TECHNICAL FIELD

[0001] The invention relates to medical devices and systems and more specifically to medical puncturing devices using mechanical waves.

BACKGROUND

[0002] Surgical puncturing or suture needles allows for puncturing and suturing tissues. For example such needles can be used during cardiothoracic surgeries. Suturing is performed by a surgeon after passing through the target tissue the puncturing needle to which a suture thread is attached. Puncturing needles are usually curved to ease the passing of the needle through a tissue. In the case of cardiothoracic surgeries for example, a usual puncturing needle can be used for suturing myocardial tissue that is soft and healthy and the puncturing needle can be passed though the myocardial tissue by simple mechanical pressure of the surgeon on the puncturing needle. However, with aging, myocardial tissue is usually covered with fibrosis and calcic structures. Therefore, with aging, myocardial tissue loses its flexibility and becomes hard and difficult to be punctured by a usual puncturing needle. Since usual puncturing needles have a limited mechanical resistance, a surgeon may break or damage a usual puncturing needle while trying to puncture a calcified myocardial tissue.

[0003] Therefore, there is a need for a puncturing device.

SUMMARY

[0004] According to a broad aspect, there is provided a puncturing device for puncturing a tissue, the device comprising: an elongated body extending between a puncturing end and a connecting end, the puncturing end being designed to puncture the tissue, a suture thread being securable to the elongated body, the elongated body comprising one of a lumen and a recess extending along at least a portion thereof, the one of the lumen and the recess lumen being designed for receiving a mechanical waveguide therein, the mechanical waveguide being configured for propagating mechanical waves therealong in order to be propagated up to the tissue. [0005] In one embodiment, the one of a lumen and a recess comprises the lumen.

[0006] In one embodiment, the lumen extends from an insertion aperture and is closed by an end wall adjacent to the puncturing end of the elongated body.

[0007] In one embodiment, the insertion aperture is located at the connected end of the elongated body.

[0008] In one embodiment, the insertion aperture is located on a lateral wall of the elongated body, the lateral wall extending between the puncturing end and the connecting end.

[0009] In one embodiment, the lumen extends between an insertion aperture and a protrusion aperture, the protrusion aperture being located at the puncturing end of the elongated body

[0010] In one embodiment, the insertion aperture is located at the connected end of the elongated body.

[0011] In one embodiment, the insertion aperture is located on a lateral wall of the elongated body, the lateral wall extending between the puncturing end and the connecting end.

[0012] In one embodiment, the elongated body is curved and comprises a concave side and a convex side.

[0013] In one embodiment, the insertion aperture is located on the concave side of the elongated body.

[0014] In one embodiment, the insertion aperture is adjacent to the connecting end of the elongated body.

[0015] In one embodiment, the insertion aperture is located on the convex side of the elongated body.

[0016] In one embodiment, the insertion aperture is adjacent to the puncturing end of the elongated body. [0017] In one embodiment, the one of a lumen and a recess comprises the recess.

[0018] In one embodiment, the elongated body is curved and comprises a concave side and a convex side.

[0019] In one embodiment, the recess is located on the concave side of the elongated body.

[0020] In one embodiment, the recess is located on the convex side of the elongated body.

[0021] In one embodiment, the elongated body comprises a flat section for engaging with clamps.

[0022] In one embodiment, the flat section is adjacent to the connecting end of the elongated body.

[0023] In one embodiment, the elongated body comprises a thread receiving aperture extending from the connecting end thereof, the thread receiving aperture for securing the suture thread therein.

[0024] In one embodiment, the elongated body is made of medical grade biocompatible material.

[0025] According to another broad aspect, there is provided a system for puncturing a tissue, the system comprising: the puncturing device comprising an elongated body extending between a puncturing end and a connecting end, the puncturing end being designed to puncture the tissue, a suture thread being securable to the elongated body, the mechanical waveguide extending between a first end and a second end, the first end being operatively connectable to the puncturing device; and a mechanical wave generator operatively connectable to the second end of the mechanical waveguide for generating mechanical waves and propagating the mechanical waves along the mechanical waveguide.

[0026] In one embodiment, the first end of the mechanical waveguide is connectable to the connecting end of the elongated body. [0027] In one embodiment, the elongated body is provided with a lumen extending along at least a portion thereof, the lumen being designed for receiving the mechanical waveguide therein.

[0028] In one embodiment, the lumen extends from an insertion aperture and is closed by an end wall adjacent to the puncturing end of the elongated body.

[0029] In one embodiment, the insertion aperture is located at the connected end of the elongated body.

[0030] In one embodiment, the insertion aperture is located on a lateral wall of the elongated body, the lateral wall extending between the puncturing end and the connecting end.

[0031] In one embodiment, the lumen extends between an insertion aperture and a protrusion aperture, the protrusion aperture being located at the puncturing end of the elongated body

[0032] In one embodiment, the insertion aperture is located at the connected end of the elongated body.

[0033] In one embodiment, the insertion aperture is located on a lateral wall of the elongated body, the lateral wall extending between the puncturing end and the connecting end.

[0034] In one embodiment, the elongated body is curved and comprises a concave side and a convex side.

[0035] In one embodiment, the insertion aperture is located on the concave side of the elongated body.

[0036] In one embodiment, the insertion aperture is adjacent to the connecting end of the elongated body.

[0037] In one embodiment, the insertion aperture is located on the convex side of the elongated body. [0038] In one embodiment, the insertion aperture is adjacent to the puncturing end of the elongated body.

