Ultrasound Guidance Assembly and System

Abstract

A pacemaker lead-guide catheter kit and system having anatomical target detection and distance measurement capabilities that aid in more precise lead implantation. The kit and system comprises a guide catheter and a lead, either or both of which include at least one ultrasound transducer that is used to more precisely implant the lead. The guide catheter may include an optical viewing assembly or window capable of displaying indicia on a portion of the guide catheter, pacing lead, or other medical apparatus. The optical viewing assembly is configured to display or transmit an image of the indicia which represents a distance from an end of the guide catheter or an end of a lead to the anatomical target. Additionally, the optical viewing assembly and indicia enables a Cardiologist to determine the location and/or depth of penetration of the lead.

Claims

1. A method for measuring a distance along a projected path of a pacemaker lead that is deployed from a right side of an interventricular septum of a heart to a position proximate to a left sided endocardium of the heart, the method comprising: a. advancing a guide wire through a subclavian vein; b. advancing a guide catheter over the guide wire, wherein the guide catheter comprises a catheter body having an open end and an ultrasound transducer disposed about at least a portion of the open end that is configured to detect anatomical features; c. inserting a pacemaker lead into the guide catheter, the pacemaker lead comprising at least one marker disposed thereon configured to be visible under imaging; d. advancing guide catheter and pacemaker lead through a right atrium of the heart and positioning the guide catheter and pacemaker lead adjacent to the interventricular septum of the heart; e. image the interventricular septum using the ultrasound transducer to identify a thickness of an interventricular septum of the heart; and f. advancing the pacemaker lead a distance into interventricular septum.

2. The method of claim 1, wherein the pacemaker lead is advanced through the interventricular septum to a position proximate to a left ventricle of the heart.

3. The method of claim 2, wherein the pacemaker lead is advanced adjacent to a left bundle branch of the heart.

4. The method of claim 1, wherein the ultrasound transducer comprises a single crystal ultrasound transducer.

5. The method of claim 1, wherein the ultrasound transducer comprises a multi-crystal ultrasound transducer.

6. The method of claim 1, wherein the ultrasound transducer is mounted proximate to a tip of the guiding catheter.

7. The method of claim 1, further comprising an ultrasound transducer disposed on a portion of the pacemaker lead, wherein a location of a left ventricular endocardium can be visualized for exact placement of the pacemaker lead.

8. The method of claim 7, wherein the ultrasound transducer is located proximate to a tip of a pacemaker lead.

9. The method of claim 1, further comprising the step of identifying proper placement of the pacemaker lead by identifying the marker using imaging.

10. The method of claim 1 where the measurement of the thickness of the interventricular septum or other structure is minimized during manipulation of the guide catheter to establish the most perpendicular path through the myocardium.

11. The method of claim 1, wherein the guide catheter further comprises at least one electrode disposed on a portion thereof.

12. The method of claim 10, wherein the electrode comprises an electrocardiogram electrode configured for conducting intracardiac electrocardiograms and detecting a current of cardiac injury.

13. A method for measuring a distance along a projected path of a pacemaker lead that is deployed from a right side of an interventricular septum of a heart to a position proximate to a left sided endocardium of the heart, the method comprising: a. advancing a guide wire through a subclavian vein; b. advancing a guide catheter over the guide wire, wherein the guide catheter comprises a catheter body having an open end; c. inserting a pacemaker lead into the guide catheter, the pacemaker lead comprising at least one marker disposed thereon configured to be visible under imaging, or an ultrasound transducer disposed on at least a portion of the pacemaker lead configured to detect anatomical features; d. advancing guide catheter and pacemaker lead through a right atrium of the heart and positioning the guide catheter and pacemaker lead adjacent to the interventricular septum of the heart; e. image the interventricular septum using the ultrasound transducer to identify a thickness of an interventricular septum of the heart; and f. advancing the pacemaker lead a distance into interventricular septum.

14. The method of claim 13, wherein the pacemaker lead is advanced through the interventricular septum to a position proximate to a left ventricular endocardium of the heart and the left bundle branch of the heart.

15. The method of claim 13, wherein the ultrasound transducer comprises at least one crystal ultrasound transducer.

16. The method of claim 13, wherein the ultrasound transducer is mounted proximate to a tip of the pacemaker lead.

17. The method of claim 13, further comprising an ultrasound transducer disposed on a portion of the guide catheter and configured to image coaxially through the interventricular septum.

18. The method of claim 13, further comprising the step of identifying proper placement of the pacemaker lead by identifying the at least one marker using imaging.

19. The method of claim 13, wherein the guide catheter further comprises at least one electrode disposed on a portion thereof.

20. The method of claim 19, wherein the electrode comprises an electrocardiogram electrode configured for conducting intracardiac electrocardiograms and detecting a current of cardiac injury.

