WO2024057311A1

WO2024057311A1 - Needle system

Info

Publication number: WO2024057311A1
Application number: PCT/IL2023/050987
Authority: WO
Inventors: Liraz SHLOMOFF; Yakov NEDLIN; Matan Yakov ELBAZ; Ofer VIKINSKY
Original assignee: Marrow Wiz Ltd.
Priority date: 2022-09-13
Filing date: 2023-09-12
Publication date: 2024-03-21

Abstract

The present invention is of a needle system comprising: a flexible needle; and a drill bit guiding device; wherein the needle system is configured for bone marrow collection or for administration of one or more substances into the bone.

Description

NEEDLE SYSTEM

FIELD OF THE INVENTION

[0001] The present invention relates to a needle system. Moreover, the present invention is of a system featuring a flexible needle.

BACKGROUND OF THE INVENTION

[0002] In bone marrow aspiration and bone marrow biopsy a needle is usually inserted into the bone and fluid or a more solid portion depending on the procedure, is withdrawn. Bone marrow can be analyzed to monitor and diagnose blood disorders. The collected bone marrow can also be used therapeutically, such as in a transplant to treat blood cancers. In addition, bone marrow and components thereof, such as stem cells have found use in cosmetics and in hair transplants.

[0003] A problem associated with the aspiration needles of the art and methods of use thereof, is that common aspiration needles collect relatively small amount of marrow from a tibia bone comparatively to hip bone marrow aspiration although it is less painful and more accessible. Further, common aspiration devices access perpendicularly to the bone and collect marrow from a single position. Collection from multiple positions in the center of the bone and parallel to the length of the bone should result in larger volume of aspirated bone marrow.

[0004] It would be desirable to have an aspiration needle which is flexible. It would be beneficial to have a flexible aspiration needle which could be guided along the desired portion of the inner part of the bone. The present invention provides such a needle system and method of use thereof. SUMMARY

[0005] The invention may have several aspects.

[0006] In an aspect, the invention provides a needle system comprising: a flexible needle; and a drill bit guiding device; wherein the needle system is configured for bone marrow aspiration or for administration of one or more substances into the bone.

[0007] In one or more embodiments, the flexible needle comprises: a flexible hollow shaft, the shaft comprising a plurality of spaced apart openings along the length of the shaft; a distal end comprising a rigid, sharp tip configured to penetrate the marrow cavity of the bone; and a proximal end configured to connect to a syringe.

[0008] In one or more embodiments, the hollow shaft comprises a flexible portion manufactured from a material selected from at least one of a metal, and a polymeric material.

[0009] In one or more embodiments, the polymeric material is selected from PEEK, PTFE, silicone, and polyethylene.

[0010] In one or more embodiments, the metal is selected from stainless steel, nitinol, and titanium.

[0011] In one or more embodiments, the flexible needle is disposable.

[0012] In one or more embodiments, the needle has a bending radius of less than about the diameter of the bone.

[0013] In one or more embodiments, the flexible needle adopts various geometric forms when entering the bone such as a spiral configuration, or a pigtail form.

[0014] In one or more embodiments, the length of the flexible needle is at least about 6 cm.

[0015] In one or more embodiments, the plurality of openings is configured to allow bone marrow aspiration through each aperture. [0016] In one or more embodiments, the needle is a suction needle.

[0017] In one or more embodiments, a suction force is provided to the needle by pulling the plunger of the syringe in a direction out of the barrel of the syringe.

[0018] In one or more embodiments, the pulling can be done manually or electronically.

[0019] In one or more embodiments, the needle is configured to prevent kinks in the shaft.

[0020] In one or more embodiments, the needle is attached to the syringe via a Luer lock connection.

[0021] In one or more embodiments, the needle is reversibly attached to the drill bit guiding device.

[0022] In one or more embodiments, the shaft of the needle comprises markings indicating the length of the needle for determining the length of the needle inserted into a bone.

[0023] In one or more embodiments, the system further comprises a drilling tool comprising a motor for powering the drill bit guiding device.

[0024] In one or more embodiments, the drill bit guiding device comprises: a guiding device hub configured to attach to the drilling tool and comprising a needle entry port; and a cannula comprising a longitudinal body configured to accommodate the flexible needle, the cannula comprises a closed cutting distal tip and a side aperture for allowing exit of the needle through the side aperture.

[0025] In one or more embodiments, the guiding device hub of the drill bit guiding device is configured to externally sit about a site of penetration into the bone by the needle.

[0026] In one or more embodiments, the closed solid cutting tip is configured to prevent the needle from proceeding distally perpendicular to the first cortex and the second cortex of the bone and wherein the side aperture facilitates deflecting the needle from the path defined by the cannula through the side aperture so that the needle is parallel to the first cortex and the second cortex of the bone.

[0027] In one or more embodiments, the hub of the drill bit guiding device comprises a needle entry port that is in the same longitudinal line of the cannula, facilitating an initial insertion of the flexible needle perpendicular to the bone.

[0028] In one or more embodiments, the hub of the drill bit guiding device comprises a needle entry port that is at an angle with respect to the longitudinal line of the cannula, facilitating an initial insertion of the flexible needle at an angle of less than 180° to the bone.

[0029] In one or more embodiments, the hub of the drill bit guiding device comprises a needle entry port that is at an angle with respect to the longitudinal line of the cannula, facilitating an initial insertion of the flexible needle at an angle of less than 90° relative to the longitudinal axis of the bone.

