shaft fitted with an end cap, where an ejector injects fluid to create a working opening in the patient's leg, and withdrawing the distal end of the endoscope shaft from the working opening, inserting a cannula seal of plug into the working opening, placing the distal end of the endoscopic shaft into the working opening via the cannula seal or plug and ejecting hydrodissecting fluid from the ejector to separate the blood vessel from its surrounding tissue while advancing the distal end of the endoscope shaft through the tunnel created by the hydrodissecting fluid under direct vision.

Description

MINIMALLY INVASIVE NO TOUCH (MINT) TECHNIQUE AND SYSTEM FOR IMPLEMENTING SAMECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority under 35 USC § 119(e) and § 120 from U.S. Provisional Patent Application No. 63 / 638,992, filed on April 26, 2024 (“the ‘992 provisional application”) and from U.S. Provisional Patent Application No. 63 / 724,765, filed on November 25, 2024 (“the ‘765 provisional application”) and is a continuation-in- part (CIP) of U.S. Patent Application No. 18 / 084,374, filed on December 19, 2022 (“the ‘374 application”), which ‘374 application claims the benefit of U.S. Provisional Application No. 63 / 300,206, filed on January 17, 2022 and U.S. Provisional Application No. 63 / 328,413, filed on April 7, 2022, and is a continuation-in-part (CIP) of U.S. Patent Application No. 16 / 909,704, filed on June 23, 2020, issued as U.S. Patent No.11,540,817, on January 3, 2023 (“the ‘817 CIP application”), which ‘817 CIP application is a continuation of U.S. Patent Application No. 16 / 208,915, filed on December 4, 2018, and abandoned November 13, 2020, which continuation is a divisional of U.S. Patent Application No. 16 / 039,1 15, filed on July 18, 2018. issued as U.S. Patent No. 10,687,793 on June 23, 2020, which divisional claims the benefit of U.S. Provisional Application Nos. 62 / 533,714, filed on July 18, 2017, 62 / 640,892 filed on March 9, 2018 and 62 / 683,376, filed on June 11, 2018. The entire disclosures of these aforementioned applications are incorporated herein by reference.BACKGROUND OF THE INVENTION

[0001] Coronary Artery Disease (“CAD”) is a narrowing of the coronary arteries that supply oxygen and nutrients to the heart muscle. CAD is the primary cause of mortality in the United States (US), ranking as the third leading cause of death globally. Coronary artery bypass graft surgery (CABG) is a procedure used to treat coronary artery disease or CAD. Coronary artery bypass graft (CABG) surgery with left internal mammary artery tothe left anterior descending artery is the gold standard for CABG with a patency rate of 90% at 15 years.

[0002] As importantly, since its introduction in 1967 by Renee Favalaro, coronary artery bypass graft (CABG) surgery has saved the lives of millions of patients with coronary artery disease (CAD). As originally described, CABG was performed by harvesting the great saphenous vein (GSV) via a longitudinal incision over the entire length of the GSV, referred to as the open vein (OVH) technique. The OVH technique, however, resulted in a significant incidence of leg wound complications, including bleeding, hematoma, infection, amputation and death.

[0003] In the mid-1990’s, a minimally invasive harvesting technique was developed to reduce leg wound complications. This technique is called endoscopic vein harvesting (EVH). EVH, which is a minimally invasive surgical technique, is employed to harvest the greater saphenous vein (GSV). EVH relies upon and endoscope with an end cap on its distal end that effects the separation of the GSV from its laminar ligament and surrounding tissue, with blunt force applied by the clinician through the typically blunt ended end cap.

[0004] Endoscopes comprise a thin, flexible tubes configured with an imaging device such as a CCD-based camera (or other pick-up device) and a light to illuminate an area or volume proximal the camera in one end of the endoscope. The camera is maintained in a tip or end cap atached to or integral with the distal end of the endoscopic shaft. In conventional EVH systems, the tip or end cap to separate a blood vessel from its surrounding tissue. The blood vessels include the greater and lesser saphenous veins from the leg (GSV and LSV) and the radial artery from the arm. Conventional EVH devices include a cannula with a handle through which specialized tools to dissect and seal branches of the blood vessel, i.e., vein or artery, once exposed, are introduced.

[0005] In a known form, the EVH technique employs a 2 cm incision at the level of the knee, through which the GSV is exposed and bluntly dissected from its surrounding connective tissue, including in many patients a well-developed laminar ligament that attaches the GSV to the underlying muscular fascia. Laminar ligaments are anatomically well defined and arise from the adventitia of the GSV. And while these traditional EVHsystems and methods greatly reduced the incidence of leg wound complications, clinical evidence informs us that the patency rates of the GSV harvested by conventional EVH systems and methods are inferior to those harvested using the open vein technique (OVH). Conventional EVH leads to vein graft failure (VGF).

[0006] As EVH systems and methods developed, Dr. Domingos R Souza, Department of Cardiovascular and Thoracic Surgery, Orebro University Hospital, Orebro, Sweden, developed a so called “No Touch” technique for harvesting the GSV. Using this technique, the GSV is harvested with a cuff of surrounding tissue so that the GSV itself is never touched during the harvesting procedure. This No Touch (“NT”) technique has resulted in five year patency rates of 90% for this vascular conduit. Such GSV patencyrates are equivalent to the results obtained when utilizing the internal thoracic artery (IT A), the “gold standard” of vascular conduits for CABG. Unfortunately, this NT technique is technically demanding and results in local leg wound complications as high as 50%. As a result, the NT technique has not been widely adopted.

[0007] Conventional EVH systems and methods allow medical professionals to remove blood vessels for transplantation with less trauma and smaller incisions at the vessel extraction sites (as the leg), as compared to O VH techniques. Using EVH rather than surgically opening the leg for substantially its entire length (to access the entire length of the GSV) has been shown to reduce the size of the surgical wounds at the extraction site, which leads to faster recovery times and fewer complications, like infection or scarring.

[0008] The reader should note that conventional EVH-harvested GSVs are the second most common vascular conduit used for CABG in the U.S. This is despite the poor longterm patency of this conduit due to vein graft failure (VGF). VGF is a leading cause of increased short- and long-term morbidity after CABG procedures; the number one technical problem associated with CABG. Lundy; Edward F., et al., INTRAOPERATIVE OPTICAL COHERENCE TOMOGRAPHY OF THE SAPHENOUS VEING CONDUIT IN PATIENTS UNDERGOING CORONARY ARTERY BYPASS SURGERY; Circ. Cardiovasc Interv., pages 662-664 (October 2021). And intravascular ultrasound studies have shown that intraluminal integrity is a critical predictor of ear ly vein graft closure. Hozumi, et al., USE OF INTRAVASCULAR ULTRASOUND FOR IN VIVOASSESSMENT OF CHANGES IN INTIMAL THICKNESS OF AN ANGIOGRAPHICALLY NORMAL SAPHENOUUS VEIN GRAFTS ONE YEAR AFTER AORTOCORONARY BYPASS SURGERY; Heart; vol. 76, pages 317-320 (1996).

[0009] US Patent No. 10,687,793 (MINIMALLY INVASIVE NO TOUCH (MINT) PROCEDURE FOR HARVESTING THE GREAT SAPHENOUS VEIN (GSV) AND VENOUS HYDRODISSECTOR AND RETRACTOR FOR USE DURING THE MINT PROCEDURE to Gallagher et al. (“the ‘793 patent”) discloses a minimally invasive no touch (MINT) laparoscopic surgical technique that relies upon hydrodissection rather than blunt dissection. The MINT method disclosed therein relies upon the hydrodissecting fluid remaining in situ post hydrodissection, to treat the vein before it is extracted. The ‘793 patent also discloses a MINT-based hydrodissector with a shaft extending from a handle at an angle and including a tapered blunt dissection tip at a distal end. The tapered tip includes a port sized to provide hydrodissecting fluid under sufficient pressure and velocity to hydrodissect vascular targets while an image pick-up device, arranged within the tapered tip provides for direct vision in the tumescent fluid environment.

[0010] Dr. Gallagher and coinventors of the ‘793 patent developed improvements and modifications to the conventional MINT-based methods and apparatus disclosed therein. US Patent Appln. Ser. No. 18 / 084,374, filed on December 19, 2022 (MINIMALLY INVASIVE NO TOUCH (MINT) PROCEDURE FOR HARVESTING THE GREAT SAPHENOUS VEIN (GSV), ENDOSCOPIC ASVAL TECHNIQUE AND ASSISTED PIN STRIPPING OF SUPERFICIAL GSV, HYDRODISSECTION-BASED ENDOSCOPIC VEIN HARVESTING (EVH) SYSTEM, VENOUS HYDRODISSECTOR, RETRACTOR AND TIP ADAPTER FOR USE WITH FLEXIBLE CYSTOSOPE AND ADAPTED CYSTOSCOPE SYSTEM) (“the ‘374 application”), is a continuation-in-part application of the application that issued as the ‘793 patent. The ‘374 application discloses techniques for modifying existing endoscopes and cystoscopes to enable them to implement conventional MINT-based EVH.

[0011] Like the ‘793 patent, the ‘374 application and its MINT-based methods and apparatus seek to eliminate trauma to the extracted vessels, which is understood to be a significant factor in long term VGF. Frequency domain optical coherence tomography (FD-OCT) studies support the findings by the inventors’ of the ‘793 patent and the ‘374 application on MINT, demonstrating abundant vaso vasorum in the thick adventitia / perivascular adipose tissue layer of veins harvested using a no touch (NT); Sugaya, Akira, et al.; VASA VASORUM OF THE NO TOUCH SAPHENOUS VEIN GRAFT OBSERVED USING FREQUNCY-DOMAIN OPTICAL COHERENCE TOMOGRAPHY; Oxford University Press. The method and systems taught by the Gallagher ‘374 published application facilitate microvascular dissection while not affecting the patency of the microvascular pedicle itself.SUMMARY OF THE INVENTION

[0012] The present invention overcomes the shortcomings of prior art endoscopic vein harvesting systems and methods.

[0013] The inventors herein have found however, that using hydrodissection taught by the Gallagher ‘374 application could still raise challenges to separating the laminar ligament that attaches the GSV to the underlying muscular fascia, at the adventitia. Having a clear view and an efficient and effective cautery device insures minimal trauma to the GSV while separating and side branches. The instant invention improves the conventional MINT technology found in the Gallagher ’374 published application with the modified hydrodissector that allows for implementing the modified MINT method to efficiently and effectively divide the side branches after first hydroseeding. The modified minimally invasive no touch (MINT) technique incorporates and improves the best features of conventional EVH and known MINT processes.

[0014] Broadly, the modified MINT procedure employs hydrodissection, a process that utilizes fluid pressure to gently separate a vessel (veins, arteries, ducts) from the vessel’s surrounding tissue. After hydrodissection, the hydrodissected GSV portion is harvested during a harvesting phase of modified MINT. As the entire length of the vessel is hydrodissected, an annular volumetric ring of tumescent fluid forms about the vessel andany tissues surrounding the vessel. For that matter, the hydrodissected vessel may be thought of as floating in a “tunnel” created and maintained by presence and pressure of the hydrodissecting fluid. This hydrodissecting portion of the process is accomplished under direct vision in the tumescent fluid.

