HK40002541B - Catheter device for delivering mechanical waves - Google Patents

Description

Catheter device for transmitting mechanical waves

Technical Field

The present invention relates to the field of medical catheters, and more particularly to a catheter suitable for transmitting shock waves for medical treatment of cells, tissues or organs.

Background Art

Non-invasive therapies using ultrasound or shock waves are commonly used to treat various medical conditions, such as kidney stones and prostate cancer. This treatment method or procedure is attractive because the source of the mechanical waves is located outside the patient's body and delivered through the skin. Therefore, this procedure can be considered non-invasive. By properly designing the mechanical energy source, the delivered energy can be focused directly on the target being treated within the body. However, these techniques have limitations. For example, the exact location of the target can be difficult to determine due to the limitations of the imaging methods used. Furthermore, due to the physical limitations of the focused waves themselves and the heterogeneity within the various tissues and organs through which the waves must propagate, the energy may not be accurately focused at the desired location. Finally, the energy density at the target may be insufficient to achieve the desired treatment.

Therefore, there is a need for an improved method and apparatus for delivering shock waves to target cells, tissues, or organs.

Summary of the Invention

According to a broad aspect, there is provided a catheter device comprising: an internal elongated and hollow body extending along a longitudinal axis between a proximal end and a distal end, the internal elongated and hollow body defining a longitudinal bore extending between the proximal end and the distal end thereof, the longitudinal bore being shaped and sized to accommodate a guidewire therein; and at least one mechanical waveguide secured to the internal elongated and hollow body and extending longitudinally along at least a portion of the internal elongated and hollow body, the at least one mechanical waveguide being adapted to propagate at least one mechanical wave therealong.

In one embodiment, the catheter device further comprises an outer elongated hollow body defining a cavity, an inner elongated hollow body and at least one mechanical waveguide inserted into the cavity, the at least one mechanical waveguide being located between the inner elongated hollow body and the outer elongated hollow body.

In one embodiment, the catheter device further comprises at least one plate projecting outwardly from an outer surface of the inner elongated and hollow body, each plate being at a respective position along the length of the inner elongated and hollow body, each of the at least one plate comprising at least one waveguide receiving hole therethrough, each of the at least one waveguide receiving hole having a respective one of the at least one mechanical waveguide inserted therein.

In one embodiment, each of the at least one plate is integrally formed with the inner elongated and hollow body.

In another embodiment, each of the at least one plate is independent of the inner elongated and hollow body and fixedly secured thereto, and each of the at least one plate has a main hole into which the inner elongated and hollow body is inserted.

In one embodiment, the at least one waveguide receiving aperture comprises a plurality of waveguide receiving apertures.

In one embodiment, the waveguide receiving apertures are arranged according to at least one row.

In one embodiment, on each of the at least one plate, the waveguide receiving holes are symmetrically positioned.

In another embodiment, on each of the at least one plate, the waveguide receiving apertures are asymmetrically positioned.

In one embodiment, the at least one plate comprises a plurality of plates.

In one embodiment, a position of a given one of the plurality of waveguide receiving apertures, in which the same one of the at least one mechanical waveguide is inserted, varies from one of the plurality of panels to another of the plurality of panels.

In one embodiment, the distance between the center of the inner elongated and hollow body and the center of the waveguide receiving aperture varies along the length of the inner elongated and hollow body.

In one embodiment, a distance between adjacent plates of the plurality of plates is constant along the inner elongated and hollow body.

In another embodiment, the distance between adjacent plates in the plurality of plates varies along the inner elongated hollow body.

In one embodiment, at least one plate has one of a circular, square, rectangular, triangular, and hexagonal shape.

In one embodiment, at least one waveguide receiving aperture has one of a circular, square, rectangular, triangular, and hexagonal shape.

In one embodiment, at least one panel is made of acoustically insulating material.

In one embodiment, the catheter arrangement further comprises at least one acoustic insulator, each acoustic insulator being interposed around a respective one of the at least one mechanical waveguide.

In one embodiment, each of the at least one mechanical waveguide is provided with a respective one of the at least one acoustic insulator.

In one embodiment, the at least one acoustic insulator each comprises at least one wire, each wire being wound around a respective one of the at least one mechanical waveguide.

In one embodiment, the at least one wire has a helical shape to form a helical winding around a respective one of the at least one mechanical waveguide.

In one embodiment, the axial pitch of the helical windings is constant along the length of a respective one of the at least one mechanical waveguide.

In another embodiment, the axial pitch of the helical windings varies along the length of a respective one of the at least one mechanical waveguide.

In one embodiment, the axial spacing is greater than a cross-sectional dimension of at least one of the wires.

In one embodiment, at least one wire is made of acoustically insulating material.

In one embodiment, the at least one wire has one of a circular, square, rectangular, triangular and hexagonal cross-sectional shape.

In one embodiment, the at least one acoustic insulator comprises at least one mesh, each mesh being inserted around a respective one of the at least one mechanical waveguide.

In one embodiment, the pattern of at least one web is constant along a respective one of the at least one mechanical waveguide.

In another embodiment, the pattern of at least one web varies along a respective one of the at least one mechanical waveguide.

In one embodiment, at least one acoustic insulator extends along at least a longitudinal portion of a respective one of the at least one mechanical waveguide.

In one embodiment, a given portion of a respective one of the at least one mechanical waveguide is not covered by the at least one acoustic insulator.

In one embodiment, the at least one acoustic insulator is made of an acoustic insulating material.

In one embodiment, the outer elongated hollow body is flexible to correspond to the sheath.

In one embodiment, the distal end of the at least one mechanical waveguide is movable along the longitudinal axis relative to the distal end of the inner elongated hollow body.

In one embodiment, the distal end of the at least one mechanical waveguide is further one of radially and laterally movable relative to the distal end of the outer elongated hollow body.

In one embodiment, the catheter device further comprises at least one arm extending between the inner elongated hollow body and the outer elongated hollow body.

In one embodiment, at least one arm is made of an acoustically insulating material.

In one embodiment, at least one of the inner elongated hollow body and the outer elongated hollow body is made of an acoustically insulating material.

In one embodiment, at least one of the inner elongated hollow body and the outer elongated hollow body is made from one of a polymer and a graded polymer.

In one embodiment, at least one of the outer elongated and hollow body, the inner elongated and hollow body, and the at least one mechanical waveguide have a circular cross-sectional shape.

In one embodiment, the at least one mechanical waveguide comprises a plurality of mechanical waveguides.

In one embodiment, the mechanical waveguides are positioned symmetrically around the inner elongated and hollow body.

In one embodiment, the mechanical waveguide is arranged according to at least one row of waveguides around the inner elongated and hollow body.

In one embodiment, the catheter device further comprises at least one tube inserted into the outer elongated hollow body.

In one embodiment, at least one tube is adapted to blow fluid at its distal end.

In another embodiment, the at least one tube is adapted to aspirate at least one of fluid and debris from a distal end thereof.

In one embodiment, the outer elongated hollow body comprises a mesh sleeve.

In one embodiment, at least one mechanical waveguide has a distal beveled end.

In one embodiment, at least one mechanical waveguide is provided with one of a circular, square, rectangular, triangular and hexagonal cross-sectional shape.

In one embodiment, the distal end of the at least one mechanical waveguide is coplanar with the distal end of the inner elongated hollow body.

In another embodiment, the distal end of the at least one mechanical waveguide projects forwardly from the distal end of the inner elongated hollow body.

In one embodiment, the at least one mechanical waveguide is movable relative to the inner elongated and hollow body.

In one embodiment, the cross-sectional shape of the longitudinal hole is one of circular, square, rectangular and hexagonal.

In one embodiment, the cross-sectional shape of the outer elongated hollow body is one of circular, square, rectangular, and hexagonal.

In one embodiment, the catheter device further comprises a radiopaque element.

In one embodiment, the radiopaque element comprises a radiopaque ring.

In one embodiment, a radiopaque ring is secured to the outer elongated hollow body.

In one embodiment, the catheter device further comprises a drug capsule located distal to the at least one mechanical waveguide.

For the purposes of this specification, a mechanical wave is understood to be a signal with arbitrary amplitude, duration, waveform, frequency, etc. For example, a mechanical wave can have high/low amplitude, short/long duration, different waveforms, and any frequency content.

For the purposes of this specification, a mechanical pulse is understood to be a mechanical wave of short duration. The duration of a mechanical pulse is approximately 1/fc.

In one embodiment, the center frequency fc of the mechanical pulse is between about 20 kHz and about 10 MHz. In one embodiment, the amplitude of the mechanical pulse upon reaching the distal end of the catheter device is between about 10 MPa and about 1000 MPa. In one embodiment, the duration of the mechanical pulse upon reaching the distal end of the catheter device is about 1/fc.

