CN117379134A

CN117379134A - Lithotripter device

Info

Publication number: CN117379134A
Application number: CN202311278490.7A
Authority: CN
Inventors: 请求不公布姓名
Original assignee: Acotec Scientific Co Ltd
Current assignee: Acotec Scientific Co Ltd
Priority date: 2022-09-28
Filing date: 2023-09-28
Publication date: 2024-01-12

Abstract

The present disclosure provides a lithotripter, comprising: an elongate body comprising a distal tip portion having an end face forming a non-zero angle with a longitudinal axis of the elongate body; a balloon circumferentially surrounding a portion of the elongate body and surrounding an end face of the tip portion, the balloon defining an interior for receiving a fluid; at least one emitter positioned at the end face of the end portion of the elongated body. The at least one emitter is configured to generate pressure waves in the fluid that propagate through the balloon to break up calcified lesions. A method of using the lithotripter is also provided.

Description

Lithotripter device

Cross Reference to Related Applications

The present application claims priority from U.S. patent application Ser. No. 63/410623, filed on Ser. No. 2022, 9, 28, and U.S. patent application Ser. No. 18/470132, filed on Ser. No. 2023, 9, 19, the entire disclosures of which are incorporated herein by reference.

Technical Field

The present disclosure relates generally to medical devices and methods of using medical devices. In particular, various embodiments of lithotripsy devices and methods of decomposing calcified lesions are described.

Background

Calcified lesions may occur in various parts of the human body, including blood vessels, organs, soft tissues and bones. Depending on location and severity, calcified lesions may cause pain, inflammation, and other diseases. For example, calcified lesions of blood vessels can lead to atherosclerosis or arteriosclerosis, which can increase the risk of heart attacks, strokes, and other health problems. Chronic Total Occlusion (CTO) is the complete occlusion of a blood vessel caused by plaque and other matter build-up within the vessel wall. CTO can lead to heart attacks, sudden cardiac death, heart failure, and strokes, thereby causing serious and/or long-term effects to the patient.

Lithotripsy devices are known and have been used to treat diseases associated with calcified lesions. Conventional lithotripsy devices include balloon catheters and utilize shock waves to break up calcified lesions. For example, in angioplasty, a balloon catheter is inserted into the affected vessel and the balloon is inflated to press the plaque against the vessel wall. High frequency shock waves are then generated and transmitted to the plaque, causing the plaque to break down into smaller parts that are more easily absorbed by the body. The balloon is then deflated and removed from the vessel. However, since conventional lithotripsy balloon catheters cannot pass through the hardened mass of the CTO, they cannot deliver high frequency shock waves from inside the plaque to break the hardened mass into smaller fragments, so they cannot be used to treat CTO.

Thus, there remains a need for improved lithotripsy devices to treat diseases associated with calcified lesions, especially CTO. It is desirable to provide a lithotripsy balloon catheter that can deliver high frequency pressure waves that propagate forward and laterally, allowing a single device to treat CTO.

Disclosure of Invention

In one aspect, embodiments of the present disclosure feature a lithotripsy device. Generally, one embodiment of a lithotripter comprises an elongate body comprising a distal tip portion having an end surface forming a non-zero angle with a longitudinal axis of the elongate body; a balloon circumferentially surrounding a portion of the elongate body and surrounding an end face of the tip portion, the balloon defining an interior for receiving a fluid; and at least one emitter positioned at an end face of the distal portion of the elongate body, the at least one emitter configured to generate pressure waves in the fluid, the pressure waves propagating through the balloon to break up calcified lesions.

In various embodiments of this aspect, the end face of the tip portion includes a first end face and a second end face that is substantially symmetrical to the first end face, and the at least one emitter includes a first emitter positioned at the first end face and a second emitter positioned at the second end face.

In various embodiments of this aspect, the non-zero angle formed between the end face and the longitudinal axis is in the range of 20 degrees to 70 degrees.

In various embodiments of this aspect, the elongate body comprises a tubular body having an inner surface defining a lumen, and wherein the balloon comprises a distal portion secured to the inner surface of the tubular body. The distal portion of the balloon forms a seal circumferentially around the inner surface, the seal configured for fluidly sealing an elongate member positioned within the seal. When filled with fluid, the balloon is forward and radially expandable. The tubular body may further comprise a generally cylindrical portion adjacent the end portion, the generally cylindrical portion having an outer surface surrounded by a balloon, and wherein the lithotripsy device further comprises one or more transmitters positioned at the outer surface of the generally cylindrical portion to generate pressure waves in the fluid. At least one emitter positioned at the end face of the tip portion can be controlled independently of one or more emitters positioned at the outer surface of the generally cylindrical portion.

