Patent Application
20240382748
Without limiting the scope of the invention, its background is described in connection with pacing leads, in particular cardiac pacing leads. More particularly, the invention is concerned with cardiac pacing leads designed for implantation into cardiac tissue, such as an interventricular septum, for treating various heart conditions associated with cardiac arrhythmias and symptomatic bradycardias, as well as conditions associated with the left bundle branch (LBB) block or similar conduction disturbances associated with cardiac dyssynchrony and subject to cardiac resynchronization therapy.
Implanting a cardiac pacing lead into the interventricular septum presents several challenges. First, the procedure requires precise navigation through the heart's complex and dynamic structure, where the risk of damaging critical cardiac tissue is significant. The interventricular septum, being a muscular wall dividing the left and right ventricles, poses a challenge in terms of accessing and securing the lead in the correct position.
Accurate placement is crucial, as improper positioning can lead to inadequate pacing or complications like cardiac perforation. Additionally, there's a risk of lead dislodgement at a later point after the implantation procedure, which can cause the device to malfunction. This risk is heightened by the septum's constant motion and the pressure differences between the ventricles during the cardiac cycle.
Moreover, patients with complex cardiac anatomies, such as those with congenital heart defects or significant cardiac remodeling due to diseases like hypertrophic cardiomyopathy, present additional challenges. In these cases, the standard approach may need to be modified, demanding a higher level of expertise and customization of the procedure.
Once the pacing lead is implanted at the first position in the septum that appears to be suitable, its function is checked to ensure proper delivery of cardiac pacing. If such pacing is not adequate, the lead needs to be repositioned and implanted again in another location at the cardiac tissue nearby.
The lead implantation procedure has a number of risks and a potential for significant tissue damage. Multiple lead repositioning deep into the septum which may be required for the new direction in cardiac pacing—conduction system pacing—may result in multiple “drilled” holes into the muscular structure (myocardial damage, etc.). Pacing lead dislodgement, which may result from insufficient tip fixation or depth, can lead to inadequate pacing and necessitate additional procedures for correction. Repositioning can also increase the danger of perforating heart tissue, posing a severe risk of complications like cardiac tamponade. The procedure's duration is extended with each repositioning attempt, exposing the patient to heightened risks such as infection, increased anesthesia effects, and greater radiation exposure from prolonged fluoroscopy. Moreover, extensive maneuvering with the lead through the venous system can traumatize the veins, potentially leading to thrombosis or stenosis.
Tissue damage is another significant concern. The process of implanting and adjusting the lead can cause myocardial trauma, leading to inflammation, edema, or even necrosis. There's also a risk of inducing additional arrhythmias due to manipulation of sensitive areas in the heart's conduction system. In right heart procedures, there's a possibility of damaging the tricuspid valve, resulting in valve regurgitation and hemodynamic compromise. The lead tip, if improperly positioned, can cause focal injury and scarring, affecting the electrical impulse transmission. Lastly, the body's natural inflammatory response to the foreign object of the pacing lead can lead to fibrous tissue formation around the lead, complicating future repositioning or removal.
These challenges highlight the need for a novel pacing lead and novel lead implantation methods that minimize the need for repositioning and reduce overall tissue trauma during the procedure.
Accordingly, it is an object of the present invention to overcome these and other drawbacks of the prior art by providing a novel cardiac pacing lead configured to allow a pre-check of the implantation position before fully implanting the lead into cardiac tissue.
It is another object of the present invention to provide a novel cardiac pacing lead configured to reduce the extent of tissue damage during lead implantation procedure.
It is a further object of the present invention to provide a novel pacing lead configured to reduce the time required for pacing lead implantation.
It is yet a further object of the present invention to provide a method for implantation of a cardiac pacing lead aimed at minimizing the risks to the patient and reduce cardiac tissue trauma during the procedure.