[0039] In one embodiment, the elongated body is provided with a recess extending along at least a portion thereof, the recess being designed for receiving the mechanical waveguide therein.

[0040] In one embodiment, the elongated body is curved and comprises a concave side and a convex side.

[0041] In one embodiment, the recess is located on the concave side of the elongated body.

[0042] In one embodiment, the recess is located on the convex side of the elongated body.

[0043] In one embodiment, the elongated body comprises a flat section for engaging with clamps.

[0044] In one embodiment, the flat section is adjacent to the connecting end of the elongated body.

[0045] In one embodiment, the elongated body comprises a thread receiving aperture extending from the connecting end thereof, the thread receiving aperture for securing the suture thread therein.

[0046] In one embodiment, the elongated body is made of medical grade biocompatible material.

[0047] In one embodiment, the mechanical wave generator is configured for generating mechanical pulses.

[0048] According to a further broad aspect, there is provided a guiding device for guiding a suture needle, the guiding device comprising: an elongated body extending between a first end and a second end and comprising a lumen extending at least partially therethrough from an insertion aperture to an exit aperture located at the second end of the elongated body, the lumen being designed to receive iteratively a mechanical waveguide and the suture needle therein, the second end being configured for abutting a tissue to be sutured, the mechanical waveguide being configured for propagating mechanical waves therealong in order to be propagated up to the tissue to be sutured.

[0049] In one embodiment, the insertion aperture is located at the first end of the elongated body.

[0050] It should be understood that a mechanical wave may have an arbitrary amplitude, duration, waveform, frequency, and/or the like. For example, a mechanical wave may have a high/low amplitude, a short/long duration, different waveforms, and any frequency content.

[0051] For the purpose of the present description, a mechanical pulse should be understood as a short duration mechanical wave. The duration of a mechanical pulse is of the order of about l/fc, where fc is the center frequency of the wave. In one embodiment, the center frequency fc is comprised between 20 kHz and 10 MHz, preferably between 100 kHz and 2 MHz.

[0052] Furthermore, a mechanical waveguide should be understood as a waveguide adapted to propagate mechanical waves or pulses along its length. In the present description, the expressions“waveguide”,“mechanical waveguide” and“transmission member” may be used interchangeably. The shape and dimension of a waveguide may vary. For example, a waveguide may have a cylindrical shape. The diameter of the waveguide may be constant along its length. Alternatively, the diameter of the waveguide may vary along its length. For example, the diameter of a waveguide may decrease along its length so that the waveguide corresponds to a taper.

[0053] In one embodiment, a mechanical waveguide may comprise a single elongated element adapted to propagate mechanical waves and/or pulses therealong. In another embodiment, a mechanical waveguide may comprise a plurality of elongated elements each adapted to propagate mechanical waves and/or pulses therealong. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Having thus generally described the nature of the invention, reference will now be made to the accompanying drawings, showing by way of illustration example embodiments thereof and in which:

[0055] Figure 1 illustrates a system for puncturing system for puncturing a tissue, the system comprising a solid puncture needle, a mechanical waveguide and a mechanical wave generator, in accordance with an embodiment;

[0056] Figure 2a illustrates a puncturing needle comprising a lumen that does not extend through a distal end thereof, in accordance with an embodiment;

[0057] Figure 2b illustrates a system for puncturing system for puncturing a tissue, the system comprising the puncture needle of Figure 2, a mechanical waveguide and a mechanical wave generator, in accordance with an embodiment;

[0058] Figure 3 is a first perspective view of a puncturing curved needle provided with a lumen extending between an insertion aperture located on a concave side and a protrusion aperture located at a distal end thereof, in accordance with an embodiment;

[0059] Figure 4 is a second perspective view of the puncturing needle of Figure 3;

[0060] Figure 5 is a side view of the puncturing needle of Figure 3;

[0061] Figure 6 is a cross-sectional view of the puncturing needle of Figure 3;

[0062] Figure 7 is a first perspective view of the puncturing needle when hold by clamps, in accordance with an embodiment;

[0063] Figure 8 is a second perspective view of the puncturing needle when hold by clamps;

[0064] Figure 9 is a perspective view of the puncturing needle of Figure 3 when a mechanical waveguide is inserted into the lumen, in accordance with an embodiment; [0065] Figure 10 illustrates a needle guide for guiding a needle in accordance with an embodiment; and

[0066] Figure 11 is a perspective view of a puncturing curved needle provided with a lumen extending between an insertion aperture located on a convex side thereof and a protrusion aperture located at a distal end thereof, in accordance with an embodiment.

DETAILED DESCRIPTION

[0067] There is described a puncturing device to be used to puncture a calcified tissue or help puncturing a calcified tissue. In one embodiment, the puncturing device is a needle in which a mechanical waveguide can be inserted for propagating mechanical pulses in order to at least weaken the calcified tissue, thereby rendering easier the puncturing of the calcified tissue. In another embodiment, the puncturing device is a needle guide in which a mechanical waveguide can be inserted for propagating mechanical pulses in order to at least weaken the calcified tissue and in which a suture needle can be inserted to guide the needle for suturing the calcified tissue.

[0068] Figures 1 to 8 illustrate different embodiments of a surgical or suture needle and a suture needle guide adapted to be used with a pulse generator such as system 100 for improving the suturing of a calcified tissue for example.

[0069] In another embodiment the suture system could be used to cross bones or cartilage to facilitate chest suture closure during thoracic or cardiac surgery.

