US20080103412A1 - Removing Tissue - Google Patents

Abstract

Tissue can be removed from a patient with a catheter or other medical device having a cutting member. A source of suction can be coupled to the device for suctioning removed tissue through a lumen in the device and out of the patient's body.

Description

• This application claims priority to U.S. Provisional Patent Application No. 60/856,182, filed Nov. 1, 2006, entitled “Removing Tissue,” the entire content of which is hereby incorporated by reference.
TECHNICAL FIELD
• The present invention relates to removing tissue from a patient and to medical devices and procedures for removing tissue.
BACKGROUND INFORMATION
• Minimally invasive surgery generally reduces patient trauma and speeds recovery time as opposed to more conventional surgical procedures in which a large portion of the patient's body is opened. Minimally invasive endoscopic surgery generally involves incising through body walls for examining, viewing, and/or operating on various bodily organs or structures, including the ovaries, uterus, gall bladder, bowels, kidneys, appendix, etc. In such endoscopic procedures, a trocar typically creates an incision and trocar tubes or cannula devices are extended into and left in place (in, for example, the abdominal wall) so that endoscopic surgical tools may be inserted into the patient's body. A camera or endoscope can be inserted to enable visual inspection and magnification of a cavity in the body of the patient. The surgeon then performs the desired procedure with the aid of specialized instrumentation designed to fit through additional openings which provide additional entries into the desired body cavity. Thus, instead of a rather large incision (typically 12 inches or larger) necessary to complete a more conventional fully invasive surgical procedure, minimally invasive endoscopic surgery results in one or several smaller incisions, usually between 5 and 15 millimeters in size. In most instances, recovery is quicker and less painful than conventional surgery. In addition, because the surgical field typically is greatly magnified, surgeons are often better able to dissect blood vessels and control blood loss. In addition, heat and water loss are often reduced as a result of the smaller incisions.
• In some surgical procedures, it is necessary to remove tissue or diseased organs. This can be challenging during endoscopic surgery because the tissue or organ removal must be achieved through the small openings through which the procedure is performed. In these situations, it may be desirable to fragment, morcellate, or otherwise reduce body tissue into smaller pieces that can be readily removed through the small endoscopic openings.
• Morcellation involves fragmenting and removing diseased tissue or organ parts from healthy tissue or organs. In endoscopic morcellation, the fragmented pieces are typically removed from the patient's body through a small incision or through a trocar cannula device which extends through the abdominal wall. When the tissue or organ part is diseased or infected, it is preferred that the excised portions thereof be isolated from contact with surrounding healthy tissue. Accordingly, it is often necessary to enclose the fragmented organ during removal, thus preventing contamination of healthy tissue and bodily organs. In some instances, the organ is fragmented in a bag by a surgical device known as a morcellator, until such a time as the entire specimen is small enough to be removed while in the bag from the abdominal cavity through one of the minimally invasive endoscopic openings.
SUMMARY OF THE INVENTION
• The invention generally relates to removing tissue from a patient in a minimally invasive manner. The patient can be a human or other mammal, for example. A catheter or other medical device for removing tissue in accordance with the invention can be inexpensive and easy to manufacture.
• In one aspect, the invention relates to a medical device for removing tissue from a patient. The medical device comprises an outer catheter including a distal end and defining a lumen and a tubular member defining a lumen and an opening for cutting tissue within the body of a patient. The lumen of the tubular member is couplable to a suction source to provide suction through the opening. The tubular member is disposed movably within the lumen of the outer catheter such that at least a portion of the tubular member is extendable beyond the distal end of the outer catheter to engage tissue within the opening. The tubular member is configured to cut the engaged tissue when the tubular member is moved with respect to the outer catheter, the cut tissue being transported through the lumen of the tubular member when the suction source is coupled to lumen of the tubular member.
• Embodiments according to this aspect of the invention can include the following features. The opening can be elongate and be defined at least in part by two substantially parallel edges. At least one of the edges can define a cutting member for cutting the engaged tissue. The cutting member can be configured to cut the engaged tissue when the tubular member is rotated about a longitudinal axis of the outer catheter. Additionally or alternatively, the cutting member can be configured to cut the engaged tissue when the tubular member is moved along a longitudinal axis of the outer catheter. The medical device can further comprise an ultrasound device operably coupled to the cutting member and being adapted to facilitate cutting tissue. Moreover, the cutting member can includes an active cord cautery device, such as a monopolar or bipolar cautery device. The medical device can further include a light source configured to facilitate determining the location of the opening while inside of a patient. The light source can include a fiber optic element and/or a light emitting diode.
• In another aspect, the invention involves a system comprising a medical device as described above and a computer interface coupled to the medical device and capable of providing signals representative of a visual image of an internal portion of the body of the patient. In certain embodiments, the system includes a bag coupled to the medical device for collecting a tissue sample and/or a suction source adapted and configured to provide suction through the lumen.
• In another aspect, the invention involves a medical device comprising a main body portion including a distal end and a cutting member operably coupled to the distal end of the main body portion. The main body portion defines a longitudinal axis, and the cutting member is configured to rotate about an axis transverse to the longitudinal axis from a first position to a second position when performing a cutting operation.