[0015] Preferably, the tumescent fluid left over in the inner volume, tunnel or annular volumetric ring created by the hydrodissection is withdrawn from the inner volume for practitioners who prefer a dry imaging environment. This is accomplished with a lavage portion connected to the controller that controls the pressure and velocity of the ejected fluid as well as the pressure of the tumescent fluid in the inner volume, which is sealed. The inner volume is then insufflated with a biocompatible gas to effect the harvesting stage of the modified MINT process. Under direct vision in the gaseous environment, the side branches exposed by the hydrodissection are then divided from the main branch and sealed using cautery. Biocompatible gases include, without limitation, oxygen (Oz); Nitrous Oxide (N2O); Helium (He), Nitrogen (N2), carbon dioxide (CO2) and carbon monoxide (CO). As known to the skilled person, Each gas has its unique characteristics and requires careful management.

[0016] Vein graft failure (VGF) results from impaired endothelial function caused by excessive trauma to the vessel during extraction. The vessels hydrodissected and harvested using the modified MINT technique and apparatus are understood to maintain long term patency, effectively addressing VGF. This is very useful for clinicians that have little experience extracting vessels, for example, the GSV for a CABG, and typically must “suffer” and extended learning curve to master conventional endoscopic vein harvesting (EVH). For that matter, preliminary studies were conducted by inventor(s) herein to evaluate the quality of GSVs harvested from patients using the modified MINT process in reliance upon:1) standard EVH,2) no-touch (“NT”) harvesting techniques or3) the modified MINT harvesting procedure.The evaluation included assessing the endothelial nitric oxide synthase (eNOS) activity and nitric oxide (NO) bioavailability in the modified MINT harvested vessels. Theevaluation revealed a 3.4-fold increase in NO generation across modified MINT harvested samples compared to EVH and “NT” samples, respectively. The testing results of GSVs harvested by the modified MINT procedure show that vessels (i.e., GSVs) hydrodissected and harvested under modified MINT are structurally intact and exhibit elevated eNOS activity and nitric oxide (NO) bioavailability consistent with a functionally intact endothelium.

[0017] Modified MINT maintains transplanted veins for the long term. One embodiment of the invention provides a hydrodissector / harvester system for hydrodissecting and harvesting a vessel such as the GSV. The system comprises an endoscopic shaft with a handle and from which a hook-shaped attachment configured to extend out of the distal end of the shaft and lift the vessel during harvesting (post-hydrodissection), preferably in a CO2 environment under direct vision.

[0018] The hook-shaped attachment may be a C-shaped or U-shaped. The system has one or more ports at the proximal shaft end configured to be coupled to a fluid supply, a gas supply and / or a vacuum. A control means allows the practitioner to readily switch between supplying and withdrawing the fluid, and / or supplying and withdrawing the gas. An image capture device at a transparent tip at the distal end of the shaft, which may include a lens, an image sensor and / or one or more light sources to allow direct viewing of tire vessel to be first hydrodissected in the fluid environment and then harvested in a CO2 environment. Both parts of the modified MINT process implemented atraumatically and under direct vision.

[0019] The modified MINT procedure effectively improves the patency rates of harvested vessels such as the GSV without the local leg wound complications associated with the known “No Touch” harvesting technique. The modified MINT procedure provides more flexibility for harvesting such as in cases where the side branches are more readily separated and divided in a clear gaseous environment, reducing or eliminating a risk of damaging the vessel, for example, by a cautery device in the fluid environment. The improved visibility, and ease of use of a modified MINT-based hydrodissecting / harvesting system supports acquisition of practitioner GSV harvestingskills with a much shorter learning curve and less incidence of VGF in veins harvested during the time of the learning curves.

[0020] In a method embodiment, for example, a pre-CABG patient whose GSV is to be harvested is prepped and an incision made just above the knee proximal the GSV. The tip at the distal end of tire modified MINT -based hydrodissector (endoscope ) is inserted into the opening (as the fluid is ejected wider pressure). The tip is moved slowly and carefully under direct vision through the remainder tumescent hydrodissecting fluid as the tip is moved substantially in parallel to an axial extent of the vein, at a radius from an axial center selected by the clinician, the fluid under pressure and preceding the movement of the tip effecting hydrodissection. The exiting fluid under pressure separates by increasing the volume of the tunnel as it is created about the vessel, preferably about the same redial distance from the axial center. The “tunnel” should appear to be in a shape of an annular ring about the hydrodissected tubular vessel / tissue, separating it from the tissue surrounding the hydrodissected vessel / tissue.

[0021] The tumescent fluid remaining in the created volume is used to treat the vessel by way of additives. The additives can include one or more medications for protecting the vessel (e.g., GSV) and assisting in healing of the vessel / GSV, such as isotonic sodium bicarbonate with or without lidocaine, Viagra and / or Viagra-like compounds to drive NO2 production to minimize platelet formation, etc. in the lumen of the hydrodissected vein. The additives can also include balanced salt solution with a pH of around 7.4, such as Hank’s balanced salt solution, Isolyte solution, or isotonic saline solution and / or any other suitable tumescent fluid. The tumescent fluid may be DuraGraft (GALA Solution named after glutathione, ascorbic acid, L-arginine) endothelial damage inhibitor solution manufactured by Somahlution, Inc., based in Jupiter, Florida. DuraGraft is used for tissue preservation in the GSV specifically for CABG. (see US Patent No. 7,981,596).

[0022] The tumescent fluid also can include one or more medications for protecting the vessel (e.g.. GSV) and assisting in healing a portion of a vessel / GSV, if under certain circumstances the portion is somehow damaged during the hydrodissection and / or harv esting portions of the modified MINT method. These medications can include aspirin, which protects the endothelium, heparin, such as local low-molecular weightheparin, and one or more vasodilators, such as venous vasodilators or combination dilators, Nitroglycerine, Endothelin A receptor antagonist, Folic Acid, Angiotensin II receptor antagonist, Spermine / NO, Losartan, Perilyl alcohol, Superoxide dismutase, An titissue factor antibody, Verapamil, Heparin, Ursolic acid, Local Aspirin, Rapamycin, Azathioprin, Paclitaxel, C-type natriuretic peptide, Leoligin and Papaverine. In some embodiments, tumescent fluid may include platelet rich plasma or stem cells for strengthening the wall of the GSV, and in certain embodiments, gene therapy rely upon the tumescent fluid for delivery / administration.

[0023] In some embodiments of the modified MINT process, the GSV is hydrodissected completely from the surrounding fascia, where the harvesting is performed immediately or shortly thereafter (a CABG procedure). To completely hydrodissect the GSV from the surrounding fascia, it is sometimes necessary to perform multiple passes with the tip of the hydrodissector along the length of the GSV, e.g., two passes with the tip of the hydrodissector. The GSV also may be partially hydrodissected (e.g., in a first pass) so that all surrounding fascia is dissected from the vein except the laminar ligament. The lamina ligament can be dissected in a second pass or in a later time. For that matter, the second pass may include implementing the second pass under direct vision in a gaseous environment. The gaseous environment allows for more effective imaging and electronic cutting, subjecting tire vein to less heat exposure and trauma.

[0024] In an embodiment, a modified MINT system relies upon a cannula or endoscopic shaft, with a handle attached at a proximal end of the shaft and a specially designed working tip or end-cap attached at an opposite end of the cannula / endoscopic shaft, which is configured with an image pick-up device such a 1 mm CCD-based camera and a light source (e.g., 1 or 2 LEDs). The image pick-up device provides for direct vision in either a fluid or gas environment. A channel for fluid deliveiy (in or outside of the shaft) and an ejector to eject dissecting fluid in the end-cap. These features allow a user to atraumatically separate the vessel from the surrounding tissue. The shaft with the fluid delivery channel and ejector function as an infusion cannula.

[0025] Preferably, the working tip / end-cap is 1 to 2 cm in diameter, and most preferably 18 mm, depending upon an outside diameter of the endoscopic shaft end to which it isatached. The working tip / end-caps preferably are made of clear biocompatible acrylic plastic that are biocompatible and formed to a rounded, bullet-like contour or a pointed bullet-like contour. Each Fluid exits the ejector under controlled pressure / velocity to the tissue surrounding the vessel under harvest (e.g., the GSV), dissecting the vein from the surrounding tissue with minimal trauma. Controlled pressure means controlling the rate of hydrodissecting fluid output and its output velocity or cutting force.

[0026] After the hydrodissecting portion, the hydrodissector is converted into a harvesting device for introducing a cautery' device to divide and seal the side branches. Alternatively, the hydrodissector is converted into a harvester by attaching a clam shell to the shaft of the hydrodissector, the clamshell device including a channel for fluid delivery; inside the clamshell but outside the endoscopic shaft of the hydrodissector. The clamshell preferably contains the 5 mm contiguous channel in this embodiment, where a camera in the tip / end-cap sends images it picks up to a digital monitor that the medical professional views as he / she implements the modified MINT processes under direct vision in gaseous of fluid environment. The pressure and velocity of the infused and ejected fluid may also be controlled by controlling an infusion pump and / or ejector pump.

[0027] In a preferred embodiment, the invention provides a minimally invasive no touch (MINT) endoscopic vessel harvesting (EVH) system that harvests blood vessels atraumatically. The system includes an endoscopic shaft with a distal end, a proximal end and an inner channel extending between the proximal and distal ends, a handle connected at the proximal end of the endoscopic shaft including a fluid and / or gas infusion port in fluid communication with the inner channel, an end-cap arranged at the distal end of the endoscopic shaft including an image pick-up device and an ejection port, the ejection port in fluid and / or gas communication with the inner channel, a fluid and / or gas supply connected to the infusion port and a controller for controlling the fluid and / or gas supply to eject a fluid or gas at a controlled velocity' and / or pressure from the ejector port to separate the blood vessel from its surrounding tissue, creating a substantially annular separation volume by tumescent fluid and / or gas, as the endoscopic shaft and end-cap areadvanced along a longitudinal extent of the vessel under direct vision through the tumescent fluid and / or gas.

[0028] The tissue separation occurs at a radial distance from a central axis of the vessel that is greater than a radial distance to an outer surface of the blood vessel. The fluid and / or gas supply includes a lavage means to extract tumescent fluid and / or gas from the annular separation volume after the vessel is separated from its surrounding tissue, the annular separation volume then insufflated with a biocompatible gas and the hydrodissected blood vessel is then harvested under direct vision in the tumescent or insufflated gas through the annular volume. Preferably, the gas is CO2. The image pickup device captures images through the tumescent fluid and / or gas that a clinician views to navigate the vessel while implementing a hydrodissecting portion, a post-hydrodissecting harvesting portion and a post-harvesting portion of a minimally invasive no-touch (MINT) process. The ejection port is arranged in the end-cap so that fluid and / or gas is ejected in a direction that is substantially in parallel with a central axis of the hydrodissector shaft.