21. A pacemaker lead-guide catheter kit with distance, position, and thickness detection capabilities, the kit comprising: a. a guide catheter comprising: i. a catheter body having an end with an access opening formed therein and a tip having an opening formed therein, the catheter body having a bore extending along a length between the opening of the end and the tip; ii. at least one penetration gauge having indicia formed on a portion of the catheter body, the penetration gauge comprising a transparent material; iii. a hub extension having indicia on its body with a penetration gauge comprising a transparent material; iv. at least one ultrasound transducer disposed proximate to the tip and configured to image coaxially through the interventricular septum, wherein an image from the ultrasound transducer provides a position of the guide catheter in relation to the intraventricular septum; b. a pacemaker lead insertable in the bore for delivery to the left sided endocardium of the heart, the pacemaker lead comprising: i. an elongated body having at least one end anchorable to cardiac tissue; and ii. at least one anchor disposed on the at least one distal end of the pacemaker lead and configured to anchor the at least one distal end of the pacemaker lead proximate in the left sided endocardium of the heart.

22. The kit of claim 21, further comprising at least one marking disposed on a portion of the body of the at least one pacemaker lead that denotes a measurement, the at least one marking being alignable with a portion of catheter body, wherein a distance of travel of the pacemaker lead from the catheter tip is determined by the at least one marking and the guide catheter body.

23. The kit of claim 22, wherein the catheter body further comprises a hub extension connectable to the end of the catheter body, the hub extension having a penetration gauge with measurement indicia thereon, the penetration gauge comprising a transparent material, wherein a portion of the pacemaker lead is visible through the penetration guide, wherein the at least one marking and indicia of the penetration gauge are used to measure a distance the pacemaker lead extends from the tip of the guide catheter.

24. The kit of claim 21, wherein the at least one anchor comprises a helical configuration and further comprising: a. a rotatable sleeve having an outer surface with indicia thereon, the rotatable sleeve being configured to be placed around the body of the pacemaker lead for purposes of measuring a distance the pacemaker lead has extended from the guide catheter tip; b. wherein the at least one ultrasound transducer aids in determining a depth into the interventricular septum to insert the at least one anchor; c. wherein the indicia on the rotatable sleeve is observable to determine a depth into the interventricular septum the pacemaker lead has traveled; and d. wherein rotation of the sleeve translates into concurrent rotation of the pacemaker lead and the at least one anchor.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0036] FIG. 1 is a perspective view of the ultrasound guiding system in a pre-deployment configuration according to an example embodiment.

[0037] FIG. 1A is an enlarged cross section view of a portion of FIG. 1 bounded by the phantom circle. A screw-in pacing lead is depicted within the lumen of the guiding catheter.

[0038] FIG. 1B is an enlarged cross section view of an ultrasound transducer positioned on an end of a guiding catheter according to an example embodiment of the invention.

[0039] FIG. 1C is an enlarged cross section view of an ultrasound transducer positioned about an end of a guiding catheter according to an example embodiment of the invention.

[0040] FIG. 1D is an enlarged cross section view of an ultrasound transducer positioned in a channel extending about an end of a guiding catheter according to an example embodiment of the invention.

[0041] FIG. 1E is an enlarged cross section view of a standard guide catheter used to place an ultrasound pacemaker lead having an ultrasound transducer positioned on an end of the pacemaker lead according to an example embodiment of the invention.

[0042] FIG. 2A is a plan view of a display coupled to the ultrasound guiding system according to an example embodiment of the invention.

[0043] FIG. 2B is an illustration of the imaging guide catheter adjacent to the membranous septum with the resulting M mode echo recording showing the thin membranous septum with no systolic thickening.

[0044] FIG. 2C is an illustration of the imaging guide catheter adjacent to the muscular septum with the resulting M mode echo recording of the thick muscular septum demonstrating muscular thickening in systole.

[0045] FIG. 3A is a view of a Medtronic 3830 fixed screw pacemaker lead with dimensions of the helix length and tip to anode ring distance as would be imaged fluoroscopically.

[0046] FIG. 3B is an illustration of a pacemaker lead with an annular transducer at its tip and a retractable screw.

[0047] FIG. 3B.1 is an enlarged side view of the phantom circle of FIG. 3B.

[0048] FIG. 3C is a view of a pacemaker lead with an inset annular ultrasound crystal to provide a visible ultrasound signal of the location of the lead tip.

[0049] FIG. 3C.1 is an enlarged end view of the phantom circle of FIG. 3C.

[0050] FIG. 3D illustrates a pacemaker lead with an annular ultrasound transducer at its tip.

[0051] FIG. 4A is a cross section view of an ultrasound guiding catheter having a standard screw in pacemaker lead in its lumen. The ultrasound guiding catheter is used to take measurements.

[0052] FIG. 4B is a cross section view the ultrasound guiding catheter of FIG. 4A with the screw-in pacemaker lead deployed to its desired position. The ultrasound guiding catheter is removed after implantation of the screw-in pacemaker lead.

[0053] FIG. 4C is a cross section view of a standard guiding catheter with a catheter ultrasound probe in its lumen. The ultrasound probe is removed after measurements are made and replaced with the screw-in pacemaker lead.

[0054] FIG. 4D is a cross section view of the standard non-imaging guide catheter of FIG. 4C with a screw in pacemaker lead within its lumen and implanted in the septum. The standard non-imaging guide catheter is removed after implantation of the screw-in pacemaker lead.