• Embodiments according to this other aspect of the invention can include the following features. The main body portion can define a lumen along at least a portion of its length, a distal port at the distal end, and a proximal port proximal to the distal end. The proximal port can be in fluid communication with a suction source for removing tissue cut by the cutting member through the distal port and the lumen. The cutting member can have a substantially arcuate shape and circumscribe a volume when moved from the first position to the second position. The medical device can further include an actuator for moving the cutting member from the first position to the second position. The actuator can include a wire having a distal end, the distal end of the wire being operably coupled to the cutting member and being configured to circumscribe an arcuate path when the wire is moved along the longitudinal axis. The main body portion can define a lumen and the wire can be disposed within the lumen. The wire can be made from spring steel and/or a shape memory material, such as a nickel-titanium alloy. The cutting member can be caused to move from the first position to the second position when the wire is advanced in a proximal or distal direction with respect to the main body portion. The actuator can alternatively move the cutting member from the first position to the second position by applying an electromagnetic force thereto. The actuator and the cutting member can accordingly be configured to carry electrical currents in opposing paths. The medical device can further include a switching mechanism, a power supply and a controller operably associated with the switching mechanism and power supply, the controller adapted to operate the switching mechanism to alternate electrical current flowing through the actuator and cutting member to cause the cutting member to oscillate between the first position and the second position.
• In yet another aspect, the invention features a medical device comprising a main body portion defining a lumen therethrough and including a distal end, and a shaft rotatably disposed in the lumen of the main body portion. The shaft includes a proximal end and a distal end, and the shaft is capable of rotation with respect to the main body portion about a longitudinal axis. The device further comprises a rotational drive source operably coupled to the proximal end of the shaft and a substantially arcuate cutting member attached to the distal end of the shaft. The cutting member is configured to circumscribe a volume about the longitudinal axis when the shaft is rotated. A compartment is affixed to the distal end of the main body portion, and the compartment is configured to house the cutting member.
• Embodiments according to this aspect of the invention can include the following features. The main body portion can define a second lumen therethrough, the second lumen having a distal port proximate the cutting member and a proximal opening proximal to the distal end of the main body portion. A suction source can be coupled to the compartment by way of the second lumen to facilitate removal of tissue from a patient.
• In still another aspect, the invention relates to a medical device comprising a main body portion including a distal end and defining a lumen therethrough. The medical device also comprises a rotatable cutting member disposed in the lumen. The cutting member is defined by at least one helical cutting edge and defines at least one helical channel therethrough, and the cutting member is capable of being disposed beyond the distal end of the main body portion.
• Embodiments according to this aspect of the invention can include the following features. The cutting member can be moved in a rotational and/or longitudinal direction with respect to the main body portion. A suction source can be coupled to the medical device to facilitate removal of tissue from a patient through the lumen.
• In a further aspect, the invention features a medical device comprising a main body portion including a distal end and defining a lumen therethrough. The device also comprises a shaft slidably disposed through the lumen of the main body portion. The shaft includes a distal end and a cup shaped cutting member attached to the distal end of the shaft. The cutting member includes a cutting edge disposed proximate to a rim of the cup shaped cutting member, and the cutting member is configured to cut tissue when advanced in a proximal direction with respect to the main body portion of the medical device.
• Embodiments according to this aspect of the invention can include the following features. The cutting member can protrude from the distal end of the main body portion. The main body portion can include a closed end that defines a tissue entry port through a sidewall of the main body portion suitable to permit entry of tissue to be removed from a patient.
• In still a further aspect, the invention features a method of removing tissue from a patient. The method comprises providing a medical device including a main body portion and a cutting member slidably coupled thereto, introducing the medical device through the urethra of a patient, removing tissue from the patient by advancing the cutting member in a proximal direction with respect to the main body portion, and withdrawing the medical device from the patient. Tissue can be removed from, for example, the patient's bladder or the prostate gland.
• Both the foregoing and following descriptions are exemplary and illustrative. The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the invention and particular embodiments thereof. The drawings are not necessarily to scale and generally serve to help illustrate the principles and/or certain embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1(a) is a schematic representation of a first representative embodiment of a medical device made in accordance with the present invention.
• FIGS.1(b)-1(d) are partial views of a portion of the medical device depicted inFIG. 1(a).
• FIG. 2(a) is an isometric view of a second representative embodiment of a medical device made in accordance with the present invention.
• FIGS.2(b)-2(d) are isometric views of a portion of the medical device depicted inFIG. 2(a).
• FIG. 2(e) is a schematic representation of an alternate embodiment of the medical device depicted inFIG. 2(a).
• FIG. 3(a) is an isometric view of a third representative embodiment of a medical device made in accordance with the present invention.
• FIGS.3(b)-3(d) are isometric views of a portion of the medical device depicted inFIG. 3(a).
• FIG. 4 is an isometric view of a fourth representative embodiment of a medical device made in accordance with the present invention.
• FIG. 5(a) is an isometric view of a fifth representative embodiment of a medical device made in accordance with the present invention.
• FIGS.5(b)-5(d) are partial cross-sectional views of an alternate embodiment of the medical device depicted inFIG. 5(a).
DESCRIPTION
• The devices and methods presented, described, and shown herein may be used for resecting tissue from within the body of a patient and removing the resected tissue from the patient's body, for example. Medical devices and procedures according to the invention are particularly well suited for resecting cancerous growths from the bladder and/or the prostate gland of a patient.
• For purpose of explanation and illustration, and not limitation, a partial view of an exemplary embodiment of the medical device in accordance with the invention is shown inFIG. 1(a) and is designated generally byreference character110. Other embodiments of a system in accordance with the invention, or aspects thereof, are provided inFIGS. 2-5, as will be described.
• In accordance with one aspect of the invention, an outer catheter of a medical device includes a distal end and defines a lumen.
