WO2025240258A1

WO2025240258A1 - Blood vessel harvesting systems and methods

Info

Publication number: WO2025240258A1
Application number: PCT/US2025/028651
Authority: WO
Inventors: Tatsunori Fujii; Randal J. KADYKOWSKI; Zachary A. COON; Kevin R. LINE
Original assignee: Terumo Cardiovascular Systems Corp
Current assignee: Terumo Cardiovascular Systems Corp
Priority date: 2024-05-14
Filing date: 2025-05-09
Publication date: 2025-11-20
Anticipated expiration: 2026-11-14

Abstract

In connection with coronary artery bypass grafting (CABG), a blood vessel or vessel section, such as an artery or vein, is "harvested" (i.e., dissected and removed) from its natural location in a patient's body to use it elsewhere in the body. Medical device systems can be used for harvesting blood vessels from a subject's body (e.g., from a leg or an arm) in a minimally invasive fashion. For example, this document describes multifunctional all-in-one blood vessel harvesting systems that can include, for example, a tissue dissector, video camera sensor, vessel positioner, vessel cautery device, vessel cutting device, and user controls that are all integrated into a single device.

Description

BLOOD VESSEL HARVESTING SYSTEMS AND METHODS

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Serial No. 63/647,099 filed May 14, 2024. The disclosure of the prior application is considered part of (and is incorporated by reference in) the disclosure of this application.

BACKGROUND

1. Technical Field

This document relates to systems for dissecting/harvesting blood vessels from a subject's body (e.g., a leg or arm) and methods for the use of such systems. For example, this document relates to a multifunctional all-in-one blood vessel harvesting system that includes, for example, a tissue dissector, video camera sensor, vessel positioner, vessel cautery' device, vessel cutting device, and user controls that are all integrated into a single device.

2. Background Information

In connection with coronary' artery' bypass grafting (CABG), a blood vessel or vessel section, such as an artery or vein, is “harvested” (i.e.. removed) from its natural location in a patient's body to use it elsewhere in the body. In CABG surgery, the blood vessel is used to form a bypass between an arterial blood source and the coronary artery' that is to be bypassed. Among the preferred sources for the vessel to be used as the bypass graft are the saphenous veins in the legs and the radial artery in the arms.

Endoscopic surgical procedures for harvesting a section of a vein (e.g., the saphenous vein) subcutaneously have been developed in order to avoid disadvantages and potential complications of harvesting through a continuous incision. One such minimally -invasive technique employs a small incision for locating the desired vein and for introducing one or more endoscopic harvesting devices. Primary dissection occurs by introduction of a dissecting instrument through the incision to create a working space and separate the vein from the surrounding tissue. Then a cutting instrument is introduced into the working space to sever the blood vessel from the connective tissue and side branches of the blood vessel. The branches may be cauterized using the cutting instrument. In one typical procedure, the endoscopic entry site is located near the midpoint of the vessel being harvested, with dissection and cutting of branches proceeding in both directions along the vessel from the entry site. In order to remove the desired section of the blood vessel, a second small incision, or stab wound, is made at one end thereof and the blood vessel section is ligated. A third small incision is made at the other end of the blood vessel section which is then ligated, thereby allowing the desired section to be completely removed through the first incision. Alternatively, only the first two incisions may be necessary if the length of the endoscopic device is sufficient to obtain the desired length of the blood vessel while working in only one direction along the vessel from the entry point.

An example of a commercially available product for performing the endoscopic vein harvesting described above is the VirtuoSaph Plus™ Endoscopic Vessel Harvesting System from Terumo Cardiovascular Systems Corporation of Ann Arbor, Mich. An endoscopic vein harvesting system of this type is also shown in U.S. Pat. Nos. 7,331,971 and 8,048.100 and U.S. patent application publications 2010/0292533 and 2012/0035606. which are incorporated herein by reference in their entirety.

The conventional dissector tool typically comprises a longitudinal stainless steel or plastic rod with a tip at one end and an operator handle at the other. The tip is tapered to a blunt end and is made of transparent plastic. An endoscope including an optical cable is inserted through the hollow handle and hollow rod to abut the tip to allow for endoscopic viewing during dissection. The dissection proceeds along the perimeter of the vein being harvested to separate it from the surrounding tissue and to expose the side branches of the vein so that they can be severed with the cutting tool.

During dissection and cutting, an insufflation gas such as carbon dioxide is introduced to the subcutaneous space surrounding the blood vessel to improve visualization of the tissue structures within the operative tunnel being created around the vessel. The ability of the tunnel to be inflated is facilitated in part by the use of a trocar at the entry site to provide a partial seal around the endoscopic instrument. Since there is not a 100% trocar seal by design, a continuous supply of the insufflation gas is provided through the endoscopic instrument to be expelled distally at its tip.

The conventional blood vessel harvesting system includes multiple separate devices including, but not limited to, a dissector tool, and endoscope, and a blood vessel harvester cautery and cutting tool. SUMMARY

This document describes systems for dissecting/harvesting blood vessels from a subject’s body (e.g., a leg or arm) and methods for the use of such systems. For example, this document describes multifunctional all-in-one blood vessel harvesting systems that can include, for example, a tissue dissector, video camera sensor, vessel positioner, vessel cautery’ device, vessel cutting device, and user controls that are all integrated into a single device.

In one aspect, a vessel harvesting apparatus for removing a blood vessel from a patient includes an actuator handle, a main shaft extending from the actuator handle and defining a central longitudinal axis, a tissue dissector member at a distal end of the main shaft and comprising a pointed tip. and vessel cautery tool comprising one or more cauterization electrodes. In particular embodiments, the pointed tip is laterally offset from the central longitudinal axis of the main shaft.

Such a vessel harvesting apparatus for removing a blood vessel from a patient may optionally include one or more of the following features. The apparatus may also include a vessel positioner that is selectively extendable and retractable relative to the tissue dissector member by manipulation of a control mechanism on the actuator handle. A distal end portion of the vessel positioner may be extendable distally beyond the tissue dissector member and retractable proximally of the tissue dissector member. The tissue dissector member may include a transparent portion. The apparatus may also include an image sensor positioned to capture images distal of the tissue dissector member through the transparent portion of the tissue dissector member. In some embodiments, the tissue dissector member comprises a transparent cone member. The apparatus may also include a selectively extendable vessel cutting blade. The vessel cautery tool may also include an elongate shaft construct that is coupled to the actuator handle, and/or a jaw structure attached at a distal end portion of the elongate shaft construct. In some embodiments, the cauterization electrodes are attached to the jaw structure. The main shaft may define a first lumen. The vessel cautery tool may be slidably disposed in the first lumen. In some embodiments, the vessel cautery tool is retractable so that the jaw structure is fully within the first lumen. The vessel cautery’ tool may be extendable so that the jaw structure is positioned distally of the tissue dissector member. In some embodiments, the vessel cautery tool is rotatable within the first lumen. The first lumen may be offset from the central longitudinal axis of the main shaft. In another aspect, this disclosure is directed to a computing device that includes at least one processor, and a memory storing instructions, which when executed by the at least one processor cause the computing device to: (i) receive image data from a vessel harvesting device, the vessel harvesting device including a vessel cautery tool, a vessel positioner, and an image sensor capturing the image data; (ii) process the image data to generate an image; and (iii) provide the image to a display.

Such a computing device may optionally include one or more of the following features. In some embodiments, processing the image includes rotating the image to maintain a fixed orientation. The image may include a device orientation indicator providing a reference for an orientation of the vessel harvesting device. The device orientation indicator may comprise a digital device orientation indicator. The device orientation indicator may comprise a physical indicator on a lens of the image sensor. The device orientation indicator may comprise a physical indicator on a dissector member of the vessel harvesting device at a position that is within a field of view of the image sensor. In some embodiments, processing the image includes applying distortion coefficients to the image data to correct distortion cause by a dissector member of the vessel harvesting device. In particular embodiments, processing the image includes shifting the image by a calibrated offset to align a center of the image with a region in the image that captures light transmitted through a tip of the dissector member.

In another aspect, this disclosure is directed to a method for presenting a digital device orientation indicator on an image indicating an orientation of a vessel harvesting device. The method can include: (a) receiving the image and sensor data from the vessel harvesting device; (b) setting the digital device orientation indicator overlaid on the image at a designated position that is indicative of an orientation of the vessel harvesting device; (c) rotating the image to a fixed reference orientation based on the sensor data received form the vessel harvesting device; and (d) presenting the rotated image with the digital device orientation indicator on a display.

In another aspect, this disclosure is directed to a method for correcting distortion in an image captured by a vessel harv esting device (the distortion caused by a dissector member of the vessel harvesting device). The method includes: receiving the image from the vessel harvesting device; shifting the image based on a calibrated offset; applying distortion coefficients to the shifted image to correct the distortion in the image; and presenting the corrected image on a display.