[0070] Figure 1 illustrates a first embodiment of a suture needle 100 for suturing a calcified tissue 102 of a subject’s body such as calcified tissues located around or within the heart. In this embodiment, the suture needle 100 is operatively connectable to a pulse generator 104, such as the pulse generator 102 of system 100, via a mechanical waveguide 106.

[0071] In the illustrated embodiment, the suture needle 100 comprises an elongated body 108 having a hook-like shape extending between a distal or puncturing end 110 and a proximal or connecting end 112. The puncturing end 110 of the body 108 is designed to penetrate through the calcified tissue, bone or cartilage 102. The connecting end 112 of the body 108 is connectable to the mechanical waveguide 106. In this embodiment, the hook-like body 108 comprises a concave portion/side 114 and a convex portion/side 116.

[0072] While the illustrated suture needle 100 is provided with a hook-like shape, it should be understood that the suture needle 100 may be provided with any other adequate shape. For example, the suture needle may have a straight shape, a half-curved shape, a J- shape or the like. When the suture needle is curved or comprises at least a curved section, the curvatures of the concave and/or convex portions may vary along the length of the suture needle.

[0073] As illustrated in Figure 1, a suture thread 122 is further attachable to the connecting end 112 of the suture needle 100 and is adapted to suture the calcified tissue, bone or cartilage 102 during suturing. It should be understood that any adequate method for fixedly or removably secure the suture thread 122 to the suture needle 100 may be used. For example, an adhesive may be used. In another example, the suture needle 100 may be provided with an aperture in which the suture thread 122 is inserted and maintained into position via mechanical compression forces.

[0074] In one embodiment, the suture thread 122 is chosen depending on the type of tissue being repaired and the duration of time needed for the suture to stay in place. Further, the suture thread 122 may be of different kinds such as absorbable or non-absorbable, monofilament or multifilament, etc.

[0075] The mechanical waveguide 106 has an elongated shape and extends between a proximal end 118 operatively connectable to the pulse generator 104 and a distal end 120 operatively connectable to the connecting end 112 of the body 108. The mechanical waveguide 106 is configured to propagate mechanical pulses generated from the pulse generator 104 from the proximal end 118 to the distal end 120 up to the proximal end 112 of the suture needle 100. When it reaches the distal end 120 of the mechanical waveguide 106, a mechanical pulse emitted by the pulse generator 104 and propagating along the mechanical waveguide 106 is at least partially coupled into the body 108 of the suture needle 100 and propagates from the connecting end 112 of the elongated body 108 up to the puncturing end 110 thereof.

[0076] When it reaches the distal end 110 of the elongated body 108, the mechanical pulse is transmitted at the distal end 110, which creates a displacement of the distal end 110 resulting in a mechanical pulse that propagates in the medium surrounding the distal end 110 of the elongated body 108 away from the distal end 110 towards the calcified tissue, bone or cartilage 102. In one embodiment, substantially all of the mechanical pulse is transmitted at the distal end 110 of the elongated body 108. In another embodiment, only a portion of the mechanical pulse is transmitted at the distal end 110 of the elongated body 108 depending, among other things, on the acoustical impedance continuity at the interface between the distal end 110 and the surrounding medium. While reaching the calcified tissue, bone or cartilage 102, the mechanical pulse cracks, erodes, cleaves, tunnels, crosses and/or breaks at least partially the calcified tissue, bone or cartilage 102.

[0077] It should be understood that any adequate method/system for securing the mechanical waveguide 106 to the elongated body 108 of the needle 100 or engaging the mechanical waveguide 106 with the elongated body 108 of the needle 100 so as to at least partially propagate mechanical pulses from the mechanical waveguide 106 to the needle 100 may be used. For example, the distal end 120 of the mechanical waveguide 106 may be fixedly secured to the proximal end 112 of the elongated body 108. In this case, the distal end 120 of the mechanical waveguide 106 may be welded to the proximal end 112 of the elongated body 108. In another embodiment, the mechanical waveguide 106 may be removably secured to the elongated body 108 or removably engaged with the elongated body 108. For example, a cavity or lumen may extend within the elongated body of the needle 100 from its proximal end 112 along at least a section of the elongated body 108. The lumen may be shaped and sized so as to receive therein at least a portion of the mechanical waveguide 106 adjacent to its distal end 120. In this case, the mechanical waveguide 106 is removably engaged with the elongated body 108 of the needle 100 by inserting the distal end 120 of the mechanical waveguide 106 into the lumen and abutting the distal end 120 of the mechanical waveguide against the internal wall of the elongated body at the end of the lumen. In one embodiment, the wall surrounding the lumen may be threaded and the distal section of the mechanical waveguide 106 may also be threaded so as to be screwed into the threaded lumen of the elongated body in order to removably secure the mechanical waveguide 106 to the needle 100.

[0078] In use, the proximal end of the mechanical waveguide 106 is operatively connected to the pulse generator 104 and the distal end 120 of the mechanical waveguide 106 is operatively connected to the needle 100.