• For purposes of illustration and not limitation, as embodied herein and as depicted inFIG. 1(a), amedical device110 has anouter catheter120 which includes aproximal end122, adistal end124, and defines alumen126 therethrough.Lumen126 includes aproximal port128 and adistal port130.Outer catheter120 can be further coupled to ahandle136 proximate itsproximal end122 for gripping by an operator such as a surgeon or other medical professional. The handle can be attached toouter catheter120 by, for example, welding, use of an adhesive, or forming the handle integrally withouter catheter120. Other ways of attachment also are possible.
• Outer catheter120 can be made from any one of a variety of materials including metal, plastic, and composite materials. Combinations of such materials also can be used to form the outer catheter. For example, theouter catheter120 can be made of a fiber reinforced plastic. Theouter catheter120 can also be constructed of a braided reinforcement layer over a lubricious inner layer such as tetrafluoroethylene (Teflon or TFE). The braid can be oversleeved or overextruded or coextruded with a thermoplastic polymer such as Nylon or Pebax graded to provide the appropriate rigidity. The braid material can be Liquid Crystal Polymer, sold as Vectran, in mono or multifilament. The braid material can also include metallic wire in one or more carriers. These wires can be stainless steel or a more radiopaque metal such as platinum. The polymer oversleeve can also be filled with a material such as barium to enhance radiopacity. A hydrophilic coating can be added to the outer catheter to improve lubricity. A knitted configuration or a coil can also substitute for the braid.
• Other examples of materials from which theouter catheter120 can be formed include silicone, nylons, urethanes and thermoplastic materials such as TFE, high density polyethylene (HDPE), law density polyethylene (LDPE), polypropylene (PP), polyethylene (PE), and PEEK™ polymer. In general, any material or combination of materials used to make theouter catheter120 should result in theouter catheter120 being biocompatible, because at least a portion of theouter catheter120 typically will be inserted into the body of a mammal (such as a human patient) when themedical device110 is used for its intended purpose.Outer catheter120 can have a uniform stiffness along its length, or a stiffness that increases or decreases along its distal length, as desired for the particular application. Adjusting the stiffness can be accomplished by varying the thickness ofouter catheter120, or by adjusting the properties and/or composition of the outer catheter. For example, a braided layer can be impregnated along a polymericouter catheter120 along a part of its length, providing anouter catheter120 with a stiff proximal segment and a flexible distal segment. If polymers are used, it is possible to adjust the blend of polymers or method of curing the polymer along the length ofcatheter120 to achieve a desired stiffness profile. Other ways of adjusting the stiffness and/or making the outer catheter more or less flexible or inflexible also can be employed.
• As indicated inFIG. 1(a), themedical device110 further includes atubular member140 including aproximal end142, adistal end144, and asidewall145, and thetubular member140 also defines alumen146 therethrough.Lumen146 includes aproximal port148 and defines anopening150 for cutting tissue.Lumen146 is couplable to asuction source160 to provide suction throughopening150 to facilitate removal of tissue from a patient, as discussed in detail below.Tubular member140 can be rotatably and/or longitudinally movable withinlumen126 ofouter catheter120. Preferably,outer catheter120 andtubular member140 are sealingly connected, such as by interposing one or more o-rings (not shown) between these two components of themedical device110.Proximal end142 oftubular member140 can also be provided with ahandle147 for gripping by an operator such as a surgeon or other medical professional.
• A variety of materials can be used to formtubular member140. For example,tubular member140 can be made of the same or similar material(s) as theouter catheter120. It is also possible to configuretubular member140 to have a desired constant or varying flexibility or stiffness along its length, as it is withouter catheter120.
• If made from plastic,outer catheter120 andtubular member140 can be manufactured from a single extrusion of material or from a multiple extrusion, such as a trilayer extrusion described in U.S. Pat. No. 6,165,166 to Samuelson et al. Other ways of making these components of themedical device110 are possible. For example,outer catheter120 andtubular member140 can be formed by shrinking polymeric tubing in layers over a mandrel or by dipping a mandrel in molten plastic material to build up layers of plastic material. Layers of reinforcement material such as various metallic or fibrous braided material can be interposed between the layers of plastic material.
• As discussed above,proximal port148 is preferably in fluid communication with asuction source160, described in detail below. Additionally or alternatively, aLuer connector134 can be provided as depicted inFIG. 1(b), orproximal port148 can be defined throughsidewall145 ofmember140 as depicted inFIG. 1(c). The Luer connector134 (FIG. 1(b)) can be used to couple thesuction source160 to themedical device110, yet still permit introduction of other components and/or beneficial agents throughlumen146 during a surgical procedure. Saline solution is one example of what can be introduced through thelumen146.
• As depicted inFIG. 1(d), anopening150 has an elongate shape and is defined insidewall145. Theopening150 is defined by two elongate substantiallyparallel edges152 and154.
• One or both of theedges152,154 can be sharpened to serve as cutting members to facilitate removal of tissue from a patient. Additionally or alternatively, proximal anddistal portions156 and158 of opening can be sharpened to form cutting members. Opening150 can be defined by the same material(s) that form(s) thetubular member140, or a separate insert can be disposed within theopening150 to define its boundary and provide the cutting edge(s) of theopening150. For example, iftubular member140 is formed of a polymer, opening150 can be defined by the same polymeric material, or can be formed from a metallic insert about whichtubular member140 is formed, such as by injection molding.
• Regardless whichportions152,154,156,158 ofopening150 are formed into cutting members, tissue that is cut from within the body of a patient can be removed from the patient's body by applying suction through opening150 fromsuction source160 such that the cut tissue is drawn through themedical device110 and out of the patient's body. To cut or resect tissue within the patient's body, thedistal end144 of the tubular member (including at least a portion of the opening150) is moved to place it distal of thedistal end124 of theouter catheter120. Tissue can then be engaged within theopening150 by manipulating themedical device110, and the engaged tissue is then cut from the patient's body by moving thetubular member140 in a longitudinal direction along longitudinal axis X and/or in a rotational direction about axis X with respect to theouter catheter120. The cut or resected tissue is then removed from within the patient's body by the use of suction which draws it up through thelumen146 and out of the patient's body.
