WO2022195426A1

WO2022195426A1 - Systems methods and computer readable storage media for a set of proximity markers disposed on opposite ends of a gap in dense regular connective tissue

Info

Publication number: WO2022195426A1
Application number: PCT/IB2022/052237
Authority: WO
Inventors: Martin Boyer; Yuval Zekharya SHEZIFI; Ilan Grunberg; Ehud Almon
Original assignee: Tendomend Ltd.
Priority date: 2021-03-14
Filing date: 2022-03-13
Publication date: 2022-09-22
Also published as: GB202103514D0

Abstract

A system for determining distances between proximity markers on opposite ends of a gap in dense regular connective tissue is described; a respective method, computer-readable storage medium and a kit-of-parts implementable for determining distances between proximity markers tissue are further described; the system comprises: a pair of tendon grasping devices, a pair of proximity markers, a monitoring appliance preferably comprising an imaging device; the method comprises: providing a pair of tendon grasping devices with a pair of proximity markers, providing a monitoring appliance preferably providing an imaging device; the computer-readable storage medium comprises computer-executable instructions for collecting imaging input data regarding proximity markers, detecting a pair of proximity markers, identifying a pair of proximity marker, calculating distance between the pair of proximity markers; the kit-of-parts implementable comprises: a pair of tendon grasping devices with a pair of proximity markers.

Description

SYSTEMS METHODS AND COMPUTER READABLE STORAGE MEDIA FOR A SET OF PROXIMITY MARKERS DISPOSED ON OPPOSITE ENDS OF A GAP IN DENSE REGULAR CONNECTIVE TISSUE

TECHNICAL FIELD

[0001] In general, the present invention pertains to the art of medical devices. In particular, the invention relates to systems methods of and computer readable storage media of monitoring a set of proximity markers disposed on opposite ends of ruptured or otherwise cut Dense Regular Connective Tissue (DRCT).

BACKGROUND ART

[0001] Dense regular connective tissue (DRCT) is subject to injuries, for example due to trauma involving laceration or rupture of a tendon or ligament, and overuse, generally resulting in inflammation and degeneration of the tendons, which may eventually lead to tendon or ligament rupture.

[0002] Generally, during a surgical procedure for tendon or ligament repair, the torn tendon ends, also known as stumps, are sutured together. If there is not enough healthy tendon or ligament to reconnect, a tendon or ligament graft is performed, namely implanting a graft of tendon from another part of the body instead of the damaged tendon or ligament.

[0003] Medical procedures rely on imaging. Therapies may include tissue suturing and/or implant of a device, such as connecting device, of a portion of a dense regular connective tissue (DRCT). In many cases these procedures may be carried out with the assistance of volumetric imaging such as Computed Tomography (CT), magnetic resonance imaging (MRI), Positron Emission Tomography (PET), and the like. They may also be carried out using optical imaging (e.g. through an endoscope), ultrasound imaging (US), X-ray imaging, etc. Imaging modalities such as US or X-ray may be used after the interventional procedure to help locate the localization marker.

[0004] The current state of the art does not allow assessment of tendon laceration or rapture recovery. Moreover, many locations include only simpler imaging devices like US or X-ray. In some cases, such as those performed using ultrasound, the anatomy may be poorly visualized or presented in a form that make it difficult for the physician to interpret. Some features or anatomy may not be suited to ultrasound at all.

[0005] Localization markers are normally passive devices that are visible from the surface or visible under at least one imaging modality or one localizing device that are temporarily or permanently in a patient or device. Localization markers are often placed into a pathology that is visible using an imaging modality to assist locating of the pathology when it cannot be directly seen. Localization markers may be placed using MRI in order to locate a tumor for surgical resection at a later time.

[0006] Once in place, localization markers may denote a region wherein a subsequent procedure may be performed, assist in registration for a computer assisted image guided surgical procedure, assist in registration for a therapy, denote a boundary, denote a critical structure or assist in measuring tissue motion. Being in the location of the pathology, there is the potential for the localization markers to also be employed in therapy of dense regular connective tissue (DRCT).

[0007] It is believed that the current state of the art is represented by the following patent literature: US9301756, US7635329, US9386981 US9763770, US10245138, US2008287965, US2013289389, US20140243976, US20150196369, US2017189006, FR2422386 and WO2018154504

[0008] Devices and methods for surgical procedure for tendon repair are known in the art. For example, US20040193217 discloses methods and apparatuses for repairing damaged tendons that include tensile members and anchors configured for insertion within the interior of a tendon. In addition, US20010004693 discloses an implant for the fixation of a soft tissue to a bone, including a shaft that penetrates the bone. US2013013065 presents a method for treating damaged tendons or ligaments using a hollow device formed by a woven fabric.

[0009] Accordingly, there is a need to solve these and other problems to facilitate procedures that provide for locating localization markers placed within tissue. For example, there is a need to locate localization markers once placed on the reconnected ends of dense regular connective tissue (DRCT) using an imaging modality. There exists a need to perform procedures using implanted localization markers that may be activated as required in order to monitor the reconnection of rupture ends of dense regular connective tissue (DRCT).

SUMMARY OF THE INVENTION

[0010] The following summary of the invention is provided in order to provide a basic understanding of some aspects and features of the invention. This summary is not an extensive overview of the invention and as such it is not intended to particularly identify key or critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented below. [0011] The invention was made in view of the deficiencies of the prior art and provides systems, methods and processes for overcoming these deficiencies. According to some embodiments and aspects of the present invention, there is provided methods, systems, and devices employing a set of proximity markers on dense regular connective tissue (DRCT). A proximity marker is a device configured to emit a signal, for instance in response to a signal transmitted by a probe. In one embodiment the method includes placing at least one proximity marker, localizing the at least one proximity marker, and performing a monitoring procedure using the at least one proximity marker.

[0012] In one embodiment, the proximity marker facilitates performing an imaging study on a dense regular connective tissue, identifying a rupture in the tissue, and placing one or more of proximity markers in the dense regular connective tissue and/or implant attached to the dense regular connective tissue and and/or a suture penetrating or attached to the dense regular connective tissue. The proximity marker may include placing a probe configured to detect the proximity marker in proximity to the one or more of proximity markers in the dense regular connective tissue, detecting the one or more of proximity markers, and indicating the position of the probe relative to the one or more of proximity markers and/or the position of each marker relative to any other marker.

[0013] In another aspect, a proximity marker device is disclosed. In one embodiment, the proximity marker device is configured to emit a signal indicative of its location relative to a probe in response to a signal transmitted by a probe, where the proximity marker is comprised of a reflective device capable of reflecting an incident signal, a device designed to transmit a signal in response to an incident signal, or a device designed to modify a property of a signal generating system. The proximity marker device further includes an element configured to constrain the proximity marker within on a dense regular connective tissue.

[0014] In a third aspect, a system for performing a monitoring procedure is disclosed. In one embodiment, the system comprises a computer, a tracking device, an imaging device, and one or more a set of proximity markers. The one or more a set of proximity markers can be configured to emit a signal in response to a signal transmitted by a probe indicative of its location.

[0015] In accordance with some aspects and embodiments of the present invention, a system for determining distances between proximity markers on opposite ends of a gap in dense regular connective tissue is described, the system comprising: at least one first tendon grasping device anchorable to a first terminal portion of a dense regular connective tissue; at least one second tendon grasping device anchorable to a second terminal portion of the dense regular connective tissue; in which the first terminal portion of the dense regular connective tissue and the second terminal portion of the dense regular connective tissue disposed on opposite ends of a gap in the dense regular connective tissue; at least one first proximity marker, disposed on the at least one first tendon grasping device; at least one second proximity marker, disposed on the at least one second tendon grasping device; a monitoring appliance comprising: a computing device, configured to receive and process input data related to the proximity markers, disposed on the at least one first and second tendon grasping devices, comprising: at least one input terminal, configured to receive input data; at least one software module, configured to process the input data; a display device configured to display output of the input data processed by the at least one software module; at least one detection module operatively connected to the computing device selected from the group consisting of: a probe directly connected to the computing device, configured for detecting the proximity markers and collecting the input data; a tracking device, not directly connected to the computing device, configured for, configured for detecting the proximity markers, collecting the input data and locally storing the input data; an imaging device, configured for obtaining images of the proximity markers; the at least one detection module is configured for detecting and identifying each one of the proximity markers, disposed on the at least one first and second tendon grasping devices; the at least one detection module is further configured for collecting the input data related to the proximity markers and transmitting the input data to the computing device.