In one embodiment, the amplitude of the mechanical pulse upon reaching the distal end of the catheter device is between about 10 MPa and about 1000 MPa.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings, in which:

FIG1 is a block diagram illustrating a system for treating a lesion according to an embodiment;

2 shows a catheter device according to an embodiment, the catheter device including a sheath, a central catheter, and four mechanical waveguides inserted between the sheath and the central catheter and evenly arranged around the circumference of the central catheter;

3 shows a catheter device according to an embodiment, the catheter device including a sheath, a central catheter, and five mechanical waveguides inserted between the sheath and the catheter and asymmetrically arranged around the circumference of the central catheter;

FIG4 illustrates a catheter device according to an embodiment, comprising a sheath, a central catheter, and two rows of mechanical waveguides inserted between the sheath and the catheter;

5 is a cross-sectional view of a catheter device including two mechanical waveguides having angled distal ends, according to an embodiment;

6a is a side view of a catheter apparatus according to an embodiment, the catheter apparatus comprising a sheath, a central catheter, and four mechanical waveguides inserted between the sheath and the central catheter, the mechanical waveguides being movable radially and outwardly away from the sheath;

FIG6 b is a front view of the catheter device of FIG6 a when the mechanical waveguide is in a retracted position;

FIG6 c is a front view of the catheter device of FIG6 a when the mechanical waveguide is in an extended position;

7a is a side view of a catheter apparatus according to an embodiment, the catheter apparatus comprising a sheath, a central catheter, and four mechanical waveguides inserted between the sheath and the central catheter, the mechanical waveguides being movable laterally and outwardly away from the sheath;

FIG7 b is a front view of the catheter device of FIG7 a when the mechanical waveguide is in a retracted position;

FIG7 c is a front view of the catheter device of FIG7 a when the mechanical waveguide is in an extended position;

FIG8 shows a catheter device according to an embodiment, comprising a catheter provided with a plurality of plates and sleeves;

FIG9 shows a conduit provided with a plurality of plates of FIG2 according to an embodiment;

FIG10 shows a disc-shaped plate according to an embodiment;

FIG11 a shows a plate provided with a single hole according to an embodiment;

FIG11b is a partial cross-sectional view of the plate of FIG11a;

FIG12 shows a catheter device according to an embodiment, the catheter device comprising a central catheter, a plurality of mechanical waveguides, and a tubular sleeve, each mechanical waveguide being provided with a helical wire;

FIG13 shows a catheter device according to an embodiment, the catheter device comprising a central catheter, a plurality of mechanical waveguides, and a tubular sleeve, each mechanical waveguide being provided with a tubular mesh; and

14 illustrates a catheter device including a central catheter, a plurality of mechanical waveguides, and a mesh sleeve, according to an embodiment.

It should be noted that throughout the drawings, like features are identified by like reference numerals.

DETAILED DESCRIPTION

1 illustrates one embodiment of a system 10 for treating a lesion 12 to illustrate the specific environment in which the present catheter is used. The system 10 includes a pulse generator 14 and a transmission member 16 adapted to propagate mechanical waves or pulses.

The pulse generator 14 is adapted to generate mechanical waves, such as high-amplitude, short-duration mechanical pulses. The pulse generator 14 may include at least one broadband source and/or at least one narrowband source. The narrowband or broadband source may be an electromechanical transducer. The pulse generator 14 may include a spatial concentrator to focus the output of the at least one source to a focal region located at the proximal end of the transmission member 16, thereby coupling the generated mechanical pulses therein.

A transmission member 16, such as a mechanical waveguide, extends between a first or proximal end and a second or distal end, the first or proximal end being operably connected to the pulse generator 14. The transmission member 16 is adapted to receive a mechanical pulse at its proximal end and propagate the mechanical pulse to its distal end. When the mechanical pulse reaches the distal end, it is at least partially transmitted to produce a transmission pulse that propagates outside the transmission member 16. It should be understood that the pulse may also be reflected by the distal end and propagate back within the transmission member 16 toward its proximal end. The transmitted mechanical pulse corresponds to a mechanical pulse that propagates in the medium surrounding the distal end of the transmission member 16 until it reaches the lesion 12. The transmitted pulse further propagates into the lesion 12, which may create cracks within the lesion 12 and ultimately cut or destroy the lesion 12 into fragments.

In embodiments where the distal end of the transmission member 16 abuts the lesion 12, the mechanical waveguide 16 can further be used to disrupt and/or drill a hole in the lesion 12. The transmission of the mechanical pulse at the distal end of the transmission member 16 produces motion of the distal end of the transmission member 16. This motion can be along the longitudinal axis of the transmission member 16. Alternatively, the motion can be perpendicular to the longitudinal axis, or it can be a combination of motion along the longitudinal axis and perpendicular to the longitudinal axis of the transmission member. During this motion, the distal end of the transmission member 16 nominally moves first toward the lesion 12 and then back to its initial position. It should be understood that depending on the polarity of the mechanical pulse reaching the distal end of the transmission member 16, the motion can be reversed (i.e., the distal end can first move away from the lesion 12 and then toward the lesion 12). When multiple different mechanical pulses are transmitted sequentially at the distal end of the transmission member 16, the motion of the distal end can be considered a pneumatic hammer motion that can be used to treat the lesion 12.

FIG2 illustrates one embodiment of a catheter device or assembly 20 that may be used as a transmission member, such as transmission member 16 of FIG1, for propagating mechanical waves or pulses from an extracorporeal mechanical energy source.

The catheter device 20 includes an elongated, hollow body or cannula 22 extending between a proximal end 24 and a distal end 26. The catheter device 20 may also include a catheter or guide elongated, hollow body 28 inserted into the body 22 and extending between a proximal end (not shown) and a distal end 30. The guide body 28 is hollow to allow a guide wire to extend through it from its proximal end to its distal end 30. The catheter 20 also includes four mechanical waveguides 32, 34, 36, and 38, each of which is inserted into the body 22 between the body 28 and the body 22 and each of which extends between a proximal end (not shown) and a distal end 32a, 34a, 36a, and 38a, respectively. The mechanical waveguides 32, 34, 36, and 38 are designed so that mechanical waves or pulses can propagate along them.

In one embodiment, the catheter device 20 further includes at least one arm extending radially between the catheter 28 and the inner surface of the body 22 for securing the catheter 28 and the body 22 together. In one embodiment, the arm is made of an acoustically insulating material. In another embodiment, the catheter 28 and the mechanical waveguides 32, 34, 36, and 38 are retained in the body 22 by pressure. In this case, when inserted into the body 22, the mechanical waveguides 32-38 are in physical contact with the outer surface of the catheter 28 and the inner surface of the body 22. The inner diameter of the body 22 substantially corresponds to the sum of the outer diameter of the catheter 28 and twice the diameter of the mechanical waveguides 32-38.

In one embodiment, the body 22 can be omitted. In this case, the mechanical waveguides 32, 34, 36, and 38 are secured to the conduit 28. It should be understood that any suitable method for securing the mechanical waveguides 32, 34, 36, and 38 to the conduit 28 can be used. For example, the mechanical waveguides 32, 34, 36, and 38 can be glued to the conduit 28. In another example, a wire can be wrapped around the mechanical waveguides 32, 34, 36, and 38 to secure the mechanical waveguides 32, 34, 36, and 38 to the conduit 28.

In one embodiment, the body 22 can be made of a flexible material to correspond to the sheath. In one embodiment, the body 22 can be made of an acoustic insulating material. In one embodiment, the body 22 can be a single or multiple smaller diameter wires.

In use, a guidewire is inserted into the patient's body to pass through or adjacent to the lesion to be treated. The proximal end of the guidewire is then inserted into the distal end 26 of the catheter 28, and the catheter device 20 is inserted into the patient's body. The guidewire is then used to guide the catheter device 20 upward to the lesion to be treated by sliding the catheter device 20 along the guidewire. When the catheter device 20 is adequately positioned relative to the lesion to be treated, a mechanical pulse is generated and propagated along the mechanical waveguides 32, 34, 36, and 38 to treat the lesion.

Although in the illustrated embodiment, the distal ends of the mechanical waveguides 32, 34, 36, and 38 are coplanar with the distal end 26 of the body 22 and the distal end of the conduit 28, it should be understood that other configurations are possible. For example, the distal ends of the mechanical waveguides 32, 34, 36, and 38 may protrude from the distal end 26 of the body 22 and/or the distal end of the conduit 28. In another example, the distal end of the body 22 and/or the distal end of the conduit 28 may protrude from the distal ends of the mechanical waveguides 32, 34, 36, and 38. In another example, the distal ends of some of the mechanical waveguides 32, 34, 36, and 38 may protrude from the distal end of the body 22, while other mechanical waveguides 32, 34, 36, and 38 may have distal ends that are coplanar with the distal end of the body 22.

Although the catheter device 20 includes four mechanical waveguides 32, 34, 36, and 38, it should be understood that the number of mechanical waveguides inserted into the body 22 can vary, as long as the catheter device 20 includes at least one mechanical waveguide. Similarly, the shape, size, and location of the mechanical waveguides within the body 22 can vary.

Although the conduit 28 and the body are shown concentrically in FIG2 , it should be understood that other configurations are possible. For example, the mechanical waveguide on one side of the conduit 28 may have a larger diameter than the mechanical waveguide on the opposite side of the conduit, such that the conduit 28 is not centered about the central longitudinal axis of the body 22.

Although in the illustrated embodiment, the body 22, conduit 28, and waveguides 32, 34, 36, and 38 all have cylindrical shapes, it should be understood that the body 22, conduit 28, and/or waveguides 32, 34, 36, and 38 may have other shapes. For example, the conduit 28 may have a hexagonal cross-sectional shape. The mechanical waveguides 32, 34, and 36 may have a hexagonal or triangular cross-sectional shape.

