Abstract
The present invention includes devices and methods for pacing contact, lead, conduit or other medical fixture placement in tissues or organs. The invention features an articulating multiple suction foot device, comprising an inner vacuum conduit and foot slidingly contained within an outer vacuum conduit and foot, with the inner vacuum conduit and foot configured to extend beyond the outer vacuum suction foot, and to be further articulated once extended; as well as a separate tissue or waste removal vacuum assembly that extends within the inner vacuum conduit to the inner vacuum foot to remove cut tissue prior to its advancement beyond the outer vacuum suction foot. The device is configured to permit the placement foot, such as a suction foot, to articulate to a desired position with respect to the target tissue, while the pacing contact, lead, fluid conduit or other medical fixture is releasably attached to the placement foot to permit it to be released from the placement foot after stabilization on the target tissue site.
Claims
1. A device adapted for the thoracoscopic placement of a pacing contact at a target site on an epicardial surface of a heart, the device comprising: (a) an inner tubular vacuum conduit having an inner vacuum conduit distal end comprising an inner suction foot portion, said inner tubular vacuum conduit having a flexible distal end and adapted to conduct a vacuum to said relatively inner suction foot portion; (b) an outer tubular vacuum conduit having an outer vacuum conduit distal end comprising an outer suction foot portion, said outer tubular vacuum conduit having a flexible distal end and adapted to conduct a vacuum to said outer suction foot portion, said inner tubular vacuum conduit slidingly engaged within outer tubular vacuum conduit, so as to permit said inner suction foot portion to be moved from a position within said outer suction foot portion to a position extended beyond said outer suction foot portion; (c) at least one actuator adapted to articulate said outer suction foot portion while said inner suction foot portion is disposed within said outer suction foot portion; (d) a waste removal vacuum conduit having a waste removal vacuum conduit distal end, and slidingly engaged within said inner tubular vacuum conduit so as to permit said waste removal vacuum conduit distal end to be urged to the position of said inner suction foot portion; (e) an electrocautery blade extensible from between said inner suction foot portion and said outer suction foot portion; and (f) a support sheath for supporting said vacuum conduits, and having a proximal end and a distal end, with respective proximal end inlet and distal end outlet.
2. The device of claim 1 wherein said support sheath has a handle portion extending laterally therefrom.
3. The device of claim 1 wherein said support sheath has a handle portion extending laterally therefrom, said handle portion additionally comprising a vacuum manifold comprising valves to supply vacuum to said inner, outer and waste removal vacuum conduits independently.
4. The device of claim 3, additionally comprising a manifold bulkhead disposed on the proximal end of said support sheath, said manifold bulkhead adapted to conduct a vacuum from said vacuum manifold to supply vacuum to said inner, outer and waste removal vacuum conduits independently.
5. The device of claim 1 wherein said relatively inner suction foot portion and said outer suction foot portion each comprise a plurality of air channels.
6. The device of claim 1 wherein said at least one actuator comprise a first actuator and a second actuator, the first actuator comprising a first knob and at least one first tension cord adapted to articulate said outer suction foot portion while said inner suction foot portion and said waste removal vacuum conduit distal end are disposed within said outer suction foot portion; and said second actuator comprises a second knob and at least one second tension cord adapted to articulate said inner suction foot portion when said inner suction foot portion is extended beyond said outer suction foot portion.
7. The device of claim 6, additionally comprising a manifold bulkhead disposed on the proximal end of said support sheath, said manifold bulkhead having said first knob and said second knob disposed thereupon.
8. The device of claim 1 wherein said an inner tubular vacuum conduit is adapted, upon removal of said waste removal vacuum conduit, to slidingly engage a lead guide having a flexible distal portion and a contact head disposed on the distal end thereof, said contact head bearing a pacing lead and adapted to engage said inner suction foot so as to present such that said pacing lead from said inner suction foot, to extend said pacing lead from said inner suction foot.
9. The device of claim 1, additionally comprising a releasable locking mechanism adapted to releasably restrict the axial movement of said inner tubular vacuum conduit with respect to said outer vacuum conduit.
10. The device of claim 1, said distal end portion of said support sheath additionally comprising a moveable cover adapted to reversibly open and close said distal end outlet.
11. The device of claim 1, wherein said inner tubular vacuum conduit is longer than said outer tubular vacuum conduit, and additionally comprising a removable spacer adapted to maintain relatively inner suction foot portion within said outer suction foot portion.
12. The device of claim 1 wherein said electrocautery blade is adapted to be rotated 360 degrees and is energized by a spring biased switch when in an extended position from between said inner suction foot portion and said outer suction foot portion. Handle with Electrocautery Pencil and Vacuum
13. The device of claim 1 additionally comprising a handle portion extending laterally therefrom, said handle portion having a lower portion and an upper portion, and a longitudinal axis, and defining a space adapted to accommodate and support an electrosurgical pencil therein; and (1) an electrosurgical pencil disposed within said space and having an electric input contact extending from said lower portion of said handle, and an electric output contact extending from said upper portion of said handle; (2) a hollow electrocautery sheath extending from said upper portion at an angle to said longitudinal axis, said hollow electrocautery sheath having a rotatable electrocautery connection, and (3) an electrical connection between said electrosurgical pencil and said electric output to said rotatable electrocautery connection.
14. The device of claim 13, said handle additionally comprising a vacuum manifold comprising valves to supply vacuum to said inner, outer and waste removal vacuum conduits independently. Handle with Push to connect Vacuum Connection
15. The device of claim 1 additionally comprising a handle portion extending laterally therefrom, said handle portion having a lower portion and an upper portion, said lower portion comprising a vacuum manifold adapted to accept a vacuum connection and to distribute said vacuum to each of said (a) inner tubular vacuum conduit, (b) outer tubular vacuum conduit and (c) waste removal vacuum conduit independently.
