Patent Application
20140155768
The present system, device and method relate to the field of monitoring conditions of a target organ in the human body, and more specifically to implantable sensing devices adapted for measuring pressure and/or other information generating from a target organ in the human body.
Continuous monitoring of mammalian organ function and detection of adverse events in the organ in real time is an ever growing quest in modern medicine, having benefits in saving patients' lives, diminishing hospitalization time and reducing total healthcare related expenses. In circumstances where continuous accurate monitoring is required, designated sensory implants may be deployed adjacent to or inside the organ to be monitored. Common surgical interventions for delivery and implantation of sensory implants include utilization of existing natural orifices and vessels for intra-luminal delivery (i.e., through the lumen of such orifices and vessels) in which a resilient catheter and/or an endoscope are used to deliver the implant along an intra-luminal path, for example in a vascular or a gastrointestinal passage. In cases where the internal organ is adjacent to the skin surface and/or is positioned in a surgically accessible body chamber, such as the abdominal cavity, trans-dermal minimally-invasive approaches are used (for example, using laparoscopic ports and/or instrumentation).
One major condition that would greatly benefit from continuous real-time implant based monitoring is Congestive Heart Failure (CHF). CHF has emerged as a major public health problem affecting close to 7 million Europeans and 5 million North Americans each year. Despite new and more effective pharmacological and non-pharmacological therapeutic strategies, the prognosis of patients with CHF remains poor. Because of its progressive and unstable nature, many patients require multiple hospital admissions for CHF decompensation (a change in heart failure signs and symptoms resulting in a need for urgent therapy or hospitalization).
The growing cost of health care for heart failure patients is well documented. Although CHF patients are often affected by other significant co-morbidities, recurrent episodes of decompensation resulting from volume overload or changes in ventricular function are the most frequent cause for hospitalization in those patients.
Symptoms leading to hospitalization usually occur late in the course of decompensation and with current medical diagnostic methods, in some patients, decompensation requiring hospitalization may go unnoticed or not be attended to in due time in face of the lack of symptoms. The use of physical findings such as rales, edema or elevated jugular venous pressure as indicators for CHF patient condition evaluation has limited accuracy. Of the general measures that should be pursued in
patients with CHF, possibly the most effective yet least utilized measure is close and continuous monitoring of clinical signs as expressed by parameters of the cardiovascular system in general and specifically of the heart. Such continuous monitoring can prevent unnoticed clinical deterioration and late hospitalization.
One such parameter, among others, is left atrial pressure (LAP). CHF decompensation is characterized by increased LAP causing symptomatic pulmonary congestion and frank edema. Though possible precipitants of acute CHF are numerous, they all share the common precipitating factor of elevated LAP.
The rise in LAP usually is gradual and precedes symptom onset. Continuous hemodynamic monitoring of LAP may enable detection of increases in LAP before the onset of observed clinical deterioration.
In recent studies LAP estimates derived from right ventricular hemodynamics or thoracic impedance monitoring were used to guide treatment. The results of these studies suggest that there may be an important role for hemodynamic monitoring of CHF in selected outpatients. Placement of an LAP sensor in, for example, the left atrium would enable such monitoring by providing valuable data in real time regarding variations in LAP.
The current invention seeks to provide a system, device and method for implanting a sensory implant in a body organ.
There is thus provided in accordance with the current system, device and method of the present invention a system including a sensory implant adapted to sense a change in at least one parameter such as, for example, pressure, associated with a condition and/or a performance of an internal body organ. The internal body organ may be left atrium. The internal body organ includes a wall that may include muscle tissue and/or be pulsatory.
In some exemplary embodiments, the system of the present invention includes an implant delivery device including a longitudinal body enclosing a lumen communicating with an open free end thereof and adapted to provide a contained passage, optionally of 1.5 mm or less in diameter, along a linear pierced path between an entry point and a wall target associated with the internal body organ. In some embodiments of the invention, the implant delivery device further comprises an introducer releasably connected to the sensory implant and adapted to advance the sensory implant from an enclosed position in the lumen to a protruded position distal to the free end. In some embodiments, the implant delivery device is operative to penetrate the wall from the exterior surface and to release the sensory implant in a selected location in the wall.
In some embodiments in accordance with the current system, device and method the introducer is coupled to the sensory implant by a threaded mechanism and optionally, when connected to the sensory implant, may allow electrical connectivity between the sensory implant and a remote device provided outside the body. The remote device may be including an electrical power source and/or a signal receiver. In some embodiments of the invention, the introducer includes a distally positioned coiled member provided in a direct electrical contact with a proximally positioned electrically conductive member, the coiled member is adapted for inductive coupling with an implant conductor provided with the sensory implant.
In some embodiments in accordance with the current system, device and method the system also includes a positioning verification analyzer communicative with the sensory implant prior to the releasing thereof and adapted to correlate between a signal transmitted by the sensory implant, including one or more of a sensing component, a signal processing component, a telemetry component, a stored identifying data and a micro electro mechanical system (e.g., a pressure transducer type, optionally a capacitive transducer).
In some embodiments, the point of entry may be percutaneous and/or adjacent an external surface of the wall. In some embodiments, the wall target is located on an external surface of the wall or is located in the wall.
In some embodiments of the invention, the linear pierced path may be straight and may optionally be at least 1 cm, optionally at least 5 cm, optionally at least 10 cm, optionally at least 20 cm in length, or higher or lower or intermediate.
In some embodiments, the sensory implant includes at least one retention member capable of altering from a longitudinal form, when confined to lumen boundaries, to an angled form when protruding out the lumen, optionally an angled form which is perpendicular to the longitudinal form. In some embodiments, the at least one retention member includes a resilient portion being at a higher stressed condition when the at least one retention member is at the longitudinal form than when at the angled form. In some embodiments, the at least one retention member is part of an expandable anchor configured to expand from a collapsed transverse size imposed by the lumen boundaries to an expanded transverse size being 2 mm or more greater than a maximal diameter of the free end.
