Localized heat applying medical device

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TECHNICAL FIELD OF THE INVENTION

This invention relates to medical devices and procedures for applying localized heat to a site in a patient's body for such purposes as removing tissue or deposits or cauterizing tissue.

BACKGROUND OF THE INVENTION

Providing localized heat to a site in a patient's body has often been used to cauterize a lesion to stop bleeding. Localized heat can also be used to alter, remove, or destroy tissue in a patient's body. One example of such localized heating is the treatment of a bleeding ulcer. An endoscope is inserted through a patient's esophagus to view the bleeding site and direct an electric powered heating element to contact the site and cauterize the bleeding. Another example is the use of such heat to remove neoplastic pulmonary tissue.

Unfortunately, electric heating elements can be difficult to manipulate and generally heat up relatively slowly. The heating rate and maximum sustainable temperature is limited by the electric current available to the element. The available current in turn is limited by the size of the wires leading to the element. Wire size limits access to body sites for two reasons: larger wires cannot be inserted into small areas and increased wire size also means a loss of flexibility.

The electric current passing through the wires also limits the regions in the body in which such a device can be used. There is the threat of an electric shock to the patient and the generated field about the wires by flowing current can also have undesirable effects. One region where such electric currents and fields could possibly be life threatening is in the heart.

One proposal which heats the end of an endoscope to avoid dew forming on a window is shown in U.S. Pat. No. 4,279,246 to Chikama. That device heats the window to about body temperature to prevent dew formation. However, due to the design of the device, the heat generated on the window is limited to about body temperature and therefore could not be used to alter or destroy tissue.

Cardiovascular disease continues to be an ongoing problem, particularly in complex societies. It has been estimated that every year more than one-half million Americans die from cardiovascular disease. Another 3.5 million are believed to suffer some degree of incapacitation because of this disease. A particularly serious problem is the progressive blockage of a blood vessel by the collection or deposit of fatty material such as arteriosclerotic plaque. The collected material at first constricts the vessel, reducing blood flow to a relatively small channel. Eventually, blood flow can be obstructed completely.

Various devices and methods have been proposed in an attempt to deal with obstructed or constricted blood vessels. In one method, a balloon is positioned within the constricted channel and inflated, compressing the plaque into the vessel walls to widen the opening. This method is only available when the constriction in the blood vessel is not so severe that the remaining channel is too small for the deflated balloon. Compression of the plaque into the vessel walls is not possible where the plaque has become calcified and hard. Such a method is not even attempted in completely obstructed vessels. Applying radial stress to vessel wall also results in excessive and permanent deformation of this wall and subsequent loss of its integrity.

Accordingly, it would be desirable to provide a method and device which avoids the shortcomings of the prior art yet provides an effective means for delivering localized heat to a site within a patient's body. The heat provided by such a device can be used to stop bleeding or remove body tissue or material in a blood vessel, even a completely obstructed blood vessel. For such a device, the heat should be quickly developed without use of electrical current. Also, the device should be sufficiently small so that it can be directed into a patient's body cavity or lumen such as a blood vessel. It would also be desirable to provide rapid and accurate measurement of the heat produced. The present invention meets these desires.

SUMMARY OF THE INVENTION

The present invention contemplates a medical device, system and method for applying localized heat to a site in a patient's body. The localized heat provided in accordance with the present invention can be used for several purposes such as cauterizing a lesion to stop bleeding, or to remove a clot, or to remove an arteriosclerotic deposit from a blood vessel. The heat available can also be used to create an open channel in a previously occluded blood vessel.

Generally, the medical device embodying this invention includes a heat generating element mounted on the distal end of an elongated electro-magnetic energy transmitting conduit or member. A preferred conduit is a single flexible quartz optical fiber. Electro-magnetic energy in the form of visible light from an intense light source, such as a laser, an be transmitted through the conduit and emitted onto a light receiving surface of the heat generating element. The light is converted by the element to heat. The element can then be contacted with a material in a patient's body such as a clot, deposit or tissue to alter that material by melting, removing or destroying it. The heat generating element preferably has a rounded exterior surface end and is retained on the conduit by a locking means, such as a ridge on the element received in a complementary groove on the conduit.