In various embodiments of this aspect, the elongate body comprises a tubular body having an inner surface defining a lumen and an outer surface, the balloon comprises a distal portion, a proximal portion, and an expandable portion, the distal portion is secured to the inner surface of the tubular body, and the proximal portion is secured to the outer surface of the tubular body.

In various embodiments of this aspect, the elongate body can include a tubular body having an inner surface and an outer surface defining a first lumen, the balloon including a distal portion, a proximal portion, and an expandable portion, the distal portion being secured to the inner surface of the tubular body, and the proximal portion being secured to the outer surface of the tubular body. The tubular body may further include a second lumen in fluid communication with an interior defined by the balloon. The second lumen may be an annular lumen surrounding at least a portion of the first lumen.

In various embodiments of this aspect, the elongate body comprises a tubular body having an inner surface defining a lumen having a diameter in the range of 0.017 inch to 0.042 inch.

In another aspect, embodiments of the present disclosure feature a lithotripsy apparatus. Generally, one embodiment of a lithotripter comprises an elongate tubular body comprising a distal tip portion having an end face forming a non-zero angle with a longitudinal axis of the tubular body and a generally cylindrical portion adjacent the tip portion; a balloon circumferentially surrounding a portion of the tubular body and surrounding the end portion and the generally cylindrical portion, the balloon defining an interior for receiving a fluid; and at least one emitter positioned at an end face of the tip portion and one or more emitters positioned at an outer surface of the generally cylindrical portion, the at least one emitter and the one or more emitters configured to generate pressure waves in the fluid, the pressure waves propagating through the balloon to crush the calcified lesions.

In various embodiments of this aspect, at least one emitter positioned at the end face of the tip portion can be controlled independently of one or more emitters positioned at the outer surface of the generally cylindrical portion.

In various embodiments of this aspect, the elongate body may comprise a tubular body having an inner surface defining a lumen and an outer surface, the balloon comprising a distal portion, a proximal portion, and an expandable portion, the distal portion being secured to the inner surface of the tubular body, and the proximal portion being secured to the outer surface of the tubular body.

In various embodiments of this aspect, the elongate body comprises a tubular body having an inner surface and an outer surface defining a first lumen, the balloon comprises a distal portion, a proximal portion, and an expandable portion, the distal portion is secured to the inner surface of the tubular body, and the proximal portion is secured to the outer surface of the tubular body. The tubular body may further include a second lumen in fluid communication with an interior defined by the balloon.

In various embodiments of this aspect, the distal portion of the balloon may be secured to the inner surface of the tubular body.

In another aspect, embodiments of the disclosure feature a method. In one embodiment of the method, a lithotripsy device is introduced into a patient. The lithotripter comprises an elongate tubular body comprising a tip portion and a generally cylindrical portion adjacent the tip portion, the tip portion having an end face forming a non-zero angle with a longitudinal axis of the tubular body; a balloon circumferentially surrounding a portion of the tubular body and surrounding the end portion and the generally cylindrical portion, the balloon defining an interior for receiving a fluid; and at least one emitter positioned at an end face of the tip portion and one or more emitters positioned at an outer surface of the generally cylindrical portion, the at least one emitter and the one or more emitters configured to generate pressure waves in the fluid. According to the method, a lithotripsy device is advanced to position at least one emitter near a proximal end of a calcified lesion in a patient's tissue structure. Then, a first decalcification step is performed, using at least one emitter at the end face of the tip portion to decompose or soften at least a portion of the calcified lesions. The lithotripsy device is further advanced to position at least one of the one or more emitters at the outer surface of the generally cylindrical portion inside the calcified lesion, and a second decalcification step is performed to disintegrate the calcified lesion using at least one of the one or more emitters at the outer surface of the generally cylindrical portion.

In various embodiments of this aspect, the first decalcification step and the second decalcification step are performed during lithotripsy to break calcified occlusions in the patient's vasculature.

In various embodiments of this aspect, the first decalcification step and the second decalcification step are performed during lithotripsy to break calcified occlusions in the patient's kidney or ureter.

This abstract is provided to introduce a selection of aspects and embodiments of the present disclosure in a simplified form, and is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. The aspects and embodiments were chosen merely to provide the reader with a brief summary of certain forms the invention might take and are not intended to limit the scope of the invention. Other aspects and embodiments of the disclosure are described in the detailed description section.