[0030] In one or more embodiments, the drill bit guiding device comprises a drill bit and wherein the hollow shaft of the flexible needle is configured to receive and hold the drill bit within the lumen of the shaft of the flexible needle.

[0031] In one or more embodiments, the drill bit is made from a shape memory alloy and adopts a bent configuration at body temperature.

[0032] In one or more embodiments, the flexible needle adopts the configuration of the drill bit.

[0033] In one or more embodiments, the flexible needle is made from a shape memory alloy and adopts the configuration of the drill bit.

[0034] In one or more embodiments, the guiding device is configured to cut through the bone.

[0035] In one or more embodiments, the guiding device is disposable. [0036] In one or more embodiments, the bone marrow is from the tibia.

[0037] In one or more embodiments, the at least one substance is at least one of bone marrow, blood, stem cells, platelets and a drug.

[0038] In another aspect the invention provides a needle system comprising a drill bit guiding device configured to drill through and anchor a bone, the drill bit guiding device comprising a cannula comprising a longitudinal body configured to accommodate a flexible needle, the cannula comprises a closed cutting distal tip and a side aperture facilitating an exit port for the needle, wherein the side aperture facilitates deflecting the needle from the path defined by the cannula through the side aperture so that the needle is parallel to a first cortex and a second cortex of a bone.

[0039] In yet another aspect the invention provides a method of assembling a needle system comprising: providing a flexible needle; providing a drill bit guiding device of the present invention; drilling a hole into a bone using a drilling tool and said drill bit guiding device; removing the drilling tool and keeping the drill bit in the bone; inserting the flexible needle into the cannula of the drill bit; attaching a syringe to the proximal hub of the needle; and collecting bone material from within a marrow cavity of the bone or administering one or more substances into the bone.

[0040] In one or more embodiments, inserting comprises inserting a length of at least 5 cm of needle within the bone. [0041] In one or more embodiments, the method further comprises providing a suction force to the flexible needle, and suction bone marrow through a plurality of openings in the flexible needle and into a barrel of the syringe.

[0042] In one or more embodiments, the providing a suction force comprises pulling the plunger in a direction out of the barrel.

[0043] In one or more embodiments, the pulling of the plunger is done manually.

[0044] In one or more embodiments, the bone material is at least one of bone marrow, blood, stem cells, platelets and a drug.

[0045] In yet another aspect the invention provides a method of bone marrow aspiration comprising: inserting a drill bit through the lumen of the flexible needle of the system of the present invention, so that the tip of the drill bit protrudes out of the tip of the needle; attaching a drill to the proximal end of the drill bit; attaching a guiding device to the target area of a patient, the guiding device comprising an access hole; inserting the flexible needle with the drill bit therein of the system of the herein invention through the access hole of the guiding device; drilling a hole at the target body area positioned at the access hole of the guiding device; and heating the drill bit by the body temperature to facilitate bending of the drill bit and bending of the flexible needle of the system of claim 25 to align the needle to be positioned parallel to the bone marrow channel. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] The various features of the invention will best be appreciated by simultaneous reference to the description which follows and the accompanying drawings, which are not drawn to scale and in which:

[0047] FIG. 1 is a perspective view of an exemplary needle system according to an aspect of the present invention;

[0048] FIG. 2 is a side view of an exemplary needle having a flexible metal shaft according to an aspect of the present invention;

[0049] FIG. 3 is a perspective view of an exemplary needle having a flexible polymeric shaft according to an aspect of the present invention;

[0050] FIG. 4A is a perspective view of an exemplary drill bit guiding device having an exemplary square form drilling tool interface according to an aspect of the present invention;

[0051] FIG. 4B is a cross section side view of an exemplary drill bit guiding device of FIG. 4a according to an aspect of the present invention;

[0052] FIG. 5A is a perspective view of an exemplary drill bit guiding device having an exemplary AO form drilling tool interface according to an aspect of the present invention;

[0053] FIG. 5B is a side view of an exemplary drill bit guiding device of FIG. 5a according to an aspect of the present invention;

[0054] FIG. 6 is a perspective view of an exemplary drilling tool device with a drill bit guiding device attached thereto according to an aspect of the present invention;

[0055] FIG. 7A is a perspective view of an exemplary drill bit guiding device with a needle inserted therethrough according to an aspect of the present invention; [0056] FIG. 7B is a side view of an exemplary drill bit guiding device with a needle inserted therethrough according to an aspect of the present invention;

[0057] FIG. 8 is a perspective view of an exemplary syringe attached to a needle that is inserted within a drill bit guiding device according to an aspect of the present invention;

[0058] FIG. 9 is a cross section view of a distal section of an exemplary syringe attached to a needle that is inserted within a drill bit guiding device according to an aspect of the present invention;

[0059] FIG. 10 is a cross section view of an exemplary drill bit guiding device with a needle entry port that is in the same longitudinal line of the cannula, according to an aspect of the present invention;

[0060] FIG. 11 is a cross section view of an exemplary drill bit guiding device with a needle entry port that is at an angle with respect to the longitudinal line of the cannula, according to an aspect of the present invention;

[0061] FIGs. 12A-12C are side views of an exemplary drill bit and a needle, according to an aspect of the present invention;

[0062] FIGs. 13A-13B are perspective views of an exemplary drill bit with a needle and a guiding tool to guide a user to an access point for entry to a bone wherein the guiding tool has an angled port, according to an aspect of the present invention;

[0063] FIGs. 14A-14C are perspective views of the needle coupled to the guiding tool of FIGs. 13A-13B wherein the needle is attached to a syringe, according to an aspect of the present invention; and

[0064] FIG. 15 is a flow chart of an exemplary method of using an exemplary needle system according to an aspect of the present invention. DETAILED DESCRIPTION

[0065] In one aspect the present invention is of a flexible needle system. The needle system may be configured for aspiration of bone marrow. In a further aspect, the present invention provides a method of using the needle system of the present invention to extract a component from within a bone. In a still further aspect, the present invention provides a method of using the needle system of the present invention to administer at least one substance to a bone.