[0029] The system can include an elongate shell with an inner channel extending between a proximal end and an opposing distal end to which the endoscopic shaft is detachably attached; wherein the proximal end includes an opening for receiving a tool that can be controlled by a clinician to extend from the distal end opening and effect a tool operation. The tool includes any of a cautery device, forceps, an atraumatic vessel capture tool such as a C-ring and a valvulotome cutting device. The pick-up device can be a 1 mm CCD camera and wherein the shaft is a 5 cm shaft. The shell can be a cylindrical tube like structure with an inner lumen or volume that the endoscopic shaft is slid into. In an embodiment the shell can formed as a cylindrical tube like structure that has a linear slot extending along its entire length forming opposing edges that may be pried apart against inherent closing forces to insert the endoscopic shaft into the shell inner lumen, wherein the opposing edges snap closes, the shaft enveloped in the shell inner lumen.

[0030] In a preferred embodiment, the invention presents a hydrodissector for atraumatically hydrodissecting and harvesting a vascular target, which includes anergonomically-configured handle with at least one port for receiving a tool, an elongate cylindrical shaft with a proximal and distal end, the proximal end attached to the ergonomically-configured handle and the distal end attached to a back end of a transparent, cylindrical end cap, a front end of which includes an opening to an inner end cap volume in communication with an inner shaft channel that extends from the end cap opening to the at least one port in the ergonomically-configured handle, the end cap opening, the inner shaft channel configured for receiving a working tool with a working tool end that is extended from the opening, including by manipulation of the ergonomically-configured handle.

[0031] A telescoping infusion cannula with a proximal end and an opposing distal end, the telescoping cannula attached to the elongate shaft and formed with an infusion port at the proximal end and an ejector port at the distal end, a hydrodissecting fluid supply in fluid communication with the infusion port of the infusion cannula and a controller for controlling any of a pressure, a flow rate, a flow acceleration rate, a flow deceleration rate, a pulsed flow rate and a directional flow rate of a liquid and / or gas flow from the ejector port to separate the vascular target from its surrounding tissue atraumatically, leaving an annular volume between the outer surface of the vascular target and the separated, surrounding tissue; a working tool is slid in and out of the shaft inner channel via the at least one port and controlled to extend and manipulate a working tool end from the end cap opening when deployed.

[0032] The hydrodissector system can include a pick-up device in the end cap electronically connected through the at least one channel to video connector or port in the ergonomically-configured handle. Under under direct vision in a fluid environment, the vascular target may be hydrodissected and then may be harvested by the system. The vascular target may be hydrodissected in the fluid environment, wherein posthydrodissection, the hydrodissecting fluid is removed and replaced with the biocompatible gas and hydrodissected vascular target is harvested under direct vision in the gaseous environment. The end cap that may be removably attached to the distal end of the elongated shaft and interchangeable with alternatively designed end-caps. The distal end of the telescoping infusion cannula at the ejector port can be detachablyconnected a working tool end of a working tool that comprises a C-ring attached at a working tool end of a C-ring shaft fitting in the shaft inner channel, the other end of the C-ring shaft formed to enable controlling the C-ring at tool deployment, the distal end of the infusion cannula connected to a point on an inner surface of the C-ring that bisects the C-ring, and wherein controlling tire C-ring to extend from the opening concurrently extends the distal end of the telescoping infusion catheter. Preferably, turning the handle 90 degrees clockwise rotates the C-ring 90 degrees to appear as a U-shaped trough that holds the vascular target fluid and / or gas exiting the ejector port separates the the vascular target from its surrounding tissue. The target vessel may be maintained in the U- shape trough as the practitioner controls the controller to effect hydrodissection along the longitudinal extent of the vascular target.

[0033] The invention also provides a minimally invasive no-touch (MINT) procedure for atraumatically harvesting a blood vessel for implantation in reliance upon an endoscopic vein harvesting (EVH) system formed with an endoscopic shaft, a handle connected to one end of the endoscopic shaft and an end-cap with an image pick-up means and an ejector port therein, the ejector port in fluid communication with an infusion port in the handle, the end-cap connected at another end of the endoscopic shaft and a controller connected to the infusion port for controlling a fluid and / or gas supply to eject a fluid and / or gas at a controlled velocity and / or acceleration from the ejector port to effect harvesting, the method including at least a hydrodissection portion of the MINT procedure.

[0034] The hydrodissection portion comprising forming an incision and inner space at a point of access to the blood vessel; under direct vision in reliance on the image pick-up device, guiding a front end of the endoscopic shaft to which the end-cap is attached into the inner space under direct vision while controlling the EHV system to eject a fluid and / or gas from the ejector port, separating the blood vessel from its surrounding tissue,; separating the blood vessel from its surrounding tissue preferably creates a substantially annular separation volume between an outer boundary of the separated blood vessel and tissue the blood vessel is separated from. The method preferably includes a harvesting portion of the minimally invasive no-touch (MINT) procedure, the harvesting portioncomprising inserting one or more tools in a working tool channel extending between the handle and an opening proximate the ejector port in the Endoscopic harvesting (EVH) system; manipulating at least the one or more tools to separate and divide the branches atraumatically under direct vision in a gaseous environment.

[0035] The step of manipulating may include using the controller to drain fluid from the substantially annular separation volume and insufflating the volume with a gas to support separating and dividing the branches under direct vision through the gas. The method also can include a post-harvesting portion of the minimally invasive no-touch (MINT) procedure, the post-harvesting portion including placing the harvested blood vessel upon extraction into a bath of treated fluid. The method can include a pre-harvesting portion of the minimally invasive no-touch (MINT) procedure, the pre-harvesting portion including forming an incision above a decided point of access at the blood vessel location and inserting an infuser device under ultrasound guidance to infuse about 50 cc of fluid and / or gas to create the inner space.[0036j In an embodiment, the method includes providing a minimally invasive no-touch (MINT) procedure for atraumatically harvesting a blood vessel for implantation to bypass a blocked artery in a patient in reliance upon an endoscopic vein harvesting ( EVH ) system. The EVH system comprises an endoscopic shaft fitted with a handle at a proximal end and an end cap at a distal end, the end cap including an imaging means, wherein a tool inner channel extends from an opening in a distal end of the end cap through the shaft and handle to an access port in the handle, a C-ring tool comprising a Coring connected to a distal end of a tool shaft, a proximal end of the tool shaft extending out of the access port in the handle to allow C-ring tool manipulation, a diffusion cannula with a telescoping shaft formed with an ejector port proximate a distal end of the diffusion cannula, the distal end of the diffusion cannula connected to the C-ring at a central axis of the C-ring and a proximal end of the diffusion cannula connected to a controllable fluid and / or gas supply. Manipulating the the C-ring tool to extend the C-ring from the opening in the end cap extends the ejector opening and the telescoping shaft of the diffusion cannula and manipulating the C-ring tool to withdraw the C-ring back intothe opening in the end cap retracts the ejector opening and the telescoping shaft of the diffusion cannula.

[0037] The method includes pre-harvesting by making an incision at the blood vessel and create an inner volume thereunder with an approximately 50 cc of fluid or gas to access the blood vessel, plugging the incision; placing the distal end of the endoscopic shaft, the C-ring of the C-ring tool and the attached distal end of the telescoping diffusion canula into the inner volume through the cannula seal or plug; under direct vison through tumescent fluid and / or gas, manipulating the handle and / or the proximal end of the C-ring tool to to extend the C-ring and position the C-ring relative the blood vessel to include a part of the blood vessel between C-edges of the C-ring so that ejecting fluid will be ejected directly above the blood vessel in a direction that is colinear with a central axis of the blood vessel portion between the C-edges, under direct vision through tumescent fluid and / or gas, eject fluid and / or gas from the ejector port as the blood vessel, supported between the C-ring edges of the C-ring, as the endoscopic shaft is advanced along a length of the blood vessel to affect hydrodissection under direct vision in a fluid or gas environment, separating the blood vessel and leaving an annular volume between the separated blood vessel and the tissue the blood vessel is separated from.

[0038] The endoscopic vein harvesting (EVH) includes a second channel proximate the inner channel through which a second tool may be inserted under direct vision in the liquid or gas environment to effect harvesting. The harvesting includes dividing and / or separating and / or sealing the side branches. During hydrodissecting, if vessel side branches are exposed, a second tool is available to be deployed to divide and seal the side branches under direct vision in a hydrodissecting fluid environment, before withdrawing the tool and continuing the hydrodissecting. The second tool may be an electrocautery device. Manipulating the handle can include substantially aligning in parallel a central axis of the shaft with a central axis of the blood vessel. Manipulating the handle can include turning the C-ring 90 degrees so that the C-ring functions as a U-ring to support the blood vessel on a trough between the C-edges. The pre-harvesting portion further includes making an incision in the patient near the a vessel for harvesting to create an opening. The tool preferably is a valvulotome.

[0039] Preferably, after the vein for use in bypassing the blocked artery can be hydrodissected and harvested but remains in situ. In a case where the artery is a lower extremity artery, further including, post hydrodissection and han' esting, that the distal end of the endoscopic shaft fitted with the end cap, C-ring tool and ejector and telescoping infusion cannula can be inserted into a lumen of the hydrodissected / harvested vein, to separate the vein from its surrounding tissue.

[0040] In an embodiment, the invention provides a minimally invasive no touch (MINT) endoscopic vessel harvesting (EVH) method for bypassing blocked arteries in reliance upon an endoscopic harvesting (EVH) system that harvests blood vessels atraumatically, the system comprising a flexible endoscopic shaft connected to a handle connected to a controller, wherein the shaft includes an end cap at a distal end in which an image pickup device and a working end of a valvulotome mechanism are arranged, the valvulotomes controlled by a control element or dial in controller and the handle including an imaging port to support direct vision in reliance upon the pick-up device, where the method includes step.