[0055] FIG. 4E is a cross section view a coaxial ultrasound sheath having a standard non-imaging guide catheter in its lumen. A screw-in pacemaker lead having a marker is in the lumen of the standard non-imaging guide catheter.

[0056] FIG. 4F is a cross section view of the screw-in pacemaker lead of FIG. 4E implanted in the septum. The ultrasound sheath and standard non-imaging catheter are removed after implantation of the screw in pacemaker lead.

[0057] FIG. 4G is a cross section view of a standard non-imaging guide catheter. In its lumen is a screw-in pacemaker lead with an ultrasound transducer at or near its tip for purposes of obtaining coaxially directed forward images.

[0058] FIG. 4H is the cross section view of the standard non-imaging guide catheter of FIG. 4G with the screw-in pacemaker lead implanted in the septum. The standard non-imaging catheter is removed after implantation of the screw in pacemaker lead.

[0059] FIG. 4I is the cross section view of the standard non-imaging guide catheter having an ECG electrode mounted thereon and positioned in the right ventricle against IVS for the purpose of detecting a position of the pacemaker leader prior to implantation.

[0060] FIG. 4J the cross section view of the standard non-imaging guide catheter having an ECG electrode mounted thereon and positioned in the right ventricle against IVS with the pacemaker lead implanted adjacent to the left bundle.

[0061] FIG. 5A is a perspective view of the ultrasound guiding system in a post-deployment configuration according to an example embodiment.

[0062] FIG. 5B is a cross section of the heart depicting the structure of the membranous and muscular portions of the interventricular septum.

[0063] FIG. 5C is an illustration of an ECG readout including an intracardiac electrogram depicting the current of injury ST segment depression, indicating contact of the tip electrode with the septal myocardium.

[0064] FIG. 6 is a perspective view of a guiding catheter with a screw-in pacemaker lead extending through the guide catheter and out beyond the catheter tip. For the sake of an example, a Medtronic C315 His bundle guide catheter and a modified 3830 screw-in pacemaker lead combination are illustrated. The figure shows markings inscribed on the pacemaker lead body at the level of the guide catheter hub that indicate the distance that the pacemaker lead has extended beyond the guide catheter tip.

[0065] FIG. 7A is a cutaway view of a guide catheter and a pacemaker lead threaded within it. A transparent window and/or magnifying lens in set into the guide catheter hub, that allows easy readability of the distance markings inscribed on the pacemaker lead.

[0066] FIG. 7B is a plan view of the guide catheter with a magnifying lens making the markings on the pacemaker lead easily readable. An index line indicates the distance that the pacemaker lead has extended from the tip of the sheath.

[0067] FIG. 7C is a cutaway view of a hub extension containing a magnifying lens, attached to a standard guide catheter.

[0068] FIG. 7D is a plan view of a pacemaker lead with a concentric sleeve inscribed with distance markings. The sleeve is contiguous with a larger diameter rotation grip portion to permit easy rotation of the pacemaker lead.

[0069] While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular example embodiments described. On the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION OF THE INVENTION

[0070] The present invention, as illustrated in example FIGS. 1-7D, discloses and describes a guiding catheter or sheath-cardiac pacing device system or kit 10 that is generally used during a surgical procedure to implant a cardiac pacing device such as a pacemaker and pacing lead or leadless pacemaker. While the invention can be used in various surgical procedures, cardiac pacing device placement surgery will be described in detail to illustrate the present invention. Additionally, while the following description focuses on implantation of cardiac pacing leads, the described cardiac pacing lead can be replaced with a leadless pacemaker. Further, the present invention also contemplates using the various components of the system or kit (e.g., ultrasound guide catheter, sheath, pacing lead, and leadless pacemaker) alone, combined, and in various configurations.

[0071] The system or kit 10 of the present invention comprises novel ultrasound guide catheters or pacing leads having one or more transducers 20 (e.g., ultrasound transducers) to aid in performing cardiac lead placement surgical procedures. The guiding catheters and pacing leads of the system or kit 10 comprise non-imaging guiding catheters 12, ultrasound guiding catheters 12a, and implants. The implants include but are not limited to pacemaker or pacing leads 30 and ultrasound equipped pacemaker leads 30a. The ultrasound guiding catheters 12a and the ultrasound equipped pacemaker leads 30a can have one or more ultrasound transducers 20, and 20a, respectively. The ultrasound guiding catheters may contain an intracardiac ECG electrode located at the distal tip of the catheter. The system or 10 is configured to enable medical staff to select between various system or kit 10 configurations for different procedures. The following description provides example embodiments of the system or kit 10 and its various configurations.

[0072] FIGS. 1-1D illustrate example ultrasound guiding catheter 12a configurations of the system 10. The ultrasound guiding catheter 12a configurations include a catheter body 13 having at least one ultrasound transducer 20 that is used to accurately place an implant such as a standard cardiac pacemaker lead 30. As will be discussed in more detail below, the ultrasound transducer 20 is generally arranged to image in a forward coaxial orientation in order to provide a forward image as a Cardiologist advances the ultrasound guiding catheter 12a.

