US20110077674A1 - Tissue cutter with differential hardness - Google Patents

Abstract

Disclosed is a tubular cutting element for axial reciprocal movement within an outer tubular sleeve. The cutting element has an elongate tubular body, having a proximal end, a distal end and a cutting tip. The tubular body is formed in a drawing operation and the cutting tip is formed in a milling operation. The tubular body may have a Rockwell C hardness of no more than about 40, and the cutting tip may have a Rockwell C hardness of at least about 50.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application is a continuation of U.S. patent application Ser. No. 12/432,686, filed Apr. 29, 2009 (titled “TISSUE CUTTER WITH DIFFERENTIAL HARDNESS”), which is a continuation in part of U.S. patent application Ser. No. 12/098,250, filed Apr. 4, 2008 (titled “METHOD, SYSTEM AND DEVICE FOR TISSUE REMOVAL”), which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application 60/910,618, filed Apr. 6, 2007, U.S. Provisional Patent Application Ser. No. 60/910,625, filed Apr. 6, 2007, and U.S. Provisional Patent Application Ser. No. 60/986,912, filed Nov. 9, 2007, and all of the above applications are hereby incorporated herein by reference. U.S. application Ser. No. 12/432,686 is also a continuation in part of U.S. patent application Ser. No. 12/098,318, filed Apr. 4, 2008 (titled “SYSTEM FOR USE IN PERFORMING A MEDICAL PROCEDURE AND INTRODUCER DEVICE SUITABLE FOR USE IN SAID SYSTEM”), which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application Ser. No. 60/910,618, filed Apr. 6, 2007, and U.S. Provisional Patent Application Ser. No. 60/910,625, filed Apr. 6, 2007, and all of which are hereby incorporated herein by reference.
BACKGROUND OF THE INVENTION
• The present invention relates generally to methods, systems and devices for the removal of tissue and relates more particularly to methods, systems, and devices well-suited for the removal of uterine fibroids and other abnormal gynecological tissues.
• It is believed that uterine fibroids occur in a substantial percentage of the female population, perhaps in at least 20 to 40 percent of all women. Uterine fibroids are well-defined, non-cancerous tumors that are commonly found in the smooth muscle layer of the uterus. In many instances, uterine fibroids can grow to be several centimeters in diameter and may cause symptoms like menorrhagia (prolonged or heavy menstrual bleeding), pelvic pressure or pain, and reproductive dysfunction.
• Current treatments for uterine fibroids include pharmacological therapy, hysterectomy, uterine artery embolization, and hysteroscopic resection. Pharmacological therapy typically involves the administration of NSAIDS (non-steroidal anti-inflammatory drugs), estrogen-progesterone combinations, and GnRH (gonadotropin releasing hormone) analogues. However, current pharmacological therapies are largely ineffective and merely palliative. By comparison, a hysterectomy involves the surgical removal of the uterus from a patient. For this reason, a hysterectomy represents a highly effective way of ridding a patient of uterine fibroids. As a result, several hundred thousand hysterectomies are typically performed annually in the United States to treat uterine fibroids. However, despite their widespread use, hysterectomies also possess certain disadvantages, such as a loss of fertility, sexual dysfunction, and the risks commonly associated with a major surgical procedure, such as hemorrhaging, lesions, infections, pain and prolonged recovery. Uterine artery embolization involves inserting a catheter into a femoral artery and then guiding the catheter to a uterine fibroid artery. Small particles are then injected from the catheter into the fibroid artery, blocking its blood supply and causing it to eventually shrink and die. Although this procedure is less invasive than a hysterectomy, it often results in pain-related, post-surgical complications. Moreover, the physicians that are trained to perform uterine artery embolization are typically interventional radiologists, as opposed to physicians trained specifically to take care of gynecological problems, whereas the physicians trained specifically to take care of gynecological problems typically do not possess the skill to perform catheter-based uterine artery embolization.
• Hysteroscopic resection typically involves inserting a hysteroscope (i.e., an imaging scope) into the uterus through the vagina, i.e., transcervically, and then cutting away the fibroid from the uterus using a device delivered to the fibroid by the hysteroscope. Hysteroscopic resections typically fall into one of two varieties. In one variety, an electrocautery device in the form of a loop-shaped cutting wire is fixedly mounted on the distal end of the hysteroscope—the combination of the hysteroscope and the electrocautery device typically referred to as a resectoscope. The transmission of electrical current to the uterus with a resectoscope is typically monopolar, and the circuit is completed by a conductive path to the power unit for the device through a conductive pad applied to the patient's skin. In this manner, tissue is removed by contacting the loop with the part of the uterus wall of interest. Examples of such devices are disclosed, for example, in U.S. Pat. No. 5,906,615, inventor Thompson, issued May 25, 1999.
• In the other variety of hysteroscopic resection, an electromechanical cutter is inserted through a working channel in the hysteroscope. Tissue is then removed by contacting the cutter, which typically has a rotating cutting instrument, with the part of the uterus wall of interest. Examples of the electromechanical cutter variety of hysteroscopic resection are disclosed in, for example, U.S. Pat. No. 7,226,459, inventors Cesarini et al., issued Jun. 5, 2007; U.S. Pat. No. 6,032,673, inventors Savage et al., issued Mar. 7, 2000; U.S. Pat. No. 5,730,752, inventors Alden et al., issued Mar. 24, 1998; U.S. Patent Application Publication No. US 2006/0047185 A1, inventors Shener et al., published Mar. 2, 2006; and PCT International Publication No. WO 99/11184, published Mar. 11, 1999, all of which are incorporated herein by reference.
• In both of the above-described varieties of hysteroscopic resection, prior to fibroid removal, the uterus is typically distended to create a working space within the uterus. (Such a working space typically does not exist naturally in the uterus because the uterus is a flaccid organ. As such, the walls of the uterus are typically in contact with one another when in a relaxed state.) The conventional technique for creating such a working space within the uterus is to administer a fluid to the uterus through the hysteroscope under sufficient pressure to cause the uterus to become distended. Examples of the fluid used conventionally to distend the uterus include gases like carbon dioxide or, more commonly, liquids like water or certain aqueous solutions (e.g., a saline solution or a sugar-based aqueous solution). Where resection is effected using a resectoscope, it is typically necessary that the distending fluid not be current-conducting so that electricity is not conducted to undesired locations. However, because the distending fluid is administered under pressure (which pressure may be as great as 100 mm Hg or greater), there is a risk, especially when tissue is cut, that the distending fluid may be taken up by a blood vessel in the uterus, i.e., intravasation, which uptake may be quite harmful to the patient. Because excess intravasation can lead to death, it is customary to monitor the fluid uptake on a continuous basis using a scale system.
• Nevertheless, despite the aforementioned risks of intravasation, with proper monitoring of fluid uptake, hysteroscopic resection is a highly effective and safe technique for removing uterine fibroids. However, one shortcoming with hysteroscopic resection is that it typically requires that anesthesia be administered to the patient. This is because conventional resectoscopes typically have a diameter in excess of 7 mm and because conventional hysteroscopes of the type through which mechanical cutter-type devices are inserted typically have a diameter of about 9 mm. By contrast, the cervix typically cannot be dilated to a diameter greater than about 5.5 mm without causing considerable discomfort to the patient. As a result, due to the need for anesthesia, hysteroscopic resection is typically performed in a hospital operating room and, as a result, bears a large cost due to the setting and the support personnel required.
SUMMARY OF THE INVENTION
• The present invention provides a novel method, system and device for tissue removal. The method, system and device as described above may be used, for example, to remove uterine fibroids and other abnormal gynecological tissues.
• According to one aspect of the invention, there is provided a tissue removal device, the tissue removal device comprising (a) a housing; (b) an outer tube, the outer tube being fixed to the housing and extending distally therefrom, the outer tube including a resection window; (c) an inner tube disposed within the outer tube, the inner tube being slidable and rotatable relative to the outer tube, the inner tube comprising a distal end; and (d) a drive mechanism for rotating the inner tube relative to the outer tube and, at the same time, for translationally oscillating the inner tube relative to the outer tube so that the distal end of the inner tube rotates while moving back and forth across the resection window, wherein said drive mechanism comprises a drive shaft shaped to include a double helical groove, said drive shaft being translationally stationary.
• There is provided in accordance with another aspect of the present invention, a tubular cutting element for the tissue removal device of the present invention. The tubular cutting element is adapted for axial reciprocal movement within an outer tubular sleeve, the cutting element having an elongate tubular body having a proximal end, a distal end, and a cutting tip. The tubular body is formed in a drawing operation and the cutting tip is formed in a milling operation. The cutting tip is attached to the tubular body by soldering, brazing, welding, or other attachment technique.
• In accordance with a further aspect of the present invention, there is provided a tubular cutting element for axial reciprocal movement within an outer tubular sleeve. The cutting element comprises an elongate tubular body, having a proximal end, a distal end and a cutting tip. The tubular body has a Rockwell C hardness of no more than about 40 and the cutting tip has a Rockwell C hardness of at least about 50. The cutting tip may have a Rockwell C hardness of at least about 60, or at least about 70.
• A coating may be provided in-between the outer tubular sleeve and the inner tubular body. The coating may be applied to either the outer tubular sleeve or the inner tubular body. The coating may comprise a titanium nitride alloy. The coating may comprise a Rockwell C hardness of at least about 50, at least about 60, or at least about 70.
• Additional aspects, features and advantages of the present invention will be set forth in part in the description which follows. The embodiments will be described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that structural or process changes may be made without departing from the scope of the invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is best defined by the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
• The accompanying drawings, which are hereby incorporated into and constitute a part of this specification, illustrate various embodiments of the invention and, together with the description, serve to explain the principles of the invention. In the drawings wherein like reference numerals represent like parts:
• FIG. 1 is a partially exploded perspective view of a first embodiment of a tissue removal system constructed according to the teachings of the present invention;
• FIGS. 2(a) through2(d) are various views of the tissue removal device shown inFIG. 1, the tissue removal device being shown inFIGS. 2(a) through2(c) together with the distal ends of the vacuum tube and the external drive shaft;
• FIG. 3 is a perspective view of the introducer device shown inFIG. 1;
• FIGS. 4(a) and4(b) are exploded perspective views of the introducer device shown inFIG. 1;
• FIG. 5 is a right perspective view of the introducer device shown inFIG. 1, with the right half of the housing removed;
• FIG. 6 is a longitudinal section view of the introducer device shown inFIG. 1;
• FIG. 7 is an enlarged fragmentary perspective view, shown in section, of the introducer device shown inFIG. 1, with only the manifold, strain relief and sheath being shown;
• FIG. 8 is an enlarged distal end view of the multi-lumen sheath of the introducer device shown inFIG. 1;
• FIG. 9 is an enlarged fragmentary view of the instrument guide assembly of the introducer device shown inFIG. 1;
• FIGS. 10(a) and10(b) are fragmentary longitudinal section views of alternate inner tubular members that may be used in the tissue removal device shown inFIG. 1;
• FIG. 11 is a side view of an alternate indicator sleeve that may be used in the tissue removal device shown inFIG. 1;
• FIG. 12 is a fragmentary side view, partly in section, of an alternate combination of a tissue removal device and an introducer that may be used in the tissue removal system shown inFIG. 1;
• FIGS. 13(a) and13(b) are fragmentary side views, partly in section, of a further alternate combination of a tissue removal device and an introducer that may be used in the tissue removal system shown inFIG. 1;
• FIG. 14 is a fragmentary side view, partly in section, of an alternate tissue removal device that may be used in the tissue removal system ofFIG. 1;
• FIGS. 15(a) and15(b) are fragmentary perspective and fragmentary partially exploded perspective views, respectively, of another alternate tissue removal device that may be used in the tissue removal system ofFIG. 1;
• FIG. 16 is a fragmentary side view of another alternate tissue removal device that may be used in the tissue removal system ofFIG. 1;
• FIG. 17 is a fragmentary side view of another alternate tissue removal device that may be used in the tissue removal system ofFIG. 1;
• FIG. 18 is a fragmentary perspective view of another alternate tissue removal device that may be used in the tissue removal system ofFIG. 1;
• FIG. 19 is a fragmentary perspective view of another alternate tissue removal device that may be used in the tissue removal system ofFIG. 1;
• FIG. 20 is a fragmentary perspective view of another alternate tissue removal device that may be used in the tissue removal system ofFIG. 1;
• FIG. 21 is a fragmentary perspective view of another alternate tissue removal device that may be used in the tissue removal system ofFIG. 1;
• FIGS. 22(a) through22(e) are various views of another alternate tissue removal device that may be used in the tissue removal system ofFIG. 1 (the vacuum housing not being shown inFIGS. 22(c) through22(e) to reveal components positioned therewithin);
• FIG. 23 is a fragmentary section view of an obturator of the present invention inserted into the introducer shown inFIG. 1;
• FIG. 24 is a side view of an alternate combination of an obturator and an introducer constructed according to the present invention;
• FIGS. 25(a) and25(b) are unassembled side and assembled section views, respectively, of another combination of an obturator and an introducer constructed according to the present invention;
• FIGS. 26(a) through26(c) are fragmentary perspective views of another alternate introducer device to the introducer device shown inFIG. 1, with the alternate introducer device being shown in partially exploded states inFIGS. 26(b) and26(c);
• FIG. 27 is a perspective view of a second embodiment of a tissue removal system constructed according to the teachings of the present invention;
• FIGS. 28(a) through28(d) are bottom exploded perspective, top exploded perspective, bottom partially exploded, and fragmentary, partly in section, side views, respectively, of the morcellator assembly shown inFIG. 27;
• FIGS. 29(a) and29(b) are partially exploded top perspective and partially exploded bottom perspective views, respectively, of the drive assembly shown inFIG. 27;
• FIG. 30 is a fragmentary, partially exploded, perspective view of an alternate tissue removal device that may be used in the tissue removal system ofFIG. 27;
• FIGS. 31(a) and31(b) are fragmentary, partially exploded, perspective views of another alternate tissue removal device that may be used in the tissue removal system ofFIG. 27;
• FIG. 32 is a fragmentary, partially exploded, perspective view of another alternate tissue removal device that may be used in the tissue removal system ofFIG. 27;
• FIG. 33 is a fragmentary, partially exploded, perspective view of another alternate tissue removal device that may be used in the tissue removal system ofFIG. 27;
• FIG. 34 is a fragmentary section view of another alternate tissue removal device that may be used in the tissue removal system ofFIG. 27;
• FIG. 35 is a fragmentary section view of another alternate tissue removal device that may be used in the tissue removal system ofFIG. 27;
• FIGS. 36(a) and36(b) are perspective and enlarged fragmentary perspective views, respectively, of a further embodiment of a tissue removal device constructed according to the teachings of the present invention;
• FIG. 37 is a fragmentary perspective view of a further embodiment of a tissue removal device constructed according to the teachings of the present invention; and
• FIG. 38 is a fragmentary perspective view of a further embodiment of a tissue removal device constructed according to the teachings of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
• The present invention is described below primarily in the context of devices and procedures optimized for performing one or more therapeutic or diagnostic gynecological or urological procedures such as the removal of uterine fibroids or other abnormal uterine tissue. However, the devices and related procedures of the present invention may be used in a wide variety of applications throughout the body, through a variety of access pathways.
• For example, the devices of the present invention can be optimized for use via open surgery, less invasive access such as laparoscopic access, or minimally invasive procedures such as via percutaneous access. In addition, the devices of the present invention can be configured for access to a therapeutic or diagnostic site via any of the body's natural openings to accomplish access via the ears, nose, mouth, and via trans-rectal, urethral and vaginal approach.
• In addition to the performance of one or more gynecological and urologic procedures described in detail herein, the systems, methods, apparatus and devices of the present invention may be used to perform one or more additional procedures, including but not limited to access and tissue manipulation or removal from any of a variety of organs and tissues such as the bladder, breast, lung, stomach, bowel, esophagus, oral cavity, rectum, nasal sinus, Eustachian tubes, heart, gall bladder, spine, shoulder, knee, hip, brain, arteries, veins, and various ducts. Routes of access include but are not limited to trans-cervical; trans-vaginal-wall; trans-uteral; trans-vesicle; trans-urethral; and other routes.
