Devices and methods for in vivo surgery

Abstract

A device for in vivo surgery includes a cutting device rotatable by a hollow drive shaft, the cutting device being formed by a hollow anterior cutting region and a posterior region. The anterior region includes a plurality of longitudinal bore portions that are interconnected by laterally oriented cutting blade portions. The drilling portions are positioned at an angle to each other that together with the cutting blade define a conical mesh structure having a hollow interior cavity. The grid structure defines a plurality of ports between the drilling portion and the blade. A low-pressure region is formed within the hollow interior cavity, in which the cut obstructing material is drawn into the hollow interior cavity through a plurality of ports in the low-pressure region to further draw the obstructing material from the cutting device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is a partial continuation application of patent application SN16 / 192,781 filed on November 15, 2018, wherein patent application SN16 / 192,781 claims priority to provisional patent application SN62 / 586,654 filed on November 15, 2017 and priority to provisional patent application SN62 / 680,260 filed on June 4, 2018, the disclosures of which are incorporated herein by reference. Technical Field

[0003] The devices and methods of the present invention generally relate to intracorporeal surgery and treatment of obstructed body lumens. The devices and methods of the present invention particularly relate to the removal of obstructive material from blood vessels and other body lumens. Background Art

[0004] The devices and methods of the present invention are suitable for various types of in vivo surgeries, including but not limited to the cutting, destruction, coagulation, and vaporization of any human tissue (including but not limited to soft tissue, which includes tendons, ligaments, fascia, skin, fibrous tissue, fat and synovium, etc.; as well as muscles, nerves and blood vessels (not connective tissue) and hard tissue / bone and connective tissue, etc.), which involve reaching the target tissue through body channels, including but not limited to blood vessels, ureters, esophagus, stomach and duodenum (esophagogastroduodenoscopy), small intestine (enteroscopy), large intestine / colon (colonoscopy, sigmoidoscopy), or involve cutting human tissue (laparoscopic surgery) and similar operations.

[0005] Although the device and method for removing obstructive material in blood vessels and other body cavities are discussed in more detail below, it should be absolutely clear that this is one of many applications of the present invention. In fact, as mentioned above, the device and method of the present invention can be applied to many types of in vivo surgery.

[0006] Cardiovascular disease is generally caused by the accumulation of atheromatous material on the lining of the blood vessels, especially the coronary arteries, peripheral vessels, and other vasculature, resulting in a condition known as atherosclerosis. Atherosclerotic and other intravascular deposits restrict blood flow and may cause ischemia, which in acute cases may lead to myocardial infarction or heart attack, stroke, or aneurysm. Atherosclerotic deposits can be of widely varying nature, with some deposits being relatively soft and others being fibrous and / or calcified. In cases where deposits are fibrous and / or calcified, the deposits are often referred to as plaques. Atherosclerosis occurs naturally due to aging, but can also be exacerbated by factors such as diet, hypertension, genetics, vascular damage, etc.

[0007] Atherosclerosis can be treated in a variety of ways, including medications, bypass surgery, and various catheter-based approaches that rely on endovascular dilation or removal of atherosclerosis or other obstructing material. Specific catheter-based interventions include angioplasty, plaque removal, RF ablation cutting devices, stenting, etc. However, in most cases, these interventions may be difficult or impossible to achieve in the curved areas of the vascular system. In addition, the catheter used for these interventions is usually introduced over a guidewire, and the guidewire is placed around the lesion before the catheter is placed. If a guidewire needs to be placed through a long and multi-directional vascular system, the initial guidewire placement is also difficult. This is especially true when the lesion obstructs the vessel lumen to the point where the guidewire cannot be advanced through the lesion.

[0008] Blockages in blood vessels can be caused by a variety of materials, from hard bone such as calcium deposits to soft blood clots or a piece of fatty deposits. There may be multiple types of blockages in the same blood vessel. Currently, different tools are used to remove different types of blockages. The surgeon may need to remove one type of catheter and then replace the previously described catheter with another type of catheter to treat the different types of blockages. This prolongs treatment time, greatly increases costs, and increases risk to the patient. The present invention provides a more optimized and complete solution to this problem, which includes a device that analyzes the type of blocking material present and then adjusts the function of the blockage removal device accordingly. In addition, the present invention provides a combined arrangement that allows the sergeant to successfully treat different blockage types without removing one type of catheter / cutting tool and replacing the previous type of catheter / cutting tool with another type of catheter / cutting tool.

[0009] In the prior art, atherectomy devices are known that utilize a diamond drill bit / electric drill to grind hard calcified obstructions into very small particles. Although there is some discussion that the particle size (approximately 5 μm) produced by a 20 μm diamond tip electric drill used to ablate plaque into tiny particles is smaller than the size of a red blood cell (8 μm), it is also known that larger particle fragments are produced, which are generated during the blockage rupture process. Such larger particles can block capillaries and cause serious side effects. However, even when the obstructing particles are as small as blood cells, there are still certain potential risks associated with the presence of obstructing particles in the blood stream. Especially if these particles accumulate on the body's basic tissues, they can cause abnormal function of the body's vital organs. Even smaller particles (such as tattoo ink particles (less than 1 μm)) can cause malfunction of the body's vital organs. (9)) is also well known. It is well known that the accumulation of tattoo particles (tattoos) is permanent or at least long-term. Since the tattoo ink has been inserted into the skin, most of it remains in the dermis. Therefore, the impact of ink particles on other tissues and organs is localized. On the other hand, since particles are generated during the occlusion process, blood flow to important body organs is disrupted, and proper management of this becomes important. Some rotational atherectomy catheters have built-in structures for active suction to clear debris from the blood and empty the debris through the catheter or capture them in a separately inserted collection basket downstream of the blood vessel behind the occlusion area. However, these suction (debris evacuation) devices are not optimally designed to remove all or most of this debris particles. The present invention proposes a better and more complete solution to this problem.

[0010] Prior art solutions for removing calcium plaque are typically equipped with a forward-shaped rotating drill. If such a drill is pushed against the vessel wall during surgery, this design presents a risk of accidentally perforating the vessel wall. One aspect of the present invention provides a method for limiting this risk of vessel wall perforation and minimizing adverse surgical aspects to any adjacent tissues.

[0011] In the prior art, it is known to have a drill bit whose center of mass is offset from the center of the drill's axis of rotation. This creates a centrifugal force that allows the drill to drill a wider opening in the lumen. However, this can also lead to injury to the vessel wall. This is because the operator cannot control the application of centrifugal forces that are always present in prior art devices. Injury to the vessel wall during atherectomy is one of the main causes of restenosis after atherectomy - soft tissue growth of the vessel wall that closes the vessel lumen by soft obstruction.

[0012] The present invention provides a solution to prevent accidental damage to the vessel wall by creating a mechanism that allows the operator to remotely change the position of the drill's center of mass based on the distance required for the specific surgical site requirements.

[0013] In the prior art, rotational atherectomy systems using diamond drills / electric drills are known to grind hard calcified obstructions into very small particles. However, such drills are not suitable or effective for removing soft obstructive materials. The present invention provides a solution that allows the use of a mechanical drill to safely and effectively cut and remove hard and soft obstructive materials in blood vessels, including in-stent restenosis 1SR growths. The device of the present invention is acceptable in plastic surgery and other types of body surgery. Summary of the invention

[0014] One aspect of the present invention provides a device for intracorporeal surgery, the device comprising a cutting device rotatable by a hollow drive shaft, the cutting device being formed by a hollow front cutting region and a rear region. The front region is formed by a plurality of longitudinal borehole sections interconnected by transversely oriented cutting blade sections. The borehole sections are placed at an angle to each other and together with the cutting blades define a conical grid structure having a hollow lumen, wherein a plurality of ports are provided between the borehole sections and the blades. A low pressure region is formed within the hollow lumen, wherein the low pressure region draws the cut obstructive material into the hollow lumen through the plurality of ports for further extraction from the cutting device.

[0015] Another aspect of the present invention provides a surgical device having a cutting device for intravascular surgery that can be rotated by a drive shaft. The cutting device is composed of the following parts: a generally hollow front cutting area and a rear area, a connecting element extending from the rear area to connect to the distal end of the drive shaft, and a sleeve formed by a wall having a front edge and defining an internal hollow space. The sleeve is arranged at the connecting element and can be moved between an expanded position and a retracted position. In the retracted position, the wall of the sleeve is inserted between the cutting area and the vessel wall.

[0016] In the expanded position, the front end of the sleeve engages the obstruction material and allows the cutting area rotatable by the drive shaft to engage the target obstruction material through the interior space of the sleeve. When the rotational movement of the drive shaft and the cutting device begins, the sleeve moves from the locked retracted position to the expanded position.

[0017] Another aspect of the present invention provides a system for endovascular surgery, which includes a hollow catheter, a cutting device disposed at the proximal end of the catheter, a power source for energizing the cutting device, a vacuum source disposed at the distal end of the catheter to form a low pressure zone in the hollow interior of the catheter, and the cutting device.