[0016] In some embodiments, the at least one software module is further configured to process the input data, so as to calculate and/or visualize the distances, between the proximity markers, disposed on the opposite ends of the gap in the dense regular connective tissue, while the dense regular connective tissue is in motion.

[0017] In some embodiments, the at least one software module is further configured to provide indications, implementable for advising on a physiotherapy routine.

[0018] In some embodiments, the computing device of the monitoring appliance further comprises a microprocessor configured for calculating coordinates of the proximity markers, relative to a reference point.

[0019] In some embodiments, the display device of the monitoring appliance is configured to display at least one output selected from the group consisting of: polygon, ruler, line, circle, indicia.

[0020] In some embodiments, the computing device of the monitoring appliance further comprises a microprocessor configured for calculating a relative position of the proximity markers and/or distance between the proximity markers.

[0021] In some embodiments, the display device of the monitoring appliance further comprises a visual display device selected from the group consisting of: an LCD display, a plasma screen display, cathode ray tube display, LED display, ELED display, QLED display, configured to present a graphical user interface (GUI) of the at least one software module of the monitoring appliance.

[0022] In some embodiments, the tracking device is selected from the group consisting of: an electromagnetic tracking device, micropower impulse radar, optical range finder, metal detector, ultrasonic detection device.

[0023] In some embodiments, the probe further comprises at least one device selected from the group consisting of: an electromagnetic tracking device, micropower impulse radar, optical range finder, metal detector, ultrasonic device.

[0024] In some embodiments, the imaging device comprises at least one device selected form the group consisting of: an x-ray imaging device, computerized tomography device, positron emission tomography device, magnetic resonance imaging device, fluoroscopy device, ultrasound device, isocentric fluoroscopic device, rotational fluoroscopic reconstruction device, multislice computerized tomography device, intravascular ultrasound imager, optical coherence tomography (OCT) device, optical imaging device, single photon emission computed tomography device, magnetic particle imaging device.

[0025] In accordance with some aspects and embodiments of the present invention, a method of determining distances between proximity markers on opposite ends of a gap in dense regular connective tissue comprising: providing at least one first tendon grasping device anchorable to a first terminal portion of a dense regular connective tissue; providing at least one second tendon grasping device anchorable to a second terminal portion of the dense regular connective tissue; in which the first terminal portion of the dense regular connective tissue and the second terminal portion of the dense regular connective tissue disposed on opposite ends of a gap in the dense regular connective tissue; providing at least one first proximity marker, disposed on the at least one first tendon grasping device; providing at least one second proximity marker, disposed on the at least one second tendon grasping device; providing a monitoring appliance comprising: a computing device, configured to receive and process input data related to the proximity markers, disposed on the at least one first and second tendon grasping devices, comprising: at least one input terminal, configured to receive input data; at least one software module, configured to process the input data; a display device configured to display output of the input data processed by the at least one software module; at least one detection module operatively connected to the computing device selected from the group consisting of: a probe directly connected to the computing device, configured for detecting the proximity markers and collecting the input data; a tracking device, not directly connected to the computing device, configured for, configured for detecting the proximity markers, collecting the input data and locally storing the input data; an imaging device, configured for obtaining images of the proximity markers; the at least one detection module is configured for detecting and identifying each one of the proximity markers, disposed on the at least one first and second tendon grasping devices; the at least one detection module is further configured for collecting the input data related to the proximity markers and transmitting the input data to the computing device.

[0026] In some embodiments, the method further comprises calculating a relative position of and/or distance between the proximity markers.

[0027] In some embodiments, the method further comprises calculating coordinates of the proximity markers, relative to a reference point.

[0028] In some embodiments, the tracking device is selected from the group consisting of: an electromagnetic tracking device, micropower impulse radar, optical range finder, metal detector, ultrasonic detection device.

[0029] In some embodiments, the probe further comprises at least one device selected from the group consisting of: an electromagnetic tracking device, micropower impulse radar, optical range finder, metal detector, ultrasonic device.

[0030] In accordance with some aspects and embodiments of the present invention, a computer-readable storage medium, having computer-executable instructions stored thereon which, when executed by a computer micro-processor of a system for determining distances between proximity markers: collecting imaging input data regarding proximity markers by an imaging device; detecting a first proximity marker of the proximity markers, disposed on at least one first tendon grasping device; identifying the first proximity marker of the proximity markers, disposed on the at least one first tendon grasping device; detecting a second proximity marker of the proximity markers, disposed on at least one second tendon grasping device; identifying the second proximity marker of the proximity markers, disposed on the at least one second tendon grasping device; calculating a distance between the first and the second proximity markers on the opposite ends of the gap in the dense regular connective tissue.

[0031] In some embodiments, the computer-readable storage medium further comprises computer-executable instructions for displaying output of the input data by a display device.

[0032] In some embodiments, the computer-readable storage medium further comprises computer-executable instructions for processing the input data related to the proximity markers, disposed on the at least one first and second tendon grasping devices.

[0033] In some embodiments, the computer-readable storage medium further comprises computer-executable instructions for causing the proximity markers to emit a signal indicative of their location relative to a probe in response to a signal transmitted by a probe.

[0034] In some embodiments, the computer-readable storage medium further comprises computer-executable instructions for causing the proximity markers to reflect a signal by a reflective member of the proximity markers.

[0035] In some embodiments, the computer-readable storage medium further comprises computer-executable instructions for causing the proximity markers to emit a signal by an emitting member of the proximity markers.

[0036] In some embodiments, the computer-readable storage medium further comprises computer-executable instructions for processing the input data, so as to calculate coordinates of the proximity markers, relative to a reference point.

[0037] In some embodiments, the computer-readable storage medium further comprises computer-executable instructions for processing the input data, so as to calculate a relative position of and/or distance between the proximity markers.

[0038] In some embodiments, the computer-readable storage medium further comprises computer-executable instructions for processing the input data, so as to calculate and visualize the distances, between the proximity markers, disposed on the opposite ends of the gap in the dense regular connective tissue, while the dense regular connective tissue is in motion.

[0039] In accordance with some aspects and embodiments of the present invention, a method of determining distances between proximity markers on opposite ends of a gap in dense regular connective tissue comprising: providing at least one first tendon grasping device anchorable to a first terminal portion of a dense regular connective tissue; providing at least one second tendon grasping device anchorable to a second terminal portion of the dense regular connective tissue; in which the first terminal portion of the dense regular connective tissue and the second terminal portion of the dense regular connective tissue disposed on opposite ends of a gap in the dense regular connective tissue; providing at least one first proximity marker, disposed on the at least one first tendon grasping device; providing at least one second proximity marker, disposed on the at least one second tendon grasping device; providing an imaging appliance configured for collecting imaging input data regarding proximity markers by an imaging device; providing a computing device configured for analyzing the imaging input data, so as to: detect a first proximity marker of the proximity markers, disposed on at least one first tendon grasping device; identify the first proximity marker of the proximity markers, disposed on the at least one first tendon grasping device; detect a second proximity marker of the proximity markers, disposed on at least one second tendon grasping device; identify the second proximity marker of the proximity markers, disposed on the at least one second tendon grasping device; calculating a distance between the first and the second proximity markers on the opposite ends of the gap in the dense regular connective tissue.

[0040] In some embodiments, the method further comprises processing the input data related to the proximity markers, disposed on the at least one first and second tendon grasping devices.

[0041] In some embodiments, the method further comprises emitting by the proximity markers a signal indicative of their location.

[0042] In some embodiments, the method further comprises storing the imaging input data.

[0043] In some embodiments, the method further comprises reflecting a signal by a reflective member of the proximity markers.

[0044] In accordance with some aspects and embodiments of the present invention, a kit-of-parts implementable for determining distances between proximity markers on opposite ends of a gap in dense regular connective tissue comprising: at least one first tendon grasping device anchorable to a first terminal portion of a dense regular connective tissue; at least one second tendon grasping device anchorable to a second terminal portion of the dense regular connective tissue; in which the first terminal portion of the dense regular connective tissue and the second terminal portion of the dense regular connective tissue are disposable on opposite ends of a gap in the dense regular connective tissue; in combination with: at least one first proximity marker, disposed on the at least one first tendon grasping device; at least one second proximity marker, disposed on the at least one second tendon grasping device; in which a detection module of a monitoring appliance is configured for detecting and identifying each one of the proximity markers, disposable on the at least one first and second tendon grasping devices; in which the detection module is further configured for collecting input data related to the proximity markers and transmitting the input data to a computing device of the monitoring appliance.