• Referring now toFIG. 1, there is shown a partially exploded perspective view of one embodiment of a tissue removal system, the tissue removal system being constructed according to the teachings of the present invention and being represented generally byreference numeral5.
• System5 is particularly well-suited for removing uterine fibroids and other abnormal gynecological tissues. However, it should be understood thatsystem5 is not limited to such a use and may be used in other anatomies that may be apparent to those of ordinary skill in the art.
• System5 may comprise a tissue removal device (or morcellator)6, anintroducer device7, aflexible hysteroscope8, afluid supply9, avacuum assembly10, and amotor drive assembly11.
• Referring now toFIGS. 2(a) through2(d),tissue removal device6 may be seen in greater detail.Device6 may comprise complementary left and right housing halves13-1 and13-2, respectively, each of which may be made of a rigid polymer or other suitable material. Halves13-1 and13-2 may be joined together, for example, withscrews15 to form an elongatedhollow housing13 comprising arounded side wall16, an openproximal end17, and an opendistal end19.Housing13 may be bent or otherwise ergonomically shaped to fit comfortably in the hand of a user. Aproximal cap18 may be mounted inproximal end17,cap18 being shaped to include a pair of lumens18-1 and18-2. Lumen18-1 may be used to receive, for example, an external drive shaft, and lumen18-2 may be used to receive, for example, a vacuum tube. Adistal cap20 may be mounted indistal end19,cap20 being shaped to include a lumen, which may be used to receive, for example, a pair of coaxial cutting tubes.
• A plurality ofribs14 may be integrally formed and appropriately positioned along the respective interior surfaces of halves13-1 and13-2,ribs14 providing structural reinforcement tohousing13 and being used to align certain of the mechanical components that are positioned withinhousing13.
• Device6 may further comprise aninternal drive shaft21 adapted for rotation about its longitudinal axis.Shaft21, which may be an elongated unitary structure made of a suitably rigid metal or polymer, may be shaped to include a proximal end23 and adistal end25. Proximal end23 ofshaft21 may be coaxially mounted over and fixed to thedistal end27 of anexternal drive shaft29,external drive shaft29 being inserted through aretainer28 mounted inhousing13. In this manner, the rotation ofshaft21 may be mechanically coupled to the rotation ofshaft29.Distal end25 ofshaft21 may be inserted through anopening30 in anannular bushing31, whichbushing31 may be matingly mounted on a rib14-1 via acircumferential slot32 provided inbushing31.
• Device6 may further comprise atranslation drive shaft35 adapted for rotation about its longitudinal axis.Shaft35, which may be an elongated unitary structure made of a suitably rigid metal or polymer, may be shaped to include a proximal end37, anintermediate portion39, and adistal end41. Proximal end37 ofshaft35 may be coaxially mounted over and fixed to thedistal end25 ofinternal drive shaft21. In this manner, the rotation ofshaft35 may be mechanically coupled to the rotation ofshaft21.Intermediate portion39 may be shaped to include a double helical portion comprising a right-handed threadedhelical channel42 and a left-handed threaded helical channel43.Helical channels42 and43 may have identical or different pitches but preferably have identical pitches.Helical channels42 and43 may be smoothly blended together at their respective ends to form a continuous groove so that there may be a smooth transition from one helical channel to the other.Distal end41 ofshaft35 may be appropriately dimensioned to be received within anopening44 in anannular bushing45, whichbushing45 may be matingly mounted on a rib14-2 via acircumferential slot46 provided inbushing45. It should be noted that, althoughshaft35 is adapted for rotation,shaft35 is translationally stationary.
• Device6 may further comprise agear assembly50 adapted for rotation about its longitudinal axis.Gear assembly50, which may be an elongated unitary structure made of a suitably rigid metal or polymer, may be shaped to include aproximal spur gear51 and adistal tube portion52.Gear assembly50 may be coaxially mounted overintermediate portion39 ofshaft35 in an area between the double helical portion anddistal end41, andgear assembly50 may be fixed toshaft35 using a pin inserted radially throughtube portion52 and into an opening provided inshaft35. In this manner, the rotation ofspur gear51 may be mechanically coupled to the rotation ofshaft35.
• Device6 may further comprise an oscillating translation assembly61. Translation assembly61, in turn, may comprise acarriage62 and achannel engagement member63.Carriage62, which may be a unitary structure made of a suitably rigid metal or polymer, may be shaped to include a proximal portion64, anintermediate portion65, and adistal portion66. The tops of proximal portion64 anddistal portion66 may extend beyond the top ofintermediate portion65 and may be shaped to include loops67-1 and67-2, respectively, loops67-1 and67-2 being aligned with one another. A longitudinal bore68-1 may be provided near the bottom ofcarriage62, bore68-1 being appropriately dimensioned to coaxially receiveintermediate portion39 ofshaft35 while permittingintermediate portion39 to rotate freely therewithin.Channel engagement member63, which may be a unitary structure made of a suitably rigid metal or polymer, may be shaped to include abase69 and apawl70.Base69 may be disposed in an opening68-2 that may extend downwardly from the top ofintermediate portion65 into communication with bore68-1, withpawl70 traveling within the double helical portion ofshaft35. In this manner, asshaft35 rotates,pawl70 may continuously travel back and forth through the double helical portion ofshaft35, thereby causingcarriage62 to oscillate translationally. As can be appreciated, the speed at whichcarriage62 oscillates translationally may be varied, for example, by varying the translational length of the double helical portion ofshaft35, the angles ofchannels42 and43, the rotational speed ofshaft29, etc. As will be discussed further below, it may be desirable to operatedevice6 so thatcarriage62 oscillates translationally at about 2.8 cycles/second.
• Device6 may further comprise ashaft72 adapted for rotation about its longitudinal axis.Shaft72, which may be an elongated, unitary, tubular structure made of a suitably rigid metal or polymer, may be shaped to include a proximal portion72-1 and a distal portion72-2. Proximal portion72-1 may be inserted through loops67-1 and67-2 ofcarriage62 and may freely rotate relative to loops67-1 and67-2. Distal portion72-2 may be in the form of an elongated spur gear. Distal portion72-2 may be engaged withspur gear51 ofgear assembly50 so that the rotation ofspur gear51 causes the rotation ofshaft72. Distal portion72-2 may be elongated so that it may maintain engagement withspur gear51 even as distal portion72-2 moves translationally relative to spurgear51. The speed at which distal portion72-2 rotates (and, therefore, the speed at whichshaft72 rotates) may be the same as or different than the speed at whichspur gear51 rotates, depending, for example, on the relative diameters of the two gears (the ratio of the rotational speeds of the two gears being inversely proportional to the ratio of the diameters of the two gears). Consequently, by appropriately dimensioningspur gear51 and distal portion72-2, one can achieve a desired rotational speed, even where the rotational speed of the external drive shaft is fixed. For example, in the embodiment shown, distal portion72-2 has a diameter that is one-fourth the diameter ofspur gear51 and, therefore, rotates four times as fast asgear51. Therefore, if the external drive shaft has a speed of rotation of about 1500 rpm,gear51 would rotate at 1500 rpm and distal portion72-2 would rotate at 6000 rpm. As can be appreciated, the rotational speed of distal portion72-2 does not depend on the interaction of translation assembly61 with the double helical portion ofshaft35; consequently, distal portion72-2 may attain higher or lower rotational speeds than would be possible based on the requirements of a desired translational speed. Notwithstanding the above,shaft72 is translationally coupled tocarriage62. Consequently, ascarriage62 oscillates translationally, so doesshaft72.
• Device6 may further comprise astrain relief member74, which may be a unitary tubular structure made of a rigid polymer or metal. The proximal end ofstrain relief member74 may be fixedly mounted in aretainer75, which may be mounted at the distal end ofhousing13, with the distal end ofstrain relief74 extending distally fromhousing13 for a short distance, such as, for example, approximately 2 inches.
• Device6 may further comprise a cutting mechanism. In the present embodiment, the cutting mechanism may comprise anouter tubular member76 and aninner tubular member77,inner tubular member77 moving rotationally and, at the same time, oscillating translationally relative to outertubular member76 in the manner to be described further below. Outertubular member76, which may be a unitary structure made of stainless steel or another similarly suitable material, may be shaped to include an open proximal end, a closeddistal end81, and alumen82 extending from open proximal end79 to a point just prior to closeddistal end81.Member76 may be coaxially mounted withinstrain relief member74, with the proximal end ofmember76 disposed within the proximal end ofstrain relief member74 and withdistal end81 ofmember76 extending distally beyond the distal end ofstrain relief member74 for an extended distance, such as, for example, five inches. The proximal end ofmember76 may be fixed withinretainer75.
• Outertubular member76 may be further shaped to include aresection window89 into which tissue may be captured and drawn,window89 being located proximate todistal end81, such as, for example, 0.25 inch fromdistal end81.Window89 may be shaped to include a proximal end89-1 and a distal end89-2. Proximal end89-1 may slope gradually proximally, and distal end89-2 may slope gradually distally. More specifically,window89 may have a length of approximately 0.55 inch, proximal end89-1 may be a radial end having a radius of curvature of, for example, 0.085 inch, and distal end89-2 may be a radial end having a radius of curvature of, for example, 0.150 inch.Window89 may extend over a substantial portion of the circumference oftubular member76, such as, for example, about 60% of the circumference.
• Outertubular member76 may have an outer diameter less than about 5.5 mm. However, in order to reduce the risk of injury to the patient and in order to obviate the need for anesthesia to be administered to the patient, outertubular member76 preferably has an outer diameter less than about 5 mm, more preferably less than 4 mm, even more preferably less than 3 mm, and still even more preferably less than 2 mm. However, shoulddevice6 be used in an operating room setting where general anesthesia is available, the diameter of the outertubular member76 could be increased to maximize tissue removal. In such a case, outertubular member76 could have a diameter generally less than about 12 mm, preferably less than about 11 mm, and for certain applications less than 10 mm. Depending on the particular clinical application, outertubular member76 could be constructed having an outer diameter of no more than about 9 mm, in some applications less than about 8 mm, preferably less than 7 mm, and more preferably less than 6 mm where OD is desirably minimized.
• Innertubular member77, which may be an elongated unitary structure made of stainless steel or another similarly suitable material, may be shaped to include aproximal end91, adistal end92, and alongitudinal lumen93.Distal end92 may be shaped to include an external bevel, such as, for example, an external bevel of approximately 20 degrees. An intermediate length oftubular member77 may be coaxially received withinshaft72 and may be fixedly coupled toshaft72 for translational and rotational movement therewith.Proximal end91 oftubular member77 may be slideably mounted within avacuum tube connector95, which may, in turn, be coupled to avacuum tube393 inserted through lumen18-2 ofcap18. An O-ring96 may be mounted withinconnector95 to maintain a good seal withtubular member77. Anannular bushing98 mounted withinhousing13 may be used to receivetubular member77 and to maintain its alignment.
• Tubular members76 and77 may be arranged so that, whentubular member77 is in a fully retracted (i.e., proximal) position,distal end92 oftubular member77 may be withdrawn sufficiently to permit tissue to enter window89 (preferably withdistal end92 of tubular member positioned proximal to window89), and so that, whentubular member77 is in a fully advanced (i.e., distal) position,distal end92 oftubular member77 may be positioned distally of distal end89-2 ofwindow89. In this manner, astubular member77 is moved translationally and rotationallypast window89, tissue withinwindow89 may be sheared. To promote such a shearing of tissue, the outer diameter of innertubular member77 may be just slightly less (e.g., about 0.002 inch) than the inner diameter of outertubular member76.
• It has been shown that the thermal energy created by the contact of the rotatinginner tube77 andouter tube76 can lead to galling where the two tubular members fuse together. To mitigate that galling risk, the outer surface ofinner tube77 has been covered with a low friction, low abrasion coating (i.e., Titanium Nitride). Alternatively, the coating can be carried by the inner surface of theouter tube76. The coating may have a Rockwell C hardness of at least about 50, preferably at least about 60 and in some devices at least about 70.
• Device6 may further comprise anindicator sleeve98.Sleeve98, which may be an elongated tubular member made of a material that is easily distinguishable visually fromstrain relief member74, may be coaxially mounted overstrain relief member74 and fixedly mounted thereto, with a proximal end98-1 ofsleeve98 lying flush against the distal end ofhousing13. An example of a material suitable for use assleeve98 may be a white or colored length of shrink-wrap material.Sleeve98 may be dimensioned so that, whendevice6 is inserted intointroducer device7, distal end98-2 ofsleeve98 is visible to a user untildistal end81 ofdevice6 is advanced beyond the distal end ofintroducer7. In other words, distal end98-2 may be used to indicate whendistal end81 ofdevice6 lies flush with the distal end ofintroducer7. In this manner, a user may safely control the position of the distal end ofdevice6 and, therefore, keep it withinintroducer7 when insertingdevice6 into a patient, thereby reducing the risks for lacerations and perforations during introduction ofdevice6.
• Referring now toFIGS. 3 through 7,introducer7 may comprise ahousing121.Housing121, in turn, may comprise aleft handle half123 and aright handle half125.Left handle half123 andright handle half125, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be joined by a plurality ofscrews127. Instead of being joined byscrews127,left handle half123 andright handle half125 may be joined using a suitable adhesive, crush pins, or may be welded together ultrasonically or otherwise.Left handle half123 andright handle half125 jointly define a hollow, gun-shaped structure comprising ahandle portion129 and abarrel portion131.Handle portion129 may be shaped to include anopening133 provided at itsbottom end134 and anopening135 provided along itsdistal face136 nearbottom end134. A slot133-1 may be provided inright handle half125, slot133-1 extending from opening133 towardsbarrel portion131 for a short distance.Barrel portion131 may be shaped to include anopening137 provided at itsproximal end138 and anopening139 provided at itsdistal end140. In addition,barrel portion131 may be shaped to include atransverse opening141 provided inright handle half125 at a location intermediate toproximal end138 anddistal end140.
• The interior surfaces ofleft handle half123 andright handle half125 may shaped to include complementary sets of ribs (not shown). Such ribs may provide structural reinforcement to lefthandle half123 andright handle half125 and may help to maintain the correct positioning and alignment of the components positioned withinhousing121.
• Introducer7 may further comprise a manifold145.Manifold145, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be a unitary, branched structure shaped to include a maintubular member147 and aside tubular member149.Main member147 may comprise aproximal end151, an opendistal end153, aside wall155, and alongitudinal lumen157.Proximal end151 ofmain member147 may be shaped to include atop opening159 of comparatively greater diameter and abottom opening161 of comparatively smaller diameter.Side member149 may comprise an openproximal end163, an opendistal end165, aside wall167, and alongitudinal lumen169.Lumen169 ofside member149 may be in fluid communication withlumen157 ofmain member147 through opendistal end165.
• Manifold145 may be coupled tohousing121 using a pair ofpins171 and173 that may extend fromside wall155 and that may be received withinhollow embossments175 and177, respectively, provided on the interior faces ofleft handle half123 andright handle half125, respectively. Withmanifold145 thus coupled tohousing121,proximal end151 ofmanifold145 may be positioned inbarrel portion131, withside wall155 tightly fitting withinopening139 and withdistal end153 ofmanifold145 extending distally a short distance beyonddistal end140.
• Introducer7 may further comprise astrain relief member181.Strain relief member181, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be a unitary tubular structure shaped to include an openproximal end183, an opendistal end185, aside wall187, and alongitudinal lumen189.Strain relief member181 may be partially inserted intolumen157 ofmanifold145 and may be tightly fitted withinlumen157 and fixedly secured thereto using a suitable adhesive or the like, withproximal end183 ofstrain relief member181 being positioned just distal to opendistal end165 ofside member149 and withdistal end185 ofstrain relief member181 extending distally a short distance beyonddistal end153 ofmain member147.
• Introducer7 may further comprise asheath191, which is also shown separately inFIG. 8.Sheath191, which may be extruded or otherwise fabricated from a suitable polymer, such asnylon12, may be a rigid, unitary structure shaped to include aproximal end192, adistal end193, and aside wall194.Sheath191 may be further shaped to include a plurality of longitudinal lumens of fixed shape and size, such lumens including atop lumen196, abottom lumen197, and a pair of side lumens198-1 and198-2. As will be discussed further below,top lumen196 may be used as an instrument lumen,bottom lumen197 may be used as a visualization lumen, and side lumens198-1 and198-2 may be used as inflow fluid supply lumens. (Openings (not shown) may be provided inside wall194 proximate todistal end193, such side openings fluidly communicating with side lumens198-1 and198-2, for example, to dispense some of the inflow fluid supply conducted distally through side lumens198-1 and198-2.)Proximal end192 ofsheath191 may be partially inserted intolumen189 ofstrain relief member181 and may be tightly fitted withinlumen189 and fixedly secured thereto using a suitable adhesive or the like, withproximal end192 ofsheath191 flush withproximal end183 ofstrain relief member181 and withdistal end193 ofsheath191 extending distally beyonddistal end185 ofstrain relief member181 for several inches.