Although in the illustrated embodiment, the waveguides 32, 34, 36, and 38 are positioned symmetrically around the catheter 28, it should be understood that the positions of the waveguides 32, 34, 36, and 38 relative to the catheter 28 can vary. FIG3 shows a catheter device 50 comprising an elongated, hollow body or sleeve 52 into which a catheter 54 and five mechanical waveguides 56, 57, 58, 59, and 60 are inserted. The five mechanical waveguides 56, 57, 58, 59, and 60 are inserted between the body 52 and the catheter 56 such that two adjacent mechanical waveguides 56, 57, 58, 59, and 60 are in physical contact. In the illustrated embodiment, the mechanical waveguides are positioned around approximately half of the circumference of the catheter 54.

While the catheter devices 20 and 50 include a single layer of mechanical waveguides in the above-described embodiments, it should be understood that the mechanical waveguides can be arranged to form more than one layer. FIG4 illustrates one embodiment of a catheter device 70 that includes two or more rows of mechanical waveguides. The catheter device 70 includes an elongated, hollow body or cannula 72, a concentrically positioned conduit 74, a first row of mechanical waveguides 76, and a second row of mechanical waveguides 78. The first row of mechanical waveguides 76 is positioned between the central conduit 74 and the inner surface of the body 72, while the second row of mechanical waveguides 78 is positioned between the first row of mechanical waveguides 76 and the inner surface of the body 72.

The first row of mechanical waveguides 76 can be evenly distributed around the circumference of the conduit 74 and in physical contact with the conduit 74. Adjacent waveguides 76 can be in physical contact with each other or spaced apart from each other to avoid coupling between adjacent waveguides 76. The second row of mechanical waveguides 78 can be evenly distributed around the circumference of the first row of mechanical waveguides 76. Adjacent waveguides 78 can be in physical contact with each other or spaced apart from each other to avoid coupling between adjacent waveguides 78.

In one embodiment, waveguide 76 is in physical contact with waveguide 78. In another embodiment and as shown in FIG4 , catheter device 70 further includes an elongated, hollow body or sleeve 80 that is interposed between the first and second rows of mechanical waveguides. The diameter of hollow body 80 can be equal to the sum of the outer diameter of catheter 74 and twice the diameter of mechanical waveguide 76. In one embodiment, body 80 can be a sheath made of an acoustically insulating material to isolate first row of mechanical waveguides 76 from second row of mechanical waveguides 78.

Although in the above-described embodiment, the distal end of the mechanical waveguide is planar and right-angled, i.e., the surface of the distal end is perpendicular to the longitudinal axis along which the mechanical waveguide extends, it should be understood that other configurations are possible. For example, FIG5 shows a cross-section of a catheter device 90, which includes an elongated, hollow body or cannula 92, a centrally located catheter 94, and two mechanical waveguides 96 inserted between the hollow body 92 and the catheter 94. The distal ends 98 of the mechanical waveguides 96 are angled so that the plane in which the distal ends 98 extend intersects the longitudinal axis along which the mechanical waveguides 96 extend at an angle other than 90 degrees. Such an angled end 98 can facilitate penetration into the target tissue to be treated.

In one embodiment, the mechanical waveguide has a fixed position relative to the catheter 28, 54, 74, 94 and/or the outer body 22, 52, 72, 92. In another embodiment, the mechanical waveguide can be adapted to move longitudinally relative to the outer body and/or the inner catheter. For example, the mechanical waveguide can be movable between a retracted position and an extended position relative to the outer body and the inner catheter. When the mechanical waveguide is in the retracted position, the distal end of the mechanical waveguide can be coplanar with the distal end of the outer body and/or the distal end of the catheter. Alternatively, when the mechanical waveguide is in the retracted position, the distal end of the mechanical waveguide can be located between the distal end and the proximal end of the outer body. When the mechanical waveguide moves longitudinally and in a forward direction relative to the outer body and the inner catheter, the distal end of the mechanical waveguide reaches an extended position. In the extended position, the distal end of the mechanical waveguide is in a forward position relative to the distal end of the outer body and protrudes from the distal end of the outer body.

In embodiments where the mechanical waveguide is movable relative to the outer body, the distal end of the mechanical waveguide is moved in a straight line, i.e., along the longitudinal axis along which the mechanical waveguide extends. This can be achieved by moving the mechanical waveguide relative to a fixed sheath, by moving the sheath relative to a stationary mechanical waveguide, or by a combination thereof.

In another embodiment, the distal end of the mechanical waveguide can follow a curve when the mechanical waveguide is pushed and moves forward relative to the outer body. Figures 6a, 6b, and 6c show a catheter device 100 that includes an outer body or cannula 102, an inner catheter 104 concentrically positioned within the cannula 102, and four mechanical waveguides 106 interposed between the inner catheter and the outer cannula and evenly distributed around the circumference of the inner catheter 104.

FIG6 b shows an end view of the mechanical waveguide 106 in a retracted position. In this position, the distal end of the mechanical waveguide 106 is coplanar with the distal ends of the outer sheath and inner catheter, and the distance between the distal ends of the mechanical waveguide 106 is minimized. FIG6 c shows an end view of the mechanical waveguide 106 in an extended position, i.e., when the mechanical waveguide 106 is pushed forward relative to the sheath 102. In this configuration, the distance between the distal ends of the mechanical waveguide 106 is maximized. As the mechanical waveguide 106 moves forward, the distal end of the mechanical waveguide 106 moves forward away from the distal end of the sheath 102 and radially away from the axis of symmetry of the catheter 104. In this embodiment, the movement of the distal end of the mechanical waveguide 106 is symmetrical relative to the axis of symmetry of the catheter 104.

Figures 7a, 7b, and 7c illustrate another embodiment of a catheter device in which the mechanical waveguide moves nonlinearly. Catheter device 120 includes an outer sleeve or body 122, an inner catheter 124 concentrically positioned within sleeve 122, and four mechanical waveguides 126 interposed between the inner catheter and the outer sleeve and evenly distributed around the circumference of inner catheter 124.

FIG7 b shows an end view of the mechanical waveguide 126 in a retracted position. In this position, the distal end of the mechanical waveguide 126 is coplanar with the distal ends of the outer cannula and inner catheter, and the distance between the distal ends of the mechanical waveguide 106 is at a maximum. FIG7 c shows an end view of the mechanical waveguide 126 in an extended position, i.e., when the mechanical waveguide 126 is pushed forward relative to the cannula 122. In this configuration, the distance between the distal ends of the mechanical waveguide 106 is at a minimum. As the mechanical waveguide 126 moves forward, the distal end of the mechanical waveguide 106 moves forward, away from the distal end of the cannula 102, and laterally in the same direction.

It should be understood that any suitable method or device can be used to move the mechanical waveguide radially or laterally, as shown in Figures 6a-6c and 7a-7c. For example, when the mechanical waveguide is in its natural state, that is, when no force or constraint is applied, the mechanical waveguide can have a curved shape. In this case, Figures 6c and 7c show waveguides 106 and 126, respectively, in their natural state. By retracting or pulling the waveguides 106 and 126 backward toward the distal end of the cannula or body, or by pushing the cannula or body forward toward the distal tip of the waveguide, the mechanical waveguide is fully inserted into the cannula and adopts a straight shape.

In another example, a naturally curved rod can be affixed to each mechanical waveguide such that the portion of the mechanical waveguide extending outside the cannula has a curved shape. By pulling the mechanical waveguide backward, or by pushing the cannula forward toward the distal tip of the waveguide, the rod deforms such that the mechanical waveguide can assume a straight shape and extend along a straight longitudinal axis.

In another example, the catheter device may further include an extension device for each or a combination of the mechanical waveguides. The extension device is suitable for pushing the distal end of the mechanical waveguide laterally or radially while the mechanical waveguide is advanced away from the distal end of the cannula. For example, the extension device may have a structure substantially the same as an umbrella arm. In another example, the extension device may include an inclined plane, the axial translation of which can push the distal end of the mechanical waveguide laterally or radially. The inclined plane can be axisymmetric and partially or completely span the circumference of the device so as to push multiple mechanical waveguides laterally or radially. In both examples of the extension device, a mechanical element can be used to connect the proximal end of the catheter device to the extension device so as to allow the operator to push one or more mechanical waveguides laterally or radially. In another example, the extension device may include an inflatable structure, the inflation fluid (liquid or gas) of which can be supplied at the proximal end of the catheter device and delivered to the distal end.

It should be understood that the number, location, shape, and size of the mechanical waveguides 32, 34, 36, 38, 56, 76, 78, 96, 106, 126 can vary and be selected based on the desired energy deposition pattern at the distal tip of the catheter device. It should be understood that the mechanical waveguides 32, 34, 36, 38, 56, 76, 78, 96, 106, 126 are made of a material that allows mechanical wave propagation. In one embodiment, the mechanical waveguides 306, 326 can be made of titanium.

In another embodiment, the waveguides may be deflected radially or laterally around the conduit to change the overall outer diameter of the waveguide bundle or to change the symmetry of the arrangement, as shown in Figures 6c and 7c.

In one embodiment, the catheter device described above can allow for suction or insufflation from the spaces between the mechanical waveguides. Suction can be used to remove debris generated by the catheter device, and insufflation of fluid can be used to deliver fluids such as drugs to the target to be treated.

In one embodiment, the catheter device further comprises a tube extending between the mechanical waveguides for suction or insufflation purposes.

In one embodiment, the catheter device further comprises a tube extending between the mechanical waveguides to deliver a fluid, such as a drug, to the target to be treated.

In one embodiment, the catheter device may include a drug (or similar) capsule at the distal end of the mechanical waveguide bundle, which may be triggered (released) from the proximal end by a mechanism extending along the length of the catheter device.