[0018] A control unit is provided to adjust the characteristics of the catheter and / or the cutting device based on inputs obtained from a plurality of sensors disposed within the cutting device and the catheter. In response to the signals, the control unit adjusts the characteristics according to the composition of the obstructing material, the physical characteristics of the catheter and the cutting device.

[0019] According to another aspect of the present invention, a plurality of sensors are provided in the catheter and the cutting device to emit and receive various signals (optical signals, electromagnetic signals, acoustic signals, capacitance measurement signals) capable of detecting the components of the obstructing material, and to enable the control unit to generate control signals to control the operation of the cutting device.

[0020] Another aspect of the present invention provides a catheter assembly in combination with a radio frequency (RF) electrosurgical instrument.

[0021] The catheter assembly includes a catheter body having a hollow interior. A vacuum source is disposed at the distal end of the catheter to produce a low pressure zone. A plurality of active electrodes are disposed at the front end of the distal portion of the body for transmitting electrical signals and producing an electrosurgical effect near the active electrodes for cutting tissue. A plurality of passive electrodes are disposed at the front end of the distal portion in a closely spaced relationship relative to the active electrodes. Each passive electrode includes a passive tissue contact surface having an area greater than the area of ​​the active tissue contact surface of the corresponding active electrode. The electrodes are spaced apart from the inner wall of the substantially hollow interior, and the opening is configured to draw ablation debris through the low pressure zone and into the hollow interior of the human body. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In the following drawings, like parts in the various views are given like reference numerals. Reference is now made to the accompanying drawings provided to illustrate but not limit the present invention, in which:

[0023] Figure 1A is a diagram showing an electric drill according to one embodiment of the present invention;

[0024] Figure 1B yes Figure 1A A partial cross-sectional view of

[0025] Figure 1C It is shown Figure 1A Figure 1 of an alternative embodiment of the electric drill shown in ;

[0026] Figure 2 is a diagram illustrating a system of the present invention;

[0027] Figure 3 A distal end of a catheter according to another embodiment of the present invention is shown, the distal end of the catheter comprising a slidable sleeve in an extended position;

[0028] Figure 4 The slidable sleeve is shown in a retracted position;

[0029] Figure 5 Another embodiment of a slidable sleeve is shown;

[0030] Figure 6 is a diagram showing one position of an embodiment of a combined electric drill and a slidable sleeve;

[0031] Figure 7 It is shown Figure 6 a diagram of another position of the illustrated embodiment;

[0032] Figure 8 Another embodiment of the present invention is shown;

[0033] Fig. 9is a diagram showing an embodiment of the present invention utilizing ultrasonic energy;

[0034] Fig.10 yes Fig. 9 a cross-sectional view of the illustrated embodiment;

[0035] Fig.11 is a view of a modified embodiment utilizing a slidable sleeve:

[0036] Fig.12 yes Fig.11 a cross-sectional view of the illustrated embodiment;

[0037] Fig.13 and Fig.14 is a diagram showing yet another embodiment of the present invention utilizing RF energy;

[0038] Fig.13A , 14A and 14B are diagrams showing modified embodiments of the present invention utilizing RF energy;

[0039] Fig.15 The use of a rotatable blade assembly is shown Figure 8 The modified embodiment shown;

[0040] Fig.16A , 16B and 16C show embodiments of the present invention utilizing a reinforcing mandrel;

[0041] Fig.17 An embodiment utilizing a pull wire is shown; and

[0042] Fig.18A , 18B and 18C show a surgical tool according to another embodiment of the present invention. DETAILED DESCRIPTION

[0043] As used herein in the description of the various components, "proximal" refers to a direction toward a system controller and operator, while "distal" refers to a direction away from a system controller and operator and toward a distal end of the cutter assembly.

[0044] Typically, the material removal system of the present invention includes a control unit attached to one end of the catheter assembly and an axially translatable, rotatable drive shaft, wherein a cutter assembly is located at the distal end of the drive shaft supported at least in part by a guide wire. The material removal system of the present invention also includes a plurality of sensors located in the area of ​​the cutter assembly and arranged along the length of the catheter. In one embodiment, the system includes wires associated with the sensors and power delivery to an ultrasound or RF transmitter.

[0045] The cutter assembly is translated over the guidewire to the material removal site and actuated at the material removal site to cut, abrade or ablate or remove obstructing material. During the material removal operation, the control unit and manifold assembly remain outside the body.

[0046] We now refer to Figure 1A and Figure 1B , which shows a catheter assembly 10 of one embodiment of the present invention, which is configured to deliver a high-speed electric drill / cutter 20 into a blood vessel and other body cavities, and is suitable for ablating and removing abnormal obstructive materials and deposits. The electric drill / cutter 20, which is actuated by a drive shaft 30 and guided through a blood vessel to an application area by a guide wire 50, drills and cuts away obstructive materials in the blood vessel.

[0047] The flexible guide wire 50 is guided to one or more lumens, such as a blood vessel, to the desired material removal site. The catheter assembly 10 generally accommodates an electric drill / cutter 20, a drive shaft 30, and the drive shaft 30 also defines a lumen 32, which can also be used to aspirate and / or infuse fluid. The catheter assembly 10 can be fixed to the drive shaft 30 and advance with the drive shaft to actuate the cutter assembly. The guide wire 50 and the catheter assembly are introduced into the patient's lumen and directed or guided to the desired material removal operation site.

[0048] The proximal end 33 of the drive shaft is operably connected to a vacuum pump or an infusion pump, while the distal end 34 of the drive shaft is operably connected to the cutter / drill 20. The drive shaft 30 is preferably a flexible, hollow, spiral, torque-transmitting shaft.

[0049] The drill / cutter 20 is formed with a teardrop-shaped head 22 having a substantially hollow front cutting outer region 28 and a substantially solid rear region 25. The front region 28 facing the obstruction is formed by longitudinal bore portions 24 extending along the longitudinal axis of the cutter, which are interconnected by transversely oriented cutting blade portions 36. The bore portions 24 are positioned at an angle to each other, which together with the transverse cutting blades 36 define a conical grid structure that terminates at the front tip 26 of the head 22. An internal hollow cavity 48 is formed inside the grid structure, wherein a central hole 40 passes through the rear region 25 and the connecting element 35. The grid structure defines a plurality of ports 46 between the bore portions 24 and the blades 36. The central hole 40 and the inner cavity 48 extend longitudinally through the central portion of the drill / cutter body and are adapted to removably accommodate a guide wire 50. The cutter / drill 20 is mounted on the distal end 34 of a flexible drive shaft 30 that transmits torque from a torque generating device (not shown) such as an electric or pneumatic motor. The drive shaft 30 is guided by and surrounds a majority of a hollow guide wire 50. Port 46, which will be discussed in this application, provides a passage for debris from the exterior of the cutter / drill to the central hole 40 and the lumen 48. Optionally, the port 46 may also be provided in the rear region 25. A connecting element 35 extends in a proximal direction from the rear region 25 of the drill to connect to the distal end 34 of the drive shaft. In one embodiment, the connecting element 35 is cylindrical. On the other hand, any conventional configuration of the connecting element 35 is within the scope of the present invention. As discussed later in this application, a stop member 37 (see Figure 6 and Figure 7 ).

[0050] A plurality of ports 46 connect the outer surface of the drill to its inner lumen 48, which connects to the lumen 32 and aspirates debris generated by drilling of hard obstructing material or cutting of soft obstructing material. Figure 1A As shown in the figure, the central hole 40 passes through the electric drill / cutter to reach the inner cavity 48. The hole 40 is larger than the outer diameter of the guide wire 50 so that the drive shaft 30 with the cutter 20 can slide and easily translate on the guide wire 50. The longitudinal drilling portion 24 and the cutting blade 36 are formed to have sharp edges defining an outer cutting surface. The cutting blade 36 and the longitudinal drilling portion 24 can have sharp edges to provide cutting and ablation. The longitudinal drilling portion 24 and the cutting blade are arranged to guide the debris generated during the cutting operation to the interior of the head 20 through a plurality of ports 46. The longitudinal drilling portion 24 and the cutting blade 36 can additionally or alternatively have a bonding agent or cutting material that is bonded to one or more surfaces of the longitudinal drilling portion 24. Materials such as diamond abrasives are an example of a suitable bonding agent.

[0051] In one embodiment of the present invention, the cutting blades 36 are arranged in a radially symmetrical configuration. In another embodiment, the cutting blades are arranged asymmetrically with respect to the longitudinal axis of the head 22.

[0052] In a preferred embodiment, a port / opening 46 is formed in the front region 28 of the cutter / drill to provide communication with the lumen 48. More specifically, the port 46 provides communication with the lumen 48 between the cutting front region 28 that engages the obstruction material and provides communication with the bore 54 of the guide wire 50 that is disposed within the lumen 48.

[0053] Particles generated by the operation of the drill / cutter 20 are appropriately removed to prevent penetration into the bloodstream. Debris particles generated by the use of the drill / cutter 20 are aspirated into the lumen 48 through the port 46 through a low pressure area formed in the lumen by a vacuum pump connected to the distal end 34 of the drive shaft. Port 46 also allows debris generated during the operation of the drill 20 to be aspirated into a port 54 in the guidewire. As will be discussed in more detail below, the guidewire 50, which is formed into a hollow tubular structure, can also be used as an aspiration / suction catheter for aspirating obstruction debris during the drilling of obstruction material by the drill / cutter 20.