[0041] The method steps can include exposing a great saphenous vein (GSV) to form an inner volume infused or insufflated with around 50 cc of fluid or gas, under direct vision through tumescent fluid and / or gas, separate the GSV in a hydrodissecting part of the method. Then, under direct vision through tumescent fluid and or gas, the side branches may be divided and sealed in a harvesting part of the method. For an in situ arterial bypass, the GSV is divided at the SF junction and the valvulotome is used to lyse the valves under direct vision; proximal anastomosis is performed above and below the blocked arterial with a portion of the GSV with valves so lysed. Preferably, the the valvulotome is an antegrade valvulotome that contains a nano-camera. The valvulotome may be introduced through an introducer sheath. The method can include visualizing proximal anastomosis with the GSV distended with tumescent fluid being delivered via infusion pump set at 100 mm Hg. The method can include investigating flow with Duplex scanner and PVR cuff and filling bypass locations with gel containing a phosodiesterase inhibitor for slow release over hours, days, or weeks.BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Further features and advantages of the invention will become apparent from the description of embodiments that follows, with reference to the attached figures, wherein:

[0043] Fig. 1 A is a transverse representative in situ view of a vein for harvesting;[0044 i Fig. IB is a longitudinal representative in situ view of the vein of Fig. 1 A;

[0045] Fig. 2A is a transverse representative in situ view of a greater saphenous vein (GSV) in a pre-hydrodissecting phase;

[0046] Fig. 2B is a longitudinal representative in situ view of the vein of Fig. 2A being hydrodissected;

[0047] Fig. 3 is a side perspective view of a modified MINT-based hydrodissector device with a pointed end cap capable of implementing the hydrodissecting and harvesting portions of the modified MINT procedure, such as the hydrodissecting part shown in Fig. 2A;

[0048] Fig. 4 presents a side cutaway view of the modified MINT-based hydrodissector of Fig. 3, highlighting the fluid channel;

[0049] Fig. 5 presents a front end view of tire modified MINT-based hydrodissector of Fig. 3;

[0050] Fig. 6 presents a side perspecti ve view of the modified MINT-based hydrodissector of Fig. 3, highlighting a rounded or blunt end-cap and components arranged therein;[0051 [ Fig. 7 presents a bottom view of the modified MINT-based hydrodissector with a blunt end-cap and shell attached;

[0052] Fig. 8 depicts a side view of the modified MINT-based hydrodissector with a blunt end-cap and shell attached;[0053[ Fig. 9 depicts a bottom view of the modified MINT-based hydrodissector with a blunt end-cap and shell attached;

[0054] Fig. 10 depicts the modified MINT-based hydrodissector in a front perspective view ;

[0055] Fig. 11 depicts the modified MINT-based hydrodissector arranged for use with a shell that is slid onto the shaft of the hydrodissector;

[0056] Fig. 12 depicts a front view of the hydrodissector with a blunt end-cap and shell dis-attached;

[0057] Fig. 13 depicts a front perspective view of an inventive hydrodissector with the snap-on shell snapped on;[0058[ Fig. 14 depicts a rear perspective view of the inventive hydrodissector device to highlight the liquid port and channel extending from the handle to the working end-cap;

[0059] Fig. 15 depicts a front plan view of the inventive hydrodissector device to highlight the liquid port and channel extending from the handle to the working end-cap;

[0060] Fig. 16 depicts a bottom perspective view of an endoscopic dissector the device with shell on;

[0061] Fig. 17 depicts a side perspective view of the hydrodissector of Fig 16 with the shell removed and arranged in the figure alongside the shaft of the hydrodissector;

[0062] Fig. 18A depicts a dissector formed with a shaft 2012 and a shell 2020 connected to the dissector shaft;

[0063] Fig. 18B depicts the dissector of Fig. 18A separated from the shell;

[0064] Fig. 19A shows the dissector the shell and highlighting a conical dissection tip mounted on a distal end of the shaft;

[0065] Fig. 19B shows the scope connector at the proximal end of the shaft, the shaft inserted in the shell at the shaft’s proximal end, which includes a cannula allowing access to the shell’s inner lumen.

[0066] Fig. 19C presents an alternative embodiment of the shell that includes a modified ejecting port from which extends a plastic or metal cannula that follows the angle defined by a contour of an outer surface of the dissection tip;

[0067] Fig. 20A presents an embodiment of an EVH hydrodissector / harvester system that is formed from a cannula-like endoscopic shaft formed with a working end to which a preferably clear plastic bullet end cap is connected, attached or integral with and an ergonomically-designed handle with tool adaptor port and a C-ring arranged within an inner volume of the clear plastic bullet end cap and or part of an inner volume of theharvester shaft proximal working opening where the C-ring and an ejector in the end cap cooperate t effect hydrodissection / harvesting;

[0068] Fig. 20B presents a view of the inventive EVH system of Fig. 20A, highlighting that extending the C-Ring extends the ejector attached to the C-ring that bisects the C- ring, preferably at a point in a trough bisecting the two C -rings;

[0069] Fig. 21 presents one exemplary embodiment of a controller for controlling fluid and gas flow control, as required by the inventive apparatus and modified MINT method of using same’

[0070] Fig. 22A represents an in vivo environment in which a method embodiment of the invention for bypassing a blocked artery in reliance upon a novel hydrodissectioiVharvesting system including a hydrodissector with a distal end cap and fluid ejector, where valvulotomes may be extended during an arterial bypass; and

[0071] Fig. 22B presents a system level view of the hydrodissection / harvesting system of Fig. 22A.DETAILED DESCRIPTION OF THE INVENTION

[0072] The following is a detailed description of example embodiments of the invention depicted in the accompanying drawings. The example embodiments are presented in such detail as to clearly communicate the invention and are designed to make such embodiments obvious to a person of ordinary skill in tire art. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention, as defined by the appended claims.

[0073] Fig. 1A presents a transverse view of a vein 100 (e.g., the great saphenous vein (GSVj), in situ, which is to be be hydrodissected and harvested according to the modified MINT procedure herein. As used herein, a hydrodissecting portion of the MINT procedure and / or the modified MINT procedure in which a blood vessel such as the GSV is separated from its surrounding tissue using hydrodissection and a harvesting portion of the MINT procedure and / or the modified MINT procedure in which the side branches are divided and sealed while in situ. Fig. IB presents a longitudinal representation of theGSV 100 prior to any pre-infusion processing, the actual hydrodissection and harvesting portions of the modified MINT process are implemented.

[0074] The MINT and / or modified MINT procedure also includes a pre-harvesting portion and a post-harvesting portion. The pre-harvesting portion preferably is carried out under ultrasound guidance. An incision is made above the GSV 100 (Fig. 2A), at the knee just above the portion of the vessel (GSV 100) to be first accessed. The medical practitioner creates a small opening in the skin 106 and inserts a tip of and infiltrating cannula 150 to create a small volume with tumescent hydrodissecting fluid.

[0075] It is through this small volume (see FLUID in Fig. 2A) through which an infiltrating cannula 150 or hydrodissection device 1000 is inserted (Fig. 2A). Once there is a small volume with fluid, the cannula 150 or hydrodissector 100 is inserted and navigated along a longitudinal axis of the vein as hydrodissecting fluid is ejected from the cannula to hydrodissect same with the forward motion (Fig. 2B) under direct vision through the hydrodissecting fluid. That is, the vein is separated away from its attachment to the deep perivenous fascial envelope as the tip is moved along the length of the vein.

[0076] A challenge to GSV harvesting is that the vein 100 includes a ligament 102 that connects it to the underlying muscular fascia and muscle tissue 104. The ultrasound (u / s) wand or probe 108 passes sound to localize the vein 100, fascia 104 and ligament 102 (Fig. 1A) to begin the procedure under u / s guidance (the pre-infusion part of the process). The laminar ligament 102 may be thought of as under the vein at a 6 o’clock position.The separation preferably is effected at a substantially fixed radius off the axial center of the vein 100, using the fluid exiting the end of the infusion canula 150. The pressure of the ejecting fluid causes a ring of fluid between an outer surface of the hydrodissected vein (which might appear to be floating in a “tunnel) and the muscular fascia and muscle tissue 104. The end of the shaft of the infusing catheter 150 is arranged between the superior margin of the GSV (or another blood vessel such as the radial artery 100) and respective superficial fascia 102 to which it is contained, where the pressure from the expanding fluid effects separation.

[0077] In an embodiment, once the GSV 100 is hydrodissected, the modified MINT process includes a novel harvesting portion implemented by first removing a substantialportion of the tumescent hydrodissecting fluid in the ring-like tunnel from the hydrodissecting part of the process and “replacing” the hydrodissecting fluid with a biocompatible gas. The pressure from the insufflated gas maintains the ring-like volume or tunnel in a relatively gaseous (with minimal fluid) for ease of imaging and for ease of dividing and sealing the branches, particularly with medical practitioners that are learning EVH, and most importantly, with no or minimal trauma to the vessel being harvested under direct vision through the insufflated biocompatible gas.

[0078] For that matter, in some cases post-hydrodissection, the laminar ligament 102 might remain fixed to the GSV 100. In that case, the complete separation is effected the harvesting phase of the MINT and / or modified MINT procedure. The infusing catheter 150 (please note that any hydrodissector, such as hydrodissector 1020 may be used), preferably includes a 1 mm pick-up device arranged in the tip / end-cap enabling operation under direct vision in both gaseous and fluid (liquid) environments. The skilled person will note that this modified hydrodissection procedures can be performed from the knee to the groin (for the GSV) as well as on the medial and lateral aspects of the vein or artery and under direct vision in reliance upon the 1 mm device in gas or fluid.

[0079] Fig. 3 presents an alternative embodiment of the infusion catheter 150 depicted in Fig. 2A and 2B in a form of a hydrodissector 1020 (used interchangeably herein with “hydrodissector device,“ “hydrodissector apparatus” and “hydrodissector”), capable of operating as does the infusing cannula 150 of Fig. 2A and 2B, and with the additional capabilities provided under the inventive principles. The hydrodissector 1020 is a major component of hydrodissecting system 1000.

[0080] In the embodiment shown, endoscopic hydrodissector 1020 is an endoscopic dissector converted to include a tip or end-cap 1012 configured to eject a pressurized fluid or gas for the pre-infusion part, the hydrodissecting part, the harvesting part and the post-harvesting part of the modified minimally invasive no-touch (MINT) technique. Endoscopic hydrodissector device 1020 may be a converted endoscope, i.e., the basic endoscopic part of an inventive endoscopic harvesting device or system 1000 of the invention. Hydrodissector device 1020 comprises an elongate shaft 1021 (and a shell1040 that detachably attaches or is slid onto the device 1020 is not shown in Fig. 3) to which a tip / end-cap 1012 is detachably attached at a working end (distal) 1010.

[0081] An ergonomically designed handle 1030 is attached at a proximal end 1011 of the endoscopic shaft 1021, which ergonomic design enables clinicians to rotate the handle about its central axis (during use) in limited space environments, which is typical in a surgery lab or suite. The tip / end cap 1012 as shown is a “pointed” end-cap but could be any other shape such as a blunt end cap with a cylindrically-shaped body 1016 and a cone- or blunt-shaped portion 1014 (see end cap 1012 in Figs. 6 and 16, for example).

[0082] The cylindrically-shaped body 1016 of exemplary end-cap 1016 has an open proximal (back) end that connects to, is attached to or is integrally part of the distal end 1011 of shaft 1021. An opposing end of the cylindrically-shaped body 116 connects to or transitions to the cone- or blunt- shaped portion 1014 of the end cap 1012. The cone- or blunt-shaped portion 1014 includes not only ejector 118 but also an illumination means (e.g., 1013 of Fig. 6), an image capture means (e.g., 1015 of Fig. 6) and preferably light means. The ejector port (1018 of Fig. 6) is fluidly connected to inner fluid channel 1022, which at its other end, is attached or otherwise connected to an infusion device at the handle 1030. Of course, a portion of the end-cap 1012 where the ejector 118 is position includes an opening in the end cap structure, which does not affect the flow in any way. Alternatively, the end-cap opening to allow the fluid to be ejected from ejector 118 may be shaped to control a flow direction of the fluid as it is ejected, to better control the separating force imposed thereby.