16. The device of claim 15, wherein said vacuum manifold comprises three respective push valves governing said vacuum connections to each of said vacuum conduits. Contact Placement Device with Dual Suction Foot with Waste Vacuum, EC Knife and Actuators with EC Pencil and Vacuum Manifold in Handle (more elements than Claim1)
17. A device adapted for the thoracoscopic placement of a pacing contact at a target site on an epicardial surface of a heart, the device comprising: (a) an inner tubular vacuum conduit having an inner vacuum conduit distal end comprising an inner suction foot portion, said inner tubular vacuum conduit having a flexible distal end and adapted to conduct a vacuum to said relatively inner suction foot portion; (b) an outer tubular vacuum conduit having an outer vacuum conduit distal end comprising an outer suction foot portion, said outer tubular vacuum conduit having a flexible distal end and adapted to conduct a vacuum to said outer suction foot portion, said inner tubular vacuum conduit slidingly engaged within outer tubular vacuum conduit, so as to permit said inner suction foot portion to be moved from a position within said outer suction foot portion to a position extended beyond said outer suction foot portion; (c) at least one actuator adapted to articulate said outer suction foot portion while said inner suction foot portion is disposed within said outer suction foot portion; (d) a waste removal vacuum conduit having a waste removal vacuum conduit distal end, and slidingly engaged within said inner tubular vacuum conduit so as to permit said waste removal vacuum conduit distal end to be urged to the position of said inner suction foot portion; (e) an electrocautery blade extensible from between said inner suction foot portion and said outer suction foot portion; (f) a support sheath for supporting said vacuum conduits, and having a proximal end and a distal end, with respective proximal end inlet and distal end outlet; and (g) a handle portion extending laterally therefrom, said handle having a lower portion and an upper portion, and defining a space adapted to accommodate and support an electrosurgical pencil therein; and an electrosurgical pencil disposed within said space and having an electric input contact extending from said lower portion of said handle, and said lower portion comprising a vacuum manifold adapted to accept a vacuum connection and to distribute said vacuum independently respectively to each of said (a) inner tubular vacuum conduit, (b) outer tubular vacuum conduit and (c) waste removal vacuum conduit.
18. The device of claim 17, additionally a manifold bulkhead disposed on the proximal end of said support sheath, said manifold bulkhead adapted to conduct a vacuum from said vacuum manifold to supply vacuum to said inner, outer and waste removal vacuum conduits independently.
19. The device of claim 17 wherein said at least one actuator comprise a first actuator and a second actuator, the first actuator comprising a first knob and at least one first tension cord adapted to articulate said outer suction foot portion while said inner suction foot portion and said waste removal vacuum conduit distal end are disposed within said outer suction foot portion; and said second actuator comprises a second knob and at least one second tension cord adapted to articulate said inner suction foot portion when said inner suction foot portion is extended beyond said outer suction foot portion. Manifold Bulkhead on Support Sheath with Vacuum and Electrocautery Blade; Electrocautery Subassembly attached to Electrocautery Blade
20. The device of claim 1 additionally comprising, on said proximal end of said support sheath: (g) a proximal bulkhead, and wherein: i. a first of said at least one actuator comprises a first captive articulation knob extending into said proximal bulkhead and having a first spool portion having a spool of first articulation wires; ii. a second of said at least one actuator comprises a second captive articulation knob extending into said proximal bulkhead and having a second spool portion having a spool of second articulation wires; said proximal bulkhead comprising: i. a first opposed aperture pair having said first articulation wires extending therethrough; ii. a second opposed aperture pair having said second articulation wires extending therethrough; iii. at least one fluid aperture adapted to transmit a vacuum through said proximal bulkhead; said outer tubular vacuum conduit extending from said proximal bulkhead a first length; said inner tubular vacuum conduit of sufficient length so as to be adapted to extend from said proximal bulkhead a second length greater than said first length; and (h) a hollow electrocautery sheath extending from said proximal bulkhead, said hollow electrocautery sheath having a rotatable electrocautery connection, and a spring extending from the distal end of said hollow electrocautery sheath to said electrocautery blade. Contact Placement Device with Dual Suction Foot with Waste Vacuum, with adaption to accept Pacing Contact Head and with Locking Mechanism
21. A device adapted for the thoracoscopic placement of a pacing contact at a target site on an epicardial surface of a heart, the device comprising: (a) an inner tubular vacuum conduit having an inner vacuum conduit distal end comprising an inner suction foot portion, said inner tubular vacuum conduit having a flexible distal end and adapted to conduct a vacuum to said relatively inner suction foot portion; (b) an outer tubular vacuum conduit having an outer vacuum conduit distal end comprising an outer suction foot portion, said outer tubular vacuum conduit having a flexible distal end and adapted to conduct a vacuum to said outer suction foot portion, said inner tubular vacuum conduit slidingly engaged within outer tubular vacuum conduit, so as to permit said inner suction foot portion to be moved from a position within said outer suction foot portion to a position extended beyond said outer suction foot portion; said inner tubular vacuum conduit is adapted, upon removal of said waste removal vacuum conduit, to slidingly engage a lead guide having a flexible distal portion and a contact head disposed on the distal end thereof, said contact head bearing a pacing lead and adapted to engage said inner suction foot so as to present such that said pacing lead from said inner suction foot, to extend said pacing lead from said inner suction foot; (c) a releasable locking mechanism adapted to releasably restrict the axial movement of said inner tubular vacuum conduit with respect to said outer vacuum conduit; and (d) a waste removal vacuum conduit having a waste removal vacuum conduit distal end, and slidingly engaged within said inner tubular vacuum conduit so as to permit said waste removal vacuum conduit distal end to be urged to the position of said inner suction foot portion.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0086] FIG. 1 is a partially sectioned and transparent first side lateral perspective view of an elongated handle sheath subassembly for a device in accordance with one embodiment of the present invention.
[0087] FIG. 2 is a partially sectioned and transparent first side lateral perspective view of an elongated handle sheath subassembly for a device in accordance with one embodiment of the present invention.
[0088] FIG. 3 is a partially sectioned and transparent distal end perspective view of an outer sheath subassembly for a device in accordance with one embodiment of the present invention.
[0089] FIG. 4 is a partially sectioned and transparent distal end perspective view of an outer sheath subassembly for a device in accordance with one embodiment of the present invention.
[0090] FIG. 5 is detailed plan distal end view of a vacuum foot portion of the outer sheath of a device in accordance with one embodiment of the present invention.
[0091] FIG. 6 is a detailed proximal end perspective view of a vacuum foot portion of the outer sheath of a device in accordance with one embodiment of the present invention.
[0092] FIG. 7 is a detailed first lateral elevation view of a proximal end housing of the outer sheath of a device in accordance with one embodiment of the present invention.
[0093] FIG. 8 is a sectioned distal perspective view of a proximal end housing of the outer sheath of a device in accordance with one embodiment of the present invention.
[0094] FIG. 9 is a partially sectioned and transparent lateral view of a proximal end housing of the outer sheath of a device in accordance with one embodiment of the present invention.
[0095] FIG. 10 is a partially sectioned perspective view of an articulation control knob and spool of the outer sheath of a device in accordance with one embodiment of the present invention.
[0096] FIG. 11 is a partially sectioned perspective view of an articulation control knob and spool positioned on a proximal end housing of the outer sheath of a device in accordance with one embodiment of the present invention.