In one embodiment, a drug (or similar) capsule may be located at the distal end of the mechanical waveguide bundle, and the capsule may be triggered (released) from the mechanical waves at the distal end of the device.

In one embodiment, the catheter device further comprises an optical coherence tomography (OCT) or intravascular ultrasound (IVUS) imaging device between the catheter and the sheath.

In one embodiment, the catheter device operates in a pulse-echo mode, wherein at least one mechanical waveguide is configured to transmit pulses from a pulse generator at its proximal end to a lesion to be treated at its distal end, and at least one mechanical waveguide is configured to receive pulses (i.e., echoes) reflected from the lesion and transmit the echoes from its distal end back to its proximal end, where the echoes can be measured and analyzed to determine mechanical properties of the lesion from which the echoes were received. The mechanical properties of the lesion obtained from the analyzed echoes can then be displayed to a user and optionally used to determine characteristics of the mechanical pulses to be delivered to the lesion.

In one embodiment, the catheter device is operated in pulse-echo mode as described above, and the analyzed echoes are used to adapt the pulses emitted by the pulse generator to the mechanical properties of the lesion to be treated in a closed-loop control method.

In embodiments where the catheter device includes more than one mechanical waveguide, pulses propagating in different mechanical waveguides arrive at the distal ends of the mechanical waveguides simultaneously because the wave velocity and length of each mechanical waveguide are the same and the pulses are generated simultaneously by the wave generator. If the wave velocity can vary from one mechanical waveguide to another, the length of the mechanical waveguides can be adjusted to ensure that pulses simultaneously emitted and propagating in different mechanical waveguides arrive at the distal ends of the mechanical waveguides simultaneously. In another embodiment, the length and/or wave velocity of the mechanical waveguides can be adjusted, for example, to ensure that mechanical pulses simultaneously emitted and propagating in different mechanical waveguides arrive at the distal ends of the mechanical waveguides with a predetermined delay between each mechanical waveguide.

In one embodiment, the size, shape, and/or material composition of at least two mechanical waveguides can differ to adjust the flexibility of the catheter device. In one embodiment, the size, shape, and/or material composition of at least two mechanical waveguides can differ along their length to adjust the flexibility of the catheter device along the length of the catheter device. For example, a first mechanical waveguide can have a constant diameter along its entire length, while a second mechanical waveguide can include a first portion having a first diameter and a second portion having a second and different diameter.

In embodiments where the catheter device includes at least two mechanical waveguides, the catheter device can be connected to more than one wave generator. Each wave generator is then connected to the distal end of at least one mechanical waveguide. For example, the proximal end of each mechanical waveguide can be connected to a corresponding wave generator, such that each wave generator is connected to a single mechanical waveguide.

In one embodiment, a radiopaque marker may be attached to the distal end of the catheter device.

In one embodiment, a catheter device can include a single mechanical waveguide connected to a pulse generator at its proximal end. At a point along its length distal to its proximal end, the mechanical waveguide splits into at least two mechanical waveguides, each of which extends to the distal end of the catheter device and can be arranged into the catheter device as described above. It should be understood that the catheter device can include more than one mechanical waveguide, each of which splits into at least two mechanical waveguides. The proximal end of each mechanical waveguide can be connected to a corresponding wave generator.

In one embodiment, the catheter device may include a side lumen that connects to the lumen of the inner catheter at a distance from its distal end, allowing for insertion of a guidewire in a rapid exchange configuration.

In one embodiment, the distal ends of at least two mechanical waveguides may be connected together by forging, brazing, welding, gluing or any other suitable fastening method. In one embodiment, the distal ends of the mechanical waveguides are connected together to form an annular structure at the distal end of the catheter device.

In one embodiment, the catheter device may be covered with a hydrophilic or hydrophobic or friction reducing coating or a combination thereof.

In one embodiment, the above-described catheter device can be used to treat calcified and fibrotic lesions while minimizing arterial wall tissue damage and embolus size.

Although in the above description, the catheter device includes a catheter, such as catheter 28, 54, 74, 94, 104 or 124, it should be understood that the catheter can be omitted. In this case, the guidewire is introduced into the outer sleeve between the mechanical waveguide and the inner surface of the sleeve or into the opening formed at the center of the mechanical waveguide bundle.

Hereinafter, a catheter device is provided, which includes a central catheter and a plurality of annular disks protruding radially outward from an outer surface of the central catheter. Each annular disk is provided with a plurality of waveguide receiving holes for removably or permanently fixing a mechanical waveguide to the central catheter.

FIG8 illustrates one embodiment of a catheter 200 device that can be used as a transmission member, such as transmission member 16 of FIG1, for propagating mechanical waves or pulses from an extracorporeal mechanical energy source.

Catheter device 200 comprises a first elongated and hollow body or sleeve 202, a second elongated and hollow body or catheter 204 and a plurality of mechanical waveguides 206. Sleeve 202 extends between a distal end 208 and a proximal end (not shown) along a longitudinal axis. Similarly, catheter 204 extends between a distal end 210 and a proximal end (not shown) along a longitudinal axis. Each mechanical waveguide 206 also extends longitudinally between a proximal end (not shown) and a distal end 212 along a longitudinal axis. Catheter 204 is provided with a central hole 213, which extends from its proximal end to its distal end 210 to receive a guide wire therein. The guide wire is used to guide catheter device 200 in the patient's blood vessel and to position the distal end of catheter device 200 in the appropriate position relative to the lesion to be treated.

9 , the catheter device 200 further includes a plurality of plates 214, each plate 214 projecting radially outwardly from the outer surface of the catheter 204 at a different location along the longitudinal axis of the catheter 204. In one embodiment, the plates 214 are evenly spaced apart along the catheter 204.

In the illustrated embodiment, the elements of catheter device 200 have circular cross-sections, i.e., cannula 202 and catheter 204 each have a tubular shape, mechanical waveguide 206 each has a cylindrical shape, and plates 214 each have an annular disk shape. Plates 214 each protrude radially outward from the outer surface of catheter 204 in a plane substantially orthogonal to the longitudinal axis of catheter 204. Each plate 214 extends along the entire circumference of the outer surface of catheter 204 to form an annular disk having a hole through which catheter 204 is inserted. The outer diameter of each plate 214 substantially corresponds to the inner diameter of cannula 202.

In addition, each plate 214 is provided with a plurality of holes 216, each hole 216 extending in thickness from its distal end 218 to its proximal end 220. The holes 216 are located at different angular positions along the circumference of the plate 214. In the illustrated embodiment, the holes 216 are evenly distributed around the circumference of the plate 214. However, those skilled in the art will appreciate that other configurations are possible.

Each hole 216 for a given plate 214 corresponds to a corresponding hole 216 in each of the other plates to form a set of aligned holes 216. Each hole 216 in the same set receives the same mechanical waveguide 206 therein. In the illustrated embodiment, all corresponding holes 216 within a set of aligned holes 216 have the same angular position on their respective plates 214, such that the centers of the corresponding holes 216 within the same set are aligned along the same longitudinal axis, which is parallel to the longitudinal axis of the conduit 204. However, those skilled in the art will appreciate that other configurations are possible. For example, each hole 216 in a set of holes for receiving the same mechanical waveguide 206 can have a different angular position along the length of the conduit 204, such that the mechanical waveguide 206, once inserted into the hole 216, has a spiral shape surrounding the conduit 204.

Each aperture 216 is sized and shaped to receive a corresponding mechanical waveguide 206 therein. As shown in Figures 8 and 9, the catheter device 200 includes nine mechanical waveguides 206, and each plate 214 includes nine apertures 216, each for receiving a corresponding mechanical waveguide 206. As described above, each of the nine apertures 216 of a given plate 214 is associated with corresponding apertures 216 of all other plates 214 to form a set of aligned apertures for receiving a corresponding one of the nine mechanical waveguides 206.

It should be understood that the number of plates 214, the number of holes 216 within the plates 214, and the number of mechanical waveguides 206 can vary, as long as the catheter device 200 includes at least one plate 214, at least one hole 216 per plate 214, and at least one mechanical waveguide 206 inserted into the at least one hole 216.

In one embodiment, the plates 214 and their holes 216 for receiving the waveguides 206 therein serve to prevent any physical contact between the mechanical waveguides 206 themselves, between the mechanical waveguides 206 and the conduit 24, and/or between the mechanical waveguides 206 and the sleeve 202, so as to at least limit or reduce coupling losses of mechanical waves propagating into the mechanical waveguides 206.

Once each waveguide 206 has been inserted into its corresponding set of holes 216, the mechanical waveguides 206 are paralleled together and positioned radially around the catheter 204. The sleeve 202 is then positioned over the plate 214 so that the sleeve 202 covers the catheter 204 and the waveguides 206. In one embodiment, the length of the sleeve 202 is substantially equal to the length of the catheter 204, so that the sleeve 202 covers the entire catheter 204. In another embodiment, the length of the sleeve 202 is shorter than the length of the catheter 204. For example, the length of the sleeve 202 may only cover the distal portion of the catheter 204 to be introduced into the patient's body.