[0066] The needle system and methods of use thereof of the present invention have many advantages. The system provides a method of collecting a bone component from a plurality of positions parallel to the first cortex and second cortex of a bone, which may provide optimized bone marrow collection. The guidance of the needle away from the second cortex of the bone prevents damage to the second side of the bone and avoids extraction of undesired components. It is advantageous to employ a reconfigured drilling device as a guiding system for the needle to obviate the need for use of additional components and thereby minimizing the risk of infection associated with introduction of each instrument into the bone.

[0067] As used herein the term “"shape memory alloy" (SMA) refers to an alloy that displays thermoelastic martensitic transformation property. This property is defined as the ability to undergo a reversible transformation from an Austenite to a Martensite with a change in temperature such that an article made from such alloy has a heat stable configuration and is capable of being deformed to a heat unstable position.

[0068] According to one embodiment, the shape memory alloy comprises nickel-titanium (a.k.a. NiTi, nitinol). The shape memory alloy may comprise other metals, for example, the shape memory alloy may be an iron-based or a copper-based alloy. Further suitable shape memory alloys according to some embodiments of the present invention include, but are not limited to, ternary or quaternary alloy (e.g., copper-aluminum-nickel). The SMA may comprise a combination of at least two metals selected from: zinc, copper, gold, iron, titanium and nickel. The SMA may be based on NiTi alloy and may further include one or more additional alloying elements, including, but not limited to Al, Ag, Au, Cu, Fe, Ga, Ir, Nb, Pd, Pt, Rh, Ta5 or W.

[0069] As used herein the term "Austenitic state" refers to the stronger, higher temperature phase (crystal structure) present in a shape-memory alloy. Austenite start temperature “As" refers to the temperature at which a shape memory alloy starts transforming martensite to austenite upon heating. Austenite finish temperature “Af ' refers to the temperature at which a shape memory alloy finishes transforming martensite to austenite upon heating. According to some embodiments, the transition temperature is an Af temperature.

[0070] As used herein the term "Martensitic state" refers to the more deformable, lower temperature phase (crystal structure) present in a shape-memory alloy. “Ms” and “Mf ’ are the temperatures at which the transition to martensite starts and finishes upon cooling, respectively.

[0071] As used herein the term “one way shape-memory alloy" means that in the soft state, the alloy is plastic and can be bent, squeezed or stretched and will retain its deformed shape until heated to or above the transition temperature. Upon heating, the shape recovers its original configuration.

[0072] As used herein the term “Transition temperature” refers to the temperature at which the material transforms from one state to another state. The term “Transition temperature” is interchangeable with the terms “transformation temperature”, and “critical temperature”. According to some embodiments, the transition temperature refers to the temperature at which the material transforms from the Martensitic state to the Austenitic state.

[0073] As used herein the terms ‘a’ and ‘an’ may mean ‘one’ or ‘more than one’.

[0074] As used herein the terms ‘comprising’, ‘including’, ‘containing’, ‘featuring’, ‘having’ and any forms of the terms thereof are inclusive and open ended and do not exclude additional elements or method steps, which are not recited. [0075] The term 'consisting essentially of’ as used herein means that the scope is limited to the specified elements and those that do not materially affect the basic and novel characteristic(s) of the claimed device and materials.

[0076] Each of the phrases 'consisting of and 'consists of, as used herein, means 'including and limited to'.

[0077] The term 'method', as used herein, refers to steps, procedures, manners, means, or/and techniques, for accomplishing a given task including, but not limited to, those steps, procedures, manners, means, or/and techniques, either known to, or readily developed from known steps, procedures, manners, means, or/and techniques, by practitioners in the relevant field(s) of the disclosed invention.

[0078] Throughout this disclosure, a numerical value of a parameter, feature, characteristic, object, or dimension, may be stated or described in terms of a numerical range format. Such a numerical range format, as used herein, illustrates implementation of some exemplary embodiments of the invention, and does not inflexibly limit the scope of the exemplary embodiments of the invention. Accordingly, a stated or described numerical range also refers to, and encompasses, all possible sub-ranges and individual numerical values (where a numerical value may be expressed as a whole, integral, or fractional number) within that stated or described numerical range. For example, a stated or described numerical range 'from 1 to 6' also refers to, and encompasses, all possible sub-ranges, such as 'from 1 to 3', 'from 1 to 4', 'from 1 to 5', 'from 2 to 4', 'from 2 to 6', 'from 3 to 6', etc., and individual numerical values, such as T, '1.3', '2', '2.8', '3', '3.5', '4', '4.6', '5', '5.2', and '6', within the stated or described numerical range of 'from 1 to 6'. This applies regardless of the numerical breadth, extent, or size, of the stated or described numerical range.