Particular embodiments of the subject matter described in this document can be implemented to realize one or more of the following advantages. In some embodiments, a blood vessel harvesting procedure can be fully performed in a single pass using the all-in-one blood vessel harvesting systems described herein. In comparison, conventional blood vessel harvesting systems include multiple separate components and therefore require multiple passes. Accordingly, blood vessel harvesting procedures can be performed more efficiently and, in some cases, at a potentially lower cost using the all-in-one blood vessel harvesting systems described herein. In some embodiments, the all-in-one blood vessel harvesting systems described herein have enhanced user controls and visualization capabilities. Accordingly, blood vessel harvesting procedures can be performed with more accuracy and efficacy. Using the systems described herein, blood vessel harvesting procedures can be advantageously performed in a minimally invasive fashion. Such minimally invasive techniques can reduce recovery times, patient discomfort, and treatment costs.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used to practice the invention, suitable methods and materials are described herein. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety'. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description herein. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is an external view of a saphenous vein being harvested from a leg. FIG. 2 is a side view of a prior art dissector unit. FIG. 3 is a side view of a prior art harvesting unit.

FIG. 4 is a plan view of a prior art blunt dissector with an endoscope and a trocar.

FIG. 5 is a partial cross-sectional view of the dissection of a blood vessel.

FIG. 6 schematically shows a prior art harvesting unit in greater detail.

FIG. 7 is a perspective view of an example all-in-one blood vessel harvesting system in accordance with some embodiments.

FIG. 8 is an expanded view of a first configuration of a distal end portion of the all-in-one blood vessel harvesting system of FIG. 7.

FIG. 9 is an expanded view of a second configuration of the distal end portion of the all-in-one blood vessel harvesting system of FIG. 7.

FIG. 10 is a side view of the shaft and tissue dissector of the all-in-one blood vessel harvesting system of FIG. 7.

FIG. 11 is an expanded view of the distal end portion of FIG. 10.

FIG. 12 is an end view of the distal end portion of FIG. 10.

FIG. 13 is another side view of the distal end portion of FIG. 10.

FIG. 14 is a top view of FIG. 13.

FIG. 15 is transparent side view of the distal end portion of FIG. 10.

FIG. 16 illustrates an example environment for displaying images captured by the vessel harvesting device.

FIGs. 17A illustrates a field of view for the image sensor of the vessel harvesting device when the vessel positioner and the vessel cautery tool are in a retracted position.

FIGs. 17B illustrates a field of view for the image sensor of the vessel harvesting device when the vessel positioner and the vessel cautery tool are in an extended position.

FIG. 18A illustrates a first example orientation of the vessel harvesting device relative to the vessel.

FIG. 18B illustrates a second example orientation of the vessel harvesting device relative to the vessel.

FIG. 18C illustrates a third example orientation of the vessel harvesting device relative to the vessel. FIG. 19 illustrates an example method for presenting a digital device orientation indicator on an image indicating an orientation for the vessel harvesting device.

FIGs. 20A illustrates an example image captured by the vessel harvesting device.

FIG. 20B illustrates the example image of FIG. 19 with a digital device orientation indicator indicating an orientation of the vessel harvesting device.

FIG. 21 A illustrates another example image with a digital device orientation indicator indicating an orientation of the vessel harvesting device when the vessel positioner and the vessel cautery tool are positioned outside the field of view of the image sensor.

FIG. 21 B illustrates the example image of FIG. 21 A when the vessel positioner and the vessel cautery tool are positioned within the field of view of the image sensor.

FIG. 22 illustrates another example image with a digital device orientation indicator indicating a position of the vessel positioner in the image when the vessel positioner is in an extended position

FIG. 23 illustrates another example image with a first digital indicator and a second digital indicator.

FIG. 24 illustrates the vessel harvesting device and light infraction cause by the tissue dissector member.

FIG. 25 illustrates an example method for correcting distortion caused by the dissector member.

FIG. 26 illustrates an example of correcting a distorted image represented by an image plot.

FIG. 27A illustrates the dissector member with a cross-sectional line.

FIG. 27B illustrates a cross-sectional view of the dissector member 150, taken along the cross-sectional line shown in FIG. 27A.

FIG. 27C illustrates an example of shifting an input image to generate a shifted image.

FIG. 28 illustrates an example of shifting and correcting a distorted image represented by an image plot.

FIG. 29A illustrates a first perspective view of a first example dissector member with markers. FIG. 29B illustrates a second perspective view of the first example dissector member illustrated in FIG. 29A.

FIG. 30 illustrates a second example dissector member with markers.

FIG. 31 A illustrates a first perspective view of a third example dissector member with a marker.

FIG. 3 IB illustrates a second perspective view of the third example dissector member shown in FIG. 31 A.

FIG. 32A illustrates a first perspective view of a fourth example dissector member a marker.

FIG. 32B illustrates a second perspective view of the fourth example dissector member shown in FIG. 32A.

FIG. 33A illustrates a first perspective view of a fifth example dissector member with a marker.

FIG. 33B illustrates a second perspective view of the fourth example dissector member shown in FIG. 33 A.

FIG. 34 illustrates an example calibration tool.

Like reference numbers represent corresponding parts throughout.

DETAILED DESCRIPTION

This document describes systems for dissecting/harvesting blood vessels from a subject’s body (e g., a leg or arm) and methods for the use of such systems. For example, this document describes multifunctional all-in-one blood vessel harvesting systems that can include, for example, a tissue dissector, video camera sensor, vessel positioner, vessel cautery’ device, vessel harvesting device, and user controls that are all integrated into a single disposable device.

Referring to FIG. 1, a patient 10 has a saphenous vein 11 within a lower limb 12 (e.g., leg). An incision 13 is made directly above vein 11, and tissue is peeled back from incision 13 to access the vein. Endoscopic instruments are inserted through incision 13 to separate vein 11 from connective tissue and then to cauterize and sever side branches that extend from vein 11. A second incision or stab wound 14 is created at a second position on limb 12 so that a second end of vein 11 can be severed. Vein 11 is then extracted through one of the incisions. The entry point and/or second incision or stab wound can be placed at various locations along vein 11 as shown at 15, for example. While FIG. 1 illustrates the leg 12 as an example vessel harvesting site, the use of the vessel harvesting systems described herein are not limited to use in the leg 12. For example, in some cases the vessel harvesting systems described herein can be used to harvest a vessel from an arm of the patient 10. In other words, while the harvesting of a blood vessel from the leg 12 will be used as an example context herein, the uses of the vessel harvesting systems described herein are not limited to use in the leg 12.

A conventional dissector unit 16 is shown in FIG. 2. Dissector unit 1 can be used for endoscopic dissection of a saphenous vein or other vessel by insertion through an initial incision and then pressing a dissector tip 17 into the fat along the direction of the vessel to separate it from adjacent tissue. Dissector unit 16 has a handle 18 connected to a longitudinal rod 19 having dissector tip 17 at its distal end. A receiver 20 at the end of handle 18 receives an endoscope and optical cable (not shown) for extending through rod 19 to dissector tip 17. The dissector tip 17 can be at least partially transparent to allow visualization of the vessel and surrounding tissue. An insufflation tube 21 passes through handle 12 and is part of an insufflation gas channel extending to a release hole in or near tip 17. Tube 21 is connected to a source of CO2 or other insufflation gas for filling and expanding the cavity adjacent the vessel as it is being formed. The insufflation provides enhanced endoscopic visibility of the vessel and surrounding tissues during the harvesting procedure.

After the initial blunt dissection around the vessel, a harvester cutting unit 22 as shown in FIG. 3 is used subcutaneously to grasp the vessel being dissected and to cauterize/sever any branches or connective tissue connecting to the vessel. Harvester 22 has a handle 23 connected to an elongated sleeve member 24 and an endoscope receiver 25. At the distal end of sleeve 24 are a vessel keeper (V-keeper) 26 for retaining the vessel being dissected and a vessel cutter (V-cutter) 27 for cauterizing/sev ering branches. V-keeper 26 is manipulated by V-keeper buttons 28 on handle 23. V-cutter 27 is extended or retracted by manipulating a V-cutter extender button 29 on handle 23. An insufflator tube 30 is adapted to be connected to an insufflation gas source to deliver the gas to the distal end of sleeve 24 via a gas channel extending between handle 23 at the proximal end and a release hole at the distal end. An integrated bipolar cord 31 connects to a source of high frequency voltage, and includes conductors for supplying the voltage to electrodes on V-cutter 27 for cauterizing and cutting the branches and connective tissue. FIG. 4 shows another conventional vessel harvesting system which includes an endoscope unit 30 to perform observation in a patient's body, a dissector unit 31 to dissect a blood vessel in the body, and a trocar 32 to help insert the endoscope 30 and dissector apparatus 31 into the body. An optical system is shown as a rigid endoscope 30 and includes an elongated rod-like inserting portion 33. The proximal end of inserting portion 33 connects to an end adapter 34 to transmit an endoscopic image. A light guide port 35 projects from end adapter 34 to connect to a light guide cable which supplies illumination light to endoscope 30. In other embodiments, the optical system can employ a camera and LED light source installed at the distal end of endoscope 30 connected via electrical cables to power and a video processor.