• Sheath191, which is preferably the only component ofintroducer7 that is to be inserted into a patient, may be dimensioned to have an outer diameter of about 5.5 mm, withlumen196 having a diameter of about 3 mm,lumen197 having a diameter of about 2 mm, and lumens198-1 and198-2 each having a diameter of about 1.33 mm. It can be further stated the ratio of the outer diameter to the working channel is an exemplary metric of introducer efficiency. It can be seen that the optimal ratio would be about 1.0, preferably no more than about 2.1 and more preferably no more than about 1.9. In the case provided herein, the ratio of these diameters is about 1.83 while predicate systems have ratios of 2.25. By thus dimensioningsheath191, ifsheath191 is inserted through the cervix of a patient, the risk of injury to the patient and the need for anesthesia to be administered to the patient may be minimized. However, it should be understood that the above dimensions forsheath191 are merely exemplary and may be varied depending upon howintroducer7 is to be used.
• Introducer7 may further comprise an instrument guide assembly mounted withinhousing121 for providing a continuous channel aligned withlumen196 into whichtissue removal device6 may be inserted. The instrument guide assembly may comprise aguide body201.Body201, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be a unitary tubular structure shaped to include aproximal portion203, adistal portion205 and anintermediate portion207.Intermediate portion207 may be reduced in inner diameter and in outer diameter relative toproximal portion203 anddistal portion205 so that anannular seat208 is formed withinbody201 at the juncture ofintermediate portion207 anddistal portion205. The interior surface ofbody201 may taper inwardly fromproximal portion203 tointermediate portion207 to facilitate insertion ofdevice6 intointermediate portion207 and to delimit the extent to whichdevice6 may be inserted intobody201.
• Body201 may be tightly fitted within opening137 ofhousing121 and fixedly secured thereto using a suitable adhesive or the like, withdistal portion205 andintermediate portion207 ofbody201 being positioned withinbarrel portion131 ofhousing121 and withproximal portion203 ofbody201 extending throughopening137 and continuing proximally for a short distance beyondproximal end138 ofhousing121.
• The instrument guide assembly may further comprise asleeve211.Sleeve211, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be a unitary, branched structure shaped to include a maintubular member213 and aside tubular member215.Main member213 may comprise an openproximal end216, an opendistal end217, and alongitudinal lumen219.Proximal end216 ofmain member213 may be shaped to be tightly fitted withindistal portion205 ofbody201 and may be bonded thereto using a suitable adhesive.Side member215 may comprise an openproximal end220, an opendistal end221 and a longitudinal lumen223. Lumen223 ofside member215 may be in fluid communication withlumen219 ofmain member213 through openproximal end220.Distal end221 ofside member215 may extend throughopening141 provided inright handle half125 ofhousing121 and may be coupled to avalve228.Valve228 may be an actively-controlled valve, such as a stopcock valve, or a passively-controlled valve, such as a spring-activated ball valve.Valve228 may be connected at its output end to a length of tubing (not shown), as well as to a fluid receptacle (not shown), for conducting, as well as collecting, for example, outflow fluid passing throughvalve228, for example, whendevice6 is not present withinintroducer7.
• The instrument guide assembly may further comprise the combination of aseal231 and avalve233.Seal231 andvalve233 may be elastomeric members securely positioned betweenseat208 ofbody201 andproximal end216 of sleeve211 (seeFIG. 9).Seal231, which may be located proximally relative tovalve233, may include acentral opening235. Opening235 may be appropriately dimensioned so that, whendevice6 is inserted therethrough, fluid may not readily pass proximally throughseal231 around the outside ofdevice6.Valve233, which may be shaped to include a dome having a cross-slit at its top, may be designed so that, in the absence ofdevice6 being inserted therethrough, fluid may not readily pass proximally therethrough.
• The instrument guide assembly may further comprise atube241.Tube241, which may be a rigid hypotube made of stainless steel or the like, may comprise aproximal end243 and adistal end245.Proximal end243 may be fixedly mounted withinlumen219 ofsleeve211 using a suitable adhesive or the like.Distal end245 oftube241 may be tightly fitted withinlumen196 ofsheath191 and may be secured therewithin using a suitable adhesive or the like.
• Introducer7 may further comprise a visualization guide assembly mounted withinhousing121 for providing a continuous channel aligned withlumen197 into whichhysteroscope8 may be inserted. The visualization guide assembly may comprise aguide body251.Body251, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be a unitary tubular structure shaped to include aproximal portion253 of comparatively greater diameter, adistal portion255 of comparatively smaller diameter, and anintermediate portion257 tapering in diameter fromproximal portion253 todistal portion255.Body251 may be disposed withinhandle portion129 ofhousing121, withproximal portion253 spaced inwardly a short distance from opening133 and withdistal portion255 facing towardsbarrel portion131.Proximal portion253 may be tightly fitted between and fixedly secured to lefthandle half123 andright handle half125 ofhousing121 using adhesive or other suitable means. As will be discussed further below,proximal portion253 may be appropriately dimensioned to receive the proximal portion ofhysteroscope8, withintermediate portion257 ofbody251 being appropriately dimensioned to serve as a stop to limit the extent to whichhysteroscope8 may be inserted intobody251. Anannular seat258 may be provided withindistal portion255 and may be spaced proximally relative todistal end259 ofdistal portion255.
• The visualization guide assembly may further comprise aguide connector261.Guide connector261, which may be molded or otherwise fabricated from a rigid polymer or other suitable material, may be a unitary tubular structure shaped to include aproximal portion263 of comparatively greater diameter, adistal portion265 of comparatively smaller diameter, and anintermediate portion267 tapering in diameter fromproximal portion263 todistal portion265.Proximal portion263 may be shaped to be tightly fitted withindistal portion255 ofbody251 and may be bonded thereto using a suitable adhesive.
• The visualization guide assembly may further comprise the combination of aseal271 and avalve273.Seal271 andvalve273 may be elastomeric members securely positioned betweenseat258 ofbody251 andproximal portion263 ofconnector261.Seal271, which may be located proximally relative tovalve273, may include a central opening appropriately dimensioned so that, whenhysteroscope8 is inserted therethrough, fluid may not readily pass proximally throughseal271 around the outside ofhysteroscope8.Valve273, which may be shaped to include a dome having a cross-slit at its top, may be designed so that, in the absence ofhysteroscope8 being inserted therethrough, fluid may not readily pass proximally therethrough.
• The visualization guide assembly may further comprise atube281.Tube281, which may be a flexible unitary member fabricated from a suitable polymer or other material, may comprise aproximal end283, adistal end285, and a lumen286.Proximal end283 may be fixedly mounted withindistal portion265 ofconnector261 using a suitable adhesive or the like.Distal end285 oftube281 may be tightly fitted withinlumen197 ofsheath191 and may be secured therewithin using a suitable adhesive or the like. Lumen286 may be appropriately dimensioned so that the distal portion ofhysteroscope8 may be inserted thereinto and, in this manner, guided bytube281 tolumen197.
• Introducer7 may further comprise a mechanism for reversibly couplinghysteroscope8 to the visualization guide assembly. This mechanism may comprise acam lock291.Lock291, which may be fabricated from a rigid polymer or other suitable material, may be a unitary structure shaped to comprise alever292 and afulcrum293. Thefulcrum293 may be pivotally mounted onhousing121 using apivot pin294 inserted through atransverse opening295 infulcrum293 and securely received at its opposite ends inopenings296 and297 provided inleft handle half123 andright handle half125, respectively.Fulcrum293 may comprise aface298 adapted to frictionally engage the proximal portion ofhysteroscope8 whenlever292 is pivoted towardshandle portion129.
• Introducer7 may further comprise atube301.Tube301, which may be fabricated from a suitable polymer or other material, may be a flexible unitary structure shaped to include aproximal end303 and adistal end305.Proximal end303 may be secured to the distal end of a luer fitting307 securely mounted within opening135 ofhousing121.Distal end305 may be positioned withinlumen169 ofmanifold145 and may be secured in place using an adhesive or other suitable means. As will be discussed further below, luer fitting307 may be connected to the output offluid supply9. In this manner, fluid dispensed through fitting307 and intotube301 may be conducted bytube301 tomanifold145. Thereafter, the fluid inmanifold145 may flow distally through lumens198-1 and198-2 ofsheath191.
• Referring back now toFIG. 1,hysteroscope8, which may be, for example, a conventional flexible hysteroscope, may comprise a proximal portion311 and adistal portion313. Proximal portion311, which may be comparatively rigid, compact in length, and wide in diameter, may comprise aninput port315, anoutput port317, and a distal end318.Distal portion313, which may be comparatively flexible, elongated in length, and narrow in diameter, may comprise adistal end319.Hysteroscope8 may be appropriately dimensioned so that distal end318 of proximal portion311 may be received inbody251, withdistal portion313 extending distally throughseal271,valve273,connector261,tube281 andlumen197 and withdistal end319 positioned at or a short distance beyonddistal end193 ofsheath191. Although not present in the embodiment shown, proximal portion311 ofhysteroscope8 may be provided with notches or other physical features that may be used to mate with or otherwise engagecam lock291.Distal end319 ofhysteroscope8 may be constructed to permit the viewing of objects, such as at 0, 15 or 30 degree angles, relative to the longitudinal axis ofdistal portion313. In this manner, by placinghysteroscope8 in a particular angular orientation,hysteroscope8 may be used to view the operation of the distal end ofdevice6. Such an angular orientation may be ensured by orientinghysteroscope8 so thatinput port315 is aligned with and extends through slot133-1.
• Fluid supply9 may comprise a fluid-containing syringe, a peristaltic pump or another suitable fluid-dispensing device having anoutput end321 that may be coupled toluer fitting307.Fluid supply9 may comprise automated means (not shown) for dispensing inflow fluid therefrom at a desired rate.
• Vacuum assembly10 may include aspecimen collection container391 and avacuum source392. The distal end of anevacuation tube393 may be connected to the proximal end ofvacuum tube connector95, and the proximal end ofevacuation tube393 may be coupled to afirst port394 ofcontainer391. The distal end of atube395 may be coupled to asecond port396 ofcontainer391, and the proximal end oftube395 may be coupled tovacuum source392. In this manner,vacuum source392 may be used to apply suction todevice6, and any withdrawn tissue, liquids or similar matter suctioned throughdevice6 may be collected incontainer391.
• Motor drive assembly11, which may be coupled to a source of electricity, such as an AC wall outlet, using a power cord (not shown), may include ahousing397, in which there may be disposed electronics (not shown) and a motor (not shown). Afoot pedal398 may be coupled to the motor drive assembly by a cable398-1 and may be used as a power switch to selectively activate or de-activate the motor. The proximal end ofshaft29 may be mechanically coupled for rotation to the motor, and the distal end ofshaft29 may be inserted through opening18-1 in mountingblock18 and coupled tointernal shaft21 in the manner discussed above. Aprotective sheath399 may cover much of the length ofshaft29.Motor drive assembly11 may further include avacuum sensor400, which may be coupled tocontainer391 by atube401, so that the pressure withincontainer391 may be monitored. In this manner, a sudden increase in vacuum pressure may indicate that a clog has occurred. The presence of a clog may be indicated via an alarm (not shown) located onhousing397. The detection of a clog is often a clear indication that the further operation ofdevice6 may only aggravate the clogging situation and that a cessation of tissue removal may be necessary.Motor drive assembly11 may be configured to synchronize actuation of the motor with actuation ofvacuum source392. In this manner, turning on the motor will turn onvacuum source392 at the same time. Correspondingly,vacuum source392 may be deactivated whenever the motor is turned off.
• In use,distal end319 ofhysteroscope8 may be inserted first through the visualization guide channel ofintroducer7, next throughmanifold145, and then throughlumen197 ofsheath191. Withhysteroscope8 thus inserted intointroducer7,cam lock291 may be used to secure proximal portion311 ofhysteroscope8 tointroducer7.Input end315 andoutput end317 ofhysteroscope8 may then be coupled to a light source and to a camera, respectively. Alternatively, the camera may be omitted, andoutput end317 may be observed directly with the unaided eye.Fluid supply9 may then be coupled to luer fitting307 ofintroducer7.Distal end193 ofsheath191 may then be inserted transcervically, i.e., through the vagina and the cervix, into the uterus of the patient. Prior to introducingdistal end193 ofsheath191 into the patient, the cervix may be gradually dilated in the conventional manner using obturators of increasing diameter. The uterus may then be washed of blood and other debris that may be present by dispensing fluid fromfluid supply9 intointroducer7, which fluid may then exitintroducer7 distally through lumens198-1 and198-2.Valve228 may be opened during this washing procedure so that fluid and any debris present in the uterus may exit the uterus proximally throughlumen196 ofsheath191 and, thereafter, may exitintroducer7 by passing proximally throughtube241, intomain member213 ofsleeve211, throughside member215 ofsleeve211, and throughvalve228. When the washing procedure is complete,valve228 may be closed while fluid may continue to be dispensed into the uterus through lumens198-1 and198-2, thereby causing the uterus to become distended by the fluid. When the uterus becomes sufficiently distended by such fluid,valve228 may be opened while fluid may continue to be dispensed into the uterus. In this manner, the uterus may be maintained at a desired degree of distension while fluid is continuously circulated through the uterus. With the uterus thus distended with fluid,hysteroscope8 may be used to examine the interior of the uterus.
• If abnormalities are detected that one wishes to remove,tissue removal device6 may be loaded intointroducer7, i.e., by inserting the distal ends of outertubular member76 and innertubular member77 distally through the instrument channel guide ofintroducer7 and then throughchannel196 ofsheath191, withhousing13 remaining external to the patient.Device6 may then be manipulated so thatwindow89 of outertubular member76 may be positioned in proximity to the fibroid or other targeted tissue. Next,vacuum source392 may be operated so as to cause suction to be applied to innertubular member77, thereby drawing tissue into outertubular member76 throughwindow89. In addition, the motor ofmotor drive assembly11 may be actuated, thereby causinginner tubular member77 simultaneously to rotate and to oscillate back and forth translationally within outertubular member76, resulting in the tissue drawn throughwindow89 to be cut. The cut tissue may then be suctioned from the patient through innertubular member77 by means of the aforementioned suction and, thereafter, collected incontainer391. Once the fibroids or other targeted tissues have thus been removed from the patient,vacuum source392 and the motor may be turned off,device6 may be withdrawn fromintroducer7, andintroducer7 may be withdrawn from the patient.Device6 may be designed to be a single use device. If so,device6 may then be disconnected fromevacuation tube393 and flexible motor shaft398-2 and disposed of properly.
• It should be noted that, although the above-discussion contemplates usingintroducer7 to introducedevice6 into the uterus, one may insertdevice6 transcervically into the uterus without the use ofintroducer7. In such a situation, fluid may be administered transcervically to the uterus by a fluid dispensing device in order to distend the uterus, and, thereafter, observation of the uterus may be accomplished, for example, by ultrasonic imaging using an ultrasonic probe inserted transcervically into the uterus. Such an ultrasonic probe may be separate fromdevice6 or may be integrated intodevice6. Alternatively, imaging of the uterus may be performed by MRI imaging.
• Although one may vary one or more of the speed of rotational movement of innertubular member77, the frequency of oscillating translational movement of innertubular member77, the advance ratio of inner tubular member77 (i.e., the ratio of the speed at whichtubular member77 oscillates translationally to the speed at whichtubular member77 rotates), and the magnitude of suction provided byvacuum source392, particularly good results have been achieved under the following conditions: speed of rotation oftubular member77—at least 1100 rpm, more preferably at least 5000 rpm, even more preferably approximately 6000 rpm; frequency of oscillating translational movement oftubular member77—at least 1.5 cycles/second, more preferably about 2.5 to 4 cycles/second, even more preferably about 2.8 cycles/second; advance ratio of preferably less than 0.25, more preferably less than 0.15; and vacuum pressures in the range of 200 to 650 mm Hg. Preferably, the above parameters are selected to achieve a rate of tissue removal of at least 1.5 gm/min while outertubular member76 has an outer diameter of no greater than about 3.0 mm.
• As can be appreciated, as suction is applied to innertubular member77, some of the distension fluid located in the uterus may incidentally be withdrawn from the uterus through innertubular member77. This loss of distension fluid from the uterus may be undesirable if it interferes with maintenance of the uterus in an adequately distended state. Preferably,system5 is constructed and operated so that, with a vacuum in excess of 300 mm Hg, a volume of no more than about 300 cc/min of fluid is removed. This may involve, for example, applying suction only at specific times, for example, only when the motor for moving innertubular member77 is actuated or by closingresection window89 with innertubular member77 each time the motor control is stopped.