The cardiac pacing lead of the present invention may include an elongated flexible body with at least one lead electrode positioned at a distal end thereof. In other embodiments, the distal end of the elongated body may include two, three, or more electrodes, as well as a defibrillation coil or other electrically active components known in the art. The lead electrode may be electrically connected to at least one lead connector at the proximal end of the elongated body. The elongated body and its components may be configured to transmit electrical signals to or from the distal lead electrode using the proximal lead connector.
The elongated body may include a lumen, such as located in the center of the lead cross-section. The lumen may be sized to slidingly and, optionally, removably accept an electrically active elongated stylet positioned therein. The elongated stylet may feature at least one stylet electrode located at a distal end thereof. In other embodiments, more than one electrode may be positioned at the distal end of the elongated stylet and configured to be electrically connected to at least one or more stylet connectors at a proximal end thereof. These connectors may be used to transmit electrical signals to or from corresponding distal stylet electrodes.
A novel method of implanting a cardiac pacing lead and providing a pacing therapy to a target cardiac tissue may include the steps of:
In embodiments, a step of improving orthogonality of implantation may be performed after step (b) which may include a provisional shallow engagement of the pacing lead with the cardiac tissue to anchor the pacing lead at the surface of the cardiac tissue. The proximal end of the pacing lead may be pushed, pulled, or rotated to cause the distal end to be oriented perpendicularly to the surface of the cardiac tissue. Step (c) may then be attempted to cause the distal end of the elongated stylet to be implanted into cardiac tissue at the desired orthogonal orientation thereto.
Subject matter is particularly pointed out and distinctly claimed in the concluding portion of the specification. The foregoing and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only several embodiments in accordance with the disclosure and are, therefore, not to be considered limiting of its scope, the disclosure will be described with additional specificity and detail through use of the accompanying drawings, in which:
The following description sets forth various examples along with specific details to provide a thorough understanding of claimed subject matter. It will be understood by those skilled in the art, however, that claimed subject matter may be practiced without one or more of the specific details disclosed herein. Further, in some circumstances, well-known methods, procedures, systems, components and/or circuits have not been described in detail in order to avoid unnecessarily obscuring claimed subject matter. In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated and make part of this disclosure.
Additional lead electrodes may also be formed, as described below, as the invention is not limited in this regard. Such additional electrodes may be used to monitor impedance and, therefore, determine the depth of implantation, as described in greater detail in my other patents, as well as in this paper: Orlov M V, Nikolaychuk M, Koulouridis I, Goldman A, Natan S, Armstrong J, Bhattacharya A, Hicks A, King M, Wylie J. Left bundle area pacing: Guiding implant depth by ring measurements. Heart Rhythm. 2023 Jan.; 20 (1): 55-60. doi: 10.1016/j.hrthm.2022.09.013. PMID: 36152975.
The pacing lead 100 may have an internal lumen extending from the proximal end 170 to the distal end 110 thereof. The lumen may be sized and configured to house an elongated stylet 192 slidably positioned therein. The elongated stylet 192, in turn, may feature at least one stylet electrode 190 at the distal end 196 thereof. The stylet electrode 190 may be configured to electrically communicate with the stylet connector 161 located at the proximal end of the elongated lead 192 to transmit electrical signals. The elongated stylet 192 may be placed in the lumen of the pacing lead 100 with the ability to slide back and forth and protrude from the distal end 110 of the pacing lead 100 beyond the helical tip 120. The length of the elongated stylet may be selected to exceed the length of the pacing lead 100 so as to allow the distal stylet electrode 190 to extend beyond the helical tip 120 while still controlling the stylet 192 at its proximal end protruding back from the corresponding proximal end 170 of the pacing lead 100.
Steps of the novel implantation method are described in connection with
The next step of the method may be a step of positioning the distal end 110 of the pacing lead 100 adjacent to a first target position at the cardiac tissue, with the elongated stylet 192 either preloaded in the lumen of the pacing lead 100 or inserted once the pacing lead 100 is in position. This step may be accomplished using conventional techniques of pacing lead implantation via the venous system of the patient and through the right atria of the heart, as may be known to a person skilled in the art. A suitable sized and shaped delivery sheath may be used for that purpose (not shown in the drawings).