In some embodiments, the sensory implant includes at least one retention member capable changing at least one of its spatial configuration and orientation so that to be capable of fitting inside the lumen. In some embodiments, the sensory implant includes at least one retention member capable of changing at least one of its spatial configuration and orientation from a first folded state inside the lumen to a second released state outside the lumen; and wherein the axis of the largest dimension in the folded state and the axis of the largest dimension in the released state are perpendicular to each other. In some embodiments, the sensory implant includes at least one retention member capable of changing its spatial orientation from a first folded state inside the lumen to a second released state outside the lumen; and wherein the longitudinal axis of the retention member in the folded state and the longitudinal axis of the retention member in the released state are perpendicular or at an angle to each other. In still some embodiments, the sensory implant includes at least one retention member capable of changing at least one of its spatial configuration and orientation from a first state inside the lumen folded along the longitudinal axis of the implant to a second outstretched state outside the lumen having an outstretched diameter along an axis perpendicular to the longitudinal axis of the implant and the outstretched diameter of the retention member is 2 times, optionally 3 times, optionally 5 times, optionally 10 times or more, the diameter of the sensory implant.
In an exemplary embodiment, the sensory implant includes at least two separate capsules, each housing and/or is connected to an electronic or electromechanical member, inter-connected by a retention member (e.g., a wire or a thin bar), wherein each capsule is capable of changing orientation from a first folded state inside the lumen to a second released state outside the lumen. Optionally, the longitudinal axes of the capsules in the folded state are parallel to the longitudinal axis of the retention portion; and optionally the their longitudinal axes in the released state is perpendicular or at an angle to the longitudinal axis of the retention portion.
In some embodiments of the present invention, the sensory implant includes an expandable inductor configured to expand from a collapsed transverse size imposed by the lumen boundaries to at least 3 mm, optionally to at least 5 mm, optionally to at least 10, optionally about 8 mm, in diameter, when is unstressed (e.g., when no compressive forces are applied thereto and/or where no external object confine it to smaller boundaries). In some embodiments, the expandable inductor is further configured to perform as an anchoring device when expanding over the collapsed transverse size. Optionally, the expandable inductor includes an induction coil interlaced with an antenna coil.
In another aspect of some embodiments, there is provided a sensory implant for implantation in a muscular wall of a cardiac left atrium adapted to sense pressure changes developing inside the atrium, the sensory implant includes: a capsule being 1.5 mm or less, optionally about 1 mm or less, in diameter, and containing a micro electro mechanical sensing component, wherein the capsule is provided coupled with an inductor and with an anchor adapted to alter from a longitudinal form, equal or less than the capsule diameter, to an angled form having a diameter greater than capsule diameter, optionally by at least 2 times, optionally by at least 3 times, optionally by at least 5 times, optionally by at least 10 times. In some embodiments, the anchor comprises the inductor and/or is interlaced thereto.
In another embodiment, the sensory implant is including a housing encapsulating passive electrical components including a micro electro mechanical sensing component, optionally being positioned at a distal portion, and a wireless transmission coil component, optionally being positioned at a proximal portion, along housing length, and including a retaining member adapted to prevent axial movement of the sensory implant in the muscular wall. In some embodiments, the wireless transmission coil and/or the retaining member are adapted to alter from a longitudinal form, equal or less than the housing diameter, to a surfaced form having a diameter at least 3 times greater than the housing diameter. Optionally, alternatively or additionally, the sensory implant includes a housing encapsulating passive electrical components including a micro electro mechanical sensing component positioned on one side/at one end thereof and a wireless transmission coil component positioned at another/at a different end thereof; wherein the housing is 1.5 mm or less in diameter and includes a retaining member adapted to prevent axial movement of the sensory implant in the muscular wall; and wherein the wireless transmission coil and/or the retaining member are adapted to alter from a longitudinal form, equal to or less than the housing diameter, to an outstretched form having a diameter at least 3 times greater than the housing diameter. In some embodiments, the retaining member includes the wireless transmission coil.
There is also provided in accordance with the current system, device and method of the present invention a method including introducing an implant delivery device carrying an implant along a selected linear pierced path and arriving at a wall target located on an external surface of a cardiovascular organ wall; and anchoring at least a portion of the implant in the cardiovascular organ wall. Optionally, the wall target includes the site of implantation.
In another embodiment there is provided another method including introducing an implant delivery device carrying an implant such as, for example, a sensory implant, optionally including a pressure sensor, along a selected linear pierced path and arriving at a wall target located on an external surface of an internal body organ; and anchoring at least a portion of the implant in the internal body organ wall. Optionally, the site of implantation includes or is included in the wall target. Optionally, the selected linear pierced path is selected prior to percutaneous introduction of the implant delivery device. In some embodiments, the method is further including implanting the implant in a site of implantation in the wall of the internal body organ.
In some embodiments, the selected linear pierced path is a direct path that accommodates introduction and advancement of the implant delivery device in a straight line. In some embodiment, the delivery device passes at least once through lung tissue during its advancement along the linear pierced path. In some embodiment, the method also includes verifying implant location prior to the anchoring. In some embodiments, the selected linear pierced path is selected prior to the introducing. Optionally, such selecting is followed by a preliminary imagery scan analysis. Optionally, the method also includes selecting an entry point defining the linear pierced path in-between the organ target.
In some embodiments of the invention, the implant delivery device comprises:
In another embodiment there is provided a method including selecting a wall target located on an external surface of an internal body organ, choosing a linear path between an entry point and the wall target, using the system described hereinabove to pierce across tissues along the linear path, penetrating the wall of the internal body organ from the external surface and the sensory implant in the wall. In some embodiments, the method further comprising: advancing the sensory implant from an enclosed position in the lumen to a protruded position distal to the free end.
In yet another embodiment the implant delivery device is included of a rigid elongated member having an open free end and a lumen extending at least partially along a length of the rigid elongated member, and wherein the lumen directly communicates with the open free end. In still another embodiment the implant delivery device is further included of a selectively attached implant. In another embodiment the percutaneous implant point of entry is identified based on the selected path of introduction. In yet another embodiment the method also includes verifying correct positioning of the delivery device tip and the implant carried thereby at a site of implantation at the target, deploying and implanting the implant at the site of implantation, verifying correct implantation of the implant and the functionality thereof and deploying an implant anchor and anchoring the implant at the site of implantation.
Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. In the drawings:
The following preferred embodiments may be described in the context of exemplary cardiovascular related sensory implants implantations for ease of description and understanding. However, the invention is not limited to the specifically described devices and methods, and may be adapted to various clinical applications without departing from the overall scope of the invention, for example implantations of sensory implants in other regions or internal organs of the body and/or implantations of other non-sensory implants (e.g., in a cardiovascular organ or in any other internal body organ.
It is to be understood that the terminology used herein is used for the purpose of describing particular embodiments only, and is not intended to limit the scope of the invention. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which the invention pertains. The embodiments of the invention and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments and examples that are described and/or illustrated in the accompanying drawings and detailed in the following description. It should be noted that the features illustrated in the drawings are not necessarily drawn to scale, and features of one embodiment may be employed with other embodiments as the skilled artisan would recognize, even if not explicitly stated herein. Descriptions of well-known components and processing techniques may be omitted so as to not unnecessarily obscure the embodiments of the invention. The examples used herein are intended merely to facilitate an understanding of ways in which the invention may be practiced and to further enable those of skill in the art to practice the embodiments of the invention.
Moreover, provided immediately below is a “Definition” section, where certain terms related to the invention are defined specifically. Particular methods, devices, and materials are described, although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the invention. All references referred to herein are incorporated by reference herein in their entirety.
The term “patient” as used herein refers to a mammalian individual afflicted with or prone to a condition, disease or disorder as specified herein, and includes both humans and animals.
The term “sensory implant” as used herein refers to an artifact which includes a sensor or a sensing mechanism designed to receive a signal or stimulus and responds to it in a distinctive manner. The signal or stimulus can be a change in condition and/or a performance of an internal body organ (for example, a change in pressure, temperature, PH or others). The sensory implant may also include other means, optionally provided in an electrical circuit, designed to generate readable or measurable information corresponding to received signal or stimulus and/or designed to transmit a digital signal correlative to the change in condition and/or performance. The sensory implants of this invention may be considered “micro-” or “micro sized” in the sense they are limited in size, and more particularly characterized in a maximal diameter of 2 mm or less, and in some instances of 1.5 mm or less. The sensory implants may be of any length, usually depending optionally in the range of 1 to 20 mm, optionally in the range of 3 to 10 mm.
The term “Organ” or “body organ” as used herein refer to a collection of tissues joined in structural unit to serve a common function. The term “internal body organ” as used herein refers to organs, usually chambers or conduits in a patient's body enclosed with a wall, that are commonly positioned distally to a skin tissue and/or muscle tissue and/or bone tissue. Internal body organs may include, but are not limited to, the heart and chambers thereof, veins, arteries, brain, lung, kidney, muscles, ureter, bladder, urethra, mouth, esophagus, stomach, small and large intestines.
The term “wall” as used herein as in a “wall target” or “internal body organ wall” refers to the barrier of the internal body organ, either completely or only partially covering it, having a thickness, and comprising a soft tissue (connective and/or muscular). For example, a wall of a heart chamber will commonly include several layers of soft tissues, including: external fibrous layer, parietal pericardium, visceral pericardium, myocardium and endocardium. An “external surface” of a body organ refers to the overlying surface of the wall at the exterior of the internal body organ. A “wall target” as used herein refers to an area or a point adjacent, on or in the wall or the external surface, to which a sensory implant is carried prior to or as part of deployment and implantation in the wall at the site of implantation. The term “site of implantation” as used herein refers to the physical location where an implant, such as a sensory implant, is inserted into a wall of a body organ and fixedly anchored thereto.
The term “contained passage” as used herein refers to a man-made, usually elongated, conduit, lumen or track through which the sensory implant can be advanced or delivered to a target point, for example a wall target. The contained passage can be a lumen enclosed with a rigid or semi-rigid protective covering, as for example a needle lumen. The term “entry point” as used herein refers to a point distal to the wall target through which the sensory implant, the contained passage and/or the implant delivery device is initially inserted. The entry point may be located on patient's skin (therefore considered a percutaneous entry point) or at an internal tissue.
The terms “path” or “path of introduction” as used herein refers to a chosen course or route along which the sensory implant, the contained passage and/or the implant delivery device travels. The term “linear pierced path” as used herein refers to a continuous non-natural path in the human body between an entry point and a target point, for example a wall target, that crosses through tissues and/or organs in patient's body. For example, a liner pierced path can be made by percutaneously inserting a sharpened needle in patient's body and advancing it towards a wall target. The linear pierced path excludes naturally existing lumens and conduits such as of the vascular or gastrointestinal systems.
Reference is now made to
In
In some embodiments, any one of sensory implants 100, 120 and 130 may be operative to measure one or more hemodynamic parameters selected from a group of parameters including blood pressure, blood velocity, degree of blood oxygenation (i.e., blood oxygen saturation) and temperature within the lumen of the monitored target organ. Additionally and optionally, sensory implants 100, 120 and 130 may be operative to measure one or more of existence and location of cyclic and/or dynamic blood flow and presence of continuous turbulent flow across the sensor boundaries.
A sensory implant if implanted inside the wall of an organ may be operative to measure one or more parameters associated with the physiological state of the organ such as wall myocardial contractility (e.g., in a wall of a heart chamber), wall tissue pulsation, contraction and wall tension. Measured parameters regarding muscle contraction forces may be used to derive information indicative of one or more changes in a subject's condition in general and especially changes that may be indicative of the subject entering into an acute condition.