[0054] As mentioned above, in an alternative embodiment, the port 46 may also be disposed in the rear portion 25 of the drill. The guide wire may be removed after the drill / cutter 20 is guided to the obstructing material in the body cavity. Thus, the entire lumen 48 of the drill and the lumen 32 of the shaft may be used for suction purposes.

[0055] The front region 28 of the cutter facing the obstruction material may have a coating on its inside or outside for various purposes, for example, to prevent body fluids from corroding the cutter or to isolate the high energy emitted to its distal region. It may have any size suitable for its intended use.

[0056] Additional structures at the front region 28 can help prevent clogging of the suction catheter. For example, a filter, screen, mesh, shield or other barrier can be provided at the distal region of the suction catheter.

[0057] In an alternative embodiment, if Figure 1C As shown, the interior of the rear region 25 is substantially hollow. A plurality of knives 29 are provided at the inner surface of the rear region 25 to further process the obstructing material accumulated in the inner cavity 48. More specifically, these knives further cut and transport the material along the chamber to the hollow interior of the drive shaft. In an alternative embodiment, a plurality of knives 29 are provided in the hollow interior of the rear region 25 to further process the obstructing material accumulated in the inner cavity 48. More specifically, these knives further cut and transport the material along the chamber to the hollow interior of the drive shaft. Figure 8 and 1580. Such a processing unit includes a chamber having a drive shaft assembly having a delivery member rotatably positioned therein. The delivery member receives obstructing material from the lumen 48, further cuts it and delivers the material along the chamber to the hollow interior of the drive shaft.

[0058] In one embodiment of the present invention, the guide wire 50 is formed as a hollow tube. The drive shaft 30 is also hollow. Blood with particles can flow from the electric drill 20 through the port 46 into the lumen 48 and the hole 40 and face the guide wire 50, which is at least partially arranged in the hollow lumen 32 of the drive shaft connected to the suction or injection device.

[0059] The hollow tube or central channel 52 of the guide wire 50 is used as a conduit for suctioning obstruction material debris. As shown, the guide wire 50 includes a plurality of holes 54 along its distal end 56. Using this hollow guide wire enables the clinician to capture obstruction material debris more effectively. This is because the holes 54 allow the debris to be captured / collected just at the site where the debris is generated during the operation and before the debris is dispersed. The hollow guide wire 50 can be made of metal, plastic, or fine particles or any other material that meets the requirements of the guide wire and cannot be used for liquids containing obstruction material or embolic debris.

[0060] If desired, the hollow / tubular guidewire 50 can also deliver fluids / drugs / coolants to a target location. Liquids / fluids / drugs are allowed to leak from the hollow passage 52 into the vasculature passageway by means of the holes 54. The location where the liquid / drug / coolant is discharged from the tubular guidewire 50 can be controlled by controlling the size of the holes 54 and their location.

[0061] When the hole 54 is used in conjunction with the port 46, other important functions of the hole 54 of the hollow guidewire 50 also become applicable.

[0062] With regard to the suction aspect of the present invention, vacuum pump 70 (see Figure 2 ) A low pressure area is formed at the proximal end 33 of the drive shaft and the hollow guide wire to aspirate debris of obstructive material or embolism generated by the device of the present invention in the blood vessel or body cavity.

[0063] It is necessary to ensure that the cutter / drill 20 can enter the calcified obstructive material / obstructive lesion in a controlled manner for its predictable advancement. Therefore, in order to facilitate the advancement of such a cutter, the drive shaft 30 should be axially translatable relative to the guide wire 50. In the current prior art, removing the residual debris is usually a complex and time-consuming technique / process. In current practice, a tool similar to the drill / cutter 20 is pushed into the calcified obstructive area during rotation and then retracted. This operation in the prior art procedure allows the residual debris to be emptied and the local circulation to be reestablished before another cutting cycle is performed on the lesion. On the other hand, in the present invention, the port 46 of the drill / cutter 20 establishes a reliable connection between the drill cutting blade 36, the hollow channel 52 and the hole 54 of the guide wire. In this way, the residual debris is continuously discharged during the operation without the complex operation discussed above. In addition, in the prior art, the device for capturing the debris of the obstructive material is usually located behind the cutting drill (leading to the debris collection sleeve or the debris collection basket). This method is very likely to allow some debris to escape into the patient's vascular system. In the present invention, due to negative pressure suction through the plurality of ports 46, debris is collected near the location where it accumulates.

[0064] Although the cutter / drill 20 has been discussed above for use in removing obstructive material from a blood vessel, it should be noted that the use of the drill for many types of intracorporeal surgery (as described above) also forms a part of the present invention.

[0065] For example, the drill 20 may be used in conjunction with a corresponding flexible scope during ureteroscopy for the treatment and removal of stones in the kidneys and ureters. During the examination, the physician will pass a scope with a drill through the patient's bladder and ureters into the kidneys. The drill 20 may be particularly useful for larger stone removal and may be used in conjunction with other techniques and / or tools, including energy-based devices, to break up stones. The drill 20 may also be useful in ureteroscopy to remove polyps, tumors, or abnormal tissue in the urethra. A further application of the drill 20 is to reach the stone in conjunction with a tubule during percutaneous nephrolithotomy or percutaneous nephrolithotomy, where the drill grinds / breaks up the stone. This action may be used in conjunction with high-frequency sound waves, radio frequency, or other energy-based devices. Following the operation, a stone is vacuumed and removed from the system using the suction device of the present invention.

[0066] Figure 1AAlso shown is an optional feature of the drill / cutter 20 in which the center of mass is not at the center of the drill's rotation, thereby creating an orbital effect. More specifically, this feature provides a mechanism 21 that moves the center of mass away from the center of the drill's rotation, thereby providing an alternative control function for the operator. When the operator wishes to drill a wider opening in an obstructing material, the center of mass moves away from the center of the drill's rotation. On the other hand, during other surgical procedures, the center of mass of the drill remains at the center of rotation, thereby preventing damage to the vessel due to uncontrollable rotational forces that would press the drill's ablation surface against the vessel wall. As shown in FIG. Figure 1A As shown, the mechanism 23 consists of a plurality of or at least two counterweights initially positioned symmetrically with respect to the axis of rotation of the electric drill, wherein one of the counterweights 23 moves away from the center of rotation. When the counterweight 23 is released by the operator, the pivoting arm 31 with the counterweight 23 pivots away from the connecting portion 35. In this mechanism, the release and movement of the arm can be controlled in any conventional manner, i.e. mechanically, electrically, wirelessly.

[0067] We now refer to Fig.18A , 18B and 18C, which show additional embodiments of the electric drill / cutter of the present invention for orthopedic and other types of surgical procedures. The applications of these surgical tools include, but are not limited to, drilling and surface ablation of bones, scrubbing or scraping of bones, ligaments, menisci, cartilage, etc. Fig.18A The drill / cutter 20' in the embodiment of the present invention is formed with a conical head 22' having a substantially hollow front cutting outer region 28' and a substantially solid rear region 25'. The front region 28' facing the operating area is formed by a longitudinal drilling portion 24' extending along the longitudinal axis of the cutter, and the longitudinal drilling portion 24' is interconnected by a transversely oriented cutting blade portion 36. The drilling portions 24' are positioned at an angle to each other to define a conical grid structure together with the transverse cutting blade 36, which terminates at the tip 26' of the head. The grid structure defines a plurality of ports 46' between the drilling portion 24' and the blade 36'. The ports 46' provide a debris passage from the outside of the cutter / drill to the inner cavity 48'. As described above, the conical surface of the drill / cutter 20' is used for drilling, surface ablation of bones, etc. Fig.18C Drill / cutter 20' with Fig.18AThe drill / cutter 20" in Figure 18b is similar to the drill / cutter in Figure 18b, except that it is also provided with an outer shield / cover 45", which prevents the material / particles formed during the operation from being dispersed, thereby guiding them into the inner cavity 48' to be extracted from the device by suction. The drill / cutter 20" in Figure 18b is formed to have a cylindrical head 22', which has a substantially hollow front cutting outer region 28", and a substantially solid rear region 25". The front region 28" is formed by a substantially straight drilling portion 24", which is interconnected by a transversely oriented cutting blade portion 36". The drilling portion 24" and the transverse cutting blade 36" combine to define a cylindrical grid structure with multiple ports 46". Optionally, multiple knives 29" can be set at the inner surface of the hollow rear region 25" to further deal with obstructive materials accumulated in the inner cavity 48".

[0068] like Figure 2 As shown, the control unit 12 houses a programmable logic controller 14 or microchip and a power supply 15 that can communicate operatively to provide power and control the operation of the various units of the system of the present invention. The control unit 12 preferably includes a base that is arranged so that the control unit can be stably supported on a work surface or body surface during the material removal operation. The control unit 12 also preferably includes a control system that is used to actuate, regulate and provide system information about power, drive shaft speed, drive shaft axial translation, suction, infusion, which displays readings of sensors located on catheters and cutting instruments, etc. The control unit may include, but is not limited to, a vacuum control unit, a cutter pusher unit, a guidewire control unit, a cutter assembly drive control, and a suction and infusion control unit. The control unit 12 also controls a block that provides information about operating conditions and provides feedback from the material removal site to the operator.