[0097] FIG. 12 is a top perspective view of an articulation control knob of the outer sheath of a device in accordance with one embodiment of the present invention.
[0098] FIG. 13 is a first perspective partially transparent view of the proximal end of an electrocautery blade subassembly of a device, in accordance with one embodiment of the present invention.
[0099] FIG. 14 is a partially sectioned and transparent first perspective view of the proximal end of an electrocautery blade subassembly of a device in accordance with one embodiment of the present invention.
[0100] FIG. 15 is a first perspective view of the distal end of an electrocautery blade subassembly of a device, in accordance with one embodiment of the present invention.
[0101] FIG. 16 is a detailed sectioned first perspective view of the proximal end of an electrocautery blade subassembly of a device in accordance with one embodiment of the present invention.
[0102] FIG. 17 is a detailed perspective view of the distal end of an electrocautery blade subassembly of a device in accordance with one embodiment of the present invention.
[0103] FIG. 18 is a partially sectioned distal end perspective view of distal end of an inner vacuum subassembly of a device in accordance with one embodiment of the present invention.
[0104] FIG. 19 is a partially transparent perspective view of an inner vacuum subassembly of a device, with vacuum connector, in accordance with one embodiment of the present invention.
[0105] FIG. 20 is a partially sectioned and transparent distal end perspective view of the distal end of an inner vacuum subassembly of a device in accordance with one embodiment of the present invention.
[0106] FIG. 21 is a partially transparent perspective view of an inner vacuum subassembly of a device, with vacuum connector, in accordance with one embodiment of the present invention.
[0107] FIG. 22 is a partially transparent perspective view of a tissue or waste removal vacuum subassembly of a device, with vacuum connector, in accordance with one embodiment of the present invention.
[0108] FIG. 23 is a partially transparent perspective view of a tissue remover vacuum subassembly of a device, with vacuum connector, in accordance with one embodiment of the present invention.
[0109] FIG. 24 is a partially sectioned and transparent distal end perspective view of the lead drive subassembly of a device in accordance with one embodiment of the present invention.
[0110] FIG. 25 is a partially sectioned and transparent distal end perspective view of the proximal end of a lead drive of a device in accordance with one embodiment of the present invention.
[0111] FIG. 26 is a distal end elevation view of the distal end of a lead drive subassembly of a device in accordance with one embodiment of the present invention, and also showing the distal end of the lead drive adaptation to securely hold the lead or contact head in place.
[0112] FIG. 27 is a distal end lateral perspective view of the distal end of a lead drive subassembly of a device in accordance with one embodiment of the present invention.
[0113] FIG. 28 is a proximal end lateral perspective view of an elongated handle sheath subassembly for a device in accordance with one embodiment of the present invention.
[0114] FIG. 29 is a distal end partial elevation view of an elongated handle sheath subassembly for a device in accordance with one embodiment of the present invention.
[0115] FIG. 30 is a lateral perspective view of an elongated handle sheath subassembly for a device in accordance with one embodiment of the present invention.
[0116] FIG. 31 is a partially transparent partial lateral perspective view of an elongated handle sheath with the outer vacuum conduit, electrocautery knife, inner vacuum conduit and tissue or waste removal vacuum conduit subassembly for a device in accordance with one embodiment of the present invention.
[0117] FIG. 32 is a detailed partial lateral perspective view of an elongated handle sheath with outer and inner vacuum conduits subassembly with control knobs for a device in accordance with one embodiment of the present invention.
[0118] FIG. 33 is a detailed partial lateral perspective view of an elongated handle sheath with the outer vacuum, electrocautery, inner vacuum and waste or tissue removal vacuum conduit subassembly with control knobs for a device in accordance with one embodiment of the present invention.
[0119] FIG. 34 is a detailed partially sectioned and transparent partial lateral elevation view of an elongated handle sheath with outer and inner vacuum conduits subassembly with control knobs for a device in accordance with one embodiment of the present invention.
[0120] FIG. 35 is a detailed partial lateral perspective view of an elongated handle sheath subassembly with electrocautery pen and suction tube in accordance with one embodiment of the present invention.
[0121] FIG. 36 is a detailed partially sectioned and transparent lateral elevation view of an elongated handle sheath subassembly with control knobs with electrocautery connection for a device in accordance with one embodiment of the present invention.
[0122] FIG. 37 is a detailed partially sectioned and transparent lateral elevation view of the distal end of a device in accordance with one embodiment of the present invention, with the electrocautery blade inside.
[0123] FIG. 38 is a detailed partially sectioned and transparent lateral elevation view of the distal end of a device showing the advancement of electrocautery blade with rotation in accordance with one embodiment of the present invention.
[0124] FIG. 39 is a detailed partially sectioned and transparent lateral elevation view of an elongated handle sheath subassembly with control knobs, and depicting rotation of electrocautery knob for a device in accordance with one embodiment of the present invention.
[0125] FIG. 40 is a detailed partially sectioned and transparent lateral elevation view of the distal end of a device in accordance with one embodiment of the present invention.
[0126] FIG. 41 is a detailed partially sectioned and transparent lateral elevation view of the distal end of a device in accordance with one embodiment of the present invention.
[0127] FIG. 42 is a detailed partial lateral perspective view of an elongated handle sheath subassembly with control knobs and vacuum conduits for a device in accordance with one embodiment of the present invention.
[0128] FIG. 43 is a detailed partial lateral perspective view of an elongated handle sheath subassembly with control knobs and vacuum conduits for a device in accordance with one embodiment of the present invention.
[0129] FIG. 44 is a detailed partial lateral perspective view of an elongated handle sheath subassembly with control knobs and vacuum conduits for a device in accordance with one embodiment of the present invention.
[0130] FIG. 45 is a detailed partially transparent lateral perspective view of the proximal end of an inner vacuum handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0131] FIG. 46 is a detailed partially transparent proximal end perspective view of the proximal end of an inner vacuum handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0132] FIG. 47 is a detailed partially transparent first lateral elevation view of the proximal end of an inner vacuum handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0133] FIG. 48 is a detailed partially transparent second lateral elevation view of the proximal end of an inner vacuum handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0134] FIG. 49 is a distal end elevation view of the distal end of a device arrangement, with outer vacuum conduit, inner vacuum conduit and lead drive cooperating, in accordance with one embodiment of the present invention.
[0135] FIG. 50 is a distal end elevation view of the distal end of a device arrangement, with outer vacuum conduit, inner vacuum conduit and lead drive cooperating, in accordance with one embodiment of the present invention.