[0045] In some embodiments, the kit-of-parts is selected from the group consisting of: an electromagnetic trackable marker, micropower impulse radar trackable marker, optical range finder trackable marker, metal detector trackable marker, ultrasonically trackable marker.

[0046] In some embodiments, the kit-of-parts is selected from the group consisting of: an x-ray imaging trackable marker, computerized tomography trackable marker, positron emission tomography trackable marker, magnetic resonance imaging trackable marker, fluoroscopy trackable marker, ultrasonically trackable marker, isocentric fluoroscopic trackable marker, rotational fluoroscopic reconstruction trackable marker, multislice computerized tomography trackable marker, intravascular ultrasound imager trackable marker, optical coherence tomography (OCT) trackable marker, optical imaging trackable marker, single photon emission computed tomography trackable marker, magnetic particle imaging trackable marker.

DEFINITIONS

[0047] The term Dense regular connective tissue (DRCT), as referred to herein, is to be construed as any tissue providing connection between different tissues in the human body. The collagen fibers in dense regular connective tissue are bundled in a parallel fashion. Dense regular connective tissue (DRCT) is divided into white fibrous connective tissue and yellow fibrous connective tissue, both of which occur in two forms: cord arrangement and sheath arrangement. In cord arrangement bundles of collagen and matrix are distributed in regular alternate patterns. In sheath arrangement collagen bundles and matrix are distributed in irregular patterns, sometimes in the form of a network. Structures formed by DRCT include: tendons, which connect muscle to bone and derive their strength from the regular, longitudinal arrangement of bundles of collagen fibers, ligaments that bind bone to bone and are similar in structure to tendons, and aponeuroses which are layers of flat broad tendons that join muscles and the body parts the muscles act upon, whether it be bone or muscle. Functions of dense regular connective tissue has great tensile strength that resists pulling forces especially well in one direction. DRCT however has a very poor blood supply, which is why damaged tendons and ligaments are slow to heal.

[0048] The term marker, as referred to herein, is to be construed in a non-limiting manner, as including any physical markers, e.g. radio-opaque or breast lesions markers as defined in class A61 B90/39 of cooperative patent classification (CPC), markers specially adapted for marking specified tissue as defined in class A61 B2090/3904 of the CPC, markers for soft tissue as defined in CPC class A61 B2090/3908, ultrasonic markers as defined in CPC class A61 B2090/3925, active markers as defined in CPC class A61B2090/3929, magnetic markers, e.g. visible by NMR or MRI, as defined in CPC class A61B2090/3954, markers emitting a signal as defined in CPC class A61B2090/3958, radiopaque markers visible in an X-ray image as defined in CPC class A61 B2090/3966, electromagnetic other than visible, e.g. microwave, as defined in CPC class A61B2090/397, as well as multi-modality markers as defined in CPC class A61B2090/3995.

[0049] The term modality, as referred to herein, is to be construed in a non-limiting manner, as including a method or respective appliance of diagnosis performed using any of variety of techniques, for example, X-rays, computed tomographic (CT) X-ray imaging, ultrasound, and magnetic resonance (MR) imaging, or MRI.

[0050] The term modular, as referred to herein, should be construed as a stand-alone automated unit, removably connectable or forming a standardized unit that may be conveniently installed or deployed without significant impact to the components of an underlying system and/or component. The term modular, however, doesn’t necessarily means providing for ease of interchange or replacement. The term modular is optionally satisfied by providing for ease of at least onetime deployment or installation.

[0051] The term readily connectable, as referred to herein, should be construed as a standardized unit that may be conveniently connected. The term readily connectable, however, doesn’t necessarily means readily disconnectable or removable. The term readily connectable is optionally satisfied by providing for ease of at least onetime connection or coupling.

[0052] The terms matching and/or matchable as referred to herein is to be construed as a cross-sectional area and/or shape of one component is equal or essentially similar to a cross-sectional area and/or shape of another component.

[0053] The term structured as referred to herein is to be construed as including any geometrical shape, exceeding in complexity a plain linear shape or a shape embodying simple cylindrical, elliptical or polygonal contour or profile. A more complex shape, a plain linear shape or a shape embodying simple cylindrical, elliptical or polygonal contour or profile, constitutes an example of structured geometry.

[0054] The terms firm rigid, or stiff, as referred to herein, are to be construed as having rigidity modulus value, otherwise referred to as the shear modulus, of 4800 MPa or more. Materials are considered to be firm rigid, or stiff but not tensile, when such materials are incapable of being efficiently elastically flexed or bent. Stiff materials, such as steel, are defined as having rigidity modulus value well exceeding 4800 MPa.

[0055] The terms pliable or pliant, as referred to herein, are to be construed as having high tensile strength and capable of being efficiently elastically flexed or bent but not being resilient and incapable of being efficiently stretched or expanded. The term tensile or tensile strength, as referred to herein, is to be construed inter alia as a shortcut of the known term ultimate tensile strength, frequently represented acronym as UTS, meaning an intensive property of a material or structure to withstand loads tending to elongate, namely to resist tension, defined as the maximum stress that a material can withstand while been stretched or pulled before sustaining breaking, substantial deformation and/or necking before fracture, such as nylon, relating to essentially non-ductile materials, having UTS value ranging between about 600 and 1000 MPa or more, but not including rigid, firm or stiff materials.

[0056] The term “biasing means” or alike, as referred to herein, should be construed as including any material, structure or mechanism, configured to accumulate mechanical energy, by changing the configuration thereof, upon a force exerted thereon, such as a compressive, tensile, shear or torsional force, and for releasing the energy accumulated therein, by returning to the normal configuration thereof and by performing a mechanical work, typically by linear or radial displacement. Examples of “biasing means” in a non limiting manner include, springs, elastomers, leaf-springs, coil-springs, tension/extension spring, compression spring torsion spring, constant spring, variable spring, variable stiffness spring, flat spring, machined spring, serpentine spring, garter spring, cantilever spring, helical spring, hollow tubing springs, volute spring, V-spring, belleville washer or belleville spring, constant-force spring, gas spring, mainspring, negator spring, progressive rate coil springs, rubber band, spring washer and wave spring.

[0057] The term storage as referred to herein is to be construed as including one or more of volatile or non-volatile memory, hard drives, flash storage devices and/or optical storage devices, e.g. CDs, DVDs, etc. The term "computer-readable media" as referred to herein can include transitory and non-transitory computer-readable instructions, whereas the term "computer-readable storage media" includes only non-transitory readable storage media and excludes any transitory instructions or signals. The terms "computer-readable media" and "computer-readable storage media" encompass only a computer-readable media that can be considered a manufacture (i.e., article of manufacture) or a machine. Computer-readable storage media includes "computer-readable storage devices". Examples of computer-readable storage devices include volatile storage media, such as RAM, and non-volatile storage media, such as hard drives, optical discs, and flash memory, among others.

[0058] The term network, as referred to herein, should be understood as encompassing any type of computer and/or data network, in a non-limiting manner including one or more intranets, extranets, local area networks (LAN), wide area networks (WAN), wireless networks (WIFI), the Internet, including the world wide web, and/or other arrangements for enabling communication between the computing devices, whether in real time or otherwise, e.g., via time shifting, cashing, batch processing, etc.

[0059] By "operationally connected" and "operably coupled", as used herein, is meant connected in a specific way (e.g., in a manner allowing water to move and/or electric power to be transmitted) that allows the disclosed system and its various components to operate effectively in the manner described herein.

[0060] In the specification or claims herein, any term signifying an action or operation, such as: a verb, whether in base form or any tense, gerund or present/past participle, is not to be construed as necessarily to be actually performed but rather in a constructive manner, namely as to be performed merely optionally or potentially.

[0061] The term “substantially” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to being largely but not necessarily wholly that which is specified.

[0062] As used herein, the term “essentially” changes a specific meaning, meaning an interval of plus or minus ten percent (± 10%). For any embodiments disclosed herein, any disclosure of a particular value, in some alternative embodiments, is to be understood as disclosing an interval approximately or about equal to that particular value (i.e., ± 10%).