[0069] With the aid of a computer or microchip 14, the control unit 12 utilizes input received from a plurality of sensors 16 located at other key areas of the drill / cutter 20 and / or the catheter assembly to continuously update operating parameters output to the operator, such as the temperature of the material removal site; the rotational speed and / or advancement speed of the cutter assembly; the suction rate and / or amount; the infusion rate and / or volume; etc. The control unit 12 may additionally provide adjustable controls to allow the operator to control the operating parameters of the cutter assembly and the material removal operation. Figure 2As shown, the control unit 12 is configured to adjust the power source 15 based on the type and characteristics of the target obstruction (hard, soft, blood, etc.) and / or the characteristics of the drill catheter (length, diameter, temperature, etc.) to obtain an optimal output level. The characteristics of the control unit 12 can be adjusted by the operator, or can be automatically adjusted based on input from the sensor 16. The various characteristics / parameters at the control operating position are based on information provided by sensors located at the distal end of the catheter and the drill, such as rotation speed, temperature, etc. Such characteristics can be adjusted manually or automatically based on signals and data received from the sensor 16 installed in the cutter / drill 20.

[0070] The sensor 16 can emit and receive various types of signals (optical signals, electromagnetic signals, acoustic signals, capacitance measurement signals) that will change parameters depending on the composition or other physical properties of the obstruction and / or the physical properties of the tissue surrounding the obstruction and / or the catheter itself, thereby allowing the control unit 12 to calculate and generate appropriate signals to control the operation / rotation speed of the electric drill 20, etc.

[0071] The sensor 16 located at the front 24 of the electric drill 20 is capable of identifying (determining) the physical and chemical properties of the obstruction. The computer or microchip 14 associated with the control unit 12 receives and analyzes the information / data obtained by the sensor 16 and generates signals to adjust the parameters of the power source 15 to optimize the destruction of the obstruction in the blood vessel and / or produce other beneficial effects on the target tissue. As an example, the control unit 12 analyzes the information / data obtained by the sensor 16 and generates signals to adjust the parameters of the power source 15 to optimize the rotation speed of the electric drill 20, etc.

[0072] This also includes applying different physical mechanisms of action to disrupt the blockage. For example, the cutting device may combine a mechanical cutting tool and an RF cutting electrode, which may be activated interchangeably by the control unit 12 based on signals from sensors describing the characteristics of the blocking material, which may require the use of different tools to optimally remove the blocking material.

[0073] The sensor 16 can detect the degree of hardness / calcification, water / moisture content, etc. within the obstruction material. As the electric drill 20 passes through various areas of the obstruction, the optimal level of rotation speed, etc. can be achieved for each treatment area. For example, a higher rotation speed can be provided to destroy ablation obstructions with higher hardness. On the other hand, for areas with softer obstruction materials, a lower speed will be generated to allow for more effective blade cutting.

[0074] The use of the cutting drill 20 is also accompanied by automatic target feedback, such as thermal feedback, to accurately control the rotation speed, etc. This is necessary to prevent damage to surrounding tissue. To this end, a non-contact thermal detector 17 can be provided. The output of the non-contact thermal detector 17 can be used to adjust the output of the power supply 15 to maintain selected characteristics, including the temperature of the treatment site.

[0075] In the present invention, in order to effectively control the destruction of the blockage, the condition of the entire arterial body and / or tissue surrounding the surgical site is monitored by a detector 17, which is adapted to detect radiation reflected by such tissue. One of the basic functions of the detector 17 is to control the effect of the drilling / ablation on the tissue surrounding the site. In each case, the physician sets specific rotation, etc. characteristics to produce the desired effect. If the conditions at the surgical site become unfavorable, such as the temperature exceeds a predetermined limit, the detector 17 generates a signal directed to the control unit 80, which in turn generates a correction signal to the power supply 15 or the control unit 12.

[0076] The computer or microchip 14 of the control unit 12 receives and analyzes the information obtained by the detector 17 and generates control signals to adjust the parameters of the power supply 15 to optimize the disruption of blockages in the blood vessels and other beneficial effects on the target soft tissue.

[0077] In an alternative embodiment, the control signal generated by the thermal detector 17 energizes a cooling device (see above) to directly or indirectly reduce / regulate the temperature at the site. This is necessary to eliminate the possibility of damaging adjacent tissue. The detector 17 and sensor 16 can be made using a variety of photoelectric elements, photoresistors, photodiodes and similar devices. Overheating can also occur along the length of the catheter, especially along the length where the catheter bends at an acute angle, so installing temperature sensors along the length of the catheter can improve the safety of the device.

[0078] As described above, friction due to engagement / drilling between the electric drill 20 and the obstructing material, as well as other factors, may cause the temperature of the surrounding tissue to increase. In the present invention, the temperature increase occurs in a controllable manner without causing irreversible thermal damage to the tissue surrounding the artery. The control unit 12 adjusts the energy to maintain a preselected target temperature at the site. In one embodiment of the present invention, in order to make the patient as safe as possible, an optional continuous or pulse cooling device may be provided to deliver coolant from an infusion material reservoir 55 to the surgical site via a guidewire 50 during or after the procedure with the aid of an infusion pump 53.

[0079] Figure 2A system according to one embodiment of the present invention is schematically depicted that can be connected to a cutter 20 to extract ablated or cored body material from a subject's vascular system using various embodiments of the cutter / drill 20. A vacuum pump 70 disposed at the proximal end 33 of the drive shaft creates a low pressure region to generate suction pressure within the lumen or hollow interior space 32 of the drive shaft or channel 52 of the guidewire 50 to expel the cut and / or ablated body material directly from the surgical site in the vascular system.

[0080] In another embodiment, the vacuum pump 70 is interconnected to a pulse modulator 71, actuation of which generates one or more pressure differentials for the aspiration system. Thus, by using the pulse modulator 71, rather than generating a constant aspiration pressure within the system to aspirate the cut and / or ablated bodily material from the subject's vascular system, the aspiration system of the present invention applies an alternative pressure to generate aspiration pressure pulses within the lumen. Utilizing a series of constant and / or varying pressure pulses may be beneficial in aspirating bodily material, particularly when aspirating a larger cylindrical core or plug-shaped bodily material.

[0081] Aspirated liquid and / or particles from the area near the distal end of the tool accumulate and are stored in a disposable debris storage 76. A filter 74 may also be provided upstream of the system to filter debris and aspirated body material and also to provide visual feedback to the user regarding the type, quantity, and flow rate of material removed from the patient. The debris container 76 may be in fluid communication with the vacuum pump 70 and may include one or more known devices for collecting and filtering material removed from the patient. The container 76 may have a transparent sidewall for providing visual feedback to the user regarding flow rate, contents, color, etc. Those skilled in the art will appreciate that various types of collection containers may be used. The collection container 76 and / or the filter 74 may also include one or more custom filter features having various mesh sizes, capacities, etc. based on a specific application.

[0082] The distal end 56 of the hollow guidewire 50 used as a suction catheter can be made of a variety of flexible or rigid materials or a combination of the two, such as metal or plastic. In addition, the distal end 56 of the guidewire formed as a suction catheter can be made of a different material from the main body of the hollow guidewire. For example, one may want to make the distal end 56 of a more heat-resistant material to withstand the high energy directed at it. It may also be desirable to use a more impact-resistant material to withstand the initial impact of solid particles attracted by the suction force.

[0083] Now refer to Figure 3, shows the deployment / working position of a sleeve 60 provided for sliding motion along the outside of a catheter according to another embodiment of the present invention. The distal end of the catheter assembly 10 is provided with a sliding sleeve 60 having an activation mechanism 62, which is arranged to controllably move the sleeve back and forth along the outside of the catheter. In one embodiment of the present invention, the activation mechanism 62 is spring-controlled. However, the activation mechanism 62 can be energized / actuated in any conventional manner, such as electric, pneumatic, etc. mechanisms. The front end / distal end 65 of the sleeve 60 is designed to establish close contact with the obstruction. For example, the distal end 65 can be made of an elastic material that can adopt an evolving configuration of the outside of the obstruction during surgery. Therefore, the function of capturing obstruction debris and guiding it into the hollow tubular channel 66 for suction has been enhanced. As shown in the figure, in the working position, the sleeve 60 extends outward from the outside of the catheter 10. In this arrangement, the diameter of the outer circumference at the distal end of the catheter is slightly increased. In the retracted position, the sleeve 60 is positioned along the outer surface of the catheter.