[0136] FIG. 51 is a detailed first lateral elevation view of the proximal end of an outer and inner vacuum handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0137] FIG. 52 is a detailed first lateral elevation view of the proximal end of an outer and inner vacuum conduit handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0138] FIG. 53 is a detailed partially transparent lateral perspective view of the distal end outer and inner vacuum conduit handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0139] FIG. 54 is a detailed lower lateral perspective view of the proximal end of an outer and inner vacuum conduit handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0140] FIG. 55 is a detailed lower lateral perspective view of the proximal end of an outer and inner vacuum conduit handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0141] FIG. 56 is a detailed first lateral elevation view of the proximal end of an outer and inner vacuum conduit handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0142] FIG. 57 is a detailed first lateral elevation view of the proximal end of an outer and inner vacuum conduit handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0143] FIG. 58 is a detailed partially transparent lateral perspective view of the distal end of outer and inner vacuum conduit handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0144] FIG. 59 is a detailed partially sectioned and transparent lateral elevation view of the distal end of an outer and inner vacuum conduit handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0145] FIG. 60 is a detailed partially sectioned and transparent lateral elevation view of the distal end of an outer and inner vacuum handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0146] FIG. 61 is a detailed first lateral elevation view of the proximal end of an outer and inner vacuum conduit handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0147] FIG. 62 is a detailed partially transparent lateral perspective view of the distal end of an outer and inner vacuum conduit handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0148] FIG. 63 is a detailed first lateral elevation view of the proximal end of an outer and inner vacuum conduit handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0149] FIG. 64 is a detailed partially transparent lateral perspective view of the distal end of an outer and inner vacuum conduit handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
[0150] FIG. 65 is a detailed first lateral elevation view of the proximal end of an outer and inner vacuum conduit handle and lead drive assembly of a device in accordance with one embodiment of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0151] In accordance with the foregoing summary, the following provides a detailed description of the preferred embodiments, which are presently considered to be the respective best modes thereof.
[0152] As used herein the distal end refers to the working end or patient end, while the proximal end refers to the operator end or actuator end from which the device of the present invention may be operated. The handle as shown in the described embodiment is on the side of the device referred to as the bottom side or the ventral aspect. The side opposite the bottom side is referred to as the top side or dorsal aspect. The right side is the side on the right hand when looking from the operator end, end-on. Conversely, the left side is the side on the left hand when looking from the operator end, end-on.
[0153] FIG. 1 is a partially sectioned and transparent first side lateral perspective view of an elongated handle sheath subassembly for a device in accordance with the displayed embodiment of the present invention. FIG. 1 shows of a support sheath 1 for a device in accordance with one embodiment of the present invention, having longitudinal axis A extending from the proximal to distal end. The displayed embodiment shows how a commercially available electrocautery pen may be fit into the handle. It also shows the outside suction attaches to the lower end of the handle. Inside the ergonomic handle the main suction line splits into 3 lines which opens on the side of the handle with “push to connect” adaptors. Suction or vacuum line for each of the three vacuum tubes can be individually connected or disconnected to the handle. When disconnected, the self-locking “push to connect” adaptor closes up to halt the vacuum.
[0154] The support sheath 8071 [1] has a beveled distal end 8071a [2] with a spring biased door or cover 8030 [3]. It has a handle 8095 [4] to be grasped by the operator, in this embodiment comprising right- and left-hand handle portions 8095 [4a] and 8096 [4b]. The right- and left-hand handle portions 8095 [4a] and 8096 [4b] are shaped so as to accommodate and support commercially available electrosurgical pencil [99].
[0155] In the displayed embodiment, the sheath 8071 [1] is about 15 cms long, and forms a hollow probe made of solid unyielding material such as metal or hard plastic, to gain access into the chest cavity through the access incision in between the ribs. It also has a set screw [5] on the top surface of the operator end. This set screw when tightened will hold the outer vacuum tube in a set position (see e.g., FIGS. 31-34).
[0156] FIG. 1 also shows main vacuum connector 8090 [90] that attaches to external line vacuum, such as provided in an operating suite, and manifold 8094 [94] that distributes the vacuum to the three vacuum conduits included in the device such as by way of the self-locking “push to connect” adaptor.
[0157] FIG. 1 also shows some of the electric components of the device, such as connector wire 8097 [97] and adapter 8098 [98] that serve to facilitate the electric connection to the electrocautery blade of the device.
[0158] FIG. 2 is a partially sectioned and transparent first side lateral perspective view of an elongated handle sheath subassembly for a device in this embodiment of the present invention. FIG. 2 shows the device of FIG. 1, and further describes some of its features, components and component functions, including the set screw [5] to lock position of inserted tubing of the vacuum/electrocautery blade components, the standard diameter connector to the commercially available electrosurgical pencil [99], the open adapter 8098 [98] to accept connection from device's electrocautery handle. The indent in handle's shape is to allow the buttons to be pressed by the operator. FIG. 2 also shows the position of the commercially available electrosurgical pencil, and the introducer with the flip open cover.
[0159] FIG. 2 shows the position of three screws used to connect the right-hand and left-hand sides of the handle which may have any appropriate shape, which typically will have an ergonomic shape adapted to fit the hand of the operator. FIG. 2 also shows the quick-release valves by way of the self-locking “push to connect” adaptor, which may incorporate an auto-shut-off valve feature when disconnected. FIG. 2 also shows that the manifold may connect to wall vacuum (or portable vacuum source) input to three outputs for device, such as, for example a ¼′ OD connector to wall vacuum.
[0160] FIG. 3 is a partially sectioned and transparent distal end perspective view of an outer sheath subassembly for a device in accordance with the displayed embodiment of the present invention. FIG. 3 shows outer conduit straight tube 8003, vacuum air hose or tubing 8004, oval suction foot 8029, outer proximal end manifold bulkhead 8008 of the device, spool knob 8009, pulley knob 8082, outer vacuum connector 8044, outer spring 8072, inner sleeve 8073 and mesh sleeve 8074. The proximal end manifold bulkhead 8008 of the device supports spool knob 8009 and pulley knob 8082 and allows their rotation, so as to be able to actuate respective articulation wires (not pictured).
[0161] FIG. 4 is a partially sectioned and transparent distal end perspective view of an outer vacuum conduit subassembly for a device of this embodiment of the present invention. FIG. 4 shows manifold bulkhead 8008 and outer conduit straight tube 8003 which may include mesh sleeve 8074.