Since light is used to transfer energy to the heat generating element, there are no electrical currents present which could possibly threaten the patient. Also, far more energy can be conducted by light through an optical fiber than by electricity through wires of the same diameter. The use of an intense light from a laser allows a substantial amount of energy to be rapidly transferred to the heat generating element for rapid heating. This avoids the difficulties inherent in electrical systems, including the presence of electrical currents and the relatively slow heating rate of the element.

In one embodiment of the present medical device an elongated guide wire can be selectively positioned within the lumen in association with the heat generating element. To this end, the heat generating element can include an elongated channel, e.g., a slot or bore, for slidably receiving the external guide wire situated along the light transmitting conduit. The heat generating element, with the attached light transmitting fiber, can be slid along the guide wire until a selected region of the lumen has been reached. The light source can then be activated, and the heat generated by the heating element applied to a contiguous region of the lumen.

In yet another embodiment of the medical device, usable with or without the guide wire, the heat generating element has a central aperture or bore which permits a portion of the light transmitted to the heat generating element to pass through the aperture and directly impinge upon a selected region of the plaque obstruction. With this form of heat generating element, both radiant and heat energy can be applied sequentially or simultaneously to the lumen or to the obstruction therein.

The heat generating element can have an eliptical cross-section. Such a cross-section readily slides into and through the lumen(s). In the eliptical cross-section also minimizes the accumulation of cellular material on the distal end of the heat generating element.

The heat generating element can also include a vent or escape port that permits gases formed therein to escape from within that element. The gas escape port can be located adjacent the region where the heat generating element is coupled to the light transmitting fiber.

The medical device can be used as part of a system which also includes a light source for providing sufficient light energy to raise the temperature of the heat generating element sufficiently to soften a plaque deposit or the like in a blood vessel, as well as a temperature sensing means associated with the light transmitting conduit for monitoring the temperature of the element. The preferred light source is a laser and the preferred temperature sensing means is a pyrometer. Other such means can be utilized, however. The laser is activated to transmit an intense light pulse through the conduit. The light is emitted by the conduit onto the receiving surface of the heat generating element which converts the light energy into heat. When the laser is deactivated, the light or glow from the hot element is transmitted back through the light transmitting conduit. This glow could then be converted by the pyrometer into a temperature reading or measurement.

The medical device can also be provided with an elongated tube which carries the light transmitting conduit. The heat generating element extends beyond the distal portion of the tube so it may be brought into contact with the tissue or deposit to be heated. The tube helps guide the conduit to the desired location and is particularly useful for providing access to a blood vessel. The exterior of the tube can be provided with blood flow occlusion means such as an inflatable balloon to selectively stop the flow of blood. A fluid such as saline, a radiopaque liquid or carbon dioxide can also be introduced through a passageway defined by the tube.

A viewing system to permit viewing within the lumen or blood vessel can also be provided as part of the medical device. Generally, the viewing system includes a fiberoptic viewing bundle carried by the tube to provide a view of the heat generating element and the tissue or obstruction about to be contacted. A suitable clear flushing fluid can be introduced through the passageway defined by the tube to provide improved viewing.

In use, the medical device is inserted into a patient's body such as by positioning the distal end of the medical device within a blood vessel. The element is contacted with a site such as a constriction, and light energy is transmitted through the conduit to heat the element rapidly and sufficiently to soften and open at least a portion of the constriction as the element contacts the constriction and is urged forward. In one preferred method aspect, the blood flow is occluded by the balloon and a radiopaque liquid is introduced into the vessel to allow fluoroscopic study of the constriction and location of the medical device. A bubble of biologically compatible gas such as carbon dioxide can be introduced into the vessel about the element prior to the light transmission and attendant heating. This avoids dissipation of heat into the liquid or blood otherwise in contact with the element.