[0084] In another embodiment, if Figure 4 As shown, a circumferential recess 68 is formed in the distal end of the catheter body, and the circumferential recess 68 has a depth and length corresponding to the various dimensions of the sleeve 60. The outer surface of the sleeve is flush with the outer surface of the catheter. Before the catheter is placed through the vascular cavity to the surgical site, the sleeve 60 is pressed inwardly in the proximal direction to overcome the resistance of the activation mechanism 62. As a result, the sleeve 60 is immersed in the circumferential recess 68. In this locked position, the outside of the sleeve 60 is flush with the outside of the catheter. After delivery and proper positioning at the site, the activation mechanism 62 is released-unlocked and the sleeve 60 is moved to the expanded working position to provide a closer contact between the distal end 65 of the sleeve 60 and the obstruction.

[0085] Now see Figure 5 , which shows an alternative embodiment that provides for further increasing the sleeve's ability to adapt to randomly shaped obstructions to optimally seal the cut / drilled site. Figure 5 As shown, longitudinal slits 67 are arranged circumferentially in the sleeve body to form a plurality of segments. The slits 67 extend inwardly from the distal end of the sleeve to divide the sleeve body into a plurality of segments 69. In one embodiment of the present invention, the front region of the segment may be curved and / or formed of an elastic material to further improve engagement with the obstruction. Any reasonable number and configuration of slits and / or segments is within the scope of the present invention.

[0086] Now see Fig.11 and Fig.12, another embodiment of a sleeve assembly 120 is shown, which is provided to further increase the sleeve's ability to enhance randomly shaped blockages to optimally seal the cutting / drilling site to maximize the capture of disrupted blocking debris. Longitudinal slits are arranged circumferentially within the sleeve body to form a plurality of segments. Such segments are able to move longitudinally independently of each other to optimally adapt to the random shapes of possible blocking deposits. The assembly 120 is composed of an outer base 122 formed by a cylindrical side wall 131 and a rear wall 124, thereby defining a hollow inner cavity 129 therebetween. A plurality of mutually separated engagement segments 127 are located in the inner cavity 129 to slide independently along the longitudinal axis of the assembly.

[0087] Any reasonable number of segments can be symmetrically arranged in the cavity. Each engagement segment is composed of at least one front portion 126 suitable for engaging with the obstruction material and a rear portion 128 suitable for moving in the inner cavity 129. A biasing member or spring 130 is located between the rear portion 128 of each segment and the bottom wall 124 of the base. In use, when the sleeve approaches the obstruction, the front portion of each segment squeezed by the biasing member 130 engages the corresponding area of ​​the obstruction with a specific structure. This occurs independently of other segments. The front portion 126 of each segment is formed to provide close contact with the corresponding area of ​​the obstruction. In one embodiment, the front portion 126 is made of an elastic material that can adopt the evolving structure of each part of the obstruction. Therefore, during surgery, the sleeve assembly 120 provides an improved, tighter contact between the front portion of the segment and the obstruction.

[0088] Figure 6 and Figure 7 A further embodiment of the present invention is shown which combines the use of the above-described electric drill / cutter 20 with a sliding sleeve 60 movably positioned at the connecting element 35 of the electric drill. A stop member 37 is provided at the proximal end of the connecting element 35. As shown, the sleeve 60 is arranged to move along the connecting element 35. The advancement of the sleeve in the proximal direction is limited by the stop member 37. The hollow interior of the sleeve defines an interior space 64 which accommodates the electric drill 20 and serves as its housing. Figure 6 As shown, in the initial position on the connecting element, the drill 20 is positioned within the chamber 64 so that the wall of the sleeve extends outside the drill. This position of the sleeve is locked by the key 39. This arrangement allows the drill 20 covered by the sleeve 60 to be safely advanced through the blood vessel to the blocked area. When the drill covered by the sleeve reaches the blockage, the drive shaft begins to rotate the drill. The torque moment at the beginning of the rotation breaks the key 39, thereby disengaging the drill and the sleeve. Thus, independent operation of the drill and the sleeve begins. Figure 7As shown, the obstruction is drilled by rotating the electric drill 20. On the other hand, the sleeve becomes independently slidable by the loaded spring device 41, which pushes the sleeve 60 toward the obstruction to establish contact therebetween, thereby further maximizing the capture of cut debris into the inner hollow space 48 of the electric drill.

[0089] An abrasive or cutting material is bonded to or attached to the distal end 67 of the sleeve by any other conventional means, thereby forming an auxiliary cutting region. In an alternative embodiment, a cutting element or cutting edge may be formed at the distal end 67 in lieu of an abrasive material. In this manner, the assembly is provided with two cutting regions at the distal end 67, including the drill / cutter 20 and the auxiliary cutting region.

[0090] To drill out the obstruction, the rotating drill 20 is moved in the distal direction through the advancing catheter. After that, the sleeve 60 starts the rotational movement. In this process, the main central part of the obstruction is cut or drilled out by the cutting drill 20. In addition, as Figure 7 As shown, a portion of the obstruction along the inner wall of the blood vessel or lumen is removed or cut off by rotating the auxiliary cutting area provided at the distal end 67 of the rotating sleeve. Therefore, this arrangement enables the doctor to eliminate or cut off the entire obstruction in one surgical step. However, in the prior art, since the outer diameter of the electric drill is relatively small, the obstruction portion provided along the inner wall of the blood vessel or lumen is not removed.

[0091] During insertion of the catheter through the blood vessel to the point of the blockage and during the cutting process, the wall of the sleeve 60 isolates the electric drill 20 from the blood vessel wall 63. Therefore, the risk of accidental perforation of the blood vessel wall 63 or any other adjacent tissue during the procedure is minimized. The interior space 64 of the sleeve forms a conduit that contains the material cut during the procedure and improves the flow of various fluids during aspiration and / or infusion.

[0092] Figure 6 and Figure 7 The basic function of the sleeve assembly shown in is to form an enhanced engagement with the obstruction. Therefore, once the distal end of the sleeve is engaged with the obstruction, it provides isolation and possible vacuum within the space 64, allowing the electric drill to be placed therein. As the electric drill rotates / drills, the resulting debris or cut material accumulates / arranges within the interior space 64 and is emptied into the interior hollow space 48 of the electric drill through multiple ports 46 by suction. The present invention also provides electric drill-sleeve assemblies of various sizes to enable practitioners to more accurately adapt to the details or dimensions of each blood vessel or lumen being operated on. Therefore, larger sizes are accommodated in sleeves 60 having larger diameters, while sleeves of smaller diameters are provided for smaller sized blood vessels. This function is particularly important when close contact between the exterior of the sleeve and the interior of the blood vessel is required to remove a partial obstruction located adjacent to the inner surface of the blood vessel.

[0093] During the stage of inserting the catheter into the blood vessel and moving it through multiple blood vessels to finally reach the surgical site (occlusion), the sleeve 60 is locked so that it surrounds the electric drill / cutting surface, thereby protecting the inner wall of the blood vessel from being injured by the cutting surface of the electric drill, while minimizing the risk of undesired growth of blood vessels in soft tissue, which is caused by such cutting surface being pushed through the blood vessel to the occlusion site. When the electric drill / cutting device reaches the occlusion position, the sleeve 60 is released from the locked position as the rotation of the shaft begins.

[0094] It should be noted that the application of the slidable sleeve 60 is not limited to removing obstructive material from a blood vessel. The sleeve 60 can be used for various types of in vivo surgeries (as described above). For example, it can be used in ureteroscopy, where stones in the kidneys and ureters can be treated and removed. The sleeve 60 can be used in conjunction with a flexible scope that passes through the patient's bladder and ureters to enhance contact with the kidney. The sleeve 60 is used in conjunction with an RF cutting device to help remove larger stones, wherein the RF cutting device passes through the flexible scope to break up the stones. Another example is the use of a movable sleeve 60 during ureteroscopy to remove polyps, tumors, or abnormal tissue in the urethra during plastic surgery or general surgery. Similar to the applications discussed above, the sleeve 60 can be used for percutaneous nephrolithotomy or percutaneous nephrolithotomy, in conjunction with a tubule to reach the stone and break up the stone with high-frequency sound waves or an RF cutting device. The broken fragments are vacuumed and removed from the system by the suction device of the present invention.

[0095] Although the above has discussed an assembly combining a drill / cutter 20 with a sliding sleeve 60, it should be noted that it is within the scope of the present invention to use a cutter / drill with other types of protective devices. For example, an assembly is also contemplated in which the drill / cutter 20 is combined with a sliding sleeve 60. Fig.11 , the sleeve assembly combination shown in 12 and 14.

[0096] exist Figure 8 In another embodiment of the present invention shown, a processing unit 80 having a rotatable blade assembly or cutting element 85 is provided at the distal end of the drive shaft 30 to cut and macerate the obstruction (embolism) and transfer the cut material away from the site. The rotatable blade assembly 85 includes a hub and a plurality of blades arranged at the hub. Each blade is formed with a front cutting edge and a rear cutting edge and extends in a plane generally perpendicular to the axis of rotation.

[0097] The processing unit 80 includes a chamber 82 having a drive shaft assembly 84 having a delivery member 86 rotatably located therein. The delivery member 86 receives the obstructing material cut by the cutting element 85 and delivers the obstructing material along the chamber 82.