As an optional next step, the helical tip 120 of the pacing lead 100 may be provisionally engaged with the cardiac tissue to anchor the distal end 110 of the pacing lead 100 therein—as seen in
The next step of the method may be a step of advancing the elongated stylet 192 through the lumen in the cardiac pacing lead 100 and out of the distal end 110 thereof to position the stylet electrode 190 at a desirable depth of the first position for implantation—as seen in
Once the stylet electrode 190 is in place, a step of pre-checking the first position for implantation in the cardiac tissue may be performed. This may be done by temporarily confirming the ability to deliver the pacing therapy thereat using the stylet electrode 190. In one example, this step may further include a step of pacing the heart using the stylet electrode 190. As an alternative, or in addition, it may further include a step of monitoring an intracardiac electrogram signal. Such signal may be acquired using the stylet electrode 190 or other electrodes configured to record the electrical activity of the heart.
Additional distal electrodes may be provided on one or both distal ends of the pacing lead 100 and the elongated stylet 192. Such additional electrodes may be used during the insertion procedure to monitor impedance or other pacing parameters and therefore determine the depth of implantation for the elongated stylet and/or the pacing lead, as described in greater detail in my other patents. Additional distal electrodes may also be used for image-based depth determination using X-Ray or fluoroscopy, as they have excellent radiopacity.
If the pacing therapy is selected to pace a left bundle branch area, in step (d) or step (e) the step of temporarily confirming the ability to deliver the pacing therapy may include a step of temporary pacing the left bundle branch area using the stylet electrode of the elongated stylet to verify the ability to capture thereof. Furthermore, it can be used for additionally recording a specific electrogram from the same electrode.
The capturing of the conduction system of the heart may be confirmed using one or several criteria as accepted in the field of cardiac pacing. For example, Marek Jastrzębski et al. discuss various criteria for determining the capture of the conduction system, see Jastrzębski M et al. Left bundle branch area pacing outcomes: the multicentre European MELOS study, European Heart Journal (2022) 43, 4161-4173, incorporated herein in its entirety by reference. Other criteria may also be used, as the present invention is not limited in this regard—it provides the necessary tool to temporarily assess and, therefore, pre-check the position of the implantation of a cardiac pacing lead prior to the actual implantation thereof at that location.
Several other criteria may be considered to be indicative of left bundle branch area capture, such as the following non-limiting examples:
Alternatively, or in addition, the step of temporarily confirming the ability to deliver the pacing therapy using the elongated stylet may further include a step of verifying a pacing capture of the cardiac tissue or the presence of a predetermined feature on the cardiac electrogram, as known in the art of cardiac pacing. Recording of certain electrogram characteristics may be considered indicative of the first distal end electrode being in the vicinity of the left bundle branch, such as a recording of a discrete left bundle branch potential, typically 25-35 ms in front of the QRS, or a discrete sharp signal indicative of Purkinje potential recorded less than 25 ms in front of the QRS.
Optionally, the step of pre-checking the position for implantation in the cardiac tissue by temporarily confirming the ability to deliver the pacing therapy thereat may include a step of confirming the pacing location using a predetermined acceptability criterion. Such acceptability criterion may be based on an ECG recording at the target site as described above or on image-based guidance, for example, using fluoroscopy to identify the position of the stylet electrode 190.
Furthermore, if the distal end of the elongated stylet includes a stylet electrode and at least one or more additional distal stylet electrodes, the step of temporarily confirming the ability to deliver the pacing therapy may include a step of temporary pacing and monitoring an intracardiac electrogram using either two or more of any available stylet electrodes—in a unipolar pacing fashion or in a bipolar pacing fashion.
If the intended cardiac pacing therapy is to pace the left bundle branch area, the step of temporarily confirming the ability to deliver the pacing therapy may further include a step of temporarily pacing the left bundle branch area using the stylet electrode to verify the ability to capture thereof.