Dissector unit 31 includes a tubular main body portion 36 comprising a hollow longitudinal rod within which endoscope 30 is to be inserted. Endoscope 30 is inserted or removed from longitudinal rod 36 through a handle portion 37. The material of longitudinal rod 36 material is selected from fluoropolymers, which are well known materials. In some embodiments, the outer surface of longitudinal rod 36 comprises polytetrafluoroethylene (PTFE). The use of a fluoropolymer reduces the friction caused by moving rod 36 through connective tissue, thereby reducing the force required to perform a dissection.

A blunt dissector tip 38 is disposed at the distal end of longitudinal rod 36. Tip 38 has a conical shape and comprises a transparent synthetic resin material to facilitate viewing through tip 38 using endoscope 30. Trocar 32 includes a body 39 to guide dissector unit 31 into the incision site. An aperture seal 40 is located on the surface of the proximal end of body 39. Aperture seal 40 allows dissector unit 31 to be inserted in body 39 of trocar 32 in one fluid forward motion. The outer surface of trocar body 39 includes a projection to engage with living tissue and a holding portion 41 to hold the body 39 onto the living tissue (e.g., the patient's skin).

FIG. 5 is cross-sectional view showing a dissector unit 42 inserted subcutaneously within a lower limb 43 via a trocar 44 from a skin incision in the direction of the inguinal region, for example. Since the inserting direction of dissector 10 is along the direction of a blood vessel 45 being dissected, the operator gradually inserts the dissector so as to dissect peripheral tissue 46 from blood vessel 45 while viewing the endoscope image.

An insufflation gas (e.g.. carbon dioxide) may be fed via a tube 47 from a regulated insufflation gas source 48. An insufflation unit such as the UHI-3 High Flow Insufflation Unit, available from Olympus Medical Systems Corporation, can be used. As blood vessel 35 is dissected from the peripheral tissue, the CO2 gas inflates the area between the dissected tissue and the blood vessel to create an open tunnel 49. Therefore, the field of view of the endoscope is opened wide by gas inflation so that visualization of the internal tissue structures is improved. Following blunt dissection, a cutter unit is inserted through trocar 44 and tunnel 49 is insufflated in the same manner. An example conventional cutter unit 50 as shown in FIG. 6 can be used. An insufflation tube 51 can be connected to the same gas source. Cutter unit 50 is also connected to an electrical bipolar source via electrical cable 52 for cauterization and/or cutting of blood vessels (such as vessels that branch off from the main vessel being harvested).

FIG. 7 illustrates an all-in-one vessel harvesting device 100 in accordance with some example embodiments described herein. The harvesting device 100 is a device for dissecting/harvesting a blood vessel from a patient in a minimally-invasive manner. In some cases, the harvesting device 100 is used to dissect/harvest and remove a blood vessel from a leg of the patient, or from an arm of the patient.

In comparison to the prior art devices described above, for example, the vessel harvesting device 100 includes the functionalities of the dissector unit 16 (FIG. 2), the harvester cutting unit 22 (FIG. 4), the endoscope unit 30 (FIG. 4), plus other features, in a single vessel harvesting device 100. Accordingly, the procedure for dissecting/harvesting the blood vessel from the patient can be performed in a more efficient manner as compared to conventional prior art systems, because all the required functionality is present in the depicted single vessel harvesting device 100.

The vessel harvesting device 100 includes, broadly speaking, an actuator handle 110, a main shaft 120, and a distal working end portion 130. The main shaft 120 extends distally from the actuator handle 110. The main shaft 120 defines a central longitudinal axis 121 (e.g., see FIGs. 10-15). The working end portion 130 is at a distal end of the main shaft 120.

In use, the working end portion 130 and a distal portion of the main shaft 120 are inserted through an incision (e.g., see incisions 13, 14, and 15 in FIG. 1) and are then utilized within the body of the patient. The actuator handle 110 remains external to the patient. Using the actuator handle 110, a clinician operator can manipulate, control, and operate the main shaft 120 and the working end portion 130 to perform the vessel dissection/harvesting procedure. While not shown, it should be understood that a complete system for harvesting blood vessels typically includes various other equipment in addition to the depicted example vessel harvesting device 100. For example, such a complete system may include, but is not limited to, a video system (e.g., including an image processing system and one or more display monitors), an electrocauterization energy source and control system, an insufflation gas supply and control system, and various other medical devices and systems that can be used to support/perform such vessel harvesting procedures. In some embodiments, the vessel harvesting device 100 system can include a gyrosensor as described in U.S. Patent Application 17/498,891 filed on October 12, 2021, which is hereby incorporated by reference in its entirety.

Referring also to FIGs. 8 and 9, the working end portion 130 can include, but is not limited to, a shaft transition portion 140, a tissue dissector member 150, a vessel positioner 160, and a vessel cautery tool 170. The shaft transition portion 140 extends from the distal end of the main shaft 120. The tissue dissector member 150 extends from a distal end of the shaft transition portion 140. The vessel positioner 160 is selectively extendable (e.g., as shown in FIG. 8) and retractable (e.g.. as shown in FIG. 9) relative to the tissue dissector member 150 and the shaft transition portion 140. The vessel cautery tool 170 is also selectively extendable (e.g., as shown in FIG. 8) and retractable (e.g., as shown in FIG. 9) relative to the tissue dissector member 150 and the shaft transition portion 140. In FIG. 9, the vessel cautery tool 170 is not visible because it is fully retracted into a lumen 122 that is defined by the shaft transition portion 140 and the main shaft 120.

In the depicted embodiment, the tissue dissector member 150 comprises a pointed tip that a clinician can use to effectuate tissue dissection by movement of the main shaft 120 by manipulation of the actuator handle 110. In some embodiments, such as the depicted embodiment, the tissue dissector member 150 is conical. As described further below , tissue dissector member 150 can have a transparent portion (or can be entirely transparent) to facilitate a clinician’s visualization of areas around and beyond the distal working end portion 130 during the dissection and other steps of the vessel harvesting procedure. In the depicted example embodiment, the tissue dissector member 150 comprises a transparent cone member with a pointed tip. As described further below; the pointed tip is laterally offset from the central longitudinal axis 121 of the main shaft 120 (e.g., see FIG. 10, etc.). The vessel positioner 160 can be used by the clinician to move and/or control the positions of vessels during the vessel harvesting procedure. For example, in some cases the vessel positioner 160 (when extended) can be placed in contact with the main vessel to be harvested while the vessel cautery tool 170 is used to cauterize and cut a branch vessel that extends laterally from the main vessel. In such a case, the vessel positioner 160 is used to establish the position the main vessel (and its branch vessels) and to stabilize/control the main vessel while a branch is being isolated, cauterized, and/or cut.

In the depicted embodiment, the vessel positioner 160 includes a vessel contact member 162 that is attached to the distal ends of two elongate flexible arm members 164. The vessel contact member 162 has a concave surface that defines a groove that can releasably receive/contain a blood vessel when the vessel positioner 160 is extended. The concave surface also allows the vessel contact member 162 to closely fit against, and meld with, the transition portion 140 when the vessel positioner 160 is retracted. Accordingly, the vessel positioner 160 is out of the way when the working end portion 130 is being used for tissue dissection (e.g., while the vessel positioner 160 is retracted as shown in FIG. 9).

The longitudinal and lateral position and orientation of the vessel positioner 160 can be controlled by the clinician operator of the vessel harvesting device 100. For example, the vessel positioner 160 can be selectively longitudinally extended and retracted by the clinician by manipulating an actuation member at the actuator handle 110. When retracted (as show n in FIG. 9), the distal end portion of the vessel positioner 160 is closely nested with the transition portion 140. The vessel positioner 160 can be extended distally beyond the pointed tip of the tissue dissector member 150 (as shown in FIG. 8).

