US 7655014 B2
Devices and methods for electrode implantation. A first embodiment includes an electrode insertion tool adapted to tunnel through tissue and attach, at its distal end, to a lead, such that the lead may be pulled into the tunneled space as the electrode insertion tool is removed. Additional embodiments include methods for inserting electrode/lead assemblies, including a method wherein an insertion tool is first used to tunnel through tissue, then to pull an electrode/lead into the tunneled space. In a further embodiment the insertion tool is next used, with a splittable sheath disposed thereon, to create an additional path into tissue, after which the insertion tool is removed, leaving the sheath in place; a lead is inserted to the sheath, and, finally, the splittable sheath is removed over the lead.
1. A method of inserting a lead electrode assembly subcutaneously into a patient, the method comprising:
making a first incision;
making a second incision spaced from the first incision;
advancing a tool having proximal and distal ends through the first incision toward the second incision, the distal end of the tool being adapted for dissecting tissue, wherein the tool is advanced by dissecting tissue with the distal end of the tool;
securing the lead electrode assembly to the tool near the distal end of the tool near the second incision;
withdrawing the tool through the first incision such that the lead electrode assembly is pulled into the patient through the second incision via a first subcutaneous path;
advancing the tool along a second subcutaneous path through the first incision toward a chosen subcutaneous location;
withdrawing the tool from the second subcutaneous path; and
inserting a length of the lead electrode assembly that has been passed into the patient through the second incision and toward the first incision via the first subcutaneous path along the second subcutaneous path:
during the step of advancing the tool from the first incision toward the second incision, a splittable sheath is secured onto the tool;
during the step of withdrawing the tool through the first incision such that the lead electrode assembly is pulled into the patient through the second incision, the splittable sheath continues to be secured onto the tool;
during the step of advancing the tool along the second subcutaneous path through the first incision toward the chosen subcutaneous location, the splittable sheath is disposed over the tool;
during the step of withdrawing the tool from the second subcutaneous path, the splittable sheath is retained in place along the the tool, the splittable sheath is retained in place along the second subcutaneous path and is no longer secured to the tool; and
the step of inserting the length of lead electrode assembly along the second subcutaneous path includes the length of lead electrode assembly along the path includes advancing a distal end of the lead electrode assembly into the splittable sheath.
2. The method of
the first incision is along the patient's sternum relatively near the patient's median plane; and
the second incision is laterally spaced from the first incision.
3. The method of
the first incision is along the patient's sternum relatively near the patient's median plane;
the second incision is laterally spaced from the first incision; and
the chosen subcutaneous location is located cephalic of the first incision.
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13. A method of subcutaneously inserting a lead electrode assembly into a patient comprising:
making a first incision in the patient's torso;
making a second incision in the patient's torso;
providing a tool having proximal and distal ends with a splittable sheath disposed thereon;
advancing the tool and sheath through the first incision toward the second incision;
advancing the distal end of the tool through the second incision;
securing the lead electrode assembly to the distal end of the tool;
withdrawing the tool through the first incision such that the lead electrode assembly is pulled into the patient through the second incision, and
pulling the lead assembly through the first incision until a first length of the lead assembly extends out of the first incision;
wherein the method includes retaining the splittable sheath in a fixed position on the tool at least until a portion of the lead electrode is drawn through the first incision.
14. The method of
after pulling the lead assembly through the first incision until a first length of the lead assembly extends out of the first incision, advancing the tool and sheath through the first incision to a chosen subcutaneous location spaced from both the first incision and the second incision, creating a subcutaneous path from the first incision to the chosen subcutaneous location;
withdrawing the tool while maintaining the splittable sheath in place;
advancing the first length of the lead assembly into the sheath; and
withdrawing the sheath while maintaining the first length of the lead assembly in place in the subcutaneous path.
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The present invention is related to the field of medical treatments including electrode implantations. More particularly, the present invention is related to the field of electrode implantation or insertion for cardiac treatments.
The use of implantable pacing and defibrillation devices to treat or prevent various cardiac problems has become relatively widespread. Several difficulties with such treatments relate to placement and durability of electrodes. Typically, well practiced, careful and gentle maneuvers are required during insertion to avoid breaking the leads and/or electrodes. Once placed, leads may fracture after being subjected to repeated stresses as the heart beats and the patient moves. Leads and electrodes may also migrate from their desired position.
For transvenous implantation, a lead is typically introduced by advancing it through a vein to a location in or near the heart with the aid of fluoroscopy. The lead is then anchored to heart tissue or a passive anchor mechanism such as tines are utilized to prevent the lead from moving. The heart tissue will tend to form around the lead, attenuating sensed signals as well as altering pacing and/or defibrillating thresholds. Because implantation requires traversing the vasculature as well as placement and anchoring within the heart, many problems can arise.