These and various other aspects, embodiments, features and advantages of the present disclosure will be better understood upon reading the following detailed description taken in conjunction with the accompanying drawings.

Drawings

Fig. 1 illustrates an exemplary lithotripsy system according to an embodiment of the present disclosure.

Fig. 2 illustrates a treatment end of an exemplary lithotripter according to an embodiment of the disclosure.

Fig. 3 illustrates a treatment end of an exemplary lithotripter device according to an alternative embodiment of the present disclosure.

Fig. 4 is a flowchart illustrating steps of an example method for decomposing calcified lesions, according to an embodiment of the disclosure.

Detailed Description

Various embodiments of lithotripsy devices, systems, and methods will be described with reference to the accompanying drawings. The drawings are intended to facilitate a description of embodiments of the disclosure and are not necessarily drawn to scale. Certain specific details may be set forth in the accompanying drawings and the description to provide a thorough understanding of the disclosure. It will be apparent to one of ordinary skill in the art that some of these specific details may not be used to practice embodiments of the present disclosure. In other instances, structures, materials, components, systems, and/or operations normally associated with medical procedures may not be shown or described in detail to avoid unnecessarily obscuring descriptions of the embodiments of the disclosure.

Embodiments of the present disclosure provide a lithotripsy device that includes a forward emitter and a lateral emitter. The forward transmitter may generate pressure waves in the fluid that propagate primarily in the direction of the longitudinal axis of the balloon catheter, while the side transmitter may generate pressure waves in the fluid that propagate primarily transversely with respect to the longitudinal axis of the balloon catheter. Thus, the lithotripsy device of the present disclosure allows forward lithotripsy and lateral lithotripsy using a single device. The lithotripsy devices of the present disclosure are particularly useful in treating Chronic Total Occlusions (CTOs). The forward emitter may be used to soften the CTO, allowing the balloon catheter to pass through the lesion, and then treated again with the side emitter. The forward and side emitters may be controlled separately or independently to allow for selective treatment of the anterior and lateral sides of the calcified lesions. Conventional lithotripsy balloon catheters can only be used to treat calcified lesions through which the balloon can pass. Conventional lithotripsy balloon catheters cannot be used to treat CTO.

As used herein, the term "lithotripsy" broadly refers to a medical procedure that uses pressure waves generated by a pressure wave emitter to break up, break down, or soften calcified lesions in a patient's anatomy. Calcified lesions may be located at any tissue structure of a patient, including but not limited to treatment sites in the vascular system (e.g., neurovascular system, coronary vascular system, peripheral vascular system), body organs (e.g., kidneys, uterus, pelvis), and soft tissues (e.g., breast). Thus, the "lithotripsy" devices or systems described and claimed herein are not limited to treating calcified lesions at a particular target site (e.g., kidney, uterus), but may be used or adapted for use in treating calcified lesions in any tissue structure of a patient.

As used herein, the term "emitter" refers to a device capable of receiving energy and generating pressure waves in a fluid that propagate through a balloon to a treatment site. For example, the emitter may include a first electrode and a second electrode connected to an energy source via wires. While not intending to limit the disclosure to a particular theory, it is generally believed that when the electrodes receive a high voltage from an energy source, an arc or spark is created between the electrodes, thereby creating a pressure wave in the fluid. Variable high voltage pulses may be delivered to the electrodes to generate pressure waves in the fluid that propagate through the balloon to the treatment site to break up calcified lesions, and in another example, the transmitter may be configured to receive optical energy (e.g., optical signals) from an energy source via a fiber optic line or tube and transmit the optical energy to generate pressure waves. As used herein, the term "transmitter" may refer to a single transmitter that is controllable independently of other transmitters on the lithotripsy device, or a single unit in an array or assembly of transmitters that operate as a whole.