In one embodiment, the mechanical waveguide 206 is positioned relative to the catheter 204 such that the distal end 212 of the mechanical waveguide 206 is coplanar with the distal end 210 of the catheter 204. In another embodiment, the mechanical waveguide 206 is in a retracted position relative to the distal end 210 of the catheter 204, i.e., the distal end 212 of the mechanical waveguide 206 is positioned between the distal end 210 and the proximal end of the catheter 204. In another embodiment, the mechanical waveguide 206 is in a forward position relative to the distal end 210 of the catheter 204, i.e., the distal end 210 of the catheter 204 is positioned between the distal end 212 and the proximal end of the mechanical waveguide 206, such that the distal end 212 of the mechanical waveguide 206 protrudes forward from the distal end 210 of the catheter 204. In another example, the distal ends 212 of some mechanical waveguides 206 may protrude from the distal end 210 of the catheter 202, while other mechanical waveguides 206 may have distal ends 212 that are coplanar with the distal end 210 of the catheter 202.

As described above with respect to the catheter device 20 , the mechanical waveguide 206 is movable relative to the catheter 204 .

In one embodiment and as described above, the holes 216 of the same group of holes may have the same angular position on their respective plates 214. In another embodiment, the angular position of the holes 216 of the same group may vary from one plate 214 to another, and when the mechanical waveguide 26 is inserted into the holes 216, the longitudinal axis of the mechanical waveguide 26 is not parallel to the longitudinal axis of the conduit 204.

9 , the radial positions of the holes 216 of the same group, i.e., the distances between the centers of the catheters 204 and the centers of the holes 216, are the same. In another embodiment, the radial positions of the holes 216 of the same group of holes can vary from one plate 214 to another plate 214, such that when the mechanical waveguides 206 are inserted into the holes 216, the longitudinal axes of the mechanical waveguides 206 are not parallel to the longitudinal axes of the catheters 204. For example, the distances between the centers of the catheters 204 and the centers of the holes 216 can decrease from the proximal plate to the distal plate, such that the distal end 212 of each mechanical waveguide 206 is in physical contact with the distal end of the catheter 204 and/or with the distal ends of its adjacent waveguides 206.

It should be understood that the number and position of plates 214 can vary. Similarly, the number of holes 216 and the number of waveguides 206 can also vary. In one embodiment, the number of holes 216 in each plate 214 is equal to the number of mechanical waveguides 206, such that for each plate 214, each hole 216 receives a corresponding mechanical waveguide 206 therein. In another embodiment, the number of holes 216 in each plate 214 can be greater than the number of mechanical waveguides 206. In this case, at least one group of holes 216 does not receive a mechanical waveguide 206. In another embodiment, the number of mechanical waveguides 206 can be greater than the number of holes 214, such that at least one group of aligned holes can be sized and shaped to receive more than one mechanical waveguide 206 therein.

Although the holes 216 of the same plate 214 have the same shape and size, those skilled in the art will understand that the shape and/or size of the holes 216 of the same plate may vary between the holes 216 to receive, for example, mechanical waveguides having different shapes and/or sizes.

In one embodiment, the spacing or longitudinal distance between adjacent plates 214 along the length of the catheter 204 is selected to ensure that each mechanical waveguide 206 cannot physically contact the catheter 204, the cannula 202, or any other mechanical waveguide 206, and to provide a predetermined constant bending stiffness along the longitudinal axis of the catheter device 200. The spacing between adjacent plates 214 can be constant along the length of the catheter 204, or can vary.

In one embodiment, plate 214 is integral with conduit 204. In this case, plate 214 corresponds to a protrusion protruding from conduit 204. In another embodiment, plate 214 is separate from conduit 204 and subsequently secured to the outer surface of conduit 204. In this case, plate 214 can each have the shape of an annular disk, such as disk 220 shown in FIG. 10 . Disk 220 is provided with a central hole 222, the shape and size of which are selected to correspond to the shape and size of the outer surface of conduit 204 so as to fit snugly onto the outer surface of conduit 204. Disk 220 is then inserted into the outer surface of conduit 204 at a desired longitudinal position along the length of conduit 204 and securely secured thereto. It should be understood that any suitable method for securely securing disk 220 to conduit 204 can be used. For example, disk 220 can be secured to conduit 204 by press-fitting, heat shrinking, a suitable adhesive, and/or the like. In another embodiment, conduit 200, mechanical waveguide 206, and disk 220 are retained within sleeve 202 by pressure. In another embodiment, the catheter 204 may include a pair of protrusions or projections for each disc 220 for securing each disc 220 to the catheter 204. The distance between the two protrusions or projections of the same pair is substantially equal to, or may be slightly greater than, the width of the disc 220. Each disc 220 is inserted onto the catheter 204 between its two corresponding protrusions or projections, which restricts longitudinal movement of the disc 220 relative to the catheter 204. In one embodiment, the disc 220 is first positioned over the catheter 204 in the desired position, and then protrusions are formed on the catheter on each side of the disc 220. In another embodiment, the protrusions or projections are first formed on the catheter 204, each in the appropriate position, and the diameter of the disc's central hole 222 is selected based on the size of the protrusions so that the disc 220 can be inserted between the two protrusions and passed through by applying force to the disc 220.

While the plates 214 extend substantially orthogonally from the outer surface of the conduit 204, it should be understood that other configurations are possible. For example, the plates 214 may each extend in a respective plane that intersects the longitudinal axis of the conduit 204 at an angle other than 90 degrees. While the plates 214 are planar, it should be understood that the plates may be curved, for example.

The disk 220 also includes nine holes 224 located between the central hole 222 and an edge 226 of the disk 220. The holes 224 are evenly distributed around the circumference of the disk 220.

Each aperture 224 has a substantially trapezoidal shape with rounded corners, and the dimensions of the apertures 224 are selected to receive the mechanical waveguide 206 therein. In one embodiment, the shape of the apertures 224 is selected to reduce the contact surface area, or the number of contact points, between the disc 220 and the mechanical waveguide 206 once the mechanical waveguide 206 is inserted into the apertures 224. For example, when the mechanical waveguide 206 has a circular cross-section, the apertures 224 may have a square, rectangular, or trapezoidal shape such that when the mechanical waveguide 206 is inserted into the apertures 224, only four contact points exist between the disc 220 and the mechanical waveguide 206. In another example, the apertures 224 may have a triangular shape such that when the mechanical waveguide 206 is inserted into the apertures 224, only three contact points exist between the disc 220 and the cylindrical mechanical waveguide 206.

Similarly, the shape of the wall 228 formed around the aperture 224 can be selected to reduce the surface area of contact between the wall 228 and the mechanical waveguide 206 when the mechanical waveguide 206 is inserted into the aperture 224. For example, and as shown in FIG10 , the wall 228 can be rounded outwardly toward the center of the aperture 224 to reduce the surface area of contact between the disk 220 and the mechanical waveguide 206. In another embodiment, the wall 228 can have a triangular shape, with the apex of the triangle contacting the cylindrical mechanical waveguide 206 to reduce the surface area of contact between the disk 220 and the mechanical waveguide 206.

In one embodiment, the plates 214, 220 are made of a material suitable for reducing coupling of mechanical waves from the mechanical waveguide 206 to the plates 214, 220. For example, the plates 214, 220 may be made of an acoustically insulating material.

10 , the center of the central hole 222 corresponds to the center of the disk 220 , it should be understood that other configurations are possible. For example, the hole 222 may not be located at the center of the disk 220 .

Although the holes 224 are symmetrically and evenly distributed around the circumference of the disk 220, that is, the angular distance between two adjacent holes 224 is constant throughout the holes 224, it should be understood that the holes 224 can be positioned asymmetrically around the circumference of the disk 220 so that the angular distance between adjacent holes 224 can vary.

While the distance between the center of the disk 220 and the center of the hole 224 is constant from one disk 220 to another, it should be understood that other configurations are possible, i.e., the distance between the center of the disk 220 and the center of the hole 224 may vary from one disk 220 to another.

While disk 220 includes a single row of holes 224, it should be understood that disk 220 may include more than one row of holes. For example, disk 220 may include a first row of holes and a second row of holes, with the center of the first row of holes located at a first distance from the center of disk 220 and the center of the second row of holes located at a second distance from the center of disk 220, the second distance being greater than the first distance. Each hole in the first row may be aligned with a corresponding hole in the second row, i.e., each hole in the first row has the same angular position as a corresponding hole in the second row. Alternatively, the holes in the first row and the holes in the second row may not be aligned. In one embodiment, the first and second rows may include the same number of holes. In another embodiment, the first and second rows of holes may include different numbers of holes. Similarly, the holes in the first row may be the same as the holes in the second row. Alternatively, the holes in the second row may be different from the holes in the second row, e.g., they may have different shapes, sizes, angular positions, etc.

Although the central hole 222 has a circular shape that matches the shape of the conduit 204, it should be understood that other configurations are possible. For example, the central hole 222 can be square while the conduit 204 is cylindrical.

Although the aperture 224 has a different shape than the cross-section of the mechanical waveguide 206, it should be understood that the aperture 224 may have the same shape as the cross-section of the mechanical waveguide 206. For example, the aperture 224 may be circular to receive a cylindrical mechanical waveguide therein.

Figure 11a shows one embodiment of an annular disk-shaped plate or disk 230 that includes a conduit receiving aperture 232 that is not located centrally within the disk 230. The disk 230 also includes a rectangularly shaped aperture 234 that is adapted to receive a cylindrical mechanical waveguide 236 therein.

As shown in FIG. 11 b , the wall formed around the hole 234 is rounded so that the single point of contact 238 between the mechanical waveguide 236 and the disk 230 is spaced apart around the circumference of the mechanical waveguide 236 to reduce losses of mechanical waves propagating in the mechanical waveguide 236 .