• In general, morcellators may be built in accordance with the present invention to have a lower outside diameter or crossing profile than current commercial products such as the Smith & Nephew Hysteroscopic Morcellator, but at the same time accomplish a higher tissue resection rate. In addition, morcellators in accordance with the present invention may be operated at a significantly higher vacuum while managing total fluid flow within acceptable limits.
• For example, the cross sectional area of the aspiration lumen in morcellators in accordance with the present invention will typically be no more than about 12.0 square millimeters, and often no more than about 10.0 square millimeters. In certain embodiments, a cross sectional area of the aspiration lumen will be no more than about 8.0 millimeters squared, and, for certain applications, the area will be no more than about 7.5 square millimeters.
• The tissue resection rate is generally at least about 1.5 gm/min, and often at least about 1.8 gm/min. In certain embodiments, the tissue resection rate is at least about 2.0 gm/min, and, in one embodiment, 2.2 or more gm/min.
• Morcellators in accordance with the present invention may be constructed to have a fluid usage of no more than about 350 ml/min. In certain embodiments, fluid usage of no more than about 300 ml/min or no more than about 275 ml/min may be constructed.
• Applied vacuum to the morcellators of the present invention will generally be in the range of from about 200 to about 650 mm Hg. The morcellator will typically be run at a vacuum of at least about 350 mm Hg, and, often at least about 500 mm Hg.
• In one embodiment of the present invention, the cross sectional area of the aspiration lumen was about 7.1 mm², and yielded a tissue resection rate of about 1.4 gm/min, under vacuum of approximately 600 mm Hg.
• In general, procedures accomplished in accordance with the present invention will require no more than about 10 minutes, and preferably, no more than about 8 or 9 minutes of active morcellation. During that time, total fluid (e.g. saline) introduced into the uterus will generally be no greater than about 12 liters, and, preferably no greater than about 10 liters or 8 liters. Distension fluid will preferably be maintained at a low enough pressure and short enough time to keep the total saline intravasation below 2.5 liters.
• In a typical procedure in accordance with the present invention, utilizing a morcellator having an outside diameter of 3 mm, the fluid flow rate for aspiration of saline through the morcellator is approximately 260 ml/min (e.g. within the range of from about 240 to about 280 ml/min). Thus, in a ten minute procedure, approximately 2.6 liters of saline is aspirated through the morcellator. In that same procedure, the tissue resection rate is typically in excess of about 2 gm/min.
• In a comparative experiment, a device manufactured in accordance with the present invention was compared to the performance of a reciprocating hysteroscopic morcellator from Smith and Nephew. Over a series of experiments with the predicate device, the vacuum was maintained on average in the 200 to 270 mm Hg range, morcellator speed was approximately 1100 rpm, tissue resection rate was approximately 1.4 gm/min, the fluid flow rate through the morcellator was approximately 247 ml/min, and the outside diameter of the morcellator was 4.0 mm.
• The device constructed in accordance with the present invention was operated at a vacuum of 600 mm Hg, a speed of about 6000 rpm, to produce a resection rate of approximately 2.2 gm/min and an aspiration flow rate of about 266 ml/min through the morcellator. The outside diameter of the device was 3 mm.
• The morcellator in accordance with the present invention thus produced a significantly higher resection rate, through a smaller outside diameter morcellator, at a roughly comparable flow rate of aspirated saline. In order to increase the resection rate of the predicate device, the vacuum must be significantly increased. For example, when the vacuum pressure in the predicate system was increased to about 670 mm Hg, the tissue cutting improved to 3.5 gm/min but fluid flow rate jumped to 540 ml/min.
• One challenge with increased fluid flow rate which is responsive to increased vacuum is that the replacement fluid must be infused into the procedure site at an equal rate. In order to infuse fluid at a sufficient rate to allow the predicate device to function at a higher vacuum, the diameter of the already larger predicate morcellator must be increased. Applicants have determined that the use of the morcellator disclosed herein, with an outside diameter of no more than about 3 mm, in combination with the optic system, allows the dilatation of the cervix be limited to no more than about 5.5 mm. Increasing the diameter of the morcellator to accommodate the higher infusion rate as well as the already larger outside diameter of the predicate system is believed to cross the pain threshold and appears to impose the need or desirability for conducting the procedure under a general anesthetic. Applicants believe it to be a significant benefit for many patients to be able to avoid general anesthesia.
• Referring now toFIGS. 10(a) and10(b), there are shown fragmentary longitudinal section views of certain alternate inner tubular members that may be used intissue removal device6. A first such alternate inner tubular member is shown inFIG. 10(a) and is represented generally by reference numeral411. Inner tubular member411 may be similar in certain respects to innertubular member77; however, one notable difference between the two tubular members is that, whereas innertubular member77 may be a unitary structure made from a single piece of material, inner tubular member411 may be formed by joining together two separate pieces of material. More specifically, inner tubular member411 may comprise a first piece in the form of aproximal stem413 and a second piece in the form of adistal tip415, withdistal tip415 preferably having a length greater than the length ofresection window89 and more preferably having a length of less than about 2 inches and in one construction, about 1 inch.Proximal stem413 anddistal tip415 may be made of the same material or may be made of different materials. Comparatively hard stainless steel materials, such as 400-series stainless steels (e.g.,440C stainless steel) where hardness exceeds Rockwell C values of about 50, are preferred fordistal tip415 as these materials enable a much sharper edge todistal tip415 to be created. On the other hand, less hard stainless steel materials, such as 300-series stainless steels (e.g.,304 stainless steel), may be preferred forproximal stem413 as these materials may be comparatively inexpensively formed into long tubular structures, for example, by extrusion whereas harder stainless steel materials must be machined to form tubular structures. The Rockwell C hardness of these proximal tube materials is less than about 40.Proximal stem413 anddistal tip415 may be joined together by welding or other suitable techniques. Any of a variety of cutter edge and window configurations may be used, depending upon the desired performance, including any of those disclosed in U.S. patent application Ser. No. 12/098,250, filed Apr. 4, 2008 to Gruber, et al., the disclosure of which is hereby incorporated by reference in its entirety herein.
• Another notable difference between tubular member411 andtubular member77 is that, whereastubular member77 may have a uniform inner diameter over its length, the inner diameter ofdistal tip415 may be reduced as compared to the inner diameter of proximal stem413 (e.g., 0.082 inch vs. 0.085 inch). Applicants believe that this increase in inner diameter fromdistal tip415 toproximal stem413 may result in a reduction in the incidence of clogging in tubular member411 as the cut specimen, which has an outer diameter similar todistal tip415, moves fromdistal tip415 intoproximal stem413, which has a greater diameter than the cut specimen. This clearance withinproximal stem413 facilitates the proximal movement of the specimen through tubular member411.
• A second alternate inner tubular member is shown inFIG. 10(b) and is represented generally byreference numeral421.Tubular member421 may be similar in certain respects to tubular member411, the principal difference between the two tubular members being thattubular member421 may be a unitary structure made from a single piece of material, which may be, for example, a 17-7-series stainless steel. To formtubular member421 from a tubular structure having a uniform inner diameter, one may first swage or roll the distal end of the tubular structure to reduce the inner diameter of the distal end and then may increase the inner diameter of the remainder of the structure by mechanically honing, expanding, or chemically etching.
• Referring now toFIG. 11, there is shown a side view of analternate indicator sleeve431 that may be used intissue removal device6.Indicator sleeve431 may be similar in most respects toindicator sleeve98, the principal difference between the two indicator sleeves being thatsleeve431 may be provided with labeled orunlabeled gradations433 along its length to indicate the distance between each gradation and a distal end431-1 ofsleeve431. Becausesleeve431 is preferably dimensioned and positioned so that distal end431-1 ofsleeve431 indicates whendistal end92 ofdevice6 is aligned with the distal end ofintroducer7,gradations433 indicate the relative distance betweendistal end92 ofdevice6 and the distal end ofintroducer7.Gradations433 may comprise, for example, numerical markings, symbols, hash marks, rings, or the like.
• Referring now toFIG. 12, there is shown a fragmentary side view, partly in section, of an alternate combination of a tissue removal device and an introducer that may be used intissue removal system5, the subject tissue removal device being represented generally byreference numeral441 and the subject introducer being represented generally byreference numeral443.
• Device441 andintroducer443 may be similar in most respects todevice6 andintroducer7, respectively, the principal differences being thatdevice441 may include, instead ofsleeve98, aposition indicator ring445 fixedly mounted onstrain relief member74, andintroducer443 may include, instead ofproximal portion203 ofbody201, aproximal portion447 appropriately shaped to provide just enough interference with bumps445-1 and445-2 onring445 so that a user may be given a tactile indication that ring445 is being inserted intoproximal portion447.
• Referring now toFIGS. 13(a) and13(b), there are shown fragmentary side views, partly in section, of another alternate combination of a tissue removal device and an introducer that may be used intissue removal system5, the subject tissue removal device being represented generally byreference numeral451 and the subject introducer being represented generally byreference numeral453.
• Device451 may be identical todevice441.Introducer453 may be similar in most respects tointroducer7, the principal difference between the two introducers being thatintroducer453 may be shaped to include asound chamber455 and may additionally include a spring clip orband457.Clip457 may have a fixed end457-1 that is mounted withinsound chamber455 and a free end457-2 that is constructed so as to be deflected byring445 whenring445 is moved distally pastclip457. The deflection ofclip457 byring445 causes clip457 to oscillate and to generate an audible signal.
• Referring now toFIG. 14, there is shown a fragmentary side view, partly in section, of an alternate tissue removal device that may be used intissue removal system5, said tissue removal device being represented generally byreference numeral470. Certain aspects ofdevice470 not important to an understanding of the invention are neither shown nor described herein.
• Device470 may be similar in most respects todevice6, the principal differences between the two devices being that, whereasdevice6 may comprise a rotational mechanism comprising aspur gear51 engaged with a gear-shaped distal portion72-2 of ashaft72,device470 instead may comprise a rotational mechanism comprising ashaft472 comprising a tubular elastomeric distal portion472-2 engaged for rotation with an elastomeric O-ring474 fixedly mounted within agroove476 of acylindrical member478 fixedly coupled totranslation drive shaft35.
• Referring now toFIGS. 15(a) and15(b), there are shown fragmentary perspective and exploded perspective views, respectively, of another alternate tissue removal device that may be used intissue removal system5, said tissue removal device being represented generally byreference numeral500. Certain aspects ofdevice500 not important to an understanding of the invention are neither shown nor described herein.
• Device500 may be similar in many respects todevice6, one difference between the respective tissue removal devices being thatdevice500 may comprise a mountingbracket501.Bracket501, which may be a unitary structure made of a rigid metal or polymer, may be shaped to include abase portion503, aproximal block505 extending upwardly from the proximal end ofbase portion503, adistal block507 extending upwardly from the distal end ofbase portion503, and anintermediate block509 extending upwardly from an intermediate portion ofbase portion503.
• Another difference betweendevice500 anddevice6 is that, whereasdevice6 may comprise aninternal drive shaft21, atranslation drive shaft35, and agear assembly50,device500 may instead comprise aninternal drive shaft510, atranslation drive shaft511, and agear assembly512.Internal drive shaft510, which may be an elongated unitary structure made of a suitably rigid metal or polymer, may be shaped to include aproximal end513 and adistal end515.Proximal end513 ofshaft510 may be coaxially mounted over and fixed to the distal end ofexternal drive shaft29. In this manner, the rotation ofshaft510 may be mechanically coupled to the rotation ofshaft29. An intermediate portion ofshaft510 may be received within alongitudinal bore520 provided inblock505 ofbracket501.Gear assembly512 may be fixedly mounted ondistal end515 ofshaft510 so as to rotate withshaft510.Gear assembly512 may include a larger diameterproximal spur gear523 and a smaller diameterdistal spur gear525.Translation drive shaft511, which may be an elongated unitary structure made of a suitably rigid metal or polymer, may be shaped to include aproximal end537, anintermediate portion539, and a distal end541.Proximal end537 ofshaft511 may be in the shape of a spur gear, which may be engaged withdistal gear525. In this manner, the rotation ofshaft511 may be mechanically coupled to the rotation ofshaft510, with the speed of rotation ofshaft511 being dependent on the speed of rotation ofshaft510 and the relative sizes ofgear525 andproximal end537.Intermediate portion539 may extend through a longitudinal bore509-1 provided inblock509 ofbracket501.Intermediate portion539 may be shaped to include a doublehelical portion540 similar to the double helical portion ofshaft35. Distal end541 ofshaft511 may be appropriately dimensioned to be received within anopening544 provided inblock507 ofbracket501. It should be noted that, althoughshaft511 is adapted for rotation,shaft511 is translationally stationary.
• Another difference betweendevice500 anddevice6 is that, whereasdevice6 may comprise ashaft72 mechanically coupled to innertubular member77 so as to rotate and to oscillate translationally therewith,device500 may instead comprise anelongated shaft551 mechanically coupled to innertubular member77 so as to rotate and to oscillate translationally therewith.Shaft551, which may be a unitary tubular structure made of a rigid metal or polymer, may be shaped to include a spur gear engaged withproximal gear523. The gear may be elongated so that it may maintain engagement withproximal gear523 even as the gear moves translationally relative toproximal gear523. The speed at whichshaft551 rotates may be the same as or different than the speed at whichgear523 rotates, depending, for example, on the relative diameters of the two gears (the ratio of the rotational speeds of the two gears being inversely proportional to the ratio of the diameters of the two gears). Consequently, by appropriately dimensioning the gears, one can achieve a desired rotational speed, even where the rotational speed of the external drive shaft is fixed. For example, in the embodiment shown, the gear ofshaft551 may have a diameter that is one-third the diameter ofgear523 and, therefore, rotates three times as fast asgear523. At the same time,proximal end537 ofshaft511 may have a diameter that is four-thirds the diameter ofgear525 and, therefore, rotates three-quarters as fast asgear525. Therefore, if the external drive shaft has a speed of rotation of about 2000 rpm, shaft551 (and inner tubular member77) would rotate at about 6000 rpm andshaft511 would rotate at about 1500 rpm, which, with an appropriate shaping of the double helix portion ofshaft511, could be used to achieve an oscillating translational speed for innertubular member77 of about 2.8 cycles/second.
• Referring now toFIG. 16, there is shown a fragmentary side view of an alternate tissue removal device that may be used intissue removal system5, said tissue removal device being represented generally byreference numeral570. Certain aspects ofdevice570 not important to an understanding of the invention are neither shown nor described herein.
• Device570 may be similar in many respects todevice6. One difference between the two devices may be that, whereasdevice6 may fixinner drive shaft21 toexternal drive shaft29 for rotation therewith and may couple the rotation of innertubular member77 toinner drive shaft21 through the engagement ofshaft72 andgear51,device570 may instead fix innertubular member77 toexternal drive shaft29 for rotation therewith and may couple the rotation ofinner drive shaft21 to innertubular member77 through the engagement of a pair of spur gears572 and574.Gear572 may be coaxially inserted over and fixed to innertubular member77, andgear574 may be coaxially inserted over and fixed toinner drive shaft21.Gears572 and574 may be sized to be, for example, in a 1:4 ratio, respectively, so that, ifexternal drive shaft29 rotates at about 6000 rpm,inner tubular member77 also rotates at about 6000 rpm whereasinner drive shaft21 rotates at about 1500 rpm.
• Referring now toFIG. 17, there is shown a fragmentary side view of an alternate tissue removal device that may be used intissue removal system5, said tissue removal device being represented generally byreference numeral580. Certain aspects ofdevice580 not important to an understanding of the invention are neither shown nor described herein.
• Device580 may be similar in many respects todevice6. One difference between the two devices may be that, whereasdevice6 may fixinner drive shaft21 toexternal drive shaft29 for rotation therewith and may couple the rotation of innertubular member77 toinner drive shaft21 through the engagement ofshaft72 andgear51,device580 instead may couple the rotation ofinner drive shaft21 toexternal drive shaft29 through the engagement of a pair of spur gears582 and584 and may couple the rotation of innertubular member77 toexternal drive shaft29 through the engagement of aspur gear586 withgear582.Gear582 may be coaxially inserted over and fixed toexternal drive shaft29,gear584 may be coaxially inserted over and fixed toinner drive shaft21, andgear586 may be coaxially inserted over and fixed to innertubular member77.Gears582 and584 may be sized to be, for example, in a 1:2 ratio, respectively, and gears582 and586 may be sized to be, for example, in a 2:1 ratio, respectively. In this manner, ifexternal drive shaft29 rotates at about 3000 rpm,inner tubular member77 rotates at about 6000 rpm andinner drive shaft21 rotates at about 1500 rpm.