A method of removing vascular obstructions and recanalizing an occuluded vascular member is also provided. The method includes the steps of:

Moving a heat generating element through the vascular system and positioning that element in a selected vascular member in contact with the occulsion;

transmitting electro-magnetic, radiant, energy through an elongated fiberoptic transmitting member to the heat generating element;

heating the heat generating element with the radiant energy;

conducting heat from a circumferential region of the heat generating element to a corresponding circumferential region of the occlusion in contact with that element; and

sliding the heat generating element into and through the occlusion to recanalize the vascular member.

Numerous other advantages and features of the present invention will be readily apparent to those skilled in the art from the following detailed description of the preferred embodiments of the invention, the drawings, and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a system including a medical device embodying the present invention;

FIG. 2 is an enlarged cross-sectional elevational view of the distal end portion of the medical device of FIG. 1;

FIG. 3 is another enlarged elevational view, partly in section, of a further alternative embodiment of the medical device shown received, within a blood vessel having a constriction;

FIG. 4 is an enlarged elevational view, partly in section, of the distal end portion of a further alternative embodiment for the medical device;

FIG. 5 is further enlarged cross-sectional view taken generally along plane 5--5 of FIG. 4 showing the internal structure of the medical device of FIG. 4;

FIG. 6 is an elevational view of a further alternative embodiment for the medical device;

FIG. 7 is an enlarged cross-sectional view taken generally along plane 7--7 of FIG. 6 showing the internal structure of the medical device of FIG. 6;

FIG. 8 is a cross-sectional view of a still further embodiment for the medical device.

FIG. 9 is an enlarged cross-sectional view of another embodiment of the medical device shown received within a blood vessel that has a constriction therein;

FIG. 10 is an enlarged cross-sectional view of still another embodiment of the medical device shown received within a blood vessel that has a constriction therein;

FIG. 11 is an enlarged cross-sectional view of a further embodiment of the medical device of FIG. 1 shown received within a blood vessel that has a constriction therein;

FIG. 12 is an enlarged cross-sectional view of another embodiment of the medical device of shown received within a blood vessel that has a constriction therein;

FIG. 13 is an enlarged cross-sectional view of a further embodiment of the medical device of shown received within a blood vessel that has a constriction therein;

FIG. 14 is a schematic representation of a heat generating element with thermocouple attached thereto for equilibrium measurement of distal end and medial region temperatures;

FIG. 15 is a schematic representation of a heat generating element with thermocouples attached thereto for equilibrium measurement of distal end and proximal end temperatures;

FIG. 16 is a graph of distal end temperature vs. time for various levels of input power; and

FIG. 17 is a graph of distal end temperature vs. time, with constant power input, generated as a heat generating element was pushed into and pulled back through a tissue sample under water.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

While this invention can be embodied in many different forms, there are shown in the drawings and described in detail, preferred embodiments of the invention. The present disclosure is an exemplification of the principles of the invention and is not intended to limit the invention to the embodiments illustrated.

The present invention is a medical device for delivering and applying localized heat to a site in a patient's body. The heat can be used to stop bleeding or remove or alter a material such as tissue or deposit in the body. The material being altered can be any solid or semi-solid substance found in the body including living tissue or deposits such as clots, fat or arteriosclerotic plaque.

FIGS. 1 and 2 show a medical device 10 embodying the present invention and including an elongated electro-magnetic energy transmitting member 12 the member 12 can be an optical fiber, a microwave channel or waveguide, having a proximal end 14 and a distal end 16. If the member 12 is an optical fiber, radiant energy in the form of light can be transmitted by it. A heat generating element 18 is mounted with respect to the distal end 16 of the member 12 such that light or like radiant energy transmitted by the fiber is absorbed and converted by the element into heat. The light is emitted by the distal end 16 of the conduit and is received and collected by a light receiving surface 20 on the element 18. The element 18 is preferably mounted on the distal end 16 of the conduit 12 and retained in that position by appropriate means discussed in more detail below. Mounting the element 18 directly on the conduit 12 insures that the light is properly delivered and the element will not become disengaged from the conduit.