[0079] The suture needle 100 is then positioned so as to align its puncturing end 110 with a desired position on the calcified tissue, bone or cartilage 102 in order to penetrate the calcified tissue, bone or cartilage 102. The pulse generator 104 is subsequently actuated for generating mechanical pulses, having a high amplitude and short duration. The mechanical pulses propagate along the mechanical waveguide 106 from its proximal end 118 towards its distal end 120. When reaching the distal end 120 of the mechanical waveguide 106, the mechanical pulses are at least partially coupled into the body 108 of the suture needle 100 and propagate along the elongated body 108 towards its puncturing end 110. Upon arrival of a mechanical pulse at the puncturing end 110, a movement is created. This movement may be along the longitudinal axis of the suture needle 100. Alternatively, the movement may be in a direction other than along the longitudinal axis of the suture needle 100 such as perpendicularly to the longitudinal axis, i.e. along a perpendicular axis. In another example, the movement may be a combination of movements along both the longitudinal axis and the perpendicular axis of the suture needle 100.

[0080] During this movement, the puncturing end 110 first moves towards the tissue 102 to be sutured and then moves back into its initial position. It should be understood that the movement may be inverted depending on the polarity of the mechanical pulse reaching the puncturing end 110. For example, the puncturing end 110 may first move away from the tissue 102 and then move towards the tissue 102. In one embodiment, substantially all of the mechanical pulse is transmitted at the distal end 120 of the mechanical waveguide 106. In another embodiment, only a portion of the mechanical pulse is transmitted at the distal end 120 of the mechanical waveguide 120 depending, among other things, on the acoustical impedance continuity at the connecting end 112. [0081] In one embodiment, a train of successive mechanical pulses are generated at a given repetition rate during a given period of time. In one embodiment, the repetition rate may be substantially constant in time. In another embodiment, the repetition rate may vary in time.

[0082] Successive and repeated distinct mechanical pulses arriving at the puncturing end 110 of the elongated body 108 may trigger a jackhammer movement thereof which may be used to penetrate into the tissue 102 to be sutured. This movement may therefore facilitate the penetration of the puncturing end 110 into the tissue 102 by creating cracks, eroding, cleaving, tunneling and/or breaking therein. During the suturing process and as the puncturing end 110 drills multiple adjacent holes each time it penetrates the calcified tissue 102, the suture thread 122 is inserted and tightened through the holes to hold the tissue 102 together after surgery.

[0083] Although in the illustrated embodiment of Figure 1, the mechanical waveguide 106 is connected to the suture needle 100 at the connecting end 112 of the elongated body 108, other embodiments are possible. For instance, the mechanical waveguide 106 may be connected to the body 108 at the concave portion 114, the convex portion 116 or a lateral portion located between the concave portion 114 and the convex portion 116. Similarly, the mechanical waveguide 106 may be connected at any adequate position along the length of the elongated body 108. As described above, the elongated body 108 may be provided with a lumen for receiving the mechanical waveguide therein and thereby engaging the mechanical waveguide with the suture needle 100. The lumen may extend along a longitudinal section of the elongated body 108 and emerge from the portion of the elongated body 108 adjacent to the puncturing end 110 of the elongated body 108. The distal end 120 of the mechanical waveguide 106 is introduced into the lumen until abutting against the end wall of the lumen so that mechanical pulses propagating along the mechanical waveguide 106 may be coupled into the elongated body 108 and propagate up to the puncturing end 110 of elongated body 108.

[0084] Figures 2a and 2b illustrate a further embodiment of a suture needle 200. In this embodiment, the suture needle 200 has a shape substantially similar to that of the suture needle 100 and comprises an elongated body 202. The elongated body 202 is provided with an inner lumen 204 which extends from a distal or puncturing end 206 to a proximal or connecting end 208. The inner lumen 204 is sized and shaped so as to receive a mechanical waveguide 210.

[0085] In the illustrated embodiment, the lumen 204 emerges from the elongated body 202 at the connecting end 208 and ends by a wall adjacent to the puncturing end 206 of the elongated body 202 so that the distal end of the lumen 204 does not emerge from the elongated body 202 and, once the mechanical waveguide 210 is inserted into the lumen 204, the distal end of the mechanical waveguide 210 cannot emerge from the distal end 206 of the elongated body 202.

[0086] In one embodiment, the mechanical waveguide 210 is substantially similar to the mechanical waveguide 120 and has a cylindrical shape. The mechanical waveguide 210 extends between a proximal end 220 operatively connectable or connected to a pulse generator 218 and a distal end insertable into the inner lumen 204. The mechanical waveguide 210 is configured for propagating the mechanical pulses generated by the pulse generator 218 from its proximal end 220 to its distal end. When the mechanical waveguide 210 is inserted into the lumen 204 of the elongated body 202, the distal end of the mechanical waveguide 210 abuts against the end wall of the lumen 204 so that mechanical pulses propagating along the mechanical waveguide 210 may be at least partially coupled in the elongated body 202 and propagate up to the puncturing end 206 of the elongated body 202.

[0087] While in the illustrated embodiment, it does not extend up to the puncturing end 206 of the elongated body 202, the lumen 204 may extend up to the puncturing end 206 so that the puncturing end 206 of the elongated body 202 is provided with an aperture connected to the lumen 204 so that the distal end of the mechanical waveguide 210 may protrude from the elongated body 202.

[0088] As illustrated in Figure 2b, a suture thread 214 is attachable to the proximal end 208 of the suture needle 200. The suture thread 214 is adapted to suture the calcified tissue 216 during suturing. [0089] In one embodiment, the suture thread 214 is chosen depending on the type of tissue being repaired and the duration of time needed for the suture to stay in place. Further, the suture thread 214 may be of different kinds such as absorbable or non-absorbable, monofilament or multifilament, etc.