• Referring now toFIG. 18, there is shown a fragmentary perspective view of an alternate tissue removal device that may be used intissue removal system5, said tissue removal device being represented generally byreference numeral600. Certain aspects ofdevice600 not important to an understanding of the invention are neither shown nor described herein.
• Device600 may be similar in many respects todevice6. One difference between the two devices may be their respective mechanisms for rotating and translationally reciprocatinginner tubular member77. More specifically,device600 may comprise aninternal drive shaft603 fixed to an external drive shaft (not shown) so as to rotate therewith.Internal drive shaft603 may comprise aproximal portion605 and adistal portion607. Aspur gear609 and abevel gear611 may be coaxially mounted overdistal portion607 and fixed thereto for rotation therewith, withbevel gear611 being positioned distally relative tospur gear609. Aspur gear613 may be coaxially mounted over innertubular member77 and fixed thereto for rotation therewith,gear613 being engaged withgear609 so that the rotation ofinternal drive shaft603 causes the rotation of innertubular member77. (The speed of rotation of innertubular member77, as compared to that ofdrive shaft603, may be controlled by the relative diameters ofgears609 and613). Abevel gear615, positioned distally relative tointernal drive shaft603, may be engaged withbevel gear611. Asaddle619 may be coaxially mounted over innertubular member77,saddle619 being fixed to innertubular member77 for translational movement therewith but permittingtubular member77 to freely rotate therewithin.Saddle619 andbevel gear615 may be coupled to one another by a pin (not shown) extending upwardly from thetop surface621 ofgear615 and a slot (not shown) provided on the bottom surface ofsaddle619, the slot insaddle619 receiving the pin onbevel gear615. The slot insaddle619 may be oriented perpendicularly to the longitudinal axis of innertubular member77 and may be appropriately dimensioned so that the pin onbevel gear615 travels back and forth within the slot insaddle619 asbevel gear615 rotates. In this manner, the rotation ofbevel gear615 may cause the translational oscillation of innertubular member77.
• Referring now toFIG. 19, there is shown a fragmentary perspective view of an alternate tissue removal device that may be used intissue removal system5, said tissue removal device being represented generally byreference numeral700. Certain aspects ofdevice700 not important to an understanding of the invention are neither shown nor described herein.
• Device700 may be similar in many respects todevice6. One difference between the two devices may be their respective mechanisms for rotating and translationally reciprocatinginner tubular member77. More specifically,device700 may comprise aninternal drive shaft703 fixed to an external drive shaft (not shown) so as to rotate therewith. Aspur gear705 and atranslation cam707 may be coaxially mounted overdrive shaft703 and fixed thereto for rotation therewith, withtranslation cam707 being positioned distally relative tospur gear705. Aspur gear711 may be coaxially mounted over innertubular member77 and fixed thereto for rotation therewith,gear711 being engaged withgear705 so that the rotation ofinternal drive shaft703 causes the rotation of innertubular member77. (The speed of rotation of innertubular member77, as compared to that ofdrive shaft703, may be controlled by the relative diameters ofgears705 and711). Asaddle713 may be coaxially mounted over innertubular member77,saddle713 being fixed to innertubular member77 for translational movement therewith but permittingtubular member77 to freely rotate therewithin.Saddle713 andtranslation cam707 may be coupled to one another by a pin (not shown) extending downwardly fromsaddle713 and a loopedgroove717 provided incam707, groove717 receiving the pin onsaddle713. Groove717 incam707 may be shaped to extend from about the proximal end707-1 ofcam707 to about the distal end707-2 ofcam707 and back to about the proximal end707-1 ofcam707 over the course of one rotation ofcam707. In this manner, ascam707 rotates and the pin travels back and forth withingroove717,inner tubular member77 may be translationally oscillated correspondingly.
• Referring now toFIG. 20, there is shown a fragmentary perspective view of an alternate tissue removal device that may be used intissue removal system5, said tissue removal device being represented generally byreference numeral800. Certain aspects ofdevice800 not important to an understanding of the invention are neither shown nor described herein.
• Device800 may be similar in many respects todevice6. One difference between the two devices may be their respective mechanisms for rotating and translationally reciprocatinginner tubular member77. More specifically,device800 may comprise aninternal drive shaft801 fixed to an external drive shaft (not shown) so as to rotate therewith. Aspur gear803 may be coaxially mounted overdrive shaft801 and fixed thereto for rotation therewith. In addition, atranslation cam805 may be coaxially mounted overdrive shaft801 and fixed thereto for rotation therewith.Translation cam805 may comprise a tubular portion805-1 and a disc portion805-2, disc portion805-2 being fixedly mounted on tubular portion805-1 at a non-perpendicular angle relative to the longitudinal axis of tubular portion805-2. Aspur gear813 may be coaxially mounted over innertubular member77 and fixed thereto for rotation therewith,gear813 being engaged withgear803 so that the rotation ofinternal drive shaft801 causes the rotation of innertubular member77. (The speed of rotation of innertubular member77, as compared to that ofdrive shaft801, may be controlled by the relative diameters ofgears803 and813). Asaddle819 may be coaxially mounted over innertubular member77,saddle819 being fixed to innertubular member77 for translational movement therewith but permittingtubular member77 to freely rotate therewithin.Saddle819 may be shaped to include arecess821, which may receive the top of disc portion805-2. In this manner, asdrive shaft801 rotates, causing disc portion805-2 to “wobble” back and forth,saddle819, and thus innertubular member77, may be translationally oscillated correspondingly.
• Referring now toFIG. 21, there is shown a fragmentary perspective view of an alternate tissue removal device that may be used intissue removal system5, said tissue removal device being represented generally byreference numeral900. Certain aspects ofdevice900 not important to an understanding of the invention are neither shown nor described herein.
• Device900 may be similar in many respects todevice6. One difference between the two devices may be their respective mechanisms for rotating and translationally reciprocatinginner tubular member77. More specifically,device900 may comprise aninternal drive shaft901 fixed to an external drive shaft (not shown) so as to rotate therewith. Aspur gear903 and aworm gear905 may be coaxially mounted overdrive shaft901 and fixed thereto for rotation therewith. Aspur gear907 may be coaxially mounted over innertubular member77 and fixed thereto for rotation therewith,gear907 being engaged withgear903 so that the rotation ofinternal drive shaft901 causes the rotation of innertubular member77. (The speed of rotation of innertubular member77, as compared to that ofdrive shaft901, may be controlled by the relative diameters ofgears903 and907). Aworm gear911 may be engaged withworm gear905 so thatworm gear911 rotates asworm gear905 rotates. Apin913 may be mounted near the periphery of a front face911-1 ofworm gear911. Areciprocation arm915 may have a first end secured to pin913 and a second end secured to ablock917 translationally coupled to innertubular member77. In this manner, asworm gear911 rotates and the position ofpin913 onworm gear911 changes,arm915 moves block917 and innertubular member77 back and forth translationally.
• As can be appreciated, one would like to minimize the amount of distension fluid that flows from the uterus of the patient through the tissue removal device when the tissue removal device is left in the patient but the cutting motor for the tissue removal device has temporarily been turned off, e.g., during those periods when the operator of the tissue removal device stops cutting to examine the patient. Such a loss of distension fluid is undesirable for at least the reason that the lost distension fluid will need to be replenished in order to keep the uterus distended. Indevice6, this problem may be addressed through electronics by sensing when the motor fordevice6 is about to be turned off and, in those instances, by positioninginner tubular member77 translationally relative to outertubular member76 so thatresection window89 is closed. An alternate approach to this problem is exemplified bytissue removal device940, which is shown inFIGS. 22(a) through22(e). Certain aspects ofdevice940 not important to an understanding of the invention are neither shown nor described herein.
• Device940 is similar in certain respects todevice6. However, one difference between the respective devices is thatdevice940 may comprise an innertubular member943 having a closedproximal end945 and aside window947. Aspring mount949 may be coaxially mounted over innertubular member943 and fixed thereto for rotation therewith. The proximal end of aspring951 may be fixed tospring mount949, and the distal end ofspring951 may be fixed to avalve member953 coaxially mounted over innertubular member943,valve member953 being capable of rotating relative to innertubular member943.Valve member953 may include a side window955. Side window955 may be alignable withside window943 depending on the respective rotational positions of innertubular member943 andvalve member953. Astop957 may be formed on innertubular member943, stop957 being detachably engageable withvalve member953 to couple the rotation ofvalve member953 with innertubular member943. Avacuum housing959 may be coaxially mounted overvalve member953,valve member953 being freely rotatable withinvacuum housing959. Outertubular member76 may be fixedly mounted onvacuum housing959. A pair of O-rings961-1 and961-2 may be provided to function as seals.
• Prior to the cutting motor ofdevice940 being actuated, side window955 ofvalve member953 andside window947 of innertubular member943 are 90 degrees out of register with one another. However, once the cutting motor ofdevice940 is actuated, innertubular member943 begins to rotate. This causesspring951 to try to unwind, thereby causingvalve member953 to rotate so that side window955 ofvalve member953 is aligned withside window947 of innertubular member943. Withvalve member953 thus rotationally aligned with innertubular member943, stop957 prevents further rotation ofvalve member953 relative to innertubular member943. When the cutting motor ofdevice940 is then turned off,spring951 causesvalve member953 to be rotated back to its original orientation relative to innertubular member943.
• As noted above,introducer7 preferably comprisesvalve233, which is designed to keep fluid from escaping from the patient whendevice6 is not inserted intointroducer7. However, there may be situations in which it is desirable to simultaneously have fluid flowing into and out of the patient without havingdevice6 inserted intointroducer7. Therefore, referring now toFIG. 23, there is shown a fragmentary section view of anobturator965 positioned within a channel ofintroducer7.Obturator965 may be shaped to include a bluntdistal end967 and a plurality ofopenings969 leading to a longitudinally-extendingchannel971.Obturator965 may be positioned ininstrument channel196, as shown, or may be positioned in fluid input channel198-1 or fluid input channel198-2 to provide bidirectional fluid flow (for example, with fluid inflow exiting channels198-1 or198-2 in the space between channels198-1 or198-2 andobturator965 and with fluidoutflow entering obturator965 through openings969). The fluidoutflow entering channel971 throughopenings969 may exitobturator965 through the proximal end (not shown) ofobturator965.
• Analternate obturator972 is shown inFIG. 24,obturator972 having a side opening973 at an intermediate location along its length, side opening973 being aligned with anoutflow fluid channel975 provided in analternate introducer977. If desired,obturator972 may be made of a resilient member having a bend andintroducer977 may be provided with asheath978 made of a flexible material. In this manner,obturator972 may be used to provide a bend tosheath978, which, by rotating theproximal end979 ofobturator972, may be used to steer the distal end ofsheath978.
• Referring now toFIGS. 25(a) and25(b), there is shown an alternate combination of an obturator and an introducer according to the present invention, the obturator being represented generally byreference numeral980 and the introducer being represented generally byreference numeral981.
• Obturator980, which may be similar in many respects toobturator965, may comprise adistal member982 and aproximal member983.Distal member982 may be tubular and may comprise an opendistal end984, a closedproximal end985, and aside opening986, withproximal member983 being mounted overproximal end985 ofdistal member982.
• Introducer981 may be similar in many respects tointroducer7, one difference between the respective introducers being thatintroducer981 may additionally comprise afluid outflow channel987.Channel987 may comprise a distal end987-1 that may be aligned with side opening986 ofobturator980 whenobturator980 is installed inintroducer981. In this manner, outflow fluid may flow fromobturator980 to channel987 and may exitintroducer981 through a proximal end987-2 ofchannel987.Introducer981 may additionally comprise a valve988-1 and a valve989-2. Valve988-1, which may be a stopcock valve, may be used to control the flow of fluid throughchannel987. Valve988-2, which may be a stopcock valve, may be used to control the flow of fluid throughinflow channel989.
• Referring now toFIGS. 26(a) through26(c), there are shown various views of an alternate introducer device tointroducer device7, the alternate introducer device being represented generally byreference numeral990.
• Introducer device990 may be similar in many respects tointroducer device7. One difference betweenintroducer device990 andintroducer device7 may be that, whereasintroducer device7 may comprise asheath191 having atop lumen196, abottom lumen197 and a pair of side lumens198-1 and198-2,introducer device990 may comprise a toptubular member991, abottom tubular member992, asleeve993, and adistal cap994. Toptubular member991 may be used, for example, as an instrument channel to receive, for example,tissue removal device6 orobturator965. Bottomtubular member992 may be used, as is shown, for example, to receivedistal end319 ofhysteroscope8.Sleeve993, which may be made of stainless steel or the like, may be appropriately dimensioned to coaxially receive toptubular member991 and bottomtubular member992 and may be shaped to define a pair offluid channels995 on opposite sides oftubular members991 and992 in the spaces between the inner surface ofsleeve993 and the outer surfaces oftubular members991 and992. A plurality oftransverse openings996 may be provided insleeve993 near thedistal end997 thereof,openings996 providing side access tofluid channels995. In this manner, fluid inflow to the patient may be provided by having the fluid pass distally throughchannels995 and then exit radially throughopenings996. Fluid outflow from the patient may travel proximally throughcap994 and then proximally through top tubular member991 (for example, by passing through an instrument positioned in top tubular member991). It is believed that the fluid flow pattern provided byintroducer device990 may be particularly effective in removing blood and other undesired fluids from a patient.Cap994 may include aretainer998, which may receive the distal ends oftubular members991 and992 and which may be inserted into and fixed to thedistal end997 ofsleeve993.
• Referring now toFIG. 27, there is shown a partially exploded perspective view of a second embodiment of a tissue removal system, the tissue removal system being constructed according to the teachings of the present invention and being represented generally byreference numeral1007.
• System1007 may comprise atissue removal device1008, avacuum assembly1009, and a motor drive assembly1010. Although not shown in the present embodiment,system1007 may also include an introducer device, a flexible hysteroscope, and a fluid supply similar to those ofsystem5 described above.
• Tissue removal device1008 may comprise amorcellator assembly1013 and adrive assembly1015,morcellator assembly1013 being removably mounted ondrive assembly1015 in the manner described further below.
• Referring now toFIGS. 28(a) through28(d),morcellator assembly1013 may be seen in greater detail.Morcellator assembly1013 may comprise ahousing1021.Housing1021, which may be an elongated unitary structure made of a rigid polymer or metal, may be a generally tubular member shaped to include aproximal end1023, adistal end1025, and aside wall1027.Side wall1027 may be generally cylindrical, with aportion1028 of its bottom surface being beveled. Alongitudinal lumen1029 may extend fromproximal end1023 todistal end1025. Anintermediate portion1031 oflumen1029 may be expanded in diameter and may be accessible through anopening1033 inside wall1027. Aproximal portion1035 oflumen1029 extending distally fromproximal end1023 to a point spaced proximally fromintermediate portion1031 may be expanded in diameter and may be internally threaded.
• Morcellator assembly1013 may additionally comprise a pair oftubular bushings1041 and1043.Bushing1041, which may be a unitary structure made of a rigid polymer or metal, may be seated withinintermediate portion1031 oflumen1029, near its proximal end, and may be fixedly secured tohousing1021 withscrews1042.Bushing1043, which may be a unitary structure made of a rigid polymer or metal, may be seated withinintermediate portion1031 oflumen1029, near its distal end, and may be fixedly secured tohousing1021 withscrews1044. Bushing1041 may be shaped to include abore1045, andbushing1043 may be shaped to include abore1047, bores1045 and1047 being coaxially aligned withlumen1029 ofhousing1021.
• Morcellator assembly1013 may further comprise anelongated shaft1051.Shaft1051, which may be a unitary structure made of brass or another suitable rigid metal or polymer, may be shaped to include aproximal portion1053, adistal portion1055, anintermediate portion1057, and alongitudinal bore1059.Proximal portion1053 ofshaft1051 may be slidably mounted inbore1045 ofbushing1041 and may be sized to freely rotate therewithin.Distal portion1055 ofshaft1051 may be slidably mounted inbore1047 ofbushing1043 and may be sized to freely rotate therewithin.Intermediate portion1057 ofshaft1051 may be positioned betweenbushings1041 and1043 and may be in the shape of a gear having an enlarged external diameter relative toproximal portion1053 anddistal portion1055.