The flexible arm members 164 of the vessel positioner 160 have a natural curve that laterally moves the position of the vessel contact member 162 toward the pointed tip of the tissue dissector member 150, or even below the pointed tip of the tissue dissector member 150 (i.e., wherein '‘below⁷’ means in the lateral direction opposite of the vessel cautery tool 170). In some embodiments, the flexible arm members 164 are made of a super elastic shape memory' material such as, but not limited to, nitinol (a metal alloy comprising nickel and titanium). As the vessel positioner 160 is being extended, the natural curves of the flexible arm members 164 exhibit themselves and the vessel contact member 162 thereby moves laterally (as well as distally). In reverse, as the vessel positioner 160 is being retracted, the natural curves of the flexible arm members 164 elastically straighten as the flexible arm members 164 are moved into the confines of lumens defined by the transition portion 140, causing the vessel contact member 162 to move laterally above the tissue dissector member 150 (as well as proximally) to the position shown in FIG. 9.

The working end portion 130 of the vessel harvesting device 100 also includes the vessel cautery tool 170 that includes a jaw structure 172. The vessel cautery tool 170 can be used to cauterize and/or cut blood vessels (such as branch vessels extending from a main vessel being harvested).

Examples of the vessel cautery tool 170 and the jaw structure 172 are provided in references such as, but not limited to, PCT publication WO2023/204231 having a priority date of April 21, 2022; PCT publication WO2023/204232 having a priority date of April 21, 2022; and PCT publication WO2023/204233 having a priority date of April 21, 2022; which are hereby incorporated by reference in their entireties and for all purposes.

As shown in FIG. 8, the vessel cautery tool 170 includes the jaw structure 172 that is pivotably coupled to a distal end portion of an elongate shaft construct 174. A proximal end portion of the elongate shaft construct 174 is coupled to the actuator handle 110. Accordingly, a clinician operator can operate the functions of the vessel cautery tool 170 by manipulating various control actuators/mechanisms of the actuator handle 1 10.

The vessel cautery tool 170 has multiple functions that are controllable by the clinician. For example, the jaw structure 172 of the vessel cautery' tool 170 can be selectively extended (e.g., extended distally beyond the pointed tip of the tissue dissector member 150 as shown in FIG. 8) and retracted (e.g., fully within the lumen 122 as shown in FIG. 9). To that end, the vessel cautery tool 170 is slidably disposed within the lumen 122 that is defined by the shaft transition portion 140 and the main shaft 120. While FIGs. 8 and 9 illustrate two longitudinal positions of the distal end portion of the vessel cautery tool 170, it should be understood that the longitudinal position of the distal end portion of the vessel cautery tool 170 is infinitely adjustable by the clinician to any longitudinal position desired by the clinician (up to a distal travel limit and proximally to completely within the lumen 122 that is defined by the shaft transition portion 140 and the main shaft 120). The vessel cautery tool 170 is also selectively rotatable about its longitudinal axis. The vessel cautery tool 170, being slidably disposed within the lumen 122, is thereby axially rotatable relative to the main shaft 120. The clinician can use this functionality to manually rotate the vessel cautery tool 170, as desired by the clinician, to position/orient the jaws of the jaw structure 172 to capture blood vessels, for example.

The vessel cautery tool 170 also has a grasping functionality. That is. the two jaws of the jaw structure 172 can be selectively opened and closed by the clinician using various control actuators/mechanisms of the actuator handle 110. For example, a clinician can operate the jaw structure 172 to capture a blood vessel within the jaw structure 172 by closing the jaw structure 172 on the blood vessel.

The vessel cautery tool 170 also has a cauterization functionality. Accordingly, the jaws of the jaw structure 172 can have one or more cauterization electrodes mounted thereon. The clinician operator can selectively energize the one or more cauterization electrodes to cauterize a blood vessel that is captured within the jaws.

The vessel cautery tool 170 also has a blood vessel cutting functionality. For example, the vessel cautery tool 170 can include a selectively extendable/actuatable cutting blade or other type of tissue cutting mechanism. Accordingly, a clinician can use the various control actuators/mechanisms of the actuator handle 110 to cut a blood vessel that is captured within the jaw structure 172 (e.g., after the cauterization of the blood vessel has occurred).

The vessel harvesting device 100 also includes the actuator handle 110. The actuator handle 110 includes various actuators and functionalities that a clinician can use to control the working end portion 130 of the vessel harvesting device 100 during a blood vessel harvesting procedure. Such actuators can be any type of, or combinations of, slidable, rotatable, pivotable, twistable, and the like. Such actuators can be mechanical, electro-mechanical, electrical, and the like. As described above, a clinician can operate the actuator handle 110 to initiate and perform actions such as, but not limited to, manipulating the tissue dissector member 150 to dissect tissue, extending and positioning the vessel positioner 160 to capture and stabilize a blood vessel, extending the vessel cautery tool 170, opening the jaws of the jaw structure 172, closing the jaws of the jaw structure 172 to capture a blood vessel, locking the jaws of the jaw structure 172 in a closed position, cauterizing a blood vessel, and cutting a blood vessel.

In some embodiments, the vessel harvesting device 100 can be used by a clinician in the following manner to perform a vessel harvesting procedure that includes the steps of: (1) dissecting blood vessels from adipose tissue using the tissue dissector member 150, (2) capturing and stabilizing the position of a blood vessel using the vessel positioner 160, (3) extending the vessel cautery tool 170 and opening the jaws of the vessel cautery tool 170 around a blood vessel, (4) closing/compressing the jaws of the vessel cautery tool 170 on/around the blood vessel, (4) locking the jaws in the closed position on/around the blood vessel, (5) cauterizing the blood vessel with the jaws in the locked arrangement, and (6) cutting the blood vessel using the vessel cautery tool 170 and with the jaws in the locked arrangement. All of the foregoing actions can be performed while visualized by the clinician using the imaging functionality of the vessel harvesting device 100.

FIGs. 10-12 illustrate the longitudinal axes of the main shaft 120. the lumen 122, and the conical tissue dissector member 150. These three axes are separated from each other.

The central longitudinal axis of the main shaft 120 is axis 121. The central longitudinal axis of the lumen 122 is axis 123. The central longitudinal axis of the tissue dissector member 150 is axis 151. The axis 151 extends through the pointed tip of the tissue dissector member 150.

The central longitudinal axis 121 of the main shaft 120 is located between: (i) the central longitudinal axis 123 of the lumen 122 and (ii) the central longitudinal axis 151 of the tissue dissector member 150. Said another way, the central longitudinal axis 123 of the lumen 122 is laterally offset from the central longitudinal axis 121 of the main shaft 120, and the central longitudinal axis 151 of the tissue dissector member 150 is laterally offset from the central longitudinal axis 121.

The lateral offset of the lumen 122 relative to the central longitudinal axis 121 of the main shaft 120 means that the lumen 122 that slidably contains the vessel cautery tool 170 is not centralized in/along the main shaft 120. Similarly, the lateral offset of the central longitudinal axis 151 of the tissue dissector member 150 means that the conical tissue dissector member 150 (including its pointed tip) is not centralized with the main shaft 120. That is significant in that the pointed tip of the conical tissue dissector member 150, being useful for tissue dissection, is not centered in relation to the main shaft 120. Also, because the conical tissue dissector member 150, being at least partially transparent, is used for endoscopic visualization, the in vivo view of the working end portion 130 of the vessel harvesting device 100 is laterally offset relative to the central longitudinal axis 121 of the main shaft 120.

FIG. 13 further illustrates the lateral offset of the tissue dissector member 150 as facilitated by the shape of the shaft transition portion 140. That is. the shaft transition portion 140 extends from the distal end of the main shaft 120 at an angle al relative to the central longitudinal axis 121 of the main shaft 120. In some embodiments, the angle al is in a range of about 10° to 40°, or about 20° to 50°, or about 30° to 60°, or about 20° to 30°, without limitation.

FIG. 14 illustrates that the shaft transition portion 140 and the tissue dissector member 150 have distally reducing diameters as compared to the main shaft 120, terminating at the pointed tip of the tissue dissector member 150. Said another way, the transition portion 140 and the tissue dissector member 150 neck down in diameter from the main shaft 120 to the pointed tip of the tissue dissector member 150. An angle a2 is defined between: (i) a line extending between the pointed tip of the tissue dissector member 150 and the outer diameter at the junction between the shaft transition portion 140 and (ii) the main shaft 120 (or the central longitudinal axis 121 of the main shaft 120). In some embodiments, the angle a2 is in a range of about 10° to 40°, or about 20° to 30°, or about 20° to 40°. or about 10° to 30°, or about 10° to 20°, or about 5° to 20°, without limitation.

FIG. 15 transparently illustrates the main shaft 120, the transition portion 140, and the tissue dissector member 150. In the depicted embodiment, an image sensor 180 is positioned within the transition portion 140. The image sensor 180 is pointed/aimed distally toward the tissue dissector member 150. In this arrangement, the image sensor 180 is positioned to capture images that are distal of the tissue dissector member 150 by viewing the images through the transparent portion(s) of the tissue dissector member 150. Accordingly, in this illustration it can be readily seen that the axis 151 (which is also the central axis of the image sensor 180 in this embodiment) is offset from the central longitudinal axis 121 of the main shaft 120.