[0063] The term "essentially" further means that the composition, method or structure may include additional ingredients, stages and or parts, but only if the additional ingredients, the stages and/or the parts do not materially alter the basic and new characteristics of the composition, method or structure claimed.

[0064] As used herein, the term “about” or “approximately” modifies a particular value, by referring to a range equal to the particular value, plus or minus twenty percent (+/- 20%). For any of the embodiments, disclosed herein, any disclosure of a particular value, can, in various alternate embodiments, also be understood as a disclosure of a range equal to about that particular value (i.e. +1-20%). [0065] As used herein, the term “or” is an inclusive “or” operator, equivalent to the term “and/or,” unless the context clearly dictates otherwise; whereas the term “and” as used herein is also the alternative operator equivalent to the term “and/or,” unless the context clearly dictates otherwise.

[0066] It should be understood, however, that neither the briefly synopsized summary nor particular definitions hereinabove are not to limit interpretation of the invention to the specific forms and examples but rather on the contrary are to cover all modifications, equivalents and alternatives falling within the scope of the invention.

DESCRIPTION OF THE DRAWINGS

[0067] The present invention will be understood and appreciated more comprehensively from the following detailed description taken in conjunction with the appended drawings in which:

[0068] FIG 1A schematically illustrates, according to an embodiment, an anteroposterior view, of a tendon grasping device;

[0069] FIG 1B schematically illustrates, according to an embodiment, a lateral view, of a tendon grasping device;

[0070] FIG 1C schematically illustrates, according to an embodiment, a tendon grasped by a tendon grasping device in the loose state of grasping device; threaded onto a tendon;

[0071] FIG 1D schematically illustrates, according to an embodiment, a tendon grasped by a tendon grasping device in the contacting or grasping state of grasping device, contacting or grasping the tendon;

[0072] FIG 1E schematically illustrates, according to an embodiment, an anteroposterior view, of a first tendon stump reconnected with a second tendon stump by using a tendon grasping device;

[0073] FIG 1F schematically illustrates, according to an embodiment, a lateral view, of a first tendon stump reconnected and secured to a second tendon stump by using a tendon grasping device;

[0074] FIG 2A illustrates according to an embodiment anchoring of a device to a severed end of a tendon;

[0075] FIG 2B illustrates according to an embodiment anchoring of a tensioner to the tendon; [0076] FIG 2C illustrates according to an embodiment gripping of the adjustable self locking loop of the tensioner;

[0077] FIG 2D illustrates according to an embodiment approximating by pulling free ends of the tensioner;

[0078] FIG 2E illustrates according to an embodiment that repaired tendon where the desired approximation is achieved the free ends are cut;

[0079] FIG 3 is schematic view of a system for assisting or performing guided procedures that utilize an implantable set of proximity markers;

[0080] FIG 4 is a schematic diagram of an exemplary computing environment.

[0081] While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown merely by way of example in the drawings. The drawings are not necessarily complete and components are not essentially to scale; emphasis instead being placed upon clearly illustrating the principles underlying the present invention.

DETAILED DISCLOSURE OF EMBODIMENTS

[0082] Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of actual implementation are described in this specification. It should be appreciated that various features or elements described in the context of some embodiment may be interchangeable with features or elements of any other embodiment described in the specification. Moreover, it will be appreciated that for the development of any actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with technology- or business- related constraints, which may vary from one implementation to another, and the effort of such a development might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure.

[0083] In accordance with some embodiments of the present invention, reference is now made to FIG 1A and 1B, which schematically illustrate an anteroposterior and lateral view, respectively, of a tendon grasping device 10, configured to grasp a tendon stump. The tendon grasping device 10 comprises a series of a plurality of curved elements, in the embodiment of the FIG 1A and 1B, the curved elements are the loops 12, made of a thread and arranged sequentially, i.e. successively arranged and connected one after the other, in a flexible and deformable hollow tubular-like disposition to form a tubular-like structure, such as a cylinder-like structure having a first end and a second end. Such a structure may have any cross-section, for example a circular cross- section or an elliptical cross-section. The hollow structure is made of flexible material, so that the loops are deformable. In contrast to prior art devices, which are inserted into the tendon tissue in order to anchor a tendon stump to another tendon stump or to a bone, the tendon grasping device 10 of the present invention surrounds and tightly grasps the tendon, thus eliminating the damage that might be caused to the tendon tissue following the usage of prior art devices. A loop is a structural element of the tendon grasping device 10 extending along a path that crosses itself. Crossing may be affected by various ways, for example by intercrossing, using a connector, tying a knot, using a ring etc.

[0084] Alternatively, the tendon grasping device may comprise a series of coils that are arranged sequentially in a flexible hollow tubular-like structure having a first end and a second end. A coil is a structural element of the tendon grasping device 10 extending along a full turn of a helical path. A loop at one end of the coil facilitates the attachment of the coil to the tendon. The coil may be provided with loops at its two ends. The tendon grasping device 10 is made of any material known in the art suitable for surgery-compatible threads. According to one embodiment, the tendon grasping device 10 is made of a biocompatible material, for example biocompatible fibers. According to another embodiment, the tendon grasping device 10 is made of an absorbable (bio-degradable) biocompatible material. According to yet another embodiment, the tendon grasping device 10 is made of a non absorbable biocompatible material.

[0085] According to a preferred embodiment, the tendon grasping device 10 vis made of any suture thread material or suture string material known in the art, for example a biological material like silk; a synthetic absorbable (bio-degradable) material like polyglycolic acid, polylactic acid, monoacryl and polydioxanose; and a synthetic non-absorbable material like nylon, polyester, polyvinylidene difluoride and polypropylene. According to another preferred embodiment the tendon grasping device 10 is made at least partially from nitinol, i.e. nickel titanium or any other biocompatible alloy.

[0086] In accordance with some embodiments of the present invention, reference is now made to FIG 1C and 1D, schematically illustrate a tendon 500 grasped by a tendon grasping device 10 in the two major states: loose tendon grasping device 10A and contacting tendon grasping device 10B. FIG 1C schematically illustrates, according to an exemplary embodiment, an anteroposterior view of a loose tendon 500A inserted into a hollow cylinder-like structure defined by a loose tendon grasping device 10A. At this loose state, there is a gap between the loose loops 12 of the tendon grasping device 10A and the loose tendon 500A. Thus, a loose tendon 500A may be freely inserted into the hollow cylinder-like structure of the loose tendon grasping device 10A, allowing easy positioning of the loose loops 12 of tendon grasping device 10A along the loose tendon 500A.

[0087] Then, the loose tendon grasping device 10A is stretched until the loops 12 come in contact with the tendon 500B. In general, the tendon grasping device 10 deforms between a radially extended condition 10A, with the curved elements, i.e. the loop(s) or/and coil(s), being loose or partially loose around tendon 500A and a radially retracted condition 10B, with the curved elements 12, tightly grasping the tendon 500B. The radial direction is the direction perpendicular to the axis of the tendon, when the tendon grasping device 10 surrounds a tendon 500, or perpendicular to the longitudinal direction of the tendon grasping device 10.

[0088] FIG 1D schematically illustrates, an anteroposterior view of a contacted tendon 500B being in contact with a contacting tendon grasping device 10B. At the contact state, the contacted tendon 500B is slightly distracted due to a slight pressure exerted on the contacted tendon 500B by the contacting loops 10B of the contacting tendon grasping device 10B. Then, the contacting tendon grasping device 10B is stretched until the loops squeeze the tendon 500B.

[0089] FIG 1E and 1E schematically illustrate, according to an exemplary embodiment, an anteroposterior view and a lateral view, respectively, of a first tendon stump 501 reconnected with a second tendon stump 503 by using a tendon grasping devices 10- 1 and 10-2. The tendon grasping device 10-1 is configured to grasp the first tendon stump 501 and tendon grasping device 10-2 is configured to grasp he second tendon stump 503. When tendon grasping device 10-1 is held in close proximity to tendon grasping device 10- 1 by tighteners 20, the end of the first tendon stump 501 is held in close proximity to an end of the second tendon stump 503, until the first tendon stump 501 knits with the second tendon stump 503, and the gap 600 between the two tendon ends is enclosed, to form a healed tendon.