[0090] In use, the proximal end 220 of the mechanical waveguide 210 is operatively connected to the pulse generator 218 and the distal end of the mechanical waveguide 210 is inserted through the inner lumen 204 at the proximal end 208 of the elongated body 202. The mechanical waveguide 210 is inserted until its distal end abuts against the end wall closing the lumen 204 adjacent to the puncturing end 206 of the elongated body 202.

[0091] The suture needle 200 is then positioned to align its puncturing end 206 with a desired position on the calcified tissue, bone or cartilage 216 in order to penetrate the calcified tissue, bone or cartilage 216.. The mechanical pulse generator 218 is then actuated for generating mechanical pulses, each having a high amplitude and short duration.

[0092] The mechanical pulses propagate along the mechanical waveguide 210 from its proximal end 220 towards its distal end. When reaching the distal end of the mechanical waveguide 210, the mechanical pulses are at least partially coupled into the elongated body 202 of the suture needle 200 and propagate along the elongated body 202 towards its puncturing end 206. Upon arrival of a mechanical pulse at the puncturing end 206, a movement is created. This movement may be along the longitudinal axis of the suture needle 200. Alternatively, the movement may be in a direction other than along the longitudinal axis of the suture needle 200 such as perpendicularly to the longitudinal axis, i.e. along a perpendicular axis. In another example, the movement may be a combination of movements along both the longitudinal axis and the perpendicular axis of the suture needle 200.

[0093] During this movement, the puncturing end 206 first moves towards the tissue 216 to be sutured and then moves back into its initial position. It should be understood that the movement may be inverted depending on the polarity of the mechanical pulse reaching the puncturing end 206. For example, the puncturing end 206 of the suture needle 200 may first move away from the tissue 216 and then move towards the tissue 216. In one embodiment, substantially all of the mechanical pulse is transmitted at the distal end of the mechanical waveguide 210. In another embodiment, only a portion of the mechanical pulse is transmitted at the distal end of the mechanical waveguide 210 depending, among other things, on the acoustical impedance continuity at the interface between the mechanical waveguide 210 and the elongated body 202.

[0094] In an embodiment in which the lumen 204 extends through the puncturing end 206 of the elongated body 202, the mechanical waveguide 210 may be further advanced through the inner lumen 204 in order to protrude from the puncturing end 206 and be in physical contact with the calcified tissue 216 in order to crack, erode, cleave, tunnel, cross and/or break at least partially the calcified tissue 216.

[0095] In one embodiment, a train of successive mechanical pulses are generated at a given repetition rate during a given period of time. In one embodiment, the repetition rate may be substantially constant in time. In another embodiment, the repetition rate may vary in time. As previously explained, a plurality of distinct mechanical pulses successively arriving at the distal end of the mechanical waveguide 210 create a jackhammer movement thereof which may be used to facilitate the penetration of the puncturing end 206 into the calcified tissue 216 by creating cracks, eroding, cleaving, tunneling and/or breaking therein. Once the suture needle 200 has penetrated through the tissue 216, the mechanical waveguide 210 may be removed from the inner lumen 204 and the suturing may be performed using the suture thread 214.

[0096] In one embodiment, the cross section of the inner lumen 204 is circular so that a cylindrical waveguide may be inserted into the lumen 204. However, it should be understood that other shapes for the cross-section of the lumen 204 may be contemplated as long as a mechanical waveguide may be inserted into the lumen. For example, the cross-section of the lumen may be rectangular, square, hexagonal or the like.

[0097] It should be understood the shape and/or size of the needle 200 may vary along the length thereof. Similarly, the shape and/or size of the lumen 204 may vary along the length thereof in order to facilitate insertion and withdrawal of the mechanical waveguide 210. [0098] Figures 3 to 6 illustrate a further embodiment of a suture needle 300. In this embodiment, the suture needle 300 has a curved shape and comprises an elongated body 302 having substantially a circular cross-section. The elongated body 302 extends longitudinally between a connecting or proximal end 304 and a distal or puncturing end 306. The external diameter of the elongated body 302 is substantially constant along a length thereof except for a distal section 308 adjacent to the puncturing end 306 in which the external diameter decreases towards the puncturing end 306.

[0099] As illustrated in Figure 6, the elongated body 302 is provided with a first aperture 310 on a concave or internal portion and a second aperture 312 located at the puncturing end 306. A lumen 314 extends between the first and second apertures 310 and 312 along a section of the length of the elongated body 302. The lumen 314 is shaped and sized for receiving therein a mechanical waveguide. While in the illustrated embodiment, the lumen 314 has a circular cross-section, it should be understood that the lumen 314 may have any other adequate shape as described above.

[00100] The elongated body 302 is also provided with a recess or cavity 320 which extends from the proximal end 304 of the elongated body 302 along a given section of the length of the elongated body 302. The cavity 320 is used for securing a suture thread to the suture needle 300. For example, the distal end of the suture thread may be inserted into the cavity 320 and maintained in position using an adhesive. In another example, the cross- sectional size of the cavity 320 may be less than that of the distal end of the suture thread so that the suture thread, once inserted into the cavity 320, may be maintained in position into the cavity 320 via compression forces.

[00101] The elongated body 302 is further provided with a substantially flat section 322 for manipulating the suture needle 300 as described below. In the illustrated embodiment, the flat section 322 is located adjacent to the proximal end 304 of the elongated body 302 on an internal or concave portion 324 of the elongated body 302. While the flat section 322 is provided with a substantially rectangular shape, it should be understood that the flat section 322 may have any other adequate shape such as a circular shape, an oval shape, or the like. It should also be understood that the section 322 may not be flat. For example, the section 322 may be texturized so as to form a grip for allowing clamps to hold the suture needle 300. In one example, the section 322 may comprise a series of recesses and protrusions forming together teeth.