[0073] The system 10, regardless of configuration, generally includes a pre-deployment configuration, wherein the cardiac pacemaker lead 30 is stored in a lumen extending through the catheter body 13 and a deployed configuration, wherein cardiac pacemaker lead 30 is advanced out of the catheter body 13 for being implanted in a patient.

[0074] Continuing with FIGS. 1-1D, the catheter body 13 of the ultrasound guiding catheter 12a comprises a proximal end 14a (see FIG. 1) that is operatively coupled to a hub, a distal end 14b (see FIGS. 1A and 1B) that supports an ultrasound transducer 20, and an axial lumen 16 extending through the catheter body 13 of the ultrasound guiding catheter 12a. The catheter body 13 of the ultrasound guiding catheter 12a includes at least one opening 18 (see FIG. 1A) at its leading or distal end 14b that provides access to the lumen 16 and for storage or deployment of the cardiac pacemaker lead 30.

[0075] The catheter body 13 of the ultrasound guiding catheter 12a may take a number of shapes or configurations to optimize the placement of the tip or distal end 14b of the ultrasound guiding catheter 12a near the basal interventricular septum. The ultrasound guiding catheter 12a, may also contain a mechanism (e.g., pull wire) for the distal end 14b to be steered to a desired anatomical location. Further, the ultrasound guiding catheter 12a may also comprise more than one lumen 16 and opening 18, with the lumens 16 and/or openings 18 being at least partially separated by one or more inner walls or partitions. The multiple lumens 16 and openings 18 provide for storage and deployment of various tools and implants.

[0076] As briefly mentioned above, the distal end 14b of the catheter body 13 is configured to support one or more ultrasound transducers 20. The ultrasound transducer 20 is configured for at least coaxial imaging. The ultrasound transducer 20 may comprise an annular configuration coupled to at least a portion of the catheter body 13 of the ultrasound guiding catheter 12a. While described as having a partial or complete annular shape, it should be noted that the ultrasound transducer 20 may have any shape and the example(s) disclosed herein should not be considered limiting.

[0077] In one example embodiment, as illustrated in FIGS. 1A and 1B, the ultrasound transducer 20 is coupled to the distal end 14b and coaxially aligned with the lumen 16 of the catheter body 13. In this configuration, the ultrasound guiding catheter 12a and ultrasound transducer 20 are configured generally isodiametric without projections. Additionally, the cardiac pacemaker or pacing lead 30 is able to be deployed through an opening 18 extending through the annular ultrasound transducer 20. Once the cardiac pacemaker lead 30 is implanted the ultrasound guiding catheter 12a and ultrasound transducer 20 are removed. As illustrated in FIG. 1B, an ultrasound reflecting marker 34 can be coupled to the pacemaker lead 30 that can be detected by the ultrasound transducer 20 to aid in obtaining the location of the pacemaker lead within the septum A.

[0078] In another example embodiment, as illustrated in FIG. 1C, the ultrasound transducer 20 is coupled to and extends about an outer surface of the catheter body 13 of the ultrasound guiding catheter 12a. In this configuration, the ultrasound transducer 20 is positioned further away from a cardiac pacemaker lead 30 upon deployment. The distance aids in reducing ultrasound image artifacts that may appear because of the ultrasound waves producing reflections from the cardiac pacemaker lead 30 or the anchor member 33.

[0079] As illustrated in the example embodiment of FIG. 1D, the ultrasound transducer 20 is recessed in a channel or groove (not shown) formed in and extending about an outer surface 24 of the catheter body 13. In yet another example embodiment, the ultrasound guiding catheter 12a includes a reduced section or portion proximate its distal end 14b, whereby a shoulder 22 is formed as it transitions toward the reduced section. The ultrasound transducer 20 extends about the reduced section and rests upon the shoulder. In this configuration, ultrasound transducer 20 is able to emit unimpeded ultrasound waves.

[0080] The ultrasound transducers 20 of the various configurations generally comprise one or more send-receive crystal or crystals. The send-receive crystals are positioned in or proximate to the distal end 14b of the catheter body 13. The send-receive crystals can be as simple as a single crystal recording an M mode tracing. A multi-crystal array can also be used in a phased array that can display a two-dimensional or three-dimensional image of the interventricular septum, which may be useful for the additional spatial information that would be provided.

[0081] The ultrasound pacing lead 30a of the present invention is constructed of one or more conductive wires or coils insulated by a non-conductive sheath. One or more ultrasound transducers 20a are coupled to or disposed on the pacemaker lead 30. The ultrasound pacing lead 30a can be used with a standard non-imaging guide catheter 12, the ultrasound guide catheter 12a, ultrasound reflector, or ultrasound transmitting crystal in a pacemaker lead. Like the pacemaker leads 30 discussed above, the ultrasound pacing leads 30a are movable, slidable, or retractable within the lumen 16 of the catheter body 13 of the guide catheter 12 or 12a.