[0098] The drive shaft assembly 84 both transports the cut tissue / matter within the treatment unit 80 and drives the rotation of the cutting element 85. In other embodiments, the drive shaft 84 can transport the cut tissue proximally within the treatment unit 80 but does not drive the rotation of the cutting element 85. Figure 8 Drive shaft assembly 84 is shown attached to cutting element 85 .

[0099] The drive shaft 84 is generally cylindrical and may include a solid tube or a hollow tube. The drive shaft with the delivery member 86 is manufactured to be flexible enough to facilitate traveling in the curved vascular anatomical structure, and is manufactured to be strong enough to withstand the stress encountered when the high-speed rotation, torque is transmitted through the drive shaft to the cutter 85 at the distal end of the treatment unit, and to deliver the obstruction material. The delivery member 86 can be a separate element that is attached or fixed to the substantially cylindrical drive shaft in some way. Alternatively, the drive shaft 84 and the delivery member 86 can be formed as a single integral element.

[0100] The drive shaft 84 is formed with a central lumen 88 for delivering the guidewire 50 and may be coated with a lubricious material to avoid binding with the guidewire. The central lumen 88 of the shaft 84 may also be used to deliver fluids to the surgical site in conjunction with or in lieu of a guidewire.

[0101] In one embodiment of the invention, a plate 95 having a plurality of holes 97 is placed in the chamber 82 transverse to its longitudinal axis, the plurality of holes passing from one side of the plate to the other side of the plate. In this way, the obstructing material initially cut by the cutting member 85 is transported by the conveying member 86 to the chamber 82 to pass through the plurality of holes of the plate 95 for further processing. The receiving chamber 82, the shaft 84 and the conveying member 86, and the optional plate 97 form the first processing part 83 of the unit 80. Alternatively, it can be the second chamber 82'. The obstructing material from the chamber 82 / 82' is pushed by the conveying member 86 to the space 52, through which the broken debris is evacuated into a disposable reservoir located in the control unit.

[0102] The delivery member 86 can be an auger type system or an Archimedean screw that moves debris and cut material generated during surgery away from the surgical site. The delivery member 86 has a raised surface or blade that moves material away from the surgical site. The blades of the delivery member 86 can extend to the entire diameter of the internal chamber 82 or a portion thereof.

[0103] The debris is expelled from the body by the action of the transport member 86 along the length of the catheter, with or without the assistance of a vacuum pump connected to the catheter. Alternatively, the debris may accumulate in a reservoir within the device.

[0104] Optionally, a plurality of generally equally spaced ridges 87 are provided that are foldable in nature and extend from the inner wall 89 of the chamber. The ridges 87 tend to provide adequate clearance around the delivery member 86. In this way, initially processed obstructing material can be advanced through the processing unit 80 without creating back pressure as the assembly becomes clogged. The ridges 87 are aligned to increase the throughput of material by directing the material toward the proximal end of the unit 80.

[0105] like Figure 8 As further shown, the tool of the present invention can optionally be provided with a second processing portion 90. The second portion 90 includes a second chamber 82', the second chamber 82' having a second drive shaft 84' portion, the second drive shaft 84' portion having a delivery member 8", the second pitch of the delivery member being generally smaller than the pitch of the first delivery member 86. The first and second delivery members are coaxially arranged and formed with longitudinally extending holes, one of the functions of these holes is to accommodate the hollow guide wire of the present invention. The second portion 90 can optionally be provided with a second plate 95', the second plate 95' having a second plurality of holes 97' extending from one surface of the second plate 95' through the other surface. The second plate 95' The holes 97' of the first plurality of holes 97 can be smaller than the holes of the first plurality of holes 97. In this way, as previously discussed, the obstructing material is first processed by passing through the first plurality of holes 97 under the impetus of the first conveying member 86. The material is then further processed to a smaller size by passing through the second plurality of holes 97' under the impetus of the second conveying member 86'. The first and second conveying members can be formed as an integral continuous structure or as two separate units. The conveying member 86' pushes the debris through the opening 97' and into the space 52, which is connected to the vacuum in the control unit.

[0106] The second processing chamber may be used in certain situations, for example, where a highly calcified obstruction is encountered. In such a situation, the material exiting the first plurality of holes may be in a relatively coarse agglomerated form. The material is then picked up and advanced by the second delivery member to help direct the material toward the second plate. As the cut material passes through the second plurality of holes of the second plate, the size of the obstructing particles is further reduced.

[0107] like Figure 8As shown, the treatment unit 80 may optionally be provided with a sleeve 60 that is slidably arranged on the outside of the catheter. In the deployed position shown, the sleeve 60 extends outward from the distal end of the unit 80. The hollow interior of the sleeve forms an interior space 64 that serves as a housing for the cutting element 85. The connection area between the drive shaft and the drive element is also accommodated in the space 64. When the sleeve 60 is retracted in the proximal direction, the cutting element 85 is exposed to the outside.

[0108] In use, when the sleeve 60 is in the expanded working position, the distal end 65 of the sleeve 60 engages the obstruction, and the cutting element 85 is then delivered to the surgical site through the interior space 64 by the drive shaft. The interior space 64 also forms a conduit that holds the material cut during surgery and improves the flow of various fluids during aspiration and / or infusion. In this embodiment, the cutting element 85 is precisely delivered to the obstruction. In addition, the wall of the sleeve 60 isolates the cutting element 85 from the inner surface of the vessel wall to minimize the risk of accidental perforation / damage of the vessel wall.

[0109] In operation of the processing unit 80, the obstruction material cut by the cutting element 85 is first processed and delivered to the chamber 82. In the embodiment provided with the plate 95, the drive shaft assembly 84 having the delivery member 86 pushes the cut obstruction material toward the hole 97 and passes the obstruction material through the hole 97. Thus, as previously discussed, the size of the initially cut obstruction material is reduced to become more suitable for suction, collection and disposal. In order to further reduce the size of the cut obstruction material, the second processing chamber 82' can be utilized in the manner described above.

[0110] The use of the processing unit 80 in combination with the cutting element 85 for various types of intracorporeal surgery (as described above) also forms part of the present invention. For example, in ureteroscopy for the treatment and removal of stones in the kidneys and ureters, the processing unit 80 can be used in combination with a corresponding flexible scope. The use of the processing unit 80 is also suitable for use in combination with an RF cutting device to remove larger stones, which is passed through the flexible scope to break up the stones. In addition, in ureteroscopy, the processing unit 80 can be used to remove polyps, tumors or abnormal tissue in the urethra. The processing unit 80 including the cutting element 85 can also be used for percutaneous nephrolithotomy or percutaneous nephrolithotomy, in combination with a tubule to reach the stone and break up the stone by high-frequency sound waves or RF cutting devices. In addition, the processing unit 80 can be used in intracorporeal surgery, laparoscopic surgery and endoscopic plastic surgery, including but not limited to spinal surgery, knee or hip replacement, etc. The processing unit 80 can be used to safely and effectively remove any soft tissue. After the operation, the scraps of the soft tissue are vacuumed with the suction device of the present invention.

[0111] Now see Fig.15, which shows a processing unit 180, which is provided with a cutting assembly 185 at the distal end of a drive shaft 184. The assembly 185 is formed with a hub 160, a plurality of blades 162, and the plurality of blades are arranged in an outer band 164, which is in turn arranged at the periphery of the blades 162. In one embodiment, the hub, the blades and the outer band can be formed integrally. Each blade 162 is formed to have a front cutting edge 168 and a rear cutting edge 167, and the front cutting edge 168 and the rear cutting edge 167 extend in a plane generally perpendicular to the axis of rotation.

[0112] The outer band 164 has a front / distal region 166 and a rear / proximal region facing the obstruction. Abrasive cutting materials are combined or attached to the distal region by any other conventional means to form an auxiliary cutting region 170. Alternatively, a cutting element or edge may be formed at the front region 166 of the outer band. Therefore, the cutting assembly 185 is formed with two cutting regions, including a main cutting region defined by the front cutting edge 168 of the blade 162 and an auxiliary cutting region 170 defining the front region 166 of the outer band. In use, when approaching the obstruction, the leading edge 168 of the main cutting region removes or cuts off the central region of the obstruction. On the other hand, the obstructing tissue at the inner wall of the blood vessel is eliminated or removed by the auxiliary cutting region 170. In the surgical procedures of the prior art, such obstructing tissue is often not removed due to the outer diameter of the cutting tool being smaller than the inner diameter of the blood vessel and other reasons. Therefore, the application of the cutting assembly 185 of this embodiment enables the practitioner to eliminate or remove the entire obstruction in one procedural step. This embodiment can be used to cut soft obstructing tissue and is particularly suitable for stent restenosis surgery.

[0113] Similar to Figure 8 ,like Fig.15 In the illustrated embodiment, the treatment unit 180 includes a chamber 182 having a drive shaft 184 provided with a transport member 186. The drive shaft and the transport member transport the tissue to be removed or cut in the treatment unit 180 and drive the cutting assembly 185 to rotate. Fig.15 As shown, the catheter is formed with an outer sheath / will be shown / separated from an inner hollow tube housing the drive shaft. The drive shaft 184 is formed with a central lumen 188 for delivering the guidewire 50 and may also be used to deliver fluids to the surgical site.