[0083] During intended use in support of the MINT process, and or modified MINT process, hydrodissecting fluid is ejected under proper pressure / velocity from the ejector port 118 in end cap 1012, effecting any of the various portions of the inventive MINT- centric processes, such as pre-harvesting, hydrodissecting, harvesting and post=harvesting. Preferably, the end-cap 112 includes a an adjustable constrictor (not shown in Fig. 3), for example, operating as a nozzle that enables the practitioner to turn the constrictor clockwise, for example, to constrict the opening at the ejector port and increase the hydrodissecting force and to the constrictor counter-clockwise to increase the diameter of the opening in the port, decreasing ejecting velocity and force.

[0084] Fig. 4 presents a side cutaway view of the hydrodissector 1020 of Fig. 3, highlighting inner liquid channel 1022 extending from the infusion port 1024 proximal the handle 1030 to the ejector port 1018 in the tip / end-cap 1012. The hydrodissecting fluid is ejected under controlled pressure / velocity out of the ejector opening or port 1018 while under direct vision by tire 1 mm pickup device 1015. Fig. 5 presents a front end view of the hydrodissector 1020 to highlight the infusion port 1024 in handle 1030, where Fig. 6 presents a side perspective view of a MINT-based hydrodissector device 1020, highlighting tip / end cap 1012.

[0085] In the embodiment shown, the tip / end-cap 1012 is clear to facilitate image pickup by image pick-up means 1015 in the cone-shaped end 1014 of end cap 1012. Lights 1013, preferably LED lights, iliummate the working area directly in front of the tip / end- cap 1014. Ejector port 1018 ejects the pressure-adjustable flow. Hydrodissector Device 1020 uses only an appropriate amount of cutting force imposed by the fluid ejected for hydrodissection to minimize trauma to the vein.. Hence, a control means for controlling an infusion pump connected to the infusion port 1024 to control the pressure and / or velocity of the ejected fluid is preferred .

[0086] The hydrodissector system 1000 includes a hydrodissector 1020 (with or without shell 1040 (see Figs. 7 and 8) is able to implement the MINT and modified MINT methods. The hydrodissection system 1000 may be used to map out the GSV 100 for harvest with ultrasound guidance from ankle to groin. For example, in a pre-infusion part of the modified MINT process, 50 cc of tumescent fluid (Plasma Lyte A or DuraGraft solution with additives) is then injected (see Fig. 2A) around GSV 100 just above the knee for three cm. The GSV 100 is essentially exposed via the 2 cm incision at level of perivenous tumescent fluid. Preferably, an introducer sheath is inserted in the incision opening with a sealing balloon (into two cm incision). Hydrodissecting fluid is then infused via a side port to displace air and create fluid environment in the small volume created by the incision and fluid.

[0087] Then, the hydrodissector 1020 is introduced into the opening and manipulated so that a central axis of the hydrodissector 1020 of system 1000 is substantially aligned in parallel with a central axis of the GSV under harvest. The is done under direct visionthrough the tumescent hydrodissecting fluid, where the images are displayed on a monitor. Starting at the 12 o'clock position, the clinician controls the force of the fluid ejected from ejection port 1018 to hydrodissect the GSV as the tip / end-cap 1012 is moved from the incision to the groin. In this method embodiment, the branches are exposed via the hydrodissection part. However, the harvesting portion of the process may be intertwined with the hydrodissecting part whereby pausing hydrodissection when side branches are uncovered and dividing and sealing same with a cautery device in reliance upon the shall 1040 that attached to the outside of shaft 1021. Then, after dividing and sealing each side branch, the cautery device may be retracted back into the shell and hydrodissection part resumes again to the next side branch, if any.

[0088] As the branches become visible, conventional MINT relies upon the hydrodissector to divide them at least one cm away from the main GSV. The branches are divided along with any soft tissue surrounding the branches, using cautery means. Hie steps of introducing and starting at the 6 o'clock position of the GSV are repeated, both hydrodissecting and harvesting portions under direct vision in the fluid environment. For that matter, the method can include performing the hydrodissection and the harvesting portions of modified MINT separately, where the hydrodissecting is implemented under direct vision in a fluid environment.

[0089] Under the modified MINT process, a medical practitioner who is just learning EVH might wish to perform the harvesting portion in a gaseous environment under direct vision. It may be easier and, therefore, less traumatic to the GSV being harvested if the inexperienced practitioner can implement the harvesting portion under direct vision in a gaseous environment. And of course, MINT and modified MINT may be carried out using the inventive systems described herein. To effect the harvesting phase under direct vision in a gaseous environment, the fluid is drained from the inner volume or ring-like tunnel created in the hydrodissecting phase and replaced with a biologically compatible gas. And at this point, the GSV is then totally disarticulated from all surrounding branches and soft tissue from the knee to the groin in the gaseous environment.

[0090] The modified MINT method may then include a vein extraction as a post harvesting part of the modified MINT process, where the hydrodissected vein, nowseparated in the harvesting part, is physically removed from the patient’s leg through the incision created in the pre-infusion part.

[0091] Continuing, a 5 mm trocar is placed over the proximal GSV in the groin. A 10 cm long, 5 mm wide clip applier is applied via the trocar and preferably three (3) eight (8) mm hemoclips are arranged at locations across the proximal GSV portion. The proximal GSV is divided just distal to the clips, preferably with a 10 cm long, 5 nun wide laparoscopic shears passed via the 5 mm trocar. Most preferably, the GSV is divided at the knee and the divided vessel removed and placed in a treatment solution, for example, DuraGraft solution.FOR HARVESTING THE GSV BELOW THE KNEE:

[0092] To harvest the GSV 100 below the knee, the GSV is first separated from its surrounding tissue and then, after dividing and sealing the side branches, the only remaining “connection points” are proximal the groin and the knee, depending on how much of the GSV is required for the implantation. The clinician typically makes a 5 nun incision at the groin and using a snap / hemostat / Adson clamp (SNID) and grasp the disarticulated vein segment under direct vision and draw it up percutaneously through the 5mm incision. Depending on training, the medical practitioner can use clips, suture ligation, or silk ties or a combination to ligate the vein proximally, cutting with vascular sc issors and grasping and extracting the segment out of the harvesting tunnel at the knee incision. Where the vein segment is still connected, hemoclips or a silk tie are used to ligate the vein at the distal portion of the incision. Once harvested, the GSV segments are “prepared” for use as a conduit for the coronary' bypasses. ”

[0093] Once extracted, the extracted GSV is prepared for transplantation. In this phase, the medical practitioner places an arteriotomy cannula into the distal segment of the vein (n the vein’s lumen), wherein in view of the venous valves, the inserted cannula ensures forward flow. Hemoclips can be used, e.g., 2 hemoclips, at each branch to ensure that there are no injuries, branch evulsion or holes that require a 7-0 Prolene repair suture. Preferably, any surrounding extra fat or connective tissue is removed from the harvested vessel segments. Once the vein is prepared and deemed good for use it is placed in asolution such as Lactate Ringers, normal saline (even though it is acidic- depends on the institution and the surgeon) and heparin. In the modified MINT method, an extended hemoclips applier is used that allows for hemoclips to be placed at the time of harvesting. Veins harvested this way are more hemostatic, as known cautery devices not always efficient and effective, particularly when a side branch is “large caliber.” Large caliber branches are prone to bleeding if they don’t seal well enough. The inventive method relies upon a small laparoscopic shear to divide the branches, such as Maquet’s Generation 7xb, which uses a bipolar cautery device with a small knife blade to divide and seal the branches. While circumstances define the required action, typically, the modified MINT method requires placing 2 clips on the vein side and 1 or 2 hemoclips on the patient side and the branch is cut in the middle.

[0094] Figs. 7 and 8 present a top plan view and a side plan view of the inventive hydrodissector-based harvester system 1000, where a detachable shell 1040 for effecting a harvesting portion of the modified MINT method is shown attached to the endoscopic hydrodissector 1020,zhydrodissector 1021 with end cap 1012. The shell 1040 includes a working port 1050. Various tools may be inserted into an insertion opening 150 at the proximal end of the shell, through a lumen or channel 151 formed between an outer surface of the shaft 1021 and an inner surface of the shell 1040. Fig. 9 presents a rear view of the system 1000 including handle 1030 and infusion port 1024 and tool insertion opening 1050.

[0095] Fig. 10 depicts a front end of the system 1000 with the hydrodissector device 1020, with the shell 1040 attached to shaft 1021 of the hydrodissector device 1020 ( after being slid on, as it is cylindrical), in a front perspective view to highlight the end-cap 1012 and the working opening 1042 of the shell 1040 from which a tool (such as an electric cautery device such as a bipolar cautery' deice, a laparoscopic shears, a harmonic scalpel, laparoscopic hemoclips, etc., without limitation) is extended under clinician control using the handle. Tools are inserted through working port 1050 (at the distal end) and through an inner channel (formed by the attached shell 1040) 1051 (se Fig. 8) and out the working opening 1042.[0096| Fig. 11 depicts hydrodissector system 1000 with hydrodissector device 1020 proximate the (separate) shell 1040, which separate shell is snapped onto or slid onto the shaft 1021 of the hydrodissector device 1020.. As the skilled person will note, the shell 1040 with an open clam- like portion that is pried open to snap the hydrodissector device shaft 1020 into a channel 1053. But the shell 1040 as shown could be replaced by a cylindrical shaft-like shell that completely surrounds the hydrodissector device 1020, in inner channel 1053 of the shell. The shell receives tools through opening 1050 that extend through the other shell lumen 151 and out working end 1042 for use under direct vision, for example, in the harvesting phase. The shaft device 1020 is attached and held in the inner shell lumen 252 by a sliding friction fit.

[0097] Fig. 12 is a front perspective view of the hydrodissector system 1000 with the hydrodissector device 1020 and end-cap 1012, and the cylindrical shell 1040; the hydrodissector device is dis-attached or separated from the shell by sliding it out..

[0098] Fig. 13 shows a front perspective view of the hydrodissector 1020 and snap-on shell 1040’, which is a clamshell design, snapped on. Fig. 14 is a rear perspective cutaway view of hydrodissector system 1000, highlighting the infusion port 1024 and fluid channel 1022 extending from the handle 1030 to the working end-cap 1012 at shaft end 1011 and part of the clamshell-like shell 1040’ cutaway. The hydrodissector device 1012 is attached to the shell 1040’ to highlight the inner tool channel 1051. In the shell 1040’, the shaft is inserted between the clamping ends and the clamping ends snapped shut. In the shell 1040 (Figs. 3-12), the shaft is slid into the channel 1053.

[0099] Fig. 15 presents a front view of the the system 1000 including the shell 1040 attached to the hydrodissector device 1020. Fig. 15 highlights the channel extending from the handle to the working end-cap 1012 of the hydrodissector 1020 / 1021, where shell 1040 is attached and highlights the working ports 1050 and 1042. Fig. 16 presents a bottom perspective view of hydrodissector device 1020 with the shell 1040 connected / attached, highlighting fluid channel 1022 and working channel 1051 in the shell. Fig. 17 presents a side perspective view of the system 1000. where the shell 1040 is separated from the hydrodissector ( 1020) shaft 2021 ; the shell 1040 is arranged in the figure alongside the shaft 1021. Fig. 17 highlights that the shell 1040 includes a channelabove tool channel 1051 that receives the shaft of endoscopic device 1020, whether it is snapped on (in the embodiment shown) or slid on and held by friction (not shown in Fig. 17), enveloping the surface 1021.