[0082] The ultrasound pacing lead 30a can take any configuration. As with conventional pacemaker leads 30, the ultrasound pacing lead 30a comprises an anode ring 31 that is operatively coupled with a cathode portion 33 of the ultrasound pacing lead 30a. The ultrasound pacing lead 30a can also comprise a screw or attachment end 32 having an anchor member 33 fixed or retractable mounted thereon.

[0083] The anchor member 33 is configured to permit attachment to tissue at or proximate to the tissue to be treated. In one example embodiment, the anchor member 33 comprises a helical configuration having a pointed end. Other anchor member 33 configurations are also contemplated herein and may include barbs, hooks, toggles, and the like.

[0084] All of the pacemaker leads 30 and 30a of the present invention are generally positionable between a pre-deployed configuration (see standard non-imaging pacemaker lead position of FIG. 1) where the pacemaker leads 30 and 30a are contained within the lumen 16 of a catheter body 13, and a post-deployed configuration (see standard non-imaging pacemaker lead position of FIG. 5A) where the pacemaker leads 30 and 30a are moved out of the lumen 16 of the catheter body 13, and into a portion of the patient's anatomy.

[0085] As particularly illustrated in FIG. 1E, the ultrasound transducer 20a is coupled at or near the tip, free end, or attachment end 32 of the ultrasound equipped pacemaker lead 30a. Placing an ultrasound transducer 20a on or proximate to the free end or attachment end 32 of the ultrasound equipped pacemaker lead 30a allows for measuring the distance to an anatomical target such as the left ventricular endocardium. Placement of the ultrasound transducer 20a in this manner allows for a more accurate measurement as it is measuring directly from or proximate to the tip, free end, or attachment end 32 of the ultrasound equipped pacemaker lead 30a.

[0086] Turning to FIGS. 3B through 3D, example embodiments of the ultrasound equipped pacemaker leads 30a of the present invention are illustrated. For reference, FIG. 3A illustrates a standard pacemaker lead 30 having a ring electrode 31. As mentioned above, FIG. 3C illustrates a pacemaker lead 30a having a marker 34 that can be used during imaging to echocardiographically identify the location of the pacemaker lead end or tip 32. The marker 34 comprises an ultrasound reflective material that is readily detected by the imaging technology, or an active ultrasound crystal emitting signals easily detectable by the imaging transducer on a guide catheter or sheath. The standard pacemaker lead 30 can be used in the system 10 configurations employing the ultrasound guiding catheter 12a. The standard pacemaker lead 30 may also include an anchor member 33 that can have any configuration, as described above.

[0087] The ultrasound equipped pacemaker lead 30a, illustrated in FIG. 3B, comprises an ultrasound transducer 20a (see FIG. 3B.1) coupled to its screw or attachment end 32. An anchor member 33 is mounted on the attachment end 32 to anchor the ultrasound equipped pacemaker lead 30a to the tissue. In this example embodiment, the ultrasound equipped pacemaker lead 30a provides a cardiologist with an ultrasound image as the ultrasound equipped pacemaker lead 30a is advanced rather than relying upon other techniques such as fluoroscopy and electrical measurements to approximate its position.

[0088] The present invention also comprises a movable or retractable anchor member 33. The anchor member 33 can be moved between a retracted position (illustrated in phantom lines of FIG. 3B) and an extended position, as illustrated in FIGS. 3A, 3C, and 3D. In the retracted position, the anchor member 33 is positioned inside a bore or channel 35 formed in the attachment end 32 of the ultrasound equipped pacemaker lead 30a. The anchor member 33 can be moved into the retracted position to provide a clear ultrasound image or reading without artifacts that may be created when the anchor member 33 is in the extended position. The anchor member 33 may also comprise a material or configuration that does not interfere with the ultrasound imaging.

[0089] The ultrasound equipped pacemaker lead 30a embodiment of FIG. 3C includes an ultrasound transducer 20a (incorporated into the attachment end 32 of the ultrasound equipped pacemaker lead 30a to provide an alternative to using an ultrasound catheter 12a (discussed below). The ultrasound transducer 20a of this embodiment is be mounted or set into a bore 36 extending into the attachment end 32.

[0090] In one example embodiment, the bore 36 comprises an annular bore 36 that is formed in the attachment end 32 to house an annular ultrasound crystal for the purpose of location. As illustrated in FIG. 3C.1, a central post 38 extends axially through the annular bore 36 to support the anchor member 33. The central post 38 can have an internal chamber configured to accommodate a retractable anchor member 33.

[0091] The annular ultrasound transducer 20a may be flush with an end of the ultrasound equipped pacemaker lead 30a or it may extend a distance beyond the end of the ultrasound equipped pacemaker lead 30a. While the ultrasound transducer 20a is shown having an annular shape, one skilled in the art will appreciate that any shape and configuration may be used. For example, individual ultrasound transducers 20a may be spaced around the central post 38.