[0114] To facilitate rotation of the drive shaft and cutting assembly 185, the distal end (not shown) of the processing unit 180 is spaced apart from the cutting assembly 185 by a gap (not shown). Fig.15As shown, the front end can be expanded. In addition, lubricant can be delivered through the space separating the interior of the hollow tube and the drive shaft. The wall of the housing 180 can optionally be expanded to a larger diameter than the average diameter of the catheter to accommodate a wider blade assembly 185 to optimally ablate blockages in larger diameter vessels.

[0115] As previously in Figure 8 As discussed in the embodiment of the present invention, the transport member 186 transports the obstructing material cut by the cutting assembly 185 to the chamber 182 for further processing. The processed cut material debris is then discharged through the space separating the outer sheath from the inner tube with or without the assistance of a vacuum pump connected to the catheter. Alternatively, the debris can be accumulated in a reservoir within the device.

[0116] Now see Fig. 9 , which shows yet another embodiment of the present invention in which the source (generator) of ultrasonic energy is disposed at the proximal end of the catheter. In the illustrated embodiment, the source is a pair of ultrasonic generators spaced apart from one another, which are configured to produce ultrasound waves / beams focused on a specific area near the proximal end of the catheter. In use, the proximal end is delivered to the obstruction so that the ultrasound beam is focused to an area within the obstructing body to selectively destroy the obstructing tissue. Because the focus is separated from the surrounding tissue, the risk of collateral damage to the surrounding vessel wall is minimized. Although a pair of cooperating ultrasonic generators are shown, it should be understood that the distal end of the catheter may be provided with any reasonable number of cooperating ultrasonic generators.

[0117] like Fig. 9 As shown in FIG. 1 , the distal end 102 of the catheter 100 is formed with a convex region 104 having a pair of symmetrically arranged ultrasonic energy generators 106 and 108. The convex region 104 reflects the energy emitted from the ultrasonic generator, and the beam of ultrasonic energy is optimally focused on a specific / predetermined area within the obstruction body to selectively destroy tissue. The focus of the beam 110 is arranged along the longitudinal axis AA of the catheter and is spaced apart from the distal end 102.

[0118] Optionally, the distal end 102 of the catheter is made of an elastic material and the convex region 104 forms a suction cup to further improve the engagement between the distal end and the obstruction. This arrangement prevents the spread of debris while helping to capture the debris. In addition, an ultrasonic energy detector and / or other sensors 105, including but not limited to temperature sensors, may be provided at the distal end 102 to control the operation of the ultrasonic energy generators 106 and 108. The sensors / detectors 105 detect data related to the physical characteristics and chemical composition of the obstruction and transmit such data to the control unit. As previously described with respect to Figure 2As discussed, the computer or microchip 35 of the control unit 30 receives and analyzes the information obtained by the sensor / detector 105 and generates control signals to adjust the function of the ultrasonic energy generators 106 and 108 to optimize the disruption of the obstruction and produce other beneficial effects on the targeted soft tissue.

[0119] like Fig.10 As shown, the convex region 104 provided with ultrasonic energy generators 106, 108 can be used with a sleeve 60 that is slidably disposed in an outer region of a catheter 114. In the deployed position shown, the hollow interior space 64 of the sleeve 60 serves as a housing for the convex region 104 including the ultrasonic energy generators 106 and 108. During use, the sleeve is placed in an expanded working position while the distal end of the catheter with the ultrasonic energy generator is delivered through the interior space 64 to the proximal end of the obstruction. In this manner, the ultrasonic beam 110 is optimally focused at a specific region of the obstruction to selectively destroy tissue. The interior space 64 of the sleeve 60 forms a conduit that contains material cut during surgery and improves the flow of various fluids during aspiration and / or infusion associated with the use of the catheter. The convex region 104 with the ultrasonic energy generators 106, 108 is precisely delivered to the obstruction, and the walls of the sleeve further separate the generators 106, 108 from the inner surface of the vessel wall 112, thereby minimizing the risk of inadvertent damage and / or perforation of the vessel wall.

[0120] Now see Fig.13 and Fig.14 , which shows an electrosurgical tool 190 according to another embodiment of the present invention. In this embodiment of the present invention, the electrosurgical effects of ablation and resection are achieved by applying a radio frequency (RF) current to the tissue through an active electrode (+) 192, from which the RF current flows to a ground or return (-) electrode 194. As it passes through the tissue from the active electrode to the ground electrode, the RF current cuts and / or coagulates the tissue depending on the combination of power and wavelength. The flexible, elongated hollow tubular body 200 is typically flexible and made of an electrically insulating material. To this end, any of a variety of polymeric or plastic materials may be used. The distal end 197 of the tool includes a plurality of active electrodes and associated ground electrodes. A source (generator) of RF (radio frequency) energy (not shown) is located at the proximal end 198 of the tool or the proximal end of the catheter in the control unit power supply. As Fig.13 As shown in , in one application, the catheter includes a plurality of wire conductors 191 extending longitudinally within the hollow interior of the body 200 to deliver current / voltage to RF electrodes 192, 194 disposed at the distal end.

[0121] The ground electrode (-) 194 is positioned sufficiently close to the active (+) electrode 192 so that the RF current flows a short distance. In this manner, the loss of RF current due to dissipation to tissue and / or conductive irrigation fluid is reduced, and the desired effect or cutting performance of the tool 190 is not significantly reduced. In the bipolar instrument of the present invention, the active electrode 192 and the associated return electrode 194 are arranged in close proximity to each other. Therefore, the current is less likely to flow to other tissues besides the intended tissue to be operated on. When ablating thinner or more delicate areas of tissue, or when there is concern about possible collateral damage to target or non-target tissue, it is preferable to deliver the bipolar RF energy of the device of this embodiment in a more controlled manner.

[0122] like Fig.13 As shown, the wire 191 that transmits the RF current to the electrode is located in the inner cavity of the tubular body. The wire and electrode are designed so that they do not occupy a large amount of the internal space of the tubular body 200, and the individual electrodes / wires do not interfere with each other. The open space formed in the catheter body between the wires and / or electrodes is used to evacuate the ablated body material generated during the operation. Evacuation can be achieved, for example, by a vacuum pump provided at the proximal end of the system, which creates a region of permissive pressure, thereby generating a suction pressure in the hollow internal space of the catheter, which can directly remove the ablated body material at the surgical site.

[0123] In an alternative embodiment, if Fig.13A As shown, the electrosurgical tool 190 can also be configured as a bipolar RF device having a single return / passive electrode 202 associated with multiple active electrodes disposed at the distal end of the body. The single passive electrode 202 is disposed at the distal end 196 of the catheter body in a manner closely spaced from the active electrodes. In one embodiment, the single return / passive electrode 202 (see Fig.13A , 14A) can be an integral conductive ring positioned at the distal end of the catheter that completely and partially surrounds the distal end, and the surface area of ​​the single return / passive electrode 202 is much larger than the surface area of ​​any of the active delivery electrodes 192. However, it should be noted that other shapes / forms / designs of passive electrodes are within the scope of the present invention.

[0124] In an alternative embodiment (see Fig. 14B ), the conductive ring at the distal end of the catheter can be divided into multiple segments 205, thereby forming multiple return / passive electrodes 194 juxtaposed with a single active electrode 192. These electrodes are in the form of metal parts / inserts that are electrically insulated from each other and completely and partially surround the distal periphery. In this way, multiple bipolar tissue cutting segments are formed over the entire cross-section of the tool 190.

[0125] The electrodes are located distally so that the alternating current between the electrodes disrupts the blockage in contact with the electrodes. Since the RF energy is delivered via alternating current between electrodes that are isolated / separated from the internal area of ​​the vessel wall, the application of RF technology provides increased safety compared to other methods. Therefore, the possibility of damaging the adjacent vessel wall / tissue is minimized.

[0126] In the manner discussed above, a detector and / or sensor 196 may be provided at the distal end of the catheter for determining the physical and chemical composition of the obstruction, and the function of the RF transmitter may be regulated by means of a computer or microchip of the control unit.

[0127] Fig. 9 and 10 The embodiments discussed above are directed to a source (generator) of ultrasonic energy being disposed at the proximal end of the catheter. However, the use of other energy generators is also within the scope of the invention. For example, the catheter may be provided with a cavitation source disposed at the distal end to transmit cavitation waves for intracorporeal surgery. In use, the catheter is passed through / placed within a blood vessel (vein or artery) so that such waves damage or affect soft tissue or organs in some reasonable manner through mechanical or chemomechanical properties and / or forces. An outlet for emitting cavitation energy may be added to the distal end of an existing catheter.

[0128] According to one embodiment of the present invention, the cavitation energy outlet is located on the outer diameter of the catheter tip and is arranged on the longitudinal axis through the catheter. This is conducive to focusing the cavitation waves on the central area of ​​the obstruction. In this arrangement, when the obstruction is broken, the risk of damage to the vessel wall is greatly reduced or minimized.