In some embodiments, a plurality of sensory implants may be implanted in two or more locations such as, for example, two or more heart chambers or one or more heart chambers and a major blood vessel. For example, a plurality of sensory implants, one of which may be located in the left atrium and a second in the Vena Cava, may provide data regarding various parameters (e.g., pressure and/or saturation) both in the pulmonary (lung) circulation system and in the systemic venous circulation system such as filling pressures of the right atrium and volume status of the hepatic, intestine and lower limbs veins; In some embodiments, a plurality of sensory implants may be applied to monitor filling pressures of both the left and the right atria optionally collecting data for managing a subject's volume status and/or reducing exacerbations rates. Two or more sensory implants, operative to measure the same parameter may be implanted in two or more organs in propinquity to and communicating with each other for improved overall measurement accuracy. Such an example may be implanting one or more sensory implants such as sensory implant 100 in wall 102 of left atrium 108 and one or more sensory implants such as sensory implant 120 in wall 122 of vein 124 (not shown).
Organs to be monitored and location of sites of implantation may be determined in accordance with the associated clinical application, as shown in the examples hereinafter. (1) Selecting the right atrium, superior or inferior vena cava as sites of implantation may enable to monitor right sided or combined left and right sides heart failure to better manage HF patients and reduce fluid retention and its complications. (2) Selecting the pulmonary arteries as sites of implantation may enable monitoring primary pulmonary hypertension, help titrate treatment medication and assist pharmaceutical companies to develop and test new drugs. (3) In cases of aortic aneurysms, selecting the aneurysm sac as a sensory implant site of implantation, for example, following implantation of a stent graft to repair the aneurysm, may enable close follow up of the patient to evaluate if there is an endo leak from the aorta to the aneurysm sac. This may replace a CT angiogram, which today is the method of choice to assess the sac. An implanted sensory implant may detect endo-leaks earlier and reduce radiation dose. (4) Implanting sensory implants in the right and left atrium and ventricles may also enable mapping the pressure gradients across the various heart valves and the blood pressure in each of the various heart chambers and enable optimization of the synchronization between the different heart chambers and their contractility by, for example, optimizing a pacemaker performance. In this case, one or more sensory implants may be implanted in walls of different heart chambers, as desired.
Sites of implantation of the present invention are not limited to cardiovascular system organs and one or more sensory implants may be implanted at other sites, including in walls of organs such as the intestinal tract, the gall bladder, the urinary bladder, the brain ventricles (to monitor hydrocephalus treatment), the subarachnoid space and others. In some embodiments, the sensory implant is adapted for long-term coupling to or implantation in an organ wall employing designated anchoring means as will be described in detail hereinafter.
The inventors have developed a system, devices and method for delivering, positioning and deploying or implanting a sensory implant in a body organ by first introducing a small-diameter implant delivery device as described hereinafter. In one aspect of exemplary non-limiting embodiments, some systems, devices and methods are designed to be implemented by employing minimally invasive procedures while minimizing undesired injury to body tissues or by directly visually targeting a body organ during invasive surgical procedures such as, for example, open heart surgery.
Reference is now made to
Elongated body or needle 204 may be sufficiently firm so that a force applied to axially advance longitudinal body 204 through tissue will be maintained along the projection of its longitudinal axis and be sufficient to enable distal free end 208 to penetrate tissue. Additionally, a non-bending longitudinal body 204 may be easily manipulated and provide high accuracy in aiming distal free end 208 and steering it to a specific point on a tissue wall via a chosen path of introduction. Longitudinal body 204 may also be operative to releasably accommodate sensory implant 250, as will be described in greater detail below.
In
Free end 208 may be operative to penetrate the exterior of an organ wall and deploy sensory implant 250 in a selected location in a wall of an organ. Free end 208 may also include a beveled and/or sharp tip 210 operative to cut through tissue. In some embodiments, sensory implant 250 is a micro sized implant, and for example may have a diameter between 0.1 to 2 mm, optionally 0.5 to 1 mm; optionally 1 to 20 mm, optionally 5 to 10 mm in length.
A pusher type introducer 212 may be operative to advance axially through lumen 206 of system elongated body or needle 204 by manual activation of actuator 214 on handle 202 or by employing a motor. Sensory implant 250 and introducer 212 are sized and configured for axial travel in lumen 206, including a forward travel to a point at which introducer 212 and/or sensory implant 250 protrudes a selected distance from the shaft's distal free end. Optionally, introducer 212 may be operative to rotate (not shown) while advancing through lumen 206. Alternatively and optionally, walls of lumen 206 may include a spiral groove corresponding to a matching thread on sensory implant 250 so that to apply rotational motion thereto about its longitudinal axis as it advances through lumen 206. Introducer 212 may be operative to advance through lumen 206 of body or needle 204 pushing a sensory implant 250 located ahead of pusher 212 through lumen 206. In such a configuration, neither pusher 212 nor sensory implant 250 includes means connecting therebetween.
Longitudinal body 204 may also be operative to enable introduction of fluids, including saline, medications, vitamins, tissue glue or other substances, either via lumen 206 or via a dedicated separate lumen (not shown). Additionally and optionally, delivery system 200 may also include a mandrel to prevent tissue from entering the needle during advancement.
Additionally and optionally, longitudinal body 204 may also include an inflatable balloon (not shown) in propinquity to free end 208 operative to deflect tissue away from the wall target. The inflatable balloon may be inflated and/or deflated manually or automatically employing filling media such as saline via a dedicated separate lumen (not shown).
Reference is now made to
Alternatively and optionally, sensory implant 250 may form a detachable tip of system 300 and be releasably secured thereto by a tether 302 secured to introducer 304. After implantation and as seen in
Reference is now made to
Reference is now made to
Sensory implants 540 and 570 include one or more anchors (anchors 514 and 516 and anchors 574 and 576, respectively) operative to be deployed at both opposing sides of an organ wall to anchor the sensory implant thereto, as will be further described in greater detail below. In an alternative embodiment, and as seen in
The anchors, 514, 516, 574, 576, for example, when deployed, may be capable of changing their spatial configuration from a folded configuration to an expanded configuration having a diameter along an axis perpendicular to the longitudinal axis of lumen 500. The longitudinal axis of any of capsules 554 and 556 (as shown in
Referring back to
The constraints imposed by the dimensions (i.e., diameter) of lumen 502 necessitate a change in the spatial configuration and/or orientation of sensory implant 540 from an expanded or open configuration to a closed or folded configuration so that it fits inside lumen 502. As seen in
When in the packed configuration, the length of sensory implant 540, with or without anchors 514 and 516 becomes the largest dimension of thereof in diameter, for example double or more, optionally 5 times or more, optionally 10 times or more, larger than the largest dimension of its pre-deployed formation, i.e., in the packed or folded configuration.