[0162] FIG. 4 shows articulation spool knob 8009 that may be rotated to provide side to side articulation and articulation pulley knob 8082 that may be rotated to provide up-down articulation. Also shown is the ¼′ OD connector to the handle, and vacuum air hose or tubing 8004 that supplies vacuum pressure to end effector, and outer spring 8072 that allows for articulation flexibility. As may be appreciated from this Figure, the suction foot 8029 supplies vacuum force to the area to secure the device to the target tissue site, such as the pericardium. As can be seen in this Figure, vacuum or suction foot 8029 has outer suction area 8029a, conduit aperture 8029b, locking tabs 8029c and outer suction foot vacuum hose attachment apertures 8029f.
[0163] In one such embodiment, mesh sleeve 8074 protects the device components in the distal articulating portion.
[0164] FIG. 5 is a detailed plan distal end view of an outer vacuum or suction foot portion 8209 of a device in accordance with this embodiment of the present invention. FIG. 5 shows an oval variant of the outer suction foot 8029.
[0165] FIG. 5 also shows locking tabs 8029c to hold the position of inner suction foot portion with respect to outer suction foot portion 8029. The tabs cooperate with corresponding locking tabs structure 8062a on the outer surface of the inner vacuum foot surface to permit the two suction feet to move with respect to one another once the inner suction foot is rotated with respect to outer suction foot portion.
[0166] Application of vacuum to outer suction foot portion 8029 causes vacuum area 8029a to be secured against the target tissue area, such as for securement to the pericardium. In the displayed embodiment, an oval shape of outer suction foot portion 8029 may be used to maximize vacuum area, though other shapes may be used.
[0167] FIG. 6 is a detailed proximal end perspective view of a vacuum foot portion of this embodiment of the present invention. FIG. 6 shows circular opening or channel 8029e for mounting to outer spring 8072. Threaded feature 8029e in the proximal end of outer suction foot portion 8029 is provided to engage electrocautery spring (not shown).
[0168] FIG. 6 also shows two opposing vacuum hose attachments 8029f that are provided to connect the vacuum air hose or tubing 8004 as shown in FIG. 3.
[0169] FIG. 7 is a detailed first lateral elevation view of a proximal end manifold bulkhead 8008 housing of a device in accordance with the displayed embodiment of the present invention. FIG. 7 shows four articulation wire outlets 8008a-8008d, with articulation wire outlets 8008a and 8008b positioned to accept articulation wires controlled by pulley knob 8082 as the articulation knob to be rotated to bring about and control side-to-side articulation, and articulation wire outlets 8008c and 8008d positioned to accept articulation wires controlled by spool knob 8009 as the articulation knob to be rotated to bring about and control side-to-side articulation.
[0170] FIG. 7 also shows two vacuum hose attachment apertures 8008e and 8008f that communicate with vacuum air hoses or tubing, such as vacuum air hose or tubing 8004. FIG. 7 also shows electrocautery aperture 8029 that functions as through-hole for passage of electrocautery connector.
[0171] FIG. 8 is a sectioned distal perspective view of a proximal end manifold bulkhead 8008 housing of a device of the displayed embodiment of the present invention. FIG. 8 also shows two articulation knob/spool cavities 8008h and 8008i that accept and permit rotation of pulley knob 8082 and spool knob 8009, respectively. FIG. 8 also shows cavity 8008j for passage of the vacuum to vacuum hose attachment apertures 8008e and 8008f, and which in turn communicate with attachment point 8008k for vacuum connector.
[0172] FIG. 9 is a partially sectioned and transparent lateral view of a proximal end manifold bulkhead 8008 housing of the displayed embodiment of the present invention. FIG. 9 shows routing cavity 80081 for articulation wires actuated by pulley knob 8082, and routing cavity 8008m for articulation wires actuated by spool knob 8009.
[0173] FIG. 10 is a partially sectioned perspective view of an articulation control knob and spool of a device in accordance with the displayed embodiment of the present invention. FIG. 10 shows pulley knob 8082 and the cutout feature on underside of pulley knob 8082 to engage spool having upper spool area 8082a and aperture 8082b for attachment of an articulation wire (such as by feeding through and knotting), and lower spool area 8082c and aperture 8082d for attachment of an articulation wire (such as by feeding through and knotting).
[0174] FIG. 11 is a partially sectioned perspective view of an articulation control knob and spool positioned on a proximal end housing of a device in accordance with one embodiment of the present invention.
[0175] FIG. 11 shows lip portion 8082e of pulley knob 8082 to engage the corresponding end feature of proximal end manifold bulkhead 8008 housing to prevent knob pull-out during operation.
[0176] FIG. 12 is a top perspective view of an articulation control knob, such as pulley knob 8082, of a device in accordance with this embodiment of the present invention.
[0177] FIG. 12 shows an assembled pulley knob 8082 (i.e., made of two handle halves and a spool portion), an adhesive being used to adjoin the handle halves in engagement with the spool portion.
[0178] It will be appreciated that spool knob 8009 is engaged with and cooperates with proximal end manifold bulkhead 8008 housing in the same fashion as does pulley knob 8082.
[0179] FIG. 13 is a first perspective partially transparent view of the proximal end of an electrocautery blade subassembly of a device of the displayed embodiment of the present invention. In the displayed embodiment, it shows the electrical pin connection to the handle and the continued electrical connection to the electrocautery blade at the distal end via a circular coil and plate (slip ring mechanism), such that the electrical contact is maintained as the electrocautery blade rotates.
[0180] FIG. 13 shows circular copper contact plate 8099 and knob springs 8099a that maintain sprung distance between rotational knob cap 8041 and copper contact plate 8099 that in turn bears against float ring 8042 (slip ring mechanism), as may be appreciated from FIG. 16.
[0181] FIG. 14 is a partially sectioned and transparent first perspective view of the proximal end of an electrocautery blade subassembly of a device in accordance with this particular embodiment of the present invention. FIG. 14 shows rotational knob assembly 8022, straight electrocautery sheath 8023, electrocautery connector pin 8040, rotational knob cap 8041, float ring 8042 and electrocautery spring 8048.
[0182] Rotational knob cap 8041 can be turned to rotate electrocautery spring 8048 and the electrocautery blade 8048a it bears; and advance it longitudinally through threaded feature 8029e in the inner side of distal end of outer suction foot portion 8029a. This threaded feature is provided to engage electrocautery spring, as shown in FIG. 6, to permit it to be urged forward to make a circular cutting movement in a reliable and regulated fashion as it is rotated to extend beyond the inner and outer suction feet when in a parallel position.