[0129] As previously discussed, at the distal end of the catheter there is a detector and / or sensor capable of determining the physical and chemical composition of the obstruction and regulating the performance of the cavitation energy outlet with the aid of a computer or microchip of a control unit.

[0130] like Fig.16A As shown, the distal end 220 of the guidewire 210 may include a curved portion that facilitates navigation of the guidewire in the vascular system. Although various angles of inclination of the distal end to the rest of the guidewire are contemplated, in a preferred embodiment, the distal end 210 is inclined at an angle of approximately 30 degrees.

[0131] During an atherectomy procedure, a guidewire is first installed from an entry point into the patient's vein or artery until the target blocked area of ​​the target vessel is reached. This guidewire is designed to be thin and easy to pass through the vascular vasculature. However, the surgeon moves the guidewire longitudinally within the vessel by pushing it forward along the vessel. To achieve this movement, the guidewire must have a certain stiffness to keep it straight and prevent it from coiling within the vessel. However, this stiffness further complicates the passage of the guidewire through difficult vasculature, which has a vessel curvature approaching 90 degrees or an obtuse angle. Now see Fig.16A , which shows that the distal end portion of the guidewire 220 can be bent to an optimal angle, which can facilitate the guidewire to pass through difficult angle vasculature. The surgeon can push the guidewire and rotate the guidewire at the same time so that the curved end of the guidewire is more likely to enter the difficult angle vessel, while the straight end guidewire will stop by simply pushing into the vessel wall. Fig. 16B A prior art straight guidewire is shown inserted through a hole or lumen of a blood vessel 232 to stop at the vessel wall to make a sharp 90 degree turn. The present invention utilizes a curved end guidewire to facilitate passage through a sharply curved end vessel by providing an optional lateral orientation for the guidewire to be pushed forward by the surgeon. Fig. 16C A particular application of this feature of the invention is shown where the 90 degree curved tip of guidewire 220 is successfully pushed through a 90 degree turn in the vasculature by the primarily straight portion of guidewire 210 .

[0132] like Fig.17 As shown, the hollow guidewire 210 may also include a string 212 connected to the exterior of the distal end 214. As further shown, the string 212 enters the interior hollow portion of the guidewire through a hole 216 located at a predetermined optimal distance from the distal end.

[0133] In this embodiment, by pulling on wire 212, an operator can remotely steer and / or bend the distal region of guidewire 210 to an optimal angle to align the distal end in a desired direction within the patient's body lumen.

Claims

1. A device for intracorporeal surgery, comprising: A cutting device for intravascular surgery rotatable by a drive shaft; The cutting device is formed by a substantially hollow front cutting region and a rear region, a connecting element extending from the rear region to connect to the distal end of the drive shaft, and a sleeve formed by a wall having a front edge and defining an internal hollow space, at least a portion of the cutting region being disposed within the internal hollow space of the sleeve, the sleeve being arranged at the connecting element so as to be movable between an expanded position and a contracted position, wherein in the contracted position the wall of the sleeve is inserted between the cutting region and the vessel wall to prevent damage to the vessel, and in the expanded position the front end of the sleeve engages the obstructing material and allows the cutting region, which can be rotated by the drive shaft, to engage with the target obstructing material in the vessel lumen through the internal space of the sleeve, and when the rotational movement of the drive shaft and the cutting device begins, the sleeve moves from the locked contracted position to the expanded position.

2. The device according to claim 1, characterized in that The electric drill defines a main cutting area, and the outer edge of the sleeve defines an auxiliary cutting area, wherein during use, the electric drill of the main cutting area removes the central area of ​​the obstruction, and the auxiliary cutting area removes the peripheral tissue of the obstruction at the inner wall of the body lumen.

3. The device according to claim 1, characterized in that The leading edge of the auxiliary cutting region is selected from the group consisting of an abrasive cutting material and a cutting element.

4. The device according to claim 1, characterized in that A plurality of longitudinal slits are circumferentially arranged in the sleeve, extending inwardly from a distal end of the sleeve to divide the sleeve into a plurality of segments, the ends being longitudinally movable independently of one another to best accommodate the random shapes of possible obstructing deposits.

5. The device according to claim 1, characterized in that Also includes: An outer base is formed by a cylindrical side wall and a rear wall to define a hollow interior cavity in which the plurality of engagement ends are located for independent slidable movement.

6. The device according to claim 5, characterized in that Also includes: A biasing member is located between the rear of each segment and the rear wall of the base, wherein when the sleeve approaches the block, the front of each segment engages the block independently of the other segments to provide close contact between the front of the segment and the block.

7. A system for endovascular surgery, comprising: a hollow catheter disposed within the blood vessel, the catheter extending between a proximal end and a distal end thereof; A cutting device, disposed at the proximal end of the catheter and suitable for ablating obstructed soft and / or hard tissue in the blood vessel; a power source, powering the cutting device; a vacuum source, disposed at the distal end of the catheter to form a low-pressure area in the hollow interior of the catheter and the cutting device, wherein the low-pressure area helps to remove obstructing debris ablated by the cutting device; an infusion pump, which inputs liquid material into the hollow interior of the catheter; a control unit, suitable for adjusting the characteristics of the catheter and / or cutting device based on input and information obtained from multiple sensors, wherein the multiple sensors are disposed in the cutting device and the catheter; in response to the signal, the control unit adjusts the characteristics according to the composition of the obstructing material, the physical properties of the catheter and the cutting device.

8. The system according to claim 7, characterized in that The multiple sensors are arranged in the catheter and cutting device to emit and receive various signals (optical signals, electromagnetic signals, acoustic signals, capacitive measurement signals) capable of detecting the components of the obstruction, while allowing the control unit to generate control signals for controlling the operation of the cutting device, wherein when the sensor detects at least one parameter in the obstruction in the body, the control unit generates a control signal for adjusting the rotational characteristics of the cutting device.

9. The system according to claim 7, characterized in that The sensor is located at the distal end of the cutting device and is capable of determining the physical and chemical composition of the obstruction, wherein a computer or microchip associated with the control unit receives and analyzes the information / data obtained by the sensor and generates signals to adjust the parameters of the power supply to optimize the rotation speed of the electric drill and ultimately optimize the destruction of the obstruction in the body area.

10. The system according to claim 7, characterized in that A computer or microchip associated with the control unit receives and analyzes information / data obtained by a temperature sensor located at the drill to generate signals to adjust continuously updated operating parameters, including the temperature at the material removal site.

11. A guide wire for an intravascular surgery device, comprising: A hollow tubular portion extends between proximal and distal ends thereof to enable an operator to remotely manipulate the distal end of the guidewire from the proximal end to an optimal angle to orient the distal end in a desired direction within a patient's body lumen.

12. The guide wire according to claim 11, characterized in that The guidewire has a portion at the distal end that is curved less than 90 degrees relative to a front portion of the guidewire, such that the curved portion facilitates entry and passage of the guidewire through difficult vasculature.

13. The guide wire according to claim 11, characterized in that The hollow guide wire is formed with a hole at a predetermined optimal distance from the distal end, the thin rope is attached to the distal end of the guide wire from the outside and enters the interior of the hollow guide wire through the hole, and during the manipulation, the operator pulls the thin rope at the proximal end to form the bend at the distal end.

14. A catheter assembly in combination with a radio frequency (RF) electrosurgical instrument, the catheter assembly comprising: a catheter body having a substantially hollow interior and extending between a proximal portion and a distal portion; a vacuum source disposed at the distal end of the catheter to create a low pressure region within the hollow interior of the catheter; a plurality of active electrodes disposed at a front end of the distal portion of the body for transmitting electrical signals to produce an electrosurgical effect for tissue cutting in the vicinity of the active electrodes; at least one passive electrode disposed at said forward end of said distal end of said body in closely spaced relationship relative to said active electrode, each of said at least one passive electrode including a passive tissue contacting surface having an area greater than an area of ​​an active tissue contacting surface of said corresponding active electrode, said active electrode and said at least one passive electrode optimally covering a predetermined ablation zone; The electrode is spaced from an inner wall of the substantially hollow interior, and the opening is configured to draw ablation debris through the low pressure region and into the hollow interior of the body.

15. The catheter assembly combined with a radiofrequency electrosurgical instrument according to claim 14, characterized in that: The at least one passive electrode is associated with the plurality of active electrodes disposed at a distal end of the body, the at least one passive electrode being a single conductive ring surrounding the distal end, the conductive ring having a surface area substantially greater than a surface area of ​​any of the active electrodes.

16. The catheter assembly combined with a radiofrequency electrosurgical instrument according to claim 15, characterized in that: The conductive ring is divided into a plurality of segments, thereby forming a plurality of passive electrodes juxtaposed with the active electrode.

17. The catheter assembly combined with a radiofrequency electrosurgical instrument according to claim 15, characterized in that: The plurality of electrodes are in the form of metal inserts that are electrically insulated from each other and surround the distal periphery.

18. A catheter assembly combined with the radiofrequency electrosurgical instrument according to claim 15, characterized in that: Also included is a sensor disposed at the distal end of the catheter for determining the physical and chemical composition of the obstruction and adjusting the function of the RF transmitter with the aid of a computer or microchip of the control unit.

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