[0092] FIG. 3D illustrates another example embodiment of the ultrasound equipped pacemaker lead 30a of the present invention. The ultrasound transducer 20a of this embodiment comprises an annular shape set into a notch 37 formed at the free or attachment end 32 of the ultrasound equipped pacemaker lead 30a. The annular ultrasound transducer 20a can also be fixed, fused, or adhered to the attachment end 32, whereby it extends at least partially about the anchor member 33. To limit interference of the ultrasound imaging by the anchor member 33, the present invention employs an anchor member 33 having a wave deflecting shape or configuration. Additionally, the system 10 of the present invention can replace an imaging artifact, caused by an anchor member 33, with previously captured images. The system can scale the replaced images to provide an accurate image.

[0093] FIGS. 4A through 4H illustrate a number of ultrasound guidance system 10 configurations of the present invention. The ultrasound guidance system 10 configurations are provided as examples only and should not be considered limiting. Other ultrasound guidance system 10 configurations falling within the spirit and scope of those illustrated are also contemplated herein.

[0094] Turning to FIG. 4A, the ultrasound guiding system 10 comprises a separate ultrasound guiding catheter 12a having a transducer 20 mounted on its end to capture measurements recording of the thickness and/or configuration of the interventricular septum. A standard non-imaging pacemaker lead 30 is stowed in the lumen 16 of the ultrasound guiding catheter 12a. Once the measurements and configuration of the interventricular septum has been determined the standard pacemaker lead 30 is the implanted as shown in FIG. 4B. The ultrasound guiding catheter 12a is then removed.

[0095] Turning to FIG. 4C, the ultrasound guiding system 10 comprises a separate non-imaging guide catheter 12 and a combined catheter body 13 and ultrasound transducer 20. In this embodiment, a standard non-imaging guide catheter 12 is used, but the pacemaker lead 30 is temporarily replaced with an ultrasound equipped catheter body 13 having the ultrasound transducer 20 at its tip. The ultrasound equipped catheter body 13 is used to make a recording of the thickness and/or configuration of the interventricular septum, and then exchanged for the pacemaker lead 30, which is then placed (see FIG. 4D) with knowledge of the interventricular wall thickness.

[0096] As illustrated in FIG. 4E, another embodiment of the ultrasound guiding system 10 comprises an ultrasound equipped coaxial sheath 60 having an ultrasound transducer 20 at its tip, which may be placed external to the guide catheter 12 and advanced to a position at or near the right side of the interventricular septum A for imaging of the septum A. The pacemaker lead 30 may then be inserted into a non-imaging guide catheter 12 for placement in the septum A (see FIG. 4F).

[0097] Continuing with FIGS. 4E and 4F, a passive ultrasound reflector or an active ultrasound crystal 34 may be placed or positioned on the pacemaker lead 30, to assist in visualizing the location of the pacemaker lead 30 relative to the left ventricular endocardium on ultrasound imaging. The active ultrasound crystal 34, vibrating at a frequency detectable by the guide catheter 60 echocardiogram, can also assist in locating the tip of the pacemaker lead 30.

[0098] As illustrated in the embodiment of FIGS. 4G and 4H, an ultrasound transducer 20a is built into the ultrasound equipped pacemaker lead 30a tip within the lead 30a as shown, or as an annular transducer 20a at the lead 30a tip. The ultrasound equipped pacemaker lead 30a can be stowed in a lumen 16 of a standard non-imaging guide catheter 12 as illustrated in FIG. 4G. After the ultrasound equipped pacemaker lead 30a is implanted into the septum A, as illustrated in FIG. 4H, the standard guide catheter 12 can be removed.

[0099] The ultrasound transducers 20 and 20a may comprise any ultrasound transducer configurations now known or developed in the future. While any ultrasound frequency needed for a particular procedure may be employed, the present invention uses a frequency generally between 2.0 Mhz and 40 Mhz to capture anatomical and positioning images during a surgical procedure.

[0100] As illustrated in FIG. 2A, the present invention also comprises a display 40 operatively coupled to or in wireless communication with the ultrasound transducer 20 or 20a of the system 10. The display 40 is configured to display an image sent by the ultrasound transducer 20 or 20a, which may comprise a typical M mode, two-dimensional, or three-dimensional display. The display 40 may comprise a monitor, phone, tablet, or any other display capable of receiving and displaying an image.

[0101] In use, a Cardiologist makes an incision and creates a surgical pocket under the skin. A needle is used within the pocket to puncture the subclavian vein. A guidewire is threaded through the needle and a dilator/sheath combination are used to allow insertion of the guide catheter 12 or 12a into the subclavian vein. Alternately, a cutdown may be made on the cephalic vein to access the subclavian vein. The guide catheter 12 or 12a is then placed in the central circulation.

[0102] Once the guide catheter 12 or 12a is inserted, the pacemaker lead 30 or 30a is inserted or threaded into the guide body 12. The catheter body of guide catheter 12 or 12a may be pre-shaped and/or steerable, and with manipulation under fluoroscopy, it may be initially placed in a spot or location adjacent to the membranous septum which is depicted in FIGS. 2B and 5A.