• Morcellator assembly1013 may further comprise atranslational coupling block1061.Block1061, which may be a unitary structure made of a rigid polymer or metal, may be a tubular member shaped to include aproximal end1063, adistal end1064, aside wall1065, and alongitudinal bore1066.Block1061 may be coaxially mounted overproximal portion1053 ofshaft1051, withbore1066 being sized relative toproximal portion1053 so thatproximal portion1053 may freely rotate withinbore1066.Side wall1065 ofblock1061 may be shaped to correspond generally to the shape ofintermediate portion1031 oflumen1029. In this manner, block1061 may be kept rotationally stationary withinhousing1021.Block1061 may be translationally fixed relative toshaft1051 with aretaining ring1067 inserted coaxially overproximal portion1053 and secured toproximal portion1053 with aset screw1068. Awasher1069 may be inserted coaxially overproximal end1053 ofshaft1051 betweendistal end1063 ofblock1061 andintermediate portion1057 ofshaft1051 to prevent any wear caused by contact betweenintermediate portion1057 againstdistal end1063 ofblock1061 asintermediate portion1057 rotates.Side wall1065 ofblock1061 may further be shaped to include awaist1070 of reduced external diameter. In this manner, withblock1061 coaxially mounted overproximal portion1053 ofshaft1051, a pair of slots1071-1 and1071-2 may be formed betweenblock1061 andhousing1021.
• Morcellator assembly1013 may further comprise astrain relief member1072.Strain relief member1072, which may be a unitary structure made of a rigid polymer or metal, may be a tubular member shaped to include aproximal portion1073 and adistal portion1074.Proximal portion1073 may be slightly greater in diameter thandistal portion1074 and may include abifurcating slot1075.Proximal portion1073 ofstrain relief member1072 may be disposed within the distal portion oflumen1029, withdistal portion1074 ofstrain relief member1072 extending distally fromdistal end1025 ofhousing1021 for a short distance, such as, for example, approximately 2 inches.
• Morcellator assembly1013 may further comprise a cutting mechanism. In the present embodiment, the cutting mechanism may comprise anouter tubular member1076 and aninner tubular member1077,inner tubular member1077 moving rotationally and, at the same time, oscillating translationally relative toouter tubular member1076 in the manner to be described further below.Outer tubular member1076, which may be a unitary structure made of stainless steel or another similarly suitable material, may be shaped to include an openproximal end1079, a closeddistal end1081, and alumen1083 extending from openproximal end1079 to a point just prior to closeddistal end1081.Member1076 may be coaxially mounted withinstrain relief member1072, withproximal end1079 ofmember1076 disposed withinproximal portion1073 ofstrain relief member1072 and withdistal end1081 ofmember1076 extending distally beyonddistal portion1074 ofstrain relief member1072 for an extended distance, such as, for example, five inches. The combination ofproximal end1079 ofmember1076 andproximal portion1073 ofstrain relief member1072 may be securely retained inhousing1021 using ascrew1085 inserted through anopening1087 inhousing1021,screw1085 pressingproximal portion1073 ofstrain relief member1072 tightly againstproximal end1079 ofmember1076.
• Outer tubular member1076 may be further shaped to include aresection window1089 into which tissue may be captured and drawn,window1089 being located proximate todistal end1081, such as, for example, 0.25 inch fromdistal end1081.Window1089 may be shaped to include a proximal end1089-1 and a distal end1089-2. Proximal end1089-1 may slope gradually proximally, and distal end1089-2 may slope gradually distally. More specifically,window1089 may have a length of approximately 0.55 inch, proximal end1089-1 may be a radial end having a radius of curvature of, for example, 0.085 inch, and distal end1089-2 may be a radial end having a radius of curvature of, for example, 0.150 inch.Window1089 may extend over a substantial portion of the circumference oftubular member1076, such as, for example, about 60% of the circumference.
• Outer tubular member1076 may have an outer diameter less than about 5.5 mm. However, in order to reduce the risk of injury to the patient and in order to obviate the need for anesthesia to be administered to the patient,outer tubular member1076 preferably has an outer diameter less than about 5 mm, more preferably less than 4 mm, even more preferably less than 3 mm, and still even more preferably less than 2 mm.
• Inner tubular member1077, which may be an elongated unitary structure made of stainless steel or another similarly suitable material, may be shaped to include aproximal end1091, adistal end1092, and alongitudinal lumen1093.Distal end1092 may be shaped to include an external bevel, such as, for example, an external bevel of approximately 20 degrees. An intermediate portion oftubular member1077 may be received withinbore1059 ofshaft1051 and may be fixedly coupled toshaft1051 for translational and rotational movement therewith using a retaining ring1094-1, a slotted sleeve1094-2 and a pair ofset screws1095. The proximal portion of ring1094-1 may be screwed onto the distal end ofshaft1051, with the distal portion of ring1094-1 extending overmember1077. Sleeve1094-2 may be inserted coaxially betweenmember1077 and ring1094-1, and setscrews1095 may be inserted through a transverse opening1096 in retaining ring1094-1 to couple ring1094-1 and sleeve1094-2 tomember1077.Tubular member1077 may have a suitable length so that, whentubular member1077 is in a fully retracted (i.e., proximal) position,proximal end1091 oftubular member1077 may extend proximally a short distance fromproximal end1023 ofhousing1021 anddistal end1092 oftubular member1077 may be withdrawn sufficiently to permit tissue to enterwindow1089. At the same time,tubular member1077 may have a length so that, whentubular member1077 is in a fully advanced (i.e., distal) position,distal end1092 oftubular member1077 may be positioned distally of distal end1089-2 ofwindow1089.
• Morcellator assembly1013 may further comprise a fitting1097. Fitting1097, which may be a unitary structure made of a rigid polymer or metal, may be a tubular member shaped to include aproximal portion1098, adistal portion1099 and alongitudinal lumen1100.Proximal portion1098, which may be barbed, may be coupled through a length of tubing tovacuum assembly1009.Distal portion1099 of fitting1097 may be externally threaded for mating engagement withproximal portion1035 ofhousing1021.Lumen1100 of fitting1097 may be dimensioned to slidably receiveproximal end1091 oftubular member1077. An O-ring1101 may be disposed withinlumen1100 to provide a seal aroundtubular member1077.
• Referring now toFIGS. 29(a) and29(b),drive assembly1015 may be seen in greater detail.Drive assembly1015 may include amain body1105.Main body1105, which may be a unitary structure made of a rigid polymer or metal, may be a generally trough-shaped member shaped to include adistal end1107, aproximal end1109, and aside wall1111.Distal end1107 may be generally circular and may include a distal surface that includes a central portion1115 and a peripheral portion1117. Central portion1115 may be recessed relative to peripheral portion1117. A centraltransverse opening1119 may be provided in central portion1115, and a pair of smallertransverse openings1120 may be provided in central portion1115 on opposite sides ofcentral opening1119.Proximal end1109 may be generally circular and may include a proximal surface that includes a central portion1123 and aperipheral portion1125. Central portion1123 may be recessed relative toperipheral portion1125. A centraltransverse opening1127 may be provided in central portion1123, and a pair of smaller transverse openings1129 may be provided in central portion1123 on opposite sides ofcentral opening1127.Side wall1111 may extend fromdistal end1107 toproximal end1109 but only over about the top half of their respective circumferences. Alongitudinal groove1131 may be provided along the outer surface ofside wall1111 to receive a corresponding portion ofhousing1021 ofmorcellator assembly1013.Groove1131 may include a firsttransverse slot1133 extending thoughside wall1111 and a secondtransverse slot1135 extending throughside wall1111. Firsttransverse slot1133 may be spaced a short distance fromdistal end1107 and may be oriented generally circumferentially relative toside wall1111. Secondtransverse slot1135 may be spaced a short distance fromproximal end1109 and from firsttransverse slot1133 and may be oriented generally longitudinally relative toside wall1111. The inner surface ofside wall1111 may additionally be shaped to include a block1141 located between firsttransverse slot1133 and secondtransverse slot1135. Block1141 may be shaped to include anexterior groove1143 on its bottom surface,groove1143 extending parallel to secondtransverse slot1135. Abracket1145, which may be a unitary structure made of a rigid polymer or metal, may be secured to the bottom surface of block1141 with a pair ofscrews1146.Bracket1145 may be shaped to include agroove1147 on its top surface that is complementarily shaped to groove1143, withgrooves1143 and1147 jointly defining a channel of generally cylindrical shape.
• Drive assembly1015 may additionally comprise a mechanism for driving rotational movement ofinner tubular member1077. Such a mechanism may comprise a first motor1151. Motor1151, in turn, may comprise afirst end1152 having ashaft1153 extending therefrom.First end1152 may be received within central portion1115 ofdistal end1107 ofbody1105 and may be secured thereto withscrews1156 inserted throughopenings1120 and intocomplementary openings1157 infirst end1152 of motor1151. With motor1151 thus secured todistal end1107,shaft1153 may extend through centraltransverse opening1119 and may freely rotate therewithin. Cables1159 may be used to connect motor1151 to control unit1010.
• In addition, the aforementioned mechanism for driving rotational movement ofinner tubular member1077 may further comprise acoupling block1161 and agear1162.Coupling block1161, which may be a unitary structure made of a rigid polymer or metal, may be shaped to include adistal base1163 and a proximal post, the proximal post extending proximally frombase1163.Base1163 may be shaped to include acavity1164 accessible from its distal end into whichshaft1153 of motor1151 may be received and secured with ascrew1165, thereby mechanically couplingshaft1153 to block1161. The proximal post may be shaped to include a distal portion1166 of increased diameter and aproximal portion1167 of decreased diameter.Gear1162, which may be a unitary member made of a rigid polymer or metal, may be shaped to include adistal tube1168 and a proximaltoothed wheel1169.Tube1168 may be coaxially mounted on portion1166 ofblock1161 and mechanically coupled thereto with a screw1170.Wheel1169 may be positioned so that a portion ofwheel1169 extends throughslot1133 for engagement withintermediate portion1057 ofshaft1051. In this manner, rotation ofwheel1169 causes the rotation ofshaft1051.Proximal portion1167 ofpost1165, which may extend proximally a short distance beyondwheel1169, may be seated within abearing1173, bearing1173 being seated within the distal end of the channel jointly defined by block1141 andbracket1145.
• Drive assembly1015 may further comprise a mechanism for driving oscillating translational movement ofinner tubular member1077. Such a mechanism may comprise asecond motor1181.Motor1181, in turn, may comprise afirst end1182 having ashaft1183 extending therefrom.First end1182 may be received within central portion1123 ofproximal end1109 ofbody1105 and may be secured thereto with screws1186 inserted through openings1129 and intocomplementary openings1187 infirst end1182 ofmotor1181. Withmotor1181 thus secured toproximal end1109,shaft1183 may extend through centraltransverse opening1127 and may freely rotate therewithin. Acable1189 may be used to connectmotor1181 to control unit1010.
• In addition, the aforementioned mechanism for driving oscillating translational movement ofinner tubular member1077 may further comprise acoupling block1191, a threadedbolt1192, and acarriage1193.Coupling block1191, which may be a unitary structure made of a rigid polymer or metal, may be shaped to include aproximal opening1194 and adistal opening1195.Proximal opening1194 may be dimensioned to securely receiveshaft1183 ofmotor1181, thereby mechanically couplingshaft1183 to block1191.Distal opening1195 may be dimensioned to securely receive the proximal end of threadedbolt1192, thereby mechanically couplingbolt1192 to block1191. The distal end ofbolt1192 may be seated within abearing1196, which, in turn, may be seated within the proximal end of the channel jointly defined by block1141 andbracket1145.Carriage1193, which may be a unitary structure made of a rigid polymer or metal, may be shaped to include abore1197 and a pair of upwardly extendingtines1198. Arigid collar1199 may be fixedly mounted withinbore1197 ofcarriage1193 using a pair ofscrews1200.Collar1199 may be internally threaded to engagebolt1192. In this manner, asbolt1192 rotates,carriage1193 moves translationally along the longitudinal axis ofbolt1192, with proximal or distal translational movement ofcarriage1193 effected by the clockwise or counterclockwise rotation, respectively, ofbolt1192.Carriage1193 may be mechanically coupled for translational movement toshaft1051 bytines1198, withtines1198 extending throughslot1135 ofbody1105 and being received within slots1071-1 and1071-2 ofmorcellator assembly1013.
• As can be appreciated from the above description, the speed at whichinner tubular member1077 rotates and the speed at whichinner tubular member1077 oscillates translationally are separately and independently controlled, with the rotation ofinner tubular member1077 being controlled by motor1151 and with the oscillating translation ofinner tubular member1077 being controlled bymotor1181.
• Drive assembly1015 may further comprise abody1201.Body1201, which may be a unitary structure made of a rigid polymer or metal, may be shaped to include adistal end1203, aproximal end1205, aside wall1207, and acavity1208.Distal end1203 may be generally semi-circular in shape, andproximal end1205 may be generally semi-annular in shape.Side wall1207 may be semi-annular in transverse cross-section and may extend fromdistal end1203 toproximal end1205. Alongitudinal groove1209, similar in shape to groove1131 ofbody1105, may be provided along the top, outer surface ofside wall1207 to receive a corresponding portion ofhousing1021 ofmorcellator assembly1013.Cavity1208 may be dimensioned to receive motor1151. A pair oflongitudinal lumens1213 may be provided inbody1201,lumens1213 extending throughdistal end1203,proximal end1205, andside wall1207.Lumens1213 may be aligned with corresponding threaded cavities1215 inbody1105 so thatproximal end1205 ofbody1201 and may be fixed todistal end1107 ofbody1105 usingscrews1217 inserted throughbody1201 and into cavities1215.
• Drive assembly1015 may further comprise alocking clip1221.Locking clip1221, which may be a unitary structure made of a rigid polymer or metal, may be shaped to include abase1223, a pair ofparallel legs1225, and a pair ofparallel feet1227.Legs1225 may extend upwardly from base1223, withlegs1225 being spaced inwardly a short distance from the ends ofbase1223.Feet1227 may extend transversely fromlegs1225.Base1223 may be received within a matingly-shapedrecess1229 provided onbody1105 and may be securely retained withinrecess1229 by securingbody1201 tobody1105. Withclip1221 thus mounted onbody1105,legs1225 extend upwardly beyondbody1105 and may be inserted into corresponding L-shapedslots1230 inhousing1021 ofmorcellator assembly1013. In this manner,clip1221 may be used to reversibly and lockablycouple drive assembly1015 tomorcellator assembly1013. More specifically, to lockablycouple drive assembly1015 tomorcellator assembly1013, one may insertfeet1227 into the proximal portions1230-1 ofslots1230 and may then slidefeet1227 distally to the distal portions1230-2 ofslots1230. To uncoupledrive assembly1015 frommorcellator1013,feet1227 may be slid proximally from distal portions1230-2 to proximal portions1230-1 and may then be removed fromslots1230.
• Drive assembly1015 may further comprise abody1231.Body1231, which may be a unitary structure made of a rigid polymer or metal, may be a generally cylindrical member shaped to include aproximal end1233, adistal end1235, and aside wall1237. Acavity1239 may extend proximally fromdistal end1235,cavity1239 being dimensioned to receive substantially all butfirst end1182 andshaft1183 ofmotor1181. A pair oflongitudinal lumens1241 may be provided inbody1231,lumens1241 extending throughproximal end1233,distal end1235, andside wall1237.Lumens1241 may be aligned with corresponding threaded cavities1242 inbody1105 so thatdistal end1235 ofbody1231 may be fixed toproximal end1109 ofbody1105 usingscrews1243 inserted throughbody1231 and into cavities1242. Agroove1245 may extend longitudinally fromproximal end1233 todistal end1235 along the top surface ofside wall1237.Groove1245 may be aligned withgroove1131 ofbody1105 in order to receive a corresponding portion ofhousing1021 ofmorcellator assembly1013.
• Drive assembly1015 may further comprise anendplate1251.Endplate1251, which may be a unitary structure made of a rigid polymer or metal, may be a generally disc-shaped structure shaped to include aretaining loop1253 at its top. Retainingloop1253 may be dimensioned to receive the proximal end ofhousing1021 ofmorcellator assembly1013. A pair ofopenings1255 may be provided inendplate1251.Openings1255 may be aligned with corresponding threadedcavities1257 inbody1231 so thatendplate1241 may be fixed toproximal end1233 ofbody1231 usingscrews1259 inserted throughendplate1241 and intocavities1257.
• Drive assembly1015 may further comprise acover1261.Cover1261, which may be a unitary structure made of a rigid polymer or metal, may be in the shape of a half-pipe having aproximal end1263 and adistal end1265.Cover1261 may be dimensioned to complementside walls1111 and1207 ofbodies1105 and1201, respectively. In addition,cover1261 may be fixed tobody1105 with ascrew1267 inserted through anopening1269 incover1261 and into acorresponding cavity1271 inproximal end1109 ofbody1105 and with ascrew1273 inserted through anopening1275 incover1261 and into a corresponding cavity1277 indistal end1107 ofbody1105. Additionally,cover1261 may be fixed tobody1201 by joiningcover1261 to ablock1281 using ascrew1283 and by joiningblock1281 todistal end1203 ofbody1201 using a pair ofscrews1285.
• Referring back now toFIG. 27,vacuum assembly1009 may include aspecimen collection container1291 and avacuum source1292. The distal end of an evacuation tube1293 may be inserted over fitting1097 and may be secured thereto by a friction fit, and the proximal end of evacuation tube1293 may be coupled to afirst port1294 ofcontainer1291. The distal end of atube1295 may be coupled to asecond port1296 ofcontainer1291, and the proximal end oftube1295 may be coupled tovacuum source1292. In this manner,vacuum source1292 may be used to apply suction todevice1008, and any withdrawn tissue, liquids or similar matter suctioned throughdevice1008 may be collected incontainer1291.