The conduit 12 is preferably a single, flexible light-transmitting fiber such as used in fiberoptic devices and generally has a total exterior diameter of about one millimeter or less. A single fiber generally has the rigidity needed to press the element into a deposit or tissue. Larger or smaller fibers can be used depending on the available area in a patient. Generally, the single, light-transmitting fiber 13 includes a fiber core 22 surrounded by cladding 28. The internal reflection caused by the cladding 28 should be such that the fiber 13 has a low divergence as the light exits the distal end 16. The core 22 is made of glass, e.g. silica quartz. The cladding 28 is made of silicone, plastic or silica. The core 22 and cladding 28 have a combined diameter of less than about 0.5 millimeter to about 1.0 millimeter. Substantially all of the light exiting the distal end 16 should be directed forward to be absorbed by the light receiving surface 20. This generates the majority of the heat at the forward end of the heat generating element 18 where it is needed while minimizing the heat on the rearward portions of the element where it could otherwise be detrimental to the fiber 13.

To protect the fiber core 22 and cladding 28, the fiber also includes a jacket 26 which surrounds the cladding 28 and is held in place by a resin coating 24. The external jacket 26 is usually made of a flexible plastic material such as poly(ethylene) or poly(tetrafluoroethylene). This also provides a flexible and smooth surface allowing easy manipulation of the medical device. Fiber optic bundles are not prefered since the adhesive between individual fibers limits the amount of light which can be transmitted without melting of the bundle.

The conduit 12 should be flexible yet sufficiently resilient so that it is possible to push the conduit along a lumen to drive the heat generating element 18 into and through an obstruction. One such suitable conduit is a fiber optic having a core diameter of 0.4 millimeters which is marketed under the trademark Med 400 by Quartz Products Corporation of Plainfield, N.J.

The forward portion of the heat generating element 18 is preferably generally rounded on its exterior surface to facilitate pressing the element into and through softened body material while minimizing the risk of mechanical perforation. The heat generating element can alternatively have other shapes as desired including oblong or eccentric with respect to the axis of the fiber or even generally crescent-shaped. Such an eccentric or oblong shape can be rotated to generate an even larger channel through an obstruction. A crescent-shaped element allows for fluid flow and viewing past the element.

The element 18 is preferably made of metal such as surgical stainless steel, but could also be made of a combination of thermally conductive and insulating material such as metal and ceramic. The inside light receiving surface 20 is preferably treated, e.g., oxidized, to increase its coefficient of emissivity to about 0.95 or greater to further increase the absorption of light by the element 18. Alternatively, the surface 20 can be treated by being coated by a material having a high coefficient of emissivity such as lamp or carbon black. The exterior surface of the heat generating element 18 is preferably coated with a non-stick or release surface such as poly(tetrafluoroethylene) to provide easy release from the tissue. Poly(tetrafluoroethylene) usually is used for operating temperatures below about 300 degrees C.

The distal end 16 of the conduit 12 is preferably positioned or received in cavity 30 defined by the rear portion of the heat generating element 18. The element 18 can be retained on the distal end 16 by appropriate means for mounting such as an adhesive, an appropriate locking means, or a combination of both. The locking means is preferably at least one inwardly extending, peripheral ridge 34 on the element 18 received in a complimentary groove 36 defined by the conduit 12. The groove 36 should extend into the jacket 26 but not into either the core 22 or the cladding 28. The adhesive such as hardened epoxy resin can be used to retain the element 18 on the conduit 12 while the ridges 34 are crimped into the groove. Since some adhesives may become ineffective under intense heat, the locking means provides a backup to ensure the element remains in place.