Many lead insertion techniques push a lead into place into tissue or through the vasculature. Pushing the lead stresses the lead and can cause lead failure. With vascular implantations, the pathway is defined but is subject to constrictions and tight turns. Non-vascular implantation calls for tunneling through existing tissue. While extra stiffness may help with lead insertion and aid accurate lead placement, stiffer leads create their own problems with migration, perforation, and fracture. As stiffness increases, the ability of the lead to inadvertently perforate tissue rises. Further, with extra stiffness, the lead does not rest in place during muscle movement, tending to increase the size of any associated fibroid, and potentially leading to migration.
The present invention, in a first embodiment, includes a tool for implanting a lead electrode assembly. The tool may include a handle and a relatively stiff shaft having a proximal end and a distal end, with the handle secured to the proximal end of the shaft. The distal end of the shaft includes an attachment feature which can be used to attach to a lead electrode assembly. The attachment feature, in use, allows the tool to be secured to the lead electrode assembly after it is advanced through tissue. Once so secured, the tool enables pulling or pushing of the lead electrode assembly through the portion of tissue that has already been tunneled by the tool.
The shaft may also define a lumen extending distally from a port or hub (such as a Luer hub) in the handle. The shaft may then include a fluid infusion port for infusing a fluid forced through the lumen into tissue during an implantation procedure. In an illustrative method embodiment, the fluid infusion port and lumen are used to infuse a local anesthetic such as lidocaine during an implantation.
The attachment feature may take the form of a suture hole allowing a suture to be passed therethrough. In a preferred embodiment, the fluid infusion port opens into a suture hole. The shaft may be straight, may include a curve, or may define an arc of curvature. In one embodiment, the shaft is provided with a curvature that mimics the curvature of a patient's lower ribcage. The shaft may also be shapeable such that a user can adapt the shaft to the shape of a selected portion of anatomy such as a patient's ribcage.
In another embodiment, an electrode insertion tool kit is provided, the tool kit including a tool for inserting an electrode and a splittable sheath for use in conjunction with the tool. The tool may have one or more of the features noted above. The splittable sheath is preferably sized to snugly fit over the tool. The kit may also include more than one insertion tool, one being straight and one having a curved shape, as well as an infusion tubing set for coupling to the one or more insertion tools, and a shaping tool for re-shaping or modifying the shape of an insertion tool.
Further embodiments include methods for inserting electrodes and leads to a patient subcutaneously. In one such embodiment, first and second incisions are made at spaced apart locations. An insertion tool having proximal and distal ends is inserted via the first incision and advanced subcutaneously toward the second incision. The distal end of the insertion tool may be passed out through the second incision. An electrode/lead assembly is then attached to the distal end of the insertion tool, and the insertion tool is withdrawn via the same path it was inserted through. As the insertion tool is withdrawn, the electrode/lead assembly is pulled subcutaneously into the patient. An alternative embodiment does not include passing the distal end of the insertion tool out of the second incision, instead only passing the distal end proximate the incision such that the electrode/lead assembly may be attached thereto.
In a further embodiment, the insertion tool is completely withdrawn through the first incision until the portion of the electrode/lead assembly connected to the insertion tool is pulled through the first incision. Then the insertion tool is inserted via the first incision and advanced subcutaneously in a direction different from the direction of the second incision. Preferably, the insertion tool is advanced in a direction that is at a significant angle with respect to a line along which the first and second incisions lie. The insertion tool is then removed and the electrode/lead assembly advanced through the path defined by the insertion tool.
In yet a further embodiment, the insertion tool, at least during the second insertion through the first incision, is inserted with a sheath placed thereover. Once the insertion tool and sheath are inserted to a desired extent, the insertion tool is removed, leaving the sheath in place. Then the electrode/lead assembly is inserted into the sheath to a desired extent. Finally, the sheath is removed. Preferably the sheath includes a line of axial weakness, or is a splittable sheath, so that it can be removed over the electrode/lead assembly without damaging or moving the assembly.
The following detailed description should be read with reference to the drawings. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.
It should be noted that the terms “lead” and “lead electrode assembly” as used herein carry distinct meanings, with a lead electrode assembly being a lead and electrode coupled together. U.S. patent application Ser. No. 09/940,377 to Bardy et al., now U.S. Pat. No. 6,866,044, is incorporated herein by reference. Bardy et al. suggest several methods for insertion of a defibrillator device including a subcutaneous canister and electrode(s), and explain additional details of subcutaneous defibrillation devices and methods.
The distal end 24 of the shaft 22 illustrates a number of attachment features, including a groove 30 and a suture hole 32. For example, the groove 30 may be a radial groove allowing for slipknot attachment to a thread such as a suture. The suture hole 32 may allow for a thread or suture to be passed therethrough and then tied. The end of the tool might also possess specific geometries for attachment to specific electrode designs.