[0090] Referring now made to FIG 1A to 1E schematically show radiologic marker 30 and ultrasonic marker 32 associated with tendon grasping devices 10. Radiologic marker 30 is exemplarily shaped in a form of a bead, threaded onto loops 12 with tendon grasping devices 10. In some embodiments, radiologic marker 30 exemplarily shaped as a bead, is optionally movable along loops 12 of tendon grasping device 10. In other embodiments, radiologic marker 30 exemplarily shaped as a bead, is affixed to loop 12 of tendon grasping device 10. Ultrasonic marker 32 is exemplarily embedded within loops 12 of tendon grasping devices 10. In some embodiments, ultrasonic marker 32 exemplarily embedded within loops 12, is affixed within loop 12 of tendon grasping device 10. [0091] Examples of radiologic marker 30 in a non-limiting manner include an x-ray marker device for x-ray film wherein, comprising a unit-member fabricated from radiologically opaque material, such as a metal. Examples of radiologic marker 30 in a non limiting manner include a solid element registerable on at least two distinct imaging devices, comprising a first material, such as a metal, capable of functioning as a contrast agent for a first imaging modality, and a second material, such as a silicone-based polymer used in association with an MRI device, that functions as a contrast agent for a second imaging modality different from said first imaging modality.

[0092] Examples of radiologic marker 30 in a non-limiting manner include radio opaque material such as: titanium, gold, MP35N (R) material, including a nonmagnetic, nickel-cobalt-chromium-molybdenum alloy, or the like. In some examples, non-metallic polymeric materials can also be used, e.g., an acrylic, epoxy, polycarbonate, nylon, polyethylene, PEEK, ABS, or PVC or any thermoplastic elastomer or thermoplastic polyurethane that is fabricated to be visible under x-ray (e.g., embedded with barium).

[0093] Radiopaque materials and radiologic marker 30 may include metal objects such as clips, bands, strips, coils, and other objects made of radiopaque metal and metal alloys, and may also include powders or particulate masses of radiopaque materials. Radiopaque markers, such as marker 30, may have any suitable shape or size, and are normally shaped with a recognizable shape not found naturally within a patient's body, such as a star, square, rectangular, geometric, gamma, letter, coil or loop. Suitable radiopaque materials include stainless steel, platinum, gold, iridium, tantalum, tungsten, silver, rhodium, nickel, bismuth, radiopaque metals, alloys and oxides of these metals, barium salts, iodine salts, iodized materials, and combinations of these. The radiopaque materials and markers may be permanent, or they may be temporary and undetectable and/or dissolved after a period of time subsequent to their placement within a patient.

[0094] According to one embodiment, radiologic marker 30 is made of a biocompatible material, for example nitinol. According to another embodiment, radiologic marker 30 is made of an absorbable (bio-degradable) biocompatible material. According to yet another embodiment, radiologic marker 30 is made of a non-absorbable biocompatible material.

[0095] Examples of ultrasonic marker 32 in a non-limiting manner include bioabsorbable material suitable for temporarily marking a site inside a patient. Materials that implement features of the invention are detectable inside a patient, remain detectable for a period of time, and then are not detectable after the period of time. Such materials include bioabsorbable materials that are dissolved and absorbed in the body tissue at or near the biopsy site. Typically, such materials include a bioabsorbable polymer such as polylactic acid, polyglycolic acid, polycaprolactone, and copolymers, alloys, mixtures of these polymers, and combinations of these materials.

[0096] Normally, bio-absorbable polymeric materials suitable for use in the manufacture of ultrasonic detectable ultrasonic marker 32 have a density per unit volume of between about 0.8 g / ml and about 1.5 g / ml. Preferably, the bio-absorbable polymeric material with a density per unit volume after processing of less than about 1 g / ml, more preferably between about 0.8 g / ml and about 1 g / ml. Normally, an ultrasound detectable ultrasonic marker 32 should remain in place and be detectable inside a patient for several weeks to have a practical clinical value. Therefore, an ultrasonic detectable marker material that implements features of the invention is detectable at a biopsy site inside a patient for a period of at least several weeks, preferably at least about 20 weeks, and may remain detectable for a period of time of up to about 30 weeks, more preferably for a period of time of up to about 50 weeks. Optionally, an ultrasound detectable ultrasonic marker 32 material that implements features of the invention is not detectable approximately 6 months after placement. Optionally, an ultrasonic detectable marker material that implements features of the invention is not detectable by ultrasound approximately 30 weeks after being placed in a biopsy site. A preferred in vivo lifespan for an ultrasonic detectable biopsy marker mass having features of the invention is between about 6 weeks and about 50 weeks or more.

[0097] Examples of ultrasonic marker 32 in a non-limiting manner include materials that implement features of the invention may also include radiopaque materials or radiopaque elements, so that the detected both by ultrasound and X-ray or other imaging techniques. Alternatively or additionally, ultrasound-detectable materials of ultrasonic marker 32 that implement features of the invention may also include MRI-detectable materials or markers, so that the biopsy site can be detected both by ultrasound and by MRI or other imaging techniques. MRI contrast agents such as gadolinium and gadolinium compounds, for example, are suitable for use with ultrasonic detectable biopsy marker materials that implement features of the invention. Dyes, such as dyes (for example, methylene blue and carbon black) and pigments (for example, barium sulfate), may also be included in the ultrasound-detectable materials of ultrasonic marker 32 that implement features of the invention.

[0098] Radiologic marker 30-1 and/or ultrasonic marker 32-1 associated with tendon grasping devices 10-1 are utilized to assess the proximity to radiologic marker 30-2 and/or ultrasonic marker 32-2 associated with tendon grasping devices 10-2, using the monitoring device, as elaborated infra. [0099] In accordance with some embodiments of the present invention, reference is now made to FIG 2A to 2E, illustrates anchoring of device 100 on tendon 102. Referring to FIG 2A illustrates adjustable self-locking loops 200 and 240 of device 100 are positioned around the stump of tendon 102 and are tightened by drawing ends 160 and 220 while maintaining the relatively oval profile (cross-section) of the tendon. Adjustable self-locking loops 200 and 240 of device 100 include at least one marker. Optionally, self-locking loops 200 and/or 240 of device 100 include radiologic marker 300. Optionally, self-locking loops 200 and/or 240 of device 100 include ultrasonic marker 320. Optionally, self-locking loops 200 and/or 240 of device 100 include a combination of radiologic-ultrasonic marker 330.

[0100] Referring to FIG 2B illustrates anchoring of tensioner 500 to tendon 102. Using a needle (not shown), fixed loop 600 is threaded into and out of tendon 102 around loops 200 and 240 of device 100. Tensioner 500 includes a marker, exemplarily in-between fixed loop 600 and self-locking loop 640. Optionally, tensioner 500 includes a radiologic marker. Optionally, tensioner 500 includes an ultrasonic marker. Optionally, tensioner 500 includes a combination of radiologic-ultrasonic marker 330.

[0101] Referring to FIG 2C, following performing the above on both severed ends of tendon 102A and 102B, two needles 660 are inserted into and along the tendon to grip adjustable self-locking loop 640 of tensioner 500 and to pull it inside and over device 100. The loops of devices 100A and 100B include a marker. Optionally, loops of devices 100A and 100B includes a radiologic marker. Optionally, loops of devices 100Aand 100B include an ultrasonic marker. Optionally, loops of devices 100A and 100B include combined radiologic-ultrasonic markers 330A and 330B.

[0102] Referring to FIG 2D, following performing the above, the fixation system approximates ends 102A and 102B of the tendon in the direction of arrows 110 by pulling free ends 620 of tensioner 500. Optionally, he loops of the devices include combined radiologic-ultrasonic markers 330A and 330B. Distance D1 is defined as the distance between markers 330A and 330B. Distance D1 includes distance D2, which is defined as the gap between ends 102A and 102B of the tendon.