[0183] FIG. 15 is a first perspective view of the distal end of an electrocautery blade subassembly of a device, in accordance with the displayed embodiment of the present invention. FIG. 15 shows various additional operational features of the electrocautery blade subassembly. FIG. 15 shows that rotational knob cap 8041 can be spun to rotate electrocautery spring 8048 and associated electrocautery cutter and advance 8048a longitudinally through threads provided in the suction foot 8029 as shown in FIG. 6.
[0184] Electrocautery connector pin 8040 routes through outer vacuum handle and plugs into adapter on sheath handle.
[0185] The electrocautery wire 8048b thus delivers electrical signal from handle to spring 8048/cutter blade 8048a assembly as shown and described in detail in FIGS. 16 and 17.
[0186] FIG. 16 is a detailed sectioned first perspective view of the distal end of an electrocautery blade subassembly of a device in the displayed embodiment of the present invention. This Figure shows the partially sectioned proximal end of the electrocautery assembly. In the displayed embodiment, it shows the electrical pin connection to the handle and the continued electrical connection to the electrocautery blade at the distal end via a circular coil and plate (slip ring mechanism), such that the electrical contact is maintained as the electrocautery blade rotates.
[0187] FIG. 16 elucidates that rotational knob cap 8041 is assembled by attachment of rotational knob cap bottom closure ring 8041a that is adhered to rotational knob cap 8041 to capture float ring 8042 and copper contact plate 8099 (slip ring mechanism), such that float ring 8042 and electrocautery connector pin 8040 can rotate freely relative to the balance of the rotational knob assembly 8022.
[0188] Electrocautery connector pin 8040 extends through rotational knob cap bottom closure ring 8041a of rotational knob assembly 8022, and plugs into corresponding adapter on the rotational knob cap 8041.
[0189] The electrocautery cutter blade 8048a is welded onto electrocautery spring 8048 such that cutter blade 8048a performs cutting.
[0190] Knob springs 8099a ensure constant contact between circular copper contact plate 8099 and electrocautery connector pin 8040.
[0191] FIG. 16 also shows that an adhesive is used to join cap to knob, lock in float ring, and that the straight electrocautery sheath 8023 is fixed relative to rotational knob cap 8041.
[0192] The electrocautery wire 8048b is soldered to circular copper contact plate 8099.
[0193] Electrocautery connector pin 8040 is in contact with circular copper contact plate 8099 which contact is maintained by knob springs 8099a.
[0194] FIG. 17 is a detailed perspective view of the distal end of an electrocautery blade subassembly of a device in accordance with one embodiment of the present invention. FIG. 17 shows electrocautery wire 8048b attached to electrocautery spring 8048 through a conductive epoxy. The electrocautery spring 8048 is provided with a flat notch for placement of the weld to attach the electrocautery cutter blade 8048a.
[0195] FIG. 18 is a partially sectioned distal end perspective view of the distal end of an inner vacuum subassembly of a device in this embodiment of the present invention. FIG. 18 shows adapter 8015 and its engagement with inner circular suction foot 8062.
[0196] FIG. 19 is a partially transparent perspective view of an inner vacuum subassembly of a device, with vacuum connector, in accordance with this embodiment of the present invention. FIG. 19 shows inner sheath straight tube 8114, inner circular suction foot 8062, inner proximal end manifold bulkhead 8017, inner vacuum position lock 8011, inner air hose 8012, floating inner port 8013, inner vacuum proximal end cap 8014 and inner vacuum connector 8091.
[0197] Inner sheath straight tube 8114 has two inner air hoses 8012 extending from the inner proximal end manifold bulkhead 8017. The two inner air hoses 8012 supply vacuum pressure to the inner circular suction foot 8062 through adapter 8015. The vacuum area of inner circular suction foot 8062 secures the device to tissue at a target site. FIG. 19 also shows the distal tubular part is flexible and articulating compared to the proximal tubular part that is rigid.
[0198] FIG. 20 is a partially sectioned and transparent distal end perspective view of the distal end of an inner vacuum subassembly of a device in accordance with the displayed embodiment of the present invention.
[0199] FIG. 20 shows various additional operational features of the inner vacuum subassembly. As shown in FIG. 20, the vacuum lines of the two inner air hoses 8012 may be disposed so as to act as a rail for lead holder shown in FIG. 24.
[0200] Adapter 8015 ensures smooth transition from vacuum line 8012 to inner circular suction foot 8062 whose vacuum area secures device to the tissue at the target site.
[0201] FIG. 21 is a partially transparent perspective view of an inner vacuum subassembly of a device, with vacuum connector, in accordance with this embodiment of the present invention, and shows various additional operational features of the inner vacuum subassembly.
[0202] FIG. 21 shows floating inner port 8013 piece, within inner proximal end manifold bulkhead 8017 and enclosed by inner vacuum proximal end cap 8014, allows for longitudinal movement of vacuum lines 8012 during articulation, and shows that the port passes vacuum from inner vacuum connector 8091 (in this embodiment ¼′ OD connector to the handle, and to the tubing of inner air hose 8012 that supplies vacuum pressure to end effector, the inner circular suction foot 8062).
[0203] The inner vacuum position lock 8011 holds position of lead driver (described in FIGS. 24-27) until the operator is ready to attach lead.
[0204] Locking tabs 8062a hold position of inner vacuum foot 8062 relative to the outer oval suction foot 8029 until inner vacuum foot 8062 is rotated with respect to oval suction foot 8029, as described in FIGS. 49 and 50.
[0205] FIG. 21 also shows that inner sheath straight tube 8114 may be provided with cutouts 8114a to allow for articulation flexibility during use.
[0206] FIG. 22 is a partially transparent perspective view of a tissue remover vacuum subassembly of a device, with associated vacuum connector, in accordance with the displayed embodiment of the present invention. FIG. 22 shows tissue remover vacuum tube 8120, its tissue remover handle 8121 and tissue remover vacuum connector 8092.
[0207] FIG. 23 is a partially transparent perspective view of a tissue remover vacuum subassembly of a device, with vacuum connector, in accordance with one embodiment of the present invention, and shows various additional operational features of the tissue remover vacuum subassembly.
[0208] FIG. 23 shows that the tissue remover handle 8121 conducts the vacuum from the tissue remover vacuum connector 8092 (in this embodiment a ¼′ OD connector to handle) to the tissue remover vacuum tube 8120 which in this embodiment has a ¼″ diameter area and sufficient length with respect to the length of the inner sheath straight tube 8114 into which it is extended during use, to provide suction to the pericardial tissue for removal after cutting.