Any one of the component of the systems and devices described above may be made by any applicable biocompatible material, such as metal alloys or polymers and may include radiolucent and/or radio-opaque portions and/or elements operative to change their geometry (i.e., expand, inflate and similar so that its advancement along the path of introduction may be monitored by appropriate imaging devices such as a CT or MRI scanner. Additionally and optionally, longitudinal body 200 may include on the surface thereof colored or etched markings to allow visual observation and evaluation of the depth of penetration into tissue such as would be done in, for example, open heart surgery.
In some embodiments, any of the systems described above may include safety mechanisms such as a securing tether element connected to the sensory implant thereby preventing untimely detachment from delivery needle. After implantation and verifying fixation, the tether may be detached and pulled out through the lumen.
In some embodiments of the system, method and device, deployment begins by first penetrating through, fully or partially, the wall of the internal organ from its external site towards its inner layers and/or surface, optionally using the sharp distal tip of the shaft, until reaching a maximal progression, which is the point at which the sensory implant maximally protrudes out of the shaft distal free end. Maximal progression may be achieved for example, by pushing the implant forward with respect to the shaft lumen using a pusher or an introducer and/or releasing, disconnecting or anchoring the implant to the organ wall. Alternatively and optionally, the sensory implant may be deployed by withdrawing the shaft while maintaining the sensory implant in-place, for example by using a pusher or introducer releasably connected or unattached to the implant.
In an exemplary embodiment, the sensory implant may include at least one distal anchoring or retaining member for resisting backward motion of the sensory implant, operative to be selectively or inherently deployed after the sensory implant protrudes out of shaft lumen at a first predetermined length.
Optionally, alternatively or additionally, the sensory implant may include one or more proximal anchoring or retaining member for resisting forward motion of the sensory implant, operative to be selectively or inherently deployed after the sensory implant protrudes out of shaft lumen at a second predetermined length greater than the first predetermined length. Once both distal and proximal anchors are deployed, the sensory implant may be released and/or disconnected from the delivery device. Before, during or after such release/disconnecting, other steps may be performed, optionally including at least one of: powering the sensory implant; testing, adjusting and/or calibrating subunits of the sensory implant; deploying a second sensor at a different implantation site; and/or collapsing at least one anchor and retracting the sensory implant back into shaft lumen for redeployment or discarding.
In some embodiments and as will be described in greater detail below, the use of systems and method of the present invention may enable at least one of: simplified and safe fixation, minimal protrusion (about 1-1.5 mm) of the sensory implant in the organ interior, repeatable fixation of the sensory implant, in the same position relatively to the atrial wall and its lumen, minimal movement of the sensory implant, minimal damage to the atrial pulsating wall (contracts and relaxes), conformability to the atrial wall, long term durability and minimal interference with the electrical activity on the atrial wall.
Reference is now made to
Reference is now made to
In some embodiments, the site of implantation 616 encompasses wall target 606 or is included within wall target 606 or, alternatively, is adjacent to wall target 606. A preferable selected path of introduction 650 may be the shortest [i.e., smallest possible value of (d)] direct path possible, that accommodates introduction and advancement of a needle type delivery device in a straight line with minimal overall contact with body tissues or with minimal overall undesired injury to body tissues located along a linear pierced path. The path may be curvilinear or direct/straight linear extending from entry point 602 to target 606.
Alternatively and optionally, delivery and deployment of the sensory implant may be performed directly into wall 612 of body organ 610 obviating the need for a percutaneous path of introduction 650. Such would be the case in open heart surgery. A percutaneous entry point 602 may be identified based on the selected target 606 and a desired path of introduction 650. An implant delivery device similar to device 202 of
As described above, the delivery device may include radiolucent and/or radio-opaque portions and/or elements operative to change their geometry (i.e., expand, inflate and similar so that its advancement along the path of introduction may be monitored by appropriate imaging devices such as a CT or MRI scanner.
Once the delivery device has arrived at wall target 606 on external surface 608 of left atrial wall 612 (
The correct implantation of the sensory implant and the functionality thereof may be verified by testing 780 the sensory implant in-situ (e.g., by taking measurements of pressure and analyzing and/or correlating the data with known or stored information/database). Such testing 780 may follow or be followed by anchoring 790 the sensory implant in place. The exact location of the site of implantation and the implantation process end point may be verified by appropriate imaging devices and/or by readings picked up by a sensor in the sensory implant.
In some embodiment, for example, verification 750 and/or testing 780 of a sensory implant location and function may be carried out electrically. For example, the needle may also include one or more electrodes (not shown) in propinquity to free end 208 (
In some embodiments of the invention, once the delivery device has reached the wall target, a positioning and/or orientation verification may be optionally performed, for example if necessary or as per a protocol, either by using the sensory implant, by using another dedicated sensory means, visually by observing markers on the exterior surface of the delivery device needle and/or by using non-invasive imaging. After optionally performing the verification, deployment of the sensory implant in the implantation site can take place.
In some embodiments, the site of implantation encompasses the wall target or is included within the wall target, or alternatively is adjacent to the target so that the practitioner repositions and/or realigns the delivery device or any of its parts or members (e.g., the elongated slender body or a part thereof), either as part of the positioning and/or orientation verification or at a following step.