[0100] The modified MINT technique relies upon a “hydrodissecting cannula” to perform a hydrodissection function in the pre-infusion and hydrodissecting pails of modified MINT, e.g., by hydrodissector device / shaft 1020 / 1021, cone-shaped tip / end-cap 1012 and fluid ejection port 1018. The ejection port preferably is arranged proximal to or at the geometric center of the cone part 1014 to ensure that the fluid heading during ejection is parallel to a central axis of the GSV. The straight angle of attack of the ejected fluid minimizes damage that might occur if the fluid is ejected at an off-angle towards the vein.

[0101] The harvesting part of the modified MINT process includes snapping the shell 1040 onto the shaft 1020 (with surface 1021) of the hydrodissector 1020. The shell 1040 allows the hydrodissector system 1000 to receive tools such as electrocautery devices and valvulotomes, which support the hydrodissecting device 1020, through inner tool channel 1051. And as the skilled person knows, using conventional tools such as cautery devices (Ligasure, ThunderBeat, Sonocision) ring hole can at times come in contact with the leg or the table where the leg is resting, which is undesirable. Hence, the ergonomic handles deployed in the inventive EVH systems are able to rotate around the camera within the device in a 360 degree plane.

[0102] With regards to the fluid environment vs CO2, conventional arthroscopic surgery towers and instruments are known to supply fluid through one fluid delivery channel. In the inventive EVH system 1000, the gas, like a fluid, may be supplied through the handle for ejection out of end-cap 1012 (i.e., fluid ejection opening 1018), which accumulates under pressure to maintain an annular ring-like tunnel separating the outer surface of the organ and the muscular fascia from which it is separated.

[0103] Using CO2 in the harvesting phase provides for very clear imaging (a “dry” tunnel), and simpler division of side branches. This reduces learning curves for clinicians entering EVH practice. And since the vein is already immersed in the tumescent, treated hydrodissecting fluid before being temporarily exposed to CO2 little or no effect will besuffered on the harvested vessel from the post-hydrodissecting gaseous environment. To do so a good deal or substantially all of the hydrodissecting fluid is removed from the tunnel. The inner volume formed by the hydrodissecting part is insufflated with CO2. (under pressure) and maintains the ring-like tunnel to maintain separation of the vein from the tissue it is separated from. This optional part of modified MINT may be utilized by new practitioners until they master the harvesting portion under direct vision through the tumescent hydrodissecting fluid.

[0104] In an embodiment, the invention provides an inventive EVH system 2000. Figs. 18 A, 18B, 19A, 19B, and 19C describe to inventive EVH system 2000, which supports both the conventional MINT and modified MINT vessel harvesting techniques. In EVH system 2000, the fluid is provided via a shell 2040, rather than through an end cap, as is now explained in greater detail

[0105] EVH system 2000 comprises an endoscopic dissector 2020 formed with a dissector shaft 2021 , and a shell 2040 that detachably connects to the dissector shaft 2021. The endoscopic dissector 2020 may be an equivalent to the 7 nun dissector / scope, which is part of a Vasoview™ Hemopro™ (“Vasoview™”) endoscopic vessel harvesting (EVH) system. The Vasoview™ system is available through a Swedish Medical Technology company Getinge.

[0106] Endoscopic dissector 2020 includes a handle 2030 with a port 2024 detachably connected at the proximal end 2011 of the dissector shaft 2021 by a connector 2031. An end cap 2012 comprises a cylindrical part 2016 and a cone or blunt-shaped part 2014 at a distal end 2010 of shaft 2021. In this embodiment, the end cap 2012 is not used for blunt dissection as Getinge intends, but merely for imaging, as the fluid is ejected from an ejector port 2044 at the distal end of 2042 of shell 2040.

[0107] The shell 2040 is elongate and may be a closed cylinder or a cylindrical tube formed with a slot that can be pried open to access an inner volume or lumen formed between two clamshell-like ends when they snap closed about the dissector. The clamshell-like ends (formed by the slot) are spread apart against a closing force to access an inner volume or lumen 2053. Alternatively, the shell 2040 may be formed as a cylindrical form, whereby dissector shaft 2021 is slid into the shell’s inner volume(lumen) 2053, designed for same. Fig. 18A shows the shell 2040 attached to the endoscopic dissector 2020 / dissector shaft 2021; Fig. 18B shows the dissector 2020 and shell 2040 separated.

[0108] A second lumen or inner channel 2051 is formed in the shell 2040, preferably under the lumen 2053. The second inner lumen or channel 2051 is sufficient to accommodate a working tool and a fluid conduit 2052. The lumen of channel accommodates both the working tool body and the fluid conduit. The fluid conduit carries fluid for ejection from ejector port 2042 at opening 2044. The tool can be controlled to extend out of opening 2044 and the hydrodissecting fluid and / or gas is controlled to be ejected from ejector opening 2042.

[0109] The inner channel or lumen 2051 extends between port 2050 at a proximal end2041 of the elongate shell 2040 and the opening 2044 at a distal end. The fluid supply conduit 2052 may be connected to a gas and / or fluid supply or alternatively, to a controller for controlling a gas or fluid supply (not shown in this figure) to eject the gas or fluid at a controlled force, velocity and / or pressure to atraumatically harvest the vascular target.

[0110] Whether the shell 2040 is formed to snap on to or to be slid on to the dissector shaft 2021, the outside diameter of the EVH system 2000, after the shell 2014 is attached and circumscribes the outer surface of the shaft 2021, preferably is less than or equal to an inner diameter of a cannula seal or plug. The dissector 2020 / dissector shaft 2021 is inserted in the shell 2040 to form the system 2000, the attached devices inserted through a central opening in the cannula seal or plug that substantially seals the incision opening against uncontrolled release of tumescent gas and / or fluid. That is, the dissector / harvester system 2000 is received through an opening in the plug. The cannula plug seals gas or hydrodissecting fluid in the tunnel formed by the fluid or gas under controlled pressure in a substantially gas and fluid-tight environment.

[0111] Fig. 19A shows the endoscopic dissector 2020 / dissector shaft 2021 separated from the shell 2040. As shown therein, the end-cap 2012’ mounted on the distal end 2010 of the shaft 2021 is not used for dissection or hydrodissection. End-cap 2012’ (and pickup device therein) is used to image the space in front of the end-cap, as fluid or gas isejected from ejection port 2042 or distal opening 2044, effecting hydrodissection. As shown, fluid conduit 2052 may be inserted into channel 2051, which communicatively connects a supply at the port 2050 to the ejector port 2042 at distal opening 2044. Alternatively, a gas and / or fluid supply (not shown) may be connected directly to port2050 to provide a gas / fluid under controlled pressure and / or velocity through channel2051 (without a fluid conduit 2052) and out ejection opening 2042. For that matter, a lavage means preferably is include at or proximate the port 2050 or handle 2030 to withdraw tumescent fluid from a “tunnel” for example, to remove most fluid and insufflate with a biocompatible gas such as CO2.

[0112] In both the conventional and the modified MINT methods, the hydrodissecting fluid is ejected under controlled pressure and direction out of ejecting port 2042 or opening 2044 (of shell 2040) to effect hydrodissection. Certain tools also may be inserted and passed through opening 2050 into the shell inner lumen, whether between a fluid conduit and the shaft 2020 / 2021 or as a fluid channel. This enables the clinician to use a tool and eject hydrodissecting fluid concurrently, as long as the handle may be handled in a crowded surgical environment. The hydrodissecting force is directed by the clinician, and so may be described as a vector quantity. Fig. 19B highlights a proximal end 2021 of the dissector 2020, which includes a scope connector 2030. As shown, dissector shaft 2021 has been inserted in the shell 2040.

[0113] Fig. 19C presents a modified shell 2040’, which is an example of an alternative embodiment of the shell 2040 (and EVH system 2000). Shell 2040’ includes a modified ejecting port 2042’, proximate opening 2044, from which port 2042’ extends a plastic or metal cannula 2048. Cannula 2048 follows a contour angle of an outer surface 2014s of the dissection tip 2012. The 2048 may be arranged as shown fixedly, or alternatively, may be withdrawn into lumen 2053 during non-use and controlled to extend out of the shell for deployment. Fluid and / or is ejected with a force limited by that angle. The angle that follows the angle of the dissection tip 2012 is understood to direct the hydrodissecting force in what experienced clinicians might refer to as the sweet spot for effecting dissection. A significant advantage of the inventive hydrodissector / harvester2000 is that it can be used readily as a dissector harvester in either the conventional or modified MINT-based methods.

[0114] In another embodiment, the invention provides an EVH hydrodissector / harvester system 2500, as shown in Fig. 20A and Fig. 20B. EVH hydrodissector / harvester system 2500 is formed from a cannula-like endoscopic shaft 2510, such as the harvesting cannula that is part of the Vasoview™ Hemopro™ EVH system. Cannular-like shaft 2510 is formed with an open working end 2512, to which a preferably clear plastic bullet end cap 2513 is connected, attached or integral with. An ergonomically-designed handle 2514 with tool adaptor port 2515 is connected to the proximal end of cannular-like shaft 2510.

[0115] A C-ring 2517 is arranged within an inner volume of the clear plastic bullet end cap 2513 and or part of an inner volume of the harvester shaft proximal working opening 2512. The C-ring 2517 is connected by mechanical connecting means, or mechanical linkage means to an actuator or lever 2516 at the handle, for example, on a surface of the handle 2514. The clinician may push the actuator or lever 2516 forward to extend the C- ring 2517 out of the opening at the open working end 2512 and draw the C-ring back into the inner volume. For that matter, the handle 2514 is designed so that it may be rotated clockwise and / or counterclockwise, which rotates the C-ring.

[0116] EVH hydrodissector / harvester system 2500 also includes a specially configured telescoping cannula 2520 affixed to the outside of the harvest cannula 2510 using attachment means 2511. This allows the harvesting cannula to effect BOTH hydrodissection and harvesting. Telescoping cannula 2520 is connected to a fluid / gas controller 2524. Fluid / gas controller 2524 can include a Luer lock device 2526 that has capability to connect the telescoping cannula (e.g., an 11g telescoping cannula) at the distal end of telescoping cannula 2520C. The fluid gas controller may be in fluid communication with a source of fluid, a source of gas and a fluid sink or lavage device. Once connected, pressure-controllable fluid input 2528A and pressure controllable biocompatible gas input 2528B allow for pressure and velocity controlled fluid and gas ejection, respectively. Telescoping cannula has a working tip 2520t, at its distal end and a fluid / gas connector 2520c at its proximal end.

[0117] Preferably, the telescoping cannula 2520 is arranged so that its working tip 2520t is affixed to the C-ring 2517 at a substantially exact center of the “C” structure, separating the edges of theUC” structure. The connector end 2520c connects to the Luer lock means 2526. Moving the C-ring forward or back using lever 2516 moves the working tip 2520t of at least the telescoping cannula 2520 forward and backwards (the push force effecting telescoping of the inner and outer tubes).