[0103] Referring to FIG 2E, when the desired approximation is achieved the free ends are cut and the tendon is now repaired as is shown. Distance D2 between ends 102A and 102B of the tendon is essentially equals about zero and interface 108 is formed between ends 102A and 102B. Distance D1 between markers 330A and 330B when distance D2 is essentially equals about zero, is defined as distance D3, which represent the optimal point of the recuperation onset and the reference for follow-ups monitoring. [0104] Referring to FIG 2A to 2E, as well as any other part of the disclosure herein, it should be acknowledged that any number and/or type of proximity markers, such as radiologic markers and/or ultrasonic markers, for example markers 300, 320 and/or 330, can furnish any end of a tendon or other DRCT, such as tendon ends 102A and 102B. The any number and/or type of proximity markers, that can furnish any end of a tendon or other DRCT, optionally face in different directions and/or are disposed on different portions or parts of the anchors or other constituents that are attached to the tendon or other DRCT. For example any number and/or type of proximity markers optionally furnish any portion of the loops of devices 100A and 100B shown in FIG 2C and or of tensioner 500 shown in FIG 2D, so that any number and/or type of proximity markers are disposed above, underneath, on the left side, the right side and/or within any end of tendon or other DRCT.

[0002] In accordance with some embodiments of the present invention, reference is now made to FIG 3 illustrates system 1000 for assisting or performing monitoring procedures. System 1000 is configured for detecting and/or identifying each one of the set proximity markers disposed on opposite ends of ruptured or otherwise cut Dense Regular Connective Tissue (DRCT), such as markers 330A and 330B, shown in FIG 2A to 2E. System 1000 is further configured for determining and/or calculating and/or visualizing distances, such as distance D1 between markers 330A and 330B, distance D2 of the gap between ends 102Aand 102B of the tendon, distance D3 between markers 330A and 330B when distance D2 is essentially equals about zero, as well as preferably monitoring the change in such distances, while the proximity markers and/or DRCT are in motion. System 1000 is yet further preferably configured for providing indications, useful for advising on a customized physiotherapy routine for the patient.

[0105] System 1000 may include computer element 1010, tracking device 1020, imaging device 1030, as well as other components. Computer element 1010 may include a processor 1040, a memory device 1050, a power source 1060, control application 1070, one or more software modules 1080, one or more inputs/outputs 1090, a display device 1100, a user input device 1110, as well as other components. In some embodiments, the processor 1040 is configured to perform the features and functions of the invention as described herein. Memory device 1050 or other memory or data storage elements or methods may store data or otherwise provide instructions to the processor 1040.

[0106] Computer element 1010 may be or include one or more servers, personal computers, laptop computers, mobile computers, tablet computers, or other computer devices. Computer element 1010 may receive, send, store, or manipulate data necessary to perform any of the processes, calculations, image formatting, image display, or other operations described herein. Computer element 1010 may also perform any processes, calculations, or operations necessary for the function of the devices, elements, instruments, or apparatus described herein.

[0107] In some embodiments, computer element 1010 may host a control application 1070. Control application 1070 may comprise a computer application which enables one or more software modules 1080. Software modules 1080 may enable processor 1040 to receive (e.g., via a data reception module), send, or manipulate data regarding the anatomy of a patient, one or more objects, or other data. This data may be stored in memory device 1050 or other data storage location. In some embodiments, software modules 1080 enable processor 1040 to receive live or stored data (e.g., via the data reception module), send, or manipulate data regarding the location, position, orientation, or coordinate of a position indicating element (e.g., sensor coils or other position indicating elements) received by position sensor 1020. This data may be stored in memory device 1050 or other data storage location.

[0108] In some embodiments, software modules 1080 enable processor 1040 to produce, format, or reformat one or more images, position/orientation/location data, or other data. Images may be displayed on a display device 1100. In some embodiments, processor 1040 displays one or more live images. In some embodiments, display device 1100 may display audio data in addition to or instead of visual data. Such an audio display may produce tones or other indicators regarding the system.

[0109] Software modules 1080, may enable the generation and display of images of the anatomy of the patient with the position or orientation of an instrument, a set of proximity markers or both superimposed thereon in real time (such that motion of the tracked instrument within the anatomy of the patient is indicated on the superimposed images) for use in image-guided recommendations for physiotherapy. In some embodiments, software modules 1080 enables processor 1040 to produce markings, lines, circles, spheres, letters, numbers or other indicators on an image of the anatomy of a patient. These markings may indicate features such as the boundaries of another image stored in memory device 1050.

[0110] Display device 1100 may include a computer monitor or other visual display device such as, for example, an LCD display, plasma screen display, cathode ray tube display, or other display device. Input device 1110 may include a mouse, a stylus, a keyboard, a touchscreen interface (which may be associated with or integrated with display device 1100), a voice activated input device (including a microphone and associated voice processing software), or other device wherein a user (e.g., a physician performing a procedure or assistant thereto) can provide input to system 1000 or its components. [0111] In some embodiments, tracking device 1020 may be used. It need not be directly operatively connected to computer element 1010, but data may be sent and received between tracking device 1020 and computer element 1010. Tracking device 1020 may include an electromagnetic tracking device, micropower impulse radar (MIR) or other radar device, optical range finder, a metal detector, an ultrasonic device, or other type of measurement device capable of determining the spatial distance between a proximity marker and tracking device 1020, while in motion. Tracking device 1020 may incorporate a radiofrequency identification (RFID) reader device. Tracking device 1020 may be used to obtain data regarding the three-dimensional location, position, coordinates, or other information regarding one or more proximity markers within or around an anatomical region of the patient, while in motion.

[0112] Probe 1120 may be operatively connected to computer element 1010 via input/output 109. Probe 1120 may include an electromagnetic tracking device, micropower impulse radar (MIR) or other radar device, optical range finder, a metal detector, an ultrasonic device, or other type of measurement device capable of determining the spatial distance between a proximity marker and the probe. Probe 1120A may incorporate a radiofrequency identification (RFID) device. Probe 1120 may be used to obtain data regarding the three-dimensional location, position, coordinates, or other information regarding one or more proximity marker elements 1130 within or around an anatomical region of the patient. Probe device 1120 may provide this data or information to computer element 1010.

[0113] Imaging device 1030 may include x-ray equipment, computerized tomography equipment, positron emission tomography equipment, magnetic resonance imaging equipment, fluoroscopy equipment, ultrasound equipment, an isocentric fluoroscopic device, a rotational fluoroscopic reconstruction system, a multislice computerized tomography device, an intravascular ultrasound imager, an optical coherence tomography (OCT) device, an optical imaging device, a single photon emission computed tomography device, a magnetic particle imaging device, or other imaging/scanning equipment.

[0114] Proximity marker element 1130 may include one or more of retroreflective devices, such as a "radar corner retroreflector," etc. Alternatively, proximity marker element 1130 may include simpler diffusely reflective surfaces that may produce a spatially broader reflective electromagnetic signal.

[0115] In an embodiment, metal detection technology may be employed so that proximity marker element 1130, which may be constructed from a metallic substance, can be detectable using one or more of the commonly used metal detection technologies that may include Very Low Frequency (VLF), Pulse Induction (PI) and/or Beat-frequency Oscillation (BFO). In this embodiment, a signal may be received by the receiver that indicates the distance and/or direction between the detector antenna or emitter and the proximity marker. In an embodiment the proximity marker element itself may not necessarily be made entirely of metal but may contain metal elements including coils and antennas within a metal or nonmetal housing. Proximity marker element 1130 may also contain elements such as a coil, inductive-capacitive (LC) or resitive-inductive-capacitive (RLC) circuit that may be tuned to resonate at a specific frequency that may be generated by the detector or is otherwise detectable by the detector. When using a plurality of sets of proximity markers, each may be tuned to a different frequency by appropriate modification of the R, L or C component of the circuit enabling the system to differentiate between them. Differentiation may also be achieved through appropriate design of the geometry of the proximity marker. This may also be achieved by manufacturing a set of proximity markers from different materials to assist in differentiating between them. In these cases, the conductivity or other properties may be slightly modified through the addition or change in the proportion of constituent elements. A set of proximity markers may be also made to contain different amounts of conductive material housed within a commonly sized carrier.

[0116] A set of proximity markers may be individualized by altering the size, shape, surface area, material, electrical, magnetic, thermal, optical, sonic, chemical, and other properties of all or part of each proximity marker that must be differentiated from another proximity marker. Non-limiting examples of properties of a set of proximity markers that may be altered (either alone or in combination with one another) in order to assist in differentiating individual or groups of a set of proximity markers from one another include changes to the proximity marker's electrical conductivity, electrical impedance, electrical capacitance, dielectric permittivity, magnetic inductance, magnetic susceptibility, magnetic permeability, diamagnetism, paramagnetic properties, gyromagnetic properties, ferromagnetic properties, reflectivity, absorptivity, transmissivity, polarization, spectral absorptivity, fluorescence, refractivity, or other detectable property of the proximity marker.