An exemplary method of implanting a sensory implant in the left atrium may include any or all of the following steps: (1) The subject is positioned (not shown) in a prone or prone oblique position; (2) A CT scan is performed to locate and identify a target on the wall of the left atrium; (3) The CT scan is also employed to plan the exact path of introduction and identify an exact cutaneous entry point and inter-costal space at which the delivery system needle will be inserted into the chest; (4) A needle, such as for example needle 200 (
In some embodiments of the invention, once the needle tip location in the left atrium wall is verified, the delivery system needle may be employed to implant the sensory implant in the atrium wall. The implantation may be carried out employing an introducer 210 in a needle of the type shown in
Verification of the needle tip location and implant functionality may be carried out employing any one or combination of the following methods: (1) CT/MRI with or without a contrast agent; (2) Readings that enable the physician to extract therefrom a left atrium pressure curve from a pressure sensor at the tip of the delivery device/needle or from the sensory implant itself; (3) Pulsating movement of the delivery device/needle corresponding to the heart rate; and (4) Oxygenated blood detected in an injector attached to the needle.
When implanting some types of devices, such as for example, a sensory implant comprising separated members or capsules, the longitudinal body of the delivery device may need to be slightly retracted back into the atrial wall before implantation of the device in the atrial wall.
Once in-place, the sensory implant may be attached and/or anchored to the atrial wall as described above. Delivery and deployment of a sensory implant may be performed directly into a wall of a body organ such as the left atrium obviating the need for a percutaneous path of introduction, such as in open heart surgery.
An exemplary method of sensory implant placement in the left atrium may include any or all of the following steps: (1) During the course of an open-heart procedure a target on the left atrium wall is identified visually; (2) A needle, such as for example needle 200 (
The location of the needle tip may be verified by any one or combination of the following methods: (1) Readings that enable the physician to extract therefrom a left atrium pressure curve from a pressure sensor at the tip of the delivery device/needle or from the sensory implant itself; (2) Pulsating movement of the delivery device/needle corresponding to the heart rate; and (3) Oxygenated blood detected in an injector attached to the needle.
Once the needle tip location in the left atrium wall is verified, the delivery system needle may be employed to implant the sensory implant in the atrium wall. The implantation may be carried out employing an introducer 210 in a needle of the type shown in
Reference is now made to
Either one or both of implanted portion 14 and anchor portion 12 may include, house or be one or more electrically driven components of sensory implant 10 including an electrical rechargeable power storing component 812, a sensing component 814, a signal processing component 816, an induction coil for receiving inductive energy (not shown) and a telemetry component 818. Sensing component 814 may be capable of transforming a change in physiological conditions associated with a performance or a condition of the monitored internal organ to a mechanical, electrical or chemical signal. In some embodiments, sensing component 814 may include at least one sensor operative for continuous measurements at relatively low power consumptions. In some embodiments, the sensor is micro or nano sized, for example a micro mechanical based sensor such as a micro electro mechanical system (MEMS), a nano electro mechanical system (NEMS), a micro optic mechanical system (MOMS), a micro optical electro mechanical system (MOEMS), a biological micro electro mechanical system (BioMEMS), a “lab-on-a-chip” system (LOC), or any combination thereof.
Rechargeable power storing component 812 may include a power conditioning circuitry mechanism that detects the level of power delivered and switches on the other components when adequate power levels are reached. The power conditioning circuitry mechanism may employ application-specific integrated circuitry (ASIC) and be included in signal processing component 816.
In some embodiments, signal processing component 816 may digitize the readouts from sensing component 814, process the readouts and prepare them for transmission. Processing may include a unique digital identification (signature) for identification and authentication of device 250 and the subject being monitored. The digital identification may be transmitted to an external unit by telemetry component 818 as will be explained in detail below. Signal processing component 816 may be an application specific integrated chip (ASIC). The ASIC may be encapsulated within a seamless biocompatible and flexible sheathing, such as silicon, and easily integrated with the additional components employing MEMS technique.
By way of example only, a MEMS capacitive pressure transducer 902 may be in contact with a membrane 904 wherein changes in the pressure effected on membrane 904 correspondingly vary the capacitance of transducer 902 in comparison to a reference fixed capacitor 906. The detected differential capacitance between capacitor 906 and capacitive transducer 902 is converted by converter 908 into a signal such as electronic module output pulses. The sampling data may be expressed in the pulses frequency. Alternatively an optionally, the electronic module output pulses may, for example activate an on/off switch 910 in which case the sampling data may be expressed in the on and off durations of the signal.
The sampling data may be expressed, for example via switch 910, by variations in the impedance of a load 912 having an impedance that matches that of a load 916 of external unit 914. External unit 914 may, in turn, be operative to reconstruct the sampled data from the detected changes in the impedance of load 912. In this configuration the electrical circuitry of sensory implant 10 may employ magnetic inductance (implemented as a transformer) between external unit 914 and sensing component 814 for remote power feeding to charge electrical rechargeable power storing component 812 (
Alternatively and optionally, the differential capacitive signal may be modulated and transmitted to external unit 914 via a separate antenna 918 and received by an antenna 920 on external unit 914. Additionally or alternatively, antenna 918 may also be employed as part of telemetry component 818 and receive transmissions from antenna 920 of external unit 914. In this configuration magnetic inductance (implemented as a transformer) may be used only for remote power feeding to charge electrical rechargeable power storing component 812 (
Either one or both of inductance coil 920 and antenna 918 may be placed outside the external surface 922 of wall 806, while the remaining portion of sensing component 814 may be fully implanted inside wall 806 or partially implanted in wall 806 and having a portion 924 protruding into lumen 810 defined by wall 806.
Either one or both of inductance coil 920 and antenna 918 may also be incorporated in, or serve themselves as an anchor such as anchor portion 254 (
Other means of remote powering of and/or communication with an implanted sensor such as sensing component 814 as known in the art may also be employed to communicate one or more hemodynamic parameters selected from a group of parameters including blood pressure, blood velocity, degree of blood oxygenation (i.e., blood oxygen saturation) and temperature within the lumen of the monitored target organ between sensing component 814 and external unit 914.
Sensing component 814 may be configured for continuous real-time measurements for prolonged periods, for example at least one week, optionally at least one month, optionally at least one year, optionally at least 5 years, optionally at least 10 years; while wirelessly transmitting measured and/or analyzed signals/data to a remote out-of-body receiver.