• While a sharpened edge of opening150 has been described as acting as a cutting member for cutting tissue and thus allowing its removal from a patient's body, other mechanisms for cutting tissue within a patient's body are possible. For example, a cutting member can be provided in the form of an active cord cautery device such as a bipolar cautery device or a monopolar cautery device. Moreover, an ultrasound device170 (seeFIG. 1(a)) can be operably coupled to one ormore edges152,154,156,158 of opening150 to facilitate tissue removal.
• A suction source can be operably coupled to the medical device to facilitate removal of tissue from a patient. As depicted inFIG. 1(a),suction source160 can take the form of a constant vacuum that can be applied through thelumens146 of themedical device110. Thesuction source160 can be provided at a wall connection in an operating room or other medical treatment area, or it can be a portable source of suction provided by a movable vacuum generator. Thesuction source160 can be placed in fluid communication with themedical device110 by way of acontrollable valve162 that can be opened or closed to apply a desired amount of suction through themedical device110. The surgeon operating themedical device110 or some other medical professional can operate thevalve162.
• Acollector164 can be provided to collect tissue that is removed from a patient after it has been cut from the patient and suctioned out of the patient's body. Thecollector164 could be a bag or some other type of container.
• A light source can be provided to facilitate determination of the location of the opening of the medical device while inside a patient. For example, alight source172 can be disposed on themedical device110 to aid the operator of thedevice110, as depicted inFIG. 1(a). The light source can include one or more fiberoptic elements174 and/orlight emitting diodes176. By using thelight source172, the positioning and/or location of the portion of themedical device110 inserted into the body of the patient can be more easily and/or accurately determined, resulting in a more efficient surgical procedure.
• Other elements can be included with a medical device as described herein to assist a surgeon or other medical professional in performing a surgical procedure using the medical device. For example, as depicted inFIG. 1(a), acomputer interface180 can be used to provide a visual image of the surgical site to the surgeon. As such, the computer interface can be operably coupled to one or more optical elements (such as elements174) in visual communication with the surgical site.
• In operation, a surgeon can introducemedical device110 into a patient. Signals in the form of visual information are received through fiberoptic elements174 and directed tocomputer interface180.Computer interface180 is configured and adapted to display a representative image of the surgical site on agraphical user interface182 as depicted inFIG. 1.Graphical user interface182 can comprise a display panel configured to display a plurality of data objects184, such as a window for displaying an image of the surgical site, touch screen menus and the like. A control panel186 (such as a keyboard and pointing device, if desired) can also be provided to navigate through images collected of the surgical site.
• Suitable fiber optic probes such as Spyglass™ fiber optic probes commercially available from Boston Scientific of Massachusetts can be used. Moreover, other types of imaging systems can be used in combination with the medical device of the present invention including, but not limited to, CT imaging, Magnetic Resonance Imaging, fluoroscopic and ultrasound imaging. Data obtained from each of these types of imaging systems can be routed through leads intocomputer interface180 to provide a real time image of the surgical site. Moreover, it is possible and within the scope of the invention to use other computer assisted visual tools to perform a surgical procedure. For example, virtual imaging software can be used to simulate the surgical site based on data acquired through other means, such as position sensors.
• A bag can be provided for collecting a tissue sample. For example, as depicted inFIG. 1(a), abag190 is provided for collecting a tissue sample.Bag190 can be coupled to thedistal end144 oftubular member140 ofmedical device110 as depicted inFIG. 1(a), or can be introduced by means of a separate catheter (not shown).Bag190 can be used to collect a sample in lieu of or in addition to suction fromsuction source160.
• Depicted in FIGS.2(a)-5(d) are other embodiments of medical devices according to the invention. These devices also can be used to remove tissue from within the body of a patient, and these devices can be used with or without suction.
• As depicted inFIG. 2(a), amedical device210 includes amain body portion220, and themain body portion220 includes a proximal end222 and adistal end224.Main body portion220 extends along a longitudinal axis X. If desired, proximal end222 ofmain body portion220 can be affixed to and/or integrally formed with ahandle portion236.Main body portion220 can be made from a variety materials as withportions120,140 ofmedical device110. A cuttingmember250 is operably coupled to thedistal end224 of themain body portion220. As depicted in FIGS.2(b)-2(d), cuttingmember250 is configured to rotate and/or pivot about an axis T that is transverse to the longitudinal axis X from a first position as depicted inFIG. 2(b) to a second position as depicted inFIG. 2(d) when performing a cutting operation.
• Medical device210 can take on a variety of forms. Whilemedical device210 can be provided with abag290 for collecting tissue removed from a patient,main body portion220 can define alumen226 along at least a portion of its length, the lumen having adistal port230 at thedistal end224 of themedical device210 and aproximal port228 proximal to thedistal end224 of the medical device. Theproximal port228 can be in fluid communication with a suction source similar to the embodiment ofFIG. 1(a) for removing tissue cut by the cuttingmember250 through thelumen226. The cuttingmember250 can have an substantially arcuate shape and circumscribe a volume when moved from the first position to the second position that is substantially hemispherical.
• Main body portion220 can be made of a variety of materials and by a variety of methods as withouter catheter120 described above. Also,main body portion220 can have a uniform or increasing or decreasing stiffness along its length to provide the surgeon with the appropriate stiffness or flexibility required by the application at hand.
• The cuttingmember250 can be made from surgical grade steel. A variety of other materials could be used to form the cutting member. The cuttingmember250 can be manufactured by stamping out an appropriately shaped piece of metal or by any of a variety of other processes.
• As depicted in FIGS.2(b)-2(d), anactuator260 is provided. Theactuator260 can be a wire including aproximal end262 and adistal end264, with thedistal end264 of the actuator operably coupled to the cuttingmember250. Thedistal end264 of theactuator260 can be configured to circumscribe an arcuate path when the proximal end of thewire262 is moved along the longitudinal axis X, as shown in FIGS.2(b)-2(d). Optionally, the wire can be received by asecond lumen266 traversing the length of themain body portion220 ofmedical device210. Theactuator260 can be made at least in part from spring steel with adistal end264 that is biased to form an arc as disposed inFIG. 2(d). When actuator260 is withdrawn intolumen266 it straightens out until it is once again moved distally out oflumen266. The cuttingmember250 can be caused to move from the first position to the second position when the wire is advanced in a distal or proximal direction with respect to the main body portion. By way of further example, if desired, it is possible to form actuator260 of a shape memory material such as an alloy of nickel and titanium (e.g., Nitinol™). Other materials can be used to form theactuator260.