[00102] While the flat section 322 is located on the internal or concave portion 324 of the elongated body 302, it should be understood that the flat section may be located on another portion of the elongated body 302. For example, the flat section 322 may be located on the external or convex portion 326 of the elongated body 302. Similarly while the flat section 322 is located adjacent to the end 304 of the elongated body 302, it should be understood that the flat section 322 may be located at any other adequate location. For example, the flat section 322 may be located adjacent to the waveguide receiving aperture 310 between the waveguide receiving aperture 310 and the end 306 of the elongated body 306.

[00103] It should also be understood that the elongated body 302 may be provided with more than one flat or grip section. For example, the elongated body 302 may comprise the flat section 322 located on the internal or concave portion 324 of the elongated body 302 and another flat section located on the external or convex portion 326 facing the flat section 322.

[00104] While the waveguide receiving aperture 310 is located on the internal or concave portion 324 of the elongated body 302, it should be understood that the waveguide receiving aperture 310 may be located on any other adequate position on the elongated body 302. For example, the waveguide receiving aperture 310 could be located on the external or convex portion 326 of the elongated body 302.

[00105] While the lumen 314 and the cavity 320 are each provided with a circular cross- section, it should be understood that the lumen 314 and/or the cavity 320 may have any other adequate cross-sectional shape as long as the lumen 314 is shaped and sized for receiving therein a mechanical waveguide and the cavity 320 allows for securing a suture thread therein.

[00106] As illustrated in Figures 7 and 8, a suture thread 350 is secured in the cavity 320 of the elongated body 302 located at the proximal end 304 thereof. The distal end of a mechanical waveguide (not shown) is inserted into the lumen 314 via the aperture 310 of the elongated body 302. The mechanical waveguide is pushed into the lumen 314 until the distal end of the mechanical waveguide be adjacent to the puncturing end 306 of the elongated body 302.

[00107] The proximal end of the mechanical waveguide is operatively connected to a pulse generator configured for generating high amplitude and short duration mechanical pulses that propagate from the proximal end of the mechanical waveguide up to the distal end of the mechanical waveguide.

[00108] In use, after securing the suture thread 350 to the suture needle 300 and inserting the mechanical waveguide into the lumen 314 of the elongated body 302, the suture needle 300 may be manipulated using clamps 352 as illustrated in Figures 7 and 8. The clamps 352 hold the suture needle 300 at the flat section 322. The suture needle 300 is then positioned to align its puncturing end 306 with a desired position on a calcified tissue, bone or cartilage 360 in order to penetrate the calcified tissue, bone or cartilage 360, as illustrated in Figure 9. The mechanical waveguide 362 is pushed into the lumen 324 so that its distal end abuts against the calcified tissue, bone or cartilage 360. The mechanical pulse generator that is operatively connected to the proximal end of the mechanical waveguide is then actuated for generating mechanical pulses, each having a high amplitude and short duration. As the mechanical pulses arrive at the distal end of the mechanical waveguide 362, a movement is created. This movement may be along the longitudinal axis of the mechanical waveguide. Alternatively, the movement may be in a direction other than along the longitudinal axis of the mechanical waveguide such as perpendicularly to the longitudinal axis. In another example, the movement may be a combination of movements along both the longitudinal axis and the perpendicular axis of the mechanical waveguide.

[00109] During this movement, the distal end of the mechanical waveguide 362 first moves towards the calcified tissue and then moves back into its initial position. As described above, it should be understood that the movement may be inverted depending on the polarity of the mechanical pulse reaching the distal end of the mechanical waveguide 362.

[00110] In one embodiment, successive and repeated distinct mechanical pulses arriving at the distal end of the mechanical waveguide 362 triggers a jackhammer movement thereof which may be used to penetrate into the calcified tissue to be sutured 360. [00111] As the tissue 360 is cracked, the mechanical waveguide 362 is further pushed into the lumen 314 so that its distal end protrudes from the puncturing end 306 of the elongated body 302 and further penetrates into the calcified tissue 360.

[00112] Once the calcified tissue has been cracked, eroded, cleaved, tunneled and/or broken, the mechanical waveguide is removed from the suture needle 300 and the needle may be used for suturing the tissue.

[00113] It should be understood the shape and/or size of the needle 300 may vary along the length thereof. Similarly, the shape and/or size of the lumen 314 may vary along the length thereof in order to facilitate insertion and withdrawal of the mechanical waveguide 410.

[00114] In one embodiment, the suture thread 350 is chosen depending on the type of tissue being repaired and the duration of time needed for the suture to stay in place. As described above, the suture thread 350 may be of different kinds such as absorbable or non absorbable, monofilament or multifilament and the like.

[00115] Figure 10 illustrates one embodiment of a needle guide 400 used for guiding a suture needle to be used for suturing a tissue 401. The needle guide 400 has a curved shape and comprises an elongated body 402. The elongated body 402 extends between a distal or puncturing end 404 and a proximal or connecting end 406. The distal end 404 of the elongated body 402 is provided with an aperture 408 while the proximal end 406 is a provided with an aperture 410. The elongated body 402 is provided with a lumen 412 that extends between the apertures 408 and 410 along the length of the elongated body 402.