Referring now back to
In an embodiment in accordance to the current system, device and method, Sensory implant 10 may include only passive components. In such a configuration no electrical circuitry is employed to digitize the acquired measurement values, which obviates the need for electrically driven components of sensory implant 10, namely rechargeable power storing component 812, signal processing component 816 and telemetry component 818. Sensing component 814 values may be read employing external antenna 918 by applying an excitation signal. Resonant frequency of sensory implant 10 passive elements, which may be dependent on its conductive properties, may be analyzed telemetrically using only external circuitry.
Sensory implant 10 may be operative to be arranged in a packed configuration that enables its accommodation inside the lumen, for example of the rigid elongated member 504 along its longitudinal axis X. In some embodiments, for example, sensory implant 10 may include an outer diameter of 2 mm or less, optionally 1 mm or less. In some embodiments, sensory implant may be 10 mm or less in length.
Reference is now made to
Wire 1058 may be elongated having a tubular or any other appropriate geometric cross-section and be made of a rigid, semi-rigid or flexible material. Additionally and optionally, wire 1058 may be made of a resilient material having super elastic properties. The resilience along the longitudinal axis of retention portion 1058 may be limited by a selection of a suitable material to allow a predetermined limited level of axial movement of members 1052 and 1054 along the longitudinal axis of wire 1058 and preventing members 1052 and 1054 from becoming too distant from each other losing their function as anchors. The relative axial movement with respect to sensory implant 20 as derived from the on-going oscillatory movement of the organ (e.g., atrial wall) may allow periodic measurement of the contraction force of the atrium muscles and/or serve as generating/recharging mechanism in a power harvesting scheme.
Additionally and optionally, wire 1058 may include a mesh portion improving scar tissue growth into the mesh openings over time thus further fixing sensory implant 20 in place. As explained above, the physical characteristics of wire 1058 may be employed to harness and convert mechanical energy produced by pulsating (e.g., 0 on-going deformation and stretching-contracting behavior) muscular wall tissue in which a sensory implant, such as device 250 is implanted into electrical energy that may be stored, for example, in a capacitor.
Reference is now made to
Anchor portion 1154 may be made of one or more resilient elements 1110 made of a material such as, for example a wire, textile or polymer mesh having super elastic properties to bring anchor portion 1154 from a temporary closed or packed loaded state shown in
Alternatively and optionally, anchor portion 1154 may be made of a temperature sensitive material that changes its geometrical shape from that shown in
Alternatively and optionally, anchor portion 1154 may be made of a mesh (not shown) expanded by employing an inflatable balloon on the implant delivery system as described above. Alternatively and optionally, anchor portion 1154 may be expanded when deployed by an umbrella-type expanding mechanism (not shown).
When in a closed or packed configuration (
In its deployed or expanded configuration (
Alternatively and optionally, anchor portion 1154 may include any one of an inflatable chamber, a shape memory material (e.g., Ni—Ti based alloy), cage, mesh or spring type expandable mechanism selectively changeable by an operator from outside the body.
In some embodiments, additional optional elements such as ring-like elements, protrusions or indentations (not shown) may be provided and/or lateral or longitudinal geometrical cross-sections in various shapes may be applied to sensory implant 30 to enhance fixation and stabilization thereof in the wall.
Reference is now made to
Anchor portions 1254 and 1256 may be made of one or more resilient elements made of a material such as, for example a wire or mesh having super elastic properties to bring anchor portions 1254 and 1256 from a temporary closed loaded state shown in
Once implanted, scar tissue may grow over time into gaps 1218 and/or partially or completely cover anchors 1254 and 1256 further fixing sensory implant 40 in place. In such a case, pressure sensitive member 1208 may be covered with scar tissue interfering with its function. As shown in
Reference is now made to
Sensory implant 50 may be held suspended in lumen 1312 defined by walls 1314 and 1316, by two or more retention portions 1358 and two or more anchors 1354 and 1356, abutting respective walls 1314 and 1316.
Retention portions 1358 may be elongated having a tubular or any other appropriate geometric cross-section and be made of a rigid, semi-rigid or flexible material. Additionally and optionally, portion 1358 may be made of a resilient material having super elastic properties. The resilience along the longitudinal axis of retention portion 1358 may be limited by a selection of a suitable material to allow a predetermined limited level of freedom of axial movement of anchors 1354 and 1356 along the longitudinal axis of portions 1358 and preventing anchors 1354 and 1356 from becoming too distant from each other losing their function.
Sensory implant 50 as shown in
In some embodiments, any of the anchors described in the present invention may be operative to allow relative axial movement of the sensory implant relative to the organ wall so that to prevent tearing of the organ wall issue resulting from shearing forces exerted by a axial movement of the pulsating wall tissue against a stationary implanted body. Allowing relative axial movement of the sensory implant also diminishes forces exerted by the organ wall tissue thus reducing fatigue and lengthening the sensory implant longevity. Additionally, anchors such as anchor 1154 (
Reference is now made to
Capsule 2100 encapsulates juxtaposed electrical circuit 2400 in the following distal-to-proximal order:
Electrical circuit 2400 is electrically connected to inductor 2450, optionally via a wire 2452, set to introduce induction to the circuit for powering thereof by a remote power source (not shown).
Reference is now made to
In
At any deployment phase, at least until releasing sensory implant 2000, in case the operator wish to redeploy or totally discard sensory implant 2000, he may re-enclose it and re-collapse distal anchor 2200 and proximal anchor 2300 by pushing longitudinal body 3100 over it. As shown, both anchors 2200 and 2300 include retention members connected at proximal portions thereof and having free ends angled distally, thereby facilitating such complete recollapsing ability.
In some embodiments of the invention, a system is provided comprising sensory implant 2000 that is adapted to sense a change in at least one parameter associated with a condition and/or a performance of an internal body organ, optionally a cardiac left atrium. In some embodiments, the wall includes muscle tissue, optionally the wall is pulsatory. In some embodiments, sensory implant 2000 includes a sensing component, a signal processing component, and a telemetry component. In some embodiments, sensory implant 2000 includes a micro electro mechanical pressure transducer.