• Control unit1010, which may be coupled to a source of electricity, such as an AC wall outlet, using a power cord (not shown), may include electronics (not shown) for controlling the operation ofmotors1151 and1181 using a cable1298-1 connected tocables1159 and1189. Afoot pedal1297 may be coupled to control unit1010 by a cable1298-2 and may be used as a power switch to selectively activate or de-activatemotors1151 and1181. Control unit1010 may further include avacuum sensor1299, which may be coupled tocontainer1291 by atube1300, so that the pressure withincontainer1291 may be monitored by control unit1010. In this manner, a sudden increase in vacuum pressure may indicate that a clog has occurred. The presence of a clog may be indicated via an alarm (not shown) located on control unit1010. The detection of a clog is often a clear indication that the further operation ofdevice1008 may only aggravate the clogging situation and that a cessation of tissue removal may be necessary. Control unit1010 may be configured to synchronize actuation ofdrive assembly1015 with actuation ofvacuum source1292. In this manner, turning ondrive assembly1015 will turn onvacuum source1292 at the same time. Correspondingly,vacuum source1292 may be deactivated wheneverdrive assembly1015 is turned off.
• In use, the distal end of a hysteroscope may be inserted transcervically into a patient, and a suitable fluid may be conducted through the inlet fluid port of the hysteroscope into the uterus until the uterus is distended. Observation of the uterus and detection of fibroids or other abnormal gynecological tissues may then be performed using the visualization channel of the hysteroscope. The distal ends ofouter tubular member1076 andinner tubular member1077 may be inserted through a working channel of the hysteroscope and into the uterus, with the remainder ofsystem1007 remaining proximal to the hysteroscope.Device1008 may then be manipulated so thatwindow1089 ofouter tubular member1076 may be positioned in proximity to the fibroid or other targeted tissue. Next,vacuum source1292 may be operated so as to cause suction to be applied toinner tubular member1077, thereby drawing tissue intoouter tubular member1076 throughwindow1089. In addition,motors1151 and1181 may be operated so as to causeinner tubular member1077 simultaneously to rotate and to oscillate back and forth translationally withinouter tubular member1076, thereby causing the tissue drawn throughwindow1089 to be cut. The cut tissue may then be suctioned from the patient throughinner tubular member1077 by means of the aforementioned suction and, thereafter, collected incontainer1291. Once the fibroids or other targeted tissues have thus been removed from the patient,vacuum source1292 andmotors1151 and1181 may be turned off,device1008 may be withdrawn from the hysteroscope, and the hysteroscope may be withdrawn from the patient.Morcellator assembly1013 may then be detached fromdrive assembly1015 and disconnected fromvacuum source1292.Morcellator assembly1013 may be designed to be a single use device and, if so, may be disposed of after being used on a patient. By contrast,drive assembly1015 may be used on a number of different patients prior to its disposal, with adifferent morcellator assembly1013 preferably being used with each patient.
• It should be noted that, although the above-discussion contemplates insertingdevice1008 through the working channel of a hysteroscope, one may insertdevice1008 transcervically into the uterus without the use of a hysteroscope. In such a situation, fluid may be administered transcervically to the uterus by a fluid dispensing device in order to distend the uterus, and, thereafter, observation of the uterus may be accomplished, for example, by ultrasonic imaging using an ultrasonic probe inserted transcervically into the uterus. Such an ultrasonic probe may be separate fromdevice1008 or may be integrated intodevice1008. Alternatively, imaging of the uterus may be performed by MRI imaging.
• Referring now toFIG. 30, there is shown a fragmentary exploded perspective view of an alternate tissue removal device adapted for use insystem1007, said tissue removal device being represented generally byreference numeral1450. For simplicity and clarity, certain aspects ofdevice1450 not important to an understanding of the invention are neither shown nor described herein.
• Device1450 may be similar in most respects todevice1008, the principal differences between the two devices being thatcarriage1193 andtranslational coupling block1061 ofdevice1008 may be replaced withcarriage1461 andtranslational coupling block1463, respectively, ofdevice1450.Carriage1461 ofdevice1450 may be similar in many respects tocarriage1193 ofdevice1008, the principal difference between the two carriages being thatcarriage1461 may include an upwardly biased spring-loadedpin1465.Translational coupling block1463 ofdevice1450 may be similar in many respects totranslation coupling block1061 ofdevice1008, the principal differences between the two blocks being that (i)translation coupling block1463 may be shaped to include acavity1467 adapted to receivepin1465 and (ii)translation coupling block1463 may be shaped to include ramped surfaces1469-1 and1469-2 sloping downwardly towards the open end ofcavity1467 from the proximal and distal ends, respectively, oftranslation coupling block1463. In use, the morcellator assembly, which comprisestranslation coupling block1463, may be attached to the drive assembly, which comprisescarriage1461, and the translational motor ofdevice1008 may be actuated to movecarriage1461 translationally back and forth one complete cycle. Regardless of wherecarriage1461 andtranslational coupling block1463 may be initially positioned translationally relative to one another, ascarriage1461 is moved translationally one complete cycle,pin1465 is automatically assured of being aligned withcavity1467. For example, ifpin1465 is initially positioned proximally relative totranslation coupling block1463, ascarriage1461 is moved distally, the top surface ofpin1465 travels across ramped surface1469-1 and is then received incavity1467. One advantage of this arrangement is thatpin1465 andcavity1467 need not be aligned with one another as the morcellator assembly and the drive assembly are attached to one other. As can be appreciated, because the morcellator assembly may be a single-use item whereas the drive assembly may be a reusable item,pin1465 andcavity1467 may not initially be aligned with one another.
• Referring now toFIGS. 31(a) and31(b), there are shown fragmentary, partially exploded, perspective views of another alternate tissue removal device adapted for use insystem1007, said tissue removal device being represented generally byreference numeral1500. For simplicity and clarity, certain aspects ofdevice1500 not important to an understanding of the invention are neither shown nor described herein.
• Device1500 may comprise amorcellator assembly1513 and adrive assembly1515.Morcellator assembly1513 and driveassembly1515 may be similar in most respects tomorcellator assembly1013 and driveassembly1015, respectively, the principal differences between the respective morcellator assemblies and drive assemblies being thatmorcellator assembly1513 and driveassembly1515 may be detachably matingly secured to one another by means of adetent1517 provided onmorcellator assembly1513 and aslot1519 provided indrive assembly1515. Accordingly, when one wishes to usedevice1500,detent1517 ofmorcellator assembly1513 is preferably inserted intoslot1519 ofdrive assembly1515, thereby physically and operatively coupling togethermorcellator assembly1513 and driveassembly1515.Device1500 may then be used in the same manner discussed above in connection withdevice1008. Afterdevice1500 has been used,morcellator assembly1513 may be separated fromdrive assembly1515, for example, by pulling apart their respective proximal ends untildetent1517 is removed fromslot1519. If desired,morcellator assembly1513 may then be disposed of whereasdrive assembly1515 may be reused.
• Referring now toFIG. 32, there is shown a fragmentary, partially exploded, perspective view of another alternate tissue removal device adapted for use insystem1007, said tissue removal device being represented generally byreference numeral1600. For simplicity and clarity, certain aspects ofdevice1600 not important to an understanding of the invention are neither shown nor described herein.
• Device1600 may comprise amorcellator assembly1613 and adrive assembly1615.Morcellator assembly1613 and driveassembly1615 may be similar in most respects tomorcellator assembly1013 and driveassembly1015, respectively, the principal differences between the respective morcellator assemblies and drive assemblies being thatmorcellator assembly1613 and driveassembly1615 may be detachably secured to one another by means ofhooks1617 provided onmorcellator assembly1613 near its distal end andcorresponding slots1619 provided indrive assembly1615 near its distal end. In addition,drive assembly1615 may further comprise aspring retention member1621 at its proximal end for engaging the proximal end ofmorcellator1613. Accordingly, when one wishes to usedevice1600, hooks1617 ofmorcellator assembly1613 are preferably inserted intoslots1619 ofdrive assembly1615 and then springretention member1621 engages the proximal end ofmorcellator assembly1613, thereby physically and operatively coupling togethermorcellator assembly1613 and driveassembly1615.Device1600 may then be used in the same manner discussed above in connection withdevice1008. Afterdevice1600 has been used,morcellator assembly1613 may be separated fromdrive assembly1615, for example, by pulling apart their respective proximal ends untilhooks1617 are removed fromslots1619. If desired,morcellator assembly1613 may then be disposed of whereasdrive assembly1615 may be reused.
• Referring now toFIG. 33, there is shown a fragmentary, partially exploded, perspective view of another alternate tissue removal device adapted for use insystem1007, said tissue removal device being represented generally byreference numeral1700. For simplicity and clarity, certain aspects ofdevice1700 not important to an understanding of the invention are neither shown nor described herein.
• Device1700 may comprise amorcellator assembly1713 and adrive assembly1715.Morcellator assembly1713 and driveassembly1715 may be similar in many respects tomorcellator assembly1013 and driveassembly1015, respectively, the principal differences between the respective morcellator assemblies and drive assemblies being that (i)morcellator assembly1713 may be shaped to include acavity1717 and (ii)drive assembly1715 may be shaped to be removably received withincavity1717 ofmorcellator assembly1713. (Although not shown,morcellator assembly1713 and/or driveassembly1715 preferably includes a mechanism for releasably retainingdrive assembly1715 withincavity1717.) Accordingly, when one wishes to usedevice1700,drive assembly1715 is preferably inserted intocavity1717 ofmorcellator assembly1713 untilmorcellator assembly1713 and driveassembly1715 are physically and operatively coupled to one another.Device1700 may then be used in the same manner discussed above in connection withdevice1008. Afterdevice1700 has been used,drive assembly1715 may be withdrawn fromcavity1717 ofmorcellator assembly1713. If desired,morcellator assembly1713 may then be disposed of whereasdrive assembly1715 may be reused.
• Although the present invention has been discussed above in the context of removing tissue from within a patient's uterus, it should be understood that there may be situations in which it may be desirable to remove fibroids or other tissue located on the exterior of a patient's uterus or elsewhere within a patient. In such situations, it may be desirable to access the targeted tissue by laparoscopy. Unfortunately, however, one cannot simply apply suction in this type of case to draw the tissue into the resection window of the device because the tissue would not be bathed in a liquid, but rather, would simply be surrounded by air. Therefore, according to the present invention, one approach to this problem is to deliver a suitable material to the targeted tissue, which may then be used, with the application of suction, to create a seal to promote the drawing of the targeted tissue into the resection window of the device. Referring now toFIG. 34, there is shown an embodiment of a device designed for such a purpose, the device being represented generally byreference numeral1800. Certain aspects ofdevice1800 not important to an understanding of the invention are neither shown nor described herein.
• Device1800 may be similar in certain respects todevice6. One difference between the two devices is thatdevice1800 may comprise aninner tubular member1803 and anouter tubular member1805.Inner tubular member1803 andouter tubular member1805 may be similar to innertubular member77 and outertubular member76, respectively, ofdevice6, except that (i)outer tubular member1805 may comprise aport1807 adapted to receive a suitable liquid or gel (e.g., water, glycine, a thixotropic gel, etc.) from a supply (not shown) and (ii)inner tubular member1803 may have an outer diameter that is about 0.005-0.006 inch less than the inner diameter of outer tubular member1805 (as opposed to the about 0.002 inch of device6) to permit the liquid or gel delivered toouter tubular member1805 throughport1807 to be delivered to the targeted tissue through aresection window1809.
• An alternate tissue removal device todevice1800 is shown inFIG. 35, said alternate tissue removal device being represented generally byreference numeral1900. Certain aspects ofdevice1900 not important to an understanding of the invention are neither shown nor described herein.
• Device1900 may be similar in most respects todevice6, the principal difference between the two devices being that, whereasdevice6 may comprise outertubular member76,device1900 may comprise anouter tubular member1903.Outer tubular member1903 may be similar to outertubular member76, except thatouter tubular member1903 may be additionally shaped to include achannel1905 having aproximal input port1907 and adistal output port1909.Input port1907 may be adapted for connection to a supply (not shown) for receipt of a suitable liquid or gel (e.g., water, glycine, a thixotropic gel, etc.).Distal port1909 may be positioned proximate to aresection window1911.
• Referring now toFIGS. 36(a) and36(b), there are shown perspective and enlarged fragmentary perspective views, respectively, of a further embodiment of a tissue removal device constructed according to the teachings of the present invention, said tissue removal device being represented generally byreference numeral2381.
• Tissue removal device2381 may be similar in many respects todevice1008. However, one notable difference between the two devices may be that, whereasdevice1008 may comprise a cutting mechanism includingouter tubular member1076 andinner tubular member1077, both of which may be straight,device2381 may comprise a cutting mechanism including anouter tubular member2383 and aninner tubular member2385, whereinouter tubular member2383 may include abent region2387 andinner tubular member2385 may contain a corresponding compliant section2389.Outer tubular member2383 may be formed into the desired configuration using conventional tooling to provide a fixed bent angle. Alternatively, one may furnish the user with a forming tool that allows the user to form the outer tubular member into any desired angle to ease delivery of the device. Theinner tubular member2385 may include aflexible drive shaft2391 located in the bent region.Flexible drive shaft2391 may be directed around thebent region2387 to transmit torque and translational motion. Such a configuration may enabledevice2381 to more closely mimic the angles of the cervix and uterus and, as a result, make introduction easier. The angled tip may also make direction of the cutting tip easier to direct, especially when trying to access the fallopian regions of the uterus. The tip may be rotated by rotating the entire device, or the device may be provided with arotation knob2392 to permit the cutting mechanism to be rotated relative to the drive assembly. As can be appreciated, any reduction in the time required to direct the device towards the target pathology may reduce overall procedure duration and increase the probability of successful removal of the entire tissue specimen.
• Referring now toFIG. 37, there is shown a fragmentary perspective view of a further embodiment of a tissue removal device constructed according to the teachings of the present invention, said tissue removal device being represented generally byreference numeral2401.
• Tissue removal device2401 may be similar in many respects todevice1008. However, one notable difference between the two devices may be that, whereasdevice1008 may comprise a cutting mechanism includingouter tubular member1076 andinner tubular member1077, both of which may be straight and axially inflexible,device2401 may comprise a cutting mechanism including an outer tube having some axial flexibility and an inner tube having some axial flexibility, the inner tube being independently rotatable and translationally oscillatable within the outer tube. The outer tube may comprise an axially flexibletubular shaft2403 and a rigidtubular tip2405,tip2405 being fixed to the distal end ofshaft2403. (Tip2405 may have an open distal end, which may be sealed with aplug2406.) The inner tube may comprise an axially flexibletubular shaft2407 and a rigidtubular tip2409,tip2409 being fixed to the distal end ofshaft2407.Tubular tip2405 may have a shape similar to the distal portion ofouter tubular member1076 so thatshaft2403 andtip2405 may collectively have a shape corresponding generally to that ofouter tubular member1076.Tubular tip2409 may have a shape similar to the distal end ofinner tubular member1077 so thatshaft2407 andtip2409 may collectively have a shape corresponding generally to that ofinner tubular member1077. Each ofshaft2403 andshaft2407 may be made of a suitable metal, such as Nitinol (nickel-titanium alloy) or Microflex hypo tubing, or may be made of a suitable polymeric material, such as TEFLON® polytetrafluoroethylene, polyamide, polyimide, polyetheretherketones etc.
• Because of its flexible construction,device2401 may provide a cutting mechanism that more closely mimics the access angles of the body in places like the bladder, cervix and uterus. The ability to flex may reduce introduction forces and may reduce the probability of a perforation. In addition, any reduction in the time required to direct the cutting mechanism towards the target pathology may reduce overall procedure duration and increase the probability of successful removal of the entire targeted tissue.
• Referring now toFIG. 38, there is shown a fragmentary perspective view of a further embodiment of a tissue removal device constructed according to the teachings of the present invention, said tissue removal device being represented generally byreference numeral2421.Device2421 may be similar in many respects todevice2401,device2421 differing principally fromdevice2401 in thatdevice2421 may additionally comprise a pair ofpull wires2422 and2423. Pullwires2422 and2423, which may be used to flexshaft2403 at a desired angle, may be fixed at their respective distal ends toshaft2403 and may be fixed at their respective proximal ends to a spring-torsioned, rotatable hub (not shown). Because of its own flexibility,shaft2407 will bend to accommodate the deflection ofshaft2403.
• The embodiments of the present invention described above are intended to be merely exemplary and those skilled in the art shall be able to make numerous variations and modifications to it without departing from the spirit of the present invention. All such variations and modifications are intended to be within the scope of the present invention as defined in the appended claims.