[0209] FIG. 24 is a partially sectioned and transparent distal end perspective view of the proximal end of a lead drive subassembly of a device in accordance with the displayed embodiment of the present invention.
[0210] FIG. 24 shows lead 8032, lead holder 8033, lead drive tube (flexible) extension 8035, and lead drive main (relatively stiff) tube 8036 and lead drive knob 8037.
[0211] FIG. 25 is a partially sectioned and transparent distal end perspective view of the proximal end of a lead drive subassembly of a device in accordance with the displayed embodiment of the present invention, and shows various additional operational features of the lead drive subassembly.
[0212] FIG. 25 shows that lead drive knob 8037 is used to advance the lead 8032, and to rotate it to screw the lead 8032 into the tissue at the target site.
[0213] The relatively stiff lead drive main tube 8036 permits easier insertion and rotation of the lead 8032 extending from the lead head 8032a, while the relatively flexible lead drive tube extension 8035 permits the operator to conform to the articulated shape and path provided by the flexible distal portion of the inner vacuum conduit straight tube 8114 (that, for instance may be articulated at its distal end, such as by the provision of cutouts 8114a, or the use of a relatively flexible material).
[0214] FIG. 26 is a distal end elevation view of the distal end of a lead drive subassembly of a device in accordance with the displayed embodiment of the present invention. FIG. 26 shows lead holder outer wall 8033a that supports folded lead wire.
[0215] Cutouts, such as opposed cutouts 8033b in lead holder 8033, ride along the tubular shapes of tubes 8012 of the inner vacuum conduit, during insertion of the lead drive main tube 8036.
[0216] FIG. 27 is a distal end lateral perspective view of the distal end of a lead drive subassembly of a device in accordance with the displayed embodiment of the present invention. FIG. 27 shows lead holder inner walls 8033c that serve to pinch lead 8032 in lead head 8032a to hold it in place during insertion.
[0217] As to the procedure for using the device of the present invention and otherwise to practice its method, the following steps may be used:
[0218] In order to prepare and use the device of the present invention as exemplified by the embodiment shown in FIGS. 1-65, the following procedure may be used as described stepwise by reference to FIGS. 28-65.
[0219] Referring to FIG. 28, the electrocautery (EC) pencil switch is inserted into device handle 8095/8096, by plugging it, through connector wire 8097, into the embedded connector 8098. The device handle tubing is attached to wall suction in the medical treatment suite or operating room through connector 8090.
[0220] Referring to distal end view of the device in FIG. 29, an access incision is first made in the left chest wall, with a 3 to 4 cm diameter maximum (e.g., 35 mm×43 mm). The left lung is then decompressed and collapsed, thereby exposing the pericardial sac, such as by using the standard thoracoscopic, single lung ventilation technique.
[0221] As may be appreciated with reference to FIG. 30, the support sheath 8071 [1] is then inserted by passing its distal end through the chest wall via the access.
[0222] As shown in FIG. 31, the co-engaged outer vacuum assembly, electrocautery subassembly, inner vacuum subassembly, and waste or tissue removal tubes are urged through the sheath 8071 [1] as a unitary assembly unit.
[0223] Referring to FIG. 32, the spool knob 8009 may be rotated to provide side-to-side articulation, and articulation pulley knob 8082 may be rotated to provide up-down articulation, to position the distally facing faces or surfaces of the inner circular suction foot 8062 and outer suction foot portion 8029 with respect to the target site.
[0224] The distal ends of the coterminously positioned inner and outer vacuum conduits, respectively inner sheath straight tube 8114 and inner sleeve 8073/mesh sleeve 8074 (i.e., presenting respectively inner circular suction foot 8062 and outer suction foot portion 8029), are urged through the support sheath 8071 [1], opening the spring biased cover 8030 [3] of the introducing distal end of the sheath.
[0225] As may be appreciated with reference to FIGS. 33 and 34, the inner and outer vacuum connectors 8091 and 8044 are inserted into the device handle 8095/8096 to turn on the vacuum suction.
[0226] Using rotational knob cap 8041 of the straight electrocautery sheath 8023 and the device handle 8095/8096, slight traction is brought to the device.
[0227] As shown in FIG. 34, the electrocautery knob 8041 is urged forward to ensure connection with device handle 8095/8096 (with electrocautery connector pin 8040 extending through outer proximal end manifold bulkhead 8008 of the device), in which case the electrocautery spring 8048 will compress, such that the electrocautery blade 8048a will not move forward.
[0228] Making reference to FIGS. 35-37, the switch in handle is operated so as to rotate electrocautery knob counterclockwise (CCW) ˜1.25 rotations, such that the electrocautery blade 8048a will translate forward 3 mm with each rotation in the displayed embodiment.
[0229] As shown in FIGS. 39-41, the electrocautery rotational knob cap 8041 is rotated clockwise (CW)>360° to translate electrocautery blade 8048a back to starting position, as shown in FIGS. 40-41.
[0230] As shown in FIGS. 42-44, the tissue remover vacuum connector 8092 of the tissue removal assembly is connected to its vacuum source, and its handle 8121 are advanced flush to inner vacuum proximal end cap 8014, to secure and remove cut tissue with vacuum suction.
[0231] FIG. 43 shows the step of disconnecting the inner vacuum connector 8091 from device handle 8095/8096 to turn off suction to the inner vacuum assembly.
[0232] As shown in FIG. 44, the tissue removal assembly is withdrawn completely from the device to discard the cut pericardial tissue.
[0233] As shown in FIGS. 45-47, the lead holder 8033 with opposed cutouts 8033b are aligned with the vacuum line rails 8012 by inserting it into floating inner port 8013, such that opposed cutouts 8033b in lead holder 8033, ride along inner vacuum tubes 8012 during insertion, and insert the lead drive assembly up to position lock.
[0234] Referring to FIG. 48, the inner vacuum is then turned on.
[0235] As shown in FIGS. 49 and 50, inner vacuum assembly is then rotated approximately 70° counterclockwise (CCW) to align keyhole formed by locking tab 8029c in the oval suction foot 8029.
[0236] As shown in FIGS. 51 and 52, inner vacuum assembly is advanced to target site by advancing inner sheath straight tube 8114 bearing inner circular suction foot 8062 (i.e., lead drive main (relatively stiff) tube 8036 with lead drive tube (relatively flexible) extension 8035 bearing lead holder 8033/lead head 8032a/lead 8032, through use of lead drive knob 8037). This causes inner circular suction foot 8062 and lead holder 8033/lead head 8032a/lead 8032 to be advanced beyond oval suction foot 8029, as shown in FIG. 53, so as to urge lead driver against left ventricular wall.