Referring to fig. 1, an embodiment of an exemplary lithotripsy system 100 of the present disclosure is now described. Generally, the lithotripsy system 100 includes an energy source 102 and a lithotripsy device 200, the lithotripsy device 200 being connected to the energy source 102 by suitable cables and connectors. The energy source 102 provides energy to the lithotripsy device 200 to perform a lithotripsy procedure. The lithotripsy device 200 generally includes an elongate body 210 and a balloon 250 circumferentially surrounding a portion of the elongate body. The elongate body 210 includes a proximal portion 212 and a distal portion 214, the distal portion 214 being constructed or arranged to traverse a curved tissue structure of a patient to a treatment site, such as a calcified lesion in the patient's vasculature. Balloon 250 may be constructed of a polymeric material and inflated by a fluid. One or more emitters (e.g., 280 or 282 in fig. 2) are carried by the distal portion 214 of the elongate body 210 and enclosed within the balloon 250. One or more emitters are electrically or optically connected to the energy source 102 and are configured to generate pressure waves in the fluid that propagate through the balloon 250 to soften, break up, or break up calcified lesions. The hub member 110 may be connected to a proximal portion 212 of the elongate body 210, such as providing a port 112 for introducing fluid to inflate the balloon 250, a port 114 for receiving a guidewire for guiding the catheter device 200 to a treatment site, and a port 116 for connecting a transmitter of the lithotripsy device 200 to the energy source 102. The energy source 102 may include an electrical energy source. For example, the energy source 102 may include a high voltage pulse generator that may deliver variable high voltage pulses to an electrical-based transmitter. Alternatively, the energy source 102 may comprise an optical energy source capable of transmitting a high energy laser beam to an optical-based emitter.

Referring to fig. 2, an exemplary lithotripter 200 according to an embodiment of the present disclosure will now be described. Fig. 2 shows an enlarged view of a treatment or distal portion of lithotripter 200. As shown, the lithotripsy device 200 includes an elongate body 210, the elongate body 210 having a tip or tip portion 216 carrying at least one emitter 280. The end portion 216 may be cut or shaped such that one or more end faces 218 of the end portion 216 form a non-zero angle with respect to the longitudinal axis 211 of the elongate body 210. At least one emitter 280 may be positioned at one or more end faces 218 of the end portion 216. At least one emitter 280 located at one or more end faces 218 of the tip portion 216 may generate a pressure wave stream that flows or propagates in a generally forward direction or in a direction that is at an acute angle relative to the longitudinal axis 211 of the elongate body 210 ("forward-facing emitter"), as indicated by the arrows in fig. 2. The direction of propagation of the pressure wave generated by the transmitter 280 depends, at least in part, on the non-zero angle of the end face 218 on or in which the transmitter 280 is located. The elongate body 210 may include a distal tip portion 216 that is cut or shaped to provide one, two, three, or more end faces 218, each end face 218 having a plane that forms a non-zero angle with respect to the longitudinal axis 211 of the elongate body 210. The example end portion 216 shown in fig. 2 includes a first end surface 218a and a second end surface 218b. The first emitter 280a is positioned at the first end surface 218a and the second emitter 280b is positioned at the second end surface 218b. For simplicity of illustration, two emitters 280a, 280b are shown in fig. 2 at the two end faces 218a, 218b of the end portion 216. It will be apparent that more or less than two emitters may be provided in more or less than two end faces of the end portion 216 of the elongate body 210. The end faces 218a, 218b of the end portion 216 may be symmetrically arranged with respect to the longitudinal axis 211 of the elongated body 210. The non-zero angle between the end face 218 of the end portion 216 and the longitudinal axis 211 of the elongate body 210 may be in the range of 20 degrees to 70 degrees. For example, the non-zero angle between the end face 218a or 218b of the end portion 216 and the longitudinal axis 211 of the elongate body may be 20 degrees, 25 degrees, 30 degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, or any angle therebetween.

Referring to fig. 2, the elongate body 210 may include a generally cylindrical portion 220 adjacent the end portion 216. One or more emitters 282 may be positioned on or within the outer surface 222 of the generally cylindrical portion 220. One or more emitters 282 located on the outer surface of the generally cylindrical portion 220 of the elongate body 210 may generate a pressure wave stream that flows or propagates in a generally lateral direction or in a direction generally perpendicular to the longitudinal axis 211 of the elongate body 210 ("lateral emitters"), as indicated by the arrows. For illustrative purposes, twelve emitters 282 on or in the outer surface 222 of the generally cylindrical portion 220 are shown in fig. 2. Obviously, the generally cylindrical portion 220 of the elongated body 210 may carry more or less than twelve emitters 282.