• As depicted inFIG. 2(e), themedical device210 includes the cuttingmember250 and the cuttingmember250 is moved between a first position and a second position by use of an electromagnetic force applied to the cuttingmember250. In this embodiment, theactuator260 and the cuttingmember250 can be configured to carry electrical currents in opposing paths to create attractive and repulsive forces to cause a desired movement of the cuttingmember250. For example, the cuttingmember250 can be mounted on insulatedelectrical leads250a,250bthat are routed to a switchedpower supply258.Electrical loops252 and254 can be provided embedded in theface225 ofdistal end224 ofmain body portion220 ofmedical device210 that are also connected to thepower supply258. Electrical power can be routed through each of the circuits defined byloops250a,250b,252 and254, for example, by use of a switching mechanism having pin diodes256(a)-(f) that are controlled by acontroller259. By sending electrical current through the cuttingmember250 andloop252 in opposite directions, a repulsive force can be achieved between the two conductors, causing cuttingmember250 to pivot away fromloop252. Similarly, by operating a current in the same direction throughloop254 and cuttingmember250, an attractive force can be imposed between the two conductors. Thus, for example, by ramping and switching the direction of the current going through cuttingmember250 and maintaining the directions of the current going throughloops252 and254 in opposite directions, it is possible to cause cuttingmember250 to oscillate between first and second positions. Other ways of actuating and moving the cuttingmember250 are possible.
• In operation, themedical device210 of FIGS.2(a)-2(e) can be used as follows. Themedical device210 is introduced into a patient and the cuttingmember250 is positioned close to or in contact with tissue to be removed from within the body of the patient. For example, a medical device according to the invention can be inserted through a urethra of a patient to remove tissue from the patient's bladder or prostate. Theactuator260 can be actuated to move the cuttingmember250 between the first position to the second position. As the cuttingmember250 is moved from the first position to the second position, scalloped shaped pieces of tissue are removed from the patient. If a lumen of themedical device210 is operably coupled to a suction source (such as thesuction source160 described above), substantially continuous removal of tissue can be accomplished through the lumen as the tissue is cut from within the patient's body by the cuttingmember250.
• In accordance with another aspect of the invention, a medical device includes a main body portion, a shaft rotatably disposed in a lumen of the main body portion, and a substantially arcuate cutting member attached to the distal end of the shaft. As depicted in FIGS.3(a)-3(d), amedical device310 is provided including amain body portion320 defining alumen326 through themain body portion320, themain body portion320 having aproximal end322 and adistal end324. Ashaft328 rotatable about a longitudinal axis X with respect tomain body portion320 is also provided, disposed in thelumen326 of themain body portion320. Additionally, a substantiallyarcuate cutting member350 andcompartment360 are attached to thedistal end332 of the shaft. In one embodiment, cuttingmember350 andcompartment360 are smaller than depicted in FIGS.3(a)-3(d). Cuttingmember350 andcompartment360 can be at least small enough to fit through the smallest cannula, incision or lumen that allows passage of themain body portion320 ofdevice310. For illustrative purposes, cuttingmember350 andcompartment360 are shown enlarged in FIGS.3(a)-3(d) so that details of these elements can be seen more easily. In another embodiment, to permit resection of larger amounts of tissue, cuttingmember350 andcompartment360 can be made larger or at least as shown in FIGS.3(a)-3(d), in which case themain body portion320 ofdevice310 can be introduced through a larger incision, lumen or cannula. Other shapes are possible instead of the substantially arcuate shape. The cuttingmember350 is configured to circumscribe a volume about the longitudinal axis X when the shaft is rotated as depicted in FIGS.3(a)-3(d).
• Acompartment360 can be disposed at thedistal end324 of themain body portion320 as depicted inFIG. 3(a)-3(d).Compartment360houses cutting member350 when it is not in use, such as whenmedical device310 is being introduced into or withdrawn from a patient.Compartment360 can thus protect cuttingmember350 from being damaged when not in use.Compartment360 can also be used to capture pieces of tissue cut from a target area using cuttingmember350. As depicted in FIGS.3(a),3(b) and3(d),compartment360 is defined by a solidhemispherical wall364 having aninterior surface362.
• Main body portion320 andcompartment360 can be made of a variety of materials and by a variety of methods as withouter catheter120 andmain body portion220 described above.Main body portion320 can be attached tocompartment360 by various processes. For example, welding can be used to attached themain body portion320 to thecompartment360. Alternatively, themain body portion320 and thecompartment360 can be integrally formed together as one piece. Themain body portion320 can have a uniform or increasing or decreasing stiffness along its length.
• The cuttingmember350 can be made from a variety of materials as described above for cuttingmember250. The cuttingmember350 can also be manufactured in various ways, as with cuttingmember250. The cuttingmember350 can be formed from the same piece of material asshaft328. If formed from the same piece of material,shaft328 and cuttingmember350 can be formed in tandem in a single manufacturing operation or in separate operations. Alternatively, cuttingmember350 can be formed separately fromshaft328 and attached thereto, such as by welding or any other means known in the art. It is also possible to form both portions from the same piece of material. The cuttingmember350 can be made from surgical grade steel, or another material can be used.
• Arotational drive source355 can be coupled to the proximal end330 of theshaft328. Drivesource355 can be a manual source, such as a handle for manual rotation as depicted inFIG. 3(a). Alternatively, drivesource355 can be a motor attached toshaft328 by way of a rotational coupling.