[0103] As illustrated in FIGS. 2B and 2C, using ultrasound transducer 20 to image the thin membranous septum B and the thicker interventricular septum A allows precise anatomic positioning of the ultrasound guide catheter 12a to an ideal location, rather than relying on the surrogate of electrical measurement of the Bundle of His electrogram, which is often difficult and time consuming to obtain. The anatomy of the membranous and muscular interventricular septum is particularly appreciated when viewing FIG. 5A, a cross section of the heart, which shows in great detail the structures of the interventricular septum A and B. The thin membranous septum B, which contains the Bundle of His, is attached to the muscular septum A, which typically measures 8-12 mm thickness in the normal heart. As shown in FIGS. 2A and 2B, an ultrasound guiding catheter 12a can easily distinguish the thin membranous septum B from the thicker muscular septum A for accurate anatomic placement of a left bundle area pacemaker lead 30. Alternatively, ultrasound equipped pacemaker lead 30a having ultrasound transducer 20a can be used to image or visualize the structures of the interventricular septum A and B.

[0104] The ultrasound crystal(s) of the ultrasound transducer 20 or 20a transmits a pulsatile signal into the interventricular septal myocardium and reflected sound waves are used to construct an image of the adjacent heart structures.

[0105] The membranous septum B may be identified echocardiographically as a thin non-contractile structure as seen in FIG. 2B. The fluoroscopic image of this location is saved as a reference and then the guide body 13 of the ultrasound guiding catheter 12a/standard pacemaker lead 30 configuration, or the guiding catheter 12/ultrasound equipped pacemaker lead 30a configuration, is advanced distally as shown in the FIG. 2C to a point 1-2 cm toward the right ventricular apex, which is the location of the proximal bundle branches.

[0106] Additional information about the position of the pacemaker lead 30 in the heart may be obtained from detecting the so called “current of injury” that results when the pacemaker electrodes 33 within the guide catheter 12a makes contact with the interventricular myocardium. The current of injury shown in FIG. 5C is a marked ECG ST segment deflection that is seen when heart muscle is contacted by the helical tip electrode. FIG. 5C depicts a recording of the surface ECG and an intracardiac electrogram showing the current of injury that is seen when an intracardiac electrode is in contact with ventricular muscle.

[0107] The typical His bundle electrogram is recorded with a high pass electrical filter set at 300 Hz. At this setting the current of injury is filtered out and is not visible, but with the high pass filter adjusted in a range of approximately 5 Hz, 0.5 Hz, or more precisely at 0.05 Hz (as is used in the standard 12 lead ECG), the current of injury is very easily seen. As the guide catheter 12a with the pacemaker lead tip 32 positioned at the opening 14b is advanced from the right atrium across the tricuspid valve, the ECG QRS abruptly becomes much larger as it enters the right ventricle, and the ST segment current of injury becomes apparent when the helical electrode 33 contacts ventricular muscle, indicating the proximal portion of the interventricular septum has been reached.

[0108] As illustrated in FIGS. 4I-4J, a modification of the guide catheter 14a, in which an ECG electrode 50 is placed at the tip 15 of the guide catheter 14a, so that the electrocardiogram to detect the current of injury may is recorded from the guide catheter 14a. This is an alternative to recording the ECG from the tip electrode 33 of the pacemaker lead 30, because it is often uncertain whether the electrode tip 33 of the pacemaker lead 30 is positioned exactly at the tip 15 of the guide catheter 14a, whether it is still within the guide catheter 14a and proximal to the tip 15, or whether it extends beyond the tip 15 of the guide catheter 14a. In another example embodiment, the guide catheter 14a includes both an ECG electrode 50 and an ultrasound transducer 20a.

[0109] When the guide body 13 of the ultrasound guiding catheter 12a/standard pacemaker lead 30 configuration, or the guiding catheter 12/ultrasound equipped pacemaker lead 30a configuration, is advanced to a desired anatomical location or site, the cardiologist is able to echocardiographically identify the interventricular septum as a contractile 8-12 mm thick structure which thickens in systole as shown in FIG. 2C. The ultrasonic display (40) image of the septum allows exact measurement of the distance to the left side of the interventricular septum at the left ventricular endocardium and left bundle.

[0110] It is important for the pacemaker lead to enter the interventricular septum at an angle that is perpendicular to the wall. Rotating the guide catheter 12 or 12a by the hub to obtain the minimum echocardiographic thickness of the wall serves to assure the operator that the guide catheter 12 or 12a is pointed at an axis perpendicular to the wall of the interventricular septum.

[0111] The anatomic approach to placement of the pacemaker lead 30 or ultrasound equipped pacemaker lead 30a obviates the often difficult and time consuming step of locating the bundle of His using electrical measurements. It also quickly identifies the basal muscular interventricular septum as the appropriate spot and at the correct angle to begin screwing the lead toward the left ventricular endocardium.

[0112] The importance of the ultrasound guided anatomic approach taught herein is that the sophisticated and expensive equipment used in an electrophysiology laboratory for detecting the bundle of His electrical potentials is no longer needed. Currently, left bundle area pacing leads may only be implanted in such fully equipped electrophysiology laboratories. Standard pacemakers with right ventricular pacemaker leads may be implanted in a variety of settings in a cardiac catheterization laboratory or an operating room with fluoroscopy. The present invention eliminates the constraint of needing to use an electrophysiology laboratory to detect the His bundle electrogram for implantation of left bundle area pacemaker leads.

