FIELD OF THE INVENTION

The devices and methods of the invention generally relate to intrabody surgery and to treatment of occluded body lumens. In particular, the invention relates to an improved laser system to optimally generate and deliver through catheters laser energy for use in the removal of the occluding material from the blood vessels as well as other body lumens.

BACKGROUND OF THE INVENTION

The laser system, devices and methods of the invention are applicable for various types of intrabody surgery including, but not limited to cutting, breaking, coagulation, vaporization of any body tissue (including but not limited to Soft tissue includes tendons, ligaments, fascia, skin, fibrous tissues, fat, and synovial membranes; and muscles, nerves and blood vessels (which are not connective tissue) as well as hard tissue/bone and connective tissue) which involves reaching the targeted tissue through body channels including but not limited to blood vessels, ureter, esophagus, stomach and duodenum (esophagogastroduodenoscopy), small intestine (enteroscopy), large intestine/colon (colonoscopy, sigmoidoscopy) or incision or cut through the body tissues (laparoscopic surgery).

Although laser system, devices and methods for removal of the occluding material from the blood vessels as well as other body lumens are discussed below in greater detail, it should be clear that these are some of many possible applications of the invention. Laser system, devices and methods of the invention are applicable to many types of intrabody surgery, as identified above including but not limited to general surgery, cardiology, orthopedic surgery, urology and gastroenterology surgery.

Cardiovascular diseases frequently arise from the accumulation of atheromatous material on the inner walls of vascular lumens, particularly arterial lumens of the coronary and other vasculature including coronary artery disease (CAD) build-up of plaque in the arteries of the heart, as well as peripheral artery disease (PAD)—a narrowing of the peripheral arteries serving the legs, stomach, arms and head, resulting in a condition known as atherosclerosis. Atheromatous and other vascular deposits restrict blood flow and can cause ischemia which, in acute cases, can result in myocardial infarction or a heart attack. Atheromatous deposits can have widely varying properties, with some deposits being relatively soft and others being fibrous and/or calcified. In the latter case, the deposits are frequently referred to as plaque. Atherosclerosis occurs naturally as a result of aging but may also be aggravated by factors such as diet, hypertension, heredity, vascular injury, and the like.

Atherosclerosis can be treated in a variety of ways, including drugs, bypass surgery, and a variety of catheter-based approaches which rely on intravascular widening or removal of the atheromatous or other material occluding the blood vessel. Catheter-based interventions include angioplasty, atherectomy, laser ablation, stenting, and the like. For the most part, the catheters used for these interventions are introduced over a guidewire, and the guidewire is placed across the lesion prior to catheter placement. Initial guidewire placement, however, can be difficult or impossible in tortuous regions of the vasculature. Moreover, it can be equally difficult if the lesion is total or near total, i.e. the lesion occludes the blood vessel lumen to such an extent that the guidewire cannot be advanced across the lesion.

Occlusion in a blood vessel can be caused by a variety of materials from hard bone like calcium deposits to soft blood clot or piece of fatty deposit. Multiple type occlusions may be present in the same vessel. Currently different tools are used to remove different types of occlusion. Surgeons may need to remove one type of catheter and replace it with another one in order to successfully work with different occlusion types. This extends treatment time, substantially raises cost, and increase risk for a patient. The inventions provide a more optimal and complete solution to this problem which includes means to analyze the type of occlusion material present and then adapt the function of the occlusion removal device accordingly.

In prior art, there are known rotational atherectomy systems utilizing diamond drill tips/burrs to sand hard-calcified occlusions to very small particles. While there are some discussions that the particles produced from 20 μm diamond-tipped burr that ablates plaque into micro-particles are smaller in size (˜5 μm) than a red blood cell (8 μm), it is also known that larger particles of debris produced when occlusion is being broken are generated. Such larger particles can block blood capillaries and cause serious side effects. However, even when the occlusion particles are as small as blood cells, their presence in the blood stream may present a potential risk. This is especially so if such particles are accumulated at the essential body tissues causing malfunctioning of the vital body organs. Visible accumulation of even smaller particles, for example tattoo ink particles (less than 1 μm(9)), is very known. The tattoos particles accumulation (tattoo) is well known to be permanent or at least long term. Since the tattoo ink is inserted into the skin, it mostly stays in the dermis. Thus, impact of the ink particles on other tissue and organs is localized. On the other hand, since the particles generated during the occlusion destruction can be carried out through the blood stream to the vital body organs, proper management of such particles become important. Some of the rotational atherectomy catheters have built-in arrangements with active aspiration to remove debris from the blood stream and evacuate the debris through the catheter. However, these aspiration (debris evacuation) arrangements are not optimally designed to remove all or most of such debris particles. The inventions propose more optimal and complete solutions to this problem.

The prior art solutions for removal of calcium plaque are often provided with forwardly shaped rotational drills. Some of such prior art design presents a risk of accidental perforation of the blood vessel walls if such drill is pushed against the wall during the procedure. One of the aspects of the invention provides ways to limit such risks of vessel wall perforation as well as minimizes negative aspects of the procedure on any adjacent tissue.

SUMMARY OF THE INVENTION

One aspect of the invention provides apparatus for laser ablation of biological tissue which includes a hollow guide wire having one or more openings along the distal end to facilitate aspiration designed to be used to suck and remove debris of occlusion or embolus in the blood vessel. The guide wire made as a hollow tube designed to be used as a conduit for aspiration of occlusion debris produced by the laser energy applied to the occlusion material with such guide wire also having openings along the distal end to facilitate aspiration.

Another aspect of the invention provides alight delivery catheter for laser ablation of biological tissue provided to deliver light energy from a source to occlusion in the blood vessel. The light energy is emitted from the distal end of the light guide. The light energy destroys/affects/removes an occlusion in the blood vessel or a soft tissue in through vaporization, coagulation, cavitation or opto-acoustical waves, optical-chemical or other physical mechanisms of light interaction with a targeted tissue.

A further aspect of the invention provides a laser atherectomy device including a light delivery catheter equipped with sensors for monitoring physical characteristics at a laser application site. An integrated control unit utilizing data from the sensors is provided to optimally adjust laser energy parameters and to provide for safe and efficacious ablation of the blood vessel occlusion.

Still aspect of the invention provides a sterile package housing an atherectomy treatment catheter allowing conveniently drawing part of the catheter outside of the package for the intravenous application while keeping the rest of the catheter in sterile internal storage compartment; —with such package housing comprising of two reels capable of independently rotating and releasing catheter winded on each reel.