Referring to fig. 2, forward emitter 280 at distal tip portion 216 and side emitter 282 at generally cylindrical portion 220 may be independently controlled. This may be accomplished by programming the energy source 102 to deliver, for example, voltage pulses to the forward emitter 280 and the side emitter 282, respectively, or by separately or independently controlling the electrical connection for the forward emitter 280 and the electrical connection for the side emitter 282, or by any other suitable means. Thus, the lithotripsy device 200 of the present disclosure may be used to perform sequential decalcification steps or phases on calcified lesions with a single device. For example, a first decalcification phase for the proximal portion of the calcification lesion may be performed by positioning the device 200 near the calcification lesion using a forward emitter 280 at the distal tip portion 216 of the elongate body 210, and a second or subsequent decalcification phase may be performed by positioning the device 200 inside the calcification lesion using a side emitter 282 at the cylindrical portion 220 of the elongate body 210.

Referring to fig. 2, the elongate body 210 may be or include a tubular body or catheter having a lumen 230 (fig. 1) extending between a proximal portion 212 and a distal portion 214. Alternatively, the elongate body 210 can include a non-tubular body or solid shaft that extends at least a portion of the elongate body. According to embodiments of the present disclosure, a plurality of conduits or channels 234 may be provided in the wall of the tubular body 210. A plurality of conduits or channels 234 allow fluid to be injected into and/or out of interior 251 of balloon 250 through lumen 230 of tubular body 210 for inflation and/or deflation of balloon 250. For example, the lumen 230 of the elongate body 210 can have a diameter in the range of 0.017 inch to 0.042 inch, such as 0.017 inch, 0.021 inch, 0.027 inch, 0.038 inch, 0.042 inch, or any diameter therebetween.

Although not shown in fig. 2, the elongate body 210 may be configured to provide features for retaining the emitters 280, 282 or emitter assemblies. For example, the elongate body 210 may include an elongate groove in an outer surface of the elongate body configured to receive a wire, cable, or electrode. In other examples, the elongate body 210 may have features or retention features that form part of the emitter. For example, the elongate body 210 may hold one or more loops, bands, sheaths, etc., which may be used as electrode components.

Referring to fig. 2, balloon 250 circumferentially surrounds a portion of elongate body 210, e.g., distal tip portion 216 and generally cylindrical portion 220. Balloon 250 encloses or encloses forward emitter 280 at end portion 216 and side emitter 282 at generally cylindrical portion 220. Balloon 250 defines an interior or volume 251 for receiving a fluid, such as saline or a mixture containing a contrast agent. Balloon 250 may be constructed of a flexible polymeric material and is configured to expand radially and forward (pouch or bulge) when inflated by a fluid during operation. Thus, balloon 250 in its inflated or expanded state may laterally contact or lightly press a treatment site, such as a calcified lesion in a blood vessel, from the proximal end of the calcified lesion or from within the calcified lesion. This allows for a first decalcification phase or procedure on the proximal end of the calcification lesion using the forward emitter 280 and a subsequent decalcification phase or procedure on the calcification lesion from within the calcification lesion using the side emitter 282 by a single device, as will be further described below.

Referring to fig. 2, balloon 250 includes a proximal portion 252, a distal portion 254, and an intermediate or inflatable portion 256. Proximal portion 252 of balloon 250 may be secured to elongate body 210, such as outer surface 222 of elongate body 210, by, for example, adhesive or other suitable means. Distal portion 254 of balloon 250 may be secured to distal portion 216 of elongate body 210 by, for example, adhesive or other suitable means. According to embodiments of the present disclosure, the elongate body 210 may include a tubular body having a lumen 230 defined by an inner surface 232 of the tubular body 210. In this way, distal portion 254 of balloon 250 may be secured to inner surface 232 of tubular body 210. Having distal portion 254 of balloon 250 secured to inner surface 232 of tubular body 210 may facilitate positioning one or more forward emitters 280 at tip portion 216 and surrounding or encasing forward emitters 280 with balloon 250. When balloon 250 is inflated in operation, the fluid present between end surface 218 of tip portion 216 and bagged or bulged balloon 250 allows pressure waves generated by forward transmitter 280 to propagate forward or in a direction at an acute angle relative to longitudinal axis 211 of elongate body 210, for example, to perform lithotripsy procedures on the proximal portion of a calcified lesion.

Referring to fig. 2, a seal 258 may be disposed circumferentially around the inner surface 232 of the tubular body 210 in accordance with embodiments of the present disclosure. The seal 258 may be configured to fluidly seal an elongate member, such as a guidewire, catheter, or other device (not shown in fig. 2) positioned within the seal 258. When the inner elongate member is positioned or received in the seal 258, an inflation lumen is formed between the seal 258, the tubular body 210, and the inner elongate member. A pressurized fluid, such as saline or a mixture containing contrast agent, may be introduced into lumen 230 from proximal portion 212 of tubular body 210, through tubing or passage 234 in the wall of tubular body 210, and into interior 251 of balloon 250 to inflate balloon 250. The inner elongate member may be longitudinally movable within the lumen 230 of the tubular body 210 and may extend through the open end of the tubular body 210 to guide the lithotripsy device 200 or perform other medical procedures.