[0079] All ranges disclosed herein include the endpoints. The use of the term “or” shall be construed to mean “and/or” unless the specific context indicates otherwise. [0080] The term 'about', in some embodiments, refers to ±30 % of the stated numerical value. In further embodiments, the term refers to ±20 % of the stated numerical value. In yet further embodiments, the term refers to ±10 % of the stated numerical value.

[0081] As used herein the term "distal" refers to the part of the herein device which, when in use, is located farthest from the center of the body of the user/surgeon/practitioner.

[0082] As used herein the term "proximal" refers to the part of the herein device which, when in use, is located closest to the center of the body of the user/surgeon/practitioner.

[0083] The principles and operation of a needle system, as well as methods of use thereof according to the present invention may be better understood with reference to the figures. The figures show non-limiting aspects of the present invention.

[0084] The present invention provides a needle system. The needle system may be used for bone marrow aspiration. The needle system may include a flexible needle and a drill bit guiding device.

[0085] Figure 1 shows an exemplary needle system 100 according to an aspect of the present invention. The system 100 includes a drill bit guiding device 113, and a needle 101. The system 100 may further include a syringe 107, and drilling tool 103. The drilling tool 103 and the guiding device 113 are used to drill a hole in a bone through an external access point. The guiding device 113 is used to allow access to needle 101 so it can be inserted therethrough and reach the marrow cavity of the bone in a position that is parallel to the bone cortex. The syringe 107 and needle 101 are used to aspirate bone material from within a bone, such as from a marrow cavity.

[0086] Figure 2 shows an exemplary needle 101 according to an aspect of the present invention. [0087] Figures 3 shows an exemplary needle 201 according to an aspect of the present invention.

[0088] The needles 101/201 include a needle shaft 108/208 which may have a rigid smooth portion 109/209 and a flexible portion 110/210. The flexible portion 110 of shaft 108 may be constructed from a flexible material. Suitable materials include but are not limited to at least one metal (e.g., metal alloy such as nitinol, pattern-laser-cut stainless-steel tubes). The metal may be a biocompatible material. The material used may be kink resistant to avoid kinks in needle 101. The flexible portion 210 of shaft 208 may be constructed from a flexible material. Suitable materials include but are not limited to at least one of polymeric material (e.g., silicone, Polyether ether ketone (PEEK), Polytetrafluoroethylene (PTFE), and polyethylene). The materials may be produced as a braid or as woven metal tubing. The polymeric material may be a biocompatible material. The material used may be kink resistant to avoid kinks in needle 201.

[0089] The following description will refer to needle 101 for avoiding redundancy, but contemplates any suitable alternative- needles such as, but not limited to needle 201.

[0090] The bending radius of needle 101 may be between about one third to two thirds of the average diameter of the bone in which the needle 101 is to be used. The shaft 108 may be hollow with a cavity, which is configured to hold a substance which has been extracted from the bone or is to be administered to the bone. Shaft 108 may have any suitable dimensions. A suitable length may be determined according to the length of the target bone. In some embodiments the length of the shaft 108 may be from about 6 cm to about 15 cm. For example, the length of the shaft may be at least about 6 cm, 7 cm, 8 cm, 9 cm, or 10 cm. Each possibility represents a separate embodiment of the invention. In some embodiments the length of the shaft 108 may be up to about 15 cm. In some embodiments, the length of the shaft 108 may include not less than ten centimeters (cm) of active suction length. The length of shaft 108 may have a suitable diameter for sufficiently extracting a substance from the bone. The diameter of shaft 108 may be from about 1.5 millimeters (mm) to about 4 mm. The length or a portion thereof of shaft 108 may have a thickness of from about 0.05 mm to about 0.3 mm. Shaft 108 may include one or more side opening 136 through which a substance can be extracted from a bone or administered to the bone. Shaft 108 may include a plurality of openings 136 along the length of shaft 108. Opening 136 may provide an opening into the cavity of shaft 108. Each of the plurality of openings 136 may be configured for extraction or administration of a substance from or to a bone respectively and into or out of the needle cavity. The plurality of openings 136 may be spaced apart from each other. The openings 136 may be evenly spaced or spaced at different uneven distances. The openings 136 may have a size of from about 0.5 square mm to about 5 square mm, with a variety of geometries. Optionally rigid portion 109 may not include openings 136 to avoid collection of non-desired substances or negatively affecting suction pressure. The length of portion 109 of shaft 108 may be from about 2 cm to about 5 cm. For example, the length of portion 109 of shaft 108 may be at least about 2. For example, the length of portion 109 of shaft 108 may be up to about 5 cm. The shaft 108 of the needles 101 may include markings which can be, for example, every 1 cm from the distal end indicating the measurement of the length of the needles 101 at that marked point. Such markings may be used to determine the depth of shaft 108 and the length of the shaft 108 being employed to extract or administer a substance from or to a bone. The proximal end 102 of the needle 101 may be configured for attaching to a syringe 107 (figure 1). The proximal end 102 of the needle 101 may include a needle hub 111 for connecting within a syringe 107 such as, but not limited to a corresponding part of a Luer lock of a syringe 107. The distal end 122 of the needle 101 may include a tip 146. Tip 146 may be configured to be sufficiently sharp, strong and/or rigid to cut through bone or facilitate the needle insertion into the in-bone medium. Tip 146 may be constructed from the tube itself, cut to the desired shape, or, in another embodiment, from welded rigid drilling tip made of appropriate metal. Tip 146 may be blunt. Tip 146 may include a distal opening (not shown). Alternatively, tip 146 may be closed. Needle 101 may be disposable. Needle 101 may be for one time use. Needle 101 may be reusable. The distal tip 146 may be jagged 246 for easier insertion through the in-bone soft tissue, as shown for example in figure 3.