[0113] Once the septal thickness measurement is obtained and the proximal muscular intraventricular septum A is located via ultrasound, the pacemaker lead 30 or ultrasound guiding pacemaker lead 30a or ultrasound equipped pacemaker lead 30a is rotated and screwed into the tissue. The screw or anchor member 33 and the pacing lead 30 or ultrasound equipped pacemaker lead 30a continue to be rotated into and advanced through the interventricular septum A until the tip of the pacing lead 30 or ultrasound equipped pacemaker lead 30a is subendocardial on the left side of the septum A using measurements obtained from the ultrasound transducer 20 or 20a and the penetration depth measurement on the pacemaker lead and guide catheter hub as described in detail below.

[0114] In another example embodiment, contrast dye injection through the ultrasound guide catheter 12a may also be used to visualize the right side of the septum A to judge the distance that the pacemaker lead 30 has penetrated into the septum A. Alternately, the location of the tip 32 of the pacemaker lead 30 may be echocardiographically visualized directly relative to the location of the endocardial surface of the left ventricle. Identification of the lead tip 32 may be further aided by visualizing the ultrasound marker 34. Once the correct anatomic location of tip 32 of the pacemaker lead 30 is obtained, electrical measurements described above are made to confirm the appropriate position of the lead 30.

[0115] A simple and expedient method of precisely placing the tip 32 of the pacemaker lead 30 at a subendocardial location on the left side of the interventricular septum is illustrated in the lead penetration markings 70 of FIG. 6. Once the thickness of the interventricular septum has been accurately measured using one of the ultrasound methods described herein, the pacemaker lead 30 is screwed into the myocardium to a distance judged to be subendocardial as indicated by the indexed penetration markings 70 on the body of the pacemaker lead 30, which corresponds to the distance the lead 30 has extended beyond the tip 15 of the guide catheter 12a.

[0116] The zero index mark 72 (see FIG. 7) on the body of the pacemaker lead 30 is inscribed at a point where the tip 32 of the pacemaker lead 30 would be flush with the tip 15 of the guide catheter 12a. Millimeter markings inscribed proximal to the zero index mark 72 indicate the distance that the tip 32 of the pacemaker lead 30 has extended beyond the tip 15 of the guide catheter 12a.

[0117] With the tip 15 of the guide catheter 12a against the interventricular septum, the indexed markings 70 on the body of the pacemaker lead 30 will correlate exactly with the depth of lead 30 penetration into the interventricular septum. In FIG. 6, the tip 32 of the pacemaker lead 30 has extended 14 mm and the markings 70 on the body of the pacemaker lead 30 indicate the 14 mm penetration into the interventricular septum.

[0118] An alternate embodiment of the lead penetration gauge 76 is illustrated in FIGS. 7A and 7B. Here the pacemaker lead 30 and guide 12a operate as a complementary system permitting easy visualization of the lead 30 penetration depth as the lead 30 is screwed into the interventricular septum. The penetration may be continuously monitored via the magnifying lens 78, making the pacemaker lead 30 markings 70 more readable, while the operator is able to see the advancement as the lead 30 is rotated, without having to take their fingers off the lead 30 as would be necessary in the embodiment shown in FIG. 6.

[0119] In the case where an integral magnifying lens 78 is not available in a guide catheter 12a, an additional embodiment of a hub extension 80 shown in FIG. 7C may be used. The hub extension 80 may be attached to a standard guide catheter hub 82. The hub extension 80 contains a magnifying lens 78 similar to that shown in FIG. 7A for purposes of reading the distance markings 70 on a pacemaker lead 30.

[0120] In the case of a pacemaker lead 30 that has no distance markings 70, another embodiment may be envisioned as shown in FIG. 7D. A sleeve 86 with distance markings 88 may be placed around the lead 30 and secured in a position where the zero index 89 on the sleeve 86 is aligned with a corresponding index 70 on the guide catheter hub 82 or hub extension 80 or hub extension 80. The two index markers are to be aligned at the point where the tip 32 of the pacemaker lead 30 is flush with the tip 15 of the guide catheter 12a. The sleeve 86 is then secured onto the lead 30 with a suture or other desired mechanism.

[0121] As shown in FIG. 7D, the sleeve 86 may have an attached proximal feature 90 that has greater grip and/or a larger diameter, that permits accurate rotation of the pacemaker lead 30 while still allowing visualization of the distance markings 88 during lead 30 rotation. The sleeve 86 is removed after the lead 30 has been placed.

[0122] While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiments, it will be apparent to those of ordinary skill in the art that the invention is not to be limited to the disclosed embodiments. It will be readily apparent to those of ordinary skill in the art that many modifications and equivalent arrangements can be made thereof without departing from the spirit and scope of the present disclosure, such scope to be accorded the broadest interpretation of the appended claims so as to encompass all equivalent structures and products. Moreover, features or aspects of various example embodiments may be mixed and matched (even if such combination is not explicitly described herein) without departing from the scope of the invention.