Referring to fig. 2, the seal 258 may be formed by a variety of suitable means, such as thermally compressing the sealing material with a mandrel. For example, a plurality of through holes may be drilled or provided in the wall of the tubular body 210 (e.g., near the distal tip portion 216). A mandrel having a recess or recessed area may be disposed in lumen 230 of tubular body 210. The recessed region of the mandrel may be positioned to face the through-hole in the tubular body 210. The sealing material may be pressed through the hole by thermal compression. The sealing material driven through the bore may be received in the recessed area of the mandrel to form a seal 258 circumferentially around the inner surface 232 of the tubular body 210.

Referring to fig. 3, a lithotripter 300 in accordance with an alternative embodiment of the present disclosure will now be described. As shown, the exemplary lithotripsy device 300 is similar in many respects to the lithotripsy device 200 shown in fig. 2, except that the lithotripsy device 300 shown in fig. 3 includes a dual lumen tubular body 310. The tubular body 310 includes a first lumen 330 and a second lumen 340. The first lumen 330 of the tubular body 310 may be configured to receive an internal elongate member, such as a guidewire, catheter, or other device (not shown in fig. 3) for guiding a lithotripsy device or performing other medical procedures. The second lumen 340 may be an annular lumen surrounding a portion of the first lumen 330 and used to introduce a fluid to inflate the balloon 350. The second lumen 340 is in fluid communication with an interior or volume 351 defined by the balloon 350 via a conduit or passage 334. The tubular body 310 may include an end portion 316, a first generally cylindrical portion 320a adjacent the end portion 316, and a second generally cylindrical portion 320b adjacent the first generally cylindrical portion 320a, the end portion 316 having one or more end surfaces 318 forming a non-zero angle with respect to the longitudinal axis 311 of the tubular body 310. Between the first and second generally cylindrical portions 320a, 320b is a tapered transition portion 320c. One or more emitters 380 may be positioned at the end portion 316 (forward emitter 380) and one or more emitters 382 may be positioned at each of the first and second cylindrical portions 320a, 320b (side emitter 382). Balloon 350 may surround forward emitter 380 at distal tip portion 316 and surround side emitter 382 at first and second cylindrical portions 320a, 320 b. The proximal portion 352 of the balloon 350 may be secured to the outer surface 322 of the tubular body 310 by adhesive or other suitable means. The distal portion 354 of the balloon 350 may be secured to the inner surface 332 of the tubular body 310 by adhesive or other suitable means.

Referring now to fig. 4, a method 400 of treating or disrupting calcified lesions will now be described. The method 400 may begin at step 402 by introducing a lithotripsy device into a patient at step 402. For example, lithotripsy devices may be introduced into the vascular system of a patient through an access vessel (e.g., the femoral artery or inferior vena cava in the inguinal region). The lithotripter or the balloon of the lithotripter may be in a contracted or deflated state when introduced into the patient. The lithotripter may be the lithotripter 200, 300 described above in connection with fig. 2-3 or any other suitable lithotripter. For example, the lithotripter may include an elongate tubular body including a tip portion having an end face forming a non-zero angle with a longitudinal axis of the tubular body, and a generally cylindrical portion adjacent the tip portion, with a balloon circumferentially surrounding a portion of the tubular body and surrounding the tip portion and the generally cylindrical portion. At least one emitter may be positioned at an end face of the end portion (forward emitter) and one or more emitters are positioned at an outer surface of the generally cylindrical portion (side emitter). The at least one forward emitter and the one or more side emitters may be configured to generate pressure waves in the fluid that propagate through the balloon.

At step 404, the lithotripsy device is advanced, positioning at least one forward emitter at a distal portion of the device, proximal to the calcified lesion of the patient. Advancement, delivery and positioning of the lithotripsy device in the patient's vasculature may be assisted by a guidewire and visualized, for example, by x-ray fluoroscopy. Once the lithotripsy device is properly positioned near the calcified lesion, the balloon may be inflated by a pressurized fluid (e.g., a mixture of saline and contrast agent) injected through a port at the proximal end of the tubular body. The inflated balloon may contact or gently press against the proximal portion of the calcified lesion.