[0091] Figures 4 and 5 show exemplary drill bit guiding devices 113/213 according to an aspect of the present invention.

[0092] Figures 4A-4B show a guiding device 113 according to an aspect of the present invention. The guiding device 113 includes a square form drilling tool interface 104 within guiding device hub 112. The square form drilling tool interface 104 is immersed within guiding device hub 112.

[0093] Figures 5A-5B show a guiding device 213 according to an aspect of the present invention. The guiding device 213 includes an Association for Osteosynthesis (AO) connection drilling tool interface 204 within guiding device hub 212. The AO connection extends proximally from guiding device hub 212 and features a tubelike form.

[0094] The following description will refer to guiding device 113 for avoiding redundancy, but the herein invention contemplates any suitable additional guiding devices such as, but not limited to guiding device 213.

[0095] The guiding device 113 may be made from any suitable material. In some embodiments, the guiding device 113 is constructed from a metal. The guiding device 113 may include a drilling tool interface 104 within a guiding device hub 112, and a cannula 105. Interface 104 may be configured to connect to a drilling tool 103. The drilling tool 103 may be attached to the guiding device 113 in any suitable way such as via a quick connect interface 104. Cannula 105 may include a sharp distal tapered guiding device tip 182 which is configured to facilitate drilling of the bone from the outside the body of a patient. The guiding device tip 182 may be closed to avoid entry of a needle 101/201 in a perpendicular configuration. Cannula 105 may also include a side aperture 184 that guides a needle such as needlei 01 and 201 of the present invention into a bone and into a position that is substantially parallel to a bone. By “side aperture” it is meant to refer to an opening located on a wall of the cannula 105 and not at the edge/tip thereof. The aperture may feature a circular or any other opening shape. Un an embodiment, the aperture is sized such that it allows exit of at least the flexible section 110. For example, the aperture 184 may have a dimeter that is above the diameter of at least the flexible section 110. For example, the diameter of the aperture 184 is above 1.5 mm, 2 mm, 3 mm, 3.5 mm, or 4 mm. Each possibility represents a separate embodiment of the invention.

[0096] Figure 6 shows an exemplary drilling tool 103 attached to a guiding device 113 according to an aspect of the present invention. A suitable incision and site of entry may be formed using any suitable device, such as a surgical scalpel. In some embodiments, the guiding device 113 is also configured as at least part of the bone drilling tool 103. In some embodiments, the guiding device 113 features at least part of a surgical drilling tool 103. The drilling tool 103 may include at a distal end thereof a drill connector 114 that can suitably engage interface 104. The drilling tool 103 may have any suitable speed and torque. In one non-limiting example the drilling tool 103 may have a load speed of about 150 rpm (revolutions per minute) and a load torque of about 0.7 Nm.

[0097] Figures 7A-7B show an exemplary guiding device 113 and an exemplary needle 101 inserted therethrough. After the guiding device 113 anchors a bone, the needle 101 can be inserted thereto through needle entry port 115 (shown for example in figures 4A and 4B) of guiding device 113 and extend into the cannula 105. By pushing the needle 101 distally into cannula 105. Since guiding device tip 182 is closed, the needle can only exit the guiding device 113 from aperture 184 (figure 4B) and extends into a marrow cavity and into a position substantially parallel to a bone.

[0098] Figure 8 shows an exemplary needle 101 extending from guiding device 113 and when attached to a syringe 107 according to an aspect of the present invention.

[0099] Figure 9 shows a cross section of a distal portion of an exemplary needle 101 attached to a syringe 107 according to an aspect of the present invention. [00100] The syringe 107 may be any suitable syringe, which can be used to collect a component from the bone or administer at least one substance to the bone. The syringe 107 may include a barrel 150 for accommodating a substance. The substance may be a substance extracted using the syringe 107, or a substance to be administered to the bone with the syringe 107. A plunger 152 may be connected to barrel 150, for providing a pushing or suction force to the attached needle 101 depending on which way the barrel 150 is maneuvered. When plunger 152 is pulled out of the barrel 150 a suction force is applied to an attached needle 101. When plunger 152 is pushed into the barrel 150 a pushing force is applied to the attached needle 101. The plunger 152 may be moved manually. In some embodiments, plunger 152 may be automatically moved proximally or distally in relation to the needle 101 according to the required applied force. The syringe 107 may include a connection means 114 at a distal end thereof for attachment to a needle 101. One non limiting example of a suitable connection means 114 is a Luer lock, which is configured to attach to hub 111 of needle 101. When the flexible needle 101 of the present invention is attached to the syringe 107, an unobstructed channel may be formed extending from the interior of the barrel 150 through the lumen of the needle 101 to the tip 146 of the needle 101. The syringe 107 may be disposable. The syringe 107 may be reusable.