[0117] Proximity marker element 1130 may also be constructed as an RFID tag, in which an electromagnetic field is used to power the tag by electromagnetic induction. The tag may then act as a passive transponder to emit microwaves, UFIF radio waves or other signals. Proximity marker element 1130 may also include a local power source such as a battery to power it and allow it to send and receive signals.

[0118] In some embodiments, proximity marker elements 1130 may be placed on or integrated to be detectable by probe 1120, which may include integrated emitting and receiving components or as shown in 1120, these functions may be separated with emitter 112A separated from the receiving aspects of the probe 112B.

[0119] With reference to FIG 4, an exemplary system for implementing aspects described herein includes a computing device, such as computing device 400. In its most basic configuration, computing device 400 typically includes at least one processing unit 402 and memory 404. Depending on the exact configuration and type of computing device, memory 404 may be volatile (such as random access memory (RAM)), non-volatile (such as read-only memory (ROM), flash memory, etc.), or some combination of the two. This most basic configuration is illustrated in FIG 4 by dashed line 406.

[0120] Computing device 400 may have additional features/functionality. For example, computing device 400 may include additional storage (removable and/or non removable) including, but not limited to, magnetic or optical disks or tape. Such additional storage is illustrated in FIG 4 by removable storage 408 and non-removable storage 410.

[0121] Computing device 400 typically includes a variety of computer readable media. Computer readable media can be any available media that can be accessed by computing device 400 and include both volatile and non-volatile media, and removable and non-removable media. Computer storage media include volatile and non-volatile, and removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data. Memory 404, removable storage 408, and non-removable storage 410 are all examples of computer storage media. Computer storage media include, but are not limited to, RAM, ROM, electrically erasable program read-only memory (EEPROM), flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by computing device 400. Any such computer storage media may be part of computing device 400.

[0122] Computing device 400 may contain communications connection(s) 412 that allow the device to communicate with other devices. Computing device 400 may also have input device(s) 414 such as a keyboard, mouse, pen, voice input device, touch input device, etc. Output device(s) 416 such as a display, speakers, printer, etc. may also be included. All these devices are well known in the art and need not be discussed at length here.

[0123] It should be understood that the various techniques described herein may be implemented in connection with hardware or software or, where appropriate, with a combination of both. Thus, the processes and apparatus of the presently disclosed subject matter, or certain aspects or portions thereof, may take the form of program code (i.e., instructions) embodied in tangible media, such as floppy diskettes, CD-ROMs, hard drives, or any other machine-readable storage medium where, when the program code is loaded into and executed by a machine, such as a computer, the machine becomes an apparatus for practicing the presently disclosed subject matter.

[0124] Although exemplary implementations may refer to utilizing aspects of the presently disclosed subject matter in the context of one or more stand-alone computer systems, the subject matter is not so limited, but rather may be implemented in connection with any computing environment, such as a network or distributed computing environment.

Still further, aspects of the presently disclosed subject matter may be implemented in or across a plurality of processing chips or devices, and storage may similarly be effected across a plurality of devices. Such devices might include PCs, network servers, and handheld devices, for example. [0125] It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described herein above. Rather the scope of the invention is defined by the claims which follow:

Claims

1. A system for determining distances between proximity markers on opposite ends of a gap in a dense regular connective tissue comprising:

(a) at least one first tendon grasping device anchorable to a first terminal portion of a dense regular connective tissue;

(b) at least one second tendon grasping device anchorable to a second terminal portion of said dense regular connective tissue; wherein said first terminal portion of said dense regular connective tissue and said second terminal portion of said dense regular connective tissue disposed on opposite ends of a gap in said dense regular connective tissue;

(c) at least one first proximity marker, disposed on said at least one first tendon grasping device;

(d) at least one second proximity marker, disposed on said at least one second tendon grasping device;

(e) a monitoring appliance comprising:

(I) a computing device, configured to receive and process input data related to said proximity markers, disposed on said at least one first and second tendon grasping devices, comprising:

(i) at least one input terminal, configured to receive input data;

(ii) at least one software module, configured to process said input data;

(iii) a display device configured to display output of said input data processed by said at least one software module;

(II) at least one detection module operatively connected to said computing device selected from the group consisting of:

(i) a probe directly connected to said computing device, configured for detecting said proximity markers and collecting said input data;

(ii) a tracking device, not directly connected to said computing device, configured for, configured for detecting said proximity markers, collecting said input data and locally storing said input data;

(iii) an imaging device, configured for obtaining images of said proximity markers; said at least one detection module is configured for detecting and identifying each one of said proximity markers, disposed on said at least one first and second tendon grasping devices; said at least one detection module is further configured for collecting said input data related to said proximity markers and transmitting said input data to said computing device.

2. The system for determining distances between proximity markers, as in claim 1, wherein said at least one software module is further configured to process said input data, so as to calculate and/or visualize said distances, between said proximity markers, disposed on said opposite ends of said gap in said dense regular connective tissue, while said dense regular connective tissue is in motion.

3. The system for determining distances between proximity markers, as in any one of the claims 1 or 2, wherein said at least one software module is further configured to provide indications, implementable for advising on a physiotherapy routine.

4. The system for determining distances between proximity markers, as in any one of the claims 1 to 3, wherein said computing device of said monitoring appliance further comprises a microprocessor configured for calculating coordinates of said proximity markers, relative to a reference point.

5. The system for determining distances between proximity markers, as in any one of the claims 1 to 4, wherein said display device of said monitoring appliance is configured to display at least one output selected from the group consisting of: polygon, ruler, line, circle, indicia.

6. The system for determining distances between proximity markers, as in any one of the claims 1 to 5, wherein said computing device of said monitoring appliance further comprises a microprocessor configured for calculating a relative position of said proximity markers and/or distance between said proximity markers.

7. The system for determining distances between proximity markers, as in any one of the claims 1 to 6, wherein said display device of said monitoring appliance further comprises a visual display device selected from the group consisting of: an LCD display, a plasma screen display, cathode ray tube display, LED display, ELED display, QLED display, configured to present a graphical user interface (GUI) of said at least one software module of said monitoring appliance.

8. The system for determining distances between proximity markers, as in any one of the claims 1 to 7, wherein said tracking device is selected from the group consisting of: an electromagnetic tracking device, micropower impulse radar, optical range finder, metal detector, ultrasonic detection device.

9. The system for determining distances between proximity markers, as in any one of the claims 1 to 8, wherein said probe further comprises at least one device selected from the group consisting of: an electromagnetic tracking device, micropower impulse radar, optical range finder, metal detector, ultrasonic device.

10. The system for determining distances between proximity markers, as in any one of the claims 1 to 9, wherein said imaging device comprises at least one device selected form the group consisting of: an x-ray imaging device, computerized tomography device, positron emission tomography device, magnetic resonance imaging device, fluoroscopy device, ultrasound device, isocentric fluoroscopic device, rotational fluoroscopic reconstruction device, multislice computerized tomography device, intravascular ultrasound imager, optical coherence tomography (OCT) device, optical imaging device, single photon emission computed tomography device, magnetic particle imaging device.

11. A method of determining distances between proximity markers on opposite ends of a gap in a dense regular connective tissue comprising:

(a) providing at least one first tendon grasping device anchorable to a first terminal portion of a dense regular connective tissue;

(b) providing at least one second tendon grasping device anchorable to a second terminal portion of said dense regular connective tissue; wherein said first terminal portion of said dense regular connective tissue and said second terminal portion of said dense regular connective tissue disposed on opposite ends of a gap in said dense regular connective tissue;

(c) providing at least one first proximity marker, disposed on said at least one first tendon grasping device;

(d) providing at least one second proximity marker, disposed on said at least one second tendon grasping device;

(e) providing a monitoring appliance comprising:

(i) at least one input terminal, configured to receive input data;

(ii) at least one software module, configured to process said input data;

(i) a probe directly connected to said computing device, configured for detecting said proximity markers and collecting said input data; (ii) a tracking device, not directly connected to said computing device, configured for, configured for detecting said proximity markers, collecting said input data and locally storing said input data;

(iii) an imaging device, configured for obtaining images of said proximity markers;

(f) said at least one detection module is configured for detecting and identifying each one of said proximity markers, disposed on said at least one first and second tendon grasping devices;

(g) said at least one detection module is further configured for collecting said input data related to said proximity markers and transmitting said input data to said computing device.