[0118] During a hydrodissection operation, using either the known or modified MINT methods, the front end of system 2500 is inserted into an incision (e.g., at the knee), creating an inner volume with the fluid or gas, exposing the GSV. Then, the front end is moved along a longitudinal axis of the vein, hydrodissecting tire vein, leaving an annular tunnel filled with tumescent hydrodissecting fluid or gas. That is, the fluid is ejected under direct vision via the working tip 2520t of the cannula 2520, and under controlled pressure (controlled by the fluid / gas controller 2524), to hydrodissect or harvest the GSV.

[0119] During hydrodissection, the handle may be rotated 90 degrees so that the ends of the “C” structure of the C-ring 2517 are facing up. The vein sits in a trough created by the C-ring rotated 90 degrees by rotating the handle. The tissue for hydrodissection is always at a forward heading in the trough The GSV and any tissue remaining thereon may be supported by the then “u-shaped” C-ring. When a clinician extends the C-ring 2517 rotated to be a U shape, as shown in Figs. 20A, 20B, the working tip 2520 moves in and out as the U-arranged C-ring support the vein in the trough, the fluid exiting the working tip 2520t readily hydrodissecting and separating the vein / attached tissue from the leg.

[0120] A cutting tool may be inserted in the opening 2515 of the handle 2514 attached to the shaft 2510 and out past the C-ring 2517 to effect division and sealing of side branches. In that case, both the hydrodissecting and harvesting parts of the process are combined and implemented under direct vision. But please note that the harvesting portion of the modified MINT method can rely upon the gas / fluid supply connected through Luer lock means 2526 to allow for fluid to be removed (the means 2526 including a lavage mechanism therefor). Gas is then insufflated, filling the inner volume with the gas through a cannula seal (not shown in Fig. 20A, 20B).

[0121] An embodiment of the fluid / gas controller 2524 is shown in Fig. 21. Controller 2524 controls the flow rates of hydrodissecting fluid and / or inert gas provided to the cannula 2520 and out ejector ports in the various embodiments. Controller 2540 includes tubing 2542, preferably plastic. On / off switch 2544 activates / deactivates the controller. .An electronic or mechanical flow-rate control device 2546 provides for adjusting the flow rate through the tubing 2542. The flow-rate control device 2546 defines how much fluid, if any, will flow through the tubing using the device’s releasable clamping mechanism. Constricting the diameter of the tubing can increase the pressure, if the fluid supply supplies the tubing at a fixed rate, substantially independent of any impedance to flow created inadvertently by the constriction.

[0122] A pulsing element 2548 provides the fluid or gas in a pulsed flow. For example, the element 2548 ejects a steam of hydrodissecting fluid or gas at for some part of the pulse period, such as a 40 % duty cycle. As can be seen in Fig. 20, the tubing may be arranged so that the flow is backwards, to drain some or the fluid or gas from the inner volume. For that matter, the inventive EVH system embodiments that might include the controller 2540 also may have a need for more than one gas supply or more than one supply of treating hydrodissecting fluid. The controller can be configured to accommodate and control multiple supplies, such as gas and fluid supplies through switches / dials 2551, 2552 and control a fluid drainage means vias lavage control switch or dial 2553. The lavage control switch or dial controls at least one suction port included and connected to suck out excess or unwanted fluid or gas from the Tunnel (though the various system embodiments. The inventive controller also provides the clinician with the capability to select a variety' of pulse waveforms, and varying an intensity (e.g., the velocity or flow rate and pressure) for a pule waveform selected by the clinician.

[0123] In an embodiment, the invention provides a method of bypassing a blocked artery 2755 that relies upon hydrodissection / harvesting system 1000” shown in Figs 22 A and 22B.

[0124] EVH system 1000” includes a flexible endoscopic hydrodissector shaft 2021” with end cap 1012” connected to the shaft at distal end 1010”. EVH system 1000” includes a pick-up device 1015, lights 1013 and valvulotomes 2750. The valvulotomes2750 are controlled to extend from the end cap 1012” of the hydrodissector 1020”. The valvulotomes are used to cut valves in vein 2755 to allow proximal to distal directional flow therethrough (antegrade). Disabling the vales ensures that the arterial blood flow is enabled when the vein is utilized to bypass an artery blockage, e.g., the in situ vein to proximal common femoral artery anastomosis as shown.

[0125] In addition to providing hydrodissection, the EVH system 1000” enables the clinician to visualize directly and lyse the valves inside the hydrodissected vein so the harvested vein may be used for arterial bypass. The modified MINT method may rely upon the hydrodissector to hydrodissect and harvest a vein or prepare a vein for bypass. The vein may be attached and the valves cut in a procedure by inserting the hydrodissector shaft 1020” inside the vein in situ.

[0126] That is, once the vein is prepared for in situ use or harvested for a reverse vein graft bypass and treated as taught herein using EVH system 1000”, the harvested vein portion is attached (anastomosed) on both sides of the blockage in the occluded artery, i.e., above and below the occlusion. The shaft 2020” is then inserted into the anastomosed vein lumen, as shown, and the valvulotomes 2750 guided in and out end cap 1012” to cut and disable the valves under direct vision. Use of the use of the system 1000” to lyse the valves in a post-harvesting part of the modified MINT procedure, after the vein is hydrodissected, where the hydrodissecting and cutting of the valves in the vein used for the arterial bypass under direct vision in a fluid or gaseous environment is novel and non- obvious.

[0127] Fig. 22B highlights that the shaft 1020” is flexible and is connected to a handle 1030”. The handle is connected to a controller 2752. The valvulotomes 2750 are controlled by control element or dial 2760. Gas and / or fluid is provided as an input at fluid connector 1024. A light source may be attached at controller port or cannula 1039, which is carried inside flexible shaft or tube 1020” for example, in a light tube or fiber optic light channel. The light elements also can be simple LED lights connected by ware in flexible shaft 1020”. Element 2762 is an adjustable eyepiece. Connector 2764 operates as video port for outputting captur ed images and video for presentation to the user in a compact tower and compact display screen, or a compact screen that can receive anddisplay the captured images without a tower. The connector may may be connected to a display means for viewing what the camera 1015 sees under direct vision. The clinician must manage the controls in handle 1030” as well and on controller 2752. Element 1030 is an insertion port for a light source.[01.28] The invention provides an embodiment of modified Mint method in reliance upon the invention of Figs. 22A and 22B.

[0129] In a pre-hydrodissection portion of the method, xylocaine is added to Plasma Lyte A solution. Then local anesthesia is infiltrated over blood vessel such as the GSV at level of medial malleolus. Then, 50 cc of Plasma Lyte A with heparin, papaverine and xylocaine is infused around the distal GSV under ultrasound guidance. The GSV is exposed using the inventive modified minimum invasive no touch (MINT) technique by inserting the en-cap end of one of the inventive EVH systems through a 2 cm longitudinal incision. Preferably, the GSV is hydrodissect from ankle to groin under direct vision, using the pick-up device, which is a nano camera. A second 2 cm incision around the knee will be required

[0130] Under direct vision, divide all side branches of GSV and harvest GSV just like for coronary artery bypass graft (CABG) for reversed saphenous vein bypass is performed. The standard reversed saphenous vein bypass. is performed from easily exposed proximal and distal anastomotic sites. For in situ bypass, the GSV is divided at the SF junction, remove first valve under direct vision and perform proximal anastomosis. Then, a smart (contains nano camera) antegrade valvulotome via standard introducer sheath placed in proximal the CFA. The smart antegrade valvulotome is inserted through an introducer sheath and visualizes proximal anastomosis with GSV distended with tumescent fluid being delivered via infusion pump set at 100 mm Hg. The device is advanced down the GSV and each valve is lysed as it is encountered w'ith care to only lyse the gossamer portion of the valve. Do not touch the thick ridge at base of valve of the endothelium.The antegrade valvulotome is removed and the lysed valves allow' antegrade flow' through the bypass. The distal anastomosis is then performed and investigate flow with Duplex scanner and PVR cuff. If OK, then the around either bypass is filled with gel containing aphosodiesterase inhibitor for slow release over hours, days, or weeks. The incisions are then closed and followed monthly with Duplex scans.

[0131] One embodiment provides a minimally invasive no-touch (MINT) procedure for atraumatically harvesting a blood vessel for implantation in reliance upon an endoscopic vein harvesting (EVH) system formed with an endoscopic shaft, a handle connected to one end of the endoscopic shaft and an end-cap with an image pick-up means and an ejector port therein, the ejector port in fluid communication with an infusion port in the handle, the end-cap connected at another end of the endoscopic shaft and a controller connected to the infusion port for controlling a fluid and / or gas supply to eject a fluid and / or gas at a controlled velocity and / or acceleration from the ejector port to effect harvesting, the method including at least a hydrodissection portion of the MINT procedure.

[0132] The hydrodissection portion comprising steps of: forming an incision and inner space at a point of access to the blood vessel; under direct vision in reliance on the image pick-up device, guiding a front end of the endoscopic shaft to which the end-cap is attached into the inner space under direct vision while controlling the EHV system to eject a fluid and / or gas from the ejector port, separating the blood vessel from its surrounding tissue. Separating the blood vessel from its surrounding tissue creates a substantially annular separation volume between an outer boundary of the separated blood vessel and tissue the blood vessel is separated from.

[0133] The method includes a harvesting portion of the minimally invasive no-touch (MINT) procedure, the harvesting portion comprising the steps of inserting one or more tools in a working tool channel extending between the handle and an opening proximate the ejector port in the Endoscopic harvesting (EVH) system, and manipulating at least the one or more tools to separate and divide the branches atraumatically under direct vision in a gaseous environment. The manipulating can include using the controller to drain fluid from the substantially annular separation volume and insufflating the volume with a gas to support separating and dividing the branches under direct vision through the gas. The method also can include a post-harvesting portion of the minimally invasive notouch (MINT) procedure, the post-harvesting portion including placing the harvestedblood vessel upon extraction into a bath of treated fluid. The method also can include a pre-harvesting portion of the minimally invasive no-touch (MINT) procedure, the preharvesting portion including forming an incision above a decided point of access at the blood vessel location and inserting an infuser device under ultrasound guidance to infuse about 50 cc of fluid and / or gas to create the inner space.

[0134] As will be evident to persons skilled in the art, the foregoing detailed description and figures are presented as examples of the invention, and that variations are contemplated that do not depart from the fair scope of the teachings and descriptions set forth in this disclosure. The foregoing is not intended to limit what has been invented, except to the extent that the following claims so limit that.

Claims

WHAT IS CLAIMED IS:

1. A minimally invasive no touch (MINT) endoscopic vessel harvesting (EVH) system that harvests blood vessels atraumatically, the system comprising: an endoscopic shaft with a distal end, a proximal end and an inner channel extending between the proximal and distal ends; a handle connected at the proximal end of the endoscopic shaft including a fluid and / or gas infusion port in fluid communication with the inner channel; an end-cap arranged at the distal end of the endoscopic shaft including an image pick-up device and an ejection port, the ejection port in fluid and / or gas communication with the inner channel; a fluid and / or gas supply connected to the infusion port; and a controller for controlling the fluid and / or gas supply to eject a fluid or gas at a controlled velocity and / or pressure from the ejector port to separate the blood vessel from its surrounding tissue, creating a substantially annular separation volume by tumescent fluid and / or gas, as the endoscopic shaft and end-cap are advanced along a longitudinal extent of the vessel under direct vision through the tumescent fluid and / or gas.