In some embodiments, the image sensor 180 is a high-resolution solid state image sensor such as a charge-coupled device (CCDs) image sensor or a complementary metal oxide semiconductor (CMOS) image sensor. In some embodiments, one or more visible light emitters are included as part of the image sensor 180 or near to the image sensor 180. For example, in some embodiments multiple light emitting diodes ("LEDs") are positioned around the outer periphery of the image sensor 180.

FIG. 16 illustrates an example environment 1000 for displaying images 1010 captured by the vessel harvesting device 100. The environment 1000 includes the vessel harvesting device 100, a computing device 1002, and a display 1004.

The vessel harvesting device 100 captures image data 1006 and sensor data 1014 that is transferred to the computing device 1002. In some examples, the vessel harvesting device 100 interfaces with the computing device 1002 via a communication cable (not shown) to transfer the image data 1006 and the sensor data 1014. In some examples, the image data 1006 and sensor data 1014 are transferred wirelessly. In some examples, the vessel harvesting device 100 is connected to a controller device that transfers the image data 1006 to the computing device 1002 (either wirelessly or via a cable). In some examples, the sensor data 1014 is indicative of an orientation of the vessel harvesting device 100 when the image data 1006 is collected (e.g.. relative to a vertical upward direction or any other reference direction). For example, the vessel harvesting device 100 can include a gyroscope which senses rotational movement of the device to determine an orientation of the vessel harvesting device 100 relative to a reference direction (e.g., as described in U.S. Patent Application 17/498,891 filed on October 12, 2021, which is hereby incorporated by reference in its entirety).

The computing device 1002 interfaces with the display device 1004. The computing device 1002 processes the image data 1006 received from the vessel harvesting device 100 to generate the images 1010 and present the images 1010 on the display device 1004. In some examples, the images 1010 are a stream of video images that are captured and presented in real time (e.g., as the images are captured at the vessel harvesting device 100). In some examples, the computing device 1002 and the display device 1004 are integrated within a single device (e.g., a laptop, tablet, smartphone, integrated desktop computer, etc.). In other examples, the computing device is configured to interface with a separate display device (e g., computer configured to interface with a monitor).

In some examples, the computing device 1002 operates an image processing module 1008 which processes the image data 1006 to generate the images 1010. In some examples, the image processing module 1008 processes the image data 1006 to correct for orientation. For example, the vessel harvesting device 100 can include sensors that can be used to sense a position (e.g., via rotational movement or other movement) of the vessel harvesting device 100. The image processing module 1008 processes this data to provide a steady orientation of the images 1010 on the display 1004. For example, the images displayed can have an orientation that remains substantially fixed. Examples of endoscopic vessel harvesters with gyrosensor on handle for rotating camera view are described in U.S. Patent Application 17/498.891. Similar techniques can be implemented in the vessel harvester device 100 to maintain a camera view (e.g., via the images 1010) with a fixed orientation.

The images 1010 are displayed to a user who views the images 1010 to see various processes through the end of the dissector member of the vessel harvesting device 100. For example, the images 1010 are viewed by a user to allow the user to cauterize, cut, and/or dissect the tissue.

In some examples, the image processing module 1008 processes the images 1010 to present a device orientation indicator 1012 indicating a device orientation (e.g.. relative to a top portion from which the vessel positioner 160 and the vessel cautery tool 170 extend from, as shown in FIGs. 7-9). FIGs. 17A-23 illustrate examples of systems, methods, devices, and techniques for implementing the device orientation indicator 1012 indicating an orientation of the vessel harvesting device on images captured by the image sensor of the vessel harvesting device 100. In some examples, the device orientation indicator 1012 is displayed on the images 1010 captured by the vessel harvesting devices 100 to indicate an orientation of the device relative to a vessel surface. The device orientation indicator 1012 can assist a user to know where the vessel positioner 160 and the vessel cautery tool 170 reside relative to the vessel surface when they are retracted from the field of view of an image sensor of the vessel harvesting device 100.

In some examples, the image processing module 1008 processes the image data 1006 to correct distortion caused by the transparent cone member of the dissector member of the vessel harvesting device 100. FIGs. 24-34 illustrate examples of systems, methods, devices, and techniques for correcting distortion caused by the transparent cone member of the dissector member.

FIGs. 17A-B illustrate a field of view' 1602 for the image sensor 180 of the vessel harvesting device 100. Referring to FIG. 17A, the vessel positioner 160 and the vessel cautery tool 170 are in a retracted position and are not visible in the field of view 1602 of the image sensor 180. In FIG. 17B, the vessel positioner 160 and the vessel cautery tool 170 are in an extended position and are visible in the field of view 1602 of the image sensor 180. Because the camera view displayed to a user is fixed to an orientation, the user may have difficulty determining a position of the vessel positioner 160 and the vessel cautery tool 170 when they are in a retracted position (e.g., or otherwise outside of the field of view 1602). For example, as shown in FIG. 17A. The vessel positioner 160 and the vessel cautery tool 170 begin movement from behind the field of view 1602 and a user may be unable to determine which direction these components are positioned relative to the displayed images until they⁷ are moved distally into the field view (shown in FIG. 17B). In these examples, the user may be unable to understand or recognize the orientation of the device (e.g., the positioning of the vessel positioner 160 and the vessel cautery tool 170 in the camera view presented on the display relative to the vessel displayed in an image).

FIGs. 18A-C illustrate different orientations of the vessel harvesting device 100 relative to the vessel 1704. FIG. 18A illustrates a first example orientation of the vessel harvesting device 100 relative to the vessel 1704. FIG. 18B illustrates a second example orientation of the vessel harvesting device 100 relative to the vessel 1704. FIG. 17B illustrates a third example orientation of the vessel harvesting device 100 relative to the dissected vessel 1704. Depending on the orientation of the vessel harvesting device 100 relative to the dissected vessel 1704, resistance for dissection can be different. As discussed above it is difficult for users to recognize which part of the vessel harvesting device 100 is contacting the vessel 1704 based on the camera view image with a fixed image orientation. Accordingly, the camera view image will be similar when the vessel harvesting device 100 is in the first orientation (shown in FIG. 17 A), the second orientation (shown in FIG. 17B), and the third orientation (Shown in FIG. 17C). This makes certain process of operating the vessel positioner and the vessel cautery⁷ tool challenging. Accordingly, this document describes - examples of systems, methods, devices, and techniques for implementing a device position indicator that indicates an onentation of the vessel harvesting device 100 on images captured by the image sensor of the vessel harvesting device 100 and display the images with the device position indicator to provide orientation information to a user during an operation.

The device orientation indicator assists with determining where the vessel positioner and the vessel cautery tool will be extended from relative to the vessel. The device orientation indicator can also be used to allow a user to determine which portion of the vessel harvesting device is on the vessel surface. In some examples, the device orientation indicator is a digital indicator. For example, added by the image processing module 1008 shown in FIG. 16. In some examples, a physical mark is added on the camera lens, the transparent cone member of the dissector member, and or another section which exists in the field of view. In these examples, the device orientation indicator is captured by the image sensor and transmitted to be presented on a display. In further examples, the device orientation indicator is presented by a projected light (e.g., with a specific shape to designate an indicator).

The device orientation indicator can be of different types and shapes. Examples of the device orientation indicator shape/type include a groove, protrusion, line, and/or words or letters identifying components in the captured image. In some embodiments, the device orientation indicator is placed on the edge of the image to avoid or minimize the device orientation indicator obstructing the image.

In some examples, the device orientation indicator is a physical device orientation indicator on the dissector member. The physical device orientation indicator can be on the inner and/or outer surface of the dissector member. In some examples, the physical device orientation indicator is a groove in the dissector member. In some examples, the physical device orientation indicator is a protrusion in the dissector member. In some examples, the physical device orientation indicator is painted on the inner surface and/or outer surface of the dissector member. In some examples, the physical device orientation indicator is formed as part of the dissector member. Example shapes of the physical device orientation indicator include an arrow, line, dot, circle, oval, square, letter, word, symbol, or any shape that is visible in the image captured by the image sensor. In some examples, the device orientation indicator is located at a position of the dissector member near the edge of the field of view of the image sensor to reduce the marker obstructing the view of the region captured by the image sensor.