The tool 40 includes a shaft portion 42 that is preferably stiff enough to provide pushability to a distal end 44 for creating a path through tissue. In several embodiments, a relatively rigid metallic member, such as a stainless steel shaft, is used for the shaft portion 42. The shaft 42 is secured to a handle 46 near its proximal end, where a Luer connector 48 is provided. Instead of a metallic member, a pushable polymeric member may be used, or, alternatively, a braided shaft member including polymeric layers and a braided support structure.
The distal end 44 of the shaft 42 illustrates a couple of attachment features, including a groove 50 and a suture hole 52. For example, the groove 50 may be a radial groove allowing for slipknot attachment to a thread such as a suture. The suture hole 52 may allow for a thread or suture to be passed therethrough and then tied. In another embodiment, a staple may pass through the hole 52 such that, rather than having a person physically tie or knot a suture, a surgical stapler may be used instead.
In an illustrative example, a local anesthetic such as lidocaine may be infused. Other anesthetics, anti-infection drugs, or drugs designed/chosen to prevent or limit swelling or other tissue injury responses may be infused as well. An advantage of providing a medication limiting tissue injury response may be to limit the size of any tissue growth around an implanted lead. Alternatively, for example to ensure good anchoring of a lead, a substance designed to cause or maximize local tissue injury response may be provided. Additionally, certain tissue adhesives could also be delivered through the lumen.
The main handle portion 64, as seen in
The tip 80 with end 82, suture hole 84 and groove 86 is also shown in
As further shown in
Alternatively, though not shown in
As shown in
Instead of suture holes 216, 222, other attachment features such as hooks or radial grooves, as illustrated above, may be used. Magnetic, screw-type, locking ball, snap fit, or other types of attachment may be substituted as well, though for the purposes of illustration, magnetic, screw-type, locking ball and snap fit attachment features have not been shown herein. It is sufficient that the attachment feature enable attachment of the insertion tool distal end to another element such as a lead electrode assembly. Advantageously, the suture holes, hooks or radial grooves allow for relatively simple and reliable attachment using readily available (and strong) suture material or staples. In particular, attaching a suture or staple is relatively simple. For sutures, any type of knot may be used, from simple slipknots to many stronger and more complex knots, to achieve a strong attachment. Removal is also simple, easy, and foolproof, being performed by merely cutting the suture/staple 224.
Referring now to
In one embodiment of the present invention, the method may stop here. With the lead electrode assembly 220 pulled into the path between the incisions 206, 208, the lead assembly 220 may be sized such that a canister 230 attached to the proximal end of the lead electrode assembly 220 is pulled into the pocket 207. The suture 224 is then cut and the incisions 206, 208 sewn shut, such that implantation is essentially complete insofar as device placement is concerned. Because the lead assembly 220 is pulled into position after tunneling, rather than being carried or pushed into position, the resultant strains on the lead assembly 220 are reduced. Further, by advancing from a first incision 206 at a definite location to a second incision 208 at another definite location, both ends of the path so defined can be tightly controlled. Thus, placement inaccuracy is avoided.
An alternative embodiment continues in
As shown in
After the insertion tool 210 has tunneled a desired distance, and while the splittable sheath 218 may still be accessed from outside the patient, the insertion tool 210 is removed to leave the splittable sheath 218 in place, as shown in
An advantage of the configuration for implantation of the electrode assembly shown in
Given sensor X on a canister 300, and sensors Y and Z on the lead electrode assembly 302, the primary difficulty arises when the need for backup sensing is greatest. In particular, if a minimal signal is sensed between a first sensor pair XY, a similarly minimal signal will be received by sensor pair YZ as well as signal pair XZ, since the three electrodes are collinear. If the minimal received signal is too close to the noise floor, then the sensors will fail to provide adequate data for reliable QRS detection, let alone sufficient information to provide pacing or defibrillating assistance. Even if X is offset from the line of the lead electrode assembly 302, the angular distinctions between pairs XY, XZ and YZ are quite small.
As shown in
In another embodiment (relying on another form of analysis), the insertion method is performed so that three sensors define a plane which at least partly intersects the heart. In yet another embodiment, sensors are placed so that at least one angle between sensor pair vectors is greater than 30 degrees. More preferably, at least one angle between sensor pair vectors is greater than about 60 degrees, while most preferably at least one angle between sensor pair vectors is in the range of about 70-90 degrees. Note that when referring to angles between sensor pair vectors, the angles referred to are the lesser angles between pairs of intersecting vectors. Another preferred layout is one in which the sine of the angles between sensing vectors is intentionally increased, preferably so that the sine of at least one such angle between sensing vectors is greater than or equal to about 0.5.
The layout of
Those skilled in the art will recognize that the present invention may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, departures in form and detail may be made without departing from the scope and spirit of the present invention as described in the appended claims.
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