In one embodiment, the sleeve 202 can be made of a flexible material to correspond to the sheath. In one embodiment, the sleeve 202 can be made of an acoustically insulating material. In one embodiment, the sleeve 202 can be a single or multiple smaller diameter wires. Similarly, the conduit 204 can be made of a flexible material. In one embodiment, the conduit 204 can be made of an acoustically insulating material, such as foam.

In one embodiment, the cannula 202 and/or the catheter 204 are made of a polymer or a graded polymer.

Although in the illustrated embodiment, the cannula 202, the conduit 204, and the waveguide 206 all have cylindrical shapes, it should be understood that other shapes are possible. For example, the conduit 204 can have a hexagonal cross-sectional shape. In the same or another example, the mechanical waveguide 206 can have a hexagonal or triangular cross-sectional shape.

While in the above-described embodiment, the distal end of the mechanical waveguide 206 is perpendicular, i.e., the surface of the distal end 212 is perpendicular to the longitudinal axis along which the mechanical waveguide 206 extends, it should be understood that other configurations are possible. For example, the distal end 212 of the mechanical waveguide 206 can be beveled or angled. Such a beveled or angled end 212 can facilitate penetration into the target tissue to be treated. However, those skilled in the art will appreciate that other configurations are possible.

It should be understood that the number, location, shape, and size of the mechanical waveguides 206 can be selected based on the desired energy deposition pattern at the distal tip of the catheter device 200. It should be understood that the mechanical waveguides are made of a material that allows mechanical waves to propagate. In one embodiment, the mechanical waveguides can be made of titanium.

In one embodiment, the portion of catheter 200 adjacent to its distal end 208 is tapered. In this case, distal end 212 of mechanical waveguide 206 is in physical contact with distal end 210 of catheter 204 and cannula 202. Within the tapered portion of catheter 200, the diameter of cannula 202 decreases, and the distance between mechanical waveguide 206 and catheter 204 also decreases. In one embodiment, the tapered portion of catheter device 200 does not include plates 214 or disks 220. In another embodiment, the tapered portion of catheter device 200 includes plates 214 or disks 220. In this case, the size of plates 214 or disks 220 is reduced to create the tapered shape of cannula 202, and the position of holes 216 or 224 can be changed to bring mechanical waveguide 206 closer to catheter 204.

In one embodiment, the sleeve 202 is made of a heat shrinkable material to maintain the distal end 212 of the mechanical waveguide 206 in physical contact with the distal end 210 of the catheter 204 .

In one embodiment, the catheter device 200 further includes a ring secured to the distal end of the sleeve 202 to maintain the distal end 212 of the mechanical waveguide 206 in position against the catheter 204. In one embodiment, the ring can be made of a radiopaque material.

In one embodiment, the catheter device 200 described above can allow for suction or insufflation from the spaces between the mechanical waveguides 206. Suction can be used to remove debris generated by the catheter device 200, and insufflation of fluid can be used to deliver fluid, such as medication, to the target to be treated.

In one embodiment, the catheter device 200 further includes a tube extending between the mechanical waveguides for suction or insufflation purposes. In this case, the disc 220 may include additional holes for inserting the suction tube therein. Alternatively, a set of holes not occupied by the mechanical waveguides 206 may be used to receive the suction tube therein.

In one embodiment, catheter device 200 further includes at least one tube extending between mechanical waveguides 206 to deliver a fluid, such as a drug, to the target being treated. For example, the tube can be inserted into another set of aligned holes 216 not occupied by mechanical waveguides 206. In another configuration, the tube can be inserted into a set of holes into which mechanical waveguides 206 are already inserted. In this case, the tube is positioned within hole 216 between mechanical waveguides 206 and the walls of hole 216.

In one embodiment, the catheter device 200 may include a drug (or similar) capsule at the distal end of the mechanical waveguide 206 bundle, which may be triggered (released) from the proximal end by a mechanism extending along the length of the catheter device 200 .

In one embodiment, a drug (or similar) capsule may be located at the distal end of the mechanical waveguide 206 bundle, and the capsule may be triggered (released) from the mechanical waves at the distal end of the catheter device 200 .

In one embodiment, the catheter device 200 further includes radiopaque markers. The radiopaque markers can be located on the cannula 202 or on the catheter 204 or on one or more mechanical waveguides 206. In another example, a plate 214 adjacent to the distal end of the catheter device 200 can be made of a radiopaque material.

In one embodiment, the catheter device 200 further includes an optical coherence tomography (OCT) or intravascular ultrasound (IVUS) imaging device between the catheter 24 and the sheath 22.

In one embodiment, the catheter device 200 can be covered with a hydrophilic or hydrophobic or friction reducing coating, or a combination thereof. For example, the outer surface of the cannula 202 can be covered with a hydrophilic or hydrophobic or friction reducing coating, or a combination thereof.

In one embodiment, the catheter device 200 described above can be used to treat calcified and fibrotic lesions while minimizing arterial wall tissue damage and embolus size.

In one embodiment, the cannula 202 may be omitted such that the catheter device 200 includes only the catheter 204 , the disc 220 , and the mechanical waveguide 206 .

Hereinafter, another exemplary conduit assembly is described that can be used with a transmission member such as the transmission member 16. The conduit assembly includes a first or central elongated and hollow body, hereinafter referred to as a conduit, a plurality of mechanical waveguides surrounding the conduit, an acoustic insulator positioned over each mechanical waveguide, and a second or outer elongated body, hereinafter referred to as a sleeve, surrounding the mechanical waveguides. The acoustic insulator allows each mechanical waveguide to be acoustically isolated from its surrounding mechanical waveguides as well as the conduit and sleeve.

FIG12 illustrates one embodiment of a catheter device 300 that may be used as a transmission member, such as transmission member 16 of FIG1, for propagating mechanical waves or pulses or shock waves from an extracorporeal mechanical energy source.

The catheter device 300 includes a first elongated and hollow body or sleeve 302, a second elongated and hollow body or catheter 304, and a plurality of mechanical waveguides 306. The sleeve 302 extends along a longitudinal axis between a distal end 308 and a proximal end (not shown). Similarly, the catheter 304 extends along a longitudinal axis between a distal end 310 and a proximal end (not shown). Each mechanical waveguide 306 also extends longitudinally along a longitudinal axis between a proximal end (not shown) and a distal end 312. The catheter 304 is provided with a central hole 314 extending from its proximal end to its distal end 310 to receive a guide wire therein. The guide wire is used to guide the catheter device 300 within the patient's blood vessel and to position the distal end of the catheter device 300 in an appropriate position relative to the lesion to be treated.

The catheter apparatus 300 further includes an acoustic insulator for each mechanical waveguide 306. Each acoustic insulator at least partially surrounds its respective mechanical waveguide 306 along at least a portion of its length. Each acoustic insulator prevents or at least reduces any coupling of mechanical waves propagating into its respective mechanical waveguide 306 with the surrounding mechanical waveguides, the catheter 304, and/or the sleeve 302.

In the embodiment shown, the acoustic insulator is in the form of a wire 316 that is wound around and along the mechanical waveguide 306 so as to be arranged in a helical shape. As a result, each helical wire 316 is located between its corresponding mechanical waveguide 306 and the sleeve 302, the conduit 304, and the surrounding mechanical waveguide 306.

The inner side of each spiral 316 is in physical contact with its corresponding mechanical waveguide 306. The outer side of each spiral 316 has at least two contact points: a first contact point with the catheter 304 and a second contact point with the cannula 302. The outer side of each spiral 316 can have more than two contact points. For example, and in addition to the contact points with the catheter 304 and the cannula 302, the outer side of each spiral 316 can have at least one additional contact point with at least one adjacent mechanical waveguide 306 or the spiral 316 of at least one adjacent mechanical waveguide 306. For example, the outer side of each spiral 316 can have a third contact point with a first adjacent mechanical waveguide 306 or the spiral 316 of the first adjacent mechanical waveguide 306, and a fourth contact point with a second adjacent mechanical waveguide 306 or the spiral 316 of the second adjacent mechanical waveguide 306.

In the illustrated embodiment, the distal end 318 of the helical wire 316 is not aligned with the distal end 312 of its corresponding mechanical waveguide 306, such that a portion 319 of the mechanical waveguide 306 is not covered by the helical wire 316. However, those skilled in the art will appreciate that the distal end 318 of the helical wire 316 can be aligned with the distal end 312 of its corresponding mechanical waveguide 306, such that the entire mechanical waveguide 306 is covered by the helical wire 316.

In one embodiment, the cross-sectional dimensions of the helical wire 316 are smaller than the cross-sectional dimensions of the mechanical waveguide 306 around which it is wound. If both the wire 316 and the mechanical waveguide 306 have cylindrical shapes, the diameter of the helical wire 316 is smaller than the diameter of the mechanical waveguide 306 around which it is wound. It should be understood that other configurations are possible. For example, the diameter of the wire 316 can be substantially equal to the diameter of the mechanical waveguide 306, or larger than the diameter of the mechanical waveguide 306.

In the embodiment shown, each wire 316 is wound in a single helical winding with an axial spacing around its corresponding mechanical waveguide 306. In one embodiment, the axial spacing is selected to ensure that each mechanical waveguide 306 cannot physically contact the catheter 304, the sleeve 302, or any other mechanical waveguide 306.