If the desired confirmation is not reached in the previous step, the depth of the stylet electrode 190 may be gradually changed by inserting it further into the cardiac tissue. The stylet electrode 190 may be continuously or intermittently monitored to detect the depth of the insertion—for example, by using impedance measurements, as described in my previous patent applications. The stylet electrode 190 may be used to record paced ECG, conduction system potentials, and other suitable metrics as may be customary. In addition, monitoring the position of the proximal end of the elongated stylet 192 in relationship to the proximal end 170 of the pacing lead 100 and/or observing the distal end 196 of the elongated stylet may be conducted using fluoroscopy or other imaging methods. In that sense, the elongated stylet 192 may be used in a manner similar to that of a pacing wire. Once the desired depth is reached, a temporary pacing therapy delivery may be verified using the stylet electrode 190. If that still does not produce the desired result, the distal end 110 of the cardiac pacing lead 100 and the elongated stylet 192 may be moved to a second or further position at the cardiac tissue. As can be appreciated by those skilled in the art, inserting the elongated stylet 192 deeper into the cardiac tissue may only be done within acceptable depth limits, as can be determined by other methods, so as to avoid tissue perforation.
Importantly, at this point in the procedure, the only trauma to the cardiac tissue is the penetration of a thin stylet tip 196 and not the much larger helical tip 120 of the cardiac pacing lead 100. The procedure of verifying temporary pacing therapy delivery may be repeated one or more times until the proper implantation position and a suitable implantation depth are found. Although the trauma to the heart tissue is minimal, it is suggested that redeployment of the elongated stylet 192 and the pacing lead 100 is not done more than a few times in order to further limit tissue damage.
Upon reaching the confirmation of the position being adequate for delivery of pacing therapy, the helical tip 120 of the cardiac pacing lead 190 may be advanced over the elongated stylet 192 as a monorail to locate the lead electrode next to the stylet electrode 190—see
The implantation procedure may be performed using a suitable delivery sheath. One example of a suitable delivery sheath may be a sheath having a preferred curve at the distal end thereof. Another example is a delivery sheath configured to be deflectable to assist in positioning of the distal end of the pacing lead at the target cardiac tissue.
In addition to the steps described above, the present invention may allow for an optional maneuver described below aimed at improving the quality of lead implantation, namely at achieving implantation at about a 90-degree angle to the target cardiac tissue. A desire to do so is described in various publications, for example, in Vijayaraman P, Subzposh F A, Naperkowski A, et al. Prospective evaluation of feasibility and electrophysiologic and echocardiographic characteristics of left bundle branch area pacing. Heart Rhythm 2019; 16:1774-1782.
The approach direction through the tricuspid valve to implant the pacing lead into the interventricular septum, for example, may not necessarily be at an optimal 90-degree angle to the septal wall. Various curved shapes of the distal end of the delivery sheath are typically used to make the approach more orthogonal, but it may still not be able to accomplish the desired orientation of the pacing lead and cardiac tissue. The present invention may also be advantageously used to further improve the pacing lead deployment and achieve an optimal orthogonal orientation of the distal end of the lead during deployment.
The present invention may be used to facilitate optimal pacing lead delivery in the following way. Once the distal end of the pacing lead 100 is positioned next to the cardiac tissue at the first or at additional positions targeted for implantation, the helical tip 120 may be advanced to provisionally engage with the underlying tissue at a “shallow” depth, typically 1-3 mm or so as described above. The distal end of the pacing lead 110 is now “hooked” onto the cardiac tissue and acts as an anchor and allows the operator to manipulate and pivot the delivery sheath or the pacing lead 100 to achieve a proper angle of implantation for the remaining steps of the procedure.
If the initial angle between the distal end of the pacing lead 100 and the underlying tissue is acute, as seen in
If the initial angle between the distal end of the pacing lead 100 and the underlying tissue is obtuse, as seen in
If the plane of the delivery sheath curve is tilted to the surface of the cardiac tissue forming a side angle therewith, the operator may apply torque in the appropriate direction to rotate the plane to be perpendicular to the cardiac tissue.