[00101] As shown in Figure 10, cannula 105 may facilitate an insertion into a bone B between the first cortex Cl and the second cortex C2 of the bone B. Cannula 105 may form a channel that allows access into the marrow cavity M. The side aperture 184 of the cannula 105 affords an exit port for the needle 101 in a position that is parallel to the bone cortex Cl and C2 and at a suitable distance from the first cortex Cl and the second cortex C2. The external dimensions of the guiding device hub 112 may be configured so that it is wider than the cannula 105 and outwardly protrudes from the periphery of cannula 105. This design limits the depth of entry of the guiding device 113 so that it is restricted to the length of cannula 105. Namely, guiding device hub 112 ensures insertion of cannula 105 until it reaches the marrow cavity and before hitting second cortex C2. As illustrated, guiding device hub 112 is configured to accommodate a needle so that it is perpendicular to a bone B. The hub 112 may include an internal sealing ring 117 for providing sealing of the drilling tool 103 when attached to the guiding device 113. In one nonlimiting example, the sealing ring 117 may be a rubber ring, which is applied on the inside of interface 104.

[00102] Figure 11 illustrates yet another exemplary drill bit guiding device 313 that includes an angled port 315 within hub 312. The angled port 315 is configured to allow an angled insertion of a needle 101. The angle of the port 315 may be above 0° and up to about 30°. For example, the angled port may include an angled cannula relative to the longitudinal axis of the bone B and be of at least 10°, or at least 15°, or at least 20°, or at least 35°. Each possibility represents a separate embodiment of the invention. Such an angled port 315 may provide needle 101 to be inserted at an angle with respect to the bone B, wherein the angle is not perpendicular. A closed tip 382 due to a front closed wall of the guiding device 313 may form a barrier and prevent the needle 101 from proceeding to and through the second cortex C2 of the bone B causing the flexible needle 101 to bend and reconfigure so that the flexible portion 110 of the needle 101 is lying parallel to the bone B. Optionally, the flexible needle 101 adopts various geometric forms when entering the bone B such as a spiral configuration, or a pigtail form. The sharp cutting tip 382 allows drilling the guiding device 313 into the bone B.

[00103] FIGs. 12A- 12C illustrate yet another exemplary needle system 200 which includes a needle 101 as described with reference to system 100, and a drill bit guiding device 413. Drill bit guiding device 413 does not include a side aperture and optionally does not include guiding device hub, such as guiding device hub 212. The drill bit 413 is sized and configured so that it can be inserted and accommodated in the lumen of the needle 101 as shown in Figure 12B. At its proximal end the drill bit 413 includes an interface with AO connection 404, or another type of drill connection interface, for connecting to a drilling tool 103. Drill bit 413 is made from a shape memory alloy having a transition temperature of between about 35 °C and about 40 °C. The drill bit 413 may be pre-shaped so that it is bent with a desired arc 419, for example having an angle of about 90°, as shown in Figure 12C. The desired arc 419 may be configured for facile insertion of the needle 101 at an optimal position in the bone marrow channel. The drill bit 413 may be unbent prior to insertion into the body (figure 12B). When inserted into the body, such as into the bone, the body temperature may facilitate the bending of the drill bit 413, which in turn will cause the flexible needle 101 in which the drill bit is held, to bend in a similar way and adopt the arced configuration of the drill bit (figure 12C).

[00104] The needle system 200 of the present invention may be inserted into the bone using a guiding device 360, as shown in Figures 13 A and 13B. FIGs. 13A-13B are perspective views of an exemplary drill bit 413 with a needle 101 and a guiding device 360 to guide a user to an access point for entry to a bone, according to an aspect of the present invention. A user may insert drill bit 413 into the lumen of the flexible needle 101. The drill bit 413 may be inserted so that the tip of the drill bit 413 with the cutting edge may protrude out of the opening 147 of the tip 146 of the needle 101. The user may then attach a drilling tool 103 (not shown) to the interface 404 of the drill bit 413. The guiding device 360 may include an access hole 362. The guiding device 360 may be coupled to the body in such a way so that insertion of the needle system 200 through the access hole 362 provides the drill bit 413 and the needle 101 at the optimal trajectory in the bone. A user may insert needle 101 and the drill bit 413 held within through the access hole 362 of the guiding device 360 and drill an access hole in the bone. The body temperature may elevate the temperature of the inserted shape memory drill bit 413 so that it forms into its preshaped bent configuration. The bent configuration of drill bit 413 causes the encircling aspiration needle 101 to bend so that the needle aligns parallel to the bone marrow channel. The drill may be detached from the drill bit and the drill removed.

[00105] When the needle 101 is at the desired position in the bone, the user may detach drill bit 413 from the needle system 200. The drill bit 413 may be pulled out of the bone and out of the system 200 through the proximal end of the needle 101. The user may then attach a syringe 107 to the proximal end of the flexible needle 101. The syringe 107 may employ a suitable connection means such as a Luer lock to attach to the proximal end of the needle 101. FIGs. 14A-14C show perspective views of the needle 101 coupled to the guiding tool 360 wherein the needle is attached to a syringe 107, according to an aspect of the present invention. The user may then perform bone marrow aspiration. After the bone marrow is collected, system 200 may be detached from the body of the patient. The needle 101 may be removed from the bone by pulling it out of the access hole 362 of the guiding tool 360.

[00106] The present invention provides a method 400 of assembling the needle system of the present invention such as system 100 as shown in the flow chart of Figure 15. The order of the steps is not meant to be limiting and any suitable order may be used. The method may be used to extract bone marrow from a bone. The method may be used to administer at least one substance to a bone. An access point within the bone is determined and an incision is made using dedicated devices such as a scalpel 402. A surgical drilling tool may be provided and used for drilling a hole through access point 404. The drilling tool may be any suitable drilling tool for drilling a hole in a bone. A drill bit guiding device of the present invention may be attached to the drilling tool. The drilling tool and guiding device may connect together using for example an AO connection through an interface, such as interface 104/204. The guiding device may be used to drill a hole at a suitable point of incision in a bone.