It should be understood that the axial spacing can be selected to be substantially constant along the length of the mechanical waveguide 306. In one embodiment, the axial spacing of the windings is selected to be longer than the diameter of the helical wire 316 so that consecutive windings do not physically contact each other. In another embodiment, the axial spacing can vary along the length of the mechanical waveguide 306. For example, the spacing can vary according to a prescribed pattern that ensures that each mechanical waveguide 306 cannot physically contact the catheter 304, cannula 302, or any other mechanical waveguide 306 while the catheter device 300 is in actual use and may bend, for example, within a tortuous vascular anatomy.

Although in the illustrated embodiment, the mechanical waveguide 306 and the helical line 316 have circular cross-sections, it should be understood that other shapes are possible. For example, the mechanical waveguide 306 and/or the helical line 316 can have square, rectangular, triangular, or hexagonal cross-sectional shapes. In another example, the mechanical waveguides 306 can each have a square cross-sectional shape, while the helical line 316 can have a circular cross-sectional shape.

While in the illustrated embodiment, the helical wire 316 has a cross-section that is provided with a constant dimension along the length of the mechanical waveguide 306, it should be understood that the dimension of the cross-section of the helical wire 316 may vary along the length of the mechanical waveguide 306. For example, the dimension of the cross-section of the helical wire 316, such as its diameter, may decrease from its proximal end to its distal end.

FIG13 illustrates another embodiment of a catheter device 320. The catheter device includes a first elongated, hollow body or cannula 322, a second elongated, hollow body or cannula 324, and a plurality of mechanical waveguides 326. Cannula 322 extends along a longitudinal axis between a distal end 328 and a proximal end (not shown). Similarly, cannula 324 extends along a longitudinal axis between a distal end 330 and a proximal end (not shown). Each mechanical waveguide 326 also extends longitudinally along the longitudinal axis between a proximal end (not shown) and a distal end 332. Cannula 324 is provided with a central bore 334 extending from its proximal end to its distal end 330 for receiving a guidewire therein.

The catheter device 320 also includes an acoustic insulator 336 for each mechanical waveguide 306, and the acoustic insulator is in the form of a tubular mesh 336 that is inserted around and along the mechanical waveguide 326. As a result, each tubular mesh 336 is positioned between its corresponding mechanical waveguide 326 and the sleeve 322, the catheter 324, and the surrounding mechanical waveguide 326 to prevent direct physical contact between the corresponding mechanical waveguide 326 and the sleeve 322, the catheter 324, and the surrounding mechanical waveguide 326.

In the illustrated embodiment, the distal ends 338 of the tubular mesh 336 are aligned with the distal ends 332 of their corresponding mechanical waveguides 326 such that the entire mechanical waveguide 326 is covered by the tubular mesh 336. However, those skilled in the art will appreciate that the distal ends 338 of the tubular mesh 336 may be retracted relative to the distal ends 332 of their corresponding mechanical waveguides 326 such that a portion of the mechanical waveguide 326 may not be covered by the tubular mesh 336.

While in the illustrated embodiment, the tubular mesh 336 has a uniform pattern along the length of the mechanical waveguide 326 , it should be understood that the pattern of the tubular mesh 336 may vary along the length of the mechanical waveguide 336 .

In one embodiment, the thickness of the tubular mesh 336 is substantially constant along its length. In another embodiment, the thickness of the tubular mesh 336 can vary along at least a portion thereof.

In one embodiment, the tubular mesh 336 is made of a single material. In another embodiment, the tubular mesh 336 is made of multiple materials.

Although in the illustrated embodiment, the distal ends 308, 328 of the sleeves 302, 322 are not coplanar with the distal ends 32, 332 of the mechanical waveguides 306, 326, it will be appreciated that other configurations are possible. For example, the sleeves 302, 322 may cover the mechanical waveguides 306, 326 along their entire length up to their distal ends 32, 332.

The acoustic insulators described above, namely the helical wire 316 and the tubular mesh 336, serve to prevent any physical contact between the mechanical waveguides 306, 326 themselves, between the mechanical waveguides 306, 326 and the guide tubes 304, 324, and between the mechanical waveguides 306, 326 and the sleeves 302, 326, in order to prevent or at least limit or reduce coupling losses of mechanical waves propagating into the mechanical waveguides 306, 326. The specific shape of the helical wire 316 and the specific shape of the tubular mesh 336 allow limiting the number of contact surface areas or contact points between the mechanical waveguides 306, 326 and the helical wire 316 or the tubular mesh 336, which allows limiting or minimizing energy losses from the waveguides 306, 326 to the helical wire 316 or the tubular mesh 336.

Although in the illustrated embodiment, each mechanical waveguide 306 is provided with a helical wire 316 and each mechanical waveguide 326 is provided with a tubular mesh 336, it should be understood that only some of the mechanical waveguides 306 may be provided with a helical wire 316 and only some of the mechanical waveguides 326 may be provided with a tubular mesh 336. For example, only one of the two mechanical waveguides 306 may be provided with a helical wire 316.

In one embodiment, the catheter device may include some mechanical waveguides provided with helical wire 316, while other mechanical waveguides are provided with tubular mesh 336. In the same or another embodiment, some mechanical waveguides may be provided without helical wire 316 and without tubular mesh 336.

Each helical wire 316 and/or tubular mesh 336 can be wound into place over the waveguide 306, 326. Alternatively, the helical wire 316 and/or tubular mesh 336 can be pre-formed and then slid or stretched over the mechanical waveguide 306, 326. Once each helical wire 316 and/or tubular mesh 336 is mounted on its corresponding mechanical waveguide 306, 326, each mechanical waveguide 306, 326 is positioned around the conduit 304, 324, and then the sleeve 302, 322 is positioned over the mechanical waveguide 306, 326 such that the sleeve 302, 322 covers the mechanical waveguide 306, 326 along at least one longitudinal cross-section thereof. In one embodiment, the length of the sleeve 302, 322 is substantially equal to the length of the conduit 304, 324, such that the sleeve 302, 322 covers the entire conduit 304, 324. In another embodiment, the length of the sleeve 302, 322 is shorter than the length of the catheter 304, 324. For example, the sleeve 302, 322 may cover only the portion of the catheter 304, 324 that is to be introduced into the patient's body.

In one embodiment, the mechanical waveguide 306, 326 is positioned relative to the catheter 304, 324 such that the distal end 312, 332 of the mechanical waveguide 306, 326 is coplanar with the distal end 310, 330 of the catheter 304, 324. In another embodiment, the mechanical waveguide 306, 326 is in a retracted position relative to the distal end 310, 330 of the catheter 304, 324, i.e., the distal end 312, 332 of the mechanical waveguide 306, 326 is positioned between the distal end 310, 330 and the proximal end of the catheter 304, 324. In another embodiment, the mechanical waveguides 306, 326 are in a forward position relative to the distal ends 310, 330 of the catheters 304, 324, i.e., the distal ends 310, 330 of the catheters 304 are positioned between the distal ends 32, 332 and the proximal ends of the mechanical waveguides 306, 326, such that the distal ends 312, 332 of the mechanical waveguides 306, 326 protrude forward from the distal ends 310, 330 of the catheters 304, 324. In another example, the distal ends 312, 332 of some of the mechanical waveguides 306, 326 may protrude from the distal ends 310, 330 of the catheters 302, 322, while other mechanical waveguides 306, 326 may have distal ends 312, 332 that are coplanar with the distal ends 310, 330 of the catheters 302, 332.

In one embodiment, the helical wire 316 and/or the tubular mesh 336 are made of one or more materials suitable for reducing the coupling of mechanical waves from the mechanical waveguides 306, 326 to the helical wire 316 and/or the tubular mesh 336. For example, the helical wire 316 and/or the tubular mesh 336 may be made of an acoustically insulating material.

In another embodiment, the helical wire 316 and/or the tubular mesh 336 can be made of metal or polymer. The diameter, material, and geometry of the helical wire 316 and/or the tubular mesh 336 define the additional flexural and torsional stiffness that each helical wire 316 and/or each tubular mesh 336 imparts to its corresponding mechanical waveguide 306, 326. In one embodiment, the additional flexural and torsional stiffness provided by the helical wire 316 and/or the tubular mesh 336 is small compared to the inherent flexural and torsional stiffness of the mechanical waveguide 306, 326, such that the helical wire 316 or the mesh 336 has no reinforcing effect.

In the illustrated embodiment, the elements of the catheter devices 300, 320 have circular cross-sections, i.e., the cannulas 302, 322 and the catheters 304, 324 each have a tubular shape, and the mechanical waveguides 306, 326 each have a cylindrical shape. It will be appreciated that other shapes are possible. For example, the catheter devices 300, 320, the catheters 304, 324, and/or the cannulas 302, 322 may have an elliptical or hexagonal cross-sectional shape.

In the illustrated embodiment, the mechanical waveguides 306, 326 are evenly distributed around the circumference of the conduits 304, 324. However, those skilled in the art will appreciate that other configurations are possible, as described above.

In the illustrated embodiment, the catheter apparatus 300, 320 is provided with a single layer or row of mechanical waveguides 306, 326 around the circumference of the catheter 304, 324. In another embodiment, there may be more than one layer or row of mechanical waveguides 306, 326 around the catheter 304, 324.

In one embodiment, the sleeves 302, 322 can be made of a flexible material to correspond to a sheath. In one embodiment, the sleeves 302, 322 can be made of an acoustically insulating material. In one embodiment, the sleeves 302, 322 can be a single or multiple relatively small diameter wires. In one embodiment, the sleeves 302, 322 can correspond to a tube having a continuous surface. In another embodiment, the sleeves 302, 322 can be a wire mesh 337, as shown in FIG14 .