As can be understood by a person skilled in the art, a combination of pull and torque or push and torque may be required in order to take advantage of the distal tip of the pacing lead 100 acting as an anchor in the cardiac tissue. Additionally or alternatively, the same maneuvers can be applied to the delivery sheath to facilitate the same goal of orthogonality to the external surface of the cardiac tissue.
Once the orientation of the pacing lead 100 is satisfactory, the operator may proceed to implant the stylet electrode 190 to a desired depth, as seen in
Pacing Lead with a Fixed Helical Tip
The present invention may be practiced with a variety of pacing leads, including pacing leads with a fixed helical tip as well as pacing leads with an extendable helical tip.
The term “helical tip” is used herein to broadly describe spiral and other suitable tissue fixation tips that are generally known in the art of securing a pacing lead to the target tissue, as the invention is not limited to just a tip having a strictly helical geometry. In embodiments, the geometry of the helical tip may be selected such that it allows the elongated stylet to pass through the outer boundaries of the tip, such as to pass along its central longitudinal axis. The central opening or open space at the center of the helical tip may be selected to be at least that of the external diameter of the elongated stylet or larger, depending on the design preferences and specific lead considerations.
A general perspective view of a distal and of a suitable pacing lead with a fixed helical tip at the distal end is seen in
In embodiments, the fourth spiral wire may not necessarily extend all the way from the spiral bundle 130 to the helical tip 120, but rather, it may make an electrical connection with the internal coil 132. A metal sleeve 136 may be attached to both the distal portion of the internal coil 132, as well as to the beginning of the helical tip 120 via a welded connection 138. This allows not only the retention of the helical tip 120 at the distal opening of the distal end 110, but also allows electrical communication between the helical tip 120 through the metal sleeve 136, through the internal coil 132, and to the fourth wire of the spiral bundle 130.
Exemplary dimensions of the pacing lead 100 are as follows. The pacing lead 100 may be sized to be from 0.8 mm to 2.5 mm in diameter, and in particular from 1.4 mm to 1.8 mm in diameter. The helical tip may extend from the distal end 110 by about 1.5 to 7 mm, and in particular by 2.5 to 3.0 mm. The first ring electrode 114 may be about 4-8 mm long and may extend from the distal opening at the distal end 110 by 5-15 mm. The second coil electrode 116 and the third coil electrode 118 may be 2-4 mm long and may be spaced apart from each other and from the distal end of the pacing lead by about 2-4 mm or so. Those skilled in the art may appreciate that the numbers given above are exemplary and not limiting.
Pacing Lead with an Extendable Helical Tip
In a further alternative of the invention, the length of the intermediate ring electrode 116 may be selected to be elongated, such as 5-12 mm, for example, 5, 6, 7, 8, 9, 10, 11, 12 mm. In this case, as the intermediate electrode 116 enters the cardiac tissue, its impedance measurement will include a combination of tissue impedance and blood impedance. A shift in the overall impedance may be detected and used as a measure of the depth of penetration of the intermediate ring electrode 116 into the cardiac tissue.
An internal flexible tube 150 may be slidingly placed inside the elongated body 112 with the ability to rotate and advance inside thereof by manipulating the internal tube 150 from the proximal end of the pacing lead 100. The internal tube 150 may also be made from an insulating polymer material and may include at least one wire 152 embedded therein. A distal bushing 154 may be placed at the distal end of the internal tube 150 with the wire 152 connected thereto, which may be used to electrically connect the bushing 154 on the proximal end thereof with electrical connectors on the proximal end 170 of the pacing lead 100. The distal end of the bushing 154 may be electrically and mechanically attached (welded or soldered, for example) to the helical tip 120. Rotation and advancement of internal tube 150 may be used to urge the helical tip 120 to emerge from the distal opening of the elongated body 112 and engage with the cardiac tissue after positioning the pacing lead at the target implantation location.