In some examples, the device orientation indicator is a physical device orientation indicator on the lens of the image sensor. The physical device orientation indicator can be on the inner and/or outer surface of the lens. In some examples, the physical device orientation indicator is a groove in the lens. In some examples, the physical device orientation indicator is a protrusion in the lens. In some examples, the physical device orientation indicator is painted on the inner surface and/or outer surface of the lens. Example shapes of the physical device orientation indicator include an arrow, line, dot. circle, oval, square, letter, word, symbol, or any shape that is visible in the image captured by the image sensor. In some examples, the device orientation indicator is located near an edge of the lens to reduce the marker obstructing the view of the region captured by the image sensor.

In some examples, the device orientation indicator is projected light with a specific shape to designate the indicator. In some examples, one or more lights are positioned adjacent to the image sensor. In some examples, the one or more lights are LED lights. The light is projected in the region in a manner that indicates an orientation of the vessel harvesting device.

In some examples, the device orientation indicator is a digital device orientation indicator that is overlay ed over the image captured by the vessel harvesting device. Examples of the digital device orientation indicator are illustrated and described in reference to FIGs. 19-23.

FIG. 19 illustrates an example method 1800 for presenting a digital device orientation indicator indicating an orientation for the vessel harvesting device 100. In some examples, the method 1800 is performed by the computing device 1002 as part of the image processing module 1008, as shown in FIG. 16. For example, as instructions stored in memory and executed by a processor. Other image processors can also perform the method 1800. In alternative embodiments, the images can be processed at a server or cloud computing environment. In other embodiments, the vessel harvesting may include a processor configured to perform the method 1800. The method 1800 includes the operations 1802, 1804, 1806, and 1808.

At the operation 1802, the computing device obtains an image from the vessel harvesting device. The images are captured at the vessel harvesting device and the captured image data is transferred to the computing device via a communication cable. In alternative examples, the image data can be received wirelessly.

At the operation 1804, the computing device sets a digital device orientation indicator on the image at a designated position. For example, the device orientation indicator may be placed at or near a top position of the image (e.g., when the top of the image corresponds to the top side of the vessel harvesting device. Other reference positions can also be used. For example, the digital device orientation indicators can be positioned in positions where the vessel positioner and/or the vessel cautery tool are in an extended position. Example shapes of the digital device orientation indicator include an arrow, line, dot, circle, oval, square, letter, word, symbol, or any shape that is visible when overlay ed on the image captured by the image sensor.

In some examples, digital device orientation indicator labels or otherwise indicates features detected in the image. For example, the images can be processed with a machine vision algorithm to identify features in the image, such as the vessel, vessel positioner, vessel cautery tool, and/or other tissue or tools visible in the image. The identified features can then be labeled on the image that is displayed to a user.

In some examples, a digital device orientation indicator labels the vessel, vessel position and/or vessel cautery tool as they become visible. For example, when the vessel position and/or vessel cautery tool enter the field of view a label is added to the vessel position and/or vessel cautery tool. In some examples, the placement of the labels is based on sensor data from the vessel harvesting device that is indicative of the position of the vessel positioner and/or vessel cautery tool. For example, the sensor data can indicate whether the vessel position and/or vessel cautery tool are extended or retreated and a distance of that vessel cautery tool is extended. This data is processed to overall the digital device orientation indicator at the correct location on the image. In some examples, the digital device orientation indicator is an AR object (e.g., a digital representation of the vessel positioner and/or vessel cautery' tool in the extended position).

At the operation 1806, the computing device trims the image. For example, to frame a predetermined portion of the image, where the portion of the image is presented on the display. In some examples, this includes cropping the image to remove outer portions of the image. In some examples, the image is cropped in the shape of the circle. In some examples, the image is cropped to focus on a region of interest.

At the operation 1808, the computer device adjusts the image orientation based on sensor data from the vessel harvesting device. After the device orientation indicator is set on the image and the image orientation is adjusted the processed image can be presented on a display. In some examples, the method 1800 is performed in real time so the image displayed to a user is continuously updated as the images are captured and the vessel harvesting device orientation changes. For example, the device orientation indicator may rotate on the display as the user rotates the vessel harvesting device. The operations 1802, 1804, 1806, and 1808 may be performed in a different order than the one shown and one or more of the operations can be optional or not included in different embodiments. For example, the operation 1806 may not be performed in some embodiments.

FIG. 20A illustrates an example image 1900 captured by the vessel harvesting device 100. FIG. 20B illustrates the example image 1900 of FIG. 19 with a digital device orientation indicator 1904 indicating an orientation of the vessel harvesting device 100. In the example shown, the digital device orientation indicator 1904 is shaped like an arrow. In other examples, the digital device orientation indicator 1904 can be a different shape. Example shapes include grooves, lines, circles, squares, or other shapes that would be visible when displayed to a user. In some examples, the device orientation indicator 1904 is located on or adjacent to an edge the image 1900.

FIG. 21 A illustrates another example image 2000 with the digital device orientation indicator 1902 indicating an orientation of the vessel harvesting device 100, when the vessel positioner 160 and the vessel cautery’ tool 170 are positioned outside the field of view of the image sensor. FIG. 21 B illustrates the example image of FIG. 21A when the vessel positioner 160 and the vessel cautery tool 170 are positioned within the field of view of the image sensor. In the example of FIGs. 21 A- B, the digital device orientation indicator 1902 indicates where the vessel positioner 160 and the vessel cautery tool 170 relative to what is shown in the image 2000.

FIG. 22 illustrates another example image 2100 with a digital device orientation indicator 2102 indicating a position of the vessel positioner 160 in the image 2100 when the vessel positioner 160 is in an extended position. In this example, the digital device orientation indicator 2102 is a circle shape, however the digital device orientation indicator can be of other shapes or could include a label (e.g., a letter or word at the position of the digital device orientation indicator 2102).

FIG. 23 illustrates another example image 2100 with a first digital indicator 2202 and a second digital indicator 2204. The first digital indicator 2202 indicates a position of the vessel positioner 160 in the image 2100 when the vessel positioner 160 is in an extended position and the second digital indicator 2204 indicates a position of the vessel cautery' tool 170 when the vessel cautery' tool 170 is in the extended position. Although two digital indicators are shown in FIG. 23, any number of digital indicators can be used to identify one or more different reference points in the image. In some examples, a user can configure the digital indicator to include the features described in FIGs. 18-23 individually or in user selected combinations. For example, a user can select a setting to have the digital indicator be of a certain shape or color.

FIGs. 24-34 illustrate examples of systems, methods, devices, and techniques for correcting distortion caused by the transparent cone member of the dissector member. In some examples, a computing device receives images from the vessel dissector and applies distortion coefficients to the images to correct for the distortion caused by the dissector member. In some examples, the distortion coefficients based on characteristics of the dissector member (e.g., material, shape of the dissector member, shape of the walls of the dissector member, dimensions, other structural characteristics causing refraction of light that is transmitted through the dissection member). In some examples, the coefficients are calibrated before the vessel harvesting device is used in an operation (e.g., by a manufacturer of the vessel harvesting device or by a user configuration of the vessel harvesting device before an operation). In some examples, the images are shifted by an offset to center the image at a region in the image capturing the tip of the dissector member.

In t pical embodiments, the distortion coefficients and/or the offset are determined (e.g., calculated and/or calibrated) before the vessel harvesting device is used in an operation. In other examples, the distortion coefficients and/or the offset are determined in real time. For example, as the images are received during an operation using offset markers on the dissector member.

FIG. 24 illustrates the vessel harvesting device 100 and light refraction 2302 caused by the tissue dissector member 150. The image sensor 180 is positioned to capture light which travels through the dissector member 150. As discussed above, the dissector member 150 can be a conical shape and includes a transparent portion (or is entirely transparent) that allows light reflected from the operation region to reach the image sensor. The vessel harvesting device may include a light source that emits light in the operation region which is then reflected and detected by the image sensor to capture an image. In some examples, the dissector member 150 is formed, or partially formed, from a polycarbonate material. The shape and material of the dissector member 150 can affect the light, such that the light is refracted before reaching the image sensor 180. For example, as shown at 2302. The refraction of light by the dissector member 150 causes distortion in the image captured by the image sensor 180. This distortion may affect the user recognizing proper distances between a position of a vessel, the vessel positioner, and /or the vessel cautery tool. This document describes examples of systems, methods, devices, and techniques for correcting this distortion. Correcting this distortion improves the usability of the vessel harvesting device 100. For example, by improving the visibility of a region captured by the image sensor of the vessel harvesting device 100 during an operation.

FIG. 25 illustrates an example method 2400 for correcting distortion caused by the dissector member. In some examples, the method 2400 is performed by the computing device 1002 as part of the image processing module 1008, as show n in FIG. 16. For example, as instructions stored in memory and executed by a processor of the computing device 1002. Other image processors can also perform the method 1800. In alternative embodiments, the images can be processed at a server or cloud computing environment. In other examples, the vessel harvesting device includes a processor and the method 2400 is performed at this processor included in the vessel harvesting device. The method 2400 includes the operations 2402, 2404. and 2406.