[0237] Referring to FIGS. 54 and 55, the operator may then test sensing and pacing parameters by contact of the lead 8032 to different positions to establish a final lead insertion point. At this point, the inner vacuum position lock 8011 may be disengaged to permit lead holder 8033/lead head 8032a/lead 8032 to be advanced beyond inner circular suction foot 8062.
[0238] As shown in FIGS. 56-58, the operator may attach the lead 8032 to heart wall by rotating lead drive knob 8037 clockwise 3 full rotations.
[0239] Referring to FIGS. 54 and 55, the operator may then pull lead drive (i.e., lead drive main (relatively stiff) tube 8036 with lead drive tube (relatively flexible) extension 8035 bearing lead holder 8033) back 5 mm to release lead 8032 with lead head 8032a from lead holder 8033. At this point the inner vacuum suction may be turned off by removing green inner vacuum connector 8091 from device handle 8095/8096.
[0240] As shown in FIGS. 61-64, the lead driver and inner vacuum assembly components are withdrawn to their original position by withdrawing inner sheath straight tube 8114 bearing inner circular suction foot 8062 to a concealed position within oval outer suction foot 8029 (comparing associated positions of FIGS. 61 and 62 with that of FIGS. 63 and 64).
[0241] Referring to FIG. 65, this Figure shows the device in the last steps of the procedure including: turning off the vacuum suction for outer vacuum by removing blue outer vacuum connector 8044 from the device handle 8095/8096; twist spool knob 8009 and pulley knob 8082 on outer proximal end manifold bulkhead 8008 to return device to un-articulated alignment; and fully retract outer vacuum, electrocautery, inner vacuum, and lead holder assemblies.
[0242] A summary of an example of a PLAD procedure is presented as follows: [0243] 1. Make access in left chest wall [0244] 2. Circular or oblong: [0245] i. 3 cm dia. maximum [0246] ii. 3 cm×4 cm maximum [0247] 3. Decompress/collapse left lung thereby exposing pericardial sac (Standard thoracoscopic, single lung ventilation technique) [0248] 4. Pass distal end of sheath through chest wall via access [0249] 5. Push distal end of the outer and relatively inner vacuum tubes through sheath with the waste removal vacuum tube resident therein, opening the spring biased cover of the introducing sheath [0250] 6. Position faces of outer and relatively inner vacuum feet on pericardium by rotating articulation knob A [0251] 7. Tighten set screw on the support sheath for outer vacuum tube [0252] 8. May rotate sheath around its long axis for fine positioning [0253] 9. Turn on vacuum for outer, inner and waste removal vacuum tubes via stop cocks on all three heads respectively [0254] 10. Using handle of sheath, place slight traction to pull the yielding pericardium away from the subjacent myocardium or heart muscle [0255] 11. Push Electrocautery knob to position 2 [0256] 12. Rotate Electrocautery knob>360 degrees thereby cutting pericardium held captive between outer and inner suction ring [0257] 13. Cut piece of pericardium held by relatively inner vacuum foot and by waste removal vacuum conduit [0258] 14. Pull Electrocautery knob back to position 1 [0259] 15. Turn off suction in the relatively inner vacuum tube and remove waste removal vacuum conduit (with the held piece of cut pericardial tissue) [0260] 16. Turn off vacuum to waste removal vacuum conduit [0261] 17. Remove cut pericardial tissue [0262] 18. Remove spacer A from relatively inner vacuum tube [0263] 19. Load lead and drive assembly into relatively inner tube until drive assembly contacts position lock [0264] 20. All this time, the outer vacuum foot is still attached to the pericardium with suction, keeping it taut and splayed with a central hole [0265] 21. Position relatively inner vacuum foot against left ventricular wall through the pericardial hole created in Step 9 [0266] 22. Second plane of plane of articulation possible by rotating articulation knob B [0267] 23. May rotate relatively inner vacuum tube along its long axis for fine positioning [0268] 24. Turn on vacuum for relatively inner vacuum tube [0269] 25. Loaded Lead is positioned inside relatively inner suction tube in such a way that it is in touch with myocardium with the distal end of the pacer lead screw [0270] 26. Test sensing and pacing parameters [0271] 27. Disengage position lock for drive [0272] 28. Attach lead to heart wall by rotating drive clockwise while applying slight axial force [0273] 29. Test sensing and pacing parameters [0274] 30. Withdraw lead drive [0275] 31. Turn off vacuum for relatively inner vacuum tube [0276] 32. Remove relatively inner vacuum tube in a direction axial to lead (to prevent dislodgement of lead) by simultaneously relaxing articulation and withdrawing relatively inner vacuum tube from outer vacuum conduit [0277] 33. Turn off vacuum for outer vacuum conduit [0278] 34. Remove outer vacuum conduit tube in a direction axial to the lead (to prevent dislodgement of lead, if used) by simultaneously relaxing articulation and withdrawing outer vacuum conduit and sheath together from chest cavity [0279] 35. The proximal end of the lead can now be channeled and connected with the pacemaker/defibrillator device [0280] 36. Close access site
[0281] From this point, the balance of the surgical operation and energizes of the pacing lead made be completed in accordance with methods and apparatus known and used in the art.
[0282] It will be appreciated that the mechanical arrangements in the device and the logical order of the steps in the described methods are used for purposes of illustration only, and that the steps may be varied where not otherwise inconsistent with the purpose and result obtained in the practice of the invention.
[0283] It will be also be appreciated that the mechanical arrangements in the device include their individual subassemblies and elements thereof and that the steps of the method include individual steps and series of steps within subroutines of the methods as described.
[0284] The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein. The scope of the invention is thus indicated by the appended claims rather than by the foregoing description of which the claims are to be read as a portion thereof, and all changes that come within the meaning and range of equivalency of the claims are intended to be embraced therein.
[0285] The present invention may be used in accordance with other methods and devices relating to lead and conduit placement, such as those described in the following references that are hereby incorporated herein by reference:
TABLE-US-00001 References 4146037 4271846 4972847 5139033 5203772 5342413 5882333 5902331 5972013 6132456 6697677 6868291 7270669 7526342 7544197 7890192 7930040 9623236 9656062 9675799 9987484 9987485 10039919 10118031 10328243 10524817 10525262 20030187461 20030187461 20040153098 20040215139 20050004644 20060009827 20060161238 20090182347 20090198251 20100312256 EP452278 WO2004058326 WO2008058265 WO9906104 [0286] Contact Placement Device with Dual Suction Foot with Waste Vacuum, EC Knife and Actuators