[00116] The size and shape of the lumen 412 are chosen so that a mechanical waveguide may be inserted into at least a portion of the lumen 412 and a suture needle may be inserted into the lumen 412. In the illustrated embodiment, the lumen 412 has a circular cross-section which has a constant diameter along the length of the lumen 412. In this case, a mechanical waveguide may be inserted into the lumen 412 via the aperture 410 and the distal end of the mechanical waveguide may protrude from the aperture 408 located at the distal end 404 of the elongated body 402. Similarly a suture needle may be inserted into the lumen 412 via the aperture 410 and the suture needle may exit the elongated body 402 via the aperture 408 located at the distal end 404 of the elongated body 402. In this case, the diameter of the lumen 412 is chosen to be greater than the cross-sectional dimension of the mechanical waveguide and that of the suture needle at all points along the length of the lumen 412.

[00117] In another embodiment, the diameter of the lumen is not constant along the length thereof. For example, over a given section of the lumen 412, the diameter of the lumen 412 may be greater than the cross-sectional dimension of the suture needle and less than the cross- sectional dimension of the mechanical waveguide. In this case, the suture needle may entirely be inserted within the lumen 412 via the aperture 410 and exit the elongated body 402 via the aperture 408 while the mechanical waveguide may only be inserted along a portion of the lumen 412 until its distal end abuts against the given section having a reduced diameter and cannot protrude from the distal end 404 of the elongated body 402.

[00118] In use, the mechanical waveguide is operatively connected to a pulse generator 420 adapted to generate high amplitude and short duration mechanical pulses. The distal end of the mechanical waveguide is inserted into the lumen 412 of the elongated body 402 via the aperture 410. The distal end 404 of the suture needle 400 is aligned with a desired position on the tissue 401 to be sutured. For example, the distal end 404 may be abutted against the tissue at the desired position.

[00119] If the distal end of the mechanical waveguide may protrude from the distal aperture 408 of the elongated body 402, the mechanical waveguide is pushed within the lumen 412 until the distal end of the mechanical waveguide abuts against the tissue 401. Mechanical pulses are then generated and propagated until the distal end of the mechanical waveguide where a movement is created. As described above, this movement of the distal end of the mechanical waveguide allows for cracking, eroding, cleaving, tunneling, crossing and/or breaking at least partially the calcified tissue 401. The mechanical waveguide is then removed from the elongated body 402 and the suture needle is inserted into the lumen 412 of the elongated body 402. It should be understood that the length of the suture needle is chosen so as to be longer than that of the needle guide 400. Once the suture needle has been inserted into the elongated body 402, the needle guide 400 is removed and the suture of the tissue 401 may be performed using the suture needle. [00120] If the distal end of the mechanical waveguide cannot protrude from the distal aperture 408 of the elongated body 402, then the needle guide 400 is used for cracking, eroding, cleaving, tunneling, crossing and/or breaking at least partially the calcified tissue 401. The mechanical waveguide is then inserted into the lumen 412 of the elongated body 402 and the mechanical waveguide is pushed until its distal end abuts against the reduced diameter section of the lumen 402. Mechanical pulses are then generated and propagated until the distal end of the mechanical waveguide. The mechanical pulses are at least partially coupled from the mechanical waveguide into the elongated body 402 and propagate up to the distal end 404 of the elongated body 402 where a movement is created. As described above, this movement of the distal end 404 of the elongated body 402 allows for cracking, eroding, cleaving, tunneling, crossing and/or breaking at least partially the calcified tissue 401. The mechanical waveguide is then removed from the elongated body 402 and the suture needle is inserted into the lumen 412 of the elongated body 402. It should be understood that the length of the suture needle is chosen so as to be longer than that of the needle guide 400. Once the suture needle has been inserted into the elongated body 402, the needle guide 400 is removed and the suture of the tissue 401 may be performed using the suture needle.

[00121] In one embodiment, the above-described suture needles and/or the suture needle guide are made of medical grade biocompatible material such as stainless steel, adapted to propagate mechanical waves. In an alternative embodiment, other medical grade biocompatible materials may be used, such as titanium alloys or titanium-nickel (nitinol) alloys.

[00122] In one embodiment the above-described suture needle is used during minimally invasive surgery guided by laparoscopy, fluoroscopy or ultrasound imaging to fix or improve fixation of an implanted device as such implanted cardiac valve.

[00123] As described above, the waveguide receiving aperture 310 may be located at any adequate location on the elongated body forming the suture needle. Figure 11 illustrates one embodiment of a suture needle 500 comprising a curved elongated body 502 extending longitudinally between a proximal end 504 and a distal end 506. The elongated body 502 extends laterally between an internal or concave side 508 and an external or convex side 510. The distal end 506 is provided with an aperture 512 while the convex side 510 of the elongated body 502 is provided with an aperture 514. A lumen 516 extends between the apertures 512 and 514 so that a mechanical waveguide may be inserted into the lumen 516 via the aperture 514 and protrude from the aperture 512.

[00124] While for the suture needle 300 the aperture 310 for inserting a mechanical waveguide is located closer to the proximal end 304 of the elongated body 302 than to the distal end 306 of the elongated body 302, Figure 11 illustrates an embodiment of a suture needle 500 in which the aperture 514 for inserting a mechanical waveguide is located closer to the distal end 506 of the elongated body 502 than to the proximal end 504 of the elongated body 502.

[00125] While the above-described embodiments show a lumen enclosed and extending within the elongated body for receiving a mechanical waveguide therein, Figures 12 and 13 illustrate a puncture needle 600 which comprises a rail or elongated recess for receiving a mechanical waveguide therein.