At the operation 2402. the computing device receives an image from the vessel harvesting device. The vessel harvesting device includes an image sensor that captures image data via light that passes through a transparent portion of the dissector member (e.g., as shown in FIG. 24). The image data for the image is electronically communicated to the computing device (e.g., via a cable or wirelessly).

At the operation 2404, the computing device shifts the image based on a calibrated offset. In some examples, the cone tip of the dissector member, lens, and image are aligned causing the center of the image to not be aligned with the light which passes through the center of the dissector member (e.g., the tip of the dissector member). In some of these examples, the image is shifted by an offset to move the region of the image that corresponds to the light received through the center of the dissector member to the center of the image before applying the distortion coefficients to correct the received image. In some examples, the computing device identifies at least one standard point of the captured image and shifts the image to align the at least one standard point to a predetermined location. For example, as illustrated and described in reference to FIGs. 27A-C and 28.

At the operation 2404, the computing device applies distortion coefficients to the shifted image to generate a corrected image. In some examples, distortion coefficients are applied to the shifted image to correct the distortion. The distortion coefficients are determined based on the refraction caused by the dissector member 150. In some examples, the distortion coefficients are predetermined and saved in the computing device. An example of applying distortion coefficients is illustrated and described in reference to FIG. 26.

FIG. 26 illustrates an example of correcting a distorted image represented by a distorted image plot 2502. In this example, the image received by the computing device is distorted. For example, as shown by the distorted image plot 2502. A distortion coefficients image plot 2504 illustrates the distortion coefficients being applied to the distorted image plot 2502 to generate the corrected image plot 2506. As shown each point (e.g., pixel) on the image has a different magnitude and direction of distortion that is corrected by the distortion coefficients. The distortion coefficients are determined based on characteristics of the dissector member that cause the refraction of light transmitted through the dissector member.

FIG. 27A illustrates the dissector member 150 with a cross-sectional line. FIG. 27B illustrates a cross-sectional view of the dissector member 150, taken along the cross-sectional line shown in FIG. 27 A. As shown, the dissector member 150 includes a tip 2550 corresponding to the center of the dissector member in the cross- sectional view. In some examples, the image is shifted so the center of the image is aligned with the region in the image capturing the tip 2550, for example as shown at the point 2608 in FIG. 27C.

FIG. 27C illustrates an example of shifting an input image 2600 to generate a shifted image 2602. In the example shown, the center of the image 2606 is not aligned with the region of the image that captures the light through the tip 2550 (e.g.. the point 2608). In some examples, the computing system identifies markers 2604A- C in the received image 2600. These markers are used to identify the point 2608. For example, the X axis for point 2608 is calculated at the midpoint between marker 2604 and 2604C and the Y axis is calculated at the midpoint between marker 2604A and 2604B. The offset is determined as the difference between the center point of the image 2606 and the point 2608. Once determined the offset is used to shift the image to move the center of the image to the point 2608.

In some examples, the markers 2604A-C can be physical markers positioned on the dissector member. For example, as illustrated in FIGs. 28A-32B. The markers can be positioned on the inner or outer surface of the dissector member 150. The marker can be positioned anywhere on the dissector member 150 that is within the field of view of the image sensor. In some examples, the maker is positioned at a location near the edge of the field of view of the sensor to prevent and/or minimize the marker obstructing the view of the image captured by the image sensor.

In some examples, the marker is a protrusion on the dissector member (e.g., as shown in FIGs. 29A-30). In some examples, the marker is a groove in the dissector member (e.g., as shown in FIGs. 31A-32B). In some examples, the marker is painted on a surface of the dissector member. In some examples, the marker is a portion of the dissector member that is of a different transparency than the surrounding portions of the dissector member. For example, the marker may be a portion of the dissector member that is made of a material that obstructs light or a material that is of a different level of transparency as compared to the translucent portions of the dissector member. In some examples, the marker is small to avoid or reduce the obstruction of the image.

In some examples three markers are used to define a surface plane, where the surface plane defines parallelism between the image sensor and the cone tip. The information defining the surface plane can be processed to provide distortion correction.

In some examples, the dissector member 150 does not include markers and a user view(s). An image captured by the vessel harvesting device and selects one or more points which are indicative of the region in the image corresponding to the tip of the dissector member. For example, a user can select the region that corresponds to the tip of the dissector member on a user interface to calibrate the offset. In some of these examples, the device is calibrated by a manufacturer.

In some examples, image processing (e.g.. machine vision) is used to identify a portion of the image corresponding to the region capturing the tip of the dissector member.

In some examples, a calibration sheet is used to determine the offset. For example, the vessel harvesting device can be placed on a calibration tool with a calibration sheet including one or more markers. The offset can then be calculated based on characteristics in the captured image (e.g., based on an expected location and/or shape of the one or more markers). An example of a calibration tool is illustrated and described in reference to FIG. 33.

FIG. 28 illustrates an example of shifting and correcting a distorted image represented by a distorted image plot 2702. Markers are used to identify points 2704A-C. The points 2704A-C are used to identify the center point 2706. Next, the image is shifted to move the center point 2706 to the center of the image, as shown in the shifted distorted image plot 2704. The distortion coefficients are applied to the shifted distorted image plot 2704 to generate the corrected image plot 2706.

FIGs. 29A-33B illustrate example markers located on the dissector member 150. As described in reference to FIGs. 27A-C and FIG. 28 the markers are captured in an image taken by the vessel harvester, where the captured makers in the image are used to identify⁷ a region (or point) in the image that captures the light transmitted through the tip of the dissector member.

FIG. 29A illustrates a first perspective view of a first example dissector member 150 with markers 2802. FIG. 29B illustrates a second perspective view of the first example dissector member 150 illustrated in FIG. 29 A. The markers 2802 are triangular shaped protrusions on the inner surface of the dissector member.

FIG. 30 illustrates a second example dissector member 150 with markers 2808. The markers 2902 are line shaped protrusions on the inner surface of the dissector member 150.

Referring to FIGs 29A-30, the protrusions (2802, 2902) are located near the edge of the inner surface of the dissector member to prevent or reduce the obstruction of the image to a user. In other examples other shaped protrusions can be used. In some examples, the protrusions can be located on the outer surface of the dissector member 150. In some examples, grooves of the same or similar shapes can be used on the inner surface and/or outer surface of the dissector member 150.

FIG. 31 A illustrates a first perspective view of a third example dissector member 150 with a marker 3102. FIG. 3 IB illustrates a second perspective view of the third example dissector member 150 shown in FIG. 31A. The marker 3102 is a grove along a circumference of an inner surface of the dissector member 150.

FIG. 32A illustrates a first perspective view of a fourth example dissector member 150 a marker 3102. FIG. 32B illustrates a second perspective view of the fourth example dissector member 150 shown in FIG. 32A. The markers 3002 include two groves in the inner surface of the dissector member 150.

FIG. 33A illustrates a first perspective view of a fifth example dissector member 150 with a marker 3202. FIG. 33B illustrates a second perspective view of the fourth example dissector member 150 shown in FIG. 33 A. The markers 3202 includes a grove in the inner surface of the dissector member 150. FIG. 34 illustrates an example calibration tool 3302. The calibration tool 3302 is used to calculate the optimized distortion coefficients that are used to correct the distorted images captured by the vessel harvesting device 100. In the example shown, the calibration tool 3302 includes a calibration sheet 3304. The calibration sheet 3304 can include one or more reference points 3306 which are captured in an image by the image sensor of the vessel harvesting device 100. The reference points 3306 captured in the image are used to calibrate relationships between the pixels captured in the image and the physical location of the reference points 3306 on the calibration sheet 3304. These relationships can be used to identify an offset (e.g., caused by the relative position of the cone of the dissection member 150, the image sensor, and/or the lens of the image sensor) and/or distortion coefficients. For example, the image captured during a calibration process can be compared to a reference image stored in memory to calibrate distortion coefficients for the vessel harvesting device 100.

This specification uses the term “configured” in connection with systems and computer program components. For a system of one or more computers to be configured to perform particular operations or actions means that the system has installed on it software, firmware, hardware, or a combination of them that in operation cause the system to perform the operations or actions. For one or more computer programs to be configured to perform particular operations or actions means that the one or more programs include instructions that, when executed by data processing apparatus, cause the apparatus to perform the operations or actions.