• By way of further example and as depicted inFIG. 3(a), cuttingmember350 can be disposed within acompartment360 affixed to thedistal end324 of themain body portion320 as depicted inFIG. 3(a)-3(d). In operation,medical device310 is introduced into a patient, andcompartment360 is placed proximate a target tissue area to be removed.Shaft328 is then rotated with respect tomain body portion320, and cuttingmember350 is rotated out ofcompartment360, and about longitudinal axis X. As cuttingmember350 is rotated outside ofcompartment360, it slices through target tissue, separating the tissue from the patient. Once separated, the tissue is collected incompartment360, at which point the tissue can be removed from the patent. To facilitate tissue removal,main body portion320 can define asecond lumen334 therethrough.Second lumen334 includes adistal port338 proximate the cuttingmember350 defined in theinterior surface362 ofcompartment360 and aproximal port336 proximal to thedistal end324 of themain body portion320. To facilitate tissue removal, a suction source (such assuction source160 described above) can be placed in fluid communication withproximal port336 oflumen334. Thus, as tissue is cut by cuttingmember350 and collected bycontainer360, suction will draw morcellated tissue throughdistal port338 and throughsecond lumen334.
• In accordance with still another aspect of the invention, a medical device includes a main body portion including a proximal end and a distal end, and the main body portion defines a lumen therethrough. The medical device further includes a rotatable cutting member disposed in the lumen. As depicted inFIG. 4, amedical device410 includes amain body portion420. Themain body portion420 includes aproximal end422 and adistal end424, and themain body portion420 defines alumen426 therethrough with aproximal port428 and adistal port430.Medical device410 further includes a cuttingmember450 in the form of an auger that is disposed in thelumen426. Cuttingmember450 is rotatably and/or longitudinally movable withinmain body portion420. Cuttingmember450 includes at least onehelical cutting edge452 and defines at least onehelical channel454 therethrough that is in fluid communication withlumen426. Theauger450 can be extended out of thelumen426 and beyond thedistal end424 of themain body portion420 throughdistal port430, with or without suction being applied toproximal port428 oflumen426. It is possible to provide theauger450 with varying configurations including different blade edge configurations and pitches.
• Main body portion420 can be made of a variety of materials and by a variety of methods as withouter catheter320 described above. Likewise,main body portion420 can have a varying or uniform stiffness along the length of catheter. Theauger450 can be made from any of a variety of materials such as surgical grade steel, and theauger450 can be manufactured using any of a variety of processes such as forging, swaging, and machining.
• In operation, themedical device410 is introduced into a patient (such as through the urethra) and theauger450 is positioned near or in contact with tissue to be removed from within the body of the patient (such as from the bladder or prostate gland).Distal end456 of theauger450 can be made to extend or protrude fromdistal end424 ofmain body portion420. Whether or not theauger450 is extended out of themain body portion420, rotational movement of theauger450 with respect tomain body portion420 will grab tissue near or in contact with theauger450. While rotating, thehelical cutting edge452 of theauger450 slices tissue and carries it up thechannel454. If thelumen426 is operably coupled to a suction source (such as thesuction source160 described above), substantially continuous removal of tissue can be accomplished through lumen as it is cut from the patient by theauger450. Even without suction, therotating auger450 causes tissue to be drawn through thechannel454 and up into thelumen426.
• In accordance with another aspect of the invention, a medical device includes a main body portion with a shaft slidably disposed therein and a cup shaped cutting member attached to a distal end of the shaft. As depicted in FIGS.5(a)-5(d), amedical device510 includes amain body portion520. Themain body portion520 includes a proximal end522 and adistal end524, and themain body portion520 defines alumen526 therethrough. Ahandle528 can be connected to the proximal end522 ofmain body portion520 for gripping by the surgeon or other operator of themedical device510.Medical device510 further includes ashaft540 slidably disposed through thelumen526 of themain body portion520, and a cup shaped cuttingmember550 attached to thedistal end544 of theshaft540.Shaft540 also can have ahandle548 attached to theproximal end542 thereof for gripping. Cuttingmember550 can have acutting edge552 disposed proximate torim554 of the cup shaped cuttingmember550. The cuttingmember550 is preferably configured to cut tissue when advanced in a proximal direction with respect to themain body portion520 of themedical device510.
• Main body portion520 can be made of a variety of materials and by a variety of methods as withmain body portion220 described above. Likewise,main body portion520 can have a uniform or increasing or decreasing stiffness along the length thereof. The cuttingmember550 can be made from a variety of materials, and the cuttingmember550 can be manufactured using any of a variety of processes. Also, the cuttingmember550 can be affixed to theshaft540 in various ways such as welding.
• In operation,medical device510 can be configured as depicted inFIG. 5(a), wherein the cuttingmember550 can protrude beyond thedistal end520 of themain body portion520. In operation,main body portion520 ofmedical device510 can be held stationary within the patient by grippinghandle528, and, by grippinghandle548shaft540carrying cutting member550 can be advanced distally with respect to main body portion into or adjacent to a mass to be removed.Shaft540 can then be withdrawn proximally causingcutting edge552 to slice through and remove tissue and capture the removed tissue using cup shaped cuttingmember550. Cuttingmember550 can then be withdrawn intomain body portion520 ofmedical device510 and flushed and cleaned by way or irrigation and suction throughlumen526 if sufficiently large or a second lumen, if needed, and then redeployed to collect more tissue, if desired.
• Alternatively, and as depicted in FIGS.5(b)-5(d),main body portion520 can be provided with a closeddistal end524 and define atissue entry port560 through a sidewall525 ofmain body portion520 suitable to permit entry of tissue to be removed from a patient. In accordance with this embodiment suction can be applied tolumen526 to initiate a flow therethrough that draws tissue to be removed intoport560. Cuttingmember550 can then be drawn proximally to cut the tissue from the patient, and the suction can cause the resected tissue to be removed throughlumen526.
• In accordance with another aspect of the invention, a method of removing tissue from within the body of a patient includes the steps of providing a medical device (such as one of the medical devices described herein), introducing the medical device through the urethra of a patient, removing tissue from the patient by advancing a cutting member in a proximal direction with respect to the main body portion, and withdrawing the medical device from the patient. The method can be used to remove tissue from the bladder and/or prostate gland of the patient, for example.
• Particular embodiments according to the invention are described and shown herein, but the invention is not limited to these particular embodiments. Various modifications, additions, and deletions can be made to the embodiments described and shown herein without departing from the spirit or scope of the invention. Also, the various features described and/or shown with respect to the embodiments can be combined in various ways even if not specifically described or shown in those combinations.