At step 406, a first decalcification step or procedure is performed using at least one forward transmitter of the device end portion. Because the forward emitter at the end portion of the device can be controlled independently of the side emitter at the cylindrical portion of the device, a high voltage pulse from the energy source can be delivered only to the forward facing emitter to perform the first decalcification phase. The pressure wave stream generated by the forward emitter in the fluid may propagate through the balloon, disrupting, disintegrating or softening at least the proximal portion of the calcified lesions.

At step 408, the lithotripter is advanced, positioning a side-facing emitter at a generally cylindrical portion inside the calcified lesion. The balloon may be deflated by withdrawing inflation fluid from the balloon to reduce the size of the lithotripter for further advancement. After a first calcification step or procedure, at least a proximal portion of the calcified lesion is disintegrated or softened, allowing a cylindrical portion of the lithotripsy device to pass through a portion of the calcified lesion. Once the lithotripsy device is properly positioned within the calcified lesion, the balloon may be inflated again with pressurized fluid. The inflated balloon may contact the calcified lesion from inside the calcified lesion or gently press the calcified lesion. High voltage pulses from an energy source may be delivered to a side-facing emitter located inside the calcified lesion to perform a second or subsequent decalcification step or procedure on the calcified lesion, as shown in step 410. The pressure wave stream generated by the side-facing emitter in the fluid may propagate through the balloon, destroying or disrupting the calcified lesions.

Various embodiments of a balloon catheter guide have been described with reference to the accompanying drawings. It should be noted that aspects described in connection with a particular embodiment are not necessarily limited to that embodiment and may be practiced in any other embodiment. The drawings are intended to illustrate embodiments, but are not intended to be an exhaustive description or limiting of the scope of the disclosure. Alternative structures, components, and materials will be readily recognized as viable without departing from the principles of the claimed invention.

Unless otherwise defined explicitly, all technical and scientific terms used herein have the meanings commonly understood by one of ordinary skill in the art. As used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The term "or" refers to a non-exclusive "or" unless the context clearly dictates otherwise. The term "proximal" and grammatical equivalents thereof refers to a position, direction, or orientation toward the user or physician's side. The term "distal" and grammatical equivalents thereof refers to a location, direction, or direction away from the user or physician's side. The terms "first" or "second" and the like may be used to distinguish one element from another element when describing various similar elements. It should be noted that the terms "first" and "second" as used herein include references to two or more. Moreover, the use of the terms "first" or "second" should not be interpreted in any particular order unless the context clearly dictates otherwise. In alternative embodiments, the order in which the method steps are performed may be changed. One or more method steps may be skipped entirely and one or more optional steps may be included. All numerical values are provided for purposes of illustration and are assumed to be modified by the term "about," whether or not explicitly indicated. The term "generally" refers to a series of numbers that one of ordinary skill in the art would consider equivalent to the recited value, e.g., having the same function or result. The term "substantially" may include numbers rounded to the nearest significant figure. The term "approximately" may be used to refer to a value that may include a variation of + -10% of the value modified by the term. The recitation of numerical ranges by endpoints includes all numbers subsumed within that range.

Those skilled in the art will appreciate that various other modifications may be made. All of these and other variations and modifications are contemplated by the inventors and are within the scope of the invention.

Claims

1. A lithotripter, comprising:

an elongate body comprising a distal tip portion having an end face forming a non-zero angle with a longitudinal axis of the elongate body;

a balloon circumferentially surrounding a portion of the elongate body and surrounding an end face of the tip portion, the balloon defining an interior for receiving a fluid; and

at least one emitter positioned at the end face of the end portion of the elongate body, the at least one emitter configured to generate pressure waves in the fluid that propagate through the balloon to break up calcified lesions.

2. The lithotripter of claim 1, wherein the end surface of the end portion comprises a first end surface and a second end surface that is substantially symmetrical to the first end surface, and the at least one emitter comprises a first emitter positioned at the first end surface and a second emitter positioned at the second end surface.

3. The lithotripter of claim 1, wherein the non-zero angle formed between the end surface and the longitudinal axis is in a range of 20 degrees to 70 degrees.

4. The lithotripter of claim 1, wherein the elongate body comprises a tubular body having an inner surface defining a lumen, and wherein the balloon comprises a distal portion secured to the inner surface of the tubular body.

5. The lithotripter of claim 4, wherein the distal portion of the balloon forms a seal circumferentially around the inner surface, the seal configured for fluidly sealing an elongate member positioned within the seal.