The system may further include an implant delivery device 3000 which includes longitudinal body 3100 enclosing a lumen 3120 communicating with an open free end 3110 thereof and adapted to provide a contained passage along a linear pierced path between an entry point and a wall target associated with the internal body organ. In some embodiments, the entry point is percutaneous or alternatively is adjacent an external surface of the wall (for example, during open surgeries). In some embodiments of the invention, the wall target is located on an external surface of the wall. Optionally and alternatively, the wall target is located in the wall. In some embodiments of the invention, the contained passage is of 2 mm or less, optionally 1.5 mm or less, optionally 1 mm or less in diameter, or higher or lower or intermediate.
Implant delivery device 3000 further includes introducer 3200 that is releasably connected to sensory implant 2000 and adapted to advance the sensory implant from an enclosed position in lumen 3120 to a protruded position distal to free end 3110. In some embodiments of the invention, introducer 3200 is coupled to sensory implant 2000 by a threaded mechanism. When connected to sensory implant 2000, introducer 3200 may allow electrical connectivity between sensory implant 2000 and a remote device provided outside the body (not shown), optionally including an electrical power source and/or a signal receiver. In some embodiments of the invention, introducer 3200 includes a distally positioned coiled member 3310 provided in a direct electrical contact with a proximally positioned electrically conductive member (not shown), the coiled member 3310 is adapted for inductive coupling with inductor 2450 provided with sensory implant 2000.
In some embodiments of the invention, implant delivery device 3000 is operative to penetrate the wall from its external surface and to release sensory implant 2000 in the wall.
In some embodiments of the invention, the linear pierced path is straight, optionally is at least 10 cm in length.
In some embodiments of the invention, sensory implant 2000 includes at least one retention member (2210 and/or 2310) capable of altering from a longitudinal form when confined to lumen 3120 boundaries, to an angled form when protruding out lumen 3120. In some embodiments, at least one of retention members 2210/2310 includes a resilient portion being at a higher stressed condition when retention member 2210/2310 is at the longitudinal form than when at the angled form. Optionally, the angled form is perpendicular to the longitudinal form. In some embodiments, anchor 2200 and/or anchor 2300 is configured to expand from a collapsed transverse size imposed by lumen 3120 boundaries to an expanded transverse size being 2 mm or more greater than a maximal diameter of free end 3110.
In some embodiments, inductor 2450 is expandable and configured to expand from a collapsed transverse size imposed by lumen 3120 boundaries to at least 5 mm in diameter when is unstressed. In some embodiments, an expandable inductor is further configured to perform as an anchoring device when expanding over the collapsed transverse size. Optionally, an expandable inductor includes an induction coil interlaced with an antenna coil.
In some embodiments of the invention, the system further includes a positioning verification analyzer communicative with the sensory implant prior to the releasing thereof and adapted to correlate between a signal transmitted by the sensory implant and a stored identifying data.
In some embodiments of the present invention, sensory implant 2000 is implantable in a muscular wall of a cardiac left atrium and is adapted to sense pressure changes developing inside the atrium. In some embodiments, sensory implant 2000 includes capsule 2100 being 1.5 mm or less in diameter, optionally 1 mm or less, optionally about 0.5 mm or less, or higher, or lower, or intermediate. In some embodiments, capsule 2100 contains a micro electro mechanical sensing component. In some embodiments, capsule 2100 is provided coupled with inductor 2450 and with an anchor (2200 and/or 2300) adapted to alter from a longitudinal form, equal to or less than the capsule diameter, to an angled form having a diameter greater than the lumen 3120 diameter. In some embodiments of the invention (not shown), a retaining member or an anchor includes and/or is interlaced with an inductor.
In an aspect of some embodiments the is provided a method which includes an introducing of implant delivery device 3000, carrying an implant, such as sensory implant 2000, along a selected linear pierced path and arriving at a wall target located on an external surface of a cardiovascular organ; and anchoring at least a portion of the implant in the cardiovascular organ wall.
In an aspect of some embodiments the is provided, in parallel, a method which includes an of
introducing implant delivery device 3000, carrying an implant, such as sensory implant 2000, along a selected linear pierced path and arriving at a wall target located on an external surface of an internal body organ; and anchoring at least a portion of the implant in the internal body organ wall. In some embodiments, the method further includes an implanting the implant in a site of implantation in the wall of the internal body organ; the site of implantation includes or is included in the wall target. In some embodiments, the method includes verifying implant location prior to the anchoring.
In some embodiments of the invention, the selected linear pierced path is a direct path that accommodates introduction and advancement of implant delivery device 3000 in a straight line. In some embodiments, delivery device 3000 passes at least once through lung tissue during its advancement along the linear pierced path. Optionally, the selected linear pierced path is selected prior to the introducing. Optionally, such a selecting is followed by a preliminary imagery scan analysis. In some embodiments, the method further includes selecting an entry point defining the linear pierced path in-between the organ target.
In some embodiments, the method includes a first step of selecting a wall target located on an external surface of an internal body organ, and then choosing a linear path between an entry point and the wall target. In some embodiments, the system or the implant delivery device, is used to pierce across tissues along the linear path. Optionally, sensory implant 2000 is advanced from an enclosed position in lumen 3120 to a protruded position distal to free end 3110. In some embodiments, the wall of the internal body organ is penetrated from the exterior surface. After penetration, following an optional verification phase, sensory implant 2000 is released in the wall.
It will be appreciated by those skilled in the art that the system, device and method described above may be used not just for the vascular system and may be applicable to other various organ types, body regions etc.
It will also be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the invention includes both combinations and sub-combinations of various features described hereinabove as well as modifications and variations thereof which would occur to a person skilled in the art upon reading the foregoing description and which are not in the prior art.
This application is related to U.S. Provisional Patent Application No. 61/428,432 filed Dec. 30, 2010 and entitled “PERCUTANEOUSLY IMPLANTABLE VASCULAR SENSOR”, the disclosure of which is incorporated herein by reference in their entirety, as if fully set forth herein.
| Number | Date | Country | |
|---|---|---|---|
| 61428432 | Dec 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/IL2011/050082 | Dec 2011 | US |
| Child | 13929405 | US |