Claims (43)

1. A medical device, comprising:

a) an outer catheter including a distal end and defining a lumen; and

b) a tubular member defining a lumen and an opening for cutting tissue within the body of a patient, the lumen of the tubular member being couplable to a suction source to provide suction through the opening, the tubular member disposed movably within the lumen of the outer catheter such that at least a portion of the tubular member is extendable beyond the distal end of the outer catheter to engage tissue within the opening, the tubular member being configured to cut the engaged tissue when the tubular member is moved with respect to the outer catheter, the cut tissue being transported through the lumen of the tubular member when the suction source is coupled to lumen of the tubular member.

2. The medical device ofclaim 1, wherein the opening is elongate and is defined at least in part by two substantially parallel edges.

3. The medical device ofclaim 2, wherein at least one of the edges defines a cutting member for cutting the engaged tissue.

4. The medical device ofclaim 3, wherein the cutting member is configured to cut the engaged tissue when the tubular member is rotated about a longitudinal axis of the outer catheter.

5. The medical device ofclaim 3, wherein the cutting member is configured to cut the engaged tissue when the tubular member is moved along a longitudinal axis of the outer catheter.

6. The medical device ofclaim 3, further comprising an ultrasound device operably coupled to the cutting member and being adapted to facilitate cutting tissue.

7. The medical device ofclaim 3, wherein the cutting member includes an active cord cautery device.

8. The medical device ofclaim 3, wherein the cutting member includes a bipolar cautery device.

9. The medical device ofclaim 3, wherein the cutting member is a monopolar cautery device.

10. The medical device ofclaim 1, further including a light source configured to facilitate determining the location of the opening while inside of a patient.

11. The medical device ofclaim 10, wherein the light source includes a fiber optic element.

12. The medical device ofclaim 10, wherein the light source includes a light emitting diode.

13. A system, comprising:

a) a medical device, comprising

an outer catheter including a distal end and defining a lumen; and

a tubular member defining a lumen and an opening for cutting tissue within the body of a patient, the lumen of the tubular member being couplable to a suction source to provide suction through the opening, the tubular member disposed movably within the lumen of the outer catheter such that at least a portion of the tubular member is extendable beyond the distal end of the outer catheter to engage tissue within the opening, the tubular member being configured to cut the engaged tissue when the tubular member is moved with respect to the outer catheter, the cut tissue being transported through the lumen of the tubular member when the suction source is coupled to lumen of the tubular member; and

b) a computer interface coupled to the medical device and capable of providing signals representative of a visual image of an internal portion of the body of the patient.