12. The method of determining distances between proximity markers, as in claim 11, wherein said at least one software module is further configured to process said input data, so as to calculate and/or visualize said distances, between said proximity markers, disposed on said opposite ends of said gap in said dense regular connective tissue, while said dense regular connective tissue is in motion.

13. The method of determining distances between proximity markers, as in any one of the claims 11 or 12, wherein said at least one software module is further configured to provide indications, implementable for advising on a physiotherapy routine.

14. The method of determining distances between proximity markers, as in any one of the claims 11 to 13, further comprises calculating a relative position of and/or distance between said proximity markers.

15. The method of determining distances between proximity markers, as in any one of the claims 11 to 14, wherein said display device of said monitoring appliance is configured to display at least one output selected from the group consisting of: polygon, ruler, line, circle, indicia.

16. The method of determining distances between proximity markers, as in any one of the claims 11 to 15, further comprises calculating coordinates of said proximity markers, relative to a reference point.

17. The method of determining distances between proximity markers, as in any one of the claims 11 to 16, wherein said display device of said monitoring appliance further comprises a visual display device selected from the group consisting of: an LCD display, a plasma screen display, cathode ray tube display, LED display, ELED display, QLED display, configured to present a graphical user interface (GUI) of said at least one software module of said monitoring appliance.

18. The method of determining distances between proximity markers, as in any one of the claims 11 to 17, wherein said tracking device is selected from the group consisting of: an electromagnetic tracking device, micropower impulse radar, optical range finder, metal detector, ultrasonic detection device.

19. The method of determining distances between proximity markers, as in any one of the claims 11 to 18, wherein said probe further comprises at least one device selected from the group consisting of: an electromagnetic tracking device, micropower impulse radar, optical range finder, metal detector, ultrasonic device.

20. The method of determining distances between proximity markers, as in any one of the claims 11 to 19, wherein said imaging device comprises at least one device selected form the group consisting of: an x-ray imaging device, computerized tomography device, positron emission tomography device, magnetic resonance imaging device, fluoroscopy device, ultrasound device, isocentric fluoroscopic device, rotational fluoroscopic reconstruction device, multislice computerized tomography device, intravascular ultrasound imager, optical coherence tomography (OCT) device, optical imaging device, single photon emission computed tomography device, magnetic particle imaging device.

21. A computer-readable storage medium, having computer-executable instructions stored thereon which, when executed by a computer micro-processor of a system for determining distances between proximity markers:

(a) collecting imaging input data regarding proximity markers by an imaging device;

(b) detecting a first proximity marker of said proximity markers, disposed on at least one first tendon grasping device;

(c) identifying said first proximity marker of said proximity markers, disposed on said at least one first tendon grasping device;

(d) detecting a second proximity marker of said proximity markers, disposed on at least one second tendon grasping device;

(e) identifying said second proximity marker of said proximity markers, disposed on said at least one second tendon grasping device;

(f) calculating a distance between said first and said second proximity markers on said opposite ends of said gap in said dense regular connective tissue.

22. The computer-readable storage medium, as in claim 21 , further comprises computer- executable instructions for displaying output of said input data by a display device.

23. The computer-readable storage medium, as in any one of the claims 21 or 22, further comprises computer-executable instructions for processing said input data related to said proximity markers, disposed on said at least one first and second tendon grasping devices.

24. The computer-readable storage medium, as in any one of the claims 21 to 23, further comprises computer-executable instructions for causing said proximity markers to emit a signal indicative of their location relative to a probe in response to a signal transmitted by a probe.

25. The computer-readable storage medium, as in any one of the claims 21 to 24, further comprises computer-executable instructions for causing said proximity markers to reflect a signal by a reflective member of said proximity markers.

26. The computer-readable storage medium, as in any one of the claims 21 to 25, further comprises computer-executable instructions for causing said proximity markers to emit a signal by an emitting member of said proximity markers.

27. The computer-readable storage medium, as in any one of the claims 21 to 26, further comprises computer-executable instructions for processing said input data, so as to calculate coordinates of said proximity markers, relative to a reference point.

28. The computer-readable storage medium, as in any one of the claims 21 to 27, further comprises computer-executable instructions for processing said input data, so as to calculate a relative position of and/or distance between said proximity markers.

29. The computer-readable storage medium, as in any one of the claims 21 to 28, further comprises computer-executable instructions for processing said input data, so as to calculate and visualize said distances, between said proximity markers, disposed on said opposite ends of said gap in said dense regular connective tissue, while said dense regular connective tissue is in motion.

30. A method of determining distances between proximity markers on opposite ends of a gap in a dense regular connective tissue comprising:

(e) providing an imaging appliance configured for collecting imaging input data regarding proximity markers by an imaging device;

(f) providing a computing device configured for analyzing said imaging input data, so as to:

(I) detect a first proximity marker of said proximity markers, disposed on at least one first tendon grasping device;

(II) identify said first proximity marker of said proximity markers, disposed on said at least one first tendon grasping device;

(III) detect a second proximity marker of said proximity markers, disposed on at least one second tendon grasping device;

(IV) identify said second proximity marker of said proximity markers, disposed on said at least one second tendon grasping device;

(g) calculating a distance between said first and said second proximity markers on said opposite ends of said gap in said dense regular connective tissue.

31. The method of determining distances between proximity markers, as in claim 30, further comprises displaying processed output of said input data on a graphical user interface of a display device.

32. The method of determining distances between proximity markers, as in any one of the claims 30 or 31 , further comprises processing said input data related to said proximity markers, disposed on said at least one first and second tendon grasping devices.

33. The method of determining distances between proximity markers, as in any one of the claims 30 to 32, further comprises emitting by said proximity markers a signal indicative of their location.

34. The method of determining distances between proximity markers, as in any one of the claims 30 to 33, further comprises storing said imaging input data.

35. The method of determining distances between proximity markers, as in any one of the claims 30 to 34, further comprises reflecting a signal by a reflective member of said proximity markers.

36. The method of determining distances between proximity markers, as in claim 30, further comprises calculating and/or visualizing said distances, between said proximity markers, disposed on said opposite ends of said gap in said dense regular connective tissue, while said dense regular connective tissue is in motion.

37. A kit-of-parts implementable for determining distances between proximity markers on opposite ends of a gap in a dense regular connective tissue comprising: (a) at least one first tendon grasping device anchorable to a first terminal portion of a dense regular connective tissue;

(b) at least one second tendon grasping device anchorable to a second terminal portion of said dense regular connective tissue; wherein said first terminal portion of said dense regular connective tissue and said second terminal portion of said dense regular connective tissue are disposable on opposite ends of a gap in said dense regular connective tissue; in combination with:

(d) at least one second proximity marker, disposed on said at least one second tendon grasping device; wherein a detection module of a monitoring appliance is configured for detecting and identifying each one of said proximity markers, disposable on said at least one first and second tendon grasping devices; wherein said detection module is further configured for collecting input data related to said proximity markers and transmitting said input data to a computing device of said monitoring appliance.

38. The kit-of-parts implementable for determining distances between proximity markers, as in claim 37, wherein said distances, between said proximity markers, disposed on said opposite ends of said gap in said dense regular connective tissue, are calculable while said dense regular connective tissue is in motion.

39. The kit-of-parts implementable for determining distances between proximity markers, as in any one of the claims 37 or 38, wherein said markers are selected from the group consisting of: an electromagnetic trackable marker, micropower impulse radar trackable marker, optical range finder trackable marker, metal detector trackable marker, ultrasonically trackable marker.

40. The kit-of-parts implementable for determining distances between proximity markers, as in any one of the claims 37 or 39, wherein said markers are selected from the group consisting of: an x-ray imaging trackable marker, computerized tomography trackable marker, positron emission tomography trackable marker, magnetic resonance imaging trackable marker, fluoroscopy trackable marker, ultrasonically trackable marker, isocentric fluoroscopic trackable marker, rotational fluoroscopic reconstruction trackable marker, multislice computerized tomography trackable marker, intravascular ultrasound imager trackable marker, optical coherence tomography (OCT) trackable marker, optical imaging trackable marker, single photon emission computed tomography trackable marker, magnetic particle imaging trackable marker.