The internal tube 150 may, in turn, be made hollow with an open central lumen which may be occupied by a removable elongated stylet 192. One useful purpose of including the elongated stylet 192 within the central lumen of the internal tube 150 at the beginning of the implantation procedure is to increase the stiffness of the pacing lead 100 during the insertion steps of the procedure. Other useful purposes include using the elongated stylet for temporary pacing, mapping of the heart, determination of implantation depth, stabilization of the distal end of the pacing lead, improving orthogonality of lead implantation, etc—as described elsewhere in this description.
The bushing 154 may have an opening 156 inside thereof sized to allow the elongated stylet 192 to advance through the internal tube 150 and emerge past the helical tip 120. Removal of the elongated stylet 192 at the end of the procedure may help to reduce the overall stiffness of the pacing lead and improve its conformance to the patient's anatomy. In addition, an empty channel along the central lumen of the internal tube 150 may be used to inject medication, contrast, or for other purposes during and after the initial implantation of the pacing lead 100.
In use, the pacing lead 100 of this embodiment may be positioned first at the implantation site. The helical tip 120 may be stowed inside the elongated body 112. The elongated stylet 192 may be positioned inside the internal tube 150. After the distal end is positioned at the first implantation site, the elongated stylet 192 may be advanced forward and used for pre-checking the suitability of the implantation position. Once the implantation position is identified, the helical tip 120 may be advanced to emerge from the distal end 110 and engage with the cardiac tissue. The helical tip 120 may then be advanced to the location of the stylet electrode 190. Remaining portion of the pacing lead 100 may follow the helical tip 120 until the entire pacing lead 100 is fully implanted at the confirmed position in the cardiac tissue. As an alternative, or during a part of the implantation procedure, rotation of the pacing lead 100 and the elongated stylet 192 may be implemented to avoid autorotation of the helical tip 120 back inside. Fixation of the elongated stylet 192 to the pacing lead 100 may be done at a proximal end. During the procedure, the operator may detect the implantation depth from known dimensions of the elongated body 112 and the location of the ring electrodes 116 and 118 thereon.
As can be appreciated by those skilled in the art, additional features of the distal end 110 pf the pacing lead 100 described above for the pacing lead with a fixed helical tip and shown in
In embodiments, the proximal end of the pacing lead 100 may be bifurcated into two parts: the electrical wires of the elongated body 112, as well as the internal tube 150, may be separated into a first group of wires and a second group of wires. The first group of wires may be dedicated to permanent pacing purposes and may be connected to a first proximal connector 174 adapted for use with a conventional pacemaker. The second group of wires may be attached to a separate second connector 180 located in the vicinity of the proximal portion of the pacing lead 100—see
The following describes various designs of the proximal end of the elongated stylet 192 and designs of a transition hub 164 associated therewith.
One exemplary embodiment of the proximal end of the elongated stylet 192 is seen in
The transition hub 164 may have a second thread located across the threaded channel 167 and sized to accept a fixation knob 165, which allows for a fixed positioning of the transition hub 164 over the proximal electrical connector 178 of the IS-1 compatible connector 174 of the present invention.
In use, the transition hub 164 may be first positioned over the proximal electrical connector 174 while still allowing an electrical connection thereto-see
The torque handle 162 may be gradually turned as the screw 163 is slowly inserted into the transition hub 164. The end of the screw 163 is visible and may be used to monitor the degree of extension of the elongated stylet beyond the distal end of the pacing lead 100, for example, following the indicia 166 on the transition hub 164. The length of the screw 163 would limit the extent of protrusion of the stylet electrode 190 from the distal end 110 of the pacing lead 100. In other words, once the torque handle 162 reaches the body of the transition hub 164, any further insertion of the elongated stylet 192 out of the proximal end 110 is avoided. Once the pre-check of the insertion position and implantation of the pacing lead 100 is complete, the transition hub 164 may be disconnected from the proximal end 170, and the handle 162 may be removed together with the rest of the elongated stylet 192.