[00107] The bone may be any suitable bone. In one non-limiting example the bone is the tibia. The drill bit guiding device may be positioned so that it is securely anchored about the point of entry in the bone. The drilling tool may be detached from the drill bit guiding device after insertion of the guiding device and the guiding device may be kept in bone 406. The guiding device may be positioned between the first cortex and the second cortex of the bone. The guiding device may be perpendicular to the bone. The needle may be inserted into the guiding device through the needle entry port and extend through the cannula 408. The flexible needle may be inserted so that it is initially perpendicular to the bone. As the needle is inserted deeper into the cannula, the tip of the needle may be bended by exiting the guiding device through the side aperture. The exit of the needle through the side aperture may cause the flexible section of the cannula of the needle to bend and reconfigure so that it is parallel to the bone 410. The needle may be inserted to a depth of about 12 cm. A flexible needle of the present invention may be attached to a syringe at step 412.

[00108] At step 414, bone material may be aspirated or one or more substance(s) may be administered to the bone according to the medical requirement of a patient 414. For aspirating a bone material from within the bone, a suction force may be provided to the flexible needle, which is positioned in the bone. The suction force may result from pulling the plunger in a direction out of the barrel of the syringe. The pulling of the plunger may be done manually or electronically. The suction force may responsively suck bone marrow from within the bone and through the plurality of openings spaced apart along the shaft 108/208 of the needle 101/201 and into the cavity of the needle. The bone marrow may be sucked into the syringe. When sufficient bone marrow has been collected the applied suction force may be removed. The collection of the bone marrow may take any suitable amount of time. In one non-limiting example the collection takes a few minutes. For administering a substance, the syringe may be filled with at least one substance for administering into a bone. The bone may be the tibia. The at least one substance may be but is not limited to at least one of bone marrow, blood, stem cells, platelets, and a drug. A pushing force may be provided to the syringe contents. The pushing force may be provided by pushing the plunger into the barrel of the syringe. The pushing of the plunger may be done manually or electronically. The pushing force may push the at least one substance contained in the syringe into the needle and through the plurality of opening spaced apart along the shaft of the needle 101/201. The at least one substance may be administered through each hole of the needle into the bone. When a sufficient amount of the at least one substance has been administered into the bone the pushing force may be removed.

[00109] The needle may then be removed from within the bone 416. Removal may be done by pulling the syringe out of the cavity of the guiding device, which facilitates pulling the attached needle out of the bone. In some embodiments, the needle is disposed after use. The drill bit guiding device may be removed in any suitable way. The drilling tool may be reattached to the drill bit guiding device for removal thereof from the bone. In one non-limiting example, the drill bit guiding device may be removed manually.

[00110] Reference is made to the following example, which together with the above descriptions illustrates the invention in a non-limiting fashion.

[00111] Example 1

[00112] A surgeon employs the needle system 100/200 of the present invention to extract bone marrow from the tibia. The surgeon attaches the drill bit guiding device 113/213 of the present invention to a drilling tool 103. The surgeon drills into the tibia at a determined entry position to provide a hole in the tibia. The surgeon detaches the drilling tool 103 from the inserted drill bit guiding device. The guiding device hub 112 of the drill bit guiding device 113/213 is positioned on the outside of the body sitting on the skin surrounding the formed hole. The attached guiding device 113/213 is located within the bone and is perpendicular to the bone. The surgeon attaches a syringe 107 with an attached flexible needle 101/201 of the present invention to the drill bit guiding device 113/213. Alternatively, the flexible needle 101/201 is inserted into the drill bit guiding device 113/213 and then the syringe 107 is attached to the needle. The connected flexible needle is lowered into the bone, vertically into the incision along the longitudinal length of the drill bit guiding device 113/213 until it is deflected by exiting the drill bit guiding device 113/213 from the side aperture. When the needle is in the correct position between the two sides of the bone, the surgeon pulls the plunger outwards from the barrel of the syringe to provide a suction force to suck the bone marrow through the apertures in the flexible needle and into the syringe. When the surgeon has extracted enough bone marrow, he stops applying a suction force and removes the syringe. The drill bit guiding device is then removed from the bone.

[00113] One skilled in the art can appreciate from the foregoing description that the broad systems, devices, and techniques of the aspects of the present invention can be implemented in a variety of forms. Therefore, while the aspects of this invention have been described in connection with particular examples thereof, the true scope of the aspects of the invention should not be so limited since other modifications will become apparent to the skilled practitioner upon a study of the specification and following claims.

Claims

WHAT IS CLAIMED IS:

1. A needle system comprising: a flexible needle; and a drill bit guiding device; wherein the needle system is configured for bone marrow aspiration or for administration of one or more substances into the bone.

2. The system of claim 1, wherein the flexible needle comprises: a flexible hollow shaft, the shaft comprising a plurality of spaced apart openings along the length of the shaft; a distal end comprising a rigid, sharp tip configured to penetrate the marrow cavity of the bone; and a proximal end configured to connect to a syringe.

3. The system of claim 2, wherein the hollow shaft comprises a flexible portion manufactured from a material selected from at least one of a metal, and a polymeric material.