[00126] The puncture needle 600 comprises an elongated body 602 extending between a proximal end 604 and a distal or puncturing end 606 having a sharp shape adequate for puncturing a tissue. In the illustrated embodiment, the elongated body 602 is curved. However, it should be understood that the elongated body 602 may be provided with any other adequate shape.

[00127] The elongated body 602 is provided with an elongated recess or rail 610 which extends longitudinally from the distal end 606 of the elongates body 620 towards the proximal end 604 along a portion of the length of the elongated body 602. In the illustrated embodiment, the rail 610 is located on the concave side/face 612 of the elongated body 602. However, it should be understood that the rail 610 could be located on another side/face of the elongated body 602. For example, the rail 610 could be located on the convex side/face of the elongated body 602.

[00128] The rail 610 is designed so as to receive therein a mechanical waveguide. Any adequate method/device for removably securing the mechanical waveguide within the rail 610 may be used. For example, a tubular connector may be used. The tubular connector may comprise two half tubular portions hingedly secured together on one side and connectable together on the other side. Once the mechanical waveguide has been inserted into the rail 610, the connector is secured over the elongated body 602. For example, the connector may be positioned over the elongated body 602 with the mechanical waveguide received in the rail 610 at the proximal end of the rail 610.

[00129] In one embodiment, the mechanical waveguide is slidably received within the rail 610 so that the distal end of the mechanical waveguide may protrude from the distal end 606 of the elongated body 602 in order to penetrate into a tissue.

[00130] As illustrated in Figures 12 and 13, clamps 614 can be used to manipulate the puncture needle 600 and a suture thread 616 is securable to the distal end 604 of the elongated body 602.

[00131] While the rail 610 extends along only a portion of the length of the elongated body, it should be understood that the rail 610 may extend from the distal end 606 of the elongated body 602 up to the proximal end 604 along the entire length of the elongated body 602.

[00132] In the following there is described an exemplary mechanical pulse generator that can be used for generating mechanical pulses for weakening a calcified tissue.

[00133] The mechanical pulse generator is configured to generate high amplitude and short duration mechanical pulses.

[00134] In one embodiment, the high amplitude and short duration mechanical pulse produced by the pulse generator has a center frequency fc comprised between about 20 kHz and about 10 MHz. In one embodiment, the duration of the mechanical pulse generated by the mechanical pulse generator is less than 10 microseconds, preferably around 1 microsecond, and may have an amplitude greater than 5 MPa, preferably greater than 10 MPa. In some embodiments, such values for the duration and amplitude of the mechanical pulse optimize the drilling efficiency of the jackhammer movement at the distal end of the mechanical waveguide when a series or sequence of mechanical pulses is generated. [00135] The pulse generator may comprise one broadband source and/or one narrow band source. The narrow or broadband source may be an electromechanical transducer that converts electrical energy into mechanical energy.

[00136] In one embodiment, the pulse generator comprises a plurality of broadband sources and/or a plurality of narrowband sources. The outputs of several sources covering adjacent frequency bands are combined to generate the mechanical pulse. In one embodiment, the outputs of at least two broadband sources, i.e., the mechanical pulses generated by the at least two broadband sources, are combined. In another embodiment, the outputs of at least one broadband source and at least one narrowband source are combined.

[00137] In another embodiment, the mechanical pulse is generated by focusing, via a pulse focusing device, the output of a large broadband source toward a focal zone. It should be understood that the outputs of more than one large broadband source may be concurrently focused on the same focal zone.

[00138] In one embodiment, the pulse focusing device is a spatial concentrator, an acoustic lens, an acoustic mirror or the like.

[00139] In a further embodiment, a high amplitude mechanical pulse may be generated by spatially and/or temporally combining mechanical pulses or waves sequentially emitted by a single broadband source using a reverberating cavity. It should be understood that the mechanical pulses generated by more than one broadband source may be spatially and/or temporally combined together by a reverberating cavity to provide the high amplitude mechanical pulse.

[00140] In still another embodiment, high amplitude mechanical pulses may be generated by using a dispersive medium and/or a dispersive geometry to combine the component waves emitted sequentially by a single broadband source. It should be understood that the mechanical pulses generated by more than one source may be combined together using the dispersive medium or the dispersive geometry.

[00141] In still a further embodiment, the mechanical pulse may be amplified. In an embodiment in which a temporal concentrator is present, the mechanical wave becomes a mechanical pulse of which the amplitude is greater than that of each component wave of the mechanical wave. In an embodiment in which a spatial concentrator is present, the amplitude of a mechanical pulse or wave is increased while propagating through the spatial concentrator. In another embodiment in which a spatial concentrator is present, different mechanical waves or pulses are combined to generate a greater amplitude mechanical wave or pulse, i.e. the different mechanical waves or pulses add to each other.

[00142] In one embodiment, the amplitude of the mechanical pulse when reaching the distal end of the mechanical waveguide is comprised between about 1 MPa and about 1000 MPa. In one embodiment, the duration of the short duration mechanical pulse when reaching the distal end of the transmission member is in the order of l/fc.

[00143] In one embodiment, the mechanical waveguide is made of medical grade biocompatible material such as stainless steel, nitinol or a titanium alloy, although other materials may be used.

[00144] The embodiments described above are intended to be exemplary only. The scope of the invention is therefore intended to be limited solely by the appended claims.