Similarly, the conduits 304, 324 can be made of a flexible material.In one embodiment, the conduits 304, 324 can be made of an acoustically insulating material.

In one embodiment, the sleeves 302, 322 and/or the catheters 304, 324 are made of a polymer or a graded polymer.

While in the above-described embodiment, the distal ends 312, 332 of the mechanical waveguides 306, 326 are rectangular, i.e., the surface of the distal ends 312, 332 is orthogonal to the longitudinal axis along which the mechanical waveguides 306, 326 extend, it should be understood that other configurations are possible. For example, the distal ends 312, 332 of the mechanical waveguides 306, 326 can be beveled or angled. Such beveled or angled ends 312, 332 can facilitate penetration into the target tissue to be treated. However, those skilled in the art will appreciate that other configurations are possible.

It should be understood that the number, location, shape, and size of the mechanical waveguides 306, 326 can be selected based on the desired energy deposition pattern at the distal tip of the catheter device 300, 320. It should be understood that the mechanical waveguides 306, 326 are made of a material that allows mechanical waves to propagate. In one embodiment, the mechanical waveguides 306, 326 can be made of titanium.

In one embodiment, the portion of the catheter apparatus 300, 320 adjacent to its distal end is tapered. In this case, the distal ends 312, 332 of the mechanical waveguides 306, 326 can be in physical contact with the distal ends 310, 330 of the catheters 304, 324 and the cannulas 302, 322. Within the tapered portion of the catheters 304, 324, the thickness of the helical wire 316 or the thickness of the mesh 336 decreases, and the distance between the mechanical waveguides 306, 326 and the catheters 304, 324 also decreases. In one embodiment, the tapered portion of the catheter apparatus 300, 320 does not include the helical wire 316 or the mesh 336. In another embodiment, the tapered portion of the catheter apparatus 300, 320 includes some helical wire 316 or the mesh 336. In this case, the distance between the distal end of each helical wire 316 or mesh 336 and the distal end 310 , 330 of the catheter 304 , 324 varies from one mechanical waveguide 306 , 326 to the next to form the tapered shape of the cannula 302 , 322 .

In one embodiment, the sleeves 302 , 322 are made of a heat shrinkable material to maintain the distal ends 32 , 332 of the mechanical waveguides 306 , 326 in physical contact with the distal ends 310 , 330 of the catheters 304 , 324 .

In one embodiment, the catheter device 300, 320 further includes a ring secured to the distal end of the sheath 302, 322 to maintain the distal end 32, 332 of the mechanical waveguide 306, 326 in position against the catheter 304, 324. In one embodiment, the ring may be made of a radiopaque material.

In one embodiment, the catheter devices 300, 320 described above can allow for suction or insufflation from the spaces between the mechanical waveguides 306, 326, the cannulas 302, 322, and the catheters 304, 324. Suction can be used to remove debris generated by the catheter devices 300, 320, and insufflation of fluid can be used to deliver fluids, such as medications, to the target to be treated.

In one embodiment, the catheter arrangement 300, 320 further comprises a longitudinal tube extending between the mechanical waveguides for suction or insufflation purposes.

In one embodiment, the catheter device 300, 320 further includes at least one longitudinal tube extending between the mechanical waveguides 306, 326 to deliver a fluid, such as a drug, to the target to be treated.

In one embodiment, the catheter device 300 , 320 may include a drug (or similar) capsule at the distal end of the bundle of mechanical waveguides 306 , 326 , which may be triggered (released) proximally by a mechanism extending along the length of the catheter device 300 , 320 .

In one embodiment, a drug (or similar) capsule may be located at the distal end of the bundle of mechanical waveguides 306 , 326 , and the capsule may be triggered (released) from the mechanical waves at the distal end of the catheter device 300 , 320 .

In one embodiment, the catheter device 300, 320 further includes a radiopaque marker. The radiopaque marker can be positioned on the cannula 302, 322 or on the catheter 304, 324 or on one or more mechanical waveguides 306, 326. In another example, the wire 316 or mesh 336 or a portion of the wire 316 or mesh 336 can be made of a radiopaque material.

In one embodiment, the catheter device 300 , 320 further includes an optical coherence tomography (OCT) or intravascular ultrasound (IVUS) imaging device between the catheter 304 , 324 and the cannula 302 , 322 .

In one embodiment, the wire 316 or mesh 336 includes at least one optical fiber. In another embodiment, the catheter assembly 300, 320 includes at least one optical fiber between the catheter 304, 324 and the cannula 302, 322.

In one embodiment, the catheter device 300, 320 can be covered with a hydrophilic or hydrophobic or friction reducing coating, or a combination thereof. For example, the outer surface of the sleeve 302, 322 can be covered with a hydrophilic or hydrophobic or friction reducing coating, or a combination thereof.

In one embodiment, the catheter devices 300, 320 described above can be used to treat calcified and fibrotic lesions while minimizing arterial wall tissue damage and embolus size.

Those skilled in the art will appreciate that different catheter devices described above may be combined together. For example, at least one mechanical waveguide 206 of the catheter device 200 may each be provided with a helical wire 316 or a tubular mesh 336.

The embodiments of the present invention described above are intended to be exemplary only. Accordingly, the scope of the present invention is to be limited solely by the scope of the appended claims.

Claims (27)

1. A catheter device for treating a patient's lesion, comprising: An elongated, hollow body extending along a longitudinal axis between its proximal and distal ends defines a longitudinal aperture extending between its proximal and distal ends, the shape and size of which are adapted to receive a guidewire; and At least one mechanical waveguide is fixed to an internally elongated and hollow body and extends longitudinally along at least a portion of the internally elongated and hollow body, the distal end of the at least one mechanical waveguide being adapted to abut a lesion, the at least one mechanical waveguide being used to propagate at least one high-amplitude and short-duration mechanical pulse along it to the distal end to treat the lesion. 2. The catheter device according to claim 1, further comprising an outer elongated and hollow body defining a cavity, wherein the inner elongated and hollow body and at least one mechanical waveguide are inserted into the cavity, the at least one mechanical waveguide being located between the inner elongated and hollow body and the outer elongated and hollow body. 3. The conduit device according to claim 1 or 2, further comprising at least one plate projecting outward from the outer surface of an internally elongated and hollow body, each plate at a corresponding position along the length of the internally elongated and hollow body, each of the at least one plate including at least one waveguide receiving aperture therethrough, each of the at least one waveguide receiving aperture having a corresponding one of at least one mechanical waveguide inserted therein. 4. The conduit device according to claim 3, wherein at least one plate is made of an acoustically insulating material. 5. The conduit device according to claim 1 or 2, further comprising at least one acoustic insulator, each acoustic insulator surrounding a corresponding insertion in at least one mechanical waveguide. 6. The conduit device of claim 5, wherein at least one acoustic insulator comprises at least one wire, each wire being wound around a corresponding one of at least one mechanical waveguide. 7. The conduit device of claim 6, wherein at least one wire has a helical shape to form a helical winding around a corresponding one of at least one mechanical waveguide. 8. The conduit device according to claim 6 or 7, wherein at least one wire is made of an acoustically insulating material. 9. The conduit device of claim 5, wherein at least one acoustic insulator comprises at least one mesh, each mesh surrounding a corresponding insertion in at least one mechanical waveguide. 10. The conduit device of claim 5, wherein at least one acoustic insulator extends along at least a longitudinal portion of a corresponding one of at least one mechanical waveguide. 11. The conduit device according to claim 5, wherein at least one acoustic insulator is made of an acoustic insulating material. 12. The catheter device according to claim 2, wherein the outer elongated and hollow body is flexible to correspond to the sheath. 13. The conduit device of claim 1, wherein the distal end of at least one mechanical waveguide is movable along a longitudinal axis relative to the distal end of the internal elongated and hollow body. 14. The conduit device according to claim 13, wherein the distal end of at least one mechanical waveguide is also one of the distal ends of the external elongated and hollow body that is capable of radial and lateral movement. 15. The conduit device according to claim 2, wherein at least one of the inner elongated and hollow body and the outer elongated and hollow body is made of an acoustically insulating material. 16. The conduit device according to claim 1 or 2, wherein at least one mechanical waveguide comprises a plurality of mechanical waveguides. 17. The catheter device of claim 2, further comprising at least one tube inserted into an external elongated and hollow body. 18. The catheter device of claim 17, wherein at least one tube is adapted to blow fluid at its distal end. 19. The catheter device of claim 17, wherein at least one tube is adapted to aspirate at least one of fluid and debris from its distal end. 20. The catheter device according to claim 2, wherein the outer elongated and hollow body comprises a mesh sleeve. 21. The conduit device according to claim 1, wherein at least one mechanical waveguide has a distal tilted end. 22. The conduit device according to claim 1, wherein the distal end of at least one mechanical waveguide is coplanar with the distal end of the internal elongated and hollow body. 23. The conduit device according to claim 1, wherein the distal end of at least one mechanical waveguide protrudes forward from the distal end of the internally elongated and hollow body. 24. The conduit device according to claim 1, wherein at least one mechanical waveguide is movable relative to the internal elongated and hollow body. 25. The catheter device according to claim 2 further includes a non-transparent element. 26. The catheter device of claim 1, further comprising a drug capsule located at the distal end of at least one mechanical waveguide. 27. The catheter device according to claim 1, further comprising at least one optical fiber.