6. The lithotripter of claim 4, wherein the balloon is forward and radially expandable when filled with the fluid.

7. The lithotripter of claim 4, wherein the tubular body comprises a generally cylindrical portion adjacent the tip portion, the generally cylindrical portion having an outer surface surrounded by the balloon, and wherein the lithotripter further comprises one or more transmitters positioned at the outer surface of the generally cylindrical portion to generate pressure waves in the fluid.

8. The lithotripter of claim 7, wherein the at least one emitter positioned at the end face of the tip portion is controllable independently of one or more emitters positioned at an outer surface of a generally cylindrical portion.

9. The lithotripter of claim 1, wherein the elongate body comprises a tubular body having an inner surface and an outer surface defining a lumen, the balloon comprising a distal portion, a proximal portion, and an expandable portion, the distal portion being secured to the inner surface of the tubular body, and the proximal portion being secured to the outer surface of the tubular body.

10. The lithotripter of claim 1, wherein the elongate body comprises a tubular body having an inner surface and an outer surface defining a first lumen, the balloon comprising a distal portion, a proximal portion, and an inflatable portion, the distal portion being secured to the inner surface of the tubular body and the proximal portion being secured to the outer surface of the tubular body, and wherein the tubular body further comprises a second lumen in fluid communication with an interior defined by the balloon.

11. The lithotripter of claim 10, wherein the second lumen comprises an annular lumen surrounding at least a portion of the first lumen.

12. The lithotripter of claim 1, wherein the elongate body comprises a tubular body having an inner surface defining a lumen having a diameter ranging from 0.017 inches to 0.042 inches.

13. A lithotripter, comprising:

an elongate tubular body comprising a distal tip portion and a generally cylindrical portion adjacent the tip portion, the distal tip portion having an end face forming a non-zero angle with a longitudinal axis of the tubular body;

a balloon circumferentially surrounding a portion of the tubular body and surrounding the end portion and the generally cylindrical portion, the balloon defining an interior for receiving a fluid; and

at least one emitter positioned at an end face of the tip portion and one or more emitters positioned at an outer surface of the generally cylindrical portion, the at least one emitter and the one or more emitters configured to generate pressure waves in the fluid that propagate through the balloon to pulverize calcified lesions.

14. The lithotripter of claim 13, wherein the at least one emitter positioned at an end face of the tip portion is controllable independently of one or more emitters positioned at an outer surface of the substantially cylindrical portion.

15. The lithotripter of claim 13, wherein the elongate body comprises a tubular body having an inner surface and an outer surface defining a lumen, the balloon comprising a distal portion, a proximal portion, and an expandable portion, the distal portion being secured to the inner surface of the tubular body, and the proximal portion being secured to the outer surface of the tubular body.

16. The lithotripter of claim 13, wherein the elongate body comprises a tubular body having an inner surface and an outer surface defining a first lumen, the balloon comprising a distal portion, a proximal portion, and an inflatable portion, the distal portion being secured to the inner surface of the tubular body and the proximal portion being secured to the outer surface of the tubular body, and wherein the tubular body further comprises a second lumen in fluid communication with an interior defined by the balloon.

17. The lithotripter of claim 13, wherein the balloon comprises a distal portion secured to an inner surface of the tubular body.

18. A method, comprising:

introducing a lithotripsy device into a patient, the lithotripsy device comprising:

an elongate tubular body comprising an end portion and a generally cylindrical portion adjacent the end portion, the end portion having an end face forming a non-zero angle with a longitudinal axis of the tubular body;

at least one emitter positioned at an end face of the tip portion and one or more emitters positioned at an outer surface of the generally cylindrical portion, the at least one emitter and the one or more emitters configured to generate pressure waves in the fluid;

advancing the lithotripsy device to position the at least one emitter near a proximal end of a calcified lesion in a patient tissue structure;

performing a first decalcification step, using the at least one emitter at the end face of the tip portion to decompose or soften at least a portion of the calcified lesion;

advancing the lithotripsy device to position at least one of the one or more emitters at an outer surface of the generally cylindrical portion inside the calcified lesion; and

a second decalcification step is performed, using the at least one of the one or more emitters at the outer surface of the generally cylindrical portion to decompose the calcified lesion.

19. The method of claim 18, wherein the first decalcification step and the second decalcification step are performed during lithotripsy to break calcified occlusions in the patient's vasculature.

20. The method of claim 18, wherein the first and second decalcification steps are performed during lithotripsy to break calcified occlusions in the patient's kidneys or ureter.