Embodiments of the subject matter and the functional operations described in this specification can be implemented in digital electronic circuitry, in tangibly- embodied computer software or firmware, in computer hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them. Embodiments of the subj ect matter described in this specification can be implemented as one or more computer programs, i.e., one or more modules of computer program instructions encoded on a tangible non transitory storage medium for execution by. or to control the operation of, data processing apparatus. The computer storage medium can be a machine-readable storage device, a machine-readable storage substrate, a random or serial access memory' device, or a combination of one or more of them. Alternatively or in addition, the program instructions can be encoded on an artificially generated propagated signal, e.g., a machine-generated electrical, optical, or electromagnetic signal, that is generated to encode information for transmission to suitable receiver apparatus for execution by a data processing apparatus.

The term '‘data processing apparatus’’ refers to data processing hardware and encompasses all kinds of apparatus, devices, and machines for processing data, including by way of example a programmable processor, a computer, or multiple processors or computers. The apparatus can also be, or further include, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit). The apparatus can optionally include, in addition to hardware, code that creates an execution environment for computer programs, e.g., code that constitutes processor firmware, a protocol stack, a database management system, an operating system, or a combination of one or more of them.

A computer program, which may also be referred to or described as a program, software, a software application, an app, a module, a software module, a script, or code, can be written in any form of programming language, including compiled or interpreted languages, or declarative or procedural languages; and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A program may, but need not, correspond to a file in a file system. A program can be stored in a portion of a file that holds other programs or data, e.g., one or more scripts stored in a markup language document, in a single file dedicated to the program in question, or in multiple coordinated files, e g., files that store one or more modules, sub programs, or portions of code. A computer program can be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a data communication network.

In this specification, the term “database” is used broadly to refer to any collection of data: the data does not need to be structured in any particular way, or structured at all, and it can be stored on storage devices in one or more locations. Thus, for example, the index database can include multiple collections of data, each of which may be organized and accessed differently.

Similarly, in this specification the term “engine” is used broadly to refer to a software-based system, subsystem, or process that is programmed to perform one or more specific functions. Generally, an engine will be implemented as one or more software modules or components, installed on one or more computers in one or more locations. In some cases, one or more computers will be dedicated to a particular engine; in other cases, multiple engines can be installed and running on the same computer or computers.

The processes and logic flows described in this specification can be performed by one or more programmable computers executing one or more computer programs to perform functions by operating on input data and generating output. The processes and logic flows can also be performed by special purpose logic circuitry’, e.g., an FPGA or an ASIC, or by a combination of special purpose logic circuitry and one or more programmed computers.

Computers suitable for the execution of a computer program can be based on general or special purpose microprocessors or both, or any other kind of central processing unit. Generally, a central processing unit will receive instructions and data from a read only memory or a random access memory’ or both. The essential elements of a computer are a central processing unit for performing or executing instructions and one or more memory devices for storing instructions and data. The central processing unit and the memory can be supplemented by, or incorporated in, special purpose logic circuitry. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto optical disks, or optical disks. However, a computer need not have such devices. Moreover, a computer can be embedded in another device, e.g., a mobile telephone, a personal digital assistant (PDA), a mobile audio or video player, a game console, a Global Positioning System (GPS) receiver, or a portable storage device, e.g., a universal serial bus (USB) flash drive, to name just a few.

Computer readable media suitable for storing computer program instructions and data include all forms of non-volatile memory⁷, media and memory devices, including by way of example semiconductor memory devices, e.g., EPROM, EEPROM, and flash memory' devices; magnetic disks, e.g., internal hard disks or removable disks; magneto optical disks; and CD ROM and DVD-ROM disks.

To provide for interaction with a user, embodiments of the subject matter described in this specification can be implemented on a computer having a display device, e.g., a CRT (cathode ray tube) or LCD (liquid cry stal display) monitor, for displaying information to the user and a keyboard and a pointing device, e.g.. a mouse or a trackball, by which the user can provide input to the computer. Other kinds of devices can be used to provide for interaction with a user as well; for example, feedback provided to the user can be any form of sensory feedback, e.g., visual feedback, auditory feedback, or tactile feedback; and input from the user can be received in any form, including acoustic, speech, or tactile input. In addition, a computer can interact with a user by sending documents to and receiving documents from a device that is used by the user; for example, by sending web pages to a web browser on a user’s device in response to requests received from the web browser.

Embodiments of the subject matter described in this specification can be implemented in a computing system that includes a back end component, e g., as a data server, or that includes a middleware component, e.g., an application server, or that includes a front end component, e g., a client computer having a graphical user interface, a web browser, or an app through which a user can interact with an implementation of the subject matter described in this specification, or any combination of one or more such back end, middleware, or front end components. The components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network. Examples of communication networks include a local area network (LAN) and a wide area network (WAN), e g., the Internet.

The computing system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. In some embodiments, a server transmits data, e.g., an HTML page, to a user device, e.g., for purposes of displaying data to and receiving user input from a user interacting with the device, which acts as a client. Data generated at the user device, e.g., a result of the user interaction, can be received at the server from the device.

While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any invention or of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments of particular inventions. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described herein as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system modules and components in the embodiments described herein should not be understood as requiring such separation in all embodiments.

Claims

WHAT IS CLAIMED IS:

1. A device for dissecting a blood vessel from a patient, the device comprising: an actuator handle; a main shaft extending from the actuator handle and defining a central longitudinal axis; a tissue dissector member at a distal end of the main shaft and comprising a pointed tip; and vessel cautery tool comprising one or more cauterization electrodes, wherein the pointed tip is laterally offset from the central longitudinal axis of the main shaft.

2. The device of claim 1, further comprising a vessel positioner that is selectively extendable and retractable relative to the tissue dissector member by manipulation of a control mechanism on the actuator handle.

3. The device of claim 2, wherein a distal end portion of the vessel positioner is extendable distally beyond the tissue dissector member and retractable proximally of the tissue dissector member.

4. The device of claim 1 , wherein the tissue dissector member comprises a transparent portion.

5. The device of claim 4. further comprising an image sensor positioned to capture images distal of the tissue dissector member through the transparent portion of the tissue dissector member.

6. The device of claim 1. wherein the tissue dissector member comprises a transparent cone member.

7. The device of claim 1, further comprising a selectively extendable vessel cutting blade.

8. The device of claim 1, wherein the vessel cautery tool further comprises: an elongate shaft construct that is coupled to the actuator handle; and a jaw structure attached at a distal end portion of the elongate shaft construct, wherein the cauterization electrodes are attached to the jaw structure.

9. The device of claim 8, wherein the main shaft defines a first lumen, and wherein the vessel cautery’ tool is slidably disposed in the first lumen.

10. The device of claim 9, wherein the vessel cautery tool is retractable so that the jaw structure is fully within the first lumen, wherein the vessel cautery’ tool is extendable so that the jaw structure is positioned distally of the tissue dissector member, and wherein the vessel cautery tool is rotatable within the first lumen.

11. The device of claim 9, yvherein the first lumen is offset from the central longitudinal axis of the main shaft.

12. A computing device comprising: at least one processor; and a memory' storing instructions, which when executed by the at least one processor cause the computing device to: receive image data from a vessel harvesting device, the vessel harvesting device including a vessel cautery tool, a vessel positioner, and an image sensor capturing the image data; process the image data to generate an image; and provide the image to a display.

13. The computing device of claim 12, yvherein processing the image includes rotating the image to maintain a fixed orientation, wherein the image includes a device orientation indicator providing a reference for an orientation of the vessel harvesting device.

14. The computing device of claim 13, yvherein the device orientation indicator is a digital device orientation indicator.

15. The computing device of claim 13, yvherein the device orientation indicator is a physical indicator on a lens of the image sensor.

16. The computing device of claim 13, wherein the device orientation indicator is a physical indicator on a dissector member of the vessel harvesting device at a position that is within a field of view of the image sensor.

17. The computing device of claim 12, wherein processing the image includes: applying distortion coefficients to the image data to correct distortion cause by a dissector member of the vessel harvesting device.

18. The computing device of claim 17, wherein processing the image includes: shifting the image by a calibrated offset to align a center of the image wi th a region in the image that captures light transmitted through a tip of the dissector member.

19. A method for presenting a digital device orientation indicator on an image indicating an orientation of a vessel harvesting device, the method comprising: receiving the image and sensor data from the vessel harvesting device; setting the digital device orientation indicator overlaid on the image at a designated position that is indicative of an orientation of the vessel harvesting device; rotating the image to a fixed reference orientation based on the sensor data received form the vessel harvesting device; and presenting the rotated image with the digital device orientation indicator on a display.

20. A method for correcting distortion in an image captured by a vessel harvesting device, the distortion caused by a dissector member of the vessel harvesting device, the method comprising: receiving the image from the vessel harvesting device; shifting the image based on a calibrated offset; applying distortion coefficients to the shifted image to correct the distortion in the image; and presenting the corrected image on a display.