4. The system of claim 3, wherein the polymeric material is selected from PEEK, PTFE, silicone, and polyethylene.

5. The system of claim 3, wherein the metal is selected from stainless steel, nitinol, and titanium.

6. The system of any one of claims 1-5, wherein the flexible needle is disposable.

7. The system of any one of claims 1-6, wherein the needle has a bending radius of less than about the diameter of the bone.

8. The system of any one of claims 1-7, wherein the length of the flexible needle is at least about 6 cm.

9. The system of claim 2, wherein the plurality of openings is configured to allow bone marrow aspiration through each aperture.

10. The system of any one of claims 1-9, wherein the needle is a suction needle.

11. The system of claim 10, wherein a suction force is provided to the needle by pulling the plunger of the syringe in a direction out of the barrel of the syringe.

12. The system of claim 11 , wherein the pulling can be done manually or electronically.

13. The system of any one of claims 1-11, wherein the needle is configured to prevent kinks in the shaft.

14. The system of claim 2, wherein the needle is attached to the syringe via a Luer lock connection.

15. The system of any one of claims 1-14, wherein the needle is reversibly attached to the drill bit guiding device.

16. The system of claim 2, wherein the shaft of the needle comprises markings indicating the length of the needle for determining the length of the needle inserted into a bone.

17. The system of any one of claims 1-16, wherein the system further comprises a drilling tool comprising a motor for powering the drill bit guiding device.

18. The system of claim 16, wherein the drill bit guiding device comprises: a guiding device hub configured to attach to the drilling tool and comprising a needle entry port; and a cannula comprising a longitudinal body configured to accommodate the flexible needle, the cannula comprises a closed cutting distal tip and a side aperture for allowing exit of the needle through the side aperture.

19. The system of claim 18, wherein the guiding device hub of the drill bit guiding device is configured to externally sit about a site of penetration into the bone by the needle.

20. The system of claim 18, wherein the closed distal cutting tip is configured to prevent the needle from proceeding distally perpendicular to the first cortex and the second cortex of the bone and wherein the side aperture facilitates deflecting the needle from the path defined by the cannula through the side aperture so that the needle is parallel to the first cortex and the second cortex of the bone.

21. The system of claim 18, wherein the hub of the drill bit guiding device comprises a needle entry port that is in the same longitudinal line of the cannula, facilitating an initial insertion of the flexible needle perpendicular to the bone.

22. The system of claim 18, wherein the hub of the drill bit guiding device comprises a needle entry port that is at an angle with respect to the longitudinal line of the cannula, facilitating an initial insertion of the flexible needle at an angle of less than 90° relative to the bone.

23. The system of claim 2, wherein the drill bit guiding device comprises a drill bit and wherein the hollow shaft of the flexible needle is configured to receive and hold the drill bit within the lumen of the shaft of the flexible needle.

24. The system of claim 23, wherein the drill bit is made from a shape memory alloy and adopts a bent configuration at body temperature.

25. The system of claim 24, wherein the flexible needle adopts the configuration of the drill bit.

26. The system of any one of claims 1-25, wherein the guiding device is configured to cut through the bone.

27. The system of any one of claims 1-26, wherein the guiding device is disposable.

28. The system of any one of claims 1-27, wherein the bone marrow is from the tibia.

29. The system of any one of claims 1-28, wherein the at least one substance is at least one of bone marrow, blood, stem cells, platelets and a drug.

30. A needle system comprising a drill bit guiding device configured to drill through and anchor a bone, the drill bit guiding device comprising a cannula comprising a longitudinal body configured to accommodate a flexible needle, the cannula comprises a closed cutting distal tip and a side aperture facilitating an exit port for the needle, wherein the side aperture facilitates deflecting the needle from the path defined by the cannula through the side aperture so that the needle is parallel to a first cortex and a second cortex of a bone.

31. A method of assembling a needle system comprising: providing a flexible needle; providing a drill bit guiding; drilling a hole into a bone using a drilling tool and said drill bit guiding device; removing the drilling tool and keeping the drill bit in the bone; inserting the flexible needle into the cannula of the drill bit; attaching a syringe to the proximal hub of the needle; and collecting bone material from within a marrow cavity of the bone or administering one or more substances into the bone.

32. The method of claim 31, wherein inserting comprises inserting a length of at least 5 cm of needle within the bone.

33. The method of claim 31, further comprising providing a suction force to the flexible needle; and suction bone marrow through a plurality of openings in the flexible needle and into a barrel of the syringe.

34. The method of claim 33, wherein the providing a suction force comprises pulling the plunger in a direction out of the barrel.

35. The method of claim 34, wherein the pulling of the plunger is done manually.

36. The method of claim 31 , wherein the bone material is at least one of bone marrow, blood, stem cells, platelets and a drug.

37. A method of bone marrow aspiration comprising: inserting the drill bit through the lumen of a flexible needle, so that the tip of the drill bit protrudes out of the tip of the needle; attaching a drill to the proximal end of the drill bit; attaching a guiding device to the target area of a patient, the guiding device comprising an access hole; inserting the flexible needle with the drill bit therein through the access hole of the guiding device; drilling a hole at the target body area positioned at the access hole of the guiding device; and heating the drill bit by the body temperature to facilitate bending of the drill bit and bending of the flexible needle of the system of claim 30 to align the needle to be positioned parallel to the bone marrow channel.