While the above discussion shows a transition hub 164 as a stand-alone component, in further embodiments of the invention, the transition hub 164 may be incorporated at the proximal end of the pacing lead 100.
The following describes various distal end designs suitable for the electrically active elongated stylet of the present invention, as seen in
In further yet embodiments, the elongated stylet 192 may have more than one distal stylet electrode, as illustrated in
It is contemplated that any embodiment discussed in this specification can be implemented with respect to any method of the invention, and vice versa. It will be also understood that particular embodiments described herein are shown by way of illustration and not as limitations of the invention. The principal features of this invention can be employed in various embodiments without departing from the scope of the invention. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, numerous equivalents to the specific procedures described herein. Such equivalents are considered to be within the scope of this invention and are covered by the claims.
All publications and patent applications mentioned in the specification are indicative of the level of skill of those skilled in the art to which this invention pertains. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Incorporation by reference is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein, no claims included in the documents are incorporated by reference herein, and any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.
The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and/or the specification may mean “one,” but it is also consistent with the meaning of “one or more,” “at least one,” and “one or more than one.” The use of the term “or” in the claims is used to mean “and/or” unless explicitly indicated to refer to alternatives only or the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and/or.” Throughout this application, the term “about” is used to indicate that a value includes the inherent variation of error for the device, the method being employed to determine the value, or the variation that exists among the study subjects.
As used in this specification and claim(s), the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps. In embodiments of any of the compositions and methods provided herein, “comprising” may be replaced with “consisting essentially of” or “consisting of”. As used herein, the phrase “consisting essentially of” requires the specified integer(s) or steps as well as those that do not materially affect the character or function of the claimed invention. As used herein, the term “consisting” is used to indicate the presence of the recited integer (e.g., a feature, an element, a characteristic, a property, a method/process step or a limitation) or group of integers (e.g., feature(s), element(s), characteristic(s), propertie(s), method/process steps or limitation(s)) only.
The term “or combinations thereof” as used herein refers to all permutations and combinations of the listed items preceding the term. For example, “A, B, C, or combinations thereof” is intended to include at least one of: A, B, C, AB, AC, BC, or ABC, and if order is important in a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, expressly included are combinations that contain repeats of one or more item or term, such as BB, AAA, AB, BBC, AAABCCCC, CBBAAA, CABABB, and so forth. The skilled artisan will understand that typically there is no limit on the number of items or terms in any combination, unless otherwise apparent from the context.
As used herein, words of approximation such as, without limitation, “about”, “substantial” or “substantially” refers to a condition that when so modified is understood to not necessarily be absolute or perfect but would be considered close enough to those of ordinary skill in the art to warrant designating the condition as being present. The extent to which the description may vary will depend on how great a change can be instituted and still have one of ordinary skilled in the art recognize the modified feature as still having the required characteristics and capabilities of the unmodified feature. In general, but subject to the preceding discussion, a numerical value herein that is modified by a word of approximation such as “about” may vary from the stated value by at least±1, 2, 3, 4, 5, 6, 7, 10, 12, 15, 20 or 25%.
All of the devices and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices and methods of this invention have been described in terms of preferred embodiments, it will be apparent to those of skill in the art that variations may be applied to the devices and/or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims.
This patent application claims a priority date benefit from the U.S. Provisional Patent Application No. 63/471,479 filed 6 Jun. 2023 by the same inventor and entitled “SYSTEMS AND METHODS FOR POSITION PRE-CHECK AND ATRAUMATIC CARDIAC PACING LEAD IMPLANTATION,” incorporated herein by reference in its entirety. This patent application further claims a priority date benefit from the U.S. Provisional Patent Application No. 63/467,058 filed 17 May 2023 by the same inventor and entitled “LEFT BUNDLE BRANCH PACING CATHETER WITH DEPTH CONTROL USING A MULTI-ELECTRODE LEAD WITH A FIXED OR AN EXTENDABLE-RETRACTABLE TIP,” also incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63467058 | May 2023 | US | |
| 63471479 | Jun 2023 | US |