Claims (20)

1. A tissue removal device comprising:

a housing having a distal end and a proximal end;

an outer tube having a distal end and a proximal end, the proximal end of the outer tube supported by the housing, the outer tube configured for transcervical insertion, the outer tube having an opening at the distal end of the outer tube;

an inner tube being hollow and comprising a first material, the inner tube being disposed within the outer tube and configured to be slidable and rotatable relative to the outer tube, wherein the inner tube is sufficiently flexible to bend in conformity with a bend in the outer tube while rotating within the outer tube;

a distal tip element comprising a second material, the distal tip element attached to a distal end of the inner tube so that distal tip element moves rotationally and translationally across the side opening to sever tissue extending therethrough;

wherein the second material comprises a hardness that exceeds the hardness of the first material by a Rockwell C hardness of at least about 10.

2. The tissue removal device ofclaim 1, wherein the second material comprises a Rockwell C hardness of at least about 50.

3. The tissue removal device ofclaims 1, wherein the second material comprises a Rockwell C hardness of at least about 60.

4. The tissue removal device ofclaims 1, wherein the second material comprises a hardness that exceeds the hardness of the first material by a Rockwell C hardness of at least about 20.

5. The tissue removal device ofclaims 1, further comprising an assembly configured to drive the inner tube.

6. The tissue removal device ofclaims 1, wherein the distal tip element comprises a longitudinal length greater than the longitudinal length of the opening of the outer tube.

7. The tissue removal device ofclaim 6, wherein the longitudinal length of the distal tip element is less than 2 inches.

8. The tissue removal device ofclaim 6, wherein the longitudinal length of the distal tip element is about 1 inch.

9. The tissue removal device ofclaims 1, wherein the distal tip element comprises a sharpened cutting edge.

10. The tissue removal device ofclaims 1, the distal tip having a proximal end and a distal end, the proximal end of the distal tip having a diameter greater than the diameter of the distal end of the distal tip.

11. A method for removing intrauterine tissue comprising:

inserting transcervically into a uterus, an outer tube having a distal end and a proximal end, the proximal end of the outer tube supported by a distal end of a housing, the outer tube having a side opening at the distal end of the outer tube;

rotating and translating an inner tube disposed within the outer tube, the inner tube comprising a first material, the inner tube being hollow, the inner tube disposed within the outer tube, the inner tube configured to be slidable and rotatable relative to the outer tube, the inner tube being sufficiently flexible so as to bend in conformity with a bend in the outer tube while rotating within the outer tube;

severing with a sharpened distal tip element, tissue extending into the outer tube through the side opening, the distal tip element comprising a second material, the distal tip element attached to a distal end of the inner tube so that distal tip element moves rotationally and translationally across the side opening;

wherein the second material comprises a hardness that exceeds the hardness of the first material by a Rockwell C hardness of at least about 10.

12. The method for removing intrauterine tissue ofclaim 11, wherein the second material comprises a Rockwell C hardness of at least about 50.

13. The method for removing intrauterine tissue ofclaim 11, wherein the second material comprises a Rockwell C hardness of at least about 60.

14. The method for removing intrauterine tissue ofclaim 11, wherein the second material comprises a hardness that exceeds the hardness of the first material by a Rockwell C hardness of at least about 20.

15. The method for removing intrauterine tissue ofclaim 11, further comprising an assembly configured to drive the inner tube.

16. The method for removing intrauterine tissue ofclaim 11, wherein the distal tip element comprises a longitudinal length greater than the longitudinal length of the side opening of the outer tube.

17. The method for removing intrauterine tissue ofclaim 16, wherein the longitudinal length of the distal tip element is less than 2 inches.

18. The method for removing intrauterine tissue ofclaim 11, wherein the longitudinal length of the distal tip element comprises a cutting edge.

19. The method for removing intrauterine tissue ofclaim 11, the distal tip having a proximal end and a distal end, the proximal end of the distal tip having a diameter greater than the diameter of the distal end of the distal tip.

20. The method for removing intrauterine tissue ofclaim 11, wherein the distal tip has a uniform diameter over an entire length of the distal tip.

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