The heat generating element 18 has sufficient mass to avoid burn-through during use. However, the mass is not so great as to materially slow its heating rate. For this reason, it is advantageous to place the thickest portion of material in the forward portion of the element 18 where the radiant energy, e.g., light, impinges. A minimum amount of space between the distal end 16 of the fiber and the radiant energy receiving surface 20 of the element 18 reduces the presence of other matter such as air or liquid which, if present in excess may require venting due to expansion as a result of the heat generated. Where such a space is provided, one or more vents are supplied to provide communication between the space and the outside surface of the element to the ambient surroundings.

The distal end 16 of the fiber is preferably spaced no more than 2 diameters of the core 22 away from the light receiving surface 20. Where the core is about 0.5 millimeters, this spacing should be no more than about 1 millimeter. This relatively close spacing insures that substantially all of the light is received on the forward light receiving surface 20 and is not dispersed on the inside side walls of the cavity 30.

The medical device can serve as part of a system which, as shown in FIG. 1, includes a light source such as a laser associated with the proximal end 14 of the fiber 13. The light source is chosen to deliver sufficient light energy to raise the temperature of the element 18 above the body temperature of the patient to soften material causing an obstruction or to destroy tissue. The system further includes temperature sensing means such as a pyrometer also associated with the proximal end 14 of the fiber for measuring the temperature of the element 18. Both the light source and temperature sensing means can be associated with the proximal end 14 of the fiber 13 by a beam splitting means 42. The beam splitting means 42 can be a partial mirror or a system such as a rotating or movable mirror. When the mirror is in a first position the laser light is directed into the fiber 13. After the laser is deactivated, the mirror is then placed in a second position to direct the resulting radiation or glow of the element 18 emitted by the fiber proximal end 14 to the pyrometer. A thermocouple can be affixed to the heat generating element to sense temperature.

The laser produces the light which is converted by the heat generating element 18 into heat. The word light is used in its broad sense, meaning electromagnetic radiation which propagates through space and includes not only visible light, but also infrared, ultraviolet and microwave radiation. The laser is preferably activated simultaneously with the temperature measurement. By monitoring the glow of the heated element 18 it is also possible to provide an advance warning of approaching burn-through where the element 18 has been provided with a layer of different metallic or non-metallic material 46 embedded within the forward portion of the element 18.

The light can enter the fiber continuously or intermittently, as desired, to maintain the element 18 above a predetermined temperature such that it is capable of softening a plaque deposit or cauterizing bleeding tissue. Where the medical device is used in a blood vessel, rapid heating of the element 18 is preferred since this allows the softening and removal of obstructing material while minimizing the amount of heat transferred to the tissues surrounding the blood vessel. A slower heating rate releases a greater total amount of energy into the entire tissue area while a rapid heating rate releases less total energy, but concentrates it in a small area within the material to be softened and removed. The element can be first heated i.e., light transmission begun, and then contacted with the deposit. This minimizes heat dissipation into the surrounding tissue and allows the element to reach a higher temperature before contact.

An alternative embodiment for the medical device 110 is shown in FIG. 3. The medical device is shown received within a blood vessel 152 having a deposit 154 which reduces the operative size of the blood vessel to a relatively small constricted channel 156. The medical device 110 includes a light transmitting conduit 112 and a heat generating element 118 substantially as described above. The element 118 includes an enlarged head portion to create a channel of relatively larger diameter in the deposit 154.

The medical device 110 also includes an elongated tube 158 having a proximal portion (not shown) and a distal portion 162 and defining a passageway 164 along its length. The elongated tube 158 allows for positioning the light transmitting conduit 112 and heated element 118 in a lumen such as blood vessel 152 by passing the tube through the skin and muscle layers of the patient into the blood vessel. The conduit 112 is slidingly received in the tube 158 so that it can be moved longitudinally with respect to the tube and the element 118 extended beyond the distal portion 162 of the tube. The element can be of such size that it may be received within the passageway 164 during the placement of the device within the blood vessel 152. The tube 158 is then first located in a vessel and a conduit 112 with a relatively small heated element as shown in FIG. 2 inserted into the tube 158.

Alternatively, the element 118 as shown in FIG. 3 can be relatively larger in cross section than the passageway 164 to create a larg