2. The system of claim 1, wherein the tissue separation occurs at a radial distance from a central axis of the vessel that is greater than a radial distance to an outer surface of the blood vessel.

3. The system of claim 1, wherein the fluid and / or gas supply includes a lavage means to extract tumescent fluid and / or gas from the annular separation volume after the vessel is separated from its surrounding tissue, the annular separation volume then insufflated with a biocompatible gas; and wherein the hydrodissected blood vessel is then harvested under direct vision in the tumescent or insufflated gas through the annular volume.

4. The system of claim 1, where the gas is CO2.

5. The system of claim 1, wherein the image pick-up device captures images through the tumescent fluid and / or gas that a clinician views to navigate the vessel while implementing a hydrodissecting portion, a post-hydrodissecting harvesting portion and a post-harvesting portion of a minimally invasive no-touch (MINT) process.

6. The system of claim 1, wherein the ejection port is arranged in the end-cap so that fluid and / or gas is ejected in a direction that is substantially in parallel with a central axis of the hydrodissector shaft.

7. The system of claim 1 , further comprising an elongate shell with an inner channel extending between a proximal end and an opposing distal end to which the endoscopic shaft is detachably attached; wherein the proximal end includes an opening for receiving a tool that can be controlled by a clinician to extend from the distal end opening and effect a tool operation.

8. The system of claim 8, wherein the tool includes any of a cautery device, forceps, an atraumatic vessel capture tool such as a C-ring and a valvulotome cutting device.

9. The system of claim 1, wherein the pick-up device is a 1 mm CCD camera and wherein the shaft is a 5 cm shaft.

10. The system of claim 7, wherein the shell is a cylindrical tube like structur e with an inner lumen or volume that the endoscopic shaft is slid into.

11. The system of claim 7, wherein the shell is formed as a cylindrical tube like structure that has a linear slot extending along its entire length forming opposing edges that may be pried apart against inherent closing forces to insert the endoscopic shaft into the shell inner lumen, wherein the opposing edges snap closes, the shaft enveloped in the shell inner lumen.

12. A hydrodissector for atraumatically hydrodissecting and harvesting a vascular target. comprising: an ergonomically-configured handle with at least one port for receiving a tool; an elongate cylindrical shaft with a proximal and distal end, the proximal end attached to the ergonomically-configured handle and the distal end attached to a back end of a transparent, cylindrical end cap, a front end of which includes an opening to an inner end cap volume in communication with an inner shaft channel that extends from the end cap opening to the at least one port in the ergonomically-configured handle, the end cap opening, the inner shaft channel configured for receiving a working tool with a working tool end that is extended from the opening, including by manipulation of the ergonomically-configured handle; a telescoping infusion cannula with a proximal end and an opposing distal end, the telescoping cannula attached to the elongate shaft and formed with an infusion port at the proximal end and an ejector port at the distal end; a hydrodissecting fluid supply in fluid communication with the infusion port of the infusion cannula; and a controller for controlling any of a pressure, a flow rate, a flow acceleration rate, a flowrdeceleration rate, a pulsed flow rate and a directional flow rate of a liquid and / or gas flow from the ejector port to separate the vascular target from its surrounding tissue atraumatically, leaving an annular volume between the outer surface of the vascular target and the separated, surrounding tissue; wherein a working tool is slid in and out of the shaft inner channel via the at least one port and controlled to extend and manipulate a working tool end from the end cap opening when deployed.

13. The hydrodissector of claim 12, further comprising a pick-up device in the end cap electronically connected through the at least one channel to video connector or port in the ergonomically-configured handle.

14. The hydrodissector of claim 13, wherein, under direct vision in a fluid environment, the vascular target is hydrodissected and then harvested.

15. The hydrodissector of claim 13, wherein the vascular target is hydrodissected in the fluid environment, wherein post-hydrodissection, the hydrodissecting fluid is removed and replaced with the biocompatible gas and hydrodissected vascular target is harvested under direct vision in the gaseous environment.

16. The hydrodissector of claim 13, wherein the end cap that is removably attached to the distal end of the elongated shaft and interchangeable with alternatively designed end-caps.

17. The hydrodissector of claim 13, wherein the distal end of the telescoping infusion cannula at the ejector port is detachably connected a 'working tool end of a working tool that comprises a C-ring attached at a working tool end of a C-ring shaft fitting in the shaft inner channel, the other end of the C-ring shaft formed to enable controlling the C-ring at tool deployment, the distal end of the infusion cannula connected to a point on an inner surface of the C-ring that bisects the C-ring, and wherein controlling the C-ring to extend from the opening concurrently extends the distal end of the telescoping infusion catheter.

18. The system of claim 17, where turning the handle 90 degrees clockwise rotates the C- ring 90 degrees to appear as a U-shaped trough that holds the vascular target fluid and / or gas exiting the ejector port separates the the vascular target from its surrounding tissue.

19. The system of claim 18, where the target vessel is maintained in tire U-shape trough as the practitioner controls the controller to effect hydrodissection along the longitudinal extent of the vascular target.

20. A minimally invasive no-touch (MINT) procedure for atraumatically harvesting a blood vessel for implantation to bypass a blocked artery in a patient in reliance upon an endoscopic vein harvesting (EVH) system, the EVH system comprising an endoscopic shaft fitted with a handle at a proximal end and an end cap at a distal end, the end cap including an imaging means, wherein a tool inner channel extendsfrom an opening in a distal end of the end cap through the shaft and handle to an access port in the handle, a C-ring tool comprising a C-ring connected to a distal end of a tool shaft, a proximal end of the tool shaft extending out of the access port in the handle to allow C- ring tool manipulation; a diffusion cannula with a telescoping shaft formed with an ejector port proximate a distal end of the diffusion cannula, the distal end of the diffusion cannula connected to the C-ring at a central axis of the C-ring and a proximal end of the diffusion cannula connected to a controllable fluid and / or gas supply; and wherein manipulating the the C-ring tool to extend the C-ring from the opening in the end cap extends the ejector opening and the telescoping shaft of the diffusion cannula, and manipulating the C-ring tool to withdr aw the C-ring back into the opening in the end cap retracts the ejector opening and the telescoping shaft of the diffusion cannula; the method comprising steps of: pre-harvesting by making an incision at tire blood vessel and create an inner volume thereunder with an approximately 50 cc of fluid or gas to access the blood vessel; plug the incision; place the distal end of the endoscopic shaft, the C-ring of the C-ring tool and the attached distal end of the telescoping diffusion canula into the inner volume through the cannula seal or plug; under direct vison through tumescent fluid and / or gas, manipulate the handle and / or the proximal end of the C-ring tool to to extend the C-ring and position the C-ring relative the blood vessel to include a part of the blood vessel between C-edges of the C-ring so that ejecting fluid will be ejected directly above the blood vessel in a direction that is colinear with a central axis of the blood vessel portion between the C-edges; under direct vision through tumescent fluid and / or gas, eject fluid and / or gas from the ejector port as the blood vessel, supported between the C-ring edges of the C-ring, as the endoscopic shaft is advanced along a length of the blood vessel to affect hydrodissection under direct vision in a fluid or gas environment, separating the blood vessel and leaving an annular volume between the separated blood vessel and the tissue the blood vessel is separated from.21, The minimally invasive no-touch (MINT) procedure of claim 20, wherein the endoscopic vein harvesting (EVH) includes a second channel proximate the inner channel through which a second tool may be inserted under direct vision in the liquid or gas environment to effect harvesting.22 The minimally invasive no-touch (MINT) procedure of claim 20, wherein the harvesting includes dividing and / or separating and / or sealing the side branches.

23. The minimally invasive no-touch (MINT) procedure of claim 22, wherein during hydrodissecting, if vessel side branches are exposed, a second tool is available to be deployed to divide and seal the side branches under direct vision in a hydrodissecting fluid environment, before withdrawing the tool and continuing the hydrodissecting.

24. The minimally invasive no-touch (MINT) procedure of claim 22, wherein the second tool is an electrocautery device.

25. The minimally invasive no-touch (MINT) procedure of claim 22, wherein manipulating the handle inc ludes substantially aligning in parall el a central axis of the shaft with a central axis of the blood vessel.

26. The minimally invasive no-touch (MINT) procedure of claim 22, wherein manipulating the handle includes turning the C-ring 90 degrees so that the C-ring functions as a U-ring to support the blood vessel on a trough between the C-edges.

27. The minimally invasive no-touch (MINT) procedure of claim 22, wherein the preharvesting portion further includes making an incision in the patient near the a vessel for harvesting to create an opening.

28. The method of claim 23, wherein the tool is a valvulotome.

19. The method of claim 22, wherein after the vein for use in bypassing the blocked artery is hydrodissected and harvested but remains in situ.

30. The method of clam 22, wherein, in case where the artery is a lower extremity artery, further including, post hydrodissection and harvesting, that the distal end of the endoscopic shaft fitted with the end cap, C-ring tool and ejector and telescoping infusion cannula is inserted into a lumen of the hydrodissected / harvested vein, to separate the vein from its surrounding tissue.

31. A minimally invasive no touch (MINT) endoscopic vessel harvesting (E VH) method for bypassing blocked arteries in reliance upon an endoscopic harvesting (EVH) system that harvests blood vessels atraumatically, the system comprising a flexible endoscopic shaft connected to a handle connected to a controller, wherein the shaft includes an end cap at a distal end in which an image pick-up device and a working end of a valvulotome mechanism are arranged, the valvulotomes controlled by a control element or dial in controller and the handle including an imaging port to support direct vision in reliance upon the pick-up device, the method comprising steps of: exposing a great saphenous vein (GSV) to form an inner volume infused or insufflated with around 50 cc of fluid or gas; under direct vision through tumescent fluid and / or gas, separate the GSV in a hydrodissecting par t of the method;Under direct vision through tumescent fluid and / or gas, divide and seal all side branches in a harvesting part of the method; wherein for an in situ arterial bypass, the GSV is divided at the SF junction and the valvulotome is used to lyse the valves under direct vision; proximal anastomosis is performed above and below the blocked arterial with a portion of the GSV with valves so lysed.

32. The method of claim 31, wherein the valvulotome is an antegrade valvulotome that contains a nano-camera.

33. The method of claim 31, wherein the valvulotome may be introduced through an introducer sheath.

34. The method of claim 31, further includes visualizes proximal anastomosis with the GSV distended with tumescent fluid being delivered via infusion pump set at 100 mm Hg.

35. The method of claim 31, further including investigate flow with Duplex scanner and PVR cuff and filling bypass locations with gel containing a phosodiesterase inhibitor for slow release over hours, days, or weeks.

Images