14. The system ofclaim 13, further including a bag coupled to the medical device for collecting a tissue sample.

15. A system, comprising:

a) a medical device, comprising

an outer catheter including a distal end and defining a lumen; and

a tubular member defining a lumen and an opening for cutting tissue within the body of a patient, the lumen of the tubular member being couplable to a suction source to provide suction through the opening, the tubular member disposed movably within the lumen of the outer catheter such that at least a portion of the tubular member is extendable beyond the distal end of the outer catheter to engage tissue within the opening, the tubular member being configured to cut the engaged tissue when the tubular member is moved with respect to the outer catheter, the cut tissue being transported through the lumen of the tubular member when the suction source is coupled to lumen of the tubular member; and

b) a suction source adapted and configured to provide suction through the lumen.

16. A medical device comprising:

a main body portion including a distal end, the main body portion defining a longitudinal axis;

a cutting member operably coupled to the distal end of the main body portion, the cutting member being configured to rotate about an axis transverse to the longitudinal axis from a first position to a second position when performing a cutting operation.

17. The medical device ofclaim 16, wherein the main body portion defines a lumen along at least a portion of its length, a distal port at the distal end, and a proximal port proximal to the distal end.

18. The medical device ofclaim 17, wherein the proximal port is in fluid communication with a suction source for removing tissue cut by the cutting member through the distal port and the lumen.

19. The medical device ofclaim 16, wherein the cutting member has a substantially arcuate shape and circumscribes a volume when moved from the first position to the second position.

20. The medical device ofclaim 19, further including an actuator for moving the cutting member from the first position to the second position.

21. The medical device ofclaim 20, wherein the actuator includes a wire having a distal end, the distal end of the wire being operably coupled to the cutting member and being configured to circumscribe an arcuate path when the wire is moved along the longitudinal axis.

22. The medical device ofclaim 21, wherein the main body portion defines a lumen and the wire is disposed within the lumen.

23. The medical device ofclaim 21, wherein the wire is made from spring steel.

24. The medical device ofclaim 21, wherein the wire is made from a shape memory material.

25. The medical device ofclaim 24, wherein the wire is made from a nickel-titanium alloy.

26. The medical device ofclaim 21, wherein the cutting member moves from the first position to the second position when the wire is advanced in a distal direction with respect to the main body portion.

27. The medical device ofclaim 21, wherein the cutting member moves from the first position to the second position when the wire is advanced in a proximal direction with respect to the main body portion.

28. The medical device ofclaim 20, wherein the actuator moves the cutting member from the first position to the second position by applying an electromagnetic force thereto.

29. The medical device ofclaim 28, wherein the actuator and the cutting member are configured to carry electrical currents in opposing paths.

30. The medical device ofclaim 29, further including a switching mechanism, a power supply and a controller operably associated with the switching mechanism and power supply, the controller adapted to operate the switching mechanism to alternate electrical current flowing through the actuator and cutting member to cause the cutting member to oscillate between the first position and the second position.

31. A medical device comprising:

a main body portion defining a lumen therethrough and including a distal end;

a shaft rotatably disposed in the lumen of the main body portion, the shaft including a proximal end and a distal end, the shaft being capable of rotation with respect to the main body portion about a longitudinal axis;

a rotational drive source operably coupled to the proximal end of the shaft;

a substantially arcuate cutting member attached to the distal end of the shaft, the cutting member configured to circumscribe a volume about the longitudinal axis when the shaft is rotated; and

a compartment affixed to the distal end of the main body portion, the compartment configured to house the cutting member.

32. The medical device ofclaim 31, wherein the main body portion defines a second lumen therethrough, the second lumen having a distal port proximate the cutting member and a proximal opening proximal to the distal end of the main body portion.

33. The medical device ofclaim 32, further comprising a suction source operably coupled to the compartment by way of the second lumen to facilitate removal of tissue from a patient.

34. A medical device comprising:

a main body portion including a distal end and defining a lumen therethrough;

a rotatable cutting member disposed in the lumen, the cutting member defined by at least one helical cutting edge and defining at least one helical channel therethrough, the cutting member being capable of being disposed beyond the distal end of the main body portion.

35. The medical device ofclaim 34, wherein the cutting member can be moved in a rotational direction with respect to the main body portion.

36. The medical device ofclaim 34, wherein the cutting member can be moved in a longitudinal direction with respect to the main body portion.

37. The medical device ofclaim 34, wherein the cutting member can be moved in a longitudinal direction and in a rotational direction with respect to the main body portion.

38. A medical device comprising:

a main body portion including a distal end and defining a lumen therethrough;

a shaft slidably disposed through the lumen of the main body portion, the shaft including a distal end and a cup shaped cutting member attached to the distal end of the shaft, the cutting member including a cutting edge disposed proximate to a rim of the cup shaped cutting member, the cutting member configured to cut tissue when advanced in a proximal direction with respect to the main body portion of the medical device.

39. The medical device ofclaim 38, wherein the cutting member protrudes from the distal end of the main body portion.

40. The medical device ofclaim 38, wherein the main body portion includes a closed end and defines a tissue entry port through a sidewall of the main body portion suitable to permit entry of tissue to be removed from a patient.

41. A method of removing tissue from a patient, comprising;

providing a medical device including a main body portion and a cutting member slidably coupled thereto;

introducing the medical device through the urethra of a patient;

removing tissue from the patient by advancing the cutting member in a proximal direction with respect to the main body portion; and

withdrawing the medical device from the patient.

42. The method ofclaim 41, wherein the removing step comprises removing tissue from the bladder of the patient.

43. The method ofclaim 42, wherein the removing step comprises removing tissue from the prostate gland of the patient.

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